恩替卡韦治疗乙型肝炎病毒感染的严重肾功能不全患者和血

StephenW

Hepatol Res. 2019 Jul 1. doi: 10.1111/hepr.13399. [Epub ahead of print]
Entecavir treatment of hepatitis B virus-infected patients with severe renal impairment and those on hemodialysis.
Suzuki K1, Suda G1, Yamamoto Y2, Furuya K3, Baba M3, Kimura M1, Maehara O2, Shimazaki T1, Yamamoto K1, Shigesawa T1, Nakamura A1, Ohara M1, Kawagishi N1, Nakai M1, Sho T1, Natsuizaka M1, Morikawa K1, Ogawa K1, Sakamoto N1; NORTE Study Group.
Author information

1
    Department of Gastroenterology and Hepatology, Graduate School of Medicine, Hokkaido University, Hokkaido, Japan.
2
    Department of Gastroenterology, Hakodate Municipal Hospital, Hokkaido, Japan.
3
    JCHO Hokkaido Hospital, Hokkaido, Japan.

Abstract
BACKGROUND:

Entecavir (ETV), tenofovir-disoproxil-fumarate (TDF), and tenofovir-alafenamide (TAF) are first-line nucleos(t)ide analogues for hepatitis B virus (HBV)-infected patients. However, consecutive TDF administration causes renal dysfunction, and the safety and efficacy of TAF have not been established in severe renal dysfunction patients, including hemodialysis patients. The efficacy and safety of ETV in these populations has not been clarified. Thus, this study aimed to clarify this.
METHODS:

In this retrospective multicenter study, between 2006 and 2018, a total of 567 HBV-infected patients treated with ETV monotherapy were screened. Patients were included if >20 years old, treated with ETV monotherapy for >1 year, and had proper clinical information. The efficacy of ETV and changes in renal function were evaluated according to renal function.
RESULTS:

A total of 273 patients were included; 9.2% (25/273), 1.8% (5/273), and 3.7% (10/273) had chronic kidney disease (CKD) stage G3 and G4/5 and were on hemodialysis, respectively. Overall, 84.2%, 94.0%, and 96.2% of patients experienced serum HBV-DNA disappearance at 1, 2, and 3 years, respectively, after treatment initiation. In patients with CKD stage G3/4/5, estimated glomerular filtration rate tended to restore with time, which was in contrast to patients without renal dysfunction. The rate of disappearance in serum HBV-DNA, alanine transaminase normalization, and virological breakthrough was similar between patients with or without renal dysfunction. ETV showed high efficacy for all 10 hemodialysis patients without virological breakthrough.
CONCLUSIONS:

ETV for HBV-infected patients with severe renal dysfunction, including hemodialysis patients, is highly effective and does not affect renal function.

This article is protected by copyright. All rights reserved.
KEYWORDS:

Hepatitis B virus; dialysis; entecavir; renal impairment

PMID:
    31260579
DOI:
    10.1111/hepr.13399

StephenW

Hepatol Res。 2019年7月1日：doi：10.1111 / hepr.13399。 [印刷前的电子版]
恩替卡韦治疗乙型肝炎病毒感染的严重肾功能不全患者和血液透析患者。
Suzuki K1，Suda G1，Yamamoto Y2，Furuya K3，Baba M3，Kimura M1，Maehara O2，Shimazaki T1，Yamamoto K1，Shigesawa T1，Nakamura A1，Ohara M1，Kawagishi N1，Nakai M1，Sho T1，Natsuizaka M1，Morikawa K1 ，Ogawa K1，Sakamoto N1; NORTE研究组。
作者信息

1
日本北海道北海道大学大学院医学研究科消化内科和肝病学系。
2
日本北海道函馆市立医院消化内科。
3
JCHO日本北海道北海道医院。

抽象
背景：

恩替卡韦（ETV），替诺福韦 - 地索普西 - 富马酸盐（TDF）和替诺福韦 - 丙氨酰胺（TAF）是乙型肝炎病毒（HBV）感染患者的一线核苷（酸）类似物。然而，连续TDF给药导致肾功能障碍并且TAF的安全性和有效性尚未在包括血液透析患者在内的严重肾功能障碍患者中建立。 ETV在这些人群中的有效性和安全性尚未阐明。因此，本研究旨在澄清这一点。
方法：

在这项回顾性多中心研究中，在2006年至2018年间，共筛选了567名接受ETV单药治疗的HBV感染患者。如果> 20岁，接受ETV单药治疗> 1年的患者，并且具有适当的临床信息。根据肾功能评估ETV的功效和肾功能的变化。
结果：

共纳入273名患者; 9.2％（25/273），1.8％（5/273）和3.7％（10/273）患有慢性肾脏疾病（CKD）G3期和G4 / 5期并且接受血液透析，总体而言，84.2％，94.0％，治疗开始后，分别在1年，2年和3年时，96.2％的患者出现血清HBV-DNA消失。对于CKD分期为G3 / 4/5的患者，估计肾小球滤过血清HBV-DNA消失率，丙氨酸转氨酶正常化和病毒学突破在有或无肾功能不全的患者中相似。对于没有病毒学突破的所有10名血液透析患者，ETV显示出高效率。
结论：

对于HBV感染的严重肾功能不全患者（包括血液透析患者）的ETV非常有效且不影响肾功能。

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关键词：

乙型肝炎病毒;透析;恩替卡韦;肾功能不全

结论：
31260579
DOI：
10.1111 / hepr.13399