BACKGROUND AND AIM
Current recommended regimens to treat patients with HCV infection after liver transplantation include the use of ribavirin (RBV). Limited data are available on the efficacy of RBV-free regimens post-transplant, particularly the use of Sofosbuvir/Ledipasvir without RBV in this patient population. We aimed to assess the efficacy and safety of Sofosbuvir/Ledipasvir fixed-dose combination without RBV in patients with HCV recurrence post-transplant.
This is a retrospective study of 46 patients with HCV recurrence post-transplant. Sofosbuvir/Ledipasvir without ribavirin was used for 12 weeks in patients with early stage fibrosis (F0-F2) or for 24 weeks in those with advanced fibrosis (F3-F4) and/or cholestatic hepatitis. The primary end point was sustained virologic response at 12 weeks after the end of treatment. Secondary outcomes included relapse after treatment and adverse events.
Forty-six patients, with a mean age of 62 ± 8 years, a median duration since time of transplant of 904 days (range 78-3525 days), an HCV genotype 1, and a mean baseline viral load of 7.79 million IU/ml, were treated. Of these, 32 patients were treated for 12 weeks and 14 patients were treated for 24 weeks. Twenty-five patients (54%) were treatment experienced (21 with Interferon and 4 with Sofosbuvir). All 46 patients(100%) achieved SVR 12. Neither virologic relapses nor serious adverse events were noted.
The combination of Sofosbuvir/Ledipasvir without RBV for 12 or 24 weeks produced 100% SVR 12 in patients with HCV recurrence after liver transplantation. The use of RBV may not be necessary to achieve SVR in this patient population.