<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/NCT01667731</url>
  </required_header>
  <id_info>
    <org_study_id>GS-US-334-0123</org_study_id>
    <nct_id>NCT01667731</nct_id>
  </id_info>
  <brief_title>Efficacy and Safety of Sofosbuvir Plus Ribavirin in Chronic Genotype 1, 2 and 3 Hepatitis C Virus (HCV) and Human Immunodeficiency Virus (HIV) Co-infected Adults</brief_title>
  <official_title>A Phase 3, Open-label Study to Investigate the Efficacy and Safety of GS-7977 Plus Ribavirin in Chronic Genotype 1, 2 and 3 Hepatitis C Virus (HCV) and Human Immunodeficiency Virus (HIV) Co-infected Subjects</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Gilead Sciences</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Gilead Sciences</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study will evaluate the efficacy, safety, and tolerability of sofosbuvir (SOF; GS-7977)&#xD;
      plus ribavirin (RBV) in adults with chronic genotypes 1, 2, and 3 HCV infection who are&#xD;
      coinfected with HIV-1.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>July 2012</start_date>
  <completion_date type="Actual">February 2014</completion_date>
  <primary_completion_date type="Actual">November 2013</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Percentage of Participants With Sustained Virologic Response (SVR) at 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, 25 IU/mL) at 12 weeks after stopping study treatment.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Incidence of Adverse Events Leading to Permanent Discontinuation of Study Drug(s)</measure>
    <time_frame>Up to 24 weeks</time_frame>
    <description>The percentage of participants discontinuing any study drug due to an adverse event was summarized.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With Sustained Virologic Response at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)</measure>
    <time_frame>Posttreatment Weeks 4 and 24</time_frame>
    <description>SVR4 and SVR24 were defined as HCV RNA &lt; LLOQ at 4 and 24 weeks following the last dose of study drug, respectively.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in HCV RNA at Week 1</measure>
    <time_frame>Baseline; Week 1</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in HCV RNA at Week 2</measure>
    <time_frame>Baseline; Week 2</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in HCV RNA at Week 4</measure>
    <time_frame>Baseline; Week 4</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in HCV RNA at Week 6</measure>
    <time_frame>Baseline; Week 6</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in HCV RNA at Week 8</measure>
    <time_frame>Baseline; Week 8</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Experiencing On-treatment Virologic Failure</measure>
    <time_frame>Up to 24 weeks</time_frame>
    <description>On-treatment virologic failure was defined as:&#xD;
Viral breakthrough: HCV RNA ≥ LLOQ after having previously had HCV RNA &lt; LLOQ while on treatment, confirmed with 2 consecutive values (second confirmation value may have been posttreatment) or with a last available on-treatment measurement and no subsequent follow-up values, or&#xD;
Viral rebound: &gt; 1 log10 IU/mL increase in HCV RNA from nadir while on treatment, confirmed with 2 consecutive values (second confirmation value may have been posttreatment) or with a last available on-treatment measurement and no subsequent follow-up values, or&#xD;
Nonresponse: HCV RNA persistently ≥ LLOQ through 8 weeks of treatment</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Experiencing Viral Relapse</measure>
    <time_frame>Up to Posttreatment Week 24</time_frame>
    <description>Viral relapse was defined as having achieved undetectable HCV RNA levels (HCV RNA &lt; LLOQ) at end of treatment, but did not achieve an SVR.</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">224</enrollment>
  <condition>Hepatitis C</condition>
  <condition>Human Immunodeficiency Virus</condition>
  <arm_group>
    <arm_group_label>SOF+RBV 12 Weeks (GT 2/3, TN)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Treatment-naive (TN) participants coinfected with HIV-1 and genotype (GT) 2 or genotype 3 HCV infection will receive SOF+RBV for 12 weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>SOF+RBV 24 Weeks (GT 2/3, TE)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Treatment-experienced (TE) participants coinfected with HIV-1 and genotype 2 or genotype 3 HCV infection will receive SOF+RBV for 24 weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>SOF+RBV 24 Weeks (GT 1, TN)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Treatment-naive (TN) participants coinfected with HIV-1 and genotype 1 HCV infection will receive SOF+RBV for 24 weeks.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>SOF</intervention_name>
    <description>Sofosbuvir (SOF) 400 mg tablet administered orally once daily</description>
    <arm_group_label>SOF+RBV 12 Weeks (GT 2/3, TN)</arm_group_label>
    <arm_group_label>SOF+RBV 24 Weeks (GT 1, TN)</arm_group_label>
    <arm_group_label>SOF+RBV 24 Weeks (GT 2/3, TE)</arm_group_label>
    <other_name>GS-7977</other_name>
    <other_name>PSI-7977</other_name>
    <other_name>Sovaldi®</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>RBV</intervention_name>
    <description>Ribavirin (RBV) tablets administered orally in a divided daily dose according to package insert weight-based dosing recommendations (&lt; 75kg = 1000 mg and ≥ 75 kg = 1200 mg)</description>
    <arm_group_label>SOF+RBV 12 Weeks (GT 2/3, TN)</arm_group_label>
    <arm_group_label>SOF+RBV 24 Weeks (GT 1, TN)</arm_group_label>
    <arm_group_label>SOF+RBV 24 Weeks (GT 2/3, TE)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Willing and able to provide written informed consent&#xD;
&#xD;
          -  Male or female, age ≥ 18 years with chronic HCV and HIV-1 infection&#xD;
&#xD;
          -  HCV RNA &gt; 1 x 10^4 IU/mL at screening&#xD;
&#xD;
          -  Infection with HCV genotype 1, 2 or 3 as determined at screening&#xD;
&#xD;
          -  HIV-1 infection confirmed with positive ELISA or Western blot at screening&#xD;
&#xD;
          -  Medical records must be sufficient to be categorized on interferon (IFN) eligibility&#xD;
             or prior treatment history with PEG/RBV.&#xD;
&#xD;
          -  Confirmation of chronic HCV infection&#xD;
&#xD;
          -  Ability to determine presence/absence of cirrhosis.&#xD;
&#xD;
          -  HIV antiretroviral therapy (ARV) criteria of one of the following:&#xD;
&#xD;
               -  ARV untreated with a CD4 T-cell count &gt; 500 cells/mm^3&#xD;
&#xD;
               -  On a stable, protocol-approved, ARV for &gt; 8 weeks prior to screening with a CD4&#xD;
                  T-cell count &gt; 200 cells/mm^3 and a documented undetectable plasma HIV-1 RNA&#xD;
                  level for ≥ 8 weeks preceding the screening visit&#xD;
&#xD;
          -  Approved HIV antiretroviral medications based on drug interaction studies&#xD;
&#xD;
          -  Not been treated with any investigational drug or device within 30 days of the&#xD;
             screening visit&#xD;
&#xD;
          -  Females if confirmed that she is not pregnant or nursing of non-childbearing potential&#xD;
             or of childbearing potential but has a negative serum pregnancy test at screening and&#xD;
             agrees to use protocol approved method of birth control from screening through 6&#xD;
             months after the last dose of RBV&#xD;
&#xD;
          -  Males who agree to consistently and correctly use a condom while their female partner&#xD;
             agrees to use protocol approved method of birth control from screening through 7&#xD;
             months after the last dose of RBV&#xD;
&#xD;
          -  Must be of generally good health as determined by the investigator.&#xD;
&#xD;
          -  Liver imaging within 6 months of baseline/Day 1 is required in cirrhotic patients&#xD;
             only, to exclude hepatocellular carcinoma (HCC)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Non-genotype 1/2/3 or mixed genotype at screening&#xD;
&#xD;
          -  Genotype 1 with prior treatment for HCV&#xD;
&#xD;
          -  Poor control with ARV regimen&#xD;
&#xD;
          -  Prior exposure to a direct-acting antiviral targeting the HCV nonstructural protein&#xD;
             (NS)5B polymerase&#xD;
&#xD;
          -  Chronic liver disease of a non-HCV etiology (eg, hemochromatosis, Wilson's disease, α1&#xD;
             antitrypsin deficiency, cholangitis)&#xD;
