<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/NCT01701401</url>
  </required_header>
  <id_info>
    <org_study_id>GS-US-337-0102</org_study_id>
    <secondary_id>2012-003387-43</secondary_id>
    <nct_id>NCT01701401</nct_id>
  </id_info>
  <brief_title>Safety and Efficacy of Ledipasvir/Sofosbuvir Fixed-Dose Combination (FDC) With and Without Ribavirin for the Treatment of HCV</brief_title>
  <official_title>A Phase 3, Multicenter, Randomized, Open-Label Study to Investigate the Efficacy and Safety of Sofosbuvir/GS-5885 Fixed-Dose Combination (FDC) +/- Ribavirin for 12 and 24 Weeks in Treatment-Naive 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>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to evaluate the safety, tolerability, and antiviral efficacy of&#xD;
      ledipasvir (LDV)/sofosbuvir (SOF) fixed-dose combination (FDC) tablets with or without&#xD;
      ribavirin (RBV) administered for 12 and 24 weeks in treatment-naive subjects with chronic&#xD;
      genotype 1 HCV infection.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>September 2012</start_date>
  <completion_date type="Actual">April 2014</completion_date>
  <primary_completion_date type="Actual">March 2014</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Study Drug (SVR12)</measure>
    <time_frame>Posttreatment Week 12</time_frame>
    <description>SVR12 was defined as HCV RNA level &lt; the lower limit of quantification (LLOQ, ie, &lt; 25 copies/mL) 12 weeks after last dose of study drug.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Incidence of Adverse Events Leading to Permanent Discontinuation From Any Study Drug</measure>
    <time_frame>Up to 24 weeks</time_frame>
    <description>The percentage of participants who experienced an adverse event leading to permanent discontinuation from any study drug was summarized.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With SVR at 4 and 24 Weeks After Discontinuation of Study Drug</measure>
    <time_frame>Posttreatment Weeks 4 and 24</time_frame>
    <description>SVR4 and SVR24 were defined as HCV RNA level &lt; LLOQ at 4 and 24 weeks after discontinuation of study drug, respectively.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With HCV RNA &lt; LLOQ at Week 2</measure>
    <time_frame>Week 2</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With HCV RNA &lt; LLOQ at Week 4</measure>
    <time_frame>Week 4</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With HCV RNA &lt; LLOQ at Week 8</measure>
    <time_frame>Week 8</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in HCV RNA at Week 2</measure>
    <time_frame>Baseline; Week 2</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in HCV RNA at Week 4</measure>
    <time_frame>Baseline; Week 4</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in HCV RNA at Week 8</measure>
    <time_frame>Baseline; Week 8</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With Virologic Failure</measure>
    <time_frame>Baseline to posttreatment Week 24</time_frame>
    <description>On-treatment virologic failure was defined as:&#xD;
Breakthrough: HCV RNA ≥ LLOQ after having previously had HCV RNA &lt; LLOQ, while on treatment, confirmed with 2 consecutive values (second confirmation value could have been posttreatment), or last available on-treatment measurement with no subsequent follow- up values, OR&#xD;
Rebound: &gt; 1 log10 IU/mL increase in HCV RNA from nadir while on treatment, confirmed with 2 consecutive values (second confirmation value could have been posttreatment), or last available on-treatment measurement with no subsequent follow-up values, OR&#xD;
Nonresponse: HCV RNA persistently ≥ LLOQ through 8 weeks of treatment&#xD;
Virologic 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>4</number_of_arms>
  <enrollment type="Actual">870</enrollment>
  <condition>Chronic Hepatitis C Virus</condition>
  <arm_group>
    <arm_group_label>LDV/SOF 12 weeks</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>LDV/SOF administered for 12 weeks</description>
  </arm_group>
  <arm_group>
    <arm_group_label>LDV/SOF+RBV 12 weeks</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>LDV/SOF+RBV administered for 12 weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>LDV/SOF 24 weeks</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>LDV/SOF administered for 24 weeks</description>
  </arm_group>
  <arm_group>
    <arm_group_label>LDV/SOF+RBV 24 weeks</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>LDV/SOF+RBV administered for 24 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 12 weeks</arm_group_label>
    <arm_group_label>LDV/SOF 24 weeks</arm_group_label>
    <arm_group_label>LDV/SOF+RBV 12 weeks</arm_group_label>
    <arm_group_label>LDV/SOF+RBV 24 weeks</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>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</arm_group_label>
    <arm_group_label>LDV/SOF+RBV 24 weeks</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age ≥ 18, with chronic genotype 1 HCV infection&#xD;
&#xD;
          -  HCV treatment-naive&#xD;
&#xD;
          -  HCV RNA &gt; 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;
          -  Co-infection with HIV or hepatitis B virus (HBV)&#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>Jenny Yang, Pharm D</last_name>
    <role>Study Director</role>
    <affiliation>Gilead Sciences</affiliation>
  </overall_official>
  <location>
    <facility>
      <address>
        <city>Birmingham</city>
        <state>Alabama</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>La Jolla</city>
        <state>California</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Long Beach</city>
        <state>California</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Palo Alto</city>
        <state>California</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Sacramento</city>
        <state>California</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>San Diego</city>
        <state>California</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Aurora</city>
        <state>Colorado</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Englewood</city>
        <state>Colorado</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Washington</city>
        <state>District of Columbia</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Gainesville</city>
        <state>Florida</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Orlando</city>
        <state>Florida</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Tampa</city>
        <state>Florida</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Wellington</city>
        <state>Florida</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Atlanta</city>
        <state>Georgia</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Decatur</city>
        <state>Georgia</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Marietta</city>
        <state>Georgia</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Indianapolis</city>
        <state>Indiana</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Baltimore</city>
        <state>Maryland</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Lutherville</city>
        <state>Maryland</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Detroit</city>
        <state>Michigan</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Rochester</city>
        <state>Minnesota</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Saint Paul</city>
        <state>Minnesota</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Kansas City</city>
        <state>Missouri</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Saint Louis</city>
        <state>Missouri</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Hillsborough</city>
        <state>New Jersey</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Albuquerque</city>
        <state>New Mexico</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Santa Fe</city>
        <state>New Mexico</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Bronx</city>
        <state>New York</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Manhasset</city>
        <state>New York</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>New York</city>
        <state>New York</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Asheville</city>
        <state>North Carolina</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Chapel Hill</city>
        <state>North Carolina</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Durham</city>
        <state>North Carolina</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Fayetteville</city>
        <state>North Carolina</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Statesville</city>
        <state>North Carolina</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Winston-Salem</city>
        <state>North Carolina</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Cincinnati</city>
        <state>Ohio</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Germantown</city>
        <state>Tennessee</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Nashville</city>
        <state>Tennessee</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Arlington</city>
        <state>Texas</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>San Antonio</city>
        <state>Texas</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Fairfax</city>
        <state>Virginia</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Falls Church</city>
        <state>Virginia</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Norfolk</city>
