Effectiveness of telaprevir or boceprevir in treatment-experienced patients with HCV genotype 1 infection and cirrhosis.: Triple therapy in HCV genotype 1 cirrhotics

Christophe Hézode 1, 2 Hélène Fontaine 3, 4 Céline Dorival 5 Fabien Zoulim 6, 7 Dominique Larrey 8, 9 Valérie Canva 10 Victor De Ledinghen 11, 12 Thierry Poynard 13, 14 Didier Samuel 15 Marc Bourlière 16 Laurent Alric 17, 18 Jean-Jacques Raabe 19 Jean-Pierre Zarski 20, 21 Patrick Marcellin 22, 23 Ghassan Riachi 24 Pierre-Henri Bernard 12, 25 Véronique Loustaud-Ratti 26, 27 Olivier Chazouillères 28 Armand Abergel 29, 30 Dominique Guyader 31, 32 Sophie Métivier 33 Albert Tran 34, 35 Vincent Di Martino 36 Xavier Causse 37 Thong Dao 38, 39 Damien Lucidarme 40 Isabelle Portal 41 Patrice Cacoub 42, 43 Jérôme Gournay 44 Véronique Grando-Lemaire 45 Patrick Hillon 46 Pierre Attali 47 Thierry Fontanges 48 Isabelle Rosa 49 Ventzislava Petrov-Sanchez 50 Yoann Barthe 5 Jean-Michel Pawlotsky 1, 51 Stanislas Pol 3, 4 Fabrice Carrat 5, 52 Jean-Pierre Bronowicki 53, 54, *
* Auteur correspondant
Abstract : BACKGROUND & AIMS: We investigated the effectiveness of the protease inhibitors peginterferon and ribavirin in treatment-experienced patients with hepatitis C virus (HCV) genotype 1 infection and cirrhosis. METHODS: In the Compassionate Use of Protease Inhibitors in Viral C Cirrhosis study, 511 patients with HCV genotype 1 infection and compensated cirrhosis who did not respond to a prior course of peginterferon and ribavirin (44.3% relapsers or patients with viral breakthrough, 44.8% partial responders, and 8.0% null responders) were given either telaprevir (n = 299) or boceprevir (n = 212) for 48 weeks. We assessed percentages of patients with sustained viral responses 12 weeks after therapy and safety. This observational study did not allow for direct comparison of the 2 regimens. RESULTS: Among patients given telaprevir, 74.2% of relapsers, 40.0% of partial responders, and 19.4% of null responders achieved SVR12. Among those given boceprevir, 53.9% of relapsers, 38.3% of partial responders, and none of the null responders achieved SVR12. In multivariate analysis, factors associated with SVR12 included prior response to treatment response, no lead-in phase, HCV subtype 1b (vs 1a), and baseline platelet count greater than 100,000/mm(3). Severe adverse events occurred in 49.9% of cases, including liver decompensation, severe infections in 10.4%, and death in 2.2%. In multivariate analysis, baseline serum albumin level less than 35 g/L and baseline platelet counts of 100,000/mm(3) or less predicted severe side effects or death. CONCLUSIONS: Relatively high percentages of real-life, treatment-experienced patients with HCV genotype 1 infection and cirrhosis respond to the combination of peginterferon and ribavirin with telaprevir or boceprevir. However, side effects are frequent and often severe. Baseline levels of albumin and platelet counts can be used to guide treatment decisions. ClinicalTrials.gov number: NCT01514890.
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Gastroenterology, WB Saunders, 2014, 147 (1), pp.132-142.e4. 〈10.1053/j.gastro.2014.03.051〉
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Christophe Hézode, Hélène Fontaine, Céline Dorival, Fabien Zoulim, Dominique Larrey, et al.. Effectiveness of telaprevir or boceprevir in treatment-experienced patients with HCV genotype 1 infection and cirrhosis.: Triple therapy in HCV genotype 1 cirrhotics. Gastroenterology, WB Saunders, 2014, 147 (1), pp.132-142.e4. 〈10.1053/j.gastro.2014.03.051〉. 〈inserm-01057763〉

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