| Summary: | Objective To evaluate the safety and efficacy of 12-week sofosbuvir/velpatasvir (SOF/VEL) in chronic hepatitis C (CHC) patients with end-stage renal disease (ESRD) on maintenance hemodialysis (MHD) in a real-world setting. Methods From October 10, 2020 to January 28, 2021, 18 CHC patients received full-dose sofosbuvir (400 mg) plus velpatasvir (100 mg) once daily for 12 weeks. HCV RNA quantification, hepaticorenal function and electrolytes were assessed at baseline, end of treatment (EOT) and Week 12/48 after discontinuing therapy. Primary outcome was sustained virological response at Week 12 post-treatment (SVR12, HCV RNA negative). Safety profile was evaluated by monitoring adverse events and laboratory parameters. Results A total 18 treatment-naïve CHC patients on MHD were recruited. And 14 of them underwent MHD for primary chronic glomerulonephritis. All of them were of HCV genotype 1b. One patient developed compensated cirrhosis. The average time of HCV infection was (150.6±47.6)month. Baseline HCV-RNA ranged from (4.61×106 )U/L to (4.47×109)U/L. And 12-week SOF/VEL treatment was completed and HCV-RNA stayed negative at EOT and PTW12/48. Significant reductions occurred in ALT [19.0(13.8, 24.0)U/L vs 9.0(8.0, 10.0)U/L] and AST [18.0(12.5, 21.0)U/L vs 10.0(8.0, 12.0)U/L] from baseline to PTW48 (P<0.05). There was a marked rise in blood platelet from baseline to PTW48 [120.0(108.3, 142.8)×109/L vs 154.0(131.0, 181.8)×109/L](P<0.05). Serum levels of potassium at EOT were comparable to baseline. The most common adverse events included pruritus, nausea and fatigue. Conclusions The above 12-week treatment of SOF/VEL is well-tolerated and highly efficacious for CHC patients on MHD. The results support the management of uncomplicated HCV cases by nephrologists. It may be scaled up to HCV elimination during MHD.
|
|---|