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Safety & Efficacy of Boceprevir/Peginterferon/Ribavirin for HCV G1 Compensated Cirrhotics: Meta-Analysis of 5 Trials
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EASL/2013: Safety & Efficacy of Boceprevir/PegInterferon/Ribavirin (BOC/P/R) Combination Therapy for Chronic HCV G1 Patients with Compensated Cirrhosis: A Meta-Analysis of Five Phase 3 Clinical Trials.......http://www.natap.org/2013/EASL/EASL_47.htm
Journal of Hepatology Article in Press April 17 2014
Abstract
Background & Aims
HCV-infected cirrhotics may urgently need therapy but are often under-represented in clinical trials resulting in limited data to guide their management. We performed a meta-analysis of well-compensated cirrhotic patients from five Phase 3 trials.
Methods
Patients received P/R (peginterferon/ribavirin; 4 weeks) followed by BOC(boceprevir)/P/R or P/R for 24, 32 or 44 weeks. Sustained virologic response (SVR) rates were calculated by Metavir score. Multivariate logistic regression (MLR) models identified baseline and on-treatment predictors of SVR. Safety was evaluated by adverse-event (AE) reporting and laboratory monitoring.
Results
Pooled meta-estimates for SVR rates (95% confidence interval) in 212 F4 (cirrhotic) patients were 55% (43, 66) with BOC/P/R vs.17% (0, 41) with P/R. MLR identified 4 predictors of SVR in F3/F4 patients: undetectable HCV-RNA at treatment week (TW) 8; ≥1 log10 decline in HCV-RNA from baseline at TW4; male; and baseline HCV-RNA ≤800,000 IU/mL. SVR rate was 89% (65/73) in F4 patients who were HCV-RNA undetectable at TW8. No F3(0/5) or F4(0/17) patients with <3 log10 decline and detectable HCV-RNA at TW8 achieved SVR. Anemia and diarrhea occurred more frequently in cirrhotic than non-cirrhotic patients. Serious AEs, discontinuations due to an AE, interventions to manage anemia, infections and thrombocytopenia occurred more frequently in cirrhotics with BOC/P/R than P/R. Potential hepatic decompensation and/or sepsis were identified in 2 P/R and 3 BOC/P/R recipients.
Conclusions
BOC/P/R appears to have a generally favorable benefit-risk profile in compensated cirrhotic patients. SVR rates were particularly high in cirrhotic patients with undetectable HCV-RNA at TW8.
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