<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/NCT02249182</url>
  </required_header>
  <id_info>
    <org_study_id>GS-US-337-1116</org_study_id>
    <secondary_id>2014-003578-17</secondary_id>
    <nct_id>NCT02249182</nct_id>
  </id_info>
  <brief_title>Safety and Efficacy of Ledipasvir/Sofosbuvir Fixed Dose Combination +/- Ribavirin 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 Ledipasvir/Sofosbuvir Fixed Dose Combination +/- Ribavirin 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>
      The primary objective of the PK Lead-in Phase of the study is to evaluate the steady state&#xD;
      pharmacokinetics (PK) and confirm the dose of ledipasvir/sofosbuvir (LDV/SOF) fixed dose&#xD;
      combination (FDC) in hepatitis C virus (HCV)-infected pediatric participants. The PK Lead-in&#xD;
      Phase will also evaluate the safety, tolerability, and antiviral activity of 10 days of&#xD;
      dosing of LDV/SOF FDC in HCV-infected pediatric participants.&#xD;
&#xD;
      The Treatment Phase will be initiated by age cohort after confirmation of age-appropriate&#xD;
      LDV/SOF FDC dosage levels. Participants from the PK Lead-in Phase will immediately rollover&#xD;
      into the Treatment Phase with no interruption of study drug administration. The primary&#xD;
      objective of the Treatment Phase is to evaluate the antiviral efficacy, safety, and&#xD;
      tolerability of LDV/SOF FDC +/- ribavirin (RBV) for 12 or 24 weeks in pediatric participants&#xD;
      with HCV.&#xD;
&#xD;
      During screening, participants will receive placebo to match LDV/SOF FDC to assess ability to&#xD;
      swallow tablets.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 5, 2014</start_date>
  <completion_date type="Actual">August 24, 2018</completion_date>
  <primary_completion_date type="Actual">June 15, 2018</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>For Participants in the PK Lead-in Phase, Pharmacokinetic (PK) Parameter: AUCtau of GS-331007 (Metabolite of SOF), LDV, and SOF</measure>
    <time_frame>Cohorts 1 and 2 (6 to &lt; 18 years of age): predose, 0.5, 1, 2, 3, 4, 5, 8, and 12 hours postdose on Day 10; Cohort 3 (3 to &lt; 6 years of age): predose, 0.5, 2, 4, 8, and 12 hours postdose on Day 10</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>Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event During the PK Lead-in Phase or the Treatment Phase</measure>
    <time_frame>Up to 24 weeks</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>For Participants in the PK Lead-in Phase, Change From Baseline in HCV RNA</measure>
    <time_frame>Baseline; Weeks 1, 2, 4, 8, and 12</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event During the PK Lead-in Phase</measure>
    <time_frame>Up to Day 10</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>For the Treatment Phase, Percentage of Participants With Sustained Virologic Response (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; the lower limit of quantitation (LLOQ; ie, 15 IU/mL) at 4 weeks after stopping study treatment.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>For the Treatment Phase, Percentage of Participants With 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; LLOQ at 12 weeks after stopping study treatment.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>For the Treatment Phase, Percentage of Participants With SVR at 24 Weeks After Discontinuation of Therapy (SVR24)</measure>
    <time_frame>Posttreatment Week 24</time_frame>
    <description>SVR24 was defined as HCV RNA &lt; LLOQ at 24 weeks after stopping study treatment.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>For the Treatment Phase, Percentage of Participants Experiencing Viral Breakthrough</measure>
    <time_frame>Up to 24 weeks</time_frame>
    <description>Viral breakthrough was defined as having confirmed HCV RNA ≥ LLOQ after having previously had HCV RNA &lt; LLOQ while on treatment.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>For the Treatment Phase, Percentage of Participants Experiencing Viral Relapse</measure>
    <time_frame>Up to Posttreatment Week 24</time_frame>
    <description>Viral relapse was defined as having 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>For the Treatment Phase, Change From Baseline in HCV RNA</measure>
    <time_frame>Baseline; Weeks 1, 2, 4, 8, 12, 16 (24 Week groups only), 20 (24 Week groups only), and 24 (24 Week groups only)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>For the Treatment Phase, Percentage of Participants With HCV RNA &lt; LLOQ While On Treatment</measure>
    <time_frame>Weeks 1, 2, 4, 8, 12, 16 (24 Week groups only), 20 (24 Week groups only), and 24 (24 Week groups only)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>For the Treatment Phase, Percentage of Participants With Alanine Aminotransferase (ALT) Normalization</measure>
    <time_frame>Weeks 1, 2, 4, 8, 12, 16 (24 Week groups only), 20 (24 Week groups only), and 24 (24 Week groups only), and Posttreatment Week 4</time_frame>
    <description>ALT normalization was defined as ALT &gt; the upper limit of normal (ULN) at baseline and ALT ≤ ULN at each visit.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>For the Treatment Phase, Change From Baseline in Height</measure>
    <time_frame>Baseline; Weeks 1, 2, 4, 8, 12, 16 (24 Week groups only), 20 (24 Week groups only), and 24 (24 Week groups only), and Posttreatment Weeks 4, 12, and 24</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>For the Treatment Phase, Change From Baseline in Weight</measure>
    <time_frame>Baseline; Weeks 1, 2, 4, 8, 12, 16 (24 Week groups only), 20 (24 Week groups only), and 24 (24 Week groups only), and Posttreatment Weeks 4, 12, and 24</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>For the Treatment Phase, Number of Male Participants With a Change From Baseline in Tanner Stage for Pubic Hair</measure>
    <time_frame>Baseline; End of Treatment (either Week 12 or 24), Posttreatment Week 12, and Posttreatment Week 24</time_frame>
    <description>Tanner Stages is a scale that defines physical measurements of development based on external primary and secondary sex characteristics. It was used in this study to assess pubertal development with values ranging from Stage 1 (pre-pubertal characteristics) to Stage 5 (adult or mature characteristics). Any shifts (increase or decrease) in Tanner Stage from Baseline were analyzed and presented.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>For the Treatment Phase, Number of Male Participants With a Change From Baseline in Tanner Stage for Genitalia Development</measure>
    <time_frame>Baseline; End of Treatment (either Week 12 or 24), Posttreatment Week 12, and Posttreatment Week 24</time_frame>
    <description>Tanner Stages is a scale that defines physical measurements of development based on external primary and secondary sex characteristics. It was used in this study to assess pubertal development with values ranging from Stage 1 (pre-pubertal characteristics) to Stage 5 (adult or mature characteristics). Any shifts (increase or decrease) in Tanner Stage from Baseline were analyzed and presented.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>For the Treatment Phase, Number of Female Participants With a Change From Baseline in Tanner Stage for Pubic Hair</measure>
    <time_frame>Baseline; End of Treatment (either Week 12 or 24), Posttreatment Week 12, and Posttreatment Week 24</time_frame>
    <description>Tanner Stages is a scale that defines physical measurements of development based on external primary and secondary sex characteristics. It was used in this study to assess pubertal development with values ranging from Stage 1 (pre-pubertal characteristics) to Stage 5 (adult or mature characteristics). Any shifts (increase or decrease) in Tanner Stage from Baseline were analyzed and presented.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>For the Treatment Phase, Number of Female Participants With a Change From Baseline in Tanner Stage for Breast Development</measure>
    <time_frame>Baseline; End of Treatment (either Week 12 or 24), Posttreatment Week 12, and Posttreatment Week 24</time_frame>
    <description>Tanner Stages is a scale that defines physical measurements of development based on external primary and secondary sex characteristics. It was used in this study to assess pubertal development with values ranging from Stage 1 (pre-pubertal characteristics) to Stage 5 (adult or mature characteristics). Any shifts (increase or decrease) in Tanner Stage from Baseline were analyzed and presented.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Acceptability of LDV/SOF Tablets as Measured by the Percentage of Participants Able/Unable to Swallow Placebo Tablet at Day 1</measure>
    <time_frame>Day 1</time_frame>
    <description>Participants who were able/unable to swallow placebo tablets were assessed. Participants 12 to &lt; 18 years old were first asked to perform the swallowability assessment using the 90/400 mg placebo tablet. If they were unable to swallow this, they were then asked to perform the swallowability assessment with 22.5/100 mg placebo tablets. Participants 6 to &lt; 12 years old were to be assessed with the 22.5/100 mg placebo tablets. However, 8 participants were mistakenly assessed using the 90/400 mg placebo tablet.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Acceptability of LDV/SOF Granules as Measured by Palatability at Day 1</measure>
    <time_frame>Day 1</time_frame>
    <description>Participants who were dosed with granules were asked if they tasted the study drug. If they tasted it, then they were asked to provide a number from 0 to 100 to rate the taste of the study drug, with higher scores indicating better taste. Data was then summarized as percentage of participants choosing the following palatability categories: 1) Did not taste the study drug, 2) Tasted drug with score &gt; 60 to 100, 3) Tasted drug with score 40 to 60, and 4) Tasted drug with score of 0 to &lt; 40.</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">226</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>Participants between 12 to &lt; 18 years of age weighing ≥ 45 kg will receive LDV/SOF FDC (90/400 mg tablet or 4 x 22.5 mg/100 mg tablets or 8 x 11.25/50 mg granules based on swallowability assessment during screening).&#xD;
Treatment duration will be dependent on HCV genotype, prior treatment experience, cirrhosis status, and country of enrollment.&#xD;
United Kingdom:&#xD;
HCV genotypes (GT) 1, 4, 5, or 6 treatment-naive (TN) with or without cirrhosis = LDV/SOF 12 weeks&#xD;
HCV GT 1, 4, 5, or 6 treatment-experienced (TE) without cirrhosis = LDV/SOF 12 weeks&#xD;
HCV GT 1, 4, 5, or 6 TE with cirrhosis = LDV/SOF 24 weeks&#xD;
HCV GT 3 TE with or without cirrhosis = LDV/SOF+RBV 24 weeks&#xD;
United States/Australia/New Zealand:&#xD;
HCV GT 1, 4, 5, or 6 TN with or without cirrhosis = LDV/SOF 12 weeks&#xD;
HCV GT 1, 4, 5, or 6 TE without cirrhosis = LDV/SOF 12 weeks&#xD;
HCV GT 1 TE with cirrhosis = LDV/SOF 24 weeks&#xD;
HCV GT 4, 5, or 6 TE with cirrhosis = LDV/SOF 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>Participants between 6 to &lt; 12 years of age weighing ≥ 17 kg and &lt; 45 kg will receive LDV/SOF FDC (45/200 mg as 2 x 22.5/100 mg tablets or 4 x 11.25/50 mg granules based on swallowability assessment during screening).&#xD;
Treatment duration will be dependent on HCV genotype, prior treatment experience, cirrhosis status, and country of enrollment.&#xD;
United Kingdom:&#xD;
HCV GT 1, 4, 5, or 6 TN with or without cirrhosis = LDV/SOF 12 weeks&#xD;
HCV GT 1, 4, 5, or 6 TE without cirrhosis = LDV/SOF 12 weeks&#xD;
HCV GT 1, 4, 5, or 6 TE with cirrhosis = LDV/SOF 24 weeks&#xD;
HCV GT 3 TE with or without cirrhosis = LDV/SOF+RBV 24 weeks&#xD;
United States/Australia/New Zealand:&#xD;
HCV GT 1, 4, 5, or 6 TN with or without cirrhosis = LDV/SOF 12 weeks&#xD;
HCV GT 1, 4, 5, or 6 TE without cirrhosis = LDV/SOF 12 weeks&#xD;
HCV GT 1 TE with cirrhosis = LDV/SOF 24 weeks&#xD;
HCV GT 4, 5, or 6 TE with cirrhosis = LDV/SOF 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>Participants between 3 to &lt; 6 years of age weighing ≥ 17 kg will receive LDV/SOF FDC (45/200 mg granules as 4 x 11.25/50 mg packets) and participants weighing &lt; 17 kg will receive LDV/SOF FDC (33.75/150 mg oral granules as 3 x 11.25/50 mg packets).&#xD;
Treatment duration will be dependent on HCV genotype, prior treatment experience, cirrhosis status, and country of enrollment.&#xD;
United Kingdom:&#xD;
HCV GT 1, 4, 5, or 6 TN with or without cirrhosis = LDV/SOF 12 weeks&#xD;
HCV GT 1, 4, 5, or 6 TE without cirrhosis = LDV/SOF 12 weeks&#xD;
HCV GT 1, 4, 5, or 6 TE with cirrhosis = LDV/SOF 24 weeks&#xD;
HCV GT 3 TE with or without cirrhosis = LDV/SOF+RBV 24 weeks&#xD;
United States/Australia/New Zealand:&#xD;
HCV GT 1, 4, 5, or 6 TN with or without cirrhosis = LDV/SOF 12 weeks&#xD;
HCV GT 1, 4, 5, or 6 TE without cirrhosis = LDV/SOF 12 weeks&#xD;
HCV GT 1 TE with cirrhosis = LDV/SOF 24 weeks&#xD;
HCV GT 4, 5, or 6 TE with cirrhosis = LDV/SOF 12 weeks</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>LDV/SOF</intervention_name>
    <description>LDV/SOF FDC administered orally once daily</description>
    <arm_group_label>12 to &lt; 18 Years Old</arm_group_label>
    <arm_group_label>3 to &lt; 6 Years Old</arm_group_label>
    <arm_group_label>6 to &lt; 12 Years Old</arm_group_label>
    <other_name>Harvoni®</other_name>
    <other_name>GS-5885/GS-7977</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>RBV</intervention_name>
    <description>Ribavirin (RBV) oral solution or capsules will be administered orally in a divided daily dose based on weight</description>
    <arm_group_label>12 to &lt; 18 Years Old</arm_group_label>
    <arm_group_label>3 to &lt; 6 Years Old</arm_group_label>
    <arm_group_label>6 to &lt; 12 Years Old</arm_group_label>
    <other_name>REBETOL®</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Key Inclusion Criteria:&#xD;
&#xD;
          -  Consent of parent or legal guardian required&#xD;
&#xD;
          -  Chronic HCV infection&#xD;
&#xD;
          -  Screening laboratory values within defined thresholds&#xD;
&#xD;
        Key Exclusion Criteria:&#xD;
&#xD;
          -  History of clinically significant illness or any other medical disorder that may&#xD;
             interfere with individual's treatment, assessment or compliance with the protocol.&#xD;
&#xD;
          -  Co-infection with HIV, acute hepatitis A virus, or hepatitis B virus&#xD;
&#xD;
          -  Clinical hepatic decompensation (i.e., ascites, encephalopathy or variceal hemorrhage)&#xD;
&#xD;
          -  Pregnant or nursing females&#xD;
&#xD;
          -  Known hypersensitivity to study medication&#xD;
&#xD;
          -  Use of any prohibited concomitant medications as within 28 days of the Day 1 visit&#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>
      <address>
        <city>Birmingham</city>
        <state>Alabama</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>San Francisco</city>
        <state>California</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Aurora</city>
        <state>Colorado</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Washington</city>
        <state>District of Columbia</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Atlanta</city>
        <state>Georgia</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Indianapolis</city>
        <state>Indiana</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Louisville</city>
        <state>Kentucky</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Baltimore</city>
        <state>Maryland</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Saint Louis</city>
        <state>Missouri</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Omaha</city>
        <state>Nebraska</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>New York</city>
        <state>New York</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Chapel Hill</city>
        <state>North Carolina</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Cincinnati</city>
        <state>Ohio</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Columbus</city>
        <state>Ohio</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Nashville</city>
        <state>Tennessee</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Fort Worth</city>
        <state>Texas</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>San Antonio</city>
        <state>Texas</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Seattle</city>
        <state>Washington</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Morgantown</city>
        <state>West Virginia</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Newcastle</city>
        <state>New South Wales</state>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Westmead</city>
        <state>New South Wales</state>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Parkville</city>
        <state>Victoria</state>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Auckland</city>
        <country>New Zealand</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Birmingham</city>
        <state>England</state>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Leeds</city>
        <state>England</state>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>London</city>
        <state>England</state>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Glasgow</city>
        <state>Scotland</state>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Australia</country>
    <country>New Zealand</country>
    <country>United Kingdom</country>
    <country>United States</country>
  </location_countries>
  <results_reference>
    <citation>Kirby B, German P, Kanwar B, Ni L, Lakatos I, Ling J, Mathias A. Pharmacokinetics of Once-Daily Sofosbuvir and Ledipasvir/Sofosbuvir in HCV-Infected Adolescents. Hepatology 2015;62 (S1): 1040A-1041A</citation>
  </results_reference>
  <results_reference>
    <citation>Garrison KL, Mathias A, Kersey K, Kanwar B, Ni L, Jain A, et al. Pharmacokinetics of Once-Daily Sofosbuvir and Ledipasvir/Sofosbuvir in HCV-Infected Pediatrics Aged 6 to &lt; 12 Years Old. Hepatology 2016;64 (S1): 436A</citation>
  </results_reference>
  <results_reference>
    <citation>Schwarz K, Murray KF, Rosenthal P, Bansal S, Lin CH, Ni L, et al. High Rates of SVR12 in Adolescents Treated with the Combination of Ledipasvir/Sofosbuvir. J Hepatol 2016; 64 (2): S184-S185</citation>
  </results_reference>
  <results_reference>
    <citation>K.F. Murray, W. Balistreri, S. Bansal, S. Whitworth, H. Evans, R.P. Gonzalez-Peralta, et al. Ledipasvir/sofosbuvir ± ribavirin for 12 or 24 weeks is safe and effective in children 6-11 years old with chronic hepatitis C infection. J Hepatol 2017;66: S33-S62</citation>
  </results_reference>
  <results_reference>
    <citation>Balistreri WF, Murray KF, Rosenthal P, Bansal S, Lin CH, Kersey K, Massetto B, Zhu Y, Kanwar B, German P, Svarovskaia E, Brainard DM, Wen J, Gonzalez-Peralta RP, Jonas MM, Schwarz K. The safety and effectiveness of ledipasvir-sofosbuvir in adolescents 12-17 years old with hepatitis C virus genotype 1 infection. Hepatology. 2017 Aug;66(2):371-378. doi: 10.1002/hep.28995. Epub 2017 Jun 19.</citation>
    <PMID>27997679</PMID>
  </results_reference>
  <results_reference>
    <citation>Younossi ZM, Stepanova M, Balistreri W, Schwarz K, Murray KF, Rosenthal P, Bansal S, Hunt S. Health-related Quality of Life in Adolescent Patients With Hepatitis C Genotype 1 Treated With Sofosbuvir and Ledipasvir. J Pediatr Gastroenterol Nutr. 2018 Jan;66(1):112-116. doi: 10.1097/MPG.0000000000001754.</citation>
    <PMID>28957984</PMID>
  </results_reference>
  <results_reference>
    <citation>Begley R, Meng A, Massetto B, Shao J, Ling J, and Mathias A. Pharmacokinetics of Once Daily Sofosbuvir or Ledipasvir/Sofosbuvir in HCV-Infected Pediatrics Aged 3 to &lt;6 Years Old. Hepatology 2018;68 (S1): 582A.</citation>
  </results_reference>
  <results_reference>
    <citation>Schwarz KB, Rosenthal P, Murray KF, Honegger JR, Hardikar W, Hague R, et al. Ledipasvir/Sofosbuvir for 12 Weeks Is Safe and Effective in Children 3 to &lt;6 Years Old with Chronic Hepatitis C Virus Infection. Hepatology 2018;68 (S1): 116A-117A.</citation>
  </results_reference>
  <results_reference>
    <citation>Murray KF, Balistreri WF, Bansal S, Whitworth S, Evans HM, Gonzalez-Peralta RP, Wen J, Massetto B, Kersey K, Shao J, Garrison KL, Parhy B, Brainard DM, Arnon R, Gillis LA, Jonas MM, Lin CH, Narkewicz MR, Schwarz K, Rosenthal P. Safety and Efficacy of Ledipasvir-Sofosbuvir With or Without Ribavirin for Chronic Hepatitis C in Children Ages 6-11. Hepatology. 2018 Dec;68(6):2158-2166. doi: 10.1002/hep.30123. Epub 2018 Nov 17.</citation>
    <PMID>30070726</PMID>
  </results_reference>
  <verification_date>March 2019</verification_date>
  <study_first_submitted>September 23, 2014</study_first_submitted>
  <study_first_submitted_qc>September 23, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 25, 2014</study_first_posted>
  <results_first_submitted>February 15, 2019</results_first_submitted>
  <results_first_submitted_qc>March 29, 2019</results_first_submitted_qc>
  <results_first_posted type="Actual">April 24, 2019</results_first_posted>
  <last_update_submitted>February 18, 2020</last_update_submitted>
  <last_update_submitted_qc>February 18, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">March 2, 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>Ribavirin</mesh_term>
    <mesh_term>Sofosbuvir</mesh_term>
    <mesh_term>Ledipasvir, sofosbuvir drug combination</mesh_term>
