Sofosbuvir compassionate use program for patients with severe recurrent hepatitis C after liver transplantation

Area of Science:

• Hepatology
• Transplantation Medicine
• Virology

Background:

• Recurrent hepatitis C virus (HCV) infection post-liver transplantation (LT) accelerates liver disease, leading to graft loss and mortality.
• Current treatments for severe recurrent HCV infection have limited efficacy, tolerability, and drug interaction profiles.

Purpose of the Study:

• To evaluate the efficacy and clinical outcomes of sofosbuvir (SOF) and ribavirin (RBV) in patients with severe recurrent HCV infection after LT.
• To assess treatment response in patients with fibrosing cholestatic hepatitis (FCH) and decompensated cirrhosis.

Main Methods:

• Compassionate-use administration of SOF and RBV for 24-48 weeks to patients with severe recurrent HCV and a limited life expectancy.
• Optional addition of pegylated interferon at investigator discretion.
• Analysis of data from 104 patients who completed or discontinued treatment.

Main Results:

• 59% (54/92) of patients achieved sustained virological response (SVR) at 12 weeks post-treatment.
• SVR rates were higher in patients with early severe recurrence (73%; 35/48).
• 57% (59/103) of patients showed clinical improvement, while 18% experienced serious adverse events related to hepatic decompensation.

Conclusions:

• SOF and RBV demonstrate high SVR rates in patients with severe recurrent HCV, encompassing early recurrence, FCH, and cirrhosis.
• The treatment offers a viable option for patients with limited therapeutic choices.