<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/NCT02201940</url>
  </required_header>
  <id_info>
    <org_study_id>GS-US-342-1138</org_study_id>
    <secondary_id>2014-001683-35</secondary_id>
    <nct_id>NCT02201940</nct_id>
  </id_info>
  <brief_title>Sofosbuvir/Velpatasvir Fixed Dose Combination for 12 Weeks in Adults With Chronic HCV Infection</brief_title>
  <acronym>ASTRAL-1</acronym>
  <official_title>A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Investigate the Efficacy and Safety of Sofosbuvir/GS-5816 Fixed Dose Combination for 12 Weeks in Subjects With Chronic HCV</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>
  </oversight_info>
  <brief_summary>
    <textblock>
      The primary objectives of this study are to evaluate the efficacy, safety, and tolerability&#xD;
      of sofosbuvir/velpatasvir (SOF/VEL) fixed dose combination (FDC) for 12 weeks in adults with&#xD;
      chronic genotype 1, 2, 4, 5, or 6 hepatitis C virus (HCV) infection.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>July 2014</start_date>
  <completion_date type="Actual">September 2015</completion_date>
  <primary_completion_date type="Actual">June 2015</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12)</measure>
    <time_frame>Posttreatment Week 12</time_frame>
    <description>SVR12 was defined as HCV RNA &lt; the lower limit of quantitation (LLOQ; ie, 15 IU/mL) at 12 weeks after stopping study treatment.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event</measure>
    <time_frame>Up to 12 weeks</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With SVR at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)</measure>
    <time_frame>Posttreatment Weeks 4 and 24</time_frame>
    <description>SVR4 and SVR 24 were defined as HCV RNA &lt; LLOQ at 4 and 24 weeks after stopping study treatment, respectively.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With HCV RNA &lt; LLOQ at Weeks 1, 2, 4, 6, 8, 10, and 12</measure>
    <time_frame>Weeks 1, 2, 4, 6, 8, 10, and 12</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in HCV RNA at Weeks 1, 2, 4, 6, 8, 10, and 12</measure>
    <time_frame>Baseline; Weeks 1, 2, 4, 6, 8, 10, and 12</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With Virologic Failure</measure>
    <time_frame>Up 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>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">741</enrollment>
  <condition>Hepatitis C Virus Infection</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>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>SOF/VEL placebo for 12 weeks</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>SOF/VEL</intervention_name>
    <description>400/100 mg FDC tablet administered orally once daily</description>
    <arm_group_label>SOF/VEL</arm_group_label>
    <other_name>Epclusa®</other_name>
    <other_name>GS-7977/GS-5816</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Tablet administered orally once daily</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Willing and able to provide written informed consent&#xD;
&#xD;
          -  HCV RNA ≥ 10^4 IU/mL at screening&#xD;
&#xD;
          -  HCV genotype 1, 2, 4, 5, 6, or indeterminate assessed at screening by the central&#xD;
             laboratory&#xD;
&#xD;
          -  Chronic HCV infection (≥ 6 months) documented by prior medical history or liver biopsy&#xD;
&#xD;
          -  Classification as treatment naive or treatment experienced&#xD;
&#xD;
          -  Males and females of childbearing potential who engage in heterosexual intercourse&#xD;
             must agree to use protocol specified method(s) of contraception&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Current or prior history of clinically-significant illness (other than HCV) or any&#xD;
             other major medical disorder that may interfere with treatment, assessment, or&#xD;
             compliance with the protocol; individuals currently under evaluation for a potentially&#xD;
             clinically-significant illness (other than HCV) are also excluded.&#xD;
&#xD;
          -  Screening ECG with clinically significant abnormalities&#xD;
&#xD;
          -  Laboratory results outside of acceptable ranges at Screening&#xD;
&#xD;
          -  Prior exposure to SOF or other nucleotide analogue HCV NS5B inhibitor or any HCV NS5A&#xD;
             inhibitor&#xD;
&#xD;
          -  Infection with hepatitis B virus (HBV) or human immunodeficiency virus (HIV)&#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>John McNally, PhD</last_name>
    <role>Study Director</role>
    <affiliation>Gilead Sciences</affiliation>
  </overall_official>
  <location>
    <facility>
      <address>
        <city>Little Rock</city>
        <state>Arkansas</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Long Beach</city>
        <state>California</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90027</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90036</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90048</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Palo Alto</city>
        <state>California</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Sacramento</city>
        <state>California</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>San Diego</city>
        <state>California</state>
        <zip>92123</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>San Diego</city>
        <state>California</state>
        <zip>92154</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Aurora</city>
        <state>Colorado</state>
        <zip>80045</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Gainesville</city>
        <state>Florida</state>
        <zip>32610-0272</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Jacksonville</city>
        <state>Florida</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Orlando</city>
        <state>Florida</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Wellington</city>
        <state>Florida</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Atlanta</city>
        <state>Georgia</state>
        <zip>30308</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Marietta</city>
        <state>Georgia</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60611</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Indianapolis</city>
        <state>Indiana</state>
        <zip>46237</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Baltimore</city>
        <state>Maryland</state>
        <country>United States</country>
      </address>
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  </location>
  <location>
    <facility>
      <address>
        <city>Lutherville</city>
        <state>Maryland</state>
        <zip>21093</zip>
        <country>United States</country>
