The Italian compassionate use of sofosbuvir in HCV patients waitlisted for liver transplantation: A national real‐life experience. (6th October 2017)

• Record Type: Journal Article
• Authors: Martini, Silvia; Donato, Maria Francesca; Mazzarelli, Chiara; Rendina, Maria; Visco‐Comandini, Ubaldo; Filì, Daniela; Gianstefani, Alice; Fagiuoli, Stefano; Melazzini, Mario; Montilla, Simona; Pani, Luca; Petraglia, Sandra; Russo, Pierluigi; Trotta, Maria Paola; Carrai, Paola; Caraceni, Paolo
• Other Names: Angeli Paolo investigator.; Ballardini Giorgio investigator.; Bernabucci Veronica investigator.; Bhoori Sherrie investigator.; Burra Patrizia investigator.; Civolani Alberto investigator.; D'Offizi Gianpiero investigator.; Felder Martina investigator.; Gaeta Giovanni Battista investigator.; Ganga Roberto investigator.; Ginanni Corradini Stefano investigator.; Iemmolo Rosa Maria investigator.; Lenci Ilaria investigator.; Lionetti Raffaella investigator.; Montalbano Marzia investigator.; Morelli Maria Cristina investigator.; Picciotto Antonino investigator.; Sapere Cristina investigator.; Serviddio Gaetano investigator.; Tamè Mariarosa investigator.; Verucchi Gabriella investigator.; Zignego Anna Linda investigator.
• Is Part Of: Liver international. Volume 38:Number 4(2018)
• Page Start: 733
• Page End: 741
• Publication Date: 2017-10-06
• Subjects: bridging therapy -- decompensated cirrhosis -- delisting -- direct‐acting antivirals -- hepatitis C -- liver transplantation; Liver -- Periodicals; Liver -- Diseases -- Periodicals; 616.362
• DOI: 10.1111/liv.13588
• Languages: English
• ISSNs: 1478-3223

Abstract

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 (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. 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.