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.

The Italian compassionate use of sofosbuvir in HCV patients waitlisted for liver transplantation: A national real-life experience / 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; Angeli, Paolo; Ballardini, Giorgio; Bernabucci, Veronica; Bhoori, Sherrie; Burra, Patrizia; Civolani, Alberto; D'Offizi, Gianpiero; Felder, Martina; Gaeta, Giovanni Battista; Ganga, Roberto; Ginanni Corradini, Stefano; Iemmolo, Rosa Maria; Lenci, Ilaria; Lionetti, Raffaella; Montalbano, Marzia; Morelli, Maria Cristina; Picciotto, Antonino; Sapere, Cristina; Serviddio, Gaetano; Tamè, Mariarosa; Verucchi, Gabriella; Zignego, Anna Linda. - In: LIVER INTERNATIONAL. - ISSN 1478-3223. - 38:4(2018), pp. 733-741. [10.1111/liv.13588]

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

Pani, Luca;Angeli, Paolo;Bernabucci, Veronica;
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.
6-ott-2017
38
4
733
741
The Italian compassionate use of sofosbuvir in HCV patients waitlisted for liver transplantation: A national real-life experience / 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; Angeli, Paolo; Ballardini, Giorgio; Bernabucci, Veronica; Bhoori, Sherrie; Burra, Patrizia; Civolani, Alberto; D'Offizi, Gianpiero; Felder, Martina; Gaeta, Giovanni Battista; Ganga, Roberto; Ginanni Corradini, Stefano; Iemmolo, Rosa Maria; Lenci, Ilaria; Lionetti, Raffaella; Montalbano, Marzia; Morelli, Maria Cristina; Picciotto, Antonino; Sapere, Cristina; Serviddio, Gaetano; Tamè, Mariarosa; Verucchi, Gabriella; Zignego, Anna Linda. - In: LIVER INTERNATIONAL. - ISSN 1478-3223. - 38:4(2018), pp. 733-741. [10.1111/liv.13588]
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; Angeli, Paolo; Ballardini, Giorgio; Bernabucci, Veronica; Bhoori, Sherrie; Burra, Patrizia; Civolani, Alberto; D'Offizi, Gianpiero; Felder, Martina; Gaeta, Giovanni Battista; Ganga, Roberto; Ginanni Corradini, Stefano; Iemmolo, Rosa Maria; Lenci, Ilaria; Lionetti, Raffaella; Montalbano, Marzia; Morelli, Maria Cristina; Picciotto, Antonino; Sapere, Cristina; Serviddio, Gaetano; Tamè, Mariarosa; Verucchi, Gabriella; Zignego, Anna Linda
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