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    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02215</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Detroit</city>
        <state>Michigan</state>
        <zip>48188</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Bronx</city>
        <state>New York</state>
        <zip>10468</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10021</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19104</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Pittsburgh</city>
        <state>Pennsylvania</state>
        <zip>15213</zip>
        <country>United States</country>
      </address>
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  </location>
  <location>
    <facility>
      <address>
        <city>Pittsburgh</city>
        <state>Pennsylvania</state>
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        <country>United States</country>
      </address>
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    <facility>
      <address>
        <city>Providence</city>
        <state>Rhode Island</state>
        <zip>02905</zip>
        <country>United States</country>
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    <facility>
      <address>
        <city>Germantown</city>
        <state>Tennessee</state>
        <country>United States</country>
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  <location>
    <facility>
      <address>
        <city>Nashville</city>
        <state>Tennessee</state>
        <country>United States</country>
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      <address>
        <city>San Antonio</city>
        <state>Texas</state>
        <zip>78215</zip>
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    <facility>
      <address>
        <city>Norfolk</city>
        <state>Virginia</state>
        <country>United States</country>
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  </location>
  <location>
    <facility>
      <address>
        <city>Richmond</city>
        <state>Virginia</state>
        <country>United States</country>
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    </facility>
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  <location>
    <facility>
      <address>
        <city>Antwerp</city>
        <zip>2060</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Brussels</city>
        <zip>1070</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Kortrijk</city>
        <zip>8500</zip>
        <country>Belgium</country>
      </address>
    </facility>
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  <location>
    <facility>
      <address>
        <city>Calgary</city>
        <state>Alberta</state>
        <zip>T2N 4Z6</zip>
        <country>Canada</country>
      </address>
    </facility>
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  <location>
    <facility>
      <address>
        <city>Edmonton</city>
        <state>Alberta</state>
        <zip>T6G 2B7</zip>
        <country>Canada</country>
      </address>
    </facility>
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  <location>
    <facility>
      <address>
        <city>Vancouver</city>
        <state>British Columbia</state>
        <zip>V5Z 1M9</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Vancouver</city>
        <state>British Columbia</state>
        <zip>V6Z2C7</zip>
        <country>Canada</country>
      </address>
    </facility>
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  <location>
    <facility>
      <address>
        <city>Ottawa</city>
        <state>Ontario</state>
        <zip>K1H 8L6</zip>
        <country>Canada</country>
      </address>
    </facility>
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    <facility>
      <address>
        <city>Montreal</city>
        <state>Quebec</state>
        <zip>H2X 0A9</zip>
        <country>Canada</country>
      </address>
    </facility>
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    <facility>
      <address>
        <city>Toronto</city>
        <zip>M5T 2S8</zip>
        <country>Canada</country>
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  <location>
    <facility>
      <address>
        <city>Hong Kong</city>
        <country>China</country>
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    </facility>
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    <facility>
      <address>
        <city>Clermont-Ferrand</city>
        <zip>63000</zip>
        <country>France</country>
      </address>
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    <facility>
      <address>
        <city>Clichy</city>
        <zip>92110</zip>
        <country>France</country>
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    </facility>
  </location>
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    <facility>
      <address>
        <city>Creteil</city>
        <zip>94000</zip>
        <country>France</country>
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    <facility>
      <address>
        <city>Lille</city>
        <zip>59037</zip>
        <country>France</country>
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    </facility>
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    <facility>
      <address>
        <city>Limoges</city>
        <zip>87042</zip>
        <country>France</country>
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    </facility>
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      <address>
        <city>Lyon</city>
        <zip>69004</zip>
        <country>France</country>
      </address>
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      <address>
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        <zip>13008</zip>
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        <zip>75014</zip>
        <country>France</country>
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      <address>
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        <zip>33604</zip>
        <country>France</country>
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    <facility>
      <address>
        <city>Toulouse</city>
        <zip>31059</zip>
        <country>France</country>
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    <facility>
      <address>
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        <zip>94804</zip>
        <country>France</country>
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  <location>
    <facility>
      <address>
        <city>Frankfurt am Main</city>
        <state>Hessin</state>
        <zip>60590</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Duesseldorf</city>
        <state>North Rhine-Westphalia</state>
        <zip>40237</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Hufelandstr</city>
