Sofosbuvir compassionate use in liver transplant recipients

Recurrent hepatitis C virus (HCV) infection following liver transplantation (LT) is associated with an accelerated progression of liver disease, which can lead to graft loss and death. The authors provided sofosbuvir and ribavirin on a compassionate-use basis to patients with severe recurrent HCV, including those with fibrosing cholestatic hepatitis (FCH) and decompensated cirrhosis who had a life expectancy of one year or less. All of the patients received 24–48 weeks of sofosbuvir plus ribavirin. Of the first 104 patients analysed, 52 had an early severe recurrence (diagnosed <12 months after LT) and 52 had cirrhosis (diagnosed >12 months after LT). Of 92 patients assessed, 59% achieved sustained virologic response at 12 weeks after the end of treatment (SVR12), with a higher rate (73%) in patients with early severe recurrence. 57% of patients reported a clinical improvement at the last study visit, 22% were unchanged, 3% had a worsened clinical status and 13% had died. Overall, 123 serious adverse events (SAEs) occurred in 47% of the patients. SAEs associated with hepatic decompensation were the most common, with 26 such events occurring in 18% of patients. Therefore sofosbuvir and ribavirin lead to high rates of sustained virologic response in patients with severe recurrent HCV, including patients with early severe recurrence, FCH and cirrhosis.

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