Similar efficacy and safety of tenofovir in Asians and non-Asians with chronic hepatitis B

作     者：Calvin Q Pan Sing Chan Huy Trinh Alan Yao Ho Bae Lillian Lou 

作者机构：Division of Gastroenterology Department of Medicine New York University Langone Medical Center New York University School of Medicine Sing Chan Endoscopy FlushingNew York City NY 11355 United States San Jose GastroenterologySan Jose Ca 95128 United States AE and LY Medical associatesFlushing New York City NY 11355 United States Asian Pacific Liver Center St. Vincent Medical Center Nexus Development Palo alto Ca 94301 United States 

出 版 物：《World Journal of Gastroenterology》 (世界胃肠病学杂志（英文版）)

年 卷 期：2015年第21卷第18期

页      面：5524-5531页

核心收录：

学科分类：1004[医学-公共卫生与预防医学(可授医学、理学学位)] 100401[医学-流行病与卫生统计学] 10[医学] 

基　　金：Supported by Gilead Sciences Editorial support was provided by Carol Lovegrove,associated with Elements Communications(Westerham,United Kingdom),and funded by Gilead Sciences 

主　　题：Chronic hepatitis B Tenofovir Asian patients Fibrosis High viral load 

摘      要：AIM:To compare the efficacy and safety of tenofovir disoproxil fumarate(TDF)in Asian and non-Asian chronic hepatitis B(CHB)***:The efficacy and safety of the initial 48wk of treatment with TDF was compared in a posthoc analysis of combined data from 217 Asians and299 non-Asians included in Studies 102 and 103and a post-approval,open-label trial(Study 123).Patient groups were compared according to baseline hepatitis B e antigen(HBe Ag)status and viral *** main outcome measures included the proportion of patients who achieved a hepatitis B virus(HBV)DNA level400 copies/m L at Week 48 of *** measures included:HBV DNA and alanine aminotransaminase(ALT)levels over time;proportion of patients with normal ALT levels;proportion of patients with HBe Ag loss/seroconversion and proportion of patients with hepatitis B surface antigen loss/seroconversion;changes in liver *** and tolerability were evaluated by the occurrence of adverse events(AEs),serious AEs,laboratory abnormalities,discontinuation of the study drug due to AEs,or *** primary efficacy and safety analysis set included all patients who were randomly assigned to treatment and received at least one dose of study ***:At week 48,similar proportions of Asians and non-Asians reached HBV DNA400 copies/m L(96%of Asian and 97%of non-Asian patients with HBe Ag-negative CHB and 83%of Asian and 79%of non-Asian patients with HBe Ag-positive CHB had HBV DNA)and normal ALT(78%of Asian and 81%of nonAsian patients with HBe Ag-negative CHB and 71%of Asian and 74%of non-Asian patients with HBe Agpositive CHB had normal ALT).On-treatment HBV DNA decline rates were similar between Asians and nonAsians regardless of baseline HBe Ag status and *** DNA decline during the first four weeks was2.9 log10 copies/m L in HBe Ag-negative Asians and nonAsians,and in HBe Ag-positive non-Asians,and 3.1log10 copies/m L in HBe Ag-positive *** Ag loss and seroconversion wa