<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/NCT01682720</url>
  </required_header>
  <id_info>
    <org_study_id>GS-US-334-0133</org_study_id>
    <secondary_id>2012-001942-16</secondary_id>
    <nct_id>NCT01682720</nct_id>
  </id_info>
  <brief_title>Sofosbuvir and Ribavirin in Treatment-Naive and Treatment-Experienced Subjects With Chronic Genotype 2 or 3 HCV Infection</brief_title>
  <official_title>A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Investigate the Efficacy and Safety of GS-7977+Ribavirin for 12 Weeks in Treatment Naive and Treatment Experienced Subjects With Chronic Genotype 2 or 3 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>
      This study will evaluate the safety, tolerability, and antiviral efficacy of GS-7977 with&#xD;
      ribavirin (RBV) in participants with genotype 2 or 3 hepatitis C virus (HCV) infection.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>September 2012</start_date>
  <completion_date type="Actual">January 2014</completion_date>
  <primary_completion_date type="Actual">October 2013</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>Triple (Participant, Care Provider, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Percentage of Participants With Sustained Virologic Response 12 Weeks After Discontinuation of Therapy (SVR12)</measure>
    <time_frame>Posttreatment Week 12</time_frame>
    <description>SVR12 was defined as HCV RNA &lt; the lower limit of quantitation (LLOQ, ie, &lt; 25 IU/mL) 12 weeks following the last dose of study drug. Data for this outcome measure was not collected for the Placebo 12 Weeks (GT2/3) group.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Adverse Events Leading to Permanent Discontinuation of Study Drug(s)</measure>
    <time_frame>Up to 24 weeks</time_frame>
    <description>The percentage of participants experiencing an adverse event leading to permanent discontinuation of study drug(s) was analyzed.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With Sustained Virologic Response at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)</measure>
    <time_frame>Posttreatment Weeks 4 and 24</time_frame>
    <description>SVR4 and SVR24 was defined as HCV RNA &lt; LLOQ at 4 and 24 weeks following the last dose of study drug, respectively. Data for this outcome measure was not collected for the Placebo 12 Weeks (GT2/3) group.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Experiencing Viral Breakthrough or Viral Relapse</measure>
    <time_frame>Up to Posttreatment Week 24</time_frame>
    <description>Viral breakthrough was defined as having confirmed detectable HCV RNA levels (HCV RNA &gt; LLOQ) after having previously had undetectable HCV RNA levels (HCV RNA &lt; LLOQ) while on treatment.&#xD;
Viral relapse was defined as having achieved undetectable HCV RNA levels (HCV RNA &lt; LLOQ) at end of treatment, but did not achieve an SVR.&#xD;
Data for this outcome measure was not collected for the Placebo 12 Weeks (GT2/3) group.</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">421</enrollment>
  <condition>Hepatitis C</condition>
  <arm_group>
    <arm_group_label>Placebo 12 Weeks (GT2/3)</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placebo to match SOF + weight-based RBV (1000-1200 mg as 200 mg tablets in a divided daily dose) for 12 weeks in participants with genotype 2 or 3 HCV infection.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>SOF 12 Weeks (GT2/3)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Placebo to match SOF + weight-based RBV (1000-1200 mg as 200 mg tablets in a divided daily dose) for 12 weeks in participants with genotype 2 or 3 HCV infection.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>SOF 24 Weeks (GT3)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>SOF 400 mg tablet once daily + weight-based RBV (1000-1200 mg as 200 mg tablets in a divided daily dose) for 24 weeks in participants with genotype 3 HCV infection.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>SOF</intervention_name>
    <description>Sofosbuvir (SOF) 400 mg tablet administered orally once daily</description>
    <arm_group_label>SOF 12 Weeks (GT2/3)</arm_group_label>
    <arm_group_label>SOF 24 Weeks (GT3)</arm_group_label>
    <other_name>Sovaldi®</other_name>
    <other_name>GS-7977</other_name>
    <other_name>PSI-7977</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>RBV</intervention_name>
    <description>Ribavirin (RBV) 200 mg 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>SOF 12 Weeks (GT2/3)</arm_group_label>
    <arm_group_label>SOF 24 Weeks (GT3)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo to match SOF</intervention_name>
    <description>Placebo to match SOF administered orally once daily</description>
    <arm_group_label>Placebo 12 Weeks (GT2/3)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo to match RBV</intervention_name>
    <description>Placebo to match RBV administered orally in a divided daily dose</description>
    <arm_group_label>Placebo 12 Weeks (GT2/3)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age &gt; 18 with chronic genotype 2 or 3 HCV infection&#xD;
&#xD;
          -  HCV RNA &gt; 10,000 IU/mL at screening&#xD;
&#xD;
          -  Subjects must be treatment naive or treatment experienced&#xD;
&#xD;
          -  Presence or absence of cirrhosis; a liver biopsy may be required&#xD;
&#xD;
          -  Healthy according to medical history and physical examination with the exception of&#xD;
             HCV diagnosis&#xD;
&#xD;
          -  Agree to use two forms of highly effective contraception for the duration of the study&#xD;
             and 6 months after the last dose of study medication&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Prior use of any other inhibitor of the HCV NS5B Polymerase&#xD;
&#xD;
          -  History of any other clinically significant chronic liver disease&#xD;
&#xD;
          -  Evidence of or history of decompensated liver disease&#xD;
&#xD;
          -  HIV or chronic hepatitis B virus (HBV) infection&#xD;
&#xD;
          -  Hepatocellular carcinoma (HCC) or other malignancy (with exception of certain resolved&#xD;
             skin cancers)&#xD;
&#xD;
          -  Chronic use of immunosuppressive agents or immunomodulatory agents&#xD;
&#xD;
          -  History or current evidence of any condition, therapy, laboratory abnormality or other&#xD;
             circumstance that might confound the results of the study, or interfere with the&#xD;
             subject's participation for the full duration of the study or not be in the best&#xD;
             interest of the subject in the opinion of the investigator&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Rob Hyland, DPhil</last_name>
    <role>Study Director</role>
    <affiliation>Gilead Sciences Study Director</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Medizinische Universitat Graz</name>
      <address>
        <city>Graz</city>
        <zip>A-8036</zip>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medizinische Universitat Wien</name>
      <address>
        <city>Wien</city>
        <zip>1090</zip>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Wilhelminenspital</name>
      <address>
        <city>Wien</city>
        <zip>1160</zip>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>West Tallinn Central Hospital</name>
      <address>
        <city>Tallin</city>
        <zip>10617</zip>
        <country>Estonia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tartu University Hospital</name>
      <address>
        <city>Tartu</city>
        <zip>51014</zip>
        <country>Estonia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHRU de Lille, Hopital Claude Huriez</name>
      <address>
        <city>CHRU Lille</city>
        <zip>59037</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU Estaing</name>
      <address>
        <city>Clermont Ferrand</city>
        <zip>63003</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hopital Beaujon</name>
      <address>
        <city>Clichy Cedex</city>
        <zip>92110</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hopital Henri Mondor</name>
      <address>
        <city>Creteil Cedex</city>
