New studies that popped up in Clinical Trials.gov looking at Pharmasett's PSI-7977 with and without Peg in Genotypes 1, 2, 3, 4 and 5. Many thanks to the good people over at NATAP.org for the heads' up on these trials.
PSI-7977 With Pegylated Interferon and Ribavirin Hepatitis C Virus (HCV) Genotypes 1,4,5,6 (ATOMIC)
Open-Labeled Study of PSI-7977 and RBV With and Without PEG-IFN in Treatment-Naïve Patients With HCV GT2 or GT3
Showing posts with label genotype 3. Show all posts
Showing posts with label genotype 3. Show all posts
Thursday, June 2, 2011
Tuesday, February 22, 2011
Antiviral Activity of Boceprevir Monotherapy inTreatment-Naive Subjects With Chronic Hepatitis C Genotype 2/3...
(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.
"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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