        <state>NRW</state>
        <zip>45122</zip>
        <country>Germany</country>
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        <city>Koln</city>
        <state>NRW</state>
        <zip>50932</zip>
        <country>Germany</country>
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    <facility>
      <address>
        <city>Berlin</city>
        <zip>12157</zip>
        <country>Germany</country>
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  <location>
    <facility>
      <address>
        <city>Berlin</city>
        <zip>D-10969</zip>
        <country>Germany</country>
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    <facility>
      <address>
        <city>Hamburg</city>
        <zip>20099</zip>
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      <address>
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        <zip>30625</zip>
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      <address>
        <city>München</city>
        <zip>81377</zip>
        <country>Germany</country>
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    <facility>
      <address>
        <city>San Giovanni Rotondo</city>
        <state>Foggia</state>
        <zip>71013</zip>
        <country>Italy</country>
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  <location>
    <facility>
      <address>
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    <facility>
      <address>
        <city>Plymouth</city>
        <state>Devon</state>
        <zip>PL6 8DH</zip>
        <country>United Kingdom</country>
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    <facility>
      <address>
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        <state>Hampshire</state>
        <zip>PO6 3LY</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
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    <facility>
      <address>
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        <zip>G12 0YN</zip>
        <country>United Kingdom</country>
      </address>
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    <facility>
      <address>
        <city>London</city>
        <zip>E1 4AT</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
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    <facility>
      <address>
        <city>London</city>
        <zip>NW3 2PF</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
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    <facility>
      <address>
        <city>London</city>
        <zip>SE5 9RS</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
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  <location>
    <facility>
      <address>
        <city>London</city>
        <zip>SW170QT</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>London</city>
        <zip>W2 1NY</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Manchester</city>
        <zip>M8 5RB</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Nottingham</city>
        <zip>NG7 2UH</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Oxford</city>
        <zip>OX3 9DU</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Belgium</country>
    <country>Canada</country>
    <country>China</country>
    <country>France</country>
    <country>Germany</country>
    <country>Italy</country>
    <country>Puerto Rico</country>
    <country>United Kingdom</country>
    <country>United States</country>
  </location_countries>
  <results_reference>
    <citation>Asselah T, Charlton M, Feld J, Foster GR, Mcnally J, Brainard DM, et al. The ASTRAL Studies: Evaluation of SOF/GS-5816 Single Tablet Regimen for the Treatment of Genotype 1-6 HCV Infection [Poster P1332]. J Hepatol 2015;62:S855-S6.</citation>
  </results_reference>
  <results_reference>
    <citation>Feld JJ, Jacobson IM, Hezode C, Asselah T, Ruane PJ, Gruener N, Abergel A, Mangia A, Lai CL, Chan HL, Mazzotta F, Moreno C, Yoshida E, Shafran SD, Towner WJ, Tran TT, McNally J, Osinusi A, Svarovskaia E, Zhu Y, Brainard DM, McHutchison JG, Agarwal K, Zeuzem S; ASTRAL-1 Investigators. Sofosbuvir and Velpatasvir for HCV Genotype 1, 2, 4, 5, and 6 Infection. N Engl J Med. 2015 Dec 31;373(27):2599-607. doi: 10.1056/NEJMoa1512610. Epub 2015 Nov 16.</citation>
    <PMID>26571066</PMID>
  </results_reference>
  <results_reference>
    <citation>Feld JJ, Agarwal K, Hezode C, Asselah T, Ruane PJ, Gruener N, et al. A Phase 3 Double-Blind Placebo-Controlled Evaluation of Sofosbuvir/Velpatasvir Fixed Dose Combination for 12 Weeks in Naive and Experienced Genotype 1, 2, 4, 5, 6 HCV Infected Patients with and without Cirrhosis: Results of the ASTRAL-1 Study. J Hepatol 2015;62(6) Suppl:1379A-1380A.</citation>
  </results_reference>
  <verification_date>July 2016</verification_date>
  <study_first_submitted>July 24, 2014</study_first_submitted>
  <study_first_submitted_qc>July 24, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 28, 2014</study_first_posted>
  <results_first_submitted>July 27, 2016</results_first_submitted>
  <results_first_submitted_qc>July 27, 2016</results_first_submitted_qc>
  <results_first_posted type="Estimate">September 16, 2016</results_first_posted>
  <disposition_first_submitted>April 8, 2016</disposition_first_submitted>
  <disposition_first_submitted_qc>April 8, 2016</disposition_first_submitted_qc>
  <disposition_first_posted type="Estimate">May 5, 2016</disposition_first_posted>
  <last_update_submitted>October 19, 2018</last_update_submitted>
  <last_update_submitted_qc>October 19, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">November 15, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Sofosbuvir</keyword>
  <keyword>SOF/VEL</keyword>
  <keyword>Velpatasvir</keyword>
  <keyword>Hepatitis C</keyword>
  <keyword>HCV</keyword>
  <keyword>cirrhosis</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Infections</mesh_term>
    <mesh_term>Hepatitis C</mesh_term>
    <mesh_term>Hepatitis</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 http://www.gilead.com/research/disclosure-and-transparency.</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>http://www.gilead.com/research/disclosure-and-transparency</ipd_url>
  </patient_data>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Participants were enrolled at study sites in the United States, Canada, Europe, and Asia. The first participant was screened on 18 July 2014. The last study visit occurred on 23 September 2015.</recruitment_details>
      <pre_assignment_details>847 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 administered orally once daily for 12 weeks</description>
        </group>
        <group group_id="P2">
          <title>Placebo</title>
          <description>SOF/VEL placebo tablet administered 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="625"/>