        <zip>94000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Département Hépatogastroentérologie - CHU de Grenoble</name>
      <address>
        <city>Grenoble</city>
        <zip>38043</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hopital Saint Joseph</name>
      <address>
        <city>Marseille, Cedex 8</city>
        <zip>13008</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hopital Saint Eloi</name>
      <address>
        <city>Montpellier</city>
        <zip>34295</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hopital de l Archet 2</name>
      <address>
        <city>Nice</city>
        <zip>6202</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hopitaux Universitaires</name>
      <address>
        <city>Paris, Cedex 14</city>
        <zip>75679</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hopital Saint Antoine</name>
      <address>
        <city>Paris</city>
        <zip>75012</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hopital Pitie Salpetriere</name>
      <address>
        <city>Paris</city>
        <zip>75013</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Groupe Hospitalier Sud - Hôpital Haut-Lévêque - USN</name>
      <address>
        <city>Pessac</city>
        <zip>33604</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU Pontchaillou - Hématologie Clinique</name>
      <address>
        <city>Rennes Cedex 9</city>
        <zip>35033</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre Hospitalier Universitaire de Strasbourg</name>
      <address>
        <city>Strasbourg</city>
        <zip>67091</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU de Nancy, Hôpital de Brabois</name>
      <address>
        <city>Vandoeuvre les Nancy</city>
        <zip>54511</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Praxiszentrum</name>
      <address>
        <city>Freiburg</city>
        <state>Baden Wuerttemberg</state>
        <zip>79098</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Leber- and Studienzentrum am Checkpoint</name>
      <address>
        <city>Berlin</city>
        <zip>10969</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitaetsklinikum Bonn</name>
      <address>
        <city>Bonn</city>
        <zip>53125</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Heinrich Heine Unversitat</name>
      <address>
        <city>Dusseldorf</city>
        <zip>40225</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>JWG-Universität Frankfurt</name>
      <address>
        <city>Frankfurt am Main</city>
        <zip>60590</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Asklepios Klinik Sankt Georg H</name>
      <address>
        <city>Hamburg</city>
        <zip>20099</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitatsklinikum</name>
      <address>
        <city>Hamburg</city>
        <zip>20246</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medizinische Hochschule Hannov</name>
      <address>
        <city>Hannover</city>
        <zip>30625</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medizinische Klinik IV, Dep. o</name>
      <address>
        <city>Heidelberg</city>
        <zip>69120</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Gastroenterologische Gemeinsch</name>
      <address>
        <city>Herne</city>
        <zip>44623</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Leberstudienzentrum Kiel</name>
      <address>
        <city>Kiel</city>
        <zip>24146</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitaetsklinikum Leipzig</name>
      <address>
        <city>Leipzig</city>
        <zip>4103</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Klinikum der Universität Münch</name>
      <address>
        <city>Munchen</city>
        <zip>81377</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centrum fuer interdisziplinaere Medizin Muenster GmbH</name>
      <address>
        <city>Münster</city>
        <zip>D-48143</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ospedale Casa Sollievo</name>
      <address>
        <city>San Giovanni Rotondo</city>
        <state>Foggia</state>
        <zip>71013</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Azienda Ospedaliera di Bologna - Policlinico S. Orsola Malpighi</name>
      <address>
        <city>Bologna</city>
        <zip>40138</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ospedale S. Annunziata</name>
      <address>
        <city>Florence</city>
        <zip>50011</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ente Ospedaliero Ospedali Galliera</name>
      <address>
        <city>Genova</city>
        <zip>16128</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fondazione IRCCS CA Granada - Ospedale Maggiore Policlinico</name>
      <address>
        <city>Milano</city>
        <zip>20122</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Azienda Ospedaliera Ospedale Niguarda Cà Granda</name>
      <address>
        <city>Milano</city>
        <zip>20162</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Padova</name>
      <address>
        <city>Padova</city>
        <zip>35100</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Palermo</name>
      <address>
        <city>Palermo</city>
        <zip>90127</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Azienda Ospedaliero Universitaria di Parma</name>
      <address>
        <city>Parma</city>
        <zip>43100</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fondazione PTV - Policlinico Tor Vergata</name>
      <address>
        <city>Roma</city>
        <zip>133</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>INMI &quot;Lazzaro Spallanzani&quot; I.R.C.C.S.</name>
      <address>
        <city>Roma</city>
        <zip>149</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Azienda Ospedaliera Universitaria San Giovanni Battista di Torino</name>
      <address>
        <city>Torino</city>
        <zip>10126</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Academisch Medisch Centrum</name>
      <address>
        <city>Amsterdam</city>
        <zip>1105 AZ</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Leids Universitair Medisch Centrum</name>
      <address>
        <city>Leiden</city>
        <zip>2300 RC</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UMC St. Radboud - Gastroenterology</name>
      <address>
        <city>Nijmegen</city>
        <zip>6500 HB</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Erasmus MC</name>
      <address>
        <city>Rotterdam</city>
        <zip>3015 CE</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Wojewodzki Szpital Specjalistyczny im Dluskeigo</name>
      <address>
        <city>Bialystok</city>
        <zip>15-540</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Wojewodzki Specjalistyczny Szpital im. W. Bieganskiego</name>
      <address>
        <city>Lodz</city>
        <zip>91-347</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>SP ZOZ Wojewodzki Szpital Zakazny w Warszawie</name>
      <address>
        <city>Warszawa</city>
        <zip>01-201</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>NZOZ Centrum Badan Klinicznych</name>
      <address>
        <city>Wroclaw</city>
        <zip>50-349</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitari Vall d'H</name>
      <address>
        <city>Barcelona</city>
        <zip>08035</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Casa de la Maternidad</name>
      <address>
        <city>Barcelona</city>
        <zip>08036</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Carlos III</name>
      <address>
        <city>Madrid</city>
        <zip>28029</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario La Paz</name>
      <address>
        <city>Madrid</city>
        <zip>28046</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Puerta de Hierro Maja</name>
      <address>
        <city>Majadahonda</city>
        <zip>28222</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Complejo Hospitalario de Especialidades Virgen de la Victoria</name>
      <address>
        <city>Malaga</city>
        <zip>29071</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario Marques</name>
      <address>
        <city>Santander</city>
