<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/NCT02219490</url>
  </required_header>
  <id_info>
    <org_study_id>M14-423</org_study_id>
    <secondary_id>2014-001022-14</secondary_id>
    <nct_id>NCT02219490</nct_id>
  </id_info>
  <brief_title>A Study to Evaluate Long-term Outcomes Following Treatment With ABT-450/Ritonavir/ABT-267 (ABT-450/r/ABT-267) and ABT-333 With or Without Ribavirin (RBV) in Adults With Genotype 1 Chronic Hepatitis C Virus (HCV) Infection</brief_title>
  <acronym>TOPAZ-I</acronym>
  <official_title>An Open-Label, Multicenter Study to Evaluate Long-Term Outcomes With ABT-450/Ritonavir/ ABT-267 (ABT-450/r/ABT-267) and ABT-333 With or Without Ribavirin (RBV) in Adults With Genotype 1 Chronic Hepatitis C Virus (HCV) Infection (TOPAZ-I)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>AbbVie</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>AbbVie</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study was to evaluate the effect of treatment with ABT-450 co-formulated&#xD;
      with ritonavir and ABT-267 (ABT-450/r/ABT-267) and ABT-333; 3-DAA regimen, with or without&#xD;
      ribavirin (RBV) in adults with chronic hepatitis C virus genotype 1 (HCV GT1) infection.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study (TOPAZ-I; M14-423), was a Phase 3b, open-label, multicenter study conducted&#xD;
      outside of the United States which, together with its companion study TOPAZ-II (M14-222; NCT&#xD;
      02167945) conducted in the United States, was designed with the primary objective of&#xD;
      assessing the effect of treatment response on long-term clinical outcomes in adults with&#xD;
      chronic HCV GT1 infection with or without compensated cirrhosis, who were either&#xD;
      treatment-naïve or interferon/ribavirin (IFN/RBV) treatment- experienced. In both studies,&#xD;
      participants were treated with the 3-DAA regimen with or without RBV. This study consisted of&#xD;
      a screening period of up to 42 days, a treatment period of either 12 weeks for HCV&#xD;
      GT1a-infected subjects without cirrhosis and for HCV GT1b-infected subjects without cirrhosis&#xD;
      or with compensated cirrhosis or 24 weeks for GT1a-infected participants with compensated&#xD;
      cirrhosis, and a 260-week post-treatment period.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 30, 2014</start_date>
  <completion_date type="Actual">May 13, 2021</completion_date>
  <primary_completion_date type="Actual">May 13, 2021</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>All-Cause Death: Time to Event</measure>
    <time_frame>At Post-Treatment Weeks 52, 104, 156, 208, and 260</time_frame>
    <description>Time to all-cause death was defined as the number of days from the first day of study drug dosing for the participant to the date of death. All deaths were to be included, regardless of whether the death occurred while the participant was still taking study drug or had previously discontinued study drug. If the participant did not die, their data was to be censored at the date of their last available assessment of clinical outcomes. For participants with no post-baseline assessment, the participant's data was to be censored on the first day of study drug dosing. The event-free survival rates were estimated using Kaplan-Meier methodology and incidence estimates are presented with 95% confidence intervals. The pre-specified analysis of all-cause death included pooled data from TOPAZ-I (this study) and the companion study TOPAZ-II (M14-222; NCT02167945).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Liver-Related Death: Time to Event</measure>
    <time_frame>At Post-Treatment Weeks 52, 104, 156, 208, and 260</time_frame>
    <description>Time to liver-related death was defined as days from the 1st day of study drug dosing for the subject to date of liver-related death. All liver-related deaths were to be included, regardless of whether the death occurred while subject was still taking study drug or had previously discontinued study drug. If the subject didn't experience event of interest nor had died (all-cause death), their data was to be censored at date of last available assessment. For those with no post-baseline assessment, data was to be censored on 1st day of study drug dosing. All-cause death was a censoring event for liver-related death. The event-free survival rates were estimated using Kaplan-Meier methodology and incidence estimates are presented with 95% confidence intervals. The pre-specified analysis of liver-related death included pooled data from TOPAZ-I (this study) and the companion study TOPAZ-II (M14-222; NCT02167945).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Liver Decompensation: Time to Event</measure>
    <time_frame>At Post-Treatment Weeks 52, 104, 156, 208, and 260</time_frame>
    <description>Time to liver decompensation was defined as number of days from the 1st day of study drug dosing for the participant to the date of liver decompensation. All liver decompensation was to be included, regardless of whether it occurred while the participant was still taking study drug or had previously discontinued study drug. If the participant didn't experience the event of interest nor had died (all-cause death), their data was to be censored at the date of their last available assessment of clinical outcomes. For participants with no post-baseline assessment, their data was to be censored on the 1st day of study drug dosing. All-cause death was a censoring event for liver decompensation. The event-free survival rates were estimated using Kaplan-Meier methodology and incidence estimates are presented with 95% confidence intervals. The pre-specified analysis of liver decompensation included pooled data from TOPAZ-I (this study) and the companion study TOPAZ-II (M14-222; NCT02167945).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Liver Transplantation: Time to Event</measure>
    <time_frame>At Post-Treatment Weeks 52, 104, 156, 208, and 260</time_frame>
    <description>Time to liver transplantation was defined as days from 1st day of study drug dosing for subject to date of liver transplantation. All liver transplantation was to be included, whether it occurred while the subject was still taking study drug or had previously discontinued study drug. If the subject didn't experience event of interest nor had died (all-cause death), their data was to be censored at the date of their last available assessment. For those with no post-baseline assessment, data was to be censored on 1st day of study drug dosing. All-cause death was a censoring event for liver transplantation. The event-free survival rates were estimated using Kaplan-Meier methodology and incidence estimates are presented with 95% confidence intervals. The pre-specified analysis of liver transplantation included pooled data from TOPAZ-I (this study) and the companion study TOPAZ-II (M14-222; NCT02167945).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Hepatocellular Carcinoma: Time to Event</measure>
    <time_frame>At Post-Treatment Weeks 52, 104, 156, 208, and 260</time_frame>
    <description>Time to hepatocellular carcinoma (HCC) was defined as number of days from 1st day of study drug dosing for subject to date of hepatocellular carcinoma. All HCC was to be included, whether it occurred while subject was still taking study drug or had previously discontinued study drug. If the subject didn't experience the event of interest nor had died (all-cause death), their data was to be censored at the date of their last available assessment. For those with no post-baseline assessment, their data was to be censored on the 1st day of study drug dosing. All-cause death was a censoring event for HCC. The event-free survival rates were estimated using Kaplan-Meier methodology and incidence estimates are presented with 95% confidence intervals. The pre-specified analysis of hepatocellular carcinoma included pooled data from TOPAZ-I (this study) and the companion study TOPAZ-II (M14-222; NCT02167945).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>All-Cause Death, Liver-Related Death, Liver Decompensation, Liver Transplantation, Hepatocellular Carcinoma: Time to Event</measure>
    <time_frame>At Post-Treatment Weeks 52, 104, 156, 208, and 260</time_frame>
    <description>Time to the composite of clinical outcomes is the time to the first occurrence of all-cause death, liver-related death, liver decompensation, liver transplantation, or hepatocellular carcinoma. All first occurrences were to be included, regardless of whether it occurred while the participant was still taking study drug or had previously discontinued study drug. If the participant did not experience any of these events, their data was to be censored at the date of their last available assessment of clinical outcomes. For participants with no post-baseline assessment, the participant's data was to be censored on the first day of study drug dosing. The event-free survival rates were estimated using Kaplan-Meier methodology and incidence estimates are presented with 95% confidence intervals. Pre-specified analysis included pooled data from this study and from TOPAZ-II; NCT02167945.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in FibroScan Score by SVR12 Status</measure>
    <time_frame>At the final treatment visit and Post-Treatment Weeks 12, 24, 52, 104, 156, 208, and 260</time_frame>
    <description>The FibroScan test is a validated non-invasive test used to assess liver fibrosis in participants with chronic liver disease, and it was performed at study sites where it was available. For participants with Hepatitis C infection, a FibroScan score of 2-7 kPa indicates no liver scarring or mild scarring; a score of 8 or 9 is associated with moderate liver scarring; 9-14 indicates severe liver scarring; and 14 or higher is indicative of advanced liver scarring, cirrhosis. Negative changes from baseline indicate improvement in liver fibrosis.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12)</measure>
    <time_frame>12 weeks after the last actual dose of study drug</time_frame>
    <description>SVR12 is defined as hepatitis C virus ribonucleic acid (HCV RNA) less than the lower limit of quantification (LLOQ) 12 weeks after the last actual dose of study drug. Flanking imputation, where applicable, was used to impute missing data. After applying flanking imputation, if there was no value in the window but there was an HCV RNA value from a local laboratory present, then it was to be imputed into the SVR window. Otherwise, participants with missing data were counted as failures.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">1596</enrollment>
  <condition>Chronic Hepatitis C Virus (HCV) Infection Genotype 1</condition>
  <arm_group>
    <arm_group_label>ABT-450/r/ABT-267 plus ABT-333 with or without ribavirin (RBV)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants with HCV GT1b without cirrhosis received the 3-DAA (ABT-450/ritonavir/ABT-267 and ABT-333) regimen: two 75 mg ABT-450/50 mg ritonavir/12.5 mg ABT-267 tablets taken orally every morning (QD) and one ABT-333 250 mg tablet taken orally twice a day (BID) for 12 weeks. Participants with HCV GT1a without cirrhosis and those with HCV GT1b with cirrhosis received the 3-DAA regimen and weight-based ribavirin (RBV; 1000 to 1200 mg divided twice daily per local label) for 12 weeks. Participants with HCV GT1a with cirrhosis received the 3-DAA regimen and weight-based RBV per local label for 24 weeks.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>ABT-450/r/ABT-267</intervention_name>
    <description>Tablet for oral use</description>
    <arm_group_label>ABT-450/r/ABT-267 plus ABT-333 with or without ribavirin (RBV)</arm_group_label>
    <other_name>ABT-450 also known as paritaprevir</other_name>
    <other_name>ABT-267 also known as ombitasvir</other_name>
    <other_name>Paritaprevir/ritonavir/ombitasvir also known as Viekirax</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>ABT-333</intervention_name>
    <description>Tablet for oral use</description>
    <arm_group_label>ABT-450/r/ABT-267 plus ABT-333 with or without ribavirin (RBV)</arm_group_label>
    <other_name>ABT-333 also known as dasabuvir</other_name>
    <other_name>ABT-333 also known as Exviera</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Ribavirin (RBV)</intervention_name>
    <description>Ribavirin was provided as 200 mg tablets, and dosed based on weight,1000 to 1200 mg divided twice daily per local label. For example, for participants weighing &lt; 75 kg, RBV may have been taken orally as 2 tablets in the morning and 3 tablets in the evening which corresponds to a 1000 mg total daily dose. For participants weighing ≥ 75 kg, RBV may have been taken orally as 3 tablets in the morning and 3 tablets in the evening which corresponds to a 1200 mg total daily dose.</description>
    <arm_group_label>ABT-450/r/ABT-267 plus ABT-333 with or without ribavirin (RBV)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Males and females at least 18 years old at screening&#xD;
&#xD;
          2. Females must be post-menopausal for more than 2 years or surgically sterile or&#xD;
             practicing acceptable forms of birth control&#xD;
&#xD;
          3. Chronic hepatitis C, genotype 1 infection&#xD;
&#xD;
          4. Males must be surgically sterile or agree to practice acceptable forms of birth&#xD;
             control&#xD;
&#xD;
          5. Screening laboratory result indicating HCV genotype 1 infection&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Use of contraindicated medications within 2 weeks of dosing&#xD;
&#xD;
          2. Abnormal laboratory tests&#xD;
&#xD;
          3. Current or past clinical evidence of Child-Pugh B or C classification or history of&#xD;
             liver decompensation&#xD;
&#xD;
          4. Confirmed presence of hepatocellular carcinoma&#xD;
&#xD;
          5. History of solid organ transplant&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>99 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>ABBVIE INC.</last_name>
    <role>Study Director</role>
    <affiliation>AbbVie</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>CHU Bab El Oued /ID# 145420</name>
      <address>
        <city>Algiers</city>
        <zip>16000</zip>
        <country>Algeria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU Bologhine Hospital /ID# 145421</name>
      <address>
        <city>Algiers</city>
        <zip>16000</zip>
        <country>Algeria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU Mustapha Bacha /ID# 132130</name>
      <address>
        <city>Algiers</city>
        <zip>16000</zip>
        <country>Algeria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St Vincent's Hospital Sydney /ID# 131001</name>
      <address>
        <city>Darlinghurst</city>
        <state>New South Wales</state>
        <zip>2010</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nepean Hospital /ID# 130999</name>
      <address>
        <city>Kingswood</city>
        <state>New South Wales</state>
        <zip>2747</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Westmead Hospital /ID# 130997</name>
      <address>
        <city>Westmead</city>
        <state>New South Wales</state>
        <zip>2145</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Greenslopes Private Hospital /ID# 131003</name>
      <address>
        <city>Greenslopes</city>
        <state>Queensland</state>
        <zip>4120</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Royal Brisbane and Women's Hospital /ID# 131004</name>
      <address>
        <city>Herston</city>
        <state>Queensland</state>
        <zip>4029</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Royal Adelaide Hospital /ID# 131002</name>
      <address>
        <city>Adelaide</city>
        <state>South Australia</state>
        <zip>5000</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St Vincent's Hospital Melbourne /ID# 131000</name>
      <address>
        <city>Fitzroy Melbourne</city>
        <state>Victoria</state>
        <zip>3065</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Royal Melbourne Hospital /ID# 130998</name>
      <address>
        <city>Parkville</city>
        <state>Victoria</state>
        <zip>3050</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ordensklinikum Linz GmbH Elisabethinen /ID# 131017</name>
      <address>
        <city>Linz</city>
        <state>Oberoesterreich</state>
        <zip>4010</zip>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medizinische Universitaet Graz /ID# 131018</name>
      <address>
        <city>Graz</city>
        <state>Steiermark</state>
        <zip>8036</zip>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medizinische Universitaet Wien /ID# 131015</name>
      <address>
        <city>Vienna</city>
        <state>Wien</state>
        <zip>1090</zip>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cliniques Universitaires de Bruxelles Hopital Erasme /ID# 131020</name>
      <address>
        <city>Brussels</city>
        <state>Bruxelles-Capitale</state>
        <zip>1070</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UCL Saint-Luc /ID# 131019</name>
      <address>
        <city>Woluwe-Saint-Lambert</city>
        <state>Bruxelles-Capitale</state>
        <zip>1200</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitair Ziekenhuis Leuven /ID# 131021</name>
      <address>
        <city>Leuven</city>
        <state>Vlaams-Brabant</state>
        <zip>3000</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tokuda Hospital Sofia /ID# 131022</name>
