<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03022981</url>
  </required_header>
  <id_info>
    <org_study_id>GS-US-342-1143</org_study_id>
    <secondary_id>2016-002446-23</secondary_id>
    <nct_id>NCT03022981</nct_id>
  </id_info>
  <brief_title>Study to Investigate the Safety and Efficacy of Sofosbuvir/Velpatasvir in Adolescents and Children With Chronic HCV Infection</brief_title>
  <official_title>A Phase 2, Open-Label, Multicenter, Multi-cohort Study to Investigate the Safety and Efficacy of Sofosbuvir/Velpatasvir in Adolescents and Children With Chronic HCV Infection</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Gilead Sciences</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Gilead Sciences</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study will have 2 parts: Pharmacokinetics (PK) Lead-in Phase and the Treatment Phase.&#xD;
&#xD;
      The primary objective of the PK Lead-in Phase is to evaluate the steady state PK and confirm&#xD;
      the dose of sofosbuvir/velpatasvir (SOF/VEL) fixed-dose combination (FDC) in pediatric&#xD;
      participants with chronic hepatitis C virus (HCV) infection.&#xD;
&#xD;
      The primary objective of the Treatment Phase is to evaluate the safety and tolerability of&#xD;
      SOF/VEL for 12 weeks in pediatric participants with chronic HCV.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 26, 2017</start_date>
  <completion_date type="Actual">February 26, 2020</completion_date>
  <primary_completion_date type="Actual">November 19, 2019</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>PK Lead-in Phase: AUCtau: Area Under the Plasma Concentration Versus Time Curve Over the Dosing Interval of Velpatasvir (VEL)</measure>
    <time_frame>Day 7: 0 (predose), 0.5, 1, 2, 3, 4, 6 (Cohorts 1 and 2 only), 8, and 12 hours postdose</time_frame>
    <description>AUCtau is defined as concentration of drug over time (the area under the concentration versus time curve over the dosing interval).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>PK Lead-in Phase: AUCtau: Area Under the Plasma Concentration Versus Time Curve Over the Dosing Interval of Sofosbuvir (SOF)</measure>
    <time_frame>Day 7: 0 (predose), 0.5, 1, 2, 3, 4, 6 (Cohorts 1 and 2 only), 8, and 12 hours postdose</time_frame>
    <description>AUCtau is defined as concentration of drug over time (the area under the concentration versus time curve over the dosing interval).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>PK Lead-in Phase: AUCtau: Area Under the Plasma Concentration Versus Time Curve Over the Dosing Interval of GS-331007 (Metabolite of SOF)</measure>
    <time_frame>Day 7: 0 (predose), 0.5, 1, 2, 3, 4, 6 (Cohorts 1 and 2 only), 8, and 12 hours postdose</time_frame>
    <description>AUCtau is defined as concentration of drug over time (the area under the concentration verses time curve over the dosing interval).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Treatment Phase: Percentage of Participants Who Discontinued Study Drug Due to Any Treatment-Emergent Adverse Event (TEAE)</measure>
    <time_frame>From first dose through last dose of the study drug (Up to 12 weeks) plus 30 days</time_frame>
    <description>An AE is any untoward medical occurrence in a clinical study participant administered a medicinal product, which does not necessarily have a causal relationship with the treatment. An AE can therefore be any unfavorable and/or unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. TEAEs were defined as 1 or both of the following: Any AEs with an onset date on or after the study drug start date and no later than 30 days after permanent discontinuation of study drug and/or Any AEs leading to premature discontinuation of study drug.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>PK Lead-in Phase: Change From Baseline in Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) at Day 7</measure>
    <time_frame>Baseline; Day 7</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>PK Lead-in Phase: Percentage of Participants Who Permanently Discontinued Study Drug Due to an Adverse Event (AE)</measure>
    <time_frame>First dose date up to Day 7</time_frame>
    <description>An AE is any untoward medical occurrence in a clinical study participant administered a medicinal product, which does not necessarily have a causal relationship with the treatment. An AE can therefore be any unfavorable and/or unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Treatment Phase: Percentage of Participants With Sustained Virologic Response (SVR) at 12 Weeks After Discontinuation of Therapy (SVR12)</measure>
    <time_frame>Posttreatment Week 12</time_frame>
    <description>SVR12 was defined as HCV RNA &lt; the lower limit of quantitation (LLOQ; ie, 15 IU/mL) at 12 weeks after stopping study treatment.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Treatment Phase: Percentage of Participants With SVR at 4 Weeks After Discontinuation of Therapy (SVR4)</measure>
    <time_frame>Posttreatment Week 4</time_frame>
    <description>SVR4 was defined as HCV RNA &lt; LLOQ (ie, 15 IU/mL) at 4 weeks after stopping study treatment.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Treatment Phase: Percentage of Participants With SVR at 24 Weeks After Discontinuation of Therapy (SVR24)</measure>
    <time_frame>Posttreatment Week 24</time_frame>
    <description>SVR 24 was defined as HCV RNA &lt; LLOQ (ie, 15 IU/mL) at 24 weeks after stopping study treatment.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Treatment Phase: Percentage of Participants With Virologic Failure</measure>
    <time_frame>Up to Posttreatment Week 24</time_frame>
    <description>Virologic failure was defined as: On-treatment virologic failure - Breakthrough (confirmed HCV RNA ≥ LLOQ after having previously had HCV RNA &lt; LLOQ while on treatment), or Rebound (confirmed &gt; 1 log10 IU/mL increase in HCV RNA from nadir while on treatment), or Non-response (HCV RNA persistently ≥ LLOQ through 8 weeks of treatment); Virologic relapse: Confirmed HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA &lt; LLOQ at last on-treatment visit.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Treatment Phase: Percentage of Participants With HCV RNA &lt; LLOQ On Treatment</measure>
    <time_frame>Weeks 1, 4, 8, and 12</time_frame>
    <description>Percentage of participants with HCV RNA &lt; LLOQ while on treatment by analysis visit.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Treatment Phase: Percentage of Participants Who Develop Viral Resistance to SOF and/or VEL During Treatment and After Discontinuation of Treatment</measure>
    <time_frame>First dose date up to Posttreatment Week 24</time_frame>
    <description>Drug-resistant substitutions were analyzed as part of the Virology Study. Plasma samples were collected and stored for potential HCV sequencing. Impact on the treatment outcomes of SVR12 and SVR24 were observed during the study. Baseline deep sequencing of the HCV nonstructural protein (NS)5A and NS5B genes was performed for all participants at the first time point after virologic failure if the plasma or serum sample was available. Pretreatment full-length NS5A deep sequencing data were obtained at a 15% assay cutoff for the Resistance Analysis Population which covered all NS5A and NS5B nucleoside inhibitor (NI) resistance-associated variants (RAVs).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Treatment Phase: Change From Baseline in HCV RNA at Weeks 1, 4, 8, and 12</measure>
    <time_frame>Baseline; Weeks 1, 4, 8, and 12</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Treatment Phase: Quality of Life (QoL) and Neuropsychiatric Assessments as Measured by PedsQL™ Pediatric QoL Survey</measure>
    <time_frame>Baseline; Week 12, End of Treatment (EOT), Posttreatment/Follow-up (FU) Week-12 (FU-12), and FU Week-24 (FU-24)</time_frame>
    <description>To evaluate the effect of treatment with SOF/VEL on general and disease-specific health-related QoL, the PedsQL™ Pediatric QoL Inventory V4.0 Short Form (SF15) was completed at Day 1, end of treatment, early termination (if applicable), and posttreatment Weeks 12 and 24. The SF15 questionnaire represented 4 domains: physical, emotional, social, and school functioning, with the emotional, social, and school functioning domains representing the psychosocial health summary. Neuropsychiatric assessment was conducted using the PedsQL™ Pediatric QoL Inventory V4.0 SF15 psychosocial domain-related scores. Items were calculated and transformed into an overall score with a range of 0 to 100 points, with more points indicating better QoL.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Treatment Phase: Change From Baseline in Growth and Development as Measured by Height Percentiles</measure>
    <time_frame>Baseline; Weeks 1, 4, 8, 12, Follow-up (FU) Week 4 (FU-4), FU-12, and FU-24</time_frame>
    <description>An age- and sex-specific percentile was derived for each weight, height, and body mass index (BMI) measurement according to the statistical analysis system (SAS) program available on the Centers for Disease Control and Prevention (CDC) website using the year 2000 growth charts.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Treatment Phase: Change From Baseline in Growth and Development as Measured by Weight Percentiles</measure>
    <time_frame>Baseline; Weeks 1, 4, 8, 12, FU-4, FU-12, and FU-24</time_frame>
    <description>An age- and sex-specific percentile was derived for each weight, height, and BMI measurement according to the SAS program available on the CDC website using the year 2000 growth charts.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Treatment Phase: Changes in Growth and Development as Measured by Tanner Stage Assessment From Baseline</measure>
    <time_frame>Baseline; EOT, FU-12 and FU-24</time_frame>
    <description>Tanner Pubertal Staging was assessed for pubic hair growth and genitalia development (males) and for pubic hair growth and breast development (females) in stages 1 to 5. Tanner stages were used to evaluate the onset and progression of pubertal changes from stage 1 (pre-pubertal) to stage 5 (adult). If a participant had reached Tanner stage 5, no further Tanner pubertal stage assessments were to be completed. Pubic hair growth: Tanner stages (1: No hair, 2: Downy hair, 3: More coarse and curly hair, 4: Adult-like hair quality; 5: Hair extends to the medial surface of the thighs); Breast development: Tanner stages (1: No glandular tissue, 2: Breast bud forms,3: More elevated, outside areola, 4: Increased breast size,5: Final adult-size breasts); Genitalia development: Tanner stages (1: Testes, scrotum, and penis about same size, 2: Enlargement of scrotum, testes and penis, 3: Enlargement of penis, 4: Penis size enlargement, 5: Genitalia adult in size and shape).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Treatment Phase: Growth and Development as Measured by Parental Height</measure>
    <time_frame>Day 1</time_frame>
    <description>Mid-parental height was calculated as the average of the biological father's and mother's heights. For boys, the sex-adjusted mid-parental height was calculated by adding 2.5 inches or 6.5 cm to the mean of the parents' heights. For girls, 2.5 inches or 6.5 cm was subtracted from the mean of the parents' heights.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Treatment Phase: Change From Baseline in Growth and Development as Measured by Bone Age</measure>
    <time_frame>Baseline; FU-24</time_frame>
    <description>Bone age was determined based on x-ray of the left wrist, hand, and fingers. Baseline value is the last available value on or prior to first dose date of study drug.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Treatment Phase: Swallowability of SOF/VEL as Assessed by the Participant's Ability to Swallow SOF/VEL Placebo Tablets at Baseline</measure>
    <time_frame>Baseline</time_frame>
    <description>A SOF/VEL FDC swallowability assessment was performed using placebo tablets at baseline.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Treatment Phase: Number of Participants With Acceptability of SOF/VEL as Measured by a Questionnaire to Assess Acceptability, Including Palatability at Day 1</measure>
    <time_frame>Day 1</time_frame>
    <description>Acceptability was assessed by numeric response marked on line between numbers 0 - 100. Higher scores indicate better acceptability and/or palatability.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Treatment Phase: Number of Participants With Acceptability of SOF/VEL as Measured by a Questionnaire to Assess Acceptability, Including Palatability at Week 12</measure>
    <time_frame>Week 12</time_frame>
    <description>Acceptability was assessed by numeric response marked on line between numbers 0 - 100. Higher scores indicate better acceptability and/or palatability.</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">216</enrollment>
  <condition>Hepatitis C Virus Infection</condition>
  <arm_group>
    <arm_group_label>12 to &lt; 18 Years Old</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>PK Lead-in Phase: Sofosbuvir/Velpatasvir (SOF/VEL) 400/100 mg once daily for 7 days. Participants who complete the PK lead-in phase, continue into the treatment phase with no interruption of study drug administration and additional participants will be enrolled into the treatment phase once the appropriateness of the dose is confirmed by PK results from the PK lead-in phase.&#xD;
Treatment Phase: SOF/VEL 400/100 mg once daily for 12 weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>6 to &lt; 12 Years Old</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>PK Lead-in Phase: SOF/VEL 200/50 mg once daily for 7 days. Participants who complete the PK lead-in phase, continue into the treatment phase with no interruption of study drug administration and additional participants will be enrolled into the treatment phase once the appropriateness of the dose is confirmed by PK results from the PK lead-in phase.&#xD;
Treatment Phase: SOF/VEL 200/50 mg once daily for 12 weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>3 to &lt; 6 Years Old</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>PK Lead-in Phase: SOF/VEL 200/50 mg once daily for 7 days for participants who weigh ≥ 17 kg. SOF/VEL 150/37.5 mg once daily for 7 days for participants who weigh &lt; 17 kg. Participants who complete the PK lead-in phase, continue into the treatment phase with no interruption of study drug administration and additional participants will be enrolled into the treatment phase once the appropriateness of the dose is confirmed by PK results from the PK lead-in phase.&#xD;
Treatment Phase: SOF/VEL 200/50 mg once daily for 12 weeks for participants who weigh ≥ 17 kg. SOF/VEL 150/37.5 mg once daily for 12 weeks for participants who weigh &lt; 17 kg.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>SOF/VEL</intervention_name>
    <description>SOF/VEL fixed-dose combination (FDC) 400/100 mg tablets or SOF/VEL FDC 200/50 mg tablets (based on swallowability assessment)</description>
    <arm_group_label>12 to &lt; 18 Years Old</arm_group_label>
    <arm_group_label>6 to &lt; 12 Years Old</arm_group_label>
    <other_name>Epclusa®</other_name>
    <other_name>GS-7977/GS-5816</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>SOF/VEL</intervention_name>
    <description>SOF/VEL FDC 200/50 mg oral granules</description>
    <arm_group_label>3 to &lt; 6 Years Old</arm_group_label>
    <other_name>Epclusa®</other_name>
    <other_name>GS-7977/GS-5816</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Key Inclusion Criteria:&#xD;
&#xD;
          -  Chronic HCV-infected, treatment-naive and treatment-experienced adolescent and&#xD;
             pediatric individuals aged 3 to &lt; 18 as determined at Day 1.&#xD;
&#xD;
        Note: Other protocol defined Inclusion/Exclusion criteria may apply.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>3 Years</minimum_age>
    <maximum_age>17 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Gilead Study Director</last_name>
    <role>Study Director</role>
    <affiliation>Gilead Sciences</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Children's Hospital Los Angeles</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90027</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of California, San Francisco</name>
      <address>
        <city>San Francisco</city>
        <state>California</state>
        <zip>94158</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Children's Hospital of Colorado</name>
      <address>
        <city>Aurora</city>
        <state>Colorado</state>
        <zip>80045</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Children's National Medical Center</name>
      <address>
        <city>Washington</city>
        <state>District of Columbia</state>
        <zip>20010</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Florida Shands Medical</name>
      <address>
        <city>Gainesville</city>
        <state>Florida</state>
        <zip>32610</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Florida Gastroenterology Care for Children</name>
      <address>
        <city>Orlando</city>
        <state>Florida</state>
        <zip>32803</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Emory Children's Center</name>
      <address>
        <city>Atlanta</city>
        <state>Georgia</state>
        <zip>30322</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Riley Hospital for Children</name>
      <address>
        <city>Indianapolis</city>
        <state>Indiana</state>
        <zip>46202</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kosair Charities Pediatric Clinical Research Unit</name>
      <address>
        <city>Louisville</city>
        <state>Kentucky</state>
        <zip>40202</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Johns Hopkins University (JHU) - The Johns Hopkins Hospital (JHH)</name>
      <address>
        <city>Baltimore</city>
        <state>Maryland</state>
        <zip>21287</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Boston Children's Hospital</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02115</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Children's Mercy Hospital</name>
      <address>
        <city>Kansas City</city>
        <state>Missouri</state>
        <zip>64108</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Children's Hospital &amp; Medical Center</name>
      <address>
        <city>Omaha</city>
        <state>Nebraska</state>
        <zip>68198-5331</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mount Sinai Medical Center</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10029</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cincinnati Children's Hospital Medical Center</name>
      <address>
        <city>Cincinnati</city>
        <state>Ohio</state>
        <zip>45229</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nationwide Children's Hospital- The Ohio State University (OSU)</name>
      <address>
        <city>Columbus</city>
        <state>Ohio</state>
        <zip>43205</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Children's Hospital of Philadelphia</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19104</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Monroe Carell Jr. Children's Hospital at Vanderbilt</name>
      <address>
        <city>Nashville</city>
        <state>Tennessee</state>
        <zip>37232</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cook Children's Medical Center</name>
      <address>
        <city>Fort Worth</city>
        <state>Texas</state>
        <zip>76104</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Baylor College of Medicine</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77030</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Seattle Children's Hospital</name>
      <address>
        <city>Seattle</city>
        <state>Washington</state>
        <zip>98105</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cliniques Universitaires Saint Luc</name>
      <address>
        <city>Brussels</city>
        <zip>1200</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Azienda Ospedaliero-Universitaria di Bologna - Policlinico S. Orsola - Malpighi</name>
      <address>
        <city>Bologna</city>
        <zip>40138</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Azienda Ospedaliera Universitaria Meyer</name>
      <address>
        <city>Firenze</city>
        <zip>50139</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ospedale Casa Sollievo della Sofferenza</name>
      <address>
        <city>San Giovanni Rotondo</city>
        <zip>71013</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Leeds Teaching Hospitals NHS Trust</name>
      <address>
        <city>Leeds</city>
        <state>England</state>
        <zip>LS1 3EX</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>King's College Hospital NHS Trust</name>
      <address>
        <city>London</city>
        <state>England</state>
        <zip>SE5 9RS</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Belgium</country>
    <country>Italy</country>
    <country>United Kingdom</country>
    <country>United States</country>
  </location_countries>
  <results_reference>
    <citation>Jonas MM, Romero R, Sokal EM, Rosenthal P, Verucchi G, Lin CH, et al. The Safety and Efficacy of Sofosbuvir/Velpatasvir in Pediatric Patients 6 to &lt; 18 years old with Chronic Hepatitis C Infection [Abstract]. AASLD; 2019 08-12 November; Boston, Massachusetts.</citation>
  </results_reference>
  <verification_date>October 2020</verification_date>
  <study_first_submitted>January 13, 2017</study_first_submitted>
  <study_first_submitted_qc>January 13, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 18, 2017</study_first_posted>
  <results_first_submitted>August 24, 2020</results_first_submitted>
  <results_first_submitted_qc>October 5, 2020</results_first_submitted_qc>
  <results_first_posted type="Actual">October 8, 2020</results_first_posted>
  <last_update_submitted>October 5, 2020</last_update_submitted>
  <last_update_submitted_qc>October 5, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">October 8, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Infections</mesh_term>