        <zip>39008</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Valme Hospital</name>
      <address>
        <city>Sevilla</city>
        <zip>41014</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital General Universitario de Valencia</name>
      <address>
        <city>Valencia</city>
        <zip>46014</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sahlgrenska University Hospital</name>
      <address>
        <city>Göteborg</city>
        <zip>41685</zip>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Skånes Universitetssjukhus, Lund</name>
      <address>
        <city>Lund</city>
        <zip>22185</zip>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Skanes Universitetssjukhus</name>
      <address>
        <city>Malmo</city>
        <zip>20502</zip>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Karolinska Instituet</name>
      <address>
        <city>Stockholm</city>
        <zip>14186</zip>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Birmingham</name>
      <address>
        <city>Edgbaston</city>
        <state>Birmingham</state>
        <zip>B15 2TH</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Southampton University Hospital NHS Trust</name>
      <address>
        <city>Southhampton</city>
        <state>Hampshire</state>
        <zip>SO41 3QP</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>King's College Hospital</name>
      <address>
        <city>Denmark Hill</city>
        <state>London</state>
        <zip>SE5 9RS</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Liver Unit</name>
      <address>
        <city>Paddington</city>
        <state>London</state>
        <zip>W2 1NY</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>North Manchester General Hospital</name>
      <address>
        <city>Crumpsall</city>
        <state>Manchester</state>
        <zip>M8 5RB</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Bristol Royal Infirmary</name>
      <address>
        <city>Bristol</city>
        <zip>BS2 8HW</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Queen Marys University of London</name>
      <address>
        <city>London</city>
        <zip>E1 2AT</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Royal Free Hospital and University College London Hospital</name>
      <address>
        <city>London</city>
        <zip>NW3 2PF</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Chelsea &amp; Westminster Hospital</name>
      <address>
        <city>London</city>
        <zip>SW109NH</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nottingham University Hospitals-NHS</name>
      <address>
        <city>Nottingham</city>
        <zip>NG7 2UH</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Austria</country>
    <country>Estonia</country>
    <country>France</country>
    <country>Germany</country>
    <country>Italy</country>
    <country>Netherlands</country>
    <country>Poland</country>
    <country>Spain</country>
    <country>Sweden</country>
    <country>United Kingdom</country>
  </location_countries>
  <results_reference>
    <citation>Zeuzem S, Dusheiko GM, Salupere R, Mangia A, Flisiak R, Hyland RH, Illeperuma A, Svarovskaia E, Brainard DM, Symonds WT, Subramanian GM, McHutchison JG, Weiland O, Reesink HW, Ferenci P, Hezode C, Esteban R; VALENCE Investigators. Sofosbuvir and ribavirin in HCV genotypes 2 and 3. N Engl J Med. 2014 May 22;370(21):1993-2001. doi: 10.1056/NEJMoa1316145. Epub 2014 May 4.</citation>
    <PMID>24795201</PMID>
  </results_reference>
  <verification_date>October 2014</verification_date>
  <study_first_submitted>September 5, 2012</study_first_submitted>
  <study_first_submitted_qc>September 6, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 11, 2012</study_first_posted>
  <results_first_submitted>October 2, 2014</results_first_submitted>
  <results_first_submitted_qc>October 8, 2014</results_first_submitted_qc>
  <results_first_posted type="Estimate">October 9, 2014</results_first_posted>
  <last_update_submitted>October 8, 2014</last_update_submitted>
  <last_update_submitted_qc>October 8, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 9, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>HCV</keyword>
  <keyword>Genotype 2</keyword>
  <keyword>Genotype 3</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hepatitis C</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Sofosbuvir</mesh_term>
  </intervention_browse>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Participants were enrolled at a total of 77 study sites in Europe. The first participant was screened on 19 September 2012. The last participant observation occurred on 08 January 2014.</recruitment_details>
      <pre_assignment_details>475 participants were screened and 421 were randomized.&#xD;
419 participants were randomized and received at least 1 dose of study drug (Safety Analysis Set).&#xD;
334 participants with genotype 2 or 3 hepatitis C virus (HCV) infection were randomized and received at least 1 dose of sofosbuvir (Full Analysis Set).</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Placebo 12 Weeks (GT2/3)</title>
          <description>Placebo to match sofosbuvir (SOF) + placebo to match ribavirin (RBV) for 12 weeks in participants with genotype (GT)2 or 3 HCV infection.</description>
        </group>
        <group group_id="P2">
          <title>SOF 12 Weeks (GT2)</title>
          <description>SOF 400 mg tablet once daily + weight-based RBV (1000-1200 mg as 200 mg tablets in a divided daily dose) for 12 weeks in participants with genotype 2 HCV infection.</description>
        </group>
        <group group_id="P3">
          <title>SOF 12 Weeks (GT3)</title>
          <description>SOF 400 mg tablet once daily + weight-based RBV (1000-1200 mg as 200 mg tablets in a divided daily dose) for 12 weeks in participants with genotype 3 HCV infection.</description>
        </group>
        <group group_id="P4">
          <title>SOF 24 Weeks (GT3)</title>
          <description>SOF 400 mg tablet once daily + weight-based RBV (1000-1200 mg as 200 mg tablets in a divided daily dose) for 24 weeks in participants with genotype 3 HCV infection.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="85"/>
                <participants group_id="P2" count="74"/>
                <participants group_id="P3" count="12"/>
                <participants group_id="P4" count="250"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Included in Full Analysis Set</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="73"/>
                <participants group_id="P3" count="11"/>
                <participants group_id="P4" count="250"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="69"/>
                <participants group_id="P3" count="5"/>
                <participants group_id="P4" count="211"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="85"/>
                <participants group_id="P2" count="5"/>
                <participants group_id="P3" count="7"/>
                <participants group_id="P4" count="39"/>
              </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="0"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="1"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Terminated by Sponsor</title>
              <participants_list>
                <participants group_id="P1" count="83"/>
                <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>Efficacy Failure</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="3"/>
                <participants group_id="P3" count="3"/>
                <participants group_id="P4" count="30"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="6"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Subject Withdrew Consent</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="2"/>
                <participants group_id="P4" count="2"/>
              </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="1"/>
                <participants group_id="P4" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.</population>
      <group_list>
        <group group_id="B1">
          <title>Placebo 12 Weeks (GT2/3)</title>
          <description>Placebo to match SOF + placebo to match RBV for 12 weeks in participants with genotype 2 or 3 HCV infection.</description>
        </group>
