Sofosbuvir in combination with simeprevir +/- ribavirin in genotype 4 hepatitis C patients with advanced fibrosis or cirrhosis: a real-life experience from Belgium

Background: All-oral, interferon-free regimens that combine direct-acting antiviral drugs have significantly advanced the treatment of hepatitis C (HCV), especially for genotype 1(G1) patients. However, efficacy and safety data of interferon-free regimens in HCV genotype 4 (G4) patients are scarce. In Belgium, Sofosbuvir (SOF) and Simeprevir (SMV) treatment is available since January 2015 for G4 patients with advanced fibrosis (F3-F4 METAVIR) for 12 weeks. Methods: analysis of HCV G4 patients receiving SOF and SMV treatment in Belgium. The aim of the study was to evaluate the safety and efficacy of the treatment. Results: 73 G4 patients were enrolled in this data collection including 32 (43.8%) patients with severe fibrosis F3 and 41(56.2%) cirrhotic patients. The study population comprised 58.9% male, 77.8% treatment experienced patients. Median age was 59 [51-66] years and 5 patients were HCV/HIV co-infected. 24 patients received the treatment associated with ribavirin, 11/32 (34.37%) of patients with advanced fibrosis and 13/41 (31.71%) of cirrhotic patients. In cirrhotic patients, median MELD and Child-Pugh score were 9 [7-12.5] and 5 [5-6], 46.2% had platelet below 100.000/mm and 28.6% had albumin below 35 g/L. W4 HCV RNA was undetectable in 31.25% (15/48). 9 of the 15 patients with undetectable W4 HCV RNA received RBV. At W12, 100% (23/23) had HCV RNA below the limit of quantification, with 6/23 still detectable. All SVR12 data will be available at the time of presentation. No patient experienced serious adverse event. Conclusions: these preliminary results in difficult-to-treat G4 HCV patients show that SOF/SIM +/- RBV treatment is safe and seems promising, in line with that was observed in G1 HCV patients