3 years ago

The Italian Compassionate use of Sofosbuvir in HCV patients waitlisted for liver transplantation: a national real-life experience

Ubaldo Visco-Comandini, Chiara Mazzarelli, Maria Francesca Donato, Silvia Martini, Paolo Caraceni, Simona Montilla, Stefano Fagiuoli, Alice Gianstefani, Sandra Petraglia, Daniela Filì, Pierluigi Russo, Maria Paola Trotta, Luca Pani, Mario Melazzini, , Maria Rendina, Paola Carrai
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 (SVR12: 88%) and 49 negative for <4 weeks or still viremic 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. Conclusions These real-life data indicate that in waitlisted patients: 1. bridging antiviral therapy can be an option for patients still viremic or negative <4 weeks at LT; and 2. clinical improvement to a condition suitable for delisting can occur even in patients with advanced decompensated cirrhosis. This article is protected by copyright. All rights reserved.

Publisher URL: http://onlinelibrary.wiley.com/resolve/doi

DOI: 10.1111/liv.13588

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