        <group group_id="B2">
          <title>SOF 12 Weeks (GT2)</title>
          <description>SOF 400 mg tablet once daily + weight-based RBV (1000-1200 mg as 200 mg tablets in a divided daily dose) for 12 weeks in participants with genotype 2 HCV infection.</description>
        </group>
        <group group_id="B3">
          <title>SOF 12 Weeks (GT3)</title>
          <description>SOF 400 mg tablet once daily + weight-based RBV (1000-1200 mg as 200 mg tablets in a divided daily dose) for 12 weeks in participants with genotype 3 HCV infection.</description>
        </group>
        <group group_id="B4">
          <title>SOF 24 Weeks (GT3)</title>
          <description>SOF 400 mg tablet once daily + weight-based RBV (1000-1200 mg as 200 mg tablets in a divided daily dose) for 24 weeks in participants with genotype 3 HCV infection.</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="85"/>
            <count group_id="B2" value="73"/>
            <count group_id="B3" value="11"/>
            <count group_id="B4" value="250"/>
            <count group_id="B5" value="419"/>
          </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="49" spread="10.5"/>
                    <measurement group_id="B2" value="58" spread="10.1"/>
                    <measurement group_id="B3" value="46" spread="8.8"/>
                    <measurement group_id="B4" value="48" spread="10.1"/>
                    <measurement group_id="B5" value="50" spread="10.8"/>
                  </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="36"/>
                    <measurement group_id="B2" value="33"/>
                    <measurement group_id="B3" value="5"/>
                    <measurement group_id="B4" value="95"/>
                    <measurement group_id="B5" value="169"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="49"/>
                    <measurement group_id="B2" value="40"/>
                    <measurement group_id="B3" value="6"/>
                    <measurement group_id="B4" value="155"/>
                    <measurement group_id="B5" value="250"/>
                  </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="10"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="36"/>
                    <measurement group_id="B5" value="53"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Not Hispanic or Latino</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="71"/>
                    <measurement group_id="B2" value="65"/>
                    <measurement group_id="B3" value="10"/>
                    <measurement group_id="B4" value="203"/>
                    <measurement group_id="B5" value="349"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Not Permitted</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="11"/>
                    <measurement group_id="B5" value="17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race/Ethnicity, Customized</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>Black or African American</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>White</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="81"/>
                    <measurement group_id="B2" value="65"/>
                    <measurement group_id="B3" value="11"/>
                    <measurement group_id="B4" value="236"/>
                    <measurement group_id="B5" value="393"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Asian</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="9"/>
                    <measurement group_id="B5" value="13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Not permitted</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="5"/>
                    <measurement group_id="B5" value="7"/>
                  </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="13"/>
                    <measurement group_id="B2" value="15"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="53"/>
                    <measurement group_id="B5" value="81"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Estonia</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="4"/>
                    <measurement group_id="B4" value="6"/>
                    <measurement group_id="B5" value="15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Spain</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="11"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="31"/>
                    <measurement group_id="B5" value="48"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Poland</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="18"/>
                    <measurement group_id="B5" value="22"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Austria</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="12"/>
                    <measurement group_id="B5" value="18"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Netherlands</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="14"/>
                    <measurement group_id="B5" value="25"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Germany</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="14"/>
                    <measurement group_id="B2" value="8"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="46"/>
                    <measurement group_id="B5" value="69"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>United Kingdom</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="17"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="4"/>
                    <measurement group_id="B4" value="31"/>
                    <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="9"/>
                    <measurement group_id="B2" value="25"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="27"/>
                    <measurement group_id="B5" value="62"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Sweden</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="7"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="12"/>
                    <measurement group_id="B5" value="24"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>HCV Genotype</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>Genotype 2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="18"/>
                    <measurement group_id="B2" value="73"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="91"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Genotype 3</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="67"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="11"/>
                    <measurement group_id="B4" value="250"/>
                    <measurement group_id="B5" value="328"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Liver Cirrhosis</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>No</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="68"/>
                    <measurement group_id="B2" value="62"/>
                    <measurement group_id="B3" value="9"/>
                    <measurement group_id="B4" value="190"/>
                    <measurement group_id="B5" value="329"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Yes</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="17"/>
                    <measurement group_id="B2" value="11"/>
                    <measurement group_id="B3" value="2"/>
                    <measurement group_id="B4" value="60"/>
                    <measurement group_id="B5" value="90"/>
                  </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="22"/>
                    <measurement group_id="B2" value="24"/>
                    <measurement group_id="B3" value="4"/>
                    <measurement group_id="B4" value="86"/>
                    <measurement group_id="B5" value="136"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>CT</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="49"/>
                    <measurement group_id="B2" value="41"/>
                    <measurement group_id="B3" value="4"/>
                    <measurement group_id="B4" value="131"/>
                    <measurement group_id="B5" value="225"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>TT</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="14"/>
                    <measurement group_id="B2" value="8"/>
