<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/NCT02994056</url>
  </required_header>
  <id_info>
    <org_study_id>GS-US-342-4022</org_study_id>
    <secondary_id>2016-003066-10</secondary_id>
    <nct_id>NCT02994056</nct_id>
  </id_info>
  <brief_title>Evaluate the Efficacy and Safety of Sofosbuvir/Velpatasvir Fixed-Dose Combination and Ribavirin for 12 Weeks in Participants With Chronic HCV Infection and Child-Pugh-Turcotte Class C Cirrhosis</brief_title>
  <official_title>A Phase 2, Multicenter, Open-Label Study to Evaluate the Efficacy and Safety of Sofosbuvir/Velpatasvir Fixed-Dose Combination and Ribavirin for 12 Weeks in Subjects With Chronic HCV Infection and Child-Pugh-Turcotte Class C 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>No</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The primary objectives of this study are to evaluate the efficacy, safety, and tolerability&#xD;
      of the treatment with sofosbuvir velpatasvir (SOF/VEL) fixed-dose combination (FDC) with&#xD;
      ribavirin (RBV) for 12 weeks in participants with chronic hepatitis C virus (HCV) infection&#xD;
      and Child-Pugh-Turcotte (CPT) Class C cirrhosis.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 23, 2017</start_date>
  <completion_date type="Actual">December 12, 2018</completion_date>
  <primary_completion_date type="Actual">September 25, 2018</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12)</measure>
    <time_frame>Posttreatment Week 12</time_frame>
    <description>SVR12 was defined as HCV RNA &lt; the lower limit of quantitation (LLOQ; ie, 15 IU/mL) at 12 weeks after stopping study treatment.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of Participants Who Permanently Discontinued Study Drug (SOF/VEL or RBV) Due to an Adverse Event</measure>
    <time_frame>First dose date up to Week 12</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With Sustained Virologic Response 4 Weeks After Discontinuation of Therapy (SVR4)</measure>
    <time_frame>Posttreatment Week 4</time_frame>
    <description>SVR4 was defined as HCV RNA &lt; LLOQ 4 weeks after stopping study treatment.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With Sustained Virologic Response 24 Weeks After Discontinuation of Therapy (SVR24)</measure>
    <time_frame>Posttreatment Week 24</time_frame>
    <description>SVR24 was defined as HCV RNA &lt; LLOQ at 24 weeks after stopping study treatment.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With HCV RNA &lt; LLOQ While on Study Treatment</measure>
    <time_frame>Weeks 2, 4, 8, and 12</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With No Change, Improved, and Worsened Child-Pugh-Turcotte (CPT) Class</measure>
    <time_frame>Baseline to Posttreatment Week 24</time_frame>
    <description>CPT is a chronic liver disease classification system. Classes include CPT Class A, CPT Class B, and CPT Class C, in order of greater disease severity. Participants with improved CPT class was defined as having Class C at Baseline and Class B or A at Posttreatment Week 24 or Class B at Baseline and Class A at Posttreatment Week 24. Participants with worsened CPT class was defined as having Class A at Baseline and Class B or C at Posttreatment Week 24 or Class B at Baseline and Class C at Posttreatment Week 24. Participants with no change CPT class was defined as having CPT Class same between Baseline and Posttreatment Week 24.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With a Decrease, No Change, or Increase in Model for End Stage Liver Disease (MELD) Score</measure>
    <time_frame>Baseline to Posttreatment Week 24</time_frame>
    <description>MELD score is a chronic liver disease severity scoring system. Scores can range from 6 to 40, with higher scores indicating greater disease severity. &quot;No change&quot; was assigned for differences (posttreatment visits minus baseline score) of -1, 0 or 1; &quot;Decrease&quot; was assigned for differences that were less than or equal to -2; and &quot;Increase&quot; was assigned for values that were greater than or equal to 2.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Absolute HCV RNA Level Through Week 12</measure>
    <time_frame>Baseline; Weeks 2, 4, 8, and 12</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in HCV RNA</measure>
    <time_frame>Baseline; Weeks 2, 4, 8, and 12</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Virologic Failure</measure>
    <time_frame>Baseline up to Posttreatment Week 24</time_frame>
    <description>Virologic failure was defined as:&#xD;
On-treatment virologic failure:&#xD;
Breakthrough (confirmed HCV RNA ≥ LLOQ after having previously had HCV RNA &lt; LLOQ while on treatment), or&#xD;
Rebound (confirmed &gt; 1 log10 IU/mL increase in HCV RNA from nadir while on treatment), or&#xD;
Non-response (HCV RNA persistently ≥ LLOQ through 8 weeks of treatment)&#xD;
Virologic relapse:&#xD;
Confirmed HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA &lt; LLOQ at last on-treatment visit</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">32</enrollment>
  <condition>Hepatitis C Virus Infection</condition>
  <arm_group>
    <arm_group_label>SOF/VEL+ RBV</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>SOF/VEL FDC plus RBV for 12 weeks</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>SOF/VEL</intervention_name>
    <description>400/100 mg FDC tablet administered orally once daily</description>
    <arm_group_label>SOF/VEL+ RBV</arm_group_label>
    <other_name>Epclusa®</other_name>
    <other_name>GS-7977/GS-5816</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>RBV</intervention_name>
    <description>Tablets administered orally at 600 mg, if well tolerated then up to a maximum total daily dose of 1000 to 1200 mg (based on weight) divided twice daily.</description>
    <arm_group_label>SOF/VEL+ RBV</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Key Inclusion Criteria:&#xD;
&#xD;
          -  A body mass index (BMI) of ≥ 18 kg/m^2&#xD;
&#xD;
          -  Chronic HCV infection (≥ 6 months) as documented by either prior medical history or&#xD;
             liver biopsy&#xD;
&#xD;
          -  Quantifiable HCV RNA at screening&#xD;
&#xD;
          -  Individuals may be non-transplanted or with recurrent HCV post-liver transplant.&#xD;
&#xD;
               -  If listed for liver transplant, then the projected date of transplant must be ≥12&#xD;
                  weeks after Day1 of treatment&#xD;
&#xD;
               -  If post-liver transplant, then Day1 must be ≥ 6 months from date of transplant&#xD;
&#xD;
          -  CPT score of 10 to 12, inclusive, as determined at screening&#xD;
&#xD;
          -  Liver imaging within 6 months of Day 1 to exclude hepatocellular carcinoma (HCC)&#xD;
&#xD;
          -  If treatment-experienced, the most recent HCV treatment must have been completed at&#xD;
             least 8 weeks prior to Screening&#xD;
&#xD;
          -  Females of childbearing potential must have a negative serum pregnancy test at&#xD;
             screening and a negative urine pregnancy test on Day 1 prior to randomization&#xD;
&#xD;
          -  Males and females of childbearing potential who engage in heterosexual intercourse&#xD;
             must agree to use protocol specified method(s) of contraception&#xD;
&#xD;
          -  Females must agree to refrain from egg donation and in vitro fertilization during&#xD;
             treatment until at least 30 days after the last dose of SOF/VEL or 6 months after the&#xD;
             last dose of RBV, whichever occurs last&#xD;
&#xD;
          -  Lactating females must agree to discontinue nursing before the study drugs are&#xD;
             administered&#xD;
&#xD;
          -  Males must agree to refrain from sperm donation from the date of screening until at&#xD;
             least 7 months after the last dose of RBV or 30 days after the last dose of SOF/VEL,&#xD;
             whichever occurs last&#xD;
&#xD;
          -  Adults must be able to comply with the dosing instructions for study drug&#xD;
             administration and able to complete the study schedule of assessments&#xD;
&#xD;
        Key Exclusion Criteria:&#xD;
&#xD;
          -  Current or prior history of any of the following:&#xD;
&#xD;
