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Efficacy and safety of treatment of chronic hepatitis C with sofosbuvir and ribavirin with or without peginterferon

a French prospective real-life cohort study of unselected 211 patients

Garioud, Armanda,*; Heng, Ratmonya,*; Amiot, Xavierc; Rémy, André-Jeand; Ollivier-Hourmand, Isabellee; Mokhtari, Cameliab; Medmoun, Mourada; Renou, Christophef; Zougmoré, Honoréa; Pulwermacher, Philippea; Lucidarme, Damieng; Rosa-Hézode, Isabelleh; Causse, Xavieri; Arotcarena, Ramuntchoj; Zanditenas, Davidk; Halfon, Philippel; Pariente, Alexandrej; Cadranel, Jean-Françoisa and Association Nationale des Hépato-gastroentérologues des Hôpitaux Généraux (ANGH), France

European Journal of Gastroenterology & Hepatology: June 18, 2019 - Volume Publish Ahead of Print - Issue - p
doi: 10.1097/MEG.0000000000001450
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Introduction Sofosbuvir is the first directly-acting antiviral for the treatment of hepatitis C virus. First, the regimens were combinations with sofosbuvir+ribavirin (SR) or with sofosbuvir+ribavirin and pegylated-interferon α-2a (SPR) with cure rates around 90%. The aim of this study was to report the results of these combinations in ‘real-life’ in France.

Materials and methods Main features of patients treated with SR or SPR in 24 hospitals were collected. Undetectable hepatitis C virus week 12 viral load after treatment defined sustained virological response (SVR12). Statistics were performed using StatView software for descriptive analysis and χ2 for the sub-groups comparisons.

Results Two hundred and eleven patients were analyzed. The average age was 56.1. One hundred and seventy-one (89%) patients had a fibrosis score of at least 3. Seventy-nine patients were infected by a genotype 1 (G1). One hundred and thirteen patients were treated with SR and 95 with SPR. In naive patients: with SPR for 12 weeks, SVR12 was 93% in G1, 100% in G3 and 83% in G4. With SR for 12 weeks, SVR12 was 100% in G2 patients (6/6). The safety of these regimens was satisfactory with only two patients who had to stop P due to severe side effects. Multivariate analysis shows a higher SVR in SPR versus SR (odds ratio=1.28; P=0.05) and in G2 or G3 versus others (odds ratio=1.56; P=0.04). Moreover, Child–Pugh score B or C (P=0.02), platelets count under 100G/l (P=0.05) or a past event of ascites (P=0.04) was independently associated with less SVR.

Conclusion This multicenter large study confirms the good results of SR for 12 weeks in G2 naive patients. Finally, a decompensated cirrhosis, a past event of ascites and a baseline low platelet count were strongly associated with poor response.

aHepatogastroenterology Unit

bLaboratory of Virology, General Hospital GHPSO, Creil

cHepatogastroenterology Unit, Tenon University Hospital, APHP, Paris

dHepatogastroenterology Unit, General Hospital, Perpignan

eHepatogastroenterology Unit, University Hospital, Caen

fHepatogastroenterology Unit, General Hospital, Hyères

gHepatogastroenterology Unit, General Hospital GHICL, Lomme

hHepatogastroenterology Unit, General Hospital CHIC, Créteil

iHepatogastroenterology Unit, General Hospital, Orléans

jHepatogastroenterology Unit, General Hospital, Pau

kHepatogastroenterology Unit, General Hospital, Bry-sur-Marne

lDepartment of Internal Medicine, European Hospital, Marseille, France

* Armand Garioud and Ratmony Heng contributed equally to the writing of this article.

Correspondence to Armand Garioud, MD, Hepatogastroenterology Unit, General Hospital GHPSO, Boulevard Laennec, Creil 60100, France Tel: +33 344 616 444; fax: +33 344 616 440; e-mail: armand.garioud@ghpso.fr

Received January 28, 2019

Accepted April 19, 2019

Copyright © 2019 Wolters Kluwer Health, Inc. All rights reserved.