Safety and on-treatment efficacy of telaprevir: The early access programme for patients with advanced hepatitis C

M. Colombo, I. Fernández, D. Abdurakhmanov, P. A. Ferreira, S. I. Strasser, P. Urbanek, C. Moreno, A. Streinu-Cercel, A. Verheyen, W. Iraqi, R. Demasi, A. Hill, J. M. Läuffer, I. Lonjon-Domanec, H. Wedemeyer

Research output: Contribution to journalArticle

Abstract

Background and aim: Severe adverse events (AEs) compromise the outcome of direct antiviral agent-based treatment in patients with advanced liver fibrosis due to HCV infection. HEP3002 is an ongoing multinational programme to evaluate safety and efficacy of telaprevir (TVR) plus pegylated-interferon-α (PEG-IFNα) and ribavirin (RBV) in patients with advanced liver fibrosis caused by HCV genotype 1 (HCV-1). Methods: 1782 patients with HCV-1 and bridging fibrosis or compensated cirrhosis were prospectively recruited from 16 countries worldwide, and treated with 12 weeks of TVR plus PEG-IFN/RBV, followed by 12 or 36 weeks of PEG-IFN and RBV (PR) alone dependent on virological response to treatment and previous response type. Results: 1587 patients completed 12 weeks of triple therapy and 4 weeks of PR tail (53% cirrhosis, 22% HCV-1a). By week 12, HCV RNA was undetectable in 85% of naives, 88% of relapsers, 80% of partial responders and 72% of null responders. Overall, 931 patients (59%) developed grade 1-4 anaemia (grade 3/4 in 31%), 630 (40%) dose reduced RBV, 332 (21%) received erythropoietin and 157 (10%) were transfused. Age and female gender were the strongest predictors of anaemia. 64 patients (4%) developed a grade 3/4 rash. Discontinuation of TVR due to AEs was necessary in 193 patients (12%). Seven patients died (0.4%, six had cirrhosis). Conclusions: In compensated patients with advanced fibrosis due to HCV-1, triple therapy with TVR led to satisfactory rates of safety, tolerability and on-treatment virological response with adequate managements of AEs.

Original languageEnglish
Pages (from-to)1150-1158
Number of pages9
JournalGut
Volume63
Issue number7
DOIs
Publication statusPublished - 2014

ASJC Scopus subject areas

  • Gastroenterology

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    Colombo, M., Fernández, I., Abdurakhmanov, D., Ferreira, P. A., Strasser, S. I., Urbanek, P., Moreno, C., Streinu-Cercel, A., Verheyen, A., Iraqi, W., Demasi, R., Hill, A., Läuffer, J. M., Lonjon-Domanec, I., & Wedemeyer, H. (2014). Safety and on-treatment efficacy of telaprevir: The early access programme for patients with advanced hepatitis C. Gut, 63(7), 1150-1158. https://doi.org/10.1136/gutjnl-2013-305667