<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/NCT02226549</url>
  </required_header>
  <id_info>
    <org_study_id>GS-US-337-1512</org_study_id>
    <nct_id>NCT02226549</nct_id>
  </id_info>
  <brief_title>Ledipasvir/Sofosbuvir Fixed-Dose Combination and Vedroprevir With or Without Ribavirin in Treatment-Experienced Participants With Chronic Genotype 1 HCV Infection and Cirrhosis</brief_title>
  <official_title>A Phase 2, Randomized, Open-Label Study of Ledipasvir/Sofosbuvir Fixed-Dose Combination and Vedroprevir With or Without Ribavirin in Treatment-Experienced Subjects With Chronic Genotype 1 HCV Infection and Cirrhosis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Gilead Sciences</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Gilead Sciences</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study is to evaluate the antiviral efficacy, safety, and tolerability of combination&#xD;
      therapy with ledipasvir/sofosbuvir (LDV/SOF) fixed-dose combination (FDC) + vedroprevir (VDV)&#xD;
      ± ribavirin (RBV) for 8 weeks in treatment-experienced adults with chronic genotype 1&#xD;
      hepatitis C virus (HCV) infection and cirrhosis.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>July 2014</start_date>
  <completion_date type="Actual">February 2015</completion_date>
  <primary_completion_date type="Actual">February 2015</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) 12 Weeks After Discontinuation of Therapy (SVR12)</measure>
    <time_frame>Posttreatment Week 12</time_frame>
    <description>SVR12 was defined as HCV RNA &lt; the lower limit of quantitation (LLOQ; ie, 15 IU/mL) at 12 weeks after stopping study treatment.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event</measure>
    <time_frame>Up to 8 weeks</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With SVR at 4 Weeks After Discontinuation of Therapy (SVR4)</measure>
    <time_frame>Posttreatment Week 4</time_frame>
    <description>SVR4 was defined as HCV RNA &lt; LLOQ at 4 weeks after stopping study treatment.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">47</enrollment>
  <condition>Hepatitis C Virus Infection</condition>
  <arm_group>
    <arm_group_label>LDV/SOF+VDV</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will receive LDV/SOF+VDV for 8 weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>LDV/SOF+VDV+RBV</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will receive LDV/SOF+VDV+RBV for 8 weeks.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>LDV/SOF</intervention_name>
    <description>LDV/SOF (90/400 mg) FDC tablet administered orally once daily</description>
    <arm_group_label>LDV/SOF+VDV</arm_group_label>
    <arm_group_label>LDV/SOF+VDV+RBV</arm_group_label>
    <other_name>Harvoni®</other_name>
    <other_name>GS-5885/GS-7977</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>VDV</intervention_name>
    <description>VDV 80 mg tablet administered orally once daily</description>
    <arm_group_label>LDV/SOF+VDV</arm_group_label>
    <arm_group_label>LDV/SOF+VDV+RBV</arm_group_label>
    <other_name>GS-9451</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+VDV+RBV</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age ≥ 18 years, with chronic HCV genotype 1 infection&#xD;
&#xD;
          -  Documentation as treatment-experienced having received pegylated interferon (Peg-IFN)&#xD;
             + RBV ≥ 4 weeks of duration without an additional agent in the regimen without&#xD;
             achieving sustained viral response (SVR)&#xD;
&#xD;
          -  Presence of compensated cirrhosis&#xD;
&#xD;
          -  Screening laboratory values within defined thresholds&#xD;
&#xD;
          -  Must use specific contraceptive methods if female of childbearing potential or&#xD;
             sexually active male&#xD;
&#xD;
          -  Not pregnant or a nursing female&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Co-infection with HIV or hepatitis B virus (HBV)&#xD;
&#xD;
          -  Current or prior history of clinical hepatic decompensation&#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>Robert Hyland, DPhil</last_name>
    <role>Study Director</role>
    <affiliation>Gilead Sciences</affiliation>
  </overall_official>
  <location>
    <facility>
      <address>
        <city>San Antonio</city>
        <state>Texas</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>February 2016</verification_date>
  <study_first_submitted>August 25, 2014</study_first_submitted>
  <study_first_submitted_qc>August 25, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 27, 2014</study_first_posted>
  <results_first_submitted>February 5, 2016</results_first_submitted>
  <results_first_submitted_qc>February 5, 2016</results_first_submitted_qc>
  <results_first_posted type="Estimate">March 4, 2016</results_first_posted>
  <last_update_submitted>October 19, 2018</last_update_submitted>
  <last_update_submitted_qc>October 19, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">November 16, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>hepatitis C</keyword>
  <keyword>Gilead</keyword>
  <keyword>GS-9451</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Infections</mesh_term>
    <mesh_term>Communicable Diseases</mesh_term>
    <mesh_term>Hepatitis C</mesh_term>
    <mesh_term>Hepatitis</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Sofosbuvir</mesh_term>
    <mesh_term>Ledipasvir, sofosbuvir drug combination</mesh_term>
    <mesh_term>Ledipasvir</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 24 July 2014. The last study visit occurred on 06 February 2015.</recruitment_details>
      <pre_assignment_details>72 participants were screened.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>LDV/SOF+VDV</title>
          <description>Ledipasvir/sofosbuvir (LDV/SOF) (90/400 mg) fixed-dose combination (FDC) tablet + vedroprevir (VDV) 80 mg tablet once daily for 8 weeks</description>
        </group>
        <group group_id="P2">
          <title>LDV/SOF+VDV+RBV</title>
          <description>LDV/SOF (90/400 mg) FDC tablet once daily + VDV 80 mg tablet once daily + ribavirin (RBV) tablets (1000 or 1200 mg daily based on weight) for 8 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="23"/>
