Gastrohepatology Unit, AOU Città della Salute e della Scienza di Torino, Turin, Italy.
First Division of Gastroenterology, IRCCS Fondazione Ospedale Maggiore Policlinico, Mangiagalli e Regina Elena, Milan, Italy.
Hepatology and Gastroenterology Unit, Niguarda Ca' Granda Hospital, Milan, Italy.
Gastroenterology and Digestive Endoscopy, University Hospital, Bari, Italy.
Infectious Diseases - Hepatology Division, National Institute for Infectious Diseases Spallanzani IRCSS, Rome, Italy.
Department for the Treatment and Study of Abdominal Diseases and Abdominal Transplantation, Hepatology Unit, IRCCS - ISMETT (Mediterranean Institute for Transplantation and Advanced Specialized Therapies), Palermo, Italy.
Department of Surgical and Medical Sciences, University of Bologna, Bologna, Italy.
Gastroenterology and Transplant Hepatology, Ospedale Papa Giovanni XXIII di Bergamo, Bergamo, Italy.
Italian Medicines Agency (AIFA), Rome, Italy.
Hepatobiliary Surgery and Liver Transplantation, University of Pisa, Pisa, Italy.
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.
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.
Of 100 transplanted patients, 51 were HCV-RNA negative for >4 weeks before LT (SVR12: 88%) and 49 negative for <4 weeks or still viraemic at transplant: 34 patients continued treatment after LT (bridging therapy) (SVR12: 88%), while 15 stopped treatment (SVR12: 53%). 98 patients completed SOF/R without LT (SVR12: 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.
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.