<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/NCT02201901</url>
  </required_header>
  <id_info>
    <org_study_id>GS-US-342-1137</org_study_id>
    <nct_id>NCT02201901</nct_id>
  </id_info>
  <brief_title>Sofosbuvir/Velpatasvir Fixed-Dose Combination in Adults With Chronic HCV Infection and Child-Pugh Class B Cirrhosis</brief_title>
  <acronym>ASTRAL-4</acronym>
  <official_title>A Phase 3, Multicenter, Open-Label Study to Investigate the Efficacy and Safety of Sofosbuvir/GS-5816 Fixed-Dose Combination in Subjects With Chronic HCV Infection and Child-Pugh Class B Cirrhosis</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 (SOF)/velpatasvir (VEL) fixed dose combination (FDC) with and without ribavirin&#xD;
      (RBV) for 12 weeks and SOF/VEL FDC for 24 weeks in adults with chronic hepatitis C virus&#xD;
      (HCV) infection and Child-Pugh-Turcotte (CPT) class B cirrhosis.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>July 2014</start_date>
  <completion_date type="Actual">November 2015</completion_date>
  <primary_completion_date type="Actual">August 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) 12 weeks following the last dose of study drug.</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 24 weeks plus 30 days</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With Sustained Virologic Response 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)</measure>
    <time_frame>Posttreatment Weeks 4 and 24</time_frame>
    <description>SVR4 and SVR24 were defined as HCV RNA &lt; LLOQ at 4 and 24 weeks following the last dose of study drug, respectively.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With HCV RNA &lt; LLOQ at Weeks 1, 2, 4, 6, 8, 10, 12, 16, 20, and 24</measure>
    <time_frame>Weeks 1, 2, 4, 6, 8, 10, 12, 16, 20, and 24</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in HCV RNA at Weeks 1, 2, 4, 6, 8, 10, 12, 16, 20, and 24</measure>
    <time_frame>Baseline; Weeks 1, 2, 4, 6, 8, 10, 12, 16, 20, and 24</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;
HCV RNA ≥ LLOQ after having previously had HCV RNA &lt; LLOQ, while on treatment,&#xD;
&gt; 1 log10 IU/mL increase in HCV RNA from nadir while on treatment,&#xD;
HCV RNA persistently ≥ LLOQ through 8 weeks of treatment (ie nonresponse)&#xD;
Relapse&#xD;
HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA &lt; LLOQ at end of treatment, confirmed with 2 consecutive values or last available posttreatment measurement</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With a Decrease, No Change, or Increase Between Baseline and Posttreatment Week 24 in MELD Score</measure>
    <time_frame>Baseline to Posttreatment Week 24</time_frame>
    <description>Model for End-Stage Liver Disease (MELD) scores are used to assess prognosis and suitability for liver transplantation. Scores can range from 6 to 40; higher scores/increased scores indicate greater severity of disease.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With a Decrease, No Change, or Increase Between Baseline and Posttreatment Week 24 in Child-Pugh-Turcotte (CPT) Score</measure>
    <time_frame>Baseline to Posttreatment Week 24</time_frame>
    <description>CPT scores grade the severity of cirrhosis and are used to determine the need for liver transplantation. Scores can range from 5 to 15; higher scores/increased scores indicate greater severity of disease.</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">268</enrollment>
  <condition>Hepatitis C Virus Infection</condition>
  <arm_group>
    <arm_group_label>SOF/VEL 12 weeks</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will receive SOF/VEL FDC for 12 weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>SOF/VEL+RBV 12 weeks</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will receive SOF/VEL FDC plus RBV for 12 weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>SOF/VEL 24 weeks</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will receive SOF/VEL FDC for 24 weeks.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>SOF/VEL</intervention_name>
    <description>400/100 mg tablets administered orally once daily</description>
    <arm_group_label>SOF/VEL 12 weeks</arm_group_label>
    <arm_group_label>SOF/VEL 24 weeks</arm_group_label>
    <arm_group_label>SOF/VEL+RBV 12 weeks</arm_group_label>
    <other_name>GS-7977/GS-5816</other_name>
    <other_name>Epclusa®</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>RBV</intervention_name>
    <description>Ribavirin (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/VEL+RBV 12 weeks</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Willing and able to provide written informed consent&#xD;
&#xD;
          -  HCV RNA &gt; 10^4 IU/mL at screening&#xD;
&#xD;
          -  Chronic HCV infection (≥ 6 months)&#xD;
&#xD;
          -  Confirmed CPT class B (7-9) at screening&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Current or prior history of solid organ transplantation, significant pulmonary&#xD;
             disease, significant cardiac disease, or porphyria&#xD;
&#xD;
          -  Inability to exclude hepatocellular carcinoma (HCC) by imaging within 6 months of&#xD;
             baseline/Day 1&#xD;
&#xD;
          -  Infection with hepatitis B virus (HBV) or human immunodeficiency virus (HIV)&#xD;
&#xD;
          -  Screening ECG with clinically significant abnormalities&#xD;
&#xD;
          -  Prior exposure to SOF or any other nucleotide analogue HCV nonstructural protein 5B&#xD;
             (NS5B) inhibitor or any HCV NS5A inhibitor&#xD;
&#xD;
          -  Laboratory results outside of acceptable ranges at screening&#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 M Osinusi, MD, MPH</last_name>
    <role>Study Director</role>
    <affiliation>Gilead Sciences</affiliation>
  </overall_official>
  <location>
    <facility>
      <address>
        <city>Phoenix</city>
        <state>Arizona</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>La Jolla</city>
        <state>California</state>
        <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>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Pasadena</city>
        <state>California</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>San Francisco</city>
        <state>California</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Aurora</city>
        <state>Colorado</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Washington</city>
        <state>District of Columbia</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Gainesville</city>
        <state>Florida</state>
        <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>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Tampa</city>
        <state>Florida</state>
        <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>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Indianapolis</city>
        <state>Indiana</state>
        <zip>46202</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>Kansas City</city>
        <state>Kansas</state>
        <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>New Orleans</city>
        <state>Louisiana</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Baltimore</city>
        <state>Maryland</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Ann Arbor</city>
        <state>Michigan</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Detroit</city>
        <state>Michigan</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Rochester</city>
        <state>Minnesota</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Jackson</city>
        <state>Mississippi</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Saint Louis</city>
        <state>Missouri</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Santa Fe</city>
        <state>New Mexico</state>
        <zip>87505</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10016</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>New York</city>
        <state>New York</state>
        <zip>10032</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Chapel Hill</city>
        <state>North Carolina</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Charlotte</city>
        <state>North Carolina</state>
        <zip>28204</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Durham</city>
        <state>North Carolina</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Cleveland</city>
        <state>Ohio</state>
        <zip>44195</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Cleveland</city>
        <state>Ohio</state>
        <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>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19107</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Pittsburgh</city>
        <state>Pennsylvania</state>
        <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>Dallas</city>
        <state>Texas</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>San Antonio</city>
        <state>Texas</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Murray</city>
        <state>Utah</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Fairfax</city>
        <state>Virginia</state>
