<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/NCT01685203</url>
  </required_header>
  <id_info>
    <org_study_id>M13-393</org_study_id>
    <secondary_id>2011-005762-38</secondary_id>
    <nct_id>NCT01685203</nct_id>
  </id_info>
  <brief_title>A Study to Evaluate the Safety and Effect of Co-administration of ABT-450 With Ritonavir (ABT-450/r) and ABT-267 in Adults With Chronic Hepatitis C Virus Infection</brief_title>
  <acronym>PEARL-I</acronym>
  <official_title>A Randomized, Open-Label Study to Evaluate the Safety and Efficacy of Coadministration of ABT-450 With Ritonavir (ABT-450/r) and ABT-267 in Adults With Chronic Hepatitis C Virus Infection (PEARL-I)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>AbbVie (prior sponsor, Abbott)</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>AbbVie</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to evaluate the safety and efficacy of co-administration of&#xD;
      ABT-450 (also known as paritaprevir) with ritonavir (ABT-450/r) and ABT-267 (also known as&#xD;
      ombitasvir) in adults with chronic hepatitis C virus infection.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This was a Phase 2, randomized, open-label, combination treatment study of the 2-DAA regimen&#xD;
      (ABT-450 150 mg QD + ritonavir 100 mg QD + ABT-267 25 mg QD) in adult HCV GT1b-infected&#xD;
      treatment-naïve and Pegylated-interferon/ribavirin (pegIFN/RBV) treatment-experienced&#xD;
      participants without cirrhosis and with compensated cirrhosis, and in adult GT4-infected&#xD;
      treatment-naïve and pegIFN/RBV treatment-experienced participants without cirrhosis.&#xD;
      Treatment Group 5 was not open to enrollment, based on a protocol-specified interim review of&#xD;
      results from the treatment-naïve GT4 Groups 1 and 4 that indicated higher sustained virologic&#xD;
      response (SVR) rates among participants receiving the 2-DAA regimen with RBV. All other&#xD;
      groups completed the study.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>August 2012</start_date>
  <completion_date type="Actual">February 2015</completion_date>
  <primary_completion_date type="Actual">June 2014</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Percentage of Participants in Each Treatment Group With Sustained Virologic Response 12 Weeks Post-treatment</measure>
    <time_frame>12 weeks after the last actual dose of study drug</time_frame>
    <description>The percentage of participants with sustained virologic response (plasma Hepatitis C virus ribonucleic acid [HCV RNA] level less than the lower limit of quantitation [&lt;LLOQ]) 12 weeks after the last dose of study drug.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants in Each Treatment Group With Sustained Virologic Response 24 Weeks Post-treatment</measure>
    <time_frame>24 weeks after the last actual dose of study drug</time_frame>
    <description>The percentage of participants with sustained virologic response (plasma Hepatitis C virus ribonucleic acid [HCV RNA] level less than the lower limit of quantitation [&lt;LLOQ]) 24 weeks after the last dose of study drug.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants in Each Treatment Group With On-treatment Virologic Failure.</measure>
    <time_frame>Baseline (Day 1), Day 3, and Treatment Weeks 1, 2 ,3 ,4, 6, 8, 10, and 12 for all participants and Treatment Weeks 16, 20 and 24 for Groups 7 and 8</time_frame>
    <description>Virologic failure during treatment was defined as rebound (confirmed HCV RNA greater than or equal to the lower limit of quantitation [≥ LLOQ] after HCV RNA &lt; LLOQ during treatment, or confirmed increase from the lowest value post baseline in HCV RNA [2 consecutive HCV RNA measurements &gt; 1 log(subscript)10(subscript) IU/mL above the lowest value post baseline] at any time point during treatment), or fail to suppress (HCV RNA ≥ LLOQ persistently during treatment with at least 6 weeks [≥ 36 days] of treatment).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants in Each Treatment Group With Post-treatment Virologic Relapse.</measure>
    <time_frame>Within 12 weeks after the last dose of study drug</time_frame>
    <description>Participants were considered to have virologic relapse after treatment if they had confirmed quantifiable plasma Hepatitis C virus ribonucleic acid (HCV RNA) ≥ lower limit of quantification (LLOQ) between the end of treatment and 12 weeks after the last dose of study drug among participants who completed treatment with HCV RNA &lt; LLOQ at the end of treatment.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants in Each Treatment Group With Treatment-emergent Adverse Events</measure>
    <time_frame>From the start of study drug administration until 30 days after the last dose,16 weeks for Groups 1, 2, 3, 4, and 6, and 28 weeks for Groups 7 and 8.</time_frame>
    <description>Treatment-emergent adverse events were defined as any event that began or worsened in severity after initiation of study drug through 30 days after the last dose of study drug.</description>
  </secondary_outcome>
  <number_of_arms>8</number_of_arms>
  <enrollment type="Actual">316</enrollment>
  <condition>Hepatitis C, Chronic</condition>
  <arm_group>
    <arm_group_label>Group 1</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>ABT-450 150 mg/ r 100 mg, and ABT-267 25 mg once daily for 12 weeks to adult noncirrhotic, treatment-naïve, HCV GT4-infected participants</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group 2</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>ABT-450 150 mg/ r 100 mg, and ABT-267 25 mg once daily for 12 weeks to adult noncirrhotic, treatment-naïve HCV GT1b-infected participants</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group 3</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>ABT-450 150 mg/ r 100 mg, and ABT-267 25 mg once daily for 12 weeks to adult noncirrhotic, HCV GT1b-infected, pegylated-interferon/ribavirin (pegIFN/RBV) treatment null responder participants</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group 4</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>ABT-450 150 mg/ r 100 mg, ABT-267 25 mg , once daily and weight-based ribavirin (RBV; 1,000 mg/day if &lt; 75 kg or 1,200 mg/day if ≥ 75 kg, divided twice daily) for 12 weeks to adult noncirrhotic, treatment-naïve, HCV GT4-infected participants</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group 5</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>ABT-450 150 mg/ r 100 mg, and ABT-267 25 mg once daily for 12 weeks to adult noncirrhotic, treatment-experienced, HCV GT4-infected participants</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group 6</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>ABT-450 150 mg/ r 100 mg, ABT-267 25 mg , once daily and weight-based ribavirin (RBV; 1,000 mg/day if &lt; 75 kg or 1,200 mg/day if ≥ 75 kg, divided twice daily) for 12 weeks to adult noncirrhotic, HCV GT4-infected, pegylated-interferon/RBV (pegIFN/RBV) treatment-experienced participants</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group 7</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>ABT-450 150 mg/ r 100 mg, and ABT-267 25 mg once daily for 24 weeks to adult, HCV GT1b-infected, treatment-naïve participants with compensated cirrhosis</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group 8</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>ABT-450 150 mg/ r 100 mg, and ABT-267 25 mg once daily for 24 weeks to adult, HCV GT1b-infected, pegylated-interferon/RBV(pegIFN/RBV) treatment-experienced participants with compensated cirrhosis</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>ABT-450/r</intervention_name>
    <description>Tablet; ABT-450; Capsule; ritonavir</description>
    <arm_group_label>Group 1</arm_group_label>
    <arm_group_label>Group 2</arm_group_label>
    <arm_group_label>Group 3</arm_group_label>
    <arm_group_label>Group 4</arm_group_label>
    <arm_group_label>Group 5</arm_group_label>
    <arm_group_label>Group 6</arm_group_label>
    <arm_group_label>Group 7</arm_group_label>
    <arm_group_label>Group 8</arm_group_label>
    <other_name>ABT-450 also known as paritaprevir</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>ABT-267</intervention_name>
    <description>Tablet</description>
    <arm_group_label>Group 1</arm_group_label>
    <arm_group_label>Group 2</arm_group_label>
    <arm_group_label>Group 3</arm_group_label>
    <arm_group_label>Group 4</arm_group_label>
    <arm_group_label>Group 5</arm_group_label>
    <arm_group_label>Group 6</arm_group_label>
    <arm_group_label>Group 7</arm_group_label>
    <arm_group_label>Group 8</arm_group_label>
    <other_name>ABT-267 also known as ombitasvir</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Ribavirin (RBV)</intervention_name>
    <description>Tablet</description>
    <arm_group_label>Group 4</arm_group_label>
    <arm_group_label>Group 6</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Females must be practicing specific forms of birth control on study treatment, or be&#xD;
             postmenopausal for more than 2 years or surgically sterile&#xD;
&#xD;
          -  Subjects must meet one of the following:&#xD;
&#xD;
               -  Treatment-naive: Subject has never received antiviral treatment for hepatitis C&#xD;
                  infection OR&#xD;
&#xD;
               -  Treatment Experienced (Prior null responders, Partial responders or Relapsers to&#xD;
                  pegIFN/RBV);&#xD;
&#xD;
          -  Body mass index (BMI) is ≥ 18 to &lt; 38 kg/m^2.&#xD;
&#xD;
          -  Chronic HCV genotype 1b infection/with or without cirrhosis or HCV genotype 4&#xD;
             infection/without cirrhosis for at least 6 months prior to study screening.&#xD;
&#xD;
          -  Subject has plasma HCV RNA level &gt; 10,000 IU/mL at Screening&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  History of severe, life-threatening or other significant sensitivity to any drug.&#xD;
&#xD;
          -  Females who were pregnant or planned to become pregnant, or breastfeeding, or&#xD;
             GT4-infected males whose partners were pregnant or planning to become pregnant within&#xD;
             7 months (or per local RBV label) after their last dose of study drug/RBV.&#xD;
&#xD;
          -  Recent history of drug or alcohol abuse that could preclude adherence to the protocol.&#xD;
