title: Recommendation of lamivudine-to-entecavir switching treatment in chronic hepatitis B responders: Randomized controlled trial.
abstract: OBJECTIVE
  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 3 years 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 3 years 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).
  
  
  CONCLUSIONS
  In patients treated with LAM for more than 3 years maintaining HBV DNA less than 2.6 log copies/mL, switching treatment to ETV is recommended at least during the 2 years' follow-up period.
authors.affiliation: Department of Virology and Liver Unit, Nagoya City University Graduate School of Medical Sciences, Nagoya.
authors.forename: Kentaro
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authors.lastname: Matsuura
authors.forename: Yasuhito
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authors.lastname: Tanaka
authors.forename: Atsunori
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authors.lastname: Kusakabe
authors.forename: Shuhei
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authors.forename: Jun
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authors.forename: Masashi
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authors.forename: Tomoyuki
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authors.forename: Katsuharu
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authors.forename: Tomoyoshi
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authors.lastname: Ohno
authors.forename: Izumi
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authors.lastname: Hasegawa
authors.forename: Haruhiko
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authors.lastname: Kobashi
authors.forename: Keisuke
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authors.lastname: Hino
authors.forename: Yoichi
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authors.lastname: Hiasa
authors.forename: Hideyuki
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authors.lastname: Nomura
authors.forename: Fuminaka
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authors.lastname: Sugauchi
authors.forename: Shunsuke
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authors.lastname: Nojiri
authors.forename: Takashi
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authors.lastname: Joh
authors.forename: Masashi
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authors.lastname: Mizokami