      <address>
        <city>Sofia</city>
        <zip>1407</zip>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UMHAT Sveti Ivan Rilski /ID# 131026</name>
      <address>
        <city>Sofia</city>
        <zip>1431</zip>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Univ Hosp for Active Treat /ID# 131023</name>
      <address>
        <city>Sofia</city>
        <zip>1527</zip>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Diagnostic Consultative Center /ID# 131027</name>
      <address>
        <city>Sofia</city>
        <zip>1612</zip>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UMHAT Sveta Marina /ID# 131025</name>
      <address>
        <city>Varna</city>
        <zip>9010</zip>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Calgary /ID# 134370</name>
      <address>
        <city>Calgary</city>
        <state>Alberta</state>
        <zip>T2N 4Z6</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GI Research &amp; Associates /ID# 132169</name>
      <address>
        <city>Edmonton</city>
        <state>Alberta</state>
        <zip>T5H 4B9</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>LAIR Centre /ID# 130970</name>
      <address>
        <city>Vancouver</city>
        <state>British Columbia</state>
        <zip>V5Z 1H3</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Vancouver Infectious Diseases Centre /ID# 134369</name>
      <address>
        <city>Vancouver</city>
        <state>British Columbia</state>
        <zip>V6Z 2C7</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GIRI Gastrointestinal Research Institute /ID# 132171</name>
      <address>
        <city>Vancouver</city>
        <state>British Columbia</state>
        <zip>V6Z 2K5</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Manitoba / Health Scuience Centre / John Buhler Research Centre /ID# 130969</name>
      <address>
        <city>Winnipeg</city>
        <state>Manitoba</state>
        <zip>R3E 3P4</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Saint John Regional Hospital /ID# 131210</name>
      <address>
        <city>Saint John</city>
        <state>New Brunswick</state>
        <zip>E2L 4L2</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ottawa Hospital Research Institute /ID# 132170</name>
      <address>
        <city>Ottawa</city>
        <state>Ontario</state>
        <zip>K1H 8L6</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Toronto General Hospital /ID# 132134</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <zip>M5G 2C4</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Toronto Liver Centre /ID# 132168</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <zip>M6H 3M1</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Toronto Digestive Disease Asso /ID# 130968</name>
      <address>
        <city>Vaughan</city>
        <state>Ontario</state>
        <zip>L4L 4Y7</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinique Medicale L'Actuel /ID# 132167</name>
      <address>
        <city>Montreal</city>
        <state>Quebec</state>
        <zip>H2L 4P9</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Jewish General Hospital /ID# 132165</name>
      <address>
        <city>Montreal</city>
        <state>Quebec</state>
        <zip>H3T 1E2</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Royal Victoria Hospital / McGill University Health Centre /ID# 132166</name>
      <address>
        <city>Montreal</city>
        <state>Quebec</state>
        <zip>H4A 3J1</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU de Quebec-Université Laval hôpital CHUL /ID# 132132</name>
      <address>
        <city>Québec</city>
        <state>Quebec</state>
        <zip>G1V 4G2</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kobenhavns Universitet - Hvidovre Hospital (HH) /ID# 131031</name>
      <address>
        <city>Hvidovre</city>
        <state>Hovedstaden</state>
        <zip>2650</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Odense University Hospital /ID# 131029</name>
      <address>
        <city>Odense C</city>
        <state>Syddanmark</state>
        <zip>5000</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Aarhus Univ Hospital, Skejby /ID# 131030</name>
      <address>
        <city>Aarhus</city>
        <zip>8200</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Helsinki University Hospital /ID# 131034</name>
      <address>
        <city>Helsinki</city>
        <state>Uusimaa</state>
        <zip>00290</zip>
        <country>Finland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Turku University Hospital /ID# 131032</name>
      <address>
        <city>Turku</city>
        <zip>20520</zip>
        <country>Finland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hopital Saint Joseph /ID# 132177</name>
      <address>
        <city>Marseille</city>
        <state>Bouches-du-Rhone</state>
        <zip>13008</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU Limoges - Dupuytren 1 /ID# 131038</name>
      <address>
        <city>Limoges CEDEX 1</city>
        <state>Franche-Comte</state>
        <zip>87042</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hopital Haut-Lévêque /ID# 131036</name>
      <address>
        <city>Pessac CEDEX</city>
        <state>Gironde</state>
        <zip>33604</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hopital Saint Eloi /ID# 131037</name>
      <address>
        <city>Montpellier CEDEX 5</city>
        <state>Herault</state>
        <zip>34295</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU de Nantes, Hotel Dieu -HME /ID# 132179</name>
      <address>
        <city>Nantes</city>
        <state>Pays-de-la-Loire</state>
        <zip>44000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hopital Jean Verdier /ID# 135877</name>
      <address>
        <city>Bondy</city>
        <zip>93140</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU Grenoble - Hopital Michallon /ID# 131041</name>
      <address>
        <city>La Tronche</city>
        <zip>38700</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>HCL - Hopital de la Croix-Rousse /ID# 131042</name>
      <address>
        <city>Lyon</city>
        <zip>69004</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Duplicate_Hopital lArchet 2 /ID# 131040</name>
      <address>
        <city>Nice</city>
        <zip>06202</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHRU Pontchaillou /ID# 132173</name>
      <address>
        <city>Rennes</city>
        <zip>35033</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU Strasbourg - Hopital Civil /ID# 132174</name>
      <address>
        <city>Strasbourg cedex</city>
        <zip>67091</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hopital Universitaire Purpan Hopital Rangueil /ID# 131035</name>
      <address>
        <city>Toulouse</city>
        <zip>31059</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitaetsklinikum Freiburg /ID# 131044</name>
      <address>
        <city>Freiburg</city>
        <state>Baden-Wuerttemberg</state>
        <zip>79106</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitaetsklinik Heidelberg /ID# 134371</name>
      <address>
        <city>Heidelberg</city>
        <state>Baden-Wuerttemberg</state>
        <zip>69120</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitaetsklinikum Tuebingen Medizinische Klinik /ID# 131045</name>
      <address>
        <city>Tubingen</city>
        <state>Baden-Wuerttemberg</state>
        <zip>72076</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>LMU Klinikum der Universitat Muchen /ID# 131049</name>
      <address>
        <city>Munich</city>
        <state>Bayern</state>
        <zip>81377</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitaetsklinikum Frankfurt /ID# 131055</name>
      <address>
        <city>Frankfurt am Main</city>
        <state>Hessen</state>
        <zip>60590</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Zentru fur HIV und Heaptogastroenterologie /ID# 131052</name>
      <address>
        <city>Düsseldorf</city>
        <state>Nordrhein-Westfalen</state>
        <zip>40237</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Gastroenterologische Gemeinschaftspraxis Herne /ID# 131050</name>
      <address>
        <city>Herne</city>
        <state>Nordrhein-Westfalen</state>
        <zip>44623</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medizinische Klinik mit Schwerpunkt Hepatologie und Gastroenterologie /ID# 131053</name>
      <address>
        <city>Berlin</city>
        <zip>13353</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitaetsklinikum Essen /ID# 131048</name>
      <address>
        <city>Essen</city>
        <zip>45147</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitaetsklinikum Hamburg-Eppendorf (UKE) /ID# 131051</name>
      <address>
        <city>Hamburg</city>
        <zip>20246</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medizinische Hochschule Hannover /ID# 131054</name>
      <address>
        <city>Hannover</city>
        <zip>30625</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centrum für interdisziplinaere Medizin /ID# 131046</name>
      <address>
        <city>Muenster</city>
        <zip>48143</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>General Hospital of Athens Ippokratio /ID# 131057</name>
      <address>
        <city>Athens</city>
        <state>Attiki</state>
        <zip>11527</zip>
        <country>Greece</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>General Hospital of Athens Laiko /ID# 131088</name>
      <address>
        <city>Athens</city>
        <state>Attiki</state>
        <zip>11527</zip>
        <country>Greece</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>General University Hospital of Alexandroupolis /ID# 131056</name>
      <address>
        <city>Alexandroupolis</city>
        <zip>68100</zip>
        <country>Greece</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Beaumont Hospital /ID# 131089</name>
      <address>
        <city>Beaumont</city>
        <state>Dublin</state>
        <zip>D09 XR63</zip>
        <country>Ireland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St James Hospital /ID# 132180</name>
      <address>
        <city>Dublin 8</city>
        <state>Dublin</state>
        <zip>D08 NHY1</zip>
        <country>Ireland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St Vincent's University Hospital /ID# 132181</name>
      <address>
        <city>Elm Park</city>
        <state>Dublin</state>
        <zip>D04 T6F4</zip>
        <country>Ireland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Chaim Sheba Medical Center /ID# 131092</name>
      <address>
        <city>Ramat Gan</city>
        <state>Tel-Aviv</state>
        <zip>5265601</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tel Aviv Sourasky Medical Center /ID# 132182</name>
      <address>
        <city>Tel Aviv-Yafo</city>
        <state>Tel-Aviv</state>
        <zip>6423906</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Rambam Health Care Campus /ID# 131090</name>
      <address>
        <city>Haifa</city>
        <zip>3109601</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Lady Davis Carmel Medical Center /ID# 131091</name>
      <address>
        <city>Haifa</city>
        <zip>34362</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Duplicate_A.O.U. Policlinico S.Orsola-Malpighi /ID# 131095</name>
      <address>
        <city>Bologna</city>
        <state>Emilia-Romagna</state>
        <zip>40138</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Azienda Ospedaliero-Universitaria di Ferrara-Arcispedale Sant Anna /ID# 131102</name>
      <address>
        <city>Cona</city>
        <state>Ferrara</state>
        <zip>44124</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fondazione di Religione e di Culto Casa Sollievo della Sofferenza /ID# 132190</name>
      <address>
        <city>San Giovanni Rotondo</city>
        <state>Foggia</state>
        <zip>71013</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Policlinico Agostino Gemelli /ID# 131098</name>
      <address>
        <city>Rome</city>
        <state>Lazio</state>
        <zip>00168</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ospedale San Raffaele IRCCS /ID# 131093</name>
      <address>
        <city>Milan</city>
        <state>Lombardia</state>
        <zip>20132</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fondazione PTV Policlinico Tor Vergata /ID# 132185</name>
      <address>
        <city>Rome</city>
        <state>Roma</state>
        <zip>00133</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII (Presidio Papa Giovanni /ID# 132188</name>
      <address>
        <city>Bergamo</city>
        <zip>24127</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Azienda Ospedaliero Universitaria Careggi /ID# 132197</name>
      <address>
        <city>Florence</city>
        <zip>50134</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Azienda Ospedaliera Universitaria Ospedali Riuniti /ID# 132195</name>
      <address>
        <city>Foggia</city>
        <zip>71122</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>A.O.U. Policlinico G. Martino /ID# 132193</name>
      <address>
        <city>Messina</city>
        <zip>98125</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>ASST Fatebenefratelli Sacco-Ospedale Sacco /ID# 134372</name>
      <address>
        <city>Milano</city>
        <zip>20157</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Azienda Ospedaliera Niguarda Ca' Granda Hospital /ID# 131104</name>
      <address>
        <city>Milano</city>
        <zip>20162</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico /ID# 131097</name>
      <address>
        <city>Milan</city>
        <zip>20122</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ospedale S Giuseppe /ID# 132194</name>
      <address>
        <city>Milan</city>
        <zip>20123</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>ASST Santi Paolo e Carlo/Presidio Ospedale San Paolo /ID# 132198</name>
      <address>
        <city>Milan</city>
        <zip>20142</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Azienda Ospedaliera Universitaria Federico II /ID# 131096</name>
      <address>
        <city>Napoli</city>
        <zip>80131</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Azienda Ospedaliera Universitaria Federico II /ID# 132191</name>
      <address>
        <city>Napoli</city>
        <zip>80131</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Azienda Ospedaliera Universitaria Paolo Giaccone /ID# 132184</name>
      <address>
        <city>Palermo</city>
        <zip>90127</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Azienda Ospedaliero-Universitaria di Parma /ID# 132183</name>
      <address>
        <city>Parma</city>
        <zip>43126</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Azienda Ospedaliera Universitaria &quot;San Giovanni di Dio e Ruggi d'Aragona /ID# 132192</name>
      <address>
        <city>Salerno</city>
        <zip>84131</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>A.O.U. Citta della Salute e della Scienza di Torino /ID# 131100</name>
      <address>
        <city>Turin</city>
        <zip>10126</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Azienda Ospedaliera Universitaria Friuli Centrale/Presidio Ospedaliero Universit /ID# 132196</name>
      <address>
        <city>Udine</city>
        <zip>33100</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital General de Tijuana /ID# 130972</name>
      <address>
        <city>Tijuana</city>
        <state>Baja California</state>
        <zip>22680</zip>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cife /Id# 130974</name>
      <address>
        <city>Guadalajara</city>
        <state>Jalisco</state>
        <zip>44160</zip>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>ITESM campus Ciudad de Mexico /ID# 132383</name>
      <address>
        <city>Ciudad de Mexico</city>
        <zip>14380</zip>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Instituto Metropolitano de Inv /ID# 132201</name>
      <address>
        <city>Delegacion Tlalpan</city>
        <zip>14308</zip>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Instituto Nacional de Clencias Medicas y Nutricion Salvador Zubrian Departament /ID# 130975</name>
      <address>
        <city>Distrito Federal</city>
        <zip>14000</zip>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CIF-BIOTEC/Medica Sur /ID# 134971</name>
      <address>
        <city>Mexico City</city>
        <zip>14050</zip>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Erasmus Medisch Centrum /ID# 132206</name>
      <address>
        <city>Rotterdam</city>
        <state>Zuid-Holland</state>
        <zip>3015 GD</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Academisch Medisch Centrum /ID# 132205</name>
      <address>
        <city>Amsterdam</city>
        <zip>1105 AZ</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Leids Universitair Medisch Centrum /ID# 132204</name>
      <address>
        <city>Leiden</city>
        <zip>2333 ZA</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Akershus Universitetssykehus_MAIN /ID# 132212</name>
      <address>
        <city>Lorenskog</city>
        <state>Akershus</state>
        <zip>1478</zip>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St. Olavs Hospital HF /ID# 132213</name>
      <address>
        <city>Trondheim</city>
        <state>Sor-Trondelag</state>