    <mesh_term>Ledipasvir</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 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: Original</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>July 10, 2014</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/82/NCT02249182/Prot_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Study Protocol: Amendment 1</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>October 8, 2014</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/82/NCT02249182/Prot_001.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Study Protocol: Amendment 2</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>December 8, 2014</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/82/NCT02249182/Prot_002.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Study Protocol: Amendment 3</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>May 28, 2015</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/82/NCT02249182/Prot_003.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Study Protocol: Amendment 4</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>March 15, 2016</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/82/NCT02249182/Prot_004.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Study Protocol: Amendment 5</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>November 4, 2016</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/82/NCT02249182/Prot_005.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Study Protocol: Amendment 6</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 8, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/82/NCT02249182/Prot_006.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>July 10, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/82/NCT02249182/SAP_007.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Participants were enrolled at study sites in the United States, United Kingdom, Australia, and New Zealand. The first participant was screened on 05 November 2014. The last study visit occurred on 24 August 2018.</recruitment_details>
      <pre_assignment_details>240 participants were screened.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>12 to &lt; 18 Years Old - LDV/SOF 12 Weeks</title>
          <description>Participants 12 to &lt; 18 years of age with hepatitis C virus (HCV) genotype 1 treatment-naive (TN) with or without cirrhosis or treatment-experienced (TE) without cirrhosis received ledipasvir/sofosbuvir (LDV/SOF) fixed-dose combination (FDC) 90/400 mg (1 x 90/400 mg tablet or 4 x 22.5/100 mg tablets) once daily for 12 weeks. Participants participating in the PK Lead-in Phase immediately rolled over into the Treatment Phase without interruption to study drug administration.</description>
        </group>
        <group group_id="P2">
          <title>6 to &lt; 12 Years Old - LDV/SOF 12 Weeks</title>
          <description>Participants 6 to &lt; 12 years of age with HCV genotypes 1 or 4 TN with or without cirrhosis or HCV genotype 1 TE without cirrhosis received LDV/SOF FDC 45/200 mg (2 x 22.5/100 mg tablets or 4 x 11.25/50 mg granules) once daily for 12 weeks. Participants participating in the PK Lead-in Phase immediately rolled over into the Treatment Phase without interruption to study drug administration.</description>
        </group>
        <group group_id="P3">
          <title>6 to &lt; 12 Years Old - LDV/SOF 24 Weeks</title>
          <description>Participants 6 to &lt; 12 years of age with HCV genotype 1 TE with cirrhosis received LDV/SOF FDC 45/200 mg (2 x 22.5/100 mg tablets or 4 x 11.25/50 mg granules) once daily for 24 weeks.</description>
        </group>
        <group group_id="P4">
          <title>6 to &lt; 12 Years Old - LDV/SOF+RBV 24 Weeks</title>
          <description>Participants 6 to &lt; 12 years of age with HCV genotype 3 TE without cirrhosis received LDV/SOF FDC 45/200 mg (2 x 22.5/100 mg tablets or 4 x 11.25/50 mg granules) once daily + ribavirin (RBV) capsules or oral solution (dose depending on weight) for 24 weeks.</description>
        </group>
        <group group_id="P5">
          <title>3 to &lt; 6 Years Old - LDV/SOF 12 Weeks</title>
          <description>Participants 3 to &lt; 6 years of age with HCV genotypes 1 or 4 TN without cirrhosis received LDV/SOF FDC (weight ≥ 17 kg: 45/200 mg granules; weight &lt; 17 kg: 33.75/150 mg granules) once daily for 12 weeks. Participants participating in the PK Lead-in Phase immediately rolled over into the Treatment Phase without interruption to study drug administration.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>PK Lead-In Phase</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="10"/>
                <participants group_id="P2" count="12"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="17"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="10"/>
                <participants group_id="P2" count="12"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="17"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
        <period>
          <title>Treatment Phase</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="100">90 participants enrolled directly into the Treatment Phase, without entering the PK Lead-In Phase.</participants>
                <participants group_id="P2" count="89">77 participants enrolled directly into the Treatment Phase, without entering the PK Lead-In Phase.</participants>
                <participants group_id="P3" count="1">1 participant enrolled directly into the Treatment Phase, without entering the PK Lead-In Phase.</participants>
                <participants group_id="P4" count="2">2 participants enrolled directly into the Treatment Phase, without entering the PK Lead-In Phase.</participants>
                <participants group_id="P5" count="34">17 participants enrolled directly into the Treatment Phase, without entering the PK Lead-In Phase.</participants>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="96"/>
                <participants group_id="P2" count="89"/>
                <participants group_id="P3" count="1"/>
                <participants group_id="P4" count="2"/>
                <participants group_id="P5" count="34"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Safety Analysis Set included all participants who were enrolled into the study and received at least 1 dose of study drug.</population>
      <group_list>
        <group group_id="B1">
          <title>12 to &lt; 18 Years Old - LDV/SOF 12 Weeks</title>
          <description>Participants 12 to &lt; 18 years of age with HCV genotype 1 TN with or without cirrhosis or HCV genotype 1 TE without cirrhosis received LDV/SOF FDC 90/400 mg (1 x 90/400 mg tablet or 4 x 22.5/100 mg tablets) once daily for 12 weeks.</description>
        </group>
        <group group_id="B2">
          <title>6 to &lt; 12 Years Old - LDV/SOF 12 Weeks</title>
          <description>Participants 6 to &lt; 12 years of age with HCV genotypes 1 or 4 TN with or without cirrhosis or HCV genotype 1 TE without cirrhosis received LDV/SOF FDC 45/200 mg (2 x 22.5/100 mg tablets or 4 x 11.25/50 mg granules) once daily for 12 weeks.</description>
        </group>
        <group group_id="B3">
          <title>6 to &lt; 12 Years Old - LDV/SOF 24 Weeks</title>
          <description>Participants 6 to &lt; 12 years of age with HCV genotype 1 TE with cirrhosis received LDV/SOF FDC 45/200 mg (2 x 22.5/100 mg tablets or 4 x 11.25/50 mg granules) once daily for 24 weeks.</description>
        </group>
        <group group_id="B4">
          <title>6 to &lt; 12 Years Old - LDV/SOF+RBV 24 Weeks</title>
          <description>Participants 6 to &lt; 12 years of age with HCV genotype 3 TE without cirrhosis received LDV/SOF FDC 45/200 mg (2 x 22.5/100 mg tablets or 4 x 11.25/50 mg granules) once daily + ribavirin capsules or oral solution (dose depending on weight) for 24 weeks.</description>
        </group>
        <group group_id="B5">
          <title>3 to &lt; 6 Years Old - LDV/SOF 12 Weeks</title>
          <description>Participants 3 to &lt; 6 years of age with HCV genotypes 1 or 4 TN without cirrhosis received LDV/SOF FDC (weight ≥ 17 kg: 45/200 mg granules; weight &lt; 17 kg: 33.75/150 mg granules) once daily for 12 weeks.</description>
        </group>
        <group group_id="B6">
          <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="100"/>
            <count group_id="B2" value="89"/>
            <count group_id="B3" value="1"/>
            <count group_id="B4" value="2"/>
            <count group_id="B5" value="34"/>
            <count group_id="B6" value="226"/>
          </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="1.7"/>
                    <measurement group_id="B2" value="9" spread="1.6"/>
                    <measurement group_id="B3" value="11" spread="NA">Standard deviation of a single sample is undefined.</measurement>
                    <measurement group_id="B4" value="9" spread="2.8"/>
                    <measurement group_id="B5" value="4" spread="0.7"/>
                    <measurement group_id="B6" value="11" spread="4.1"/>
                  </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="63"/>
                    <measurement group_id="B2" value="36"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="1"/>
                    <measurement group_id="B5" value="24"/>
                    <measurement group_id="B6" value="125"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="37"/>
                    <measurement group_id="B2" value="53"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="1"/>
                    <measurement group_id="B5" value="10"/>
                    <measurement group_id="B6" value="101"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race/Ethnicity, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="91"/>
                    <measurement group_id="B2" value="70"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="2"/>
                    <measurement group_id="B5" value="27"/>
                    <measurement group_id="B6" value="191"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                    <measurement group_id="B2" value="7"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="1"/>
                    <measurement group_id="B6" value="15"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Other</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="4"/>
                    <measurement group_id="B6" value="9"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="2"/>
                    <measurement group_id="B6" value="9"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race/Ethnicity, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="13"/>
                    <measurement group_id="B2" value="9"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="6"/>
                    <measurement group_id="B6" value="28"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="85"/>
                    <measurement group_id="B2" value="75"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="2"/>
                    <measurement group_id="B5" value="28"/>
                    <measurement group_id="B6" value="191"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Disclosed</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="7"/>
                  </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>New Zealand</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="91"/>
                    <measurement group_id="B2" value="70"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="29"/>
                    <measurement group_id="B6" value="190"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>United Kingdom</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="9"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="2"/>
                    <measurement group_id="B5" value="3"/>
                    <measurement group_id="B6" value="15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Australia</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="2"/>
                    <measurement group_id="B6" value="17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>HCV Genotype</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Genotype 1</title>
                  <measurement_list>
                    <measurement group_id="B1" value="100"/>
                    <measurement group_id="B2" value="87"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="33"/>
                    <measurement group_id="B6" value="221"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Genotype 3</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="2"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Genotype 4</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="1"/>
                    <measurement group_id="B6" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Cirrhosis Status</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Yes</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>No</title>
                  <measurement_list>
                    <measurement group_id="B1" value="43"/>
                    <measurement group_id="B2" value="33"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="2"/>
                    <measurement group_id="B5" value="14"/>
                    <measurement group_id="B6" value="92"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown</title>
                  <measurement_list>
                    <measurement group_id="B1" value="56"/>
                    <measurement group_id="B2" value="55"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="20"/>
                    <measurement group_id="B6" value="131"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>IL28b Status</title>
          <description>The CC, CT, and TT alleles are different forms of the IL28b gene.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>CC</title>
                  <measurement_list>
                    <measurement group_id="B1" value="24"/>
                    <measurement group_id="B2" value="23"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="10"/>
                    <measurement group_id="B6" value="57"/>
                  </measurement_list>
                </category>
                <category>
                  <title>CT</title>
                  <measurement_list>
                    <measurement group_id="B1" value="53"/>
                    <measurement group_id="B2" value="53"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="2"/>
                    <measurement group_id="B5" value="16"/>
                    <measurement group_id="B6" value="124"/>
                  </measurement_list>
                </category>
                <category>
                  <title>TT</title>
                  <measurement_list>
                    <measurement group_id="B1" value="23"/>
                    <measurement group_id="B2" value="12"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="6"/>
                    <measurement group_id="B6" value="42"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Missing</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="2"/>
                    <measurement group_id="B6" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>HCV RNA Category</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt; 800,000 IU/mL</title>
                  <measurement_list>
                    <measurement group_id="B1" value="45"/>
                    <measurement group_id="B2" value="37"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="1"/>
                    <measurement group_id="B5" value="15"/>
                    <measurement group_id="B6" value="98"/>
                  </measurement_list>
                </category>
                <category>
                  <title>≥ 800,000 IU/mL</title>
                  <measurement_list>
                    <measurement group_id="B1" value="55"/>
                    <measurement group_id="B2" value="52"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="1"/>
                    <measurement group_id="B5" value="19"/>
                    <measurement group_id="B6" value="128"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Prior Treatment Experience</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Treatment-Naive</title>
                  <measurement_list>
                    <measurement group_id="B1" value="80"/>
                    <measurement group_id="B2" value="72"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="34"/>
                    <measurement group_id="B6" value="186"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Treatment-Experienced</title>
                  <measurement_list>
                    <measurement group_id="B1" value="20"/>
                    <measurement group_id="B2" value="17"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="2"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="40"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>For Participants in the PK Lead-in Phase, Pharmacokinetic (PK) Parameter: AUCtau of GS-331007 (Metabolite of SOF), LDV, and 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>Cohorts 1 and 2 (6 to &lt; 18 years of age): predose, 0.5, 1, 2, 3, 4, 5, 8, and 12 hours postdose on Day 10; Cohort 3 (3 to &lt; 6 years of age): predose, 0.5, 2, 4, 8, and 12 hours postdose on Day 10</time_frame>
        <population>Intensive PK Analysis Set included all participants in the PK lead-in phase who received at least 1 dose of study drug and for whom at least 1 nonmissing PK concentration value, during the intensive sampling period, was reported by the PK laboratory.</population>
        <group_list>
          <group group_id="O1">
            <title>PK Lead-in: 12 to &lt; 18 Years Old - LDV/SOF 12 Weeks</title>
            <description>Participants 12 to &lt; 18 years of age weighing ≥ 45 kg received LDV/SOF FDC 90/400 mg (1 x 90/400 mg tablet or 4 x 22.5/100 mg tablets) once daily for 12 weeks.</description>
          </group>
          <group group_id="O2">
            <title>PK Lead-in: 6 to &lt; 12 Years Old - LDV/SOF 12 Weeks</title>
            <description>Participants 6 to &lt; 12 years of age weighing ≥ 17 kg and &lt; 45 kg received LDV/SOF FDC 45/200 mg (2 x 22.5/100 mg tablets or 4 x 11.25/50 mg granules) once daily for 12 weeks.</description>
          </group>
          <group group_id="O3">
            <title>PK Lead-in: 3 to &lt; 6 Years Old - LDV/SOF 12 Weeks</title>
            <description>Participants 3 to &lt; 6 years of age received LDV/SOF FDC (weight ≥ 17 kg: 45/200 mg granules; weight &lt; 17 kg: 33.75/150 mg granules) once daily for 12 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>For Participants in the PK Lead-in Phase, Pharmacokinetic (PK) Parameter: AUCtau of GS-331007 (Metabolite of SOF), LDV, and 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>Intensive PK Analysis Set included all participants in the PK lead-in phase who received at least 1 dose of study drug and for whom at least 1 nonmissing PK concentration value, during the intensive sampling period, was reported by the PK laboratory.</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="10"/>
                <count group_id="O2" value="10"/>
                <count group_id="O3" value="13"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>GS-331007 (metabolite of SOF)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="10"/>
                    <count group_id="O2" value="10"/>
                    <count group_id="O3" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12682.5" spread="1732.66"/>
                    <measurement group_id="O2" value="8210.3" spread="2542.42"/>
                    <measurement group_id="O3" value="11688.9" spread="3400.79"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>LDV</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="10"/>
                    <count group_id="O2" value="10"/>
                    <count group_id="O3" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10202.4" spread="5196.49"/>
                    <measurement group_id="O2" value="7288.3" spread="4547.33"/>
                    <measurement group_id="O3" value="9316.3" spread="3280.51"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>SOF</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="10"/>
                    <count group_id="O2" value="9"/>
                    <count group_id="O3" value="3"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2175.7" spread="578.92"/>
                    <measurement group_id="O2" value="1754.4" spread="419.18"/>
                    <measurement group_id="O3" value="2495.2" spread="412.64"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <groups_desc>AUCtau of GS-331007 for the 12 to &lt; 18 Years old group in the PK Lead-in Phase was compared against historical data collected in adult Phase 2/3 studies.</groups_desc>
            <non_inferiority_type>Equivalence</non_inferiority_type>
            <non_inferiority_desc>Equivalence was determined if the 90% confidence intervals (CI) were within the predefined equivalence boundaries of 50% to 200% for all age groups.</non_inferiority_desc>
            <param_type>Percentage Geometric Mean Ratio</param_type>
            <param_value>105.20</param_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>90.61</ci_lower_limit>
            <ci_upper_limit>122.13</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>AUCtau of GS-331007 for the 6 to &lt; 12 Years Old group in the PK Lead-in Phase was compared against historical data collected in adult Phase 2/3 studies.</groups_desc>
            <non_inferiority_type>Equivalence</non_inferiority_type>
            <non_inferiority_desc>Equivalence was determined if the 90% CIs were within the predefined equivalence boundaries of 50% to 200% for all age groups.</non_inferiority_desc>
            <param_type>Percentage Geometric Mean Ratio</param_type>
            <param_value>65.76</param_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>56.62</ci_lower_limit>
            <ci_upper_limit>76.37</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>AUCtau of GS-331007 for the 3 to &lt; 6 Years Old group in the PK Lead-in Phase was compared against historical data collected in adult Phase 2/3 studies.</groups_desc>
            <non_inferiority_type>Equivalence</non_inferiority_type>
            <non_inferiority_desc>Equivalence was determined if the 90% CIs were within the predefined equivalence boundaries of 50% to 200% for all age groups.</non_inferiority_desc>
            <param_type>Percentage Geometric Mean Ratio</param_type>
            <param_value>94.08</param_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>82.51</ci_lower_limit>
            <ci_upper_limit>107.27</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <groups_desc>AUCtau of LDV for the 12 to &lt; 18 Years Old group in the PK Lead-in Phase was compared against historical data collected in adult Phase 2/3 studies.</groups_desc>
            <non_inferiority_type>Equivalence</non_inferiority_type>
            <non_inferiority_desc>Equivalence was determined if the 90% CIs were within the predefined equivalence boundaries of 50% to 200% for all age groups.</non_inferiority_desc>
            <param_type>Percentage Geometric Mean Ratio</param_type>
            <param_value>127.18</param_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>94.89</ci_lower_limit>
            <ci_upper_limit>170.45</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>AUCtau of LDV for the 6 to &lt; 12 Years Old group in the PK Lead-in Phase was compared against historical data collected in adult Phase 2/3 studies.</groups_desc>