                <participants group_id="P2" count="116"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="613"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="12"/>
                <participants group_id="P2" count="116"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Randomized/Enrolled but Never Treated</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lack of Efficacy</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="113"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="5"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrew Consent</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Investigator's Discretion</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Death</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Safety Analysis Set: participants who received at least 1 dose of study drug.</population>
      <group_list>
        <group group_id="B1">
          <title>SOF/VEL</title>
          <description>SOF/VEL (400/100 mg) FDC tablet administered orally once daily for 12 weeks</description>
        </group>
        <group group_id="B2">
          <title>Placebo</title>
          <description>SOF/VEL placebo tablet administered orally once daily for 12 weeks</description>
        </group>
        <group group_id="B3">
          <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="624"/>
            <count group_id="B2" value="116"/>
            <count group_id="B3" value="740"/>
          </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="54" spread="10.9"/>
                    <measurement group_id="B2" value="53" spread="10.4"/>
                    <measurement group_id="B3" value="54" spread="10.8"/>
                  </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="250"/>
                    <measurement group_id="B2" value="48"/>
                    <measurement group_id="B3" value="298"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="374"/>
                    <measurement group_id="B2" value="68"/>
                    <measurement group_id="B3" value="442"/>
                  </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="31"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="36"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="589"/>
                    <measurement group_id="B2" value="111"/>
                    <measurement group_id="B3" value="700"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race/Ethnicity, Customized</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>Black or African American</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="52"/>
                    <measurement group_id="B2" value="12"/>
                    <measurement group_id="B3" value="64"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>White</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="493"/>
                    <measurement group_id="B2" value="89"/>
                    <measurement group_id="B3" value="582"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Asian</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="62"/>
                    <measurement group_id="B2" value="11"/>
                    <measurement group_id="B3" value="73"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>American Indian/ Alaska Native</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hawaiian or Pacific Islander</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Other</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Not Disclosed</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <description>All randomized participants were analyzed for Region of Enrollment (N = 741).</description>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>Canada</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="55"/>
                    <measurement group_id="B2" value="7"/>
                    <measurement group_id="B3" value="62"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Belgium</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="40"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="45"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="234"/>
                    <measurement group_id="B2" value="45"/>
                    <measurement group_id="B3" value="279"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>China</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="19"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="23"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Italy</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="16"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="18"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>United Kingdom</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="91"/>
                    <measurement group_id="B2" value="13"/>
                    <measurement group_id="B3" value="104"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>France</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="126"/>
                    <measurement group_id="B2" value="32"/>
                    <measurement group_id="B3" value="158"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Germany</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="44"/>
                    <measurement group_id="B2" value="8"/>
                    <measurement group_id="B3" value="52"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Cirrhosis Status</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>Present</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="121"/>
                    <measurement group_id="B2" value="21"/>
                    <measurement group_id="B3" value="142"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Absent</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="501"/>
                    <measurement group_id="B2" value="95"/>
                    <measurement group_id="B3" value="596"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Missing</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>HCV Genotype</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>Genotype 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="328"/>
                    <measurement group_id="B2" value="65"/>
                    <measurement group_id="B3" value="393"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Genotype 2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="104"/>
                    <measurement group_id="B2" value="21"/>
                    <measurement group_id="B3" value="125"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Genotype 4</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="116"/>
                    <measurement group_id="B2" value="22"/>
