Efficacy and predictors of the virologic response to entecavir therapy in nucleoside-naive patients with chronic hepatitis B.
10.3350/kjhep.2010.16.1.57
- Author:
Hyung Joon MYUNG
1
;
Sook Hyang JEONG
;
Jin Wook KIM
;
Hee Sup KIM
;
Je Hyuck JANG
;
Dong Ho LEE
;
Nayoung KIM
;
Jin Hyeok HWANG
;
Young Soo PARK
;
Sang Hyub LEE
Author Information
1. Department of Internal Medicine, Seoul National University College of Medicine, Seoul, Korea.
- Publication Type:Original Article ; English Abstract
- Keywords:
Hepatitis B virus;
Entecavir;
Hepatitis B chronic;
Treatment efficacy;
Drug resistance
- MeSH:
Adult;
Alanine Transaminase/blood;
Antiviral Agents/*therapeutic use;
DNA, Viral/blood;
Female;
Genotype;
Guanine/*analogs & derivatives/therapeutic use;
Hepatitis B e Antigens/analysis;
Hepatitis B, Chronic/*drug therapy;
Humans;
Male;
Middle Aged;
Predictive Value of Tests;
Retrospective Studies;
Time Factors
- From:The Korean Journal of Hepatology
2010;16(1):57-65
- CountryRepublic of Korea
- Language:Korean
-
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.
