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.

BackgroundIn 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). MethodsAll HCV LT recipients with severe fibrosis in 15 Italian transplant centers were treated with DCV+SOFRBV for 24weeks; sustained virological response was assessed at 12weeks post-treatment (SVR12). ResultsEighty-seven patients were enrolled (75.9% males, mean age 58.4 +/- 7.2years, 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. ConclusionAn extended course of SOF plus DCV for 24weeks, with or without RBV, is effective and well tolerated for the treatment of post-LT HCV recurrence with severe fibrosis.