                    <measurement group_id="B3" value="138"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Genotype 5</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="35"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="35"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Genotype 6</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="41"/>
                    <measurement group_id="B2" value="8"/>
                    <measurement group_id="B3" value="49"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>IL28b Status</title>
          <description>CC, CT, and TT alleles are different forms of the IL28b gene.</description>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>CC</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="186"/>
                    <measurement group_id="B2" value="36"/>
                    <measurement group_id="B3" value="222"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>CT</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="339"/>
                    <measurement group_id="B2" value="53"/>
                    <measurement group_id="B3" value="392"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>TT</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="94"/>
                    <measurement group_id="B2" value="26"/>
                    <measurement group_id="B3" value="120"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Missing</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" 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="6.3" spread="0.66"/>
                    <measurement group_id="B2" value="6.3" spread="0.58"/>
                    <measurement group_id="B3" value="6.3" spread="0.65"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>HCV RNA Category</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>&lt; 800,000 IU/mL</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="163"/>
                    <measurement group_id="B2" value="29"/>
                    <measurement group_id="B3" value="192"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>≥ 800,000 IU/mL</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="461"/>
                    <measurement group_id="B2" value="87"/>
                    <measurement group_id="B3" value="548"/>
                  </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 (SVR) 12 Weeks After Discontinuation of Therapy (SVR12)</title>
        <description>SVR12 was defined as HCV RNA &lt; the lower limit of quantitation (LLOQ; ie, 15 IU/mL) at 12 weeks after stopping study treatment.</description>
        <time_frame>Posttreatment Week 12</time_frame>
        <population>Full Analysis Set: participants randomized or enrolled into the study and 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 administered orally once daily for 12 weeks</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>SOF/VEL placebo tablet administered orally once daily for 12 weeks</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12)</title>
          <description>SVR12 was defined as HCV RNA &lt; the lower limit of quantitation (LLOQ; ie, 15 IU/mL) at 12 weeks after stopping study treatment.</description>
          <population>Full Analysis Set: participants randomized or 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="624"/>
                <count group_id="O2" value="116"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="99.0" lower_limit="97.9" upper_limit="99.6"/>
                    <measurement group_id="O2" value="0" lower_limit="0.0" upper_limit="3.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>&lt; 0.001</p_value>
            <p_value_desc>Participants in the SOF/VEL group were compared to the performance goal of 85% using a 2-sided exact 1-sample binomial test at the 0.05 significance level.</p_value_desc>
            <method>Binomial test</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event</title>
        <time_frame>Up to 12 weeks</time_frame>
        <population>Safety Analysis Set</population>
        <group_list>
          <group group_id="O1">
            <title>SOF/VEL</title>
            <description>SOF/VEL (400/100 mg) FDC tablet administered orally once daily for 12 weeks</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>SOF/VEL placebo tablet administered orally once daily for 12 weeks</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event</title>
          <population>Safety Analysis Set</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="624"/>
                <count group_id="O2" value="116"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.2"/>
                    <measurement group_id="O2" value="1.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With SVR at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)</title>
        <description>SVR4 and SVR 24 were defined as HCV RNA &lt; LLOQ at 4 and 24 weeks after stopping study treatment, respectively.</description>
        <time_frame>Posttreatment Weeks 4 and 24</time_frame>
        <population>Full Analysis Set</population>
        <group_list>
          <group group_id="O1">
            <title>SOF/VEL</title>
            <description>SOF/VEL (400/100 mg) FDC tablet administered orally once daily for 12 weeks</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>SOF/VEL placebo tablet administered orally once daily for 12 weeks</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With SVR at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)</title>
          <description>SVR4 and SVR 24 were defined as HCV RNA &lt; LLOQ at 4 and 24 weeks after stopping study treatment, respectively.</description>
          <population>Full Analysis Set</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="624"/>
                <count group_id="O2" value="116"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>SVR4</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="99.2" lower_limit="98.1" upper_limit="99.7"/>
                    <measurement group_id="O2" value="0" lower_limit="0.0" upper_limit="3.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>SVR24</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="99.0" lower_limit="97.9" upper_limit="99.6"/>
                    <measurement group_id="O2" value="0" lower_limit="0.0" upper_limit="3.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With HCV RNA &lt; LLOQ at Weeks 1, 2, 4, 6, 8, 10, and 12</title>
        <time_frame>Weeks 1, 2, 4, 6, 8, 10, and 12</time_frame>
        <population>Participants in the Full Analysis Set with available data were analyzed.</population>
        <group_list>
          <group group_id="O1">
            <title>SOF/VEL</title>
            <description>SOF/VEL (400/100 mg) FDC tablet administered orally once daily for 12 weeks</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>SOF/VEL placebo tablet administered orally once daily for 12 weeks</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With HCV RNA &lt; LLOQ at Weeks 1, 2, 4, 6, 8, 10, and 12</title>
