<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/NCT02185794</url>
  </required_header>
  <id_info>
    <org_study_id>GS-US-338-1121</org_study_id>
    <nct_id>NCT02185794</nct_id>
  </id_info>
  <brief_title>Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Antiviral Activity of Voxilaprevir in Adults With Chronic Hepatitis C Virus Infection</brief_title>
  <official_title>Phase 1b, Randomized, Double-Blind, Multiple-Dose Ranging Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Antiviral Activity of GS-9857 in Subjects With Chronic Hepatitis C Virus Infection</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Gilead Sciences</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Gilead Sciences</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The primary objective of the study is to evaluate the safety and tolerability of voxilaprevir&#xD;
      (formerly GS-9857) alone or with sofosbuvir (SOF)/velpatasvir (VEL) fixed dose combination&#xD;
      (FDC) and antiviral activity of voxilaprevir in adults with genotype 1, 2, 3, 4 hepatitis C&#xD;
      virus (HCV) infection. All participants will be monitored for up to 48 weeks after the last&#xD;
      dose.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 13, 2014</start_date>
  <completion_date type="Actual">September 28, 2015</completion_date>
  <primary_completion_date type="Actual">December 22, 2014</primary_completion_date>
  <phase>Phase 1</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>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Percentage of Participants Experiencing Treatment Emergent Adverse Events</measure>
    <time_frame>First dose date up to Day 3 plus 30 days</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities</measure>
    <time_frame>First dose date up to Day 3 plus 30 days</time_frame>
    <description>Treatment-emergent laboratory abnormalities were defined as values that increase at least one toxicity grade from baseline. The severity of laboratory abnormalities was assessed as Grade 0, 1 (mild), 2 (moderate), 3 (severe), or 4 (potentially life threatening) using the Common Terminology Criteria for Adverse Events (CTCAE), version 4.03. The most severe graded abnormality from all tests was counted for each participant.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Antiviral Activity of Voxilaprevir as Measured by Change From Baseline in Plasma HCV RNA</measure>
    <time_frame>Baseline; Days 4, 5, 6, 7, 8, 10, and Week 48</time_frame>
    <description>The outcome measure was assessed to evaluate antiviral activity of voxilaprevir only (cohorts 1 through 6). Data are summarized by treatment/cohort and placebo.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Antiviral Activity of Voxilaprevir as Measured by Absolute HCV RNA Level Through Week 48</measure>
    <time_frame>Baseline (Pre Day 1 Dose); Days 4, 5, 6, 7, 8, 10, and Week 48</time_frame>
    <description>The outcome measure was assessed to evaluate antiviral activity of voxilaprevir only (cohorts 1 through 6).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Antiviral Activity of Voxilaprevir as Measured by Number of Participants Achieving Reductions From Baseline in HCV RNA</measure>
    <time_frame>Baseline; Days 4, 5, 6, 7, 8, 10, and Week 48</time_frame>
    <description>Categorical declines from baseline were summarized by the number of participants with a &lt; 1, ≥ 1 to &lt;2, ≥ 2 to &lt;3, or ≥ 3 log10 IU/mL decrease in HCV RNA from baseline to each postdose assessment up to Week 48 by treatment/cohort and placebo. The outcome measure was assessed to evaluate antiviral activity of voxilaprevir only (cohorts 1 through 6).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Who Have HCV RNA &lt; Lower Limit of Quantitation (LLOQ) Detected, and &lt; LLOQ Target Not Detected (TND)</measure>
    <time_frame>Days 4, 5, 6, 7, 8, 10, and Week 48</time_frame>
    <description>The lower limit of quantitation (LLOQ) detection for HCV RNA levels was 15 IU/mL. HCV detected means calculated HCV RNA level is below LLOQ of the assay. The outcome measure was assessed to evaluate antiviral activity of voxilaprevir only (cohorts 1 through 6).</description>
  </secondary_outcome>
  <number_of_arms>16</number_of_arms>
  <enrollment type="Actual">101</enrollment>
  <condition>Hepatitis C Virus Infection</condition>
  <arm_group>
    <arm_group_label>Placebo (GT 1a, Cohort 1)</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Participants with genotype (GT) 1a HCV infection will receive placebo once daily for 3 days under fasted conditions.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Voxilaprevir 50 mg (GT 1a, Cohort 1)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants with GT 1a HCV infection will receive voxilaprevir 50 mg once daily for 3 days under fasted conditions.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Voxilaprevir 100 mg (GT 1a, Cohort 1)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants with GT 1a HCV infection will receive voxilaprevir 100 mg once daily for 3 days under fasted conditions.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Voxilaprevir 300 mg (GT 1a, Cohort 1)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants with GT 1a HCV infection will receive voxilaprevir 300 mg once daily for 3 days under fasted conditions.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo (GT 3, Cohort 2)</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Participants with GT 3 HCV infection will receive placebo once daily for 3 days under fasted conditions.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Voxilaprevir 50 mg (GT 3, Cohort 2)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants with GT 3 HCV infection will receive voxilaprevir 50 mg once daily for 3 days under fasted conditions.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Voxilaprevir 100 mg (GT 3, Cohort 2)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants with GT 3 HCV infection will receive voxilaprevir 100 mg once daily for 3 days under fasted conditions.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Voxilaprevir 300 mg (GT 3, Cohort 2)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants with GT 3 HCV infection will receive voxilaprevir 300 mg once daily for 3 days under fasted conditions.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo (GT 2, Cohort 3)</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Participants with GT 2 HCV infection will receive placebo once daily for 3 days under fasted conditions.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Voxilaprevir 100 mg (GT 2, Cohort 3)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants with GT 2 HCV infection will receive voxilaprevir 100 mg once daily for 3 days under fasted conditions.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Voxilaprevir 100 mg (GT 4, Cohort 4)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants with GT 4 HCV infection will receive voxilaprevir 100 mg once daily for 3 days under fasted conditions.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Voxilaprevir 100 mg (GT 1b, Cohort 5)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants with GT 1b HCV infection will receive voxilaprevir 100 mg once daily for 3 days under fasted conditions.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Voxilaprevir 100 mg Fed (GT 3a, Cohort 6)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants with GT 3a HCV infection will receive voxilaprevir 100 mg once daily for 3 days under fed conditions.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Voxilaprevir 600 mg (Cohorts 7-9)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants with genotypes 1a, 1b, 2, 3, or 4 HCV infection will receive voxilaprevir up to 600 mg under fasted or fed conditions for 3 days.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Voxilaprevir 100 mg + SOF/VEL 400/100 mg (Group 1, Cohort 10)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants with any GT HCV infection received voxilaprevir 100 mg on Day 1 after moderate fat meal and voxilaprevir 100 mg plus sofosbuvir (SOF)/velpatasvir (VEL) (400/100 mg) fixed-dose combination (FDC)on Days 2 and 3 after either a light or moderate-fat meal.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Voxilaprevir 100 mg + SOF/VEL 400/100 mg (Group 2, Cohort 10)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants with any GT HCV infection received voxilaprevir 100 mg on Day 1 and voxilaprevir 100 mg plus SOF/VEL (400/100 mg) FDC on Days 2 and 3 after moderate fat meal.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Voxilaprevir</intervention_name>
    <description>Voxilaprevir tablets administered orally once daily</description>
    <arm_group_label>Voxilaprevir 100 mg (GT 1a, Cohort 1)</arm_group_label>
    <arm_group_label>Voxilaprevir 100 mg (GT 1b, Cohort 5)</arm_group_label>
    <arm_group_label>Voxilaprevir 100 mg (GT 2, Cohort 3)</arm_group_label>
    <arm_group_label>Voxilaprevir 100 mg (GT 3, Cohort 2)</arm_group_label>
    <arm_group_label>Voxilaprevir 100 mg (GT 4, Cohort 4)</arm_group_label>
    <arm_group_label>Voxilaprevir 100 mg + SOF/VEL 400/100 mg (Group 1, Cohort 10)</arm_group_label>
    <arm_group_label>Voxilaprevir 100 mg + SOF/VEL 400/100 mg (Group 2, Cohort 10)</arm_group_label>
    <arm_group_label>Voxilaprevir 100 mg Fed (GT 3a, Cohort 6)</arm_group_label>
    <arm_group_label>Voxilaprevir 300 mg (GT 1a, Cohort 1)</arm_group_label>
    <arm_group_label>Voxilaprevir 300 mg (GT 3, Cohort 2)</arm_group_label>
    <arm_group_label>Voxilaprevir 50 mg (GT 1a, Cohort 1)</arm_group_label>
    <arm_group_label>Voxilaprevir 50 mg (GT 3, Cohort 2)</arm_group_label>
    <arm_group_label>Voxilaprevir 600 mg (Cohorts 7-9)</arm_group_label>
    <other_name>GS-9857</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo to match voxilaprevir</intervention_name>
    <description>Placebo to match voxilaprevir tablets administered orally once daily</description>
    <arm_group_label>Placebo (GT 1a, Cohort 1)</arm_group_label>
    <arm_group_label>Placebo (GT 2, Cohort 3)</arm_group_label>
    <arm_group_label>Placebo (GT 3, Cohort 2)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>SOF/VEL</intervention_name>
    <description>400 mg/100 mg FDC tablet administered orally once daily</description>
    <arm_group_label>Voxilaprevir 100 mg + SOF/VEL 400/100 mg (Group 1, Cohort 10)</arm_group_label>
    <arm_group_label>Voxilaprevir 100 mg + SOF/VEL 400/100 mg (Group 2, Cohort 10)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Key Inclusion Criteria:&#xD;
&#xD;
          -  Chronic genotype 1-4 HCV infection&#xD;
&#xD;
          -  For Cohorts 1-9, HCV RNA ≥ 100,000 IU/mL at screening (no HCV RNA restriction for&#xD;
             Cohort 10)&#xD;
&#xD;
          -  Screening laboratory values within defined thresholds&#xD;
&#xD;
          -  Use of two effective contraception methods if female of childbearing potential or&#xD;
             sexually active male&#xD;
&#xD;
        Key Exclusion Criteria:&#xD;
&#xD;
          -  Pregnant or nursing female or male with pregnant female partner&#xD;
&#xD;
          -  Presence of cirrhosis&#xD;
&#xD;
          -  Prior exposure to approved or experimental HCV Protease Inhibitors&#xD;
&#xD;
          -  Co-infection with HIV or hepatitis B virus (HBV)&#xD;
&#xD;
          -  Current or prior history of clinical hepatic decompensation&#xD;
&#xD;
          -  Chronic use of systemic immunosuppressive agents&#xD;
&#xD;
          -  History of clinically significant illness or any other medical disorder that may&#xD;
             interfere with participant's treatment, assessment or compliance with the protocol&#xD;
&#xD;
        Note: Other protocol defined Inclusion/Exclusion criteria may apply.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Gilead Study Director</last_name>
    <role>Study Director</role>
    <affiliation>Gilead Sciences</affiliation>
  </overall_official>
  <location>
    <facility>
      <address>
        <city>Costa Mesa</city>
        <state>California</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>DeLand</city>
        <state>Florida</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Orlando</city>
        <state>Florida</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Kansas City</city>
        <state>Missouri</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Saint Louis</city>
        <state>Missouri</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Berlin</city>
        <state>New Jersey</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Marlton</city>
        <state>New Jersey</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Knoxville</city>
        <state>Tennessee</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>San Antonio</city>
        <state>Texas</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>San Juan</city>
        <country>Puerto Rico</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Puerto Rico</country>
    <country>United States</country>
  </location_countries>
  <results_reference>
    <citation>Rodriguez-Torres M, Glass S, Hill J, Freilich B, Hassman D, Di Bisceglie A, Taylor J, Kirby B, Yang J, An D, Stamm L, Brainard D, Kim S, Krefetz D, Smith W, Marbury T, Lawitz E. The Pangenotypic NS3/4A Protease Inhibitor GS-9857 Demonstrates Potent Antiviral Activity in Patients Infected With HCV Genotype 1, 2, 3, or 4 in a 3-Day Monotherapy Study [Poster P0901]. Presented at the European Association for the Study of the Liver (EASL) 50th International Liver Congress 2015, April 22-26, 2015, Vienna, Austria.</citation>
  </results_reference>
  <results_reference>
    <citation>Lawitz E, Yang JC, Stamm LM, Taylor JG, Cheng G, Brainard DM, Miller MD, Mo H, Dvory-Sobol H. Characterization of HCV resistance from a 3-day monotherapy study of voxilaprevir, a novel pangenotypic NS3/4A protease inhibitor. Antivir Ther. 2018;23(4):325-334. doi: 10.3851/IMP3202.</citation>
    <PMID>29063860</PMID>
  </results_reference>
  <verification_date>August 2020</verification_date>
  <study_first_submitted>July 7, 2014</study_first_submitted>
  <study_first_submitted_qc>July 7, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 10, 2014</study_first_posted>
  <results_first_submitted>August 6, 2020</results_first_submitted>
  <results_first_submitted_qc>August 6, 2020</results_first_submitted_qc>
  <results_first_posted type="Actual">August 21, 2020</results_first_posted>
  <last_update_submitted>August 28, 2020</last_update_submitted>
  <last_update_submitted_qc>August 28, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">September 17, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Sustained Virologic Response</keyword>
  <keyword>Direct Acting Antiviral</keyword>
  <keyword>Combination Therapy</keyword>
  <keyword>Liver Diseases</keyword>
  <keyword>Digestive System Diseases</keyword>
  <keyword>Hepatitis, Viral, Human</keyword>
  <keyword>Enterovirus Infections</keyword>
  <keyword>Picornaviridae Infections</keyword>
  <keyword>RNA Virus Infections</keyword>
  <keyword>Flaviviridae Infections</keyword>
  <keyword>Antiviral Agents</keyword>
  <keyword>Anti-Infective Agents</keyword>
  <keyword>Therapeutic Uses</keyword>
  <keyword>Pharmacologic Actions</keyword>
  <keyword>Antimetabolites</keyword>
  <keyword>Molecular Mechanisms of Pharmacological Action</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Infections</mesh_term>
    <mesh_term>Communicable Diseases</mesh_term>
    <mesh_term>Hepatitis A</mesh_term>
    <mesh_term>Virus Diseases</mesh_term>
    <mesh_term>Hepatitis C</mesh_term>
    <mesh_term>Hepatitis C, Chronic</mesh_term>
    <mesh_term>Hepatitis</mesh_term>
  </condition_browse>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Participants were enrolled at study sites in United States and Puerto Rico. The first participant was screened on 13 June 2014. The last study visit occurred on 28 September 2015.</recruitment_details>
      <pre_assignment_details>Participants were enrolled in Cohorts 1, 2, 3, 4, 5, 6 and 10. Cohorts 7, 8, and 9 were not conducted.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Placebo</title>
          <description>Participants with HCV infection received placebo once daily for 3 days under fasted conditions. This arm was part of cohorts 1, 2 and 3.</description>
        </group>