&#xD;
          -  Positive test result for hepatitis B surface antigen or anti-Human Immunodeficiency&#xD;
             Virus (HIV) antibodies.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Nilou Mobashery, MD</last_name>
    <role>Study Director</role>
    <affiliation>AbbVie</affiliation>
  </overall_official>
  <removed_countries>
    <country>France</country>
    <country>Hungary</country>
    <country>Italy</country>
    <country>Poland</country>
    <country>Puerto Rico</country>
    <country>Romania</country>
    <country>Spain</country>
    <country>Turkey</country>
    <country>United States</country>
  </removed_countries>
  <link>
    <url>http://www.rxabbvie.com</url>
    <description>Related Info</description>
  </link>
  <reference>
    <citation>Hezode C, Asselah T, Reddy KR, Hassanein T, Berenguer M, Fleischer-Stepniewska K, Marcellin P, Hall C, Schnell G, Pilot-Matias T, Mobashery N, Redman R, Vilchez RA, Pol S. Ombitasvir plus paritaprevir plus ritonavir with or without ribavirin in treatment-naive and treatment-experienced patients with genotype 4 chronic hepatitis C virus infection (PEARL-I): a randomised, open-label trial. Lancet. 2015 Jun 20;385(9986):2502-9. doi: 10.1016/S0140-6736(15)60159-3. Epub 2015 Mar 31.</citation>
    <PMID>25837829</PMID>
  </reference>
  <reference>
    <citation>Lawitz E, Makara M, Akarca US, Thuluvath PJ, Preotescu LL, Varunok P, Morillas RM, Hall C, Mobashery N, Redman R, Pilot-Matias T, Vilchez RA, Hezode C. Efficacy and Safety of Ombitasvir, Paritaprevir, and Ritonavir in an Open-Label Study of Patients With Genotype 1b Chronic Hepatitis C Virus Infection With and Without Cirrhosis. Gastroenterology. 2015 Oct;149(4):971-80.e1. doi: 10.1053/j.gastro.2015.07.001. Epub 2015 Jul 11.</citation>
    <PMID>26170136</PMID>
  </reference>
  <verification_date>July 2021</verification_date>
  <study_first_submitted>September 12, 2012</study_first_submitted>
  <study_first_submitted_qc>September 12, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 14, 2012</study_first_posted>
  <results_first_submitted>June 9, 2015</results_first_submitted>
  <results_first_submitted_qc>August 3, 2015</results_first_submitted_qc>
  <results_first_posted type="Estimate">August 4, 2015</results_first_posted>
  <last_update_submitted>July 28, 2021</last_update_submitted>
  <last_update_submitted_qc>July 28, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">July 30, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Hepatitis C Virus</keyword>
  <keyword>Ribavirin-Free</keyword>
  <keyword>Hepatitis C Genotype 1</keyword>
  <keyword>Hepatitis C</keyword>
  <keyword>Interferon-Free</keyword>
  <keyword>Chronic Hepatitis C</keyword>
  <keyword>Compensated cirrhosis</keyword>
  <keyword>Hepatitis C Genotype 4</keyword>
  <keyword>Paritaprevir</keyword>
  <keyword>Ombitasvir</keyword>
  <keyword>Ritonavir</keyword>
  <keyword>Ribavirin</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hepatitis A</mesh_term>
    <mesh_term>Hepatitis C</mesh_term>
    <mesh_term>Hepatitis C, Chronic</mesh_term>
    <mesh_term>Virus Diseases</mesh_term>
    <mesh_term>Hepatitis</mesh_term>
    <mesh_term>Hepatitis, Chronic</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Ribavirin</mesh_term>
  </intervention_browse>

  <clinical_results>

    <participant_flow>
      <pre_assignment_details>The study originally planned to enroll Group 5 (GT4 treatment-experienced, 2-DAA regimen for 12 weeks), but based on a protocol-specified interim review of results from the treatment-naïve GT4 Groups 1 and 4 that indicated higher SVR rates among participants receiving the 2-DAA regimen with RBV, Group 5 was not opened to enrollment.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Group 1</title>
          <description>ABT-450 150 mg/ r 100 mg, and ABT-267 25 mg once daily for 12 weeks to adult noncirrhotic, treatment-naïve, HCV GT4-infected participants</description>
        </group>
        <group group_id="P2">
          <title>Group 2</title>
          <description>ABT-450 150 mg/ r 100 mg, and ABT-267 25 mg once daily for 12 weeks to adult noncirrhotic, treatment-naïve HCV GT1b-infected participants</description>
        </group>
        <group group_id="P3">
          <title>Group 3</title>
          <description>ABT-450 150 mg/ r 100 mg, and ABT-267 25 mg once daily for 12 weeks to adult noncirrhotic, HCV GT1b-infected, pegylated-interferon/ribavirin (pegIFN/RBV) treatment null responder participants</description>
        </group>
        <group group_id="P4">
          <title>Group 4</title>
          <description>ABT-450 150 mg/ r 100 mg, ABT-267 25 mg , once daily and weight-based ribavirin (RBV; 1,000 mg/day if &lt; 75 kg or 1,200 mg/day if ≥ 75 kg, divided twice daily) for 12 weeks to adult noncirrhotic, treatment-naïve, HCV GT4-infected participants</description>
        </group>
        <group group_id="P5">
          <title>Group 6</title>
          <description>ABT-450 150 mg/ r 100 mg, ABT-267 25 mg , once daily and weight-based ribavirin (RBV; 1,000 mg/day if &lt; 75 kg or 1,200 mg/day if ≥ 75 kg, divided twice daily) for 12 weeks to adult noncirrhotic, HCV GT4-infected, pegylated-interferon/RBV (pegIFN/RBV) treatment-experienced participants</description>
        </group>
        <group group_id="P6">
          <title>Group 7</title>
          <description>ABT-450 150 mg/ r 100 mg, and ABT-267 25 mg once daily for 24 weeks to adult, HCV GT1b-infected, treatment-naïve participants with compensated cirrhosis</description>
        </group>
        <group group_id="P7">
          <title>Group 8</title>
          <description>ABT-450 150 mg/ r 100 mg, and ABT-267 25 mg once daily for 24 weeks to adult, HCV GT1b-infected, pegylated-interferon/RBV(pegIFN/RBV) treatment-experienced participants with compensated cirrhosis</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="44"/>
                <participants group_id="P2" count="42"/>
                <participants group_id="P3" count="40"/>
                <participants group_id="P4" count="42"/>
                <participants group_id="P5" count="49"/>
                <participants group_id="P6" count="47"/>
                <participants group_id="P7" count="52"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Completed Study Drug</title>
              <participants_list>
                <participants group_id="P1" count="42"/>
                <participants group_id="P2" count="40"/>
                <participants group_id="P3" count="39"/>
                <participants group_id="P4" count="42"/>
                <participants group_id="P5" count="49"/>
                <participants group_id="P6" count="43"/>
                <participants group_id="P7" count="52"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="40"/>
                <participants group_id="P2" count="39"/>
                <participants group_id="P3" count="40"/>
                <participants group_id="P4" count="41"/>
                <participants group_id="P5" count="49"/>
                <participants group_id="P6" count="44"/>
                <participants group_id="P7" count="52"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
                <participants group_id="P2" count="3"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="1"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="3"/>
                <participants group_id="P7" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="3"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="1"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="2"/>
                <participants group_id="P7" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Adverse event and withdrew consent</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Patient's decision</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="1"/>
                <participants group_id="P7" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>All participants who received at least 1 dose of study drug.</population>
      <group_list>
        <group group_id="B1">
          <title>Group 1</title>
          <description>ABT-450 150 mg/ r 100 mg, and ABT-267 25 mg once daily for 12 weeks to adult noncirrhotic, treatment-naïve, HCV GT4-infected participants</description>
        </group>
        <group group_id="B2">
          <title>Group 2</title>
          <description>ABT-450 150 mg/ r 100 mg, and ABT-267 25 mg once daily for 12 weeks to adult noncirrhotic, treatment-naïve HCV GT1b-infected participants</description>
        </group>
        <group group_id="B3">
          <title>Group 3</title>
          <description>ABT-450 150 mg/ r 100 mg, and ABT-267 25 mg once daily for 12 weeks to adult noncirrhotic, HCV GT1b-infected, pegylated-interferon/ribavirin (pegIFN/RBV) treatment null responder participants</description>
        </group>
        <group group_id="B4">
          <title>Group 4</title>
          <description>ABT-450 150 mg/ r 100 mg, ABT-267 25 mg , once daily and weight-based ribavirin (RBV; 1,000 mg/day if &lt; 75 kg or 1,200 mg/day if ≥ 75 kg, divided twice daily) for 12 weeks to adult noncirrhotic, treatment-naïve, HCV GT4-infected participants</description>
        </group>
        <group group_id="B5">
          <title>Group 6</title>
          <description>ABT-450 150 mg/ r 100 mg, ABT-267 25 mg , once daily and weight-based ribavirin (RBV; 1,000 mg/day if &lt; 75 kg or 1,200 mg/day if ≥ 75 kg, divided twice daily) for 12 weeks to adult noncirrhotic, HCV GT4-infected, pegylated-interferon/RBV (pegIFN/RBV) treatment-experienced participants</description>
        </group>
        <group group_id="B6">
          <title>Group 7</title>
          <description>ABT-450 150 mg/ r 100 mg, and ABT-267 25 mg once daily for 24 weeks to adult, HCV GT1b-infected, treatment-naïve participants with compensated cirrhosis</description>
        </group>
        <group group_id="B7">
          <title>Group 8</title>
          <description>ABT-450 150 mg/ r 100 mg, and ABT-267 25 mg once daily for 24 weeks to adult, HCV GT1b-infected, pegylated-interferon/RBV(pegIFN/RBV) treatment-experienced participants with compensated cirrhosis</description>
        </group>
        <group group_id="B8">
          <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="44"/>
            <count group_id="B2" value="42"/>
            <count group_id="B3" value="40"/>
            <count group_id="B4" value="42"/>