    <mesh_term>Communicable Diseases</mesh_term>
    <mesh_term>Hepatitis C</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Sofosbuvir</mesh_term>
    <mesh_term>Sofosbuvir-velpatasvir drug combination</mesh_term>
    <mesh_term>Velpatasvir</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Qualified external researchers may request IPD for this study after study completion. For more information, please visit our website at https://www.gilead.com/science-and-medicine/research/clinical-trials-transparency-and-data-sharing-policy</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_time_frame>18 months after study completion</ipd_time_frame>
    <ipd_access_criteria>A secured external environment with username, password, and RSA code.</ipd_access_criteria>
    <ipd_url>https://www.gilead.com/science-and-medicine/research/clinical-trials-transparency-and-data-sharing-policy</ipd_url>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>June 15, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/81/NCT03022981/Prot_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>April 20, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/81/NCT03022981/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Participants were enrolled at 28 study sites in Belgium, Italy, the United Kingdom, and the United States. The first participant was screened on 26 January 2017. The last study visit occurred on 26 February 2020.</recruitment_details>
      <pre_assignment_details>221 participants were screened.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>12 to &lt; 18 Years Old</title>
          <description>Pharmacokinetic (PK) Lead-in Phase: Sofosbuvir/Velpatasvir (SOF/VEL) fixed-dose combination (FDC) 400/100 mg tablets once daily for 7 days. Participants who completed the PK lead-in phase, continued into the treatment phase with no interruption of study drug administration and additional participants were enrolled into the treatment phase once the appropriateness of the dose was confirmed by PK results from the PK lead-in phase.&#xD;
Treatment Phase: SOF/VEL 400/100 mg (adult and smaller size tablets based on swallowability assessment) once daily for 12 weeks.</description>
        </group>
        <group group_id="P2">
          <title>6 to &lt; 12 Years Old</title>
          <description>PK Lead-in Phase: SOF/VEL FDC 200/50 mg tablets or oral granules once daily for 7 days. Participants who completed the PK lead-in phase, continued into the treatment phase with no interruption of study drug administration and additional participants were enrolled into the treatment phase once the appropriateness of the dose was confirmed by PK results from the PK lead-in phase.&#xD;
Treatment Phase: SOF/VEL FDC 200/50 mg tablets or oral granules once daily for 12 weeks.</description>
        </group>
        <group group_id="P3">
          <title>3 to &lt; 6 Years Old</title>
          <description>PK Lead-in Phase: SOF/VEL FDC 200/50 mg oral granules once daily for 7 days for participants who weighed ≥ 17 kg. SOF/VEL FDC 150/37.5 mg oral granules once daily for 7 days for participants who weighed &lt; 17 kg. Participants who completed the PK lead-in phase, continued into the treatment phase with no interruption of study drug administration and additional participants were enrolled into the treatment phase once the appropriateness of the dose was confirmed by PK results from the PK lead-in phase.&#xD;
Treatment Phase: SOF/VEL FDC 200/50 mg oral granules once daily for 12 weeks for participants who weighed ≥ 17 kg. SOF/VEL FDC 150/37.5 mg oral granules once daily for 12 weeks for participants who weighed &lt; 17 kg.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="102"/>
                <participants group_id="P2" count="73"/>
                <participants group_id="P3" count="41"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Participated in PK Lead-in (PKL) Phase</title>
              <participants_list>
                <participants group_id="P1" count="17">All 17 participants completed treatment in the PK Lead-in phase and continued into treatment phase.</participants>
                <participants group_id="P2" count="20">All 20 participants completed treatment in the PK Lead-in phase and continued into treatment phase.</participants>
                <participants group_id="P3" count="19">All 19 participants completed treatment in the PK Lead-in phase and continued into treatment phase.</participants>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="96"/>
                <participants group_id="P2" count="69"/>
                <participants group_id="P3" count="35"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="6"/>
                <participants group_id="P2" count="4"/>
                <participants group_id="P3" count="6"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Investigator's Discretion</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="6"/>
                <participants group_id="P2" count="2"/>
                <participants group_id="P3" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Non-Compliance With Study Drug</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrew Assent By Parent/Guardian</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>The Safety Analysis Set included all participants who were enrolled into the study and received at least 1 dose of study drug (SOF/VEL FDC).</population>
      <group_list>
        <group group_id="B1">
          <title>12 to &lt; 18 Years Old</title>
          <description>PK Lead-in Phase: Sofosbuvir/Velpatasvir (SOF/VEL) fixed-dose combination (FDC) 400/100 mg tablets once daily for 7 days. Participants who completed the PK lead-in phase, continued into the treatment phase with no interruption of study drug administration and additional participants were enrolled into the treatment phase once the appropriateness of the dose was confirmed by PK results from the PK lead-in phase.&#xD;
Treatment Phase: SOF/VEL 400/100 mg (adult and smaller size tablets based on swallowability assessment) once daily for 12 weeks.</description>
        </group>
        <group group_id="B2">
          <title>6 to &lt; 12 Years Old</title>
          <description>PK Lead-in Phase: SOF/VEL FDC 200/50 mg tablets or oral granules once daily for 7 days. Participants who completed the PK lead-in phase, continued into the treatment phase with no interruption of study drug administration and additional participants were enrolled into the treatment phase once the appropriateness of the dose was confirmed by PK results from the PK lead-in phase.&#xD;
Treatment Phase: SOF/VEL FDC 200/50 mg tablets or oral granules once daily for 12 weeks.</description>
        </group>
        <group group_id="B3">
          <title>3 to &lt; 6 Years Old</title>
          <description>PK Lead-in Phase: SOF/VEL FDC 200/50 mg oral granules once daily for 7 days for participants who weighed ≥ 17 kg. SOF/VEL FDC 150/37.5 mg oral granules once daily for 7 days for participants who weighed &lt; 17 kg. Participants who completed the PK lead-in phase, continued into the treatment phase with no interruption of study drug administration and additional participants were enrolled into the treatment phase once the appropriateness of the dose was confirmed by PK results from the PK lead-in phase.&#xD;
Treatment Phase: SOF/VEL FDC 200/50 mg oral granules once daily for 12 weeks for participants who weighed ≥ 17 kg. SOF/VEL FDC 150/37.5 mg oral granules once daily for 12 weeks for participants who weighed &lt; 17 kg.</description>
        </group>
        <group group_id="B4">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="102"/>
            <count group_id="B2" value="73"/>
            <count group_id="B3" value="41"/>
            <count group_id="B4" value="216"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="15" spread="1.9"/>
                    <measurement group_id="B2" value="8" spread="1.6"/>
                    <measurement group_id="B3" value="4" spread="0.8"/>
                    <measurement group_id="B4" value="10" spread="4.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="52"/>
                    <measurement group_id="B2" value="38"/>
                    <measurement group_id="B3" value="24"/>
                    <measurement group_id="B4" value="114"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="50"/>
                    <measurement group_id="B2" value="35"/>
                    <measurement group_id="B3" value="17"/>
                    <measurement group_id="B4" value="102"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race/Ethnicity, Customized</title>
          <description>Not Permitted = local requirements did not permit collection of race or ethnicity information.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Race</title>
              <category_list>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="74"/>
                    <measurement group_id="B2" value="66"/>
                    <measurement group_id="B3" value="32"/>
                    <measurement group_id="B4" value="172"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="9"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="3"/>
                    <measurement group_id="B4" value="16"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="11"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="12"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Other</title>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="5"/>
                    <measurement group_id="B4" value="12"/>
                  </measurement_list>
                </category>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Permitted</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race/Ethnicity, Customized</title>
          <description>Not Permitted = local requirements did not permit collection of race or ethnicity information.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Ethnicity</title>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="14"/>
                    <measurement group_id="B2" value="7"/>
                    <measurement group_id="B3" value="4"/>
                    <measurement group_id="B4" value="25"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="83"/>
                    <measurement group_id="B2" value="64"/>
                    <measurement group_id="B3" value="36"/>
                    <measurement group_id="B4" value="183"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Permitted</title>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="77"/>
                    <measurement group_id="B2" value="57"/>
                    <measurement group_id="B3" value="38"/>
                    <measurement group_id="B4" value="172"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Italy</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="17"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="2"/>
                    <measurement group_id="B4" value="24"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>United Kingdom</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="9"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Belgium</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>PK Lead-in Phase: AUCtau: Area Under the Plasma Concentration Versus Time Curve Over the Dosing Interval of Velpatasvir (VEL)</title>
        <description>AUCtau is defined as concentration of drug over time (the area under the concentration versus time curve over the dosing interval).</description>
        <time_frame>Day 7: 0 (predose), 0.5, 1, 2, 3, 4, 6 (Cohorts 1 and 2 only), 8, and 12 hours postdose</time_frame>
        <population>The Lead-in Phase Pharmacokinetic (PK) Analysis Set included all PK lead-in phase participants with available data who received at least 1 dose of study drug and whom at least one non-missing PK concentration data value is available from the PK Lead-in Phase intensive sampling.</population>
        <group_list>
          <group group_id="O1">
            <title>12 to &lt; 18 Years Old</title>
            <description>PK Lead-in Phase: Sofosbuvir/Velpatasvir (SOF/VEL) fixed-dose combination (FDC) 400/100 mg tablets once daily for 7 days.</description>
          </group>
          <group group_id="O2">
            <title>6 to &lt; 12 Years Old</title>
            <description>PK Lead-in Phase: SOF/VEL FDC 200/50 mg tablets or oral granules once daily for 7 days.</description>
          </group>
          <group group_id="O3">
            <title>3 to &lt; 6 Years Old</title>
            <description>PK Lead-in Phase: SOF/VEL FDC 200/50 mg oral granules once daily for 7 days for participants who weighed ≥ 17 kg. SOF/VEL FDC 150/37.5 mg oral granules once daily for 7 days for participants who weighed &lt; 17 kg.</description>
          </group>
        </group_list>
        <measure>
          <title>PK Lead-in Phase: AUCtau: Area Under the Plasma Concentration Versus Time Curve Over the Dosing Interval of Velpatasvir (VEL)</title>
          <description>AUCtau is defined as concentration of drug over time (the area under the concentration versus time curve over the dosing interval).</description>
          <population>The Lead-in Phase Pharmacokinetic (PK) Analysis Set included all PK lead-in phase participants with available data who received at least 1 dose of study drug and whom at least one non-missing PK concentration data value is available from the PK Lead-in Phase intensive sampling.</population>
          <units>hours*nanograms per milliliter (h*ng/mL)</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="16"/>
                <count group_id="O2" value="17"/>
                <count group_id="O3" value="18"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4479.3" spread="2105.66"/>
                    <measurement group_id="O2" value="3697.5" spread="1653.25"/>
                    <measurement group_id="O3" value="4450.3" spread="3285.75"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>PK Lead-in Phase: AUCtau: Area Under the Plasma Concentration Versus Time Curve Over the Dosing Interval of Sofosbuvir (SOF)</title>
        <description>AUCtau is defined as concentration of drug over time (the area under the concentration versus time curve over the dosing interval).</description>
        <time_frame>Day 7: 0 (predose), 0.5, 1, 2, 3, 4, 6 (Cohorts 1 and 2 only), 8, and 12 hours postdose</time_frame>
        <population>Participants in the Lead-in Phase PK Analysis Set with available data were analyzed.</population>
        <group_list>
          <group group_id="O1">
            <title>12 to &lt; 18 Years Old</title>
            <description>PK Lead-in Phase: SOF/VEL FDC 400/100 mg tablets once daily for 7 days.</description>
          </group>
          <group group_id="O2">
            <title>6 to &lt; 12 Years Old</title>
            <description>PK Lead-in Phase: SOF/VEL FDC 200/50 mg tablets or oral granules once daily for 7 days.</description>
          </group>
          <group group_id="O3">
            <title>Cohort 3 (3 to &lt; 6 Years Old)</title>
            <description>PK Lead-in Phase: SOF/VEL FDC 200/50 mg oral granules once daily for 7 days for participants who weighed ≥ 17 kg. SOF/VEL FDC 150/37.5 mg oral granules once daily for 7 days for participants who weighed &lt; 17 kg.</description>
          </group>
        </group_list>
        <measure>
          <title>PK Lead-in Phase: AUCtau: Area Under the Plasma Concentration Versus Time Curve Over the Dosing Interval of Sofosbuvir (SOF)</title>
          <description>AUCtau is defined as concentration of drug over time (the area under the concentration versus time curve over the dosing interval).</description>
          <population>Participants in the Lead-in Phase PK Analysis Set with available data were analyzed.</population>
          <units>h*ng/mL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="16"/>
                <count group_id="O2" value="17"/>
                <count group_id="O3" value="17"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3020.1" spread="1162.56"/>
                    <measurement group_id="O2" value="1764.5" spread="690.12"/>
                    <measurement group_id="O3" value="3306.2" spread="3499.49"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>PK Lead-in Phase: AUCtau: Area Under the Plasma Concentration Versus Time Curve Over the Dosing Interval of GS-331007 (Metabolite of SOF)</title>
        <description>AUCtau is defined as concentration of drug over time (the area under the concentration verses time curve over the dosing interval).</description>
        <time_frame>Day 7: 0 (predose), 0.5, 1, 2, 3, 4, 6 (Cohorts 1 and 2 only), 8, and 12 hours postdose</time_frame>
        <population>Participants in the Lead-in Phase PK Analysis Set with available data were analyzed.</population>
        <group_list>
          <group group_id="O1">
            <title>12 to &lt; 18 Years Old</title>
            <description>PK Lead-in Phase: SOF/VEL FDC 400/100 mg tablets once daily for 7 days.</description>
          </group>
          <group group_id="O2">
            <title>6 to &lt; 12 Years Old</title>
            <description>PK Lead-in Phase: SOF/VEL FDC 200/50 mg tablets or oral granules once daily for 7 days.</description>
          </group>
          <group group_id="O3">
            <title>3 to &lt; 6 Years Old</title>
            <description>PK Lead-in Phase: SOF/VEL FDC 200/50 mg oral granules once daily for 7 days for participants who weighed ≥ 17 kg. SOF/VEL FDC 150/37.5 mg oral granules once daily for 7 days for participants who weighed &lt; 17 kg.</description>
          </group>
        </group_list>
        <measure>
          <title>PK Lead-in Phase: AUCtau: Area Under the Plasma Concentration Versus Time Curve Over the Dosing Interval of GS-331007 (Metabolite of SOF)</title>
          <description>AUCtau is defined as concentration of drug over time (the area under the concentration verses time curve over the dosing interval).</description>
          <population>Participants in the Lead-in Phase PK Analysis Set with available data were analyzed.</population>
          <units>h*ng/mL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="16"/>
                <count group_id="O2" value="17"/>
                <count group_id="O3" value="18"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="13852.9" spread="3565.85"/>
                    <measurement group_id="O2" value="9913.8" spread="3071.79"/>
                    <measurement group_id="O3" value="11604.0" spread="2732.57"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Treatment Phase: Percentage of Participants Who Discontinued Study Drug Due to Any Treatment-Emergent Adverse Event (TEAE)</title>
        <description>An AE is any untoward medical occurrence in a clinical study participant administered a medicinal product, which does not necessarily have a causal relationship with the treatment. An AE can therefore be any unfavorable and/or unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. TEAEs were defined as 1 or both of the following: Any AEs with an onset date on or after the study drug start date and no later than 30 days after permanent discontinuation of study drug and/or Any AEs leading to premature discontinuation of study drug.</description>
        <time_frame>From first dose through last dose of the study drug (Up to 12 weeks) plus 30 days</time_frame>
        <population>The Safety Analysis Set included all participants who were enrolled into the study and received at least 1 dose of study drug (SOF/VEL FDC).</population>
        <group_list>
          <group group_id="O1">
            <title>12 to &lt; 18 Years Old</title>
            <description>Treatment Phase: SOF/VEL 400/100 mg (adult and smaller size tablets based on swallowability assessment) once daily for 12 weeks.</description>
          </group>
          <group group_id="O2">
            <title>6 to &lt; 12 Years Old</title>
            <description>Treatment Phase: SOF/VEL FDC 200/50 mg tablets or oral granules once daily for 12 weeks.</description>
          </group>
          <group group_id="O3">
            <title>3 to &lt; 6 Years Old</title>
            <description>Treatment Phase: SOF/VEL FDC 200/50 mg oral granules once daily for 12 weeks for participants who weighed ≥ 17 kg. SOF/VEL FDC 150/37.5 mg oral granules once daily for 12 weeks for participants who weighed &lt; 17 kg.</description>
          </group>
        </group_list>
        <measure>
          <title>Treatment Phase: Percentage of Participants Who Discontinued Study Drug Due to Any Treatment-Emergent Adverse Event (TEAE)</title>
          <description>An AE is any untoward medical occurrence in a clinical study participant administered a medicinal product, which does not necessarily have a causal relationship with the treatment. An AE can therefore be any unfavorable and/or unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. TEAEs were defined as 1 or both of the following: Any AEs with an onset date on or after the study drug start date and no later than 30 days after permanent discontinuation of study drug and/or Any AEs leading to premature discontinuation of study drug.</description>
          <population>The Safety Analysis Set included all participants who were enrolled into the study and received at least 1 dose of study drug (SOF/VEL FDC).</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="102"/>
                <count group_id="O2" value="73"/>
                <count group_id="O3" value="41"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0"/>
                    <measurement group_id="O2" value="2.7"/>
                    <measurement group_id="O3" value="2.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>PK Lead-in Phase: Change From Baseline in Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) at Day 7</title>
        <time_frame>Baseline; Day 7</time_frame>
        <population>Participants in the Lead-in Phase PK Analysis Set with available data were analyzed.</population>
        <group_list>
          <group group_id="O1">
            <title>12 to &lt; 18 Years Old</title>
            <description>PK Lead-in Phase: SOF/VEL FDC 400/100 mg tablets once daily for 7 days.</description>
