<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/NCT03036852</url>
  </required_header>
  <id_info>
    <org_study_id>GS-US-342-4062</org_study_id>
    <secondary_id>2016-003625-42</secondary_id>
    <nct_id>NCT03036852</nct_id>
  </id_info>
  <brief_title>Sofosbuvir/Velpatasvir in Adults With Chronic Hepatitis C Virus Infection Who Are on Dialysis for End Stage Renal Disease</brief_title>
  <acronym>SOF/VEL ESRD</acronym>
  <official_title>A Phase 2, Multicenter, Open-Label Study to Evaluate the Efficacy and Safety of Sofosbuvir/Velpatasvir for 12 Weeks in Subjects With Chronic HCV Infection Who Are on Dialysis for End Stage Renal Disease</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>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The primary objectives of this study are to evaluate safety, efficacy, and tolerability of&#xD;
      treatment with sofosbuvir/velpatasvir (SOF/VEL) for 12 weeks in adults on dialysis for end&#xD;
      stage renal disease (ESRD) with chronic hepatitis C virus (HCV) infection of any genotype.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 22, 2017</start_date>
  <completion_date type="Actual">November 7, 2018</completion_date>
  <primary_completion_date type="Actual">August 13, 2018</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Percentage of Participants With Sustained Virologic Response 12 Weeks After Discontinuation of Therapy (SVR12)</measure>
    <time_frame>Posttreatment Week 12</time_frame>
    <description>SVR12 was defined as HCV RNA &lt; the lower limit of quantitation (LLOQ; ie, 15 IU/mL) 12 weeks after stopping the study treatment.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of Participants Who Permanently Discontinued the Study Drug Due to an Adverse Event</measure>
    <time_frame>First dose date up to Week 12</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With Sustained Virologic Response 4 Weeks After Discontinuation of Therapy (SVR4)</measure>
    <time_frame>Posttreatment Week 4</time_frame>
    <description>SVR4 was defined as HCV RNA &lt; LLOQ 4 weeks after stopping study treatment.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With Sustained Virologic Response 24 Weeks After Discontinuation of Therapy (SVR24)</measure>
    <time_frame>Posttreatment Week 24</time_frame>
    <description>SVR24 was defined as HCV RNA &lt; LLOQ 24 weeks after stopping study treatment.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in HCV RNA</measure>
    <time_frame>Baseline; Weeks 2, 4, 6, 8, and 12</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With HCV RNA &lt; LLOQ on Treatment</measure>
    <time_frame>Weeks 2, 4, 6, 8, and 12</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With Virologic Failure</measure>
    <time_frame>Baseline to Posttreatment Week 24</time_frame>
    <description>Virologic failure was defined as:&#xD;
On-treatment virologic failure:&#xD;
Breakthrough (confirmed HCV RNA ≥ LLOQ after having previously had HCV RNA &lt; LLOQ while on treatment), or&#xD;
Rebound (confirmed &gt; 1 log10 IU/mL increase in HCV RNA from nadir while on treatment), or&#xD;
Non-response (HCV RNA persistently ≥ LLOQ through 8 weeks of treatment)&#xD;
Virologic relapse:&#xD;
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>Number of Participants Who Develop Viral Resistance (as Assessed by Presence of HCV NS5A and NS5B Genes) to SOF and VEL During Treatment and After Discontinuation of Treatment</measure>
    <time_frame>First dose date up to Posttreatment Week 24</time_frame>
    <description>Baseline deep sequencing of the HCV NS5A and NS5B genes was performed for all participants. For all participants with virologic failure, deep sequencing was performed at the first time point after virologic failure if the plasma or serum sample was available and HCV RNA was &gt; 1000 IU/mL.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pharmacokinetic (PK) Parameter: AUCtau of SOF</measure>
    <time_frame>Sparse PK samples at Weeks 6, 8, and 12 (all participants). Intensive PK samples at predose, 0.25, 0.5, 1, 2, 4, 6, 8, 10, and 12 hours postdose once at Week 6, 8, or 12 (participants who enrolled in the optional PK substudy (N=1))</time_frame>
    <description>AUCtau is defined as the population PK derived area under the concentration versus time curve of the drug over the dosing interval.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>PK Parameter: AUCtau of GS-331007 (Metabolite of SOF)</measure>
    <time_frame>Sparse PK samples at Weeks 6, 8, and 12 (all participants). Intensive PK samples at predose, 0.25, 0.5, 1, 2, 4, 6, 8, 10, and 12 hours postdose once at Week 6, 8, or 12 (participants who enrolled in the optional PK substudy (N=1))</time_frame>
    <description>AUCtau is defined as the population PK derived area under the concentration versus time curve of the drug over the dosing interval.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>PK Parameter: AUCtau of VEL</measure>
    <time_frame>Sparse PK samples at Weeks 6, 8, and 12 (all participants). Intensive PK samples at predose, 0.25, 0.5, 1, 2, 4, 6, 8, 10, and 12 hours postdose once at Week 6, 8, or 12 (participants who enrolled in the optional PK substudy (N=1))</time_frame>
    <description>AUCtau is defined as the population PK derived area under the concentration verses time curve of the drug over the dosing interval.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>PK Parameter: Cmax of SOF</measure>
    <time_frame>Sparse PK samples at Weeks 6, 8, and 12 (all participants). Intensive PK samples at predose, 0.25, 0.5, 1, 2, 4, 6, 8, 10, and 12 hours postdose once at Week 6, 8, or 12 (participants who enrolled in the optional PK substudy (N=1))</time_frame>
    <description>Cmax is defined as the population PK derived maximum concentration of the drug.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>PK Parameter: Cmax of GS-331007 (Metabolite of SOF)</measure>
    <time_frame>Sparse PK samples at Weeks 6, 8, and 12 (all participants). Intensive PK samples at predose, 0.25, 0.5, 1, 2, 4, 6, 8, 10, and 12 hours postdose once at Week 6, 8, or 12 (participants who enrolled in the optional PK substudy (N=1))</time_frame>
    <description>Cmax is defined as the population PK derived maximum concentration of the drug.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>PK Parameter: Cmax of VEL</measure>
    <time_frame>Sparse PK samples at Weeks 6, 8, and 12 (all participants). Intensive PK samples at predose, 0.25, 0.5, 1, 2, 4, 6, 8, 10, and 12 hours postdose once at Week 6, 8, or 12 (participants who enrolled in the optional PK substudy (N=1))</time_frame>
    <description>Cmax is defined as the population PK derived maximum concentration of the drug.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>PK Parameter: Ctau of VEL</measure>
    <time_frame>Sparse PK samples at Weeks 6, 8, and 12 (all participants). Intensive PK samples at predose, 0.25, 0.5, 1, 2, 4, 6, 8, 10, and 12 hours postdose once at Week 6, 8, or 12 (participants who enrolled in the optional PK substudy (N=1))</time_frame>
    <description>Ctau is defined as the population PK derived concentration of the drug at the end of a 24 hour dosing interval. The 24 hour Ctau is estimated based on the combination of sparse PK samples collected at random times across the dosing interval as well as intensive PK samples collected for up to 12 hours post-dose.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">59</enrollment>
  <condition>Chronic Hepatitis C</condition>
  <arm_group>
    <arm_group_label>SOF/VEL</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>SOF/VEL for 12 weeks</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>SOF/VEL</intervention_name>
    <description>400/100 mg fixed-dose combination (FDC) tablet(s) administered orally once daily</description>
    <arm_group_label>SOF/VEL</arm_group_label>
    <other_name>GS-7977/GS-5816</other_name>
    <other_name>Epclusa®</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Key Inclusion Criteria:&#xD;
&#xD;
          -  Chronic HCV infected, male and non-pregnant/non-lactating females aged 18 years or&#xD;
             older who are on dialysis for ESRD, including adults with HIV co-infection if they are&#xD;
             suppressed on a stable, protocol-approved antiretroviral (ARV) regimen for ≥8 weeks&#xD;
             prior to screening.&#xD;
&#xD;
        NOTE: Other protocol defined Inclusion/ Exclusion criteria may apply.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Gilead Study Director</last_name>
    <role>Study Director</role>
    <affiliation>Gilead Sciences</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Royal Adelaide Hospital</name>
      <address>
        <city>Adelaide</city>
        <state>South Australia</state>
        <zip>5000</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kaye Edmonton Clinic</name>
      <address>
        <city>Edmonton</city>
        <state>Alberta</state>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Gordon and Leslie Diamond Health Care Center, Vancouver General Hospital, UBC Division of Gastroenterology</name>
      <address>
        <city>Vancouver</city>
        <state>British Columbia</state>
        <zip>BC V5Z 1M9</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>William Osler Health System- Brampton Civic Hospital</name>
      <address>
        <city>Brampton</city>
        <state>Ontario</state>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hamilton Health Sciences - McMaster University Medical Centre Site</name>
      <address>
        <city>Hamilton</city>
        <state>Ontario</state>
        <zip>ON L8V</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ottawa Hospital Research Institute</name>
      <address>