                    <measurement group_id="B3" value="3"/>
                    <measurement group_id="B4" value="33"/>
                    <measurement group_id="B5" value="58"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>HCV RNA</title>
          <units>log10 IU/mL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="6.5" spread="0.69"/>
                    <measurement group_id="B2" value="6.5" spread="0.70"/>
                    <measurement group_id="B3" value="6.2" spread="0.77"/>
                    <measurement group_id="B4" value="6.3" spread="0.74"/>
                    <measurement group_id="B5" value="6.4" spread="0.72"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>HCV RNA Category</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>&lt; 6 log10 IU/mL</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="21"/>
                    <measurement group_id="B2" value="16"/>
                    <measurement group_id="B3" value="4"/>
                    <measurement group_id="B4" value="72"/>
                    <measurement group_id="B5" value="113"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>≥ 6 log10 IU/mL</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="64"/>
                    <measurement group_id="B2" value="57"/>
                    <measurement group_id="B3" value="7"/>
                    <measurement group_id="B4" value="178"/>
                    <measurement group_id="B5" value="306"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Prior HCV Treatment Experience</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>Experienced</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="50"/>
                    <measurement group_id="B2" value="41"/>
                    <measurement group_id="B3" value="9"/>
                    <measurement group_id="B4" value="145"/>
                    <measurement group_id="B5" value="245"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Naive</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="35"/>
                    <measurement group_id="B2" value="32"/>
                    <measurement group_id="B3" value="2"/>
                    <measurement group_id="B4" value="105"/>
                    <measurement group_id="B5" value="174"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Response to prior HCV treatment</title>
          <description>Only participants who were treatment-experienced at baseline were analyzed.</description>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>Interferon intolerant</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="10"/>
                    <measurement group_id="B5" value="13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Nonresponse</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="18"/>
                    <measurement group_id="B2" value="10"/>
                    <measurement group_id="B3" value="4"/>
                    <measurement group_id="B4" value="41"/>
                    <measurement group_id="B5" value="73"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Relapse/Breakthrough</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="32"/>
                    <measurement group_id="B2" value="28"/>
                    <measurement group_id="B3" value="5"/>
                    <measurement group_id="B4" value="94"/>
                    <measurement group_id="B5" value="159"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Interferon Eligibility</title>
          <description>Only participants who were treatment-naive at baseline were analyzed.</description>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>Interferon eligible</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="30"/>
                    <measurement group_id="B2" value="27"/>
                    <measurement group_id="B3" value="2"/>
                    <measurement group_id="B4" value="94"/>
                    <measurement group_id="B5" value="153"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Interferon ineligible</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="11"/>
                    <measurement group_id="B5" value="21"/>
                  </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 12 Weeks After Discontinuation of Therapy (SVR12)</title>
        <description>SVR12 was defined as HCV RNA &lt; the lower limit of quantitation (LLOQ, ie, &lt; 25 IU/mL) 12 weeks following the last dose of study drug. Data for this outcome measure was not collected for the Placebo 12 Weeks (GT2/3) group.</description>
        <time_frame>Posttreatment Week 12</time_frame>
        <population>Full Analysis Set: participants with genotype 2 or 3 HCV infection were randomized and received at least 1 dose of SOF.</population>
        <group_list>
          <group group_id="O1">
            <title>SOF 12 Weeks (GT2)</title>
            <description>SOF 400 mg tablet once daily + weight-based RBV (1000-1200 mg as 200 mg tablets in a divided daily dose) for 12 weeks in participants with genotype 2 HCV infection.</description>
          </group>
          <group group_id="O2">
            <title>SOF 12 Weeks (GT3)</title>
            <description>SOF 400 mg tablet once daily + weight-based RBV (1000-1200 mg as 200 mg tablets in a divided daily dose) for 12 weeks in participants with genotype 3 HCV infection.</description>
          </group>
          <group group_id="O3">
            <title>SOF 24 Weeks (GT3)</title>
            <description>SOF 400 mg tablet once daily + weight-based RBV (1000-1200 mg as 200 mg tablets in a divided daily dose) for 24 weeks in participants with genotype 3 HCV infection.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Sustained Virologic Response 12 Weeks After Discontinuation of Therapy (SVR12)</title>
          <description>SVR12 was defined as HCV RNA &lt; the lower limit of quantitation (LLOQ, ie, &lt; 25 IU/mL) 12 weeks following the last dose of study drug. Data for this outcome measure was not collected for the Placebo 12 Weeks (GT2/3) group.</description>
          <population>Full Analysis Set: participants with genotype 2 or 3 HCV infection were randomized and received at least 1 dose of SOF.</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="73"/>
                <count group_id="O2" value="11"/>
                <count group_id="O3" value="250"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="93.2"/>
                    <measurement group_id="O2" value="27.3"/>
                    <measurement group_id="O3" value="85.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Adverse Events Leading to Permanent Discontinuation of Study Drug(s)</title>
        <description>The percentage of participants experiencing an adverse event leading to permanent discontinuation of study drug(s) was analyzed.</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>Placebo 12 Weeks (GT2/3)</title>
            <description>Placebo to match SOF + weight-based RBV (1000-1200 mg as 200 mg tablets in a divided daily dose) for 12 weeks in participants with genotype 2 or 3 HCV infection.</description>
          </group>
          <group group_id="O2">
            <title>SOF 12 Weeks (GT2/3)</title>
            <description>SOF 400 mg tablet once daily + weight-based RBV (1000-1200 mg as 200 mg tablets in a divided daily dose) for 12 weeks in participants with genotype 2 or 3 HCV infection.</description>
          </group>
          <group group_id="O3">
            <title>SOF 24 Weeks (GT3)</title>
            <description>SOF 400 mg tablet once daily + weight-based RBV (1000-1200 mg as 200 mg tablets in a divided daily dose) for 24 weeks in participants with genotype 3 HCV infection.</description>
          </group>
        </group_list>
        <measure>
          <title>Adverse Events Leading to Permanent Discontinuation of Study Drug(s)</title>
          <description>The percentage of participants experiencing an adverse event leading to permanent discontinuation of study drug(s) was analyzed.</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="85"/>
                <count group_id="O2" value="84"/>
                <count group_id="O3" value="250"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.2"/>
                    <measurement group_id="O2" value="1.2"/>