          </group>
          <group group_id="O2">
            <title>6 to &lt; 12 Years Old</title>
            <description>PK Lead-in Phase: SOF/VEL FDC 200/50 mg tablets or oral granules once daily for 7 days.</description>
          </group>
          <group group_id="O3">
            <title>3 to &lt; 6 Years Old</title>
            <description>PK Lead-in Phase: SOF/VEL FDC 200/50 mg oral granules once daily for 7 days for participants who weighed ≥ 17 kg. SOF/VEL FDC 150/37.5 mg oral granules once daily for 7 days for participants who weighed &lt; 17 kg.</description>
          </group>
        </group_list>
        <measure>
          <title>PK Lead-in Phase: Change From Baseline in Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) at Day 7</title>
          <population>Participants in the Lead-in Phase PK Analysis Set with available data were analyzed.</population>
          <units>log10 international units per mL (IU/mL)</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="17"/>
                <count group_id="O2" value="20"/>
                <count group_id="O3" value="19"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.09" spread="0.569"/>
                    <measurement group_id="O2" value="5.84" spread="0.656"/>
                    <measurement group_id="O3" value="5.77" spread="1.275"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change from Baseline at Day 7</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-4.48" spread="0.656"/>
                    <measurement group_id="O2" value="-4.20" spread="0.642"/>
                    <measurement group_id="O3" value="-3.94" spread="1.082"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>PK Lead-in Phase: Percentage of Participants Who Permanently Discontinued Study Drug Due to an Adverse Event (AE)</title>
        <description>An AE is any untoward medical occurrence in a clinical study participant administered a medicinal product, which does not necessarily have a causal relationship with the treatment. An AE can therefore be any unfavorable and/or unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.</description>
        <time_frame>First dose date up to Day 7</time_frame>
        <population>Participants in the Lead-in Phase PK Analysis Set were analyzed.</population>
        <group_list>
          <group group_id="O1">
            <title>12 to &lt; 18 Years Old</title>
            <description>PK Lead-in Phase: SOF/VEL FDC 400/100 mg tablets once daily for 7 days.</description>
          </group>
          <group group_id="O2">
            <title>6 to &lt; 12 Years Old</title>
            <description>PK Lead-in Phase: SOF/VEL FDC 200/50 mg tablets or oral granules once daily for 7 days.</description>
          </group>
          <group group_id="O3">
            <title>3 to &lt; 6 Years Old</title>
            <description>PK Lead-in Phase: SOF/VEL FDC 200/50 mg oral granules once daily for 7 days for participants who weighed ≥ 17 kg. SOF/VEL FDC 150/37.5 mg oral granules once daily for 7 days for participants who weighed &lt; 17 kg.</description>
          </group>
        </group_list>
        <measure>
          <title>PK Lead-in Phase: Percentage of Participants Who Permanently Discontinued Study Drug Due to an Adverse Event (AE)</title>
          <description>An AE is any untoward medical occurrence in a clinical study participant administered a medicinal product, which does not necessarily have a causal relationship with the treatment. An AE can therefore be any unfavorable and/or unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.</description>
          <population>Participants in the Lead-in Phase PK Analysis Set were analyzed.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="17"/>
                <count group_id="O2" value="20"/>
                <count group_id="O3" value="19"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0"/>
                    <measurement group_id="O2" value="0.0"/>
                    <measurement group_id="O3" value="0.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Treatment Phase: Percentage of Participants With Sustained Virologic Response (SVR) at 12 Weeks After Discontinuation of Therapy (SVR12)</title>
        <description>SVR12 was defined as HCV RNA &lt; the lower limit of quantitation (LLOQ; ie, 15 IU/mL) at 12 weeks after stopping study treatment.</description>
        <time_frame>Posttreatment Week 12</time_frame>
        <population>The Full Analysis Set included all participants who were enrolled into the study and received at least 1 dose of study drug (SOF/VEL FDC).</population>
        <group_list>
          <group group_id="O1">
            <title>12 to &lt; 18 Years Old</title>
            <description>Treatment Phase: SOF/VEL 400/100 mg (adult and smaller size tablets based on swallowability assessment) once daily for 12 weeks.</description>
          </group>
          <group group_id="O2">
            <title>6 to &lt; 12 Years Old</title>
            <description>Treatment Phase: SOF/VEL FDC 200/50 mg tablets or oral granules once daily for 12 weeks.</description>
          </group>
          <group group_id="O3">
            <title>3 to &lt; 6 Years Old</title>
            <description>Treatment Phase: SOF/VEL FDC 200/50 mg oral granules once daily for 12 weeks for participants who weighed ≥ 17 kg. SOF/VEL FDC 150/37.5 mg oral granules once daily for 12 weeks for participants who weighed &lt; 17 kg.</description>
          </group>
        </group_list>
        <measure>
          <title>Treatment Phase: Percentage of Participants With Sustained Virologic Response (SVR) at 12 Weeks After Discontinuation of Therapy (SVR12)</title>
          <description>SVR12 was defined as HCV RNA &lt; the lower limit of quantitation (LLOQ; ie, 15 IU/mL) at 12 weeks after stopping study treatment.</description>
          <population>The Full Analysis Set included all participants who were enrolled into the study and received at least 1 dose of study drug (SOF/VEL FDC).</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="102"/>
                <count group_id="O2" value="73"/>
                <count group_id="O3" value="41"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="95.1" lower_limit="88.9" upper_limit="98.4"/>
                    <measurement group_id="O2" value="93.2" lower_limit="84.7" upper_limit="97.7"/>
                    <measurement group_id="O3" value="82.9" lower_limit="67.9" upper_limit="92.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Treatment Phase: Percentage of Participants With SVR at 4 Weeks After Discontinuation of Therapy (SVR4)</title>
        <description>SVR4 was defined as HCV RNA &lt; LLOQ (ie, 15 IU/mL) at 4 weeks after stopping study treatment.</description>
        <time_frame>Posttreatment Week 4</time_frame>
        <population>Participants in the Full Analysis Set were analyzed.</population>
        <group_list>
          <group group_id="O1">
            <title>12 to &lt; 18 Years Old</title>
            <description>Treatment Phase: SOF/VEL 400/100 mg (adult and smaller size tablets based on swallowability assessment) once daily for 12 weeks.</description>
          </group>
          <group group_id="O2">
            <title>6 to &lt; 12 Years Old</title>
            <description>Treatment Phase: SOF/VEL FDC 200/50 mg tablets or oral granules once daily for 12 weeks.</description>
          </group>
          <group group_id="O3">
            <title>3 to &lt; 6 Years Old</title>
            <description>Treatment Phase: SOF/VEL FDC 200/50 mg oral granules once daily for 12 weeks for participants who weighed ≥ 17 kg. SOF/VEL FDC 150/37.5 mg oral granules once daily for 12 weeks for participants who weighed &lt; 17 kg.</description>
          </group>
        </group_list>
        <measure>
          <title>Treatment Phase: Percentage of Participants With SVR at 4 Weeks After Discontinuation of Therapy (SVR4)</title>
          <description>SVR4 was defined as HCV RNA &lt; LLOQ (ie, 15 IU/mL) at 4 weeks after stopping study treatment.</description>
          <population>Participants in the Full Analysis Set were analyzed.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="102"/>
                <count group_id="O2" value="73"/>
                <count group_id="O3" value="41"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="96.1" lower_limit="90.3" upper_limit="98.9"/>
                    <measurement group_id="O2" value="94.5" lower_limit="86.6" upper_limit="98.5"/>
                    <measurement group_id="O3" value="82.9" lower_limit="67.9" upper_limit="92.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Treatment Phase: Percentage of Participants With SVR at 24 Weeks After Discontinuation of Therapy (SVR24)</title>
        <description>SVR 24 was defined as HCV RNA &lt; LLOQ (ie, 15 IU/mL) at 24 weeks after stopping study treatment.</description>
        <time_frame>Posttreatment Week 24</time_frame>
        <population>Participants in the Full Analysis Set were analyzed.</population>
        <group_list>
          <group group_id="O1">
            <title>12 to &lt; 18 Years Old</title>
            <description>Treatment Phase: SOF/VEL 400/100 mg (adult and smaller size tablets based on swallowability assessment) once daily for 12 weeks.</description>
          </group>
          <group group_id="O2">
            <title>6 to &lt; 12 Years Old</title>
            <description>Treatment Phase: SOF/VEL FDC 200/50 mg tablets or oral granules once daily for 12 weeks.</description>
          </group>
          <group group_id="O3">
            <title>3 to &lt; 6 Years Old</title>
            <description>Treatment Phase: SOF/VEL FDC 200/50 mg oral granules once daily for 12 weeks for participants who weighed ≥ 17 kg. SOF/VEL FDC 150/37.5 mg oral granules once daily for 12 weeks for participants who weighed &lt; 17 kg.</description>
          </group>
        </group_list>
        <measure>
          <title>Treatment Phase: Percentage of Participants With SVR at 24 Weeks After Discontinuation of Therapy (SVR24)</title>
          <description>SVR 24 was defined as HCV RNA &lt; LLOQ (ie, 15 IU/mL) at 24 weeks after stopping study treatment.</description>
          <population>Participants in the Full Analysis Set were analyzed.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="102"/>
                <count group_id="O2" value="73"/>
                <count group_id="O3" value="41"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="95.1" lower_limit="88.9" upper_limit="98.4"/>
                    <measurement group_id="O2" value="93.2" lower_limit="84.7" upper_limit="97.7"/>
                    <measurement group_id="O3" value="82.9" lower_limit="67.9" upper_limit="92.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Treatment Phase: Percentage of Participants With Virologic Failure</title>
        <description>Virologic failure was defined as: On-treatment virologic failure - Breakthrough (confirmed HCV RNA ≥ LLOQ after having previously had HCV RNA &lt; LLOQ while on treatment), or Rebound (confirmed &gt; 1 log10 IU/mL increase in HCV RNA from nadir while on treatment), or Non-response (HCV RNA persistently ≥ LLOQ through 8 weeks of treatment); Virologic relapse: Confirmed HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA &lt; LLOQ at last on-treatment visit.</description>
        <time_frame>Up to Posttreatment Week 24</time_frame>
        <population>Participants in the Full Analysis Set were analyzed.</population>
        <group_list>
          <group group_id="O1">
            <title>12 to &lt; 18 Years Old</title>
            <description>Treatment Phase: SOF/VEL 400/100 mg (adult and smaller size tablets based on swallowability assessment) once daily for 12 weeks.</description>
          </group>
          <group group_id="O2">
            <title>6 to &lt; 12 Years Old</title>
            <description>Treatment Phase: SOF/VEL FDC 200/50 mg tablets or oral granules once daily for 12 weeks.</description>
          </group>
          <group group_id="O3">
            <title>3 to &lt; 6 Years Old</title>
            <description>Treatment Phase: SOF/VEL FDC 200/50 mg oral granules once daily for 12 weeks for participants who weighed ≥ 17 kg. SOF/VEL FDC 150/37.5 mg oral granules once daily for 12 weeks for participants who weighed &lt; 17 kg.</description>
          </group>
        </group_list>
        <measure>
          <title>Treatment Phase: Percentage of Participants With Virologic Failure</title>
          <description>Virologic failure was defined as: On-treatment virologic failure - Breakthrough (confirmed HCV RNA ≥ LLOQ after having previously had HCV RNA &lt; LLOQ while on treatment), or Rebound (confirmed &gt; 1 log10 IU/mL increase in HCV RNA from nadir while on treatment), or Non-response (HCV RNA persistently ≥ LLOQ through 8 weeks of treatment); Virologic relapse: Confirmed HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA &lt; LLOQ at last on-treatment visit.</description>
          <population>Participants in the Full Analysis Set were analyzed.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="102"/>
                <count group_id="O2" value="73"/>
                <count group_id="O3" value="41"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.0"/>
                    <measurement group_id="O2" value="1.4"/>
                    <measurement group_id="O3" value="0.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Treatment Phase: Percentage of Participants With HCV RNA &lt; LLOQ On Treatment</title>
        <description>Percentage of participants with HCV RNA &lt; LLOQ while on treatment by analysis visit.</description>
        <time_frame>Weeks 1, 4, 8, and 12</time_frame>
        <population>Participants in the Full Analysis Set were analyzed.</population>
        <group_list>
          <group group_id="O1">
            <title>12 to &lt; 18 Years Old</title>
            <description>Treatment Phase: SOF/VEL 400/100 mg (adult and smaller size tablets based on swallowability assessment) once daily for 12 weeks.</description>
          </group>
          <group group_id="O2">
            <title>6 to &lt; 12 Years Old</title>
            <description>Treatment Phase: SOF/VEL FDC 200/50 mg tablets or oral granules once daily for 12 weeks.</description>
          </group>
          <group group_id="O3">
            <title>3 to &lt; 6 Years Old</title>
            <description>Treatment Phase: SOF/VEL FDC 200/50 mg oral granules once daily for 12 weeks for participants who weighed ≥ 17 kg. SOF/VEL FDC 150/37.5 mg oral granules once daily for 12 weeks for participants who weighed &lt; 17 kg.</description>
          </group>
        </group_list>
        <measure>
          <title>Treatment Phase: Percentage of Participants With HCV RNA &lt; LLOQ On Treatment</title>
          <description>Percentage of participants with HCV RNA &lt; LLOQ while on treatment by analysis visit.</description>
          <population>Participants in the Full Analysis Set were analyzed.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="102"/>
                <count group_id="O2" value="73"/>
                <count group_id="O3" value="41"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="44.1" lower_limit="34.3" upper_limit="54.3"/>
                    <measurement group_id="O2" value="39.7" lower_limit="28.5" upper_limit="51.9"/>
                    <measurement group_id="O3" value="36.8" lower_limit="21.8" upper_limit="54.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 4</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="96.1" lower_limit="90.3" upper_limit="98.9"/>
                    <measurement group_id="O2" value="94.4" lower_limit="86.2" upper_limit="98.4"/>
                    <measurement group_id="O3" value="91.4" lower_limit="76.9" upper_limit="98.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 8</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="100.0" lower_limit="96.4" upper_limit="100.0"/>
                    <measurement group_id="O2" value="98.6" lower_limit="92.3" upper_limit="100.0"/>
                    <measurement group_id="O3" value="100.0" lower_limit="89.7" upper_limit="100.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 12</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="100.0" lower_limit="96.4" upper_limit="100.0"/>
                    <measurement group_id="O2" value="98.6" lower_limit="92.3" upper_limit="100.0"/>
                    <measurement group_id="O3" value="100.0" lower_limit="89.7" upper_limit="100.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Treatment Phase: Percentage of Participants Who Develop Viral Resistance to SOF and/or VEL During Treatment and After Discontinuation of Treatment</title>
        <description>Drug-resistant substitutions were analyzed as part of the Virology Study. Plasma samples were collected and stored for potential HCV sequencing. Impact on the treatment outcomes of SVR12 and SVR24 were observed during the study. Baseline deep sequencing of the HCV nonstructural protein (NS)5A and NS5B genes was performed for all participants at the first time point after virologic failure if the plasma or serum sample was available. Pretreatment full-length NS5A deep sequencing data were obtained at a 15% assay cutoff for the Resistance Analysis Population which covered all NS5A and NS5B nucleoside inhibitor (NI) resistance-associated variants (RAVs).</description>
        <time_frame>First dose date up to Posttreatment Week 24</time_frame>
        <population>The Resistance Analysis Population with all adolescent or pediatric participants in the Safety Analysis Set with a virologic outcome with available data were analyzed.</population>
        <group_list>
          <group group_id="O1">
            <title>12 to &lt; 18 Years Old</title>
            <description>Treatment Phase: SOF/VEL 400/100 mg (adult and smaller size tablets based on swallowability assessment) once daily for 12 weeks.</description>
          </group>
          <group group_id="O2">
            <title>6 to &lt; 12 Years Old</title>
            <description>Treatment Phase: SOF/VEL FDC 200/50 mg tablets or oral granules once daily for 12 weeks.</description>
          </group>
          <group group_id="O3">
            <title>3 to &lt; 6 Years Old</title>
            <description>Treatment Phase: SOF/VEL FDC 200/50 mg oral granules once daily for 12 weeks for participants who weighed ≥ 17 kg. SOF/VEL FDC 150/37.5 mg oral granules once daily for 12 weeks for participants who weighed &lt; 17 kg.</description>
          </group>
        </group_list>
        <measure>
          <title>Treatment Phase: Percentage of Participants Who Develop Viral Resistance to SOF and/or VEL During Treatment and After Discontinuation of Treatment</title>
          <description>Drug-resistant substitutions were analyzed as part of the Virology Study. Plasma samples were collected and stored for potential HCV sequencing. Impact on the treatment outcomes of SVR12 and SVR24 were observed during the study. Baseline deep sequencing of the HCV nonstructural protein (NS)5A and NS5B genes was performed for all participants at the first time point after virologic failure if the plasma or serum sample was available. Pretreatment full-length NS5A deep sequencing data were obtained at a 15% assay cutoff for the Resistance Analysis Population which covered all NS5A and NS5B nucleoside inhibitor (NI) resistance-associated variants (RAVs).</description>
          <population>The Resistance Analysis Population with all adolescent or pediatric participants in the Safety Analysis Set with a virologic outcome with available data were analyzed.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="98"/>
                <count group_id="O2" value="68"/>
                <count group_id="O3" value="33"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Pretreatment NS5A NI RAVs</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="98"/>
                    <count group_id="O2" value="68"/>
                    <count group_id="O3" value="33"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="16.3"/>
                    <measurement group_id="O2" value="10.2"/>
                    <measurement group_id="O3" value="18.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Pretreatment NS5B NI RAVs</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="66"/>
                    <count group_id="O2" value="68"/>
                    <count group_id="O3" value="33"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.1"/>
                    <measurement group_id="O2" value="0.0"/>
                    <measurement group_id="O3" value="3.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Treatment Phase: Change From Baseline in HCV RNA at Weeks 1, 4, 8, and 12</title>
        <time_frame>Baseline; Weeks 1, 4, 8, and 12</time_frame>
        <population>Participants in the Full Analysis Set with available data were analyzed.</population>
        <group_list>
          <group group_id="O1">
            <title>12 to &lt; 18 Years Old</title>
            <description>Treatment Phase: SOF/VEL 400/100 mg (adult and smaller size tablets based on swallowability assessment) once daily for 12 weeks.</description>
          </group>
          <group group_id="O2">
            <title>6 to &lt; 12 Years Old</title>
            <description>Treatment Phase: SOF/VEL FDC 200/50 mg tablets or oral granules once daily for 12 weeks.</description>
          </group>
          <group group_id="O3">
            <title>3 to &lt; 6 Years Old</title>
            <description>Treatment Phase: SOF/VEL FDC 200/50 mg oral granules once daily for 12 weeks for participants who weighed ≥ 17 kg. SOF/VEL FDC 150/37.5 mg oral granules once daily for 12 weeks for participants who weighed &lt; 17 kg.</description>
          </group>
        </group_list>
        <measure>
          <title>Treatment Phase: Change From Baseline in HCV RNA at Weeks 1, 4, 8, and 12</title>
          <population>Participants in the Full Analysis Set with available data were analyzed.</population>
          <units>log10 IU/mL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="102"/>
                <count group_id="O2" value="73"/>
                <count group_id="O3" value="41"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="102"/>
