Université d'Auvergne Clermont1 | CNRS

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Multicentre experience using daclatasvir and sofosbuvir to treat hepatitis C recurrence after liver transplantation - The CO23 ANRS CUPILT study.

TitleMulticentre experience using daclatasvir and sofosbuvir to treat hepatitis C recurrence after liver transplantation - The CO23 ANRS CUPILT study.
Publication TypeJournal Article
Year of Publication2016
AuthorsCoilly, A., C. Fougerou-Leurent, V. de Ledinghen, P. Houssel-Debry, C. Duvoux, V. Di Martino, S. Radenne, N. Kamar, L. D'Alteroche, V. Leroy, V. Canva, P. Lebray, C. Moreno, J. Dumortier, C. Silvain, C. Besch, P. Perre, D. Botta-Fridlund, R. Anty, C. Francoz, A. Abergel, M. Debette-Gratien, F. Conti, F. Habersetzer, A. Rohel, E. Rossignol, H. Danjou, A. - M. Roque-Afonso, D. Samuel, J. - C. Duclos-Vallee, and G. - P. Pageaux
Corporate AuthorsANRS C023 CUPILT study group
JournalJournal of hepatology
Date Published2016 Jun 1
ISSN1600-0641
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 ANRS CUPILT 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% versus 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.

CONCLUSION: 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.

DOI10.1016/j.jhep.2016.05.039
Alternate JournalJ. Hepatol.