               -  Clinically significant medical or psychiatric illness or individual is currently&#xD;
                  under evaluation for a potentially clinically significant illness&#xD;
&#xD;
               -  Gastrointestinal disorder or post-operative condition that could interfere with&#xD;
                  the absorption of the study drug&#xD;
&#xD;
               -  Difficulty with blood collection and/or poor venous access for the purposes of&#xD;
                  phlebotomy&#xD;
&#xD;
               -  Significant pulmonary disease, significant cardiac disease or porphyria&#xD;
&#xD;
               -  Malignancy within the 5 years prior to screening, with the exception of specific&#xD;
                  cancers that have been cured by surgical resection (basal cell skin cancer,&#xD;
                  etc.). Adults under evaluation for possible malignancy are not eligible&#xD;
&#xD;
               -  Significant drug allergy (such as anaphylaxis or hepatotoxicity)&#xD;
&#xD;
          -  Any history of organ transplant other than liver or kidney&#xD;
&#xD;
          -  Chronic liver disease of a non-HCV etiology&#xD;
&#xD;
          -  Inability to exclude HCC by imaging within 6 months of Day 1&#xD;
&#xD;
          -  Alpha-fetoprotein (AFP) &gt; 50 unless negative imaging for hepatic masses within the&#xD;
             last 6 months or during screening&#xD;
&#xD;
          -  Active spontaneous bacterial peritonitis at screening&#xD;
&#xD;
          -  Infection requiring systemic antibiotics at the time of screening&#xD;
&#xD;
          -  Evidence of fibrosing cholestatic hepatitis at screening&#xD;
&#xD;
          -  Life threatening serious adverse event (SAE) during screening&#xD;
&#xD;
          -  Active variceal bleeding within 6 months of screening&#xD;
&#xD;
          -  Prior placement of a portosystemic shunt (such as TIPS)&#xD;
&#xD;
          -  ECG with clinically significant abnormalities&#xD;
&#xD;
          -  Laboratory parameters with clinically significant abnormalities&#xD;
&#xD;
          -  Hepatitis B surface antigen positive at screening&#xD;
&#xD;
          -  Infection with human immunodeficiency virus (HIV)&#xD;
&#xD;
          -  Clinically-relevant alcohol or drug abuse within 12 months of screening. A positive&#xD;
             drug screen will exclude individuals unless it can be explained by a prescribed&#xD;
             medication; the diagnosis and prescription must be approved by the Investigator&#xD;
&#xD;
          -  Prior exposure to any HCV Non-structural Protein 5A (NS5A) inhibitor&#xD;
&#xD;
          -  Current use of corticosteroids at any dose &gt;10 mg of prednisone/day (or equivalent&#xD;
             dose of corticosteroid)&#xD;
&#xD;
          -  Use of any prohibited concomitant medications&#xD;
&#xD;
          -  Use of granulocyte macrophage colony-stimulating factor (GM-CSF), epoetin alfa or&#xD;
             other hematopoietic stimulating agents within 2 weeks of screening&#xD;
&#xD;
          -  Male with pregnant female partner&#xD;
&#xD;
          -  History of clinically significant hemoglobinopathy (eg, sickle cell disease,&#xD;
             thalassemia)&#xD;
&#xD;
          -  Contraindications to RBV therapy&#xD;
&#xD;
          -  Known hypersensitivity to VEL, RBV, SOF, the metabolites, or formulation excipients&#xD;
&#xD;
          -  Participation in a clinical study with an investigational drug or biologic within 3&#xD;
             months prior to Day 1&#xD;
&#xD;
        NOTE: Other protocol defined Inclusion/ Exclusion criteria may apply.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Gilead Study Director</last_name>
    <role>Study Director</role>
    <affiliation>Gilead Sciences</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Tampa General Medical Group</name>
      <address>
        <city>Tampa</city>
        <state>Florida</state>
        <zip>33606</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Northwestern Memorial Hospital; Clinical Research Unit</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60611</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Digestive Disease Associates, PA</name>
      <address>
        <city>Catonsville</city>
        <state>Maryland</state>
        <zip>21228</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Southern Therapy and Advanced Research LLC</name>
      <address>
        <city>Jackson</city>
        <state>Mississippi</state>
        <zip>39216</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Icahn School of Medicine at Mount Sinai</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10029</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital of the University of Pennsylvania</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19104</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>American Research Corporation at Texas Liver Institute</name>
      <address>
        <city>San Antonio</city>
        <state>Texas</state>
        <zip>78215</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Intermountain Liver Disease and Transplant Center</name>
      <address>
        <city>Murray</city>
        <state>Utah</state>
        <zip>84107</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Bon Secours St. Mary's Hospital of Richmond, Inc. d/b/a Bon Secours Liver Institute of Virginia</name>
      <address>
        <city>Richmond</city>
        <state>Virginia</state>
        <zip>23226</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Washington/ Harborview Medical Center</name>
      <address>
        <city>Seattle</city>
        <state>Washington</state>
        <zip>98105</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hopital Henri Mondor</name>
      <address>
        <city>Créteil</city>
        <zip>94010</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hopital Paul Brousse</name>
      <address>
        <city>Villejuif</city>
        <zip>94800</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
    <country>United States</country>
  </location_countries>
  <results_reference>
    <citation>Flamm S, Lawitz E, Borg B, Charlton M, Landis C, Reddy R, et al. High Efficacy and Improvement in CPT Class With Sofosbuvir/Velpatasvir Plus Ribavirin for 12 Weeks in Patients With CPT C Decompensated Cirrhosis [Poster THU-138]. EASL: The International Liver Congress; 2019 10-14 April; Vienna, Austria.</citation>
  </results_reference>
  <verification_date>September 2019</verification_date>
  <study_first_submitted>December 13, 2016</study_first_submitted>
  <study_first_submitted_qc>December 13, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 15, 2016</study_first_posted>
  <results_first_submitted>September 17, 2019</results_first_submitted>
  <results_first_submitted_qc>September 17, 2019</results_first_submitted_qc>
  <results_first_posted type="Actual">October 8, 2019</results_first_posted>
  <last_update_submitted>February 18, 2020</last_update_submitted>
  <last_update_submitted_qc>February 18, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">March 2, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Infections</mesh_term>
    <mesh_term>Communicable Diseases</mesh_term>
    <mesh_term>Hepatitis C</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Sofosbuvir</mesh_term>
    <mesh_term>Sofosbuvir-velpatasvir drug combination</mesh_term>
    <mesh_term>Velpatasvir</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Qualified external researchers may request IPD for this study after study completion. For more information, please visit our website at https://www.gilead.com/science-and-medicine/research/clinical-trials-transparency-and-data-sharing-policy.</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_time_frame>18 months after study completion</ipd_time_frame>
    <ipd_access_criteria>A secured external environment with username, password, and RSA code.</ipd_access_criteria>
    <ipd_url>https://www.gilead.com/science-and-medicine/research/clinical-trials-transparency-and-data-sharing-policy</ipd_url>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>November 22, 2016</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/56/NCT02994056/Prot_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>October 24, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/56/NCT02994056/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Participants were enrolled at study sites in the United States and France. The first participant was screened on 23 January 2017. The last study visit occurred on 12 December 2018.</recruitment_details>