            <count group_id="B5" value="49"/>
            <count group_id="B6" value="47"/>
            <count group_id="B7" value="52"/>
            <count group_id="B8" value="316"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="48.9" spread="10.0"/>
                    <measurement group_id="B2" value="55.8" spread="6.9"/>
                    <measurement group_id="B3" value="54.2" spread="9.6"/>
                    <measurement group_id="B4" value="44.2" spread="12.7"/>
                    <measurement group_id="B5" value="50.9" spread="10.1"/>
                    <measurement group_id="B6" value="57.8" spread="7.1"/>
                    <measurement group_id="B7" value="57.1" spread="6.0"/>
                    <measurement group_id="B8" value="52.8" spread="10.1"/>
                  </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="20"/>
                    <measurement group_id="B2" value="17"/>
                    <measurement group_id="B3" value="25"/>
                    <measurement group_id="B4" value="14"/>
                    <measurement group_id="B5" value="13"/>
                    <measurement group_id="B6" value="24"/>
                    <measurement group_id="B7" value="19"/>
                    <measurement group_id="B8" value="132"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="24"/>
                    <measurement group_id="B2" value="25"/>
                    <measurement group_id="B3" value="15"/>
                    <measurement group_id="B4" value="28"/>
                    <measurement group_id="B5" value="36"/>
                    <measurement group_id="B6" value="23"/>
                    <measurement group_id="B7" value="33"/>
                    <measurement group_id="B8" value="184"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants in Each Treatment Group With Sustained Virologic Response 24 Weeks Post-treatment</title>
        <description>The percentage of participants with sustained virologic response (plasma Hepatitis C virus ribonucleic acid [HCV RNA] level less than the lower limit of quantitation [&lt;LLOQ]) 24 weeks after the last dose of study drug.</description>
        <time_frame>24 weeks after the last actual dose of study drug</time_frame>
        <population>All randomized participants who received at least 1 dose of study drug.</population>
        <group_list>
          <group group_id="O1">
            <title>Group 1</title>
            <description>ABT-450 150 mg/ r 100 mg, and ABT-267 25 mg once daily for 12 weeks to adult noncirrhotic, treatment-naïve, HCV GT4-infected participants</description>
          </group>
          <group group_id="O2">
            <title>Group 2</title>
            <description>ABT-450 150 mg/ r 100 mg, and ABT-267 25 mg once daily for 12 weeks to adult noncirrhotic, treatment-naïve HCV GT1b-infected participants</description>
          </group>
          <group group_id="O3">
            <title>Group 3</title>
            <description>ABT-450 150 mg/ r 100 mg, and ABT-267 25 mg once daily for 12 weeks to adult noncirrhotic, HCV GT1b-infected, pegylated-interferon/ribavirin (pegIFN/RBV) treatment null responder participants</description>
          </group>
          <group group_id="O4">
            <title>Group 4</title>
            <description>ABT-450 150 mg/ r 100 mg, ABT-267 25 mg , once daily and weight-based ribavirin (RBV; 1,000 mg/day if &lt; 75 kg or 1,200 mg/day if ≥ 75 kg, divided twice daily) for 12 weeks to adult noncirrhotic, treatment-naïve, HCV GT4-infected participants</description>
          </group>
          <group group_id="O5">
            <title>Group 6</title>
            <description>ABT-450 150 mg/ r 100 mg, ABT-267 25 mg , once daily and weight-based ribavirin (RBV; 1,000 mg/day if &lt; 75 kg or 1,200 mg/day if ≥ 75 kg, divided twice daily) for 12 weeks to adult noncirrhotic, HCV GT4-infected, pegylated-interferon/RBV (pegIFN/RBV) treatment-experienced participants</description>
          </group>
          <group group_id="O6">
            <title>Group 7</title>
            <description>ABT-450 150 mg/ r 100 mg, and ABT-267 25 mg once daily for 24 weeks to adult, HCV GT1b-infected, treatment-naïve participants with compensated cirrhosis</description>
          </group>
          <group group_id="O7">
            <title>Group 8</title>
            <description>ABT-450 150 mg/ r 100 mg, and ABT-267 25 mg once daily for 24 weeks to adult, HCV GT1b-infected, pegylated-interferon/RBV(pegIFN/RBV) treatment-experienced participants with compensated cirrhosis</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants in Each Treatment Group With Sustained Virologic Response 24 Weeks Post-treatment</title>
          <description>The percentage of participants with sustained virologic response (plasma Hepatitis C virus ribonucleic acid [HCV RNA] level less than the lower limit of quantitation [&lt;LLOQ]) 24 weeks after the last dose of study drug.</description>
          <population>All randomized participants who received at least 1 dose of study drug.</population>
          <units>Percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="44"/>
                <count group_id="O2" value="42"/>
                <count group_id="O3" value="40"/>
                <count group_id="O4" value="42"/>
                <count group_id="O5" value="49"/>
                <count group_id="O6" value="47"/>
                <count group_id="O7" value="52"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="86.4" lower_limit="72.6" upper_limit="94.8"/>
                    <measurement group_id="O2" value="92.9" lower_limit="80.5" upper_limit="98.5"/>
                    <measurement group_id="O3" value="90.0" lower_limit="76.3" upper_limit="97.2"/>
                    <measurement group_id="O4" value="100.0" lower_limit="91.6" upper_limit="100.0"/>
                    <measurement group_id="O5" value="100.0" lower_limit="92.7" upper_limit="100.0"/>
                    <measurement group_id="O6" value="97.9" lower_limit="88.7" upper_limit="99.9"/>
                    <measurement group_id="O7" value="98.1" lower_limit="89.7" upper_limit="100.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Participants in Each Treatment Group With Sustained Virologic Response 12 Weeks Post-treatment</title>
        <description>The percentage of participants with sustained virologic response (plasma Hepatitis C virus ribonucleic acid [HCV RNA] level less than the lower limit of quantitation [&lt;LLOQ]) 12 weeks after the last dose of study drug.</description>
        <time_frame>12 weeks after the last actual dose of study drug</time_frame>
        <population>All randomized participants who received at least 1 dose of study drug.</population>
        <group_list>
          <group group_id="O1">
            <title>Group 1</title>
            <description>ABT-450 150 mg/ r 100 mg, and ABT-267 25 mg once daily for 12 weeks to adult noncirrhotic, treatment-naïve, HCV GT4-infected participants</description>
          </group>
          <group group_id="O2">
            <title>Group 2</title>
            <description>ABT-450 150 mg/ r 100 mg, and ABT-267 25 mg once daily for 12 weeks to adult noncirrhotic, treatment-naïve HCV GT1b-infected participants</description>
          </group>
          <group group_id="O3">
            <title>Group 3</title>
            <description>ABT-450 150 mg/ r 100 mg, and ABT-267 25 mg once daily for 12 weeks to adult noncirrhotic, HCV GT1b-infected, pegylated-interferon/ribavirin (pegIFN/RBV) treatment null responder participants</description>
          </group>
          <group group_id="O4">
            <title>Group 4</title>
            <description>ABT-450 150 mg/ r 100 mg, ABT-267 25 mg , once daily and weight-based ribavirin (RBV; 1,000 mg/day if &lt; 75 kg or 1,200 mg/day if ≥ 75 kg, divided twice daily) for 12 weeks to adult noncirrhotic, treatment-naïve, HCV GT4-infected participants</description>
          </group>
          <group group_id="O5">
            <title>Group 6</title>
            <description>ABT-450 150 mg/ r 100 mg, ABT-267 25 mg , once daily and weight-based ribavirin (RBV; 1,000 mg/day if &lt; 75 kg or 1,200 mg/day if ≥ 75 kg, divided twice daily) for 12 weeks to adult noncirrhotic, HCV GT4-infected, pegylated-interferon/RBV (pegIFN/RBV) treatment-experienced participants</description>
          </group>
          <group group_id="O6">
            <title>Group 7</title>
            <description>ABT-450 150 mg/ r 100 mg, and ABT-267 25 mg once daily for 24 weeks to adult, HCV GT1b-infected, treatment-naïve participants with compensated cirrhosis</description>
          </group>
          <group group_id="O7">
            <title>Group 8</title>
            <description>ABT-450 150 mg/ r 100 mg, and ABT-267 25 mg once daily for 24 weeks to adult, HCV GT1b-infected, pegylated-interferon/RBV(pegIFN/RBV) treatment-experienced participants with compensated cirrhosis</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants in Each Treatment Group With Sustained Virologic Response 12 Weeks Post-treatment</title>
          <description>The percentage of participants with sustained virologic response (plasma Hepatitis C virus ribonucleic acid [HCV RNA] level less than the lower limit of quantitation [&lt;LLOQ]) 12 weeks after the last dose of study drug.</description>
          <population>All randomized participants who received at least 1 dose of study drug.</population>
          <units>Percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="44"/>
                <count group_id="O2" value="42"/>
                <count group_id="O3" value="40"/>
                <count group_id="O4" value="42"/>
                <count group_id="O5" value="49"/>
                <count group_id="O6" value="47"/>
                <count group_id="O7" value="52"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="90.9" lower_limit="78.3" upper_limit="97.5"/>
                    <measurement group_id="O2" value="95.2" lower_limit="83.8" upper_limit="99.4"/>
                    <measurement group_id="O3" value="90.0" lower_limit="76.3" upper_limit="97.2"/>
                    <measurement group_id="O4" value="100" lower_limit="91.6" upper_limit="100.0"/>
                    <measurement group_id="O5" value="100" lower_limit="92.7" upper_limit="100.0"/>
                    <measurement group_id="O6" value="97.9" lower_limit="88.7" upper_limit="99.9"/>
