<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/NCT01726517</url>
  </required_header>
  <id_info>
    <org_study_id>GS-US-337-0118</org_study_id>
    <nct_id>NCT01726517</nct_id>
  </id_info>
  <brief_title>Safety and Efficacy of LDV/SOF Fixed-Dose Combination (FDC) ± Ribavirin in HCV Genotype 1 Subjects</brief_title>
  <official_title>A Phase 2, Randomized, Open-Label Study of Sofosbuvir/GS-5885 Fixed-Dose Combination ± Ribavirin in Subjects With Chronic Genotype 1 HCV Infection</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Gilead Sciences</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Gilead Sciences</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study is to evaluate the safety, tolerability, and antiviral efficacy of&#xD;
      ledipasvir/sofosbuvir (LDV/SOF) fixed-dose combination (FDC) with or without ribavirin (RBV),&#xD;
      administered for 8 or 12 weeks of treatment in participants with chronic genotype 1 hepatitis&#xD;
      C virus (HCV) infection who are treatment-naive, and for 12 weeks in participants who had&#xD;
      previously received a regimen containing a protease inhibitor for the treatment of HCV.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>October 2012</start_date>
  <completion_date type="Actual">January 2014</completion_date>
  <primary_completion_date type="Actual">July 2013</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Percentage of Participants With Sustained Virologic Response (SVR) 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) 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>Baseline to Week 12</time_frame>
    <description>The number of participants experiencing an adverse event leading to permanent discontinuation of study drug(s) was summarized.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With SVR at 2, 4, 8, and 24 Weeks After Discontinuation of Therapy (SVR2, SVR4, SVR8, and SVR24)</measure>
    <time_frame>Posttreatment Weeks 2, 4, 8, and 24</time_frame>
    <description>SVR2, SVR4, SVR8, and SVR24 was defined as HCV RNA &lt; LLOQ at 2, 4, 8, and 24 weeks following the last dose of study drug, respectively.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Experiencing Viral Breakthrough or Viral Relapse</measure>
    <time_frame>Baseline to Posttreatment Week 24</time_frame>
    <description>Viral breakthrough was defined as HCV RNA ≥ LLOQ after having previously had HCV RNA &lt; LLOQ while receiving treatment, confirmed with 2 consecutive values (second confirmation value could be posttreatment), or last available on-treatment measurement with no subsequent follow-up values.&#xD;
Viral relapse was defined as HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA &lt; LLOQ at end of treatment, confirmed with 2 consecutive values or last available posttreatment measurement.</description>
  </secondary_outcome>
  <number_of_arms>5</number_of_arms>
  <enrollment type="Actual">100</enrollment>
  <condition>Chronic Hepatitis C Virus</condition>
  <arm_group>
    <arm_group_label>LDV/SOF 8 Weeks (TN)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Treatment-naive (TN) participants will be randomized to receive LDV/SOF for 8 weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>LDV/SOF+RBV 8 Weeks (TN)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Treatment-naive participants will be randomized to receive LDV/SOF plus RBV for 8 weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>LDV/SOF 12 Weeks (TN)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Treatment-naive participants will be randomized to receive LDV/SOF for 12 weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>LDV/SOF 12 Weeks (TE)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Treatment-experienced (TE) participants (had virologic failure following prior therapy with a protease-inhibitor [PI]+pegylated interferon [PEG]+RBV regimen) will be randomized to receive LDV/SOF for 12 weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>LDV/SOF+RBV 12 Weeks (TE)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Treatment-experienced participants (had virologic failure following prior therapy with a PI+PEG+RBV regimen) will be randomized to receive LDV/SOF plus RBV for 12 weeks.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>LDV/SOF</intervention_name>
    <description>LDV 90 mg/SOF 400 mg FDC tablet administered orally once daily</description>
    <arm_group_label>LDV/SOF 12 Weeks (TE)</arm_group_label>
    <arm_group_label>LDV/SOF 12 Weeks (TN)</arm_group_label>
    <arm_group_label>LDV/SOF 8 Weeks (TN)</arm_group_label>
    <arm_group_label>LDV/SOF+RBV 12 Weeks (TE)</arm_group_label>
    <arm_group_label>LDV/SOF+RBV 8 Weeks (TN)</arm_group_label>
    <other_name>Harvoni®</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>RBV</intervention_name>
    <description>RBV tablets administered orally in a divided daily dose according to package insert weight-based dosing recommendations (&lt; 75 kg = 1000 mg and ≥ 75 kg = 1200 mg)</description>
    <arm_group_label>LDV/SOF+RBV 12 Weeks (TE)</arm_group_label>
    <arm_group_label>LDV/SOF+RBV 8 Weeks (TN)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age ≥ 18 years, with chronic genotype 1 HCV infection&#xD;
&#xD;
          -  HCV RNA equal to or greater than 10,000 IU/mL at screening&#xD;
&#xD;
          -  Cirrhosis determination; a liver biopsy may be required&#xD;
&#xD;
          -  Screening laboratory values within defined thresholds&#xD;
&#xD;
          -  Use of two effective contraception methods if female of childbearing potential or&#xD;
             sexually active male&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnant or nursing female or male with pregnant female partner&#xD;
