1Department of Gastroenterology and Hepatology, Cleveland Clinic, Cleveland, OH.
2Department of Internal Medicine, Cleveland Clinic, Cleveland, OH.
3Department of Gastroenterology and Hepatology, Cleveland Clinic Florida, Weston, FL.
The interferon-free antiviral regimen, Sofosbuvir (SOF) and Simeprevir (SIM) without ribavirin has been reported to achieve high sustained virologic response (SVR) rates with few adverse effects when treating patients with hepatitis C genotype 1 (HCV GT1) infection. However, there is scarcity of safety and efficacy data in this regimen after liver transplantation (LT).
AIM AND METHODS:
We aim to report the safety, tolerability and efficacy of SOF+SIM to treat LT recipients with recurrent HCV GT1 in a multi-center cohort study.
81 patients with HCV GT1 met criteria to be considered for treatment. 67 patients received SOF+SIM following aLT to date: 69% male, 39% with HCV RNA >6,000,000 IU/mL, 22% advanced hepatic fibrosis (stage 3-4), 6% cholestatic recurrence. 58% previously failed or did not tolerate interferon-based treatments. Mean time from LT to treatment was 6.1 years ± 5.2. All patients had estimated GFR >30 mL/min. Tacrolimus was primary immunosuppression in 84% of patients and minimal immunosuppression dose adjustments were required during treatment. In intention to treat analysis, 90% achieved end of treatment virologic response and 88% achieved sustained virologic response.
SOF+SIM combination therapy without ribavirin is well tolerated and results in high virological response rates in recurrent HCV GT1 infection after liver transplantation.