Efficacy and safety of sofosbuvir/ledipasvir for the treatment of patients with hepatitis C virus re‐infection after liver transplantation. Issue 3 (10th May 2016) - Ciesek, S.
Abstract: Background: Hepatitis C virus (HCV) infection is associated with a particularly poor outcome after liver transplantation. In December 2014, sofosbuvir/ledipasvir (SOF/LDV) fixed‐dose combination (FDC) was approved for HCV genotype 1 and 4 in Europe. In orthotopic liver transplantation (OLT) recipients, the interferon‐free treatment of HCV re‐infection with novel direct‐acting antivirals has been demonstrated to be safe and effective in clinical trials, but real‐world data are missing. The aim of this study was to investigate the safety and efficacy of SOF/LDV FDC in OLT recipients in the real‐life setting. Methods: All consecutive OLT patients started on SOF/LDV FDC for 12 or 24 weeks at the University Medical Center Hamburg‐Eppendorf and Medical School Hannover between October 2014 and August 2015 were retrospectively analyzed ( n = 30). The primary efficacy endpoint was sustained virological response (SVR), i.e., absence of viremia 12 weeks after end of treatment (SVR 12). Liver function tests, creatinine, blood count, and HCV RNA (by polymerase chain reaction assay) were determined at each visit. Results: SVR was achieved in 29/30 patients (96.67%) treated with SOF/LDV ± ribavirin (RBV) for 12 ( n = 4) or 24 weeks ( n = 25). Twenty‐five patients (86.2%) received RBV. However, in 15 of the 25 patients, RBV administration had to be discontinued because of severe anemia (57.7%). One RBV‐treated patient died of a myocardial infarction during antiviral therapy; this event was most likely not directly related to SOF/LDV. Aside from RBV‐associated anemia, no severe side effects of the antiviral regimen were observed. Conclusion: Antiviral treatment with SOF/LDV is highly effective, safe, and well tolerated in OLT recipients. The addition of RBV often results in severe anemia, requiring dose reduction or discontinuation.