<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/NCT02220998</url>
  </required_header>
  <id_info>
    <org_study_id>GS-US-342-1139</org_study_id>
    <nct_id>NCT02220998</nct_id>
  </id_info>
  <brief_title>Comparison of Sofosbuvir/Velpatasvir Fixed Dose Combination for 12 Weeks With Sofosbuvir and Ribavirin for 12 Weeks in Adults With Chronic Genotype 2 HCV Infection</brief_title>
  <acronym>ASTRAL-2</acronym>
  <official_title>A Phase 3, Multicenter, Randomized, Open-Label Study to Compare the Efficacy and Safety of Sofosbuvir/GS-5816 Fixed Dose Combination for 12 Weeks With Sofosbuvir and Ribavirin for 12 Weeks in Subjects With Chronic Genotype 2 HCV Infection</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Gilead Sciences</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Gilead Sciences</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The primary objectives of this study are to evaluate the efficacy, safety, and tolerability&#xD;
      of treatment with sofosbuvir/velpatasvir (SOF/VEL) fixed-dose combination (FDC) for 12 weeks&#xD;
      compared to treatment with sofosbuvir (SOF) plus ribavirin (RBV) for 12 weeks in participants&#xD;
      with chronic genotype 2 hepatitis C virus (HCV) infection.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>September 2014</start_date>
  <completion_date type="Actual">September 2015</completion_date>
  <primary_completion_date type="Actual">July 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>None (Open Label)</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">269</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 FDC for 12 weeks</description>
  </arm_group>
  <arm_group>
    <arm_group_label>SOF+RBV</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>SOF+RBV for 12 weeks</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>SOF/VEL</intervention_name>
    <description>SOF/VEL (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>SOF</intervention_name>
    <description>SOF 400 mg tablet administered orally once daily</description>
    <arm_group_label>SOF+RBV</arm_group_label>
    <other_name>Sovaldi®</other_name>
    <other_name>GS-7977</other_name>
    <other_name>PSI-7977</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>RBV</intervention_name>
    <description>RBV tablets administered orally in a divided daily dose according to package insert weight-based dosing recommendations (&lt; 75 kg = 1000 mg and ≥ 75 kg = 1200 mg)</description>
    <arm_group_label>SOF+RBV</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&#xD;
&#xD;
          -  HCV genotype 2&#xD;
&#xD;
          -  Chronic HCV infection (≥ 6 months)&#xD;
&#xD;
          -  Females of childbearing potential must have a negative serum pregnancy test&#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;
          -  Must be of generally good health, with the exception of chronic HCV infection, as&#xD;
             determined by the investigator.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Current or prior history of clinically-significant illness (other than HCV that may&#xD;
             interfere with treatment, assessment or compliance with the protocol;&#xD;
&#xD;
          -  Screening electrocardiogram (ECG) with clinically significant abnormalities&#xD;
&#xD;
          -  Laboratory results outside of acceptable ranges at Screening&#xD;
&#xD;
          -  Pregnant or nursing female or male with pregnant female partner&#xD;
&#xD;
          -  Chronic liver disease of a non-HCV etiology (e.g., hemochromatosis, Wilson's disease,&#xD;
             alfa-1 antitrypsin deficiency, cholangitis)&#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>Anu Osinusi, MD</last_name>
    <role>Study Director</role>
    <affiliation>Gilead Sciences</affiliation>
  </overall_official>
  <location>
    <facility>
      <address>
        <city>Long Beach</city>
        <state>California</state>
        <zip>90822</zip>
        <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>Los Angeles</city>
        <state>California</state>
        <zip>90057</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90073</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Palo Alto</city>
        <state>California</state>
        <zip>94304</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Pasadena</city>
        <state>California</state>
        <zip>91105</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Sacramento</city>
        <state>California</state>
        <zip>95817</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>San Diego</city>
        <state>California</state>
        <zip>92103</zip>
        <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>San Francisco</city>
        <state>California</state>
        <zip>94110</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>San Francisco</city>
        <state>California</state>
        <zip>94118</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>Bradenton</city>
        <state>Florida</state>
        <zip>34205</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>
        <zip>32256</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33136</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Orlando</city>
        <state>Florida</state>
