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 language | English (US) |
|---|---|
| Pages (from-to) | 1195-1206 |
| Number of pages | 12 |
| Journal | New England Journal of Medicine |
| Volume | 364 |
| Issue number | 13 |
| DOIs | |
| State | Published - Mar 31 2011 |
Fingerprint
ASJC Scopus subject areas
- Medicine(all)
Cite this
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 journal › Article
}
TY - JOUR
T1 - Boceprevir for untreated chronic HCV genotype 1 infection
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 - Bowlus, Christopher
AU - Rossaro, Lorenzo
PY - 2011/3/31
Y1 - 2011/3/31
N2 - 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
AB - 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
UR - http://www.scopus.com/inward/record.url?scp=79953173221&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=79953173221&partnerID=8YFLogxK
U2 - 10.1056/NEJMoa1010494
DO - 10.1056/NEJMoa1010494
M3 - Article
C2 - 21449783
AN - SCOPUS:79953173221
VL - 364
SP - 1195
EP - 1206
JO - New England Journal of Medicine
JF - New England Journal of Medicine
SN - 0028-4793
IS - 13
ER -