Abstract / Summary
Background: Patients with chronic kidney disease undergoing hemodialysis are at risk of hepatitis C virus exposure due to nosocomial transmission and the duration of hemodialysis. The treatment for hepatitis C in patients with chronic kidney disease undergoing hemodialysis is oral direct-acting antiviral (DAA) therapy, which works directly as an antiviral. Currently, the DAA considered safe for use in patients with chronic kidney disease is grazoprevir/elbasvir. However, this DAA is expensive and effective in patients with genotypes 1 and 4. Recent studies have shown that sofosbuvir-based regimens are safe. Therefore, this study aimed to compare the efficacy and safety of sofosbuvir/daclatasvir with grazoprevir/elbasvir in patients with chronic hepatitis C undergoing hemodialysis. Methods: We conducted a multicenter, single-blind, randomized clinical trial that included 120 treatment-naïve, HCV-infected hemodialysis patients. We randomized only participants with fibrosis < F4. Patients with cirrhosis (F4) were assigned to sofosbuvir/daclatasvir per guideline-based contraindications for grazoprevir/elbasvir. Participants received sofosbuvir/daclatasvir or grazoprevir/elbasvir. The primary endpoints were sustained virologic response at week 12 (SVR12) and treatment-related adverse events. Statistical comparisons were conducted using the Mann–Whitney U test for continuous variables and the chi-square test for categorical variables. Results: 120 patients completed the study, with no dropouts or missing SVR12 data. All patients (100%) achieved SVR12 in both treatment groups. Sofosbuvir/daclatasvir and grazoprevir/elbasvir achieved 100% SVR at 12 weeks, with good safety and no adverse events in 98.3% of patients. Conclusion: Both sofosbuvir/daclatasvir and grazoprevir/elbasvir are highly effective and safe for treating hepatitis C in patients undergoing hemodialysis. Sofosbuvir/daclatasvir offers broader applicability across all fibrosis stages and genotypes, with substantially lower treatment costs.