Comparative Renal Safety of Tenofovir Alafenamide vs. Tenofovir Disoproxil Fumarate in Chronic Hepatitis B: A Korean Nationwide Study.

BACKGROUND

The long-term renal safety of tenofovir-based therapy in patients with chronic hepatitis B virus (HBV) infection remains uncertain, particularly regarding end-stage kidney disease requiring renal replacement therapy (RRT). We investigated the comparative risk of renal dysfunction between tenofovir alafenamide (TAF) and tenofovir disoproxil fumarate (TDF).

METHODS

We identified treatment-naïve adult patients with chronic HBV infection who initiated TAF or TDF between 2017 and 2020 from the Korean National Health Insurance Service. After 1:1 propensity score (PS) matching, we compared the incidence of RRT and chronic kidney disease (CKD) between the two groups.

RESULTS

Among 46,663 eligible patients (TAF, n = 16,885; TDF, n = 29,778), the median follow-up was 2.61 years. The incidence of RRT were 0.56 and 0.96 per 1,000 person-years in the TAF and TDF groups, respectively (hazard ratio [HR], 0.74; 95% confidence interval [CI], 0.47-1.16). In the PS-matched cohort (n = 31,218), the adjusted HR for RRT was 0.67 (95% CI, 0.40-1.10) in TAF compared to TDF. Male sex, older age, hypertension, cirrhosis and current smoking were associated with the increased risk of RRT.

CONCLUSION

In this nationwide claims-based cohort, TAF and TDF showed comparable renal safety with respect to RRT and the development of CKD. Male sex, older age, hypertension, and liver cirrhosis were associated with increased renal risk and warrant close monitoring.