            <non_inferiority_type>Equivalence</non_inferiority_type>
            <non_inferiority_desc>Equivalence was determined if the 90% CIs were within the predefined equivalence boundaries of 50% to 200% for all age groups.</non_inferiority_desc>
            <param_type>Percentage Geometric Mean Ratio</param_type>
            <param_value>82.25</param_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>61.34</ci_lower_limit>
            <ci_upper_limit>110.30</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>AUCtau of LDV for the 3 to &lt; 6 Years Old group in the PK Lead-in Phase was compared against historical data collected in adult Phase 2/3 studies.</groups_desc>
            <non_inferiority_type>Equivalence</non_inferiority_type>
            <non_inferiority_desc>Equivalence was determined if the 90% CIs were within the predefined equivalence boundaries of 50% to 200% for all age groups.</non_inferiority_desc>
            <param_type>Percentage Geometric Mean Ratio</param_type>
            <param_value>120.46</param_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>93.18</ci_lower_limit>
            <ci_upper_limit>155.73</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <groups_desc>AUCtau of SOF for the 12 to &lt; 18 Years Old group in the PK Lead-in Phase was compared against historical data collected in adult Phase 2/3 studies.</groups_desc>
            <non_inferiority_type>Equivalence</non_inferiority_type>
            <non_inferiority_desc>Equivalence was determined if the 90% CIs were within the predefined equivalence boundaries of 50% to 200% for all age groups.</non_inferiority_desc>
            <param_type>Percentage Geometric Mean Ratio</param_type>
            <param_value>159.88</param_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>137.89</ci_lower_limit>
            <ci_upper_limit>185.37</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>AUCtau of SOF for the 6 to &lt; 12 Years Old group in the PK Lead-in Phase was compared against historical data collected in adult Phase 2/3 studies.</groups_desc>
            <non_inferiority_type>Equivalence</non_inferiority_type>
            <non_inferiority_desc>Equivalence was determined if the 90% CIs were within the predefined equivalence boundaries of 50% to 200% for all age groups.</non_inferiority_desc>
            <param_type>Percentage Geometric Mean Ratio</param_type>
            <param_value>129.48</param_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>110.79</ci_lower_limit>
            <ci_upper_limit>151.32</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>AUCtau of SOF for the 3 to &lt; 6 Years Old group in the PK Lead-in Phase was compared against historical data collected in adult Phase 2/3 studies.</groups_desc>
            <non_inferiority_type>Equivalence</non_inferiority_type>
            <non_inferiority_desc>Equivalence was determined if the 90% CIs were within the predefined equivalence boundaries of 50% to 200% for all age groups.</non_inferiority_desc>
            <param_type>Percentage Geometric Mean Ratio</param_type>
            <param_value>187.76</param_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>143.41</ci_lower_limit>
            <ci_upper_limit>245.82</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event During the PK Lead-in Phase or the Treatment Phase</title>
        <time_frame>Up to 24 weeks</time_frame>
        <population>Safety Analysis Set included all participants who were enrolled into the study and received at least 1 dose of study drug.</population>
        <group_list>
          <group group_id="O1">
            <title>12 to &lt; 18 Years Old - LDV/SOF 12 Weeks</title>
            <description>Participants 12 to &lt; 18 years of age with HCV genotype 1 TN with or without cirrhosis or TE without cirrhosis received LDV/SOF FDC 90/400 mg (1 x 90/400 mg tablet or 4 x 22.5/100 mg tablets) once daily for 12 weeks.</description>
          </group>
          <group group_id="O2">
            <title>6 to &lt; 12 Years Old - LDV/SOF 12 Weeks</title>
            <description>Participants 6 to &lt; 12 years of age with HCV genotypes 1 or 4 TN with or without cirrhosis or HCV genotype 1 TE without cirrhosis received LDV/SOF FDC 45/200 mg (2 x 22.5/100 mg tablets or 4 x 11.25/50 mg granules) once daily for 12 weeks.</description>
          </group>
          <group group_id="O3">
            <title>6 to &lt; 12 Years Old - LDV/SOF 24 Weeks</title>
            <description>Participants 6 to &lt; 12 years of age with HCV genotype 1 TE with cirrhosis received LDV/SOF FDC 45/200 mg (2 x 22.5/100 mg tablets or 4 x 11.25/50 mg granules) once daily for 24 weeks.</description>
          </group>
          <group group_id="O4">
            <title>6 to &lt; 12 Years Old - LDV/SOF+RBV 24 Weeks</title>
            <description>Participants 6 to &lt; 12 years of age with HCV genotype 3 TE without cirrhosis received LDV/SOF FDC 45/200 mg (2 x 22.5/100 mg tablets or 4 x 11.25/50 mg granules) once daily + ribavirin capsules or oral solution (dose depending on weight) for 24 weeks.</description>
          </group>
          <group group_id="O5">
            <title>3 to &lt; 6 Years Old - LDV/SOF 12 Weeks</title>
            <description>Participants 3 to &lt; 6 years of age with HCV genotypes 1 or 4 TN without cirrhosis received LDV/SOF FDC (weight ≥ 17 kg: 45/200 mg granules; weight &lt; 17 kg: 33.75/150 mg granules) once daily for 12 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event During the PK Lead-in Phase or the Treatment Phase</title>
          <population>Safety Analysis Set included all participants who were enrolled into the study and received at least 1 dose of study drug.</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="100"/>
                <count group_id="O2" value="89"/>
                <count group_id="O3" value="1"/>
                <count group_id="O4" value="2"/>
                <count group_id="O5" value="34"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="2.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>For Participants in the PK Lead-in Phase, Change From Baseline in HCV RNA</title>
        <time_frame>Baseline; Weeks 1, 2, 4, 8, and 12</time_frame>
        <population>Participants who were enrolled in the PK lead-in phase with available data were analyzed.</population>
        <group_list>
          <group group_id="O1">
            <title>PK Lead-in: 12 to &lt; 18 Years Old - LDV/SOF 12 Weeks</title>
            <description>Participants 12 to &lt; 18 years of age weighing ≥ 45 kg received LDV/SOF FDC 90/400 mg (1 x 90/400 mg tablet or 4 x 22.5/100 mg tablets) once daily for 12 weeks.</description>
          </group>
          <group group_id="O2">
            <title>PK Lead-in: 6 to &lt; 12 Years Old - LDV/SOF 12 Weeks</title>
            <description>Participants 6 to &lt; 12 years of age weighing ≥ 17 kg and &lt; 45 kg received LDV/SOF FDC 45/200 mg (2 x 22.5/100 mg tablets or 4 x 11.25/50 mg granules) once daily for 12 weeks.</description>
          </group>
          <group group_id="O3">
            <title>PK Lead-in: 3 to &lt; 6 Years Old - LDV/SOF 12 Weeks</title>
            <description>Participants 3 to &lt; 6 years of age received LDV/SOF FDC (weight ≥ 17 kg: 45/200 mg granules; weight &lt; 17 kg: 33.75/150 mg granules) once daily for 12 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>For Participants in the PK Lead-in Phase, Change From Baseline in HCV RNA</title>
          <population>Participants who were enrolled in the PK lead-in phase 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="10"/>
                <count group_id="O2" value="12"/>
                <count group_id="O3" value="17"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Change at Week 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="10"/>
                    <count group_id="O2" value="12"/>
                    <count group_id="O3" value="17"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-4.34" spread="0.621"/>
                    <measurement group_id="O2" value="-4.29" spread="0.518"/>
                    <measurement group_id="O3" value="-4.32" spread="0.616"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Week 2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="10"/>
                    <count group_id="O2" value="12"/>
                    <count group_id="O3" value="15"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-4.71" spread="0.651"/>
                    <measurement group_id="O2" value="-4.55" spread="0.636"/>
                    <measurement group_id="O3" value="-4.87" spread="0.724"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Week 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="10"/>
                    <count group_id="O2" value="12"/>
                    <count group_id="O3" value="16"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-4.73" spread="0.667"/>
                    <measurement group_id="O2" value="-4.75" spread="0.702"/>
                    <measurement group_id="O3" value="-4.92" spread="0.715"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Week 8</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="10"/>
                    <count group_id="O2" value="12"/>
                    <count group_id="O3" value="16"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-4.73" spread="0.667"/>
                    <measurement group_id="O2" value="-4.76" spread="0.710"/>
                    <measurement group_id="O3" value="-4.92" spread="0.715"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Week 12</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="10"/>
                    <count group_id="O2" value="12"/>
                    <count group_id="O3" value="16"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-4.73" spread="0.667"/>
                    <measurement group_id="O2" value="-4.76" spread="0.710"/>
                    <measurement group_id="O3" value="-4.92" spread="0.715"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event During the PK Lead-in Phase</title>
        <time_frame>Up to Day 10</time_frame>
        <population>Participants who were enrolled in the PK lead-in phase were analyzed.</population>
        <group_list>
          <group group_id="O1">
            <title>PK Lead-in: 12 to &lt; 18 Years Old - LDV/SOF 12 Weeks</title>
            <description>Participants 12 to &lt; 18 years of age weighing ≥ 45 kg received LDV/SOF FDC 90/400 mg (1 x 90/400 mg tablet or 4 x 22.5/100 mg tablets) once daily for 12 weeks.</description>
          </group>
          <group group_id="O2">
            <title>PK Lead-in: 6 to &lt; 12 Years Old - LDV/SOF 12 Weeks</title>
            <description>Participants 6 to &lt; 12 years of age weighing ≥ 17 kg and &lt; 45 kg received LDV/SOF FDC 45/200 mg (2 x 22.5/100 mg tablets or 4 x 11.25/50 mg granules) once daily for 12 weeks.</description>
          </group>
          <group group_id="O3">
            <title>PK Lead-in: 3 to &lt; 6 Years Old - LDV/SOF 12 Weeks</title>
            <description>Participants 3 to &lt; 6 years of age received LDV/SOF FDC (weight ≥ 17 kg: 45/200 mg granules; weight &lt; 17 kg: 33.75/150 mg granules) once daily for 12 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event During the PK Lead-in Phase</title>
          <population>Participants who were enrolled in the PK lead-in phase 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="10"/>
                <count group_id="O2" value="12"/>
                <count group_id="O3" value="17"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="5.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>For the Treatment Phase, Percentage of Participants With Sustained Virologic Response (SVR) at 4 Weeks After Discontinuation of Therapy (SVR4)</title>
        <description>SVR4 was defined as HCV RNA &lt; the lower limit of quantitation (LLOQ; ie, 15 IU/mL) at 4 weeks after stopping study treatment.</description>
        <time_frame>Posttreatment Week 4</time_frame>
        <population>Full Analysis Set included all participants who were enrolled into the study and received at least 1 dose of study drug.</population>
        <group_list>
          <group group_id="O1">
            <title>12 to &lt; 18 Years Old - LDV/SOF 12 Weeks</title>
            <description>Participants 12 to &lt; 18 years of age with HCV genotype 1 TN with or without cirrhosis or HCV genotype 1 TE without cirrhosis received LDV/SOF FDC 90/400 mg (1 x 90/400 mg tablet or 4 x 22.5/100 mg tablets) once daily for 12 weeks.</description>
          </group>
          <group group_id="O2">
            <title>6 to &lt; 12 Years Old - LDV/SOF 12 Weeks</title>
            <description>Participants 6 to &lt; 12 years of age with HCV genotypes 1 or 4 TN with or without cirrhosis or HCV genotype 1 TE without cirrhosis received LDV/SOF FDC 45/200 mg (2 x 22.5/100 mg tablets or 4 x 11.25/50 mg granules) once daily for 12 weeks.</description>
          </group>
          <group group_id="O3">
            <title>6 to &lt; 12 Years Old - LDV/SOF 24 Weeks</title>
            <description>Participants 6 to &lt; 12 years of age with HCV genotype 1 TE with cirrhosis received LDV/SOF FDC 45/200 mg (2 x 22.5/100 mg tablets or 4 x 11.25/50 mg granules) once daily for 24 weeks.</description>
          </group>
          <group group_id="O4">
            <title>6 to &lt; 12 Years Old - LDV/SOF+RBV 24 Weeks</title>
            <description>Participants 6 to &lt; 12 years of age with HCV genotype 3 TE without cirrhosis received LDV/SOF FDC 45/200 mg (2 x 22.5/100 mg tablets or 4 x 11.25/50 mg granules) once daily + ribavirin capsules or oral solution (dose depending on weight) for 24 weeks.</description>
          </group>
          <group group_id="O5">
            <title>3 to &lt; 6 Years Old - LDV/SOF 12 Weeks</title>
            <description>Participants 3 to &lt; 6 years of age with HCV genotypes 1 or 4 TN without cirrhosis received LDV/SOF FDC (weight ≥ 17 kg: 45/200 mg granules; weight &lt; 17 kg: 33.75/150 mg granules) once daily for 12 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>For the Treatment Phase, Percentage of Participants With Sustained Virologic Response (SVR) at 4 Weeks After Discontinuation of Therapy (SVR4)</title>
          <description>SVR4 was defined as HCV RNA &lt; the lower limit of quantitation (LLOQ; ie, 15 IU/mL) at 4 weeks after stopping study treatment.</description>
          <population>Full Analysis Set included all participants who were enrolled into the study and received at least 1 dose of study drug.</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="100"/>
                <count group_id="O2" value="89"/>
                <count group_id="O3" value="1"/>
                <count group_id="O4" value="2"/>
                <count group_id="O5" value="34"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="98.0" lower_limit="93.0" upper_limit="99.8"/>
                    <measurement group_id="O2" value="98.9" lower_limit="93.9" upper_limit="100.0"/>
                    <measurement group_id="O3" value="100.0" lower_limit="2.5" upper_limit="100.0"/>
                    <measurement group_id="O4" value="100.0" lower_limit="15.8" upper_limit="100.0"/>
                    <measurement group_id="O5" value="97.1" lower_limit="84.7" upper_limit="99.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>For the Treatment Phase, Percentage of Participants With SVR at 12 Weeks After Discontinuation of Therapy (SVR12)</title>
        <description>SVR12 was defined as HCV RNA &lt; LLOQ at 12 weeks after stopping study treatment.</description>
        <time_frame>Posttreatment Week 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 - LDV/SOF 12 Weeks</title>
            <description>Participants 12 to &lt; 18 years of age with HCV genotype 1 TN with or without cirrhosis or HCV genotype 1 TE without cirrhosis received LDV/SOF FDC 90/400 mg (1 x 90/400 mg tablet or 4 x 22.5/100 mg tablets) once daily for 12 weeks.</description>
          </group>
          <group group_id="O2">
            <title>6 to &lt; 12 Years Old - LDV/SOF 12 Weeks</title>
            <description>Participants 6 to &lt; 12 years of age with HCV genotypes 1 or 4 TN with or without cirrhosis or HCV genotype 1 TE without cirrhosis received LDV/SOF FDC 45/200 mg (2 x 22.5/100 mg tablets or 4 x 11.25/50 mg granules) once daily for 12 weeks.</description>
          </group>
          <group group_id="O3">
            <title>6 to &lt; 12 Years Old - LDV/SOF 24 Weeks</title>
            <description>Participants 6 to &lt; 12 years of age with HCV genotype 1 TE with cirrhosis received LDV/SOF FDC 45/200 mg (2 x 22.5/100 mg tablets or 4 x 11.25/50 mg granules) once daily for 24 weeks.</description>
          </group>
          <group group_id="O4">
            <title>6 to &lt; 12 Years Old - LDV/SOF+RBV 24 Weeks</title>
            <description>Participants 6 to &lt; 12 years of age with HCV genotype 3 TE without cirrhosis received LDV/SOF FDC 45/200 mg (2 x 22.5/100 mg tablets or 4 x 11.25/50 mg granules) once daily + ribavirin capsules or oral solution (dose depending on weight) for 24 weeks.</description>
          </group>
          <group group_id="O5">
            <title>3 to &lt; 6 Years Old - LDV/SOF 12 Weeks</title>
            <description>Participants 3 to &lt; 6 years of age with HCV genotypes 1 or 4 TN without cirrhosis received LDV/SOF FDC (weight ≥ 17 kg: 45/200 mg granules; weight &lt; 17 kg: 33.75/150 mg granules) once daily for 12 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>For the Treatment Phase, Percentage of Participants With SVR at 12 Weeks After Discontinuation of Therapy (SVR12)</title>
          <description>SVR12 was defined as HCV RNA &lt; LLOQ at 12 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="100"/>
                <count group_id="O2" value="89"/>
                <count group_id="O3" value="1"/>
                <count group_id="O4" value="2"/>
                <count group_id="O5" value="34"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="98.0" lower_limit="93.0" upper_limit="99.8"/>
                    <measurement group_id="O2" value="98.9" lower_limit="93.9" upper_limit="100.0"/>
                    <measurement group_id="O3" value="100.0" lower_limit="2.5" upper_limit="100.0"/>
                    <measurement group_id="O4" value="100.0" lower_limit="15.8" upper_limit="100.0"/>
                    <measurement group_id="O5" value="97.1" lower_limit="84.7" upper_limit="99.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>For the Treatment Phase, Percentage of Participants With SVR at 24 Weeks After Discontinuation of Therapy (SVR24)</title>
        <description>SVR24 was defined as HCV RNA &lt; LLOQ 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 - LDV/SOF 12 Weeks</title>
            <description>Participants 12 to &lt; 18 years of age with HCV genotype 1 TN with or without cirrhosis or HCV genotype 1 TE without cirrhosis received LDV/SOF FDC 90/400 mg (1 x 90/400 mg tablet or 4 x 22.5/100 mg tablets) once daily for 12 weeks.</description>
          </group>
          <group group_id="O2">
            <title>6 to &lt; 12 Years Old - LDV/SOF 12 Weeks</title>
            <description>Participants 6 to &lt; 12 years of age with HCV genotypes 1 or 4 TN with or without cirrhosis or HCV genotype 1 TE without cirrhosis received LDV/SOF FDC 45/200 mg (2 x 22.5/100 mg tablets or 4 x 11.25/50 mg granules) once daily for 12 weeks.</description>
          </group>
          <group group_id="O3">
            <title>6 to &lt; 12 Years Old - LDV/SOF 24 Weeks</title>
            <description>Participants 6 to &lt; 12 years of age with HCV genotype 1 TE with cirrhosis received LDV/SOF FDC 45/200 mg (2 x 22.5/100 mg tablets or 4 x 11.25/50 mg granules) once daily for 24 weeks.</description>
          </group>
          <group group_id="O4">
            <title>6 to &lt; 12 Years Old - LDV/SOF+RBV 24 Weeks</title>
            <description>Participants 6 to &lt; 12 years of age with HCV genotype 3 TE without cirrhosis received LDV/SOF FDC 45/200 mg (2 x 22.5/100 mg tablets or 4 x 11.25/50 mg granules) once daily + ribavirin capsules or oral solution (dose depending on weight) for 24 weeks.</description>
          </group>
          <group group_id="O5">
            <title>3 to &lt; 6 Years Old - LDV/SOF 12 Weeks</title>
            <description>Participants 3 to &lt; 6 years of age with HCV genotypes 1 or 4 TN without cirrhosis received LDV/SOF FDC (weight ≥ 17 kg: 45/200 mg granules; weight &lt; 17 kg: 33.75/150 mg granules) once daily for 12 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>For the Treatment Phase, Percentage of Participants With SVR at 24 Weeks After Discontinuation of Therapy (SVR24)</title>
          <description>SVR24 was defined as HCV RNA &lt; LLOQ 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="100"/>
                <count group_id="O2" value="89"/>
                <count group_id="O3" value="1"/>
                <count group_id="O4" value="2"/>
                <count group_id="O5" value="34"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="98.0" lower_limit="93.0" upper_limit="99.8"/>
                    <measurement group_id="O2" value="98.9" lower_limit="93.9" upper_limit="100.0"/>
                    <measurement group_id="O3" value="100.0" lower_limit="2.5" upper_limit="100.0"/>
                    <measurement group_id="O4" value="100.0" lower_limit="15.8" upper_limit="100.0"/>
                    <measurement group_id="O5" value="97.1" lower_limit="84.7" upper_limit="99.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>For the Treatment Phase, Percentage of Participants Experiencing Viral Breakthrough</title>
        <description>Viral breakthrough was defined as having confirmed HCV RNA ≥ LLOQ after having previously had HCV RNA &lt; LLOQ while on treatment.</description>
        <time_frame>Up to 24 weeks</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 - LDV/SOF 12 Weeks</title>
            <description>Participants 12 to &lt; 18 years of age with HCV genotype 1 TN with or without cirrhosis or HCV genotype 1 TE without cirrhosis received LDV/SOF FDC 90/400 mg (1 x 90/400 mg tablet or 4 x 22.5/100 mg tablets) once daily for 12 weeks.</description>
          </group>
          <group group_id="O2">
            <title>6 to &lt; 12 Years Old - LDV/SOF 12 Weeks</title>
            <description>Participants 6 to &lt; 12 years of age with HCV genotypes 1 or 4 TN with or without cirrhosis or HCV genotype 1 TE without cirrhosis received LDV/SOF FDC 45/200 mg (2 x 22.5/100 mg tablets or 4 x 11.25/50 mg granules) once daily for 12 weeks.</description>