        <group group_id="P2">
          <title>Voxilaprevir 50 mg</title>
          <description>Participants with HCV infection received voxilaprevir 50 mg once daily for 3 days under fasted conditions. This arm was part of cohorts 1 and 2.</description>
        </group>
        <group group_id="P3">
          <title>Voxilaprevir 100 mg</title>
          <description>Participants with HCV infection received voxilaprevir 100 mg once daily for 3 days under fasted conditions. This arm was part of cohorts 1, 2, 3, 4, 5 and 6.</description>
        </group>
        <group group_id="P4">
          <title>Voxilaprevir 300 mg</title>
          <description>Participants with HCV infection received voxilaprevir 300 mg once daily for 3 days under fasted conditions. This arm was part of cohorts 1 and 2.</description>
        </group>
        <group group_id="P5">
          <title>Voxilaprevir 100 mg Fed</title>
          <description>Participants with HCV infection received voxilaprevir 100 mg once daily for 3 days under fed conditions. This arm was part of cohorts 1, 2, 3, 4, 5 and 6.</description>
        </group>
        <group group_id="P6">
          <title>Voxilaprevir 100 mg + SOF/VEL 400/100 mg</title>
          <description>Participants with HCV infection received voxilaprevir 100 mg on Day 1 and voxilaprevir 100 mg plus sofosbuvir (SOF)/velpatasvir (VEL) (400/100 mg) fixed-dose combination (FDC) on Days 2 and 3 after moderate fat or light meal. This arm was part of cohort 10.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="9"/>
                <participants group_id="P2" count="20"/>
                <participants group_id="P3" count="33"/>
                <participants group_id="P4" count="16"/>
                <participants group_id="P5" count="7"/>
                <participants group_id="P6" count="16"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
                <participants group_id="P2" count="7"/>
                <participants group_id="P3" count="17"/>
                <participants group_id="P4" count="8"/>
                <participants group_id="P5" count="4"/>
                <participants group_id="P6" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="5"/>
                <participants group_id="P2" count="13"/>
                <participants group_id="P3" count="16"/>
                <participants group_id="P4" count="8"/>
                <participants group_id="P5" count="3"/>
                <participants group_id="P6" count="16"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Enrolled but Never Dosed</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="6"/>
                <participants group_id="P3" count="3"/>
                <participants group_id="P4" count="1"/>
                <participants group_id="P5" count="1"/>
                <participants group_id="P6" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Investigator's Discretion</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="2"/>
                <participants group_id="P5" count="2"/>
                <participants group_id="P6" count="15"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrew Consent</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="5"/>
                <participants group_id="P3" count="10"/>
                <participants group_id="P4" count="2"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
              </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="2"/>
                <participants group_id="P3" count="2"/>
                <participants group_id="P4" count="3"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug (voxilaprevir or placebo).</population>
      <group_list>
        <group group_id="B1">
          <title>Placebo</title>
          <description>Participants with HCV infection received placebo once daily for 3 days under fasted conditions. This arm was part of cohorts 1, 2 and 3.</description>
        </group>
        <group group_id="B2">
          <title>Voxilaprevir 50 mg</title>
          <description>Participants with HCV infection received voxilaprevir 50 mg once daily for 3 days under fasted conditions. This arm was part of cohorts 1 and 2.</description>
        </group>
        <group group_id="B3">
          <title>Voxilaprevir 100 mg</title>
          <description>Participants with HCV infection received voxilaprevir 100 mg once daily for 3 days under fasted conditions. This arm was part of cohorts 1, 2, 3, 4, 5 and 6.</description>
        </group>
        <group group_id="B4">
          <title>Voxilaprevir 300 mg</title>
          <description>Participants with HCV infection received voxilaprevir 300 mg once daily for 3 days under fasted conditions. This arm was part of cohorts 1 and 2.</description>
        </group>
        <group group_id="B5">
          <title>Voxilaprevir 100 mg Fed</title>
          <description>Participants with HCV infection received voxilaprevir 100 mg once daily for 3 days under fed conditions. This arm was part of cohorts 1, 2, 3, 4, 5 and 6.</description>
        </group>
        <group group_id="B6">
          <title>Voxilaprevir 100 mg + SOF/VEL 400/100 mg</title>
          <description>Participants with HCV infection received voxilaprevir 100 mg on Day 1 and voxilaprevir 100 mg plus SOF/VEL (400/100 mg) FDC on Days 2 and 3 after moderate fat meal. This arm was part of cohort 10.</description>
        </group>
        <group group_id="B7">
          <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="8"/>
            <count group_id="B2" value="14"/>
            <count group_id="B3" value="30"/>
            <count group_id="B4" value="15"/>
            <count group_id="B5" value="6"/>
            <count group_id="B6" value="16"/>
            <count group_id="B7" value="89"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="52" spread="6.1"/>
                    <measurement group_id="B2" value="49" spread="7.7"/>
                    <measurement group_id="B3" value="52" spread="8.0"/>
                    <measurement group_id="B4" value="43" spread="9.4"/>
                    <measurement group_id="B5" value="51" spread="6.2"/>
                    <measurement group_id="B6" value="56" spread="5.2"/>
                    <measurement group_id="B7" value="51" spread="8.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="9"/>
                    <measurement group_id="B4" value="5"/>
                    <measurement group_id="B5" value="2"/>
                    <measurement group_id="B6" value="7"/>
                    <measurement group_id="B7" value="29"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                    <measurement group_id="B2" value="9"/>
                    <measurement group_id="B3" value="21"/>
                    <measurement group_id="B4" value="10"/>
                    <measurement group_id="B5" value="4"/>
                    <measurement group_id="B6" value="9"/>
                    <measurement group_id="B7" value="60"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race/Ethnicity, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="12"/>
                    <measurement group_id="B4" value="3"/>
                    <measurement group_id="B5" value="1"/>
                    <measurement group_id="B6" value="0"/>
                    <measurement group_id="B7" value="22"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                    <measurement group_id="B2" value="10"/>
                    <measurement group_id="B3" value="18"/>
                    <measurement group_id="B4" value="12"/>
                    <measurement group_id="B5" value="5"/>
                    <measurement group_id="B6" value="16"/>
                    <measurement group_id="B7" value="67"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race/Ethnicity, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="7"/>
                    <measurement group_id="B3" value="12"/>
                    <measurement group_id="B4" value="8"/>
                    <measurement group_id="B5" value="6"/>
                    <measurement group_id="B6" value="9"/>
                    <measurement group_id="B7" value="44"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                    <measurement group_id="B2" value="7"/>
                    <measurement group_id="B3" value="18"/>
                    <measurement group_id="B4" value="7"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="7"/>
                    <measurement group_id="B7" value="45"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>HCV Genotype</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>1a</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="8"/>
                    <measurement group_id="B3" value="8"/>
                    <measurement group_id="B4" value="8"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="9"/>
                    <measurement group_id="B7" value="37"/>
                  </measurement_list>
                </category>
                <category>
                  <title>1b</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="6"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="3"/>
                    <measurement group_id="B7" value="9"/>
                  </measurement_list>
                </category>
                <category>
                  <title>2</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="1"/>
                    <measurement group_id="B7" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>2a/2c</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="2"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                    <measurement group_id="B7" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>2b</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="4"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="2"/>
                    <measurement group_id="B7" value="8"/>
                  </measurement_list>
                </category>
                <category>
                  <title>3a</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="6"/>
                    <measurement group_id="B4" value="7"/>
                    <measurement group_id="B5" value="6"/>
                    <measurement group_id="B6" value="1"/>
                    <measurement group_id="B7" value="28"/>
                  </measurement_list>
                </category>
                <category>
                  <title>4</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="2"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                    <measurement group_id="B7" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>4a/4c/4d</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="2"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                    <measurement group_id="B7" value="2"/>
                  </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="6.6" spread="0.39"/>
                    <measurement group_id="B2" value="6.0" spread="0.64"/>
                    <measurement group_id="B3" value="6.4" spread="0.53"/>
                    <measurement group_id="B4" value="6.0" spread="0.64"/>
                    <measurement group_id="B5" value="6.0" spread="0.87"/>
                    <measurement group_id="B6" value="6.2" spread="0.83"/>
                    <measurement group_id="B7" value="6.2" spread="0.65"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>HCV RNA Category</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt; 800,000 IU/mL</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="7"/>
                    <measurement group_id="B3" value="6"/>
                    <measurement group_id="B4" value="6"/>
                    <measurement group_id="B5" value="4"/>
                    <measurement group_id="B6" value="4"/>
                    <measurement group_id="B7" value="28"/>
                  </measurement_list>
                </category>
                <category>
                  <title>≥ 800,000 IU/mL</title>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                    <measurement group_id="B2" value="7"/>
                    <measurement group_id="B3" value="24"/>
                    <measurement group_id="B4" value="9"/>
                    <measurement group_id="B5" value="2"/>
                    <measurement group_id="B6" value="12"/>
                    <measurement group_id="B7" value="61"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Participants Experiencing Treatment Emergent Adverse Events</title>
        <time_frame>First dose date up to Day 3 plus 30 days</time_frame>
        <population>The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug (voxilaprevir or placebo). Data were summarized by dose.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants with HCV infection received placebo once daily for 3 days under fasted conditions. This arm was part of cohorts 1, 2, and 3.</description>
          </group>
          <group group_id="O2">
            <title>Voxilaprevir 50 mg</title>
            <description>Participants with HCV infection received voxilaprevir 50 mg once daily for 3 days under fasted conditions. This arm was part of cohorts 1 and 2.</description>
          </group>
          <group group_id="O3">
            <title>Voxilaprevir 100 mg</title>
            <description>Participants with HCV infection received voxilaprevir 100 mg once daily for 3 days under fasted conditions. This arm was part of cohorts 1, 2, 3, 4, 5 and 6.</description>
          </group>
          <group group_id="O4">
            <title>Voxilaprevir 300 mg</title>
            <description>Participants with HCV infection received voxilaprevir 300 mg once daily for 3 days under fasted conditions. This arm was part of cohorts 1 and 2.</description>
          </group>
          <group group_id="O5">
            <title>Voxilaprevir 100 mg Fed</title>
            <description>Participants with HCV infection received voxilaprevir 100 mg once daily for 3 days under fed conditions. This arm was part of cohorts 1, 2, 3, 4, 5 and 6.</description>
          </group>
          <group group_id="O6">
            <title>Voxilaprevir 100 mg + SOF/VEL 400/100 mg</title>
            <description>Participants with HCV infection received voxilaprevir 100 mg on Day 1 and voxilaprevir 100 mg plus SOF/VEL (400/100 mg) FDC on Days 2 and 3 after moderate fat meal. This arm was part of cohort 10.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Experiencing Treatment Emergent Adverse Events</title>
          <population>The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug (voxilaprevir or placebo). Data were summarized by dose.</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="8"/>
                <count group_id="O2" value="14"/>
                <count group_id="O3" value="30"/>
                <count group_id="O4" value="15"/>
                <count group_id="O5" value="6"/>
                <count group_id="O6" value="16"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="25.0"/>
                    <measurement group_id="O2" value="14.3"/>
                    <measurement group_id="O3" value="16.7"/>
                    <measurement group_id="O4" value="13.3"/>
                    <measurement group_id="O5" value="33.3"/>
                    <measurement group_id="O6" value="12.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities</title>
        <description>Treatment-emergent laboratory abnormalities were defined as values that increase at least one toxicity grade from baseline. The severity of laboratory abnormalities was assessed as Grade 0, 1 (mild), 2 (moderate), 3 (severe), or 4 (potentially life threatening) using the Common Terminology Criteria for Adverse Events (CTCAE), version 4.03. The most severe graded abnormality from all tests was counted for each participant.</description>
        <time_frame>First dose date up to Day 3 plus 30 days</time_frame>
        <population>Participants in the Safety Analysis Set were analyzed. Data were summarized by dose.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants with HCV infection received placebo once daily for 3 days under fasted conditions. This arm was part of cohorts 1, 2, and 3.</description>
          </group>
          <group group_id="O2">
            <title>Voxilaprevir 50 mg</title>