                    <count group_id="O2" value="73"/>
                    <count group_id="O3" value="41"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.06" spread="0.585"/>
                    <measurement group_id="O2" value="5.87" spread="0.686"/>
                    <measurement group_id="O3" value="5.86" spread="1.057"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change from Baseline at Week 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="102"/>
                    <count group_id="O2" value="71"/>
                    <count group_id="O3" value="36"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-4.46" spread="0.661"/>
                    <measurement group_id="O2" value="-4.28" spread="0.632"/>
                    <measurement group_id="O3" value="-4.06" spread="0.914"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change from Baseline at Week 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="102"/>
                    <count group_id="O2" value="71"/>
                    <count group_id="O3" value="34"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-4.89" spread="0.578"/>
                    <measurement group_id="O2" value="-4.64" spread="0.860"/>
                    <measurement group_id="O3" value="-4.49" spread="1.040"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change from Baseline at Week 8</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="101"/>
                    <count group_id="O2" value="70"/>
                    <count group_id="O3" value="34"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-4.91" spread="0.588"/>
                    <measurement group_id="O2" value="-4.69" spread="0.678"/>
                    <measurement group_id="O3" value="-4.56" spread="1.066"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change from Baseline at Week 12</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="101"/>
                    <count group_id="O2" value="69"/>
                    <count group_id="O3" value="34"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-4.91" spread="0.588"/>
                    <measurement group_id="O2" value="-4.70" spread="0.683"/>
                    <measurement group_id="O3" value="-4.56" spread="1.066"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Treatment Phase: Quality of Life (QoL) and Neuropsychiatric Assessments as Measured by PedsQL™ Pediatric QoL Survey</title>
        <description>To evaluate the effect of treatment with SOF/VEL on general and disease-specific health-related QoL, the PedsQL™ Pediatric QoL Inventory V4.0 Short Form (SF15) was completed at Day 1, end of treatment, early termination (if applicable), and posttreatment Weeks 12 and 24. The SF15 questionnaire represented 4 domains: physical, emotional, social, and school functioning, with the emotional, social, and school functioning domains representing the psychosocial health summary. Neuropsychiatric assessment was conducted using the PedsQL™ Pediatric QoL Inventory V4.0 SF15 psychosocial domain-related scores. Items were calculated and transformed into an overall score with a range of 0 to 100 points, with more points indicating better QoL.</description>
        <time_frame>Baseline; Week 12, End of Treatment (EOT), Posttreatment/Follow-up (FU) Week-12 (FU-12), and FU Week-24 (FU-24)</time_frame>
        <population>Participants in the Full Analysis Set with available data were analyzed.</population>
        <group_list>
          <group group_id="O1">
            <title>12 to &lt; 18 Years Old</title>
            <description>Treatment Phase: SOF/VEL 400/100 mg (adult and smaller size tablets based on swallowability assessment) once daily for 12 weeks.</description>
          </group>
          <group group_id="O2">
            <title>6 to &lt; 12 Years Old</title>
            <description>Treatment Phase: SOF/VEL FDC 200/50 mg tablets or oral granules once daily for 12 weeks.</description>
          </group>
          <group group_id="O3">
            <title>3 to &lt; 6 Years Old</title>
            <description>Treatment Phase: SOF/VEL FDC 200/50 mg oral granules once daily for 12 weeks for participants who weighed ≥ 17 kg. SOF/VEL FDC 150/37.5 mg oral granules once daily for 12 weeks for participants who weighed &lt; 17 kg.</description>
          </group>
        </group_list>
        <measure>
          <title>Treatment Phase: Quality of Life (QoL) and Neuropsychiatric Assessments as Measured by PedsQL™ Pediatric QoL Survey</title>
          <description>To evaluate the effect of treatment with SOF/VEL on general and disease-specific health-related QoL, the PedsQL™ Pediatric QoL Inventory V4.0 Short Form (SF15) was completed at Day 1, end of treatment, early termination (if applicable), and posttreatment Weeks 12 and 24. The SF15 questionnaire represented 4 domains: physical, emotional, social, and school functioning, with the emotional, social, and school functioning domains representing the psychosocial health summary. Neuropsychiatric assessment was conducted using the PedsQL™ Pediatric QoL Inventory V4.0 SF15 psychosocial domain-related scores. Items were calculated and transformed into an overall score with a range of 0 to 100 points, with more points indicating better QoL.</description>
          <population>Participants in the Full Analysis Set with available data were analyzed.</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="102"/>
                <count group_id="O2" value="73"/>
                <count group_id="O3" value="41"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Parents Reports, Total Score at Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="98"/>
                    <count group_id="O2" value="73"/>
                    <count group_id="O3" value="41"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="80.0" spread="17.71"/>
                    <measurement group_id="O2" value="79.7" spread="15.58"/>
                    <measurement group_id="O3" value="86.5" spread="12.43"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Parents Reports, Total Score at Week 12</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="97"/>
                    <count group_id="O2" value="68"/>
                    <count group_id="O3" value="32"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="82.4" spread="18.13"/>
                    <measurement group_id="O2" value="82.8" spread="14.26"/>
                    <measurement group_id="O3" value="87.3" spread="11.31"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Parents Reports, Total Score at EOT</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="97"/>
                    <count group_id="O2" value="70"/>
                    <count group_id="O3" value="34"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="82.4" spread="18.13"/>
                    <measurement group_id="O2" value="82.2" spread="14.95"/>
                    <measurement group_id="O3" value="87.0" spread="11.65"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Parents Reports, Total Score at Follow Up-12</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="94"/>
                    <count group_id="O2" value="68"/>
                    <count group_id="O3" value="35"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="81.7" spread="17.39"/>
                    <measurement group_id="O2" value="81.5" spread="15.34"/>
                    <measurement group_id="O3" value="87.7" spread="14.11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Parents Reports, Total Score at Follow Up-24</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="94"/>
                    <count group_id="O2" value="69"/>
                    <count group_id="O3" value="35"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="80.8" spread="18.65"/>
                    <measurement group_id="O2" value="79.7" spread="15.30"/>
                    <measurement group_id="O3" value="88.3" spread="9.79"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Participants Reports, Total Score at Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="100"/>
                    <count group_id="O2" value="73"/>
                    <count group_id="O3" value="18"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="79.9" spread="15.22"/>
                    <measurement group_id="O2" value="77.9" spread="13.33"/>
                    <measurement group_id="O3" value="82.2" spread="12.47"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Participants Reports, Total Score at Week 12</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="101"/>
                    <count group_id="O2" value="68"/>
                    <count group_id="O3" value="21"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="80.9" spread="16.38"/>
                    <measurement group_id="O2" value="80.0" spread="14.21"/>
                    <measurement group_id="O3" value="83.3" spread="11.62"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Participants Reports, Total Score at EOT</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="101"/>
                    <count group_id="O2" value="70"/>
                    <count group_id="O3" value="21"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="80.9" spread="16.38"/>
                    <measurement group_id="O2" value="79.7" spread="14.13"/>
                    <measurement group_id="O3" value="83.3" spread="11.62"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Participants Reports, Total Score at Follow Up-12</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="98"/>
                    <count group_id="O2" value="68"/>
                    <count group_id="O3" value="23"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="82.5" spread="15.41"/>
                    <measurement group_id="O2" value="81.1" spread="13.32"/>
                    <measurement group_id="O3" value="80.5" spread="14.18"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Participants Reports, Total Score at Follow Up-24</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="98"/>
                    <count group_id="O2" value="69"/>
                    <count group_id="O3" value="25"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="81.4" spread="16.34"/>
                    <measurement group_id="O2" value="81.7" spread="15.43"/>
                    <measurement group_id="O3" value="82.1" spread="12.56"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Treatment Phase: Change From Baseline in Growth and Development as Measured by Height Percentiles</title>
        <description>An age- and sex-specific percentile was derived for each weight, height, and body mass index (BMI) measurement according to the statistical analysis system (SAS) program available on the Centers for Disease Control and Prevention (CDC) website using the year 2000 growth charts.</description>
        <time_frame>Baseline; Weeks 1, 4, 8, 12, Follow-up (FU) Week 4 (FU-4), FU-12, and FU-24</time_frame>
        <population>Participants in the Safety Analysis Set with available data were analyzed.</population>
        <group_list>
          <group group_id="O1">
            <title>12 to &lt; 18 Years Old</title>
            <description>Treatment Phase: SOF/VEL 400/100 mg (adult and smaller size tablets based on swallowability assessment) once daily for 12 weeks.</description>
          </group>
          <group group_id="O2">
            <title>6 to &lt; 12 Years Old</title>
            <description>Treatment Phase: SOF/VEL FDC 200/50 mg tablets or oral granules once daily for 12 weeks.</description>
          </group>
          <group group_id="O3">
            <title>3 to &lt; 6 Years Old</title>
            <description>Treatment Phase: SOF/VEL FDC 200/50 mg oral granules once daily for 12 weeks for participants who weighed ≥ 17 kg. SOF/VEL FDC 150/37.5 mg oral granules once daily for 12 weeks for participants who weighed &lt; 17 kg.</description>
          </group>
        </group_list>
        <measure>
          <title>Treatment Phase: Change From Baseline in Growth and Development as Measured by Height Percentiles</title>
          <description>An age- and sex-specific percentile was derived for each weight, height, and body mass index (BMI) measurement according to the statistical analysis system (SAS) program available on the Centers for Disease Control and Prevention (CDC) website using the year 2000 growth charts.</description>
          <population>Participants in the Safety Analysis Set with available data were analyzed.</population>
          <units>percentile</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="102"/>
                <count group_id="O2" value="73"/>
                <count group_id="O3" value="41"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="102"/>
                    <count group_id="O2" value="73"/>
                    <count group_id="O3" value="41"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="44.5" lower_limit="16.2" upper_limit="74.1"/>
                    <measurement group_id="O2" value="41.9" lower_limit="20.5" upper_limit="65.2"/>
                    <measurement group_id="O3" value="39.3" lower_limit="13.9" upper_limit="70.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change From Baseline at Week 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="102"/>
                    <count group_id="O2" value="73"/>
                    <count group_id="O3" value="36"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0" lower_limit="-0.4" upper_limit="0.9"/>
                    <measurement group_id="O2" value="0.1" lower_limit="-0.7" upper_limit="2.4"/>
                    <measurement group_id="O3" value="0.5" lower_limit="-1.1" upper_limit="3.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change From Baseline at Week 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="101"/>
                    <count group_id="O2" value="71"/>
                    <count group_id="O3" value="34"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0" lower_limit="-0.7" upper_limit="1.7"/>
                    <measurement group_id="O2" value="0.2" lower_limit="-1.9" upper_limit="1.9"/>
                    <measurement group_id="O3" value="1.4" lower_limit="-0.3" upper_limit="3.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change From Baseline at Week 8</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="101"/>
                    <count group_id="O2" value="69"/>
                    <count group_id="O3" value="34"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0" lower_limit="-1.2" upper_limit="1.5"/>
                    <measurement group_id="O2" value="-0.1" lower_limit="-2.2" upper_limit="2.2"/>
                    <measurement group_id="O3" value="0.3" lower_limit="-2.1" upper_limit="3.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change From Baseline at Week 12</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="100"/>
                    <count group_id="O2" value="65"/>
                    <count group_id="O3" value="28"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.1" lower_limit="-1.4" upper_limit="1.0"/>
                    <measurement group_id="O2" value="0.2" lower_limit="-2.6" upper_limit="2.8"/>
                    <measurement group_id="O3" value="0.2" lower_limit="-2.0" upper_limit="5.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change From Baseline at FU-4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="99"/>
                    <count group_id="O2" value="70"/>
                    <count group_id="O3" value="34"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0" lower_limit="-2.0" upper_limit="1.3"/>
                    <measurement group_id="O2" value="0.2" lower_limit="-2.3" upper_limit="2.5"/>
                    <measurement group_id="O3" value="1.2" lower_limit="-0.7" upper_limit="5.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change From Baseline at FU-12</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="98"/>
                    <count group_id="O2" value="68"/>
                    <count group_id="O3" value="35"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.2" lower_limit="-2.4" upper_limit="1.4"/>
                    <measurement group_id="O2" value="0.1" lower_limit="-1.7" upper_limit="2.6"/>
                    <measurement group_id="O3" value="0.6" lower_limit="-3.1" upper_limit="4.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change From Baseline at FU-24</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="91"/>
                    <count group_id="O2" value="67"/>
                    <count group_id="O3" value="33"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.6" lower_limit="-2.6" upper_limit="1.9"/>
                    <measurement group_id="O2" value="-0.2" lower_limit="-3.1" upper_limit="3.5"/>
                    <measurement group_id="O3" value="0.3" lower_limit="-2.1" upper_limit="6.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Treatment Phase: Change From Baseline in Growth and Development as Measured by Weight Percentiles</title>
        <description>An age- and sex-specific percentile was derived for each weight, height, and BMI measurement according to the SAS program available on the CDC website using the year 2000 growth charts.</description>
        <time_frame>Baseline; Weeks 1, 4, 8, 12, FU-4, FU-12, and FU-24</time_frame>
        <population>Participants in the Safety Analysis Set with available data were analyzed.</population>
        <group_list>
          <group group_id="O1">
            <title>12 to &lt; 18 Years Old</title>
            <description>Treatment Phase: SOF/VEL 400/100 mg (adult and smaller size tablets based on swallowability assessment) once daily for 12 weeks.</description>
          </group>
          <group group_id="O2">
            <title>6 to &lt; 12 Years Old</title>
            <description>Treatment Phase: SOF/VEL FDC 200/50 mg tablets or oral granules once daily for 12 weeks.</description>
          </group>
          <group group_id="O3">
            <title>3 to &lt; 6 Years Old</title>
            <description>Treatment Phase: SOF/VEL FDC 200/50 mg oral granules once daily for 12 weeks for participants who weighed ≥ 17 kg. SOF/VEL FDC 150/37.5 mg oral granules once daily for 12 weeks for participants who weighed &lt; 17 kg.</description>
          </group>
        </group_list>
        <measure>
          <title>Treatment Phase: Change From Baseline in Growth and Development as Measured by Weight Percentiles</title>
          <description>An age- and sex-specific percentile was derived for each weight, height, and BMI measurement according to the SAS program available on the CDC website using the year 2000 growth charts.</description>
          <population>Participants in the Safety Analysis Set with available data were analyzed.</population>
          <units>percentile</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="102"/>
                <count group_id="O2" value="73"/>
                <count group_id="O3" value="41"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="102"/>
                    <count group_id="O2" value="73"/>
                    <count group_id="O3" value="41"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="67.2" lower_limit="31.5" upper_limit="84.1"/>
                    <measurement group_id="O2" value="45.9" lower_limit="23.3" upper_limit="78.6"/>
                    <measurement group_id="O3" value="64.6" lower_limit="38.0" upper_limit="86.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change From Baseline at Week 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="102"/>
                    <count group_id="O2" value="73"/>
                    <count group_id="O3" value="36"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0" lower_limit="-0.4" upper_limit="0.9"/>
                    <measurement group_id="O2" value="0.1" lower_limit="-0.6" upper_limit="1.2"/>
                    <measurement group_id="O3" value="-0.5" lower_limit="-2.7" upper_limit="0.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change From Baseline at Week 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="102"/>
                    <count group_id="O2" value="71"/>
                    <count group_id="O3" value="34"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0" lower_limit="-0.9" upper_limit="1.8"/>
                    <measurement group_id="O2" value="0.2" lower_limit="-1.4" upper_limit="1.5"/>
                    <measurement group_id="O3" value="0.3" lower_limit="-1.2" upper_limit="2.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change From Baseline at Week 8</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="101"/>
                    <count group_id="O2" value="69"/>
                    <count group_id="O3" value="34"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0" lower_limit="-1.3" upper_limit="2.1"/>
                    <measurement group_id="O2" value="0.1" lower_limit="-1.6" upper_limit="2.5"/>
                    <measurement group_id="O3" value="0.2" lower_limit="-3.7" upper_limit="2.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change From Baseline at Week 12</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="100"/>
                    <count group_id="O2" value="65"/>
                    <count group_id="O3" value="28"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.2" lower_limit="-1.0" upper_limit="2.9"/>
                    <measurement group_id="O2" value="0.5" lower_limit="-1.7" upper_limit="2.5"/>
                    <measurement group_id="O3" value="-1.7" lower_limit="-4.7" upper_limit="0.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change From Baseline at FU-4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="99"/>
                    <count group_id="O2" value="70"/>
                    <count group_id="O3" value="34"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.1" lower_limit="-3.0" upper_limit="3.1"/>
                    <measurement group_id="O2" value="0.0" lower_limit="-2.3" upper_limit="2.6"/>
                    <measurement group_id="O3" value="-0.8" lower_limit="-4.9" upper_limit="2.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change From Baseline at FU-12</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="98"/>