        <zip>32803</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Wellington</city>
        <state>Florida</state>
        <zip>33414</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Emory university</name>
      <address>
        <city>Atlanta</city>
        <state>Georgia</state>
        <zip>30308</zip>
        <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>
        <zip>30060</zip>
        <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>Chicago</city>
        <state>Illinois</state>
        <zip>60637</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>Monroe</city>
        <state>Louisiana</state>
        <zip>71280</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Baltimore</city>
        <state>Maryland</state>
        <zip>21205</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Lutherville</city>
        <state>Maryland</state>
        <zip>21093</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02129</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Detroit</city>
        <state>Michigan</state>
        <zip>48202</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Saint Louis</city>
        <state>Missouri</state>
        <zip>63104</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Santa Fe</city>
        <state>New Mexico</state>
        <zip>87505</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>Great Neck</city>
        <state>New York</state>
        <zip>11021</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>New York</city>
        <state>New York</state>
        <zip>10029</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Asheville</city>
        <state>North Carolina</state>
        <zip>28801</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>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Pittsburgh</city>
        <state>Pennsylvania</state>
        <zip>15240</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Providence</city>
        <state>Rhode Island</state>
        <zip>02905</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Germantown</city>
        <state>Tennessee</state>
        <zip>38138</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Nashville</city>
        <state>Tennessee</state>
        <zip>37211</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Arlington</city>
        <state>Texas</state>
        <zip>76012</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>San Antonio</city>
        <state>Texas</state>
        <zip>78215</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Norfolk</city>
        <state>Virginia</state>
        <zip>23502</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Richmond</city>
        <state>Virginia</state>
        <zip>23226</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Richmond</city>
        <state>Virginia</state>
        <zip>23298</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>San Juan</city>
        <zip>00909</zip>
        <country>Puerto Rico</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Puerto Rico</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>Sulkowski, MS., Brau N., Lawitz E., Shiffman ML, Towner WL, Ruane PJ et al. A Randomized Controlled Trial of Sofosbuvir/GS-5816 Fixed Dose Combination for 12 Weeks Compared to Sofosbuvir with Ribavirin for 12 Weeks in Genotype 2 HCV Infected Patients: The Phase 3 ASTRAL-2 Study [Oral 205] Hepatology 2015; 62: 1 (SUPPL) 313A.</citation>
  </results_reference>
  <results_reference>
    <citation>Foster GR, Afdhal N, Roberts SK, Brau N, Gane EJ, Pianko S, Lawitz E, Thompson A, Shiffman ML, Cooper C, Towner WJ, Conway B, Ruane P, Bourliere M, Asselah T, Berg T, Zeuzem S, Rosenberg W, Agarwal K, Stedman CA, Mo H, Dvory-Sobol H, Han L, Wang J, McNally J, Osinusi A, Brainard DM, McHutchison JG, Mazzotta F, Tran TT, Gordon SC, Patel K, Reau N, Mangia A, Sulkowski M; ASTRAL-2 Investigators; ASTRAL-3 Investigators. Sofosbuvir and Velpatasvir for HCV Genotype 2 and 3 Infection. N Engl J Med. 2015 Dec 31;373(27):2608-17. doi: 10.1056/NEJMoa1512612. Epub 2015 Nov 17.</citation>
    <PMID>26575258</PMID>
  </results_reference>
  <verification_date>September 2016</verification_date>
  <study_first_submitted>August 18, 2014</study_first_submitted>
  <study_first_submitted_qc>August 18, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 20, 2014</study_first_posted>
  <results_first_submitted>July 27, 2016</results_first_submitted>
  <results_first_submitted_qc>September 26, 2016</results_first_submitted_qc>
  <results_first_posted type="Estimate">November 15, 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>Hepatitis C</keyword>
  <keyword>HCV</keyword>
  <keyword>cirrhosis</keyword>
  <keyword>Sofosbuvir</keyword>
  <keyword>Sovaldi</keyword>
  <keyword>SOF/VEL</keyword>
  <keyword>GS-5816</keyword>
  <keyword>GS-7977</keyword>
  <keyword>liver</keyword>
  <keyword>Treatment naive</keyword>
  <keyword>Treatment Experience</keyword>
  <keyword>genotype 2</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Infections</mesh_term>
    <mesh_term>Communicable Diseases</mesh_term>
    <mesh_term>Hepatitis C</mesh_term>
    <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>
