Long-term use of entecavir in nucleoside-naïve Japanese patients

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Journal of Hepatology
Volume 52, Issue 6, June 2010, Pages 791-799
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doi:10.1016/j.jhep.2009.12.036 | How to Cite or Link Using DOI
Copyright © 2010 Published by Elsevier Ireland Ltd.
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Research Article
Long-term use of entecavir in nucleoside-naïve Japanese patients with chronic
hepatitis B infection


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Osamu Yokosuka1, Koichi Takaguchi2, Shinichi Fujioka3, Michiko Shindo4,
Kazuaki Chayama5, Haruhiko Kobashi6, Norio Hayashi7, Chifumi Sato8, Kendo
Kiyosawa9, Kyuichi Tanikawa10, Hiroki Ishikawa11, Nobuyuki Masaki11, Taku
Seriu11 and Masao Omata12, ,

1 Department of Medicine and Clinical Oncology, Graduate School of Medicine,
Chiba University, 1-8-1 Inohana, Chiba 260-8670, Japan
2 Department of Internal Medicine, Kagawa Prefectural Central Hospital,
Kagawa, Japan
3 Department of Internal Medicine, Okayama Saiseikai General Hospital,
Okayama, Japan
4 Division of Liver Disease, Department of Internal Medicine, Akashi Municipal
Hospital, Hyogo, Japan
5 Department of Medicine and Molecular Science, Graduate School of Biomedical
Sciences, Hiroshima University, Hiroshima, Japan
6 Department of Gastroenterology and Hepatology, Okayama University Graduate
School of Medicine, Dentistry, and Pharmaceutical Sciences, Okayama, Japan
7 Department of Gastroenterology and Hepatology, Osaka University Graduate
School of Medicine, Osaka, Japan
8 Department of Analytical Health Science, Graduate School of Allied Health
Sciences, Tokyo Medical and Dental University, Tokyo, Japan
9 Nagano Red Cross Hospital, Nagano, Japan
10 International Institute for Liver Research, Kurume Research Center,
Fukuoka, Japan
11 Research and Development, Bristol-Myers Squibb Japan, Tokyo, Japan
12 Department of Gastroenterology, Graduate School of Medicine, University of
Tokyo, Tokyo, Japan

Received 22 April 2009;  revised 1 December 2009;  accepted 9 December 2009.
Available online 24 March 2010.


Background & Aims
To evaluate the long-term efficacy of entecavir in nucleoside-naïve chronic
hepatitis B patients.

Methods
One hundred and sixty-seven patients treated with entecavir 0.01 mg, 0.1 mg or
0.5 mg for 24–52 weeks in Phase II studies entered rollover study ETV-060
and received entecavir 0.5 mg daily. Responses were evaluated among patients
with available samples.

Results
After 96 weeks in ETV-060 (120–148 weeks total entecavir treatment time),
88% (127/144) of patients had HBV-DNA <400 copies/ml; 90.1% (128/142) had
alanine aminotransferase (ALT) 1× the upper limit of normal (ULN) among those
with abnormal baseline ALT; and 26% (32/121) achieved HBe seroconversion among
those HBeAg(+) at baseline. A subset of 66 patients received entecavir 0.5 mg
(approved dose) from Phase II baseline: at week 96 in ETV-060, 83% (48/58) had
HBV-DNA <400 copies/ml, 88% (52/59) had ALT 1× ULN, and 20% (10/49) achieved
HBe seroconversion. Twenty-one out of 66 patients had paired baseline and
on-treatment biopsies: 100% (21/21) and 57% (12/21) demonstrated histologic
improvement, and improvement in fibrosis, respectively, over 3 years. The
3-year cumulative probability of resistance was 3.3% for all patients and 1.7%
for the 0.5 mg subset.

Conclusions
Long-term entecavir for nucleoside-naïve patients resulted in high rates of
virological, biochemical, and histological response, with minimal resistance.



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