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.

The Italian compassionate use of sofosbuvir observational cohort study for the treatment of recurrent hepatitis C: clinical and virological outcomes / Carrai P.; Morelli C.; Cordone G.; Romano A.; Tame M.; Lionetti R.; Pietrosi G.; Lenci I.; Piai G.; Russo F.P.; Coppola C.; Melazzini M.; Montilla S.; Pani L.; Petraglia S.; Russo P.; Trotta M.P.; Martini S.; Toniutto P.; Bandiera F.; Bhoori S.; Brillanti S.; Burra P.; Corsale S.; De Luca A.; Fagiuoli S.; Fattovich G.; Fava G.; Felder M.; Forte P.; Galeota-Lanza A.; Gitto S.; Grieco A.; Grossi P.; Ialungo A.M.; Iemmolo R.M.; Loiacono L.; Mangia A.; Merli M.; Piacentini A.; Pellicelli A.; Rigamonti C.; Gabriella V.; Zignego A.L.. - In: TRANSPLANT INTERNATIONAL. - ISSN 0934-0874. - ELETTRONICO. - 30:(2017), pp. 1253-1265. [10.1111/tri.13018]

The Italian compassionate use of sofosbuvir observational cohort study for the treatment of recurrent hepatitis C: clinical and virological outcomes

Lionetti R.;Russo F. P.;Pani L.;Gitto S.;Grieco A.;PIACENTINI, ANGELO;Zignego A. L.
2017

Abstract

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.
2017
30
1253
1265
Goal 3: Good health and well-being for people
Carrai P.; Morelli C.; Cordone G.; Romano A.; Tame M.; Lionetti R.; Pietrosi G.; Lenci I.; Piai G.; Russo F.P.; Coppola C.; Melazzini M.; Montilla S.;...espandi
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Utilizza questo identificatore per citare o creare un link a questa risorsa: https://hdl.handle.net/2158/1168928
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