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

John M. Vierling, Mitchell Davis, Steven Flamm, Stuart C. Gordon, Eric Lawitz, Eric M. Yoshida, Joseph Galati, Velimir Luketic, Jonathan McCone, Ira Jacobson, Patrick Marcellin, Andrew J. Muir, Fred Poordad, Lisa D. Pedicone, Janice Albrecht, Clifford Brass, Anita Y.M. Howe, Lynn Y. Colvard, Frans A. Helmond, Weiping DengMichelle Treitel, Janice Wahl, Jean Pierre Bronowicki

Research output: Contribution to journalArticle

36 Scopus citations

Abstract

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.

Original languageEnglish (US)
Pages (from-to)748-756
Number of pages9
JournalJournal of Hepatology
Volume60
Issue number4
DOIs
StatePublished - Apr 2014

Keywords

  • Boceprevir
  • Null response
  • Partial response
  • Relapse
  • Sustained virological response

ASJC Scopus subject areas

  • Hepatology

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