                    <measurement group_id="O3" value="0.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With Sustained Virologic Response at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)</title>
        <description>SVR4 and SVR24 was defined as HCV RNA &lt; LLOQ at 4 and 24 weeks following the last dose of study drug, respectively. Data for this outcome measure was not collected for the Placebo 12 Weeks (GT2/3) group.</description>
        <time_frame>Posttreatment Weeks 4 and 24</time_frame>
        <population>Full Analysis Set: participants with genotype 2 or 3 HCV infection were randomized and received at least 1 dose of SOF.</population>
        <group_list>
          <group group_id="O1">
            <title>SOF 12 Weeks (GT2)</title>
            <description>SOF 400 mg tablet once daily + weight-based RBV (1000-1200 mg as 200 mg tablets in a divided daily dose) for 12 weeks in participants with genotype 2 HCV infection.</description>
          </group>
          <group group_id="O2">
            <title>SOF 12 Weeks (GT3)</title>
            <description>SOF 400 mg tablet once daily + weight-based RBV (1000-1200 mg as 200 mg tablets in a divided daily dose) for 12 weeks in participants with genotype 3 HCV infection.</description>
          </group>
          <group group_id="O3">
            <title>SOF 24 Weeks (GT3)</title>
            <description>SOF 400 mg tablet once daily + weight-based RBV (1000-1200 mg as 200 mg tablets in a divided daily dose) for 24 weeks in participants with genotype 3 HCV infection.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Sustained Virologic Response at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)</title>
          <description>SVR4 and SVR24 was defined as HCV RNA &lt; LLOQ at 4 and 24 weeks following the last dose of study drug, respectively. Data for this outcome measure was not collected for the Placebo 12 Weeks (GT2/3) group.</description>
          <population>Full Analysis Set: participants with genotype 2 or 3 HCV infection were randomized and received at least 1 dose of SOF.</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="73"/>
                <count group_id="O2" value="11"/>
                <count group_id="O3" value="250"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>SVR4</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="93.2"/>
                    <measurement group_id="O2" value="45.5"/>
                    <measurement group_id="O3" value="87.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>SVR24</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="93.2"/>
                    <measurement group_id="O2" value="27.3"/>
                    <measurement group_id="O3" value="84.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants Experiencing Viral Breakthrough or Viral Relapse</title>
        <description>Viral breakthrough was defined as having confirmed detectable HCV RNA levels (HCV RNA &gt; LLOQ) after having previously had undetectable HCV RNA levels (HCV RNA &lt; LLOQ) while on treatment.&#xD;
Viral relapse was defined as having achieved undetectable HCV RNA levels (HCV RNA &lt; LLOQ) at end of treatment, but did not achieve an SVR.&#xD;
Data for this outcome measure was not collected for the Placebo 12 Weeks (GT2/3) group.</description>
        <time_frame>Up to Posttreatment Week 24</time_frame>
        <population>Full Analysis Set: participants with genotype 2 or 3 HCV infection were randomized and received at least 1 dose of SOF.</population>
        <group_list>
          <group group_id="O1">
            <title>SOF 12 Weeks (GT2)</title>
            <description>SOF 400 mg tablet once daily + weight-based RBV (1000-1200 mg as 200 mg tablets in a divided daily dose) for 12 weeks in participants with genotype 2 HCV infection.</description>
          </group>
          <group group_id="O2">
            <title>SOF 12 Weeks (GT3)</title>
            <description>SOF 400 mg tablet once daily + weight-based RBV (1000-1200 mg as 200 mg tablets in a divided daily dose) for 12 weeks in participants with genotype 3 HCV infection.</description>
          </group>
          <group group_id="O3">
            <title>SOF 24 Weeks (GT3)</title>
            <description>SOF 400 mg tablet once daily + weight-based RBV (1000-1200 mg as 200 mg tablets in a divided daily dose) for 24 weeks in participants with genotype 3 HCV infection.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Experiencing Viral Breakthrough or Viral Relapse</title>
          <description>Viral breakthrough was defined as having confirmed detectable HCV RNA levels (HCV RNA &gt; LLOQ) after having previously had undetectable HCV RNA levels (HCV RNA &lt; LLOQ) while on treatment.&#xD;
Viral relapse was defined as having achieved undetectable HCV RNA levels (HCV RNA &lt; LLOQ) at end of treatment, but did not achieve an SVR.&#xD;
Data for this outcome measure was not collected for the Placebo 12 Weeks (GT2/3) group.</description>
          <population>Full Analysis Set: participants with genotype 2 or 3 HCV infection were randomized and received at least 1 dose of SOF.</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="73"/>
                <count group_id="O2" value="11"/>
                <count group_id="O3" value="250"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Viral breakthrough</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Viral relapse</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.8"/>
                    <measurement group_id="O2" value="54.5"/>
                    <measurement group_id="O3" value="14.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Baseline up to Week 24 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>Placebo 12 Weeks (GT2/3)</title>
          <description>Placebo to match SOF + weight-based RBV (1000-1200 mg as 200 mg tablets in a divided daily dose) for 12 weeks in participants with genotype 2 or 3 HCV infection.</description>
        </group>
        <group group_id="E2">
          <title>SOF 12 Weeks (GT2/3)</title>
          <description>SOF 400 mg tablet once daily + weight-based RBV (1000-1200 mg as 200 mg tablets in a divided daily dose) for 12 weeks in participants with genotype 2 or 3 HCV infection.</description>
        </group>
        <group group_id="E3">
          <title>SOF 24 Weeks (GT3)</title>
          <description>SOF 400 mg tablet once daily + weight-based RBV (1000-1200 mg as 200 mg tablets in a divided daily dose) for 24 weeks in participants with genotype 3 HCV infection.</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA (16.1)</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="85"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="84"/>
                <counts group_id="E3" subjects_affected="10" subjects_at_risk="250"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Arrhythmia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="85"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="84"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="250"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Adenocarcinoma of colon</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="85"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="84"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="250"/>
              </event>
              <event>
                <sub_title>Haemorrhoidal haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="85"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="84"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="250"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Hepatobiliary disorders</title>
            <event_list>
              <event>
                <sub_title>Biliary colic</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="85"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="84"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="250"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Gastroenteritis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="85"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="84"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="250"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Road traffic accident</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="85"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="84"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="250"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Amylase increased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="85"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="84"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="250"/>
