Efficacy and safety of boceprevir-based triple therapy in HCV cirrhotic patients awaiting liver transplantation (ANRS HC29 BOCEPRETRANSPLANT) - 08/02/17
, Marianne Maynard b, 1, Cécile Bouix b, Maria Patrizia Carrieri c, d, e, Danielle Botta-Fridlund f, Louis D’Alteroche g, Filomena Conti h, Georges-Philippe Pageaux i, Vincent Leroy j, Sophie Métivier k, Rodolphe Anty l, François Durand m, Valérie Canva n, Antoine Vilotitch c, d, e, Pascal Lebray o, Laurent Alric p, Christophe Duvoux q, Ventzislava Petrov-Sanchez r, Frédérik Beaulieux b, Célia Wellems b, Christelle Paul s, Anne-Marie Roque-Afonso t, Bruno Roche t, Pierre Pradat b, Didier Samuel t, Jean-Charles Duclos-Vallée tthe BOCEPRETRANSPLANT study group
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Summary |
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.
Le texte complet de cet article est disponible en PDF.Abbreviations : HCV, CHC, HCC, LT, PEG-IFN, RBV, SVR, ANRS, VL, EOT, ITT, SAE, HRQL, IQR, MCS, PCS, RP
Plan
Vol 41 - N° 1
P. 56-65 - février 2017 Retour au numéro
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