                    <measurement group_id="O7" value="98.1" lower_limit="89.7" upper_limit="100.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other (legacy)</non_inferiority_type>
            <p_value>0.381</p_value>
            <method>Regression, Logistic</method>
            <method_desc>Treatment group, baseline log(subscript)10(subscript) HCV RNA level and Interleukin-28B (IL28B) genotype (CC or non-CC) were used as predictors</method_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other (legacy)</non_inferiority_type>
            <p_value>0.086</p_value>
            <p_value_desc>Difference in rates after adjusting for Interleukin-28 (IL28) genotype (CC or Non-CC) using stratum-adjusted Mantel-Haenszel proportions and continuity-corrected variances.</p_value_desc>
            <method>Stratum-adjusted Mantel-Haenszel</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants in Each Treatment Group With On-treatment Virologic Failure.</title>
        <description>Virologic failure during treatment was defined as rebound (confirmed HCV RNA greater than or equal to the lower limit of quantitation [≥ LLOQ] after HCV RNA &lt; LLOQ during treatment, or confirmed increase from the lowest value post baseline in HCV RNA [2 consecutive HCV RNA measurements &gt; 1 log(subscript)10(subscript) IU/mL above the lowest value post baseline] at any time point during treatment), or fail to suppress (HCV RNA ≥ LLOQ persistently during treatment with at least 6 weeks [≥ 36 days] of treatment).</description>
        <time_frame>Baseline (Day 1), Day 3, and Treatment Weeks 1, 2 ,3 ,4, 6, 8, 10, and 12 for all participants and Treatment Weeks 16, 20 and 24 for Groups 7 and 8</time_frame>
        <population>All randomized participants who received at least 1 dose of study drug.</population>
        <group_list>
          <group group_id="O1">
            <title>Group 1</title>
            <description>ABT-450 150 mg/ r 100 mg, and ABT-267 25 mg once daily for 12 weeks to adult noncirrhotic, treatment-naïve, HCV GT4-infected participants</description>
          </group>
          <group group_id="O2">
            <title>Group 2</title>
            <description>ABT-450 150 mg/ r 100 mg, and ABT-267 25 mg once daily for 12 weeks to adult noncirrhotic, treatment-naïve HCV GT1b-infected participants</description>
          </group>
          <group group_id="O3">
            <title>Group 3</title>
            <description>ABT-450 150 mg/ r 100 mg, and ABT-267 25 mg once daily for 12 weeks to adult noncirrhotic, HCV GT1b-infected, pegylated-interferon/ribavirin (pegIFN/RBV) treatment null responder participants</description>
          </group>
          <group group_id="O4">
            <title>Group 4</title>
            <description>ABT-450 150 mg/ r 100 mg, ABT-267 25 mg , once daily and weight-based ribavirin (RBV; 1,000 mg/day if &lt; 75 kg or 1,200 mg/day if ≥ 75 kg, divided twice daily) for 12 weeks to adult noncirrhotic, treatment-naïve, HCV GT4-infected participants</description>
          </group>
          <group group_id="O5">
            <title>Group 6</title>
            <description>ABT-450 150 mg/ r 100 mg, ABT-267 25 mg , once daily and weight-based ribavirin (RBV; 1,000 mg/day if &lt; 75 kg or 1,200 mg/day if ≥ 75 kg, divided twice daily) for 12 weeks to adult noncirrhotic, HCV GT4-infected, pegylated-interferon/RBV (pegIFN/RBV) treatment-experienced participants</description>
          </group>
          <group group_id="O6">
            <title>Group 7</title>
            <description>ABT-450 150 mg/ r 100 mg, and ABT-267 25 mg once daily for 24 weeks to adult, HCV GT1b-infected, treatment-naïve participants with compensated cirrhosis</description>
          </group>
          <group group_id="O7">
            <title>Group 8</title>
            <description>ABT-450 150 mg/ r 100 mg, and ABT-267 25 mg once daily for 24 weeks to adult, HCV GT1b-infected, pegylated-interferon/RBV(pegIFN/RBV) treatment-experienced participants with compensated cirrhosis</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants in Each Treatment Group With On-treatment Virologic Failure.</title>
          <description>Virologic failure during treatment was defined as rebound (confirmed HCV RNA greater than or equal to the lower limit of quantitation [≥ LLOQ] after HCV RNA &lt; LLOQ during treatment, or confirmed increase from the lowest value post baseline in HCV RNA [2 consecutive HCV RNA measurements &gt; 1 log(subscript)10(subscript) IU/mL above the lowest value post baseline] at any time point during treatment), or fail to suppress (HCV RNA ≥ LLOQ persistently during treatment with at least 6 weeks [≥ 36 days] of treatment).</description>
          <population>All randomized participants who received at least 1 dose of study drug.</population>
          <units>Percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="44"/>
                <count group_id="O2" value="42"/>
                <count group_id="O3" value="40"/>
                <count group_id="O4" value="42"/>
                <count group_id="O5" value="49"/>
                <count group_id="O6" value="47"/>
                <count group_id="O7" value="52"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.3" lower_limit="0.1" upper_limit="12.0"/>
                    <measurement group_id="O2" value="0" lower_limit="0.0" upper_limit="8.4"/>
                    <measurement group_id="O3" value="2.5" lower_limit="0.1" upper_limit="13.2"/>
                    <measurement group_id="O4" value="0" lower_limit="0.0" upper_limit="8.4"/>
                    <measurement group_id="O5" value="0" lower_limit="0.0" upper_limit="7.3"/>
                    <measurement group_id="O6" value="0" lower_limit="0.0" upper_limit="7.5"/>
                    <measurement group_id="O7" value="0" lower_limit="0.0" upper_limit="6.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants in Each Treatment Group With Post-treatment Virologic Relapse.</title>
        <description>Participants were considered to have virologic relapse after treatment if they had confirmed quantifiable plasma Hepatitis C virus ribonucleic acid (HCV RNA) ≥ lower limit of quantification (LLOQ) between the end of treatment and 12 weeks after the last dose of study drug among participants who completed treatment with HCV RNA &lt; LLOQ at the end of treatment.</description>
        <time_frame>Within 12 weeks after the last dose of study drug</time_frame>
        <population>All randomized participants who received at least 1 dose of study drug and completed treatment with HCV RNA &lt; LLOQ at the final treatment visit.</population>
        <group_list>
          <group group_id="O1">
            <title>Group 1</title>
            <description>ABT-450 150 mg/ r 100 mg, and ABT-267 25 mg once daily for 12 weeks to adult noncirrhotic, treatment-naïve, HCV GT4-infected participants</description>
          </group>
          <group group_id="O2">
            <title>Group 2</title>
            <description>ABT-450 150 mg/ r 100 mg, and ABT-267 25 mg once daily for 12 weeks to adult noncirrhotic, treatment-naïve HCV GT1b-infected participants</description>
          </group>
          <group group_id="O3">
            <title>Group 3</title>
            <description>ABT-450 150 mg/ r 100 mg, and ABT-267 25 mg once daily for 12 weeks to adult noncirrhotic, HCV GT1b-infected, pegylated-interferon/ribavirin (pegIFN/RBV) treatment null responder participants</description>
          </group>
          <group group_id="O4">
            <title>Group 4</title>
            <description>ABT-450 150 mg/ r 100 mg, ABT-267 25 mg , once daily and weight-based ribavirin (RBV; 1,000 mg/day if &lt; 75 kg or 1,200 mg/day if ≥ 75 kg, divided twice daily) for 12 weeks to adult noncirrhotic, treatment-naïve, HCV GT4-infected participants</description>
          </group>
          <group group_id="O5">
            <title>Group 6</title>
            <description>ABT-450 150 mg/ r 100 mg, ABT-267 25 mg , once daily and weight-based ribavirin (RBV; 1,000 mg/day if &lt; 75 kg or 1,200 mg/day if ≥ 75 kg, divided twice daily) for 12 weeks to adult noncirrhotic, HCV GT4-infected, pegylated-interferon/RBV (pegIFN/RBV) treatment-experienced participants</description>
          </group>
          <group group_id="O6">
            <title>Group 7</title>
            <description>ABT-450 150 mg/ r 100 mg, and ABT-267 25 mg once daily for 24 weeks to adult, HCV GT1b-infected, treatment-naïve participants with compensated cirrhosis</description>
          </group>
          <group group_id="O7">
            <title>Group 8</title>
            <description>ABT-450 150 mg/ r 100 mg, and ABT-267 25 mg once daily for 24 weeks to adult, HCV GT1b-infected, pegylated-interferon/RBV(pegIFN/RBV) treatment-experienced participants with compensated cirrhosis</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants in Each Treatment Group With Post-treatment Virologic Relapse.</title>
          <description>Participants were considered to have virologic relapse after treatment if they had confirmed quantifiable plasma Hepatitis C virus ribonucleic acid (HCV RNA) ≥ lower limit of quantification (LLOQ) between the end of treatment and 12 weeks after the last dose of study drug among participants who completed treatment with HCV RNA &lt; LLOQ at the end of treatment.</description>
          <population>All randomized participants who received at least 1 dose of study drug and completed treatment with HCV RNA &lt; LLOQ at the final treatment visit.</population>
          <units>Percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="42"/>
                <count group_id="O2" value="40"/>
                <count group_id="O3" value="39"/>
                <count group_id="O4" value="42"/>
                <count group_id="O5" value="49"/>
                <count group_id="O6" value="44"/>
                <count group_id="O7" value="52"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.8" lower_limit="0.6" upper_limit="16.2"/>
                    <measurement group_id="O2" value="0" lower_limit="0.0" upper_limit="8.8"/>
                    <measurement group_id="O3" value="7.7" lower_limit="1.6" upper_limit="20.9"/>
                    <measurement group_id="O4" value="0" lower_limit="0.0" upper_limit="8.4"/>
                    <measurement group_id="O5" value="0" lower_limit="0.0" upper_limit="7.3"/>