          <population>Participants in the Full Analysis Set with available data 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="624"/>
                <count group_id="O2" value="116"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 1 (SOF/VEL: N = 624; Placebo: N = 116)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="18.8" lower_limit="15.8" upper_limit="22.0"/>
                    <measurement group_id="O2" value="0" lower_limit="0.0" upper_limit="3.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 2 (SOF/VEL: N = 624; Placebo: N = 116)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="56.9" lower_limit="52.9" upper_limit="60.8"/>
                    <measurement group_id="O2" value="0" lower_limit="0.0" upper_limit="3.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 4 (SOF/VEL: N = 623; Placebo: N = 116)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="90.5" lower_limit="88.0" upper_limit="92.7"/>
                    <measurement group_id="O2" value="0" lower_limit="0.0" upper_limit="3.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 6 (SOF/VEL: N = 623; Placebo: N = 115)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="98.9" lower_limit="97.7" upper_limit="99.5"/>
                    <measurement group_id="O2" value="0" lower_limit="0.0" upper_limit="3.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 8 (SOF/VEL: N = 622; Placebo: N = 114)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="99.7" lower_limit="98.8" upper_limit="100.0"/>
                    <measurement group_id="O2" value="0" lower_limit="0.0" upper_limit="3.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 10 (SOF/VEL: N = 622; Placebo: N = 114)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="100.0" lower_limit="99.4" upper_limit="100.0"/>
                    <measurement group_id="O2" value="0" lower_limit="0.0" upper_limit="3.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 12 (SOF/VEL: N = 622; Placebo: N = 113)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="100.0" lower_limit="99.4" upper_limit="100.0"/>
                    <measurement group_id="O2" value="0" lower_limit="0.0" upper_limit="3.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in HCV RNA at Weeks 1, 2, 4, 6, 8, 10, and 12</title>
        <time_frame>Baseline; Weeks 1, 2, 4, 6, 8, 10, and 12</time_frame>
        <population>Participants in the Full Analysis Set with available data were analyzed.</population>
        <group_list>
          <group group_id="O1">
            <title>SOF/VEL</title>
            <description>SOF/VEL (400/100 mg) FDC tablet administered orally once daily for 12 weeks</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>SOF/VEL placebo tablet administered orally once daily for 12 weeks</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in HCV RNA at Weeks 1, 2, 4, 6, 8, 10, and 12</title>
          <population>Participants in the Full Analysis Set with available data were analyzed.</population>
          <units>log10 IU/mL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="624"/>
                <count group_id="O2" value="116"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Change at Wk 1 (SOF/VEL: N= 617; Placebo: N= 114)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-4.29" spread="0.647"/>
                    <measurement group_id="O2" value="-0.05" spread="0.561"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Wk 2 (SOF/VEL: N= 622; Placebo: N= 116)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-4.82" spread="0.685"/>
                    <measurement group_id="O2" value="0.01" spread="0.280"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Wk 4 (SOF/VEL: N= 617; Placebo: N= 114)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-5.08" spread="0.656"/>
                    <measurement group_id="O2" value="-0.01" spread="0.297"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Wk 6 (SOF/VEL: N= 623; Placebo: N= 115)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-5.11" spread="0.664"/>
                    <measurement group_id="O2" value="0.07" spread="0.298"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Wk 8 (SOF/VEL: N= 622; Placebo: N= 113)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-5.11" spread="0.664"/>
                    <measurement group_id="O2" value="0.05" spread="0.281"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Wk 10 (SOF/VEL: N= 622; Placebo: N= 112)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-5.12" spread="0.662"/>
                    <measurement group_id="O2" value="0.05" spread="0.337"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Wk 12 (SOF/VEL: N= 622; Placebo: N= 111)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-5.12" spread="0.662"/>
                    <measurement group_id="O2" value="-0.06" spread="0.580"/>
                  </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>Up to Posttreatment Week 24</time_frame>
        <population>Full Analysis Set</population>
        <group_list>
          <group group_id="O1">
            <title>SOF/VEL</title>
            <description>SOF/VEL (400/100 mg) FDC tablet administered orally once daily for 12 weeks</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>SOF/VEL placebo tablet administered orally once daily for 12 weeks</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>Full Analysis Set</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="624"/>
                <count group_id="O2" value="116"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.3"/>
                    <measurement group_id="O2" value="100"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Up to 12 weeks plus 30 days</time_frame>
      <desc>Safety Analysis Set</desc>
      <group_list>
        <group group_id="E1">
          <title>SOF/VEL</title>
          <description>SOF/VEL (400/100 mg) FDC tablet administered orally once daily for 12 weeks</description>
        </group>
        <group group_id="E2">
          <title>Placebo</title>
          <description>SOF/VEL placebo tablet administered orally once daily for 12 weeks</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA Version 18</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="15" subjects_at_risk="624"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="116"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Acute myocardial infarction</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="624"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="116"/>
              </event>
              <event>
