Nationwide analysis of renal outcomes in chronic hepatitis B patients treated with Tenofovir Alafenamide vs. Entecavir

Sci Rep. 2025 Sep 30;15(1):33872. doi: 10.1038/s41598-025-08023-0.

Abstract

Patients with chronic hepatitis B (CHB) are at a higher risk of chronic kidney disease (CKD) compared to the general population. This study compared renal outcomes in treatment-naive CHB patients receiving tenofovir alafenamide (TAF) or entecavir (ETV) using South Korea's nationwide health insurance database. Two cohorts were analyzed: patients with normal renal function (cohort 1) and those with CKD but not end-stage renal disease (ESRD) (cohort 2). Propensity score matching (PSM) balanced baseline characteristics. Before PSM, ETV users had higher CKD (10.88 vs. 4.48 per 1000 person-years, incidence rate ratio [IRR] 2.43, 95% CI 2.13-2.77) and ESRD rates (40.33 vs. 22.13, IRR 1.82, 95% CI 1.26-2.63) than TAF users. Post-PSM, CKD and ESRD incidence showed no significant difference (CKD IRR 1.20, 95% CI 0.69-2.10; ESRD IRR 1.49, 95% CI 0.81-2.75). Cox regression confirmed that the antiviral agent was not a significant predictor of CKD or ESRD. In conclusion, TAF and ETV demonstrated similar renal safety profiles in CHB patients. These findings provide robust evidence for clinical decision-making, particularly for patients at risk of renal impairment.

Keywords: Chronic hepatitis B; Kidney disease; Propensity score matching; Renal insufficiency; Tenofovir Alafenamide.

MeSH terms

  • Adenine* / adverse effects
  • Adenine* / analogs & derivatives
  • Adenine* / therapeutic use
  • Adult
  • Alanine
  • Antiviral Agents* / adverse effects
  • Antiviral Agents* / therapeutic use
  • Female
  • Guanine* / adverse effects
  • Guanine* / analogs & derivatives
  • Guanine* / therapeutic use
  • Hepatitis B, Chronic* / complications
  • Hepatitis B, Chronic* / drug therapy
  • Hepatitis B, Chronic* / epidemiology
  • Humans
  • Incidence
  • Kidney Failure, Chronic / epidemiology
  • Male
  • Middle Aged
  • Renal Insufficiency, Chronic* / epidemiology
  • Renal Insufficiency, Chronic* / etiology
  • Republic of Korea / epidemiology
  • Tenofovir* / adverse effects
  • Tenofovir* / analogs & derivatives
  • Tenofovir* / therapeutic use
  • Treatment Outcome

Substances

  • Tenofovir
  • entecavir
  • Guanine
  • tenofovir alafenamide
  • Antiviral Agents
  • Adenine
  • Alanine