&#xD;
          -  A new AIDS-defining condition diagnosed within 30 days prior to screening&#xD;
&#xD;
          -  Active, serious infection (other than HIV or HCV) requiring parenteral antibiotics,&#xD;
             antivirals or antifungals within 30 days prior to baseline&#xD;
&#xD;
          -  Infection with hepatitis B virus (HBV)&#xD;
&#xD;
          -  Contraindication to RBV therapy&#xD;
&#xD;
          -  Chronic use of systemically administered immunosuppressive agents (eg, prednisone&#xD;
             equivalent &gt; 10 mg/day)&#xD;
&#xD;
          -  History of solid organ transplantation or malignancy diagnosed or treated within 5&#xD;
             years&#xD;
&#xD;
          -  Current or prior history of clinical hepatic decompensation or other significant&#xD;
             gastrointestinal disorder&#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>Anuj Gaggar, MD, PhD</last_name>
    <role>Study Director</role>
    <affiliation>Gilead Sciences</affiliation>
  </overall_official>
  <location>
    <facility>
      <address>
        <city>Birmingham</city>
        <state>Alabama</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Coronado</city>
        <state>California</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Lutherville</city>
        <state>California</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Oakland</city>
        <state>California</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Sacramento</city>
        <state>California</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>San Francisco</city>
        <state>California</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Torrance</city>
        <state>California</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Washington DC</city>
        <state>District of Columbia</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Orlando</city>
        <state>Florida</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Tampa</city>
        <state>Florida</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Springfield</city>
        <state>Massachusetts</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Kansas City</city>
        <state>Missouri</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Hillsborough</city>
        <state>New Jersey</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Santa Fe</city>
        <state>New Mexico</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>New York</city>
        <state>New York</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Chapel Hill</city>
        <state>North Carolina</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Durham</city>
        <state>North Carolina</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Allentown</city>
        <state>Pennsylvania</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Providence</city>
        <state>Rhode Island</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Seattle</city>
        <state>Washington</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>San Juan</city>
        <country>Puerto Rico</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Puerto Rico</country>
    <country>United States</country>
  </location_countries>
  <verification_date>November 2014</verification_date>
  <study_first_submitted>August 9, 2012</study_first_submitted>
  <study_first_submitted_qc>August 16, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 17, 2012</study_first_posted>
  <results_first_submitted>November 14, 2014</results_first_submitted>
  <results_first_submitted_qc>November 14, 2014</results_first_submitted_qc>
  <results_first_posted type="Estimate">November 21, 2014</results_first_posted>
  <last_update_submitted>November 14, 2014</last_update_submitted>
  <last_update_submitted_qc>November 14, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 21, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Hepatitis C</keyword>
  <keyword>Chronic</keyword>
  <keyword>HCV</keyword>
  <keyword>HIV</keyword>
  <keyword>Human Immunodeficiency Virus</keyword>
  <keyword>Co-Infected</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hepatitis A</mesh_term>
    <mesh_term>Hepatitis C</mesh_term>
    <mesh_term>Acquired Immunodeficiency Syndrome</mesh_term>
    <mesh_term>HIV Infections</mesh_term>
    <mesh_term>Hepatitis</mesh_term>
    <mesh_term>Immunologic Deficiency Syndromes</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Sofosbuvir</mesh_term>
  </intervention_browse>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Participants were enrolled at a total of 34 study sites in the United States. The first participant was screened on 20 July 2012. The last participant observation occurred on 10 February 2014.</recruitment_details>
      <pre_assignment_details>330 participants were screened.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>SOF+RBV 12 Wk GT 2 TN</title>
          <description>Sofosbuvir (SOF) 400 mg tablet once daily + ribavirin (RBV) tablets (1000-1200 mg daily based on weight) for 12 weeks (treatment naive (TN), genotype (GT) 2)</description>
        </group>
        <group group_id="P2">
          <title>SOF+RBV 12 Wk GT 3 TN</title>
          <description>SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 12 weeks (treatment naive, genotype 3)</description>
        </group>
        <group group_id="P3">
          <title>SOF+RBV 24 Wk GT 2 TE</title>
          <description>SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks (treatment experienced (TE), genotype 2)</description>
        </group>
        <group group_id="P4">
          <title>SOF+RBV 24 Wk GT 3 TE</title>
          <description>SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks (treatment experienced, genotype 3)</description>
        </group>
        <group group_id="P5">
          <title>SOF+RBV 24 Wk GT 1 TN</title>
          <description>SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks (treatment naive, genotype 1)</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="26"/>
                <participants group_id="P2" count="42"/>
                <participants group_id="P3" count="24"/>
                <participants group_id="P4" count="17"/>
                <participants group_id="P5" count="115"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="21"/>
                <participants group_id="P2" count="26"/>
                <participants group_id="P3" count="22"/>
                <participants group_id="P4" count="15"/>
                <participants group_id="P5" count="87"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="5"/>
                <participants group_id="P2" count="16"/>
                <participants group_id="P3" count="2"/>
                <participants group_id="P4" count="2"/>
                <participants group_id="P5" count="28"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Enrolled but not treated</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Efficacy Failure</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="12"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="1"/>
                <participants group_id="P5" count="24"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="3"/>
                <participants group_id="P3" count="1"/>
                <participants group_id="P4" count="1"/>
                <participants group_id="P5" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Subject Withdrew Consent</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="1"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Death</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Safety Analysis Set: participants who were enrolled and received at least 1 dose of study drug</population>
      <group_list>
        <group group_id="B1">
          <title>SOF+RBV 12 Wk GT 2 TN</title>
          <description>SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 12 weeks (treatment naive, genotype 2)</description>
        </group>
        <group group_id="B2">
          <title>SOF+RBV 12 Wk GT 3 TN</title>
          <description>SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 12 weeks (treatment naive, genotype 3)</description>
        </group>
        <group group_id="B3">
          <title>SOF+RBV 24 Wk GT 2 TE</title>
          <description>SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks (treatment experienced, genotype 2)</description>
        </group>
        <group group_id="B4">
          <title>SOF+RBV 24 Wk GT 3 TE</title>
          <description>SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks (treatment experienced, genotype 3)</description>
