Boceprevir in Combination With Peginterferon Alfa-2a and Ribavirin in Participants With Chronic Hepatitis C Genotype 1 Who Failed Prior Treatment With Peginterferon/Ribavirin (Study P05685AM2)(COMPLETED)

Phase 3 Completed 202 enrolled Merck Sharp & Dohme LLC

RandomizedParallel-groupQuadruple-blindTreatment

Summary

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.

Timeline

Start: 2009-02
Primary completion: 2010-10
Completion: 2010-10

Outcome

Met primary endpoint

paper significantly increased the rate of SVR from 21% in the PEG2a/R group to 64% in the BOC/PEG2a/R group (P < .0001). PMID 23064222 ↗

Publications

Flamm SL, Lawitz E, Jacobson I, Bourliere M, Hezode C, Vierling JM, Bacon BR, Niederau C, Sherman M, Goteti V, Sings HL, Barnard RO, Howe JA, Pedicone LD, Burroughs MH, Brass CA, Albrecht JK, Poordad F. Boceprevir with peginterferon alfa-2a-ribavirin is effective for previously treated chronic hepatitis C genotype 1 infection. Clin Gastroenterol Hepatol. 2013 Jan;11(1):81-87.e4; quiz e5. doi: 10.1016/j.cgh.2012.10.006. Epub 2012 Oct 10.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Boceprevir	Small molecule	800 mg	Oral
Background	Peginterferon alfa-2a	Protein / enzyme biologic	180 ug	Subcutaneous
Background	Ribavirin	Small molecule	1000 mg	Oral
Background	Ribavirin	Small molecule	1200 mg	Oral