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Title: Safety and on-treatment efficacy of telaprevir: the early access programme for patients with advanced hepatitis C
Authors: Colombo, M.
Fernandez, I.
Abdurakhmanov, D.
Ferreira, P. A. [UNIFESP]
Strasser, S. I.
Urbanek, P.
Moreno, C.
Streinu-Cercel, A.
Verheyen, A.
Iraqi, W.
DeMasi, R.
Hill, A.
Laeuffer, J. M.
Lonjon-Domanec, I.
Wedemeyer, H.
Univ Milan
Hosp Univ 12 Octubre
IM Sechenov First Moscow State Med Univ
Universidade Federal de São Paulo (UNIFESP)
Univ Sydney
Charles Univ Prague
Cent Mil Hosp Prague
Univ Libre Brussels
Carol Davila Univ Med & Pharm
Janssen Pharmaceut
Janssen Res & Dev
Janssen Cilag AG
Hannover Med Sch
Issue Date: 1-Jul-2014
Publisher: Bmj Publishing Group
Citation: Gut. London: Bmj Publishing Group, v. 63, n. 7, p. 1150-1158, 2014.
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-alpha (PEG-IFN alpha) 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.
ISSN: 0017-5749
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