  </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. The first participant was screened on 22 September 2014. The last study visit occurred on 03 September 2015.</recruitment_details>
      <pre_assignment_details>317 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>SOF+RBV</title>
          <description>Sofosbuvir (SOF) 400 mg tablet administered orally once daily + ribavirin (RBV) tablets (1000 or 1200 mg daily based on weight) 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="135"/>
                <participants group_id="P2" count="134"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="128"/>
                <participants group_id="P2" count="123"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="7"/>
                <participants group_id="P2" count="11"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Randomized but Never Treated</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Death</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <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="0"/>
                <participants group_id="P2" count="5"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
                <participants group_id="P2" count="4"/>
              </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>SOF+RBV</title>
          <description>SOF 400 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) 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="134"/>
            <count group_id="B2" value="132"/>
            <count group_id="B3" value="266"/>
          </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="57" spread="10.6"/>
                    <measurement group_id="B2" value="57" spread="9.3"/>
                    <measurement group_id="B3" value="57" spread="10.0"/>
                  </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="48"/>
                    <measurement group_id="B2" value="60"/>
                    <measurement group_id="B3" value="108"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="86"/>
                    <measurement group_id="B2" value="72"/>
                    <measurement group_id="B3" value="158"/>
                  </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="26"/>
                    <measurement group_id="B2" value="23"/>
                    <measurement group_id="B3" value="49"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="104"/>
                    <measurement group_id="B2" value="107"/>
                    <measurement group_id="B3" value="211"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="6"/>
                  </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="6"/>
                    <measurement group_id="B2" value="12"/>
                    <measurement group_id="B3" value="18"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>White</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="124"/>
                    <measurement group_id="B2" value="111"/>
                    <measurement group_id="B3" value="235"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Asian</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Native Hawaiian or Pacific Islander</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Other</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Not Disclosed</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="3"/>
                  </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="19"/>
                    <measurement group_id="B2" value="19"/>
                    <measurement group_id="B3" value="38"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Absent</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="115"/>
                    <measurement group_id="B2" value="112"/>
                    <measurement group_id="B3" value="227"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Missing</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="1"/>
                  </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="55"/>
                    <measurement group_id="B2" value="46"/>
                    <measurement group_id="B3" value="101"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>CT</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="61"/>
                    <measurement group_id="B2" value="64"/>
                    <measurement group_id="B3" value="125"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>TT</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="18"/>
                    <measurement group_id="B2" value="22"/>
                    <measurement group_id="B3" value="40"/>
                  </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="6.5" spread="0.78"/>
                    <measurement group_id="B2" value="6.4" spread="0.74"/>
                    <measurement group_id="B3" value="6.4" spread="0.76"/>
                  </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="23"/>
                    <measurement group_id="B2" value="31"/>
                    <measurement group_id="B3" value="54"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>≥ 800,000 IU/mL</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="111"/>
                    <measurement group_id="B2" value="101"/>
                    <measurement group_id="B3" value="212"/>