            <description>Participants with HCV infection received voxilaprevir 50 mg once daily for 3 days under fasted conditions. This arm was part of cohorts 1 and 2.</description>
          </group>
          <group group_id="O3">
            <title>Voxilaprevir 100 mg</title>
            <description>Participants with HCV infection received voxilaprevir 100 mg once daily for 3 days under fasted conditions. This arm was part of cohorts 1, 2, 3, 4, 5 and 6.</description>
          </group>
          <group group_id="O4">
            <title>Voxilaprevir 300 mg</title>
            <description>Participants with HCV infection received voxilaprevir 300 mg once daily for 3 days under fasted conditions. This arm was part of cohorts 1 and 2.</description>
          </group>
          <group group_id="O5">
            <title>Voxilaprevir 100 mg Fed</title>
            <description>Participants with HCV infection received voxilaprevir 100 mg once daily for 3 days under fed conditions. This arm was part of cohorts 1, 2, 3, 4, 5 and 6.</description>
          </group>
          <group group_id="O6">
            <title>Voxilaprevir 100 mg + SOF/VEL 400/100 mg</title>
            <description>Participants with HCV infection received voxilaprevir 100 mg on Day 1 and voxilaprevir 100 mg plus SOF/VEL (400/100 mg) FDC on Days 2 and 3 after moderate fat meal. This arm was part of cohort 10.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities</title>
          <description>Treatment-emergent laboratory abnormalities were defined as values that increase at least one toxicity grade from baseline. The severity of laboratory abnormalities was assessed as Grade 0, 1 (mild), 2 (moderate), 3 (severe), or 4 (potentially life threatening) using the Common Terminology Criteria for Adverse Events (CTCAE), version 4.03. The most severe graded abnormality from all tests was counted for each participant.</description>
          <population>Participants in the Safety Analysis Set were analyzed. Data were summarized by dose.</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="8"/>
                <count group_id="O2" value="14"/>
                <count group_id="O3" value="30"/>
                <count group_id="O4" value="15"/>
                <count group_id="O5" value="6"/>
                <count group_id="O6" value="16"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Grade 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="37.5"/>
                    <measurement group_id="O2" value="28.6"/>
                    <measurement group_id="O3" value="26.7"/>
                    <measurement group_id="O4" value="20.0"/>
                    <measurement group_id="O5" value="50.0"/>
                    <measurement group_id="O6" value="62.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="25.0"/>
                    <measurement group_id="O2" value="28.6"/>
                    <measurement group_id="O3" value="33.3"/>
                    <measurement group_id="O4" value="13.3"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="12.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 3</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="14.3"/>
                    <measurement group_id="O3" value="10.0"/>
                    <measurement group_id="O4" value="26.7"/>
                    <measurement group_id="O5" value="33.3"/>
                    <measurement group_id="O6" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 4</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="3.3"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Antiviral Activity of Voxilaprevir as Measured by Change From Baseline in Plasma HCV RNA</title>
        <description>The outcome measure was assessed to evaluate antiviral activity of voxilaprevir only (cohorts 1 through 6). Data are summarized by treatment/cohort and placebo.</description>
        <time_frame>Baseline; Days 4, 5, 6, 7, 8, 10, and Week 48</time_frame>
        <population>The Efficacy Analysis Set included all enrolled participants with appropriate genotype who received at least one dose of the study drug (voxilaprevir or placebo) and with at least one on-treatment HCV RNA assessment. Participants in the Efficacy Analysis Set with available data were analyzed.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo (GT 1a, Cohort 1)</title>
            <description>Participants with genotype (GT) 1a HCV infection received placebo once daily for 3 days under fasted conditions.</description>
          </group>
          <group group_id="O2">
            <title>Voxilaprevir 50 mg (GT 1a, Cohort 1)</title>
            <description>Participants with GT 1a HCV infection received voxilaprevir 50 mg once daily for 3 days under fasted conditions.</description>
          </group>
          <group group_id="O3">
            <title>Voxilaprevir 100 mg (GT 1a, Cohort 1)</title>
            <description>Participants with GT 1a HCV infection received voxilaprevir 100 mg once daily for 3 days under fasted conditions.</description>
          </group>
          <group group_id="O4">
            <title>Voxilaprevir 300 mg (GT 1a, Cohort 1)</title>
            <description>Participants with GT 1a HCV infection received voxilaprevir 300 mg once daily for 3 days under fasted conditions.</description>
          </group>
          <group group_id="O5">
            <title>Placebo (GT 3, Cohort 2)</title>
            <description>Participants with GT 3 HCV infection received placebo once daily for 3 days under fasted conditions.</description>
          </group>
          <group group_id="O6">
            <title>Voxilaprevir 50 mg (GT 3, Cohort 2)</title>
            <description>Participants with GT 3 HCV infection received voxilaprevir 50 mg once daily for 3 days under fasted conditions.</description>
          </group>
          <group group_id="O7">
            <title>Voxilaprevir 100 mg (GT 3, Cohort 2)</title>
            <description>Participants with GT 3 HCV infection received voxilaprevir 100 mg once daily for 3 days under fasted conditions.</description>
          </group>
          <group group_id="O8">
            <title>Voxilaprevir 300 mg (GT 3, Cohort 2)</title>
            <description>Participants with GT 3 HCV infection received voxilaprevir 300 mg once daily for 3 days under fasted conditions.</description>
          </group>
          <group group_id="O9">
            <title>Placebo (GT 2, Cohort 3)</title>
            <description>Participants with GT 2 HCV infection received placebo once daily for 3 days under fasted conditions.</description>
          </group>
          <group group_id="O10">
            <title>Voxilaprevir 100 mg (GT 2, Cohort 3)</title>
            <description>Participants with GT 2 HCV infection received voxilaprevir 100 mg once daily for 3 days under fasted conditions.</description>
          </group>
          <group group_id="O11">
            <title>Voxilaprevir 100 mg (GT 4, Cohort 4)</title>
            <description>Participants with GT 4 HCV infection received voxilaprevir 100 mg once daily for 3 days under fasted conditions.</description>
          </group>
          <group group_id="O12">
            <title>Voxilaprevir 100 mg (GT 1b, Cohort 5)</title>
            <description>Participants with GT 1b HCV infection received voxilaprevir 100 mg once daily for 3 days under fasted conditions.</description>
          </group>
          <group group_id="O13">
            <title>Voxilaprevir 100 mg Fed (GT 3a, Cohort 6)</title>
            <description>Participants with GT 3a HCV infection received voxilaprevir 100 mg once daily for 3 days under fed conditions.</description>
          </group>
        </group_list>
        <measure>
          <title>Antiviral Activity of Voxilaprevir as Measured by Change From Baseline in Plasma HCV RNA</title>
          <description>The outcome measure was assessed to evaluate antiviral activity of voxilaprevir only (cohorts 1 through 6). Data are summarized by treatment/cohort and placebo.</description>
          <population>The Efficacy Analysis Set included all enrolled participants with appropriate genotype who received at least one dose of the study drug (voxilaprevir or placebo) and with at least one on-treatment HCV RNA assessment. Participants in the Efficacy Analysis Set with available data were analyzed.</population>
          <units>log10 IU/mL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="4"/>
                <count group_id="O2" value="8"/>
                <count group_id="O3" value="8"/>
                <count group_id="O4" value="8"/>
                <count group_id="O5" value="2"/>
                <count group_id="O6" value="6"/>
                <count group_id="O7" value="6"/>
                <count group_id="O8" value="7"/>
                <count group_id="O9" value="2"/>
                <count group_id="O10" value="6"/>
                <count group_id="O11" value="4"/>
                <count group_id="O12" value="6"/>
                <count group_id="O13" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Change at Day 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="4"/>
                    <count group_id="O2" value="7"/>
                    <count group_id="O3" value="8"/>
                    <count group_id="O4" value="8"/>
                    <count group_id="O5" value="2"/>
                    <count group_id="O6" value="5"/>
                    <count group_id="O7" value="5"/>
                    <count group_id="O8" value="7"/>
                    <count group_id="O9" value="2"/>
                    <count group_id="O10" value="6"/>
                    <count group_id="O11" value="4"/>
                    <count group_id="O12" value="6"/>
                    <count group_id="O13" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.12" spread="0.136"/>
                    <measurement group_id="O2" value="-3.81" spread="0.516"/>
                    <measurement group_id="O3" value="-3.97" spread="0.608"/>
                    <measurement group_id="O4" value="-3.33" spread="0.902"/>
                    <measurement group_id="O5" value="-0.24" spread="0.813"/>
                    <measurement group_id="O6" value="-1.47" spread="0.416"/>
                    <measurement group_id="O7" value="-3.20" spread="0.364"/>
                    <measurement group_id="O8" value="-3.57" spread="0.483"/>
                    <measurement group_id="O9" value="0.00" spread="0.104"/>
                    <measurement group_id="O10" value="-3.41" spread="0.444"/>
                    <measurement group_id="O11" value="-3.50" spread="0.677"/>
                    <measurement group_id="O12" value="-3.57" spread="0.227"/>
                    <measurement group_id="O13" value="-3.06" spread="0.752"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Day 5</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="4"/>
                    <count group_id="O2" value="8"/>
                    <count group_id="O3" value="8"/>
                    <count group_id="O4" value="7"/>
                    <count group_id="O5" value="2"/>
                    <count group_id="O6" value="6"/>
                    <count group_id="O7" value="5"/>
                    <count group_id="O8" value="7"/>
                    <count group_id="O9" value="2"/>
                    <count group_id="O10" value="6"/>
                    <count group_id="O11" value="4"/>
                    <count group_id="O12" value="6"/>
                    <count group_id="O13" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.20" spread="0.519"/>
                    <measurement group_id="O2" value="-3.58" spread="1.104"/>
                    <measurement group_id="O3" value="-4.03" spread="0.594"/>
                    <measurement group_id="O4" value="-3.37" spread="0.894"/>
                    <measurement group_id="O5" value="-0.17" spread="0.285"/>
                    <measurement group_id="O6" value="-1.43" spread="0.606"/>
                    <measurement group_id="O7" value="-3.00" spread="0.470"/>
                    <measurement group_id="O8" value="-3.28" spread="0.515"/>
                    <measurement group_id="O9" value="-0.12" spread="0.151"/>
                    <measurement group_id="O10" value="-3.37" spread="0.480"/>
                    <measurement group_id="O11" value="-3.61" spread="0.702"/>
                    <measurement group_id="O12" value="-3.60" spread="0.390"/>
                    <measurement group_id="O13" value="-2.45" spread="0.664"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Day 6</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="4"/>
                    <count group_id="O2" value="8"/>
                    <count group_id="O3" value="8"/>
                    <count group_id="O4" value="7"/>
                    <count group_id="O5" value="2"/>
                    <count group_id="O6" value="6"/>
                    <count group_id="O7" value="5"/>
                    <count group_id="O8" value="7"/>
                    <count group_id="O9" value="2"/>
                    <count group_id="O10" value="6"/>
                    <count group_id="O11" value="4"/>
                    <count group_id="O12" value="5"/>
                    <count group_id="O13" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.21" spread="0.479"/>
                    <measurement group_id="O2" value="-3.45" spread="0.829"/>
                    <measurement group_id="O3" value="-3.78" spread="0.710"/>
                    <measurement group_id="O4" value="-3.47" spread="0.763"/>
                    <measurement group_id="O5" value="-0.06" spread="0.051"/>
                    <measurement group_id="O6" value="-1.06" spread="0.632"/>
                    <measurement group_id="O7" value="-2.52" spread="0.739"/>
                    <measurement group_id="O8" value="-3.13" spread="0.736"/>
                    <measurement group_id="O9" value="-0.04" spread="0.139"/>
                    <measurement group_id="O10" value="-3.22" spread="0.689"/>
                    <measurement group_id="O11" value="-3.69" spread="0.879"/>
                    <measurement group_id="O12" value="-3.61" spread="0.601"/>
                    <measurement group_id="O13" value="-2.04" spread="0.706"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Day 7</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="4"/>
                    <count group_id="O2" value="8"/>
                    <count group_id="O3" value="8"/>
                    <count group_id="O4" value="7"/>
                    <count group_id="O5" value="2"/>
                    <count group_id="O6" value="6"/>
                    <count group_id="O7" value="6"/>
                    <count group_id="O8" value="7"/>
                    <count group_id="O9" value="2"/>
                    <count group_id="O10" value="6"/>
                    <count group_id="O11" value="4"/>
                    <count group_id="O12" value="6"/>
                    <count group_id="O13" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.01" spread="0.340"/>
                    <measurement group_id="O2" value="-3.15" spread="0.973"/>
                    <measurement group_id="O3" value="-3.88" spread="0.729"/>
                    <measurement group_id="O4" value="-3.48" spread="0.695"/>
                    <measurement group_id="O5" value="0.02" spread="0.089"/>
                    <measurement group_id="O6" value="-0.76" spread="0.352"/>
                    <measurement group_id="O7" value="-2.00" spread="0.378"/>
                    <measurement group_id="O8" value="-2.89" spread="0.763"/>
                    <measurement group_id="O9" value="-0.05" spread="0.058"/>
                    <measurement group_id="O10" value="-2.80" spread="0.494"/>
                    <measurement group_id="O11" value="-3.70" spread="0.877"/>
                    <measurement group_id="O12" value="-3.42" spread="0.710"/>
                    <measurement group_id="O13" value="-1.74" spread="0.885"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Day 8</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="4"/>
                    <count group_id="O2" value="8"/>
                    <count group_id="O3" value="8"/>
                    <count group_id="O4" value="7"/>
                    <count group_id="O5" value="2"/>
                    <count group_id="O6" value="6"/>
