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Entecavir maleate versus entecavir in Chinese chronic hepatitis B predominantly genotype B or C: Results at week 144
Author(s) -
Xu J.H.,
Wang S.,
Xu Z.N.,
Yu Y.Y.,
Si C.W.,
Zeng Z.,
Li J.,
Mao Q.,
Zhang D.Z.,
Tang H.,
Sheng J.F.,
Chen X.Y.,
Ning Q.,
Shi G.F.,
Xie Q.,
Zhang X.Q.,
Dai J.
Publication year - 2017
Publication title -
journal of viral hepatitis
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.329
H-Index - 100
eISSN - 1365-2893
pISSN - 1352-0504
DOI - 10.1111/jvh.12710
Subject(s) - entecavir , medicine , gastroenterology , chronic hepatitis , group b , seroconversion , hepatitis b , incidence (geometry) , genotype , hepatitis b virus , adverse effect , group a , virology , biology , virus , lamivudine , biochemistry , physics , optics , gene
Summary Reports on the efficacy and safety of long‐term entecavir treatment in chronic hepatitis B ( CHB ) predominantly genotype B or C are insufficient. This study presents the efficacy and safety of entecavir maleate in Chinese CHB patients. Patients were randomly assigned to receive 48‐week treatment with either 0.5 mg/day entecavir (group A) or 0.5 mg/day entecavir maleate (group B), and then all patients received treatment with 0.5 mg/day entecavir maleate from week 49. Two hundred and seventy‐five patients with CHB ( HB eAg‐positive: 218) were analysed, predominantly (98.5%) with genotype B or C. Baseline characteristics were balanced. For the HB eAg‐positive CHB patients, the mean HBV DNA level decreased similarly (A: by 6.36 log 10 IU / mL vs B: by 6.31 log 10 IU / mL ) between groups at week 144. The percentages of patients who achieved undetectable HBV DNA were similar (A: 70.59% vs B: 66.67%) between groups. Similar HB eAg loss rates (A: 43.53% vs B: 40.23%; P >.05) and HB eAg seroconversion rates (A: 21.52% vs B: 21.18%) were achieved. For the HB eAg‐negative CHB patients, similar reductions in HBV DNA levels from baseline (A: by 6.13 log 10 IU / mL vs B: by 5.65 log 10 IU / mL ) and percentages of patients who achieved undetectable HBV DNA (A: 100% vs B: 100%) were achieved. The overall incidence of adverse events was comparable between groups. In conclusions, 48‐week administration of entecavir maleate and entecavir showed similar efficacy and safety in Chinese patients with CHB . Long‐term entecavir maleate treatment was effective and safe in CHB patients.