Real-life efficacy of generic sofosbuvir/ledipasvir for treatment of Iranian patients with chronic hepatitis C: A cohort study

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.