&#xD;
          -  Current or prior history of clinical hepatic decompensation&#xD;
&#xD;
          -  Hepatocellular carcinoma (HCC) or other malignancy (with exception of certain resolved&#xD;
             skin cancers)&#xD;
&#xD;
          -  Chronic use of systemic immunosuppressive agents&#xD;
&#xD;
          -  History of clinically significant illness or any other medical disorder that may&#xD;
             interfere with subject treatment, assessment or compliance with the protocol&#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>Rob Hyland</last_name>
    <role>Study Director</role>
    <affiliation>Gilead Sciences</affiliation>
  </overall_official>
  <location>
    <facility>
      <address>
        <city>San Antonio</city>
        <state>Texas</state>
        <zip>78215</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>November 2014</verification_date>
  <study_first_submitted>November 10, 2012</study_first_submitted>
  <study_first_submitted_qc>November 10, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 15, 2012</study_first_posted>
  <results_first_submitted>November 7, 2014</results_first_submitted>
  <results_first_submitted_qc>November 7, 2014</results_first_submitted_qc>
  <results_first_posted type="Estimate">November 17, 2014</results_first_posted>
  <disposition_first_submitted>March 17, 2014</disposition_first_submitted>
  <disposition_first_submitted_qc>March 17, 2014</disposition_first_submitted_qc>
  <disposition_first_posted type="Estimate">April 14, 2014</disposition_first_posted>
  <last_update_submitted>October 19, 2018</last_update_submitted>
  <last_update_submitted_qc>October 19, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">November 16, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>HCV genotype 1 (GT-1)</keyword>
  <keyword>HCV</keyword>
  <keyword>Sustained Virologic Response</keyword>
  <keyword>Direct Acting Antiviral</keyword>
  <keyword>Combination Therapy</keyword>
  <keyword>GS-7977</keyword>
  <keyword>GS-5885</keyword>
  <keyword>Ribavirin</keyword>
  <keyword>Open Label</keyword>
  <keyword>Sofosbuvir</keyword>
  <keyword>Treatment-Naïve</keyword>
  <keyword>Protease Inhibitors</keyword>
  <keyword>PI</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hepatitis C</mesh_term>
    <mesh_term>Hepatitis C, Chronic</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Ledipasvir, sofosbuvir drug combination</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Qualified external researchers may request IPD for this study after study completion. For more information, please visit our website at http://www.gilead.com/research/disclosure-and-transparency.</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_time_frame>18 months after study completion</ipd_time_frame>
    <ipd_access_criteria>A secured external environment with username, password, and RSA code.</ipd_access_criteria>
    <ipd_url>http://www.gilead.com/research/disclosure-and-transparency</ipd_url>
  </patient_data>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Participants were enrolled at 1 study site in the United States. The first participant was screened on 22 October 2012. The last participant observation was on 13 January 2014.</recruitment_details>
      <pre_assignment_details>116 participants were screened.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>LDV/SOF 8 Weeks (TN)</title>
          <description>Treatment-naive (TN) participants were randomized to receive ledipasvir (LDV) 90 mg/sofosbuvir (SOF) 400 mg for 8 weeks.</description>
        </group>
        <group group_id="P2">
          <title>LDV/SOF+RBV 8 Weeks (TN)</title>
          <description>Treatment-naive participants were randomized to receive LDV 90 mg/SOF 400 mg plus weight-based ribavirin (RBV) (1000-1200 mg) for 8 weeks.</description>
        </group>
        <group group_id="P3">
          <title>LDV/SOF 12 Weeks (TN)</title>
          <description>Treatment-naive participants were randomized to receive LDV 90 mg/SOF 400 mg for 12 weeks.</description>
        </group>
        <group group_id="P4">
          <title>LDV/SOF 12 Weeks (TE)</title>
          <description>Treatment-experienced (TE) participants (had virologic failure following prior therapy with a protease-inhibitor [PI]+pegylated interferon [PEG]+RBV regimen) were randomized to receive LDV 90 mg/SOF 400 mg for 12 weeks.</description>
        </group>
        <group group_id="P5">
          <title>LDV/SOF+RBV 12 Weeks (TE)</title>
          <description>Treatment-experienced participants (had virologic failure following prior therapy with a PI+PEG+RBV regimen) were randomized to receive LDV 90 mg/SOF 400 mg plus weight-based RBV (1000-1200 mg) for 12 weeks.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="20"/>
                <participants group_id="P2" count="21"/>
                <participants group_id="P3" count="19"/>
                <participants group_id="P4" count="19"/>
                <participants group_id="P5" count="21"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="20"/>
                <participants group_id="P2" count="21"/>
                <participants group_id="P3" count="18"/>
                <participants group_id="P4" count="19"/>
                <participants group_id="P5" count="21"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="1"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="1"/>
                <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 received at least 1 dose of study drug</population>
      <group_list>
        <group group_id="B1">
          <title>LDV/SOF 8 Weeks (TN)</title>
