Korean J Hepatol.
2010 Mar;16(1):57-65. 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
- Affiliations
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- 1Department of Internal Medicine, Seoul National University College of Medicine, Seoul, Korea.
- 2Department of Internal Medicine, Seoul National University Bundang Hospital, Seongnam, Korea. jsh@snubh.org
- KMID: 1782221
- DOI: http://doi.org/10.3350/kjhep.2010.16.1.57
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< or = 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-naive chronic hepatitis B patients. The predictors of a virologic response were an absence of HBeAg and a low baseline HBV DNA level.
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