Recommendation of lamivudine-to-entecavir switching treatment in chronic hepatitis B responders: Randomized controlled trial

Kentaro Matsuura, Yasuhito Tanaka, Atsunori Kusakabe, Shuhei Hige, Jun Inoue, Masashi Komatsu, Tomoyuki Kuramitsu, Katsuharu Hirano, Tomoyoshi Ohno, Izumi Hasegawa, Haruhiko Kobashi, Keisuke Hino, Yoichi Hiasa, Hideyuki Nomura, Fuminaka Sugauchi, Shunsuke Nojiri, Takashi Joh, Masashi Mizokami

研究成果: Article査読

4 被引用数 (Scopus)

抄録

Aim: In the 2007-2008 guidelines of the study group (Ministry of Health, Labor and Welfare of Japan), lamivudine (LAM)-continuous treatment was recommended in patients treated with LAM for more than 3years who maintained hepatitis B virus (HBV) DNA less than 2.6 log copies/mL, because in these patients LAM resistance might exist and switching treatment to entecavir (ETV) might cause ETV resistance. However, there was no evidence on whether switching treatment to ETV- or LAM-continuous treatment was better in those patients. In the present study, we performed a randomized controlled trial of LAM-to-ETV switching treatment. Methods: Twenty-seven patients treated with LAM for more than 3years whose HBV DNA levels were less than 2.6 log copies/mL were enrolled and randomly divided into two groups, LAM-continued group or switching to ETV group. Then, we examined incidence of virological breakthrough (VBT) and breakthrough hepatitis (BTH) in each group. Results: There was no BTH in any of the patients. VBT was observed in six patients of the LAM group (6/15, 40%), and no patient of the ETV group (0/11, 0%) (P=0.02). The differences of the proportion of cumulated VBT using a log-rank test with Kaplan-Meier analysis were significant between the LAM and ETV groups (P=0.025). Conclusion: In patients treated with LAM for more than 3years maintaining HBV DNA less than 2.6 log copies/mL, switching treatment to ETV is recommended at least during the 2years' follow-up period.

本文言語English
ページ(範囲)505-511
ページ数7
ジャーナルHepatology Research
41
6
DOI
出版ステータスPublished - 2011 6

ASJC Scopus subject areas

  • Hepatology
  • Infectious Diseases

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