                <sub_title>Palpitations</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="624"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="116"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Small intestinal obstruction</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="624"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="116"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Sudden death</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="624"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="116"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Abscess limb</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="624"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="116"/>
              </event>
              <event>
                <sub_title>Appendicitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="624"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="116"/>
              </event>
              <event>
                <sub_title>Bronchitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="624"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="116"/>
              </event>
              <event>
                <sub_title>Cellulitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="624"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="116"/>
              </event>
              <event>
                <sub_title>Gastroenteritis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="624"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="116"/>
              </event>
              <event>
                <sub_title>Influenza</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="624"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="116"/>
              </event>
              <event>
                <sub_title>Vestibular neuronitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="624"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="116"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Ligament sprain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="624"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="116"/>
              </event>
              <event>
                <sub_title>Upper limb fracture</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="624"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="116"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Rotator cuff syndrome</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="624"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="116"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Lung neoplasm malignant</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="624"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="116"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Epilepsy</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="624"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="116"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Mania</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="624"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="116"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Chronic obstructive pulmonary disease</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="624"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="116"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Extremity necrosis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="624"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="116"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedDRA Version 18</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="393" subjects_at_risk="624"/>
                <counts group_id="E2" subjects_affected="77" subjects_at_risk="116"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" subjects_affected="48" subjects_at_risk="624"/>
                <counts group_id="E2" subjects_affected="8" subjects_at_risk="116"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" subjects_affected="75" subjects_at_risk="624"/>
                <counts group_id="E2" subjects_affected="13" subjects_at_risk="116"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Asthenia</sub_title>
                <counts group_id="E1" subjects_affected="42" subjects_at_risk="624"/>
                <counts group_id="E2" subjects_affected="9" subjects_at_risk="116"/>
              </event>
              <event>
                <sub_title>Fatigue</sub_title>
                <counts group_id="E1" subjects_affected="127" subjects_at_risk="624"/>
                <counts group_id="E2" subjects_affected="24" subjects_at_risk="116"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Nasopharyngitis</sub_title>
                <counts group_id="E1" subjects_affected="80" subjects_at_risk="624"/>
                <counts group_id="E2" subjects_affected="12" subjects_at_risk="116"/>
              </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="40" subjects_at_risk="624"/>
                <counts group_id="E2" subjects_affected="9" subjects_at_risk="116"/>
              </event>
              <event>
                <sub_title>Back pain</sub_title>
                <counts group_id="E1" subjects_affected="29" subjects_at_risk="624"/>
                <counts group_id="E2" subjects_affected="11" subjects_at_risk="116"/>
              </event>
              <event>
                <sub_title>Myalgia</sub_title>
                <counts group_id="E1" subjects_affected="25" subjects_at_risk="624"/>
                <counts group_id="E2" subjects_affected="6" subjects_at_risk="116"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" subjects_affected="182" subjects_at_risk="624"/>
                <counts group_id="E2" subjects_affected="33" subjects_at_risk="116"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Insomnia</sub_title>
                <counts group_id="E1" subjects_affected="50" subjects_at_risk="624"/>
                <counts group_id="E2" subjects_affected="11" subjects_at_risk="116"/>
              </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="39" subjects_at_risk="624"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="116"/>
              </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>Clinical Trial Disclosures</name_or_title>
      <organization>Gilead Sciences</organization>
      <email>ClinicalTrialDisclosures@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/NCT02201940
org study id: GS-US-342-1138
secondary id: 2014-001683-35
nct id: NCT02201940
lead sponsor: 
has dmc: Yes
The primary objectives of this study are to evaluate the efficacy, safety, and tolerability
      of sofosbuvir/velpatasvir (SOF/VEL) fixed dose combination (FDC) for 12 weeks in adults with
      chronic genotype 1, 2, 4, 5, or 6 hepatitis C virus (HCV) infection.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12)
time frame: Posttreatment Week 12
description: SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ; ie, 15 IU/mL) at 12 weeks after stopping study treatment.