        </group>
        <group group_id="B5">
          <title>SOF+RBV 24 Wk GT 1 TN</title>
          <description>SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks (treatment naive, genotype 1)</description>
        </group>
        <group group_id="B6">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="26"/>
            <count group_id="B2" value="42"/>
            <count group_id="B3" value="24"/>
            <count group_id="B4" value="17"/>
            <count group_id="B5" value="114"/>
            <count group_id="B6" value="223"/>
          </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="51" spread="9.7"/>
                    <measurement group_id="B2" value="48" spread="9.6"/>
                    <measurement group_id="B3" value="54" spread="4.9"/>
                    <measurement group_id="B4" value="54" spread="7.0"/>
                    <measurement group_id="B5" value="48" spread="8.4"/>
                    <measurement group_id="B6" value="49" spread="8.7"/>
                  </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="5"/>
                    <measurement group_id="B2" value="8"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="3"/>
                    <measurement group_id="B5" value="21"/>
                    <measurement group_id="B6" value="38"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="21"/>
                    <measurement group_id="B2" value="34"/>
                    <measurement group_id="B3" value="23"/>
                    <measurement group_id="B4" value="14"/>
                    <measurement group_id="B5" value="93"/>
                    <measurement group_id="B6" value="185"/>
                  </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="8"/>
                    <measurement group_id="B2" value="11"/>
                    <measurement group_id="B3" value="5"/>
                    <measurement group_id="B4" value="5"/>
                    <measurement group_id="B5" value="25"/>
                    <measurement group_id="B6" value="54"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="18"/>
                    <measurement group_id="B2" value="31"/>
                    <measurement group_id="B3" value="19"/>
                    <measurement group_id="B4" value="12"/>
                    <measurement group_id="B5" value="89"/>
                    <measurement group_id="B6" value="169"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race/Ethnicity, Customized</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>Black or African American</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="6"/>
                    <measurement group_id="B4" value="1"/>
                    <measurement group_id="B5" value="37"/>
                    <measurement group_id="B6" value="52"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>White</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="18"/>
                    <measurement group_id="B2" value="36"/>
                    <measurement group_id="B3" value="17"/>
                    <measurement group_id="B4" value="15"/>
                    <measurement group_id="B5" value="70"/>
                    <measurement group_id="B6" value="156"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Asian</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="1"/>
                    <measurement group_id="B6" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>American Indian/Alaska Native/First Nations</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="1"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hawaiian or Other Pacific Islander</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="1"/>
                    <measurement group_id="B6" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Other</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="5"/>
                    <measurement group_id="B6" value="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>HCV Genotype</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>Genotype 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="114"/>
                    <measurement group_id="B6" value="114"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Genotype 2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="26"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="24"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="50"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Genotype 3</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="42"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="17"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="59"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Liver Cirrhosis</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>No</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="25"/>
                    <measurement group_id="B2" value="36"/>
                    <measurement group_id="B3" value="20"/>
                    <measurement group_id="B4" value="11"/>
                    <measurement group_id="B5" value="109"/>
                    <measurement group_id="B6" value="201"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Yes</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="4"/>
                    <measurement group_id="B4" value="6"/>
                    <measurement group_id="B5" value="5"/>
                    <measurement group_id="B6" value="22"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>IL28b Status</title>
          <description>CC, CT, and TT alleles are different forms of the IL28b gene.</description>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>CC</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                    <measurement group_id="B2" value="15"/>
                    <measurement group_id="B3" value="10"/>
                    <measurement group_id="B4" value="10"/>
                    <measurement group_id="B5" value="30"/>
                    <measurement group_id="B6" value="75"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>CT</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="15"/>
                    <measurement group_id="B2" value="22"/>
                    <measurement group_id="B3" value="10"/>
                    <measurement group_id="B4" value="7"/>
                    <measurement group_id="B5" value="57"/>
                    <measurement group_id="B6" value="111"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>TT</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="4"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="26"/>
                    <measurement group_id="B6" value="36"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Missing</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="1"/>
                    <measurement group_id="B6" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>HCV RNA (log10 IU/mL)</title>
          <units>log10 IU/mL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="6.5" spread="0.59"/>
                    <measurement group_id="B2" value="6.2" spread="0.59"/>
                    <measurement group_id="B3" value="6.5" spread="0.82"/>
                    <measurement group_id="B4" value="6.4" spread="0.47"/>
                    <measurement group_id="B5" value="6.6" spread="0.83"/>
                    <measurement group_id="B6" value="6.5" spread="0.75"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>HCV RNA Category</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>&lt; 6 log10 IU/mL</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                    <measurement group_id="B2" value="15"/>
                    <measurement group_id="B3" value="5"/>
                    <measurement group_id="B4" value="2"/>
                    <measurement group_id="B5" value="22"/>
                    <measurement group_id="B6" value="50"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>≥ 6 log10 IU/mL</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="20"/>
                    <measurement group_id="B2" value="27"/>
                    <measurement group_id="B3" value="19"/>
                    <measurement group_id="B4" value="15"/>
                    <measurement group_id="B5" value="92"/>
                    <measurement group_id="B6" value="173"/>
                  </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) at 12 Weeks After Discontinuation of Therapy (SVR12)</title>
        <description>SVR12 was defined as HCV RNA &lt; the lower limit of quantitation (LLOQ; ie, 25 IU/mL) at 12 weeks after stopping study treatment.</description>