        <state>Virginia</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Richmond</city>
        <state>Virginia</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Seattle</city>
        <state>Washington</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>CHRU Lille</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Clichy</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Creteil</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>La Tronche</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Lyon</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Marseille</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Nice</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Paris</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Berlin</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Dusseldorf</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Essen</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Frankfurt</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Freiburg</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Hamburg</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Hannover</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Koln</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Mainz</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Bologna</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Brescia</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Milan</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Padova</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Palermo</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Roma</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>San Giovanni Rotondo</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Torino</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>San Juan</city>
        <country>Puerto Rico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Barcelona</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Madrid</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Malaga</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Santander</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Sevilla</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Birmingham</city>
        <state>Wstmid</state>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>London</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Manchester</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Plymouth</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
    <country>Germany</country>
    <country>Italy</country>
    <country>Puerto Rico</country>
    <country>Spain</country>
    <country>United Kingdom</country>
    <country>United States</country>
  </location_countries>
  <verification_date>March 2015</verification_date>
  <study_first_submitted>October 2, 2012</study_first_submitted>
  <study_first_submitted_qc>October 4, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 5, 2012</study_first_posted>
  <results_first_submitted>March 17, 2015</results_first_submitted>
  <results_first_submitted_qc>March 17, 2015</results_first_submitted_qc>
  <results_first_posted type="Estimate">March 27, 2015</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>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>Additional relevant MeSH terms:</keyword>
  <keyword>Hepatitis</keyword>
  <keyword>Hepatitis, Chronic</keyword>
  <keyword>Hepatitis C</keyword>
  <keyword>Hepatitis C, Chronic</keyword>
  <keyword>Liver Diseases</keyword>
  <keyword>Digestive System Diseases</keyword>
  <keyword>Hepatitis, Viral, Human</keyword>
  <keyword>Virus Diseases</keyword>
  <keyword>Enterovirus Infections</keyword>
  <keyword>Picornaviridae Infections</keyword>
  <keyword>RNA Virus Infections</keyword>
  <keyword>Flaviviridae Infections</keyword>
  <keyword>Antiviral Agents</keyword>
  <keyword>Anti-Infective Agents</keyword>
  <keyword>Therapeutic Uses</keyword>
  <keyword>Pharmacologic Actions</keyword>
  <keyword>Antimetabolites</keyword>
  <keyword>Molecular Mechanisms of Pharmacological Action</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>
    <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 a total of 100 study sites in the United States and Europe. The first participant was screened on 26 September 2012. The last study visit occurred on 30 April 2014.</recruitment_details>
      <pre_assignment_details>1015 participants were screened.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>LDV/SOF 12 Weeks</title>
          <description>Ledipasvir/sofosbuvir (LDV/SOF) 90/400 mg FDC tablet once daily for 12 weeks</description>
        </group>
        <group group_id="P2">
          <title>LDV/SOF+RBV 12 Weeks</title>
          <description>LDV/SOF 90/400 mg FDC tablet once daily plus ribavirin (RBV) tablets (1000 to 1200 mg daily based on weight) in a divided daily dose for 12 weeks</description>
        </group>
        <group group_id="P3">
          <title>LDV/SOF 24 Weeks</title>
          <description>LDV/SOF 90/400 mg FDC tablet once daily for 24 weeks</description>
        </group>
        <group group_id="P4">
          <title>LDV/SOF+RBV 24 Weeks</title>
          <description>LDV/SOF 90/400 mg FDC tablet once daily plus RBV tablets (1000 to 1200 mg daily based on weight) in a divided daily dose for 24 weeks</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="217"/>
                <participants group_id="P2" count="218"/>
                <participants group_id="P3" count="217"/>
                <participants group_id="P4" count="218"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="207"/>
                <participants group_id="P2" count="209"/>
                <participants group_id="P3" count="212"/>
                <participants group_id="P4" count="212"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="10"/>
                <participants group_id="P2" count="9"/>
                <participants group_id="P3" count="5"/>
                <participants group_id="P4" count="6"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Randomized But Not Treated</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="5"/>
                <participants group_id="P2" count="5"/>
                <participants group_id="P3" count="1"/>
                <participants group_id="P4" count="3"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrew Consent</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="3"/>
                <participants group_id="P3" count="1"/>
                <participants group_id="P4" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lack of Efficacy</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="2"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Protocol Violation</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_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.</population>
      <group_list>
        <group group_id="B1">
          <title>LDV/SOF 12 Weeks</title>
          <description>LDV/SOF 90/400 mg FDC tablet once daily for 12 weeks</description>
        </group>
        <group group_id="B2">
          <title>LDV/SOF+RBV 12 Weeks</title>
          <description>LDV/SOF 90/400 mg FDC tablet once daily plus RBV tablets (1000 to 1200 mg daily based on weight) in a divided daily dose for 12 weeks</description>
        </group>
        <group group_id="B3">
          <title>LDV/SOF 24 Weeks</title>
          <description>LDV/SOF 90/400 mg FDC tablet once daily for 24 weeks</description>
        </group>
        <group group_id="B4">
          <title>LDV/SOF+RBV 24 Weeks</title>
          <description>LDV/SOF 90/400 mg FDC tablet once daily plus RBV tablets (1000 to 1200 mg daily based on weight) in a divided daily dose for 24 weeks</description>
        </group>
        <group group_id="B5">
          <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="214"/>
            <count group_id="B2" value="217"/>
            <count group_id="B3" value="217"/>
            <count group_id="B4" value="217"/>
            <count group_id="B5" value="865"/>
          </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="52" spread="10.7"/>
                    <measurement group_id="B2" value="52" spread="11.5"/>
                    <measurement group_id="B3" value="53" spread="10.3"/>
                    <measurement group_id="B4" value="53" spread="9.9"/>
                    <measurement group_id="B5" value="52" spread="10.6"/>
                  </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="87"/>
                    <measurement group_id="B2" value="89"/>
                    <measurement group_id="B3" value="78"/>
                    <measurement group_id="B4" value="98"/>
                    <measurement group_id="B5" value="352"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="127"/>
                    <measurement group_id="B2" value="128"/>
                    <measurement group_id="B3" value="139"/>
                    <measurement group_id="B4" value="119"/>
                    <measurement group_id="B5" value="513"/>
                  </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="24"/>
                    <measurement group_id="B2" value="26"/>
                    <measurement group_id="B3" value="32"/>
                    <measurement group_id="B4" value="26"/>
                    <measurement group_id="B5" value="108"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>White</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="187"/>
                    <measurement group_id="B2" value="188"/>
                    <measurement group_id="B3" value="177"/>