measure: Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event
time frame: Up to 12 weeks
measure: Percentage of Participants With SVR at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)
time frame: Posttreatment Weeks 4 and 24
description: SVR4 and SVR 24 were defined as HCV RNA < LLOQ at 4 and 24 weeks after stopping study treatment, respectively.
measure: Percentage of Participants With HCV RNA < LLOQ at Weeks 1, 2, 4, 6, 8, 10, and 12
time frame: Weeks 1, 2, 4, 6, 8, 10, and 12
measure: Change From Baseline in HCV RNA at Weeks 1, 2, 4, 6, 8, 10, and 12
time frame: Baseline; Weeks 1, 2, 4, 6, 8, 10, and 12
measure: Percentage of Participants With Virologic Failure
time frame: Up to Posttreatment Week 24
description: Virologic failure was defined as:
On-treatment virologic failure:
Breakthrough (confirmed HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ while on treatment), or
Rebound (confirmed > 1 log10 IU/mL increase in HCV RNA from nadir while on treatment), or
Non-response (HCV RNA persistently ≥ LLOQ through 8 weeks of treatment)
Virologic relapse:
Confirmed HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA < LLOQ at last on-treatment visit.
arm group label: SOF/VEL
arm group type: Experimental
description: SOF/VEL for 12 weeks
arm group label: Placebo
arm group type: Placebo Comparator
description: SOF/VEL placebo for 12 weeks
intervention type: Drug
intervention name: SOF/VEL
description: 400/100 mg FDC tablet administered orally once daily
arm group label: SOF/VEL
other name: Epclusa®
other name: GS-7977/GS-5816
intervention type: Drug
intervention name: Placebo
description: Tablet administered orally once daily
arm group label: Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: John McNally, PhD
role: Study Director
affiliation: Gilead Sciences
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country: Belgium
country: Canada
country: China
country: France
country: Germany
country: Italy
country: Puerto Rico
country: United Kingdom
country: United States
citation: Asselah T, Charlton M, Feld J, Foster GR, Mcnally J, Brainard DM, et al. The ASTRAL Studies: Evaluation of SOF/GS-5816 Single Tablet Regimen for the Treatment of Genotype 1-6 HCV Infection [Poster P1332]. J Hepatol 2015;62:S855-S6.
citation: Feld JJ, Jacobson IM, Hezode C, Asselah T, Ruane PJ, Gruener N, Abergel A, Mangia A, Lai CL, Chan HL, Mazzotta F, Moreno C, Yoshida E, Shafran SD, Towner WJ, Tran TT, McNally J, Osinusi A, Svarovskaia E, Zhu Y, Brainard DM, McHutchison JG, Agarwal K, Zeuzem S; ASTRAL-1 Investigators. Sofosbuvir and Velpatasvir for HCV Genotype 1, 2, 4, 5, and 6 Infection. N Engl J Med. 2015 Dec 31;373(27):2599-607. doi: 10.1056/NEJMoa1512610. Epub 2015 Nov 16.
PMID: 26571066
citation: Feld JJ, Agarwal K, Hezode C, Asselah T, Ruane PJ, Gruener N, et al. A Phase 3 Double-Blind Placebo-Controlled Evaluation of Sofosbuvir/Velpatasvir Fixed Dose Combination for 12 Weeks in Naive and Experienced Genotype 1, 2, 4, 5, 6 HCV Infected Patients with and without Cirrhosis: Results of the ASTRAL-1 Study. J Hepatol 2015;62(6) Suppl:1379A-1380A.
responsible party type: Sponsor
mesh term: Infections
mesh term: Hepatitis C
mesh term: Hepatitis
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 http://www.gilead.com/research/disclosure-and-transparency.
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: http://www.gilead.com/research/disclosure-and-transparency
participant flow: 
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reported events: 
certain agreements: 
point of contact: 