        <time_frame>Posttreatment Week 12</time_frame>
        <population>Full Analysis Set: participants who were enrolled and received at least 1 dose of study drug</population>
        <group_list>
          <group group_id="O1">
            <title>SOF+RBV 12 Wk GT 2 TN</title>
            <description>SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 12 weeks (treatment naive, genotype 2)</description>
          </group>
          <group group_id="O2">
            <title>SOF+RBV 12 Wk GT 3 TN</title>
            <description>SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 12 weeks (treatment naive, genotype 3)</description>
          </group>
          <group group_id="O3">
            <title>SOF+RBV 24 Wk GT 2 TE</title>
            <description>SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks (treatment experienced, genotype 2)</description>
          </group>
          <group group_id="O4">
            <title>SOF+RBV 24 Wk GT 3 TE</title>
            <description>SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks (treatment experienced, genotype 3)</description>
          </group>
          <group group_id="O5">
            <title>SOF+RBV 24 Wk GT 1 TN</title>
            <description>SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks (treatment naive, genotype 1)</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Sustained Virologic Response (SVR) at 12 Weeks After Discontinuation of Therapy (SVR12)</title>
          <description>SVR12 was defined as HCV RNA &lt; the lower limit of quantitation (LLOQ; ie, 25 IU/mL) at 12 weeks after stopping study treatment.</description>
          <population>Full Analysis Set: participants who were enrolled and received at least 1 dose of study drug</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="26"/>
                <count group_id="O2" value="42"/>
                <count group_id="O3" value="24"/>
                <count group_id="O4" value="17"/>
                <count group_id="O5" value="114"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="88.5"/>
                    <measurement group_id="O2" value="66.7"/>
                    <measurement group_id="O3" value="91.7"/>
                    <measurement group_id="O4" value="94.1"/>
                    <measurement group_id="O5" value="76.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Incidence of Adverse Events Leading to Permanent Discontinuation of Study Drug(s)</title>
        <description>The percentage of participants discontinuing any study drug due to an adverse event was summarized.</description>
        <time_frame>Up to 24 weeks</time_frame>
        <population>Safety Analysis Set: participants who were enrolled and received at least 1 dose of study drug</population>
        <group_list>
          <group group_id="O1">
            <title>SOF+RBV 12 Wk GT 2/3 TN</title>
            <description>SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 12 weeks (treatment naive, genotypes 2 and 3)</description>
          </group>
          <group group_id="O2">
            <title>SOF+RBV 24 Wk GT 2/3 TE</title>
            <description>SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks (treatment experienced, genotypes 2 and 3)</description>
          </group>
          <group group_id="O3">
            <title>SOF+RBV 24 Wk GT 1 TN</title>
            <description>SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks (treatment naive, genotype 1)</description>
          </group>
        </group_list>
        <measure>
          <title>Incidence of Adverse Events Leading to Permanent Discontinuation of Study Drug(s)</title>
          <description>The percentage of participants discontinuing any study drug due to an adverse event was summarized.</description>
          <population>Safety Analysis Set: participants who were enrolled and received at least 1 dose of study drug</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="68"/>
                <count group_id="O2" value="41"/>
                <count group_id="O3" value="114"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.4"/>
                    <measurement group_id="O2" value="2.4"/>
                    <measurement group_id="O3" value="2.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With Sustained Virologic Response at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)</title>
        <description>SVR4 and SVR24 were defined as HCV RNA &lt; LLOQ at 4 and 24 weeks following the last dose of study drug, respectively.</description>
        <time_frame>Posttreatment Weeks 4 and 24</time_frame>
        <population>Full Analysis Set</population>
        <group_list>
          <group group_id="O1">
            <title>SOF+RBV 12 Wk GT 2 TN</title>
            <description>SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 12 weeks (treatment naive, genotype 2)</description>
          </group>
          <group group_id="O2">
            <title>SOF+RBV 12 Wk GT 3 TN</title>
            <description>SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 12 weeks (treatment naive, genotype 3)</description>
          </group>
          <group group_id="O3">
            <title>SOF+RBV 24 Wk GT 2 TE</title>
            <description>SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks (treatment experienced, genotype 2)</description>
          </group>
          <group group_id="O4">
            <title>SOF+RBV 24 Wk GT 3 TE</title>
            <description>SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks (treatment experienced, genotype 3)</description>
          </group>
          <group group_id="O5">
            <title>SOF+RBV 24 Wk GT 1 TN</title>
            <description>SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks (treatment naive, genotype 1)</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Sustained Virologic Response at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)</title>
          <description>SVR4 and SVR24 were defined as HCV RNA &lt; LLOQ at 4 and 24 weeks following the last dose of study drug, respectively.</description>
          <population>Full Analysis Set</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="26"/>
                <count group_id="O2" value="42"/>
                <count group_id="O3" value="24"/>
                <count group_id="O4" value="17"/>
                <count group_id="O5" value="114"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>SVR4</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="88.5"/>
                    <measurement group_id="O2" value="71.4"/>
                    <measurement group_id="O3" value="95.8"/>
                    <measurement group_id="O4" value="94.1"/>
                    <measurement group_id="O5" value="80.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>SVR24</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="88.5"/>
                    <measurement group_id="O2" value="66.7"/>
                    <measurement group_id="O3" value="91.7"/>
                    <measurement group_id="O4" value="88.2"/>
                    <measurement group_id="O5" value="75.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in HCV RNA at Week 1</title>
        <time_frame>Baseline; Week 1</time_frame>
        <population>Participants in the Full Analysis Set with available data were analyzed.</population>
        <group_list>
          <group group_id="O1">
            <title>SOF+RBV 12 Wk GT 2 TN</title>
            <description>SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 12 weeks (treatment naive, genotype 2)</description>
          </group>
          <group group_id="O2">
            <title>SOF+RBV 12 Wk GT 3 TN</title>
            <description>SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 12 weeks (treatment naive, genotype 3)</description>
          </group>
          <group group_id="O3">
            <title>SOF+RBV 24 Wk GT 2 TE</title>
            <description>SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks (treatment experienced, genotype 2)</description>
          </group>
          <group group_id="O4">
            <title>SOF+RBV 24 Wk GT 3 TE</title>
            <description>SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks (treatment experienced, genotype 3)</description>
          </group>
          <group group_id="O5">
            <title>SOF+RBV 24 Wk GT 1 TN</title>
            <description>SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks (treatment naive, genotype 1)</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in HCV RNA at Week 1</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="25"/>
