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Title: Sustained virological response with telaprevir in 1078 patients with advanced hepatitis C: the international telaprevir access program
Authors: Colombo, Massimo
Strasser, Simone
Moreno, Christophe
Ferreira, Paulo Roberto Abrão [UNIFESP]
Urbanek, Petr
Fernandez, Inmaculada
Abdurakmonov, Djamal
Streinu-Cerce, Adrian
Verheyen, Anke
Iraqi, Wafae
DeMasi, Ralph
Hill, Andrew
Lonjon-Domanec, Isabelle
Wedemeyer, Heiner
Univ Milan
Royal Prince Alfred Hosp
Univ Sydney
Univ Libre Bruxelles
Universidade Federal de São Paulo (UNIFESP)
Charles Univ Prague
Cent Militaty Hosp Prague
Hosp Univ 12 Octubre
IM Sechenov First Moscow State Med Univ
Carol Davila Univ Med & Pharm
Janssen Pharmaceut
Tibotec Inc
MetaVirol Ltd
Hannover Med Sch
Keywords: Hepatitis C
Pegylated interferon
Issue Date: 1-Nov-2014
Publisher: Elsevier B.V.
Citation: Journal of Hepatology. Amsterdam: Elsevier B.V., v. 61, n. 5, p. 976-983, 2014.
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/mm(3), 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 naive 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 naive/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 <10 ng/ml (OR = 2.50, 95% CI 1.87-3.36, p <0.0001) and (D) any prior response other than null (OR = 3.29, 95% CI 2.40-4.52, p <0.0001). SVR24 rose for patients who had more of these predictive factors: 6/32 (19%) for none, 38/139 (27%) for 1, 129/260 (50%) for 2, 202/329 (61%) for 3, and 194/235 (83%) for 4 factors. Grade 2-4 treatment-related adverse events (AE) were experienced by 719 (67%) patients; 169 (16%) discontinued therapy for AE and 7 (0.6%) died during the PR tail.Conclusions: Naive and experienced patients with advanced fibrosis or cirrhosis due to HCV-1 who have compensated bone marrow and liver function, can effectively and safely be treated by TVR triple therapy. Baseline predictors of outcome have been identified to optimize pre-treatment counselling. (C) 2014 European Association for the Study of the Liver. Published by Elsevier B.V. All rights reserved.
ISSN: 0168-8278
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