      <pre_assignment_details>73 participants were screened.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>SOF/VEL+ RBV</title>
          <description>Sofosbuvir/velpatasvir (SOF/VEL) (400/100 mg) fixed-dose combination (FDC) tablet once daily + ribavirin (RBV) tablet (600-1200 mg based on weight) divided twice daily for 12 weeks in participants with HCV infection and Child-Pugh-Turcotte (CPT) Class C cirrhosis</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="32"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="23"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="9"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Death</title>
              <participants_list>
                <participants group_id="P1" count="8"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrew Consent</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>The Safety Analysis Set included all participants who took at least 1 dose of study drug.</population>
      <group_list>
        <group group_id="B1">
          <title>SOF/VEL+ RBV</title>
          <description>SOF/VEL (400/100 mg) FDC tablet once daily + RBV tablet (600-1200 mg based on weight) divided twice daily for 12 weeks in participants with HCV infection and CPT Class C cirrhosis</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="32"/>
          </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="55" spread="7.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="26"/>
                  </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="7"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="19"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race/Ethnicity, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="18"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Permitted</title>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Other</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="26"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>France</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>HCV RNA</title>
          <units>log10 IU/mL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="5.2" spread="1.19"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>HCV RNA Category</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt; 800,000 IU/mL</title>
                  <measurement_list>
                    <measurement group_id="B1" value="23"/>
                  </measurement_list>
                </category>
                <category>
                  <title>≥ 800,000 IU/mL</title>
                  <measurement_list>
                    <measurement group_id="B1" value="9"/>
                  </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>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>CC</title>
                  <measurement_list>
                    <measurement group_id="B1" value="15"/>
                  </measurement_list>
                </category>
                <category>
                  <title>CT</title>
                  <measurement_list>
                    <measurement group_id="B1" value="14"/>
                  </measurement_list>
                </category>
                <category>
                  <title>TT</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Child-Pugh-Turcotte Class</title>
          <description>CPT is a chronic liver disease classification system. Classes include CPT Class A, CPT Class B, and CPT Class C, in order of greater disease severity.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>CPT B [7-9]</title>
                  <measurement_list>
                    <measurement group_id="B1" value="9"/>
                  </measurement_list>
                </category>
                <category>
                  <title>CPT C [10-15]</title>
                  <measurement_list>
                    <measurement group_id="B1" value="23"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Model for End Stage Liver Disease (MELD) Score Category</title>
          <description>MELD score is a chronic liver disease severity scoring system. Scores can range from 6 to 40, with higher scores indicating greater disease severity.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>10-15 MELD Score</title>
                  <measurement_list>
                    <measurement group_id="B1" value="13"/>
                  </measurement_list>
                </category>
                <category>
                  <title>16-20 MELD Score</title>
                  <measurement_list>
                    <measurement group_id="B1" value="17"/>
                  </measurement_list>
                </category>
                <category>
                  <title>21-25 MELD Score</title>
                  <measurement_list>
                    <measurement group_id="B1" 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; ie, 15 IU/mL) at 12 weeks after stopping study treatment.</description>
        <time_frame>Posttreatment Week 12</time_frame>
        <population>The Full Analysis Set included all enrolled participants who took at least 1 dose of study drug.</population>
        <group_list>
          <group group_id="O1">
            <title>SOF/VEL+ RBV (Total)</title>
            <description>SOF/VEL (400/100 mg) FDC tablet once daily + RBV tablet (600-1200 mg based on weight) divided twice daily for 12 weeks in participants with HCV infection and CPT Class C cirrhosis</description>
          </group>
          <group group_id="O2">
            <title>SOF/VEL+ RBV (GT-1)</title>
            <description>SOF/VEL (400/100 mg) FDC tablet once daily + RBV tablet (600-1200 mg based on weight) divided twice daily for 12 weeks in participants with genotype 1 (GT-1) HCV infection and CPT Class C cirrhosis</description>
          </group>
          <group group_id="O3">
            <title>SOF/VEL+ RBV (GT-2)</title>
            <description>SOF/VEL (400/100 mg) FDC tablet once daily + RBV tablet (600-1200 mg based on weight) divided twice daily for 12 weeks in participants with genotype 2 (GT-2) HCV infection and CPT Class C cirrhosis</description>
          </group>
          <group group_id="O4">
            <title>SOF/VEL+ RBV (GT-3)</title>
            <description>SOF/VEL (400/100 mg) FDC tablet once daily + RBV tablet (600-1200 mg based on weight) divided twice daily for 12 weeks in participants with genotype 3 (GT-3) HCV infection and CPT Class C cirrhosis</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12)</title>
          <description>SVR12 was defined as HCV RNA &lt; the lower limit of quantitation (LLOQ; ie, 15 IU/mL) at 12 weeks after stopping study treatment.</description>
          <population>The Full Analysis Set included all enrolled participants who took 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="32"/>
                <count group_id="O2" value="18"/>
                <count group_id="O3" value="5"/>
                <count group_id="O4" value="7"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="78.1" lower_limit="60.0" upper_limit="90.7"/>
                    <measurement group_id="O2" value="72.2" lower_limit="46.5" upper_limit="90.3"/>
                    <measurement group_id="O3" value="80.0" lower_limit="28.4" upper_limit="99.5"/>
                    <measurement group_id="O4" value="85.7" lower_limit="42.1" upper_limit="99.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Participants Who Permanently Discontinued Study Drug (SOF/VEL or RBV) Due to an Adverse Event</title>
        <time_frame>First dose date up to Week 12</time_frame>
        <population>The Safety Analysis Set included all participants who took at least 1 dose of study drug.</population>
        <group_list>
          <group group_id="O1">
            <title>SOF/VEL+ RBV</title>
            <description>SOF/VEL (400/100 mg) FDC tablet once daily + RBV tablet (600-1200 mg based on weight) divided twice daily for 12 weeks in participants with HCV infection and CPT Class C cirrhosis</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Who Permanently Discontinued Study Drug (SOF/VEL or RBV) Due to an Adverse Event</title>
