Sofosbuvir plus ledispasvir for recurrent hepatitis C in liver transplant recipients

Area of Science:

• Hepatology
• Virology
• Transplantation Medicine

Background:

• Hepatitis C virus (HCV) recurrence post-liver transplantation (LT) significantly worsens patient outcomes.
• Ledipasvir/sofosbuvir (LDV/SOF) is approved for HCV treatment after LT, but real-world data on its effectiveness and safety are limited.
• This study represents the largest real-world evaluation of LDV/SOF in the post-LT setting.

Purpose of the Study:

• To evaluate the real-world effectiveness and safety of ledipasvir/sofosbuvir (LDV/SOF) for Hepatitis C virus (HCV) treatment in liver transplant recipients.
• To determine the sustained virological response rate (SVR12) and assess safety in a diverse post-LT patient population.
• To analyze outcomes based on treatment duration and use of ribavirin (RBV).

Main Methods:

• A multicenter study involving 204 patients who received LDV/SOF post-LT.
• Data collected on patient demographics, HCV genotype (GT), fibrosis stage (METAVIR F3-F4), treatment history, and immunosuppression.
• Sustained virological response at 12 weeks (SVR12) was the primary efficacy endpoint; safety events were monitored.

Main Results:

• An overall SVR12 rate of 96% was achieved across the study population.
• Patients treated with 8 or 12 weeks of LDV/SOF without RBV achieved SVR12 rates of 100% and 96%, respectively.
• The treatment was well-tolerated, with one mild rejection episode and no graft loss attributed to HCV treatment; four non-treatment-related deaths occurred.

Conclusions:

• Ledipasvir/sofosbuvir (LDV/SOF) demonstrates high effectiveness and a favorable safety profile for treating Hepatitis C virus (HCV) in liver transplant recipients.
• Treatment durations of 8 or 12 weeks without ribavirin (RBV) are highly effective.
• LDV/SOF can be safely administered in the real-world post-LT setting, even in patients on calcineurin inhibitors, with minimal impact on immunosuppression.