                    <measurement group_id="B4" value="183"/>
                    <measurement group_id="B5" value="735"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Asian</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="5"/>
                    <measurement group_id="B4" value="5"/>
                    <measurement group_id="B5" value="11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>American Indian/Alaska Native</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="1"/>
                    <measurement group_id="B5" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hawaiian or Pacific Islander</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Other</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="2"/>
                    <measurement group_id="B4" value="1"/>
                    <measurement group_id="B5" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Not Disclosed</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="1"/>
                    <measurement group_id="B5" value="2"/>
                  </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="26"/>
                    <measurement group_id="B2" value="20"/>
                    <measurement group_id="B3" value="29"/>
                    <measurement group_id="B4" value="26"/>
                    <measurement group_id="B5" value="101"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Not Hispanic or Latino</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="187"/>
                    <measurement group_id="B2" value="197"/>
                    <measurement group_id="B3" value="188"/>
                    <measurement group_id="B4" value="190"/>
                    <measurement group_id="B5" value="762"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Not Disclosed</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="1"/>
                    <measurement group_id="B5" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>France</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="11"/>
                    <measurement group_id="B2" value="24"/>
                    <measurement group_id="B3" value="18"/>
                    <measurement group_id="B4" value="10"/>
                    <measurement group_id="B5" value="63"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="125"/>
                    <measurement group_id="B2" value="118"/>
                    <measurement group_id="B3" value="132"/>
                    <measurement group_id="B4" value="137"/>
                    <measurement group_id="B5" value="512"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Spain</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="14"/>
                    <measurement group_id="B2" value="15"/>
                    <measurement group_id="B3" value="12"/>
                    <measurement group_id="B4" value="14"/>
                    <measurement group_id="B5" value="55"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Germany</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="24"/>
                    <measurement group_id="B2" value="20"/>
                    <measurement group_id="B3" value="22"/>
                    <measurement group_id="B4" value="18"/>
                    <measurement group_id="B5" value="84"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>United Kingdom</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="13"/>
                    <measurement group_id="B2" value="17"/>
                    <measurement group_id="B3" value="10"/>
                    <measurement group_id="B4" value="15"/>
                    <measurement group_id="B5" value="55"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Italy</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="27"/>
                    <measurement group_id="B2" value="23"/>
                    <measurement group_id="B3" value="23"/>
                    <measurement group_id="B4" value="23"/>
                    <measurement group_id="B5" value="96"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Hepatitis C Virus (HCV) RNA</title>
          <units>log10 IU/mL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="6.4" spread="0.69"/>
                    <measurement group_id="B2" value="6.4" spread="0.64"/>
                    <measurement group_id="B3" value="6.3" spread="0.68"/>
                    <measurement group_id="B4" value="6.3" spread="0.65"/>
                    <measurement group_id="B5" value="6.4" spread="0.66"/>
                  </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="45"/>
                    <measurement group_id="B2" value="44"/>
                    <measurement group_id="B3" value="49"/>
                    <measurement group_id="B4" value="44"/>
                    <measurement group_id="B5" value="182"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>≥ 800,000 IU/mL</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="169"/>
                    <measurement group_id="B2" value="173"/>
                    <measurement group_id="B3" value="168"/>
                    <measurement group_id="B4" value="173"/>
                    <measurement group_id="B5" value="683"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>HCV Genotype</title>
          <description>There are variations of HCV which are all similar enough to be called HCV, but are distinct enough to be referred to as HCV genotypes.</description>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>Genotype 1a</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="144"/>
                    <measurement group_id="B2" value="148"/>
                    <measurement group_id="B3" value="146"/>
                    <measurement group_id="B4" value="143"/>
                    <measurement group_id="B5" value="581"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Genotype 1b</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="66"/>
                    <measurement group_id="B2" value="68"/>
                    <measurement group_id="B3" value="68"/>
                    <measurement group_id="B4" value="71"/>
                    <measurement group_id="B5" value="273"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Genotype 1 (no confirmed subtype)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="1"/>
                    <measurement group_id="B5" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Genotype 4</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="1"/>
                    <measurement group_id="B5" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Missing</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="2"/>
                    <measurement group_id="B4" value="1"/>
                    <measurement group_id="B5" value="5"/>
                  </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="55"/>
                    <measurement group_id="B2" value="76"/>
                    <measurement group_id="B3" value="52"/>
                    <measurement group_id="B4" value="73"/>
                    <measurement group_id="B5" value="256"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>CT</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="113"/>
                    <measurement group_id="B2" value="107"/>
                    <measurement group_id="B3" value="119"/>
                    <measurement group_id="B4" value="112"/>
                    <measurement group_id="B5" value="451"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>TT</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="46"/>
                    <measurement group_id="B2" value="34"/>
                    <measurement group_id="B3" value="46"/>
                    <measurement group_id="B4" value="32"/>
                    <measurement group_id="B5" value="158"/>
                  </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 Study Drug (SVR12)</title>
        <description>SVR12 was defined as HCV RNA level &lt; the lower limit of quantification (LLOQ, ie, &lt; 25 copies/mL) 12 weeks after last dose of study drug.</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 12 Weeks</title>
            <description>LDV/SOF 90/400 mg FDC tablet once daily for 12 weeks</description>
          </group>
          <group group_id="O2">
            <title>LDV/SOF+RBV 12 Weeks</title>
            <description>LDV/SOF 90/400 mg FDC tablet once daily plus RBV tablets (1000 to 1200 mg daily based on weight) in a divided daily dose for 12 weeks</description>
          </group>
          <group group_id="O3">
            <title>LDV/SOF 24 Weeks</title>
            <description>LDV/SOF 90/400 mg FDC tablet once daily for 24 weeks</description>
          </group>
          <group group_id="O4">
            <title>LDV/SOF+RBV 24 Weeks</title>
            <description>LDV/SOF 90/400 mg FDC tablet once daily plus RBV tablets (1000 to 1200 mg daily based on weight) in a divided daily dose for 24 weeks</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Study Drug (SVR12)</title>
          <description>SVR12 was defined as HCV RNA level &lt; the lower limit of quantification (LLOQ, ie, &lt; 25 copies/mL) 12 weeks after last dose of study drug.</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="214"/>
                <count group_id="O2" value="217"/>
                <count group_id="O3" value="217"/>
                <count group_id="O4" value="217"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="98.6"/>
                    <measurement group_id="O2" value="97.2"/>
                    <measurement group_id="O3" value="98.2"/>