                    <count group_id="O7" value="5"/>
                    <count group_id="O8" value="7"/>
                    <count group_id="O9" value="2"/>
                    <count group_id="O10" value="6"/>
                    <count group_id="O11" value="4"/>
                    <count group_id="O12" value="6"/>
                    <count group_id="O13" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.13" spread="0.260"/>
                    <measurement group_id="O2" value="-2.92" spread="1.069"/>
                    <measurement group_id="O3" value="-3.54" spread="0.663"/>
                    <measurement group_id="O4" value="-3.23" spread="0.726"/>
                    <measurement group_id="O5" value="-0.14" spread="0.158"/>
                    <measurement group_id="O6" value="-0.53" spread="0.379"/>
                    <measurement group_id="O7" value="-1.79" spread="0.627"/>
                    <measurement group_id="O8" value="-2.74" spread="0.916"/>
                    <measurement group_id="O9" value="-0.05" spread="0.090"/>
                    <measurement group_id="O10" value="-2.48" spread="0.355"/>
                    <measurement group_id="O11" value="-3.53" spread="0.637"/>
                    <measurement group_id="O12" value="-3.27" spread="0.627"/>
                    <measurement group_id="O13" value="-1.43" spread="0.987"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Day 10</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="4"/>
                    <count group_id="O2" value="8"/>
                    <count group_id="O3" value="8"/>
                    <count group_id="O4" value="7"/>
                    <count group_id="O5" value="2"/>
                    <count group_id="O6" value="5"/>
                    <count group_id="O7" value="5"/>
                    <count group_id="O8" value="7"/>
                    <count group_id="O9" value="2"/>
                    <count group_id="O10" value="6"/>
                    <count group_id="O11" value="4"/>
                    <count group_id="O12" value="6"/>
                    <count group_id="O13" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.06" spread="0.091"/>
                    <measurement group_id="O2" value="-2.69" spread="1.116"/>
                    <measurement group_id="O3" value="-3.33" spread="0.756"/>
                    <measurement group_id="O4" value="-2.97" spread="0.918"/>
                    <measurement group_id="O5" value="-0.23" spread="0.180"/>
                    <measurement group_id="O6" value="-0.28" spread="0.330"/>
                    <measurement group_id="O7" value="-1.18" spread="1.055"/>
                    <measurement group_id="O8" value="-2.17" spread="1.394"/>
                    <measurement group_id="O9" value="-0.13" spread="0.022"/>
                    <measurement group_id="O10" value="-2.28" spread="0.469"/>
                    <measurement group_id="O11" value="-3.61" spread="0.674"/>
                    <measurement group_id="O12" value="-3.08" spread="0.740"/>
                    <measurement group_id="O13" value="-0.62" spread="1.085"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Week 48</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="2"/>
                    <count group_id="O2" value="4"/>
                    <count group_id="O3" value="7"/>
                    <count group_id="O4" value="6"/>
                    <count group_id="O5" value="1"/>
                    <count group_id="O6" value="3"/>
                    <count group_id="O7" value="1"/>
                    <count group_id="O8" value="2"/>
                    <count group_id="O9" value="1"/>
                    <count group_id="O10" value="1"/>
                    <count group_id="O11" value="4"/>
                    <count group_id="O12" value="5"/>
                    <count group_id="O13" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.41" spread="0.873"/>
                    <measurement group_id="O2" value="0.08" spread="0.337"/>
                    <measurement group_id="O3" value="-0.80" spread="2.094"/>
                    <measurement group_id="O4" value="-0.73" spread="2.352"/>
                    <measurement group_id="O5" value="0.41"/>
                    <measurement group_id="O6" value="-0.03" spread="0.221"/>
                    <measurement group_id="O7" value="0.54"/>
                    <measurement group_id="O8" value="0.06" spread="0.370"/>
                    <measurement group_id="O9" value="-0.02"/>
                    <measurement group_id="O10" value="-0.02"/>
                    <measurement group_id="O11" value="0.18" spread="0.247"/>
                    <measurement group_id="O12" value="-0.57" spread="2.389"/>
                    <measurement group_id="O13" value="0.16" spread="0.044"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Antiviral Activity of Voxilaprevir as Measured by Absolute HCV RNA Level Through Week 48</title>
        <description>The outcome measure was assessed to evaluate antiviral activity of voxilaprevir only (cohorts 1 through 6).</description>
        <time_frame>Baseline (Pre Day 1 Dose); Days 4, 5, 6, 7, 8, 10, and Week 48</time_frame>
        <population>Participants in the Efficacy Analysis Set with available data were analyzed. Data are summarized by treatment/cohort and placebo.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo (GT 1a, Cohort 1)</title>
            <description>Participants with GT 1a HCV infection received placebo once daily for 3 days under fasted conditions.</description>
          </group>
          <group group_id="O2">
            <title>Voxilaprevir 50 mg (GT 1a, Cohort 1)</title>
            <description>Participants with GT 1a HCV infection received voxilaprevir 50 mg once daily for 3 days under fasted conditions.</description>
          </group>
          <group group_id="O3">
            <title>Voxilaprevir 100 mg (GT 1a, Cohort 1)</title>
            <description>Participants with GT 1a HCV infection received voxilaprevir 100 mg once daily for 3 days under fasted conditions.</description>
          </group>
          <group group_id="O4">
            <title>Voxilaprevir 300 mg (GT 1a, Cohort 1)</title>
            <description>Participants with GT 1a HCV infection received voxilaprevir 300 mg once daily for 3 days under fasted conditions.</description>
          </group>
          <group group_id="O5">
            <title>Placebo (GT 3, Cohort 2)</title>
            <description>Participants with GT 3 HCV infection received placebo once daily for 3 days under fasted conditions.</description>
          </group>
          <group group_id="O6">
            <title>Voxilaprevir 50 mg (GT 3, Cohort 2)</title>
            <description>Participants with GT 3 HCV infection received voxilaprevir 50 mg once daily for 3 days under fasted conditions.</description>
          </group>
          <group group_id="O7">
            <title>Voxilaprevir 100 mg (GT 3, Cohort 2)</title>
            <description>Participants with GT 3 HCV infection received voxilaprevir 100 mg once daily for 3 days under fasted conditions.</description>
          </group>
          <group group_id="O8">
            <title>Voxilaprevir 300 mg (GT 3, Cohort 2)</title>
            <description>Participants with GT 3 HCV infection received voxilaprevir 300 mg once daily for 3 days under fasted conditions.</description>
          </group>
          <group group_id="O9">
            <title>Placebo (GT 2, Cohort 3)</title>
            <description>Participants with GT 2 HCV infection received placebo once daily for 3 days under fasted conditions.</description>
          </group>
          <group group_id="O10">
            <title>Voxilaprevir 100 mg (GT 2, Cohort 3)</title>
            <description>Participants with GT 2 HCV infection received voxilaprevir 100 mg once daily for 3 days under fasted conditions.</description>
          </group>
          <group group_id="O11">
            <title>Voxilaprevir 100 mg (GT 4, Cohort 4)</title>
            <description>Participants with GT 4 HCV infection received voxilaprevir 100 mg once daily for 3 days under fasted conditions.</description>
          </group>
          <group group_id="O12">
            <title>Voxilaprevir 100 mg (GT 1b, Cohort 5)</title>
            <description>Participants with GT 1b HCV infection received voxilaprevir 100 mg once daily for 3 days under fasted conditions.</description>
          </group>
          <group group_id="O13">
            <title>Voxilaprevir 100 mg Fed (GT 3a, Cohort 6)</title>
            <description>Participants with GT 3a HCV infection received voxilaprevir 100 mg once daily for 3 days under fed conditions.</description>
          </group>
        </group_list>
        <measure>
          <title>Antiviral Activity of Voxilaprevir as Measured by Absolute HCV RNA Level Through Week 48</title>
          <description>The outcome measure was assessed to evaluate antiviral activity of voxilaprevir only (cohorts 1 through 6).</description>
          <population>Participants in the Efficacy Analysis Set with available data were analyzed. Data are summarized by treatment/cohort and placebo.</population>
          <units>log10 IU/mL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="4"/>
                <count group_id="O2" value="8"/>
                <count group_id="O3" value="8"/>
                <count group_id="O4" value="8"/>
                <count group_id="O5" value="2"/>
                <count group_id="O6" value="6"/>
                <count group_id="O7" value="6"/>
                <count group_id="O8" value="7"/>
                <count group_id="O9" value="2"/>
                <count group_id="O10" value="6"/>
                <count group_id="O11" value="4"/>
                <count group_id="O12" value="6"/>
                <count group_id="O13" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Pre Day 1 Dose</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="4"/>
                    <count group_id="O2" value="8"/>
                    <count group_id="O3" value="8"/>
                    <count group_id="O4" value="8"/>
                    <count group_id="O5" value="2"/>
                    <count group_id="O6" value="6"/>
                    <count group_id="O7" value="6"/>
                    <count group_id="O8" value="7"/>
                    <count group_id="O9" value="2"/>
                    <count group_id="O10" value="6"/>
                    <count group_id="O11" value="4"/>
                    <count group_id="O12" value="6"/>
                    <count group_id="O13" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.73" spread="0.307"/>
                    <measurement group_id="O2" value="6.30" spread="0.497"/>
                    <measurement group_id="O3" value="6.35" spread="0.526"/>
                    <measurement group_id="O4" value="6.05" spread="0.558"/>
                    <measurement group_id="O5" value="6.11" spread="0.480"/>
                    <measurement group_id="O6" value="5.61" spread="0.612"/>
                    <measurement group_id="O7" value="6.75" spread="0.346"/>
                    <measurement group_id="O8" value="6.01" spread="0.773"/>
                    <measurement group_id="O9" value="6.71" spread="0.059"/>
                    <measurement group_id="O10" value="6.24" spread="0.394"/>
                    <measurement group_id="O11" value="6.16" spread="0.730"/>
                    <measurement group_id="O12" value="6.23" spread="0.608"/>
                    <measurement group_id="O13" value="6.01" spread="0.866"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="4"/>
                    <count group_id="O2" value="7"/>
                    <count group_id="O3" value="8"/>
                    <count group_id="O4" value="8"/>
                    <count group_id="O5" value="2"/>
                    <count group_id="O6" value="5"/>
                    <count group_id="O7" value="5"/>
                    <count group_id="O8" value="7"/>
                    <count group_id="O9" value="2"/>
                    <count group_id="O10" value="6"/>
                    <count group_id="O11" value="4"/>
                    <count group_id="O12" value="6"/>
                    <count group_id="O13" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.62" spread="0.378"/>
                    <measurement group_id="O2" value="2.56" spread="0.705"/>
                    <measurement group_id="O3" value="2.38" spread="0.759"/>
                    <measurement group_id="O4" value="2.72" spread="0.943"/>
                    <measurement group_id="O5" value="5.87" spread="0.332"/>
                    <measurement group_id="O6" value="4.22" spread="0.878"/>
                    <measurement group_id="O7" value="3.54" spread="0.455"/>
                    <measurement group_id="O8" value="2.44" spread="0.693"/>
                    <measurement group_id="O9" value="6.71" spread="0.164"/>
                    <measurement group_id="O10" value="2.83" spread="0.611"/>
                    <measurement group_id="O11" value="2.65" spread="0.533"/>
                    <measurement group_id="O12" value="2.67" spread="0.500"/>
                    <measurement group_id="O13" value="2.95" spread="0.505"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 5</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="4"/>
                    <count group_id="O2" value="8"/>
                    <count group_id="O3" value="8"/>
                    <count group_id="O4" value="7"/>
                    <count group_id="O5" value="2"/>
                    <count group_id="O6" value="6"/>
                    <count group_id="O7" value="5"/>
                    <count group_id="O8" value="7"/>
                    <count group_id="O9" value="2"/>
                    <count group_id="O10" value="6"/>
                    <count group_id="O11" value="4"/>
                    <count group_id="O12" value="6"/>
                    <count group_id="O13" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.53" spread="0.426"/>
                    <measurement group_id="O2" value="2.73" spread="1.203"/>
                    <measurement group_id="O3" value="2.33" spread="0.643"/>
                    <measurement group_id="O4" value="2.67" spread="0.947"/>
                    <measurement group_id="O5" value="5.94" spread="0.195"/>
                    <measurement group_id="O6" value="4.19" spread="1.104"/>
                    <measurement group_id="O7" value="3.75" spread="0.455"/>
                    <measurement group_id="O8" value="2.73" spread="0.780"/>
                    <measurement group_id="O9" value="6.59" spread="0.210"/>
                    <measurement group_id="O10" value="2.87" spread="0.603"/>
                    <measurement group_id="O11" value="2.55" spread="0.549"/>
                    <measurement group_id="O12" value="2.63" spread="0.764"/>
                    <measurement group_id="O13" value="3.56" spread="0.273"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 6</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="4"/>
                    <count group_id="O2" value="8"/>
                    <count group_id="O3" value="8"/>
                    <count group_id="O4" value="7"/>
                    <count group_id="O5" value="2"/>
                    <count group_id="O6" value="6"/>
                    <count group_id="O7" value="5"/>
                    <count group_id="O8" value="7"/>
                    <count group_id="O9" value="2"/>
                    <count group_id="O10" value="6"/>
                    <count group_id="O11" value="4"/>
                    <count group_id="O12" value="5"/>
                    <count group_id="O13" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.52" spread="0.320"/>
                    <measurement group_id="O2" value="2.85" spread="1.000"/>
                    <measurement group_id="O3" value="2.57" spread="1.028"/>
                    <measurement group_id="O4" value="2.57" spread="0.818"/>
                    <measurement group_id="O5" value="6.05" spread="0.532"/>
                    <measurement group_id="O6" value="4.55" spread="1.203"/>
                    <measurement group_id="O7" value="4.23" spread="0.604"/>
                    <measurement group_id="O8" value="2.88" spread="0.882"/>
