Phase III China GT 1b Interferon (IFN) Intolerant Prev Exclude Dual

Inclusion Criteria

• •For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com
• •Males and females, ≥ 18 years of age
• •Subjects chronically infected with HCV Genotype (GT)-1b only as documented by positive HCV RNA and anti-HCV antibody at screening and either:
• •1. Positive anti-HCV antibody, HCV RNA or positive HCV genotype test at least 6 months prior to screening
• •or
• •2. Liver biopsy consistent with chronic HCV infection (evidence of fibrosis and/or inflammation)
• •Subjects who are intolerant to previous therapy with Interferon Alfa (IFNα) either with or without Ribavirin (RBV) (I±R)(independent of previous response to therapy) or ineligible for I±R and who meet one of the criteria below:
• •1. Anemia: the I±R intolerants are subjects who were previously treated with IFNα/RBV therapy and had a decline in hemoglobin to \< 8.5 g/dL during therapy (documented); the I±R ineligibles are subjects who have a screening hemoglobin \< 10.0 g/dL and ≥ 8.5 g/dL
• •OR
• •2. Neutropenia: the I±R intolerants are subjects who were previously treated with IFNα/RBV therapy and had a decline in absolute neutrophil count (ANC) to \< 0.5 x 10(9) during therapy (documented); the I±R ineligibles are subjects who have a screening ANC \< 1.5 x 10(9) cells/L and ≥ 0.5 x 10(9) cells/L
• •OR
• •3. Thrombocytopenia: the I±R intolerants are subjects who were previously treated with IFNα/RBV therapy and had a decline in platelet counts \< 25,000 cells/mm3 during therapy (documented); the I±R ineligibles are subjects who have a screening platelet count of \< 90 x 10(9) cells/L and ≥ 50 x 10(9) cells/L
• •HCV RNA ≥ 10,000 IU/mL
• •Seronegative for Human Immunodeficiency Virus (HIV) and hepatitis B surface antigen (HBsAg)
• •Body Mass Index (BMI) of 18 to 35 kg/m2, inclusive. BMI = weight (kg)/ \[height(m)\]2 at screening
• •Subjects with compensated cirrhosis are permitted (compensated cirrhotics are capped at approximately 40%). If a subject does not have cirrhosis, a liver biopsy within three years prior to enrollment is required to demonstrate the absence of cirrhosis. If cirrhosis is present, any prior liver biopsy is sufficient. For countries where liver biopsy is not required prior to treatment and where noninvasive imaging tests (Fibroscan® ultrasound) are approved for staging of liver disease, non-invasive imaging test results may be used to assess the extent of liver disease