                    <measurement group_id="O4" value="99.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <p_value_desc>The p-value for the comparison of the LDV/SOF 12 week group against the adjusted historical null rate (60%) was based on a 2-sided 1-sample binomial test.</p_value_desc>
            <method>Binomial test</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <p_value_desc>The p-value for the comparison of the LDV/SOF+RBV 12 week group against the adjusted historical null rate (60%) was based on a 2-sided 1-sample binomial test.</p_value_desc>
            <method>Binomial test</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <p_value_desc>The p-value for the comparison of the LDV/SOF 24 week group against the adjusted historical null rate (60%) was based on a 2-sided 1-sample binomial test.</p_value_desc>
            <method>Binomial test</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O4</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <p_value_desc>The p-value for the comparison of the LDV/SOF+RBV 24 week group against the adjusted historical null rate (60%) was based on a 2-sided 1-sample binomial test.</p_value_desc>
            <method>Binomial test</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Incidence of Adverse Events Leading to Permanent Discontinuation From Any Study Drug</title>
        <description>The percentage of participants who experienced an adverse event leading to permanent discontinuation from any study drug was summarized.</description>
        <time_frame>Up to 24 weeks</time_frame>
        <population>Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.</population>
        <group_list>
          <group group_id="O1">
            <title>LDV/SOF 12 Weeks</title>
            <description>LDV/SOF 90/400 mg FDC tablet once daily for 12 weeks</description>
          </group>
          <group group_id="O2">
            <title>LDV/SOF+RBV 12 Weeks</title>
            <description>LDV/SOF 90/400 mg FDC tablet once daily plus RBV tablets (1000 to 1200 mg daily based on weight) in a divided daily dose for 12 weeks</description>
          </group>
          <group group_id="O3">
            <title>LDV/SOF 24 Weeks</title>
            <description>LDV/SOF 90/400 mg FDC tablet once daily for 24 weeks</description>
          </group>
          <group group_id="O4">
            <title>LDV/SOF+RBV 24 Weeks</title>
            <description>LDV/SOF 90/400 mg FDC tablet once daily plus RBV tablets (1000 to 1200 mg daily based on weight) in a divided daily dose for 24 weeks</description>
          </group>
        </group_list>
        <measure>
          <title>Incidence of Adverse Events Leading to Permanent Discontinuation From Any Study Drug</title>
          <description>The percentage of participants who experienced an adverse event leading to permanent discontinuation from any study drug was summarized.</description>
          <population>Safety 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="214"/>
                <count group_id="O2" value="217"/>
                <count group_id="O3" value="217"/>
                <count group_id="O4" value="217"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0.5"/>
                    <measurement group_id="O3" value="1.8"/>
                    <measurement group_id="O4" value="3.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With SVR at 4 and 24 Weeks After Discontinuation of Study Drug</title>
        <description>SVR4 and SVR24 were defined as HCV RNA level &lt; LLOQ at 4 and 24 weeks after discontinuation of study drug, respectively.</description>
        <time_frame>Posttreatment Weeks 4 and 24</time_frame>
        <population>Full Analysis Set</population>
        <group_list>
          <group group_id="O1">
            <title>LDV/SOF 12 Weeks</title>
            <description>LDV/SOF 90/400 mg FDC tablet once daily for 12 weeks</description>
          </group>
          <group group_id="O2">
            <title>LDV/SOF+RBV 12 Weeks</title>
            <description>LDV/SOF 90/400 mg FDC tablet once daily plus RBV tablets (1000 to 1200 mg daily based on weight) in a divided daily dose for 12 weeks</description>
          </group>
          <group group_id="O3">
            <title>LDV/SOF 24 Weeks</title>
            <description>LDV/SOF 90/400 mg FDC tablet once daily for 24 weeks</description>
          </group>
          <group group_id="O4">
            <title>LDV/SOF+RBV 24 Weeks</title>
            <description>LDV/SOF 90/400 mg FDC tablet once daily plus RBV tablets (1000 to 1200 mg daily based on weight) in a divided daily dose for 24 weeks</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With SVR at 4 and 24 Weeks After Discontinuation of Study Drug</title>
          <description>SVR4 and SVR24 were defined as HCV RNA level &lt; LLOQ at 4 and 24 weeks after discontinuation 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="214"/>
                <count group_id="O2" value="217"/>
                <count group_id="O3" value="217"/>
                <count group_id="O4" value="217"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>SVR4</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="98.6"/>
                    <measurement group_id="O2" value="98.2"/>
                    <measurement group_id="O3" value="99.1"/>
                    <measurement group_id="O4" value="99.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>SVR24</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="98.6"/>
                    <measurement group_id="O2" value="97.2"/>
                    <measurement group_id="O3" value="98.2"/>
                    <measurement group_id="O4" value="99.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With HCV RNA &lt; LLOQ at Week 2</title>
        <time_frame>Week 2</time_frame>
        <population>Participants in the Full Analysis Set with available data were analyzed.</population>
        <group_list>
          <group group_id="O1">
            <title>LDV/SOF 12 Weeks</title>
            <description>LDV/SOF 90/400 mg FDC tablet once daily for 12 weeks</description>
          </group>
          <group group_id="O2">
            <title>LDV/SOF+RBV 12 Weeks</title>
            <description>LDV/SOF 90/400 mg FDC tablet once daily plus RBV tablets (1000 to 1200 mg daily based on weight) in a divided daily dose for 12 weeks</description>
          </group>
          <group group_id="O3">
            <title>LDV/SOF 24 Weeks</title>
            <description>LDV/SOF 90/400 mg FDC tablet once daily for 24 weeks</description>
          </group>
          <group group_id="O4">
            <title>LDV/SOF+RBV 24 Weeks</title>
            <description>LDV/SOF 90/400 mg FDC tablet once daily plus RBV tablets (1000 to 1200 mg daily based on weight) in a divided daily dose for 24 weeks</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With HCV RNA &lt; LLOQ at Week 2</title>
          <population>Participants in the Full Analysis Set with available data were analyzed.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="213"/>
                <count group_id="O2" value="217"/>
                <count group_id="O3" value="216"/>
                <count group_id="O4" value="217"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="82.2"/>
                    <measurement group_id="O2" value="83.4"/>
                    <measurement group_id="O3" value="82.9"/>
                    <measurement group_id="O4" value="82.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With HCV RNA &lt; LLOQ at Week 4</title>
        <time_frame>Week 4</time_frame>
        <population>Participants in the Full Analysis Set with available data were analyzed.</population>
        <group_list>
          <group group_id="O1">
            <title>LDV/SOF 12 Weeks</title>
            <description>LDV/SOF 90/400 mg FDC tablet once daily for 12 weeks</description>
          </group>
          <group group_id="O2">
            <title>LDV/SOF+RBV 12 Weeks</title>
            <description>LDV/SOF 90/400 mg FDC tablet once daily plus RBV tablets (1000 to 1200 mg daily based on weight) in a divided daily dose for 12 weeks</description>
          </group>
          <group group_id="O3">
            <title>LDV/SOF 24 Weeks</title>
            <description>LDV/SOF 90/400 mg FDC tablet once daily for 24 weeks</description>
          </group>
          <group group_id="O4">
            <title>LDV/SOF+RBV 24 Weeks</title>
            <description>LDV/SOF 90/400 mg FDC tablet once daily plus RBV tablets (1000 to 1200 mg daily based on weight) in a divided daily dose for 24 weeks</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With HCV RNA &lt; LLOQ at Week 4</title>
          <population>Participants in the Full Analysis Set with available data were analyzed.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="213"/>
                <count group_id="O2" value="217"/>
                <count group_id="O3" value="216"/>
                <count group_id="O4" value="217"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="100"/>
                    <measurement group_id="O2" value="99.1"/>
                    <measurement group_id="O3" value="100"/>
                    <measurement group_id="O4" value="100"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With HCV RNA &lt; LLOQ at Week 8</title>
        <time_frame>Week 8</time_frame>
        <population>Participants in the Full Analysis Set with available data were analyzed.</population>
        <group_list>
          <group group_id="O1">
            <title>LDV/SOF 12 Weeks</title>
