Presented in part at the 57th Annual Meeting of the American Association for the Study of Liver Diseases, October 27–31, 2006.
Loss of HBsAg antigen during treatment with entecavir or lamivudine in nucleoside-naïve HBeAg-positive patients with chronic hepatitis B*
Article first published online: 19 JUL 2009
© 2009 Blackwell Publishing Ltd
Journal of Viral Hepatitis
Volume 17, Issue 1, pages 16–22, January 2010
How to Cite
Gish, R. G., Chang, T.-T., Lai, C.-L., De Man, R., Gadano, A., Poordad, F., Yang, J., Brett-Smith, H. and Tamez, R. (2010), Loss of HBsAg antigen during treatment with entecavir or lamivudine in nucleoside-naïve HBeAg-positive patients with chronic hepatitis B. Journal of Viral Hepatitis, 17: 16–22. doi: 10.1111/j.1365-2893.2009.01146.x
- Issue published online: 14 DEC 2009
- Article first published online: 19 JUL 2009
- Received January 2009; accepted for publication March 2009
- hepatitis B surface antigen;
- hepatitis B virus
Summary. This retrospective analysis was conducted to describe the characteristics of nucleoside-naïve hepatitis B e antigen (HBeAg)-positive patients with chronic hepatitis B, who achieved hepatitis B surface antigen (HBsAg) loss during entecavir or lamivudine therapy. HBeAg-positive adults with chronic hepatitis B, elevated serum alanine aminotransferase, and compensated liver disease were randomized to double-blind treatment for up to 96 weeks with entecavir 0.5 mg/day or lamivudine 100 mg/day. HBsAg and hepatitis B virus (HBV) DNA were measured at regular intervals during and off-treatment follow-up. Through a maximum duration of 96 weeks on-treatment and 24 weeks off-treatment, HBsAg loss was confirmed in 18/354 (5.1%) patients treated with entecavir and 10/355 (2.8%) patients treated with lamivudine. Among the 28 patients with confirmed HBsAg loss, 27 (96%) achieved HBV DNA <300 copies/mL, and 27 (96%) achieved confirmed HBeAg loss. All entecavir recipients with HBsAg loss had HBV DNA <300 copies/mL. Caucasian patients, and those infected with HBV genotype A or D, were significantly more likely to lose HBsAg. This retrospective analysis of data from a randomized, global phase three trial shows that confirmed loss of HBsAg occurred in 5% of nucleoside-naïve HBeAg-positive patients treated with entecavir, and that HBsAg loss is associated with sustained off-treatment suppression of HBV DNA.