                <count group_id="O2" value="40"/>
                <count group_id="O3" value="24"/>
                <count group_id="O4" value="16"/>
                <count group_id="O5" value="108"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-4.69" spread="0.471"/>
                    <measurement group_id="O2" value="-4.52" spread="0.464"/>
                    <measurement group_id="O3" value="-4.63" spread="0.680"/>
                    <measurement group_id="O4" value="-4.78" spread="0.354"/>
                    <measurement group_id="O5" value="-4.42" spread="0.958"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in HCV RNA at Week 2</title>
        <time_frame>Baseline; Week 2</time_frame>
        <population>Participants in the Full Analysis Set with available data were analyzed.</population>
        <group_list>
          <group group_id="O1">
            <title>SOF+RBV 12 Wk GT 2 TN</title>
            <description>SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 12 weeks (treatment naive, genotype 2)</description>
          </group>
          <group group_id="O2">
            <title>SOF+RBV 12 Wk GT 3 TN</title>
            <description>SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 12 weeks (treatment naive, genotype 3)</description>
          </group>
          <group group_id="O3">
            <title>SOF+RBV 24 Wk GT 2 TE</title>
            <description>SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks (treatment experienced, genotype 2)</description>
          </group>
          <group group_id="O4">
            <title>SOF+RBV 24 Wk GT 3 TE</title>
            <description>SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks (treatment experienced, genotype 3)</description>
          </group>
          <group group_id="O5">
            <title>SOF+RBV 24 Wk GT 1 TN</title>
            <description>SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks (treatment naive, genotype 1)</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in HCV RNA at Week 2</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="26"/>
                <count group_id="O2" value="41"/>
                <count group_id="O3" value="24"/>
                <count group_id="O4" value="17"/>
                <count group_id="O5" value="112"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-5.11" spread="0.574"/>
                    <measurement group_id="O2" value="-4.84" spread="0.579"/>
                    <measurement group_id="O3" value="-5.15" spread="0.813"/>
                    <measurement group_id="O4" value="-5.06" spread="0.467"/>
                    <measurement group_id="O5" value="-5.00" spread="0.829"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in HCV RNA at Week 4</title>
        <time_frame>Baseline; Week 4</time_frame>
        <population>Participants in the Full Analysis Set with available data were analyzed.</population>
        <group_list>
          <group group_id="O1">
            <title>SOF+RBV 12 Wk GT 2 TN</title>
            <description>SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 12 weeks (treatment naive, genotype 2)</description>
          </group>
          <group group_id="O2">
            <title>SOF+RBV 12 Wk GT 3 TN</title>
            <description>SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 12 weeks (treatment naive, genotype 3)</description>
          </group>
          <group group_id="O3">
            <title>SOF+RBV 24 Wk GT 2 TE</title>
            <description>SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks (treatment experienced, genotype 2)</description>
          </group>
          <group group_id="O4">
            <title>SOF+RBV 24 Wk GT 3 TE</title>
            <description>SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks (treatment experienced, genotype 3)</description>
          </group>
          <group group_id="O5">
            <title>SOF+RBV 24 Wk GT 1 TN</title>
            <description>SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks (treatment naive, genotype 1)</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in HCV RNA at Week 4</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="26"/>
                <count group_id="O2" value="41"/>
                <count group_id="O3" value="24"/>
                <count group_id="O4" value="17"/>
                <count group_id="O5" value="114"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-5.04" spread="0.710"/>
                    <measurement group_id="O2" value="-4.86" spread="0.602"/>
                    <measurement group_id="O3" value="-5.16" spread="0.820"/>
                    <measurement group_id="O4" value="-5.06" spread="0.467"/>
                    <measurement group_id="O5" value="-5.12" spread="0.957"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in HCV RNA at Week 6</title>
        <time_frame>Baseline; Week 6</time_frame>
        <population>Participants in the Full Analysis Set with available data were analyzed.</population>
        <group_list>
          <group group_id="O1">
            <title>SOF+RBV 12 Wk GT 2 TN</title>
            <description>SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 12 weeks (treatment naive, genotype 2)</description>
          </group>
          <group group_id="O2">
            <title>SOF+RBV 12 Wk GT 3 TN</title>
            <description>SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 12 weeks (treatment naive, genotype 3)</description>
          </group>
          <group group_id="O3">
            <title>SOF+RBV 24 Wk GT 2 TE</title>
            <description>SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks (treatment experienced, genotype 2)</description>
          </group>
          <group group_id="O4">
            <title>SOF+RBV 24 Wk GT 3 TE</title>
            <description>SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks (treatment experienced, genotype 3)</description>
          </group>
          <group group_id="O5">
            <title>SOF+RBV 24 Wk GT 1 TN</title>
            <description>SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks (treatment naive, genotype 1)</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in HCV RNA at Week 6</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="26"/>
                <count group_id="O2" value="41"/>
                <count group_id="O3" value="24"/>
                <count group_id="O4" value="17"/>
                <count group_id="O5" value="110"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-5.13" spread="0.593"/>
                    <measurement group_id="O2" value="-4.86" spread="0.602"/>
                    <measurement group_id="O3" value="-5.16" spread="0.820"/>
                    <measurement group_id="O4" value="-5.06" spread="0.467"/>
                    <measurement group_id="O5" value="-5.20" spread="0.785"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in HCV RNA at Week 8</title>
        <time_frame>Baseline; Week 8</time_frame>
        <population>Participants in the Full Analysis Set with available data were analyzed.</population>
        <group_list>
          <group group_id="O1">
            <title>SOF+RBV 12 Wk GT 2 TN</title>
            <description>SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 12 weeks (treatment naive, genotype 2)</description>
          </group>
          <group group_id="O2">
            <title>SOF+RBV 12 Wk GT 3 TN</title>
            <description>SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 12 weeks (treatment naive, genotype 3)</description>
          </group>
          <group group_id="O3">
            <title>SOF+RBV 24 Wk GT 2 TE</title>
            <description>SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks (treatment experienced, genotype 2)</description>
          </group>
          <group group_id="O4">
            <title>SOF+RBV 24 Wk GT 3 TE</title>
            <description>SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks (treatment experienced, genotype 3)</description>
          </group>
          <group group_id="O5">
            <title>SOF+RBV 24 Wk GT 1 TN</title>
            <description>SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks (treatment naive, genotype 1)</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in HCV RNA at Week 8</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="26"/>
                <count group_id="O2" value="40"/>
                <count group_id="O3" value="24"/>