          <description>Treatment-naive participants were randomized to receive LDV 90 mg/SOF 400 mg for 8 weeks.</description>
        </group>
        <group group_id="B2">
          <title>LDV/SOF+RBV 8 Weeks (TN)</title>
          <description>Treatment-naive participants were randomized to receive LDV 90 mg/SOF 400 mg plus weight-based RBV (1000-1200 mg) for 8 weeks.</description>
        </group>
        <group group_id="B3">
          <title>LDV/SOF 12 Weeks (TN)</title>
          <description>Treatment-naive participants were randomized to receive LDV 90 mg/SOF 400 mg for 12 weeks.</description>
        </group>
        <group group_id="B4">
          <title>LDV/SOF 12 Weeks (TE)</title>
          <description>Treatment-experienced participants (had virologic failure following prior therapy with a PI+PEG+RBV regimen) were randomized to receive LDV 90 mg/SOF 400 mg for 12 weeks.</description>
        </group>
        <group group_id="B5">
          <title>LDV/SOF+RBV 12 Weeks (TE)</title>
          <description>Treatment-experienced participants (had virologic failure following prior therapy with a PI+PEG+RBV regimen) were randomized to receive LDV 90 mg/SOF 400 mg plus weight-based RBV (1000-1200 mg) for 12 weeks.</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="20"/>
            <count group_id="B2" value="21"/>
            <count group_id="B3" value="19"/>
            <count group_id="B4" value="19"/>
            <count group_id="B5" value="21"/>
            <count group_id="B6" value="100"/>
          </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="48" spread="10.7"/>
                    <measurement group_id="B2" value="50" spread="11.1"/>
                    <measurement group_id="B3" value="46" spread="11.6"/>
                    <measurement group_id="B4" value="54" spread="6.6"/>
                    <measurement group_id="B5" value="52" spread="9.8"/>
                    <measurement group_id="B6" value="50" spread="10.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                    <measurement group_id="B2" value="9"/>
                    <measurement group_id="B3" value="8"/>
                    <measurement group_id="B4" value="4"/>
                    <measurement group_id="B5" value="7"/>
                    <measurement group_id="B6" value="34"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="14"/>
                    <measurement group_id="B2" value="12"/>
                    <measurement group_id="B3" value="11"/>
                    <measurement group_id="B4" value="15"/>
                    <measurement group_id="B5" value="14"/>
                    <measurement group_id="B6" value="66"/>
                  </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="3"/>
                    <measurement group_id="B2" value="12"/>
                    <measurement group_id="B3" value="9"/>
                    <measurement group_id="B4" value="6"/>
                    <measurement group_id="B5" value="10"/>
                    <measurement group_id="B6" value="40"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="17"/>
                    <measurement group_id="B2" value="9"/>
                    <measurement group_id="B3" value="10"/>
                    <measurement group_id="B4" value="13"/>
                    <measurement group_id="B5" value="11"/>
                    <measurement group_id="B6" value="60"/>
                  </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 (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="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>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</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>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="2"/>
                    <measurement group_id="B5" value="2"/>
                    <measurement group_id="B6" value="9"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="15"/>
                    <measurement group_id="B2" value="21"/>
                    <measurement group_id="B3" value="17"/>
                    <measurement group_id="B4" value="16"/>
                    <measurement group_id="B5" value="19"/>
                    <measurement group_id="B6" value="88"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</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>
                  <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>Hepatitis C Virus (HCV) Genotype</title>
          <description>There are variations within HCV genotype 1 which are distinct enough to be referred to as genotypes 1a or 1b.</description>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>1a</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="17"/>
                    <measurement group_id="B2" value="19"/>
                    <measurement group_id="B3" value="17"/>
                    <measurement group_id="B4" value="18"/>
                    <measurement group_id="B5" value="16"/>
                    <measurement group_id="B6" value="87"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>1b</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="2"/>
                    <measurement group_id="B4" value="1"/>
                    <measurement group_id="B5" value="5"/>
                    <measurement group_id="B6" value="13"/>
                  </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="4"/>
                    <measurement group_id="B2" value="7"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="2"/>
                    <measurement group_id="B5" value="1"/>
                    <measurement group_id="B6" value="15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>CT</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="12"/>
