The Italian compassionate use of sofosbuvir in HCV HCV patients waitlisted for liver transplantation: A national real‐life experience

摘要

Abstract Background & Aims This study aimed to assess the real‐life clinical and virological outcomes of HCV waitlisted patients for liver transplantation ( LT ) who received sofosbuvir/ribavirin ( SOF /R) within the Italian compassionate use program. Methods Clinical and virological data were collected in 224 patients with decompensated cirrhosis and/or hepatocellular carcinoma ( HCC ) receiving daily SOF /R until LT or up a maximum of 48?weeks. Results Of 100 transplanted patients, 51 were HCV ‐ RNA negative for 4?weeks before LT ( SVR 12: 88%) and 49 negative for 4?weeks or still viraemic at transplant: 34 patients continued treatment after LT (bridging therapy) ( SVR 12: 88%), while 15 stopped treatment ( SVR 12: 53%). 98 patients completed SOF /R without LT ( SVR 12: 73%). In patients with advanced decompensated cirrhosis (basal MELD ≥15 and/or C‐P ≥B8), a marked improvement of the scores occurred in about 50% of cases and almost 20% of decompensated patients without HCC reached a condition suitable for inactivation and delisting. Conclusions These real‐life data indicate that in waitlisted patients: (i) bridging antiviral therapy can be an option for patients still viraemic or negative 4?weeks at LT ; and (ii) clinical improvement to a condition suitable for delisting can occur even in patients with advanced decompensated cirrhosis.