替诺福韦地索普西富马酸单药治疗多药耐药慢性HBV感染的远

StephenW

Clin Gastroenterol Hepatol. 2018 Oct 26. pii: S1542-3565(18)31201-1. doi: 10.1016/j.cgh.2018.10.037. [Epub ahead of print]
Long-term Efficacy of Tenofovir Disoproxil Fumarate Monotherapy for Multidrug-resistant Chronic HBV infection.
Lee HW1, Park JY1, Lee JW2, Yoon KT3, Kim CW4, Park H5, Kim YS6, Paik SK7, Lee JI1, Kim BK1, Han KH1, Ahn SH8.
Author information

1
    Department of Internal Medicine, Yonsei University College of Medicine, Seoul.
2
    Department of Internal Medicine, Inha University School of Medicine, Incheon.
3
    Department of Internal Medicine, Pusan National University School of Medicine, Yangsan.
4
    Department of Internal Medicine, The Catholic University College of Medicine, Seoul.
5
    Department of Internal Medicine, CHA University College of Medicine, Bundang.
6
    Department of Internal Medicine, Soonchunhyang University College of Medicine, Bucheon.
7
    Department of Internal Medicine, Yonsei University, Wonju College of Medicine, Wonju, Korea.
8
    Department of Internal Medicine, Yonsei University College of Medicine, Seoul. Electronic address: [email protected].

Abstract
BACKGROUND & AIMS:

There are no globally agreed upon treatment guidelines for patients with chronic hepatitis B virus (HBV) with multidrug resistance (MDR). We conducted a multicenter, prospective, real-world cohort study of effects of tenofovir disoproxyl fumarate (TDF) monotherapy and TDF-based combination therapy, as rescue therapy, in patients with multidrug-resistant chronic HBV infections.
METHODS:

We recruited patients with chronic HBV infection with resistance to antivirals from 8 tertiary hospitals in Korea. Patients (n=423) received rescue therapy with TDF monotherapy (n=174) or TDF-based combination therapy (n=249). The median follow-up period was 180 weeks. A virologic response was defined as a serum HBV DNA level of < 20 IU/mL.
RESULTS:

Cumulative rates of virologic response did not differ significantly between the groups that received TDF monotherapy vs. combination therapy at 48 weeks (71.7% vs. 68.9%), 96 weeks (85.1% vs. 84.2%), 144 weeks (92.1% vs. 92.7%), 192 weeks (93.4% vs. 95.7%), or 240 weeks (97.7% vs. 97.2%). Serum levels of HBV DNA below 4.0 log10 IU/mL (odds ratio, 2.478; 95% CI 1.959-3.135; P < 0.001) and the absence of mutations associated with resistance to adefovir (odds ratio, 1.570; 95% CI 1.279-1.926; P < 0.001) were associated with virologic response in patients with MDR. There was no significant difference of virologic response among patients of different ages, sex, patients with vs. without cirrhosis, positivity for hepatitis B e antigen, or renal function (all P > 0.05).
CONCLUSION:

In a multicenter, real-world cohort study, long-term use of TDF monotherapy showed non-inferior antiviral efficacy compared with that of TDF-based combination therapy in patients with MDR.

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

Hepatitis B; antiviral resistance; rescue therapy; tenofovir

PMID:
    30613003
DOI:
    10.1016/j.cgh.2018.10.037

StephenW

Clin Gastroenterol Hepatol。 2018年10月26日.pii：S1542-3565（18）31201-1。 doi：10.1016 / j.cgh.2018.10.037。 [提前打印]
替诺福韦地索普西富马酸单药治疗多药耐药慢性HBV感染的远期疗效。
Lee HW1，Park JY1，Lee JW2，Yoon KT3，Kim CW4，Park H5，Kim YS6，Paik SK7，Lee JI1，Kim BK1，Han KH1，Ahn SH8。
作者信息

1
    首尔延世大学医学院内科。
2
    仁川仁荷大学医学院内科。
3
    梁山国立大学医学院内科，梁山。
4
    首尔天主教大学医学院内科。
五
    盆唐市CHA大学医学院内科。
6
    富川市顺天乡大学医学院内科。
7
    韩国原州市圆州医学院延世大学内科学系。
8
    首尔延世大学医学院内科。电子地址：[email protected]。

抽象
背景与目的：

对于具有多药耐药性（MDR）的慢性乙型肝炎病毒（HBV）患者，没有全球一致的治疗指南。我们进行了一项多中心，前瞻性，现实世界的队列研究，研究替诺福韦地富马酸酯（TDF）单药治疗和基于TDF的联合治疗对多药耐药性慢性HBV感染患者的挽救治疗效果。
方法：

我们招募了来自韩国8家三级医院的抗病毒药物慢性HBV感染患者。患者（n = 423）接受TDF单药治疗（n = 174）或基于TDF的联合治疗（n = 249）的挽救治疗。中位随访期为180周。病毒学应答定义为血清HBV DNA水平<20IU / mL。
结果：

在48周时接受TDF单药治疗与联合治疗的患者（71.7％对68.9％），96周（85.1％对84.2％），144周（92.1％对比）的病毒学应答的累积率没有显着差异。 92.7％），192周（93.4％对95.7％）或240周（97.7％对97.2％）。血清HBV DNA水平低于4.0 log10 IU / mL（优势比，2.478; 95％CI 1.959-3.135; P <0.001），并且没有与阿德福韦耐药相关的突变（优势比，1.570; 95％CI 1.279-1.926） ; P <0.001）与MDR患者的病毒学应答相关。不同年龄，性别，肝硬化患者，乙型肝炎e抗原阳性或肾功能患者的病毒学应答无显着差异（均P> 0.05）。
结论：

在一项多中心，现实世界的队列研究中，长期使用TDF单药治疗与MDR患者的TDF联合治疗相比，显示出非劣效的抗病毒疗效。

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

乙型肝炎;抗病毒抗性;救援疗法;替诺福韦

结论：
    30613003
DOI：
    10.1016 / j.cgh.2018.10.037