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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<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.
Keywords
TELAPREVIR, VIRUS-INFECTION, RANDOMIZED-TRIAL, PEGINTERFERON ALPHA-2A, ALPHA-2A PLUS RIBAVIRIN, CHRONIC HEPATITIS-C, SCH-503034, INTERFERON-ALPHA-2B, INHIBITOR

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Citation

Please use this url to cite or link to this publication:

Chicago
Poordad, Fred, Julie McCone, Bruce Bacon, Sofie Bruno, Michael Manns, Michael Sulkowski, Isaac Jacobson, et al. 2011. “Boceprevir for Untreated Chronic HCV Genotype 1 Infection.” New England Journal of Medicine 364 (13): 1195–1206.
APA
Poordad, F., McCone, J., Bacon, B., Bruno, S., Manns, M., Sulkowski, M., Jacobson, I., et al. (2011). Boceprevir for untreated chronic HCV genotype 1 infection. NEW ENGLAND JOURNAL OF MEDICINE, 364(13), 1195–1206.
Vancouver
1.
Poordad F, McCone J, Bacon B, Bruno S, Manns M, Sulkowski M, et al. Boceprevir for untreated chronic HCV genotype 1 infection. NEW ENGLAND JOURNAL OF MEDICINE. 2011;364(13):1195–206.
MLA
Poordad, Fred, Julie McCone, Bruce Bacon, et al. “Boceprevir for Untreated Chronic HCV Genotype 1 Infection.” NEW ENGLAND JOURNAL OF MEDICINE 364.13 (2011): 1195–1206. Print.
@article{1211567,
  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 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{\textlangle}0.001), and in 213 of the 311 patients (68\%) in group 3 (P{\textlangle}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.},
  author       = {Poordad, Fred and McCone, Julie and Bacon, Bruce and Bruno, Sofie and Manns, Michael and Sulkowski, Michael and Jacobson, Isaac and Reddy, K Rajender and Goodman, Zachery and Boparai, Navdeep and DiNubile, Mark J and Sniukiene, Vilma and Brass, Clifford A and Albrecht, Janice K and Bronowicki, Jean-Pierre and SPRINT2-Investigators, the and Van Vlierberghe, Hans},
  issn         = {0028-4793},
  journal      = {NEW ENGLAND JOURNAL OF MEDICINE},
  keyword      = {TELAPREVIR,VIRUS-INFECTION,RANDOMIZED-TRIAL,PEGINTERFERON ALPHA-2A,ALPHA-2A PLUS RIBAVIRIN,CHRONIC HEPATITIS-C,SCH-503034,INTERFERON-ALPHA-2B,INHIBITOR},
  language     = {eng},
  number       = {13},
  pages        = {1195--1206},
  title        = {Boceprevir for untreated chronic HCV genotype 1 infection},
  volume       = {364},
  year         = {2011},
}

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