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 journalArticle

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 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 log10 HBV DNA changes from baseline were similar between the two groups (-0.004 vs -0.012 log10 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
Volume12
DOIs
Publication statusPublished - 2018 Jan 1

Fingerprint

Chronic Hepatitis B
Multicenter Studies
Eating
Hepatitis B virus
Antiviral Agents
DNA
entecavir
Food
Hepatitis B e Antigens
Virus Diseases
Patient Compliance
Alanine Transaminase
Compliance
Pharmacokinetics
Maintenance

Keywords

  • chronic hepatitis B
  • efficacy
  • entecavir
  • food effect

ASJC Scopus subject areas

  • Pharmacology
  • Pharmaceutical Science
  • Drug Discovery

Cite this

Concomitant food intake does not affect the efficacy of entecavir in chronic hepatitis B patients with virological response : a randomized, multicenter, noninferiority trial. / Cho, Eun Ju; Yu, Su Jong; Kwon, So Young; Kim, Ji Hoon; Kim, Do Young; Kim, Won; Lee, June Sung; Lee, Jin Woo; Lee, Youn Jae; Chae, Hee Bok; Yoon, Jung Hwan.

In: Drug Design, Development and Therapy, Vol. 12, 01.01.2018, p. 3767-3774.

Research output: Contribution to journalArticle

Cho, Eun Ju ; Yu, Su Jong ; Kwon, So Young ; Kim, Ji Hoon ; Kim, Do Young ; Kim, Won ; Lee, June Sung ; Lee, Jin Woo ; Lee, Youn Jae ; Chae, Hee Bok ; Yoon, Jung Hwan. / Concomitant food intake does not affect the efficacy of entecavir in chronic hepatitis B patients with virological response : a randomized, multicenter, noninferiority trial. In: Drug Design, Development and Therapy. 2018 ; Vol. 12. pp. 3767-3774.
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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 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 log10 HBV DNA changes from baseline were similar between the two groups (-0.004 vs -0.012 log10 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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T1 - Concomitant food intake does not affect the efficacy of entecavir in chronic hepatitis B patients with virological response

T2 - a randomized, multicenter, noninferiority trial

AU - Cho, Eun Ju

AU - Yu, Su Jong

AU - Kwon, So Young

AU - Kim, Ji Hoon

AU - Kim, Do Young

AU - Kim, Won

AU - Lee, June Sung

AU - Lee, Jin Woo

AU - Lee, Youn Jae

AU - Chae, Hee Bok

AU - Yoon, Jung Hwan

PY - 2018/1/1

Y1 - 2018/1/1

N2 - 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 log10 HBV DNA changes from baseline were similar between the two groups (-0.004 vs -0.012 log10 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.

AB - 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 log10 HBV DNA changes from baseline were similar between the two groups (-0.004 vs -0.012 log10 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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