Efficacy and predictors of the virologic response to entecavir therapy in nucleoside naive patients with chronic hepatitis B

doi:2010.16.1.57

Korean J Hepatol > Volume 16(1); 2010 > Article

The Korean Journal of Hepatology 2010;16(1): 57-65.
doi: https://doi.org/10.3350/kjhep.2010.16.1.57

Efficacy and predictors of the virologic response to entecavir therapy in nucleoside naive patients with chronic hepatitis B

Hyung-Joon Myung, M.D., Sook-Hyang Jeong, M.D., Jin-Wook Kim, M.D., Hee-Sup Kim, M.D., Je-Hyuck Jang, M.D., Dong Ho Lee, M.D., Nayoung Kim, M.D., Jin-Hyeok Hwang, M.D., Young Soo Park, M.D., Sang-Hyub Lee, M.D.

Department of Internal Medicine, Seoul National University College of Medicine, Seoul, Korea, Seoul National University Bundang Hospital, Seongnam, Korea.

ABSTRACT

Background/Aims
The aim of this study was to elucidate the antiviral efficacy and the predictors of entecavir treatment in nucleoside-naive chronic hepatitis B patients. Methods: A total of 160 patients treated with entecavir (0.5 mg daily) for at least 24 weeks were consecutively enrolled. The virologic response (HBV DNA<2,000 copies/mL), biochemical response (ALT≤ upper limit of normal), and virologic breakthrough (>1 log10 copies/mL increase in HBV DNA level above nadir on two consecutive occasions) were retrospectively analyzed. Results: The mean follow-up duration was 58.8 weeks, and 85 patients (53.1%) showed HBeAg positivity. The median pretreatment levels of serum ALT and HBV DNA were 99 IU/L and 7.6 log10 copies/mL, respectively. The cumulative rates at 12, 24, 48, and 72 weeks were 37.5%, 68.1%, 87.4%, and 95.8%, respectively, for the virologic response; 40.0%, 66.2%, 84.5%, and 92.7% for the biochemical response; 10.6%, 18.8%, 27.0%, and 34.5% for HBeAg loss; and 3.5%, 7.1%, 9.0%, and 13.2% for HBeAg seroconversion. There was no case of virologic breakthrough. An absence of HBeAg and a low serum HBV DNA level (<8 log10 copies/mL) at baseline were significant predictors of the virologic response in a multivariate analysis (P<0.01). Conclusions: Entecavir therapy showed excellent efficacy in nucleoside-na?ve chronic hepatitis B patients. The predictors of a virologic response were an absence of HBeAg and a low baseline HBV DNA level. (Korean J Hepatol 2010;16:57-65)

KeyWords: Hepatitis B virus; Entecavir; Hepatitis B chronic; Treatment efficacy; Drug resistance