Document Detail

Adding adefovir vs. switching to entecavir for lamivudine-resistant chronic hepatitis B (ACE study): a 2-year follow-up randomized controlled trial.
MedLine Citation:
PMID:  23295056     Owner:  NLM     Status:  In-Data-Review    
BACKGROUND: Management of lamivudine-resistant chronic hepatitis B (CHB) remains challenging, as inappropriate choice of treatment may cause multidrug resistance. Until now, randomized trials directly comparing adding adefovir and switching to entecavir monotherapy have not been reported.
AIMS: This multicentre prospective randomized study was designed to compare the efficacy of these two strategies.
METHODS: Two hundred and nineteen lamivudine-resistant CHB patients were randomized to either adefovir-lamivudine combination group or entecavir monotherapy group (n = 110 vs. 109), and followed up for 24 months.
RESULTS: One hundred and eighty patients completed this study. At month 24, virological response rate [hepatitis B virus (HBV) DNA <60 IU/ml] was higher in the adefovir-lamivudine combination group compared with entecavir group (56.7% vs. 40%, P = 0.025), although biochemical and serological response rates were not significantly different. Genotypic resistance (9.2% vs. 24.6%, P = 0.005) and combined viral breakthrough (2.0% vs. 17.6%, P < 0.001) were more frequent in the entecavir group. However, by subgroup analysis, virological response rates were not significantly different between the two therapies in HBeAg-positive patients (44.9% vs. 35.7%, P = 0.268) or in patients with high baseline HBV DNA (≥7 log IU/ml) (40.7% vs. 31.3%, P = 0.320) at month 24.
CONCLUSION: This study showed that adefovir-lamivudine combination provides significantly higher antiviral efficacy and the lower resistance rate compared with the entecavir monotherapy in the management of lamivudine-resistant CHB. However, it had limited efficacy in HBeAg-positive patients or in patients with high baseline HBV DNA.
Hyung Joon Yim; Yeon Seok Seo; Eileen L Yoon; Chang Wook Kim; Chang Don Lee; Sang Hoon Park; Myung Seok Lee; Choong Kee Park; Hee Bok Chae; Moon Young Kim; Soon Koo Baik; Yun Soo Kim; Ju Hyun Kim; Jung Il Lee; Jin Woo Lee; Sun Pyo Hong; Soon Ho Um
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Publication Detail:
Type:  Journal Article    
Journal Detail:
Title:  Liver international : official journal of the International Association for the Study of the Liver     Volume:  33     ISSN:  1478-3231     ISO Abbreviation:  Liver Int.     Publication Date:  2013 Feb 
Date Detail:
Created Date:  2013-01-08     Completed Date:  -     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  101160857     Medline TA:  Liver Int     Country:  United States    
Other Details:
Languages:  eng     Pagination:  244-54     Citation Subset:  IM    
Copyright Information:
© 2012 John Wiley & Sons A/S.
Division of Gastroenterology and Hepatology, Department of Internal Medicine, Korea University Ansan Hospital, Ansan, Korea.
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