                    <measurement group_id="O6" value="0" lower_limit="0.0" upper_limit="8.0"/>
                    <measurement group_id="O7" value="1.9" lower_limit="0.0" upper_limit="10.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants in Each Treatment Group With Treatment-emergent Adverse Events</title>
        <description>Treatment-emergent adverse events were defined as any event that began or worsened in severity after initiation of study drug through 30 days after the last dose of study drug.</description>
        <time_frame>From the start of study drug administration until 30 days after the last dose,16 weeks for Groups 1, 2, 3, 4, and 6, and 28 weeks for Groups 7 and 8.</time_frame>
        <population>All randomized participants who received at least 1 dose of study drug.</population>
        <group_list>
          <group group_id="O1">
            <title>Group 1</title>
            <description>ABT-450 150 mg/ r 100 mg, and ABT-267 25 mg once daily for 12 weeks to adult noncirrhotic, treatment-naïve, HCV GT4-infected participants</description>
          </group>
          <group group_id="O2">
            <title>Group 2</title>
            <description>ABT-450 150 mg/ r 100 mg, and ABT-267 25 mg once daily for 12 weeks to adult noncirrhotic, treatment-naïve HCV GT1b-infected participants</description>
          </group>
          <group group_id="O3">
            <title>Group 3</title>
            <description>ABT-450 150 mg/ r 100 mg, and ABT-267 25 mg once daily for 12 weeks to adult noncirrhotic, HCV GT1b-infected, pegylated-interferon/ribavirin (pegIFN/RBV) treatment null responder participants</description>
          </group>
          <group group_id="O4">
            <title>Group 4</title>
            <description>ABT-450 150 mg/ r 100 mg, ABT-267 25 mg , once daily and weight-based ribavirin (RBV; 1,000 mg/day if &lt; 75 kg or 1,200 mg/day if ≥ 75 kg, divided twice daily) for 12 weeks to adult noncirrhotic, treatment-naïve, HCV GT4-infected participants</description>
          </group>
          <group group_id="O5">
            <title>Group 6</title>
            <description>ABT-450 150 mg/ r 100 mg, ABT-267 25 mg , once daily and weight-based ribavirin (RBV; 1,000 mg/day if &lt; 75 kg or 1,200 mg/day if ≥ 75 kg, divided twice daily) for 12 weeks to adult noncirrhotic, HCV GT4-infected, pegylated-interferon/RBV (pegIFN/RBV) treatment-experienced participants</description>
          </group>
          <group group_id="O6">
            <title>Group 7</title>
            <description>ABT-450 150 mg/ r 100 mg, and ABT-267 25 mg once daily for 24 weeks to adult, HCV GT1b-infected, treatment-naïve participants with compensated cirrhosis</description>
          </group>
          <group group_id="O7">
            <title>Group 8</title>
            <description>ABT-450 150 mg/ r 100 mg, and ABT-267 25 mg once daily for 24 weeks to adult, HCV GT1b-infected, pegylated-interferon/RBV(pegIFN/RBV) treatment-experienced participants with compensated cirrhosis</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants in Each Treatment Group With Treatment-emergent Adverse Events</title>
          <description>Treatment-emergent adverse events were defined as any event that began or worsened in severity after initiation of study drug through 30 days after the last dose of study drug.</description>
          <population>All randomized participants who received at least 1 dose of study drug.</population>
          <units>Percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="44"/>
                <count group_id="O2" value="42"/>
                <count group_id="O3" value="40"/>
                <count group_id="O4" value="42"/>
                <count group_id="O5" value="49"/>
                <count group_id="O6" value="47"/>
                <count group_id="O7" value="52"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="77.3"/>
                    <measurement group_id="O2" value="73.8"/>
                    <measurement group_id="O3" value="80.0"/>
                    <measurement group_id="O4" value="88.1"/>
                    <measurement group_id="O5" value="85.7"/>
                    <measurement group_id="O6" value="85.1"/>
                    <measurement group_id="O7" value="71.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for Groups 1, 2, 3, 4, and 6, and 28 weeks for Groups 7 and 8.</time_frame>
      <desc>Serious adverse events were collected from the time of informed consent until the end of participation, up to 65 weeks.</desc>
      <group_list>
        <group group_id="E1">
          <title>Group 1</title>
          <description>ABT-450 150 mg/ r 100 mg, and ABT-267 25 mg once daily for 12 weeks to adult noncirrhotic, treatment-naïve, HCV GT4-infected participants</description>
        </group>
        <group group_id="E2">
          <title>Group 2</title>
          <description>ABT-450 150 mg/ r 100 mg, and ABT-267 25 mg once daily for 12 weeks to adult noncirrhotic, treatment-naïve HCV GT1b-infected participants</description>
        </group>
        <group group_id="E3">
          <title>Group 3</title>
          <description>ABT-450 150 mg/ r 100 mg, and ABT-267 25 mg once daily for 12 weeks to adult noncirrhotic, HCV GT1b-infected, pegylated-interferon/ribavirin (pegIFN/RBV) treatment null responder participants</description>
        </group>
        <group group_id="E4">
          <title>Group 4</title>
          <description>ABT-450 150 mg/ r 100 mg, ABT-267 25 mg , once daily and weight-based ribavirin (RBV; 1,000 mg/day if &lt; 75 kg or 1,200 mg/day if ≥ 75 kg, divided twice daily) for 12 weeks to adult noncirrhotic, treatment-naïve, HCV GT4-infected participants</description>
        </group>
        <group group_id="E5">
          <title>Group 6</title>
          <description>ABT-450 150 mg/ r 100 mg, ABT-267 25 mg , once daily and weight-based ribavirin (RBV; 1,000 mg/day if &lt; 75 kg or 1,200 mg/day if 75 kg, divided twice daily) for 12 weeks to adult noncirrhotic, HCV GT4-infected, pegylated-interferon/ RBV (pegIFN/RBV) treatment-experienced participants</description>
        </group>
        <group group_id="E6">
          <title>Group 7</title>
          <description>ABT-450 150 mg/ r 100 mg, and ABT-267 25 mg once daily for 24 weeks to adult, HCV GT1b-infected, treatment-naïve participants with compensated cirrhosis</description>
        </group>
        <group group_id="E7">
          <title>Group 8</title>
          <description>ABT-450 150 mg/ r 100 mg, and ABT-267 25 mg once daily for 24 weeks to adult, HCV GT1b-infected, pegylated-interferon/ RBV(pegIFN/RBV) treatment-experienced participants with compensated cirrhosis</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA 16.0</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="44"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="42"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="40"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="42"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E6" subjects_affected="3" subjects_at_risk="47"/>
                <counts group_id="E7" subjects_affected="2" subjects_at_risk="52"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>ATRIAL FIBRILLATION</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="44"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="42"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="42"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="47"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="52"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>OESOPHAGEAL VARICES HAEMORRHAGE</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="44"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="42"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="42"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="47"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="52"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>DEVICE EXTRUSION</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="44"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="42"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="40"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="42"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="47"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="52"/>
              </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="1" subjects_at_risk="44"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="42"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="42"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="47"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>HUMERUS FRACTURE</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="44"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="42"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="42"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="47"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>ROAD TRAFFIC ACCIDENT</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="44"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="42"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="42"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="47"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="52"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>ALANINE AMINOTRANSFERASE INCREASED</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="44"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="42"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="42"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="47"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>ASPARTATE AMINOTRANSFERASE INCREASED</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="44"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="42"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="42"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="47"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="52"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>HEPATIC NEOPLASM</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="44"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="42"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="42"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="47"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="52"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>PARTIAL SEIZURES</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="44"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="42"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="42"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="47"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="52"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="44"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="42"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="42"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="47"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="52"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>PERIPHERAL ARTERY ANEURYSM</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="44"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="42"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="42"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="47"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="52"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedDRA 16.0</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="30" subjects_at_risk="44"/>