        <city>Ottawa</city>
        <state>Ontario</state>
        <zip>K1H 8L6</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre de Recherche du Centre Hospitalier de l'Universite de Montreal (CRCHUM)</name>
      <address>
        <city>Montréal</city>
        <state>Quebec</state>
        <zip>H2X 3J4</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Shaare Zedek Medical Center</name>
      <address>
        <city>Jerusalem</city>
        <zip>9103102</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Chaim Sheba Medical Centre</name>
      <address>
        <city>Ramat Gan</city>
        <zip>52173</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tel Aviv Sourasky Medical Center</name>
      <address>
        <city>Tel Aviv</city>
        <zip>64239</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Auckland City Hospital</name>
      <address>
        <city>Grafton</city>
        <state>Auckland</state>
        <zip>1010</zip>
        <country>New Zealand</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario Fundación Alcorcón</name>
      <address>
        <city>Alcorcón</city>
        <state>Madrid</state>
        <zip>28922</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitari Vall d'Hebron</name>
      <address>
        <city>Barcelona</city>
        <zip>08035</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario Puerta de Hierro - Majadahonda</name>
      <address>
        <city>Majadahonda</city>
        <zip>28222</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario Virgen del Rocío</name>
      <address>
        <city>Sevilla</city>
        <zip>41013</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Gartnavel General Hospital</name>
      <address>
        <city>Glasgow</city>
        <zip>G12 0YN</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Barts Health NHS Trust</name>
      <address>
        <city>London</city>
        <zip>E1 1BB</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>King's College Hospital</name>
      <address>
        <city>London</city>
        <zip>SE5 9RS</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Chelsea and Westminster Hospital</name>
      <address>
        <city>London</city>
        <zip>SW10 9NH</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Imperial College Healthcare NHS Trust</name>
      <address>
        <city>London</city>
        <zip>W2 1NY</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nottingham University Hospitals NHS Trust</name>
      <address>
        <city>Nottingham</city>
        <zip>NG5 1PB</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Derriford Hospital</name>
      <address>
        <city>Plymouth</city>
        <zip>PL6 8DH</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Australia</country>
    <country>Canada</country>
    <country>Israel</country>
    <country>New Zealand</country>
    <country>Spain</country>
    <country>United Kingdom</country>
  </location_countries>
  <results_reference>
    <citation>Borgia SM, Dearden J, Lurie Y, Shafran SD, Brown A, Hyland RH, et al. Sofosbuvir/Velpatasvir for 12 Weeks Is Safe and Effective in Patients Undergoing Dialysis. American Association for the Study of Liver Diseases (AASLD); 2018 09-13 November; San Francisco, CA.</citation>
  </results_reference>
  <verification_date>November 2019</verification_date>
  <study_first_submitted>January 27, 2017</study_first_submitted>
  <study_first_submitted_qc>January 27, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 30, 2017</study_first_posted>
  <results_first_submitted>August 12, 2019</results_first_submitted>
  <results_first_submitted_qc>November 5, 2019</results_first_submitted_qc>
  <results_first_posted type="Actual">November 12, 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 6, 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>Hepatitis A</mesh_term>
    <mesh_term>Hepatitis C</mesh_term>
    <mesh_term>Hepatitis C, Chronic</mesh_term>
    <mesh_term>Hepatitis</mesh_term>
    <mesh_term>Hepatitis, Chronic</mesh_term>
    <mesh_term>Kidney Failure, Chronic</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Sofosbuvir</mesh_term>
    <mesh_term>Sofosbuvir-velpatasvir drug combination</mesh_term>
    <mesh_term>Velpatasvir</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Qualified external researchers may request IPD for this study after study completion. For more information, please visit our website at https://www.gilead.com/science-and-medicine/research/clinical-trials-transparency-and-data-sharing-policy.</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_time_frame>18 months after study completion</ipd_time_frame>
    <ipd_access_criteria>A secured external environment with username, password, and RSA code.</ipd_access_criteria>
    <ipd_url>https://www.gilead.com/science-and-medicine/research/clinical-trials-transparency-and-data-sharing-policy</ipd_url>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>March 2, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/52/NCT03036852/Prot_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>September 5, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/52/NCT03036852/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Participants were enrolled at study sites in Canada, the United Kingdom, Spain, Israel, New Zealand, and Australia. The first participant was screened on 22 March 2017. The last study visit occurred on 07 November 2018.</recruitment_details>
      <pre_assignment_details>78 participants were screened.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>SOF/VEL</title>
          <description>Sofosbuvir/velpatasvir (SOF/VEL) (400/100 mg) fixed-dose combination (FDC) tablet orally once daily for 12 weeks</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="59"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="53"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="6"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Death</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lack of Efficacy</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>The Safety Analysis Set included all participants who received at least 1 dose of study drug.</population>
      <group_list>
        <group group_id="B1">
          <title>SOF/VEL (GT-1)</title>
          <description>SOF/VEL (400/100 mg) FDC tablet orally once daily for 12 weeks in participants with genotype 1 (GT-1) HCV infection</description>
        </group>
        <group group_id="B2">
          <title>SOF/VEL (GT-2)</title>
          <description>SOF/VEL (400/100 mg) FDC tablet orally once daily for 12 weeks in participants with genotype 2 (GT-2) HCV infection</description>
        </group>
        <group group_id="B3">
          <title>SOF/VEL (GT-3)</title>
          <description>SOF/VEL (400/100 mg) FDC tablet orally once daily for 12 weeks in participants with genotype 3 (GT-3) HCV infection</description>
        </group>
        <group group_id="B4">
          <title>SOF/VEL (GT-4)</title>
          <description>SOF/VEL (400/100 mg) FDC tablet orally once daily for 12 weeks in participants with genotype 4 (GT-4) HCV infection</description>
        </group>
        <group group_id="B5">
          <title>SOF/VEL (GT-6)</title>
          <description>SOF/VEL (400/100 mg) FDC tablet orally once daily for 12 weeks in participants with genotype 6 (GT-6) HCV infection</description>
        </group>
        <group group_id="B6">
          <title>SOF/VEL (Indeterminate)</title>
          <description>SOF/VEL (400/100 mg) FDC tablet orally once daily for 12 weeks in participants with indeterminate genotype HCV infection</description>
        </group>
        <group group_id="B7">
          <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="25"/>
            <count group_id="B2" value="7"/>
            <count group_id="B3" value="16"/>
            <count group_id="B4" value="4"/>
            <count group_id="B5" value="2"/>
            <count group_id="B6" value="5"/>
            <count group_id="B7" value="59"/>
          </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="63" spread="11.9"/>
                    <measurement group_id="B2" value="67" spread="13.5"/>
                    <measurement group_id="B3" value="55" spread="8.4"/>
                    <measurement group_id="B4" value="58" spread="15.5"/>
                    <measurement group_id="B5" value="69" spread="3.5"/>
                    <measurement group_id="B6" value="52" spread="13.0"/>
                    <measurement group_id="B7" value="60" spread="12.1"/>
                  </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="10"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="5"/>
                    <measurement group_id="B4" value="1"/>
                    <measurement group_id="B5" value="1"/>
                    <measurement group_id="B6" value="3"/>
                    <measurement group_id="B7" value="24"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="15"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="11"/>
                    <measurement group_id="B4" value="3"/>
                    <measurement group_id="B5" value="1"/>
                    <measurement group_id="B6" value="2"/>
                    <measurement group_id="B7" value="35"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</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="2"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="1"/>
                    <measurement group_id="B7" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="23"/>
                    <measurement group_id="B2" value="7"/>
                    <measurement group_id="B3" value="16"/>
                    <measurement group_id="B4" value="4"/>
                    <measurement group_id="B5" value="2"/>