        <zip>7006</zip>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Stavanger University Hospital /ID# 132211</name>
      <address>
        <city>Stavanger</city>
        <zip>4068</zip>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Wojewodzki Szpital Obserwacyjno-Zakazny im. Tadeusza Browicza /ID# 131106</name>
      <address>
        <city>Bydgoszcz</city>
        <state>Kujawsko-pomorskie</state>
        <zip>85-030</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Wojewodzki Specjalistyczny Szpital im. dr. W. Bieganskiego /ID# 131107</name>
      <address>
        <city>Lodz</city>
        <state>Lodzkie</state>
        <zip>91-347</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Samodzielny Publiczny Szpital Kliniczny Nr 1 w Lublinie /ID# 131115</name>
      <address>
        <city>Lublin</city>
        <state>Lubelskie</state>
        <zip>20-081</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Wojewodzki Szpital Zakazny /ID# 131112</name>
      <address>
        <city>Warsaw</city>
        <state>Mazowieckie</state>
        <zip>01-201</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Uniwersytecki Szpital Kliniczny w Bialymstoku /ID# 131108</name>
      <address>
        <city>Bialystok</city>
        <state>Podlaskie</state>
        <zip>15-276</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>ID Clinic /ID# 131111</name>
      <address>
        <city>Myslowice</city>
        <state>Slaskie</state>
        <zip>41-406</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centro Hospitalar e Universitario de Coimbra, EPE /ID# 131119</name>
      <address>
        <city>Coimbra</city>
        <zip>3000-075</zip>
        <country>Portugal</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centro Hospitalar Universitario Lisboa Central, EPE - Hospital dos Capuchos /ID# 131116</name>
      <address>
        <city>Lisboa</city>
        <zip>1169-050</zip>
        <country>Portugal</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centro Hospitalar Universitário de Lisboa Norte, EPE - Hospital de Santa Maria /ID# 131118</name>
      <address>
        <city>Lisboa</city>
        <zip>1649-035</zip>
        <country>Portugal</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centro Hospitalar Universitário do Porto, EPE - Hospital Santo António /ID# 131117</name>
      <address>
        <city>Porto</city>
        <zip>4099-001</zip>
        <country>Portugal</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Duplicate_Institutul National de Boli Infectioase Prof. Dr. Matei Bals /ID# 131120</name>
      <address>
        <city>Sector 2</city>
        <state>Bucuresti</state>
        <zip>021105</zip>
        <country>Romania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Institutul Clinic Fundeni /ID# 131121</name>
      <address>
        <city>Sector 2</city>
        <state>Bucuresti</state>
        <zip>022328</zip>
        <country>Romania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Spitalul Clinic de Boli Infectioase Si Pneumoftiziologie Dr. Victor Babes /Id# 131126</name>
      <address>
        <city>Timisoara</city>
        <state>Timis</state>
        <zip>300310</zip>
        <country>Romania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Institutul Nat. de Boli Infectioase /ID# 131124</name>
      <address>
        <city>Bucuresti</city>
        <zip>010825</zip>
        <country>Romania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>SC Gastromedica SRL /ID# 131127</name>
      <address>
        <city>Iasi</city>
        <zip>700506</zip>
        <country>Romania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medical Company Hepatolog /ID# 132277</name>
      <address>
        <city>Samara</city>
        <state>Samarskaya Oblast</state>
        <zip>443063</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Republican Clinical Infectious Diseases Hospital n.a. Professor A. F. Agafonov /ID# 132270</name>
      <address>
        <city>Kazan</city>
        <state>Tatarstan, Respublika</state>
        <zip>420140</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>South-Ural State Med. Academy /ID# 132274</name>
      <address>
        <city>Chelyabinsk</city>
        <zip>454052</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kuzbass Center for Prevention and Fight agains AIDS /ID# 132269</name>
      <address>
        <city>Kemerovo</city>
        <zip>650056</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Krasnoyarsk Regional Center for the Prevention and Control of AIDS /ID# 132278</name>
      <address>
        <city>Krasnoyarsk</city>
        <zip>660049</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Moscow Clinical Scientific Center n.a. Loginov /ID# 132266</name>
      <address>
        <city>Moscow</city>
        <zip>111123</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Central Clinical Hospital of Russian Academy of Science /ID# 132289</name>
      <address>
        <city>Moscow</city>
        <zip>117593</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>I. M. Sechenov First Moscow State Medical University /ID# 132275</name>
      <address>
        <city>Moscow</city>
        <zip>119991</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>City Clinical Hospital #24 /ID# 132268</name>
      <address>
        <city>Moscow</city>
        <zip>127015</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Institute of Emergency Medicine named after V.I. N.V. Sklifosovsky /ID# 132288</name>
      <address>
        <city>Moscow</city>
        <zip>129090</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Infectious Diseases Hospital #1 /ID# 132272</name>
      <address>
        <city>Novosibirsk</city>
        <zip>630099</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Samara State Medical University /ID# 136913</name>
      <address>
        <city>Samara</city>
        <zip>443099</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Stavropol State Medical University /ID# 132279</name>
      <address>
        <city>Stavropol</city>
        <zip>355017</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tolyatti City Clinical Hospital #1 /ID# 132273</name>
      <address>
        <city>Tolyatti</city>
        <zip>445009</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Multidisciplinary Consultative and Diagnostic Center /ID# 131130</name>
      <address>
        <city>Tyumen</city>
        <zip>625026</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sverdlovsk Regional Clinical Hospital #1 /ID# 132267</name>
      <address>
        <city>Yekaterinburg</city>
        <zip>620102</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>King Abdulaziz Medical City /ID# 145129</name>
      <address>
        <city>Jeddah</city>
        <zip>21423</zip>
        <country>Saudi Arabia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ministry Nat Guard Hosp Health /ID# 145126</name>
      <address>
        <city>Riyadh</city>
        <zip>11426</zip>
        <country>Saudi Arabia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>King Khalid University Hospita /ID# 132291</name>
      <address>
        <city>Riyadh</city>
        <zip>11472</zip>
        <country>Saudi Arabia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario Central de Asturias /ID# 131138</name>
      <address>
        <city>Oviedo</city>
        <state>Asturias</state>
        <zip>33011</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario Germans Trias i Pujol /ID# 132293</name>
      <address>
        <city>Badalona</city>
        <state>Barcelona</state>
        <zip>08916</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Unversitario Marques de Valdecilla /ID# 131141</name>
      <address>
        <city>Santander</city>
        <state>Cantabria</state>
        <zip>39008</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Donostia /ID# 131144</name>
      <address>
        <city>Donostia</city>
        <state>Guipuzcoa</state>
        <zip>20014</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitari Son Espases /ID# 131140</name>
      <address>
        <city>Palma de Mallorca</city>
        <state>Illes Balears</state>
        <zip>07120</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital General Universitario Santa Lucia /ID# 131139</name>
      <address>
        <city>Cartagena</city>
        <state>Murcia</state>
        <zip>30202</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>OSI Ezkerraldea-Enkarterri-Cruces /ID# 131143</name>
      <address>
        <city>Barakaldo</city>
        <state>Vizcaya</state>
        <zip>48903</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario A Coruna - CHUAC /ID# 131137</name>
      <address>
        <city>A Coruna</city>
        <zip>15006</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario Reina Sofia /ID# 131135</name>
      <address>
        <city>Cordoba</city>
        <zip>14004</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario de la Princesa /ID# 131131</name>
      <address>
        <city>Madrid</city>
        <zip>28006</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario 12 de Octubre /ID# 131133</name>
      <address>
        <city>Madrid</city>
        <zip>28041</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario La Paz /ID# 131132</name>
      <address>
        <city>Madrid</city>
        <zip>28046</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario Virgen de la Victoria /ID# 131136</name>
      <address>
        <city>Malaga</city>
        <zip>29010</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario Virgen del Rocio /ID# 131134</name>
      <address>
        <city>Sevilla</city>
        <zip>41013</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Clinico Universitario Lozano Blesa /ID# 132292</name>
      <address>
        <city>Zaragoza</city>
        <zip>50009</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Skane University hospital /ID# 131146</name>
      <address>
        <city>Malmo</city>
        <state>Skane Lan</state>
        <zip>214 28</zip>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Karolinska University Hospital Solna /ID# 131145</name>
      <address>
        <city>Solna</city>
        <state>Stockholms Lan</state>
        <zip>171 64</zip>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sahlgrenska University Hospital /ID# 131147</name>
      <address>
        <city>Gothenburg</city>
        <state>Vastra Gotalands Lan</state>
        <zip>413 45</zip>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kantonsspital St. Gallen /ID# 131148</name>
      <address>
        <city>St. Gallen</city>
        <state>Sankt Gallen</state>
        <zip>9007</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitätsspital Zürich /ID# 134881</name>
      <address>
        <city>Zürich</city>
        <state>Zuerich</state>
        <zip>8091</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Inselspital, Universitätsspital Bern /ID# 132294</name>
      <address>
        <city>Bern</city>
        <zip>3010</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Izmir Tepecik Training and Research Hospital /ID# 134968</name>
      <address>
        <city>Konak</city>
        <state>Izmir</state>
        <zip>35180</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hacettepe University Faculty of Medicine /ID# 131150</name>
      <address>
        <city>Ankara</city>
        <zip>06100</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ankara Univ Medical Faculty /ID# 131151</name>
      <address>
        <city>Ankara</city>
        <zip>06590</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Uludag University Medical Faculty /ID# 132297</name>
      <address>
        <city>Bursa</city>
        <zip>16059</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Istanbul University Istanbul Medical Faculty /ID# 131153</name>
      <address>
        <city>Istanbul</city>
        <zip>34093</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ege University Medical Faculty /ID# 132298</name>
      <address>
        <city>Izmir</city>
        <zip>35040</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Karadeniz University /ID# 131152</name>
      <address>
        <city>Trabzon</city>
        <zip>61000</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Duplicate_University Hospitals Dorset NHS Foundation Trust /ID# 132306</name>
      <address>
        <city>Poole</city>
        <state>Dorset</state>
        <zip>BH15 2JB</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Hospital Southampton NHS Foundation Trust /ID# 131161</name>
      <address>
        <city>Southampton</city>
        <state>Hampshire</state>
        <zip>SO16 6YD</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Barts Health NHS Trust /ID# 132302</name>
      <address>
        <city>London</city>
        <state>London, City Of</state>
        <zip>E1 2ES</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Royal Free London NHS Foundation Trust /ID# 131159</name>
      <address>
        <city>London</city>
        <state>London, City Of</state>
        <zip>NW3 2QG</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Duplicate_Nottingham University Nottingham University Hospitals NHS Trust /ID# 131155</name>
      <address>
        <city>Nottingham</city>
        <state>Nottinghamshire</state>
        <zip>NG5 1PB</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>NHS Greater Glasgow and Clyde /ID# 131162</name>
      <address>
        <city>Glasgow</city>
        <state>Scotland</state>
        <zip>G12 0XH</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Hospitals Birmingham NHS Foundation Trust /ID# 131154</name>
      <address>
        <city>Birmingham</city>
        <zip>B15 2TH</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Duplicate_NHS Tayside /ID# 132300</name>
      <address>
        <city>Dundee</city>
        <zip>DD2 1UB</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>NHS Lothian /ID# 134368</name>
      <address>
        <city>Edinburgh</city>
        <zip>EH3 9HE</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Leeds Teaching Hospitals NHS Trust /ID# 132305</name>
      <address>
        <city>Leeds</city>
        <zip>LS9 7TF</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>King's College Hospital NHS Foundation Trusts /ID# 131157</name>
      <address>
        <city>London</city>
        <zip>SE5 9RS</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Hospital Plymouth NHS Trust /ID# 131160</name>
      <address>
        <city>Plymouth</city>
        <zip>PL6 5FP</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Portsmouth Hospitals University NHS Trust /ID# 131158</name>
      <address>
        <city>Portsmouth</city>
        <zip>PO6 3LY</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Northern Care Alliance NHS Group /ID# 131156</name>
      <address>
        <city>Salford</city>
        <zip>M6 8HD</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St George's University Hospitals NHS Foundation Trust /ID# 132301</name>
      <address>
        <city>Tooting</city>
        <zip>SW17 0QT</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Algeria</country>
    <country>Australia</country>
    <country>Austria</country>
    <country>Belgium</country>
    <country>Bulgaria</country>
    <country>Canada</country>
    <country>Denmark</country>
    <country>Finland</country>
    <country>France</country>
    <country>Germany</country>
    <country>Greece</country>
    <country>Ireland</country>
    <country>Israel</country>
    <country>Italy</country>
    <country>Mexico</country>
    <country>Netherlands</country>
    <country>Norway</country>
    <country>Poland</country>
    <country>Portugal</country>
    <country>Romania</country>
    <country>Russian Federation</country>
    <country>Saudi Arabia</country>
    <country>Spain</country>
    <country>Sweden</country>
    <country>Switzerland</country>
    <country>Turkey</country>
    <country>United Kingdom</country>
  </location_countries>
  <removed_countries>
    <country>Qatar</country>
    <country>United Arab Emirates</country>
  </removed_countries>
  <verification_date>June 2022</verification_date>
  <study_first_submitted>August 15, 2014</study_first_submitted>
  <study_first_submitted_qc>August 15, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 19, 2014</study_first_posted>
  <results_first_submitted>March 11, 2022</results_first_submitted>
  <results_first_submitted_qc>June 27, 2022</results_first_submitted_qc>
  <results_first_posted type="Actual">April 7, 2023</results_first_posted>
  <last_update_submitted>June 27, 2022</last_update_submitted>
  <last_update_submitted_qc>June 27, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">April 7, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Hepatitis C Genotype 1</keyword>
  <keyword>Compensated Cirrhosis</keyword>
  <keyword>Cirrhosis</keyword>
  <keyword>Naive</keyword>
  <keyword>Hepatitis C</keyword>
  <keyword>Hepatitis C Virus</keyword>
  <keyword>Treatment-Experienced</keyword>
  <keyword>Relapser</keyword>
  <keyword>Null responder</keyword>
  <keyword>Non responder</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Infections</mesh_term>
    <mesh_term>Communicable Diseases</mesh_term>
    <mesh_term>Hepatitis A</mesh_term>
    <mesh_term>Hepatitis C</mesh_term>
    <mesh_term>Hepatitis C, Chronic</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>Ritonavir</mesh_term>
    <mesh_term>Ribavirin</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
    <ipd_time_frame>For details on when studies are available for sharing, please refer to the link below.</ipd_time_frame>