                  </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>SOF+RBV</title>
            <description>SOF 400 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) 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="134"/>
                <count group_id="O2" value="132"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="99.3" lower_limit="95.9" upper_limit="100.0"/>
                    <measurement group_id="O2" value="93.9" lower_limit="88.4" upper_limit="97.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Non-Inferiority or Equivalence</non_inferiority_type>
            <non_inferiority_desc>A sample size of 120 per treatment group provided 90% power to establish non-inferiority in the SVR12 rates between the SOF/VEL group and the SOF+RBV group. It was based on the assumptions that the non-inferiority margin is 10%, both groups have a SVR12 rate of 94%, and the significance level is 0.025 one-sided.</non_inferiority_desc>
            <param_type>Difference in proportions</param_type>
            <param_value>5.2</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.2</ci_lower_limit>
            <ci_upper_limit>10.3</ci_upper_limit>
            <estimate_desc>Difference in proportions between treatment groups and associated 95% confidence intervals (CI) are calculated based on stratum-adjusted Mantel-Haenszel proportions.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>The superiority of SOF/VEL for 12 weeks over SOF+RBV for 12 weeks was to be tested if the efficacy of SOF/VEL for 12 weeks was demonstrated to be statistically noninferior to SOF+RBV for 12 weeks (ie, if the lower bound of the 95% CI for the strata-adjusted difference in the proportions between groups was greater than the prespecified noninferiority margin of -10%).</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.018</p_value>
            <p_value_desc>P-value was stratified by cirrhosis status and prior treatment experience.</p_value_desc>
            <method>Cochran-Mantel-Haenszel</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>SOF+RBV</title>
            <description>SOF 400 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) 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="134"/>
                <count group_id="O2" value="132"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.7"/>
                    <measurement group_id="O2" value="0"/>
                  </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>SOF+RBV</title>
            <description>SOF 400 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) 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="134"/>
                <count group_id="O2" value="132"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>SVR4</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="99.3" lower_limit="95.9" upper_limit="100.0"/>
                    <measurement group_id="O2" value="96.2" lower_limit="91.4" upper_limit="98.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>SVR24</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="99.3" lower_limit="95.9" upper_limit="100.0"/>
                    <measurement group_id="O2" value="93.9" lower_limit="88.4" upper_limit="97.3"/>
                  </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>
        <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>SOF+RBV</title>
            <description>SOF 400 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) 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>
          <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="134"/>
                <count group_id="O2" value="132"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 1 (SOF/VEL: N = 133; SOF+RBV: N = 132)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12.8" lower_limit="7.6" upper_limit="19.7"/>
                    <measurement group_id="O2" value="22.7" lower_limit="15.9" upper_limit="30.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 2 (SOF/VEL: N = 133; SOF+RBV: N = 132)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="57.1" lower_limit="48.3" upper_limit="65.7"/>
                    <measurement group_id="O2" value="59.8" lower_limit="51.0" upper_limit="68.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 4 (SOF/VEL: N = 133; SOF+RBV: N = 132)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="90.2" lower_limit="83.9" upper_limit="94.7"/>
                    <measurement group_id="O2" value="90.2" lower_limit="83.7" upper_limit="94.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 6 (SOF/VEL: N = 133; SOF+RBV: N = 132)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="97.7" lower_limit="93.5" upper_limit="99.5"/>
                    <measurement group_id="O2" value="99.2" lower_limit="95.9" upper_limit="100.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 8 (SOF/VEL: N = 133; SOF+RBV: N = 132)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="100.0" lower_limit="97.3" upper_limit="100.0"/>
                    <measurement group_id="O2" value="100.0" lower_limit="97.2" upper_limit="100.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 10 (SOF/VEL: N = 133; SOF+RBV: N = 132)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="100.0" lower_limit="97.3" upper_limit="100.0"/>