            <description>LDV/SOF 90/400 mg FDC tablet once daily for 12 weeks</description>
          </group>
          <group group_id="O2">
            <title>LDV/SOF+RBV 12 Weeks</title>
            <description>LDV/SOF 90/400 mg FDC tablet once daily plus RBV tablets (1000 to 1200 mg daily based on weight) in a divided daily dose for 12 weeks</description>
          </group>
          <group group_id="O3">
            <title>LDV/SOF 24 Weeks</title>
            <description>LDV/SOF 90/400 mg FDC tablet once daily for 24 weeks</description>
          </group>
          <group group_id="O4">
            <title>LDV/SOF+RBV 24 Weeks</title>
            <description>LDV/SOF 90/400 mg FDC tablet once daily plus RBV tablets (1000 to 1200 mg daily based on weight) in a divided daily dose for 24 weeks</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With HCV RNA &lt; LLOQ at Week 8</title>
          <population>Participants in the Full Analysis Set with available data were analyzed.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="213"/>
                <count group_id="O2" value="215"/>
                <count group_id="O3" value="215"/>
                <count group_id="O4" value="217"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="99.5"/>
                    <measurement group_id="O2" value="100"/>
                    <measurement group_id="O3" value="99.5"/>
                    <measurement group_id="O4" value="100"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in HCV RNA at Week 2</title>
        <time_frame>Baseline; Week 2</time_frame>
        <population>Participants in the Full Analysis Set with available data were analyzed.</population>
        <group_list>
          <group group_id="O1">
            <title>LDV/SOF 12 Weeks</title>
            <description>LDV/SOF 90/400 mg FDC tablet once daily for 12 weeks</description>
          </group>
          <group group_id="O2">
            <title>LDV/SOF+RBV 12 Weeks</title>
            <description>LDV/SOF 90/400 mg FDC tablet once daily plus RBV tablets (1000 to 1200 mg daily based on weight) in a divided daily dose for 12 weeks</description>
          </group>
          <group group_id="O3">
            <title>LDV/SOF 24 Weeks</title>
            <description>LDV/SOF 90/400 mg FDC tablet once daily for 24 weeks</description>
          </group>
          <group group_id="O4">
            <title>LDV/SOF+RBV 24 Weeks</title>
            <description>LDV/SOF 90/400 mg FDC tablet once daily plus RBV tablets (1000 to 1200 mg daily based on weight) in a divided daily dose for 24 weeks</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in HCV RNA at Week 2</title>
          <population>Participants in the Full Analysis Set with available data were analyzed.</population>
          <units>log10 IU/mL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="213"/>
                <count group_id="O2" value="217"/>
                <count group_id="O3" value="216"/>
                <count group_id="O4" value="216"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-4.90" spread="0.657"/>
                    <measurement group_id="O2" value="-4.94" spread="0.633"/>
                    <measurement group_id="O3" value="-4.86" spread="0.670"/>
                    <measurement group_id="O4" value="-4.89" spread="0.648"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in HCV RNA at Week 4</title>
        <time_frame>Baseline; Week 4</time_frame>
        <population>Participants in the Full Analysis Set with available data were analyzed.</population>
        <group_list>
          <group group_id="O1">
            <title>LDV/SOF 12 Weeks</title>
            <description>LDV/SOF 90/400 mg FDC tablet once daily for 12 weeks</description>
          </group>
          <group group_id="O2">
            <title>LDV/SOF+RBV 12 Weeks</title>
            <description>LDV/SOF 90/400 mg FDC tablet once daily plus RBV tablets (1000 to 1200 mg daily based on weight) in a divided daily dose for 12 weeks</description>
          </group>
          <group group_id="O3">
            <title>LDV/SOF 24 Weeks</title>
            <description>LDV/SOF 90/400 mg FDC tablet once daily for 24 weeks</description>
          </group>
          <group group_id="O4">
            <title>LDV/SOF+RBV 24 Weeks</title>
            <description>LDV/SOF 90/400 mg FDC tablet once daily plus RBV tablets (1000 to 1200 mg daily based on weight) in a divided daily dose for 24 weeks</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in HCV RNA at Week 4</title>
          <population>Participants in the Full Analysis Set with available data were analyzed.</population>
          <units>log10 IU/mL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="213"/>
                <count group_id="O2" value="216"/>
                <count group_id="O3" value="216"/>
                <count group_id="O4" value="217"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-4.99" spread="0.697"/>
                    <measurement group_id="O2" value="-5.02" spread="0.623"/>
                    <measurement group_id="O3" value="-4.93" spread="0.678"/>
                    <measurement group_id="O4" value="-4.96" spread="0.651"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in HCV RNA at Week 8</title>
        <time_frame>Baseline; Week 8</time_frame>
        <population>Participants in the Full Analysis Set with available data were analyzed.</population>
        <group_list>
          <group group_id="O1">
            <title>LDV/SOF 12 Weeks</title>
            <description>LDV/SOF 90/400 mg FDC tablet once daily for 12 weeks</description>
          </group>
          <group group_id="O2">
            <title>LDV/SOF+RBV 12 Weeks</title>
            <description>LDV/SOF 90/400 mg FDC tablet once daily plus RBV tablets (1000 to 1200 mg daily based on weight) in a divided daily dose for 12 weeks</description>
          </group>
          <group group_id="O3">
            <title>LDV/SOF 24 Weeks</title>
            <description>LDV/SOF 90/400 mg FDC tablet once daily for 24 weeks</description>
          </group>
          <group group_id="O4">
            <title>LDV/SOF+RBV 24 Weeks</title>
            <description>LDV/SOF 90/400 mg FDC tablet once daily plus RBV tablets (1000 to 1200 mg daily based on weight) in a divided daily dose for 24 weeks</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in HCV RNA at Week 8</title>
          <population>Participants in the Full Analysis Set with available data were analyzed.</population>
          <units>log10 IU/mL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="213"/>
                <count group_id="O2" value="215"/>
                <count group_id="O3" value="216"/>
                <count group_id="O4" value="217"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-4.99" spread="0.696"/>
                    <measurement group_id="O2" value="-5.02" spread="0.625"/>
                    <measurement group_id="O3" value="-4.91" spread="0.702"/>
                    <measurement group_id="O4" value="-4.96" spread="0.651"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With Virologic Failure</title>
        <description>On-treatment virologic failure was defined as:&#xD;
Breakthrough: HCV RNA ≥ LLOQ after having previously had HCV RNA &lt; LLOQ, while on treatment, confirmed with 2 consecutive values (second confirmation value could have been posttreatment), or last available on-treatment measurement with no subsequent follow- up values, OR&#xD;
Rebound: &gt; 1 log10 IU/mL increase in HCV RNA from nadir while on treatment, confirmed with 2 consecutive values (second confirmation value could have been posttreatment), or last available on-treatment measurement with no subsequent follow-up values, OR&#xD;
Nonresponse: HCV RNA persistently ≥ LLOQ through 8 weeks of treatment&#xD;
Virologic 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>
        <population>Full Analysis Set</population>
        <group_list>
          <group group_id="O1">
            <title>LDV/SOF 12 Weeks</title>
            <description>LDV/SOF 90/400 mg FDC tablet once daily for 12 weeks</description>
          </group>
          <group group_id="O2">
            <title>LDV/SOF+RBV 12 Weeks</title>
            <description>LDV/SOF 90/400 mg FDC tablet once daily plus RBV tablets (1000 to 1200 mg daily based on weight) in a divided daily dose for 12 weeks</description>
          </group>
          <group group_id="O3">
            <title>LDV/SOF 24 Weeks</title>
            <description>LDV/SOF 90/400 mg FDC tablet once daily for 24 weeks</description>
          </group>
          <group group_id="O4">
            <title>LDV/SOF+RBV 24 Weeks</title>
            <description>LDV/SOF 90/400 mg FDC tablet once daily plus RBV tablets (1000 to 1200 mg daily based on weight) in a divided daily dose for 24 weeks</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Virologic Failure</title>
          <description>On-treatment virologic failure was defined as:&#xD;
Breakthrough: HCV RNA ≥ LLOQ after having previously had HCV RNA &lt; LLOQ, while on treatment, confirmed with 2 consecutive values (second confirmation value could have been posttreatment), or last available on-treatment measurement with no subsequent follow- up values, OR&#xD;
Rebound: &gt; 1 log10 IU/mL increase in HCV RNA from nadir while on treatment, confirmed with 2 consecutive values (second confirmation value could have been posttreatment), or last available on-treatment measurement with no subsequent follow-up values, OR&#xD;
Nonresponse: HCV RNA persistently ≥ LLOQ through 8 weeks of treatment&#xD;
