Efficacy and Safety of Generic Sofosbuvir/Ledipasvir Fixed-Dose Combination in Iranian Patients with Chronic Hepatitis C Virus Infection

Background: Hepatitis C virus (HCV), as a global health concern, has infected around 1.6% of the world population. Introduction of direct-acting antiviral regimens such as sofosbuvir/ledipasvir (SOF/LDV) made the treatment of HCV infection superior to previous HCV antiviral therapies in terms of efficacy and feasibility. The current study aimed at assessing the efficacy and safety of generic SOF/LDV in the Iranian patients with HCV infection. Methods: The current prospective, cohort study was conducted on patients with HCV infection referred to Middle East Liver Diseases Center in 2016. Patients without cirrhosis were treated with daily fixed-dose combination of SOF/LDV (Sobopasvir) for 12 weeks. In cases with compensated cirrhosis, patients were treated with SOF/LDV plus daily weight adjusted ribavirin (RBV) for 12 weeks. If the patient with cirrhosis was RBV-intolerant, he/she was treated with daily fixed-dose combination of SOF/LDV for 24 weeks. Results: In the current study, 30 patients with the mean age of 52.9 years were enrolled and treated with SOF/LDV. Most of the patients were male (73.3%), had cirrhosis (53.3%), infected with HCV-1a (46.7%), and had previous history of HCV antiviral therapy (62.1%). All the patients completed the course of treatment. Rapid virologic and sustained virologic responses were observed in 29 (96.7%, 95% CI = 83.3%-99.4%) and also 29 (96.7%, 95% CI = 83.3%-99.4%) cases, respectively. The only case of treatment failure was a relapse. No serious adverse-event was observed during the treatment course. Conclusions: The generic SOF/LDV was efficacious and safe to treat Iranian patients with chronic HCV infection.