                    <measurement group_id="B2" value="11"/>
                    <measurement group_id="B3" value="14"/>
                    <measurement group_id="B4" value="13"/>
                    <measurement group_id="B5" value="11"/>
                    <measurement group_id="B6" value="61"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>TT</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="4"/>
                    <measurement group_id="B4" value="4"/>
                    <measurement group_id="B5" value="9"/>
                    <measurement group_id="B6" value="24"/>
                  </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="6.1" spread="0.82"/>
                    <measurement group_id="B2" value="6.0" spread="0.84"/>
                    <measurement group_id="B3" value="6.1" spread="0.79"/>
                    <measurement group_id="B4" value="6.3" spread="0.49"/>
                    <measurement group_id="B5" value="6.2" spread="0.42"/>
                    <measurement group_id="B6" value="6.1" spread="0.69"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>HCV RNA Category</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>&lt; 800,000 IU/mL</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="9"/>
                    <measurement group_id="B2" value="7"/>
                    <measurement group_id="B3" value="7"/>
                    <measurement group_id="B4" value="4"/>
                    <measurement group_id="B5" value="5"/>
                    <measurement group_id="B6" value="32"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>≥ 800,000 IU/mL</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="11"/>
                    <measurement group_id="B2" value="14"/>
                    <measurement group_id="B3" value="12"/>
                    <measurement group_id="B4" value="15"/>
                    <measurement group_id="B5" value="16"/>
                    <measurement group_id="B6" value="68"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Prior HCV Treatment and Response</title>
          <description>Prior HCV treatment and response was only collected for treatment-experienced participants in the LDV/SOF 12 Weeks (TE) and LDV/SOF+RBV 12 Weeks (TE) groups.</description>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>Non-responder to PI boceprevir</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="9"/>
                    <measurement group_id="B5" value="9"/>
                    <measurement group_id="B6" value="18"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Relapse/Breakthrough to PI boceprevir</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="2"/>
                    <measurement group_id="B5" value="2"/>
                    <measurement group_id="B6" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Non-responder to PI telaprevir</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="3"/>
                    <measurement group_id="B5" value="6"/>
                    <measurement group_id="B6" value="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Relapse/Breakthrough to PI telaprevir</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="5"/>
                    <measurement group_id="B5" value="4"/>
                    <measurement group_id="B6" value="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Cirrhosis</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>No</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="20"/>
                    <measurement group_id="B2" value="21"/>
                    <measurement group_id="B3" value="19"/>
                    <measurement group_id="B4" value="8"/>
                    <measurement group_id="B5" value="10"/>
                    <measurement group_id="B6" value="78"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Yes</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="11"/>
                    <measurement group_id="B5" value="11"/>
                    <measurement group_id="B6" value="22"/>
                  </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) 12 weeks after stopping study treatment.</description>
        <time_frame>Posttreatment Week 12</time_frame>
        <population>Full Analysis Set: participants were randomized and received at least 1 dose of study drug</population>
        <group_list>
          <group group_id="O1">
            <title>LDV/SOF 8 Weeks (TN)</title>
            <description>Treatment-naive participants were randomized to receive LDV 90 mg/SOF 400 mg for 8 weeks.</description>
          </group>
          <group group_id="O2">
            <title>LDV/SOF+RBV 8 Weeks (TN)</title>
            <description>Treatment-naive participants were randomized to receive LDV 90 mg/SOF 400 mg plus weight-based RBV (1000-1200 mg) for 8 weeks.</description>
          </group>
          <group group_id="O3">
            <title>LDV/SOF 12 Weeks (TN)</title>
            <description>Treatment-naive participants were randomized to receive LDV 90 mg/SOF 400 mg for 12 weeks.</description>
          </group>
          <group group_id="O4">
            <title>LDV/SOF 12 Weeks (TE)</title>
            <description>Treatment-experienced participants (had virologic failure following prior therapy with a PI+PEG+RBV regimen) were randomized to receive LDV 90 mg/SOF 400 mg for 12 weeks.</description>
          </group>
          <group group_id="O5">
            <title>LDV/SOF+RBV 12 Weeks (TE)</title>
            <description>Treatment-experienced participants (had virologic failure following prior therapy with a PI+PEG+RBV regimen) were randomized to receive LDV 90 mg/SOF 400 mg plus weight-based RBV (1000-1200 mg) for 12 weeks.</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) 12 weeks after stopping study treatment.</description>
