Document Detail

Entecavir treatment in patients with severe acute exacerbation of chronic hepatitis B.
MedLine Citation:
PMID:  21030105     Owner:  NLM     Status:  MEDLINE    
BACKGROUND & AIMS: Severe acute exacerbation of chronic hepatitis B is a unique clinical presentation with significant morbidity and mortality. Lamivudine was used in most previous studies, but the drug was limited by the development of resistance. Our objective is to study the safety and efficacy of entecavir in patients with severe acute exacerbation.
METHODS: Consecutive patients with severe acute exacerbation of chronic hepatitis B were recruited from 1998 to 2009. All patients had serum alanine aminotransferase and bilirubin increased beyond 10 and 3 times the upper limit of normal, respectively. The primary endpoint was overall mortality at week 48. Virological and biochemical responses were also studied.
RESULTS: Thirty-six patients and 117 patients were treated with entecavir and lamivudine, respectively. By week 48, 7 (19%) patients in the entecavir group and 5 (4%) patients in the lamivudine group died (adjusted hazard ratio 5.1, 95% confidence interval 1.5-17.2, p=0.010). Similarly, the entecavir group had higher liver-related mortality (adjusted hazard ratio 4.0, 95% confidence interval 1.0-15.7, p=0.044). Despite a lower prevalence of cirrhosis, more patients in the entecavir group developed prolonged jaundice, hepatic encephalopathy, and ascites. Entecavir resulted in more rapid and complete viral suppression, with 71% of patients achieving undetectable hepatitis B virus (HBV) DNA at week 48, compared to 40% in the lamivudine group (p=0.007). However, rapid HBV DNA reduction at week 4 was associated with prolonged jaundice.
CONCLUSIONS: Entecavir treatment is associated with increased short-term mortality in patients with severe acute exacerbation of chronic hepatitis B but achieves better virological response in the long run.
Vincent Wai-Sun Wong; Grace Lai-Hung Wong; Karen Kar-Lum Yiu; Angel Mei-Ling Chim; Shirley Ho-Ting Chu; Hoi-Yun Chan; Joseph Jao-Yiu Sung; Henry Lik-Yuen Chan
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Publication Detail:
Type:  Journal Article; Research Support, Non-U.S. Gov't     Date:  2010-09-07
Journal Detail:
Title:  Journal of hepatology     Volume:  54     ISSN:  1600-0641     ISO Abbreviation:  J. Hepatol.     Publication Date:  2011 Feb 
Date Detail:
Created Date:  2011-01-18     Completed Date:  2011-04-25     Revised Date:  2012-08-24    
Medline Journal Info:
Nlm Unique ID:  8503886     Medline TA:  J Hepatol     Country:  England    
Other Details:
Languages:  eng     Pagination:  236-42     Citation Subset:  IM    
Copyright Information:
Copyright © 2010 European Association for the Study of the Liver. Published by Elsevier B.V. All rights reserved.
Department of Medicine and Therapeutics, The Chinese University of Hong Kong, Hong Kong.
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MeSH Terms
Alanine Transaminase / blood
Antiviral Agents / adverse effects*
DNA, Viral / blood
Guanine / adverse effects,  analogs & derivatives*
Hepatitis B e Antigens / blood
Hepatitis B, Chronic / complications,  drug therapy*,  mortality,  virology
Lamivudine / therapeutic use
Middle Aged
Prospective Studies
Virus Activation
Reg. No./Substance:
0/Antiviral Agents; 0/DNA, Viral; 0/Hepatitis B e Antigens; 0/entecavir; 134678-17-4/Lamivudine; 73-40-5/Guanine; EC Transaminase

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