                    <count group_id="O2" value="68"/>
                    <count group_id="O3" value="35"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0" lower_limit="-2.5" upper_limit="4.7"/>
                    <measurement group_id="O2" value="0.5" lower_limit="-2.2" upper_limit="4.9"/>
                    <measurement group_id="O3" value="-0.8" lower_limit="-6.6" upper_limit="2.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change From Baseline at FU-24</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="91"/>
                    <count group_id="O2" value="67"/>
                    <count group_id="O3" value="33"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.1" lower_limit="-2.6" upper_limit="4.1"/>
                    <measurement group_id="O2" value="1.4" lower_limit="-1.2" upper_limit="5.7"/>
                    <measurement group_id="O3" value="-1.3" lower_limit="-3.5" upper_limit="2.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Treatment Phase: Changes in Growth and Development as Measured by Tanner Stage Assessment From Baseline</title>
        <description>Tanner Pubertal Staging was assessed for pubic hair growth and genitalia development (males) and for pubic hair growth and breast development (females) in stages 1 to 5. Tanner stages were used to evaluate the onset and progression of pubertal changes from stage 1 (pre-pubertal) to stage 5 (adult). If a participant had reached Tanner stage 5, no further Tanner pubertal stage assessments were to be completed. Pubic hair growth: Tanner stages (1: No hair, 2: Downy hair, 3: More coarse and curly hair, 4: Adult-like hair quality; 5: Hair extends to the medial surface of the thighs); Breast development: Tanner stages (1: No glandular tissue, 2: Breast bud forms,3: More elevated, outside areola, 4: Increased breast size,5: Final adult-size breasts); Genitalia development: Tanner stages (1: Testes, scrotum, and penis about same size, 2: Enlargement of scrotum, testes and penis, 3: Enlargement of penis, 4: Penis size enlargement, 5: Genitalia adult in size and shape).</description>
        <time_frame>Baseline; EOT, FU-12 and FU-24</time_frame>
        <population>Participants in the Safety Analysis Set with available data were analyzed. Overall Number of Participants Analyzed for each arm is the total of male plus female participants.</population>
        <group_list>
          <group group_id="O1">
            <title>12 to &lt; 18 Years Old</title>
            <description>Treatment Phase: SOF/VEL 400/100 mg (adult and smaller size tablets based on swallowability assessment) once daily for 12 weeks.</description>
          </group>
          <group group_id="O2">
            <title>6 to &lt; 12 Years Old</title>
            <description>Treatment Phase: SOF/VEL FDC 200/50 mg tablets or oral granules once daily for 12 weeks.</description>
          </group>
          <group group_id="O3">
            <title>3 to &lt; 6 Years Old</title>
            <description>Treatment Phase: SOF/VEL FDC 200/50 mg oral granules once daily for 12 weeks for participants who weighed ≥ 17 kg. SOF/VEL FDC 150/37.5 mg oral granules once daily for 12 weeks for participants who weighed &lt; 17 kg.</description>
          </group>
        </group_list>
        <measure>
          <title>Treatment Phase: Changes in Growth and Development as Measured by Tanner Stage Assessment From Baseline</title>
          <description>Tanner Pubertal Staging was assessed for pubic hair growth and genitalia development (males) and for pubic hair growth and breast development (females) in stages 1 to 5. Tanner stages were used to evaluate the onset and progression of pubertal changes from stage 1 (pre-pubertal) to stage 5 (adult). If a participant had reached Tanner stage 5, no further Tanner pubertal stage assessments were to be completed. Pubic hair growth: Tanner stages (1: No hair, 2: Downy hair, 3: More coarse and curly hair, 4: Adult-like hair quality; 5: Hair extends to the medial surface of the thighs); Breast development: Tanner stages (1: No glandular tissue, 2: Breast bud forms,3: More elevated, outside areola, 4: Increased breast size,5: Final adult-size breasts); Genitalia development: Tanner stages (1: Testes, scrotum, and penis about same size, 2: Enlargement of scrotum, testes and penis, 3: Enlargement of penis, 4: Penis size enlargement, 5: Genitalia adult in size and shape).</description>
          <population>Participants in the Safety Analysis Set with available data were analyzed. Overall Number of Participants Analyzed for each arm is the total of male plus female participants.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="102"/>
                <count group_id="O2" value="73"/>
                <count group_id="O3" value="41"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Pubic Hair (Male): Baseline, Stage 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="50"/>
                    <count group_id="O2" value="34"/>
                    <count group_id="O3" value="17"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="31"/>
                    <measurement group_id="O3" value="17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Pubic Hair (Male): Baseline, Stage 2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="50"/>
                    <count group_id="O2" value="34"/>
                    <count group_id="O3" value="17"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="2"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Pubic Hair (Male): Baseline, Stage 3</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="50"/>
                    <count group_id="O2" value="34"/>
                    <count group_id="O3" value="17"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Pubic Hair (Male): Baseline, Stage 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="50"/>
                    <count group_id="O2" value="34"/>
                    <count group_id="O3" value="17"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="14"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Pubic Hair (Male): Baseline, Stage 5</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="50"/>
                    <count group_id="O2" value="34"/>
                    <count group_id="O3" value="17"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="19"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Pubic Hair (Male): EOT, Stage 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="50"/>
                    <count group_id="O2" value="32"/>
                    <count group_id="O3" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="28"/>
                    <measurement group_id="O3" value="13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Pubic Hair (Male): EOT, Stage 2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="50"/>
                    <count group_id="O2" value="32"/>
                    <count group_id="O3" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="3"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Pubic Hair (Male): EOT, Stage 3</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="50"/>
                    <count group_id="O2" value="32"/>
                    <count group_id="O3" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Pubic Hair (Male): EOT, Stage 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="50"/>
                    <count group_id="O2" value="32"/>
                    <count group_id="O3" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="13"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Pubic Hair (Male): EOT, Stage 5</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="50"/>
                    <count group_id="O2" value="32"/>
                    <count group_id="O3" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="24"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Pubic Hair (Male): FU-12, Stage 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="47"/>
                    <count group_id="O2" value="30"/>
                    <count group_id="O3" value="14"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="26"/>
                    <measurement group_id="O3" value="14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Pubic Hair (Male): FU-12, Stage 2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="47"/>
                    <count group_id="O2" value="30"/>
                    <count group_id="O3" value="14"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                    <measurement group_id="O2" value="3"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Pubic Hair (Male): FU-12, Stage 3</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="47"/>
                    <count group_id="O2" value="30"/>
                    <count group_id="O3" value="14"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Pubic Hair (Male): FU-12, Stage 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="47"/>
                    <count group_id="O2" value="30"/>
                    <count group_id="O3" value="14"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Pubic Hair (Male): FU-12, Stage 5</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="47"/>
                    <count group_id="O2" value="30"/>
                    <count group_id="O3" value="14"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="25"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Pubic Hair (Male): FU-24, Stage 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="45"/>
                    <count group_id="O2" value="32"/>
                    <count group_id="O3" value="14"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="29"/>
                    <measurement group_id="O3" value="14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Pubic Hair (Male): FU-24, Stage 2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="45"/>
                    <count group_id="O2" value="32"/>
                    <count group_id="O3" value="14"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="2"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Pubic Hair (Male): FU-24, Stage 3</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="45"/>
                    <count group_id="O2" value="32"/>
                    <count group_id="O3" value="14"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Pubic Hair (Male): FU-24, Stage 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="45"/>
                    <count group_id="O2" value="32"/>
                    <count group_id="O3" value="14"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="13"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Pubic Hair (Male): FU-24, Stage 5</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="45"/>
                    <count group_id="O2" value="32"/>
                    <count group_id="O3" value="14"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="25"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Genitalia (Male): Baseline, Stage 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="50"/>
                    <count group_id="O2" value="34"/>
                    <count group_id="O3" value="17"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="31"/>
                    <measurement group_id="O3" value="17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Genitalia (Male): Baseline, Stage 2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="50"/>
                    <count group_id="O2" value="34"/>
                    <count group_id="O3" value="17"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="2"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Genitalia (Male): Baseline, Stage 3</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="50"/>
                    <count group_id="O2" value="34"/>
                    <count group_id="O3" value="17"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Genitalia (Male): Baseline, Stage 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="50"/>
                    <count group_id="O2" value="34"/>
                    <count group_id="O3" value="17"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="16"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Genitalia (Male): Baseline, Stage 5</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="50"/>
                    <count group_id="O2" value="34"/>
                    <count group_id="O3" value="17"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="19"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Genitalia (Male): EOT, Stage 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="50"/>
                    <count group_id="O2" value="32"/>
                    <count group_id="O3" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="28"/>
                    <measurement group_id="O3" value="13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Genitalia (Male): EOT, Stage 2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="50"/>
                    <count group_id="O2" value="32"/>
                    <count group_id="O3" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="3"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Genitalia (Male): EOT, Stage 3</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="50"/>
                    <count group_id="O2" value="32"/>
                    <count group_id="O3" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Genitalia (Male): EOT, Stage 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="50"/>
                    <count group_id="O2" value="32"/>
                    <count group_id="O3" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="15"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Genitalia (Male): EOT, Stage 5</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="50"/>
                    <count group_id="O2" value="32"/>
                    <count group_id="O3" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="23"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Genitalia (Male): FU-12, Stage 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="47"/>
                    <count group_id="O2" value="30"/>
                    <count group_id="O3" value="14"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="26"/>
                    <measurement group_id="O3" value="14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Genitalia (Male): FU-12, Stage 2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="47"/>
                    <count group_id="O2" value="30"/>
                    <count group_id="O3" value="14"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="3"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Genitalia (Male): FU-12, Stage 3</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="47"/>
                    <count group_id="O2" value="30"/>
                    <count group_id="O3" value="14"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Genitalia (Male): FU-12, Stage 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="47"/>
                    <count group_id="O2" value="30"/>
                    <count group_id="O3" value="14"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Genitalia (Male): FU-12, Stage 5</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="47"/>
                    <count group_id="O2" value="30"/>
                    <count group_id="O3" value="14"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="24"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Genitalia (Male): FU-24, Stage 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="45"/>
                    <count group_id="O2" value="32"/>
                    <count group_id="O3" value="14"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="27"/>
                    <measurement group_id="O3" value="14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Genitalia (Male): FU-24, Stage 2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="45"/>
                    <count group_id="O2" value="32"/>
                    <count group_id="O3" value="14"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="4"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Genitalia (Male): FU-24, Stage 3</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="45"/>
                    <count group_id="O2" value="32"/>
                    <count group_id="O3" value="14"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Genitalia (Male): FU-24, Stage 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="45"/>
                    <count group_id="O2" value="32"/>
                    <count group_id="O3" value="14"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="13"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Genitalia (Male): FU-24, Stage 5</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="45"/>
                    <count group_id="O2" value="32"/>
                    <count group_id="O3" value="14"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="25"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Pubic Hair (Female): Baseline, Stage 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="52"/>
                    <count group_id="O2" value="38"/>
                    <count group_id="O3" value="24"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="31"/>
                    <measurement group_id="O3" value="24"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Pubic Hair (Female): Baseline, Stage 2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="52"/>
                    <count group_id="O2" value="38"/>
                    <count group_id="O3" value="24"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="5"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Pubic Hair (Female): Baseline, Stage 3</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="52"/>
                    <count group_id="O2" value="38"/>
                    <count group_id="O3" value="24"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9"/>
                    <measurement group_id="O2" value="2"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Pubic Hair (Female): Baseline, Stage 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="52"/>
                    <count group_id="O2" value="38"/>
                    <count group_id="O3" value="24"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="16"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Pubic Hair (Female): Baseline, Stage 5</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="52"/>
                    <count group_id="O2" value="38"/>
                    <count group_id="O3" value="24"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="22"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Pubic Hair (Female): EOT, Stage 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="50"/>
                    <count group_id="O2" value="37"/>
                    <count group_id="O3" value="21"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="29"/>
                    <measurement group_id="O3" value="21"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Pubic Hair (Female): EOT, Stage 2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="50"/>
                    <count group_id="O2" value="37"/>
                    <count group_id="O3" value="21"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="5"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Pubic Hair (Female): EOT, Stage 3</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="50"/>
                    <count group_id="O2" value="37"/>
                    <count group_id="O3" value="21"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                    <measurement group_id="O2" value="2"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Pubic Hair (Female): EOT, Stage 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="50"/>
                    <count group_id="O2" value="37"/>
                    <count group_id="O3" value="21"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Pubic Hair (Female): EOT, Stage 5</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="50"/>
                    <count group_id="O2" value="37"/>
                    <count group_id="O3" value="21"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="30"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Pubic Hair (Female): FU-12, Stage 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="51"/>
                    <count group_id="O2" value="35"/>
                    <count group_id="O3" value="21"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="24"/>
                    <measurement group_id="O3" value="21"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Pubic Hair (Female): FU-12, Stage 2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="51"/>
                    <count group_id="O2" value="35"/>
                    <count group_id="O3" value="21"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="7"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Pubic Hair (Female): FU-12, Stage 3</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="51"/>
                    <count group_id="O2" value="35"/>
                    <count group_id="O3" value="21"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8"/>
                    <measurement group_id="O2" value="3"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Pubic Hair (Female): FU-12, Stage 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="51"/>
                    <count group_id="O2" value="35"/>
                    <count group_id="O3" value="21"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Pubic Hair (Female): FU-12, Stage 5</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="51"/>
                    <count group_id="O2" value="35"/>
                    <count group_id="O3" value="21"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="32"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Pubic Hair (Female): FU-24, Stage 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="50"/>
                    <count group_id="O2" value="35"/>
                    <count group_id="O3" value="21"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="24"/>
                    <measurement group_id="O3" value="20"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Pubic Hair (Female): FU-24, Stage 2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="50"/>
                    <count group_id="O2" value="35"/>