                    <measurement group_id="B6" value="4"/>
                    <measurement group_id="B7" value="56"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                    <measurement group_id="B7" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                    <measurement group_id="B7" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="7"/>
                    <measurement group_id="B4" value="1"/>
                    <measurement group_id="B5" value="2"/>
                    <measurement group_id="B6" value="1"/>
                    <measurement group_id="B7" value="18"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                    <measurement group_id="B7" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="2"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="1"/>
                    <measurement group_id="B7" value="6"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="16"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="7"/>
                    <measurement group_id="B4" value="1"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="3"/>
                    <measurement group_id="B7" value="31"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                    <measurement group_id="B7" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                    <measurement group_id="B7" value="0"/>
                  </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="9"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="6"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="1"/>
                    <measurement group_id="B6" value="3"/>
                    <measurement group_id="B7" value="23"/>
                  </measurement_list>
                </category>
                <category>
                  <title>CT</title>
                  <measurement_list>
                    <measurement group_id="B1" value="14"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="8"/>
                    <measurement group_id="B4" value="4"/>
                    <measurement group_id="B5" value="1"/>
                    <measurement group_id="B6" value="2"/>
                    <measurement group_id="B7" value="30"/>
                  </measurement_list>
                </category>
                <category>
                  <title>TT</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="2"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                    <measurement group_id="B7" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>HCV RNA</title>
          <units>log10 IU/mL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="6.0" spread="0.70"/>
                    <measurement group_id="B2" value="5.2" spread="1.04"/>
                    <measurement group_id="B3" value="6.4" spread="0.55"/>
                    <measurement group_id="B4" value="5.6" spread="1.55"/>
                    <measurement group_id="B5" value="6.4" spread="0.27"/>
                    <measurement group_id="B6" value="4.4" spread="1.69"/>
                    <measurement group_id="B7" value="5.8" spread="1.02"/>
                  </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="12"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="4"/>
                    <measurement group_id="B4" value="2"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="3"/>
                    <measurement group_id="B7" value="26"/>
                  </measurement_list>
                </category>
                <category>
                  <title>≥ 800,000 IU/mL</title>
                  <measurement_list>
                    <measurement group_id="B1" value="13"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="12"/>
                    <measurement group_id="B4" value="2"/>
                    <measurement group_id="B5" value="2"/>
                    <measurement group_id="B6" value="2"/>
                    <measurement group_id="B7" value="33"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Participants With Sustained Virologic Response 12 Weeks After Discontinuation of Therapy (SVR12)</title>
        <description>SVR12 was defined as HCV RNA &lt; the lower limit of quantitation (LLOQ; ie, 15 IU/mL) 12 weeks after stopping the study treatment.</description>
        <time_frame>Posttreatment Week 12</time_frame>
        <population>The Full Analysis Set included participants who are enrolled into the study and received at least 1 dose of study drug.</population>
        <group_list>
          <group group_id="O1">
            <title>SOF/VEL (Total)</title>
            <description>SOF/VEL (400/100 mg) FDC tablet orally once daily for 12 weeks</description>
          </group>
          <group group_id="O2">
            <title>SOF/VEL (GT-1)</title>
            <description>SOF/VEL (400/100 mg) FDC tablet orally once daily for 12 weeks in participants with genotype 1 (GT-1) HCV infection</description>
          </group>
          <group group_id="O3">
            <title>SOF/VEL (GT-2)</title>
            <description>SOF/VEL (400/100 mg) FDC tablet orally once daily for 12 weeks in participants with genotype 2 (GT-2) HCV infection</description>
          </group>
          <group group_id="O4">
            <title>SOF/VEL (GT-3)</title>
            <description>SOF/VEL (400/100 mg) FDC tablet orally once daily for 12 weeks in participants with genotype 3 (GT-3) HCV infection</description>
          </group>
          <group group_id="O5">
            <title>SOF/VEL (GT-4)</title>
            <description>SOF/VEL (400/100 mg) FDC tablet orally once daily for 12 weeks in participants with genotype 4 (GT-4) HCV infection</description>
          </group>
          <group group_id="O6">
            <title>SOF/VEL (GT-6)</title>
            <description>SOF/VEL (400/100 mg) FDC tablet orally once daily for 12 weeks in participants with genotype 6 (GT-6) HCV infection</description>
          </group>
          <group group_id="O7">
            <title>SOF/VEL (Indeterminate)</title>
            <description>SOF/VEL (400/100 mg) FDC tablet orally once daily for 12 weeks in participants with indeterminate genotype HCV infection</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Sustained Virologic Response 12 Weeks After Discontinuation of Therapy (SVR12)</title>
          <description>SVR12 was defined as HCV RNA &lt; the lower limit of quantitation (LLOQ; ie, 15 IU/mL) 12 weeks after stopping the study treatment.</description>
          <population>The Full Analysis Set included participants who are 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="59"/>
                <count group_id="O2" value="25"/>
                <count group_id="O3" value="7"/>
                <count group_id="O4" value="16"/>
                <count group_id="O5" value="4"/>
                <count group_id="O6" value="2"/>
                <count group_id="O7" value="5"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="94.9" lower_limit="85.9" upper_limit="98.9"/>
                    <measurement group_id="O2" value="92.0" lower_limit="74.0" upper_limit="99.0"/>
                    <measurement group_id="O3" value="100.0" lower_limit="59.0" upper_limit="100.0"/>
                    <measurement group_id="O4" value="93.8" lower_limit="69.8" upper_limit="99.8"/>
                    <measurement group_id="O5" value="100.0" lower_limit="39.8" upper_limit="100.0"/>
                    <measurement group_id="O6" value="100.0" lower_limit="15.8" upper_limit="100.0"/>
                    <measurement group_id="O7" value="100.0" lower_limit="47.8" upper_limit="100.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Participants Who Permanently Discontinued the Study Drug Due to an Adverse Event</title>
        <time_frame>First dose date up to Week 12</time_frame>
        <population>The Safety Analysis Set included all participants who received at least 1 dose of study drug.</population>
        <group_list>
          <group group_id="O1">
            <title>SOF/VEL</title>
            <description>SOF/VEL (400/100 mg) FDC tablet orally once daily for 12 weeks</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Who Permanently Discontinued the Study Drug Due to an Adverse Event</title>
          <population>The Safety Analysis Set included all participants who 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="59"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With Sustained Virologic Response 4 Weeks After Discontinuation of Therapy (SVR4)</title>
        <description>SVR4 was defined as HCV RNA &lt; LLOQ 4 weeks after stopping study treatment.</description>
        <time_frame>Posttreatment Week 4</time_frame>
        <population>Participants in the Full Analysis Set were analyzed.</population>
        <group_list>
          <group group_id="O1">
            <title>SOF/VEL (Total)</title>
            <description>SOF/VEL (400/100 mg) FDC tablet orally once daily for 12 weeks</description>
          </group>
          <group group_id="O2">
            <title>SOF/VEL (GT-1)</title>
            <description>SOF/VEL (400/100 mg) FDC tablet orally once daily for 12 weeks in participants with genotype 1 (GT-1) HCV infection</description>
          </group>
          <group group_id="O3">
            <title>SOF/VEL (GT-2)</title>
            <description>SOF/VEL (400/100 mg) FDC tablet orally once daily for 12 weeks in participants with genotype 2 (GT-2) HCV infection</description>
          </group>
          <group group_id="O4">
            <title>SOF/VEL (GT-3)</title>
            <description>SOF/VEL (400/100 mg) FDC tablet orally once daily for 12 weeks in participants with genotype 3 (GT-3) HCV infection</description>
          </group>
          <group group_id="O5">
