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本帖最后由 风雨不动 于 2012-4-14 16:38 编辑
J Hepatol. 2010 Mar 24. [Epub ahead of print]
Long-term use of entecavir in nucleoside-naïve Japanese patients with chronic
hepatitis B infection.
Yokosuka O, Takaguchi K, Fujioka S, Shindo M, Chayama K, Kobashi H, Hayashi N,
Sato C, Kiyosawa K, Tanikawa K, Ishikawa H, Masaki N, Seriu T, Omata M.
Department of Medicine and Clinical Oncology, Graduate School of Medicine,
Chiba University, 1-8-1 Inohana, Chiba 260-8670, Japan.
Abstract
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 0.01mg,
0.1mg or 0.5mg for 24-52weeks in Phase II studies entered rollover study
ETV-060 and received entecavir 0.5mg daily. Responses were evaluated among
patients with available samples.
RESULTS: After 96weeks in ETV-060 (120-148weeks total entecavir treatment
time), 88% (127/144) of patients had HBV-DNA <400 copies/ml; 90.1% (128/142)
had alanine aminotransferase (ALT) 1x 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
0.5mg (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 1x 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 3years.
The 3-year cumulative probability of resistance was 3.3% for all patients and
1.7% for the 0.5mg subset.
CONCLUSIONS: Long-term entecavir for nucleoside-naïve patients resulted in
high rates of virological, biochemical, and histological response, with
minimal resistance.
Copyright © 2010. Published by Elsevier B.V.
PMID: 20409606 [PubMed - as supplied by publisher]
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发表于 2010-5-6 12:01