          <population>Full Analysis Set: participants were randomized 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="20"/>
                <count group_id="O2" value="21"/>
                <count group_id="O3" value="19"/>
                <count group_id="O4" value="19"/>
                <count group_id="O5" value="21"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="95.0"/>
                    <measurement group_id="O2" value="100.0"/>
                    <measurement group_id="O3" value="94.7"/>
                    <measurement group_id="O4" value="94.7"/>
                    <measurement group_id="O5" value="100.0"/>
                  </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 number of participants experiencing an adverse event leading to permanent discontinuation of study drug(s) was summarized.</description>
        <time_frame>Baseline to Week 12</time_frame>
        <population>Safety Analysis Set</population>
        <group_list>
          <group group_id="O1">
            <title>LDV/SOF 8 Weeks (TN)</title>
            <description>Treatment-naive participants were randomized to receive LDV 90 mg/SOF 400 mg for 8 weeks.</description>
          </group>
          <group group_id="O2">
            <title>LDV/SOF+RBV 8 Weeks (TN)</title>
            <description>Treatment-naive participants were randomized to receive LDV 90 mg/SOF 400 mg plus weight-based RBV (1000-1200 mg) for 8 weeks.</description>
          </group>
          <group group_id="O3">
            <title>LDV/SOF 12 Weeks (TN)</title>
            <description>Treatment-naive participants were randomized to receive LDV 90 mg/SOF 400 mg for 12 weeks.</description>
          </group>
          <group group_id="O4">
            <title>LDV/SOF 12 Weeks (TE)</title>
            <description>Treatment-experienced participants (had virologic failure following prior therapy with a PI+PEG+RBV regimen) were randomized to receive LDV 90 mg/SOF 400 mg for 12 weeks.</description>
          </group>
          <group group_id="O5">
            <title>LDV/SOF+RBV 12 Weeks (TE)</title>
            <description>Treatment-experienced participants (had virologic failure following prior therapy with a PI+PEG+RBV regimen) were randomized to receive LDV 90 mg/SOF 400 mg plus weight-based RBV (1000-1200 mg) for 12 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Incidence of Adverse Events Leading to Permanent Discontinuation of Study Drug(s)</title>
          <description>The number of participants experiencing an adverse event leading to permanent discontinuation of study drug(s) was summarized.</description>
          <population>Safety Analysis Set</population>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="20"/>
                <count group_id="O2" value="21"/>
                <count group_id="O3" value="19"/>
                <count group_id="O4" value="19"/>
                <count group_id="O5" value="21"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With SVR at 2, 4, 8, and 24 Weeks After Discontinuation of Therapy (SVR2, SVR4, SVR8, and SVR24)</title>
        <description>SVR2, SVR4, SVR8, and SVR24 was defined as HCV RNA &lt; LLOQ at 2, 4, 8, and 24 weeks following the last dose of study drug, respectively.</description>
        <time_frame>Posttreatment Weeks 2, 4, 8, and 24</time_frame>
        <population>Full Analysis Set</population>
        <group_list>
          <group group_id="O1">
            <title>LDV/SOF 8 Weeks (TN)</title>
            <description>Treatment-naive participants were randomized to receive LDV 90 mg/SOF 400 mg for 8 weeks.</description>
          </group>
          <group group_id="O2">
            <title>LDV/SOF+RBV 8 Weeks (TN)</title>
            <description>Treatment-naive participants were randomized to receive LDV 90 mg/SOF 400 mg plus weight-based RBV (1000-1200 mg) for 8 weeks.</description>
          </group>
          <group group_id="O3">
            <title>LDV/SOF 12 Weeks (TN)</title>
            <description>Treatment-naive participants were randomized to receive LDV 90 mg/SOF 400 mg for 12 weeks.</description>
          </group>
          <group group_id="O4">
            <title>LDV/SOF 12 Weeks (TE)</title>
            <description>Treatment-experienced participants (had virologic failure following prior therapy with a PI+PEG+RBV regimen) were randomized to receive LDV 90 mg/SOF 400 mg for 12 weeks.</description>
          </group>
          <group group_id="O5">
            <title>LDV/SOF+RBV 12 Weeks (TE)</title>
            <description>Treatment-experienced participants (had virologic failure following prior therapy with a PI+PEG+RBV regimen) were randomized to receive LDV 90 mg/SOF 400 mg plus weight-based RBV (1000-1200 mg) for 12 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With SVR at 2, 4, 8, and 24 Weeks After Discontinuation of Therapy (SVR2, SVR4, SVR8, and SVR24)</title>
          <description>SVR2, SVR4, SVR8, and SVR24 was defined as HCV RNA &lt; LLOQ at 2, 4, 8, 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="20"/>
                <count group_id="O2" value="21"/>
                <count group_id="O3" value="19"/>
                <count group_id="O4" value="19"/>
                <count group_id="O5" value="21"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>SVR2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="100.0"/>
                    <measurement group_id="O2" value="100.0"/>
                    <measurement group_id="O3" value="100.0"/>
                    <measurement group_id="O4" value="94.7"/>