                <counts group_id="E2" subjects_affected="24" subjects_at_risk="42"/>
                <counts group_id="E3" subjects_affected="26" subjects_at_risk="40"/>
                <counts group_id="E4" subjects_affected="32" subjects_at_risk="42"/>
                <counts group_id="E5" subjects_affected="38" subjects_at_risk="49"/>
                <counts group_id="E6" subjects_affected="34" subjects_at_risk="47"/>
                <counts group_id="E7" subjects_affected="33" subjects_at_risk="52"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>TACHYCARDIA</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="44"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="42"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="42"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E6" subjects_affected="3" subjects_at_risk="47"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="52"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Ear and labyrinth disorders</title>
            <event_list>
              <event>
                <sub_title>VERTIGO</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="44"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="42"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="40"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="42"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E6" subjects_affected="2" subjects_at_risk="47"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="52"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>ABDOMINAL PAIN</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="44"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="42"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="42"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E6" subjects_affected="3" subjects_at_risk="47"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>ABDOMINAL PAIN UPPER</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="44"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="42"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="42"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="47"/>
                <counts group_id="E7" subjects_affected="4" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>DIARRHOEA</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="44"/>
                <counts group_id="E2" subjects_affected="6" subjects_at_risk="42"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E4" subjects_affected="6" subjects_at_risk="42"/>
                <counts group_id="E5" subjects_affected="3" subjects_at_risk="49"/>
                <counts group_id="E6" subjects_affected="7" subjects_at_risk="47"/>
                <counts group_id="E7" subjects_affected="7" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>DYSPEPSIA</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="44"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="42"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="42"/>
                <counts group_id="E5" subjects_affected="4" subjects_at_risk="49"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="47"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>FLATULENCE</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="44"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="42"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="42"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="47"/>
                <counts group_id="E7" subjects_affected="3" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>NAUSEA</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="44"/>
                <counts group_id="E2" subjects_affected="8" subjects_at_risk="42"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E4" subjects_affected="7" subjects_at_risk="42"/>
                <counts group_id="E5" subjects_affected="6" subjects_at_risk="49"/>
                <counts group_id="E6" subjects_affected="5" subjects_at_risk="47"/>
                <counts group_id="E7" subjects_affected="5" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>VOMITING</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="44"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="42"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="42"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E6" subjects_affected="2" subjects_at_risk="47"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="52"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>ASTHENIA</sub_title>
                <counts group_id="E1" subjects_affected="11" subjects_at_risk="44"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="42"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="40"/>
                <counts group_id="E4" subjects_affected="10" subjects_at_risk="42"/>
                <counts group_id="E5" subjects_affected="16" subjects_at_risk="49"/>
                <counts group_id="E6" subjects_affected="10" subjects_at_risk="47"/>
                <counts group_id="E7" subjects_affected="7" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>FATIGUE</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="44"/>
                <counts group_id="E2" subjects_affected="6" subjects_at_risk="42"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E4" subjects_affected="5" subjects_at_risk="42"/>
                <counts group_id="E5" subjects_affected="9" subjects_at_risk="49"/>
                <counts group_id="E6" subjects_affected="4" subjects_at_risk="47"/>
                <counts group_id="E7" subjects_affected="6" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>INFLUENZA LIKE ILLNESS</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="44"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="42"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="40"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="42"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="47"/>
                <counts group_id="E7" subjects_affected="2" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>IRRITABILITY</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="44"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="42"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E4" subjects_affected="6" subjects_at_risk="42"/>
                <counts group_id="E5" subjects_affected="2" subjects_at_risk="49"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="47"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>OEDEMA PERIPHERAL</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="44"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="42"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="42"/>
                <counts group_id="E5" subjects_affected="2" subjects_at_risk="49"/>
                <counts group_id="E6" subjects_affected="2" subjects_at_risk="47"/>
                <counts group_id="E7" subjects_affected="2" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>PYREXIA</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="44"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="42"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="42"/>
                <counts group_id="E5" subjects_affected="3" subjects_at_risk="49"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="47"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="52"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>BRONCHITIS</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="44"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="42"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="40"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="42"/>
                <counts group_id="E5" subjects_affected="2" subjects_at_risk="49"/>
                <counts group_id="E6" subjects_affected="3" subjects_at_risk="47"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>GASTROENTERITIS</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="44"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="42"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="40"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="42"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="47"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>INFLUENZA</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="44"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="42"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="40"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="42"/>
                <counts group_id="E5" subjects_affected="2" subjects_at_risk="49"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="47"/>
                <counts group_id="E7" subjects_affected="2" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>NASOPHARYNGITIS</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="44"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="42"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="40"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="42"/>
                <counts group_id="E5" subjects_affected="6" subjects_at_risk="49"/>
                <counts group_id="E6" subjects_affected="4" subjects_at_risk="47"/>
                <counts group_id="E7" subjects_affected="4" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>RHINITIS</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="44"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="42"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="42"/>