        <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>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Seattle</city>
        <state>Washington</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>San Juan</city>
        <zip>00927</zip>
        <country>Puerto Rico</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Puerto Rico</country>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Charlton MR, O'Leary JG, Bzowej NH, Muir AJ, Korenblat KM, Fenkel JM, et al. Sofosbuvir/Velapatasvir Fixed Dose Combination for the Treatment of HCV in Patients with Decompensated Liver Disease: The Phase 3 ASTRAL-4 Study. Hepatology 2015; 62 (6): 1387A-1388A.</citation>
  </reference>
  <results_reference>
    <citation>Curry MP, O'Leary JG, Bzowej N, Muir AJ, Korenblat KM, Fenkel JM, Reddy KR, Lawitz E, Flamm SL, Schiano T, Teperman L, Fontana R, Schiff E, Fried M, Doehle B, An D, McNally J, Osinusi A, Brainard DM, McHutchison JG, Brown RS Jr, Charlton M; ASTRAL-4 Investigators. Sofosbuvir and Velpatasvir for HCV in Patients with Decompensated Cirrhosis. N Engl J Med. 2015 Dec 31;373(27):2618-28. doi: 10.1056/NEJMoa1512614. Epub 2015 Nov 16.</citation>
    <PMID>26569658</PMID>
  </results_reference>
  <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>
  <verification_date>October 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>August 24, 2016</results_first_submitted>
  <results_first_submitted_qc>October 24, 2016</results_first_submitted_qc>
  <results_first_posted type="Estimate">December 14, 2016</results_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>Velpatasvir</keyword>
  <keyword>SOF/VEL</keyword>
  <keyword>GS-5816</keyword>
  <keyword>Hepatitis C</keyword>
  <keyword>HCV</keyword>
  <keyword>Cirrhosis</keyword>
  <keyword>CPT-B</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>
    <mesh_term>Fibrosis</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 a total of 47 study sites in the United States. The first participant was screened on 31 July 2014. The last study visit occurred on 25 November 2015.</recruitment_details>
      <pre_assignment_details>438 participants were screened.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>SOF/VEL 12 Weeks (Group 1)</title>
          <description>SOF/VEL (Sofosbuvir/velpatasvir) (400/100 mg) fixed dose combination (FDC) tablet once daily for 12 weeks</description>
        </group>
        <group group_id="P2">
          <title>SOF/VEL+RBV 12 Weeks (Group 2)</title>
          <description>SOF/VEL (400/100 mg) FDC tablet + Ribavirin (RBV) tablets (1000 or 1200 mg/day divided twice daily) administered orally once daily for 12 weeks</description>
        </group>
        <group group_id="P3">
          <title>SOF/VEL 24 Weeks (Group 3)</title>
          <description>SOF/VEL (400/100 mg) FDC tablet once daily for 24 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="90"/>
                <participants group_id="P2" count="88"/>
                <participants group_id="P3" count="90"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="75"/>
                <participants group_id="P2" count="79"/>
                <participants group_id="P3" count="77"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="15"/>
                <participants group_id="P2" count="9"/>
                <participants group_id="P3" count="13"/>
              </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="0"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lack of Efficacy</title>
              <participants_list>
                <participants group_id="P1" count="7"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="6"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Death</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="3"/>
                <participants group_id="P3" count="3"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="3"/>
                <participants group_id="P3" count="2"/>
              </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="0"/>
                <participants group_id="P3" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug.</population>
      <group_list>
        <group group_id="B1">
          <title>SOF/VEL 12 Weeks (Group 1)</title>
          <description>SOF/VEL (Sofosbuvir/velpatasvir) (400/100 mg) fixed dose combination (FDC) tablet once daily for 12 weeks</description>
        </group>
        <group group_id="B2">
          <title>SOF/VEL+RBV 12 Weeks (Group 2)</title>
          <description>SOF/VEL (400/100 mg) FDC tablet + Ribavirin (RBV) tablets (1000 or 1200 mg/day divided twice daily) administered orally once daily for 12 weeks</description>
        </group>
        <group group_id="B3">
          <title>SOF/VEL 24 Weeks ((Group 3)</title>
          <description>SOF/VEL (400/100 mg) FDC tablet once daily for 24 weeks</description>
        </group>
        <group group_id="B4">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="90"/>
            <count group_id="B2" value="87"/>
            <count group_id="B3" value="90"/>
            <count group_id="B4" value="267"/>
          </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="58" spread="6.3"/>
                    <measurement group_id="B2" value="58" spread="6.9"/>
                    <measurement group_id="B3" value="58" spread="5.8"/>
                    <measurement group_id="B4" value="58" spread="6.3"/>
                  </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="33"/>
                    <measurement group_id="B2" value="21"/>
                    <measurement group_id="B3" value="27"/>
                    <measurement group_id="B4" value="81"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="57"/>
                    <measurement group_id="B2" value="66"/>
                    <measurement group_id="B3" value="63"/>
                    <measurement group_id="B4" value="186"/>
                  </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="13"/>
                    <measurement group_id="B2" value="13"/>
                    <measurement group_id="B3" value="13"/>
                    <measurement group_id="B4" value="39"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="77"/>
                    <measurement group_id="B2" value="74"/>
                    <measurement group_id="B3" value="77"/>
                    <measurement group_id="B4" value="228"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                  </measurement_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="5"/>
                    <measurement group_id="B3" value="6"/>
                    <measurement group_id="B4" value="17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>White</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="79"/>
                    <measurement group_id="B2" value="79"/>
                    <measurement group_id="B3" value="81"/>
                    <measurement group_id="B4" value="239"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Asian</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="2"/>
                    <measurement group_id="B4" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>American Indian or Alaska Native</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="1"/>
                  </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="0"/>
                    <measurement group_id="B4" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Other</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Not Disclosed</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="1"/>
                  </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="31"/>
                    <measurement group_id="B2" value="42"/>
                    <measurement group_id="B3" value="45"/>
                    <measurement group_id="B4" value="118"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>≥ 800,000 IU/mL</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="59"/>
                    <measurement group_id="B2" value="45"/>
                    <measurement group_id="B3" value="45"/>
                    <measurement group_id="B4" value="149"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>HCV RNA</title>
          <units>log 10 IU/mL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="6.0" spread="0.54"/>
                    <measurement group_id="B2" value="5.8" spread="0.61"/>
                    <measurement group_id="B3" value="5.9" spread="0.63"/>
                    <measurement group_id="B4" value="5.9" spread="0.60"/>
                  </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="68"/>
                    <measurement group_id="B2" value="68"/>
                    <measurement group_id="B3" value="71"/>
                    <measurement group_id="B4" value="207"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Genotype 2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="4"/>
                    <measurement group_id="B4" value="12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Genotype 3</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="14"/>
                    <measurement group_id="B2" value="13"/>
