Boceprevir With Peginterferon Alfa-2a-Ribavirin Is Effective for Previously Treated Chronic Hepatitis C Genotype 1 Infection

Steven L. Flamm, Eric Lawitz, Ira Jacobson, Marc Bourlière, Christophe Hezode, John M. Vierling, Bruce R. Bacon, Claus Niederau, Morris Sherman, Venkata Goteti, Heather L. Sings, Richard O. Barnard, John A. Howe, Lisa D. Pedicone, Margaret H. Burroughs, Clifford A. Brass, Janice K. Albrecht, Fred Poordad

Research output: Contribution to journalArticlepeer-review

58 Scopus citations

Abstract

Background and Aims: The addition of boceprevir to therapy with peginterferon alfa-2b and ribavirin results in significantly higher rates of sustained virologic response (SVR) in previously treated patients with chronic hepatitis C virus (HCV) genotype-1 infection, compared with peginterferon alfa-2b and ribavirin alone. We assessed SVR with boceprevir plus peginterferon alfa-2-ribavirin (PEG2a/R) in patients with identical study entry criteria. Methods: In a double-blind, placebo-controlled trial, 201 patients with HCV genotype-1 who had relapsed or not responded to previous therapy were assigned to groups (1:2) and given a 4-week lead-in phase of PEG2a/R, followed by placebo plus PEG2a/R for 44 weeks (PEG2a/R) or boceprevir plus PEG2a/R for 44 weeks (BOC/PEG2a/R). The primary end point was SVR 24 weeks after therapy ended. Results: The addition of boceprevir after 4 weeks of lead-in therapy with PEG2a/R significantly increased the rate of SVR from 21% in the PEG2a/R group to 64% in the BOC/PEG2a/R group (P< .0001). Among patients with poor response to interferon therapy (<1-log 10 decline in HCV RNA at week 4), 39% in the BOC/PEG2a/R group had SVRs, compared with none of the patients in the PEG2a/R group. Among patients with good response to interferon (≥1-log 10 decline), 71% in the BOC/PEG2a/R group had SVRs, compared with 25% in the PEG2a/R group. A ≥1-log 10 decline in HCV RNA at treatment week 4 was the strongest independent predictor of SVR, exceeding that of IL-28Bgenotype. Among 8 patients who began the study with HCV amino acid variants associated with boceprevir resistance, 3 (38%) achieved SVRs. Fifty percent of patients in the BOC/PEG2a/R group developed anemia (hemoglobin <10.0 g/dL), compared with 27% in the PEG2a/R group; 43% vs 21%, respectively, developed neutropenia (neutrophil count <750/mm 3).

Original languageEnglish (US)
Pages (from-to)81-87.e4
JournalClinical Gastroenterology and Hepatology
Volume11
Issue number1
DOIs
StatePublished - Jan 2013
Externally publishedYes

ASJC Scopus subject areas

  • Hepatology
  • Gastroenterology

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