                    <measurement group_id="O9" value="6.68" spread="0.199"/>
                    <measurement group_id="O10" value="3.02" spread="0.754"/>
                    <measurement group_id="O11" value="2.46" spread="0.300"/>
                    <measurement group_id="O12" value="2.85" spread="0.685"/>
                    <measurement group_id="O13" value="3.98" spread="0.413"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 7</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="4"/>
                    <count group_id="O2" value="8"/>
                    <count group_id="O3" value="8"/>
                    <count group_id="O4" value="7"/>
                    <count group_id="O5" value="2"/>
                    <count group_id="O6" value="6"/>
                    <count group_id="O7" value="5"/>
                    <count group_id="O8" value="7"/>
                    <count group_id="O9" value="2"/>
                    <count group_id="O10" value="6"/>
                    <count group_id="O11" value="4"/>
                    <count group_id="O12" value="6"/>
                    <count group_id="O13" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.74" spread="0.059"/>
                    <measurement group_id="O2" value="3.15" spread="1.268"/>
                    <measurement group_id="O3" value="2.47" spread="0.821"/>
                    <measurement group_id="O4" value="2.56" spread="0.714"/>
                    <measurement group_id="O5" value="6.13" spread="0.569"/>
                    <measurement group_id="O6" value="4.85" spread="0.886"/>
                    <measurement group_id="O7" value="4.75" spread="0.268"/>
                    <measurement group_id="O8" value="3.12" spread="0.991"/>
                    <measurement group_id="O9" value="6.67" spread="0.001"/>
                    <measurement group_id="O10" value="3.44" spread="0.613"/>
                    <measurement group_id="O11" value="2.45" spread="0.359"/>
                    <measurement group_id="O12" value="2.82" spread="1.111"/>
                    <measurement group_id="O13" value="4.27" spread="0.485"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 8</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="4"/>
                    <count group_id="O2" value="8"/>
                    <count group_id="O3" value="8"/>
                    <count group_id="O4" value="7"/>
                    <count group_id="O5" value="2"/>
                    <count group_id="O6" value="6"/>
                    <count group_id="O7" value="5"/>
                    <count group_id="O8" value="7"/>
                    <count group_id="O9" value="2"/>
                    <count group_id="O10" value="6"/>
                    <count group_id="O11" value="4"/>
                    <count group_id="O12" value="6"/>
                    <count group_id="O13" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.86" spread="0.144"/>
                    <measurement group_id="O2" value="3.38" spread="1.019"/>
                    <measurement group_id="O3" value="2.81" spread="0.901"/>
                    <measurement group_id="O4" value="2.81" spread="0.671"/>
                    <measurement group_id="O5" value="5.97" spread="0.323"/>
                    <measurement group_id="O6" value="5.08" spread="0.655"/>
                    <measurement group_id="O7" value="4.96" spread="0.531"/>
                    <measurement group_id="O8" value="3.27" spread="1.100"/>
                    <measurement group_id="O9" value="6.66" spread="0.031"/>
                    <measurement group_id="O10" value="3.76" spread="0.497"/>
                    <measurement group_id="O11" value="2.62" spread="0.278"/>
                    <measurement group_id="O12" value="2.96" spread="1.111"/>
                    <measurement group_id="O13" value="4.59" spread="0.528"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 10</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="4"/>
                    <count group_id="O2" value="8"/>
                    <count group_id="O3" value="8"/>
                    <count group_id="O4" value="7"/>
                    <count group_id="O5" value="2"/>
                    <count group_id="O6" value="5"/>
                    <count group_id="O7" value="5"/>
                    <count group_id="O8" value="7"/>
                    <count group_id="O9" value="2"/>
                    <count group_id="O10" value="6"/>
                    <count group_id="O11" value="4"/>
                    <count group_id="O12" value="6"/>
                    <count group_id="O13" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.68" spread="0.263"/>
                    <measurement group_id="O2" value="3.61" spread="1.041"/>
                    <measurement group_id="O3" value="3.03" spread="0.857"/>
                    <measurement group_id="O4" value="3.07" spread="0.887"/>
                    <measurement group_id="O5" value="5.88" spread="0.300"/>
                    <measurement group_id="O6" value="5.43" spread="0.803"/>
                    <measurement group_id="O7" value="5.56" spread="0.987"/>
                    <measurement group_id="O8" value="3.83" spread="1.417"/>
                    <measurement group_id="O9" value="6.58" spread="0.081"/>
                    <measurement group_id="O10" value="3.96" spread="0.555"/>
                    <measurement group_id="O11" value="2.54" spread="0.553"/>
                    <measurement group_id="O12" value="3.15" spread="1.210"/>
                    <measurement group_id="O13" value="5.40" spread="0.697"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 48</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="2"/>
                    <count group_id="O2" value="4"/>
                    <count group_id="O3" value="7"/>
                    <count group_id="O4" value="6"/>
                    <count group_id="O5" value="1"/>
                    <count group_id="O6" value="3"/>
                    <count group_id="O7" value="1"/>
                    <count group_id="O8" value="2"/>
                    <count group_id="O9" value="1"/>
                    <count group_id="O10" value="1"/>
                    <count group_id="O11" value="4"/>
                    <count group_id="O12" value="5"/>
                    <count group_id="O13" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.97" spread="0.488"/>
                    <measurement group_id="O2" value="6.29" spread="0.825"/>
                    <measurement group_id="O3" value="5.55" spread="2.007"/>
                    <measurement group_id="O4" value="5.20" spread="2.085"/>
                    <measurement group_id="O5" value="6.18"/>
                    <measurement group_id="O6" value="5.13" spread="0.207"/>
                    <measurement group_id="O7" value="7.29"/>
                    <measurement group_id="O8" value="6.38" spread="1.479"/>
                    <measurement group_id="O9" value="6.65"/>
                    <measurement group_id="O10" value="6.13"/>
                    <measurement group_id="O11" value="6.34" spread="0.696"/>
                    <measurement group_id="O12" value="5.65" spread="2.473"/>
                    <measurement group_id="O13" value="5.98" spread="0.891"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Antiviral Activity of Voxilaprevir as Measured by Number of Participants Achieving Reductions From Baseline in HCV RNA</title>
        <description>Categorical declines from baseline were summarized by the number of participants with a &lt; 1, ≥ 1 to &lt;2, ≥ 2 to &lt;3, or ≥ 3 log10 IU/mL decrease in HCV RNA from baseline to each postdose assessment up to Week 48 by treatment/cohort and placebo. The outcome measure was assessed to evaluate antiviral activity of voxilaprevir only (cohorts 1 through 6).</description>
        <time_frame>Baseline; Days 4, 5, 6, 7, 8, 10, and Week 48</time_frame>
        <population>Participants in the Efficacy Analysis Set were analyzed.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo (GT 1a, Cohort 1)</title>
            <description>Participants with GT 1a HCV infection received placebo once daily for 3 days under fasted conditions.</description>
          </group>
          <group group_id="O2">
            <title>Voxilaprevir 50 mg (GT 1a, Cohort 1)</title>
            <description>Participants with GT 1a HCV infection received voxilaprevir 50 mg once daily for 3 days under fasted conditions.</description>
          </group>
          <group group_id="O3">
            <title>Voxilaprevir 100 mg (GT 1a, Cohort 1)</title>
            <description>Participants with GT 1a HCV infection received voxilaprevir 100 mg once daily for 3 days under fasted conditions.</description>
          </group>
          <group group_id="O4">
            <title>Voxilaprevir 300 mg (GT 1a, Cohort 1)</title>
            <description>Participants with GT 1a HCV infection received voxilaprevir 300 mg once daily for 3 days under fasted conditions.</description>
          </group>
          <group group_id="O5">
            <title>Placebo (GT 3, Cohort 2)</title>
            <description>Participants with GT 3 HCV infection received placebo once daily for 3 days under fasted conditions.</description>
          </group>
          <group group_id="O6">
            <title>Voxilaprevir 50 mg (GT 3, Cohort 2)</title>
            <description>Participants with GT 3 HCV infection received voxilaprevir 50 mg once daily for 3 days under fasted conditions.</description>
          </group>
          <group group_id="O7">
            <title>Voxilaprevir 100 mg (GT 3, Cohort 2)</title>
            <description>Participants with GT 3 HCV infection received voxilaprevir 100 mg once daily for 3 days under fasted conditions.</description>
          </group>
          <group group_id="O8">
            <title>Voxilaprevir 300 mg (GT 3, Cohort 2)</title>
            <description>Participants with GT 3 HCV infection received voxilaprevir 300 mg once daily for 3 days under fasted conditions.</description>
          </group>
          <group group_id="O9">
            <title>Placebo (GT 2, Cohort 3)</title>
            <description>Participants with GT 2 HCV infection received placebo once daily for 3 days under fasted conditions.</description>
          </group>
          <group group_id="O10">
            <title>Voxilaprevir 100 mg (GT 2, Cohort 3)</title>
            <description>Participants with GT 2 HCV infection received voxilaprevir 100 mg once daily for 3 days under fasted conditions.</description>
          </group>
          <group group_id="O11">
            <title>Voxilaprevir 100 mg (GT 4, Cohort 4)</title>
            <description>Participants with GT 4 HCV infection received voxilaprevir 100 mg once daily for 3 days under fasted conditions.</description>
          </group>
          <group group_id="O12">
            <title>Voxilaprevir 100 mg (GT 1b, Cohort 5)</title>
            <description>Participants with GT 1b HCV infection received voxilaprevir 100 mg once daily for 3 days under fasted conditions.</description>
          </group>
          <group group_id="O13">
            <title>Voxilaprevir 100 mg Fed (GT 3a, Cohort 6)</title>
            <description>Participants with GT 3a HCV infection received voxilaprevir 100 mg once daily for 3 days under fed conditions.</description>
          </group>
        </group_list>
        <measure>
          <title>Antiviral Activity of Voxilaprevir as Measured by Number of Participants Achieving Reductions From Baseline in HCV RNA</title>
          <description>Categorical declines from baseline were summarized by the number of participants with a &lt; 1, ≥ 1 to &lt;2, ≥ 2 to &lt;3, or ≥ 3 log10 IU/mL decrease in HCV RNA from baseline to each postdose assessment up to Week 48 by treatment/cohort and placebo. The outcome measure was assessed to evaluate antiviral activity of voxilaprevir only (cohorts 1 through 6).</description>
          <population>Participants in the Efficacy Analysis Set were analyzed.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="4"/>
                <count group_id="O2" value="8"/>
                <count group_id="O3" value="8"/>
                <count group_id="O4" value="8"/>
                <count group_id="O5" value="2"/>
                <count group_id="O6" value="6"/>
                <count group_id="O7" value="6"/>
                <count group_id="O8" value="7"/>
                <count group_id="O9" value="2"/>
                <count group_id="O10" value="6"/>
                <count group_id="O11" value="4"/>
                <count group_id="O12" value="6"/>
                <count group_id="O13" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day 4</title>
              <category_list>
                <category>
                  <title>Missing HCV RNA</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="1"/>
                    <measurement group_id="O7" value="1"/>
                    <measurement group_id="O8" value="0"/>
                    <measurement group_id="O9" value="0"/>
                    <measurement group_id="O10" value="0"/>
                    <measurement group_id="O11" value="0"/>
                    <measurement group_id="O12" value="0"/>
                    <measurement group_id="O13" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&lt; 1 log10 IU/mL decrease in HCV RNA</title>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="2"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="0"/>
                    <measurement group_id="O8" value="0"/>
                    <measurement group_id="O9" value="2"/>
                    <measurement group_id="O10" value="0"/>
                    <measurement group_id="O11" value="0"/>
                    <measurement group_id="O12" value="0"/>
                    <measurement group_id="O13" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>≥1 and &lt;2 log10 IU/mL decrease in HCV RNA</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="1"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="4"/>
                    <measurement group_id="O7" value="0"/>
                    <measurement group_id="O8" value="0"/>
                    <measurement group_id="O9" value="0"/>
                    <measurement group_id="O10" value="0"/>
                    <measurement group_id="O11" value="0"/>
                    <measurement group_id="O12" value="0"/>
                    <measurement group_id="O13" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>≥2 and &lt;3 log10 IU/mL decrease in HCV RNA</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="1"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="1"/>
                    <measurement group_id="O7" value="1"/>
                    <measurement group_id="O8" value="1"/>
                    <measurement group_id="O9" value="0"/>
                    <measurement group_id="O10" value="1"/>
                    <measurement group_id="O11" value="1"/>
                    <measurement group_id="O12" value="0"/>
                    <measurement group_id="O13" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>≥3 log10 IU/mL decrease in HCV RNA</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="7"/>
                    <measurement group_id="O3" value="7"/>
                    <measurement group_id="O4" value="7"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="4"/>
                    <measurement group_id="O8" value="6"/>
                    <measurement group_id="O9" value="0"/>
                    <measurement group_id="O10" value="5"/>
                    <measurement group_id="O11" value="3"/>
                    <measurement group_id="O12" value="6"/>
                    <measurement group_id="O13" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 5</title>
              <category_list>
                <category>
                  <title>Missing HCV RNA</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="1"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="1"/>
                    <measurement group_id="O8" value="0"/>
                    <measurement group_id="O9" value="0"/>
                    <measurement group_id="O10" value="0"/>
                    <measurement group_id="O11" value="0"/>
                    <measurement group_id="O12" value="0"/>
