Li Yu, Li Ya-Wei, Gao Ying
Department of Infectious Diseases, Shaanxi Provincial People's Hospital, Xi'an, Shaanxi Province, 710068, People's Republic of China.
Division of Medical Affairs, Taihe Hospital, Affiliated Hospital of Hubei University of Medicine, Shiyan, Hubei Province, 442099, People's Republic of China.
Int J Gen Med. 2025 Feb 27;18:1143-1153. doi: 10.2147/IJGM.S497550. eCollection 2025.
Entecavir (ETV), tenofovir disoproxil fumarate (TDF), and tenofovir alafenamide(TAF) are first-line nucleos(t)ide analogs (NUCs) with chronic hepatitis B (CHB). This study aimed to assess the renal safety profile in NUC-experienced CHB patients who received ETV, TDF or TAF therapy.
This retrospective observational cohort study investigated factors related to renal function in 154 patients with NUC-experienced CHB who received ETV, TDF, and TAF therapy for 48 weeks. Changes in UREA, uric acid (UA), creatinine (Cr), and estimated glomerular filtration rate (eGFR) were analyzed using a one-way analysis of variance. A linear mixed-effects model for repeated measures was used to evaluate the correlation between baseline information and eGFR changes 48 weeks following treatment initiation. The model considered sex, baseline age, viral load, aminotransferases, renal function, and treatment group as fixed effects, and incorporated random effects for individual subjects.
There were no significant differences in UA or Cr levels during therapy over time. The eGFR level was elevated in ETV-treated patients (117.5 ± 16.65 mL/min/1.7m vs 109.8 ± 15.69 mL/min/1.7m, =0.027), whereas it did not change significantly in TDF- (123.6 ± 28.54 mL/min/1.7m vs 115.5 ± 20.44 mL/min/1.7m, =0.070) and TAF-treated (121.6 ± 23.44 mL/min/1.7m vs 113.4 ± 16.90 mL/min/1.7m, =0.053) patients. Younger patients (<30 years) and those with higher HBV DNA (> 7 logIU/mL) and lower alanine aminotransferase levels (<5 × upper limit of normal) showed a significant improvement in eGFR elevation during NUCs therapy. The linear mixed-effects model showed that the baseline HBV DNA level was an important positive predictor of eGFR elevation at 48 weeks following treatment initiation (estimate was 1.437 and 2.449, <0.001).
In real-life experience, ETV, TDF, and TAF therapy may not be associated with eGFR changes in NUC-experienced CHB patients without baseline renal impairment.
恩替卡韦（ETV）、富马酸替诺福韦二吡呋酯（TDF）和丙酚替诺福韦（TAF）是用于慢性乙型肝炎（CHB）的一线核苷（酸）类似物（NUC）。本研究旨在评估接受ETV、TDF或TAF治疗的有NUC治疗史的CHB患者的肾脏安全性。
这项回顾性观察队列研究调查了154例有NUC治疗史的CHB患者的肾功能相关因素，这些患者接受ETV、TDF和TAF治疗48周。使用单因素方差分析分析尿素、尿酸（UA）、肌酐（Cr）和估算肾小球滤过率（eGFR）的变化。采用重复测量的线性混合效应模型来评估基线信息与治疗开始后48周eGFR变化之间的相关性。该模型将性别、基线年龄、病毒载量、转氨酶、肾功能和治疗组视为固定效应，并纳入个体受试者的随机效应。
治疗期间UA或Cr水平随时间无显著差异。ETV治疗患者的eGFR水平升高（117.5±16.65 mL/min/1.7m vs 109.8±15.69 mL/min/1.7m，P=0.027），而TDF治疗患者（123.6±28.54 mL/min/1.7m vs 115.5±20.44 mL/min/1.7m，P=0.070）和TAF治疗患者（121.6±23.44 mL/min/1.7m vs 113.4±16.90 mL/min/1.7m，P=0.053）的eGFR水平无显著变化。年轻患者（<30岁）以及HBV DNA水平较高（>7 logIU/mL）和丙氨酸转氨酶水平较低（<5×正常上限）的患者在接受NUC治疗期间eGFR升高有显著改善。线性混合效应模型显示，基线HBV DNA水平是治疗开始后48周eGFR升高的重要正向预测指标（估计值为1.437和2.449，P<0.001）。
在实际临床经验中，对于无基线肾功能损害的有NUC治疗史的CHB患者，ETV、TDF和TAF治疗可能与eGFR变化无关。
