单位：[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首都医科大学附属北京友谊医院[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四川大学华西医院[25]Department of Infectious Diseases, The Third Affiliated Hospital, Sun Yat-Sen University, Guangzhou, China中山大学附属第三医院[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浙江大学医学院附属第一医院[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
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.
第一作者单位：[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[J].CLINICAL GASTROENTEROLOGY and HEPATOLOGY.2020,18(2):457-+.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.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".CLINICAL GASTROENTEROLOGY and HEPATOLOGY 18..2(2020):457-+
医学