                    <measurement group_id="B3" value="12"/>
                    <measurement group_id="B4" value="39"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Genotype 4</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="2"/>
                    <measurement group_id="B4" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Genotype 6</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>IL28B</title>
          <description>The 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="20"/>
                    <measurement group_id="B2" value="22"/>
                    <measurement group_id="B3" value="20"/>
                    <measurement group_id="B4" value="62"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>CT</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="51"/>
                    <measurement group_id="B2" value="46"/>
                    <measurement group_id="B3" value="49"/>
                    <measurement group_id="B4" value="146"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>TT</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="19"/>
                    <measurement group_id="B2" value="19"/>
                    <measurement group_id="B3" value="19"/>
                    <measurement group_id="B4" value="57"/>
                  </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="0"/>
                    <measurement group_id="B3" value="2"/>
                    <measurement group_id="B4" value="2"/>
                  </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) 12 weeks following the last dose of study drug.</description>
        <time_frame>Posttreatment Week 12</time_frame>
        <population>The Full Analysis Set (FAS): participants who were randomized into the study and received at least 1 dose of study drug.</population>
        <group_list>
          <group group_id="O1">
            <title>SOF/VEL 12 Weeks (Group 1)</title>
            <description>SOF/VEL (400/100 mg) FDC tablet once daily for 12 weeks</description>
          </group>
          <group group_id="O2">
            <title>SOF/VEL+RBV 12 Weeks (Group 2)</title>
            <description>SOF/VEL (400/100 mg) FDC tablet + RBV tablets (1000 or 1200 mg/day divided twice daily) administered orally once daily for 12 weeks</description>
          </group>
          <group group_id="O3">
            <title>SOF/VEL 24 Weeks (Group 3)</title>
            <description>SOF/VEL (400/100 mg) FDC tablet once daily for 24 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) 12 weeks following the last dose of study drug.</description>
          <population>The Full Analysis Set (FAS): participants who were randomized 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="90"/>
                <count group_id="O2" value="87"/>
                <count group_id="O3" value="90"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="83.3" lower_limit="74.0" upper_limit="90.4"/>
                    <measurement group_id="O2" value="94.3" lower_limit="87.1" upper_limit="98.1"/>
                    <measurement group_id="O3" value="87.8" lower_limit="79.2" upper_limit="93.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <groups_desc>A sample size of 75 participants per treatment group would provide over 99% power to detect 40% improvement in SVR12 rate from the assumed spontaneous rate of 1% or less using a 2-sided exact 1-sample binomial test at significance level of 0.0167.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>Binomial test</method>
            <method_desc>P-value is from the 2-sided exact 1-sample binomial test for the superiority of SOF/VEL 12 weeks (Group 1) over prespecified rate of 1% .</method_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>A sample size of 75 participants per treatment group would provide over 99% power to detect 40% improvement in SVR12 rate from the assumed spontaneous rate of 1% or less using a 2-sided exact 1-sample binomial test at significance level of 0.0167.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>Binomial test</method>
            <method_desc>P-value is from the 2-sided exact 1-sample binomial test for the superiority of SOF/VEL+RBV 12 weeks (Group 2) over prespecified rate of 1%.</method_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>A sample size of 75 participants per treatment group would provide over 99% power to detect 40% improvement in SVR12 rate from the assumed spontaneous rate of 1% or less using a 2-sided exact 1-sample binomial test at significance level of 0.0167.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>Binomial test</method>
            <method_desc>P-value is from the 2-sided exact 1-sample binomial test for the superiority of SOF/VEL 24 weeks (Group 3) over prespecified rate of 1%.</method_desc>
          </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 24 weeks plus 30 days</time_frame>
        <population>Safety Analysis Set</population>
        <group_list>
          <group group_id="O1">
            <title>SOF/VEL 12 Weeks (Group 1)</title>
            <description>SOF/VEL (400/100 mg) FDC tablet once daily for 12 weeks</description>
          </group>
          <group group_id="O2">
            <title>SOF/VEL+RBV 12 Weeks (Group 2)</title>
            <description>SOF/VEL (400/100 mg) FDC tablet + RBV tablets (1000 or 1200 mg/day divided twice daily) administered orally once daily for 12 weeks</description>
          </group>
          <group group_id="O3">
            <title>SOF/VEL 24 Weeks (Group 3)</title>
            <description>SOF/VEL (400/100 mg) FDC tablet once daily for 24 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="90"/>
                <count group_id="O2" value="87"/>
                <count group_id="O3" value="90"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.1"/>
                    <measurement group_id="O2" value="16.1"/>
                    <measurement group_id="O3" value="4.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With Sustained Virologic Response 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)</title>
        <description>SVR4 and SVR24 were defined as HCV RNA &lt; LLOQ at 4 and 24 weeks following the last dose of study drug, 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 12 Weeks (Group 1)</title>
            <description>SOF/VEL (400/100 mg) FDC tablet once daily for 12 weeks</description>
          </group>
          <group group_id="O2">
            <title>SOF/VEL+RBV 12 Weeks (Group 2)</title>
            <description>SOF/VEL (400/100mg) FDC tablet + RBV tablets (1000 or 1200 mg/day divided twice daily) administered orally once daily for 12 weeks</description>
          </group>
          <group group_id="O3">
            <title>SOF/VEL 24 Weeks (Group 3)</title>
            <description>SOF/VEL (400/100 mg) FDC tablet once daily for 24 weeks</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Sustained Virologic Response 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)</title>
          <description>SVR4 and SVR24 were defined as HCV RNA &lt; LLOQ at 4 and 24 weeks following the last dose of study drug, 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="90"/>
                <count group_id="O2" value="87"/>
                <count group_id="O3" value="90"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>SVR4</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="92.2" lower_limit="84.6" upper_limit="96.8"/>
                    <measurement group_id="O2" value="95.4" lower_limit="88.6" upper_limit="98.7"/>
                    <measurement group_id="O3" value="90.0" lower_limit="81.9" upper_limit="95.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>SVR24</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="83.3" lower_limit="74.0" upper_limit="90.4"/>
                    <measurement group_id="O2" value="94.3" lower_limit="87.1" upper_limit="98.1"/>
                    <measurement group_id="O3" value="87.8" lower_limit="79.2" upper_limit="93.7"/>
                  </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, 12, 16, 20, and 24</title>
        <time_frame>Weeks 1, 2, 4, 6, 8, 10, 12, 16, 20, and 24</time_frame>
        <population>Participants in the Full Analysis Set with available data were analyzed.</population>
        <group_list>
          <group group_id="O1">
            <title>SOF/VEL 12 Weeks (Group 1)</title>
            <description>SOF/VEL (400/100 mg) FDC tablet once daily for 12 weeks</description>
          </group>
          <group group_id="O2">
            <title>SOF/VEL+RBV 12 Weeks (Group 2)</title>
            <description>SOF/VEL (400/100 mg) FDC tablet + RBV tablets (1000 or 1200 mg/day divided twice daily) administered orally once daily for 12 weeks</description>
          </group>
          <group group_id="O3">
            <title>SOF/VEL 24 Weeks (Group 3)</title>
            <description>SOF/VEL (400/100 mg) FDC tablet once daily for 24 weeks</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With HCV RNA &lt; LLOQ at Weeks 1, 2, 4, 6, 8, 10, 12, 16, 20, and 24</title>
