Efficacy and safety of boceprevir-based triple therapy in HCV cirrhotic patients awaiting liver transplantation (ANRS HC29 BOCEPRETRANSPLANT)

Hélène Fontaine 1, 2 Marianne Maynard 3 Cécile Bouix 3 Maria Patrizia Carrieri 4, 5 Danielle Botta-Fridlund 6 Louis d'Alteroche 7 Antoine Conti 8 Georges-Philippe Pageaux 9 Vincent Leroy 10 Sophie Métivier 11 Rodolphe Anty 12 François Durand 13 Valérie Canva 14 Antoine Vilotitch 4, 5 Pascal Lebray 15 Laurent Alric 16 Christophe Duvoux 17 Ventzislava Petrov-Sanchez 18, 19, 20 Frédérik Beaulieux 3 Célia Wellems 3 Christelle Paul 18, 19 Anne-Marie Roque-Afonso 21, 22 Bruno Roche 21, 22 Pierre Pradat 3 Didier Samuel 21, 22 Jean-Charles Duclos-Vallée 21, 22 Bocepretransplant Study Group
Abstract : BACKGROUND AND AIMS: In this French multicentre, open-label study, we analyzed the efficacy, safety and patient-reported outcomes of a boceprevir-based triple therapy in HCV genotype 1 cirrhotic patients awaiting liver transplantation (LT). METHODS: Patients received PEG-IFN/ribavirin (RBV) for 48 weeks (W) and boceprevir from W4 to W48 or until LT. RESULTS: Fifty-one patients (80% males, median age: 56 years) were included. Fifty-seven percent had hepatocellular carcinoma and 43% end-stage liver disease. At enrolment, the median MELD score was 9 (range: 6-18); the Child-Pugh score was A in 65%, B in 35% and C in 2%. Therapy was discontinued because of severe adverse events (SAEs) in 39% of cases and virological inefficacy in 24%. 16% of patients had undetectable HCV RNA 24 weeks after the end of treatment (SVR24). LT was performed in 18 patients (35%). HCV RNA was undetectable in 16.6% at LT. Seven patients (14%) died and three deaths were attributed to treatment. SAEs (n=129) were observed in 84% of patients. Twenty-four percent of patients developed severe infections. Albumin<35g/L was independently associated with severe infection. Compared with baseline values, a significant decrease (P=0.02) of the physical dimension of health-related quality of life was observed between W4 and W24. The mean (95% CI) number of self-reported symptoms doubled during treatment (from 6.3 [4.8-7.7] to 11.8 [9.3-14.3]; P<0.001). CONCLUSIONS: The safety of the PEG-IFN/RBV/boceprevir combination is poor in patients awaiting LT, with a high risk of severe infection. Moreover, the limited efficacy confirms the indication for IFN-free combinations in these patients.
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Submitted on : Tuesday, June 12, 2018 - 10:31:07 AM
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Hélène Fontaine, Marianne Maynard, Cécile Bouix, Maria Patrizia Carrieri, Danielle Botta-Fridlund, et al.. Efficacy and safety of boceprevir-based triple therapy in HCV cirrhotic patients awaiting liver transplantation (ANRS HC29 BOCEPRETRANSPLANT). Clinics and Research in Hepatology and Gastroenterology, Elsevier, 2017, 41 (1), pp.56 - 65. ⟨10.1016/j.clinre.2016.06.006⟩. ⟨hal-01813216⟩

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