                    <count group_id="O3" value="21"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="6"/>
                    <measurement group_id="O3" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Pubic Hair (Female): FU-24, Stage 3</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="50"/>
                    <count group_id="O2" value="35"/>
                    <count group_id="O3" value="21"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Pubic Hair (Female): FU-24, Stage 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="50"/>
                    <count group_id="O2" value="35"/>
                    <count group_id="O3" value="21"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9"/>
                    <measurement group_id="O2" value="4"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Pubic Hair (Female): FU-24, Stage 5</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="50"/>
                    <count group_id="O2" value="35"/>
                    <count group_id="O3" value="21"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="31"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Breasts (Female): Baseline, Stage 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="52"/>
                    <count group_id="O2" value="38"/>
                    <count group_id="O3" value="24"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="29"/>
                    <measurement group_id="O3" value="24"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Breasts (Female): Baseline, Stage 2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="52"/>
                    <count group_id="O2" value="38"/>
                    <count group_id="O3" value="24"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                    <measurement group_id="O2" value="6"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Breasts (Female): Baseline, Stage 3</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="52"/>
                    <count group_id="O2" value="38"/>
                    <count group_id="O3" value="24"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                    <measurement group_id="O2" value="3"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Breasts (Female): Baseline, Stage 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="52"/>
                    <count group_id="O2" value="38"/>
                    <count group_id="O3" value="24"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="17"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Breasts (Female): Baseline, Stage 5</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="52"/>
                    <count group_id="O2" value="38"/>
                    <count group_id="O3" value="24"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="23"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Breasts (Female): EOT, Stage 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="50"/>
                    <count group_id="O2" value="37"/>
                    <count group_id="O3" value="21"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="25"/>
                    <measurement group_id="O3" value="21"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Breasts (Female): EOT, Stage 2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="50"/>
                    <count group_id="O2" value="37"/>
                    <count group_id="O3" value="21"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="9"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Breasts (Female): EOT, Stage 3</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="50"/>
                    <count group_id="O2" value="37"/>
                    <count group_id="O3" value="21"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                    <measurement group_id="O2" value="2"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Breasts (Female): EOT, Stage 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="50"/>
                    <count group_id="O2" value="37"/>
                    <count group_id="O3" value="21"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="14"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Breasts (Female): EOT, Stage 5</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="50"/>
                    <count group_id="O2" value="37"/>
                    <count group_id="O3" value="21"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="27"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Breasts (Female): FU-12, Stage 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="51"/>
                    <count group_id="O2" value="35"/>
                    <count group_id="O3" value="21"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="20"/>
                    <measurement group_id="O3" value="21"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Breasts (Female): FU-12, Stage 2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="51"/>
                    <count group_id="O2" value="35"/>
                    <count group_id="O3" value="21"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="11"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Breasts (Female): FU-12, Stage 3</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="51"/>
                    <count group_id="O2" value="35"/>
                    <count group_id="O3" value="21"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                    <measurement group_id="O2" value="2"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Breasts (Female): FU-12, Stage 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="51"/>
                    <count group_id="O2" value="35"/>
                    <count group_id="O3" value="21"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="15"/>
                    <measurement group_id="O2" value="2"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Breasts (Female): FU-12, Stage 5</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="51"/>
                    <count group_id="O2" value="35"/>
                    <count group_id="O3" value="21"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="28"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Breasts (Female): FU-24, Stage 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="50"/>
                    <count group_id="O2" value="35"/>
                    <count group_id="O3" value="21"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="20"/>
                    <measurement group_id="O3" value="20"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Breasts (Female): FU-24, Stage 2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="50"/>
                    <count group_id="O2" value="35"/>
                    <count group_id="O3" value="21"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="10"/>
                    <measurement group_id="O3" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Breasts (Female): FU-24, Stage 3</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="50"/>
                    <count group_id="O2" value="35"/>
                    <count group_id="O3" value="21"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                    <measurement group_id="O2" value="3"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Breasts (Female): FU-24, Stage 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="50"/>
                    <count group_id="O2" value="35"/>
                    <count group_id="O3" value="21"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="13"/>
                    <measurement group_id="O2" value="2"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Breasts (Female): FU-24, Stage 5</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="50"/>
                    <count group_id="O2" value="35"/>
                    <count group_id="O3" value="21"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="30"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Treatment Phase: Growth and Development as Measured by Parental Height</title>
        <description>Mid-parental height was calculated as the average of the biological father's and mother's heights. For boys, the sex-adjusted mid-parental height was calculated by adding 2.5 inches or 6.5 cm to the mean of the parents' heights. For girls, 2.5 inches or 6.5 cm was subtracted from the mean of the parents' heights.</description>
        <time_frame>Day 1</time_frame>
        <population>Participants in the Safety Analysis Set with available data were analyzed.</population>
        <group_list>
          <group group_id="O1">
            <title>12 to &lt; 18 Years Old</title>
            <description>Treatment Phase: SOF/VEL 400/100 mg (adult and smaller size tablets based on swallowability assessment) once daily for 12 weeks.</description>
          </group>
          <group group_id="O2">
            <title>6 to &lt; 12 Years Old</title>
            <description>Treatment Phase: SOF/VEL FDC 200/50 mg tablets or oral granules once daily for 12 weeks.</description>
          </group>
          <group group_id="O3">
            <title>3 to &lt; 6 Years Old</title>
            <description>Treatment Phase: SOF/VEL FDC 200/50 mg oral granules once daily for 12 weeks for participants who weighed ≥ 17 kg. SOF/VEL FDC 150/37.5 mg oral granules once daily for 12 weeks for participants who weighed &lt; 17 kg.</description>
          </group>
        </group_list>
        <measure>
          <title>Treatment Phase: Growth and Development as Measured by Parental Height</title>
          <description>Mid-parental height was calculated as the average of the biological father's and mother's heights. For boys, the sex-adjusted mid-parental height was calculated by adding 2.5 inches or 6.5 cm to the mean of the parents' heights. For girls, 2.5 inches or 6.5 cm was subtracted from the mean of the parents' heights.</description>
          <population>Participants in the Safety Analysis Set with available data were analyzed.</population>
          <units>cm</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="53"/>
                <count group_id="O2" value="39"/>
                <count group_id="O3" value="23"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="170.5" lower_limit="162.0" upper_limit="176.7"/>
                    <measurement group_id="O2" value="170.0" lower_limit="163.7" upper_limit="178.6"/>
                    <measurement group_id="O3" value="168.7" lower_limit="163.0" upper_limit="174.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Treatment Phase: Change From Baseline in Growth and Development as Measured by Bone Age</title>
        <description>Bone age was determined based on x-ray of the left wrist, hand, and fingers. Baseline value is the last available value on or prior to first dose date of study drug.</description>
        <time_frame>Baseline; FU-24</time_frame>
        <population>Participants in the Full Analysis Set with available data were analyzed.</population>
        <group_list>
          <group group_id="O1">
            <title>12 to &lt; 18 Years Old</title>
            <description>Treatment Phase: SOF/VEL 400/100 mg (adult and smaller size tablets based on swallowability assessment) once daily for 12 weeks.</description>
          </group>
          <group group_id="O2">
            <title>6 to &lt; 12 Years Old</title>
            <description>Treatment Phase: SOF/VEL FDC 200/50 mg tablets or oral granules once daily for 12 weeks.</description>
          </group>
          <group group_id="O3">
            <title>3 to &lt; 6 Years Old</title>
            <description>Treatment Phase: SOF/VEL FDC 200/50 mg oral granules once daily for 12 weeks for participants who weighed ≥ 17 kg. SOF/VEL FDC 150/37.5 mg oral granules once daily for 12 weeks for participants who weighed &lt; 17 kg.</description>
          </group>
        </group_list>
        <measure>
          <title>Treatment Phase: Change From Baseline in Growth and Development as Measured by Bone Age</title>
          <description>Bone age was determined based on x-ray of the left wrist, hand, and fingers. Baseline value is the last available value on or prior to first dose date of study drug.</description>
          <population>Participants in the Full Analysis Set with available data were analyzed.</population>
          <units>years</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="102"/>
                <count group_id="O2" value="73"/>
                <count group_id="O3" value="41"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="102"/>
                    <count group_id="O2" value="72"/>
                    <count group_id="O3" value="40"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="15.5" lower_limit="13.5" upper_limit="17.0"/>
                    <measurement group_id="O2" value="7.8" lower_limit="6.8" upper_limit="9.0"/>
                    <measurement group_id="O3" value="4.8" lower_limit="4.2" upper_limit="5.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change From Baseline at FU-24</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="92"/>
                    <count group_id="O2" value="68"/>
                    <count group_id="O3" value="35"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.6" lower_limit="0.0" upper_limit="1.0"/>
                    <measurement group_id="O2" value="1.0" lower_limit="0.0" upper_limit="1.2"/>
                    <measurement group_id="O3" value="0.5" lower_limit="0.0" upper_limit="1.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Treatment Phase: Swallowability of SOF/VEL as Assessed by the Participant's Ability to Swallow SOF/VEL Placebo Tablets at Baseline</title>
        <description>A SOF/VEL FDC swallowability assessment was performed using placebo tablets at baseline.</description>
        <time_frame>Baseline</time_frame>
        <population>Participants in the Full Analysis Set with available data were analyzed. Swallowability assessment was performed in 12 to &lt;18 years old and 6 to &lt; 12 Years old only.</population>
        <group_list>
          <group group_id="O1">
            <title>12 to &lt; 18 Years Old</title>
            <description>Treatment Phase: SOF/VEL 400/100 mg (adult and smaller size tablets based on swallowability assessment) once daily for 12 weeks.</description>
          </group>
          <group group_id="O2">
            <title>6 to &lt; 12 Years Old</title>
            <description>Treatment Phase: SOF/VEL FDC 200/50 mg tablets or oral granules once daily for 12 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Treatment Phase: Swallowability of SOF/VEL as Assessed by the Participant's Ability to Swallow SOF/VEL Placebo Tablets at Baseline</title>
          <description>A SOF/VEL FDC swallowability assessment was performed using placebo tablets at baseline.</description>
          <population>Participants in the Full Analysis Set with available data were analyzed. Swallowability assessment was performed in 12 to &lt;18 years old and 6 to &lt; 12 Years old only.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="102"/>
                <count group_id="O2" value="73"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>SOF/VEL 400/100mg Placebo Tablet, Able to Swallow</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="102"/>
                    <count group_id="O2" value="1"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="92"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>SOF/VEL 400/100mg Placebo, Not Able to Swallow</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="102"/>
                    <count group_id="O2" value="1"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>SOF/VEL 200/50mg Placebo, Able to Swallow</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="10"/>
                    <count group_id="O2" value="73"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10"/>
                    <measurement group_id="O2" value="72"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>SOF/VEL 200/50mg Placebo, Not Able to Swallow</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="10"/>
                    <count group_id="O2" value="73"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Treatment Phase: Number of Participants With Acceptability of SOF/VEL as Measured by a Questionnaire to Assess Acceptability, Including Palatability at Day 1</title>
        <description>Acceptability was assessed by numeric response marked on line between numbers 0 - 100. Higher scores indicate better acceptability and/or palatability.</description>
        <time_frame>Day 1</time_frame>
        <population>Participants in the Full Analysis Set with available data were analyzed.</population>
        <group_list>
          <group group_id="O1">
            <title>12 to &lt; 18 Years Old</title>
            <description>Treatment Phase: SOF/VEL 400/100 mg (adult and smaller size tablets based on swallowability assessment) once daily for 12 weeks.</description>
          </group>
          <group group_id="O2">
            <title>12 to &lt;18 Years Old</title>
            <description>Treatment Phase: 2 * SOF/VEL 200/50 mg (adult and smaller size tablets based on swallowability assessment) once daily for 12 weeks.</description>
          </group>
          <group group_id="O3">
            <title>6 to &lt; 12 Years Old</title>
            <description>Treatment Phase: SOF/VEL FDC 200/50 mg tablets once daily for 12 weeks.</description>
          </group>
          <group group_id="O4">
            <title>6 to &lt;12 Years Old</title>
            <description>Treatment Phase: SOF/VEL FDC 200/50 mg oral granules once daily for 12 weeks.</description>
          </group>
          <group group_id="O5">
            <title>3 to &lt; 6 Years Old</title>
            <description>Treatment Phase: SOF/VEL FDC 200/50 mg oral granules once daily for 12 weeks for participants who weighed ≥ 17 kg.</description>
          </group>
          <group group_id="O6">
            <title>3 to &lt;6 Years Old</title>
            <description>SOF/VEL FDC 150/37.5 mg oral granules once daily for 12 weeks for participants who weighed &lt; 17 kg.</description>
          </group>
        </group_list>
        <measure>
          <title>Treatment Phase: Number of Participants With Acceptability of SOF/VEL as Measured by a Questionnaire to Assess Acceptability, Including Palatability at Day 1</title>
          <description>Acceptability was assessed by numeric response marked on line between numbers 0 - 100. Higher scores indicate better acceptability and/or palatability.</description>
          <population>Participants in the Full Analysis Set with available data were analyzed.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="91"/>
                <count group_id="O2" value="11"/>
                <count group_id="O3" value="72"/>
                <count group_id="O4" value="1"/>
                <count group_id="O5" value="29"/>
                <count group_id="O6" value="12"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Taste, Participants Who Did Not Taste Study Drug</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="91"/>
                    <count group_id="O2" value="11"/>
                    <count group_id="O3" value="71"/>
                    <count group_id="O4" value="1"/>
                    <count group_id="O5" value="27"/>
                    <count group_id="O6" value="12"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="61"/>
                    <measurement group_id="O2" value="5"/>
                    <measurement group_id="O3" value="42"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="8"/>
                    <measurement group_id="O6" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Taste, Participants Who Marked &gt; 60 to 100</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="91"/>
                    <count group_id="O2" value="11"/>
                    <count group_id="O3" value="71"/>
                    <count group_id="O4" value="1"/>
                    <count group_id="O5" value="27"/>
                    <count group_id="O6" value="12"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="16"/>
                    <measurement group_id="O2" value="3"/>
                    <measurement group_id="O3" value="11"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="6"/>
                    <measurement group_id="O6" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Taste, Participants Who Marked 40 to 60</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="91"/>
                    <count group_id="O2" value="11"/>
                    <count group_id="O3" value="71"/>
                    <count group_id="O4" value="1"/>
                    <count group_id="O5" value="27"/>
                    <count group_id="O6" value="12"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="6"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="4"/>
                    <measurement group_id="O6" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Taste, Participants Who Marked 0 to &lt; 40</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="91"/>
                    <count group_id="O2" value="11"/>
                    <count group_id="O3" value="71"/>
                    <count group_id="O4" value="1"/>
                    <count group_id="O5" value="27"/>
                    <count group_id="O6" value="12"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="2"/>
                    <measurement group_id="O3" value="12"/>
                    <measurement group_id="O4" value="1"/>
                    <measurement group_id="O5" value="9"/>
                    <measurement group_id="O6" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Easy to Take, Participants Who Marked &gt; 60 to 100</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="89"/>
                    <count group_id="O2" value="11"/>
                    <count group_id="O3" value="71"/>
                    <count group_id="O4" value="1"/>
                    <count group_id="O5" value="27"/>
                    <count group_id="O6" value="12"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="82"/>
                    <measurement group_id="O2" value="9"/>
                    <measurement group_id="O3" value="60"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="13"/>