            <title>SOF/VEL (GT-4)</title>
            <description>SOF/VEL (400/100 mg) FDC tablet orally once daily for 12 weeks in participants with genotype 4 (GT-4) HCV infection</description>
          </group>
          <group group_id="O6">
            <title>SOF/VEL (GT-6)</title>
            <description>SOF/VEL (400/100 mg) FDC tablet orally once daily for 12 weeks in participants with genotype 6 (GT-6) HCV infection</description>
          </group>
          <group group_id="O7">
            <title>SOF/VEL (Indeterminate)</title>
            <description>SOF/VEL (400/100 mg) FDC tablet orally once daily for 12 weeks in participants with indeterminate genotype HCV infection</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Sustained Virologic Response 4 Weeks After Discontinuation of Therapy (SVR4)</title>
          <description>SVR4 was defined as HCV RNA &lt; LLOQ 4 weeks after stopping study treatment.</description>
          <population>Participants in the Full Analysis Set were analyzed.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="59"/>
                <count group_id="O2" value="25"/>
                <count group_id="O3" value="7"/>
                <count group_id="O4" value="16"/>
                <count group_id="O5" value="4"/>
                <count group_id="O6" value="2"/>
                <count group_id="O7" value="5"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="96.6" lower_limit="88.3" upper_limit="99.6"/>
                    <measurement group_id="O2" value="96.0" lower_limit="79.6" upper_limit="99.9"/>
                    <measurement group_id="O3" value="100.0" lower_limit="59.0" upper_limit="100.0"/>
                    <measurement group_id="O4" value="93.8" lower_limit="69.8" upper_limit="99.8"/>
                    <measurement group_id="O5" value="100.0" lower_limit="39.8" upper_limit="100.0"/>
                    <measurement group_id="O6" value="100.0" lower_limit="15.8" upper_limit="100.0"/>
                    <measurement group_id="O7" value="100.0" lower_limit="47.8" upper_limit="100.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With Sustained Virologic Response 24 Weeks After Discontinuation of Therapy (SVR24)</title>
        <description>SVR24 was defined as HCV RNA &lt; LLOQ 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>SOF/VEL (Total)</title>
            <description>SOF/VEL (400/100 mg) FDC tablet orally once daily for 12 weeks</description>
          </group>
          <group group_id="O2">
            <title>SOF/VEL (GT-1)</title>
            <description>SOF/VEL (400/100 mg) FDC tablet orally once daily for 12 weeks in participants with genotype 1 (GT-1) HCV infection</description>
          </group>
          <group group_id="O3">
            <title>SOF/VEL (GT-2)</title>
            <description>SOF/VEL (400/100 mg) FDC tablet orally once daily for 12 weeks in participants with genotype 2 (GT-2) HCV infection</description>
          </group>
          <group group_id="O4">
            <title>SOF/VEL (GT-3)</title>
            <description>SOF/VEL (400/100 mg) FDC tablet orally once daily for 12 weeks in participants with genotype 3 (GT-3) HCV infection</description>
          </group>
          <group group_id="O5">
            <title>SOF/VEL (GT-4)</title>
            <description>SOF/VEL (400/100 mg) FDC tablet orally once daily for 12 weeks in participants with genotype 4 (GT-4) HCV infection</description>
          </group>
          <group group_id="O6">
            <title>SOF/VEL (GT-6)</title>
            <description>SOF/VEL (400/100 mg) FDC tablet orally once daily for 12 weeks in participants with genotype 6 (GT-6) HCV infection</description>
          </group>
          <group group_id="O7">
            <title>SOF/VEL (Indeterminate)</title>
            <description>SOF/VEL (400/100 mg) FDC tablet orally once daily for 12 weeks in participants with indeterminate genotype HCV infection</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Sustained Virologic Response 24 Weeks After Discontinuation of Therapy (SVR24)</title>
          <description>SVR24 was defined as HCV RNA &lt; LLOQ 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="59"/>
                <count group_id="O2" value="25"/>
                <count group_id="O3" value="7"/>
                <count group_id="O4" value="16"/>
                <count group_id="O5" value="4"/>
                <count group_id="O6" value="2"/>
                <count group_id="O7" value="5"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="94.9" lower_limit="85.9" upper_limit="98.9"/>
                    <measurement group_id="O2" value="92.0" lower_limit="74.0" upper_limit="99.0"/>
                    <measurement group_id="O3" value="100.0" lower_limit="59.0" upper_limit="100.0"/>
                    <measurement group_id="O4" value="93.8" lower_limit="69.8" upper_limit="99.8"/>
                    <measurement group_id="O5" value="100.0" lower_limit="39.8" upper_limit="100.0"/>
                    <measurement group_id="O6" value="100.0" lower_limit="15.8" upper_limit="100.0"/>
                    <measurement group_id="O7" value="100.0" lower_limit="47.8" upper_limit="100.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in HCV RNA</title>
        <time_frame>Baseline; Weeks 2, 4, 6, 8, and 12</time_frame>
        <population>Participants in the Full Analysis Set with available date were analyzed.</population>
        <group_list>
          <group group_id="O1">
            <title>SOF/VEL (Total)</title>
            <description>SOF/VEL (400/100 mg) FDC tablet orally once daily for 12 weeks</description>
          </group>
          <group group_id="O2">
            <title>SOF/VEL (GT-1)</title>
            <description>SOF/VEL (400/100 mg) FDC tablet orally once daily for 12 weeks in participants with genotype 1 (GT-1) HCV infection</description>
          </group>
          <group group_id="O3">
            <title>SOF/VEL (GT-2)</title>
            <description>SOF/VEL (400/100 mg) FDC tablet orally once daily for 12 weeks in participants with genotype 2 (GT-2) HCV infection</description>
          </group>
          <group group_id="O4">
            <title>SOF/VEL (GT-3)</title>
            <description>SOF/VEL (400/100 mg) FDC tablet orally once daily for 12 weeks in participants with genotype 3 (GT-3) HCV infection</description>
          </group>
          <group group_id="O5">
            <title>SOF/VEL (GT-4)</title>
            <description>SOF/VEL (400/100 mg) FDC tablet orally once daily for 12 weeks in participants with genotype 4 (GT-4) HCV infection</description>
          </group>
          <group group_id="O6">
            <title>SOF/VEL (GT-6)</title>
            <description>SOF/VEL (400/100 mg) FDC tablet orally once daily for 12 weeks in participants with genotype 6 (GT-6) HCV infection</description>
          </group>
          <group group_id="O7">
            <title>SOF/VEL (Indeterminate)</title>
            <description>SOF/VEL (400/100 mg) FDC tablet orally once daily for 12 weeks in participants with indeterminate genotype HCV infection</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in HCV RNA</title>
          <population>Participants in the Full Analysis Set with available date 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="59"/>
                <count group_id="O2" value="25"/>
                <count group_id="O3" value="7"/>
                <count group_id="O4" value="16"/>
                <count group_id="O5" value="4"/>
                <count group_id="O6" value="2"/>
                <count group_id="O7" value="5"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Change at Week 2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="55"/>
                    <count group_id="O2" value="25"/>
                    <count group_id="O3" value="6"/>
                    <count group_id="O4" value="13"/>
                    <count group_id="O5" value="4"/>
                    <count group_id="O6" value="2"/>
                    <count group_id="O7" value="5"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-4.54" spread="1.017"/>
                    <measurement group_id="O2" value="-4.69" spread="0.797"/>
                    <measurement group_id="O3" value="-3.78" spread="0.840"/>
                    <measurement group_id="O4" value="-5.07" spread="0.493"/>
                    <measurement group_id="O5" value="-4.23" spread="1.333"/>
                    <measurement group_id="O6" value="-5.29" spread="0.269"/>
                    <measurement group_id="O7" value="-3.24" spread="1.668"/>
                  </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="59"/>
                    <count group_id="O2" value="25"/>
                    <count group_id="O3" value="7"/>
                    <count group_id="O4" value="16"/>
                    <count group_id="O5" value="4"/>
                    <count group_id="O6" value="2"/>
                    <count group_id="O7" value="5"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-4.69" spread="1.020"/>
                    <measurement group_id="O2" value="-4.81" spread="0.704"/>
                    <measurement group_id="O3" value="-4.05" spread="1.041"/>
                    <measurement group_id="O4" value="-5.20" spread="0.551"/>
                    <measurement group_id="O5" value="-4.48" spread="1.547"/>
                    <measurement group_id="O6" value="-5.29" spread="0.269"/>
                    <measurement group_id="O7" value="-3.26" spread="1.692"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Week 6</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="59"/>
                    <count group_id="O2" value="25"/>
                    <count group_id="O3" value="7"/>
                    <count group_id="O4" value="16"/>
