A study to evaluate how effective different levels of Vaniprevir (MK-7009), when administered with Pegylated-Interferon (Peg-IFN) and Ribavirin, are at achieving rapid viral response (RVR) i.e., undetectable hepatitis C virus \[HCV\] viral ribonucleic acid \[RNA\] at Week 4 in participants with chronic HCV infection. The primary hypothesis was that the proportion of participants in one or more of the Vaniprevir treatment groups achieving RVR would be greater than the proportion of placebo participants achieving RVR when Vaniprevir and placebo were co-administered with Peg-IFN/Ribavirin.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
95
Vaniprevir 300 mg b.i.d., 600 mg b.i.d., 600 mg q.d., or 800 mg q.d.; duration of treatment: 28 days
Peg-IFN 180 mcg once-weekly subcutaneous injection; duration of treatment: 48 weeks
Ribavirin 200 mg tablet b.i.d. (dose based on body weight); duration of treatment: 48 weeks
Matching placebo to vaniprevir; duration of treatment: 28 days
Percentage of Participants Achieving RVR
Rapid Viral Response (RVR) was declared if Hepatitis C Virus (HCV) ribonucleic acid (RNA) was undetectable at Week 4.
Time frame: Week 4
Number of Participants Experiencing an Adverse Event (AE)
The number of participants experiencing AEs in each treatment group was monitored during the Vaniprevir/Placebo treatment (Day 1 to Day 28) and safety follow-up (Day 29 to Day 42) periods.
Time frame: Up to Day 42
Number of Participants Discontinuing From Study Therapy Due to AEs
An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of study therapy, whether or not considered related to the use of the product.
Time frame: Day 1 to Day 28
Number of Participants With ≥2-log10 Decrease in HCV RNA
The number of participants with at least a 2-log10 decrease from baseline in HCV RNA following 4 weeks of treatment with Placebo or Vaniprevir.
Time frame: Baseline and Week 4
Number of Participants With ≥3-log10 Decrease in HCV RNA
The number of participants with at least a 3-log10 decrease from baseline in HCV RNA following 4 weeks of treatment with Placebo or Vaniprevir.
Time frame: Baseline and Week 4
Mean Log Change From Baseline in HCV RNA
The mean changes from baseline in log10 HCV RNA in each vaniprevir group was compared against control treatment at Week 4.
Time frame: Baseline and Week 4
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