                <participants group_id="P2" count="24"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="22"/>
                <participants group_id="P2" count="23"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Randomized but Never Treated</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Safety Analysis Set: participants who received at least 1 dose of study drug.</population>
      <group_list>
        <group group_id="B1">
          <title>LDV/SOF+VDV</title>
          <description>LDV/SOF (90/400 mg) FDC tablet + VDV 80 mg tablet once daily for 8 weeks</description>
        </group>
        <group group_id="B2">
          <title>LDV/SOF+VDV+RBV</title>
          <description>LDV/SOF (90/400 mg) FDC tablet once daily + VDV 80 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 8 weeks</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="22"/>
            <count group_id="B2" value="24"/>
            <count group_id="B3" value="46"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="58" spread="7.9"/>
                    <measurement group_id="B2" value="56" spread="7.7"/>
                    <measurement group_id="B3" value="57" spread="7.7"/>
                  </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="10"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="16"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="12"/>
                    <measurement group_id="B2" value="18"/>
                    <measurement group_id="B3" value="30"/>
                  </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="1"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>White</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="21"/>
                    <measurement group_id="B2" value="23"/>
                    <measurement group_id="B3" value="44"/>
                  </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>Hispanic or Latino</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                    <measurement group_id="B2" value="11"/>
                    <measurement group_id="B3" value="17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Not Hispanic or Latino</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="16"/>
                    <measurement group_id="B2" value="12"/>
                    <measurement group_id="B3" value="28"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Not Permitted</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>HCV Genotype</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>Genotype 1a</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="14"/>
                    <measurement group_id="B2" value="18"/>
                    <measurement group_id="B3" value="32"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Genotype 1b</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Genotype 1a,1b</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>IL28b Status</title>
          <description>CC, CT, and TT alleles are different forms of the IL28b gene.</description>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>CC</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="5"/>
                  </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="16"/>
                    <measurement group_id="B3" value="28"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>TT</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Missing</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12)</title>
        <description>SVR12 was defined as HCV RNA &lt; the lower limit of quantitation (LLOQ; ie, 15 IU/mL) at 12 weeks after stopping study treatment.</description>
        <time_frame>Posttreatment Week 12</time_frame>
        <population>Full Analysis Set: participants who were randomized and received at least 1 dose of study drug.</population>
        <group_list>
          <group group_id="O1">
            <title>LDV/SOF+VDV</title>
            <description>LDV/SOF (90/400 mg) FDC tablet + VDV 80 mg tablet once daily for 8 weeks</description>
          </group>
          <group group_id="O2">
            <title>LDV/SOF+VDV+RBV</title>
            <description>LDV/SOF (90/400 mg) FDC tablet once daily + VDV 80 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 8 weeks</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12)</title>
          <description>SVR12 was defined as HCV RNA &lt; the lower limit of quantitation (LLOQ; ie, 15 IU/mL) at 12 weeks after stopping study treatment.</description>
          <population>Full Analysis Set: participants who 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="22"/>
                <count group_id="O2" value="24"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="95.5"/>
                    <measurement group_id="O2" value="87.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event</title>
        <time_frame>Up to 8 weeks</time_frame>
        <population>Safety Analysis Set: participants who received at least 1 dose of study drug.</population>
        <group_list>
          <group group_id="O1">
            <title>LDV/SOF+VDV</title>
            <description>LDV/SOF (90/400 mg) FDC tablet + VDV 80 mg tablet once daily for 8 weeks</description>
          </group>
          <group group_id="O2">
            <title>LDV/SOF+VDV+RBV</title>
            <description>LDV/SOF (90/400 mg) FDC tablet once daily + VDV 80 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 8 weeks</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event</title>
          <population>Safety Analysis Set: participants who 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="22"/>
                <count group_id="O2" value="24"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="8.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With SVR at 4 Weeks After Discontinuation of Therapy (SVR4)</title>
        <description>SVR4 was defined as HCV RNA &lt; LLOQ at 4 weeks after stopping study treatment.</description>
        <time_frame>Posttreatment Week 4</time_frame>
        <population>Full Analysis Set</population>
        <group_list>
          <group group_id="O1">
            <title>LDV/SOF+VDV</title>
