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Boceprevir for untreated chronic HCV genotype 1 infection.

Publication ,  Journal Article
Poordad, F; McCone, J; Bacon, BR; Bruno, S; Manns, MP; Sulkowski, MS; Jacobson, IM; Reddy, KR; Goodman, ZD; Boparai, N; DiNubile, MJ ...
Published in: N Engl J Med
March 31, 2011

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. (Funded by Schering-Plough [now Merck]; SPRINT-2 ClinicalTrials.gov number, NCT00705432.).

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Published In

N Engl J Med

DOI

EISSN

1533-4406

Publication Date

March 31, 2011

Volume

364

Issue

13

Start / End Page

1195 / 1206

Location

United States

Related Subject Headings

  • Viral Load
  • Treatment Outcome
  • Serine Proteinase Inhibitors
  • Ribavirin
  • Recombinant Proteins
  • RNA, Viral
  • Proline
  • Polyethylene Glycols
  • Middle Aged
  • Male
 

Citation

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Poordad, F., McCone, J., Bacon, B. R., Bruno, S., Manns, M. P., Sulkowski, M. S., … SPRINT-2 Investigators. (2011). Boceprevir for untreated chronic HCV genotype 1 infection. N Engl J Med, 364(13), 1195–1206. https://doi.org/10.1056/NEJMoa1010494
Poordad, Fred, Jonathan McCone, Bruce R. Bacon, Savino Bruno, Michael P. Manns, Mark S. Sulkowski, Ira M. Jacobson, et al. “Boceprevir for untreated chronic HCV genotype 1 infection.N Engl J Med 364, no. 13 (March 31, 2011): 1195–1206. https://doi.org/10.1056/NEJMoa1010494.
Poordad F, McCone J, Bacon BR, Bruno S, Manns MP, Sulkowski MS, et al. Boceprevir for untreated chronic HCV genotype 1 infection. N Engl J Med. 2011 Mar 31;364(13):1195–206.
Poordad, Fred, et al. “Boceprevir for untreated chronic HCV genotype 1 infection.N Engl J Med, vol. 364, no. 13, Mar. 2011, pp. 1195–206. Pubmed, doi:10.1056/NEJMoa1010494.
Poordad F, McCone J, Bacon BR, Bruno S, Manns MP, Sulkowski MS, Jacobson IM, Reddy KR, Goodman ZD, Boparai N, DiNubile MJ, Sniukiene V, Brass CA, Albrecht JK, Bronowicki J-P, SPRINT-2 Investigators. Boceprevir for untreated chronic HCV genotype 1 infection. N Engl J Med. 2011 Mar 31;364(13):1195–1206.

Published In

N Engl J Med

DOI

EISSN

1533-4406

Publication Date

March 31, 2011

Volume

364

Issue

13

Start / End Page

1195 / 1206

Location

United States

Related Subject Headings

  • Viral Load
  • Treatment Outcome
  • Serine Proteinase Inhibitors
  • Ribavirin
  • Recombinant Proteins
  • RNA, Viral
  • Proline
  • Polyethylene Glycols
  • Middle Aged
  • Male