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Five years of treatment with adefovir dipivoxil in C hinese patients with HBeAg ‐positive chronic hepatitis B
Author(s) -
Minde Zeng,
Yimin Mao,
Guangbi Yao,
JinLin Hou,
Hao Wang,
Hong Ren,
Yuming Wang,
Xiaqiu Zhou,
Daozhen Xu,
Yagang Chen,
Junqi Niu,
Youming Chen,
Yaozong Wang,
Dixon Jonathan,
Barker Keith
Publication year - 2012
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/j.1478-3231.2011.02641.x
Subject(s) - adefovir , medicine , hbeag , seroconversion , gastroenterology , hbsag , serology , chronic hepatitis , placebo , hepatitis b virus , virology , immunology , virus , antibody , lamivudine , pathology , alternative medicine
Abstract Background Adefovir dipivoxil ( ADV ) is a nucleotide analogue with proven efficacy in chronic hepatitis B ( CHB ). Aims This study investigated long‐term ADV treatment in HBeAg ‐positive patients. Methods A total of 480 C hinese subjects with HBeAg ‐positive CHB who participated in a 1‐year, double‐blind, placebo‐controlled study of ADV 10 mg daily were offered open‐label continuation for a further 208 weeks. Results A total of 390 subjects completed 5 years of treatment. Baseline median hepatitis B virus ( HBV ) DNA was 8.8 log 10 copies/ml and alanine aminotransferase ( ALT ) 2.6 × upper limit of normal. Treatment with ADV resulted in sustained suppression of median HBV DNA by 4.8, 5.0, 5.1, 5.4 and 5.5 log 10 copies/ml after 1, 2, 3, 4 and 5 years respectively. Continuous treatment with ADV led to a progressive increase in the proportion of subjects achieving undetectable HBV DNA , from 28% after 1 year to 58% after 5 years. HBeAg seroconversion rates increased cumulatively from 11% after 1 year to 29% after 5 years. HBsAg seroconversion was achieved by 1.0% of patients. ADV resulted in ALT normalization that was maintained throughout this study in 75–79% of subjects. Virological breakthrough associated with ADV resistant mutations (rtN236T and rtA181V) occurred in 14.6% of subjects. ADV was well tolerated. Conclusion Five years of ADV treatment in C hinese subjects with HBeAg ‐positive CHB resulted in increasing virological and serological responses and sustained biochemical responses over time. Virological resistance was identified in 14.6% of patients. Urgent switch or add‐on therapy with a nucleoside analogue is necessary if ADV resistant mutations are detected, particularly rtN236T. Treatment was well tolerated.