Boceprevir: a recently approved protease inhibitor for hepatitis C virus infection.

Purpose: The pharmacologic properties, clinical efficacy, and safety profile of the first oral protease inhibitor approved for the treatment of chronic infection with hepatitis C virus (HCV) genotype 1 are reviewed.

Summary: Boceprevir, approved by the Food and Drug Administration as an adjunct to the standard regimen for HCV genotype 1 infection (peginterferon alfa and ribavirin), is available in 200-mg capsules, to be administered thrice daily at seven-to nine-hour intervals (total daily dose, 2400 mg). In two Phase III clinical trials involving a total of nearly 1500 previously untreated patients who were not sufficiently responsive to or had relapsed after standard therapy, the adjunctive use of boceprevir was associated with significantly higher rates of sustained virologic response and a shorter cumulative duration of treatment.