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Concomitant food intake does not affect the efficacy of entecavir in chronic hepatitis B patients with virological response: a randomized, multicenter, noninferiority trialopen access

Authors
Cho, Eun JuYu, Su JongKwon, So YoungKim, Ji-HoonKim, Do YoungKim, WonLee, June SungLee, Jin WooLee, Youn JaeChae, Hee BokYoon, Jung-Hwan
Issue Date
2018
Publisher
DOVE MEDICAL PRESS LTD
Keywords
chronic hepatitis B; entecavir; food effect; efficacy
Citation
DRUG DESIGN DEVELOPMENT AND THERAPY, v.12, pp 3767 - 3774
Pages
8
Indexed
SCIE
SCOPUS
Journal Title
DRUG DESIGN DEVELOPMENT AND THERAPY
Volume
12
Start Page
3767
End Page
3774
URI
https://scholarworks.korea.ac.kr/kumedicine/handle/2020.sw.kumedicine/4272
DOI
10.2147/DDDT.S181561
ISSN
1177-8881
Abstract
Background: Little clinical data are available about the effect of food on the antiviral efficacy of entecavir for chronic hepatitis B virus (HBV) infection. The present study evaluated whether entecavir administration in the fed state had comparable efficacy to the fasted condition for maintenance of viral suppression in HBV-infected patients with virological response on entecavir therapy. Methods: In this multicenter, randomized, open-label, noninferiority study, patients who were currently receiving entecavir and showed a serum HBV DNA level of <20 IU/mL were randomised to take entecavir either under the fasted or fed condition for 48 weeks. Results: We randomly assigned 50 patients to the fasted group and 46 patients to the fed group. The full analysis set consisted o f 49 patients in the fasted group and 44 patients in the fed group. At week 48, the proportion of patients with HBV DNA <20 IU/mL was not significantly different between the fasted and fed groups (98% vs 100%, P=1.00). The mean log(10) HBV DNA changes from baseline were similar between the two groups (-0.004 vs -0.012 log(10 )IU/mL, P=0.43). There were no significant differences in the proportions of patients with normal alanine aminotransferase (87.8% vs 95.5%, P=0.27) and hepatitis B e-antigen seroconversion (0% vs 6.7%, P=0.47) between the two groups. None of the patients showed viral breakthrough. In pharmacokinetic analysis, the maximum concentration and the area under the concentration- time curve to the last quantifiable concentration decreased by 26.4% and 9.3%, respectively, in the fed group compared with the fasted group. However, the differences between two groups were not statistically significant (P=0.28 and 0.83, respectively). Conclusion: In patients with virological response under entecavir therapy, concomitant food intake did not affect the antiviral efficacy. For patients with adherence problem, taking entecavir with food may be considered to improve compliance.
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Kim, Ji Hoon
Guro Hospital (Department of Gastroenterology and Hepatology, Guro Hospital)
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