Summary:
A randomized, placebo-controlled, phase 2a study of bms-824393 in combination with peginterferon alfa-2a (pegasys®) and ribavirin (copegus®) in treatment-naïve subjects with chronic hepatitis c virus genotype 1.
Qualified Participants Must:
• Be chronically infected with HCV genotype 1 as documented by
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Be positive for anti-HCV antibody, HCV RNA, or positive HCV genotype test at least 6 months prior to screening, and positive for HCV RNA and anti-HCV antibody at the time of screening, or
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Be positive for anti-HCV antibody and HCV RNA at the time of screening with a documented liver biopsy consistent with chronic HCV infection, such as the presence of fibrosis
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Have HCV RNA viral load 105 IU/mL (100,000 IU/mL) at screening
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Be IFN and RBV treatment-naive (defined as less than 4 weeks of total therapy with either IFN, pegIFN, or RBV at any time and with no exposure to IFN, pegIFN or RBV in the 24 weeks prior to randomization)
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Have results of a liver biopsy obtained ≤ 24 months prior to randomization without evidence of cirrhosis on the biopsy
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Have results of an ultrasound (U/S), computed tomography (CT) scan, or magnetic resonance imaging (MRI) within 12 months of randomization without evidence of HCC