    <ipd_access_criteria>Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous, independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Use Agreement (DUA). For more information on the process, or to submit a request, visit the following link.</ipd_access_criteria>
    <ipd_url>https://vivli.org/ourmember/abbvie/</ipd_url>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>January 19, 2015</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/90/NCT02219490/Prot_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>March 22, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/90/NCT02219490/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <pre_assignment_details>Safety population: All participants enrolled in this study (M14-423; TOPAZ-I) who received at least one dose of study drug</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>ABT-450/r/ABT-267 Plus ABT-333 With or Without Ribavirin (RBV)</title>
          <description>Participants with HCV GT1b without cirrhosis received the 3-DAA (ABT-450/ritonavir/ABT-267 and ABT-333) regimen: two 75 mg ABT-450/50 mg ritonavir/12.5 mg ABT-267 tablets taken orally every morning (QD) and one ABT-333 250 mg tablet taken orally twice a day (BID) for 12 weeks. Participants with HCV GT1a without cirrhosis and those with HCV GT1b with cirrhosis received the 3-DAA regimen and weight-based ribavirin (RBV; 1000 to 1200 mg divided twice daily per local label) for 12 weeks. Participants with HCV GT1a with cirrhosis received the 3-DAA regimen and weight-based RBV per local label for 24 weeks.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="1596"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="1258"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="338"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="24"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrew consent</title>
              <participants_list>
                <participants group_id="P1" count="96"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="126"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>COVID-19 infection</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>COVID-19 logistical restrictions</title>
              <participants_list>
                <participants group_id="P1" count="33"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Other, not specified</title>
              <participants_list>
                <participants group_id="P1" count="57"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Safety population: All participants enrolled in this study (M14-423; TOPAZ-I) who received at least one dose of study drug</population>
      <group_list>
        <group group_id="B1">
          <title>ABT-450/r/ABT-267 Plus ABT-333 With or Without Ribavirin (RBV)</title>
          <description>Participants with HCV GT1b without cirrhosis received the 3-DAA (ABT-450/ritonavir/ABT-267 and ABT-333) regimen: two 75 mg ABT-450/50 mg ritonavir/12.5 mg ABT-267 tablets taken orally every morning (QD) and one ABT-333 250 mg tablet taken orally twice a day (BID) for 12 weeks. Participants with HCV GT1a without cirrhosis and those with HCV GT1b with cirrhosis received the 3-DAA regimen and weight-based ribavirin (RBV; 1000 to 1200 mg divided twice daily per local label) for 12 weeks. Participants with HCV GT1a with cirrhosis received the 3-DAA regimen and weight-based RBV per local label for 24 weeks.</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="1596"/>
          </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="51.2" spread="11.62"/>
                  </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="800"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="796"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race/Ethnicity, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>White</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1544"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Black or African American</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Asian</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="39"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>American Indian or Alaska Native</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Native Hawaiian or Other Pacific Islander</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Multiple</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>HCV Genotype 1 Subtype</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>GT1b without cirrhosis</title>
                  <measurement_list>
                    <measurement group_id="B1" value="757"/>
                  </measurement_list>
                </category>
                <category>
                  <title>GT1b with compensated cirrhosis</title>
                  <measurement_list>
                    <measurement group_id="B1" value="142"/>
                  </measurement_list>
                </category>
                <category>
                  <title>GT1 Non-b without cirrhosis</title>
                  <measurement_list>
                    <measurement group_id="B1" value="597"/>
                  </measurement_list>
                </category>
                <category>
                  <title>GT1 Non-b with compensated cirrhosis</title>
                  <measurement_list>
                    <measurement group_id="B1" value="97"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Missing</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Prior HCV Treatment History</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Treatment Naïve</title>
                  <measurement_list>
                    <measurement group_id="B1" value="782"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Treatment Experienced</title>
                  <measurement_list>
                    <measurement group_id="B1" value="814"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>All-Cause Death: Time to Event</title>
        <description>Time to all-cause death was defined as the number of days from the first day of study drug dosing for the participant to the date of death. All deaths were to be included, regardless of whether the death occurred while the participant was still taking study drug or had previously discontinued study drug. If the participant did not die, their data was to be censored at the date of their last available assessment of clinical outcomes. For participants with no post-baseline assessment, the participant's data was to be censored on the first day of study drug dosing. The event-free survival rates were estimated using Kaplan-Meier methodology and incidence estimates are presented with 95% confidence intervals. The pre-specified analysis of all-cause death included pooled data from TOPAZ-I (this study) and the companion study TOPAZ-II (M14-222; NCT02167945).</description>
        <time_frame>At Post-Treatment Weeks 52, 104, 156, 208, and 260</time_frame>
        <population>Intent-to-treat (ITT) population: all enrolled participants in this study (TOPAZ-I; M14-423; ITT-I) and in companion study M14-422 (TOPAZ-II; NCT02167945; ITT-II) who received at least one dose of study drug</population>
        <group_list>
          <group group_id="O1">
            <title>Participants in Studies M14-222 and M14-423 Who Did Not Achieve SVR12</title>
            <description>SVR12 was defined as hepatitis C virus ribonucleic acid (HCV RNA) less than the lower limit of quantification (LLOQ) 12 weeks after the last actual dose of study drug.</description>
          </group>
          <group group_id="O2">
            <title>Participants in Studies M14-222 and M14-423 Who Achieved SVR12</title>
            <description>SVR12 was defined as hepatitis C virus ribonucleic acid (HCV RNA) less than the lower limit of quantification (LLOQ) 12 weeks after the last actual dose of study drug.</description>
          </group>
        </group_list>
        <measure>
          <title>All-Cause Death: Time to Event</title>
          <description>Time to all-cause death was defined as the number of days from the first day of study drug dosing for the participant to the date of death. All deaths were to be included, regardless of whether the death occurred while the participant was still taking study drug or had previously discontinued study drug. If the participant did not die, their data was to be censored at the date of their last available assessment of clinical outcomes. For participants with no post-baseline assessment, the participant's data was to be censored on the first day of study drug dosing. The event-free survival rates were estimated using Kaplan-Meier methodology and incidence estimates are presented with 95% confidence intervals. The pre-specified analysis of all-cause death included pooled data from TOPAZ-I (this study) and the companion study TOPAZ-II (M14-222; NCT02167945).</description>
          <population>Intent-to-treat (ITT) population: all enrolled participants in this study (TOPAZ-I; M14-423; ITT-I) and in companion study M14-422 (TOPAZ-II; NCT02167945; ITT-II) who received at least one 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="77"/>
                <count group_id="O2" value="2134"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Kaplan-Meier estimate at PT Week 52</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.3" lower_limit="3.1" upper_limit="21.2"/>
                    <measurement group_id="O2" value="0.1" lower_limit="0.1" upper_limit="0.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Kaplan-Meier estimate at PT Week 104</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.3" lower_limit="3.1" upper_limit="21.2"/>
                    <measurement group_id="O2" value="0.7" lower_limit="0.4" upper_limit="1.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Kaplan-Meier estimate at PT Week 156</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.3" lower_limit="3.1" upper_limit="21.2"/>
                    <measurement group_id="O2" value="1.2" lower_limit="0.8" upper_limit="1.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Kaplan-Meier estimate at PT Week 208</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.3" lower_limit="3.1" upper_limit="21.2"/>
                    <measurement group_id="O2" value="1.5" lower_limit="1.1" upper_limit="2.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Kaplan-Meier estimate at PT Week 260</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.3" lower_limit="3.1" upper_limit="21.2"/>
                    <measurement group_id="O2" value="2.0" lower_limit="1.5" upper_limit="2.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Comparisons between participants in studies M14-222 and M14-423 who achieved SVR12 and those who did not were performed using a log-rank test.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>Log-rank test</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>A Cox proportional hazards (PH) model was constructed. The covariates for the model included baseline age, BMI, HCV genotype 1 subtype (1b, non-1b), IL28B genotype (CC, non-CC), prior treatment history (naive, experienced), baseline HCV RNA levels, baseline fibrosis stage (F0-1, F2, F3, F4), baseline albumin, baseline creatinine clearance, baseline platelet count, history of diabetes (yes, no), APRI, race (white, other), and alcohol use status (current, former, non-drinker).</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>Cox proportional hazards model</method>
            <param_type>Cox Proportional Hazard Ratio</param_type>
            <param_value>0.126</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.044</ci_lower_limit>
            <ci_upper_limit>0.358</ci_upper_limit>
            <estimate_desc>The estimated value represents the hazard ratio for developing the event in the group of participants in studies M14-222 and M14-423 who achieved SVR12 compared to the group of participants in studies M14-222 and M14-423 who didn't achieve SVR12.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Liver-Related Death: Time to Event</title>
        <description>Time to liver-related death was defined as days from the 1st day of study drug dosing for the subject to date of liver-related death. All liver-related deaths were to be included, regardless of whether the death occurred while subject was still taking study drug or had previously discontinued study drug. If the subject didn't experience event of interest nor had died (all-cause death), their data was to be censored at date of last available assessment. For those with no post-baseline assessment, data was to be censored on 1st day of study drug dosing. All-cause death was a censoring event for liver-related death. The event-free survival rates were estimated using Kaplan-Meier methodology and incidence estimates are presented with 95% confidence intervals. The pre-specified analysis of liver-related death included pooled data from TOPAZ-I (this study) and the companion study TOPAZ-II (M14-222; NCT02167945).</description>
        <time_frame>At Post-Treatment Weeks 52, 104, 156, 208, and 260</time_frame>
        <population>Intent-to-treat (ITT) population: all enrolled participants in this study (TOPAZ-I; M14-423; ITT-I) and in companion study M14-422 (TOPAZ-II; NCT02167945; ITT-II) who received at least one dose of study drug</population>
        <group_list>
          <group group_id="O1">
            <title>Participants in Studies M14-222 and M14-423 Who Did Not Achieve SVR12</title>
            <description>SVR12 was defined as hepatitis C virus ribonucleic acid (HCV RNA) less than the lower limit of quantification (LLOQ) 12 weeks after the last actual dose of study drug.</description>
          </group>
          <group group_id="O2">
            <title>Participants in Studies M14-222 and M14-423 Who Achieved SVR12</title>
            <description>SVR12 was defined as hepatitis C virus ribonucleic acid (HCV RNA) less than the lower limit of quantification (LLOQ) 12 weeks after the last actual dose of study drug.</description>
          </group>
        </group_list>
        <measure>
          <title>Liver-Related Death: Time to Event</title>
          <description>Time to liver-related death was defined as days from the 1st day of study drug dosing for the subject to date of liver-related death. All liver-related deaths were to be included, regardless of whether the death occurred while subject was still taking study drug or had previously discontinued study drug. If the subject didn't experience event of interest nor had died (all-cause death), their data was to be censored at date of last available assessment. For those with no post-baseline assessment, data was to be censored on 1st day of study drug dosing. All-cause death was a censoring event for liver-related death. The event-free survival rates were estimated using Kaplan-Meier methodology and incidence estimates are presented with 95% confidence intervals. The pre-specified analysis of liver-related death included pooled data from TOPAZ-I (this study) and the companion study TOPAZ-II (M14-222; NCT02167945).</description>
          <population>Intent-to-treat (ITT) population: all enrolled participants in this study (TOPAZ-I; M14-423; ITT-I) and in companion study M14-422 (TOPAZ-II; NCT02167945; ITT-II) who received at least one 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="77"/>
                <count group_id="O2" value="2134"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Kaplan-Meier estimate at PT Week 52</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.4" lower_limit="0.2" upper_limit="9.6"/>
                    <measurement group_id="O2" value="0" lower_limit="NA" upper_limit="NA">Confidence interval is not calculable due to zero events at this visit</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Kaplan-Meier estimate at PT Week 104</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.4" lower_limit="0.2" upper_limit="9.6"/>
                    <measurement group_id="O2" value="0" lower_limit="NA" upper_limit="NA">Confidence interval is not calculable due to zero events at this visit</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Kaplan-Meier estimate at PT Week 156</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.4" lower_limit="0.2" upper_limit="9.6"/>
                    <measurement group_id="O2" value="0.1" lower_limit="0.1" upper_limit="0.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Kaplan-Meier estimate at PT Week 208</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.4" lower_limit="0.2" upper_limit="9.6"/>
                    <measurement group_id="O2" value="0.1" lower_limit="0.1" upper_limit="0.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Kaplan-Meier estimate at PT Week 260</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.4" lower_limit="0.2" upper_limit="9.6"/>
                    <measurement group_id="O2" value="0.1" lower_limit="0.1" upper_limit="0.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Comparisons between participants in studies M14-222 and M14-423 who achieved SVR12 and those who did not were performed using a log-rank test.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>Log-rank test</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>A Cox proportional hazards (PH) model was constructed. The covariates for the model included baseline age, BMI, HCV genotype 1 subtype (1b, non-1b), IL28B genotype (CC, non-CC), prior treatment history (naive, experienced), baseline HCV RNA levels, baseline fibrosis stage (F0-1, F2, F3, F4), baseline albumin, baseline creatinine clearance, baseline platelet count, history of diabetes (yes, no), APRI, race (white, other), and alcohol use status (current, former, non-drinker).</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.007</p_value>
