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Boceprevir for chronic HCV genotype 1 infection in patients with prior treatment failure to peginterferon/ribavirin, including prior null response.

Publication ,  Journal Article
Vierling, JM; Davis, M; Flamm, S; Gordon, SC; Lawitz, E; Yoshida, EM; Galati, J; Luketic, V; McCone, J; Jacobson, I; Marcellin, P; Muir, AJ ...
Published in: J Hepatol
April 2014

BACKGROUND & AIMS: Boceprevir with peginterferon/ribavirin (BOC/PR) leads to significantly higher sustained virological response (SVR) rates in patients with chronic hepatitis C and partial response or relapse after prior treatment with peginterferon/ribavirin. We studied the efficacy of BOC/PR in patients with prior treatment failure, including those with a null response (<2-log10 decline in HCV RNA), to peginterferon/ribavirin. METHODS: Patients in the control arms of boceprevir Phase 2/3 studies who did not achieve SVR were re-treated with BOC/PR for up to 44 weeks. Patients enrolling >2 weeks after end-of-treatment in the prior study received PR for 4 weeks before adding boceprevir. RESULTS: Of 168 patients enrolled, four discontinued from the PR lead-in and 164 received BOC/PR. Baseline viral load was >800,000 IU/ml in 77% of patients; 62% had HCV genotype 1a, and 10% were cirrhotic. In the ITT analysis (all 168 patients), SVR was achieved in 20 (38%) of 52 patients with prior null response, 57 (67%) of 85 with prior partial response, and 27 (93%) of 29 with prior relapse. In the mITT analysis (164 BOC/PR-treated patients), SVR rates were 41% (20/49), 67% (57/85), and 96% (27/28), respectively. SVR was achieved by 48% of patients with <1-log10 decline in HCV-RNA after lead-in and 76% of those with ⩾ 1-log10 decline or undetectable HCV-RNA after lead-in. The most common adverse events were anemia (49%), fatigue (48%), and dysgeusia (35%); 8% of patients discontinued due to adverse events. CONCLUSIONS: Re-treatment with BOC/PR improved SVR rates in all patient subgroups, including those with prior null response.

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Published In

J Hepatol

DOI

EISSN

1600-0641

Publication Date

April 2014

Volume

60

Issue

4

Start / End Page

748 / 756

Location

Netherlands

Related Subject Headings

  • Viral Load
  • Treatment Outcome
  • Treatment Failure
  • Ribavirin
  • Recombinant Proteins
  • Proline
  • Polyethylene Glycols
  • Middle Aged
  • Male
  • Interferon-alpha
 

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Vierling, J. M., Davis, M., Flamm, S., Gordon, S. C., Lawitz, E., Yoshida, E. M., … Bronowicki, J.-P. (2014). Boceprevir for chronic HCV genotype 1 infection in patients with prior treatment failure to peginterferon/ribavirin, including prior null response. J Hepatol, 60(4), 748–756. https://doi.org/10.1016/j.jhep.2013.12.013
Vierling, John M., Mitchell Davis, Steven Flamm, Stuart C. Gordon, Eric Lawitz, Eric M. Yoshida, Joseph Galati, et al. “Boceprevir for chronic HCV genotype 1 infection in patients with prior treatment failure to peginterferon/ribavirin, including prior null response.J Hepatol 60, no. 4 (April 2014): 748–56. https://doi.org/10.1016/j.jhep.2013.12.013.
Vierling JM, Davis M, Flamm S, Gordon SC, Lawitz E, Yoshida EM, et al. Boceprevir for chronic HCV genotype 1 infection in patients with prior treatment failure to peginterferon/ribavirin, including prior null response. J Hepatol. 2014 Apr;60(4):748–56.
Vierling, John M., et al. “Boceprevir for chronic HCV genotype 1 infection in patients with prior treatment failure to peginterferon/ribavirin, including prior null response.J Hepatol, vol. 60, no. 4, Apr. 2014, pp. 748–56. Pubmed, doi:10.1016/j.jhep.2013.12.013.
Vierling JM, Davis M, Flamm S, Gordon SC, Lawitz E, Yoshida EM, Galati J, Luketic V, McCone J, Jacobson I, Marcellin P, Muir AJ, Poordad F, Pedicone LD, Albrecht J, Brass C, Howe AYM, Colvard LY, Helmond FA, Deng W, Treitel M, Wahl J, Bronowicki J-P. Boceprevir for chronic HCV genotype 1 infection in patients with prior treatment failure to peginterferon/ribavirin, including prior null response. J Hepatol. 2014 Apr;60(4):748–756.
Journal cover image

Published In

J Hepatol

DOI

EISSN

1600-0641

Publication Date

April 2014

Volume

60

Issue

4

Start / End Page

748 / 756

Location

Netherlands

Related Subject Headings

  • Viral Load
  • Treatment Outcome
  • Treatment Failure
  • Ribavirin
  • Recombinant Proteins
  • Proline
  • Polyethylene Glycols
  • Middle Aged
  • Male
  • Interferon-alpha