(From the APASL conference in Thailand. Thanks to Jules Levin and NATAP for the info. Looks like higher trough concentrations of BOC may result in better viral suppression of Genotype 2/3.)
"4 of 6 subjects receiving 400 mg TID had a >1 log drop in HCV-RNA"
Reported by Jules Levin
Presented at the 21st Conference of the Asian Pacific Association for the Study of the Liver; February 17-20, 2011; Bangkok, Thailand.
M. Silva,1 C. Kasserra,2 S. Gupta,2 M. Treitel,2 E. Hughes,3 E. O'Mara2 1Hospital Universitario Austral, Pilar, Argentina; 2Merck Research Laboratories, Kenilworth, NJ, USA;3Former employee of Merck Research Laboratories, Kenilworth, NJ, USA
AUTHOR CONCLUSIONS
· Boceprevir 400 mg TID is associated with a decrease in HCV-RNA in subjects with HCV G2/3 infection that is comparable to the viral load drop seen in G1 subjects receiving the same monotherapy dose in a previous study
· Boceprevir trough concentrations in the 400 mg TID group were higher than the other BID groups and may be associated with the better viral responses that were observed
· Evaluation of the clinical dose of boceprevir (800 mg TID) as a component of triple therapy for G2/3-infected subjects is of potential clinical interest
· Overall, boceprevir was well tolerated at doses of 200 mg BID, 400 mg BID, and 400 mg TID
ABSTRACT
Aim: To examine the effect of boceprevir, a novel hepatitis C virus (HCV) protease inhibitor, on HCV-RNA levels in subjects with HCV genotype (G) 2/3 infection.
Methods: This was a randomized, placebo-controlled study evaluating the antiviral activity of boceprevir monotherapy 200 mg BID (n = 11), 400 mg BID (n = 12), and 400 mg TID (n = 6) or placebo (n = 10) for 14 days in treatment-naive subjects.
Results: The maximum mean decrease in HCV-RNA was -0.37 log, -0.24 log, -1.60 log and 0.21 log in the 200 mg BID, 400 mg BID, 400 mg TID and placebo groups, respectively. Decreases in HCV-RNA in subjects receiving 200 mg BID and 400 mg BID were similar to placebo; however, the decrease in HCV-RNA in subjects receiving 400 mg TID was markedly different from placebo. At end of treatment, 4 of 6 subjects receiving 400 mg TID had a >1 log drop in HCV-RNA. Although the sample size was small, responses appeared similar in G2 (n = 9) and G3 (n = 30) subjects. Pharmacokinetic analysis revealed a less than dose proportional increase in bioavailability. Overall, boceprevir was well-tolerated.
Conclusion: Boceprevir (400 mg TID) is associated with a decrease in HCV-RNA in subjects with HCV G2/3 infection, comparable to the viral load drop seen in G1 subjects receiving the same monotherapy dose in a previous study. Evaluation of the clinical dose of boceprevir (800 mg TID) as a component of triple therapy for G2/3-infected subjects with detectable HCV RNA at week 4 is of potential clinical interest.
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