          </group>
          <group group_id="O3">
            <title>6 to &lt; 12 Years Old - LDV/SOF 24 Weeks</title>
            <description>Participants 6 to &lt; 12 years of age with HCV genotype 1 TE with cirrhosis received LDV/SOF FDC 45/200 mg (2 x 22.5/100 mg tablets or 4 x 11.25/50 mg granules) once daily for 24 weeks.</description>
          </group>
          <group group_id="O4">
            <title>6 to &lt; 12 Years Old - LDV/SOF+RBV 24 Weeks</title>
            <description>Participants 6 to &lt; 12 years of age with HCV genotype 3 TE without cirrhosis received LDV/SOF FDC 45/200 mg (2 x 22.5/100 mg tablets or 4 x 11.25/50 mg granules) once daily + ribavirin capsules or oral solution (dose depending on weight) for 24 weeks.</description>
          </group>
          <group group_id="O5">
            <title>3 to &lt; 6 Years Old - LDV/SOF 12 Weeks</title>
            <description>Participants 3 to &lt; 6 years of age with HCV genotypes 1 or 4 TN without cirrhosis received LDV/SOF FDC (weight ≥ 17 kg: 45/200 mg granules; weight &lt; 17 kg: 33.75/150 mg granules) once daily for 12 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>For the Treatment Phase, Percentage of Participants Experiencing Viral Breakthrough</title>
          <description>Viral breakthrough was defined as having confirmed HCV RNA ≥ LLOQ after having previously had HCV RNA &lt; LLOQ while on treatment.</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="100"/>
                <count group_id="O2" value="89"/>
                <count group_id="O3" value="1"/>
                <count group_id="O4" value="2"/>
                <count group_id="O5" value="34"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>For the Treatment Phase, Percentage of Participants Experiencing Viral Relapse</title>
        <description>Viral relapse was defined as having 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 - LDV/SOF 12 Weeks</title>
            <description>Participants 12 to &lt; 18 years of age with HCV genotype 1 TN with or without cirrhosis or HCV genotype 1 TE without cirrhosis received LDV/SOF FDC 90/400 mg (1 x 90/400 mg tablet or 4 x 22.5/100 mg tablets) once daily for 12 weeks.</description>
          </group>
          <group group_id="O2">
            <title>6 to &lt; 12 Years Old - LDV/SOF 12 Weeks</title>
            <description>Participants 6 to &lt; 12 years of age with HCV genotypes 1 or 4 TN with or without cirrhosis or HCV genotype 1 TE without cirrhosis received LDV/SOF FDC 45/200 mg (2 x 22.5/100 mg tablets or 4 x 11.25/50 mg granules) once daily for 12 weeks.</description>
          </group>
          <group group_id="O3">
            <title>6 to &lt; 12 Years Old - LDV/SOF 24 Weeks</title>
            <description>Participants 6 to &lt; 12 years of age with HCV genotype 1 TE with cirrhosis received LDV/SOF FDC 45/200 mg (2 x 22.5/100 mg tablets or 4 x 11.25/50 mg granules) once daily for 24 weeks.</description>
          </group>
          <group group_id="O4">
            <title>6 to &lt; 12 Years Old - LDV/SOF+RBV 24 Weeks</title>
            <description>Participants 6 to &lt; 12 years of age with HCV genotype 3 TE without cirrhosis received LDV/SOF FDC 45/200 mg (2 x 22.5/100 mg tablets or 4 x 11.25/50 mg granules) once daily + ribavirin capsules or oral solution (dose depending on weight) for 24 weeks.</description>
          </group>
          <group group_id="O5">
            <title>3 to &lt; 6 Years Old - LDV/SOF 12 Weeks</title>
            <description>Participants 3 to &lt; 6 years of age with HCV genotypes 1 or 4 TN without cirrhosis received LDV/SOF FDC (weight ≥ 17 kg: 45/200 mg granules; weight &lt; 17 kg: 33.75/150 mg granules) once daily for 12 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>For the Treatment Phase, Percentage of Participants Experiencing Viral Relapse</title>
          <description>Viral relapse was defined as having 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="100"/>
                <count group_id="O2" value="89"/>
                <count group_id="O3" value="1"/>
                <count group_id="O4" value="2"/>
                <count group_id="O5" value="34"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1.1"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>For the Treatment Phase, Change From Baseline in HCV RNA</title>
        <time_frame>Baseline; Weeks 1, 2, 4, 8, 12, 16 (24 Week groups only), 20 (24 Week groups only), and 24 (24 Week groups only)</time_frame>
        <population>Participants in the Full Analysis Set with available data were analyzed. Participants from the 12 Weeks groups were not analyzed for Change at Weeks 16, 20, and 24 because they were only treated for 12 weeks.</population>
        <group_list>
          <group group_id="O1">
            <title>12 to &lt; 18 Years Old - LDV/SOF 12 Weeks</title>
            <description>Participants 12 to &lt; 18 years of age with HCV genotype 1 TN with or without cirrhosis or HCV genotype 1 TE without cirrhosis received LDV/SOF FDC 90/400 mg (1 x 90/400 mg tablet or 4 x 22.5/100 mg tablets) once daily for 12 weeks.</description>
          </group>
          <group group_id="O2">
            <title>6 to &lt; 12 Years Old - LDV/SOF 12 Weeks</title>
            <description>Participants 6 to &lt; 12 years of age with HCV genotypes 1 or 4 TN with or without cirrhosis or HCV genotype 1 TE without cirrhosis received LDV/SOF FDC 45/200 mg (2 x 22.5/100 mg tablets or 4 x 11.25/50 mg granules) once daily for 12 weeks.</description>
          </group>
          <group group_id="O3">
            <title>6 to &lt; 12 Years Old - LDV/SOF 24 Weeks</title>
            <description>Participants 6 to &lt; 12 years of age with HCV genotype 1 TE with cirrhosis received LDV/SOF FDC 45/200 mg (2 x 22.5/100 mg tablets or 4 x 11.25/50 mg granules) once daily for 24 weeks.</description>
          </group>
          <group group_id="O4">
            <title>6 to &lt; 12 Years Old - LDV/SOF+RBV 24 Weeks</title>
            <description>Participants 6 to &lt; 12 years of age with HCV genotype 3 TE without cirrhosis received LDV/SOF FDC 45/200 mg (2 x 22.5/100 mg tablets or 4 x 11.25/50 mg granules) once daily + ribavirin capsules or oral solution (dose depending on weight) for 24 weeks.</description>
          </group>
          <group group_id="O5">
            <title>3 to &lt; 6 Years Old - LDV/SOF 12 Weeks</title>
            <description>Participants 3 to &lt; 6 years of age with HCV genotypes 1 or 4 TN without cirrhosis received LDV/SOF FDC (weight ≥ 17 kg: 45/200 mg granules; weight &lt; 17 kg: 33.75/150 mg granules) once daily for 12 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>For the Treatment Phase, Change From Baseline in HCV RNA</title>
          <population>Participants in the Full Analysis Set with available data were analyzed. Participants from the 12 Weeks groups were not analyzed for Change at Weeks 16, 20, and 24 because they were only treated for 12 weeks.</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="100"/>
                <count group_id="O2" value="89"/>
                <count group_id="O3" value="1"/>
                <count group_id="O4" value="2"/>
                <count group_id="O5" value="34"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Change at Week 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="98"/>
                    <count group_id="O2" value="85"/>
                    <count group_id="O3" value="1"/>
                    <count group_id="O4" value="2"/>
                    <count group_id="O5" value="34"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-4.34" spread="0.634"/>
                    <measurement group_id="O2" value="-4.27" spread="0.592"/>
                    <measurement group_id="O3" value="-4.30" spread="NA">Standard deviation of a single sample is undefined.</measurement>
                    <measurement group_id="O4" value="-4.54" spread="0.308"/>
                    <measurement group_id="O5" value="-4.25" spread="0.505"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Week 2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="99"/>
                    <count group_id="O2" value="88"/>
                    <count group_id="O3" value="1"/>
                    <count group_id="O4" value="2"/>
                    <count group_id="O5" value="32"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-4.74" spread="0.585"/>
                    <measurement group_id="O2" value="-4.73" spread="0.544"/>
                    <measurement group_id="O3" value="-5.09" spread="NA">Standard deviation of a single sample is undefined.</measurement>
                    <measurement group_id="O4" value="-4.54" spread="0.308"/>
                    <measurement group_id="O5" value="-4.80" spread="0.628"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Week 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="100"/>
                    <count group_id="O2" value="89"/>
                    <count group_id="O3" value="1"/>
                    <count group_id="O4" value="2"/>
                    <count group_id="O5" value="33"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-4.84" spread="0.557"/>
                    <measurement group_id="O2" value="-4.87" spread="0.592"/>
                    <measurement group_id="O3" value="-5.09" spread="NA">Standard deviation of a single sample is undefined.</measurement>
                    <measurement group_id="O4" value="-4.54" spread="0.308"/>
                    <measurement group_id="O5" value="-4.85" spread="0.628"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Week 8</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="99"/>
                    <count group_id="O2" value="89"/>
                    <count group_id="O3" value="1"/>
                    <count group_id="O4" value="2"/>
                    <count group_id="O5" value="33"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-4.85" spread="0.556"/>
                    <measurement group_id="O2" value="-4.89" spread="0.597"/>
                    <measurement group_id="O3" value="-5.09" spread="NA">Standard deviation of a single sample is undefined.</measurement>
                    <measurement group_id="O4" value="-4.54" spread="0.308"/>
                    <measurement group_id="O5" value="-4.86" spread="0.633"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Week 12</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="99"/>
                    <count group_id="O2" value="89"/>
                    <count group_id="O3" value="1"/>
                    <count group_id="O4" value="2"/>
                    <count group_id="O5" value="33"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-4.85" spread="0.556"/>
                    <measurement group_id="O2" value="-4.89" spread="0.597"/>
                    <measurement group_id="O3" value="-5.09" spread="NA">Standard deviation of a single sample is undefined.</measurement>
                    <measurement group_id="O4" value="-4.54" spread="0.308"/>
                    <measurement group_id="O5" value="-4.86" spread="0.633"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Week 16</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="1"/>
                    <count group_id="O4" value="2"/>
                    <count group_id="O5" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O3" value="-5.09" spread="NA">Standard deviation of a single sample is undefined.</measurement>
                    <measurement group_id="O4" value="-4.54" spread="0.308"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Week 20</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="1"/>
                    <count group_id="O4" value="2"/>
                    <count group_id="O5" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O3" value="-5.09" spread="NA">Standard deviation of a single sample is undefined.</measurement>
                    <measurement group_id="O4" value="-4.54" spread="0.308"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Week 24</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="1"/>
                    <count group_id="O4" value="2"/>
                    <count group_id="O5" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O3" value="-5.09" spread="NA">Standard deviation of a single sample is undefined.</measurement>
                    <measurement group_id="O4" value="-4.54" spread="0.308"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>For the Treatment Phase, Percentage of Participants With HCV RNA &lt; LLOQ While On Treatment</title>
        <time_frame>Weeks 1, 2, 4, 8, 12, 16 (24 Week groups only), 20 (24 Week groups only), and 24 (24 Week groups only)</time_frame>
        <population>Participants in the Full Analysis Set with available data were analyzed. Participants from the 12 Weeks groups were not analyzed for Weeks 16, 20, and 24 because they were only treated for 12 weeks.</population>
        <group_list>
          <group group_id="O1">
            <title>12 to &lt; 18 Years Old - LDV/SOF 12 Weeks</title>
            <description>Participants 12 to &lt; 18 years of age with HCV genotype 1 TN with or without cirrhosis or HCV genotype 1 TE without cirrhosis received LDV/SOF FDC 90/400 mg (1 x 90/400 mg tablet or 4 x 22.5/100 mg tablets) once daily for 12 weeks.</description>
          </group>
          <group group_id="O2">
            <title>6 to &lt; 12 Years Old - LDV/SOF 12 Weeks</title>
            <description>Participants 6 to &lt; 12 years of age with HCV genotypes 1 or 4 TN with or without cirrhosis or HCV genotype 1 TE without cirrhosis received LDV/SOF FDC 45/200 mg (2 x 22.5/100 mg tablets or 4 x 11.25/50 mg granules) once daily for 12 weeks.</description>
          </group>
          <group group_id="O3">
            <title>6 to &lt; 12 Years Old - LDV/SOF 24 Weeks</title>
            <description>Participants 6 to &lt; 12 years of age with HCV genotype 1 TE with cirrhosis received LDV/SOF FDC 45/200 mg (2 x 22.5/100 mg tablets or 4 x 11.25/50 mg granules) once daily for 24 weeks.</description>
          </group>
          <group group_id="O4">
            <title>6 to &lt; 12 Years Old - LDV/SOF+RBV 24 Weeks</title>
            <description>Participants 6 to &lt; 12 years of age with HCV genotype 3 TE without cirrhosis received LDV/SOF FDC 45/200 mg (2 x 22.5/100 mg tablets or 4 x 11.25/50 mg granules) once daily + ribavirin capsules or oral solution (dose depending on weight) for 24 weeks.</description>
          </group>
          <group group_id="O5">
            <title>3 to &lt; 6 Years Old - LDV/SOF 12 Weeks</title>
            <description>Participants 3 to &lt; 6 years of age with HCV genotypes 1 or 4 TN without cirrhosis received LDV/SOF FDC (weight ≥ 17 kg: 45/200 mg granules; weight &lt; 17 kg: 33.75/150 mg granules) once daily for 12 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>For the Treatment Phase, Percentage of Participants With HCV RNA &lt; LLOQ While On Treatment</title>
          <population>Participants in the Full Analysis Set with available data were analyzed. Participants from the 12 Weeks groups were not analyzed for Weeks 16, 20, and 24 because they were only treated for 12 weeks.</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="100"/>
                <count group_id="O2" value="89"/>
                <count group_id="O3" value="1"/>
                <count group_id="O4" value="2"/>
                <count group_id="O5" value="34"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="100"/>
                    <count group_id="O2" value="89"/>
                    <count group_id="O3" value="1"/>
                    <count group_id="O4" value="2"/>
                    <count group_id="O5" value="34"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="40.0" lower_limit="30.3" upper_limit="50.3"/>
                    <measurement group_id="O2" value="30.3" lower_limit="21.0" upper_limit="41.0"/>
                    <measurement group_id="O3" value="0" lower_limit="0.0" upper_limit="97.5"/>
                    <measurement group_id="O4" value="100.0" lower_limit="15.8" upper_limit="100.0"/>
                    <measurement group_id="O5" value="29.4" lower_limit="15.1" upper_limit="47.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="100"/>
                    <count group_id="O2" value="89"/>
                    <count group_id="O3" value="1"/>
                    <count group_id="O4" value="2"/>
                    <count group_id="O5" value="33"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="75.0" lower_limit="65.3" upper_limit="83.1"/>
                    <measurement group_id="O2" value="71.9" lower_limit="61.4" upper_limit="80.9"/>
                    <measurement group_id="O3" value="100.0" lower_limit="2.5" upper_limit="100.0"/>
                    <measurement group_id="O4" value="100.0" lower_limit="15.8" upper_limit="100.0"/>
                    <measurement group_id="O5" value="78.8" lower_limit="61.1" upper_limit="91.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="100"/>
                    <count group_id="O2" value="89"/>
                    <count group_id="O3" value="1"/>
                    <count group_id="O4" value="2"/>
                    <count group_id="O5" value="33"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="97.0" lower_limit="91.5" upper_limit="99.4"/>
                    <measurement group_id="O2" value="96.6" lower_limit="90.5" upper_limit="99.3"/>
                    <measurement group_id="O3" value="100.0" lower_limit="2.5" upper_limit="100.0"/>
                    <measurement group_id="O4" value="100.0" lower_limit="15.8" upper_limit="100.0"/>
                    <measurement group_id="O5" value="97.0" lower_limit="84.2" upper_limit="99.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 8</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="99"/>
                    <count group_id="O2" value="89"/>
                    <count group_id="O3" value="1"/>
                    <count group_id="O4" value="2"/>
                    <count group_id="O5" value="33"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="100.0" lower_limit="96.3" upper_limit="100.0"/>
                    <measurement group_id="O2" value="100.0" lower_limit="95.9" upper_limit="100.0"/>
                    <measurement group_id="O3" value="100.0" lower_limit="2.5" upper_limit="100.0"/>
                    <measurement group_id="O4" value="100.0" lower_limit="15.8" upper_limit="100.0"/>
                    <measurement group_id="O5" value="100.0" lower_limit="89.4" upper_limit="100.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 12</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="99"/>
                    <count group_id="O2" value="89"/>
                    <count group_id="O3" value="1"/>
                    <count group_id="O4" value="2"/>
                    <count group_id="O5" value="33"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="100.0" lower_limit="96.3" upper_limit="100.0"/>
                    <measurement group_id="O2" value="100.0" lower_limit="95.9" upper_limit="100.0"/>
                    <measurement group_id="O3" value="100.0" lower_limit="2.5" upper_limit="100.0"/>
                    <measurement group_id="O4" value="100.0" lower_limit="15.8" upper_limit="100.0"/>
                    <measurement group_id="O5" value="100.0" lower_limit="89.4" upper_limit="100.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 16</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="1"/>
                    <count group_id="O4" value="2"/>
                    <count group_id="O5" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O3" value="100.0" lower_limit="2.5" upper_limit="100.0"/>
                    <measurement group_id="O4" value="100.0" lower_limit="15.8" upper_limit="100.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 20</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="1"/>
                    <count group_id="O4" value="2"/>
                    <count group_id="O5" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O3" value="100.0" lower_limit="2.5" upper_limit="100.0"/>
                    <measurement group_id="O4" value="100.0" lower_limit="15.8" upper_limit="100.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 24</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="1"/>
                    <count group_id="O4" value="2"/>
                    <count group_id="O5" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O3" value="100.0" lower_limit="2.5" upper_limit="100.0"/>
                    <measurement group_id="O4" value="100.0" lower_limit="15.8" upper_limit="100.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>For the Treatment Phase, Percentage of Participants With Alanine Aminotransferase (ALT) Normalization</title>
        <description>ALT normalization was defined as ALT &gt; the upper limit of normal (ULN) at baseline and ALT ≤ ULN at each visit.</description>
        <time_frame>Weeks 1, 2, 4, 8, 12, 16 (24 Week groups only), 20 (24 Week groups only), and 24 (24 Week groups only), and Posttreatment Week 4</time_frame>
        <population>Participants in the Full Analysis Set with ALT &gt; ULN at Baseline with available data were analyzed. Participants from the 12 Weeks groups were not analyzed for Weeks 16, 20, and 24 because they were only treated for 12 weeks.</population>
        <group_list>
          <group group_id="O1">
            <title>12 to &lt; 18 Years Old - LDV/SOF 12 Weeks</title>
            <description>Participants 12 to &lt; 18 years of age with HCV genotype 1 TN with or without cirrhosis or HCV genotype 1 TE without cirrhosis received LDV/SOF FDC 90/400 mg (1 x 90/400 mg tablet or 4 x 22.5/100 mg tablets) once daily for 12 weeks.</description>
          </group>
          <group group_id="O2">
            <title>6 to &lt; 12 Years Old - LDV/SOF 12 Weeks</title>
            <description>Participants 6 to &lt; 12 years of age with HCV genotypes 1 or 4 TN with or without cirrhosis or HCV genotype 1 TE without cirrhosis received LDV/SOF FDC 45/200 mg (2 x 22.5/100 mg tablets or 4 x 11.25/50 mg granules) once daily for 12 weeks.</description>
          </group>
          <group group_id="O3">
            <title>6 to &lt; 12 Years Old - LDV/SOF 24 Weeks</title>
            <description>Participants 6 to &lt; 12 years of age with HCV genotype 1 TE with cirrhosis received LDV/SOF FDC 45/200 mg (2 x 22.5/100 mg tablets or 4 x 11.25/50 mg granules) once daily for 24 weeks.</description>
          </group>
          <group group_id="O4">
            <title>6 to &lt; 12 Years Old - LDV/SOF+RBV 24 Weeks</title>
