The Italian compassionate use of sofosbuvir observational cohort study for the treatment of recurrent hepatitis C: clinical and virological outcomes. (7th September 2017)

• Record Type: Journal Article
• Authors: Carrai, Paola; Morelli, Cristina; Cordone, Gabriella; Romano, Antonietta; Tamé, Mariarosa; Lionetti, Raffaella; Pietrosi, Giada; Lenci, Ilaria; Piai, Guido; Russo, Francesco Paolo; Coppola, Carmine; Melazzini, Mario; Montilla, Simona; Pani, Luca; Petraglia, Sandra; Russo, Pierluigi; Trotta, Maria Paola; Martini, Silvia; Toniutto, Pierluigi
• Other Names: Bandiera Francesco investigator.; Bhoori Sherrie investigator.; Brillanti Stefano investigator.; Burra Patrizia investigator.; Corsale Sveva investigator.; De Luca Andrea investigator.; Fagiuoli Stefano investigator.; Fattovich Giovanna investigator.; Fava Gianmarco investigator.; Felder Martina investigator.; Forte Paolo investigator.; Galeota‐Lanza Alfonso investigator.; Gitto Stefano investigator.; Grieco Antonio investigator.; Grossi Paolo investigator.; Ialungo A.M. investigator.; Iemmolo Rosa Maria investigator.; Loiacono Laura investigator.; Mangia Alessandra investigator.; Merli Manuela investigator.; Piacentini A. investigator.; Pellicelli Adriano investigator.; Rigamonti Cristina investigator.; Gabriella Verucchi investigator.; Zignego Anna Linda investigator.
• Is Part Of: Transplant international. Volume 30:Number 12(2017)
• Page Start: 1253
• Page End: 1265
• Publication Date: 2017-09-07
• Subjects: cholestatic hepatitis -- hepatitis C -- liver transplantation -- sofosbuvir; Transplantation of organs, tissues, etc -- Periodicals; 617.95405
• DOI: 10.1111/tri.13018
• Languages: English
• ISSNs: 0934-0874

Abstract

Summary: 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.