Abstract

Background: Treatment of hepatitis C virus (HCV) infection with recently introduced direct-acting antiviral agents (DAA) is effective and safe, however there is little known regarding safety and efficacy of generic DAAs in the real-life clinical setting. This study aimed to evaluate the efficacy and safety of generic sofosbuvir/ledipasvir (SOF/LDV) in a real-life clinical experience. Methods: In this prospective cohort study, patients with chronic HCV infection who referred to Middle East Liver Diseases (MELD) Center were included. Based on the patients' condition, they were treated with SOF/LDV fixed-dose combination with or without ribavirin (RBV) for 12 or 24 weeks. Results: A total of 30 (M/F: 19/11) patients with chronic HCV genotype 1 infection with a mean age of 49.8 years were treated with generic SOF/LDV with (9 patients) or without (11 patients) RBV for 12 (27 patients) or 24 (3 patients) weeks. Ten (33.3) had cirrhosis and 13 (43.3) with a previous history of treatment with interferon (IFN)-based regimens. Among the 30 patients, 26 (86.7, 95 CI=70.3-94.7) achieved a rapid virologic response, 30 (100, 95 CI=88.7-100) achieved the end of treatment response and 30 (100, 95 CI=88.7-100) achieved a sustained virologic response. No severe treatment adverse event was observed however, 6 (20) patients experienced mild to moderate adverse events. Conclusion: The treatment of HCV genotype 1 infection with generic SOF/LDV found to be safe and effective even in patients with cirrhosis and previous history of treatment with IFN-based treatments.