            <description>Participants 6 to &lt; 12 years of age with HCV genotype 3 TE without cirrhosis received LDV/SOF FDC 45/200 mg (2 x 22.5/100 mg tablets or 4 x 11.25/50 mg granules) once daily + ribavirin capsules or oral solution (dose depending on weight) for 24 weeks.</description>
          </group>
          <group group_id="O5">
            <title>3 to &lt; 6 Years Old - LDV/SOF 12 Weeks</title>
            <description>Participants 3 to &lt; 6 years of age with HCV genotypes 1 or 4 TN without cirrhosis received LDV/SOF FDC (weight ≥ 17 kg: 45/200 mg granules; weight &lt; 17 kg: 33.75/150 mg granules) once daily for 12 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>For the Treatment Phase, Percentage of Participants With Alanine Aminotransferase (ALT) Normalization</title>
          <description>ALT normalization was defined as ALT &gt; the upper limit of normal (ULN) at baseline and ALT ≤ ULN at each visit.</description>
          <population>Participants in the Full Analysis Set with ALT &gt; ULN at Baseline with available data were analyzed. Participants from the 12 Weeks groups were not analyzed for Weeks 16, 20, and 24 because they were only treated for 12 weeks.</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="49"/>
                <count group_id="O2" value="72"/>
                <count group_id="O3" value="1"/>
                <count group_id="O4" value="2"/>
                <count group_id="O5" value="27"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="47"/>
                    <count group_id="O2" value="70"/>
                    <count group_id="O3" value="1"/>
                    <count group_id="O4" value="2"/>
                    <count group_id="O5" value="27"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="72.3"/>
                    <measurement group_id="O2" value="75.7"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="50.0"/>
                    <measurement group_id="O5" value="63.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="49"/>
                    <count group_id="O2" value="66"/>
                    <count group_id="O3" value="1"/>
                    <count group_id="O4" value="2"/>
                    <count group_id="O5" value="25"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="89.8"/>
                    <measurement group_id="O2" value="84.8"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="50.0"/>
                    <measurement group_id="O5" value="84.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="48"/>
                    <count group_id="O2" value="72"/>
                    <count group_id="O3" value="1"/>
                    <count group_id="O4" value="2"/>
                    <count group_id="O5" value="25"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="93.8"/>
                    <measurement group_id="O2" value="93.1"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="100.0"/>
                    <measurement group_id="O5" value="96.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 8</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="46"/>
                    <count group_id="O2" value="71"/>
                    <count group_id="O3" value="1"/>
                    <count group_id="O4" value="2"/>
                    <count group_id="O5" value="25"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="91.3"/>
                    <measurement group_id="O2" value="90.1"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="100.0"/>
                    <measurement group_id="O5" value="92.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 12</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="45"/>
                    <count group_id="O2" value="67"/>
                    <count group_id="O3" value="1"/>
                    <count group_id="O4" value="2"/>
                    <count group_id="O5" value="24"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="93.3"/>
                    <measurement group_id="O2" value="95.5"/>
                    <measurement group_id="O3" value="100.0"/>
                    <measurement group_id="O4" value="100.0"/>
                    <measurement group_id="O5" value="91.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 16</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="1"/>
                    <count group_id="O4" value="2"/>
                    <count group_id="O5" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O3" value="100.0"/>
                    <measurement group_id="O4" value="100.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 20</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="1"/>
                    <count group_id="O4" value="2"/>
                    <count group_id="O5" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O3" value="100.0"/>
                    <measurement group_id="O4" value="100.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 24</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="1"/>
                    <count group_id="O4" value="2"/>
                    <count group_id="O5" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O3" value="100.0"/>
                    <measurement group_id="O4" value="100.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Posttreatment Week 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="41"/>
                    <count group_id="O2" value="62"/>
                    <count group_id="O3" value="0"/>
                    <count group_id="O4" value="2"/>
                    <count group_id="O5" value="23"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="90.2"/>
                    <measurement group_id="O2" value="98.4"/>
                    <measurement group_id="O4" value="100.0"/>
                    <measurement group_id="O5" value="91.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>For the Treatment Phase, Change From Baseline in Height</title>
        <time_frame>Baseline; Weeks 1, 2, 4, 8, 12, 16 (24 Week groups only), 20 (24 Week groups only), and 24 (24 Week groups only), and Posttreatment Weeks 4, 12, and 24</time_frame>
        <population>Participants in the Safety Analysis Set with available data were analyzed. Participants from the 12 Weeks groups were not analyzed for Change at Weeks 16, 20, and 24 because they were only treated for 12 weeks.</population>
        <group_list>
          <group group_id="O1">
            <title>12 to &lt; 18 Years Old - LDV/SOF 12 Weeks</title>
            <description>Participants 12 to &lt; 18 years of age with HCV genotype 1 TN with or without cirrhosis or HCV genotype 1 TE without cirrhosis received LDV/SOF FDC 90/400 mg (1 x 90/400 mg tablet or 4 x 22.5/100 mg tablets) once daily for 12 weeks.</description>
          </group>
          <group group_id="O2">
            <title>6 to &lt; 12 Years Old - LDV/SOF 12 Weeks</title>
            <description>Participants 6 to &lt; 12 years of age with HCV genotypes 1 or 4 TN with or without cirrhosis or HCV genotype 1 TE without cirrhosis received LDV/SOF FDC 45/200 mg (2 x 22.5/100 mg tablets or 4 x 11.25/50 mg granules) once daily for 12 weeks.</description>
          </group>
          <group group_id="O3">
            <title>6 to &lt; 12 Years Old - LDV/SOF 24 Weeks</title>
            <description>Participants 6 to &lt; 12 years of age with HCV genotype 1 TE with cirrhosis received LDV/SOF FDC 45/200 mg (2 x 22.5/100 mg tablets or 4 x 11.25/50 mg granules) once daily for 24 weeks.</description>
          </group>
          <group group_id="O4">
            <title>6 to &lt; 12 Years Old - LDV/SOF+RBV 24 Weeks</title>
            <description>Participants 6 to &lt; 12 years of age with HCV genotype 3 TE without cirrhosis received LDV/SOF FDC 45/200 mg (2 x 22.5/100 mg tablets or 4 x 11.25/50 mg granules) once daily + ribavirin capsules or oral solution (dose depending on weight) for 24 weeks.</description>
          </group>
          <group group_id="O5">
            <title>3 to &lt; 6 Years Old - LDV/SOF 12 Weeks</title>
            <description>Participants 3 to &lt; 6 years of age with HCV genotypes 1 or 4 TN without cirrhosis received LDV/SOF FDC (weight ≥ 17 kg: 45/200 mg granules; weight &lt; 17 kg: 33.75/150 mg granules) once daily for 12 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>For the Treatment Phase, Change From Baseline in Height</title>
          <population>Participants in the Safety Analysis Set with available data were analyzed. Participants from the 12 Weeks groups were not analyzed for Change at Weeks 16, 20, and 24 because they were only treated for 12 weeks.</population>
          <units>centimeters</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="100"/>
                <count group_id="O2" value="89"/>
                <count group_id="O3" value="1"/>
                <count group_id="O4" value="2"/>
                <count group_id="O5" value="34"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Change at Week 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="97"/>
                    <count group_id="O2" value="85"/>
                    <count group_id="O3" value="1"/>
                    <count group_id="O4" value="2"/>
                    <count group_id="O5" value="34"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.1" spread="0.68"/>
                    <measurement group_id="O2" value="0.1" spread="0.83"/>
                    <measurement group_id="O3" value="0.3" spread="NA">Standard deviation of a single sample is undefined.</measurement>
                    <measurement group_id="O4" value="0.7" spread="1.13"/>
                    <measurement group_id="O5" value="0.2" spread="1.24"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Week 2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="97"/>
                    <count group_id="O2" value="86"/>
                    <count group_id="O3" value="1"/>
                    <count group_id="O4" value="2"/>
                    <count group_id="O5" value="32"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0" spread="0.70"/>
                    <measurement group_id="O2" value="0.3" spread="0.73"/>
                    <measurement group_id="O3" value="0.5" spread="NA">Standard deviation of a single sample is undefined.</measurement>
                    <measurement group_id="O4" value="0.5" spread="0.85"/>
                    <measurement group_id="O5" value="0.3" spread="0.72"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Week 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="98"/>
                    <count group_id="O2" value="87"/>
                    <count group_id="O3" value="1"/>
                    <count group_id="O4" value="2"/>
                    <count group_id="O5" value="33"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.1" spread="0.84"/>
                    <measurement group_id="O2" value="0.5" spread="0.79"/>
                    <measurement group_id="O3" value="1.2" spread="NA">Standard deviation of a single sample is undefined.</measurement>
                    <measurement group_id="O4" value="0.6" spread="0.92"/>
                    <measurement group_id="O5" value="0.7" spread="0.79"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Week 8</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="98"/>
                    <count group_id="O2" value="88"/>
                    <count group_id="O3" value="1"/>
                    <count group_id="O4" value="2"/>
                    <count group_id="O5" value="33"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.4" spread="1.04"/>
                    <measurement group_id="O2" value="0.8" spread="0.79"/>
                    <measurement group_id="O3" value="1.3" spread="NA">Standard deviation of a single sample is undefined.</measurement>
                    <measurement group_id="O4" value="0.8" spread="0.92"/>
                    <measurement group_id="O5" value="1.0" spread="0.82"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Week 12</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="92"/>
                    <count group_id="O2" value="84"/>
                    <count group_id="O3" value="1"/>
                    <count group_id="O4" value="2"/>
                    <count group_id="O5" value="31"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.5" spread="1.10"/>
                    <measurement group_id="O2" value="1.3" spread="0.83"/>
                    <measurement group_id="O3" value="2.1" spread="NA">Standard deviation of a single sample is undefined.</measurement>
                    <measurement group_id="O4" value="1.1" spread="1.41"/>
                    <measurement group_id="O5" value="1.6" spread="0.98"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Week 16</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="1"/>
                    <count group_id="O4" value="2"/>
                    <count group_id="O5" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O3" value="3.2" spread="NA">Standard deviation of a single sample is undefined.</measurement>
                    <measurement group_id="O4" value="1.4" spread="1.06"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Week 20</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="1"/>
                    <count group_id="O4" value="2"/>
                    <count group_id="O5" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O3" value="4.3" spread="NA">Standard deviation of a single sample is undefined.</measurement>
                    <measurement group_id="O4" value="1.6" spread="0.85"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Week 24</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="1"/>
                    <count group_id="O4" value="2"/>
                    <count group_id="O5" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O3" value="4.3" spread="NA">Standard deviation of a single sample is undefined.</measurement>
                    <measurement group_id="O4" value="2.5" spread="1.48"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Posttreatment Week 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="97"/>
                    <count group_id="O2" value="89"/>
                    <count group_id="O3" value="1"/>
                    <count group_id="O4" value="2"/>
                    <count group_id="O5" value="34"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.8" spread="1.46"/>
                    <measurement group_id="O2" value="1.8" spread="1.04"/>
                    <measurement group_id="O3" value="4.3" spread="NA">Standard deviation of a single sample is undefined.</measurement>
                    <measurement group_id="O4" value="2.4" spread="1.27"/>
                    <measurement group_id="O5" value="2.1" spread="1.13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Posttreatment Week 12</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="96"/>
                    <count group_id="O2" value="87"/>
                    <count group_id="O3" value="1"/>
                    <count group_id="O4" value="2"/>
                    <count group_id="O5" value="34"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.2" spread="1.82"/>
                    <measurement group_id="O2" value="2.7" spread="0.97"/>
                    <measurement group_id="O3" value="5.0" spread="NA">Standard deviation of a single sample is undefined.</measurement>
                    <measurement group_id="O4" value="3.4" spread="1.56"/>
                    <measurement group_id="O5" value="3.3" spread="1.18"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Posttreatment Week 24</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="95"/>
                    <count group_id="O2" value="88"/>
                    <count group_id="O3" value="1"/>
                    <count group_id="O4" value="2"/>
                    <count group_id="O5" value="34"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.8" spread="2.31"/>
                    <measurement group_id="O2" value="4.1" spread="1.39"/>
                    <measurement group_id="O3" value="7.6" spread="NA">Standard deviation of a single sample is undefined.</measurement>
                    <measurement group_id="O4" value="5.6" spread="0.85"/>
                    <measurement group_id="O5" value="4.7" spread="1.31"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>For the Treatment Phase, Change From Baseline in Weight</title>
        <time_frame>Baseline; Weeks 1, 2, 4, 8, 12, 16 (24 Week groups only), 20 (24 Week groups only), and 24 (24 Week groups only), and Posttreatment Weeks 4, 12, and 24</time_frame>
        <population>Participants in the Safety Analysis Set with available data were analyzed. Participants from the 12 Weeks groups were not analyzed for Change at Weeks 16, 20, and 24 because they were only treated for 12 weeks.</population>
        <group_list>
          <group group_id="O1">
            <title>12 to &lt; 18 Years Old - LDV/SOF 12 Weeks</title>
            <description>Participants 12 to &lt; 18 years of age with HCV genotype 1 TN with or without cirrhosis or HCV genotype 1 TE without cirrhosis received LDV/SOF FDC 90/400 mg (1 x 90/400 mg tablet or 4 x 22.5/100 mg tablets) once daily for 12 weeks.</description>
          </group>
          <group group_id="O2">
            <title>6 to &lt; 12 Years Old - LDV/SOF 12 Weeks</title>
            <description>Participants 6 to &lt; 12 years of age with HCV genotypes 1 or 4 TN with or without cirrhosis or HCV genotype 1 TE without cirrhosis received LDV/SOF FDC 45/200 mg (2 x 22.5/100 mg tablets or 4 x 11.25/50 mg granules) once daily for 12 weeks.</description>
          </group>
          <group group_id="O3">
            <title>6 to &lt; 12 Years Old - LDV/SOF 24 Weeks</title>
            <description>Participants 6 to &lt; 12 years of age with HCV genotype 1 TE with cirrhosis received LDV/SOF FDC 45/200 mg (2 x 22.5/100 mg tablets or 4 x 11.25/50 mg granules) once daily for 24 weeks.</description>
          </group>
          <group group_id="O4">
            <title>6 to &lt; 12 Years Old - LDV/SOF+RBV 24 Weeks</title>
            <description>Participants 6 to &lt; 12 years of age with HCV genotype 3 TE without cirrhosis received LDV/SOF FDC 45/200 mg (2 x 22.5/100 mg tablets or 4 x 11.25/50 mg granules) once daily + ribavirin capsules or oral solution (dose depending on weight) for 24 weeks.</description>
          </group>
          <group group_id="O5">
            <title>3 to &lt; 6 Years Old - LDV/SOF 12 Weeks</title>
            <description>Participants 3 to &lt; 6 years of age with HCV genotypes 1 or 4 TN without cirrhosis received LDV/SOF FDC (weight ≥ 17 kg: 45/200 mg granules; weight &lt; 17 kg: 33.75/150 mg granules) once daily for 12 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>For the Treatment Phase, Change From Baseline in Weight</title>
          <population>Participants in the Safety Analysis Set with available data were analyzed. Participants from the 12 Weeks groups were not analyzed for Change at Weeks 16, 20, and 24 because they were only treated for 12 weeks.</population>
          <units>kilograms</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="100"/>
                <count group_id="O2" value="89"/>
                <count group_id="O3" value="1"/>
                <count group_id="O4" value="2"/>
                <count group_id="O5" value="34"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Change at Week 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="98"/>
                    <count group_id="O2" value="86"/>
                    <count group_id="O3" value="1"/>
                    <count group_id="O4" value="2"/>
                    <count group_id="O5" value="34"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.1" spread="1.00"/>
                    <measurement group_id="O2" value="0.3" spread="0.51"/>
                    <measurement group_id="O3" value="-0.5" spread="NA">Standard deviation of a single sample is undefined.</measurement>
                    <measurement group_id="O4" value="0.3" spread="1.34"/>
                    <measurement group_id="O5" value="0.1" spread="0.39"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Week 2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="97"/>
                    <count group_id="O2" value="87"/>
                    <count group_id="O3" value="1"/>
                    <count group_id="O4" value="2"/>
                    <count group_id="O5" value="33"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.3" spread="1.11"/>
                    <measurement group_id="O2" value="0.4" spread="0.54"/>
                    <measurement group_id="O3" value="0.0" spread="NA">Standard deviation of a single sample is undefined.</measurement>
                    <measurement group_id="O4" value="0.3" spread="1.77"/>
                    <measurement group_id="O5" value="0.2" spread="0.44"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Week 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="98"/>
                    <count group_id="O2" value="89"/>
                    <count group_id="O3" value="1"/>
                    <count group_id="O4" value="2"/>
                    <count group_id="O5" value="33"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.4" spread="1.44"/>
                    <measurement group_id="O2" value="0.5" spread="0.64"/>
                    <measurement group_id="O3" value="0.5" spread="NA">Standard deviation of a single sample is undefined.</measurement>
                    <measurement group_id="O4" value="0.7" spread="1.91"/>
                    <measurement group_id="O5" value="0.3" spread="0.64"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Week 8</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="98"/>
                    <count group_id="O2" value="89"/>
                    <count group_id="O3" value="1"/>
                    <count group_id="O4" value="2"/>
                    <count group_id="O5" value="33"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.5" spread="1.90"/>
                    <measurement group_id="O2" value="0.8" spread="0.84"/>
                    <measurement group_id="O3" value="1.3" spread="NA">Standard deviation of a single sample is undefined.</measurement>
                    <measurement group_id="O4" value="0.6" spread="2.33"/>
                    <measurement group_id="O5" value="0.5" spread="0.66"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Week 12</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="92"/>
                    <count group_id="O2" value="84"/>
                    <count group_id="O3" value="1"/>
                    <count group_id="O4" value="2"/>