                    <count group_id="O5" value="4"/>
                    <count group_id="O6" value="2"/>
                    <count group_id="O7" value="5"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-4.69" spread="1.020"/>
                    <measurement group_id="O2" value="-4.81" spread="0.704"/>
                    <measurement group_id="O3" value="-4.05" spread="1.041"/>
                    <measurement group_id="O4" value="-5.20" spread="0.551"/>
                    <measurement group_id="O5" value="-4.48" spread="1.547"/>
                    <measurement group_id="O6" value="-5.29" spread="0.269"/>
                    <measurement group_id="O7" value="-3.26" spread="1.692"/>
                  </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="59"/>
                    <count group_id="O2" value="25"/>
                    <count group_id="O3" value="7"/>
                    <count group_id="O4" value="16"/>
                    <count group_id="O5" value="4"/>
                    <count group_id="O6" value="2"/>
                    <count group_id="O7" value="5"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-4.69" spread="1.020"/>
                    <measurement group_id="O2" value="-4.81" spread="0.704"/>
                    <measurement group_id="O3" value="-4.05" spread="1.041"/>
                    <measurement group_id="O4" value="-5.20" spread="0.551"/>
                    <measurement group_id="O5" value="-4.48" spread="1.547"/>
                    <measurement group_id="O6" value="-5.29" spread="0.269"/>
                    <measurement group_id="O7" value="-3.26" spread="1.692"/>
                  </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="59"/>
                    <count group_id="O2" value="25"/>
                    <count group_id="O3" value="7"/>
                    <count group_id="O4" value="16"/>
                    <count group_id="O5" value="4"/>
                    <count group_id="O6" value="2"/>
                    <count group_id="O7" value="5"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-4.69" spread="1.020"/>
                    <measurement group_id="O2" value="-4.81" spread="0.704"/>
                    <measurement group_id="O3" value="-4.05" spread="1.041"/>
                    <measurement group_id="O4" value="-5.20" spread="0.551"/>
                    <measurement group_id="O5" value="-4.48" spread="1.547"/>
                    <measurement group_id="O6" value="-5.29" spread="0.269"/>
                    <measurement group_id="O7" value="-3.26" spread="1.692"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With HCV RNA &lt; LLOQ on Treatment</title>
        <time_frame>Weeks 2, 4, 6, 8, and 12</time_frame>
        <population>Participants in the Full Analysis Set were analyzed.</population>
        <group_list>
          <group group_id="O1">
            <title>SOF/VEL (Total)</title>
            <description>SOF/VEL (400/100 mg) FDC tablet orally once daily for 12 weeks</description>
          </group>
          <group group_id="O2">
            <title>SOF/VEL (GT-1)</title>
            <description>SOF/VEL (400/100 mg) FDC tablet orally once daily for 12 weeks in participants with genotype 1 (GT-1) HCV infection</description>
          </group>
          <group group_id="O3">
            <title>SOF/VEL (GT-2)</title>
            <description>SOF/VEL (400/100 mg) FDC tablet orally once daily for 12 weeks in participants with genotype 2 (GT-2) HCV infection</description>
          </group>
          <group group_id="O4">
            <title>SOF/VEL (GT-3)</title>
            <description>SOF/VEL (400/100 mg) FDC tablet orally once daily for 12 weeks in participants with genotype 3 (GT-3) HCV infection</description>
          </group>
          <group group_id="O5">
            <title>SOF/VEL (GT-4)</title>
            <description>SOF/VEL (400/100 mg) FDC tablet orally once daily for 12 weeks in participants with genotype 4 (GT-4) HCV infection</description>
          </group>
          <group group_id="O6">
            <title>SOF/VEL (GT-6)</title>
            <description>SOF/VEL (400/100 mg) FDC tablet orally once daily for 12 weeks in participants with genotype 6 (GT-6) HCV infection</description>
          </group>
          <group group_id="O7">
            <title>SOF/VEL (Indeterminate)</title>
            <description>SOF/VEL (400/100 mg) FDC tablet orally once daily for 12 weeks in participants with indeterminate genotype HCV infection</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With HCV RNA &lt; LLOQ on Treatment</title>
          <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="59"/>
                <count group_id="O2" value="25"/>
                <count group_id="O3" value="7"/>
                <count group_id="O4" value="16"/>
                <count group_id="O5" value="4"/>
                <count group_id="O6" value="2"/>
                <count group_id="O7" value="5"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="67.8" lower_limit="54.4" upper_limit="79.4"/>
                    <measurement group_id="O2" value="76.0" lower_limit="54.9" upper_limit="90.6"/>
                    <measurement group_id="O3" value="85.7" lower_limit="42.1" upper_limit="99.6"/>
                    <measurement group_id="O4" value="43.8" lower_limit="19.8" upper_limit="70.1"/>
                    <measurement group_id="O5" value="50.0" lower_limit="6.8" upper_limit="93.2"/>
                    <measurement group_id="O6" value="100.0" lower_limit="15.8" upper_limit="100.0"/>
                    <measurement group_id="O7" value="80.0" lower_limit="28.4" upper_limit="99.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 4</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="100.0" lower_limit="93.9" upper_limit="100.0"/>
                    <measurement group_id="O2" value="100.0" lower_limit="86.3" upper_limit="100.0"/>
                    <measurement group_id="O3" value="100.0" lower_limit="59.0" upper_limit="100.0"/>
                    <measurement group_id="O4" value="100.0" lower_limit="79.4" upper_limit="100.0"/>
                    <measurement group_id="O5" value="100.0" lower_limit="39.8" upper_limit="100.0"/>
                    <measurement group_id="O6" value="100.0" lower_limit="15.8" upper_limit="100.0"/>
                    <measurement group_id="O7" value="100.0" lower_limit="47.8" upper_limit="100.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 6</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="100.0" lower_limit="93.9" upper_limit="100.0"/>
                    <measurement group_id="O2" value="100.0" lower_limit="86.3" upper_limit="100.0"/>
                    <measurement group_id="O3" value="100.0" lower_limit="59.0" upper_limit="100.0"/>
                    <measurement group_id="O4" value="100.0" lower_limit="79.4" upper_limit="100.0"/>
                    <measurement group_id="O5" value="100.0" lower_limit="39.8" upper_limit="100.0"/>
                    <measurement group_id="O6" value="100.0" lower_limit="15.8" upper_limit="100.0"/>
                    <measurement group_id="O7" value="100.0" lower_limit="47.8" upper_limit="100.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 8</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="100.0" lower_limit="93.9" upper_limit="100.0"/>
                    <measurement group_id="O2" value="100.0" lower_limit="86.3" upper_limit="100.0"/>
                    <measurement group_id="O3" value="100.0" lower_limit="59.0" upper_limit="100.0"/>
                    <measurement group_id="O4" value="100.0" lower_limit="79.4" upper_limit="100.0"/>
                    <measurement group_id="O5" value="100.0" lower_limit="39.8" upper_limit="100.0"/>
                    <measurement group_id="O6" value="100.0" lower_limit="15.8" upper_limit="100.0"/>
                    <measurement group_id="O7" value="100.0" lower_limit="47.8" upper_limit="100.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 12</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="100.0" lower_limit="93.9" upper_limit="100.0"/>
                    <measurement group_id="O2" value="100.0" lower_limit="86.3" upper_limit="100.0"/>
                    <measurement group_id="O3" value="100.0" lower_limit="59.0" upper_limit="100.0"/>
                    <measurement group_id="O4" value="100.0" lower_limit="79.4" upper_limit="100.0"/>
                    <measurement group_id="O5" value="100.0" lower_limit="39.8" upper_limit="100.0"/>
                    <measurement group_id="O6" value="100.0" lower_limit="15.8" upper_limit="100.0"/>
                    <measurement group_id="O7" value="100.0" lower_limit="47.8" upper_limit="100.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With Virologic Failure</title>
        <description>Virologic failure was defined as:&#xD;
On-treatment virologic failure:&#xD;
Breakthrough (confirmed HCV RNA ≥ LLOQ after having previously had HCV RNA &lt; LLOQ while on treatment), or&#xD;
Rebound (confirmed &gt; 1 log10 IU/mL increase in HCV RNA from nadir while on treatment), or&#xD;
Non-response (HCV RNA persistently ≥ LLOQ through 8 weeks of treatment)&#xD;
Virologic relapse:&#xD;
Confirmed HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA &lt; LLOQ at last on-treatment visit</description>
        <time_frame>Baseline to Posttreatment Week 24</time_frame>
        <population>Participants in the Full Analysis Set were analyzed.</population>
        <group_list>
          <group group_id="O1">
            <title>SOF/VEL (Total)</title>
            <description>SOF/VEL (400/100 mg) FDC tablet orally once daily for 12 weeks</description>
          </group>
          <group group_id="O2">
            <title>SOF/VEL (GT-1)</title>
