Recommendation of lamivudine-to-entecavir switching treatment in chronic hepatitis B responders: Randomized controlled trial
Article first published online: 18 MAY 2011
© 2011 The Japan Society of Hepatology
Volume 41, Issue 6, pages 505–511, June 2011
How to Cite
Matsuura, K., Tanaka, Y., Kusakabe, A., Hige, S., Inoue, J., Komatsu, M., Kuramitsu, T., Hirano, K., Ohno, T., Hasegawa, I., Kobashi, H., Hino, K., Hiasa, Y., Nomura, H., Sugauchi, F., Nojiri, S., Joh, T. and Mizokami, M. (2011), Recommendation of lamivudine-to-entecavir switching treatment in chronic hepatitis B responders: Randomized controlled trial. Hepatology Research, 41: 505–511. doi: 10.1111/j.1872-034X.2011.00807.x
- Issue published online: 25 MAY 2011
- Article first published online: 18 MAY 2011
- Received 22 January 2011; revision 5 March 2011; accepted 21 March 2011.
- chronic hepatitis B;
- lamivudine resistance;
- randomized controlled trial;
- switching treatment
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 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).
Conclusion: 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.