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Safety and efficacy of daclatasvir-sofosbuvir in HCV genotype 1-mono-infected patients

Stanislas Pol 1 Marc Bourlière 2, 3 Sandy Lucier 4, 5 Christophe Hézode 6 Céline Dorival 5 Dominique Larrey 7, 8 Jean-Pierre Bronowicki 9, 10 Victor D. E. Ledinghen 11 Fabien Zoulim 12 Albert Tran 13 Sophie Metivier 14 Jean-Pierre Zarski 15, 16 Didier Samuel 17, 18 Dominique Guyader 19 Patrick Marcellin 20 Anne Minello 21, 22 Laurent Alric 23 Dominique Thabut 24, 25 Olivier Chazouillères 26, 25 Ghassan Riachi 27 Valérie Bourcier 28 Philippe Mathurin 29 Véronique Loustaud-Ratti 30, 31 Louis D’alteroche 32 Isabelle Fouchard-Hubert 33, 34 François Habersetzer 35 Xavier Causse 36 Claire Geist 37 Isabelle Rosa 38 Jérôme Gournay 39 Eric Saillard 40 Eric Billaud 41 Ventzislava Petrov-Sanchez 42 Alpha Diallo 42 Hélène Fontaine 1 Fabrice Carrat 5
1 Service d'hépatologie médicale [CHU Cochin]
2 Service d'hépato-gastro-entérologie
3 Hôpital Saint-Joseph [Marseille]
4 Département de la recherche clinique et du développement
5 iPLESP - Institut Pierre Louis d'Epidémiologie et de Santé Publique
6 AP HP, Departement Gastroenterologie
7 CHU Saint-Eloi
8 Cellules souches normales et cancéreuses
9 Service d'Hépato-gastro-entérologie [CHRU Nancy]
10 NGERE - Nutrition-Génétique et Exposition aux Risques Environnementaux
11 Physiopathologie du cancer du foie
12 Centre de Recherche sur le Cancer de Lyon
13 C3M - Centre méditerranéen de médecine moléculaire
14 Service de Gastro-entérologie - Hépatologie [Purpan]
15 Département d'hépato-gastroentérologie
16 INSERM U823 - Institut d'oncologie/développement Albert Bonniot de Grenoble
17 Physiopathologie et traitement des maladies du foie
18 Centre hépato-biliaire - CHB [Paul Brousse, Paris]
19 Foie, métabolismes et cancer
20 Service d’Hépatologie [Hôpital Beaujon]
21 LNC - Lipides - Nutrition - Cancer [Dijon - U1231]
22 Service d'Hépato-Gastro-Entérologie (CHU de Dijon)
23 IRSD - Institut de Recherche en Santé Digestive
24 Service d'Hépato-Gastroentérologie [CHU Pitié-Salpêtrière]
25 CR Saint-Antoine - Centre de Recherche Saint-Antoine
26 Service d'hépatologie [Saint-Antoine]
27 Service d'Hépato-Gastroentérologie [CHU Rouen]
28 Service d'Hépato-gastroentérologie
29 Service d'Hépato-gastroentérologie
30 PIST - Pharmacologie des Immunosuppresseurs et de la Transplantation
31 Service d'Hépato-Gastro-Entérologie et Nutrition [CHU Limoges]
32 CHU Trousseau [Tours]
33 CHU Angers - Centre Hospitalier Universitaire d'Angers
34 HIFIH - Hémodynamique, Interaction Fibrose et Invasivité tumorales Hépatiques
35 Interactions Virus-Hôte et Maladies Hépatiques
36 Service Hépato-gastro-entérologie et oncologie digestive [CHR Orléans]
37 CHR Metz-Thionville - Centre hospitalier régional Metz-Thionville
38 Service d'hépato-gastro-entérologie
39 Service d'hépato-gastro-entérologie
40 CHU Pointe-à-Pitre/Abymes [Guadeloupe]
41 Service des maladies infectieuses [Nantes]
42 Recherches fondamentales, cliniques et thérapeutiques sur les hépatites virales
