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Evaluation of Long-term Entecavir (ETV) Treatment in Chronic Hepatitis B (CHB) Patients Switched from 24-week Lamivudine (LVD) Therapy
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Reported by Jules Levin
Feb 2009 Hong Kong
19th APASL- Conference of the Asian Pacific Association for the Study of the Liver 2009
M. Tsuge1, K. Chayama1, M. Shindo2, J. Toyota3, S. Mochida4, E. Tomita5, H. Kumada6, G. Yamada7, H. Yatsuhashi8, M. Sata9, O. Yokosuka10,
N. Hayashi11, H. Ishikawa12, T. Seriu12, M. Omata13
1Department of Medicine and Molecular Science, Graduate School of Biomedical Sciences, Hiroshima University, Hiroshima, Japan; 2Division of Liver disease, Department of Internal Medicine, Akashi Municipal Hospital, Hyogo, Japan;
3Department of Gastroenterology, Sapporo Kosei General Hospital, Hokkaido, Japan; 4Department of Gastroenterology and Hepatology, Saitama Medical University, Saitama, Japan; 5Department of Gastroenterology, Gifu Municipal Hospital, Gifu,
Japan; 6Department of Gastroenterology and Hepatology, Toranomon Hospital, Tokyo, Japan; 7Center of Liver Diseases, Kawasaki Hospital, Kawasaki Medical School, Okayama, Japan;
8Clinical Research Center, National Hospital Organization Nagasaki Medical Center, Nagasaki, Japan; 9Division of Gastroenterology, Department of Medicine, Kurume University School of Medicine, Fukuoka, Japan;
10Department of Medicine and Clinical Oncology, Graduate School of Medicine, Chiba University, Chiba, Japan; 11Department of Gastroenterology and Hepatology, Osaka University Graduate School of Medicine, Osaka, Japan;
12Research and Development, Bristol-Myers Squibb K.K., Tokyo, Japan; 13Department of Gastroenterology, Graduate School of Medicine, University of Tokyo, Tokyo, Japan.
Author Summary of Results
Switching CHB patients from LVD to long-term ETV therapy
resulted in:
Additional suppression of HBV DNA replication
-- Proportion of patients with HBV DNA <400 copies/mL increased from 21% to 90% after 72 weeks of ETV and was maintained through 96 weeks of ETV
Increasing proportions of patients achieving ALT ≦1 x ULN
No evidence of resistance emergence during 96 weeks of ETV treatment
ETV was well tolerated during long-term treatment
For nucleoside-naïve patients, switching to ETV after 24 weeks of LVD may result in a lower risk of ETV resistance than switching to ETV in LVD refractory patients.
Author Conclusion
CHB patients switched from LVD to long-term ETV achieve increased rates of virologic suppression, with no evidence of resistance through 2 years of ETV treatment
Introduction
The goal of chronic hepatitis B (CHB) treatment is to achieve
sustained suppression of HBV DNA and remission of liver disease1
Long-term treatment of CHB patients with lamivudine (LVD) is associated with the development of resistance and loss of clinical benefit2
Current Japanese CHB treatment guidelines recommend that patients should be switched to entecavir (ETV) 0.5 mg daily if they have received less than 3 years of LVD therapy, have HBV DNA <400 copies/mL and no breakthrough hepatitis or YMDD mutations
ETV 0.5 mg daily for 24 weeks demonstrated superior HBV DNA reduction compared to LVD 100 mg daily in phase 2 study ETV-047 in Japan3
After completing ETV-047, all patients could enroll in open-label ETV rollover study ETV-060
We report long-term efficacy, safety and resistance for patients who were switched from LVD to ETV therapy
References
1. Lok AS and McMahon BJ. Hepatology 2007;45:507-39.
2. Lai CL, et al. Clin Infect Dis 2003;36:687-96.
3. Shindo M, et al. J Clin Virol 2006;36 (Suppl 2):S94.
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