替诺福韦地索普西富马酸钠与恩替卡韦治疗慢性HBV感染患者

StephenW

Changes in Renal Function in Patients With Chronic HBV infection Treated with Tenofovir Disoproxil Fumarate vs Entecavir
Sam Trinh
, An K. Le
, Ellen T. Chang
, Joseph Hoang
, Donghak Jeong
, Mimi Chung
, Mei-Hsuan Lee
, Uerica Wang
, Linda Henry
, Ramsey Cheung
, Mindie H. Nguyen'Correspondence information about the author Mindie H. NguyenEmail the author Mindie H. Nguyen
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    Abstract

Abstract
Background & Aims

It is unclear whether drugs used to treat chronic hepatitis B virus (HBV) infection cause significant renal impairment. We compare adjusted mean estimated glomerular filtration rates (eGFR; mL/min/1.73 m2) of patients with chronic HBV infection treated with tenofovir disoproxil fumarate (TDF) vs patients treated with entecavir.
Methods

We performed a retrospective study of patients with chronic HBV infections treated with TDF (n=239) or entecavir (n=171), from 2000 through 2016, followed for a mean time of 43–46 months. Levels of serum creatinine were measured ≥12 months while patients received treatment. Patients did not have prior exposure to adefovir or HCV, HDV, or HIV co-infection. We performed propensity score matching (PSM) for age, sex, presence of hypertension, diabetes mellitus, baseline eGFR, cirrhosis, and follow-up duration. We performed multivariate generalized linear modeling, adjusting for cirrhosis, diabetes, and hypertension, to estimate adjusted mean eGFR for matched and unmatched cohorts. Cox regression was used to identify predictors of renal impairment
Results

eGFRs were ≥60, after PSM, in 116 patients given entecavir and in 116 patients given TDF; eGFRs were <60 in 32 patients given entecavir and 26 patients given TDF. Multivariate generalized linear modeling of the unmatched overall and <60 eGFR cohorts revealed significantly lower adjusted mean eGFRs in patients given TDF (all P<.001). However, in the eGFR ≥60 PSM cohort, the adjusted mean eGFR was similar between patients receiving either treatment. In Cox regression analysis, TDF was not associated with mild or moderate renal impairment compared with entecavir.
Conclusion

In a retrospective study of patients with chronic HBV infections treated with TDF vs entecavir, we found that TDF was not associated with higher risk of worsening renal function during short- or intermediate-term follow-up periods, among patients without significant renal impairment. Additional studies, with longer follow-up periods, are needed because treatment for chronic HBV infection is generally long term or life-long. For patients with baseline renal impairment, significant renal decline was among patients given TDF compared to patients given entecavir.
Key Words:
kidney function, side effect, complication, HBV therapy
Abbreviations:
TDF (tenofovir disoproxil fumarate), eGFR (estimated glomerular filtration rate), CHB (chronic hepatitis B), ETV (entecavir), PSM (propensity score matching), HBV (hepatitis B virus), TAF (tenofovir alafenamide), GLM (generalized linear models), HRs (hazard ratios), CIs (confidence intervals)

StephenW

替诺福韦地索普西富马酸钠与恩替卡韦治疗慢性HBV感染患者肾功能的变化
Sam Trinh
，An K. Le
，Ellen T. Chang
，约瑟夫·霍恩
，Donghak Jeong
，Mimi Chung
，李梅轩
，Uerica Wang
琳达亨利
，Ramsey Cheung
，Mindie H. Nguyen'关于作者的相关信息Mindie H. Nguyen给作者Mindie H. Nguyen发邮件
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    抽象

抽象
背景与目的

尚不清楚用于治疗慢性乙型肝炎病毒（HBV）感染的药物是否会导致严重的肾功能损害。我们比较了使用替诺福韦地索普西富马酸盐（TDF）治疗的慢性HBV感染患者与恩替卡韦治疗患者的调整后平均估计肾小球滤过率（eGFR; mL / min / 1.73 m2）。
方法

我们对从2000年到2016年接受TDF（n = 239）或恩替卡韦（n = 171）治疗的慢性HBV感染患者进行了回顾性研究，随后平均时间为43-46个月。当患者接受治疗时，血清肌酐水平测量≥12个月。患者之前未接触阿德福韦或HCV，HDV或HIV共感染。我们对年龄，性别，高血压，糖尿病，基线eGFR，肝硬化和随访持续时间进行了倾向评分匹配（PSM）。我们进行了多变量广义线性建模，调整肝硬化，糖尿病和高血压，以估计匹配和不匹配队列的调整平均eGFR。 Cox回归用于确定肾功能损害的预测因子
结果

PSM后，116例给予恩替卡韦的患者和116例给予TDF的患者的eGFR>≥60;给予恩替卡韦的32名患者的eGFR <60，而给予TDF的患者为26名。不匹配的总体和<60 eGFR队列的多变量广义线性模型显示给予TDF的患者的调整平均eGFR显着降低（所有P <.001）。然而，在eGFR≥60PSM组中，接受任一治疗的患者的调整后平均eGFR相似。在Cox回归分析中，与恩替卡韦相比，TDF与轻度或中度肾功能损害无关。
结论

在对TDF治疗与恩替卡韦治疗的慢性HBV感染患者的回顾性研究中，我们发现在没有明显肾功能损害的患者中，TDF与短期或中期随访期间肾功能恶化的高风险无关。需要进行更长时间随访的其他研究，因为慢性HBV感染的治疗通常是长期的或终生的。对于有基线肾功能损害的患者，给予TDF的患者与服用恩替卡韦的患者相比，肾功能显着下降。
关键词：
肾功能，副作用，并发症，HBV治疗
缩写：
TDF（替诺福韦地索普西富马酸盐），eGFR（估计肾小球滤过率），CHB（慢性乙型肝炎），ETV（恩替卡韦），PSM（倾向评分匹配），HBV（乙型肝炎病毒），TAF（替诺福韦艾拉酚胺），GLM（广义）线性模型），HR（风险比），CI（置信区间）