TY - JOUR
T1 - The Italian compassionate use of sofosbuvir observational cohort study for the treatment of recurrent hepatitis C
T2 - clinical and virological outcomes
AU - Carrai, Paola
AU - Morelli, Cristina
AU - Cordone, Gabriella
AU - Romano, Antonietta
AU - Tamé, Mariarosa
AU - Lionetti, Raffaella
AU - Pietrosi, Giada
AU - Lenci, Ilaria
AU - Piai, Guido
AU - Russo, Francesco Paolo
AU - Coppola, Carmine
AU - Melazzini, Mario
AU - Montilla, Simona
AU - Pani, Luca
AU - Petraglia, Sandra
AU - Russo, Pierluigi
AU - Trotta, Maria Paola
AU - Martini, Silvia
AU - Toniutto, Pierluigi
AU - Bandiera, Francesco
AU - Bhoori, Sherrie
AU - Brillanti, Stefano
AU - Burra, Patrizia
AU - Corsale, Sveva
AU - De Luca, Andrea
AU - Fagiuoli, Stefano
AU - Fattovich, Giovanna
AU - Fava, Gianmarco
AU - Felder, Martina
AU - Forte, Paolo
AU - Galeota-Lanza, Alfonso
AU - Gitto, Stefano
AU - Grossi, Paolo
AU - Grossi, Paolo
AU - Ialungo, A. M.
AU - Iemmolo, Rosa Maria
AU - Loiacono, Laura
AU - Mangia, Alessandra
AU - Merli, Manuela
AU - Piacentini, A.
AU - Pellicelli, Adriano
AU - Rigamonti, Cristina
AU - Gabriella, Verucchi
AU - Zignego, Anna Linda
AU - the ITACOPS study group
PY - 2017/12/1
Y1 - 2017/12/1
N2 - Direct antivirals are available for treating recurrent hepatitis C (RHC). This study reported outcomes of 424 patients with METAVIR F3–F4 RHC who were treated for 24 weeks with sofosbuvir/ribavirin and followed for 12 weeks within the Italian sofosbuvir compassionate use program. In 55 patients, daclatasvir or simeprevir were added. Child–Pugh class and model of end stage liver disease (MELD) scores were evaluated at baseline and 36 weeks after the start of therapy. The sustained viral response (SVR) was 86.7% (316/365) in patients who received sofosbuvir/ribavirin and 98.3% (58/59) in patients who received a second antiviral (P < 0.01). In patients treated with sofosbuvir/ribavirin, a significant difference in SVR was observed between patients diagnosed with METAVIR F4 (211/250; 84.4%), METAVIR F3 (95/105; 90.5%) and fibrosing cholestatic hepatitis (10/10; 100%) (P = 0.049). A significant association was found between patients who worsened from Child–Pugh class A and who experienced viral relapse (4/26 vs. 8/189, P = 0.02). In patients with a baseline MELD score <15, a significant association was found between maintaining a final MELD score <15 and the achievement of SVR (187/219 vs. 6/10, P = 0.031). This real-world study indicates that sofosbuvir/ribavirin treatment for 24 weeks was effective, and the achievement of SVR was associated with a reduced probability of developing worsening liver function.
AB - Direct antivirals are available for treating recurrent hepatitis C (RHC). This study reported outcomes of 424 patients with METAVIR F3–F4 RHC who were treated for 24 weeks with sofosbuvir/ribavirin and followed for 12 weeks within the Italian sofosbuvir compassionate use program. In 55 patients, daclatasvir or simeprevir were added. Child–Pugh class and model of end stage liver disease (MELD) scores were evaluated at baseline and 36 weeks after the start of therapy. The sustained viral response (SVR) was 86.7% (316/365) in patients who received sofosbuvir/ribavirin and 98.3% (58/59) in patients who received a second antiviral (P < 0.01). In patients treated with sofosbuvir/ribavirin, a significant difference in SVR was observed between patients diagnosed with METAVIR F4 (211/250; 84.4%), METAVIR F3 (95/105; 90.5%) and fibrosing cholestatic hepatitis (10/10; 100%) (P = 0.049). A significant association was found between patients who worsened from Child–Pugh class A and who experienced viral relapse (4/26 vs. 8/189, P = 0.02). In patients with a baseline MELD score <15, a significant association was found between maintaining a final MELD score <15 and the achievement of SVR (187/219 vs. 6/10, P = 0.031). This real-world study indicates that sofosbuvir/ribavirin treatment for 24 weeks was effective, and the achievement of SVR was associated with a reduced probability of developing worsening liver function.
KW - cholestatic hepatitis
KW - hepatitis C
KW - liver transplantation
KW - sofosbuvir
UR - http://www.scopus.com/inward/record.url?scp=85028939133&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85028939133&partnerID=8YFLogxK
U2 - 10.1111/tri.13018
DO - 10.1111/tri.13018
M3 - Article
AN - SCOPUS:85028939133
VL - 30
SP - 1253
EP - 1265
JO - Transplant International
JF - Transplant International
SN - 0934-0874
IS - 12
ER -