Efficacy of Sofosbuvir and Velpatasvir in Achieving Sustained Virological Response in Patients with End-Stage Renal Disease Infected with Hepatitis C Virus

Background and Aim: Hepatitis C virus (HCV) infection remains a critical concern globally, especially in populations with end-stage renal disease (ESRD) on hemodialysis. This study aims to evaluate the efficacy and safety of a fixed-dose combination of Sofosbuvir and Velpatasvir (SOF/VEL) in achieving sustained virological response at 12 weeks post-treatment (SVR12) among ESRD patients infected with genotype III HCV. Methodology: A prospective cohort study was conducted at the Sindh Institute of Urology and Transplantation, Karachi, from January 2023 to December 2024. Inclusion criteria were patients aged ≥18 years with ESRD on maintenance hemodialysis for ≥3 months and genotype III HCV infection. Patients received SOF/VEL (400 mg/100 mg) daily with ribavirin (400 mg) once weekly for 12 weeks. Primary outcome measured was SVR12. Statistical analyses involved Chi-square and Student's t-tests, with significance set at p<0.05. Results: Of 109 enrolled patients (mean age 30.45 ± 8.98 years; 75.2% male), 105 (96.3%) achieved an end-of-treatment response (ETR), while SVR12 was attained in 91 (84.3%) patients. The mean duration of dialysis was 3.1 ± 1.2 years. The most common adverse effects were fatigue (28%), headache (18%), and nausea (12%). Significant biochemical improvements at treatment completion were noted in ALT (p=0.001) and AST (p=0.021), although biochemical changes were not significantly correlated with SVR12. Conclusion: The combination therapy of Sofosbuvir and Velpatasvir demonstrated good efficacy (84.3% SVR12) and a manageable safety profile in ESRD patients on hemodialysis infected with HCV genotype III. Further multi-center studies with larger sample sizes are necessary to validate and generalize these results, emphasizing the potential of SOF/VEL therapy in this challenging patient population.