            <method>Cox proportional hazards model</method>
            <param_type>Cox Proportional Hazard Ratio</param_type>
            <param_value>0.031</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.003</ci_lower_limit>
            <ci_upper_limit>0.380</ci_upper_limit>
            <estimate_desc>The estimated value represents the hazard ratio for developing the event in the group of participants in studies M14-222 and M14-423 who achieved SVR12 compared to the group of participants in studies M14-222 and M14-423 who didn't achieve SVR12.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Liver Decompensation: Time to Event</title>
        <description>Time to liver decompensation was defined as number of days from the 1st day of study drug dosing for the participant to the date of liver decompensation. All liver decompensation was to be included, regardless of whether it occurred while the participant was still taking study drug or had previously discontinued study drug. If the participant didn't experience the event of interest nor had died (all-cause death), their data was to be censored at the date of their last available assessment of clinical outcomes. For participants with no post-baseline assessment, their data was to be censored on the 1st day of study drug dosing. All-cause death was a censoring event for liver decompensation. The event-free survival rates were estimated using Kaplan-Meier methodology and incidence estimates are presented with 95% confidence intervals. The pre-specified analysis of liver decompensation included pooled data from TOPAZ-I (this study) and the companion study TOPAZ-II (M14-222; NCT02167945).</description>
        <time_frame>At Post-Treatment Weeks 52, 104, 156, 208, and 260</time_frame>
        <population>Intent-to-treat (ITT) population: all enrolled participants in this study (TOPAZ-I; M14-423; ITT-I) and in companion study M14-422 (TOPAZ-II; NCT02167945; ITT-II) who received at least one dose of study drug</population>
        <group_list>
          <group group_id="O1">
            <title>Participants in Studies M14-222 and M14-423 Who Did Not Achieve SVR12</title>
            <description>SVR12 was defined as hepatitis C virus ribonucleic acid (HCV RNA) less than the lower limit of quantification (LLOQ) 12 weeks after the last actual dose of study drug.</description>
          </group>
          <group group_id="O2">
            <title>Participants in Studies M14-222 and M14-423 Who Achieved SVR12</title>
            <description>SVR12 was defined as hepatitis C virus ribonucleic acid (HCV RNA) less than the lower limit of quantification (LLOQ) 12 weeks after the last actual dose of study drug.</description>
          </group>
        </group_list>
        <measure>
          <title>Liver Decompensation: Time to Event</title>
          <description>Time to liver decompensation was defined as number of days from the 1st day of study drug dosing for the participant to the date of liver decompensation. All liver decompensation was to be included, regardless of whether it occurred while the participant was still taking study drug or had previously discontinued study drug. If the participant didn't experience the event of interest nor had died (all-cause death), their data was to be censored at the date of their last available assessment of clinical outcomes. For participants with no post-baseline assessment, their data was to be censored on the 1st day of study drug dosing. All-cause death was a censoring event for liver decompensation. The event-free survival rates were estimated using Kaplan-Meier methodology and incidence estimates are presented with 95% confidence intervals. The pre-specified analysis of liver decompensation included pooled data from TOPAZ-I (this study) and the companion study TOPAZ-II (M14-222; NCT02167945).</description>
          <population>Intent-to-treat (ITT) population: all enrolled participants in this study (TOPAZ-I; M14-423; ITT-I) and in companion study M14-422 (TOPAZ-II; NCT02167945; ITT-II) who received at least one 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="77"/>
                <count group_id="O2" value="2134"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Kaplan-Meier estimate at PT Week 52</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.5" lower_limit="1.5" upper_limit="13.4"/>
                    <measurement group_id="O2" value="0.2" lower_limit="0.1" upper_limit="0.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Kaplan-Meier estimate at PT Week 104</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.5" lower_limit="1.5" upper_limit="13.4"/>
                    <measurement group_id="O2" value="0.2" lower_limit="0.1" upper_limit="0.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Kaplan-Meier estimate at PT Week 156</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.5" lower_limit="1.5" upper_limit="13.4"/>
                    <measurement group_id="O2" value="0.3" lower_limit="0.1" upper_limit="0.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Kaplan-Meier estimate at PT Week 208</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.5" lower_limit="1.5" upper_limit="13.4"/>
                    <measurement group_id="O2" value="0.3" lower_limit="0.2" upper_limit="0.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Kaplan-Meier estimate at PT Week 260</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.5" lower_limit="1.5" upper_limit="13.4"/>
                    <measurement group_id="O2" value="0.5" lower_limit="0.2" upper_limit="0.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Comparisons between participants in studies M14-222 and M14-423 who achieved SVR12 and those who did not were performed using a log-rank test.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>Log-rank test</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>A Cox proportional hazards (PH) model was constructed. The covariates for the model included baseline age, BMI, HCV genotype 1 subtype (1b, non-1b), IL28B genotype (CC, non-CC), prior treatment history (naive, experienced), baseline HCV RNA levels, baseline fibrosis stage (F0-1, F2, F3, F4), baseline albumin, baseline creatinine clearance, baseline platelet count, history of diabetes (yes, no), APRI, race (white, other), and alcohol use status (current, former, non-drinker).</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>Cox proportional hazards model</method>
            <param_type>Cox Proportional Hazard Ratio</param_type>
            <param_value>0.038</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.009</ci_lower_limit>
            <ci_upper_limit>0.156</ci_upper_limit>
            <estimate_desc>The estimated value represents the hazard ratio for developing the event in the group of participants in studies M14-222 and M14-423 who achieved SVR12 compared to the group of participants in studies M14-222 and M14-423 who didn't achieve SVR12.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Liver Transplantation: Time to Event</title>
        <description>Time to liver transplantation was defined as days from 1st day of study drug dosing for subject to date of liver transplantation. All liver transplantation was to be included, whether it occurred while the subject was still taking study drug or had previously discontinued study drug. If the subject didn't experience event of interest nor had died (all-cause death), their data was to be censored at the date of their last available assessment. For those with no post-baseline assessment, data was to be censored on 1st day of study drug dosing. All-cause death was a censoring event for liver transplantation. The event-free survival rates were estimated using Kaplan-Meier methodology and incidence estimates are presented with 95% confidence intervals. The pre-specified analysis of liver transplantation included pooled data from TOPAZ-I (this study) and the companion study TOPAZ-II (M14-222; NCT02167945).</description>
        <time_frame>At Post-Treatment Weeks 52, 104, 156, 208, and 260</time_frame>
        <population>Intent-to-treat (ITT) population: all enrolled participants in this study (TOPAZ-I; M14-423; ITT-I) and in companion study M14-422 (TOPAZ-II; NCT02167945; ITT-II) who received at least one dose of study drug</population>
        <group_list>
          <group group_id="O1">
            <title>Participants in Studies M14-222 and M14-423 Who Did Not Achieve SVR12</title>
            <description>SVR12 was defined as hepatitis C virus ribonucleic acid (HCV RNA) less than the lower limit of quantification (LLOQ) 12 weeks after the last actual dose of study drug.</description>
          </group>
          <group group_id="O2">
            <title>Participants in Studies M14-222 and M14-423 Who Achieved SVR12</title>
            <description>SVR12 was defined as hepatitis C virus ribonucleic acid (HCV RNA) less than the lower limit of quantification (LLOQ) 12 weeks after the last actual dose of study drug.</description>
          </group>
        </group_list>
        <measure>
          <title>Liver Transplantation: Time to Event</title>
          <description>Time to liver transplantation was defined as days from 1st day of study drug dosing for subject to date of liver transplantation. All liver transplantation was to be included, whether it occurred while the subject was still taking study drug or had previously discontinued study drug. If the subject didn't experience event of interest nor had died (all-cause death), their data was to be censored at the date of their last available assessment. For those with no post-baseline assessment, data was to be censored on 1st day of study drug dosing. All-cause death was a censoring event for liver transplantation. The event-free survival rates were estimated using Kaplan-Meier methodology and incidence estimates are presented with 95% confidence intervals. The pre-specified analysis of liver transplantation included pooled data from TOPAZ-I (this study) and the companion study TOPAZ-II (M14-222; NCT02167945).</description>
          <population>Intent-to-treat (ITT) population: all enrolled participants in this study (TOPAZ-I; M14-423; ITT-I) and in companion study M14-422 (TOPAZ-II; NCT02167945; ITT-II) who received at least one 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="77"/>
                <count group_id="O2" value="2134"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Kaplan-Meier estimate at PT Week 52</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0" lower_limit="NA" upper_limit="NA">Confidence interval is not calculable due to zero events at this visit</measurement>
                    <measurement group_id="O2" value="0" lower_limit="NA" upper_limit="NA">Confidence interval is not calculable due to zero events at this visit</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Kaplan-Meier estimate at PT Week 104</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0" lower_limit="NA" upper_limit="NA">Confidence interval is not calculable due to zero events at this visit</measurement>
                    <measurement group_id="O2" value="0" lower_limit="NA" upper_limit="NA">Confidence interval is not calculable due to zero events at this visit</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Kaplan-Meier estimate at PT Week 156</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0" lower_limit="NA" upper_limit="NA">Confidence interval is not calculable due to zero events at this visit</measurement>
                    <measurement group_id="O2" value="0.1" lower_limit="0.1" upper_limit="0.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Kaplan-Meier estimate at PT Week 208</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0" lower_limit="NA" upper_limit="NA">Confidence interval is not calculable due to zero events at this visit</measurement>
                    <measurement group_id="O2" value="0.1" lower_limit="0.1" upper_limit="0.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Kaplan-Meier estimate at PT Week 260</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0" lower_limit="NA" upper_limit="NA">Confidence interval is not calculable due to zero events at this visit</measurement>
                    <measurement group_id="O2" value="0.2" lower_limit="0.1" upper_limit="0.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Comparisons between participants in studies M14-222 and M14-423 who achieved SVR12 and those who did not were performed using a log-rank test.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.860</p_value>
            <method>Log-rank test</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>A Cox proportional hazards (PH) model was constructed. The covariates for the model included baseline age, BMI, HCV genotype 1 subtype (1b, non-1b), IL28B genotype (CC, non-CC), prior treatment history (naive, experienced), baseline HCV RNA levels, baseline fibrosis stage (F0-1, F2, F3, F4), baseline albumin, baseline creatinine clearance, baseline platelet count, history of diabetes (yes, no), APRI, race (white, other), and alcohol use status (current, former, non-drinker).</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.997</p_value>
            <p_value_desc>The Hazard Ratio for experiencing the event in the group of participants in studies M14-222 and M14-423 who achieved SVR12 compared to those who did not achieve SVR12 is infinite and the CI is not bounded due to zero events in one of the groups.</p_value_desc>
            <method>Cox proportional hazards model</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Hepatocellular Carcinoma: Time to Event</title>
        <description>Time to hepatocellular carcinoma (HCC) was defined as number of days from 1st day of study drug dosing for subject to date of hepatocellular carcinoma. All HCC was to be included, whether it occurred while subject was still taking study drug or had previously discontinued study drug. If the subject didn't experience the event of interest nor had died (all-cause death), their data was to be censored at the date of their last available assessment. For those with no post-baseline assessment, their data was to be censored on the 1st day of study drug dosing. All-cause death was a censoring event for HCC. The event-free survival rates were estimated using Kaplan-Meier methodology and incidence estimates are presented with 95% confidence intervals. The pre-specified analysis of hepatocellular carcinoma included pooled data from TOPAZ-I (this study) and the companion study TOPAZ-II (M14-222; NCT02167945).</description>
        <time_frame>At Post-Treatment Weeks 52, 104, 156, 208, and 260</time_frame>
        <population>Intent-to-treat (ITT) population: all enrolled participants in this study (TOPAZ-I; M14-423; ITT-I) and in companion study M14-422 (TOPAZ-II; NCT02167945; ITT-II) who received at least one dose of study drug</population>
        <group_list>
          <group group_id="O1">
            <title>Participants in Studies M14-222 and M14-423 Who Did Not Achieve SVR12</title>
            <description>SVR12 was defined as hepatitis C virus ribonucleic acid (HCV RNA) less than the lower limit of quantification (LLOQ) 12 weeks after the last actual dose of study drug.</description>
          </group>
          <group group_id="O2">
            <title>Participants in Studies M14-222 and M14-423 Who Achieved SVR12</title>
            <description>SVR12 was defined as hepatitis C virus ribonucleic acid (HCV RNA) less than the lower limit of quantification (LLOQ) 12 weeks after the last actual dose of study drug.</description>
          </group>
        </group_list>
        <measure>
          <title>Hepatocellular Carcinoma: Time to Event</title>
          <description>Time to hepatocellular carcinoma (HCC) was defined as number of days from 1st day of study drug dosing for subject to date of hepatocellular carcinoma. All HCC was to be included, whether it occurred while subject was still taking study drug or had previously discontinued study drug. If the subject didn't experience the event of interest nor had died (all-cause death), their data was to be censored at the date of their last available assessment. For those with no post-baseline assessment, their data was to be censored on the 1st day of study drug dosing. All-cause death was a censoring event for HCC. The event-free survival rates were estimated using Kaplan-Meier methodology and incidence estimates are presented with 95% confidence intervals. The pre-specified analysis of hepatocellular carcinoma included pooled data from TOPAZ-I (this study) and the companion study TOPAZ-II (M14-222; NCT02167945).</description>
          <population>Intent-to-treat (ITT) population: all enrolled participants in this study (TOPAZ-I; M14-423; ITT-I) and in companion study M14-422 (TOPAZ-II; NCT02167945; ITT-II) who received at least one 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="77"/>
                <count group_id="O2" value="2134"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Kaplan-Meier estimate at PT Week 52</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0" lower_limit="NA" upper_limit="NA">Confidence interval is not calculable due to zero events at this visit</measurement>
                    <measurement group_id="O2" value="0.2" lower_limit="0.1" upper_limit="0.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Kaplan-Meier estimate at PT Week 104</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0" lower_limit="NA" upper_limit="NA">Confidence interval is not calculable due to zero events at this visit</measurement>
