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Clinical outcomes in patients with chronic hepatitis C after direct-acting antiviral treatment a prospective cohort study

Fabrice Carrat 1, * Hélène Fontaine 2, 3 Céline Dorival 1 Mélanie Simony 4 Alpha Diallo Christophe Hezode 5 Victor de Ledinghen 6 Dominique Larrey 7 Georges Haour 1 Jean-Pierre Bronowicki 8, 9 Fabien Zoulim 10 Tarik Asselah 11 Patrick Marcellin 11 Dominique Thabut 12 Vincent Leroy 13 Albert Tran 14 François Habersetzer 15 Didier Samuel 16 Dominique Guyader 17 Olivier Chazouilleres 18 Philippe Mathurin 19 Sophie Metivier 20 Laurent Alric 20 Ghassan Riachi 21 Jérôme Gournay 22 Armand Abergel 23, 24 Paul Calès 25, 26 Nathalie Ganne 27 Véronique Loustaud-Ratti 28 Louis d'Alteroche 29 Xavier Causse 30 Claire Geist 31 Anne Minello 32 Isabelle Rosa 33 Moana Gelu-Simeon 34 Isabelle Portal 35 François Raffi 36 Marc Bourlière 37 Stanislas Pol 38, 2, 3, 39 
* Corresponding author
32 Equipe EPICAD (LNC - U1231)
LNC - Lipides - Nutrition - Cancer [Dijon - U1231]
Abstract : Background: Although direct-acting antivirals have been used extensively to treat patients with chronic hepatitis C virus (HCV) infection, their clinical effectiveness has not been well reported. We compared the incidence of death, hepatocellular carcinoma, and decompensated cirrhosis between patients treated with direct-acting antivirals and those untreated, in the French ANRS CO22 Hepather cohort. Methods: We did a prospective study in adult patients with chronic HCV infection enrolled from 32 expert hepatology centres in France. We excluded patients with chronic hepatitis B, those with a history of decompensated cirrhosis, hepatocellular carcinoma, or liver transplantation, and patients who were treated with interferon-ribavirin with or without first-generation protease inhibitors. Co-primary study outcomes were incidence of all-cause mortality, hepatocellular carcinoma, and decompensated cirrhosis. The association between direct-acting antivirals and these outcomes was quantified using time-dependent Cox proportional hazards models. This study is registered with ClinicalTrials.gov, number NCT01953458. Findings: Between Aug 6, 2012, and Dec 31, 2015, 10 166 patients were eligible for the study. 9895 (97%) patients had available follow-up information and were included in analyses. Median follow-up was 33·4 months (IQR 24·0-40·7). Treatment with direct-acting antivirals was initiated during follow-up in 7344 patients, and 2551 patients remained untreated at the final follow-up visit. During follow-up, 218 patients died (129 treated, 89 untreated), 258 reported hepatocellular carcinoma (187 treated, 71 untreated), and 106 had decompensated cirrhosis (74 treated, 32 untreated). Exposure to direct-acting antivirals was associated with increased risk for hepatocellular carcinoma (unadjusted hazard ratio [HR] 2·77, 95% CI 2·07-3·71) and decompensated cirrhosis (3·83, 2·29-6·42). After adjustment for variables (age, sex, body-mass index, geographical origin, infection route, fibrosis score, HCV treatment-naive, HCV genotype, alcohol consumption, diabetes, arterial hypertension, biological variables, and model for end-stage liver disease score in patients with cirrhosis), exposure to direct-acting antivirals was associated with a decrease in all-cause mortality (adjusted HR 0·48, 95% CI 0·33-0·70) and hepatocellular carcinoma (0·66, 0·46-0·93), and was not associated with decompensated cirrhosis (1·14, 0·57-2·27). Interpretation: Treatment with direct-acting antivirals is associated with reduced risk for mortality and hepatocellular carcinoma and should be considered in all patients with chronic HCV infection.
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Fabrice Carrat, Hélène Fontaine, Céline Dorival, Mélanie Simony, Alpha Diallo, et al.. Clinical outcomes in patients with chronic hepatitis C after direct-acting antiviral treatment a prospective cohort study. The Lancet, 2019, 393 (10179), pp.1453-1464. ⟨10.1016/S0140-6736(18)32111-1⟩. ⟨hal-02050395⟩

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