            <description>SOF/VEL (400/100 mg) FDC tablet orally once daily for 12 weeks in participants with genotype 1 (GT-1) HCV infection</description>
          </group>
          <group group_id="O3">
            <title>SOF/VEL (GT-2)</title>
            <description>SOF/VEL (400/100 mg) FDC tablet orally once daily for 12 weeks in participants with genotype 2 (GT-2) HCV infection</description>
          </group>
          <group group_id="O4">
            <title>SOF/VEL (GT-3)</title>
            <description>SOF/VEL (400/100 mg) FDC tablet orally once daily for 12 weeks in participants with genotype 3 (GT-3) HCV infection</description>
          </group>
          <group group_id="O5">
            <title>SOF/VEL (GT-4)</title>
            <description>SOF/VEL (400/100 mg) FDC tablet orally once daily for 12 weeks in participants with genotype 4 (GT-4) HCV infection</description>
          </group>
          <group group_id="O6">
            <title>SOF/VEL (GT-6)</title>
            <description>SOF/VEL (400/100 mg) FDC tablet orally once daily for 12 weeks in participants with genotype 6 (GT-6) HCV infection</description>
          </group>
          <group group_id="O7">
            <title>SOF/VEL (Indeterminate)</title>
            <description>SOF/VEL (400/100 mg) FDC tablet orally once daily for 12 weeks in participants with indeterminate genotype HCV infection</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Virologic Failure</title>
          <description>Virologic failure was defined as:&#xD;
On-treatment virologic failure:&#xD;
Breakthrough (confirmed HCV RNA ≥ LLOQ after having previously had HCV RNA &lt; LLOQ while on treatment), or&#xD;
Rebound (confirmed &gt; 1 log10 IU/mL increase in HCV RNA from nadir while on treatment), or&#xD;
Non-response (HCV RNA persistently ≥ LLOQ through 8 weeks of treatment)&#xD;
Virologic relapse:&#xD;
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="59"/>
                <count group_id="O2" value="25"/>
                <count group_id="O3" value="7"/>
                <count group_id="O4" value="16"/>
                <count group_id="O5" value="4"/>
                <count group_id="O6" value="2"/>
                <count group_id="O7" value="5"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.4"/>
                    <measurement group_id="O2" value="4.0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="6.3"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants Who Develop Viral Resistance (as Assessed by Presence of HCV NS5A and NS5B Genes) to SOF and VEL During Treatment and After Discontinuation of Treatment</title>
        <description>Baseline deep sequencing of the HCV NS5A and NS5B genes was performed for all participants. For all participants with virologic failure, deep sequencing was performed at the first time point after virologic failure if the plasma or serum sample was available and HCV RNA was &gt; 1000 IU/mL.</description>
        <time_frame>First dose date up to Posttreatment Week 24</time_frame>
        <population>Participants in the Resistance Analysis Population Set included all participants in the Safety Analysis Set with a virologic outcome and at least 1 gene sequenced. All data are reported at a 15% assay cutoff.</population>
        <group_list>
          <group group_id="O1">
            <title>SOF/VEL</title>
            <description>SOF/VEL (400/100 mg) FDC tablet orally once daily for 12 weeks</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Who Develop Viral Resistance (as Assessed by Presence of HCV NS5A and NS5B Genes) to SOF and VEL During Treatment and After Discontinuation of Treatment</title>
          <description>Baseline deep sequencing of the HCV NS5A and NS5B genes was performed for all participants. For all participants with virologic failure, deep sequencing was performed at the first time point after virologic failure if the plasma or serum sample was available and HCV RNA was &gt; 1000 IU/mL.</description>
          <population>Participants in the Resistance Analysis Population Set included all participants in the Safety Analysis Set with a virologic outcome and at least 1 gene sequenced. All data are reported at a 15% assay cutoff.</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="58"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Pharmacokinetic (PK) Parameter: AUCtau of SOF</title>
        <description>AUCtau is defined as the population PK derived area under the concentration versus time curve of the drug over the dosing interval.</description>
        <time_frame>Sparse PK samples at Weeks 6, 8, and 12 (all participants). Intensive PK samples at predose, 0.25, 0.5, 1, 2, 4, 6, 8, 10, and 12 hours postdose once at Week 6, 8, or 12 (participants who enrolled in the optional PK substudy (N=1))</time_frame>
        <population>Participants in the PK Analysis Set (all participants who took at least 1 dose of study drug and had at least 1 nonmissing postdose concentration value for the corresponding analyte in plasma) with available data were analyzed. Population PK analyses of all sparse and intensive PK data were utilized to estimate steady-state AUCtau of SOF.</population>
        <group_list>
          <group group_id="O1">
            <title>SOF/VEL</title>
            <description>SOF/VEL (400/100 mg) FDC tablet orally once daily for 12 weeks</description>
          </group>
        </group_list>
        <measure>
          <title>Pharmacokinetic (PK) Parameter: AUCtau of SOF</title>
          <description>AUCtau is defined as the population PK derived area under the concentration versus time curve of the drug over the dosing interval.</description>
          <population>Participants in the PK Analysis Set (all participants who took at least 1 dose of study drug and had at least 1 nonmissing postdose concentration value for the corresponding analyte in plasma) with available data were analyzed. Population PK analyses of all sparse and intensive PK data were utilized to estimate steady-state AUCtau of SOF.</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="21"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2381.9" spread="567.63"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>PK Parameter: AUCtau of GS-331007 (Metabolite of SOF)</title>
        <description>AUCtau is defined as the population PK derived area under the concentration versus time curve of the drug over the dosing interval.</description>
        <time_frame>Sparse PK samples at Weeks 6, 8, and 12 (all participants). Intensive PK samples at predose, 0.25, 0.5, 1, 2, 4, 6, 8, 10, and 12 hours postdose once at Week 6, 8, or 12 (participants who enrolled in the optional PK substudy (N=1))</time_frame>
        <population>Participants in the PK analysis Set were analyzed. Population PK analyses of all sparse and intensive PK data were utilized to estimate steady-state AUCtau of GS-331007 .</population>
        <group_list>
          <group group_id="O1">
            <title>SOF/VEL</title>
            <description>SOF/VEL (400/100 mg) FDC tablet orally once daily for 12 weeks</description>
          </group>
        </group_list>
        <measure>
          <title>PK Parameter: AUCtau of GS-331007 (Metabolite of SOF)</title>
          <description>AUCtau is defined as the population PK derived area under the concentration versus time curve of the drug over the dosing interval.</description>
          <population>Participants in the PK analysis Set were analyzed. Population PK analyses of all sparse and intensive PK data were utilized to estimate steady-state AUCtau of GS-331007 .</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="59"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="230989.2" spread="81453.30"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>PK Parameter: AUCtau of VEL</title>
        <description>AUCtau is defined as the population PK derived area under the concentration verses time curve of the drug over the dosing interval.</description>
        <time_frame>Sparse PK samples at Weeks 6, 8, and 12 (all participants). Intensive PK samples at predose, 0.25, 0.5, 1, 2, 4, 6, 8, 10, and 12 hours postdose once at Week 6, 8, or 12 (participants who enrolled in the optional PK substudy (N=1))</time_frame>
        <population>Participants in the PK Analysis Set were analyzed. Population PK analyses of all sparse and intensive PK data were utilized to estimate steady-state AUCtau of VEL.</population>
        <group_list>
          <group group_id="O1">
            <title>SOF/VEL</title>
            <description>SOF/VEL (400/100 mg) FDC tablet orally once daily for 12 weeks</description>
          </group>
        </group_list>
        <measure>
          <title>PK Parameter: AUCtau of VEL</title>
          <description>AUCtau is defined as the population PK derived area under the concentration verses time curve of the drug over the dosing interval.</description>
          <population>Participants in the PK Analysis Set were analyzed. Population PK analyses of all sparse and intensive PK data were utilized to estimate steady-state AUCtau of VEL.</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="59"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4279.4" spread="2198.77"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>PK Parameter: Cmax of SOF</title>
        <description>Cmax is defined as the population PK derived maximum concentration of the drug.</description>
        <time_frame>Sparse PK samples at Weeks 6, 8, and 12 (all participants). Intensive PK samples at predose, 0.25, 0.5, 1, 2, 4, 6, 8, 10, and 12 hours postdose once at Week 6, 8, or 12 (participants who enrolled in the optional PK substudy (N=1))</time_frame>
