80% SVR regardless of telaprevir dosing frequency:8 or 12 Hours

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

Gastroenterology
Volume 140, Issue 2 , Pages 459-468.e1, February 2011

Patrick Marcellin, Xavier Forns, Tobias Goeser, Peter Ferenci, Frederik Nevens, Giampiero Carosi, Joost P. Drenth, Lawrence Serfaty, Koen De Backer, Rolf Van Heeswijk, Donghan Luo, Gaston Picchio, Maria Beumont

Abstract

Background & Aims
Recent studies have shown that 12 weeks of treatment with telaprevir, administered every 8 hours (q8h), combined with pegylated interferon (peginterferon) alfa-2a plus 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 alfa-2b.

Methods
Treatment-naive 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/wk) and ribavirin (1000–1200 mg/day) or peginterferon alfa-2b (1.5 μg·kg−1·wk−1) and ribavirin (800–1200 mg/day). Patients received triple therapy for 12 weeks, followed by 12 or 36 additional weeks of treatment with peginterferon alfa and ribavirin, based on virologic response.

Results
Baseline characteristics were similar for all groups. SVR rates were 81.0% to 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 ≥ .787), between the pooled q8h and q12h groups (P = .997), or between the pooled peginterferon alfa-2a/ribavirin and peginterferon alfa-2b/ribavirin groups (P = .906). The safety profile was similar among all groups.

Conclusions
A high proportion (>80%) of patients achieved an SVR regardless of the telaprevir dosing frequency (q8h or q12h) or type of peginterferon alfa used (alfa-2a or alfa-2b).

http://www.gastrojournal.org/article/S0016-5085(10)01584-2/abstract