Hepatitis C Treatment With Generic Sofosbuvir-Based Regimens in Patients Undergoing Hemodialysis.

Objectives: To assess the efficacy and safety of locally manufactured generic sofosbuvir-based direct-acting antivirals in the treatment of Hepatitis C virus (HCV) infected patients on maintenance hemodialysis.

Patients and methods: We have conducted a retrospective multicenter study including patients on maintenance hemodialysis, treated with sofosbuvir-based regimens between 01/01/2017 and 09/30/2021. Patients were treated for 12 or 24 weeks, with sofosbuvir 400 mg + ledipasvir 90 mg 3 times/week, or sofosbuvir 3 times/week + daclatasvir 60 mg/d, or sofosbuvir + daclatasvir in coformulation, 3 times/week. Sustained virological response was defined as a negative HCV RNA test 12 weeks after treatment. The occurrence of serious adverse events during treatment defines intolerance to treatment. Statistical analysis was performed using SPSS software (version 25).

Results: A total of 120 patients were treated; the mean age was 50 ± 14.17 years [18-78], 50% were men. Twenty-two patients (n = 22; 18.3%) were previously treated with pegylated Interferon. Genotype 1 was predominant (n = 68; 82%). Most of the patients (n = 53; 44.2%) had no significant fibrosis, and 24 (20%) had cirrhosis. The SVR rate was 93.3% (CI 95% [88.8; 97.8]) (n = 112), the serious adverse events rate was 10.8% (CI 95% [0.054-0.166]) (n = 13), including 2 deaths unrelated to direct-acting antivirals. Early treatment discontinuation occurred in 5.8% (n = 7), and a relapse in 0.8% (n = 1). On multivariate analysis, risk factors for serious adverse events included advanced liver fibrosis, thrombocytopenia, hypoalbuminemia, high bilirubin level, and pre-treatment status.

Conclusion: Locally manufactured generic sofosbuvir-based regimens are safe and effective in maintenance hemodialysis patients. However, they should be closely monitored to manage comorbidities and complications during treatment.