                    <measurement group_id="O2" value="0.4" lower_limit="0.2" upper_limit="0.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Kaplan-Meier estimate at PT Week 156</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0" lower_limit="NA" upper_limit="NA">Confidence interval is not calculable due to zero events at this visit</measurement>
                    <measurement group_id="O2" value="0.5" lower_limit="0.3" upper_limit="1.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Kaplan-Meier estimate at PT Week 208</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0" lower_limit="NA" upper_limit="NA">Confidence interval is not calculable due to zero events at this visit</measurement>
                    <measurement group_id="O2" value="0.6" lower_limit="0.4" upper_limit="1.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Kaplan-Meier estimate at PT Week 260</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0" lower_limit="NA" upper_limit="NA">Confidence interval is not calculable due to zero events at this visit</measurement>
                    <measurement group_id="O2" value="0.9" lower_limit="0.5" upper_limit="1.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Comparisons between participants in studies M14-222 and M14-423 who achieved SVR12 and those who did not were performed using a log-rank test.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.608</p_value>
            <method>Log-rank test</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>A Cox proportional hazards (PH) model was constructed. The covariates for the model included baseline age, BMI, HCV genotype 1 subtype (1b, non-1b), IL28B genotype (CC, non-CC), prior treatment history (naive, experienced), baseline HCV RNA levels, baseline fibrosis stage (F0-1, F2, F3, F4), baseline albumin, baseline creatinine clearance, baseline platelet count, history of diabetes (yes, no), APRI, race (white, other), and alcohol use status (current, former, non-drinker).</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.992</p_value>
            <p_value_desc>The Hazard Ratio for experiencing the event in the group of participants in studies M14-222 and M14-423 who achieved SVR12 compared to those who did not achieve SVR12 is infinite and the CI is not bounded due to zero events in one of the groups.</p_value_desc>
            <method>Cox proportional hazards model</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>All-Cause Death, Liver-Related Death, Liver Decompensation, Liver Transplantation, Hepatocellular Carcinoma: Time to Event</title>
        <description>Time to the composite of clinical outcomes is the time to the first occurrence of all-cause death, liver-related death, liver decompensation, liver transplantation, or hepatocellular carcinoma. All first occurrences were to be included, regardless of whether it occurred while the participant was still taking study drug or had previously discontinued study drug. If the participant did not experience any of these events, their data was to be censored at the date of their last available assessment of clinical outcomes. For participants with no post-baseline assessment, the participant's data was to be censored on the first day of study drug dosing. The event-free survival rates were estimated using Kaplan-Meier methodology and incidence estimates are presented with 95% confidence intervals. Pre-specified analysis included pooled data from this study and from TOPAZ-II; NCT02167945.</description>
        <time_frame>At Post-Treatment Weeks 52, 104, 156, 208, and 260</time_frame>
        <population>Intent-to-treat (ITT) population: all enrolled participants in this study (TOPAZ-I; M14-423; ITT-I) and in companion study M14-422 (TOPAZ-II; NCT02167945; ITT-II) who received at least one dose of study drug</population>
        <group_list>
          <group group_id="O1">
            <title>Participants in Studies M14-222 and M14-423 Who Did Not Achieve SVR12</title>
            <description>SVR12 was defined as hepatitis C virus ribonucleic acid (HCV RNA) less than the lower limit of quantification (LLOQ) 12 weeks after the last actual dose of study drug.</description>
          </group>
          <group group_id="O2">
            <title>Participants in Studies M14-222 and M14-423 Who Achieved SVR12</title>
            <description>SVR12 was defined as hepatitis C virus ribonucleic acid (HCV RNA) less than the lower limit of quantification (LLOQ) 12 weeks after the last actual dose of study drug.</description>
          </group>
        </group_list>
        <measure>
          <title>All-Cause Death, Liver-Related Death, Liver Decompensation, Liver Transplantation, Hepatocellular Carcinoma: Time to Event</title>
          <description>Time to the composite of clinical outcomes is the time to the first occurrence of all-cause death, liver-related death, liver decompensation, liver transplantation, or hepatocellular carcinoma. All first occurrences were to be included, regardless of whether it occurred while the participant was still taking study drug or had previously discontinued study drug. If the participant did not experience any of these events, their data was to be censored at the date of their last available assessment of clinical outcomes. For participants with no post-baseline assessment, the participant's data was to be censored on the first day of study drug dosing. The event-free survival rates were estimated using Kaplan-Meier methodology and incidence estimates are presented with 95% confidence intervals. Pre-specified analysis included pooled data from this study and from TOPAZ-II; NCT02167945.</description>
          <population>Intent-to-treat (ITT) population: all enrolled participants in this study (TOPAZ-I; M14-423; ITT-I) and in companion study M14-422 (TOPAZ-II; NCT02167945; ITT-II) who received at least one 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="77"/>
                <count group_id="O2" value="2134"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Kaplan-Meier estimate at PT Week 52</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11.4" lower_limit="5.2" upper_limit="24.2"/>
                    <measurement group_id="O2" value="0.5" lower_limit="0.3" upper_limit="0.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Kaplan-Meier estimate at PT Week 104</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11.4" lower_limit="5.2" upper_limit="24.2"/>
                    <measurement group_id="O2" value="1.2" lower_limit="0.8" upper_limit="1.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Kaplan-Meier estimate at PT Week 156</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11.4" lower_limit="5.2" upper_limit="24.2"/>
                    <measurement group_id="O2" value="1.9" lower_limit="1.4" upper_limit="2.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Kaplan-Meier estimate at PT Week 208</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11.4" lower_limit="5.2" upper_limit="24.2"/>
                    <measurement group_id="O2" value="2.3" lower_limit="1.7" upper_limit="3.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Kaplan-Meier estimate at PT Week 260</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11.4" lower_limit="5.2" upper_limit="24.2"/>
                    <measurement group_id="O2" value="3.2" lower_limit="2.5" upper_limit="4.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Comparisons between participants in studies M14-222 and M14-423 who achieved SVR12 and those who did not were performed using a log-rank test.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>Log-rank test</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>A Cox proportional hazards (PH) model was constructed. The covariates for the model included baseline age, BMI, HCV genotype 1 subtype (1b, non-1b), IL28B genotype (CC, non-CC), prior treatment history (naive, experienced), baseline HCV RNA levels, baseline fibrosis stage (F0-1, F2, F3, F4), baseline albumin, baseline creatinine clearance, baseline platelet count, history of diabetes (yes, no), APRI, race (white, other), and alcohol use status (current, former, non-drinker).</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>Cox proportional hazards model</method>
            <param_type>Cox Proportional Hazard Ratio</param_type>
            <param_value>0.133</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.057</ci_lower_limit>
            <ci_upper_limit>0.313</ci_upper_limit>
            <estimate_desc>The estimated value represents the hazard ratio for developing the event in the group of participants in studies M14-222 and M14-423 who achieved SVR12 compared to the group of participants in studies M14-222 and M14-423 who didn't achieve SVR12.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in FibroScan Score by SVR12 Status</title>
        <description>The FibroScan test is a validated non-invasive test used to assess liver fibrosis in participants with chronic liver disease, and it was performed at study sites where it was available. For participants with Hepatitis C infection, a FibroScan score of 2-7 kPa indicates no liver scarring or mild scarring; a score of 8 or 9 is associated with moderate liver scarring; 9-14 indicates severe liver scarring; and 14 or higher is indicative of advanced liver scarring, cirrhosis. Negative changes from baseline indicate improvement in liver fibrosis.</description>
        <time_frame>At the final treatment visit and Post-Treatment Weeks 12, 24, 52, 104, 156, 208, and 260</time_frame>
        <population>ITT-I population: all participants enrolled in this study (M14-423; TOPAZ-I) who received at least one dose of study drug with available data</population>
        <group_list>
          <group group_id="O1">
            <title>Participants in Study M14-423 Who Did Not Achieve SVR12</title>
            <description>SVR12 was defined as hepatitis C virus ribonucleic acid (HCV RNA) less than the lower limit of quantification (LLOQ) 12 weeks after the last actual dose of study drug.</description>
          </group>
          <group group_id="O2">
            <title>Participants in Study M14-423 Who Achieved SVR12</title>
            <description>SVR12 was defined as hepatitis C virus ribonucleic acid (HCV RNA) less than the lower limit of quantification (LLOQ) 12 weeks after the last actual dose of study drug.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in FibroScan Score by SVR12 Status</title>
          <description>The FibroScan test is a validated non-invasive test used to assess liver fibrosis in participants with chronic liver disease, and it was performed at study sites where it was available. For participants with Hepatitis C infection, a FibroScan score of 2-7 kPa indicates no liver scarring or mild scarring; a score of 8 or 9 is associated with moderate liver scarring; 9-14 indicates severe liver scarring; and 14 or higher is indicative of advanced liver scarring, cirrhosis. Negative changes from baseline indicate improvement in liver fibrosis.</description>
          <population>ITT-I population: all participants enrolled in this study (M14-423; TOPAZ-I) who received at least one dose of study drug with available data</population>
          <units>kPa</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="22"/>
                <count group_id="O2" value="1187"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>At the final treatment visit</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="22"/>
                    <count group_id="O2" value="1015"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.55" spread="3.282"/>
                    <measurement group_id="O2" value="-1.41" spread="4.283"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Post-Treatment Week 12</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="18"/>
                    <count group_id="O2" value="1171"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.81" spread="2.624"/>
                    <measurement group_id="O2" value="-1.76" spread="4.213"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Post-Treatment Week 24</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="18"/>
                    <count group_id="O2" value="1175"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.26" spread="3.211"/>
                    <measurement group_id="O2" value="-1.98" spread="4.363"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Post-Treatment Week 52</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="13"/>
                    <count group_id="O2" value="1187"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.30" spread="1.986"/>
                    <measurement group_id="O2" value="-2.46" spread="4.858"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Post-Treatment Week 104</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="13"/>
                    <count group_id="O2" value="1122"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.35" spread="3.306"/>
                    <measurement group_id="O2" value="-2.80" spread="5.195"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Post-Treatment Week 156</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="12"/>
                    <count group_id="O2" value="1073"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.37" spread="3.999"/>
                    <measurement group_id="O2" value="-2.92" spread="5.249"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Post-Treatment Week 208</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="12"/>
                    <count group_id="O2" value="978"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.88" spread="2.445"/>
                    <measurement group_id="O2" value="-3.08" spread="5.560"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Post-Treatment Week 260</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="9"/>
                    <count group_id="O2" value="860"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.31" spread="3.706"/>
                    <measurement group_id="O2" value="-3.08" spread="5.662"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Final Treatment Visit&#xD;
The effect of sustained virologic response on change from baseline in FibroScan score was evaluated by comparing mean change from baseline between subjects who achieved SVR12 and those who did not using ANCOVA analyses. SVR12 status was included as a factor and baseline FibroScan score was included as a covariate in the ANCOVA model.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.151</p_value>
            <method>ANCOVA</method>
            <param_type>LS Mean Difference</param_type>
            <param_value>1</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.7</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.37</ci_lower_limit>
            <ci_upper_limit>2.37</ci_upper_limit>
            <estimate_desc>Difference = with SVR12 minus without SVR12</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Post-Treatment Week 12&#xD;
The effect of sustained virologic response on change from baseline in FibroScan score was evaluated by comparing mean change from baseline between subjects who achieved SVR12 and those who did not using ANCOVA analyses. SVR12 status was included as a factor and baseline FibroScan score was included as a covariate in the ANCOVA model.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.878</p_value>
            <method>ANCOVA</method>
            <param_type>LS Mean Difference</param_type>
            <param_value>-0.12</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.78</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.64</ci_lower_limit>
            <ci_upper_limit>1.4</ci_upper_limit>
            <estimate_desc>Difference = with SVR12 minus without SVR12</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Post-Treatment Week 24&#xD;
The effect of sustained virologic response on change from baseline in FibroScan score was evaluated by comparing mean change from baseline between subjects who achieved SVR12 and those who did not using ANCOVA analyses. SVR12 status was included as a factor and baseline FibroScan score was included as a covariate in the ANCOVA model.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>=0.199</p_value>
            <method>ANCOVA</method>
            <param_type>LS Mean Difference</param_type>
            <param_value>-0.92</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.72</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-2.33</ci_lower_limit>
            <ci_upper_limit>0.48</ci_upper_limit>
            <estimate_desc>Difference = with SVR12 minus without SVR12</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Post-Treatment Week 52&#xD;
The effect of sustained virologic response on change from baseline in FibroScan score was evaluated by comparing mean change from baseline between subjects who achieved SVR12 and those who did not using ANCOVA analyses. SVR12 status was included as a factor and baseline FibroScan score was included as a covariate in the ANCOVA model.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.021</p_value>
            <method>ANCOVA</method>
            <param_type>LS Mean Difference</param_type>
            <param_value>-2.16</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.93</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-4</ci_lower_limit>
            <ci_upper_limit>-0.33</ci_upper_limit>
