替诺福韦地索普西富马酸盐与恩替卡韦治疗慢性HBV感染患者

StephenW

Clin Gastroenterol Hepatol. 2018 Aug 18. pii: S1542-3565(18)30875-9. doi: 10.1016/j.cgh.2018.08.037. [Epub ahead of print]
Changes in Renal Function in Patients With Chronic HBV infection Treated with Tenofovir Disoproxil Fumarate vs Entecavir.
Trinh S1, Le AK1, Chang ET2, Hoang J1, Jeong D1, Chung M3, Lee MH4, Wang U1, Henry L1, Cheung R5, Nguyen MH6.
Author information

1
    Division of Gastroenterology and Hepatology, Stanford University Medical Center, Stanford, California, USA.
2
    Stanford Cancer Institute, Stanford, California, USA; Center for Health Sciences, Exponent, Inc., Menlo Park, California, USA.
3
    Division of Gastroenterology and Hepatology, Stanford University Medical Center, Stanford, California, USA; Princeton University, Princeton, New Jersey, USA.
4
    Institute of Clinical Medicine, National Yang-Ming University, Taipei, Taiwan.
5
    Division of Gastroenterology and Hepatology, Stanford University Medical Center, Stanford, California, USA; Division of Gastroenterology, Palo Alto Veterans Administration Healthcare System, Palo Alto, California, USA.
6
    Division of Gastroenterology and Hepatology, Stanford University Medical Center, Stanford, California, USA. Electronic address: [email protected].

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.

Copyright © 2018 AGA Institute. Published by Elsevier Inc. All rights reserved.
KEYWORDS:

HBV therapy; complication; kidney function; side effect

PMID:
    30130625
DOI:
    10.1016/j.cgh.2018.08.037

StephenW

Clin Gastroenterol Hepatol。 2018年8月18日.pii：S1542-3565（18）30875-9。 doi：10.1016 / j.cgh.2018.08.037。 [提前打印]
替诺福韦地索普西富马酸盐与恩替卡韦治疗慢性HBV感染患者肾功能的变化。
Trinh S1，Le AK1，Chang ET2，Hoang J1，Jeong D1，Chung M3，Lee MH4，Wang U1，Henry L1，Cheung R5，Nguyen MH6。
作者信息

1
    斯坦福大学医学中心，美国加利福尼亚州斯坦福大学消化内科和肝脏病学系。
2
    斯坦福癌症研究所，美国加利福尼亚州斯坦福;美国加利福尼亚州门洛帕克的Exponent公司健康科学中心。
3
    美国加利福尼亚州斯坦福大学斯坦福大学医学中心消化内科和肝病学科;普林斯顿大学，普林斯顿，新泽西州，美国。
4
    台湾台北国立阳明大学临床医学研究所。
五
    美国加利福尼亚州斯坦福大学斯坦福大学医学中心消化内科和肝病学科;帕洛阿尔托退伍军人管理医疗保健系统，美国加利福尼亚州帕洛阿尔托市消化内科。
6
    斯坦福大学医学中心，美国加利福尼亚州斯坦福大学消化内科和肝脏病学系。电子地址：[email protected]。

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回归分析用于确定肾功能损害的预测因素结果：PSM后eGFRs≥60，116例给予恩替卡韦，116例患者给予TDF;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。

版权所有©2018 AGA Institute。由Elsevier Inc.出版。保留所有权利。
关键词：

HBV治疗;并发症;肾功能;副作用

结论：
    30130625
DOI：
    10.1016 / j.cgh.2018.08.037