                    <measurement group_id="O13" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&lt; 1 log10 IU/mL decrease in HCV RNA</title>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="2"/>
                    <measurement group_id="O6" value="1"/>
                    <measurement group_id="O7" value="0"/>
                    <measurement group_id="O8" value="0"/>
                    <measurement group_id="O9" value="2"/>
                    <measurement group_id="O10" value="0"/>
                    <measurement group_id="O11" value="0"/>
                    <measurement group_id="O12" value="0"/>
                    <measurement group_id="O13" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>≥1 and &lt;2 log10 IU/mL decrease in HCV RNA</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="1"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="4"/>
                    <measurement group_id="O7" value="0"/>
                    <measurement group_id="O8" value="0"/>
                    <measurement group_id="O9" value="0"/>
                    <measurement group_id="O10" value="0"/>
                    <measurement group_id="O11" value="0"/>
                    <measurement group_id="O12" value="0"/>
                    <measurement group_id="O13" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>≥2 and &lt;3 log10 IU/mL decrease in HCV RNA</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="1"/>
                    <measurement group_id="O7" value="2"/>
                    <measurement group_id="O8" value="2"/>
                    <measurement group_id="O9" value="0"/>
                    <measurement group_id="O10" value="2"/>
                    <measurement group_id="O11" value="1"/>
                    <measurement group_id="O12" value="0"/>
                    <measurement group_id="O13" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>≥3 log10 IU/mL decrease in HCV RNA</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="6"/>
                    <measurement group_id="O3" value="8"/>
                    <measurement group_id="O4" value="6"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="3"/>
                    <measurement group_id="O8" value="5"/>
                    <measurement group_id="O9" value="0"/>
                    <measurement group_id="O10" value="4"/>
                    <measurement group_id="O11" value="3"/>
                    <measurement group_id="O12" value="6"/>
                    <measurement group_id="O13" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 6</title>
              <category_list>
                <category>
                  <title>Missing HCV RNA</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="1"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="1"/>
                    <measurement group_id="O8" value="0"/>
                    <measurement group_id="O9" value="0"/>
                    <measurement group_id="O10" value="0"/>
                    <measurement group_id="O11" value="0"/>
                    <measurement group_id="O12" value="1"/>
                    <measurement group_id="O13" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&lt; 1 log10 IU/mL decrease in HCV RNA</title>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="2"/>
                    <measurement group_id="O6" value="2"/>
                    <measurement group_id="O7" value="0"/>
                    <measurement group_id="O8" value="0"/>
                    <measurement group_id="O9" value="2"/>
                    <measurement group_id="O10" value="0"/>
                    <measurement group_id="O11" value="0"/>
                    <measurement group_id="O12" value="0"/>
                    <measurement group_id="O13" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>≥1 and &lt;2 log10 IU/mL decrease in HCV RNA</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="1"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="4"/>
                    <measurement group_id="O7" value="1"/>
                    <measurement group_id="O8" value="1"/>
                    <measurement group_id="O9" value="0"/>
                    <measurement group_id="O10" value="0"/>
                    <measurement group_id="O11" value="0"/>
                    <measurement group_id="O12" value="0"/>
                    <measurement group_id="O13" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>≥2 and &lt;3 log10 IU/mL decrease in HCV RNA</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="1"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="3"/>
                    <measurement group_id="O8" value="1"/>
                    <measurement group_id="O9" value="0"/>
                    <measurement group_id="O10" value="2"/>
                    <measurement group_id="O11" value="1"/>
                    <measurement group_id="O12" value="1"/>
                    <measurement group_id="O13" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>≥3 log10 IU/mL decrease in HCV RNA</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="7"/>
                    <measurement group_id="O3" value="7"/>
                    <measurement group_id="O4" value="6"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="1"/>
                    <measurement group_id="O8" value="5"/>
                    <measurement group_id="O9" value="0"/>
                    <measurement group_id="O10" value="4"/>
                    <measurement group_id="O11" value="3"/>
                    <measurement group_id="O12" value="4"/>
                    <measurement group_id="O13" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 7</title>
              <category_list>
                <category>
                  <title>Missing HCV RNA</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="1"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="1"/>
                    <measurement group_id="O8" value="0"/>
                    <measurement group_id="O9" value="0"/>
                    <measurement group_id="O10" value="0"/>
                    <measurement group_id="O11" value="0"/>
                    <measurement group_id="O12" value="0"/>
                    <measurement group_id="O13" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&lt; 1 log10 IU/mL decrease in HCV RNA</title>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="2"/>
                    <measurement group_id="O6" value="4"/>
                    <measurement group_id="O7" value="0"/>
                    <measurement group_id="O8" value="0"/>
                    <measurement group_id="O9" value="2"/>
                    <measurement group_id="O10" value="0"/>
                    <measurement group_id="O11" value="0"/>
                    <measurement group_id="O12" value="0"/>
                    <measurement group_id="O13" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>≥1 and &lt;2 log10 IU/mL decrease in HCV RNA</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="2"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="2"/>
                    <measurement group_id="O7" value="3"/>
                    <measurement group_id="O8" value="1"/>
                    <measurement group_id="O9" value="0"/>
                    <measurement group_id="O10" value="0"/>
                    <measurement group_id="O11" value="0"/>
                    <measurement group_id="O12" value="0"/>
                    <measurement group_id="O13" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>≥2 and &lt;3 log10 IU/mL decrease in HCV RNA</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="1"/>
                    <measurement group_id="O4" value="1"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="2"/>
                    <measurement group_id="O8" value="2"/>
                    <measurement group_id="O9" value="0"/>
                    <measurement group_id="O10" value="3"/>
                    <measurement group_id="O11" value="1"/>
                    <measurement group_id="O12" value="2"/>
                    <measurement group_id="O13" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>≥3 log10 IU/mL decrease in HCV RNA</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="6"/>
                    <measurement group_id="O3" value="7"/>
                    <measurement group_id="O4" value="6"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="0"/>
                    <measurement group_id="O8" value="4"/>
                    <measurement group_id="O9" value="0"/>
                    <measurement group_id="O10" value="3"/>
                    <measurement group_id="O11" value="3"/>
                    <measurement group_id="O12" value="4"/>
                    <measurement group_id="O13" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 8</title>
              <category_list>
                <category>
                  <title>Missing HCV RNA</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="1"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="1"/>
                    <measurement group_id="O8" value="0"/>
                    <measurement group_id="O9" value="0"/>
                    <measurement group_id="O10" value="0"/>
                    <measurement group_id="O11" value="0"/>
                    <measurement group_id="O12" value="0"/>
                    <measurement group_id="O13" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&lt; 1 log10 IU/mL decrease in HCV RNA</title>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="2"/>
                    <measurement group_id="O6" value="6"/>
                    <measurement group_id="O7" value="0"/>
                    <measurement group_id="O8" value="1"/>
                    <measurement group_id="O9" value="2"/>
                    <measurement group_id="O10" value="0"/>
                    <measurement group_id="O11" value="0"/>
                    <measurement group_id="O12" value="0"/>
                    <measurement group_id="O13" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>≥1 and &lt;2 log10 IU/mL decrease in HCV RNA</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="2"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="4"/>
                    <measurement group_id="O8" value="0"/>
                    <measurement group_id="O9" value="0"/>
                    <measurement group_id="O10" value="0"/>
                    <measurement group_id="O11" value="0"/>
                    <measurement group_id="O12" value="0"/>
                    <measurement group_id="O13" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>≥2 and &lt;3 log10 IU/mL decrease in HCV RNA</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="2"/>
                    <measurement group_id="O3" value="1"/>
                    <measurement group_id="O4" value="3"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="1"/>
                    <measurement group_id="O8" value="2"/>
                    <measurement group_id="O9" value="0"/>
                    <measurement group_id="O10" value="6"/>
                    <measurement group_id="O11" value="1"/>
                    <measurement group_id="O12" value="2"/>
                    <measurement group_id="O13" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>≥3 log10 IU/mL decrease in HCV RNA</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="4"/>
                    <measurement group_id="O3" value="7"/>
                    <measurement group_id="O4" value="4"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="0"/>
                    <measurement group_id="O8" value="4"/>
                    <measurement group_id="O9" value="0"/>
                    <measurement group_id="O10" value="0"/>
                    <measurement group_id="O11" value="3"/>
                    <measurement group_id="O12" value="4"/>
                    <measurement group_id="O13" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 10</title>
              <category_list>
                <category>
                  <title>Missing HCV RNA</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="1"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="1"/>
                    <measurement group_id="O7" value="1"/>
                    <measurement group_id="O8" value="0"/>
                    <measurement group_id="O9" value="0"/>
                    <measurement group_id="O10" value="0"/>
                    <measurement group_id="O11" value="0"/>
                    <measurement group_id="O12" value="0"/>
                    <measurement group_id="O13" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&lt; 1 log10 IU/mL decrease in HCV RNA</title>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="2"/>
                    <measurement group_id="O6" value="5"/>
                    <measurement group_id="O7" value="2"/>
                    <measurement group_id="O8" value="1"/>
                    <measurement group_id="O9" value="2"/>
                    <measurement group_id="O10" value="0"/>
                    <measurement group_id="O11" value="0"/>
                    <measurement group_id="O12" value="0"/>
                    <measurement group_id="O13" value="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>≥1 and &lt;2 log10 IU/mL decrease in HCV RNA</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="3"/>
                    <measurement group_id="O3" value="1"/>
                    <measurement group_id="O4" value="1"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="2"/>
                    <measurement group_id="O8" value="2"/>
                    <measurement group_id="O9" value="0"/>
                    <measurement group_id="O10" value="2"/>
                    <measurement group_id="O11" value="0"/>
                    <measurement group_id="O12" value="1"/>
                    <measurement group_id="O13" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>≥2 and &lt;3 log10 IU/mL decrease in HCV RNA</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="2"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="3"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="1"/>
                    <measurement group_id="O8" value="1"/>
                    <measurement group_id="O9" value="0"/>
                    <measurement group_id="O10" value="4"/>
                    <measurement group_id="O11" value="0"/>
                    <measurement group_id="O12" value="1"/>
                    <measurement group_id="O13" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>≥3 log10 IU/mL decrease in HCV RNA</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="3"/>
                    <measurement group_id="O3" value="7"/>
                    <measurement group_id="O4" value="3"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="0"/>
                    <measurement group_id="O8" value="3"/>
                    <measurement group_id="O9" value="0"/>
                    <measurement group_id="O10" value="0"/>
                    <measurement group_id="O11" value="4"/>
                    <measurement group_id="O12" value="4"/>
                    <measurement group_id="O13" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 48</title>
              <category_list>
                <category>
                  <title>Missing HCV RNA</title>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="4"/>
                    <measurement group_id="O3" value="1"/>
                    <measurement group_id="O4" value="2"/>
                    <measurement group_id="O5" value="1"/>
                    <measurement group_id="O6" value="3"/>
                    <measurement group_id="O7" value="5"/>
                    <measurement group_id="O8" value="5"/>
                    <measurement group_id="O9" value="1"/>
                    <measurement group_id="O10" value="5"/>
                    <measurement group_id="O11" value="0"/>
                    <measurement group_id="O12" value="1"/>
                    <measurement group_id="O13" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&lt; 1 log10 IU/mL decrease in HCV RNA</title>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="4"/>
                    <measurement group_id="O3" value="6"/>
                    <measurement group_id="O4" value="5"/>
                    <measurement group_id="O5" value="1"/>
                    <measurement group_id="O6" value="3"/>
