Boceprevir for untreated chronic HCV genotype 1 infection

SPRINT-2 Investigators

Research output: Contribution to journalArticle

2137 Citations (Scopus)

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 (US)
Pages (from-to)1195-1206
Number of pages12
JournalNew England Journal of Medicine
Volume364
Issue number13
DOIs
StatePublished - Mar 31 2011

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Ribavirin
Chronic Hepatitis C
Hepacivirus
Genotype
Infection
Placebos
Standard of Care
Protease Inhibitors
Double-Blind Method
N-(3-amino-1-(cyclobutylmethyl)-2,3-dioxopropyl)-3-(2-((((1,1-dimethylethyl)amino)carbonyl)amino)-3,3-dimethyl-1-oxobutyl)-6,6-dimethyl-3-azabicyclo(3.1.0)hexan-2-carboxamide
RNA
Control Groups
Therapeutics

ASJC Scopus subject areas

  • Medicine(all)

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Boceprevir for untreated chronic HCV genotype 1 infection. / SPRINT-2 Investigators.

In: New England Journal of Medicine, Vol. 364, No. 13, 31.03.2011, p. 1195-1206.

Research output: Contribution to journalArticle

SPRINT-2 Investigators. / Boceprevir for untreated chronic HCV genotype 1 infection. In: New England Journal of Medicine. 2011 ; Vol. 364, No. 13. pp. 1195-1206.
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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",
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AU - SPRINT-2 Investigators

AU - Poordad, Fred

AU - McCone, Jonathan

AU - Bacon, Bruce R.

AU - Bruno, Savino

AU - Manns, Michael P.

AU - Sulkowski, Mark S.

AU - Jacobson, Ira M.

AU - Reddy, K. Rajender

AU - Goodman, Zachary D.

AU - Boparai, Navdeep

AU - DiNubile, Mark J.

AU - Sniukiene, Vilma

AU - Brass, Clifford A.

AU - Albrecht, Janice K.

AU - Bronowicki, Jean Pierre

AU - Colombato, L.

AU - Curciarello, J.

AU - Silva, M.

AU - Tanno, H.

AU - Terg, R.

AU - Adler, M.

AU - Langlet, P.

AU - Lasser, L.

AU - Nevens, F.

AU - Anderson, F.

AU - Bailey, R.

AU - Bilodeau, M.

AU - Cooper, C.

AU - Feinman, S. V.

AU - Heathcote, J.

AU - Levstik, M.

AU - Ramji, A.

AU - Sherman, M.

AU - Shafran, S.

AU - Yoshida, E.

AU - Achim, A.

AU - Ben Ali, S.

AU - Bigard, M. A.

AU - Bonny, C.

AU - Bourliere, M.

AU - Boyer-Darrigrand, N.

AU - Canva, V.

AU - Couzigou, P.

AU - De Ledinghen, V.

AU - Guyader, D.

AU - Hezode, C.

AU - Larrey, D.

AU - Latournerie, M.

AU - Marcellin, P.

AU - Lee, W.

PY - 2011/3/31

Y1 - 2011/3/31

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