Renal Safety and Antiviral Effectiveness of Tenofovir Alafenamide Versus Entecavir in Patients With Chronic Hepatitis B and Chronic Kidney Disease: A Real‐World Cohort Study

ABSTRACT

Real‐world data on tenofovir alafenamide (TAF), especially in patients with advanced renal impairment, are scarce. We evaluated its renal safety and antiviral effectiveness versus entecavir (ETV) in patients with chronic hepatitis B (CHB) and pre‐existing chronic kidney disease (CKD). In this retrospective single‐centre study, CHB patients with pre‐existing CKD treated with TAF or ETV were included. The primary outcome was change in estimated glomerular filtration rate (eGFR) over 48 weeks. Secondary outcomes included virological, biochemical and metabolic responses. Exploratory subgroup analyses were performed by CKD stage and dialysis status. Among 54 patients (35 TAF, 19 ETV), renal function remained stable in both groups. eGFR change from baseline to week 48 was not significantly different between the TAF and ETV groups (1.56 ± 8.14 vs. −0.53 ± 9.78 mL/min/1.73 m ² ; Δchange, 2.09; 95% CI, −0.35 to 7.68; p  = 0.46). Both groups achieved sustained viral suppression, with no significant difference in undetectable HBV DNA in week‐48. HBsAg reduction was greater with TAF than with ETV (−0.36 ± 0.42 vs. 0.02 ± 0.34 log10 IU/mL; p  = 0.01). Exploratory analyses in patients with eGFR < 30 mL/min/1.73 m ² , TAF showed effective viral suppression and renal safety regardless of dialysis status. Metabolic parameters remained stable, without complex dose adjustments. TAF was safe and effective in CHB patients with CKD, including those with advanced renal impairment. Its renal safety and antiviral effectiveness did not differ significantly from those of ETV, with the practical advantage of fixed dosing without complex adjustment.