                <counts group_id="E5" subjects_affected="3" subjects_at_risk="49"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="47"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>UPPER RESPIRATORY TRACT INFECTION</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="44"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="42"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="42"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E6" subjects_affected="2" subjects_at_risk="47"/>
                <counts group_id="E7" subjects_affected="4" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>URINARY TRACT INFECTION</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="44"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="42"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="40"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="42"/>
                <counts group_id="E5" subjects_affected="2" subjects_at_risk="49"/>
                <counts group_id="E6" subjects_affected="2" subjects_at_risk="47"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="52"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>BLOOD PRESSURE INCREASED</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="44"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="42"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="40"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="42"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="47"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="52"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>DECREASED APPETITE</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="44"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="42"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="42"/>
                <counts group_id="E5" subjects_affected="3" subjects_at_risk="49"/>
                <counts group_id="E6" subjects_affected="2" subjects_at_risk="47"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>HYPERGLYCAEMIA</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="44"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="42"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="40"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="42"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="47"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>INCREASED APPETITE</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="44"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="42"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="42"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E6" subjects_affected="3" subjects_at_risk="47"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="52"/>
              </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="44"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="42"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="42"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E6" subjects_affected="4" subjects_at_risk="47"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>BACK PAIN</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="44"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="42"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="42"/>
                <counts group_id="E5" subjects_affected="4" subjects_at_risk="49"/>
                <counts group_id="E6" subjects_affected="6" subjects_at_risk="47"/>
                <counts group_id="E7" subjects_affected="5" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>MYALGIA</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="44"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="42"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="40"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="42"/>
                <counts group_id="E5" subjects_affected="5" subjects_at_risk="49"/>
                <counts group_id="E6" subjects_affected="3" subjects_at_risk="47"/>
                <counts group_id="E7" subjects_affected="2" subjects_at_risk="52"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>DIZZINESS</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="44"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="42"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="40"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="42"/>
                <counts group_id="E5" subjects_affected="3" subjects_at_risk="49"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="47"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>HEADACHE</sub_title>
                <counts group_id="E1" subjects_affected="13" subjects_at_risk="44"/>
                <counts group_id="E2" subjects_affected="14" subjects_at_risk="42"/>
                <counts group_id="E3" subjects_affected="10" subjects_at_risk="40"/>
                <counts group_id="E4" subjects_affected="14" subjects_at_risk="42"/>
                <counts group_id="E5" subjects_affected="14" subjects_at_risk="49"/>
                <counts group_id="E6" subjects_affected="9" subjects_at_risk="47"/>
                <counts group_id="E7" subjects_affected="10" subjects_at_risk="52"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>ANXIETY</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="44"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="42"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E4" subjects_affected="4" subjects_at_risk="42"/>
                <counts group_id="E5" subjects_affected="2" subjects_at_risk="49"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="47"/>
                <counts group_id="E7" subjects_affected="2" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>DEPRESSION</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="44"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="42"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="42"/>
                <counts group_id="E5" subjects_affected="3" subjects_at_risk="49"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="47"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>INSOMNIA</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="44"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="42"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E4" subjects_affected="4" subjects_at_risk="42"/>
                <counts group_id="E5" subjects_affected="8" subjects_at_risk="49"/>
                <counts group_id="E6" subjects_affected="3" subjects_at_risk="47"/>
                <counts group_id="E7" subjects_affected="4" subjects_at_risk="52"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>COUGH</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="44"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="42"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="40"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="42"/>
                <counts group_id="E5" subjects_affected="4" subjects_at_risk="49"/>
                <counts group_id="E6" subjects_affected="3" subjects_at_risk="47"/>
                <counts group_id="E7" subjects_affected="5" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>DYSPNOEA EXERTIONAL</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="44"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="42"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="42"/>
                <counts group_id="E5" subjects_affected="3" subjects_at_risk="49"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="47"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>EPISTAXIS</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="44"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="42"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="40"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="42"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="47"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>RHINORRHOEA</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="44"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="42"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="42"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E6" subjects_affected="2" subjects_at_risk="47"/>
                <counts group_id="E7" subjects_affected="3" subjects_at_risk="52"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>DRY SKIN</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="44"/>
                <counts group_id="E2" subjects_affected="7" subjects_at_risk="42"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="42"/>
                <counts group_id="E5" subjects_affected="3" subjects_at_risk="49"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="47"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>PRURITUS</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="44"/>
                <counts group_id="E2" subjects_affected="6" subjects_at_risk="42"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="42"/>
                <counts group_id="E5" subjects_affected="5" subjects_at_risk="49"/>
                <counts group_id="E6" subjects_affected="8" subjects_at_risk="47"/>
                <counts group_id="E7" subjects_affected="9" subjects_at_risk="52"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>HYPERTENSION</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="44"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="42"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="40"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="42"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E6" subjects_affected="7" subjects_at_risk="47"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="52"/>
              </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>AbbVie requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. AbbVie requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if AbbVie needs to secure patent or proprietary protection.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Global Medical Information</name_or_title>
      <organization>AbbVie (prior sponsor, Abbott)</organization>
      <phone>800-633-9110</phone>
    </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/NCT01685203
org study id: M13-393
secondary id: 2011-005762-38
nct id: NCT01685203
lead sponsor: 
has dmc: No
The purpose of this study is to evaluate the safety and efficacy of co-administration of
      ABT-450 (also known as paritaprevir) with ritonavir (ABT-450/r) and ABT-267 (also known as
      ombitasvir) in adults with chronic hepatitis C virus infection.