                    <measurement group_id="O2" value="100.0" lower_limit="97.2" upper_limit="100.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 12 (SOF/VEL: N = 133; SOF+RBV: N = 131)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="100.0" lower_limit="97.3" upper_limit="100.0"/>
                    <measurement group_id="O2" value="100.0" lower_limit="97.2" 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 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>SOF+RBV</title>
            <description>SOF 400 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) 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="134"/>
                <count group_id="O2" value="132"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Change at Wk 1 (SOF/VEL: N= 132; SOF+RBV: N= 131)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-4.51" spread="0.666"/>
                    <measurement group_id="O2" value="-4.51" spread="0.553"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Wk 2 (SOF/VEL: N= 132; SOF+RBV: N= 131)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-5.08" spread="0.761"/>
                    <measurement group_id="O2" value="-5.04" spread="0.701"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Wk 4 (SOF/VEL: N= 132; SOF+RBV: N= 131)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-5.29" spread="0.781"/>
                    <measurement group_id="O2" value="-5.24" spread="0.755"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Wk 6 (SOF/VEL: N= 133; SOF+RBV: N= 131)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-5.31" spread="0.781"/>
                    <measurement group_id="O2" value="-5.27" spread="0.741"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Wk 8 (SOF/VEL: N= 133; SOF+RBV: N= 132)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-5.32" spread="0.782"/>
                    <measurement group_id="O2" value="-5.27" spread="0.739"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Wk 10 (SOF/VEL: N= 133; SOF+RBV: N= 132)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-5.32" spread="0.782"/>
                    <measurement group_id="O2" value="-5.27" spread="0.739"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Wk 12 (SOF/VEL: N= 133; SOF+RBV: N= 131)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-5.32" spread="0.782"/>
                    <measurement group_id="O2" value="-5.26" spread="0.737"/>
                  </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>SOF+RBV</title>
            <description>SOF 400 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) 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="134"/>
                <count group_id="O2" value="132"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="4.5"/>
                  </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>SOF+RBV</title>
          <description>SOF 400 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA 18.0</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="2" subjects_at_risk="134"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="132"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Abdominal pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="134"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="132"/>
              </event>
              <event>
                <sub_title>Enteritis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="134"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="132"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Pneumonia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="134"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="132"/>
              </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="0" subjects_at_risk="134"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="132"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Depression</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="134"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="132"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedDRA 18.0</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="69" subjects_at_risk="134"/>
                <counts group_id="E2" subjects_affected="84" subjects_at_risk="132"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Anaemia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="134"/>
                <counts group_id="E2" subjects_affected="8" subjects_at_risk="132"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Abdominal pain</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="134"/>
                <counts group_id="E2" subjects_affected="7" subjects_at_risk="132"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" subjects_affected="14" subjects_at_risk="134"/>
                <counts group_id="E2" subjects_affected="20" subjects_at_risk="132"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="134"/>
                <counts group_id="E2" subjects_affected="8" subjects_at_risk="132"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Fatigue</sub_title>
                <counts group_id="E1" subjects_affected="20" subjects_at_risk="134"/>
                <counts group_id="E2" subjects_affected="47" subjects_at_risk="132"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Nasopharyngitis</sub_title>
