Effect of Boceprevir on HCV-specific T Cell Responses

Inclusion Criteria: Subjects must meet all of the following inclusion criteria to be eligible for participation in this study. * Male or female, aged from 18 to 70 years old, inclusive. * Willing and able to provide written informed consent * Chronic HCV infection for at least 6 month prior to baseline (Day 1) in subjects currently positive for HCV-RNA and anti-HCV antibody documented by: * A positive anti-HCV antibody test, positive HCV-RNA assay, or HCV genotype test at least 6 month prior to baseline (Day 1) or * A liver biopsy performed prior to baseline (Day 1) with evidence of chronic HCV infection * Subjects must have liver biopsy results (performed no more than two years prior the screening) indicating the absence of cirrhosis * HCV infection limited to genotype 1 * Detectable plasma HCV-RNA at screening * BMI between 18 and 36 Kg/m2 * Eligible subjects must also be HCV treatment-naïve, defined as no prior exposure to PEG-INF and ribavirin, and must be eligible to standard of care therapy with PEG/RBV * Subjects must have the following laboratory parameters at screening: ALT and AST ≤ 5 x upper limit of normal range (ULN) Hemoglobin (Hb) ≥ 12 g/dl WBC ≥ 2.500 cells/μL with absolute neutrophil count ≥ 1500 cells/μL If a woman of childbearing potential, must have negative serum β-human chorionic gonadotropin (β-HCG) pregnancy test documented at the screening visit and a negative serum or urine pregnancy test before the first dose of study drug to ensure that they are not pregnant at the time of starting treatment A female subjects of childbearing potential and nonvasectomized male subjects with a female partners of childbearing potential must agree that they and their partner will use effective contraception (two separate forms of contraception simultaneously, one of which must be a male condom with spermicide) from screening throughout the duration of study treatment and for at least 7 months Exclusion Criteria: * Pregnant women or women who may wish to become pregnant during the course of the study * Male with a female who is pregnant or is planning to become pregnant within seven month the study of anticipated last dose of ribavirin * Evidence of infection or co-infection with a no-genotype 1 HCV-strain * History of hemoglobinopathy * History of sarcoidosis * History of invasive malignancy diagnosed or treated within 5 years. * Untreated or significant psychiatric illnesses including severe depression, schizophrenia, psychosis, history of a suicide attempt * Co-infection with HBV or HIV * Chronic use of systemic immunosuppressive agents * Presence of autoimmune disorders; subjects with treated hypothyroidism with normal TSH may be enrolled * History of significant cardiac disease * Clinical evidence of chronic pulmonary disease * Known cirrhosis * History of solid organ transplantation * Suspicion of hepatocellular carcinoma * Chronic liver disease of a non-HCV etiology * Ongoing alcohol abuse * History of clinical relevant drug abuse * Positive urine screen for cocaine, opiate etc, or methadone use