This was a Phase 2, randomized, open-label, combination treatment study of the 2-DAA regimen
      (ABT-450 150 mg QD + ritonavir 100 mg QD + ABT-267 25 mg QD) in adult HCV GT1b-infected
      treatment-naïve and Pegylated-interferon/ribavirin (pegIFN/RBV) treatment-experienced
      participants without cirrhosis and with compensated cirrhosis, and in adult GT4-infected
      treatment-naïve and pegIFN/RBV treatment-experienced participants without cirrhosis.
      Treatment Group 5 was not open to enrollment, based on a protocol-specified interim review of
      results from the treatment-naïve GT4 Groups 1 and 4 that indicated higher sustained virologic
      response (SVR) rates among participants receiving the 2-DAA regimen with RBV. All other
      groups completed the study.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Percentage of Participants in Each Treatment Group With Sustained Virologic Response 12 Weeks Post-treatment
time frame: 12 weeks after the last actual dose of study drug
description: The percentage of participants with sustained virologic response (plasma Hepatitis C virus ribonucleic acid [HCV RNA] level less than the lower limit of quantitation [<LLOQ]) 12 weeks after the last dose of study drug.
measure: Percentage of Participants in Each Treatment Group With Sustained Virologic Response 24 Weeks Post-treatment
time frame: 24 weeks after the last actual dose of study drug
description: The percentage of participants with sustained virologic response (plasma Hepatitis C virus ribonucleic acid [HCV RNA] level less than the lower limit of quantitation [<LLOQ]) 24 weeks after the last dose of study drug.
measure: Percentage of Participants in Each Treatment Group With On-treatment Virologic Failure.
time frame: Baseline (Day 1), Day 3, and Treatment Weeks 1, 2 ,3 ,4, 6, 8, 10, and 12 for all participants and Treatment Weeks 16, 20 and 24 for Groups 7 and 8
description: Virologic failure during treatment was defined as rebound (confirmed HCV RNA greater than or equal to the lower limit of quantitation [≥ LLOQ] after HCV RNA < LLOQ during treatment, or confirmed increase from the lowest value post baseline in HCV RNA [2 consecutive HCV RNA measurements > 1 log(subscript)10(subscript) IU/mL above the lowest value post baseline] at any time point during treatment), or fail to suppress (HCV RNA ≥ LLOQ persistently during treatment with at least 6 weeks [≥ 36 days] of treatment).
measure: Percentage of Participants in Each Treatment Group With Post-treatment Virologic Relapse.
time frame: Within 12 weeks after the last dose of study drug
description: Participants were considered to have virologic relapse after treatment if they had confirmed quantifiable plasma Hepatitis C virus ribonucleic acid (HCV RNA) ≥ lower limit of quantification (LLOQ) between the end of treatment and 12 weeks after the last dose of study drug among participants who completed treatment with HCV RNA < LLOQ at the end of treatment.
measure: Percentage of Participants in Each Treatment Group With Treatment-emergent Adverse Events
time frame: From the start of study drug administration until 30 days after the last dose,16 weeks for Groups 1, 2, 3, 4, and 6, and 28 weeks for Groups 7 and 8.
description: Treatment-emergent adverse events were defined as any event that began or worsened in severity after initiation of study drug through 30 days after the last dose of study drug.
arm group label: Group 1
arm group type: Experimental
description: ABT-450 150 mg/ r 100 mg, and ABT-267 25 mg once daily for 12 weeks to adult noncirrhotic, treatment-naïve, HCV GT4-infected participants
arm group label: Group 2
arm group type: Experimental
description: ABT-450 150 mg/ r 100 mg, and ABT-267 25 mg once daily for 12 weeks to adult noncirrhotic, treatment-naïve HCV GT1b-infected participants
arm group label: Group 3
arm group type: Experimental
description: ABT-450 150 mg/ r 100 mg, and ABT-267 25 mg once daily for 12 weeks to adult noncirrhotic, HCV GT1b-infected, pegylated-interferon/ribavirin (pegIFN/RBV) treatment null responder participants
arm group label: Group 4
arm group type: Experimental
description: ABT-450 150 mg/ r 100 mg, ABT-267 25 mg , once daily and weight-based ribavirin (RBV; 1,000 mg/day if < 75 kg or 1,200 mg/day if ≥ 75 kg, divided twice daily) for 12 weeks to adult noncirrhotic, treatment-naïve, HCV GT4-infected participants
arm group label: Group 5
arm group type: Experimental
description: ABT-450 150 mg/ r 100 mg, and ABT-267 25 mg once daily for 12 weeks to adult noncirrhotic, treatment-experienced, HCV GT4-infected participants
arm group label: Group 6
arm group type: Experimental
description: ABT-450 150 mg/ r 100 mg, ABT-267 25 mg , once daily and weight-based ribavirin (RBV; 1,000 mg/day if < 75 kg or 1,200 mg/day if ≥ 75 kg, divided twice daily) for 12 weeks to adult noncirrhotic, HCV GT4-infected, pegylated-interferon/RBV (pegIFN/RBV) treatment-experienced participants
arm group label: Group 7
arm group type: Experimental
description: ABT-450 150 mg/ r 100 mg, and ABT-267 25 mg once daily for 24 weeks to adult, HCV GT1b-infected, treatment-naïve participants with compensated cirrhosis
arm group label: Group 8
arm group type: Experimental
description: ABT-450 150 mg/ r 100 mg, and ABT-267 25 mg once daily for 24 weeks to adult, HCV GT1b-infected, pegylated-interferon/RBV(pegIFN/RBV) treatment-experienced participants with compensated cirrhosis
intervention type: Drug
intervention name: ABT-450/r
description: Tablet; ABT-450; Capsule; ritonavir
arm group label: Group 1
arm group label: Group 2
arm group label: Group 3
arm group label: Group 4
arm group label: Group 5
arm group label: Group 6
arm group label: Group 7
arm group label: Group 8
other name: ABT-450 also known as paritaprevir
intervention type: Drug
intervention name: ABT-267
description: Tablet
arm group label: Group 1
arm group label: Group 2
arm group label: Group 3
arm group label: Group 4
arm group label: Group 5
arm group label: Group 6
arm group label: Group 7
arm group label: Group 8
other name: ABT-267 also known as ombitasvir
intervention type: Drug
intervention name: Ribavirin (RBV)
description: Tablet
arm group label: Group 4
arm group label: Group 6
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
last name: Nilou Mobashery, MD
role: Study Director
affiliation: AbbVie
country: France
country: Hungary
country: Italy
country: Poland
country: Puerto Rico
country: Romania
country: Spain
country: Turkey
country: United States
url: http://www.rxabbvie.com
description: Related Info
citation: Hezode C, Asselah T, Reddy KR, Hassanein T, Berenguer M, Fleischer-Stepniewska K, Marcellin P, Hall C, Schnell G, Pilot-Matias T, Mobashery N, Redman R, Vilchez RA, Pol S. Ombitasvir plus paritaprevir plus ritonavir with or without ribavirin in treatment-naive and treatment-experienced patients with genotype 4 chronic hepatitis C virus infection (PEARL-I): a randomised, open-label trial. Lancet. 2015 Jun 20;385(9986):2502-9. doi: 10.1016/S0140-6736(15)60159-3. Epub 2015 Mar 31.
PMID: 25837829
citation: Lawitz E, Makara M, Akarca US, Thuluvath PJ, Preotescu LL, Varunok P, Morillas RM, Hall C, Mobashery N, Redman R, Pilot-Matias T, Vilchez RA, Hezode C. Efficacy and Safety of Ombitasvir, Paritaprevir, and Ritonavir in an Open-Label Study of Patients With Genotype 1b Chronic Hepatitis C Virus Infection With and Without Cirrhosis. Gastroenterology. 2015 Oct;149(4):971-80.e1. doi: 10.1053/j.gastro.2015.07.001. Epub 2015 Jul 11.
PMID: 26170136
responsible party type: Sponsor
mesh term: Hepatitis A
mesh term: Hepatitis C
mesh term: Hepatitis C, Chronic
mesh term: Virus Diseases
mesh term: Hepatitis
mesh term: Hepatitis, Chronic
mesh term: Ribavirin
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 