                    <measurement group_id="O5" value="100.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>SVR4</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="100.0"/>
                    <measurement group_id="O2" value="100.0"/>
                    <measurement group_id="O3" value="100.0"/>
                    <measurement group_id="O4" value="94.7"/>
                    <measurement group_id="O5" value="100.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>SVR8</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="95.0"/>
                    <measurement group_id="O2" value="100.0"/>
                    <measurement group_id="O3" value="100.0"/>
                    <measurement group_id="O4" value="94.7"/>
                    <measurement group_id="O5" value="100.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>SVR24</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="95.0"/>
                    <measurement group_id="O2" value="100.0"/>
                    <measurement group_id="O3" value="94.7"/>
                    <measurement group_id="O4" value="94.7"/>
                    <measurement group_id="O5" value="100.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants Experiencing Viral Breakthrough or Viral Relapse</title>
        <description>Viral breakthrough was defined as HCV RNA ≥ LLOQ after having previously had HCV RNA &lt; LLOQ while receiving treatment, confirmed with 2 consecutive values (second confirmation value could be posttreatment), or last available on-treatment measurement with no subsequent follow-up values.&#xD;
Viral relapse was defined as HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA &lt; LLOQ at end of treatment, confirmed with 2 consecutive values or last available posttreatment measurement.</description>
        <time_frame>Baseline to Posttreatment Week 24</time_frame>
        <group_list>
          <group group_id="O1">
            <title>LDV/SOF 8 Weeks (TN)</title>
            <description>Treatment-naive participants were randomized to receive LDV 90 mg/SOF 400 mg for 8 weeks.</description>
          </group>
          <group group_id="O2">
            <title>LDV/SOF+RBV 8 Weeks (TN)</title>
            <description>Treatment-naive participants were randomized to receive LDV 90 mg/SOF 400 mg plus weight-based RBV (1000-1200 mg) for 8 weeks.</description>
          </group>
          <group group_id="O3">
            <title>LDV/SOF 12 Weeks (TN)</title>
            <description>Treatment-naive participants were randomized to receive LDV 90 mg/SOF 400 mg for 12 weeks.</description>
          </group>
          <group group_id="O4">
            <title>LDV/SOF 12 Weeks (TE)</title>
            <description>Treatment-experienced participants (had virologic failure following prior therapy with a PI+PEG+RBV regimen) were randomized to receive LDV 90 mg/SOF 400 mg for 12 weeks.</description>
          </group>
          <group group_id="O5">
            <title>LDV/SOF+RBV 12 Weeks (TE)</title>
            <description>Treatment-experienced participants (had virologic failure following prior therapy with a PI+PEG+RBV regimen) were randomized to receive LDV 90 mg/SOF 400 mg plus weight-based RBV (1000-1200 mg) for 12 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Experiencing Viral Breakthrough or Viral Relapse</title>
          <description>Viral breakthrough was defined as HCV RNA ≥ LLOQ after having previously had HCV RNA &lt; LLOQ while receiving treatment, confirmed with 2 consecutive values (second confirmation value could be posttreatment), or last available on-treatment measurement with no subsequent follow-up values.&#xD;
Viral relapse was defined as HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA &lt; LLOQ at end of treatment, confirmed with 2 consecutive values or last available posttreatment measurement.</description>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="20"/>
                <count group_id="O2" value="21"/>
                <count group_id="O3" value="19"/>
                <count group_id="O4" value="19"/>
                <count group_id="O5" value="21"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Viral breakthrough</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Viral relapse</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="5.3"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Baseline to Week 12 plus 30 days</time_frame>
      <group_list>
        <group group_id="E1">
          <title>LDV/SOF 8 Weeks (TN)</title>
          <description>Treatment-naive participants were randomized to receive LDV 90 mg/SOF 400 mg for 8 weeks.</description>
        </group>
        <group group_id="E2">
          <title>LDV/SOF+RBV 8 Weeks (TN)</title>
          <description>Treatment-naive participants were randomized to receive LDV 90 mg/SOF 400 mg plus weight-based RBV (1000-1200 mg) for 8 weeks.</description>
        </group>
        <group group_id="E3">
          <title>LDV/SOF 12 Weeks (TN)</title>
          <description>Treatment-naive participants were randomized to receive LDV 90 mg/SOF 400 mg for 12 weeks.</description>
        </group>
        <group group_id="E4">
          <title>LDV/SOF 12 Weeks (TE)</title>
          <description>Treatment-experienced participants (had virologic failure following prior therapy with a PI+PEG+RBV regimen) were randomized to receive LDV 90 mg/SOF 400 mg for 12 weeks.</description>
        </group>
        <group group_id="E5">
          <title>LDV/SOF+RBV 12 Weeks (TE)</title>