                    <count group_id="O5" value="31"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.6" spread="2.32"/>
                    <measurement group_id="O2" value="1.1" spread="1.27"/>
                    <measurement group_id="O3" value="2.1" spread="NA">Standard deviation of a single sample is undefined.</measurement>
                    <measurement group_id="O4" value="0.9" spread="2.90"/>
                    <measurement group_id="O5" value="0.6" spread="0.70"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Week 16</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="1"/>
                    <count group_id="O4" value="2"/>
                    <count group_id="O5" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O3" value="1.6" spread="NA">Standard deviation of a single sample is undefined.</measurement>
                    <measurement group_id="O4" value="1.2" spread="3.68"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Week 20</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="1"/>
                    <count group_id="O4" value="2"/>
                    <count group_id="O5" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O3" value="2.2" spread="NA">Standard deviation of a single sample is undefined.</measurement>
                    <measurement group_id="O4" value="1.8" spread="3.96"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Week 24</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="1"/>
                    <count group_id="O4" value="2"/>
                    <count group_id="O5" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O3" value="3.1" spread="NA">Standard deviation of a single sample is undefined.</measurement>
                    <measurement group_id="O4" value="2.4" spread="3.68"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Posttreatment Week 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="97"/>
                    <count group_id="O2" value="89"/>
                    <count group_id="O3" value="1"/>
                    <count group_id="O4" value="2"/>
                    <count group_id="O5" value="34"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.9" spread="2.70"/>
                    <measurement group_id="O2" value="1.4" spread="1.48"/>
                    <measurement group_id="O3" value="1.8" spread="NA">Standard deviation of a single sample is undefined.</measurement>
                    <measurement group_id="O4" value="2.2" spread="3.68"/>
                    <measurement group_id="O5" value="1.1" spread="1.09"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Posttreatment Week 12</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="96"/>
                    <count group_id="O2" value="89"/>
                    <count group_id="O3" value="1"/>
                    <count group_id="O4" value="2"/>
                    <count group_id="O5" value="34"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.6" spread="3.48"/>
                    <measurement group_id="O2" value="2.1" spread="1.87"/>
                    <measurement group_id="O3" value="3.1" spread="NA">Standard deviation of a single sample is undefined.</measurement>
                    <measurement group_id="O4" value="3.7" spread="2.90"/>
                    <measurement group_id="O5" value="1.2" spread="0.93"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Posttreatment Week 24</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="95"/>
                    <count group_id="O2" value="89"/>
                    <count group_id="O3" value="1"/>
                    <count group_id="O4" value="2"/>
                    <count group_id="O5" value="34"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.2" spread="4.38"/>
                    <measurement group_id="O2" value="3.5" spread="2.75"/>
                    <measurement group_id="O3" value="4.5" spread="NA">Standard deviation of a single sample is undefined.</measurement>
                    <measurement group_id="O4" value="5.7" spread="1.41"/>
                    <measurement group_id="O5" value="2.0" spread="1.57"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>For the Treatment Phase, Number of Male Participants With a Change From Baseline in Tanner Stage for Pubic Hair</title>
        <description>Tanner Stages is a scale that defines physical measurements of development based on external primary and secondary sex characteristics. It was used in this study to assess pubertal development with values ranging from Stage 1 (pre-pubertal characteristics) to Stage 5 (adult or mature characteristics). Any shifts (increase or decrease) in Tanner Stage from Baseline were analyzed and presented.</description>
        <time_frame>Baseline; End of Treatment (either Week 12 or 24), Posttreatment Week 12, and Posttreatment Week 24</time_frame>
        <population>Male 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 - LDV/SOF 12 Weeks</title>
            <description>Male participants 12 to &lt; 18 years of age received LDV/SOF FDC 90/400 mg (1 x 90/400 mg tablet or 4 x 22.5/100 mg tablets) once daily for 12 weeks.</description>
          </group>
          <group group_id="O2">
            <title>6 to &lt; 12 Years Old - LDV/SOF±RBV 12 or 24 Weeks</title>
            <description>Male participants 6 to &lt; 12 years of age received LDV/SOF FDC 45/200 mg (2 x 22.5/100 mg tablets or 4 x 11.25/50 mg granules) once daily ± RBV capsules or oral solution (dose depending on weight) for 12 or 24 weeks.</description>
          </group>
          <group group_id="O3">
            <title>3 to &lt; 6 Years Old - LDV/SOF 12 Weeks</title>
            <description>Male participants 3 to &lt; 6 years of age received LDV/SOF FDC (weight ≥ 17 kg: 45/200 mg granules; weight &lt; 17 kg: 33.75/150 mg granules) once daily for 12 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>For the Treatment Phase, Number of Male Participants With a Change From Baseline in Tanner Stage for Pubic Hair</title>
          <description>Tanner Stages is a scale that defines physical measurements of development based on external primary and secondary sex characteristics. It was used in this study to assess pubertal development with values ranging from Stage 1 (pre-pubertal characteristics) to Stage 5 (adult or mature characteristics). Any shifts (increase or decrease) in Tanner Stage from Baseline were analyzed and presented.</description>
          <population>Male participants in the Safety 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="37"/>
                <count group_id="O2" value="54"/>
                <count group_id="O3" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>End of Treatment</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="36"/>
                    <count group_id="O2" value="54"/>
                    <count group_id="O3" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>No Change</title>
                  <measurement_list>
                    <measurement group_id="O1" value="35"/>
                    <measurement group_id="O2" value="52"/>
                    <measurement group_id="O3" value="10"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Increase</title>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Decrease</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Posttreatment Week 12</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="35"/>
                    <count group_id="O2" value="54"/>
                    <count group_id="O3" value="9"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>No Change</title>
                  <measurement_list>
                    <measurement group_id="O1" value="32"/>
                    <measurement group_id="O2" value="51"/>
                    <measurement group_id="O3" value="9"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Increase</title>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="2"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Decrease</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Posttreatment Week 24</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="35"/>
                    <count group_id="O2" value="53"/>
                    <count group_id="O3" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>No Change</title>
                  <measurement_list>
                    <measurement group_id="O1" value="28"/>
                    <measurement group_id="O2" value="48"/>
                    <measurement group_id="O3" value="9"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Increase</title>
                  <measurement_list>
                    <measurement group_id="O1" value="7"/>
                    <measurement group_id="O2" value="4"/>
                    <measurement group_id="O3" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Decrease</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>For the Treatment Phase, Number of Male Participants With a Change From Baseline in Tanner Stage for Genitalia Development</title>
        <description>Tanner Stages is a scale that defines physical measurements of development based on external primary and secondary sex characteristics. It was used in this study to assess pubertal development with values ranging from Stage 1 (pre-pubertal characteristics) to Stage 5 (adult or mature characteristics). Any shifts (increase or decrease) in Tanner Stage from Baseline were analyzed and presented.</description>
        <time_frame>Baseline; End of Treatment (either Week 12 or 24), Posttreatment Week 12, and Posttreatment Week 24</time_frame>
        <population>Male 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 - LDV/SOF 12 Weeks</title>
            <description>Male participants 12 to &lt; 18 years of age received LDV/SOF FDC 90/400 mg (1 x 90/400 mg tablet or 4 x 22.5/100 mg tablets) once daily for 12 weeks.</description>
          </group>
          <group group_id="O2">
            <title>6 to &lt; 12 Years Old - LDV/SOF±RBV 12 or 24 Weeks</title>
            <description>Male participants 6 to &lt; 12 years of age received LDV/SOF FDC 45/200 mg (2 x 22.5/100 mg tablets or 4 x 11.25/50 mg granules) once daily ± RBV capsules or oral solution (dose depending on weight) for 12 or 24 weeks.</description>
          </group>
          <group group_id="O3">
            <title>3 to &lt; 6 Years Old - LDV/SOF 12 Weeks</title>
            <description>Male participants 3 to &lt; 6 years of age received LDV/SOF FDC (weight ≥ 17 kg: 45/200 mg granules; weight &lt; 17 kg: 33.75/150 mg granules) once daily for 12 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>For the Treatment Phase, Number of Male Participants With a Change From Baseline in Tanner Stage for Genitalia Development</title>
          <description>Tanner Stages is a scale that defines physical measurements of development based on external primary and secondary sex characteristics. It was used in this study to assess pubertal development with values ranging from Stage 1 (pre-pubertal characteristics) to Stage 5 (adult or mature characteristics). Any shifts (increase or decrease) in Tanner Stage from Baseline were analyzed and presented.</description>
          <population>Male participants in the Safety 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="37"/>
                <count group_id="O2" value="54"/>
                <count group_id="O3" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>End of Treatment</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="35"/>
                    <count group_id="O2" value="54"/>
                    <count group_id="O3" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>No Change</title>
                  <measurement_list>
                    <measurement group_id="O1" value="34"/>
                    <measurement group_id="O2" value="52"/>
                    <measurement group_id="O3" value="10"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Increase</title>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Decrease</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Posttreatment Week 12</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="35"/>
                    <count group_id="O2" value="54"/>
                    <count group_id="O3" value="9"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>No Change</title>
                  <measurement_list>
                    <measurement group_id="O1" value="33"/>
                    <measurement group_id="O2" value="50"/>
                    <measurement group_id="O3" value="9"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Increase</title>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="4"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Decrease</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Posttreatment Week 24</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="35"/>
                    <count group_id="O2" value="53"/>
                    <count group_id="O3" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>No Change</title>
                  <measurement_list>
                    <measurement group_id="O1" value="29"/>
                    <measurement group_id="O2" value="47"/>
                    <measurement group_id="O3" value="10"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Increase</title>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                    <measurement group_id="O2" value="6"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Decrease</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <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>For the Treatment Phase, Number of Female Participants With a Change From Baseline in Tanner Stage for Pubic Hair</title>
        <description>Tanner Stages is a scale that defines physical measurements of development based on external primary and secondary sex characteristics. It was used in this study to assess pubertal development with values ranging from Stage 1 (pre-pubertal characteristics) to Stage 5 (adult or mature characteristics). Any shifts (increase or decrease) in Tanner Stage from Baseline were analyzed and presented.</description>
        <time_frame>Baseline; End of Treatment (either Week 12 or 24), Posttreatment Week 12, and Posttreatment Week 24</time_frame>
        <population>Female 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 - LDV/SOF 12 Weeks</title>
            <description>Female participants 12 to &lt; 18 years of age received LDV/SOF FDC 90/400 mg (1 x 90/400 mg tablet or 4 x 22.5/100 mg tablets) once daily for 12 weeks.</description>
          </group>
          <group group_id="O2">
            <title>6 to &lt; 12 Years Old - LDV/SOF±RBV 12 or 24 Weeks</title>
            <description>Female participants 6 to &lt; 12 years of age received LDV/SOF FDC 45/200 mg (2 x 22.5/100 mg tablets or 4 x 11.25/50 mg granules) once daily ± RBV capsules or oral solution (dose depending on weight) for 12 or 24 weeks.</description>
          </group>
          <group group_id="O3">
            <title>3 to &lt; 6 Years Old - LDV/SOF 12 Weeks</title>
            <description>Female participants 3 to &lt; 6 years of age received LDV/SOF FDC (weight ≥ 17 kg: 45/200 mg granules; weight &lt; 17 kg: 33.75/150 mg granules) once daily for 12 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>For the Treatment Phase, Number of Female Participants With a Change From Baseline in Tanner Stage for Pubic Hair</title>
          <description>Tanner Stages is a scale that defines physical measurements of development based on external primary and secondary sex characteristics. It was used in this study to assess pubertal development with values ranging from Stage 1 (pre-pubertal characteristics) to Stage 5 (adult or mature characteristics). Any shifts (increase or decrease) in Tanner Stage from Baseline were analyzed and presented.</description>
          <population>Female participants in the Safety 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="63"/>
                <count group_id="O2" value="38"/>
                <count group_id="O3" value="24"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>End of Treatment</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="62"/>
                    <count group_id="O2" value="36"/>
                    <count group_id="O3" value="21"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>No Change</title>
                  <measurement_list>
                    <measurement group_id="O1" value="52"/>
                    <measurement group_id="O2" value="34"/>
                    <measurement group_id="O3" value="21"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Increase</title>
                  <measurement_list>
                    <measurement group_id="O1" value="9"/>
                    <measurement group_id="O2" value="2"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Decrease</title>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Posttreatment Week 12</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="60"/>
                    <count group_id="O2" value="34"/>
                    <count group_id="O3" value="22"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>No Change</title>
                  <measurement_list>
                    <measurement group_id="O1" value="45"/>
                    <measurement group_id="O2" value="31"/>
                    <measurement group_id="O3" value="22"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Increase</title>
                  <measurement_list>
                    <measurement group_id="O1" value="15"/>
                    <measurement group_id="O2" value="3"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Decrease</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Posttreatment Week 24</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="61"/>
                    <count group_id="O2" value="35"/>
                    <count group_id="O3" value="22"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>No Change</title>
                  <measurement_list>
                    <measurement group_id="O1" value="40"/>
                    <measurement group_id="O2" value="27"/>
                    <measurement group_id="O3" value="22"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Increase</title>
                  <measurement_list>
                    <measurement group_id="O1" value="21"/>
                    <measurement group_id="O2" value="8"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Decrease</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <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>For the Treatment Phase, Number of Female Participants With a Change From Baseline in Tanner Stage for Breast Development</title>
        <description>Tanner Stages is a scale that defines physical measurements of development based on external primary and secondary sex characteristics. It was used in this study to assess pubertal development with values ranging from Stage 1 (pre-pubertal characteristics) to Stage 5 (adult or mature characteristics). Any shifts (increase or decrease) in Tanner Stage from Baseline were analyzed and presented.</description>
        <time_frame>Baseline; End of Treatment (either Week 12 or 24), Posttreatment Week 12, and Posttreatment Week 24</time_frame>
        <population>Female 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 - LDV/SOF 12 Weeks</title>
            <description>Female participants 12 to &lt; 18 years of age received LDV/SOF FDC 90/400 mg (1 x 90/400 mg tablet or 4 x 22.5/100 mg tablets) once daily for 12 weeks.</description>
          </group>
          <group group_id="O2">
            <title>6 to &lt; 12 Years Old - LDV/SOF±RBV 12 or 24 Weeks</title>
            <description>Female participants 6 to &lt; 12 years of age received LDV/SOF FDC 45/200 mg (2 x 22.5/100 mg tablets or 4 x 11.25/50 mg granules) once daily ± RBV capsules or oral solution (dose depending on weight) for 12 or 24 weeks.</description>
          </group>
          <group group_id="O3">
            <title>3 to &lt; 6 Years Old - LDV/SOF 12 Weeks</title>
            <description>Female participants 3 to &lt; 6 years of age received LDV/SOF FDC (weight ≥ 17 kg: 45/200 mg granules; weight &lt; 17 kg: 33.75/150 mg granules) once daily for 12 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>For the Treatment Phase, Number of Female Participants With a Change From Baseline in Tanner Stage for Breast Development</title>
          <description>Tanner Stages is a scale that defines physical measurements of development based on external primary and secondary sex characteristics. It was used in this study to assess pubertal development with values ranging from Stage 1 (pre-pubertal characteristics) to Stage 5 (adult or mature characteristics). Any shifts (increase or decrease) in Tanner Stage from Baseline were analyzed and presented.</description>
          <population>Female participants in the Safety 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="63"/>
                <count group_id="O2" value="38"/>
                <count group_id="O3" value="24"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>End of Treatment</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="62"/>
                    <count group_id="O2" value="36"/>
                    <count group_id="O3" value="21"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>No Change</title>
                  <measurement_list>
                    <measurement group_id="O1" value="53"/>
                    <measurement group_id="O2" value="31"/>
                    <measurement group_id="O3" value="21"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Increase</title>
                  <measurement_list>
                    <measurement group_id="O1" value="8"/>
                    <measurement group_id="O2" value="5"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Decrease</title>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Posttreatment Week 12</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="60"/>
                    <count group_id="O2" value="34"/>
                    <count group_id="O3" value="22"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>No Change</title>
                  <measurement_list>
                    <measurement group_id="O1" value="49"/>
                    <measurement group_id="O2" value="25"/>
                    <measurement group_id="O3" value="21"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Increase</title>
                  <measurement_list>
                    <measurement group_id="O1" value="11"/>
                    <measurement group_id="O2" value="8"/>