              </event>
              <event>
                <sub_title>Lipase increased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="85"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="84"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="250"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Hyperglycaemia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="85"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="84"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="250"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Hepatocellular carcinoma</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="85"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="84"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="250"/>
              </event>
              <event>
                <sub_title>Invasive ductal breast carcinoma</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="85"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="84"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="250"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Complex regional pain syndrome</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="85"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="84"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="250"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Suicide attempt</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="85"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="84"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="250"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedDRA (16.1)</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="60" subjects_at_risk="85"/>
                <counts group_id="E2" subjects_affected="72" subjects_at_risk="84"/>
                <counts group_id="E3" subjects_affected="229" subjects_at_risk="250"/>
              </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="1" subjects_at_risk="85"/>
                <counts group_id="E2" subjects_affected="6" subjects_at_risk="84"/>
                <counts group_id="E3" subjects_affected="17" subjects_at_risk="250"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" subjects_affected="9" subjects_at_risk="85"/>
                <counts group_id="E2" subjects_affected="26" subjects_at_risk="84"/>
                <counts group_id="E3" subjects_affected="33" subjects_at_risk="250"/>
              </event>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="85"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="84"/>
                <counts group_id="E3" subjects_affected="30" subjects_at_risk="250"/>
              </event>
              <event>
                <sub_title>Abdominal pain upper</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="85"/>
                <counts group_id="E2" subjects_affected="7" subjects_at_risk="84"/>
                <counts group_id="E3" subjects_affected="15" subjects_at_risk="250"/>
              </event>
              <event>
                <sub_title>Abdominal pain</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="85"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="84"/>
                <counts group_id="E3" subjects_affected="21" subjects_at_risk="250"/>
              </event>
              <event>
                <sub_title>Dyspepsia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="85"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="84"/>
                <counts group_id="E3" subjects_affected="15" subjects_at_risk="250"/>
              </event>
              <event>
                <sub_title>Constipation</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="85"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="84"/>
                <counts group_id="E3" subjects_affected="13" subjects_at_risk="250"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Fatigue</sub_title>
                <counts group_id="E1" subjects_affected="16" subjects_at_risk="85"/>
                <counts group_id="E2" subjects_affected="19" subjects_at_risk="84"/>
                <counts group_id="E3" subjects_affected="75" subjects_at_risk="250"/>
              </event>
              <event>
                <sub_title>Asthenia</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="85"/>
                <counts group_id="E2" subjects_affected="21" subjects_at_risk="84"/>
                <counts group_id="E3" subjects_affected="53" subjects_at_risk="250"/>
              </event>
              <event>
                <sub_title>Irritability</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="85"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="84"/>
                <counts group_id="E3" subjects_affected="26" subjects_at_risk="250"/>
              </event>
              <event>
                <sub_title>Influenza like illness</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="85"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="84"/>
                <counts group_id="E3" subjects_affected="16" subjects_at_risk="250"/>
              </event>
              <event>
                <sub_title>Pyrexia</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="85"/>
                <counts group_id="E2" subjects_affected="7" subjects_at_risk="84"/>
                <counts group_id="E3" subjects_affected="9" subjects_at_risk="250"/>
              </event>
              <event>
                <sub_title>Chest pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="85"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="84"/>
                <counts group_id="E3" subjects_affected="5" subjects_at_risk="250"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Nasopharyngitis</sub_title>
                <counts group_id="E1" subjects_affected="9" subjects_at_risk="85"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="84"/>
                <counts group_id="E3" subjects_affected="36" subjects_at_risk="250"/>
              </event>
              <event>
                <sub_title>Influenza</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="85"/>
                <counts group_id="E2" subjects_affected="6" subjects_at_risk="84"/>
                <counts group_id="E3" subjects_affected="12" subjects_at_risk="250"/>
              </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="4" subjects_at_risk="85"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="84"/>
                <counts group_id="E3" subjects_affected="16" subjects_at_risk="250"/>
              </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="6" subjects_at_risk="85"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="84"/>
                <counts group_id="E3" subjects_affected="25" subjects_at_risk="250"/>
              </event>
              <event>
                <sub_title>Myalgia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="85"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="84"/>
                <counts group_id="E3" subjects_affected="22" subjects_at_risk="250"/>
              </event>
              <event>
                <sub_title>Back pain</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="85"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="84"/>
                <counts group_id="E3" subjects_affected="15" subjects_at_risk="250"/>
              </event>
              <event>
                <sub_title>Pain in extremity</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="85"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="84"/>
                <counts group_id="E3" subjects_affected="13" subjects_at_risk="250"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" subjects_affected="23" subjects_at_risk="85"/>
                <counts group_id="E2" subjects_affected="24" subjects_at_risk="84"/>
                <counts group_id="E3" subjects_affected="74" subjects_at_risk="250"/>
              </event>