          <population>Participants in the Full Analysis Set with available data were analyzed.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="90"/>
                <count group_id="O2" value="87"/>
                <count group_id="O3" value="90"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Wk 1(Group 1: N=90; Group 2: N=87; Group 3: N=90)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.2"/>
                    <measurement group_id="O2" value="14.9"/>
                    <measurement group_id="O3" value="11.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Wk 2 (Group 1: N=90; Group 2: N=87;Group 3: N=89)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="34.4"/>
                    <measurement group_id="O2" value="49.4"/>
                    <measurement group_id="O3" value="39.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Wk 4 (Group 1: N=90; Group 2: N=87; Group 3: N=89)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="81.1"/>
                    <measurement group_id="O2" value="80.5"/>
                    <measurement group_id="O3" value="91.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Wk 6(Group 1: N=89; Group 2: N=85; Group 3: N=88)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="98.9"/>
                    <measurement group_id="O2" value="97.6"/>
                    <measurement group_id="O3" value="98.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Wk 8(Group 1: N=89; Group 2: N=84; Group 3: N=87)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="98.9"/>
                    <measurement group_id="O2" value="98.8"/>
                    <measurement group_id="O3" value="100.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Wk 10(Group 1: N=89; Group 2: N=84; Group 3: N=87)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="100.0"/>
                    <measurement group_id="O2" value="98.8"/>
                    <measurement group_id="O3" value="100.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Wk 12(Group 1: N=89; Group 2: N=83; Group 3: N=87)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="100.0"/>
                    <measurement group_id="O2" value="98.8"/>
                    <measurement group_id="O3" value="97.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Wk 16(Group 1: N=0; Group 2: N=0; Group 3: N=86)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="NA">Treatment for this group was only 12 weeks.</measurement>
                    <measurement group_id="O2" value="NA">Treatment for this group was only 12 weeks.</measurement>
                    <measurement group_id="O3" value="97.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Wk 20(Group 1: N=0; Group 2: N=0;Group 3: N=84)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="NA">Treatment for this group was only 12 weeks.</measurement>
                    <measurement group_id="O2" value="NA">Treatment for this group was only 12 weeks.</measurement>
                    <measurement group_id="O3" value="100.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Wk 24(Group 1: N=0; Group 2: N=0; Group 3: N=84)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="NA">Treatment for this group was only 12 weeks.</measurement>
                    <measurement group_id="O2" value="NA">Treatment for this group was only 12 weeks.</measurement>
                    <measurement group_id="O3" value="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, 12, 16, 20, and 24</title>
        <time_frame>Baseline; Weeks 1, 2, 4, 6, 8, 10, 12, 16, 20, and 24</time_frame>
        <population>Participants in the Full Analysis Set with available data were analyzed.</population>
        <group_list>
          <group group_id="O1">
            <title>SOF/VEL 12 Weeks (Group 1)</title>
            <description>SOF/VEL (400/100 mg) FDC tablet once daily for 12 weeks</description>
          </group>
          <group group_id="O2">
            <title>SOF/VEL+RBV 12 Weeks (Group 2)</title>
            <description>SOF/VEL (400/100 mg) FDC tablet + RBV tablets (1000 or 1200 mg/day divided twice daily) administered orally once daily for 12 weeks</description>
          </group>
          <group group_id="O3">
            <title>SOF/VEL 24 Weeks (Group 3)</title>
            <description>SOF/VEL (400/100 mg) FDC tablet once daily for 24 weeks</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in HCV RNA at Weeks 1, 2, 4, 6, 8, 10, 12, 16, 20, and 24</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="90"/>
                <count group_id="O2" value="87"/>
                <count group_id="O3" value="90"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Wk 1(Group 1: N=89; Group 2: N=83; Group 3: N=88)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-3.51" spread="0.652"/>
                    <measurement group_id="O2" value="-3.63" spread="0.691"/>
                    <measurement group_id="O3" value="-3.72" spread="0.680"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Wk 2(Group 1: N=89; Group 2: N=87; Group 3: N=88)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-4.24" spread="0.677"/>
                    <measurement group_id="O2" value="-4.17" spread="0.647"/>
                    <measurement group_id="O3" value="-4.38" spread="0.669"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Wk 4(Group 1: N=88; Group 2: N=86; Group 3: N=88)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-4.78" spread="0.549"/>
                    <measurement group_id="O2" value="-4.58" spread="0.568"/>
                    <measurement group_id="O3" value="-4.70" spread="0.613"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Wk 6(Group 1: N=89; Group 2: N=85; Group 3: N=88)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-4.87" spread="0.536"/>
                    <measurement group_id="O2" value="-4.68" spread="0.607"/>
                    <measurement group_id="O3" value="-4.74" spread="0.630"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Wk 8(Group 1: N=89; Group 2: N=83; Group 3: N=87)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-4.87" spread="0.536"/>
                    <measurement group_id="O2" value="-4.68" spread="0.622"/>
                    <measurement group_id="O3" value="-4.76" spread="0.613"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Wk 10(Group 1: N=89; Group 2: N=84; Group 3, N=87)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-4.87" spread="0.536"/>
                    <measurement group_id="O2" value="-4.67" spread="0.634"/>
                    <measurement group_id="O3" value="-4.76" spread="0.613"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Wk 12(Group 1: N=89; Group 2: N=82; Group 3: N=86)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-4.87" spread="0.536"/>
                    <measurement group_id="O2" value="-4.68" spread="0.624"/>
                    <measurement group_id="O3" value="-4.75" spread="0.618"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Wk 16 (Group 1: N=0; Group 2: N=0; Group 3: N=85)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="NA" spread="NA">Treatment for this group was 12 weeks only.</measurement>
                    <measurement group_id="O2" value="NA" spread="NA">Treatment for this group was 12 weeks only.</measurement>
                    <measurement group_id="O3" value="-4.76" spread="0.617"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Wk 20 (Group 1: N=0; Group 2: N=0; Group 3: N =84)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="NA" spread="NA">Treatment for this group was 12 weeks only.</measurement>
                    <measurement group_id="O2" value="NA" spread="NA">Treatment for this group was 12 weeks only.</measurement>
                    <measurement group_id="O3" value="-4.77" spread="0.613"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Wk 24 (Group 1: N=0; Group 2: N=0; Group 3: N =84)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="NA" spread="NA">Treatment for this group was 12 weeks only.</measurement>
                    <measurement group_id="O2" value="NA" spread="NA">Treatment for this group was 12 weeks only.</measurement>
                    <measurement group_id="O3" value="-4.77" spread="0.613"/>
                  </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;
HCV RNA ≥ LLOQ after having previously had HCV RNA &lt; LLOQ, while on treatment,&#xD;
&gt; 1 log10 IU/mL increase in HCV RNA from nadir while on treatment,&#xD;
HCV RNA persistently ≥ LLOQ through 8 weeks of treatment (ie nonresponse)&#xD;
Relapse&#xD;
HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA &lt; LLOQ at end of treatment, confirmed with 2 consecutive values or last available posttreatment measurement</description>
        <time_frame>Up to Posttreatment Week 24</time_frame>
        <population>Full Analysis Set</population>
        <group_list>
          <group group_id="O1">
            <title>SOF/VEL 12 Weeks (Group 1)</title>
            <description>SOF/VEL (400/100 mg) FDC tablet once daily for 12 weeks</description>
          </group>
          <group group_id="O2">
            <title>SOF/VEL+RBV 12 Weeks (Group 2)</title>
