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.

Martini, S., Donato, M., Mazzarelli, C., Rendina, M., Visco-Comandini, U., Fili, D., et al. (2018). The Italian compassionate use of sofosbuvir in HCV patients waitlisted for liver transplantation: A national real-life experience. LIVER INTERNATIONAL, 38(4), 733-741 [10.1111/liv.13588].

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

Fagiuoli S.;Russo P.;
2018

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.
Articolo in rivista - Articolo scientifico
bridging therapy; decompensated cirrhosis; delisting; direct-acting antivirals; hepatitis C; liver transplantation;
English
733
741
9
Martini, S., Donato, M., Mazzarelli, C., Rendina, M., Visco-Comandini, U., Fili, D., et al. (2018). The Italian compassionate use of sofosbuvir in HCV patients waitlisted for liver transplantation: A national real-life experience. LIVER INTERNATIONAL, 38(4), 733-741 [10.1111/liv.13588].
Martini, S; Donato, M; Mazzarelli, C; Rendina, M; Visco-Comandini, U; Fili, D; Gianstefani, A; Fagiuoli, S; Melazzini, M; Montilla, S; Pani, L; Petraglia, S; Russo, P; Trotta, M; Carrai, P; Caraceni, P; Angeli, P; Ballardini, G; Bernabucci, V; Bhoori, S; Burra, P; Civolani, A; D'Offizi, G; Felder, M; Gaeta, G; Ganga, R; Ginanni Corradini, S; Iemmolo, R; Lenci, I; Lionetti, R; Montalbano, M; Morelli, M; Picciotto, A; Sapere, C; Serviddio, G; Tame, M; Verucchi, G; Zignego, A
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Utilizza questo identificativo per citare o creare un link a questo documento: https://hdl.handle.net/10281/354324
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