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Multicentre experience using daclatasvir and sofosbuvir to treat hepatitis C recurrence - The ANRS CUPILT study

Audrey Coilly 1, 2, 3 Claire Fougerou-Leurent 4, 5 Victor Ledinghen 6 Pauline Houssel-Debry 4, 5 Christophe Duvoux 7 Vincent Di Martino 8 Sylvie Radenne 9 Nassim Kamar 10, 11 Louis d'Alteroche 12, 13 Vincent Leroy 14 Valérie Canva 15 Pascal Lebray 16, 17 Christophe Moreno 18 Jérôme Dumortier 19 Christine Silvain 20 Camille Besch Philippe Perré Danielle Botta-Fridlund 21 Rodolphe Anty 22, 23 Claire Francoz 24 Armando Aberge Maryline Debette-Gratien 25 Filomena Conti 26, 27, 28 François Habersetzer 29 Alexandra Rohel Emilie Rossignol 5, 4 Helene Danjou 5, 4 Anne-Marie Roque-Afonso 30, 3 Didier Samuel 3, 31 Jean-Charles Duclos-Vallée 3, 32, 2, 33 Georges-Philippe Pageaux 34
1 Hôpital Paul Brousse
2 CHB - Centre hépato-biliaire
3 Physiopathologie et traitement des maladies du foie
4 CIC - Centre d'Investigation Clinique [Rennes]
5 CHU Pontchaillou [Rennes]
6 Physiopathologie du cancer du foie
7 Pôle Recherche Clinique-Santé Publique [Mondor]
8 Service d'hépatologie
9 Service d'hépatologie
10 I2MR - Institut de médecine moléculaire de Rangueil
11 Department of Multiorgan Transplantation
12 Service de gastro-entérologie [CHU Trousseau]
13 CHU Trousseau [Tours]
14 SLIDE - ScaLable Information Discovery and Exploitation [Saint Martin d’Hères]
LIG - Laboratoire d'Informatique de Grenoble
15 Service d'hépato-gastro-entérologie
16 APHP
17 UPMC - Université Pierre et Marie Curie - Paris 6
18 Hôpital Erasme
19 service d'Hépato-gastro-entérologie
20 Hôpital de la Milétrie
21 Chirurgie Digestive
22 C3M - Centre méditerranéen de médecine moléculaire
23 Département Digestif
24 Service d'hépatologie
25 RESINFIT - Anti-infectieux : supports moléculaires des résistances et innovations thérapeutiques
26 Service de chirurgie digestive hépato-bilio-pancréatique transplantation hépatique [CHU Pitié-Salpêtrière]
27 CR Saint-Antoine - Centre de Recherche Saint-Antoine
28 Human HepCell [AP-HP Hôpital Saint-Antoine]
29 Interactions Virus-Hôte et Maladies Hépatiques
30 Pathogénèse et traitement de l'hépatite fulminante et du cancer du foie
31 Centre hépato-biliaire - CHB [Paul Brousse, Paris]
32 DHU - Hepatinov
33 CNR wilson - Centre National de Référence pour la maladie de Wilson
34 Service d'hépatologie
Abstract : Background & Aims:HCV recurrence remains a major issue in the liver transplant field, as it has a negative impact on both graft and patient survival. The purpose of this study was to investigate the efficacy and safety of treating HCV recurrence with sofosbuvir (SOF) and daclatasvir (DCV) combination therapy. Methods: From October 2013 to March 2015, 559 liver recipients were enrolled in the prospective multicentre France REcherche Nord&Sud Sida-hiv Hepatites (ANRS) Compassionate use of Protease Inhibitors in viral C Liver Transplantation cohort. We selected 137 patients with an HCV recurrence receiving SOF and DCV, whatever the genotype or fibrosis stage. The use of ribavirin and the duration of therapy were at the investigator's discretion. The primary efficacy end point was a sustained virological response (SVR) 12 weeks after the end of treatment. Results: The SVR rate 12 weeks after completing treatment was 96% under the intention-to treat analysis and 99% when excluding non-virological failures. Only two patients experienced a virological failure. The serious adverse event (SAE) rate reached 17.5%. Four patients (3%) stopped their treatment prematurely because of SAEs. Anaemia was the most common AE, with significantly more cases in the ribavirin group (56% vs. 18%; p <0.0001). A slight but significant reduction in creatinine clearance was reported. No clinically relevant drug-drug interactions were noted, but 52% of patients required a change to the dosage of immunosuppressive drugs. Conclusions: Treatment with SOF plus DCV was associated with a high SVR12 and low rates of serious adverse events among liver recipients with HCV recurrence. Lay summary: The recurrence of hepatitis C used to be the first cause of graft failure in infected liver transplanted recipients. Our study demonstrates the great efficacy of one combination of new all-oral direct-acting antiviral, sofosbuvir and daclatasvir, to treat the recurrence of hepatitis C on the graft. Ninety-six per cent of recipients were cured. The safety profile of this combination seemed to be good, especially no relevant drug-drug interaction with immunosuppressive drugs. (C) 2016 European Association for the Study of the Liver. Published by Elsevier B.V. All rights reserved.
Keywords : liver-transplant recipients drug-drug interactions hcv infection natural-history virus-infection triple therapy ribavirin association combination interferon
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https://hal-univ-rennes1.archives-ouvertes.fr/hal-01395132
Contributor : Laurent Jonchère <>
Submitted on : Thursday, November 10, 2016 - 2:58:58 PM
Last modification on : Friday, March 27, 2020 - 2:32:26 AM

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UNIV-RENNES1 | CIC | CNRS | UNIV-FCOMTE | UNICE | UNIV-PARIS7 | HCL | UNILIM | UPMC | GEIST | CIC203 | BIOSIT | U938 | UR1-UFR-SVE | UNIV-PARIS5 | UGA | USPC | UNIV-PARIS-SACLAY | UNIV-COTEDAZUR | UNIV-RENNES | SORBONNE-UNIVERSITE | SU-MEDECINE | LIG | LIG-TDCGE-SLIDE | UNIV-TLSE3

Citation

Audrey Coilly, Claire Fougerou-Leurent, Victor Ledinghen, Pauline Houssel-Debry, Christophe Duvoux, et al.. Multicentre experience using daclatasvir and sofosbuvir to treat hepatitis C recurrence - The ANRS CUPILT study. Journal of Hepatology, Elsevier, 2016, 65 (4), pp.711--718. ⟨10.1016/j.jhep.2016.05.039⟩. ⟨hal-01395132⟩

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