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Outcomes of Long-term Treatment of Chronic HBV Infection With Entecavir or Other Agents From a Randomized Trial in 24 Countries(Open Access)

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收录情况： ◇ SCIE

作者：
Jin-Lin Hou[1,*1] * ; Wei Zhao[2] ; Changhyeong Lee[3] ; Hie-Won Hann[4] ; Cheng-Yuan Peng[5] ; Tawesak Tanwandee[6] ; Viacheslav Morozov[7] ; Hartwig Klinker[8] ; Jose D. Sollano[9] ; Adrian Streinu-Cercel[10] ; kk Hugo Cheinquer[11] ; Qing Xie[12] ; Yu-Ming Wang[13] ; Lai Wei[14] ; Ji-Dong Jia[15] ; Guozhong Gong[16] ; kkk Kwang-Hyub Han[17] ; Wukui Cao[18] ; Mingliang Cheng[19] ; Xiaoping Tang[20] ; Deming Tan[21] ; Hong Ren[22] ; Zhongping Duan[23] ; Hong Tang[24] ; Zhiliang Gao[25] ; Shijun Chen[26] ; Shumei Lin[27] ; Jifang Sheng[28] ; Chengwei Chen[29] ; Jia Shang[30] ; Tao Han[31] ; Yanyan Ji[32] ; Junqi Niu[33] ; Jian Sun[1] ; Yongpeng Chen[1] ; Elizabeth L. Cooney[34] ; Seng-Gee Lim[35] ;
机构： [1]Department of Infectious Diseases, Institute of Hepatology, Nanfang Hospital, Southern Medical University, Guangzhou,China [2]Department of Infectious Diseases, 2nd Hospital Nanjing, Nanjing, China [3]Daegu Catholic University Hospital, Daegu,Korea [4]Division of Gastroenterology and Hepatology, Department of Medicine, Thomas Jefferson University Hospital,Philadelphia, Pennsylvania [5]Division of Hepatogastroenterology, Department of Internal Medicine, China Medical University Hospital, Taichung, Taiwan [6]Division of Gastroenterology, Department of Medicine, Faculty of Medicine Siriraj Hospital,Bangkok, Thailand [7]LLC Medical Company “Hepatolog,” Samara, Russian Federation [8]Department of Medicine II, Division of Hepatology, University of Würzburg Medical Center, Würzberg, Germany [9]Department of Medicine, Cardinal Santos Medical Center, Manila, Philippines [10]Department of Infectious Diseases I, Carol Davila University of Medicine and Pharmacy, National Institute for Infectious Diseases,“Prof.Dr.Matei Bals,”Bucharest,Romania [11]Gastroenterology and Hepatology Division,Hospital de Clinicas de Porto Alegre, Porto Alegre, Brazil [12]Department of Infectious Diseases, Shanghai Rui Jin Hospital,Shanghai, China [13]Institute for Infectious Diseases, Southwest Hospital, Chongqing, China [14]Hepatology Department,Peking University People’s Hospital, Beijing, China [15]National Clinical Research Center for Digestive Disease, Beijing Friendship Hospital, Capitol Medical University, Beijing, China [16]Department of Infectious Disease, The Second Xiangya Hospital of Central South University, Changsha, China [17]Department of Internal Medicine, Institute of Gastroenterology and Yonsei Liver Center, Severance Hospital, Yonsei University College of Medicine, Seoul, Korea [18]Department of Infectious Diseases, Tianjin Second People’s Hospital, Tianjin, China [19]Department of Infectious Diseases, Affiliated Hospital of GuiyangMedical College, Guiyang, China [20]Department of Infectious Diseases, Guangzhou No. 8 People’s Hospital, Guangzhou,China [21]Department of Infectious Diseases, Xiangya Hospital, Central South University, Changsha, China [22]Department of Infectious Diseases, The Second Affiliated Hospital of Chongqing Medical University, Chongqing, China [23]Beijing Institute of Hepatology, Beijing YouAn Hospital, Capital Medical University, Beijing, China [24]Center of Infectious Diseases, West China Hospital, Sichuan University, Chengdu, China [25]Department of Infectious Diseases, The Third Affiliated Hospital, Sun Yat-Sen University, Guangzhou, China [26]Hepatology Department, Jinan Infectious Disease Hospital, Jinan, China [27]Department of Infectious Diseases, The First Affiliated Hospital of Xi’An Jiaotong University, Xi’An, China [28]Department of Infectious Diseases, The First Affiliated Hospital, Zhejiang University, Hangzhou, China [29]Hepatology Department, 85th Hospital of People’s Liberation Army, Shanghai, China [30]Department of Infectious Diseases, Henan Provincial People’s hospital, Zhengzhou, China [31]Department of Hepatology and Gastroenterology, Tianjin Third Central Hospital, Tianjin,China [32]Hepatology Department, Shanghai Jing’an District Central Hospital, Shanghai, China [33]Hepatobiliary Medical Ward, The First Hospital of Jilin University, Changchun, China [34]Bristol-Myers Squibb, Inc, Wallingford, Connecticut [35]Division of Gastroenterology and Hepatology, National University Health System, National University of Singapore,Singapore
出处：
DOI： 10.1016/j.cgh.2019.07.010
ISSN：

