Boceprevir for untreated chronic HCV genotype 1 infection

Fred Poordad, Jonathan McCone, Bruce R. Bacon, Savino Bruno, Michael P. Manns, Mark S. Sulkowski, Ira M. Jacobson, K. Rajender Reddy, Zachary D. Goodman, Navdeep Boparai, Mark J. DiNubile, Vilma Sniukiene, Clifford A. Brass, Janice K. Albrecht, Jean Pierre Bronowicki, L. Colombato, J. Curciarello, M. Silva, H. Tanno, R. TergM. Adler, P. Langlet, L. Lasser, F. Nevens, F. Anderson, R. Bailey, M. Bilodeau, C. Cooper, S. V. Feinman, J. Heathcote, M. Levstik, A. Ramji, M. Sherman, S. Shafran, E. Yoshida, A. Achim, S. Ben Ali, M. A. Bigard, C. Bonny, M. Bourliere, N. Boyer-Darrigrand, V. Canva, P. Couzigou, V. De Ledinghen, D. Guyader, C. Hezode, D. Larrey, M. Latournerie, P. Marcellin, P. Mathurin, M. Maynard-Muet, J. Moussalli, R. Poupon, T. Poynard, L. Serfaty, A. Tran, C. Trepo, R. Truchi, J. P. Zarski, T. Berg, N. Dikopoulos, C. Eisenbach, P. R. Galle, G. Gerken, T. Goeser, M. Gregor, D. Klass, M. R. Kraus, C. Niederau, J. F. Schlaak, R. Schmid, P. Thies, K. Schmidt, R. Thimme, H. Weidenbach, S. Zeuzem, M. Angelico, G. Carosi, A. Craxì, A. Mangia, M. Pirisi, M. Rizzetto, G. Taliani, A. L. Zignego, H. W. Reesink, F. Serejo, A. Reymunde, B. Rosado, E. Torres, R. Barcena Marugan, M. De La Mata, J. L. Calleja, G. Castellano, M. Diago, R. Esteban, C. Fernandez-Rodriguez, J. Sanchez Tapias, M. A. Serra Desfilis, N. Afdhal, A. Al-Osaimi, L. Balart, M. Bennett, D. Bernstein, M. Black, C. Bowlus, T. Boyer, D. Dalke, C. Davis, G. Davis, M. Davis, G. Everson, F. Felizarta, S. Flamm, B. Freilich, J. Galati, G. Galler, R. Ghalib, A. Gibas, E. Godofsky, F. Gordon, S. Gordon, J. Gross, S. Harrison, J. Herrera, S. Herrine, K. Q. Hu, J. Imperial, D. Jones, A. Kilby, J. King, A. Koch, K. Kowdley, E. Krawitt, P. Kwo, L. Lambiase, E. Lawitz, W. Lee, J. Levin, R. Levine, X. Li, A. Lok, V. Luketic, M. Mailliard, J. McHutchison, D. Mikolich, T. Morgan, A. Muir, Don Nelson, F. Nunes, A. Nyberg, L. Nyberg, P. Pandya, M. P. Pauly, C. Peine, G. Poleynard, D. Pound, J. Poulos, M. Rabinovitz, N. Ravendhran, J. Ready, R. Reindollar, A. Reuben, T. Riley, L. Rossaro, R. Rubin, M. Ryan, J. Santoro, E. Schiff, T. Sepe, K. Sherman, M. Shiffman, M. Sjogren, R. Sjogren, C. Smith, L. Stein, R. Strauss, R. Szyjkowski, H. Vargas, J. Vierling, D. Witt, R. Yapp, Z. Younes

Research output: Contribution to journalArticle

Abstract

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

Original languageEnglish
Pages (from-to)1195-1206
Number of pages12
JournalNew England Journal of Medicine
Volume364
Issue number13
DOIs
Publication statusPublished - Mar 31 2011

ASJC Scopus subject areas

  • Medicine(all)

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    Poordad, F., McCone, J., Bacon, B. R., Bruno, S., Manns, M. P., Sulkowski, M. S., Jacobson, I. M., Reddy, K. R., Goodman, Z. D., Boparai, N., DiNubile, M. J., Sniukiene, V., Brass, C. A., Albrecht, J. K., Bronowicki, J. P., Colombato, L., Curciarello, J., Silva, M., Tanno, H., ... Younes, Z. (2011). Boceprevir for untreated chronic HCV genotype 1 infection. New England Journal of Medicine, 364(13), 1195-1206. https://doi.org/10.1056/NEJMoa1010494