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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

 Jin-Lin Hou  ;  Wei Zhao  ;  Changhyeong Lee  ;  Hie-Won Hann  ;  Cheng-Yuan Peng  ;  Tawesak Tanwandee  ;  Viacheslav Morozov  ;  Hartwig Klinker  ;  Jose D Sollano  ;  Adrian Streinu-Cercel  ;  Hugo Cheinquer  ;  Qing Xie  ;  Yu-Ming Wang  ;  Lai Wei  ;  Ji-Dong Jia  ;  Guozhong Gong  ;  Kwang-Hyub Han  ;  Wukui Cao  ;  Mingliang Cheng  ;  Xiaoping Tang  ;  Deming Tan  ;  Hong Ren  ;  Zhongping Duan  ;  Hong Tang  ;  Zhiliang Gao  ;  Shijun Chen  ;  Shumei Lin  ;  Jifang Sheng  ;  Chengwei Chen  ;  Jia Shang  ;  Tao Han  ;  Yanyan Ji  ;  Junqi Niu  ;  Jian Sun  ;  Yongpeng Chen  ;  Elizabeth L Cooney  ;  Seng-Gee Lim 
 CLINICAL GASTROENTEROLOGY AND HEPATOLOGY, Vol.18(2) : 457-467.e21, 2020-02 
Journal Title
Issue Date
Antiviral Agents / adverse effects ; Guanine / analogs & derivatives ; Hepatitis B virus ; Hepatitis B, Chronic* / drug therapy ; Humans ; Liver Neoplasms* / drug therapy ; Liver Neoplasms* / epidemiology ; Treatment Outcome
HCC ; CHB ; Long-Term Follow-Up Study ; Complication
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.
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1. College of Medicine (의과대학) > Dept. of Internal Medicine (내과학교실) > 1. Journal Papers
Yonsei Authors
Han, Kwang-Hyub(한광협) ORCID logo https://orcid.org/0000-0003-3960-6539
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