                <count group_id="O4" value="17"/>
                <count group_id="O5" value="111"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-5.13" spread="0.593"/>
                    <measurement group_id="O2" value="-4.83" spread="0.589"/>
                    <measurement group_id="O3" value="-5.16" spread="0.820"/>
                    <measurement group_id="O4" value="-5.06" spread="0.467"/>
                    <measurement group_id="O5" value="-5.20" spread="0.785"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants Experiencing On-treatment Virologic Failure</title>
        <description>On-treatment virologic failure was defined as:&#xD;
Viral breakthrough: HCV RNA ≥ LLOQ after having previously had HCV RNA &lt; LLOQ while on treatment, confirmed with 2 consecutive values (second confirmation value may have been posttreatment) or with a last available on-treatment measurement and no subsequent follow-up values, or&#xD;
Viral rebound: &gt; 1 log10 IU/mL increase in HCV RNA from nadir while on treatment, confirmed with 2 consecutive values (second confirmation value may have been posttreatment) or with a last available on-treatment measurement and no subsequent follow-up values, or&#xD;
Nonresponse: HCV RNA persistently ≥ LLOQ through 8 weeks of treatment</description>
        <time_frame>Up to 24 weeks</time_frame>
        <population>Full Analysis Set</population>
        <group_list>
          <group group_id="O1">
            <title>SOF+RBV 12 Wk GT 2 TN</title>
            <description>SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 12 weeks (treatment naive, genotype 2)</description>
          </group>
          <group group_id="O2">
            <title>SOF+RBV 12 Wk GT 3 TN</title>
            <description>SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 12 weeks (treatment naive, genotype 3)</description>
          </group>
          <group group_id="O3">
            <title>SOF+RBV 24 Wk GT 2 TE</title>
            <description>SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks (treatment experienced, genotype 2)</description>
          </group>
          <group group_id="O4">
            <title>SOF+RBV 24 Wk GT 3 TE</title>
            <description>SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks (treatment experienced, genotype 3)</description>
          </group>
          <group group_id="O5">
            <title>SOF+RBV 24 Wk GT 1 TN</title>
            <description>SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks (treatment naive, genotype 1)</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Experiencing On-treatment Virologic Failure</title>
          <description>On-treatment virologic failure was defined as:&#xD;
Viral breakthrough: HCV RNA ≥ LLOQ after having previously had HCV RNA &lt; LLOQ while on treatment, confirmed with 2 consecutive values (second confirmation value may have been posttreatment) or with a last available on-treatment measurement and no subsequent follow-up values, or&#xD;
Viral rebound: &gt; 1 log10 IU/mL increase in HCV RNA from nadir while on treatment, confirmed with 2 consecutive values (second confirmation value may have been posttreatment) or with a last available on-treatment measurement and no subsequent follow-up values, or&#xD;
Nonresponse: HCV RNA persistently ≥ LLOQ through 8 weeks of treatment</description>
          <population>Full Analysis Set</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="26"/>
                <count group_id="O2" value="42"/>
                <count group_id="O3" value="24"/>
                <count group_id="O4" value="17"/>
                <count group_id="O5" value="114"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.8"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants Experiencing Viral Relapse</title>
        <description>Viral relapse was defined as having achieved undetectable HCV RNA levels (HCV RNA &lt; LLOQ) at end of treatment, but did not achieve an SVR.</description>
        <time_frame>Up to Posttreatment Week 24</time_frame>
        <population>Participants in the Full Analysis Set with available data were analyzed.</population>
        <group_list>
          <group group_id="O1">
            <title>SOF+RBV 12 Wk GT 2 TN</title>
            <description>SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 12 weeks (treatment naive, genotype 2)</description>
          </group>
          <group group_id="O2">
            <title>SOF+RBV 12 Wk GT 3 TN</title>
            <description>SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 12 weeks (treatment naive, genotype 3)</description>
          </group>
          <group group_id="O3">
            <title>SOF+RBV 24 Wk GT 2 TE</title>
            <description>SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks (treatment experienced, genotype 2)</description>
          </group>
          <group group_id="O4">
            <title>SOF+RBV 24 Wk GT 3 TE</title>
            <description>SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks (treatment experienced, genotype 3)</description>
          </group>
          <group group_id="O5">
            <title>SOF+RBV 24 Wk GT 1 TN</title>
            <description>SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks (treatment naive, genotype 1)</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Experiencing Viral Relapse</title>
          <description>Viral relapse was defined as having achieved undetectable HCV RNA levels (HCV RNA &lt; LLOQ) at end of treatment, but did not achieve an SVR.</description>
          <population>Participants in the Full Analysis Set with available data were analyzed.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="25"/>
                <count group_id="O2" value="42"/>
                <count group_id="O3" value="24"/>
                <count group_id="O4" value="17"/>
                <count group_id="O5" value="113"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="28.6"/>
                    <measurement group_id="O3" value="4.2"/>
                    <measurement group_id="O4" value="5.9"/>
                    <measurement group_id="O5" value="22.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Up to 24 weeks plus 30 days</time_frame>
      <desc>Safety Analysis Set</desc>
      <group_list>
        <group group_id="E1">
          <title>SOF+RBV 12 Wk GT 2/3 TN</title>
          <description>SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 12 weeks (treatment naive, genotypes 2 and 3)</description>
        </group>
        <group group_id="E2">
          <title>SOF+RBV 24 Wk GT 2/3 TE</title>
          <description>SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks (treatment experienced, genotypes 2 and 3)</description>
        </group>
        <group group_id="E3">
          <title>SOF+RBV 24 Wk GT 1 TN</title>
          <description>SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks (treatment naive, genotype 1)</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA Version 16.1</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="68"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="41"/>
                <counts group_id="E3" subjects_affected="8" subjects_at_risk="114"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Anaemia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="114"/>
              </event>
              <event>
                <sub_title>Leukocytosis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="114"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Atrial fibrillation</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="114"/>
              </event>
              <event>
                <sub_title>Atrial flutter</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="114"/>
              </event>
              <event>
                <sub_title>Acute myocardial infarction</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="68"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="114"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Abdominal pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="114"/>
              </event>
              <event>
                <sub_title>Colitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="114"/>
              </event>
              <event>
                <sub_title>Enteritis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="114"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Chest pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="114"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Cellulitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="114"/>