                    <measurement group_id="O7" value="1"/>
                    <measurement group_id="O8" value="2"/>
                    <measurement group_id="O9" value="1"/>
                    <measurement group_id="O10" value="1"/>
                    <measurement group_id="O11" value="4"/>
                    <measurement group_id="O12" value="4"/>
                    <measurement group_id="O13" value="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>≥1 and &lt;2 log10 IU/mL decrease in HCV RNA</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="0"/>
                    <measurement group_id="O8" value="0"/>
                    <measurement group_id="O9" value="0"/>
                    <measurement group_id="O10" value="0"/>
                    <measurement group_id="O11" value="0"/>
                    <measurement group_id="O12" value="0"/>
                    <measurement group_id="O13" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>≥2 and &lt;3 log10 IU/mL decrease in HCV RNA</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="0"/>
                    <measurement group_id="O8" value="0"/>
                    <measurement group_id="O9" value="0"/>
                    <measurement group_id="O10" value="0"/>
                    <measurement group_id="O11" value="0"/>
                    <measurement group_id="O12" value="0"/>
                    <measurement group_id="O13" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>≥3 log10 IU/mL decrease in HCV RNA</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="1"/>
                    <measurement group_id="O4" value="1"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="0"/>
                    <measurement group_id="O8" value="0"/>
                    <measurement group_id="O9" value="0"/>
                    <measurement group_id="O10" value="0"/>
                    <measurement group_id="O11" value="0"/>
                    <measurement group_id="O12" value="1"/>
                    <measurement group_id="O13" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants Who Have HCV RNA &lt; Lower Limit of Quantitation (LLOQ) Detected, and &lt; LLOQ Target Not Detected (TND)</title>
        <description>The lower limit of quantitation (LLOQ) detection for HCV RNA levels was 15 IU/mL. HCV detected means calculated HCV RNA level is below LLOQ of the assay. The outcome measure was assessed to evaluate antiviral activity of voxilaprevir only (cohorts 1 through 6).</description>
        <time_frame>Days 4, 5, 6, 7, 8, 10, and Week 48</time_frame>
        <population>Participants in the Efficacy Analysis Set were analyzed. Data are summarized by treatment/cohort and placebo.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo (GT 1a, Cohort 1)</title>
            <description>Participants with GT 1a HCV infection received placebo once daily for 3 days under fasted conditions.</description>
          </group>
          <group group_id="O2">
            <title>Voxilaprevir 50 mg (GT 1a, Cohort 1)</title>
            <description>Participants with GT 1a HCV infection received voxilaprevir 50 mg once daily for 3 days under fasted conditions.</description>
          </group>
          <group group_id="O3">
            <title>Voxilaprevir 100 mg (GT 1a, Cohort 1)</title>
            <description>Participants with GT 1a HCV infection received voxilaprevir 100 mg once daily for 3 days under fasted conditions.</description>
          </group>
          <group group_id="O4">
            <title>Voxilaprevir 300 mg (GT 1a, Cohort 1)</title>
            <description>Participants with GT 1a HCV infection received voxilaprevir 300 mg once daily for 3 days under fasted conditions.</description>
          </group>
          <group group_id="O5">
            <title>Placebo (GT 3, Cohort 2)</title>
            <description>Participants with GT 3 HCV infection received placebo once daily for 3 days under fasted conditions.</description>
          </group>
          <group group_id="O6">
            <title>Voxilaprevir 50 mg (GT 3, Cohort 2)</title>
            <description>Participants with GT 3 HCV infection received voxilaprevir 50 mg once daily for 3 days under fasted conditions.</description>
          </group>
          <group group_id="O7">
            <title>Voxilaprevir 100 mg (GT 3, Cohort 2)</title>
            <description>Participants with GT 3 HCV infection received voxilaprevir 100 mg once daily for 3 days under fasted conditions.</description>
          </group>
          <group group_id="O8">
            <title>Voxilaprevir 300 mg (GT 3, Cohort 2)</title>
            <description>Participants with GT 3 HCV infection received voxilaprevir 300 mg once daily for 3 days under fasted conditions.</description>
          </group>
          <group group_id="O9">
            <title>Placebo (GT 2, Cohort 3)</title>
            <description>Participants with GT 2 HCV infection received placebo once daily for 3 days under fasted conditions.</description>
          </group>
          <group group_id="O10">
            <title>Voxilaprevir 100 mg (GT 2, Cohort 3)</title>
            <description>Participants with GT 2 HCV infection received voxilaprevir 100 mg once daily for 3 days under fasted conditions.</description>
          </group>
          <group group_id="O11">
            <title>Voxilaprevir 100 mg (GT 4, Cohort 4)</title>
            <description>Participants with GT 4 HCV infection received voxilaprevir 100 mg once daily for 3 days under fasted conditions.</description>
          </group>
          <group group_id="O12">
            <title>Voxilaprevir 100 mg (GT 1b, Cohort 5)</title>
            <description>Participants with GT 1b HCV infection received voxilaprevir 100 mg once daily for 3 days under fasted conditions.</description>
          </group>
          <group group_id="O13">
            <title>Voxilaprevir 100 mg Fed (GT 3a, Cohort 6)</title>
            <description>Participants with GT 3a HCV infection received voxilaprevir 100 mg once daily for 3 days under fed conditions.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Who Have HCV RNA &lt; Lower Limit of Quantitation (LLOQ) Detected, and &lt; LLOQ Target Not Detected (TND)</title>
          <description>The lower limit of quantitation (LLOQ) detection for HCV RNA levels was 15 IU/mL. HCV detected means calculated HCV RNA level is below LLOQ of the assay. The outcome measure was assessed to evaluate antiviral activity of voxilaprevir only (cohorts 1 through 6).</description>
          <population>Participants in the Efficacy Analysis Set were analyzed. Data are summarized by treatment/cohort and placebo.</population>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="4"/>
                <count group_id="O2" value="8"/>
                <count group_id="O3" value="8"/>
                <count group_id="O4" value="8"/>
                <count group_id="O5" value="2"/>
                <count group_id="O6" value="6"/>
                <count group_id="O7" value="6"/>
                <count group_id="O8" value="7"/>
                <count group_id="O9" value="2"/>
                <count group_id="O10" value="6"/>
                <count group_id="O11" value="4"/>
                <count group_id="O12" value="6"/>
                <count group_id="O13" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day 4 &lt; LLOQ detected</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="1"/>
                    <measurement group_id="O4" value="1"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="0"/>
                    <measurement group_id="O8" value="0"/>
                    <measurement group_id="O9" value="0"/>
                    <measurement group_id="O10" value="0"/>
                    <measurement group_id="O11" value="0"/>
                    <measurement group_id="O12" value="0"/>
                    <measurement group_id="O13" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 5 &lt; LLOQ detected</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="1"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="0"/>
                    <measurement group_id="O8" value="1"/>
                    <measurement group_id="O9" value="0"/>
                    <measurement group_id="O10" value="0"/>
                    <measurement group_id="O11" value="0"/>
                    <measurement group_id="O12" value="0"/>
                    <measurement group_id="O13" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 6 &lt; LLOQ TND</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="1"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="0"/>
                    <measurement group_id="O8" value="0"/>
                    <measurement group_id="O9" value="0"/>
                    <measurement group_id="O10" value="0"/>
                    <measurement group_id="O11" value="0"/>
                    <measurement group_id="O12" value="0"/>
                    <measurement group_id="O13" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 7 &lt; LLOQ detected</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="0"/>
                    <measurement group_id="O8" value="0"/>
                    <measurement group_id="O9" value="0"/>
                    <measurement group_id="O10" value="0"/>
                    <measurement group_id="O11" value="0"/>
                    <measurement group_id="O12" value="1"/>
                    <measurement group_id="O13" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 8 &lt; LLOQ detected</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="0"/>
                    <measurement group_id="O8" value="0"/>
                    <measurement group_id="O9" value="0"/>
                    <measurement group_id="O10" value="0"/>
                    <measurement group_id="O11" value="0"/>
                    <measurement group_id="O12" value="1"/>
                    <measurement group_id="O13" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 10 &lt; LLOQ TND</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="0"/>
                    <measurement group_id="O8" value="0"/>
                    <measurement group_id="O9" value="0"/>
                    <measurement group_id="O10" value="0"/>
                    <measurement group_id="O11" value="0"/>
                    <measurement group_id="O12" value="1"/>
                    <measurement group_id="O13" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 48 &lt; LLOQ TND</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="1"/>
                    <measurement group_id="O4" value="1"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="0"/>
                    <measurement group_id="O8" value="0"/>
                    <measurement group_id="O9" value="0"/>
                    <measurement group_id="O10" value="0"/>
                    <measurement group_id="O11" value="0"/>
                    <measurement group_id="O12" value="0"/>
                    <measurement group_id="O13" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Adverse Events: First dose date up to Day 3 plus 30 days; All-Cause Mortality: First dose date up to Week 48</time_frame>
      <desc>The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug (voxilaprevir or placebo). Data were summarized by dose.</desc>
      <group_list>
        <group group_id="E1">
          <title>Placebo</title>
          <description>Participants with HCV infection received placebo once daily for 3 days under fasted conditions. This arm was part of cohorts 1, 2, and 3.</description>
        </group>
        <group group_id="E2">
          <title>Voxilaprevir 50 mg</title>
          <description>Participants with HCV infection received voxilaprevir 50 mg once daily for 3 days under fasted conditions. This arm was part of cohorts 1 and 2.</description>
        </group>
        <group group_id="E3">
          <title>Voxilaprevir 100 mg</title>
          <description>Participants with HCV infection received voxilaprevir 100 mg once daily for 3 days under fasted conditions. This arm was part of cohorts 1, 2, 3, 4, 5 and 6.</description>
        </group>
        <group group_id="E4">
          <title>Voxilaprevir 300 mg</title>
          <description>Participants with HCV infection received voxilaprevir 300 mg once daily for 3 days under fasted conditions. This arm was part of cohorts 1 and 2.</description>
        </group>
        <group group_id="E5">
          <title>Voxilaprevir 100 mg Fed</title>
          <description>Participants with HCV infection received voxilaprevir 100 mg once daily for 3 days under fed conditions. This arm was part of cohorts 1, 2, 3, 4, 5 and 6.</description>
        </group>
        <group group_id="E6">
          <title>Voxilaprevir 100 mg + SOF/VEL 400/100 mg</title>
          <description>Participants with HCV infection received voxilaprevir 100 mg on Day 1 and voxilaprevir 100 mg plus SOF/VEL (400/100 mg) FDC on Days 2 and 3 after moderate fat meal. This arm was part of cohort 10.</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA 18.0</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="16"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="16"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Atrial fibrillation</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="16"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedDRA 18.0</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="8"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="14"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="30"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="15"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E6" subjects_affected="2" subjects_at_risk="16"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Constipation</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="16"/>
              </event>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="30"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="16"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Contusion</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="16"/>
              </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="0" subjects_at_risk="8"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="16"/>
              </event>
              <event>
                <sub_title>Pain in extremity</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="16"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Dizziness</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="16"/>
              </event>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="8"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="16"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Dermatitis contact</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="16"/>
              </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>Gilead Clinical Study Information Center</name_or_title>
      <organization>Gilead Sciences</organization>
      <phone>1-833-445-3230 (GILEAD-0)</phone>
      <email>GileadClinicalTrials@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/NCT02185794
org study id: GS-US-338-1121
nct id: NCT02185794
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
The primary objective of the study is to evaluate the safety and tolerability of voxilaprevir
      (formerly GS-9857) alone or with sofosbuvir (SOF)/velpatasvir (VEL) fixed dose combination
      (FDC) and antiviral activity of voxilaprevir in adults with genotype 1, 2, 3, 4 hepatitis C
      virus (HCV) infection. All participants will be monitored for up to 48 weeks after the last
      dose.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Percentage of Participants Experiencing Treatment Emergent Adverse Events
time frame: First dose date up to Day 3 plus 30 days
measure: Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities
time frame: First dose date up to Day 3 plus 30 days
description: Treatment-emergent laboratory abnormalities were defined as values that increase at least one toxicity grade from baseline. The severity of laboratory abnormalities was assessed as Grade 0, 1 (mild), 2 (moderate), 3 (severe), or 4 (potentially life threatening) using the Common Terminology Criteria for Adverse Events (CTCAE), version 4.03. The most severe graded abnormality from all tests was counted for each participant.