        <population>Participants in the PK Analysis set with available data were analyzed. Population PK analyses of all sparse and intensive PK data were utilized to estimate steady-state Cmax of SOF.</population>
        <group_list>
          <group group_id="O1">
            <title>SOF/VEL</title>
            <description>SOF/VEL (400/100 mg) FDC tablet orally once daily for 12 weeks</description>
          </group>
        </group_list>
        <measure>
          <title>PK Parameter: Cmax of SOF</title>
          <description>Cmax is defined as the population PK derived maximum concentration of the drug.</description>
          <population>Participants in the PK Analysis set with available data were analyzed. Population PK analyses of all sparse and intensive PK data were utilized to estimate steady-state Cmax of SOF.</population>
          <units>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="21"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1041.0" spread="176.96"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>PK Parameter: Cmax of GS-331007 (Metabolite of SOF)</title>
        <description>Cmax is defined as the population PK derived maximum concentration of the drug.</description>
        <time_frame>Sparse PK samples at Weeks 6, 8, and 12 (all participants). Intensive PK samples at predose, 0.25, 0.5, 1, 2, 4, 6, 8, 10, and 12 hours postdose once at Week 6, 8, or 12 (participants who enrolled in the optional PK substudy (N=1))</time_frame>
        <population>Participants in the PK Analysis Set were analyzed. Population PK analyses of all sparse and intensive PK data were utilized to estimate steady-state Cmax of GS-331007.</population>
        <group_list>
          <group group_id="O1">
            <title>SOF/VEL</title>
            <description>SOF/VEL (400/100 mg) FDC tablet orally once daily for 12 weeks</description>
          </group>
        </group_list>
        <measure>
          <title>PK Parameter: Cmax of GS-331007 (Metabolite of SOF)</title>
          <description>Cmax is defined as the population PK derived maximum concentration of the drug.</description>
          <population>Participants in the PK Analysis Set were analyzed. Population PK analyses of all sparse and intensive PK data were utilized to estimate steady-state Cmax of GS-331007.</population>
          <units>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="59"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9776.2" spread="3433.16"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>PK Parameter: Cmax of VEL</title>
        <description>Cmax is defined as the population PK derived maximum concentration of the drug.</description>
        <time_frame>Sparse PK samples at Weeks 6, 8, and 12 (all participants). Intensive PK samples at predose, 0.25, 0.5, 1, 2, 4, 6, 8, 10, and 12 hours postdose once at Week 6, 8, or 12 (participants who enrolled in the optional PK substudy (N=1))</time_frame>
        <population>Participants in the PK Analysis Set were analyzed. Population PK analyses of all sparse and intensive PK data were utilized to estimate steady-state Cmax of VEL.</population>
        <group_list>
          <group group_id="O1">
            <title>SOF/VEL</title>
            <description>SOF/VEL (400/100 mg) FDC tablet orally once daily for 12 weeks</description>
          </group>
        </group_list>
        <measure>
          <title>PK Parameter: Cmax of VEL</title>
          <description>Cmax is defined as the population PK derived maximum concentration of the drug.</description>
          <population>Participants in the PK Analysis Set were analyzed. Population PK analyses of all sparse and intensive PK data were utilized to estimate steady-state Cmax of VEL.</population>
          <units>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="59"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="226.9" spread="92.80"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>PK Parameter: Ctau of VEL</title>
        <description>Ctau is defined as the population PK derived concentration of the drug at the end of a 24 hour dosing interval. The 24 hour Ctau is estimated based on the combination of sparse PK samples collected at random times across the dosing interval as well as intensive PK samples collected for up to 12 hours post-dose.</description>
        <time_frame>Sparse PK samples at Weeks 6, 8, and 12 (all participants). Intensive PK samples at predose, 0.25, 0.5, 1, 2, 4, 6, 8, 10, and 12 hours postdose once at Week 6, 8, or 12 (participants who enrolled in the optional PK substudy (N=1))</time_frame>
        <population>Participants in the PK Analysis Set were analyzed. Population PK analyses of all sparse and intensive PK data were utilized to estimate steady-state Ctau of VEL.</population>
        <group_list>
          <group group_id="O1">
            <title>SOF/VEL</title>
            <description>SOF/VEL (400/100 mg) FDC tablet orally once daily for 12 weeks</description>
          </group>
        </group_list>
        <measure>
          <title>PK Parameter: Ctau of VEL</title>
          <description>Ctau is defined as the population PK derived concentration of the drug at the end of a 24 hour dosing interval. The 24 hour Ctau is estimated based on the combination of sparse PK samples collected at random times across the dosing interval as well as intensive PK samples collected for up to 12 hours post-dose.</description>
          <population>Participants in the PK Analysis Set were analyzed. Population PK analyses of all sparse and intensive PK data were utilized to estimate steady-state Ctau of VEL.</population>
          <units>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="59"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="137.2" spread="95.91"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: First dose date up to Posttreatment Week 24</time_frame>
      <desc>The Safety Analysis Set included all participants who received at least 1 dose of study drug.</desc>
      <group_list>
        <group group_id="E1">
          <title>SOF/VEL</title>
          <description>SOF/VEL (400/100 mg) FDC tablet orally once daily for 12 weeks</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA 21.1</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="2" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="11" subjects_at_risk="59"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Atrial fibrillation</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Cardiac failure congestive</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="59"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Cellulitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Device related infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Lower respiratory tract infection viral</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Pneumonia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Streptococcal bacteraemia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="59"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Post procedural haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Post procedural swelling</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Pubis fracture</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="59"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Neurilemmoma benign</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="59"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Anxiety</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Depression</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="59"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedDRA 21.1</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="33" subjects_at_risk="59"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Constipation</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Dyspepsia</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Gastrooesophageal reflux disease</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" subjects_affected="8" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" subjects_affected="8" subjects_at_risk="59"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Fatigue</sub_title>
                <counts group_id="E1" subjects_affected="8" subjects_at_risk="59"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Decreased appetite</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="59"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Arthralgia</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Muscle spasms</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="59"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Dizziness</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" subjects_affected="10" subjects_at_risk="59"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Insomnia</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="59"/>
              </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="5" subjects_at_risk="59"/>
              </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/NCT03036852
org study id: GS-US-342-4062
secondary id: 2016-003625-42
nct id: NCT03036852
lead sponsor: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
is us export: Yes
The primary objectives of this study are to evaluate safety, efficacy, and tolerability of
      treatment with sofosbuvir/velpatasvir (SOF/VEL) for 12 weeks in adults on dialysis for end
      stage renal disease (ESRD) with chronic hepatitis C virus (HCV) infection of any genotype.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Percentage of Participants With Sustained Virologic Response 12 Weeks After Discontinuation of Therapy (SVR12)
time frame: Posttreatment Week 12
description: SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ; ie, 15 IU/mL) 12 weeks after stopping the study treatment.
