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Journal Articles Journal of Hepatology Year : 2016

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

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 Centre Hospitalier Universitaire de Rennes [CHU Rennes] = Rennes University Hospital
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 Département de Néphrologie et Transplantation d'organes [CHU Toulouse]
12 CHU Trousseau [APHP]
13 CHU Trousseau [Tours]
14 SLIDE - ScaLable Information Discovery and Exploitation [Grenoble]
15 Service d'hépato-gastro-entérologie
16 AP-HP - Assistance publique - Hôpitaux de Paris (AP-HP)
17 UPMC - Université Pierre et Marie Curie - Paris 6
18 ULB - Hôpital Erasme [Bruxelles]
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 CHU Pitié-Salpêtrière [AP-HP]
27 UMRS893 - Centre de Recherche Saint-Antoine
28 CHU Saint-Antoine [AP-HP]
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
Vincent Di Martino
Christophe Moreno
  • Function : Author
  • PersonId : 916416
Christine Silvain
Camille Besch
Philippe Perré
  • Function : Author
Armando Aberge
  • Function : Author
Alexandra Rohel
  • Function : Author
Georges-Philippe Pageaux


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.
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Dates and versions

hal-01395132 , version 1 (10-11-2016)



Audrey Coilly, Claire Fougerou-Leurent, Victor De 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, 2016, 65 (4), pp.711--718. ⟨10.1016/j.jhep.2016.05.039⟩. ⟨hal-01395132⟩
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