                <counts group_id="E1" subjects_affected="8" subjects_at_risk="134"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="132"/>
              </event>
              <event>
                <sub_title>Sinusitis</sub_title>
                <counts group_id="E1" subjects_affected="7" subjects_at_risk="134"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="132"/>
              </event>
              <event>
                <sub_title>Upper respiratory tract infection</sub_title>
                <counts group_id="E1" subjects_affected="8" subjects_at_risk="134"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="132"/>
              </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="6" subjects_at_risk="134"/>
                <counts group_id="E2" subjects_affected="8" subjects_at_risk="132"/>
              </event>
              <event>
                <sub_title>Back pain</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="134"/>
                <counts group_id="E2" subjects_affected="7" subjects_at_risk="132"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Dizziness</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="134"/>
                <counts group_id="E2" subjects_affected="8" subjects_at_risk="132"/>
              </event>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" subjects_affected="24" subjects_at_risk="134"/>
                <counts group_id="E2" subjects_affected="29" subjects_at_risk="132"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Anxiety</sub_title>
                <counts group_id="E1" subjects_affected="8" subjects_at_risk="134"/>
                <counts group_id="E2" subjects_affected="8" subjects_at_risk="132"/>
              </event>
              <event>
                <sub_title>Insomnia</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="134"/>
                <counts group_id="E2" subjects_affected="19" subjects_at_risk="132"/>
              </event>
              <event>
                <sub_title>Irritability</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="134"/>
                <counts group_id="E2" subjects_affected="9" subjects_at_risk="132"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Pruritus</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="134"/>
                <counts group_id="E2" subjects_affected="7" subjects_at_risk="132"/>
              </event>
              <event>
                <sub_title>Rash</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="134"/>
                <counts group_id="E2" subjects_affected="7" subjects_at_risk="132"/>
              </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/NCT02220998
org study id: GS-US-342-1139
nct id: NCT02220998
lead sponsor: 
has dmc: Yes
The primary objectives of this study are to evaluate the efficacy, safety, and tolerability
      of treatment with sofosbuvir/velpatasvir (SOF/VEL) fixed-dose combination (FDC) for 12 weeks
      compared to treatment with sofosbuvir (SOF) plus ribavirin (RBV) for 12 weeks in participants
      with chronic genotype 2 hepatitis C virus (HCV) infection.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
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 FDC for 12 weeks
arm group label: SOF+RBV
arm group type: Experimental
description: SOF+RBV for 12 weeks
intervention type: Drug
intervention name: SOF/VEL
description: SOF/VEL (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: SOF
description: SOF 400 mg tablet administered orally once daily
arm group label: SOF+RBV
other name: Sovaldi®
other name: GS-7977
other name: PSI-7977
intervention type: Drug
intervention name: RBV
description: RBV tablets administered orally in a divided daily dose according to package insert weight-based dosing recommendations (< 75 kg = 1000 mg and ≥ 75 kg = 1200 mg)
arm group label: SOF+RBV
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Anu Osinusi, MD
role: Study Director
affiliation: Gilead Sciences
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country: Puerto Rico
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: Sulkowski, MS., Brau N., Lawitz E., Shiffman ML, Towner WL, Ruane PJ et al. A Randomized Controlled Trial of Sofosbuvir/GS-5816 Fixed Dose Combination for 12 Weeks Compared to Sofosbuvir with Ribavirin for 12 Weeks in Genotype 2 HCV Infected Patients: The Phase 3 ASTRAL-2 Study [Oral 205] Hepatology 2015; 62: 1 (SUPPL) 313A.
citation: Foster GR, Afdhal N, Roberts SK, Brau N, Gane EJ, Pianko S, Lawitz E, Thompson A, Shiffman ML, Cooper C, Towner WJ, Conway B, Ruane P, Bourliere M, Asselah T, Berg T, Zeuzem S, Rosenberg W, Agarwal K, Stedman CA, Mo H, Dvory-Sobol H, Han L, Wang J, McNally J, Osinusi A, Brainard DM, McHutchison JG, Mazzotta F, Tran TT, Gordon SC, Patel K, Reau N, Mangia A, Sulkowski M; ASTRAL-2 Investigators; ASTRAL-3 Investigators. Sofosbuvir and Velpatasvir for HCV Genotype 2 and 3 Infection. N Engl J Med. 2015 Dec 31;373(27):2608-17. doi: 10.1056/NEJMoa1512612. Epub 2015 Nov 17.
PMID: 26575258
responsible party type: Sponsor
mesh term: Infections
mesh term: Communicable Diseases
mesh term: Hepatitis C
mesh term: Hepatitis
mesh term: Sofosbuvir
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: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 