Sustained virological response with telaprevir in 1078 patients with advanced hepatitis C: The international telaprevir access program

Massimo Colombo, Simone Strasser, Christophe Moreno, Paulo Abrao Ferreira, Petr Urbanek, Inmaculada Fernández, Djamal Abdurakmonov, Adrian Streinu-Cercel, Anke Verheyen, Wafae Iraqi, Ralph DeMasi, Andrew Hill, Isabelle Lonjon-Domanec, Heiner Wedemeyer

Research output: Contribution to journalArticle

Abstract

Background & Aims: There is little information regarding the extent to which difficult to cure patients with advanced liver fibrosis, due to hepatitis C virus genotype-1 (HCV-1) can successfully and safely be treated with triple therapy with telaprevir (TVR), pegylated interferon alpha (P) and ribavirin (R). In the TVR early access program HEP3002 we aimed to explore treatment safety and efficacy, and identify predictors of sustained virological response at week 24 (SVR24). Methods: 1078 patients with bridging fibrosis (n = 552) or cirrhosis (n = 526) diagnosed by either liver biopsy or non-invasive markers, with compensated bone marrow (neutrophils >1500/ mm3, Hb >12/13 g/dl) and liver function (Albumin >3.3 g/dl, Platelets >90,000/ml) received TVR PR for 12 weeks, followed by a PR tail according to label. Results: Overall, 614 (57%) achieved SVR24 by intention-to-treat analysis. The SVR24 rate was 68% in 221 treatment naïve patients (62.8% F4), 72% in 356 prior relapsers (64.4% F4), 55% in 139 partial responders (53.2% F4), and 34% in 294 null responders (28.6% F4). The SVR24 rate to response-guided therapy (24 weeks treatment duration if undetectable viremia at weeks 4 and 12) was 84% in 222 naïve/relapser F3 patients. Independent predictors of response were: (A) F3 (odds ratio (OR) = 1.51, 95% CI 1.31- 2.00, p = 0.005), (B) subtype 1b (OR = 1.63, 95% CI 1.18-2.24, p = 0.0029), (C) alpha-fetoprotein

Original languageEnglish
Pages (from-to)976-983
Number of pages8
JournalJournal of Hepatology
Volume61
Issue number5
DOIs
Publication statusPublished - 2014

Keywords

  • Cirrhosis
  • Hepatitis C
  • Pegylated interferon
  • Telaprevir

ASJC Scopus subject areas

  • Hepatology
  • Medicine(all)

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