Telaprevir is Effective Given Every 8 or 12 Hours with Ribavirin and Peginterferon Alfa-2a or 2b to Patients with Chronic Hepatitis C

Gastroenterology. 2010 Oct 26. [Epub ahead of print]

Marcellin P, Forns X, Goeser T, Ferenci P, Nevens F, Carosi G, Drenth JP, Serfaty L, De Backer K, Van Heeswijk R, Luo D, Picchio G, Beumont M.

Service d'Hépatologie and Inserm CRB3, Hôpital Beaujon, APHP University of Paris, Clichy, France.

Abstract

BACKGROUND & AIMS: Recent studies demonstrated that 12 weeks of telaprevir, administered every 8 hours (q8h), combined with peginterferon alfa-2a plus ribavirin (peginterferon alfa-2a/ribavirin), significantly increased the rate of hepatitis C virus (HCV) eradication (sustained virologic response [SVR]) in patients infected with HCV genotype-1 compared with approved therapy. We investigated the efficacy, safety, tolerability, and pharmacokinetics of telaprevir given q8h or every 12 hours (q12h), in combination with peginterferon alfa 2a or 2b.

METHODS: Treatment-naïve patients (n=161) infected with HCV genotype-1 were randomly assigned to groups that were given open-label telaprevir (750 mg q8h or 1125 mg q12h), in combination with standard doses of peginterferon alfa-2a (180 μg/week) and ribavirin (1000-1200 mg/day) or peginterferon alfa-2b (1.5 μg/kg/week) and ribavirin (800-1200 mg/day). Patients received triple therapy for 12 weeks, followed by 12 or 36 additional weeks of peginterferon alfa and ribavirin, based on virologic response.

RESULTS: Baseline characteristics were similar for all groups. SVR rates were 81.0%-85.0% among groups; most patients received 24 weeks of therapy (68.0%). There were no significant differences in SVR rates (intent-to-treat analysis) among groups (P≥0.787), between the pooled q8h and q12h groups (P = 0.997), or between the pooled peginterferon alfa-2a/ribavirin and peginterferon alfa-2b/ribavirin groups (P = 0.906). The safety profile was similar among all groups.

CONCLUSIONS: A high proportion (>80%) of patients achieved a SVR regardless of the telaprevir dosing frequency (q8h or q12h) or type of peginterferon alfa used (alfa-2a or alfa-2b). All studies published in Gastroenterology are embargoed until 3PM ET of the day they are published as corrected proofs on-line. Studies cannot be publicized as accepted manuscripts or uncorrected proofs.

Copyright © 2010 AGA Institute. Published by Elsevier Inc. All rights reserved.

PMID: 21034744 [PubMed - as supplied by publisher]

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