            <estimate_desc>Difference = with SVR12 minus without SVR12</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Post-Treatment Week 104&#xD;
The effect of sustained virologic response on change from baseline in FibroScan score was evaluated by comparing mean change from baseline between subjects who achieved SVR12 and those who did not using ANCOVA analyses. SVR12 status was included as a factor and baseline FibroScan score was included as a covariate in the ANCOVA model.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.006</p_value>
            <method>ANCOVA</method>
            <param_type>LS Mean Difference</param_type>
            <param_value>-2.47</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.89</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-4.22</ci_lower_limit>
            <ci_upper_limit>-0.71</ci_upper_limit>
            <estimate_desc>Difference = with SVR12 minus without SVR12</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Post-Treatment Week 156&#xD;
The effect of sustained virologic response on change from baseline in FibroScan score was evaluated by comparing mean change from baseline between subjects who achieved SVR12 and those who did not using ANCOVA analyses. SVR12 status was included as a factor and baseline FibroScan score was included as a covariate in the ANCOVA model.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.005</p_value>
            <method>ANCOVA</method>
            <param_type>LS Mean Difference</param_type>
            <param_value>-2.58</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.92</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-4.38</ci_lower_limit>
            <ci_upper_limit>-0.79</ci_upper_limit>
            <estimate_desc>Difference = with SVR12 minus without SVR12</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Post-Treatment Week 208&#xD;
The effect of sustained virologic response on change from baseline in FibroScan score was evaluated by comparing mean change from baseline between subjects who achieved SVR12 and those who did not using ANCOVA analyses. SVR12 status was included as a factor and baseline FibroScan score was included as a covariate in the ANCOVA model.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.172</p_value>
            <method>ANCOVA</method>
            <param_type>LS Mean Difference</param_type>
            <param_value>-1.36</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>1</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-3.32</ci_lower_limit>
            <ci_upper_limit>0.59</ci_upper_limit>
            <estimate_desc>Difference = with SVR12 minus without SVR12</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Post-Treatment Week 260&#xD;
The effect of sustained virologic response on change from baseline in FibroScan score was evaluated by comparing mean change from baseline between subjects who achieved SVR12 and those who did not using ANCOVA analyses. SVR12 status was included as a factor and baseline FibroScan score was included as a covariate in the ANCOVA model.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.322</p_value>
            <method>ANCOVA</method>
            <param_type>LS Mean Difference</param_type>
            <param_value>-1.13</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>1.14</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-3.35</ci_lower_limit>
            <ci_upper_limit>1.1</ci_upper_limit>
            <estimate_desc>Difference = with SVR12 minus without SVR12</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12)</title>
        <description>SVR12 is defined as hepatitis C virus ribonucleic acid (HCV RNA) less than the lower limit of quantification (LLOQ) 12 weeks after the last actual dose of study drug. Flanking imputation, where applicable, was used to impute missing data. After applying flanking imputation, if there was no value in the window but there was an HCV RNA value from a local laboratory present, then it was to be imputed into the SVR window. Otherwise, participants with missing data were counted as failures.</description>
        <time_frame>12 weeks after the last actual dose of study drug</time_frame>
        <population>ITT-I population: all participants enrolled in this study (M14-423; TOPAZ-I) who received at least one dose of study drug with available data</population>
        <group_list>
          <group group_id="O1">
            <title>ABT-450/r/ABT-267 Plus ABT-333 With or Without Ribavirin (RBV)</title>
            <description>Participants with HCV GT1b without cirrhosis received the 3-DAA (ABT-450/ritonavir/ABT-267 and ABT-333) regimen: two 75 mg ABT-450/50 mg ritonavir/12.5 mg ABT-267 tablets taken orally every morning (QD) and one ABT-333 250 mg tablet taken orally twice a day (BID) for 12 weeks. Participants with HCV GT1a without cirrhosis and those with HCV GT1b with cirrhosis received the 3-DAA regimen and weight-based ribavirin (RBV; 1000 to 1200 mg divided twice daily per local label) for 12 weeks. Participants with HCV GT1a with cirrhosis received the 3-DAA regimen and weight-based RBV per local label for 24 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12)</title>
          <description>SVR12 is defined as hepatitis C virus ribonucleic acid (HCV RNA) less than the lower limit of quantification (LLOQ) 12 weeks after the last actual dose of study drug. Flanking imputation, where applicable, was used to impute missing data. After applying flanking imputation, if there was no value in the window but there was an HCV RNA value from a local laboratory present, then it was to be imputed into the SVR window. Otherwise, participants with missing data were counted as failures.</description>
          <population>ITT-I population: all participants enrolled in this study (M14-423; TOPAZ-I) who received at least one dose of study drug with available data</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="1596"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="97.0" lower_limit="96.0" upper_limit="97.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>All-cause mortality is reported from enrollment to the end of study, up to five years of follow-up. Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 30 days after the last study drug administration, up to 203 days. After Post-Treatment Week 4 until the end of the study, only SAE of death was to be collected.</time_frame>
      <desc>All-cause mortality and adverse events: all participants in this study (M14-423; TOPAZ-I) who received at least one dose of study drug</desc>
      <group_list>
        <group group_id="E1">
          <title>ABT-450/r/ABT-267 Plus ABT-333 With or Without Ribavirin (RBV)</title>
          <description>Participants with HCV GT1b without cirrhosis received the 3-DAA (ABT-450/ritonavir/ABT-267 and ABT-333) regimen: two 75 mg ABT-450/50 mg ritonavir/12.5 mg ABT-267 tablets taken orally every morning (QD) and one ABT-333 250 mg tablet taken orally twice a day (BID) for 12 weeks. Participants with HCV GT1a without cirrhosis and those with HCV GT1b with cirrhosis received the 3-DAA regimen and weight-based ribavirin (RBV; 1000 to 1200 mg divided twice daily per local label) for 12 weeks. Participants with HCV GT1a with cirrhosis received the 3-DAA regimen and weight-based RBV per local label for 24 weeks.</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA 23.0</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="28" subjects_at_risk="1596"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="40" subjects_at_risk="1596"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>ANAEMIA</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1596"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>ANGINA UNSTABLE</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1596"/>
              </event>
              <event>
                <sub_title>PALPITATIONS</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1596"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>ABDOMINAL PAIN UPPER</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1596"/>
              </event>
              <event>
                <sub_title>ANAL FISSURE</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1596"/>
              </event>
              <event>
                <sub_title>ASCITES</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1596"/>
              </event>
              <event>
                <sub_title>COLITIS</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1596"/>
              </event>
              <event>
                <sub_title>CONSTIPATION</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1596"/>
              </event>
              <event>
                <sub_title>DENTAL CARIES</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1596"/>
              </event>
              <event>
                <sub_title>DIARRHOEA</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1596"/>
              </event>
              <event>
                <sub_title>GASTRIC ULCER</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1596"/>
              </event>
              <event>
                <sub_title>OESOPHAGEAL VARICES HAEMORRHAGE</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1596"/>
              </event>
              <event>
                <sub_title>VARICES OESOPHAGEAL</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1596"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>DRUG INTERACTION</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1596"/>
              </event>
              <event>
                <sub_title>OEDEMA PERIPHERAL</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1596"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Hepatobiliary disorders</title>
            <event_list>
              <event>
                <sub_title>HEPATIC FAILURE</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1596"/>
              </event>
              <event>
                <sub_title>HEPATORENAL SYNDROME</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1596"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>APPENDICITIS</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1596"/>
              </event>
              <event>
                <sub_title>DERMATITIS INFECTED</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1596"/>
              </event>
              <event>
                <sub_title>ERYSIPELAS</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1596"/>
              </event>
              <event>
                <sub_title>INFLUENZA</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1596"/>
              </event>
              <event>
                <sub_title>PERITONITIS BACTERIAL</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1596"/>
              </event>
              <event>
                <sub_title>PNEUMONIA</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="1596"/>
              </event>
              <event>
                <sub_title>PYELONEPHRITIS</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1596"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>HEAD INJURY</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1596"/>
              </event>
              <event>
                <sub_title>RADIUS FRACTURE</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1596"/>
              </event>
              <event>
                <sub_title>TENDON RUPTURE</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1596"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>ALANINE AMINOTRANSFERASE INCREASED</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1596"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>DEHYDRATION</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1596"/>
              </event>
              <event>
                <sub_title>DIABETES MELLITUS</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1596"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>PATHOLOGICAL FRACTURE</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1596"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>HEPATOCELLULAR CARCINOMA</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="1596"/>
              </event>
              <event>
                <sub_title>MALIGNANT MELANOMA</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1596"/>
              </event>
              <event>
                <sub_title>PANCREATIC NEOPLASM</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1596"/>
              </event>
              <event>
                <sub_title>PAPILLARY THYROID CANCER</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1596"/>
              </event>
              <event>
                <sub_title>TUMOUR THROMBOSIS</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1596"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>CEREBROVASCULAR ACCIDENT</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1596"/>
              </event>
              <event>
                <sub_title>DIZZINESS POSTURAL</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1596"/>
              </event>
              <event>
                <sub_title>ENCEPHALOPATHY</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1596"/>
              </event>
              <event>
                <sub_title>PARAESTHESIA</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1596"/>
              </event>
              <event>
                <sub_title>PSYCHOMOTOR SKILLS IMPAIRED</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1596"/>
              </event>
              <event>
                <sub_title>SYNCOPE</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1596"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Pregnancy, puerperium and perinatal conditions</title>
            <event_list>
              <event>
                <sub_title>ABORTION SPONTANEOUS</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1596"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>AFFECT LABILITY</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1596"/>
              </event>
              <event>
                <sub_title>ANGER</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1596"/>
              </event>
              <event>
                <sub_title>INSOMNIA</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1596"/>
              </event>
              <event>
                <sub_title>MANIA</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1596"/>
              </event>
              <event>
                <sub_title>SCHIZOAFFECTIVE DISORDER</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1596"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>ACUTE KIDNEY INJURY</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1596"/>
              </event>
              <event>
                <sub_title>CALCULUS URINARY</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1596"/>
              </event>
              <event>
                <sub_title>NEPHROLITHIASIS</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1596"/>
              </event>
              <event>
                <sub_title>RENAL COLIC</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1596"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>ECZEMA</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1596"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>HYPERTENSION</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1596"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedDRA 23.0</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="805" subjects_at_risk="1596"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>DIARRHOEA</sub_title>
                <counts group_id="E1" events="112" subjects_affected="103" subjects_at_risk="1596"/>
              </event>
              <event>
                <sub_title>NAUSEA</sub_title>
                <counts group_id="E1" events="200" subjects_affected="186" subjects_at_risk="1596"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>ASTHENIA</sub_title>
                <counts group_id="E1" events="179" subjects_affected="165" subjects_at_risk="1596"/>
              </event>
              <event>
                <sub_title>FATIGUE</sub_title>
                <counts group_id="E1" events="331" subjects_affected="300" subjects_at_risk="1596"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>HEADACHE</sub_title>
                <counts group_id="E1" events="319" subjects_affected="291" subjects_at_risk="1596"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>INSOMNIA</sub_title>
                <counts group_id="E1" events="183" subjects_affected="179" subjects_at_risk="1596"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>PRURITUS</sub_title>
                <counts group_id="E1" events="209" subjects_affected="199" subjects_at_risk="1596"/>
              </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 Services</name_or_title>
      <organization>AbbVie</organization>
      <phone>800-633-9110</phone>
      <email>abbvieclinicaltrials@abbvie.com</email>
    </point_of_contact>
  </clinical_results>
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02219490
org study id: M14-423
secondary id: 2014-001022-14
nct id: NCT02219490
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
is us export: No
The purpose of this study was to evaluate the effect of treatment with ABT-450 co-formulated
      with ritonavir and ABT-267 (ABT-450/r/ABT-267) and ABT-333; 3-DAA regimen, with or without
      ribavirin (RBV) in adults with chronic hepatitis C virus genotype 1 (HCV GT1) infection.
