Sofosbuvir plus daclatasvir with or without ribavirin is safe and effective for post-transplant hepatitis C recurrence and severe fibrosis and cirrhosis: A prospective study

Raffaella Lionetti, Vincenza Calvaruso, Paola Piccolo, Rossella Letizia Mancusi, Chiara Mazzarelli, Stefano Fagiuoli, Marzia Montalbano, Ilaria Lenci, Paola Carrai, Giovanni Guaraldi, Ubaldo Visco-Comandini, Martina Milana, Marco Biolato, Laura Loiacono, Giovanna Valente, Antonio Craxì, Mario Angelico, Gianpiero D'offizi

Research output: Contribution to journalArticle

Abstract

Background: In 2012, an Italian Named Patient Program began for hepatitis C virus (HCV)-infected liver transplant (LT) recipients with advanced fibrosis, before approval of direct antiviral agents (DAA), to benefit severely ill patients. The aim of this "real-life" study was to assess treatment efficacy and safety with an extended course of daclatasvir (DCV) plus sofosbuvir (SOF) with or without ribavirin (RBV). Methods: All HCV LT recipients with severe fibrosis in 15 Italian transplant centers were treated with DCV+SOF±RBV for 24 weeks; sustained virological response was assessed at 12 weeks post-treatment (SVR12). Results: Eighty-seven patients were enrolled (75.9% males, mean age 58.4 ± 7.2 years, 83.9% genotype 1, 81.6% cirrhosis); 52 (59.8%) received RBV. Overall, 79 obtained SVR12 (90.8%): 100% in F3 and 88.7% in cirrhotics (91.5% in Child-Pugh A, 83.3% in Child-Pugh B and C). According to the treatment group, SVR was 80% in DCV + SOF group and 98.1% in SOF + DCV + RBV. Two virological relapses occurred during follow-up in cirrhotic patients who received DCV + SOF. Four cirrhotic patients in DCV + SOF group and 1 in DCV + SOF + RBV group died on treatment. Conclusion: An extended course of SOF plus DCV for 24 weeks, with or without RBV, is effective and well tolerated for the treatment of post-LT HCV recurrence with severe fibrosis.

Original languageEnglish
JournalClinical Transplantation
DOIs
Publication statusAccepted/In press - Jan 1 2017

Keywords

  • Antiviral treatment
  • Cirrhosis
  • Direct antiviral agents
  • Hepatitis C virus
  • Liver transplantation

ASJC Scopus subject areas

  • Transplantation

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