This study will evaluate the safety, tolerability, and efficacy of vaniprevir when administered concomitantly with pegylated interferon (peg-IFN) and ribavirin (RBV) to treat treatment-naive genotype 1 hepatitis C virus (HCV)-infected patients.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
vaniprevir 300 mg soft gel capsules twice daily.
vaniprevir 600 mg soft gel capsules twice daily.
Peg-IFN 180 mcg/0.5 mL subcutaneous injection once weekly
Proportion of patients achieving SVR24 in Treatment Regimens 1 to 4
Time frame: 24 weeks after end of study therapy
Evaluate the safety and tolerability of the MK7009 treatment regiments as assessed by review of the accumulated safety data
Time frame: 72 Weeks
1) Proportion of patients achieving SVR24 in Treatment Regimen 5
Time frame: 1) 24 weeks after end of study therapy
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Ribavirin, at a total daily dose of 1000 mg or 1200 mg based on patient weight, will be administered twice daily.
Placebo to vaniprevir soft gel capsules twice daily.