关键词： CHB Complication HCC Long-Term Follow-Up Study

摘要：
Background & Aims: Treatment of chronic hepatitis B virus (HBV) infection with entecavir suppresses virus replication and reduces disease progression, but could require life-long therapy. To investigate clinical outcome events and safety associated with long-term treatment with entecavir, we followed up patients treated with entecavir or another standard-of-care HBV nucleos(t)ide analogue for up to 10 years. We assessed long-term outcomes and relationships with virologic response. Methods: Patients with chronic HBV infection at 299 centers in Asia, Europe, and North and South America were assigned randomly to groups that received entecavir (n = 6216) or an investigator-selected nonentecavir HBV nucleos(t)ide analogue (n = 6162). Study participants were followed up for up to 10 years in hospital-based or community clinics. Key end points were time to adjudicated clinical outcome events and serious adverse events. In a substudy, we examined relationships between these events and virologic response. Results: There were no significant differences between groups in time to event assessments for primary end points including malignant neoplasms, liver-related HBV disease progression, and death. There were no differences between groups in the secondary end points of nonhepatocellular carcinoma malignant neoplasms and hepatocellular carcinoma. In a substudy of 5305 patients in China, virologic response, regardless of treatment group, was associated with a reduced risk of liver-related HBV disease progression (hazard ratio, 0.09; 95% CI, 0.038–0.221) and hepatocellular carcinoma (hazard ratio, 0.03; 95% CI, 0.009–0.113). Twelve patients given entecavir (0.2%) and 50 patients given nonentecavir drugs (0.8%) reported treatment-related serious adverse events. Conclusions: In a randomized controlled trial of patients with chronic HBV infection, we associated entecavir therapy with a low rate of adverse events over 10 years of follow-up evaluation. Patients receiving entecavir vs another nucleos(t)ide analogue had comparable rates of liver- and non–liver-related clinical outcome events. Participants in a China cohort who maintained a virologic response, regardless of treatment group, had a reduced risk of HBV-related outcome events including hepatocellular carcinoma. ClinicalTrials.gov identifier no: NCT00388674. © 2020 AGA Institute