              <event>
                <sub_title>Dizziness</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="85"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="84"/>
                <counts group_id="E3" subjects_affected="19" subjects_at_risk="250"/>
              </event>
              <event>
                <sub_title>Disturbance in attention</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="85"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="84"/>
                <counts group_id="E3" subjects_affected="15" subjects_at_risk="250"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Insomnia</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="85"/>
                <counts group_id="E2" subjects_affected="9" subjects_at_risk="84"/>
                <counts group_id="E3" subjects_affected="41" subjects_at_risk="250"/>
              </event>
              <event>
                <sub_title>Sleep disorder</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="85"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="84"/>
                <counts group_id="E3" subjects_affected="23" subjects_at_risk="250"/>
              </event>
              <event>
                <sub_title>Anxiety</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="85"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="84"/>
                <counts group_id="E3" subjects_affected="13" subjects_at_risk="250"/>
              </event>
              <event>
                <sub_title>Depressed mood</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="85"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="84"/>
                <counts group_id="E3" subjects_affected="13" subjects_at_risk="250"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Dyspnoea</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="85"/>
                <counts group_id="E2" subjects_affected="12" subjects_at_risk="84"/>
                <counts group_id="E3" subjects_affected="27" subjects_at_risk="250"/>
              </event>
              <event>
                <sub_title>Cough</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="85"/>
                <counts group_id="E2" subjects_affected="8" subjects_at_risk="84"/>
                <counts group_id="E3" subjects_affected="27" subjects_at_risk="250"/>
              </event>
              <event>
                <sub_title>Dyspnoea exertional</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="85"/>
                <counts group_id="E2" subjects_affected="6" subjects_at_risk="84"/>
                <counts group_id="E3" subjects_affected="9" subjects_at_risk="250"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Pruritus</sub_title>
                <counts group_id="E1" subjects_affected="8" subjects_at_risk="85"/>
                <counts group_id="E2" subjects_affected="20" subjects_at_risk="84"/>
                <counts group_id="E3" subjects_affected="67" subjects_at_risk="250"/>
              </event>
              <event>
                <sub_title>Dry skin</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="85"/>
                <counts group_id="E2" subjects_affected="8" subjects_at_risk="84"/>
                <counts group_id="E3" subjects_affected="31" subjects_at_risk="250"/>
              </event>
              <event>
                <sub_title>Rash</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="85"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="84"/>
                <counts group_id="E3" subjects_affected="24" subjects_at_risk="250"/>
              </event>
              <event>
                <sub_title>Eczema</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="85"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="84"/>
                <counts group_id="E3" subjects_affected="14" subjects_at_risk="250"/>
              </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/NCT01682720
org study id: GS-US-334-0133
secondary id: 2012-001942-16
nct id: NCT01682720
lead sponsor: 
has dmc: Yes
This study will evaluate the safety, tolerability, and antiviral efficacy of GS-7977 with
      ribavirin (RBV) in participants with genotype 2 or 3 hepatitis C virus (HCV) infection.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Care Provider, Investigator)
measure: Percentage of Participants With Sustained Virologic Response 12 Weeks After Discontinuation of Therapy (SVR12)
time frame: Posttreatment Week 12
description: SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ, ie, < 25 IU/mL) 12 weeks following the last dose of study drug. Data for this outcome measure was not collected for the Placebo 12 Weeks (GT2/3) group.
measure: Adverse Events Leading to Permanent Discontinuation of Study Drug(s)
time frame: Up to 24 weeks
description: The percentage of participants experiencing an adverse event leading to permanent discontinuation of study drug(s) was analyzed.
measure: Percentage of Participants With Sustained Virologic Response at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)
time frame: Posttreatment Weeks 4 and 24
description: SVR4 and SVR24 was defined as HCV RNA < LLOQ at 4 and 24 weeks following the last dose of study drug, respectively. Data for this outcome measure was not collected for the Placebo 12 Weeks (GT2/3) group.
measure: Percentage of Participants Experiencing Viral Breakthrough or Viral Relapse
time frame: Up to Posttreatment Week 24
description: Viral breakthrough was defined as having confirmed detectable HCV RNA levels (HCV RNA > LLOQ) after having previously had undetectable HCV RNA levels (HCV RNA < LLOQ) while on treatment.
Viral relapse was defined as having achieved undetectable HCV RNA levels (HCV RNA < LLOQ) at end of treatment, but did not achieve an SVR.
Data for this outcome measure was not collected for the Placebo 12 Weeks (GT2/3) group.
arm group label: Placebo 12 Weeks (GT2/3)
arm group type: Placebo Comparator
description: Placebo to match SOF + weight-based RBV (1000-1200 mg as 200 mg tablets in a divided daily dose) for 12 weeks in participants with genotype 2 or 3 HCV infection.
arm group label: SOF 12 Weeks (GT2/3)
arm group type: Experimental
description: Placebo to match SOF + weight-based RBV (1000-1200 mg as 200 mg tablets in a divided daily dose) for 12 weeks in participants with genotype 2 or 3 HCV infection.
arm group label: SOF 24 Weeks (GT3)
arm group type: Experimental
description: SOF 400 mg tablet once daily + weight-based RBV (1000-1200 mg as 200 mg tablets in a divided daily dose) for 24 weeks in participants with genotype 3 HCV infection.
intervention type: Drug
intervention name: SOF
description: Sofosbuvir (SOF) 400 mg tablet administered orally once daily
arm group label: SOF 12 Weeks (GT2/3)
arm group label: SOF 24 Weeks (GT3)
other name: Sovaldi®
other name: GS-7977
other name: PSI-7977
intervention type: Drug
intervention name: RBV
description: Ribavirin (RBV) 200 mg 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: SOF 12 Weeks (GT2/3)
arm group label: SOF 24 Weeks (GT3)
intervention type: Drug
intervention name: Placebo to match SOF
description: Placebo to match SOF administered orally once daily
arm group label: Placebo 12 Weeks (GT2/3)
intervention type: Drug
intervention name: Placebo to match RBV
description: Placebo to match RBV administered orally in a divided daily dose
arm group label: Placebo 12 Weeks (GT2/3)
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Rob Hyland, DPhil
role: Study Director
affiliation: Gilead Sciences Study Director
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country: Austria
country: Estonia
country: France
country: Germany
country: Italy
country: Netherlands
country: Poland
country: Spain
country: Sweden
country: United Kingdom
citation: Zeuzem S, Dusheiko GM, Salupere R, Mangia A, Flisiak R, Hyland RH, Illeperuma A, Svarovskaia E, Brainard DM, Symonds WT, Subramanian GM, McHutchison JG, Weiland O, Reesink HW, Ferenci P, Hezode C, Esteban R; VALENCE Investigators. Sofosbuvir and ribavirin in HCV genotypes 2 and 3. N Engl J Med. 2014 May 22;370(21):1993-2001. doi: 10.1056/NEJMoa1316145. Epub 2014 May 4.
PMID: 24795201
responsible party type: Sponsor
mesh term: Hepatitis C
mesh term: Sofosbuvir
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 