                    <measurement group_id="O3" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Decrease</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Posttreatment Week 24</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="61"/>
                    <count group_id="O2" value="35"/>
                    <count group_id="O3" value="22"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>No Change</title>
                  <measurement_list>
                    <measurement group_id="O1" value="43"/>
                    <measurement group_id="O2" value="21"/>
                    <measurement group_id="O3" value="21"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Increase</title>
                  <measurement_list>
                    <measurement group_id="O1" value="18"/>
                    <measurement group_id="O2" value="14"/>
                    <measurement group_id="O3" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Decrease</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <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>Acceptability of LDV/SOF Tablets as Measured by the Percentage of Participants Able/Unable to Swallow Placebo Tablet at Day 1</title>
        <description>Participants who were able/unable to swallow placebo tablets were assessed. Participants 12 to &lt; 18 years old were first asked to perform the swallowability assessment using the 90/400 mg placebo tablet. If they were unable to swallow this, they were then asked to perform the swallowability assessment with 22.5/100 mg placebo tablets. Participants 6 to &lt; 12 years old were to be assessed with the 22.5/100 mg placebo tablets. However, 8 participants were mistakenly assessed using the 90/400 mg placebo tablet.</description>
        <time_frame>Day 1</time_frame>
        <population>Participants between 6 to &lt;18 years old in the Safety Analysis Set who performed the swallowability assessment were analyzed.</population>
        <group_list>
          <group group_id="O1">
            <title>12 to &lt; 18 Years Old - LDV/SOF 12 Weeks</title>
            <description>Participants 12 to &lt; 18 years of age received placebo to match LDV/SOF FDC to assess ability to swallow tablets on Day 1. They then received LDV/SOF FDC 90/400 mg (1 x 90/400 mg tablet or 4 x 22.5/100 mg tablets) once daily for 12 weeks.</description>
          </group>
          <group group_id="O2">
            <title>6 to &lt; 12 Years Old - LDV/SOF±RBV 12 or 24 Weeks</title>
            <description>Participants 6 to &lt; 12 years of age received placebo to match LDV/SOF FDC to assess ability to swallow tablets on Day 1. They then received LDV/SOF FDC 45/200 mg (2 x 22.5/100 mg tablets or 4 x 11.25/50 mg granules) once daily ± RBV capsules or oral solution (dose depending on weight) for 12 or 24 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Acceptability of LDV/SOF Tablets as Measured by the Percentage of Participants Able/Unable to Swallow Placebo Tablet at Day 1</title>
          <description>Participants who were able/unable to swallow placebo tablets were assessed. Participants 12 to &lt; 18 years old were first asked to perform the swallowability assessment using the 90/400 mg placebo tablet. If they were unable to swallow this, they were then asked to perform the swallowability assessment with 22.5/100 mg placebo tablets. Participants 6 to &lt; 12 years old were to be assessed with the 22.5/100 mg placebo tablets. However, 8 participants were mistakenly assessed using the 90/400 mg placebo tablet.</description>
          <population>Participants between 6 to &lt;18 years old in the Safety Analysis Set who performed the swallowability assessment 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="100"/>
                <count group_id="O2" value="92"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Able to Swallow 90/400 mg Placebo Tablet</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="100"/>
                    <count group_id="O2" value="8"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="89.0"/>
                    <measurement group_id="O2" value="100.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Unable to Swallow 90/400 mg Placebo Tablet</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="100"/>
                    <count group_id="O2" value="8"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11.0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Able to Swallow 22.5/100 mg Placebo Tablet</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="11"/>
                    <count group_id="O2" value="84"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="72.7"/>
                    <measurement group_id="O2" value="98.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Unable to Swallow 22.5/100 mg Placebo Tablet</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="11"/>
                    <count group_id="O2" value="84"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="27.3"/>
                    <measurement group_id="O2" value="1.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Acceptability of LDV/SOF Granules as Measured by Palatability at Day 1</title>
        <description>Participants who were dosed with granules were asked if they tasted the study drug. If they tasted it, then they were asked to provide a number from 0 to 100 to rate the taste of the study drug, with higher scores indicating better taste. Data was then summarized as percentage of participants choosing the following palatability categories: 1) Did not taste the study drug, 2) Tasted drug with score &gt; 60 to 100, 3) Tasted drug with score 40 to 60, and 4) Tasted drug with score of 0 to &lt; 40.</description>
        <time_frame>Day 1</time_frame>
        <population>Participants between 3 to &lt;6 years old in the Safety Analysis Set who performed the palatability test were analyzed.</population>
        <group_list>
          <group group_id="O1">
            <title>3 to &lt; 6 Years Old - LDV/SOF 12 Weeks</title>
            <description>Participants 3 to &lt; 6 years of age received LDV/SOF FDC (weight ≥ 17 kg: 45/200 mg granules; weight &lt; 17 kg: 33.75/150 mg granules) once daily for 12 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Acceptability of LDV/SOF Granules as Measured by Palatability at Day 1</title>
          <description>Participants who were dosed with granules were asked if they tasted the study drug. If they tasted it, then they were asked to provide a number from 0 to 100 to rate the taste of the study drug, with higher scores indicating better taste. Data was then summarized as percentage of participants choosing the following palatability categories: 1) Did not taste the study drug, 2) Tasted drug with score &gt; 60 to 100, 3) Tasted drug with score 40 to 60, and 4) Tasted drug with score of 0 to &lt; 40.</description>
          <population>Participants between 3 to &lt;6 years old in the Safety Analysis Set who performed the palatability test 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_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Did not taste the study drug</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="41.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Tasted drug with score &gt; 60 to 100</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="17.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Tasted drug with score 40 to 60</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Tasted drug with score of 0 to &lt; 40</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="29.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24</time_frame>
      <desc>Safety Analysis Set included all participants who were enrolled into the study and received at least 1 dose of study drug.</desc>
      <group_list>
        <group group_id="E1">
          <title>12 to &lt; 18 Years Old - LDV/SOF 12 Weeks</title>
          <description>Participants 12 to &lt; 18 years of age with HCV genotype 1 TN with or without cirrhosis or HCV genotype 1 TE without cirrhosis received LDV/SOF FDC 90/400 mg (1 x 90/400 mg tablet or 4 x 22.5/100 mg tablets) once daily for 12 weeks.</description>
        </group>
        <group group_id="E2">
          <title>6 to &lt; 12 Years Old - LDV/SOF 12 Weeks</title>
          <description>Participants 6 to &lt; 12 years of age with HCV genotypes 1 or 4 TN with or without cirrhosis or HCV genotype 1 TE without cirrhosis received LDV/SOF FDC 45/200 mg (2 x 22.5/100 mg tablets or 4 x 11.25/50 mg granules) once daily for 12 weeks.</description>
        </group>
        <group group_id="E3">
          <title>6 to &lt; 12 Years Old - LDV/SOF 24 Weeks</title>
          <description>Participants 6 to &lt; 12 years of age with HCV genotype 1 TE with cirrhosis received LDV/SOF FDC 45/200 mg (2 x 22.5/100 mg tablets or 4 x 11.25/50 mg granules) once daily for 24 weeks.</description>
        </group>
        <group group_id="E4">
          <title>6 to &lt; 12 Years Old - LDV/SOF+RBV 24 Weeks</title>
          <description>Participants 6 to &lt; 12 years of age with HCV genotype 3 TE without cirrhosis received LDV/SOF FDC 45/200 mg (2 x 22.5/100 mg tablets or 4 x 11.25/50 mg granules) once daily + ribavirin capsules or oral solution (dose depending on weight) for 24 weeks.</description>
        </group>
        <group group_id="E5">
          <title>3 to &lt; 6 Years Old - LDV/SOF 12 Weeks</title>
          <description>Participants 3 to &lt; 6 years of age with HCV genotypes 1 or 4 TN without cirrhosis received LDV/SOF FDC (weight ≥ 17 kg: 45/200 mg granules; weight &lt; 17 kg: 33.75/150 mg granules) once daily for 12 weeks.</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA 20.1</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="100"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="89"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="34"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="100"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="89"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="34"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Abdominal pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="100"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="89"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="34"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Gastroenteritis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="100"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="89"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="34"/>
              </event>
              <event>
                <sub_title>Tooth abscess</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="100"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="89"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="34"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedDRA 20.1</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="62" subjects_at_risk="100"/>
                <counts group_id="E2" subjects_affected="54" subjects_at_risk="89"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="1"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="2"/>
                <counts group_id="E5" subjects_affected="22" subjects_at_risk="34"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Ear and labyrinth disorders</title>
            <event_list>
              <event>
                <sub_title>Ear pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="100"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="89"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="2"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="34"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Abdominal pain</sub_title>
                <counts group_id="E1" subjects_affected="7" subjects_at_risk="100"/>
                <counts group_id="E2" subjects_affected="14" subjects_at_risk="89"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E5" subjects_affected="2" subjects_at_risk="34"/>
              </event>
              <event>
                <sub_title>Abdominal pain upper</sub_title>
                <counts group_id="E1" subjects_affected="7" subjects_at_risk="100"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="89"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E5" subjects_affected="2" subjects_at_risk="34"/>
              </event>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" subjects_affected="13" subjects_at_risk="100"/>
                <counts group_id="E2" subjects_affected="11" subjects_at_risk="89"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="34"/>
              </event>
              <event>
                <sub_title>Mouth ulceration</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="100"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="89"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="2"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="34"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" subjects_affected="11" subjects_at_risk="100"/>
                <counts group_id="E2" subjects_affected="9" subjects_at_risk="89"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="2"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="34"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" subjects_affected="12" subjects_at_risk="100"/>
                <counts group_id="E2" subjects_affected="12" subjects_at_risk="89"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="2"/>
                <counts group_id="E5" subjects_affected="8" subjects_at_risk="34"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Fatigue</sub_title>
                <counts group_id="E1" subjects_affected="13" subjects_at_risk="100"/>
                <counts group_id="E2" subjects_affected="13" subjects_at_risk="89"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="2"/>
                <counts group_id="E5" subjects_affected="2" subjects_at_risk="34"/>
              </event>
              <event>
                <sub_title>Pyrexia</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="100"/>
                <counts group_id="E2" subjects_affected="15" subjects_at_risk="89"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="2"/>
                <counts group_id="E5" subjects_affected="7" subjects_at_risk="34"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Conjunctivitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="100"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="89"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E5" subjects_affected="2" subjects_at_risk="34"/>
              </event>
              <event>
                <sub_title>Ear infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="100"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="89"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E5" subjects_affected="2" subjects_at_risk="34"/>
              </event>
              <event>
                <sub_title>Nasopharyngitis</sub_title>
                <counts group_id="E1" subjects_affected="7" subjects_at_risk="100"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="89"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="2"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="34"/>
              </event>
              <event>
                <sub_title>Pharyngitis streptococcal</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="100"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="89"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E5" subjects_affected="4" subjects_at_risk="34"/>
              </event>
              <event>
                <sub_title>Upper respiratory tract infection</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="100"/>
                <counts group_id="E2" subjects_affected="7" subjects_at_risk="89"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E5" subjects_affected="3" subjects_at_risk="34"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Fall</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="100"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="89"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="2"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="34"/>
              </event>
              <event>
                <sub_title>Skin abrasion</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="100"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="89"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E5" subjects_affected="2" subjects_at_risk="34"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Back pain</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="100"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="89"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="34"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Dizziness</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="100"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="89"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="34"/>
              </event>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" subjects_affected="26" subjects_at_risk="100"/>
                <counts group_id="E2" subjects_affected="16" subjects_at_risk="89"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="2"/>
                <counts group_id="E5" subjects_affected="3" subjects_at_risk="34"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Product Issues</title>
            <event_list>
              <event>
                <sub_title>Product taste abnormal</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="100"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="89"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E5" subjects_affected="3" subjects_at_risk="34"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Insomnia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="100"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="89"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E5" subjects_affected="2" subjects_at_risk="34"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Reproductive system and breast disorders</title>
            <event_list>
              <event>
                <sub_title>Dysmenorrhoea</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="100"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="89"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="34"/>
              </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="100"/>
                <counts group_id="E2" subjects_affected="11" subjects_at_risk="89"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="1"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="2"/>
                <counts group_id="E5" subjects_affected="7" subjects_at_risk="34"/>
              </event>
              <event>
                <sub_title>Epistaxis</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="100"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="89"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="1"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E5" subjects_affected="2" subjects_at_risk="34"/>
              </event>
              <event>
                <sub_title>Nasal congestion</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="100"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="89"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="1"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E5" subjects_affected="2" subjects_at_risk="34"/>
              </event>
              <event>
                <sub_title>Oropharyngeal pain</sub_title>
                <counts group_id="E1" subjects_affected="10" subjects_at_risk="100"/>
                <counts group_id="E2" subjects_affected="10" subjects_at_risk="89"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="34"/>
              </event>
              <event>
                <sub_title>Rhinorrhoea</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="100"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="89"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="1"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E5" subjects_affected="6" subjects_at_risk="34"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Dermatitis allergic</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="100"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="89"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="2"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="34"/>
              </event>
              <event>
                <sub_title>Dermatitis contact</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="100"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="89"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E5" subjects_affected="2" subjects_at_risk="34"/>
              </event>
              <event>
                <sub_title>Ecchymosis</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="100"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="89"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E5" subjects_affected="2" subjects_at_risk="34"/>
              </event>
              <event>
                <sub_title>Rash</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="100"/>
                <counts group_id="E2" subjects_affected="8" subjects_at_risk="89"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E5" subjects_affected="3" subjects_at_risk="34"/>
              </event>
              <event>
                <sub_title>Rash maculo-papular</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="100"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="89"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="2"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="34"/>
              </event>
              <event>
                <sub_title>Skin odour abnormal</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="100"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="89"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="2"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="34"/>
              </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&#xD;
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/NCT02249182
org study id: GS-US-337-1116
secondary id: 2014-003578-17
nct id: NCT02249182
lead sponsor: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
The primary objective of the PK Lead-in Phase of the study is to evaluate the steady state
      pharmacokinetics (PK) and confirm the dose of ledipasvir/sofosbuvir (LDV/SOF) fixed dose
      combination (FDC) in hepatitis C virus (HCV)-infected pediatric participants. The PK Lead-in
      Phase will also evaluate the safety, tolerability, and antiviral activity of 10 days of
      dosing of LDV/SOF FDC in HCV-infected pediatric participants.

