Recommendation of lamivudine-to-entecavir switching treatment in chronic hepatitis B responders: Randomized controlled trial.
Author(s): 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, Mizokami M
Affiliation(s): Department of Virology and Liver Unit, Nagoya City University Graduate School of Medical Sciences Department of Gastroenterology and Metabolism, Nagoya City University Graduate School of Medical Sciences Department of Gastroenterology, Social Insurance Chukyo Hospital Department of Gastroenterology, Nagoya Koseiin Medical Welfare Center, Nagoya Department of Internal Medicine, Hokkaido University Graduate School of Medicine, Sapporo Department of Gastroenterology, Tohoku University Graduate School of Medicine, Sendai Department of Gastroenterology, Akita City Hospital Kuramitsu Clinic, Akita Department of Gastroenterology and Hepatology, Juntendo University Shizuoka Hospital, Izunokuni Department of Gastroenterology and Hepatology, Okayama University Graduate School of Medicine, Dentistry, and Pharmaceutical Sciences Department of Hepatology and Pancreatology, Kawasaki Medical University, Okayama Department of Gastroenterology and Metabology, Ehime University Graduate School of Medicine, Ehime The Center for Liver Diseases, Shin-Kokura Hospital, Kitakyushu The Research Center for Hepatitis and Immunology, National Center for Global Health and Medicine, Ichikawa, Japan.
Publication date & source: 2011-06, Hepatol Res., 41(6):505-511. Epub 2011 May 18.
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. (c) 2011 The Japan Society of Hepatology.