          <description>Treatment-experienced participants (had virologic failure following prior therapy with a PI+PEG+RBV regimen) were randomized to receive LDV 90 mg/SOF 400 mg plus weight-based RBV (1000-1200 mg) for 12 weeks.</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA Version 16.0</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="21"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="21"/>
              </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="20"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="21"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Peptic ulcer</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="21"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Spinal compression fracture</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="21"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Delirium</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="21"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Suicidal ideation</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="21"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedDRA Version 16.0</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="9" subjects_at_risk="20"/>
                <counts group_id="E2" subjects_affected="12" subjects_at_risk="21"/>
                <counts group_id="E3" subjects_affected="8" subjects_at_risk="19"/>
                <counts group_id="E4" subjects_affected="7" subjects_at_risk="19"/>
                <counts group_id="E5" subjects_affected="12" subjects_at_risk="21"/>
              </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="20"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="21"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E5" subjects_affected="6" subjects_at_risk="21"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="20"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="21"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E5" subjects_affected="4" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Abdominal pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="21"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="20"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="21"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Abdominal distension</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Cheilitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Constipation</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Parotid gland enlargement</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Peptic ulcer</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="21"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Fatigue</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="21"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="21"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Upper respiratory tract infection</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="20"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E5" subjects_affected="4" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Bronchitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="21"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Influenza</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="20"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Urinary tract infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="21"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Latent tuberculosis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Pharyngitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Pneumonia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="21"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Blood pressure increased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="21"/>
              </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="0" subjects_at_risk="20"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="21"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="21"/>
              </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="1" subjects_at_risk="20"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="21"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Muscle spasms</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E5" subjects_affected="2" subjects_at_risk="21"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="20"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="21"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Tremor</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="21"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Insomnia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="21"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="21"/>
              </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="0" subjects_at_risk="20"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="21"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="21"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Dermatitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E5" subjects_affected="2" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Pruritus</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="21"/>
              </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/NCT01726517
org study id: GS-US-337-0118
nct id: NCT01726517
lead sponsor: 
has dmc: No
This study is to evaluate the safety, tolerability, and antiviral efficacy of
      ledipasvir/sofosbuvir (LDV/SOF) fixed-dose combination (FDC) with or without ribavirin (RBV),
      administered for 8 or 12 weeks of treatment in participants with chronic genotype 1 hepatitis
      C virus (HCV) infection who are treatment-naive, and for 12 weeks in participants who had
      previously received a regimen containing a protease inhibitor for the treatment of HCV.