基金：
Funding This study was sponsored by Bristol-Myers Squibb, which designed the study, conducted statistical analyses, and provided financial support for the study and manuscript preparation. Supported in part by the Ministry of Science and Technology of China (2018ZX10301202 and 2017ZX10202202 to J.-L.H. and J.S.), and by the Local Innovative and Research Teams Project of Guangdong Pearl River Talents Program (2017BT01S131 to J.-L.H.). Editorial assistance for manuscript preparation was provided by Richard Boehme of Articulate Science and funded by Bristol-Myers Squibb. Conflicts of interest These authors disclose the following: Jin-Lin Hou received grants and personal fees from Bristol-Myers Squibb during the conduct of the study, and grants and personal fees from Bristol-Myers Squibb, GlaxoSmithKline, and Novartis outside the submitted work; Hie-Won Hann received research grants from Bristol-Myers Squibb during the conduct of this study, received research grants from Gilead, Assembly Biosciences, Arbutus Biopharma, and TrioHealth, and serves on the national advisory board of Gilead; Cheng-Yuan Peng has served as an advisory committee member for AbbVie, Bristol-Myers Squibb, Gilead, and Merck; Tawesak Tanwandee received grants from Bristol-Myers Squibb and Merck during the conduct of the study; Hartwig Klinker has served as a speaker and/or an advisory board member for AbbVie, Bristol-Myers Squibb, Gilead, Hexal, Janssen, and Merck, and has received research funding from AbbVie, Arrowhead, Bristol-Myers Squibb, Gilead, Janssen, Merck, and Novartis; Adrian Streinu-Cercel received research funding from Bristol-Myers Squibb during the conduct of the study, other support from Arbutus Biopharma, and personal fees and other support from Gilead, Janssen, and Bristol-Myers Squibb outside the submitted work; Lai Wei has received research grants from AbbVie, Bristol-Myers Squibb, and Roche, and consulting fees from AbbVie, Allergan, Bristol-Myers Squibb, Gilead, and Johnson & Johnson; Ji-Dong Jia has received consulting and speaker fees from AbbVie, Bristol-Myers Squibb, Gilead, GlaxoSmithKline, and Merck; Hong Ren has received grants and personal fees from Gilead, and personal fees from Roche and Bristol-Myers Squibb outside the submitted work; Yongpeng Chen has received speaker fees from Bristol-Myers Squibb; Elizabeth L. Cooney was a salaried employee of Bristol-Myers Squibb and worked as medical monitor during the conduct of the study, and owns stock in Bristol-Myers Squibb; and Seng-Gee Lim has received grants, personal fees, and nonfinancial support from Gilead and Abbott Diagnostics, personal fees from AbbVie, Bristol Myers Squibb, and Janssen, grants and personal fees from Merck and Biopredictive, and other support from Roche outside the submitted work. The remaining authors disclose no conflicts.
语种：
外文
被引次数：
WOS：
PubmedID：
中科院(CAS)分区：
出版当年[2020]版：
大类 | 1 区 医学
小类 | 1 区 胃肠肝病学
最新[2023]版：
大类 | 1 区 医学
小类 | 1 区 胃肠肝病学
JCR分区：
出版当年[2020]版：
Q1 GASTROENTEROLOGY & HEPATOLOGY
最新[2023]版：
Q1 GASTROENTEROLOGY & HEPATOLOGY

影响因子： 最新[2023版] 最新五年平均 出版当年[2020版] 出版当年五年平均 出版前一年[2019版] 出版后一年[2021版]

第一作者：
第一作者机构： [1]Department of Infectious Diseases, Institute of Hepatology, Nanfang Hospital, Southern Medical University, Guangzhou,China [*1]Hepatology Unit, Department of Infectious Diseases, Nanfang Hospital, Southern Medical University,Guangzhou 510515, China.
通讯作者：
通讯机构： [1]Department of Infectious Diseases, Institute of Hepatology, Nanfang Hospital, Southern Medical University, Guangzhou,China [*1]Hepatology Unit, Department of Infectious Diseases, Nanfang Hospital, Southern Medical University,Guangzhou 510515, China.
推荐引用方式(GB/T 7714)：
Jin-Lin Hou,Wei Zhao,Changhyeong Lee,et al.Outcomes of Long-term Treatment of Chronic HBV Infection With Entecavir or Other Agents From a Randomized Trial in 24 Countries(Open Access)[J].Clinical Gastroenterology and Hepatology.2020,18(2):457-467.e21.doi:10.1016/j.cgh.2019.07.010.
APA：
Jin-Lin Hou,Wei Zhao,Changhyeong Lee,Hie-Won Hann,Cheng-Yuan Peng...&Seng-Gee Lim.(2020).Outcomes of Long-term Treatment of Chronic HBV Infection With Entecavir or Other Agents From a Randomized Trial in 24 Countries(Open Access).Clinical Gastroenterology and Hepatology,18,(2)
MLA：
Jin-Lin Hou,et al."Outcomes of Long-term Treatment of Chronic HBV Infection With Entecavir or Other Agents From a Randomized Trial in 24 Countries(Open Access)".Clinical Gastroenterology and Hepatology 18..2(2020):457-467.e21

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