              </event>
              <event>
                <sub_title>Pneumonia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="68"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="41"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="114"/>
              </event>
              <event>
                <sub_title>Gastroenteritis salmonella</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="114"/>
              </event>
              <event>
                <sub_title>Respiratory tract infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="114"/>
              </event>
              <event>
                <sub_title>Incision site infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="68"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="114"/>
              </event>
              <event>
                <sub_title>Septic shock</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="68"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="114"/>
              </event>
              <event>
                <sub_title>Staphylococcal bacteraemia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="68"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="114"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Intentional overdose</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="68"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="114"/>
              </event>
              <event>
                <sub_title>Fracture</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="68"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="114"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Diabetic ketoacidosis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="114"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Altered state of consciousness</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="114"/>
              </event>
              <event>
                <sub_title>Encephalopathy</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="68"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="114"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Bipolar disorder</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="114"/>
              </event>
              <event>
                <sub_title>Completed suicide</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="68"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="114"/>
              </event>
              <event>
                <sub_title>Drug abuse</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="68"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="114"/>
              </event>
              <event>
                <sub_title>Suicide attempt</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="68"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="114"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Renal failure acute</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="68"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="114"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Chronic obstructive pulmonary disease</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="41"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="114"/>
              </event>
              <event>
                <sub_title>Pulmonary embolism</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="68"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="114"/>
              </event>
              <event>
                <sub_title>Respiratory failure</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="68"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="114"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Leukocytoclastic vasculitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="41"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="114"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedDRA Version 16.1</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="57" subjects_at_risk="68"/>
                <counts group_id="E2" subjects_affected="37" subjects_at_risk="41"/>
                <counts group_id="E3" subjects_affected="106" subjects_at_risk="114"/>
              </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="6" subjects_at_risk="68"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="41"/>
                <counts group_id="E3" subjects_affected="12" subjects_at_risk="114"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" subjects_affected="12" subjects_at_risk="68"/>
                <counts group_id="E2" subjects_affected="6" subjects_at_risk="41"/>
                <counts group_id="E3" subjects_affected="18" subjects_at_risk="114"/>
              </event>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="68"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="41"/>
                <counts group_id="E3" subjects_affected="12" subjects_at_risk="114"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="68"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="41"/>
                <counts group_id="E3" subjects_affected="11" subjects_at_risk="114"/>
              </event>
              <event>
                <sub_title>Abdominal pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="68"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="41"/>
                <counts group_id="E3" subjects_affected="6" subjects_at_risk="114"/>
              </event>
              <event>
                <sub_title>Constipation</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="68"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="41"/>
                <counts group_id="E3" subjects_affected="6" subjects_at_risk="114"/>
              </event>
              <event>
                <sub_title>Abdominal discomfort</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="68"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="41"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="114"/>
              </event>
              <event>
                <sub_title>Abdominal distension</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E3" subjects_affected="6" subjects_at_risk="114"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Fatigue</sub_title>
                <counts group_id="E1" subjects_affected="24" subjects_at_risk="68"/>
                <counts group_id="E2" subjects_affected="19" subjects_at_risk="41"/>
                <counts group_id="E3" subjects_affected="41" subjects_at_risk="114"/>
              </event>
              <event>
                <sub_title>Irritability</sub_title>
                <counts group_id="E1" subjects_affected="7" subjects_at_risk="68"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="41"/>
                <counts group_id="E3" subjects_affected="14" subjects_at_risk="114"/>
              </event>
              <event>
                <sub_title>Pyrexia</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="68"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="41"/>
                <counts group_id="E3" subjects_affected="7" subjects_at_risk="114"/>
              </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="8" subjects_at_risk="68"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="41"/>
                <counts group_id="E3" subjects_affected="13" subjects_at_risk="114"/>
              </event>
              <event>
                <sub_title>Bronchitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="68"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="41"/>
                <counts group_id="E3" subjects_affected="11" subjects_at_risk="114"/>
              </event>
              <event>
                <sub_title>Nasopharyngitis</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="68"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E3" subjects_affected="10" subjects_at_risk="114"/>
              </event>
              <event>
                <sub_title>Oral herpes</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="68"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="41"/>
                <counts group_id="E3" subjects_affected="5" subjects_at_risk="114"/>
              </event>
              <event>
                <sub_title>Herpes simplex</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="68"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="114"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Decreased appetite</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="68"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="41"/>