Abstract : Background & aims - We report the first real-life results of the sofosbuvir+daclatasvir combination in hepatitis C virus (HCV) genotype 1 infected patients. Methods - The France REcherche Nord&Sud Sida-hiv Hépatites (ANRS) CO22 HEPATHER "Therapeutic options for hepatitis B and C: A French cohort" is a multicentre observational cohort which aims to include 15,000 HCV- and 10,000 HBV-infected patients. We selected all participants (n=768) with a HCV genotype 1 who initiated sofosbuvir (400mg/day) and daclatasvir (60mg/day) before October 1st 2014, with or without ribavirin (1-1.2g/day) for a duration of 12weeks or 24weeks. The main endpoint criterion was sustained virological response at 12weeks (SVR12), defined by the absence of detectable HCV-RNA 12weeks after the last treatment intake. Missing SVR12 measurements were imputed using SVR24 measurements (n=45), otherwise considered as virological failure (n=18). Results - A SVR12 was obtained in 729/768 (95%) patients, ranging from 92% (12-week sofosbuvir+daclatasvir) to 99% (24-week sofosbuvir+daclatasvir+ribavirin). The SVR12 rates did not significantly differ between the 24-week (550/574 (96%)) and the 12-week (179/194 (92%); p=0.0688) durations or between regimens with (165/169 (98%)) or without ribavirin (564/599 (94%); p=0.0850). The SVR12 rate was greater than 97% in non-cirrhotic patients irrespective of the treatment duration or the addition of ribavirin. Among cirrhotic patients, the SVR12 rate was higher with 24 than 12-week regimen (423/444 (95%) vs. 105/119 (88%); p=0.0054). Conclusion - The sofosbuvir+daclatasvir combination is associated with a high rate of SVR12 in patients infected by genotype 1, with an optimal duration of 12weeks in non-cirrhotic and 24weeks in cirrhotic patients. The number of patients receiving ribavirin was too low to adequately assess its impact. Lay summary - The sofosbuvir+daclatasvir combination of antiviral drugs is associated with a high rate (95%) of viral eradication in patients infected by HCV genotype 1. The best duration of a ribavirin-free sofosbuvir+daclatasvir combination seems to be 12weeks in non-cirrhotic patients and 24weeks for those with cirrhosis. Clinical trial number: NCT01953458.
Keywords : Genotype 1 Severe fibrosis Cirrhosis Direct antiviral agents Daclatasvir Sofosbuvir Treatment Chronic hepatitis C Hepather cohort
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UNIV-RENNES1 | UNIV-RENNES | NUMECAN-EXPRES | UR1-UFR-SVE | U938 | UNIV-BOURGOGNE | NUMECAN | UNIV-PARIS5 | UNIV-COTEDAZUR | UNIV-MONTPELLIER | LNC-UMR866 | USPC | IPLESP | GEIST | UNIV-LORRAINE | UNAM | LNC-EPICAD | UNIV-ANGERS | BIOSIT | UPMC | UNILIM | U823 | INRA | UNICE | UMR-S850 | IPPRITT | CNRS | COMUE-NORMANDIE | UNIROUEN | NGERE-UL | UNIV-LILLE | SORBONNE-UNIVERSITE | SU-MEDECINE | UNIV-TLSE3 | HIFIH | INRAE | BMS-UL | SU-TI

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Stanislas Pol, Marc Bourlière, Sandy Lucier, Christophe Hézode, Céline Dorival, et al.. Safety and efficacy of daclatasvir-sofosbuvir in HCV genotype 1-mono-infected patients. Journal of Hepatology, Elsevier, 2017, 66 (1), pp.39-47. ⟨10.1016/j.jhep.2016.08.021⟩. ⟨hal-01435007⟩

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