      The Treatment Phase will be initiated by age cohort after confirmation of age-appropriate
      LDV/SOF FDC dosage levels. Participants from the PK Lead-in Phase will immediately rollover
      into the Treatment Phase with no interruption of study drug administration. The primary
      objective of the Treatment Phase is to evaluate the antiviral efficacy, safety, and
      tolerability of LDV/SOF FDC +/- ribavirin (RBV) for 12 or 24 weeks in pediatric participants
      with HCV.

      During screening, participants will receive placebo to match LDV/SOF FDC to assess ability to
      swallow tablets.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: For Participants in the PK Lead-in Phase, Pharmacokinetic (PK) Parameter: AUCtau of GS-331007 (Metabolite of SOF), LDV, and SOF
time frame: Cohorts 1 and 2 (6 to < 18 years of age): predose, 0.5, 1, 2, 3, 4, 5, 8, and 12 hours postdose on Day 10; Cohort 3 (3 to < 6 years of age): predose, 0.5, 2, 4, 8, and 12 hours postdose on Day 10
description: AUCtau is defined as concentration of drug over time (the area under the concentration verses time curve over the dosing interval).
measure: Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event During the PK Lead-in Phase or the Treatment Phase
time frame: Up to 24 weeks
measure: For Participants in the PK Lead-in Phase, Change From Baseline in HCV RNA
time frame: Baseline; Weeks 1, 2, 4, 8, and 12
measure: Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event During the PK Lead-in Phase
time frame: Up to Day 10
measure: For the Treatment Phase, Percentage of Participants With Sustained Virologic Response (SVR) at 4 Weeks After Discontinuation of Therapy (SVR4)
time frame: Posttreatment Week 4
description: SVR4 was defined as HCV RNA < the lower limit of quantitation (LLOQ; ie, 15 IU/mL) at 4 weeks after stopping study treatment.
measure: For the Treatment Phase, Percentage of Participants With SVR at 12 Weeks After Discontinuation of Therapy (SVR12)
time frame: Posttreatment Week 12
description: SVR12 was defined as HCV RNA < LLOQ at 12 weeks after stopping study treatment.
measure: For the Treatment Phase, Percentage of Participants With SVR at 24 Weeks After Discontinuation of Therapy (SVR24)
time frame: Posttreatment Week 24
description: SVR24 was defined as HCV RNA < LLOQ at 24 weeks after stopping study treatment.
measure: For the Treatment Phase, Percentage of Participants Experiencing Viral Breakthrough
time frame: Up to 24 weeks
description: Viral breakthrough was defined as having confirmed HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ while on treatment.
measure: For the Treatment Phase, Percentage of Participants Experiencing Viral Relapse
time frame: Up to Posttreatment Week 24
description: Viral relapse was defined as having confirmed HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA < LLOQ at last on-treatment visit.
measure: For the Treatment Phase, Change From Baseline in HCV RNA
time frame: Baseline; Weeks 1, 2, 4, 8, 12, 16 (24 Week groups only), 20 (24 Week groups only), and 24 (24 Week groups only)
measure: For the Treatment Phase, Percentage of Participants With HCV RNA < LLOQ While On Treatment
time frame: Weeks 1, 2, 4, 8, 12, 16 (24 Week groups only), 20 (24 Week groups only), and 24 (24 Week groups only)
measure: For the Treatment Phase, Percentage of Participants With Alanine Aminotransferase (ALT) Normalization
time frame: Weeks 1, 2, 4, 8, 12, 16 (24 Week groups only), 20 (24 Week groups only), and 24 (24 Week groups only), and Posttreatment Week 4
description: ALT normalization was defined as ALT > the upper limit of normal (ULN) at baseline and ALT ≤ ULN at each visit.
measure: For the Treatment Phase, Change From Baseline in Height
time frame: Baseline; Weeks 1, 2, 4, 8, 12, 16 (24 Week groups only), 20 (24 Week groups only), and 24 (24 Week groups only), and Posttreatment Weeks 4, 12, and 24
measure: For the Treatment Phase, Change From Baseline in Weight
time frame: Baseline; Weeks 1, 2, 4, 8, 12, 16 (24 Week groups only), 20 (24 Week groups only), and 24 (24 Week groups only), and Posttreatment Weeks 4, 12, and 24
measure: For the Treatment Phase, Number of Male Participants With a Change From Baseline in Tanner Stage for Pubic Hair
time frame: Baseline; End of Treatment (either Week 12 or 24), Posttreatment Week 12, and Posttreatment Week 24
description: Tanner Stages is a scale that defines physical measurements of development based on external primary and secondary sex characteristics. It was used in this study to assess pubertal development with values ranging from Stage 1 (pre-pubertal characteristics) to Stage 5 (adult or mature characteristics). Any shifts (increase or decrease) in Tanner Stage from Baseline were analyzed and presented.
measure: For the Treatment Phase, Number of Male Participants With a Change From Baseline in Tanner Stage for Genitalia Development
time frame: Baseline; End of Treatment (either Week 12 or 24), Posttreatment Week 12, and Posttreatment Week 24
description: Tanner Stages is a scale that defines physical measurements of development based on external primary and secondary sex characteristics. It was used in this study to assess pubertal development with values ranging from Stage 1 (pre-pubertal characteristics) to Stage 5 (adult or mature characteristics). Any shifts (increase or decrease) in Tanner Stage from Baseline were analyzed and presented.
measure: For the Treatment Phase, Number of Female Participants With a Change From Baseline in Tanner Stage for Pubic Hair
time frame: Baseline; End of Treatment (either Week 12 or 24), Posttreatment Week 12, and Posttreatment Week 24
description: Tanner Stages is a scale that defines physical measurements of development based on external primary and secondary sex characteristics. It was used in this study to assess pubertal development with values ranging from Stage 1 (pre-pubertal characteristics) to Stage 5 (adult or mature characteristics). Any shifts (increase or decrease) in Tanner Stage from Baseline were analyzed and presented.
measure: For the Treatment Phase, Number of Female Participants With a Change From Baseline in Tanner Stage for Breast Development
time frame: Baseline; End of Treatment (either Week 12 or 24), Posttreatment Week 12, and Posttreatment Week 24
description: Tanner Stages is a scale that defines physical measurements of development based on external primary and secondary sex characteristics. It was used in this study to assess pubertal development with values ranging from Stage 1 (pre-pubertal characteristics) to Stage 5 (adult or mature characteristics). Any shifts (increase or decrease) in Tanner Stage from Baseline were analyzed and presented.
measure: Acceptability of LDV/SOF Tablets as Measured by the Percentage of Participants Able/Unable to Swallow Placebo Tablet at Day 1
time frame: Day 1
description: Participants who were able/unable to swallow placebo tablets were assessed. Participants 12 to < 18 years old were first asked to perform the swallowability assessment using the 90/400 mg placebo tablet. If they were unable to swallow this, they were then asked to perform the swallowability assessment with 22.5/100 mg placebo tablets. Participants 6 to < 12 years old were to be assessed with the 22.5/100 mg placebo tablets. However, 8 participants were mistakenly assessed using the 90/400 mg placebo tablet.
measure: Acceptability of LDV/SOF Granules as Measured by Palatability at Day 1
time frame: Day 1
description: Participants who were dosed with granules were asked if they tasted the study drug. If they tasted it, then they were asked to provide a number from 0 to 100 to rate the taste of the study drug, with higher scores indicating better taste. Data was then summarized as percentage of participants choosing the following palatability categories: 1) Did not taste the study drug, 2) Tasted drug with score > 60 to 100, 3) Tasted drug with score 40 to 60, and 4) Tasted drug with score of 0 to < 40.
arm group label: 12 to < 18 Years Old
arm group type: Experimental
description: Participants between 12 to < 18 years of age weighing ≥ 45 kg will receive LDV/SOF FDC (90/400 mg tablet or 4 x 22.5 mg/100 mg tablets or 8 x 11.25/50 mg granules based on swallowability assessment during screening).
Treatment duration will be dependent on HCV genotype, prior treatment experience, cirrhosis status, and country of enrollment.
United Kingdom:
HCV genotypes (GT) 1, 4, 5, or 6 treatment-naive (TN) with or without cirrhosis = LDV/SOF 12 weeks
HCV GT 1, 4, 5, or 6 treatment-experienced (TE) without cirrhosis = LDV/SOF 12 weeks
HCV GT 1, 4, 5, or 6 TE with cirrhosis = LDV/SOF 24 weeks
HCV GT 3 TE with or without cirrhosis = LDV/SOF+RBV 24 weeks
United States/Australia/New Zealand:
HCV GT 1, 4, 5, or 6 TN with or without cirrhosis = LDV/SOF 12 weeks
HCV GT 1, 4, 5, or 6 TE without cirrhosis = LDV/SOF 12 weeks
HCV GT 1 TE with cirrhosis = LDV/SOF 24 weeks
HCV GT 4, 5, or 6 TE with cirrhosis = LDV/SOF 12 weeks
arm group label: 6 to < 12 Years Old
arm group type: Experimental
description: Participants between 6 to < 12 years of age weighing ≥ 17 kg and < 45 kg will receive LDV/SOF FDC (45/200 mg as 2 x 22.5/100 mg tablets or 4 x 11.25/50 mg granules based on swallowability assessment during screening).
Treatment duration will be dependent on HCV genotype, prior treatment experience, cirrhosis status, and country of enrollment.
United Kingdom:
HCV GT 1, 4, 5, or 6 TN with or without cirrhosis = LDV/SOF 12 weeks
HCV GT 1, 4, 5, or 6 TE without cirrhosis = LDV/SOF 12 weeks
HCV GT 1, 4, 5, or 6 TE with cirrhosis = LDV/SOF 24 weeks
HCV GT 3 TE with or without cirrhosis = LDV/SOF+RBV 24 weeks
United States/Australia/New Zealand:
HCV GT 1, 4, 5, or 6 TN with or without cirrhosis = LDV/SOF 12 weeks
HCV GT 1, 4, 5, or 6 TE without cirrhosis = LDV/SOF 12 weeks
HCV GT 1 TE with cirrhosis = LDV/SOF 24 weeks
HCV GT 4, 5, or 6 TE with cirrhosis = LDV/SOF 12 weeks
arm group label: 3 to < 6 Years Old
arm group type: Experimental
description: Participants between 3 to < 6 years of age weighing ≥ 17 kg will receive LDV/SOF FDC (45/200 mg granules as 4 x 11.25/50 mg packets) and participants weighing < 17 kg will receive LDV/SOF FDC (33.75/150 mg oral granules as 3 x 11.25/50 mg packets).
Treatment duration will be dependent on HCV genotype, prior treatment experience, cirrhosis status, and country of enrollment.
United Kingdom:
HCV GT 1, 4, 5, or 6 TN with or without cirrhosis = LDV/SOF 12 weeks
HCV GT 1, 4, 5, or 6 TE without cirrhosis = LDV/SOF 12 weeks
HCV GT 1, 4, 5, or 6 TE with cirrhosis = LDV/SOF 24 weeks
HCV GT 3 TE with or without cirrhosis = LDV/SOF+RBV 24 weeks
United States/Australia/New Zealand:
HCV GT 1, 4, 5, or 6 TN with or without cirrhosis = LDV/SOF 12 weeks
HCV GT 1, 4, 5, or 6 TE without cirrhosis = LDV/SOF 12 weeks
HCV GT 1 TE with cirrhosis = LDV/SOF 24 weeks
HCV GT 4, 5, or 6 TE with cirrhosis = LDV/SOF 12 weeks
intervention type: Drug
intervention name: LDV/SOF
description: LDV/SOF FDC administered orally once daily
arm group label: 12 to < 18 Years Old
arm group label: 3 to < 6 Years Old
arm group label: 6 to < 12 Years Old
other name: Harvoni®
other name: GS-5885/GS-7977
intervention type: Drug
intervention name: RBV
description: Ribavirin (RBV) oral solution or capsules will be administered orally in a divided daily dose based on weight
arm group label: 12 to < 18 Years Old
arm group label: 3 to < 6 Years Old
arm group label: 6 to < 12 Years Old
other name: REBETOL®
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: Australia
country: New Zealand
country: United Kingdom
country: United States
citation: Kirby B, German P, Kanwar B, Ni L, Lakatos I, Ling J, Mathias A. Pharmacokinetics of Once-Daily Sofosbuvir and Ledipasvir/Sofosbuvir in HCV-Infected Adolescents. Hepatology 2015;62 (S1): 1040A-1041A
citation: Garrison KL, Mathias A, Kersey K, Kanwar B, Ni L, Jain A, et al. Pharmacokinetics of Once-Daily Sofosbuvir and Ledipasvir/Sofosbuvir in HCV-Infected Pediatrics Aged 6 to < 12 Years Old. Hepatology 2016;64 (S1): 436A
citation: Schwarz K, Murray KF, Rosenthal P, Bansal S, Lin CH, Ni L, et al. High Rates of SVR12 in Adolescents Treated with the Combination of Ledipasvir/Sofosbuvir. J Hepatol 2016; 64 (2): S184-S185
citation: K.F. Murray, W. Balistreri, S. Bansal, S. Whitworth, H. Evans, R.P. Gonzalez-Peralta, et al. Ledipasvir/sofosbuvir ± ribavirin for 12 or 24 weeks is safe and effective in children 6-11 years old with chronic hepatitis C infection. J Hepatol 2017;66: S33-S62
citation: Balistreri WF, Murray KF, Rosenthal P, Bansal S, Lin CH, Kersey K, Massetto B, Zhu Y, Kanwar B, German P, Svarovskaia E, Brainard DM, Wen J, Gonzalez-Peralta RP, Jonas MM, Schwarz K. The safety and effectiveness of ledipasvir-sofosbuvir in adolescents 12-17 years old with hepatitis C virus genotype 1 infection. Hepatology. 2017 Aug;66(2):371-378. doi: 10.1002/hep.28995. Epub 2017 Jun 19.
PMID: 27997679
citation: Younossi ZM, Stepanova M, Balistreri W, Schwarz K, Murray KF, Rosenthal P, Bansal S, Hunt S. Health-related Quality of Life in Adolescent Patients With Hepatitis C Genotype 1 Treated With Sofosbuvir and Ledipasvir. J Pediatr Gastroenterol Nutr. 2018 Jan;66(1):112-116. doi: 10.1097/MPG.0000000000001754.
PMID: 28957984
citation: Begley R, Meng A, Massetto B, Shao J, Ling J, and Mathias A. Pharmacokinetics of Once Daily Sofosbuvir or Ledipasvir/Sofosbuvir in HCV-Infected Pediatrics Aged 3 to <6 Years Old. Hepatology 2018;68 (S1): 582A.
citation: Schwarz KB, Rosenthal P, Murray KF, Honegger JR, Hardikar W, Hague R, et al. Ledipasvir/Sofosbuvir for 12 Weeks Is Safe and Effective in Children 3 to <6 Years Old with Chronic Hepatitis C Virus Infection. Hepatology 2018;68 (S1): 116A-117A.
citation: Murray KF, Balistreri WF, Bansal S, Whitworth S, Evans HM, Gonzalez-Peralta RP, Wen J, Massetto B, Kersey K, Shao J, Garrison KL, Parhy B, Brainard DM, Arnon R, Gillis LA, Jonas MM, Lin CH, Narkewicz MR, Schwarz K, Rosenthal P. Safety and Efficacy of Ledipasvir-Sofosbuvir With or Without Ribavirin for Chronic Hepatitis C in Children Ages 6-11. Hepatology. 2018 Dec;68(6):2158-2166. doi: 10.1002/hep.30123. Epub 2018 Nov 17.
PMID: 30070726
responsible party type: Sponsor
mesh term: Infections
mesh term: Communicable Diseases
mesh term: Hepatitis C
mesh term: Ribavirin
mesh term: Sofosbuvir
mesh term: Ledipasvir, sofosbuvir drug combination
mesh term: Ledipasvir
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 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
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participant flow: 
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outcome list: 
reported events: 
certain agreements: 
point of contact: 