            <description>SOF/VEL (400/100 mg) FDC tablet + RBV tablets (1000 or 1200 mg/day divided twice daily) administered orally once daily for 12 weeks</description>
          </group>
          <group group_id="O3">
            <title>SOF/VEL 24 Weeks (Group 3)</title>
            <description>SOF/VEL (400/100 mg) FDC tablet once daily for 24 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;
HCV RNA ≥ LLOQ after having previously had HCV RNA &lt; LLOQ, while on treatment,&#xD;
&gt; 1 log10 IU/mL increase in HCV RNA from nadir while on treatment,&#xD;
HCV RNA persistently ≥ LLOQ through 8 weeks of treatment (ie nonresponse)&#xD;
Relapse&#xD;
HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA &lt; LLOQ at end of treatment, confirmed with 2 consecutive values or last available posttreatment measurement</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="90"/>
                <count group_id="O2" value="87"/>
                <count group_id="O3" value="90"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12.2" lower_limit="6.3" upper_limit="20.8"/>
                    <measurement group_id="O2" value="3.4" lower_limit="0.7" upper_limit="9.7"/>
                    <measurement group_id="O3" value="8.9" lower_limit="3.9" upper_limit="16.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With a Decrease, No Change, or Increase Between Baseline and Posttreatment Week 24 in MELD Score</title>
        <description>Model for End-Stage Liver Disease (MELD) scores are used to assess prognosis and suitability for liver transplantation. Scores can range from 6 to 40; higher scores/increased scores indicate greater severity of disease.</description>
        <time_frame>Baseline to Posttreatment Week 24</time_frame>
        <population>Participants in the Full Analysis Set with available data were analyzed.</population>
        <group_list>
          <group group_id="O1">
            <title>SOF/VEL 12 Weeks (Group 1)</title>
            <description>SOF/VEL (400/100 mg) FDC tablet once daily for 12 weeks</description>
          </group>
          <group group_id="O2">
            <title>SOF/VEL+RBV 12 Weeks (Group 2)</title>
            <description>SOF/VEL (400/100 mg) FDC tablet + RBV tablets (1000 or 1200 mg/day divided twice daily) administered orally once daily for 12 weeks</description>
          </group>
          <group group_id="O3">
            <title>SOF/VEL 24 Weeks (Group 3)</title>
            <description>SOF/VEL (400/100 mg) FDC tablet once daily for 24 weeks</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With a Decrease, No Change, or Increase Between Baseline and Posttreatment Week 24 in MELD Score</title>
          <description>Model for End-Stage Liver Disease (MELD) scores are used to assess prognosis and suitability for liver transplantation. Scores can range from 6 to 40; higher scores/increased scores indicate greater severity of disease.</description>
          <population>Participants in the Full Analysis Set with available data were analyzed.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="69"/>
                <count group_id="O2" value="75"/>
                <count group_id="O3" value="69"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Decrease (Improvement)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="55.1"/>
                    <measurement group_id="O2" value="49.3"/>
                    <measurement group_id="O3" value="50.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>No Change</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="20.3"/>
                    <measurement group_id="O2" value="25.3"/>
                    <measurement group_id="O3" value="21.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Increase (Worsening)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="24.6"/>
                    <measurement group_id="O2" value="25.3"/>
                    <measurement group_id="O3" value="27.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With a Decrease, No Change, or Increase Between Baseline and Posttreatment Week 24 in Child-Pugh-Turcotte (CPT) Score</title>
        <description>CPT scores grade the severity of cirrhosis and are used to determine the need for liver transplantation. Scores can range from 5 to 15; higher scores/increased scores indicate greater severity of disease.</description>
        <time_frame>Baseline to Posttreatment Week 24</time_frame>
        <population>Participants in the Full Analysis Set with available data were analyzed.</population>
        <group_list>
          <group group_id="O1">
            <title>SOF/VEL 12 Weeks (Group 1)</title>
            <description>SOF/VEL (400/100 mg) FDC tablet once daily for 12 weeks</description>
          </group>
          <group group_id="O2">
            <title>SOF/VEL+RBV 12 Weeks (Group 2)</title>
            <description>SOF/VEL (400/100 mg) FDC tablet + RBV tablets (1000 or 1200 mg/day divided twice daily) administered orally once daily for 12 weeks</description>
          </group>
          <group group_id="O3">
            <title>SOF/VEL 24 Weeks (Group 3)</title>
            <description>SOF/VEL (400/100 mg) FDC tablet once daily for 24 weeks</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With a Decrease, No Change, or Increase Between Baseline and Posttreatment Week 24 in Child-Pugh-Turcotte (CPT) Score</title>
          <description>CPT scores grade the severity of cirrhosis and are used to determine the need for liver transplantation. Scores can range from 5 to 15; higher scores/increased scores indicate greater severity of disease.</description>
          <population>Participants in the Full Analysis Set with available data were analyzed.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="69"/>
                <count group_id="O2" value="75"/>
                <count group_id="O3" value="69"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Decrease (Improvement)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="44.9"/>
                    <measurement group_id="O2" value="53.3"/>
                    <measurement group_id="O3" value="63.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>No Change</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="43.5"/>
                    <measurement group_id="O2" value="37.3"/>
                    <measurement group_id="O3" value="27.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Increase (Worsening)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11.6"/>
                    <measurement group_id="O2" value="9.3"/>
                    <measurement group_id="O3" value="8.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Up to 24 weeks plus 30 days</time_frame>
      <desc>Safety Analysis Set</desc>
      <group_list>
        <group group_id="E1">
          <title>SOF/VEL 12 Weeks (Group 1)</title>
          <description>SOF/VEL (400/100 mg) FDC tablet once daily for 12 weeks</description>
        </group>
        <group group_id="E2">
          <title>SOF/VEL+RBV 12 Weeks (Group 2)</title>
          <description>SOF/VEL (400/100 mg) FDC tablet + RBV tablets (1000 or 1200 mg/day divided twice daily) administered orally once daily for 12 weeks</description>
        </group>
        <group group_id="E3">
          <title>SOF/VEL 24 Weeks (Group 3)</title>
          <description>SOF/VEL (400/100 mg) FDC tablet once daily for 24 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="17" subjects_at_risk="90"/>
                <counts group_id="E2" subjects_affected="14" subjects_at_risk="87"/>
                <counts group_id="E3" subjects_affected="16" subjects_at_risk="90"/>
              </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="1" subjects_at_risk="90"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="87"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="90"/>
              </event>
              <event>
                <sub_title>Iron deficiency anaemia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="90"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="87"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="90"/>
              </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="0" subjects_at_risk="90"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="87"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="90"/>
              </event>
              <event>
                <sub_title>Atrial fibrillation</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="90"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="87"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="90"/>
              </event>
              <event>
                <sub_title>Myocardial infarction</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="90"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="87"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="90"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Endocrine disorders</title>
            <event_list>
              <event>