                    <measurement group_id="O6" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Easy to Take, Participants Who Marked 40 to 60</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="89"/>
                    <count group_id="O2" value="11"/>
                    <count group_id="O3" value="71"/>
                    <count group_id="O4" value="1"/>
                    <count group_id="O5" value="27"/>
                    <count group_id="O6" value="12"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="3"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="4"/>
                    <measurement group_id="O6" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Easy to Take, Participants Who Marked 0 to &lt; 40</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="89"/>
                    <count group_id="O2" value="11"/>
                    <count group_id="O3" value="71"/>
                    <count group_id="O4" value="1"/>
                    <count group_id="O5" value="27"/>
                    <count group_id="O6" value="12"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="8"/>
                    <measurement group_id="O4" value="1"/>
                    <measurement group_id="O5" value="10"/>
                    <measurement group_id="O6" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Treatment Phase: Number of Participants With Acceptability of SOF/VEL as Measured by a Questionnaire to Assess Acceptability, Including Palatability at Week 12</title>
        <description>Acceptability was assessed by numeric response marked on line between numbers 0 - 100. Higher scores indicate better acceptability and/or palatability.</description>
        <time_frame>Week 12</time_frame>
        <population>Participants in the Full Analysis Set with available data were analyzed.</population>
        <group_list>
          <group group_id="O1">
            <title>12 to &lt; 18 Years Old</title>
            <description>Treatment Phase: SOF/VEL 400/100 mg (adult and smaller size tablets based on swallowability assessment) once daily for 12 weeks.</description>
          </group>
          <group group_id="O2">
            <title>12 to &lt;18 Years Old</title>
            <description>Treatment Phase: 2 * SOF/VEL 200/50 mg (adult and smaller size tablets based on swallowability assessment) once daily for 12 weeks.</description>
          </group>
          <group group_id="O3">
            <title>6 to &lt; 12 Years Old</title>
            <description>Treatment Phase: SOF/VEL FDC 200/50 mg tablets once daily for 12 weeks.</description>
          </group>
          <group group_id="O4">
            <title>6 to &lt;12 Years Old</title>
            <description>Treatment Phase: SOF/VEL FDC 200/50 mg oral granules once daily for 12 weeks.</description>
          </group>
          <group group_id="O5">
            <title>3 to &lt; 6 Years Old</title>
            <description>Treatment Phase: SOF/VEL FDC 200/50 mg oral granules once daily for 12 weeks for participants who weighed ≥ 17 kg.</description>
          </group>
          <group group_id="O6">
            <title>3 to &lt;6 Years Old</title>
            <description>SOF/VEL FDC 150/37.5 mg oral granules once daily for 12 weeks for participants who weighed &lt; 17 kg.</description>
          </group>
        </group_list>
        <measure>
          <title>Treatment Phase: Number of Participants With Acceptability of SOF/VEL as Measured by a Questionnaire to Assess Acceptability, Including Palatability at Week 12</title>
          <description>Acceptability was assessed by numeric response marked on line between numbers 0 - 100. Higher scores indicate better acceptability and/or palatability.</description>
          <population>Participants in the Full Analysis Set with available data were analyzed.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="91"/>
                <count group_id="O2" value="11"/>
                <count group_id="O3" value="72"/>
                <count group_id="O4" value="1"/>
                <count group_id="O5" value="29"/>
                <count group_id="O6" value="12"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Taste, Participants Who Did Not Taste Study Drug</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="90"/>
                    <count group_id="O2" value="11"/>
                    <count group_id="O3" value="70"/>
                    <count group_id="O4" value="1"/>
                    <count group_id="O5" value="23"/>
                    <count group_id="O6" value="8"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="49"/>
                    <measurement group_id="O2" value="2"/>
                    <measurement group_id="O3" value="33"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="8"/>
                    <measurement group_id="O6" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Taste, Participants Who Marked &gt; 60 to 100</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="90"/>
                    <count group_id="O2" value="11"/>
                    <count group_id="O3" value="70"/>
                    <count group_id="O4" value="1"/>
                    <count group_id="O5" value="23"/>
                    <count group_id="O6" value="8"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="24"/>
                    <measurement group_id="O2" value="5"/>
                    <measurement group_id="O3" value="14"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="4"/>
                    <measurement group_id="O6" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Taste, Participants Who Marked 40 to 60</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="90"/>
                    <count group_id="O2" value="11"/>
                    <count group_id="O3" value="70"/>
                    <count group_id="O4" value="1"/>
                    <count group_id="O5" value="23"/>
                    <count group_id="O6" value="8"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="12"/>
                    <measurement group_id="O4" value="1"/>
                    <measurement group_id="O5" value="4"/>
                    <measurement group_id="O6" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Taste, Participants Who Marked 0 to &lt; 40</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="90"/>
                    <count group_id="O2" value="11"/>
                    <count group_id="O3" value="70"/>
                    <count group_id="O4" value="1"/>
                    <count group_id="O5" value="23"/>
                    <count group_id="O6" value="8"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7"/>
                    <measurement group_id="O2" value="3"/>
                    <measurement group_id="O3" value="11"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="7"/>
                    <measurement group_id="O6" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Easy to Take, Participants Who Marked &gt; 60 to 100</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="89"/>
                    <count group_id="O2" value="11"/>
                    <count group_id="O3" value="70"/>
                    <count group_id="O4" value="1"/>
                    <count group_id="O5" value="23"/>
                    <count group_id="O6" value="8"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="83"/>
                    <measurement group_id="O2" value="9"/>
                    <measurement group_id="O3" value="65"/>
                    <measurement group_id="O4" value="1"/>
                    <measurement group_id="O5" value="20"/>
                    <measurement group_id="O6" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Easy to Take, Participants Who Marked 40 to 60</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="89"/>
                    <count group_id="O2" value="11"/>
                    <count group_id="O3" value="70"/>
                    <count group_id="O4" value="1"/>
                    <count group_id="O5" value="23"/>
                    <count group_id="O6" value="8"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="5"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="1"/>
                    <measurement group_id="O6" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Easy to Take, Participants Who Marked 0 to &lt; 40</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="89"/>
                    <count group_id="O2" value="11"/>
                    <count group_id="O3" value="70"/>
                    <count group_id="O4" value="1"/>
                    <count group_id="O5" value="23"/>
                    <count group_id="O6" value="8"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="2"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="2"/>
                    <measurement group_id="O6" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Feel About Taking Pills, Who Marked &gt; 60 to 100</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="88"/>
                    <count group_id="O2" value="11"/>
                    <count group_id="O3" value="70"/>
                    <count group_id="O4" value="1"/>
                    <count group_id="O5" value="23"/>
                    <count group_id="O6" value="12"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="82"/>
                    <measurement group_id="O2" value="8"/>
                    <measurement group_id="O3" value="60"/>
                    <measurement group_id="O4" value="NA">Data not applicable for the oral granules group.</measurement>
                    <measurement group_id="O5" value="NA">Data not applicable for the oral granules group.</measurement>
                    <measurement group_id="O6" value="NA">Data not applicable for the oral granules group.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Feel About Taking Pills, Who Marked 40 to 60</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="88"/>
                    <count group_id="O2" value="11"/>
                    <count group_id="O3" value="70"/>
                    <count group_id="O4" value="1"/>
                    <count group_id="O5" value="23"/>
                    <count group_id="O6" value="12"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="7"/>
                    <measurement group_id="O4" value="NA">Data not applicable for the oral granules group.</measurement>
                    <measurement group_id="O5" value="NA">Data not applicable for the oral granules group.</measurement>
                    <measurement group_id="O6" value="NA">Data not applicable for the oral granules group.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Feel About Taking Pills, Who Marked 0 to &lt; 40</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="88"/>
                    <count group_id="O2" value="11"/>
                    <count group_id="O3" value="70"/>
                    <count group_id="O4" value="1"/>
                    <count group_id="O5" value="23"/>
                    <count group_id="O6" value="12"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="2"/>
                    <measurement group_id="O3" value="3"/>
                    <measurement group_id="O4" value="NA">Data not applicable for the oral granules group.</measurement>
                    <measurement group_id="O5" value="NA">Data not applicable for the oral granules group.</measurement>
                    <measurement group_id="O6" value="NA">Data not applicable for the oral granules group.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Adverse Events: From first dose through last dose of the study drug (Up to 12 weeks) plus 30 days; All-Cause Mortality: First dose date up to Posttreatment Week 24</time_frame>
      <desc>The Safety Analysis Set included all participants who were enrolled into the study and received at least 1 dose of study drug (SOF/VEL FDC).</desc>
      <group_list>
        <group group_id="E1">
          <title>12 to &lt; 18 Years Old</title>
          <description>PK Lead-in Phase: Sofosbuvir/Velpatasvir (SOF/VEL) fixed-dose combination (FDC) 400/100 mg tablets once daily for 7 days. Participants who completed the PK lead-in phase, continued into the treatment phase with no interruption of study drug administration and additional participants were enrolled into the treatment phase once the appropriateness of the dose was confirmed by PK results from the PK lead-in phase.&#xD;
Treatment Phase: SOF/VEL 400/100 mg (adult and smaller size tablets based on swallowability assessment) once daily for 12 weeks.</description>
        </group>
        <group group_id="E2">
          <title>6 to &lt; 12 Years Old</title>
          <description>PK Lead-in Phase: SOF/VEL FDC 200/50 mg tablets or oral granules once daily for 7 days. Participants who completed the PK lead-in phase, continued into the treatment phase with no interruption of study drug administration and additional participants were enrolled into the treatment phase once the appropriateness of the dose was confirmed by PK results from the PK lead-in phase.&#xD;
Treatment Phase: SOF/VEL FDC 200/50 mg tablets or oral granules once daily for 12 weeks.</description>
        </group>
        <group group_id="E3">
          <title>3 to &lt; 6 Years Old</title>
          <description>PK Lead-in Phase: SOF/VEL FDC 200/50 mg oral granules once daily for 7 days for participants who weighed ≥ 17 kg. SOF/VEL FDC 150/37.5 mg oral granules once daily for 7 days for participants who weighed &lt; 17 kg. Participants who completed the PK lead-in phase, continued into the treatment phase with no interruption of study drug administration and additional participants were enrolled into the treatment phase once the appropriateness of the dose was confirmed by PK results from the PK lead-in phase.&#xD;
Treatment Phase: SOF/VEL FDC 200/50 mg oral granules once daily for 12 weeks for participants who weighed ≥ 17 kg. SOF/VEL FDC 150/37.5 mg oral granules once daily for 12 weeks for participants who weighed &lt; 17 kg.</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA Version 22.1</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="41"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="102"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="73"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="41"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Constipation</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="73"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="41"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Bipolar disorder</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="102"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="41"/>
              </event>
              <event>
                <sub_title>Hallucination, auditory</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="73"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="41"/>
              </event>
              <event>
                <sub_title>Suicidal ideation</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="102"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="41"/>
              </event>
              <event>
                <sub_title>Suicide attempt</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="102"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="41"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedDRA Version 22.1</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="65" subjects_at_risk="102"/>
                <counts group_id="E2" subjects_affected="53" subjects_at_risk="73"/>
                <counts group_id="E3" subjects_affected="26" subjects_at_risk="41"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Abdominal pain</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="102"/>
                <counts group_id="E2" subjects_affected="9" subjects_at_risk="73"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="41"/>
              </event>
              <event>
                <sub_title>Abdominal pain upper</sub_title>
                <counts group_id="E1" subjects_affected="10" subjects_at_risk="102"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="73"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="41"/>
              </event>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" subjects_affected="7" subjects_at_risk="102"/>
                <counts group_id="E2" subjects_affected="6" subjects_at_risk="73"/>
                <counts group_id="E3" subjects_affected="5" subjects_at_risk="41"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" subjects_affected="17" subjects_at_risk="102"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="73"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="41"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" subjects_affected="9" subjects_at_risk="102"/>
                <counts group_id="E2" subjects_affected="12" subjects_at_risk="73"/>
                <counts group_id="E3" subjects_affected="11" subjects_at_risk="41"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Fatigue</sub_title>
                <counts group_id="E1" subjects_affected="22" subjects_at_risk="102"/>
                <counts group_id="E2" subjects_affected="9" subjects_at_risk="73"/>
                <counts group_id="E3" subjects_affected="5" subjects_at_risk="41"/>
              </event>
              <event>
                <sub_title>Pyrexia</sub_title>
                <counts group_id="E1" subjects_affected="10" subjects_at_risk="102"/>
                <counts group_id="E2" subjects_affected="8" subjects_at_risk="73"/>
                <counts group_id="E3" subjects_affected="6" subjects_at_risk="41"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Nasopharyngitis</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="102"/>
                <counts group_id="E2" subjects_affected="7" subjects_at_risk="73"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="41"/>
              </event>
              <event>
                <sub_title>Upper respiratory tract infection</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="102"/>
                <counts group_id="E2" subjects_affected="7" subjects_at_risk="73"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="41"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Product use issue</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="73"/>
                <counts group_id="E3" subjects_affected="4" subjects_at_risk="41"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Decreased appetite</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="102"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="73"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="41"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Arthralgia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="102"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="73"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="41"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Dizziness</sub_title>
                <counts group_id="E1" subjects_affected="9" subjects_at_risk="102"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="73"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="41"/>
              </event>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" subjects_affected="30" subjects_at_risk="102"/>
                <counts group_id="E2" subjects_affected="11" subjects_at_risk="73"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="41"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Cough</sub_title>
                <counts group_id="E1" subjects_affected="10" subjects_at_risk="102"/>
                <counts group_id="E2" subjects_affected="11" subjects_at_risk="73"/>
                <counts group_id="E3" subjects_affected="6" subjects_at_risk="41"/>
              </event>
              <event>
                <sub_title>Epistaxis</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="102"/>
                <counts group_id="E2" subjects_affected="6" subjects_at_risk="73"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="41"/>
              </event>
              <event>
                <sub_title>Nasal congestion</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="102"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="73"/>
                <counts group_id="E3" subjects_affected="5" subjects_at_risk="41"/>
              </event>
              <event>
                <sub_title>Oropharyngeal pain</sub_title>
                <counts group_id="E1" subjects_affected="9" subjects_at_risk="102"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="73"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="41"/>
              </event>
              <event>
                <sub_title>Rhinorrhoea</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="102"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="73"/>
                <counts group_id="E3" subjects_affected="6" subjects_at_risk="41"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Rash</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E2" subjects_affected="7" subjects_at_risk="73"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="41"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>After conclusion of the study and without prior written approval from Gilead, investigators in this study may communicate, orally present, or publish in scientific journals or other media only after the following conditions have been met:&#xD;
The results of the study in their entirety have been publicly disclosed by or with the consent of Gilead in an abstract, manuscript, or presentation form; or The study has been completed at all study sites for at least 2 years.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Gilead Clinical Study Information Center</name_or_title>
      <organization>Gilead Sciences</organization>
      <phone>1-833-445-3230 (GILEAD-0)</phone>
      <email>GileadClinicalTrials@gilead.com</email>
    </point_of_contact>
  </clinical_results>
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03022981
org study id: GS-US-342-1143
secondary id: 2016-002446-23
nct id: NCT03022981
lead sponsor: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
This study will have 2 parts: Pharmacokinetics (PK) Lead-in Phase and the Treatment Phase.

