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

Direct antivirals are available for treating recurrent hepatitis C (RHC). This studyreported outcomes of 424 patients with METAVIR F3–F4 RHC who were treatedfor 24 weeks with sofosbuvir/ribavirin and followed for 12 weeks within the Ital-ian sofosbuvir compassionate use program. In 55 patients, daclatasvir or simepre-vir 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 sus-tained viral response (SVR) was 86.7% (316/365) in patients who received sofos-buvir/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 inSVR 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 whoworsened 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 associa-tion was found between maintaining a final MELD score<15 and the achievementof SVR (187/219 vs. 6/10,P=0.031). This real-world study indicates that sofos-buvir/ribavirin treatment for 24 weeks was effective, and the achievement of SVRwas associated with a reduced probability of developing worsening liver function.