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Triple therapy in treatment-experienced patients with HCV-cirrhosis in a multicentre cohort of the French Early Access Programme (ANRS CO20-CUPIC) – NCT01514890

Christophe Hézode 1 Hélène Fontaine 2 Céline Dorival 3 Dominique Larrey 4 Fabien Zoulim 5 Valérie Canva 6 Victor de Ledinghen 7, 8 Thierry Poynard 9, 10 Didier Samuel 11 Marc Bourlière 12 Jean-Pierre Zarski 13 Jean-Jacques Raabe 14 Laurent Alric 15 Patrick Marcellin 16, 17 Ghassan Riachi 18 Pierre Bernard 7, 8 Véronique Loustaud-Ratti 19, 20 Sophie Métivier 21 Albert Tran 22 Lawrence Serfaty 23 Armand Abergel 24, 25 Xavier Causse 26 Vincent Di Martino 27 Dominique Guyader 28 Damien Lucidarme 29 Véronique Grando-Lemaire 30 Patrick Hillon 31 Cyrille Feray 32 Thong Dao 33 Patrice Cacoub 34, 35 Isabelle Rosa 36 Pierre Attali 37 Ventzislava Petrov-Sanchez 38 Yoann Barthe 3 Jean-Michel Pawlotsky 1, 39 Stanislas Pol 2 Fabrice Carrat 3, 40 Jean-Pierre Bronowicki 41, 42
10 Inserm UMR_S 938 - Pathologies biliaires, fibrose et cancer du foie
CHU Saint-Antoine [AP-HP], CR Saint-Antoine - Centre de Recherche Saint-Antoine
Abstract : Background & AimsIn phase III trials, the safety profile of triple therapy (pegylated interferon/ribavirin with boceprevir or telaprevir) seems to be similar in HCV treatment-experienced cirrhotic and non-cirrhotic patients, but few cirrhotics were included. We report the week 16 safety and efficacy analysis in a cohort of compensated cirrhotics treated in the French Early Access Programme.Methods674 genotype 1 patients, prospectively included, received 48 weeks of triple therapy. The analysis is restricted to 497 patients reaching week 16.ResultsA high incidence of serious adverse events (40.0%), and of death and severe complications (severe infection or hepatic decompensation) (6.4%), and a difficult management of anaemia (erythropoietin and transfusion use in 50.7% and 12.1%) were observed. Independent predictors of anaemia <8 g/dl or blood transfusion were: female gender (OR 2.19, 95% CI 1.11–4.33, p = 0.024), no lead-in phase (OR 2.25, 95% CI 1.15–4.39, p = 0.018), age ⩾65 years (OR 3.04, 95% CI 1.54–6.02, p = 0.0014), haemoglobin level (⩽12 g/dl for females, ⩽13 g/dl for males) (OR 5.30, 95% CI 2.49–11.5, p = 0.0001). Death or severe complications were related to platelets count ⩽100,000/mm3 (OR 3.11, 95% CI 1.30–7.41, p = 0.0105) and albumin <35 g/dl (OR 6.33, 95% CI 2.66–15.07, p = 0.0001), with a risk of 44.1% in patients with both. However, the on-treatment virological response was high.ConclusionsThe safety profile was poor and patients with platelet count ⩽100,000/mm3 and serum albumin <35 g/L should not be treated with the triple therapy.
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https://hal.univ-lorraine.fr/hal-01708037
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Submitted on : Tuesday, February 13, 2018 - 12:03:29 PM
Last modification on : Wednesday, August 19, 2020 - 12:08:15 PM

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Christophe Hézode, Hélène Fontaine, Céline Dorival, Dominique Larrey, Fabien Zoulim, et al.. Triple therapy in treatment-experienced patients with HCV-cirrhosis in a multicentre cohort of the French Early Access Programme (ANRS CO20-CUPIC) – NCT01514890. Journal of Hepatology, Elsevier, 2013, 59 (3), pp.434 - 441. ⟨10.1016/j.jhep.2013.04.035⟩. ⟨hal-01708037⟩

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