[Efficacy and predictors of the virologic response to entecavir therapy in nucleoside-naive patients with chronic hepatitis B].
OBJECTIVE
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 log(10) 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 log(10) 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 log(10) 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.
Myung
Hyung Joon
HJ
Department of Internal Medicine, Seoul National University College of Medicine, Seoul, Korea.
Jeong
Sook Hyang
SH
Kim
Jin Wook
JW
Kim
Hee Sup
HS
Jang
Je Hyuck
JH
Lee
Dong Ho
DH
Kim
Nayoung
N
Hwang
Jin Hyeok
JH
Park
Young Soo
YS
Lee
Sang Hyub
SH
D000328:Adult; D000410:Alanine Transaminase / Q000097:blood; D000998:Antiviral Agents / Q000627:therapeutic use*; D004279:DNA, Viral / Q000097:blood; D005260:Female; D005838:Genotype; D006147:Guanine / Q000031:analogs & derivatives* / Q000627:therapeutic use; D006513:Hepatitis B e Antigens / Q000032:analysis; D019694:Hepatitis B, Chronic / Q000188:drug therapy*; D006801:Humans; D008297:Male; D008875:Middle Aged; D011237:Predictive Value of Tests; D012189:Retrospective Studies; D013997:Time Factors
D000998:Antiviral Agents; D004279:DNA, Viral; D006513:Hepatitis B e Antigens; C413685:entecavir; D006147:Guanine; D000410:Alanine Transaminase