A Pilot Study of Boceprevir for the Treatment of Genotype 6 HCV

Inclusion Criteria

• •Male or female, at least 18 years of age
• •Asian background
• •HCV treatment-naïve.
• •Chronic HCV infection is defined as one of the following:
• •Positive for anti-HCV antibody (Ab) or HCV RNA at least 6 months before Screening, and positive for HCV RNA and anti-HCVAb at the time of Screening; or
• •Positive for anti-HCV Ab and HCV RNA at the time of Screening with a liver biopsy consistent with chronic HCV infection (or a liver biopsy performed prior to enrollment with evidence of chronic hepatitis C disease).
• •Screening laboratory result indicating HCV genotype 6-infection (HCV-6).
• •Plasma HCV RNA level \> 10,000 IU/mL at Screening.
• •IL28B C/C genotype (rs12979860)
• •Per local standard practice, documented results of one of the following:
• •A liver biopsy within 24 months prior to or during screening demonstrating the absence of cirrhosis, e.g., a METAVIR Score of 3 or less, Ishak score of 4 or less; or
• •A screening FibroTest score of ≤ 0.72 and Aspartate Aminotransferase to Platelet Ratio Index (APRI) ≤ 2; or
• •A screening FibroScan result of \< 9.6 kPa.
• •Subjects with a non-qualifying Fibrotest/APRI or Fibroscan result may only be enrolled if they have a qualifying liver biopsy preformed within 24 months prior to or during screening.
• •Candidate for PEG/RBV therapy
• •Body mass index (BMI) between 18 and 36 kg/m2
• •Agree to use two highly effective methods of avoiding contraception for the duration of the study and for 7 months after the last dose study medication. Females of childbearing potential must have negative pregnancy test at Screening and Baseline
• •Provide written informed consent to participate in the study.
• •Subjects must have the following laboratory parameters at Screening:
• •ALT ≤ 10 × the upper limit of normal (ULN)
• •AST ≤ 10 × ULN
• •Hemoglobin ≥ 12 g/dL
• •White blood cell count ≥ 2,500 cells/μL
• •Absolute neutrophil count (ANC) ≥ 1,500 cells/mm3
• •Platelets ≥ 90,000/mm3
• •Prothrombin time ≤ 1.5 × ULN
• •Albumin \> 3 g/dL
• •Direct (conjugated) bilirubin \< ULN
• •Thyroid stimulating hormone (TSH) ≤ ULN
• •Creatinine clearance (CLcr) ≥ 50 mL/min, as calculated by the Cockcroft-Gault equation