Virologic 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>
          <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="214"/>
                <count group_id="O2" value="217"/>
                <count group_id="O3" value="217"/>
                <count group_id="O4" value="217"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>On-treatment virologic failure</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0.5"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Virologic relapse</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.5"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0.5"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Up to 24 weeks plus 30 days</time_frame>
      <desc>Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.</desc>
      <group_list>
        <group group_id="E1">
          <title>LDV/SOF 12 Weeks</title>
          <description>LDV/SOF 90/400 mg FDC tablet once daily for 12 weeks</description>
        </group>
        <group group_id="E2">
          <title>LDV/SOF+RBV 12 Weeks</title>
          <description>LDV/SOF 90/400 mg FDC tablet once daily plus RBV tablets (1000 to 1200 mg daily based on weight) in a divided daily dose for 12 weeks</description>
        </group>
        <group group_id="E3">
          <title>LDV/SOF 24 Weeks</title>
          <description>LDV/SOF 90/400 mg FDC tablet once daily for 24 weeks</description>
        </group>
        <group group_id="E4">
          <title>LDV/SOF+RBV 24 Weeks</title>
          <description>LDV/SOF 90/400 mg FDC tablet once daily plus RBV tablets (1000 to 1200 mg daily based on weight) in a divided daily dose for 24 weeks</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA (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="1" subjects_at_risk="214"/>
                <counts group_id="E2" subjects_affected="7" subjects_at_risk="217"/>
                <counts group_id="E3" subjects_affected="18" subjects_at_risk="217"/>
                <counts group_id="E4" subjects_affected="7" subjects_at_risk="217"/>
              </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="214"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="217"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="217"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="217"/>
              </event>
              <event>
                <sub_title>Factor VIII inhibition</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="214"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="217"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="217"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="217"/>
              </event>
              <event>
                <sub_title>Lymphadenopathy</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="214"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="217"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="217"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="217"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Abdominal discomfort</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="214"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="217"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="217"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="217"/>
              </event>
              <event>
                <sub_title>Colitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="214"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="217"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="217"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="217"/>
              </event>
              <event>
                <sub_title>Mesenteric vein thrombosis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="214"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="217"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="217"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="217"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Chest pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="214"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="217"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="217"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="217"/>
              </event>
              <event>
                <sub_title>Non-cardiac chest pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="214"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="217"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="217"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="217"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Cellulitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="214"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="217"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="217"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="217"/>
              </event>
              <event>
                <sub_title>Gastroenteritis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="214"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="217"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="217"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="217"/>
              </event>
              <event>
                <sub_title>Pneumonia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="214"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="217"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="217"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="217"/>
              </event>
              <event>
                <sub_title>Progressive multifocal leukoencephalopathy</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="214"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="217"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="217"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="217"/>
              </event>
              <event>
                <sub_title>Salpingitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="214"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="217"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="217"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="217"/>
              </event>
              <event>
                <sub_title>Urinary tract infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="214"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="217"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="217"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="217"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Hand fracture</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="214"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="217"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="217"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="217"/>
              </event>
              <event>
                <sub_title>Alcohol poisoning</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="214"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="217"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="217"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="217"/>
              </event>
              <event>
                <sub_title>Concussion</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="214"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="217"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="217"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="217"/>
              </event>
              <event>
                <sub_title>Fall</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="214"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="217"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="217"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="217"/>
              </event>
              <event>
                <sub_title>Foot fracture</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="214"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="217"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="217"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="217"/>
              </event>
              <event>
                <sub_title>Lower limb fracture</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="214"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="217"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="217"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="217"/>
              </event>
              <event>
                <sub_title>Rib fracture</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="214"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="217"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="217"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="217"/>
              </event>
              <event>
                <sub_title>Tibia fracture</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="214"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="217"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="217"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="217"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Intervertebral disc protrusion</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="214"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="217"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="217"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="217"/>
              </event>
              <event>