                <sub_title>Adrenal insufficiency</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="90"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="87"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="90"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Ascites</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="90"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="87"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="90"/>
              </event>
              <event>
                <sub_title>Colitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="90"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="87"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="90"/>
              </event>
              <event>
                <sub_title>Duodenal ulcer perforation</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="90"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="87"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="90"/>
              </event>
              <event>
                <sub_title>Gastric ulcer</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="90"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="87"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="90"/>
              </event>
              <event>
                <sub_title>Gastric varices haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="90"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="87"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="90"/>
              </event>
              <event>
                <sub_title>Gastrointestinal haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="90"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="87"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="90"/>
              </event>
              <event>
                <sub_title>Haematemesis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="90"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="87"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="90"/>
              </event>
              <event>
                <sub_title>Ileus</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="90"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="87"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="90"/>
              </event>
              <event>
                <sub_title>Incarcerated umbilical hernia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="90"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="87"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="90"/>
              </event>
              <event>
                <sub_title>Mallory-Weiss syndrome</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="90"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="87"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="90"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="90"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="87"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="90"/>
              </event>
              <event>
                <sub_title>Rectal haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="90"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="87"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="90"/>
              </event>
              <event>
                <sub_title>Small intestinal obstruction</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="90"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="87"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="90"/>
              </event>
              <event>
                <sub_title>Upper gastrointestinal haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="90"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="87"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="90"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="90"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="87"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="90"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Hernia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="90"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="87"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="90"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Hepatobiliary disorders</title>
            <event_list>
              <event>
                <sub_title>Hepatorenal syndrome</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="90"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="87"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="90"/>
              </event>
              <event>
                <sub_title>Hyperbilirubinaemia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="90"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="87"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="90"/>
              </event>
              <event>
                <sub_title>Jaundice</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="90"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="87"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="90"/>
              </event>
              <event>
                <sub_title>Portal vein thrombosis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="90"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="87"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="90"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Bacteraemia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="90"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="87"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="90"/>
              </event>
              <event>
                <sub_title>Bone abscess</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="90"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="87"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="90"/>
              </event>
              <event>
                <sub_title>Cellulitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="90"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="87"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="90"/>
              </event>
              <event>
                <sub_title>Device related infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="90"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="87"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="90"/>
              </event>
              <event>
                <sub_title>Escherichia infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="90"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="87"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="90"/>
              </event>
              <event>
                <sub_title>Infectious colitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="90"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="87"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="90"/>
              </event>
              <event>
                <sub_title>Localised infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="90"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="87"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="90"/>
              </event>
              <event>
                <sub_title>Osteomyelitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="90"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="87"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="90"/>
              </event>
              <event>
                <sub_title>Peritonitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="90"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="87"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="90"/>
              </event>
              <event>
                <sub_title>Pneumonia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="90"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="87"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="90"/>
              </event>
              <event>
                <sub_title>Sepsis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="90"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="87"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="90"/>
              </event>
              <event>
                <sub_title>Urinary tract infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="90"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="87"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="90"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Fall</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="90"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="87"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="90"/>
              </event>
              <event>
                <sub_title>Head injury</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="90"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="87"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="90"/>
              </event>
              <event>
                <sub_title>Hip fracture</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="90"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="87"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="90"/>
              </event>
              <event>