measure: Antiviral Activity of Voxilaprevir as Measured by Change From Baseline in Plasma HCV RNA
time frame: Baseline; Days 4, 5, 6, 7, 8, 10, and Week 48
description: The outcome measure was assessed to evaluate antiviral activity of voxilaprevir only (cohorts 1 through 6). Data are summarized by treatment/cohort and placebo.
measure: Antiviral Activity of Voxilaprevir as Measured by Absolute HCV RNA Level Through Week 48
time frame: Baseline (Pre Day 1 Dose); Days 4, 5, 6, 7, 8, 10, and Week 48
description: The outcome measure was assessed to evaluate antiviral activity of voxilaprevir only (cohorts 1 through 6).
measure: Antiviral Activity of Voxilaprevir as Measured by Number of Participants Achieving Reductions From Baseline in HCV RNA
time frame: Baseline; Days 4, 5, 6, 7, 8, 10, and Week 48
description: Categorical declines from baseline were summarized by the number of participants with a < 1, ≥ 1 to <2, ≥ 2 to <3, or ≥ 3 log10 IU/mL decrease in HCV RNA from baseline to each postdose assessment up to Week 48 by treatment/cohort and placebo. The outcome measure was assessed to evaluate antiviral activity of voxilaprevir only (cohorts 1 through 6).
measure: Percentage of Participants Who Have HCV RNA < Lower Limit of Quantitation (LLOQ) Detected, and < LLOQ Target Not Detected (TND)
time frame: Days 4, 5, 6, 7, 8, 10, and Week 48
description: The lower limit of quantitation (LLOQ) detection for HCV RNA levels was 15 IU/mL. HCV detected means calculated HCV RNA level is below LLOQ of the assay. The outcome measure was assessed to evaluate antiviral activity of voxilaprevir only (cohorts 1 through 6).
arm group label: Placebo (GT 1a, Cohort 1)
arm group type: Placebo Comparator
description: Participants with genotype (GT) 1a HCV infection will receive placebo once daily for 3 days under fasted conditions.
arm group label: Voxilaprevir 50 mg (GT 1a, Cohort 1)
arm group type: Experimental
description: Participants with GT 1a HCV infection will receive voxilaprevir 50 mg once daily for 3 days under fasted conditions.
arm group label: Voxilaprevir 100 mg (GT 1a, Cohort 1)
arm group type: Experimental
description: Participants with GT 1a HCV infection will receive voxilaprevir 100 mg once daily for 3 days under fasted conditions.
arm group label: Voxilaprevir 300 mg (GT 1a, Cohort 1)
arm group type: Experimental
description: Participants with GT 1a HCV infection will receive voxilaprevir 300 mg once daily for 3 days under fasted conditions.
arm group label: Placebo (GT 3, Cohort 2)
arm group type: Placebo Comparator
description: Participants with GT 3 HCV infection will receive placebo once daily for 3 days under fasted conditions.
arm group label: Voxilaprevir 50 mg (GT 3, Cohort 2)
arm group type: Experimental
description: Participants with GT 3 HCV infection will receive voxilaprevir 50 mg once daily for 3 days under fasted conditions.
arm group label: Voxilaprevir 100 mg (GT 3, Cohort 2)
arm group type: Experimental
description: Participants with GT 3 HCV infection will receive voxilaprevir 100 mg once daily for 3 days under fasted conditions.
arm group label: Voxilaprevir 300 mg (GT 3, Cohort 2)
arm group type: Experimental
description: Participants with GT 3 HCV infection will receive voxilaprevir 300 mg once daily for 3 days under fasted conditions.
arm group label: Placebo (GT 2, Cohort 3)
arm group type: Placebo Comparator
description: Participants with GT 2 HCV infection will receive placebo once daily for 3 days under fasted conditions.
arm group label: Voxilaprevir 100 mg (GT 2, Cohort 3)
arm group type: Experimental
description: Participants with GT 2 HCV infection will receive voxilaprevir 100 mg once daily for 3 days under fasted conditions.
arm group label: Voxilaprevir 100 mg (GT 4, Cohort 4)
arm group type: Experimental
description: Participants with GT 4 HCV infection will receive voxilaprevir 100 mg once daily for 3 days under fasted conditions.
arm group label: Voxilaprevir 100 mg (GT 1b, Cohort 5)
arm group type: Experimental
description: Participants with GT 1b HCV infection will receive voxilaprevir 100 mg once daily for 3 days under fasted conditions.
arm group label: Voxilaprevir 100 mg Fed (GT 3a, Cohort 6)
arm group type: Experimental
description: Participants with GT 3a HCV infection will receive voxilaprevir 100 mg once daily for 3 days under fed conditions.
arm group label: Voxilaprevir 600 mg (Cohorts 7-9)
arm group type: Experimental
description: Participants with genotypes 1a, 1b, 2, 3, or 4 HCV infection will receive voxilaprevir up to 600 mg under fasted or fed conditions for 3 days.
arm group label: Voxilaprevir 100 mg + SOF/VEL 400/100 mg (Group 1, Cohort 10)
arm group type: Experimental
description: Participants with any GT HCV infection received voxilaprevir 100 mg on Day 1 after moderate fat meal and voxilaprevir 100 mg plus sofosbuvir (SOF)/velpatasvir (VEL) (400/100 mg) fixed-dose combination (FDC)on Days 2 and 3 after either a light or moderate-fat meal.
arm group label: Voxilaprevir 100 mg + SOF/VEL 400/100 mg (Group 2, Cohort 10)
arm group type: Experimental
description: Participants with any GT HCV infection received voxilaprevir 100 mg on Day 1 and voxilaprevir 100 mg plus SOF/VEL (400/100 mg) FDC on Days 2 and 3 after moderate fat meal.
intervention type: Drug
intervention name: Voxilaprevir
description: Voxilaprevir tablets administered orally once daily
arm group label: Voxilaprevir 100 mg (GT 1a, Cohort 1)
arm group label: Voxilaprevir 100 mg (GT 1b, Cohort 5)
arm group label: Voxilaprevir 100 mg (GT 2, Cohort 3)
arm group label: Voxilaprevir 100 mg (GT 3, Cohort 2)
arm group label: Voxilaprevir 100 mg (GT 4, Cohort 4)
arm group label: Voxilaprevir 100 mg + SOF/VEL 400/100 mg (Group 1, Cohort 10)
arm group label: Voxilaprevir 100 mg + SOF/VEL 400/100 mg (Group 2, Cohort 10)
arm group label: Voxilaprevir 100 mg Fed (GT 3a, Cohort 6)
arm group label: Voxilaprevir 300 mg (GT 1a, Cohort 1)
arm group label: Voxilaprevir 300 mg (GT 3, Cohort 2)
arm group label: Voxilaprevir 50 mg (GT 1a, Cohort 1)
arm group label: Voxilaprevir 50 mg (GT 3, Cohort 2)
arm group label: Voxilaprevir 600 mg (Cohorts 7-9)
other name: GS-9857
intervention type: Drug
intervention name: Placebo to match voxilaprevir
description: Placebo to match voxilaprevir tablets administered orally once daily
arm group label: Placebo (GT 1a, Cohort 1)
arm group label: Placebo (GT 2, Cohort 3)
arm group label: Placebo (GT 3, Cohort 2)
intervention type: Drug
intervention name: SOF/VEL
description: 400 mg/100 mg FDC tablet administered orally once daily
arm group label: Voxilaprevir 100 mg + SOF/VEL 400/100 mg (Group 1, Cohort 10)
arm group label: Voxilaprevir 100 mg + SOF/VEL 400/100 mg (Group 2, Cohort 10)
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Gilead Study Director
role: Study Director
affiliation: Gilead Sciences
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country: Puerto Rico
country: United States
citation: Rodriguez-Torres M, Glass S, Hill J, Freilich B, Hassman D, Di Bisceglie A, Taylor J, Kirby B, Yang J, An D, Stamm L, Brainard D, Kim S, Krefetz D, Smith W, Marbury T, Lawitz E. The Pangenotypic NS3/4A Protease Inhibitor GS-9857 Demonstrates Potent Antiviral Activity in Patients Infected With HCV Genotype 1, 2, 3, or 4 in a 3-Day Monotherapy Study [Poster P0901]. Presented at the European Association for the Study of the Liver (EASL) 50th International Liver Congress 2015, April 22-26, 2015, Vienna, Austria.
citation: Lawitz E, Yang JC, Stamm LM, Taylor JG, Cheng G, Brainard DM, Miller MD, Mo H, Dvory-Sobol H. Characterization of HCV resistance from a 3-day monotherapy study of voxilaprevir, a novel pangenotypic NS3/4A protease inhibitor. Antivir Ther. 2018;23(4):325-334. doi: 10.3851/IMP3202.
PMID: 29063860
responsible party type: Sponsor
mesh term: Infections
mesh term: Communicable Diseases
mesh term: Hepatitis A
mesh term: Virus Diseases
mesh term: Hepatitis C
mesh term: Hepatitis C, Chronic
mesh term: Hepatitis
participant flow: 
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reported events: 
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