A Decade Long, Real-life Experience of Sofosbuvir-based Regimen Use for Hepatitis C Treatment in People With End-stage Renal Disease.

BACKGROUND/AIMS: Sofosbuvir (SOF) is a major directly acting antiviral (DAA) drug against hepatitis C virus (HCV) treatment. In patients with chronic kidney disease (CKD) and estimated glomerular filtration rate (eGFR) <30 mL/min, the experience of SOF based regimens is limited. We report real-life experience of treating a large cohort of patients with eGFR <30 mL/min using SOF-based regimens.

METHODS

We retrospectively reviewed the data of HCV viremic adults with eGFR <30 ml/min who were registered in our out-patient hepatitis clinic between December 2015 and April 2025. They were treated with full-dose SOF (400 mg) in combination with either velpatasvir (VEL) 100 mg or daclatasvir (DAC) 60 mg. Regardless of DAA combination, those without cirrhosis or with decompensated cirrhosis were treated for 12 and 24 weeks, respectively. Those with compensated cirrhosis were treated for 12 (SOF/VEL) or 24 (SOF/DAC) weeks. We studied the proportion of participants who could achieve sustained virological response after 12 weeks (SVR12) of treatment completion.

RESULTS

271 infection episodes (262 new; 9 reinfections) in 262 participants (men 74.1%; age 42 [32-52] years; hemodialysis 231/262 [88.2%]; dialysis duration 15 [9-25] months; no-cirrhosis 84.4%; HCV RNAlog10 5.82 [5.04-6.59]) were treated with either SOF/DAC (195; 74.4%) or SOF/Vel (67; 25.6%). In the treatment-naïve group, SVR12 was tested for 220/262 (SOF/DAC 168, SOF/VEL 52) participants (83.9%), and SVR12 was achieved in 210 (intention-to-treat analysis 210/262, 80.2%; per-protocol analysis 210/220, 95.5%). The SVR12 rates were not affected by the presence of cirrhosis, genotype, or type of DAA combination. After achieving SVR12, eight and one patient had second and third episodes of HCV re-infections after 8 (4-13.5) months and 6 months, respectively, and five of them achieved SVR12 following retreatment.

CONCLUSIONS

Sofosbuvir in combination with DAC or VEL are highly and equally effective against HCV in patients with eGFR below 30 mL/min.