                <sub_title>Joint dislocation</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="90"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="87"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="90"/>
              </event>
              <event>
                <sub_title>Radius fracture</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="90"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="87"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="90"/>
              </event>
              <event>
                <sub_title>Rib fracture</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="90"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="87"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="90"/>
              </event>
              <event>
                <sub_title>Splenic rupture</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="90"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="87"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="90"/>
              </event>
              <event>
                <sub_title>Tibia fracture</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="90"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="87"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="90"/>
              </event>
              <event>
                <sub_title>Traumatic haemothorax</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="90"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="87"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="90"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Hyperkalaemia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="90"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="87"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="90"/>
              </event>
              <event>
                <sub_title>Hyponatraemia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="90"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="87"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="90"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Rhabdomyolysis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="90"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="87"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="90"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Diffuse large B-cell lymphoma</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="90"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="87"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="90"/>
              </event>
              <event>
                <sub_title>Hepatocellular carcinoma</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="90"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="87"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="90"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Cerebrovascular accident</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="90"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="87"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="90"/>
              </event>
              <event>
                <sub_title>Hepatic encephalopathy</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="90"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="87"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="90"/>
              </event>
              <event>
                <sub_title>Seizure</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="90"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="87"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="90"/>
              </event>
              <event>
                <sub_title>Syncope</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="90"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="87"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="90"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Depression</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="90"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="87"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="90"/>
              </event>
              <event>
                <sub_title>Mental status changes</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="90"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="87"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="90"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Dyspnoea</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="90"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="87"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="90"/>
              </event>
              <event>
                <sub_title>Hypoxia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="90"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="87"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="90"/>
              </event>
              <event>
                <sub_title>Pleural effusion</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="90"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="87"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="90"/>
              </event>
              <event>
                <sub_title>Pulmonary hypertension</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="90"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="87"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="90"/>
              </event>
              <event>
                <sub_title>Respiratory failure</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="90"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="87"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="90"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Skin ulcer</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="90"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="87"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="90"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Hypotension</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="90"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="87"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="90"/>
              </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="65" subjects_at_risk="90"/>
                <counts group_id="E2" subjects_affected="74" subjects_at_risk="87"/>
                <counts group_id="E3" subjects_affected="61" subjects_at_risk="90"/>
              </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="4" subjects_at_risk="90"/>
                <counts group_id="E2" subjects_affected="26" subjects_at_risk="87"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="90"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Abdominal discomfort</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="90"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="87"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="90"/>
              </event>
              <event>
                <sub_title>Abdominal pain</sub_title>
                <counts group_id="E1" subjects_affected="7" subjects_at_risk="90"/>
                <counts group_id="E2" subjects_affected="6" subjects_at_risk="87"/>
                <counts group_id="E3" subjects_affected="4" subjects_at_risk="90"/>
              </event>
              <event>
                <sub_title>Ascites</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="90"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="87"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="90"/>
              </event>
              <event>
                <sub_title>Constipation</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="90"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="87"/>
                <counts group_id="E3" subjects_affected="6" subjects_at_risk="90"/>
              </event>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="90"/>
                <counts group_id="E2" subjects_affected="18" subjects_at_risk="87"/>
                <counts group_id="E3" subjects_affected="7" subjects_at_risk="90"/>
              </event>
              <event>
                <sub_title>Gastrooesophageal reflux disease</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="90"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="87"/>
                <counts group_id="E3" subjects_affected="8" subjects_at_risk="90"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" subjects_affected="20" subjects_at_risk="90"/>
                <counts group_id="E2" subjects_affected="22" subjects_at_risk="87"/>
                <counts group_id="E3" subjects_affected="18" subjects_at_risk="90"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" subjects_affected="7" subjects_at_risk="90"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="87"/>
                <counts group_id="E3" subjects_affected="6" subjects_at_risk="90"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Fatigue</sub_title>
                <counts group_id="E1" subjects_affected="23" subjects_at_risk="90"/>
                <counts group_id="E2" subjects_affected="34" subjects_at_risk="87"/>
                <counts group_id="E3" subjects_affected="21" subjects_at_risk="90"/>
              </event>
              <event>
