Ph IIA Study (SOC +/- NS5B)
Ph IIA Study (SOC +/- NS5B)
At least 1 dose of BMS-791325 can be identified which is safe, well tolerated, and
 efficacious when combined with peg-interferon alfa-2a (pegIFNα-2a)/ribavirin (RBV) for the
 treatment of treatment-naïve, chronically-infected hepatitis C virus (HCV) genotype 1
 subjects
Inclusion Criteria:

 -  Subjects chronically infected with HCV genotype 1 as documented by: positive for
 anti-HCV antibody, HCV RNA, or a positive HCV genotype test at least 6 months prior to
 Screening, and positive for HCV RNA and anti-HCV antibody at Screening

 -  HCV RNA ≥ 10*5* IU/mL at Screening

 -  Less than 4 weeks total prior therapy with an IFN formulation (ie, IFNα, pegIFNα-2a),
 or RBV and no exposure to IFN or RBV within 24 weeks of Randomization

 -  Results of a biopsy obtained ≤ 24 months prior to Randomization showing no evidence of
 cirrhosis

 -  Body Mass Index (BMI) of 18 to 35 kg/m², inclusive. BMI = weight (kg)/ [height (m)]²
 at Screening

 Exclusion Criteria:

 -  Liver transplant recipients

 -  Documented or suspected HCC by imaging or liver biopsy

 -  Evidence of a medical condition associated with chronic liver disease other than HCV
 (such as but not limited to: hemochromatosis, autoimmune hepatitis, metabolic liver
 disease, alcoholic liver disease, toxin exposures)

 -  History of chronic hepatitis B virus (HBV) as documented by HBV serologies (eg.
 HBsAg-seropositive). Patients with resolved HBV infection may participate (eg.
 HBsAb-seropositive)

 -  Current or known history of cancer (except in situ carcinoma of the cervix or
 adequately treated basal or squamous cell carcinoma of the skin) within 5 years prior
 to enrollment