TY - JOUR
T1 - The Italian compassionate use of sofosbuvir in HCV patients waitlisted for liver transplantation
T2 - A national real-life experience
AU - the ITACOPS study group
AU - Martini, Silvia
AU - Donato, Maria Francesca
AU - Mazzarelli, Chiara
AU - Rendina, Maria
AU - Visco-Comandini, Ubaldo
AU - Filì, Daniela
AU - Gianstefani, Alice
AU - Fagiuoli, Stefano
AU - Melazzini, Mario
AU - Montilla, Simona
AU - Pani, Luca
AU - Petraglia, Sandra
AU - Russo, Pierluigi
AU - Trotta, Maria Paola
AU - Carrai, Paola
AU - Caraceni, Paolo
AU - Angeli, Paolo
AU - Ballardini, Giorgio
AU - Bernabucci, Veronica
AU - Bhoori, Sherrie
AU - Burra, Patrizia
AU - Civolani, Alberto
AU - D'Offizi, Gianpiero
AU - Felder, Martina
AU - Gaeta, Giovanni Battista
AU - Ganga, Roberto
AU - Ginanni Corradini, Stefano
AU - Iemmolo, Rosa Maria
AU - Lenci, Ilaria
AU - Lionetti, Raffaella
AU - Montalbano, Marzia
AU - Morelli, Maria Cristina
AU - Picciotto, Antonino
AU - Sapere, Cristina
AU - Serviddio, Gaetano
AU - Tamè, Mariarosa
AU - Verucchi, Gabriella
AU - Zignego, Anna Linda
PY - 2018/4/1
Y1 - 2018/4/1
N2 - 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.
AB - 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.
KW - bridging therapy
KW - decompensated cirrhosis
KW - delisting
KW - direct-acting antivirals
KW - hepatitis C
KW - liver transplantation
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U2 - 10.1111/liv.13588
DO - 10.1111/liv.13588
M3 - Article
AN - SCOPUS:85044391848
VL - 38
SP - 733
EP - 741
JO - Liver International
JF - Liver International
SN - 1478-3223
IS - 4
ER -