          <population>The Safety Analysis Set included all participants who took at least 1 dose of study drug.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="32"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Discontinuation of SOF/VEL</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Discontinuation of RBV</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="21.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With Sustained Virologic Response 4 Weeks After Discontinuation of Therapy (SVR4)</title>
        <description>SVR4 was defined as HCV RNA &lt; LLOQ 4 weeks after stopping study treatment.</description>
        <time_frame>Posttreatment Week 4</time_frame>
        <population>Participants in the Full Analysis Set were analyzed.</population>
        <group_list>
          <group group_id="O1">
            <title>SOF/VEL+ RBV (Total)</title>
            <description>SOF/VEL (400/100 mg) FDC tablet once daily + ribavirin RBV tablet (600-1200 mg based on weight) divided twice daily for 12 weeks in participants with HCV infection and CPT Class C cirrhosis</description>
          </group>
          <group group_id="O2">
            <title>SOF/VEL+ RBV (GT-1)</title>
            <description>SOF/VEL (400/100 mg) FDC tablet once daily + RBV tablet (600-1200 mg based on weight) divided twice daily for 12 weeks in participants with genotype 1 (GT-1) HCV infection and CPT Class C cirrhosis</description>
          </group>
          <group group_id="O3">
            <title>SOF/VEL+ RBV (GT-2)</title>
            <description>SOF/VEL (400/100 mg) FDC tablet once daily + RBV tablet (600-1200 mg based on weight) divided twice daily for 12 weeks in participants with genotype 2 (GT-2) HCV infection and CPT Class C cirrhosis</description>
          </group>
          <group group_id="O4">
            <title>SOF/VEL+ RBV (GT-3)</title>
            <description>SOF/VEL (400/100 mg) FDC tablet once daily + RBV tablet (600-1200 mg based on weight) divided twice daily for 12 weeks in participants with genotype 3 (GT-3) HCV infection and CPT Class C cirrhosis</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Sustained Virologic Response 4 Weeks After Discontinuation of Therapy (SVR4)</title>
          <description>SVR4 was defined as HCV RNA &lt; LLOQ 4 weeks after stopping study treatment.</description>
          <population>Participants in the Full Analysis Set were analyzed.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="32"/>
                <count group_id="O2" value="18"/>
                <count group_id="O3" value="5"/>
                <count group_id="O4" value="7"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="87.5" lower_limit="71.0" upper_limit="96.5"/>
                    <measurement group_id="O2" value="88.9" lower_limit="65.3" upper_limit="98.6"/>
                    <measurement group_id="O3" value="80.0" lower_limit="28.4" upper_limit="99.5"/>
                    <measurement group_id="O4" value="85.7" lower_limit="42.1" upper_limit="99.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With Sustained Virologic Response 24 Weeks After Discontinuation of Therapy (SVR24)</title>
        <description>SVR24 was defined as HCV RNA &lt; LLOQ at 24 weeks after stopping study treatment.</description>
        <time_frame>Posttreatment Week 24</time_frame>
        <population>Participants in the Full Analysis Set were analyzed.</population>
        <group_list>
          <group group_id="O1">
            <title>SOF/VEL+ RBV (Total)</title>
            <description>SOF/VEL (400/100 mg) FDC tablet once daily + RBV tablet (600-1200 mg based on weight) divided twice daily for 12 weeks in participants with HCV infection and CPT Class C cirrhosis</description>
          </group>
          <group group_id="O2">
            <title>SOF/VEL+ RBV (GT-1)</title>
            <description>SOF/VEL (400/100 mg) FDC tablet once daily + RBV tablet (600-1200 mg based on weight) divided twice daily for 12 weeks in participants with genotype 1 (GT-1) HCV infection and CPT Class C cirrhosis</description>
          </group>
          <group group_id="O3">
            <title>SOF/VEL+ RBV (GT-2)</title>
            <description>SOF/VEL (400/100 mg) FDC tablet once daily + RBV tablet (600-1200 mg based on weight) divided twice daily for 12 weeks in participants with genotype 2 (GT-2) HCV infection and CPT Class C cirrhosis</description>
          </group>
          <group group_id="O4">
            <title>SOF/VEL+ RBV (GT-3)</title>
            <description>SOF/VEL (400/100 mg) FDC tablet once daily + RBV tablet (600-1200 mg based on weight) divided twice daily for 12 weeks in participants with genotype 3 (GT-3) HCV infection and CPT Class C cirrhosis</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Sustained Virologic Response 24 Weeks After Discontinuation of Therapy (SVR24)</title>
          <description>SVR24 was defined as HCV RNA &lt; LLOQ at 24 weeks after stopping study treatment.</description>
          <population>Participants in the Full Analysis Set were analyzed.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="32"/>
                <count group_id="O2" value="18"/>
                <count group_id="O3" value="5"/>
                <count group_id="O4" value="7"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="75.0" lower_limit="56.6" upper_limit="88.5"/>
                    <measurement group_id="O2" value="72.2" lower_limit="46.5" upper_limit="90.3"/>
                    <measurement group_id="O3" value="80.0" lower_limit="28.4" upper_limit="99.5"/>
                    <measurement group_id="O4" value="71.4" lower_limit="29.0" upper_limit="96.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With HCV RNA &lt; LLOQ While on Study Treatment</title>
        <time_frame>Weeks 2, 4, 8, and 12</time_frame>
        <population>Participants in the Full Analysis Set with available data were analyzed.</population>
        <group_list>
          <group group_id="O1">
            <title>SOF/VEL+ RBV (Total)</title>
            <description>SOF/VEL (400/100 mg) FDC tablet once daily + RBV tablet (600-1200 mg based on weight) divided twice daily for 12 weeks in participants with HCV infection and CPT Class C cirrhosis</description>
          </group>
          <group group_id="O2">
            <title>SOF/VEL+ RBV (GT-1)</title>
            <description>SOF/VEL (400/100 mg) FDC tablet once daily + RBV tablet (600-1200 mg based on weight) divided twice daily for 12 weeks in participants with genotype 1 (GT-1) HCV infection and CPT Class C cirrhosis</description>
          </group>
          <group group_id="O3">
            <title>SOF/VEL+ RBV (GT-2)</title>
            <description>SOF/VEL (400/100 mg) FDC tablet once daily + RBV tablet (600-1200 mg based on weight) divided twice daily for 12 weeks in participants with genotype 2 (GT-2) HCV infection and CPT Class C cirrhosis</description>
          </group>
          <group group_id="O4">
            <title>SOF/VEL+ RBV (GT-3)</title>
            <description>SOF/VEL (400/100 mg) FDC tablet once daily + RBV tablet (600-1200 mg based on weight) divided twice daily for 12 weeks in participants with genotype 3 (GT-3) HCV infection and CPT Class C cirrhosis</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With HCV RNA &lt; LLOQ While on Study Treatment</title>
          <population>Participants in the Full Analysis Set with available data were analyzed.</population>
          <units>Percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="32"/>
                <count group_id="O2" value="18"/>
                <count group_id="O3" value="5"/>
                <count group_id="O4" value="7"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="32"/>
                    <count group_id="O2" value="18"/>
                    <count group_id="O3" value="5"/>
                    <count group_id="O4" value="7"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="43.8" lower_limit="26.4" upper_limit="62.3"/>
                    <measurement group_id="O2" value="38.9" lower_limit="17.3" upper_limit="64.3"/>
                    <measurement group_id="O3" value="0" lower_limit="0.0" upper_limit="52.2"/>
                    <measurement group_id="O4" value="71.4" lower_limit="29.0" upper_limit="96.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="29"/>
