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This study evaluates the drugs Asunaprevir (ASV) and Daclatasvir (DCV), sometimes together with Pegylated-interferon alfa 2a (PegIFN) and Ribavirin (RBV), in people with chronic hepatitis C virus (genotype 1b) infection. It enrolled adults aged 18 and older who had previously not responded, partially responded, could not tolerate, or had never received treatment. The study was carried out in Phase 3 and has been completed.
The summary above is a plain-language rendering of the official record. The original English title is shown for reference.
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Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com Inclusion Criteria: * Males and females, ≥ 18 years of age * HCV Genotype 1b who previously failed treatment with peginterferon alfa and ribavirin, classified as previous null or partial responders based on previous therapy, OR intolerant or ineligible to P/R due to neutropenia, anemia, depression or thrombocytopenia with fibrosis/cirrhosis, OR treatment naive * HCV RNA ≥ 10,000 IU/mL * Seronegative for Human immunodeficiency virus (HIV) and Hepatitis B surface antigen (HBsAg) * Subjects with compensated cirrhosis are permitted (compensated cirrhotics are capped at approximately 25% of treated population) Exclusion Criteria: * Prior treatment of HCV with HCV direct acting antiviral (DAA) * Evidence of a medical condition contributing to chronic liver disease other than HCV * Evidence of decompensated liver disease including, but not limited to, a history or presence of ascites, bleeding varices, or hepatic encephalopathy * Diagnosed or suspected hepatocellular carcinoma or other malignancies * Uncontrolled diabetes or hypertension