measure: Percentage of Participants Who Permanently Discontinued the Study Drug Due to an Adverse Event
time frame: First dose date up to Week 12
measure: Percentage of Participants With Sustained Virologic Response 4 Weeks After Discontinuation of Therapy (SVR4)
time frame: Posttreatment Week 4
description: SVR4 was defined as HCV RNA < LLOQ 4 weeks after stopping study treatment.
measure: Percentage of Participants With Sustained Virologic Response 24 Weeks After Discontinuation of Therapy (SVR24)
time frame: Posttreatment Week 24
description: SVR24 was defined as HCV RNA < LLOQ 24 weeks after stopping study treatment.
measure: Change From Baseline in HCV RNA
time frame: Baseline; Weeks 2, 4, 6, 8, and 12
measure: Percentage of Participants With HCV RNA < LLOQ on Treatment
time frame: Weeks 2, 4, 6, 8, and 12
measure: Percentage of Participants With Virologic Failure
time frame: Baseline to Posttreatment Week 24
description: Virologic failure was defined as:
On-treatment virologic failure:
Breakthrough (confirmed HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ while on treatment), or
Rebound (confirmed > 1 log10 IU/mL increase in HCV RNA from nadir while on treatment), or
Non-response (HCV RNA persistently ≥ LLOQ through 8 weeks of treatment)
Virologic relapse:
Confirmed HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA < LLOQ at last on-treatment visit
measure: Number of Participants Who Develop Viral Resistance (as Assessed by Presence of HCV NS5A and NS5B Genes) to SOF and VEL During Treatment and After Discontinuation of Treatment
time frame: First dose date up to Posttreatment Week 24
description: Baseline deep sequencing of the HCV NS5A and NS5B genes was performed for all participants. For all participants with virologic failure, deep sequencing was performed at the first time point after virologic failure if the plasma or serum sample was available and HCV RNA was > 1000 IU/mL.
measure: Pharmacokinetic (PK) Parameter: AUCtau of SOF
time frame: Sparse PK samples at Weeks 6, 8, and 12 (all participants). Intensive PK samples at predose, 0.25, 0.5, 1, 2, 4, 6, 8, 10, and 12 hours postdose once at Week 6, 8, or 12 (participants who enrolled in the optional PK substudy (N=1))
description: AUCtau is defined as the population PK derived area under the concentration versus time curve of the drug over the dosing interval.
measure: PK Parameter: AUCtau of GS-331007 (Metabolite of SOF)
time frame: Sparse PK samples at Weeks 6, 8, and 12 (all participants). Intensive PK samples at predose, 0.25, 0.5, 1, 2, 4, 6, 8, 10, and 12 hours postdose once at Week 6, 8, or 12 (participants who enrolled in the optional PK substudy (N=1))
description: AUCtau is defined as the population PK derived area under the concentration versus time curve of the drug over the dosing interval.
measure: PK Parameter: AUCtau of VEL
time frame: Sparse PK samples at Weeks 6, 8, and 12 (all participants). Intensive PK samples at predose, 0.25, 0.5, 1, 2, 4, 6, 8, 10, and 12 hours postdose once at Week 6, 8, or 12 (participants who enrolled in the optional PK substudy (N=1))
description: AUCtau is defined as the population PK derived area under the concentration verses time curve of the drug over the dosing interval.
measure: PK Parameter: Cmax of SOF
time frame: Sparse PK samples at Weeks 6, 8, and 12 (all participants). Intensive PK samples at predose, 0.25, 0.5, 1, 2, 4, 6, 8, 10, and 12 hours postdose once at Week 6, 8, or 12 (participants who enrolled in the optional PK substudy (N=1))
description: Cmax is defined as the population PK derived maximum concentration of the drug.
measure: PK Parameter: Cmax of GS-331007 (Metabolite of SOF)
time frame: Sparse PK samples at Weeks 6, 8, and 12 (all participants). Intensive PK samples at predose, 0.25, 0.5, 1, 2, 4, 6, 8, 10, and 12 hours postdose once at Week 6, 8, or 12 (participants who enrolled in the optional PK substudy (N=1))
description: Cmax is defined as the population PK derived maximum concentration of the drug.
measure: PK Parameter: Cmax of VEL
time frame: Sparse PK samples at Weeks 6, 8, and 12 (all participants). Intensive PK samples at predose, 0.25, 0.5, 1, 2, 4, 6, 8, 10, and 12 hours postdose once at Week 6, 8, or 12 (participants who enrolled in the optional PK substudy (N=1))
description: Cmax is defined as the population PK derived maximum concentration of the drug.
measure: PK Parameter: Ctau of VEL
time frame: Sparse PK samples at Weeks 6, 8, and 12 (all participants). Intensive PK samples at predose, 0.25, 0.5, 1, 2, 4, 6, 8, 10, and 12 hours postdose once at Week 6, 8, or 12 (participants who enrolled in the optional PK substudy (N=1))
description: Ctau is defined as the population PK derived concentration of the drug at the end of a 24 hour dosing interval. The 24 hour Ctau is estimated based on the combination of sparse PK samples collected at random times across the dosing interval as well as intensive PK samples collected for up to 12 hours post-dose.
arm group label: SOF/VEL
arm group type: Experimental
description: SOF/VEL for 12 weeks
intervention type: Drug
intervention name: SOF/VEL
description: 400/100 mg fixed-dose combination (FDC) tablet(s) administered orally once daily
arm group label: SOF/VEL
other name: GS-7977/GS-5816
other name: Epclusa®
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Gilead Study Director
role: Study Director
affiliation: Gilead Sciences
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country: Australia
country: Canada
country: Israel
country: New Zealand
country: Spain
country: United Kingdom
citation: Borgia SM, Dearden J, Lurie Y, Shafran SD, Brown A, Hyland RH, et al. Sofosbuvir/Velpatasvir for 12 Weeks Is Safe and Effective in Patients Undergoing Dialysis. American Association for the Study of Liver Diseases (AASLD); 2018 09-13 November; San Francisco, CA.
responsible party type: Sponsor
mesh term: Hepatitis A
mesh term: Hepatitis C
mesh term: Hepatitis C, Chronic
mesh term: Hepatitis
mesh term: Hepatitis, Chronic
mesh term: Kidney Failure, Chronic
mesh term: Sofosbuvir
mesh term: Sofosbuvir-velpatasvir drug combination
mesh term: Velpatasvir
sharing ipd: Yes
ipd description: Qualified external researchers may request IPD for this study after study completion. For more information, please visit our website at https://www.gilead.com/science-and-medicine/research/clinical-trials-transparency-and-data-sharing-policy.
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd time frame: 18 months after study completion
ipd access criteria: A secured external environment with username, password, and RSA code.
ipd url: https://www.gilead.com/science-and-medicine/research/clinical-trials-transparency-and-data-sharing-policy
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