                    <count group_id="O2" value="16"/>
                    <count group_id="O3" value="4"/>
                    <count group_id="O4" value="7"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="96.6" lower_limit="82.2" upper_limit="99.9"/>
                    <measurement group_id="O2" value="100.0" lower_limit="79.4" upper_limit="100.0"/>
                    <measurement group_id="O3" value="75.0" lower_limit="19.4" upper_limit="99.4"/>
                    <measurement group_id="O4" value="100.0" lower_limit="59.0" upper_limit="100.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 8</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="29"/>
                    <count group_id="O2" value="16"/>
                    <count group_id="O3" value="4"/>
                    <count group_id="O4" value="7"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="100.0" lower_limit="88.1" upper_limit="100.0"/>
                    <measurement group_id="O2" value="100.0" lower_limit="79.4" upper_limit="100.0"/>
                    <measurement group_id="O3" value="100.0" lower_limit="39.8" upper_limit="100.0"/>
                    <measurement group_id="O4" value="100.0" lower_limit="59.0" upper_limit="100.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 12</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="29"/>
                    <count group_id="O2" value="16"/>
                    <count group_id="O3" value="4"/>
                    <count group_id="O4" value="7"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="100.0" lower_limit="88.1" upper_limit="100.0"/>
                    <measurement group_id="O2" value="100.0" lower_limit="79.4" upper_limit="100.0"/>
                    <measurement group_id="O3" value="100.0" lower_limit="39.8" upper_limit="100.0"/>
                    <measurement group_id="O4" value="100.0" lower_limit="59.0" upper_limit="100.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With No Change, Improved, and Worsened Child-Pugh-Turcotte (CPT) Class</title>
        <description>CPT is a chronic liver disease classification system. Classes include CPT Class A, CPT Class B, and CPT Class C, in order of greater disease severity. Participants with improved CPT class was defined as having Class C at Baseline and Class B or A at Posttreatment Week 24 or Class B at Baseline and Class A at Posttreatment Week 24. Participants with worsened CPT class was defined as having Class A at Baseline and Class B or C at Posttreatment Week 24 or Class B at Baseline and Class C at Posttreatment Week 24. Participants with no change CPT class was defined as having CPT Class same between Baseline and Posttreatment Week 24.</description>
        <time_frame>Baseline to Posttreatment Week 24</time_frame>
        <population>Participants in the Full Analysis Set who achieved SVR24 with available data were analyzed.</population>
        <group_list>
          <group group_id="O1">
            <title>SOF/VEL+ RBV</title>
            <description>SOF/VEL (400/100 mg) FDC tablet once daily + RBV tablet (600-1200 mg based on weight) divided twice daily for 12 weeks in participants with HCV infection and CPT Class C cirrhosis</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With No Change, Improved, and Worsened Child-Pugh-Turcotte (CPT) Class</title>
          <description>CPT is a chronic liver disease classification system. Classes include CPT Class A, CPT Class B, and CPT Class C, in order of greater disease severity. Participants with improved CPT class was defined as having Class C at Baseline and Class B or A at Posttreatment Week 24 or Class B at Baseline and Class A at Posttreatment Week 24. Participants with worsened CPT class was defined as having Class A at Baseline and Class B or C at Posttreatment Week 24 or Class B at Baseline and Class C at Posttreatment Week 24. Participants with no change CPT class was defined as having CPT Class same between Baseline and Posttreatment Week 24.</description>
          <population>Participants in the Full Analysis Set who achieved SVR24 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="19"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Improved CPT Class</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="42.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Worsened CPT Class</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>No Change CPT Class</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="57.9"/>
                  </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 in Model for End Stage Liver Disease (MELD) Score</title>
        <description>MELD score is a chronic liver disease severity scoring system. Scores can range from 6 to 40, with higher scores indicating greater disease severity. &quot;No change&quot; was assigned for differences (posttreatment visits minus baseline score) of -1, 0 or 1; &quot;Decrease&quot; was assigned for differences that were less than or equal to -2; and &quot;Increase&quot; was assigned for values that were greater than or equal to 2.</description>
        <time_frame>Baseline to Posttreatment Week 24</time_frame>
        <population>Participants in the Full Analysis Set who achieved SVR24 with available data were analyzed.</population>
        <group_list>
          <group group_id="O1">
            <title>SOF/VEL+ RBV</title>
            <description>SOF/VEL (400/100 mg) FDC tablet once daily + RBV tablet (600-1200 mg based on weight) divided twice daily for 12 weeks in participants with HCV infection and CPT Class C cirrhosis</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With a Decrease, No Change, or Increase in Model for End Stage Liver Disease (MELD) Score</title>
          <description>MELD score is a chronic liver disease severity scoring system. Scores can range from 6 to 40, with higher scores indicating greater disease severity. &quot;No change&quot; was assigned for differences (posttreatment visits minus baseline score) of -1, 0 or 1; &quot;Decrease&quot; was assigned for differences that were less than or equal to -2; and &quot;Increase&quot; was assigned for values that were greater than or equal to 2.</description>
          <population>Participants in the Full Analysis Set who achieved SVR24 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="19"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Decrease (Improvement)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="52.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>No Change</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="21.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Increase (Worsening)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="26.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Absolute HCV RNA Level Through Week 12</title>
        <time_frame>Baseline; Weeks 2, 4, 8, and 12</time_frame>
        <population>Participants in the Full Analysis Set with available data were analyzed.</population>
        <group_list>
          <group group_id="O1">
            <title>SOF/VEL+ RBV (Total)</title>
            <description>SOF/VEL (400/100 mg) FDC tablet once daily + RBV tablet (600-1200 mg based on weight) divided twice daily for 12 weeks in participants with HCV infection and CPT Class C cirrhosis</description>
          </group>
          <group group_id="O2">
            <title>SOF/VEL+ RBV (GT-1)</title>
            <description>SOF/VEL (400/100 mg) FDC tablet once daily + RBV tablet (600-1200 mg based on weight) divided twice daily for 12 weeks in participants with genotype 1 (GT-1) HCV infection and CPT Class C cirrhosis</description>
          </group>
          <group group_id="O3">
            <title>SOF/VEL+ RBV (GT-2)</title>
            <description>SOF/VEL (400/100 mg) FDC tablet once daily + RBV tablet (600-1200 mg based on weight) divided twice daily for 12 weeks in participants with genotype 2 (GT-2) HCV infection and CPT Class C cirrhosis</description>
          </group>
          <group group_id="O4">
            <title>SOF/VEL+ RBV (GT-3)</title>
            <description>SOF/VEL (400/100 mg) FDC tablet once daily + RBV tablet (600-1200 mg based on weight) divided twice daily for 12 weeks in participants with genotype 3 (GT-3) HCV infection and CPT Class C cirrhosis</description>