      The primary objective of the PK Lead-in Phase is to evaluate the steady state PK and confirm
      the dose of sofosbuvir/velpatasvir (SOF/VEL) fixed-dose combination (FDC) in pediatric
      participants with chronic hepatitis C virus (HCV) infection.

      The primary objective of the Treatment Phase is to evaluate the safety and tolerability of
      SOF/VEL for 12 weeks in pediatric participants with chronic HCV.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: PK Lead-in Phase: AUCtau: Area Under the Plasma Concentration Versus Time Curve Over the Dosing Interval of Velpatasvir (VEL)
time frame: Day 7: 0 (predose), 0.5, 1, 2, 3, 4, 6 (Cohorts 1 and 2 only), 8, and 12 hours postdose
description: AUCtau is defined as concentration of drug over time (the area under the concentration versus time curve over the dosing interval).
measure: PK Lead-in Phase: AUCtau: Area Under the Plasma Concentration Versus Time Curve Over the Dosing Interval of Sofosbuvir (SOF)
time frame: Day 7: 0 (predose), 0.5, 1, 2, 3, 4, 6 (Cohorts 1 and 2 only), 8, and 12 hours postdose
description: AUCtau is defined as concentration of drug over time (the area under the concentration versus time curve over the dosing interval).
measure: PK Lead-in Phase: AUCtau: Area Under the Plasma Concentration Versus Time Curve Over the Dosing Interval of GS-331007 (Metabolite of SOF)
time frame: Day 7: 0 (predose), 0.5, 1, 2, 3, 4, 6 (Cohorts 1 and 2 only), 8, and 12 hours postdose
description: AUCtau is defined as concentration of drug over time (the area under the concentration verses time curve over the dosing interval).
measure: Treatment Phase: Percentage of Participants Who Discontinued Study Drug Due to Any Treatment-Emergent Adverse Event (TEAE)
time frame: From first dose through last dose of the study drug (Up to 12 weeks) plus 30 days
description: An AE is any untoward medical occurrence in a clinical study participant administered a medicinal product, which does not necessarily have a causal relationship with the treatment. An AE can therefore be any unfavorable and/or unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. TEAEs were defined as 1 or both of the following: Any AEs with an onset date on or after the study drug start date and no later than 30 days after permanent discontinuation of study drug and/or Any AEs leading to premature discontinuation of study drug.
measure: PK Lead-in Phase: Change From Baseline in Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) at Day 7
time frame: Baseline; Day 7
measure: PK Lead-in Phase: Percentage of Participants Who Permanently Discontinued Study Drug Due to an Adverse Event (AE)
time frame: First dose date up to Day 7
description: An AE is any untoward medical occurrence in a clinical study participant administered a medicinal product, which does not necessarily have a causal relationship with the treatment. An AE can therefore be any unfavorable and/or unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
measure: Treatment Phase: Percentage of Participants With Sustained Virologic Response (SVR) at 12 Weeks After Discontinuation of Therapy (SVR12)
time frame: Posttreatment Week 12
description: SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ; ie, 15 IU/mL) at 12 weeks after stopping study treatment.
measure: Treatment Phase: Percentage of Participants With SVR at 4 Weeks After Discontinuation of Therapy (SVR4)
time frame: Posttreatment Week 4
description: SVR4 was defined as HCV RNA < LLOQ (ie, 15 IU/mL) at 4 weeks after stopping study treatment.
measure: Treatment Phase: Percentage of Participants With SVR at 24 Weeks After Discontinuation of Therapy (SVR24)
time frame: Posttreatment Week 24
description: SVR 24 was defined as HCV RNA < LLOQ (ie, 15 IU/mL) at 24 weeks after stopping study treatment.
measure: Treatment Phase: Percentage of Participants With Virologic Failure
time frame: Up to Posttreatment Week 24
description: Virologic failure was defined as: On-treatment virologic failure - Breakthrough (confirmed HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ while on treatment), or Rebound (confirmed > 1 log10 IU/mL increase in HCV RNA from nadir while on treatment), or Non-response (HCV RNA persistently ≥ LLOQ through 8 weeks of treatment); Virologic relapse: Confirmed HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA < LLOQ at last on-treatment visit.
measure: Treatment Phase: Percentage of Participants With HCV RNA < LLOQ On Treatment
time frame: Weeks 1, 4, 8, and 12
description: Percentage of participants with HCV RNA < LLOQ while on treatment by analysis visit.
measure: Treatment Phase: Percentage of Participants Who Develop Viral Resistance to SOF and/or VEL During Treatment and After Discontinuation of Treatment
time frame: First dose date up to Posttreatment Week 24
description: Drug-resistant substitutions were analyzed as part of the Virology Study. Plasma samples were collected and stored for potential HCV sequencing. Impact on the treatment outcomes of SVR12 and SVR24 were observed during the study. Baseline deep sequencing of the HCV nonstructural protein (NS)5A and NS5B genes was performed for all participants at the first time point after virologic failure if the plasma or serum sample was available. Pretreatment full-length NS5A deep sequencing data were obtained at a 15% assay cutoff for the Resistance Analysis Population which covered all NS5A and NS5B nucleoside inhibitor (NI) resistance-associated variants (RAVs).
measure: Treatment Phase: Change From Baseline in HCV RNA at Weeks 1, 4, 8, and 12
time frame: Baseline; Weeks 1, 4, 8, and 12
measure: Treatment Phase: Quality of Life (QoL) and Neuropsychiatric Assessments as Measured by PedsQL™ Pediatric QoL Survey
time frame: Baseline; Week 12, End of Treatment (EOT), Posttreatment/Follow-up (FU) Week-12 (FU-12), and FU Week-24 (FU-24)
description: To evaluate the effect of treatment with SOF/VEL on general and disease-specific health-related QoL, the PedsQL™ Pediatric QoL Inventory V4.0 Short Form (SF15) was completed at Day 1, end of treatment, early termination (if applicable), and posttreatment Weeks 12 and 24. The SF15 questionnaire represented 4 domains: physical, emotional, social, and school functioning, with the emotional, social, and school functioning domains representing the psychosocial health summary. Neuropsychiatric assessment was conducted using the PedsQL™ Pediatric QoL Inventory V4.0 SF15 psychosocial domain-related scores. Items were calculated and transformed into an overall score with a range of 0 to 100 points, with more points indicating better QoL.
measure: Treatment Phase: Change From Baseline in Growth and Development as Measured by Height Percentiles
time frame: Baseline; Weeks 1, 4, 8, 12, Follow-up (FU) Week 4 (FU-4), FU-12, and FU-24
description: An age- and sex-specific percentile was derived for each weight, height, and body mass index (BMI) measurement according to the statistical analysis system (SAS) program available on the Centers for Disease Control and Prevention (CDC) website using the year 2000 growth charts.
measure: Treatment Phase: Change From Baseline in Growth and Development as Measured by Weight Percentiles
time frame: Baseline; Weeks 1, 4, 8, 12, FU-4, FU-12, and FU-24
description: An age- and sex-specific percentile was derived for each weight, height, and BMI measurement according to the SAS program available on the CDC website using the year 2000 growth charts.
measure: Treatment Phase: Changes in Growth and Development as Measured by Tanner Stage Assessment From Baseline
time frame: Baseline; EOT, FU-12 and FU-24
description: Tanner Pubertal Staging was assessed for pubic hair growth and genitalia development (males) and for pubic hair growth and breast development (females) in stages 1 to 5. Tanner stages were used to evaluate the onset and progression of pubertal changes from stage 1 (pre-pubertal) to stage 5 (adult). If a participant had reached Tanner stage 5, no further Tanner pubertal stage assessments were to be completed. Pubic hair growth: Tanner stages (1: No hair, 2: Downy hair, 3: More coarse and curly hair, 4: Adult-like hair quality; 5: Hair extends to the medial surface of the thighs); Breast development: Tanner stages (1: No glandular tissue, 2: Breast bud forms,3: More elevated, outside areola, 4: Increased breast size,5: Final adult-size breasts); Genitalia development: Tanner stages (1: Testes, scrotum, and penis about same size, 2: Enlargement of scrotum, testes and penis, 3: Enlargement of penis, 4: Penis size enlargement, 5: Genitalia adult in size and shape).
measure: Treatment Phase: Growth and Development as Measured by Parental Height
time frame: Day 1
description: Mid-parental height was calculated as the average of the biological father's and mother's heights. For boys, the sex-adjusted mid-parental height was calculated by adding 2.5 inches or 6.5 cm to the mean of the parents' heights. For girls, 2.5 inches or 6.5 cm was subtracted from the mean of the parents' heights.
measure: Treatment Phase: Change From Baseline in Growth and Development as Measured by Bone Age
time frame: Baseline; FU-24
description: Bone age was determined based on x-ray of the left wrist, hand, and fingers. Baseline value is the last available value on or prior to first dose date of study drug.
measure: Treatment Phase: Swallowability of SOF/VEL as Assessed by the Participant's Ability to Swallow SOF/VEL Placebo Tablets at Baseline
time frame: Baseline
description: A SOF/VEL FDC swallowability assessment was performed using placebo tablets at baseline.
measure: Treatment Phase: Number of Participants With Acceptability of SOF/VEL as Measured by a Questionnaire to Assess Acceptability, Including Palatability at Day 1
time frame: Day 1
description: Acceptability was assessed by numeric response marked on line between numbers 0 - 100. Higher scores indicate better acceptability and/or palatability.
measure: Treatment Phase: Number of Participants With Acceptability of SOF/VEL as Measured by a Questionnaire to Assess Acceptability, Including Palatability at Week 12
time frame: Week 12
description: Acceptability was assessed by numeric response marked on line between numbers 0 - 100. Higher scores indicate better acceptability and/or palatability.
arm group label: 12 to < 18 Years Old
arm group type: Experimental
description: PK Lead-in Phase: Sofosbuvir/Velpatasvir (SOF/VEL) 400/100 mg once daily for 7 days. Participants who complete the PK lead-in phase, continue into the treatment phase with no interruption of study drug administration and additional participants will be enrolled into the treatment phase once the appropriateness of the dose is confirmed by PK results from the PK lead-in phase.
Treatment Phase: SOF/VEL 400/100 mg once daily for 12 weeks.
arm group label: 6 to < 12 Years Old
arm group type: Experimental
description: PK Lead-in Phase: SOF/VEL 200/50 mg once daily for 7 days. Participants who complete the PK lead-in phase, continue into the treatment phase with no interruption of study drug administration and additional participants will be enrolled into the treatment phase once the appropriateness of the dose is confirmed by PK results from the PK lead-in phase.
Treatment Phase: SOF/VEL 200/50 mg once daily for 12 weeks.
arm group label: 3 to < 6 Years Old
arm group type: Experimental
description: PK Lead-in Phase: SOF/VEL 200/50 mg once daily for 7 days for participants who weigh ≥ 17 kg. SOF/VEL 150/37.5 mg once daily for 7 days for participants who weigh < 17 kg. Participants who complete the PK lead-in phase, continue into the treatment phase with no interruption of study drug administration and additional participants will be enrolled into the treatment phase once the appropriateness of the dose is confirmed by PK results from the PK lead-in phase.
Treatment Phase: SOF/VEL 200/50 mg once daily for 12 weeks for participants who weigh ≥ 17 kg. SOF/VEL 150/37.5 mg once daily for 12 weeks for participants who weigh < 17 kg.
intervention type: Drug
intervention name: SOF/VEL
description: SOF/VEL fixed-dose combination (FDC) 400/100 mg tablets or SOF/VEL FDC 200/50 mg tablets (based on swallowability assessment)
arm group label: 12 to < 18 Years Old
arm group label: 6 to < 12 Years Old
other name: Epclusa®
other name: GS-7977/GS-5816
intervention type: Drug
intervention name: SOF/VEL
description: SOF/VEL FDC 200/50 mg oral granules
arm group label: 3 to < 6 Years Old
other name: Epclusa®
other name: GS-7977/GS-5816
criteria: 
gender: All
minimum age: 3 Years
maximum age: 17 Years
healthy volunteers: No
last name: Gilead Study Director
role: Study Director
affiliation: Gilead Sciences
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country: Belgium
country: Italy
country: United Kingdom
country: United States
citation: Jonas MM, Romero R, Sokal EM, Rosenthal P, Verucchi G, Lin CH, et al. The Safety and Efficacy of Sofosbuvir/Velpatasvir in Pediatric Patients 6 to < 18 years old with Chronic Hepatitis C Infection [Abstract]. AASLD; 2019 08-12 November; Boston, Massachusetts.
responsible party type: Sponsor
mesh term: Infections
mesh term: Communicable Diseases
mesh term: Hepatitis C
mesh term: Sofosbuvir
mesh term: Sofosbuvir-velpatasvir drug combination
mesh term: Velpatasvir
sharing ipd: Yes
ipd description: Qualified external researchers may request IPD for this study after study completion. For more information, please visit our website at https://www.gilead.com/science-and-medicine/research/clinical-trials-transparency-and-data-sharing-policy
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd time frame: 18 months after study completion
ipd access criteria: A secured external environment with username, password, and RSA code.
ipd url: https://www.gilead.com/science-and-medicine/research/clinical-trials-transparency-and-data-sharing-policy
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 