Boceprevir for untreated chronic HCV genotype 1 infection
| Autor: | Poordad, Fred, Mccone, Julie, Bacon, Bruce, Bruno, Sofie, Manns, Michael, Sulkowski, Michael, Jacobson, Isaac, Reddy, K. Rajender, Goodman, Zachery, Boparai, Navdeep, Dinubile, Mark J., Sniukiene, Vilma, Brass, Clifford A., Albrecht, Janice K., Bronowicki, Jean-Pierre, Sprint -Investigators, The, Hans Van Vlierberghe |
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| Jazyk: | angličtina |
| Rok vydání: | 2011 |
| Předmět: | |
| Zdroj: | NEW ENGLAND JOURNAL OF MEDICINE Ghent University Academic Bibliography |
| ISSN: | 0028-4793 |
| Popis: | 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 lead-in 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 |
| Databáze: | OpenAIRE |
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