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Adding adefovir vs. switching to entecavir for lamivudine‐resistant chronic hepatitis B ( ACE study): a 2‐year follow‐up randomized controlled trial
Author(s) -
Yim Hyung Joon,
Seo Yeon Seok,
Yoon Eileen L.,
Kim Chang Wook,
Lee Chang Don,
Park Sang Hoon,
Lee Myung Seok,
Park Choong Kee,
Chae Hee Bok,
Kim Moon Young,
Baik Soon Koo,
Kim Yun Soo,
Kim Ju Hyun,
Lee Jung Il,
Lee Jin Woo,
Hong Sun Pyo,
Um Soon Ho
Publication year - 2013
Publication title -
liver international
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.873
H-Index - 110
eISSN - 1478-3231
pISSN - 1478-3223
DOI - 10.1111/liv.12036
Subject(s) - adefovir , entecavir , lamivudine , medicine , gastroenterology , hbeag , randomized controlled trial , hepatitis b , chronic hepatitis , hepatitis b virus , virology , hbsag , virus
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 HB eAg‐positive patients or in patients with high baseline HBV DNA .