          </group>
        </group_list>
        <measure>
          <title>Absolute HCV RNA Level Through Week 12</title>
          <population>Participants in the Full Analysis Set with available data were analyzed.</population>
          <units>log10 IU/mL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="32"/>
                <count group_id="O2" value="18"/>
                <count group_id="O3" value="5"/>
                <count group_id="O4" value="7"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="32"/>
                    <count group_id="O2" value="18"/>
                    <count group_id="O3" value="5"/>
                    <count group_id="O4" value="7"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.17" spread="1.187"/>
                    <measurement group_id="O2" value="5.46" spread="0.537"/>
                    <measurement group_id="O3" value="6.01" spread="0.502"/>
                    <measurement group_id="O4" value="4.84" spread="1.058"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="29"/>
                    <count group_id="O2" value="16"/>
                    <count group_id="O3" value="4"/>
                    <count group_id="O4" value="7"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.46" spread="0.392"/>
                    <measurement group_id="O2" value="1.47" spread="0.387"/>
                    <measurement group_id="O3" value="1.63" spread="0.150"/>
                    <measurement group_id="O4" value="1.43" spread="0.526"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="28"/>
                    <count group_id="O2" value="16"/>
                    <count group_id="O3" value="3"/>
                    <count group_id="O4" value="7"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.15" spread="0.00"/>
                    <measurement group_id="O2" value="1.15" spread="0.000"/>
                    <measurement group_id="O3" value="1.15" spread="0.000"/>
                    <measurement group_id="O4" value="1.15" spread="0.000"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 8</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="29"/>
                    <count group_id="O2" value="16"/>
                    <count group_id="O3" value="4"/>
                    <count group_id="O4" value="7"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.15" spread="0.00"/>
                    <measurement group_id="O2" value="1.15" spread="0.000"/>
                    <measurement group_id="O3" value="1.15" spread="0.000"/>
                    <measurement group_id="O4" value="1.15" spread="0.000"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 12</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="29"/>
                    <count group_id="O2" value="16"/>
                    <count group_id="O3" value="4"/>
                    <count group_id="O4" value="7"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.15" spread="0.00"/>
                    <measurement group_id="O2" value="1.15" spread="0.000"/>
                    <measurement group_id="O3" value="1.15" spread="0.000"/>
                    <measurement group_id="O4" value="1.15" spread="0.000"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in HCV RNA</title>
        <time_frame>Baseline; Weeks 2, 4, 8, and 12</time_frame>
        <population>Participants in the Full Analysis Set with available data were analyzed.</population>
        <group_list>
          <group group_id="O1">
            <title>SOF/VEL+ RBV (Total)</title>
            <description>SOF/VEL (400/100 mg) FDC tablet once daily + RBV tablet (600-1200 mg based on weight) divided twice daily for 12 weeks in participants with HCV infection and CPT Class C cirrhosis</description>
          </group>
          <group group_id="O2">
            <title>SOF/VEL+ RBV (GT-1)</title>
            <description>SOF/VEL (400/100 mg) FDC tablet once daily + RBV tablet (600-1200 mg based on weight) divided twice daily for 12 weeks in participants with genotype 1 (GT-1) HCV infection and CPT Class C cirrhosis</description>
          </group>
          <group group_id="O3">
            <title>SOF/VEL+ RBV (GT-2)</title>
            <description>SOF/VEL (400/100 mg) FDC tablet once daily + RBV tablet (600-1200 mg based on weight) divided twice daily for 12 weeks in participants with genotype 2 (GT-2) HCV infection and CPT Class C cirrhosis</description>
          </group>
          <group group_id="O4">
            <title>SOF/VEL+ RBV (GT-3)</title>
            <description>SOF/VEL (400/100 mg) FDC tablet once daily + RBV tablet (600-1200 mg based on weight) divided twice daily for 12 weeks in participants with genotype 3 (GT-3) HCV infection and CPT Class C cirrhosis</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in HCV RNA</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="29"/>
                <count group_id="O2" value="16"/>
                <count group_id="O3" value="4"/>
                <count group_id="O4" value="7"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Change at Week 2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="29"/>
                    <count group_id="O2" value="16"/>
                    <count group_id="O3" value="4"/>
                    <count group_id="O4" value="7"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-3.72" spread="1.092"/>
                    <measurement group_id="O2" value="-4.06" spread="0.531"/>
                    <measurement group_id="O3" value="-4.50" spread="0.366"/>
                    <measurement group_id="O4" value="-3.41" spread="0.665"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Week 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="28"/>
                    <count group_id="O2" value="16"/>
                    <count group_id="O3" value="3"/>
                    <count group_id="O4" value="7"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-3.99" spread="1.238"/>
                    <measurement group_id="O2" value="-4.39" spread="0.520"/>
                    <measurement group_id="O3" value="-4.88" spread="0.395"/>
                    <measurement group_id="O4" value="-3.70" spread="1.058"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Week 8</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="29"/>
                    <count group_id="O2" value="16"/>
                    <count group_id="O3" value="4"/>
                    <count group_id="O4" value="7"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-4.00" spread="1.217"/>
                    <measurement group_id="O2" value="-4.39" spread="0.520"/>
                    <measurement group_id="O3" value="-4.72" spread="0.445"/>
                    <measurement group_id="O4" value="-3.70" spread="1.058"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Week 12</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="29"/>
                    <count group_id="O2" value="16"/>
                    <count group_id="O3" value="4"/>
                    <count group_id="O4" value="7"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-4.00" spread="1.217"/>
                    <measurement group_id="O2" value="-4.39" spread="0.520"/>
                    <measurement group_id="O3" value="-4.72" spread="0.445"/>
                    <measurement group_id="O4" value="-3.70" spread="1.058"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Virologic Failure</title>
        <description>Virologic failure was defined as:&#xD;
On-treatment virologic failure:&#xD;
Breakthrough (confirmed HCV RNA ≥ LLOQ after having previously had HCV RNA &lt; LLOQ while on treatment), or&#xD;
Rebound (confirmed &gt; 1 log10 IU/mL increase in HCV RNA from nadir while on treatment), or&#xD;
Non-response (HCV RNA persistently ≥ LLOQ through 8 weeks of treatment)&#xD;
Virologic relapse:&#xD;
Confirmed HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA &lt; LLOQ at last on-treatment visit</description>
        <time_frame>Baseline up to Posttreatment Week 24</time_frame>
        <population>Participants in the Full Analysis Set were analyzed.</population>
        <group_list>
          <group group_id="O1">
            <title>SOF/VEL+ RBV (GT-1)</title>