                <sub_title>Lumbar spinal stenosis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="214"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="217"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="217"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="217"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Squamous cell carcinoma</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="214"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="217"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="217"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="217"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Carotid artery stenosis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="214"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="217"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="217"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="217"/>
              </event>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="214"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="217"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="217"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="217"/>
              </event>
              <event>
                <sub_title>Migraine</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="214"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="217"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="217"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="217"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Alcohol withdrawal syndrome</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="214"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="217"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="217"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="217"/>
              </event>
              <event>
                <sub_title>Depression</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="214"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="217"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="217"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="217"/>
              </event>
              <event>
                <sub_title>Substance abuse</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="214"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="217"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="217"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="217"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Calculus ureteric</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="214"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="217"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="217"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="217"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Reproductive system and breast disorders</title>
            <event_list>
              <event>
                <sub_title>Breast mass</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="214"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="217"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="217"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="217"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Hypertension</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="214"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="217"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="217"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="217"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedDRA (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="140" subjects_at_risk="214"/>
                <counts group_id="E2" subjects_affected="168" subjects_at_risk="217"/>
                <counts group_id="E3" subjects_affected="149" subjects_at_risk="217"/>
                <counts group_id="E4" subjects_affected="189" subjects_at_risk="217"/>
              </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="214"/>
                <counts group_id="E2" subjects_affected="25" subjects_at_risk="217"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="217"/>
                <counts group_id="E4" subjects_affected="22" subjects_at_risk="217"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" subjects_affected="24" subjects_at_risk="214"/>
                <counts group_id="E2" subjects_affected="37" subjects_at_risk="217"/>
                <counts group_id="E3" subjects_affected="29" subjects_at_risk="217"/>
                <counts group_id="E4" subjects_affected="32" subjects_at_risk="217"/>
              </event>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" subjects_affected="24" subjects_at_risk="214"/>
                <counts group_id="E2" subjects_affected="18" subjects_at_risk="217"/>
                <counts group_id="E3" subjects_affected="24" subjects_at_risk="217"/>
                <counts group_id="E4" subjects_affected="14" subjects_at_risk="217"/>
              </event>
              <event>
                <sub_title>Constipation</sub_title>
                <counts group_id="E1" subjects_affected="13" subjects_at_risk="214"/>
                <counts group_id="E2" subjects_affected="12" subjects_at_risk="217"/>
                <counts group_id="E3" subjects_affected="15" subjects_at_risk="217"/>
                <counts group_id="E4" subjects_affected="10" subjects_at_risk="217"/>
              </event>
              <event>
                <sub_title>Dyspepsia</sub_title>
                <counts group_id="E1" subjects_affected="7" subjects_at_risk="214"/>
                <counts group_id="E2" subjects_affected="11" subjects_at_risk="217"/>
                <counts group_id="E3" subjects_affected="14" subjects_at_risk="217"/>
                <counts group_id="E4" subjects_affected="12" subjects_at_risk="217"/>
              </event>
              <event>
                <sub_title>Abdominal pain</sub_title>
                <counts group_id="E1" subjects_affected="12" subjects_at_risk="214"/>
                <counts group_id="E2" subjects_affected="9" subjects_at_risk="217"/>
                <counts group_id="E3" subjects_affected="7" subjects_at_risk="217"/>
                <counts group_id="E4" subjects_affected="8" subjects_at_risk="217"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" subjects_affected="7" subjects_at_risk="214"/>
                <counts group_id="E2" subjects_affected="9" subjects_at_risk="217"/>
                <counts group_id="E3" subjects_affected="6" subjects_at_risk="217"/>
                <counts group_id="E4" subjects_affected="12" subjects_at_risk="217"/>
              </event>
              <event>
                <sub_title>Abdominal pain upper</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="214"/>
                <counts group_id="E2" subjects_affected="11" subjects_at_risk="217"/>
                <counts group_id="E3" subjects_affected="7" subjects_at_risk="217"/>
                <counts group_id="E4" subjects_affected="9" subjects_at_risk="217"/>
              </event>
              <event>
                <sub_title>Gastrooesophageal reflux disease</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="214"/>
                <counts group_id="E2" subjects_affected="7" subjects_at_risk="217"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="217"/>
                <counts group_id="E4" subjects_affected="11" subjects_at_risk="217"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Fatigue</sub_title>
                <counts group_id="E1" subjects_affected="46" subjects_at_risk="214"/>
                <counts group_id="E2" subjects_affected="79" subjects_at_risk="217"/>
                <counts group_id="E3" subjects_affected="53" subjects_at_risk="217"/>
                <counts group_id="E4" subjects_affected="84" subjects_at_risk="217"/>
              </event>
              <event>
                <sub_title>Asthenia</sub_title>
                <counts group_id="E1" subjects_affected="14" subjects_at_risk="214"/>
                <counts group_id="E2" subjects_affected="23" subjects_at_risk="217"/>
                <counts group_id="E3" subjects_affected="20" subjects_at_risk="217"/>
                <counts group_id="E4" subjects_affected="26" subjects_at_risk="217"/>
              </event>
              <event>
                <sub_title>Irritability</sub_title>
                <counts group_id="E1" subjects_affected="11" subjects_at_risk="214"/>
                <counts group_id="E2" subjects_affected="17" subjects_at_risk="217"/>
                <counts group_id="E3" subjects_affected="17" subjects_at_risk="217"/>
                <counts group_id="E4" subjects_affected="24" subjects_at_risk="217"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Nasopharyngitis</sub_title>
                <counts group_id="E1" subjects_affected="14" subjects_at_risk="214"/>
                <counts group_id="E2" subjects_affected="9" subjects_at_risk="217"/>
                <counts group_id="E3" subjects_affected="13" subjects_at_risk="217"/>
                <counts group_id="E4" subjects_affected="19" subjects_at_risk="217"/>
              </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="10" subjects_at_risk="214"/>
                <counts group_id="E2" subjects_affected="12" subjects_at_risk="217"/>
                <counts group_id="E3" subjects_affected="8" subjects_at_risk="217"/>
                <counts group_id="E4" subjects_affected="9" subjects_at_risk="217"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Arthralgia</sub_title>
                <counts group_id="E1" subjects_affected="9" subjects_at_risk="214"/>
                <counts group_id="E2" subjects_affected="14" subjects_at_risk="217"/>
                <counts group_id="E3" subjects_affected="21" subjects_at_risk="217"/>
