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

Eun Ju Cho, Su Jong Yu, So Young Kwon, Ji Hoon Kim, Do Young Kim, Won Kim, June Sung Lee, Jin Woo Lee, Youn Jae Lee, Hee Bok Chae, Jung Hwan Yoon

Research output: Contribution to journalArticlepeer-review


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 randomized 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 of 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.

Original languageEnglish
Pages (from-to)3767-3774
Number of pages8
JournalDrug Design, Development and Therapy
Publication statusPublished - 2018

Bibliographical note

Funding Information:
This study was sponsored by Bukwang Pharmaceutical Co. Ltd., the manufacturer of Entecavir®. Bukwang Pharmaceutical Co. Ltd. made significant contributions to the design and analysis of the study and assisted in the preparation of research grant applications.

Publisher Copyright:
© 2018 Cho et al.

All Science Journal Classification (ASJC) codes

  • Pharmacology
  • Pharmaceutical Science
  • Drug Discovery


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