            <description>SOF/VEL (400/100 mg) FDC tablet once daily + RBV tablet (600-1200 mg based on weight) divided twice daily for 12 weeks in participants with genotype 1 (GT-1) HCV infection and CPT Class C cirrhosis</description>
          </group>
          <group group_id="O2">
            <title>SOF/VEL+ RBV (GT-2)</title>
            <description>SOF/VEL (400/100 mg) FDC tablet once daily + RBV tablet (600-1200 mg based on weight) divided twice daily for 12 weeks in participants with genotype 2 (GT-2) HCV infection and CPT Class C cirrhosis</description>
          </group>
          <group group_id="O3">
            <title>SOF/VEL+ RBV (GT-3)</title>
            <description>SOF/VEL (400/100 mg) FDC tablet once daily + RBV tablet (600-1200 mg based on weight) divided twice daily for 12 weeks in participants with genotype 3 (GT-3) HCV infection and CPT Class C cirrhosis</description>
          </group>
          <group group_id="O4">
            <title>SOF/VEL+ RBV (Total)</title>
            <description>SOF/VEL (400/100 mg) FDC tablet once daily + ribavirin RBV tablet (600-1200 mg based on weight) divided twice daily for 12 weeks in participants with HCV infection and CPT Class C cirrhosis</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Virologic Failure</title>
          <description>Virologic failure was defined as:&#xD;
On-treatment virologic failure:&#xD;
Breakthrough (confirmed HCV RNA ≥ LLOQ after having previously had HCV RNA &lt; LLOQ while on treatment), or&#xD;
Rebound (confirmed &gt; 1 log10 IU/mL increase in HCV RNA from nadir while on treatment), or&#xD;
Non-response (HCV RNA persistently ≥ LLOQ through 8 weeks of treatment)&#xD;
Virologic relapse:&#xD;
Confirmed HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA &lt; LLOQ at last on-treatment visit</description>
          <population>Participants in the Full Analysis Set were analyzed.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="18"/>
                <count group_id="O2" value="5"/>
                <count group_id="O3" value="7"/>
                <count group_id="O4" value="32"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="1"/>
                    <measurement group_id="O4" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: First dose date up to Posttreatment Week 24</time_frame>
      <desc>The Safety Analysis Set included all participants who took at least 1 dose of study drug.</desc>
      <group_list>
        <group group_id="E1">
          <title>SOF/VEL+ RBV</title>
          <description>SOF/VEL (400/100 mg) FDC tablet once daily + RBV tablet (600-1200 mg based on weight) divided twice daily for 12 weeks in participants with HCV infection and CPT Class C cirrhosis</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA Version 21.0</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="8" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="17" subjects_at_risk="32"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Atrial fibrillation</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Ventricular tachycardia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="32"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Ascites</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Gastrointestinal haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="32"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Oedema peripheral</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Pyrexia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="32"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Dermo-hypodermitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Erysipelas</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Escherichia sepsis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Gastroenteritis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Sepsis</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Urinary tract infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="32"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Dehydration</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="32"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Hepatocellular carcinoma</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Mixed hepatocellular cholangiocarcinoma</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="32"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Hepatic encephalopathy</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="32"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Acute kidney injury</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="32"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Reproductive system and breast disorders</title>
            <event_list>
              <event>
                <sub_title>Benign prostatic hyperplasia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="32"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Hepatic hydrothorax</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Pleural effusion</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Respiratory distress</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="32"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedDRA Version 21.0</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="27" subjects_at_risk="32"/>
              </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="8" subjects_at_risk="32"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Abdominal pain</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Ascites</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Constipation</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" subjects_affected="8" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="32"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Asthenia</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Fatigue</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Oedema peripheral</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="32"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Upper respiratory tract infection</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Urinary tract infection</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="32"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Muscle spasms</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="32"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="32"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Acute kidney injury</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Haematuria</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="32"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Hepatic hydrothorax</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="32"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Rash</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="32"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>After conclusion of the study and without prior written approval from Gilead, investigators in this study may communicate, orally present, or publish in scientific journals or other media only after the following conditions have been met:&#xD;
The results of the study in their entirety have been publicly disclosed by or with the consent of Gilead in an abstract, manuscript, or presentation form; or&#xD;
The study has been completed at all study sites for at least 2 years</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Gilead Clinical Study Information Center</name_or_title>
      <organization>Gilead Sciences</organization>
      <phone>1-833-445-3230 (GILEAD-0)</phone>
      <email>GileadClinicalTrials@gilead.com</email>
    </point_of_contact>
  </clinical_results>
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02994056
org study id: GS-US-342-4022
secondary id: 2016-003066-10
nct id: NCT02994056
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
The primary objectives of this study are to evaluate the efficacy, safety, and tolerability
      of the treatment with sofosbuvir velpatasvir (SOF/VEL) fixed-dose combination (FDC) with
      ribavirin (RBV) for 12 weeks in participants with chronic hepatitis C virus (HCV) infection
      and Child-Pugh-Turcotte (CPT) Class C cirrhosis.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12)
time frame: Posttreatment Week 12
description: SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ; ie, 15 IU/mL) at 12 weeks after stopping study treatment.