This study (TOPAZ-I; M14-423), was a Phase 3b, open-label, multicenter study conducted
      outside of the United States which, together with its companion study TOPAZ-II (M14-222; NCT
      02167945) conducted in the United States, was designed with the primary objective of
      assessing the effect of treatment response on long-term clinical outcomes in adults with
      chronic HCV GT1 infection with or without compensated cirrhosis, who were either
      treatment-naïve or interferon/ribavirin (IFN/RBV) treatment- experienced. In both studies,
      participants were treated with the 3-DAA regimen with or without RBV. This study consisted of
      a screening period of up to 42 days, a treatment period of either 12 weeks for HCV
      GT1a-infected subjects without cirrhosis and for HCV GT1b-infected subjects without cirrhosis
      or with compensated cirrhosis or 24 weeks for GT1a-infected participants with compensated
      cirrhosis, and a 260-week post-treatment period.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: All-Cause Death: Time to Event
time frame: At Post-Treatment Weeks 52, 104, 156, 208, and 260
description: Time to all-cause death was defined as the number of days from the first day of study drug dosing for the participant to the date of death. All deaths were to be included, regardless of whether the death occurred while the participant was still taking study drug or had previously discontinued study drug. If the participant did not die, their data was to be censored at the date of their last available assessment of clinical outcomes. For participants with no post-baseline assessment, the participant's data was to be censored on the first day of study drug dosing. The event-free survival rates were estimated using Kaplan-Meier methodology and incidence estimates are presented with 95% confidence intervals. The pre-specified analysis of all-cause death included pooled data from TOPAZ-I (this study) and the companion study TOPAZ-II (M14-222; NCT02167945).
measure: Liver-Related Death: Time to Event
time frame: At Post-Treatment Weeks 52, 104, 156, 208, and 260
description: Time to liver-related death was defined as days from the 1st day of study drug dosing for the subject to date of liver-related death. All liver-related deaths were to be included, regardless of whether the death occurred while subject was still taking study drug or had previously discontinued study drug. If the subject didn't experience event of interest nor had died (all-cause death), their data was to be censored at date of last available assessment. For those with no post-baseline assessment, data was to be censored on 1st day of study drug dosing. All-cause death was a censoring event for liver-related death. The event-free survival rates were estimated using Kaplan-Meier methodology and incidence estimates are presented with 95% confidence intervals. The pre-specified analysis of liver-related death included pooled data from TOPAZ-I (this study) and the companion study TOPAZ-II (M14-222; NCT02167945).
measure: Liver Decompensation: Time to Event
time frame: At Post-Treatment Weeks 52, 104, 156, 208, and 260
description: Time to liver decompensation was defined as number of days from the 1st day of study drug dosing for the participant to the date of liver decompensation. All liver decompensation was to be included, regardless of whether it occurred while the participant was still taking study drug or had previously discontinued study drug. If the participant didn't experience the event of interest nor had died (all-cause death), their data was to be censored at the date of their last available assessment of clinical outcomes. For participants with no post-baseline assessment, their data was to be censored on the 1st day of study drug dosing. All-cause death was a censoring event for liver decompensation. The event-free survival rates were estimated using Kaplan-Meier methodology and incidence estimates are presented with 95% confidence intervals. The pre-specified analysis of liver decompensation included pooled data from TOPAZ-I (this study) and the companion study TOPAZ-II (M14-222; NCT02167945).
measure: Liver Transplantation: Time to Event
time frame: At Post-Treatment Weeks 52, 104, 156, 208, and 260
description: Time to liver transplantation was defined as days from 1st day of study drug dosing for subject to date of liver transplantation. All liver transplantation was to be included, whether it occurred while the subject was still taking study drug or had previously discontinued study drug. If the subject didn't experience event of interest nor had died (all-cause death), their data was to be censored at the date of their last available assessment. For those with no post-baseline assessment, data was to be censored on 1st day of study drug dosing. All-cause death was a censoring event for liver transplantation. The event-free survival rates were estimated using Kaplan-Meier methodology and incidence estimates are presented with 95% confidence intervals. The pre-specified analysis of liver transplantation included pooled data from TOPAZ-I (this study) and the companion study TOPAZ-II (M14-222; NCT02167945).
measure: Hepatocellular Carcinoma: Time to Event
time frame: At Post-Treatment Weeks 52, 104, 156, 208, and 260
description: Time to hepatocellular carcinoma (HCC) was defined as number of days from 1st day of study drug dosing for subject to date of hepatocellular carcinoma. All HCC was to be included, whether it occurred while subject was still taking study drug or had previously discontinued study drug. If the subject didn't experience the event of interest nor had died (all-cause death), their data was to be censored at the date of their last available assessment. For those with no post-baseline assessment, their data was to be censored on the 1st day of study drug dosing. All-cause death was a censoring event for HCC. The event-free survival rates were estimated using Kaplan-Meier methodology and incidence estimates are presented with 95% confidence intervals. The pre-specified analysis of hepatocellular carcinoma included pooled data from TOPAZ-I (this study) and the companion study TOPAZ-II (M14-222; NCT02167945).
measure: All-Cause Death, Liver-Related Death, Liver Decompensation, Liver Transplantation, Hepatocellular Carcinoma: Time to Event
time frame: At Post-Treatment Weeks 52, 104, 156, 208, and 260
description: Time to the composite of clinical outcomes is the time to the first occurrence of all-cause death, liver-related death, liver decompensation, liver transplantation, or hepatocellular carcinoma. All first occurrences were to be included, regardless of whether it occurred while the participant was still taking study drug or had previously discontinued study drug. If the participant did not experience any of these events, their data was to be censored at the date of their last available assessment of clinical outcomes. For participants with no post-baseline assessment, the participant's data was to be censored on the first day of study drug dosing. The event-free survival rates were estimated using Kaplan-Meier methodology and incidence estimates are presented with 95% confidence intervals. Pre-specified analysis included pooled data from this study and from TOPAZ-II; NCT02167945.
measure: Change From Baseline in FibroScan Score by SVR12 Status
time frame: At the final treatment visit and Post-Treatment Weeks 12, 24, 52, 104, 156, 208, and 260
description: The FibroScan test is a validated non-invasive test used to assess liver fibrosis in participants with chronic liver disease, and it was performed at study sites where it was available. For participants with Hepatitis C infection, a FibroScan score of 2-7 kPa indicates no liver scarring or mild scarring; a score of 8 or 9 is associated with moderate liver scarring; 9-14 indicates severe liver scarring; and 14 or higher is indicative of advanced liver scarring, cirrhosis. Negative changes from baseline indicate improvement in liver fibrosis.
measure: Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12)
time frame: 12 weeks after the last actual dose of study drug
description: SVR12 is defined as hepatitis C virus ribonucleic acid (HCV RNA) less than the lower limit of quantification (LLOQ) 12 weeks after the last actual dose of study drug. Flanking imputation, where applicable, was used to impute missing data. After applying flanking imputation, if there was no value in the window but there was an HCV RNA value from a local laboratory present, then it was to be imputed into the SVR window. Otherwise, participants with missing data were counted as failures.
arm group label: ABT-450/r/ABT-267 plus ABT-333 with or without ribavirin (RBV)
arm group type: Experimental
description: Participants with HCV GT1b without cirrhosis received the 3-DAA (ABT-450/ritonavir/ABT-267 and ABT-333) regimen: two 75 mg ABT-450/50 mg ritonavir/12.5 mg ABT-267 tablets taken orally every morning (QD) and one ABT-333 250 mg tablet taken orally twice a day (BID) for 12 weeks. Participants with HCV GT1a without cirrhosis and those with HCV GT1b with cirrhosis received the 3-DAA regimen and weight-based ribavirin (RBV; 1000 to 1200 mg divided twice daily per local label) for 12 weeks. Participants with HCV GT1a with cirrhosis received the 3-DAA regimen and weight-based RBV per local label for 24 weeks.
intervention type: Drug
intervention name: ABT-450/r/ABT-267
description: Tablet for oral use
arm group label: ABT-450/r/ABT-267 plus ABT-333 with or without ribavirin (RBV)
other name: ABT-450 also known as paritaprevir
other name: ABT-267 also known as ombitasvir
other name: Paritaprevir/ritonavir/ombitasvir also known as Viekirax
intervention type: Drug
intervention name: ABT-333
description: Tablet for oral use
arm group label: ABT-450/r/ABT-267 plus ABT-333 with or without ribavirin (RBV)
other name: ABT-333 also known as dasabuvir
other name: ABT-333 also known as Exviera
intervention type: Drug
intervention name: Ribavirin (RBV)
description: Ribavirin was provided as 200 mg tablets, and dosed based on weight,1000 to 1200 mg divided twice daily per local label. For example, for participants weighing < 75 kg, RBV may have been taken orally as 2 tablets in the morning and 3 tablets in the evening which corresponds to a 1000 mg total daily dose. For participants weighing ≥ 75 kg, RBV may have been taken orally as 3 tablets in the morning and 3 tablets in the evening which corresponds to a 1200 mg total daily dose.
arm group label: ABT-450/r/ABT-267 plus ABT-333 with or without ribavirin (RBV)
criteria: 
gender: All
minimum age: 18 Years
maximum age: 99 Years
healthy volunteers: No
last name: ABBVIE INC.
role: Study Director
affiliation: AbbVie
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: Algeria
country: Australia
country: Austria
country: Belgium
country: Bulgaria
country: Canada
country: Denmark
country: Finland
country: France
country: Germany
country: Greece
country: Ireland
country: Israel
country: Italy
country: Mexico
country: Netherlands
country: Norway
country: Poland
country: Portugal
country: Romania
country: Russian Federation
country: Saudi Arabia
country: Spain
country: Sweden
country: Switzerland
country: Turkey
country: United Kingdom
country: Qatar
country: United Arab Emirates
responsible party type: Sponsor
mesh term: Infections
mesh term: Communicable Diseases
mesh term: Hepatitis A
mesh term: Hepatitis C
mesh term: Hepatitis C, Chronic
mesh term: Hepatitis
mesh term: Hepatitis, Chronic
mesh term: Ritonavir
mesh term: Ribavirin
sharing ipd: Yes
ipd description: AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd info type: Clinical Study Report (CSR)
ipd time frame: For details on when studies are available for sharing, please refer to the link below.
ipd access criteria: Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous, independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Use Agreement (DUA). For more information on the process, or to submit a request, visit the following link.
ipd url: https://vivli.org/ourmember/abbvie/
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 