Randomized Comparison of Tenofovir Disoproxil Fumarate vs Emtricitabine and Tenofovir Disoproxil Fumarate in Patients With Lamivudine-Resistant Chronic Hepatitis B
Randomized Comparison of Tenofovir Disoproxil Fumarate vs Emtricitabine and Tenofovir Disoproxil Fumarate in Patients With Lamivudine-Resistant Chronic Hepatitis B
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DOI：
10.1053/j.gastro.2013.12.028
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发表时间：
2014-04-01
期刊：
影响因子：
29.4
通讯作者：
Gane, Edward
中科院分区：
文献类型：
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作者：
Fung, Scott;Kwan, Peter;Gane, Edward
背景与目的：替诺福韦酯富马酸盐（TDF）是积极对抗拉米夫定耐药的肝炎B病毒（HBV）infection，但数据支持其临床疗效在此setting.METHODS：在前瞻性，双盲，96周的试验，患者被随机分配（1：1）组给予TDF（300毫克，n = 141）或恩曲他滨（FTC，200毫克; n 139）和TDF（300毫克，FTC/TDF）的组合。患者为乙型肝炎B e抗原（HBeAg）阳性或HBeAg阴性，HBV DNA水平>= 3 log 10 IU/mL和拉米夫定耐药突变（通过INNO-LiPA Multi-DR v3进行HBV聚合酶或逆转录酶氨基酸置换rtM 204 I/V +/-rtL 180 M; Innogenetics，Inc，Alpharetta，GA）。主要终点为HBV DNA <44 umol/L的比例、肌酐清除率
BACKGROUND & AIMS: Tenofovir disoproxil fumarate (TDF) is active against lamivudine-resistant hepatitis B virus (HBV) infection, but data to support its clinical efficacy in this setting are limited.METHODS: In a prospective, double-blind, 96-week trial, patients were randomly assigned (1:1) to groups given TDF (300 mg, n = 141) or a combination of emtricitabine (FTC, 200 mg; n 139) and TDF (300 mg, FTC/TDF). Patients were hepatitis B e antigen (HBeAg) - positive or HBeAg-negative, with levels of HBV DNA >= 3 log10 IU/mL and lamivudine resistance mutations (HBV polymerase or reverse transcriptase amino acid substitutions rtM204I/V +/- rtL180M by INNO-LiPA Multi-DR v3; Innogenetics, Inc, Alpharetta, GA). The primary end point was proportion with HBV DNA 44 umol/L], creatinine clearance