                <sub_title>Oedema peripheral</sub_title>
                <counts group_id="E1" subjects_affected="7" subjects_at_risk="90"/>
                <counts group_id="E2" subjects_affected="6" subjects_at_risk="87"/>
                <counts group_id="E3" subjects_affected="7" subjects_at_risk="90"/>
              </event>
              <event>
                <sub_title>Pyrexia</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="90"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="87"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="90"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Nasopharyngitis</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="90"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="87"/>
                <counts group_id="E3" subjects_affected="8" subjects_at_risk="90"/>
              </event>
              <event>
                <sub_title>Upper respiratory tract infection</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="90"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="87"/>
                <counts group_id="E3" subjects_affected="8" subjects_at_risk="90"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Decreased appetite</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="90"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="87"/>
                <counts group_id="E3" subjects_affected="5" subjects_at_risk="90"/>
              </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="7" subjects_at_risk="90"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="87"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="90"/>
              </event>
              <event>
                <sub_title>Back pain</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="90"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="87"/>
                <counts group_id="E3" subjects_affected="4" subjects_at_risk="90"/>
              </event>
              <event>
                <sub_title>Muscle spasms</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="90"/>
                <counts group_id="E2" subjects_affected="10" subjects_at_risk="87"/>
                <counts group_id="E3" subjects_affected="4" subjects_at_risk="90"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" subjects_affected="23" subjects_at_risk="90"/>
                <counts group_id="E2" subjects_affected="18" subjects_at_risk="87"/>
                <counts group_id="E3" subjects_affected="17" subjects_at_risk="90"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Insomnia</sub_title>
                <counts group_id="E1" subjects_affected="9" subjects_at_risk="90"/>
                <counts group_id="E2" subjects_affected="12" subjects_at_risk="87"/>
                <counts group_id="E3" subjects_affected="9" subjects_at_risk="90"/>
              </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="2" subjects_at_risk="90"/>
                <counts group_id="E2" subjects_affected="9" subjects_at_risk="87"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="90"/>
              </event>
              <event>
                <sub_title>Dyspnoea</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="90"/>
                <counts group_id="E2" subjects_affected="8" subjects_at_risk="87"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="90"/>
              </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="10" subjects_at_risk="90"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="87"/>
                <counts group_id="E3" subjects_affected="4" subjects_at_risk="90"/>
              </event>
              <event>
                <sub_title>Rash</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="90"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="87"/>
                <counts group_id="E3" subjects_affected="7" subjects_at_risk="90"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Hypertension</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="90"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="87"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="90"/>
              </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>
    <limitations_and_caveats>There were no limitations affecting the analysis or results.</limitations_and_caveats>
    <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/NCT02201901
org study id: GS-US-342-1137
nct id: NCT02201901
lead sponsor: 
has dmc: Yes
The primary objectives of this study are to evaluate the efficacy, safety, and tolerability
      of sofosbuvir (SOF)/velpatasvir (VEL) fixed dose combination (FDC) with and without ribavirin
      (RBV) for 12 weeks and SOF/VEL FDC for 24 weeks in adults with chronic hepatitis C virus
      (HCV) infection and Child-Pugh-Turcotte (CPT) class B cirrhosis.
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) 12 weeks following the last dose of study drug.
measure: Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event
time frame: Up to 24 weeks plus 30 days
measure: Percentage of Participants With Sustained Virologic Response 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)
time frame: Posttreatment Weeks 4 and 24
description: SVR4 and SVR24 were defined as HCV RNA < LLOQ at 4 and 24 weeks following the last dose of study drug, respectively.
measure: Percentage of Participants With HCV RNA < LLOQ at Weeks 1, 2, 4, 6, 8, 10, 12, 16, 20, and 24
time frame: Weeks 1, 2, 4, 6, 8, 10, 12, 16, 20, and 24
measure: Change From Baseline in HCV RNA at Weeks 1, 2, 4, 6, 8, 10, 12, 16, 20, and 24
time frame: Baseline; Weeks 1, 2, 4, 6, 8, 10, 12, 16, 20, and 24
measure: Percentage of Participants With Virologic Failure
time frame: Up to Posttreatment Week 24
description: Virologic failure was defined as
On-treatment virologic failure
HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ, while on treatment,
> 1 log10 IU/mL increase in HCV RNA from nadir while on treatment,
HCV RNA persistently ≥ LLOQ through 8 weeks of treatment (ie nonresponse)
Relapse
HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA < LLOQ at end of treatment, confirmed with 2 consecutive values or last available posttreatment measurement
measure: Percentage of Participants With a Decrease, No Change, or Increase Between Baseline and Posttreatment Week 24 in MELD Score
time frame: Baseline to Posttreatment Week 24
description: Model for End-Stage Liver Disease (MELD) scores are used to assess prognosis and suitability for liver transplantation. Scores can range from 6 to 40; higher scores/increased scores indicate greater severity of disease.
measure: Percentage of Participants With a Decrease, No Change, or Increase Between Baseline and Posttreatment Week 24 in Child-Pugh-Turcotte (CPT) Score
time frame: Baseline to Posttreatment Week 24
description: CPT scores grade the severity of cirrhosis and are used to determine the need for liver transplantation. Scores can range from 5 to 15; higher scores/increased scores indicate greater severity of disease.
arm group label: SOF/VEL 12 weeks
arm group type: Experimental
description: Participants will receive SOF/VEL FDC for 12 weeks.
arm group label: SOF/VEL+RBV 12 weeks
arm group type: Experimental
description: Participants will receive SOF/VEL FDC plus RBV for 12 weeks.
arm group label: SOF/VEL 24 weeks
arm group type: Experimental
description: Participants will receive SOF/VEL FDC for 24 weeks.
intervention type: Drug
intervention name: SOF/VEL
description: 400/100 mg tablets administered orally once daily
arm group label: SOF/VEL 12 weeks
arm group label: SOF/VEL 24 weeks
arm group label: SOF/VEL+RBV 12 weeks
other name: GS-7977/GS-5816
other name: Epclusa®
intervention type: Drug
intervention name: RBV
description: Ribavirin (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/VEL+RBV 12 weeks
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Anu M Osinusi, MD, MPH
role: Study Director
affiliation: Gilead Sciences
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country: Puerto Rico
country: United States
citation: Charlton MR, O'Leary JG, Bzowej NH, Muir AJ, Korenblat KM, Fenkel JM, et al. Sofosbuvir/Velapatasvir Fixed Dose Combination for the Treatment of HCV in Patients with Decompensated Liver Disease: The Phase 3 ASTRAL-4 Study. Hepatology 2015; 62 (6): 1387A-1388A.
citation: Curry MP, O'Leary JG, Bzowej N, Muir AJ, Korenblat KM, Fenkel JM, Reddy KR, Lawitz E, Flamm SL, Schiano T, Teperman L, Fontana R, Schiff E, Fried M, Doehle B, An D, McNally J, Osinusi A, Brainard DM, McHutchison JG, Brown RS Jr, Charlton M; ASTRAL-4 Investigators. Sofosbuvir and Velpatasvir for HCV in Patients with Decompensated Cirrhosis. N Engl J Med. 2015 Dec 31;373(27):2618-28. doi: 10.1056/NEJMoa1512614. Epub 2015 Nov 16.
PMID: 26569658
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.
responsible party type: Sponsor
mesh term: Infections
mesh term: Communicable Diseases
mesh term: Hepatitis C
mesh term: Hepatitis
mesh term: Fibrosis
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: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
limitations and caveats: There were no limitations affecting the analysis or results.
point of contact: 