            <description>LDV/SOF (90/400 mg) FDC tablet + VDV 80 mg tablet once daily for 8 weeks</description>
          </group>
          <group group_id="O2">
            <title>LDV/SOF+VDV+RBV</title>
            <description>LDV/SOF (90/400 mg) FDC tablet once daily + VDV 80 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 8 weeks</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With SVR at 4 Weeks After Discontinuation of Therapy (SVR4)</title>
          <description>SVR4 was defined as HCV RNA &lt; LLOQ at 4 weeks after stopping study 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="22"/>
                <count group_id="O2" value="24"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="95.5"/>
                    <measurement group_id="O2" value="95.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Up to 8 weeks plus 30 days</time_frame>
      <desc>Safety Analysis Set: participants who received at least 1 dose of study drug.</desc>
      <group_list>
        <group group_id="E1">
          <title>LDV/SOF+VDV</title>
          <description>LDV/SOF (90/400 mg) FDC tablet + VDV 80 mg tablet once daily for 8 weeks</description>
        </group>
        <group group_id="E2">
          <title>LDV/SOF+VDV+RBV</title>
          <description>LDV/SOF (90/400 mg) FDC tablet once daily + VDV 80 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 8 weeks</description>
        </group>
      </group_list>
      <serious_events>
        <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="22"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="24"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedDRA 17.1</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="7" subjects_at_risk="22"/>
                <counts group_id="E2" subjects_affected="12" subjects_at_risk="24"/>
              </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="22"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="24"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Sinusitis</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="22"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="24"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="22"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="24"/>
              </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="22"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="24"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Rash</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="22"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="24"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>After conclusion of the study and without prior written approval from Gilead, investigators in this study may communicate, orally present, or publish in scientific journals or other media only after the following conditions have been met:&#xD;
The results of the study in their entirety have been publicly disclosed by or with the consent of Gilead in an abstract, manuscript, or presentation form; or&#xD;
The study has been completed at all study sites for at least 2 years</restrictive_agreement>
    </certain_agreements>
    <limitations_and_caveats>There were no limitations affecting the analysis or results.</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>Clinical Trial Disclosures</name_or_title>
      <organization>Gilead Sciences</organization>
      <email>ClinicalTrialDisclosures@gilead.com</email>
    </point_of_contact>
  </clinical_results>
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02226549
org study id: GS-US-337-1512
nct id: NCT02226549
lead sponsor: 
has dmc: No
This study is to evaluate the antiviral efficacy, safety, and tolerability of combination
      therapy with ledipasvir/sofosbuvir (LDV/SOF) fixed-dose combination (FDC) + vedroprevir (VDV)
      ± ribavirin (RBV) for 8 weeks in treatment-experienced adults with chronic genotype 1
      hepatitis C virus (HCV) infection and cirrhosis.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12)
time frame: Posttreatment Week 12
description: SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ; ie, 15 IU/mL) at 12 weeks after stopping study treatment.
measure: Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event
time frame: Up to 8 weeks
measure: Percentage of Participants With SVR at 4 Weeks After Discontinuation of Therapy (SVR4)
time frame: Posttreatment Week 4
description: SVR4 was defined as HCV RNA < LLOQ at 4 weeks after stopping study treatment.
arm group label: LDV/SOF+VDV
arm group type: Experimental
description: Participants will receive LDV/SOF+VDV for 8 weeks.
arm group label: LDV/SOF+VDV+RBV
arm group type: Experimental
description: Participants will receive LDV/SOF+VDV+RBV for 8 weeks.
intervention type: Drug
intervention name: LDV/SOF
description: LDV/SOF (90/400 mg) FDC tablet administered orally once daily
arm group label: LDV/SOF+VDV
arm group label: LDV/SOF+VDV+RBV
other name: Harvoni®
other name: GS-5885/GS-7977
intervention type: Drug
intervention name: VDV
description: VDV 80 mg tablet administered orally once daily
arm group label: LDV/SOF+VDV
arm group label: LDV/SOF+VDV+RBV
other name: GS-9451
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+VDV+RBV
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Robert Hyland, DPhil
role: Study Director
affiliation: Gilead Sciences
facility: 
country: United States
responsible party type: Sponsor
mesh term: Infections
mesh term: Communicable Diseases
mesh term: Hepatitis C
mesh term: Hepatitis
mesh term: Sofosbuvir
mesh term: Ledipasvir, sofosbuvir drug combination
mesh term: Ledipasvir
sharing ipd: Yes
ipd description: Qualified external researchers may request IPD for this study after study completion. For more information, please visit our website at http://www.gilead.com/research/disclosure-and-transparency.
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd time frame: 18 months after study completion
ipd access criteria: A secured external environment with username, password, and RSA code.
ipd url: http://www.gilead.com/research/disclosure-and-transparency
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
limitations and caveats: There were no limitations affecting the analysis or results.
point of contact: 