Based on previous experience with peginterferon alfa-2b/ribavirin in combination with boceprevir, the combination with peginterferon alfa- 2a/ribavirin and boceprevir is expected to be safe and well tolerated. Given the wide utilization of both peginterferons and the clear benefit of the addition of boceprevir to peginterferon alfa-2b/ribavirin, it is important to demonstrate the safety and efficacy of boceprevir in combination with peginterferon alfa-2a/ribavirin.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
202
800 mg, using SCH 503034 200-mg capsules, three times a day (TID) orally (PO) for 48 weeks
800 mg, using placebo matching SCH 503034 200-mg capsules, three times a day (TID) orally (PO) for 48 weeks
Peginterferon alfa-2a, pre-filled syringes, given 180 μg/week subcutaneously (SC) for 48 weeks
Ribavirin 200-mg capsules, weight-based dosing * \<75 kg, 1000 mg/day orally (PO), divided twice daily (BID) * \>=75 kg, 1200 mg/day PO, divided BID for 48 weeks
Sustained Virologic Response (SVR) Rate in Full Analysis Set (FAS) Population.
SVR rate was the percentage of participants treated with at least one dose of study medication (PEG2a, Ribavirin, or Boceprevir/Placebo) who had achieved SVR. SVR was defined as undetectable Hepatitis C Virus-Ribonucleic Acid (HCV RNA).
Time frame: Follow-up Week 24
SVR Rate in the Modified Intent-to-Treat (mITT) Population
SVR rate was the percentage of participants treated with at least one dose of study medication (Boceprevir/PEG2a/Ribavirin or PEG2a/Ribavirin). Participants who discontinued study drugs during the 4-week PEG2a/Ribavirin lead-in period were not included in the mITT population.
Time frame: Follow-up Week 24
Percentage of Participants With Early Virologic Response (EVR) Who Achieved SVR
EVR was defined as the time to the first undectectable HCV-RNA result at Treatment Week (TW) 2, 4, 8, or 12. Participants with a detectable, but not quantifiable HCV-RNA result at TW 12 may have undergone retesting. Participants with a detectable result on retesting were to be discontinued per the 12-week futility rule. Participants with an undetectable result on retesting were allowed to continue on treatment, and the detectable but not quantifiable result was to be considered a false positive.
Time frame: Day 1 to Treatment Week 12
Number of Participants With Undetectable HCV-RNA at Follow-up Week 12
Time frame: Follow-up Week 12
Mean Log Change From Baseline to TW 4 in Viral Load by Visit
HCV-RNA levels were quantified using the Roche Cobas Taqman 1.0 assay; lower limit of detection of 15 international units \[IU\]/mL. Changes in HCV-RNA IU/ml were expressed on a log10 scale.
Time frame: From Baseline to TW 4
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.