measure: Percentage of Participants Who Permanently Discontinued Study Drug (SOF/VEL or RBV) Due to an Adverse Event
time frame: First dose date up to Week 12
measure: Percentage of Participants With Sustained Virologic Response 4 Weeks After Discontinuation of Therapy (SVR4)
time frame: Posttreatment Week 4
description: SVR4 was defined as HCV RNA < LLOQ 4 weeks after stopping study treatment.
measure: Percentage of Participants With Sustained Virologic Response 24 Weeks After Discontinuation of Therapy (SVR24)
time frame: Posttreatment Week 24
description: SVR24 was defined as HCV RNA < LLOQ at 24 weeks after stopping study treatment.
measure: Percentage of Participants With HCV RNA < LLOQ While on Study Treatment
time frame: Weeks 2, 4, 8, and 12
measure: Percentage of Participants With No Change, Improved, and Worsened Child-Pugh-Turcotte (CPT) Class
time frame: Baseline to Posttreatment Week 24
description: CPT is a chronic liver disease classification system. Classes include CPT Class A, CPT Class B, and CPT Class C, in order of greater disease severity. Participants with improved CPT class was defined as having Class C at Baseline and Class B or A at Posttreatment Week 24 or Class B at Baseline and Class A at Posttreatment Week 24. Participants with worsened CPT class was defined as having Class A at Baseline and Class B or C at Posttreatment Week 24 or Class B at Baseline and Class C at Posttreatment Week 24. Participants with no change CPT class was defined as having CPT Class same between Baseline and Posttreatment Week 24.
measure: Percentage of Participants With a Decrease, No Change, or Increase in Model for End Stage Liver Disease (MELD) Score
time frame: Baseline to Posttreatment Week 24
description: MELD score is a chronic liver disease severity scoring system. Scores can range from 6 to 40, with higher scores indicating greater disease severity. "No change" was assigned for differences (posttreatment visits minus baseline score) of -1, 0 or 1; "Decrease" was assigned for differences that were less than or equal to -2; and "Increase" was assigned for values that were greater than or equal to 2.
measure: Absolute HCV RNA Level Through Week 12
time frame: Baseline; Weeks 2, 4, 8, and 12
measure: Change From Baseline in HCV RNA
time frame: Baseline; Weeks 2, 4, 8, and 12
measure: Number of Participants With Virologic Failure
time frame: Baseline up to Posttreatment Week 24
description: Virologic failure was defined as:
On-treatment virologic failure:
Breakthrough (confirmed HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ while on treatment), or
Rebound (confirmed > 1 log10 IU/mL increase in HCV RNA from nadir while on treatment), or
Non-response (HCV RNA persistently ≥ LLOQ through 8 weeks of treatment)
Virologic relapse:
Confirmed HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA < LLOQ at last on-treatment visit
arm group label: SOF/VEL+ RBV
arm group type: Experimental
description: SOF/VEL FDC plus RBV for 12 weeks
intervention type: Drug
intervention name: SOF/VEL
description: 400/100 mg FDC tablet administered orally once daily
arm group label: SOF/VEL+ RBV
other name: Epclusa®
other name: GS-7977/GS-5816
intervention type: Drug
intervention name: RBV
description: Tablets administered orally at 600 mg, if well tolerated then up to a maximum total daily dose of 1000 to 1200 mg (based on weight) divided twice daily.
arm group label: SOF/VEL+ RBV
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Gilead Study Director
role: Study Director
affiliation: Gilead Sciences
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: France
country: United States
citation: Flamm S, Lawitz E, Borg B, Charlton M, Landis C, Reddy R, et al. High Efficacy and Improvement in CPT Class With Sofosbuvir/Velpatasvir Plus Ribavirin for 12 Weeks in Patients With CPT C Decompensated Cirrhosis [Poster THU-138]. EASL: The International Liver Congress; 2019 10-14 April; Vienna, Austria.
responsible party type: Sponsor
mesh term: Infections
mesh term: Communicable Diseases
mesh term: Hepatitis C
mesh term: Sofosbuvir
mesh term: Sofosbuvir-velpatasvir drug combination
mesh term: Velpatasvir
sharing ipd: Yes
ipd description: Qualified external researchers may request IPD for this study after study completion. For more information, please visit our website at https://www.gilead.com/science-and-medicine/research/clinical-trials-transparency-and-data-sharing-policy.
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd time frame: 18 months after study completion
ipd access criteria: A secured external environment with username, password, and RSA code.
ipd url: https://www.gilead.com/science-and-medicine/research/clinical-trials-transparency-and-data-sharing-policy
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 