allocation: 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) 12 weeks after stopping study treatment.
measure: Incidence of Adverse Events Leading to Permanent Discontinuation of Study Drug(s)
time frame: Baseline to Week 12
description: The number of participants experiencing an adverse event leading to permanent discontinuation of study drug(s) was summarized.
measure: Percentage of Participants With SVR at 2, 4, 8, and 24 Weeks After Discontinuation of Therapy (SVR2, SVR4, SVR8, and SVR24)
time frame: Posttreatment Weeks 2, 4, 8, and 24
description: SVR2, SVR4, SVR8, and SVR24 was defined as HCV RNA < LLOQ at 2, 4, 8, and 24 weeks following the last dose of study drug, respectively.
measure: Percentage of Participants Experiencing Viral Breakthrough or Viral Relapse
time frame: Baseline to Posttreatment Week 24
description: Viral breakthrough was defined as HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ while receiving treatment, confirmed with 2 consecutive values (second confirmation value could be posttreatment), or last available on-treatment measurement with no subsequent follow-up values.
Viral relapse was defined as HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA < LLOQ at end of treatment, confirmed with 2 consecutive values or last available posttreatment measurement.
arm group label: LDV/SOF 8 Weeks (TN)
arm group type: Experimental
description: Treatment-naive (TN) participants will be randomized to receive LDV/SOF for 8 weeks.
arm group label: LDV/SOF+RBV 8 Weeks (TN)
arm group type: Experimental
description: Treatment-naive participants will be randomized to receive LDV/SOF plus RBV for 8 weeks.
arm group label: LDV/SOF 12 Weeks (TN)
arm group type: Experimental
description: Treatment-naive participants will be randomized to receive LDV/SOF for 12 weeks.
arm group label: LDV/SOF 12 Weeks (TE)
arm group type: Experimental
description: Treatment-experienced (TE) participants (had virologic failure following prior therapy with a protease-inhibitor [PI]+pegylated interferon [PEG]+RBV regimen) will be randomized to receive LDV/SOF for 12 weeks.
arm group label: LDV/SOF+RBV 12 Weeks (TE)
arm group type: Experimental
description: Treatment-experienced participants (had virologic failure following prior therapy with a PI+PEG+RBV regimen) will be randomized to receive LDV/SOF plus RBV for 12 weeks.
intervention type: Drug
intervention name: LDV/SOF
description: LDV 90 mg/SOF 400 mg FDC tablet administered orally once daily
arm group label: LDV/SOF 12 Weeks (TE)
arm group label: LDV/SOF 12 Weeks (TN)
arm group label: LDV/SOF 8 Weeks (TN)
arm group label: LDV/SOF+RBV 12 Weeks (TE)
arm group label: LDV/SOF+RBV 8 Weeks (TN)
other name: Harvoni®
intervention type: Drug
intervention name: RBV
description: RBV tablets administered orally in a divided daily dose according to package insert weight-based dosing recommendations (< 75 kg = 1000 mg and ≥ 75 kg = 1200 mg)
arm group label: LDV/SOF+RBV 12 Weeks (TE)
arm group label: LDV/SOF+RBV 8 Weeks (TN)
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Rob Hyland
role: Study Director
affiliation: Gilead Sciences
facility: 
country: United States
responsible party type: Sponsor
mesh term: Hepatitis C
mesh term: Hepatitis C, Chronic
mesh term: Ledipasvir, sofosbuvir drug combination
sharing ipd: Yes
ipd description: Qualified external researchers may request IPD for this study after study completion. For more information, please visit our website at http://www.gilead.com/research/disclosure-and-transparency.
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd time frame: 18 months after study completion
ipd access criteria: A secured external environment with username, password, and RSA code.
ipd url: http://www.gilead.com/research/disclosure-and-transparency
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 