                <counts group_id="E4" subjects_affected="13" subjects_at_risk="217"/>
              </event>
              <event>
                <sub_title>Myalgia</sub_title>
                <counts group_id="E1" subjects_affected="9" subjects_at_risk="214"/>
                <counts group_id="E2" subjects_affected="13" subjects_at_risk="217"/>
                <counts group_id="E3" subjects_affected="12" subjects_at_risk="217"/>
                <counts group_id="E4" subjects_affected="12" subjects_at_risk="217"/>
              </event>
              <event>
                <sub_title>Back pain</sub_title>
                <counts group_id="E1" subjects_affected="12" subjects_at_risk="214"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="217"/>
                <counts group_id="E3" subjects_affected="12" subjects_at_risk="217"/>
                <counts group_id="E4" subjects_affected="14" subjects_at_risk="217"/>
              </event>
              <event>
                <sub_title>Muscle spasms</sub_title>
                <counts group_id="E1" subjects_affected="7" subjects_at_risk="214"/>
                <counts group_id="E2" subjects_affected="14" subjects_at_risk="217"/>
                <counts group_id="E3" subjects_affected="9" subjects_at_risk="217"/>
                <counts group_id="E4" subjects_affected="12" subjects_at_risk="217"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" subjects_affected="54" subjects_at_risk="214"/>
                <counts group_id="E2" subjects_affected="50" subjects_at_risk="217"/>
                <counts group_id="E3" subjects_affected="54" subjects_at_risk="217"/>
                <counts group_id="E4" subjects_affected="66" subjects_at_risk="217"/>
              </event>
              <event>
                <sub_title>Dizziness</sub_title>
                <counts group_id="E1" subjects_affected="11" subjects_at_risk="214"/>
                <counts group_id="E2" subjects_affected="10" subjects_at_risk="217"/>
                <counts group_id="E3" subjects_affected="14" subjects_at_risk="217"/>
                <counts group_id="E4" subjects_affected="18" subjects_at_risk="217"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Insomnia</sub_title>
                <counts group_id="E1" subjects_affected="17" subjects_at_risk="214"/>
                <counts group_id="E2" subjects_affected="45" subjects_at_risk="217"/>
                <counts group_id="E3" subjects_affected="26" subjects_at_risk="217"/>
                <counts group_id="E4" subjects_affected="46" subjects_at_risk="217"/>
              </event>
              <event>
                <sub_title>Anxiety</sub_title>
                <counts group_id="E1" subjects_affected="7" subjects_at_risk="214"/>
                <counts group_id="E2" subjects_affected="9" subjects_at_risk="217"/>
                <counts group_id="E3" subjects_affected="12" subjects_at_risk="217"/>
                <counts group_id="E4" subjects_affected="19" subjects_at_risk="217"/>
              </event>
              <event>
                <sub_title>Depression</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="214"/>
                <counts group_id="E2" subjects_affected="6" subjects_at_risk="217"/>
                <counts group_id="E3" subjects_affected="5" subjects_at_risk="217"/>
                <counts group_id="E4" subjects_affected="11" subjects_at_risk="217"/>
              </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="6" subjects_at_risk="214"/>
                <counts group_id="E2" subjects_affected="22" subjects_at_risk="217"/>
                <counts group_id="E3" subjects_affected="16" subjects_at_risk="217"/>
                <counts group_id="E4" subjects_affected="25" subjects_at_risk="217"/>
              </event>
              <event>
                <sub_title>Dyspnoea</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="214"/>
                <counts group_id="E2" subjects_affected="18" subjects_at_risk="217"/>
                <counts group_id="E3" subjects_affected="5" subjects_at_risk="217"/>
                <counts group_id="E4" subjects_affected="15" subjects_at_risk="217"/>
              </event>
              <event>
                <sub_title>Dyspnoea exertional</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="214"/>
                <counts group_id="E2" subjects_affected="9" subjects_at_risk="217"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="217"/>
                <counts group_id="E4" subjects_affected="11" subjects_at_risk="217"/>
              </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="16" subjects_at_risk="214"/>
                <counts group_id="E2" subjects_affected="21" subjects_at_risk="217"/>
                <counts group_id="E3" subjects_affected="16" subjects_at_risk="217"/>
                <counts group_id="E4" subjects_affected="26" subjects_at_risk="217"/>
              </event>
              <event>
                <sub_title>Pruritus</sub_title>
                <counts group_id="E1" subjects_affected="11" subjects_at_risk="214"/>
                <counts group_id="E2" subjects_affected="22" subjects_at_risk="217"/>
                <counts group_id="E3" subjects_affected="8" subjects_at_risk="217"/>
                <counts group_id="E4" subjects_affected="20" subjects_at_risk="217"/>
              </event>
              <event>
                <sub_title>Dry skin</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="214"/>
                <counts group_id="E2" subjects_affected="14" subjects_at_risk="217"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="217"/>
                <counts group_id="E4" subjects_affected="13" subjects_at_risk="217"/>
              </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/NCT01701401
org study id: GS-US-337-0102
secondary id: 2012-003387-43
nct id: NCT01701401
lead sponsor: 
has dmc: Yes
The purpose of this study is to evaluate the safety, tolerability, and antiviral efficacy of
      ledipasvir (LDV)/sofosbuvir (SOF) fixed-dose combination (FDC) tablets with or without
      ribavirin (RBV) administered for 12 and 24 weeks in treatment-naive subjects with chronic
      genotype 1 HCV infection.
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 Study Drug (SVR12)
time frame: Posttreatment Week 12
description: SVR12 was defined as HCV RNA level < the lower limit of quantification (LLOQ, ie, < 25 copies/mL) 12 weeks after last dose of study drug.
measure: Incidence of Adverse Events Leading to Permanent Discontinuation From Any Study Drug
time frame: Up to 24 weeks
description: The percentage of participants who experienced an adverse event leading to permanent discontinuation from any study drug was summarized.
measure: Percentage of Participants With SVR at 4 and 24 Weeks After Discontinuation of Study Drug
time frame: Posttreatment Weeks 4 and 24
description: SVR4 and SVR24 were defined as HCV RNA level < LLOQ at 4 and 24 weeks after discontinuation of study drug, respectively.
measure: Percentage of Participants With HCV RNA < LLOQ at Week 2
time frame: Week 2
measure: Percentage of Participants With HCV RNA < LLOQ at Week 4
time frame: Week 4
measure: Percentage of Participants With HCV RNA < LLOQ at Week 8
time frame: Week 8
measure: Change From Baseline in HCV RNA at Week 2
time frame: Baseline; Week 2
measure: Change From Baseline in HCV RNA at Week 4
time frame: Baseline; Week 4
measure: Change From Baseline in HCV RNA at Week 8
time frame: Baseline; Week 8
measure: Percentage of Participants With Virologic Failure
time frame: Baseline to posttreatment Week 24
description: On-treatment virologic failure was defined as:
Breakthrough: HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ, while on treatment, confirmed with 2 consecutive values (second confirmation value could have been posttreatment), or last available on-treatment measurement with no subsequent follow- up values, OR
Rebound: > 1 log10 IU/mL increase in HCV RNA from nadir while on treatment, confirmed with 2 consecutive values (second confirmation value could have been posttreatment), or last available on-treatment measurement with no subsequent follow-up values, OR
Nonresponse: HCV RNA persistently ≥ LLOQ through 8 weeks of treatment
Virologic 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 12 weeks
arm group type: Experimental
description: LDV/SOF administered for 12 weeks
arm group label: LDV/SOF+RBV 12 weeks
arm group type: Experimental
description: LDV/SOF+RBV administered for 12 weeks.
arm group label: LDV/SOF 24 weeks
arm group type: Experimental
description: LDV/SOF administered for 24 weeks
arm group label: LDV/SOF+RBV 24 weeks
arm group type: Experimental
description: LDV/SOF+RBV administered for 24 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 12 weeks
arm group label: LDV/SOF 24 weeks
arm group label: LDV/SOF+RBV 12 weeks
arm group label: LDV/SOF+RBV 24 weeks
other name: Harvoni®
other name: GS-5885/GS-7977
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
arm group label: LDV/SOF+RBV 24 weeks
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Jenny Yang, Pharm D
role: Study Director
affiliation: Gilead Sciences
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country: France
country: Germany
country: Italy
country: Puerto Rico
country: Spain
country: United Kingdom
country: United States
responsible party type: Sponsor
mesh term: Hepatitis C
mesh term: Hepatitis C, Chronic
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: 
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reported events: 
certain agreements: 
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