                <counts group_id="E3" subjects_affected="7" subjects_at_risk="114"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Back pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="41"/>
                <counts group_id="E3" subjects_affected="6" subjects_at_risk="114"/>
              </event>
              <event>
                <sub_title>Arthralgia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="68"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E3" subjects_affected="7" subjects_at_risk="114"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" subjects_affected="9" subjects_at_risk="68"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="41"/>
                <counts group_id="E3" subjects_affected="16" subjects_at_risk="114"/>
              </event>
              <event>
                <sub_title>Dizziness</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="68"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="41"/>
                <counts group_id="E3" subjects_affected="7" subjects_at_risk="114"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Insomnia</sub_title>
                <counts group_id="E1" subjects_affected="14" subjects_at_risk="68"/>
                <counts group_id="E2" subjects_affected="8" subjects_at_risk="41"/>
                <counts group_id="E3" subjects_affected="15" subjects_at_risk="114"/>
              </event>
              <event>
                <sub_title>Depression</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="68"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="41"/>
                <counts group_id="E3" subjects_affected="8" subjects_at_risk="114"/>
              </event>
              <event>
                <sub_title>Anxiety</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="68"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E3" subjects_affected="8" subjects_at_risk="114"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Cough</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="68"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="41"/>
                <counts group_id="E3" subjects_affected="14" subjects_at_risk="114"/>
              </event>
              <event>
                <sub_title>Dyspnoea</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="68"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="41"/>
                <counts group_id="E3" subjects_affected="9" subjects_at_risk="114"/>
              </event>
              <event>
                <sub_title>Nasal congestion</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="68"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="41"/>
                <counts group_id="E3" subjects_affected="8" subjects_at_risk="114"/>
              </event>
              <event>
                <sub_title>Respiratory tract congestion</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="68"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="41"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="114"/>
              </event>
              <event>
                <sub_title>Sinus congestion</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="68"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="41"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="114"/>
              </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="3" subjects_at_risk="68"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="41"/>
                <counts group_id="E3" subjects_affected="7" subjects_at_risk="114"/>
              </event>
              <event>
                <sub_title>Pruritus</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="68"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="41"/>
                <counts group_id="E3" subjects_affected="6" subjects_at_risk="114"/>
              </event>
              <event>
                <sub_title>Dry skin</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="68"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E3" subjects_affected="6" subjects_at_risk="114"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

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


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01667731
org study id: GS-US-334-0123
nct id: NCT01667731
lead sponsor: 
has dmc: Yes
This study will evaluate the efficacy, safety, and tolerability of sofosbuvir (SOF; GS-7977)
      plus ribavirin (RBV) in adults with chronic genotypes 1, 2, and 3 HCV infection who are
      coinfected with HIV-1.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Percentage of Participants With Sustained Virologic Response (SVR) at 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, 25 IU/mL) at 12 weeks after stopping study treatment.
measure: Incidence of Adverse Events Leading to Permanent Discontinuation of Study Drug(s)
time frame: Up to 24 weeks
description: The percentage of participants discontinuing any study drug due to an adverse event was summarized.
measure: Percentage of Participants With Sustained Virologic Response at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)
time frame: Posttreatment Weeks 4 and 24
description: SVR4 and SVR24 were defined as HCV RNA < LLOQ at 4 and 24 weeks following the last dose of study drug, respectively.
measure: Change From Baseline in HCV RNA at Week 1
time frame: Baseline; Week 1
measure: Change From Baseline in HCV RNA at Week 2
time frame: Baseline; Week 2
measure: Change From Baseline in HCV RNA at Week 4
time frame: Baseline; Week 4
measure: Change From Baseline in HCV RNA at Week 6
time frame: Baseline; Week 6
measure: Change From Baseline in HCV RNA at Week 8
time frame: Baseline; Week 8
measure: Percentage of Participants Experiencing On-treatment Virologic Failure
time frame: Up to 24 weeks
description: On-treatment virologic failure was defined as:
Viral breakthrough: HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ while on treatment, confirmed with 2 consecutive values (second confirmation value may have been posttreatment) or with a last available on-treatment measurement and no subsequent follow-up values, or
Viral rebound: > 1 log10 IU/mL increase in HCV RNA from nadir while on treatment, confirmed with 2 consecutive values (second confirmation value may have been posttreatment) or with a last available on-treatment measurement and no subsequent follow-up values, or
Nonresponse: HCV RNA persistently ≥ LLOQ through 8 weeks of treatment
measure: Percentage of Participants Experiencing Viral Relapse
time frame: Up to Posttreatment Week 24
description: Viral relapse was defined as having achieved undetectable HCV RNA levels (HCV RNA < LLOQ) at end of treatment, but did not achieve an SVR.
arm group label: SOF+RBV 12 Weeks (GT 2/3, TN)
arm group type: Experimental
description: Treatment-naive (TN) participants coinfected with HIV-1 and genotype (GT) 2 or genotype 3 HCV infection will receive SOF+RBV for 12 weeks.
arm group label: SOF+RBV 24 Weeks (GT 2/3, TE)
arm group type: Experimental
description: Treatment-experienced (TE) participants coinfected with HIV-1 and genotype 2 or genotype 3 HCV infection will receive SOF+RBV for 24 weeks.
arm group label: SOF+RBV 24 Weeks (GT 1, TN)
arm group type: Experimental
description: Treatment-naive (TN) participants coinfected with HIV-1 and genotype 1 HCV infection will receive SOF+RBV for 24 weeks.
intervention type: Drug
intervention name: SOF
description: Sofosbuvir (SOF) 400 mg tablet administered orally once daily
arm group label: SOF+RBV 12 Weeks (GT 2/3, TN)
arm group label: SOF+RBV 24 Weeks (GT 1, TN)
arm group label: SOF+RBV 24 Weeks (GT 2/3, TE)
other name: GS-7977
other name: PSI-7977
other name: Sovaldi®
intervention type: Drug
intervention name: RBV
description: Ribavirin (RBV) tablets administered orally in a divided daily dose according to package insert weight-based dosing recommendations (< 75kg = 1000 mg and ≥ 75 kg = 1200 mg)
arm group label: SOF+RBV 12 Weeks (GT 2/3, TN)
arm group label: SOF+RBV 24 Weeks (GT 1, TN)
arm group label: SOF+RBV 24 Weeks (GT 2/3, TE)
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Anuj Gaggar, MD, PhD
role: Study Director
affiliation: Gilead Sciences
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country: Puerto Rico
country: United States
responsible party type: Sponsor
mesh term: Hepatitis A
mesh term: Hepatitis C
mesh term: Acquired Immunodeficiency Syndrome
mesh term: HIV Infections
mesh term: Hepatitis
mesh term: Immunologic Deficiency Syndromes
mesh term: Sofosbuvir
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