Boceprevir for untreated chronic HCV genotype 1 infection
Background: Peginterferon-ribavirin therapy is the current standard of care for chronic infection with hepatitis C virus (HCV). The rate of sustained virologic response has been below 50% in cases of HCV genotype 1 infection. Boceprevir, a potent oral HCV-protease inhibitor, has been evaluated as an additional treatment in phase 1 and phase 2 studies. Methods: We conducted a double-blind study in which previously untreated adults with HCV genotype 1 infection were randomly assigned to one of three groups. In all three groups, peginterferon alfa-2b and ribavirin were administered for 4 weeks (the leadin period). Subsequently, group 1 (the control group) received placebo plus peginterferon-ribavirin for 44 weeks; group 2 received boceprevir plus peginterferon-ribavirin for 24 weeks, and those with a detectable HCV RNA level between weeks 8 and 24 received placebo plus peginterferon-ribavirin for an additional 20 weeks; and group 3 received boceprevir plus peginterferon- ribavirin for 44 weeks. Nonblack patients and black patients were enrolled and analyzed separately. Results: A total of 938 nonblack and 159 black patients were treated. In the nonblack cohort, a sustained virologic response was achieved in 125 of the 311 patients (40%) in group 1, in 211 of the 316 patients (67%) in group 2 (P<0.001), and in 213 of the 311 patients (68%) in group 3 (P<0.001). In the black cohort, a sustained virologic response was achieved in 12 of the 52 patients (23%) in group 1, in 22 of the 52 patients (42%) in group 2 (P = 0.04), and in 29 of the 55 patients (53%) in group 3 (P = 0.004). In group 2, a total of 44% of patients received peginterferon-ribavirin for 28 weeks. Anemia led to dose reductions in 13% of controls and 21% of boceprevir recipients, with discontinuations in 1% and 2%, respectively. Conclusions: The addition of boceprevir to standard therapy with peginterferon-ribavirin, as compared with standard therapy alone, significantly increased the rates of sustained virologic response in previously untreated adults with chronic HCV genotype 1 infection. The rates were similar with 24 weeks and 44 weeks of boceprevir. (Funded by Schering-Plough [now Merck]; SPRINT-2 ClinicalTrials.gov number, NCT00705432.) Copyright © 2011 Massachusetts Medical Society.
Poordad, F; McCone, J; Bacon, BR; Bruno, S; Manns, MP; Sulkowski, MS; Jacobson, IM; Reddy, KR; Goodman, ZD; Boparai, N; DiNubile, MJ; Sniukiene, V; Brass, CA; Albrecht, JK; Bronowicki, JP; Colombato, L; Curciarello, J; Silva, M; Tanno, H; Terg, R; Adler, M; Langlet, P; Lasser, L; Nevens, F; Anderson, F; Bailey, R; Bilodeau, M; Cooper, C; Feinman, SV; Heathcote, J; Levstik, M; Ramji, A; Sherman, M; Shafran, S; Yoshida, E; Achim, A; Ben Ali, S; Bigard, MA; Bonny, C; Bourliere, M; Boyer-Darrigrand, N; Canva, V; Couzigou, P; De Ledinghen, V; Guyader, D; Hezode, C; Larrey, D; Latournerie, M; Marcellin, P; Mathurin, P; Maynard-Muet, M; Moussalli, J; Poupon, R; Poynard, T; Serfaty, L; Tran, A; Trepo, C; Truchi, R; Zarski, JP; Berg, T; Dikopoulos, N; Eisenbach, C; Galle, PR; Gerken, G; Goeser, T; Gregor, M; Klass, D; Kraus, MR; Niederau, C; Schlaak, JF; Schmid, R; Thies, P; Schmidt, K; Thimme, R; Weidenbach, H; Zeuzem, S; Angelico, M; Carosi, G; Craxì, A; Mangia, A; Pirisi, M; Rizzetto, M; Taliani, G; Zignego, AL; Reesink, HW; Serejo, F; Reymunde, A; Rosado, B; Torres, E; Barcena Marugan, R; De La Mata, M; Calleja, JL; Castellano, G; Diago, M; Esteban, R; Fernandez-Rodriguez, C; Sanchez Tapias, J; Serra Desfilis, MA; Afdhal, N; Al-Osaimi, A
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