Myung Hyung Joon, Jeong Sook Hyang, Kim Jin Wook, Kim Hee Sup, Jang Je Hyuck, Lee Dong Ho, Kim Nayoung, Hwang Jin Hyeok, Park Young Soo, Lee Sang Hyub
Department of Internal Medicine, Seoul National University College of Medicine, Seoul, Korea.
Korean J Hepatol. 2010 Mar;16(1):57-65. doi: 10.3350/kjhep.2010.16.1.57.
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.
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.
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).
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.
背景/目的：本研究旨在阐明恩替卡韦治疗初治慢性乙型肝炎患者的抗病毒疗效及预测因素。
连续纳入160例接受恩替卡韦（每日0.5mg）治疗至少24周的患者。回顾性分析病毒学应答（HBV DNA<2,000拷贝/mL）、生化应答（ALT≤正常上限）及病毒学突破（连续两次检测HBV DNA水平较最低点升高>1 log₁₀拷贝/mL）情况。
平均随访时间为58.8周，85例患者（53.1%）HBeAg阳性。血清ALT和HBV DNA的基线中位水平分别为99 IU/L和7.6 log₁₀拷贝/mL。病毒学应答在12、24、48和72周时的累积率分别为37.5%、68.1%、87.4%和95.8%；生化应答分别为40.0%、66.2%、84.5%和92.7%；HBeAg消失分别为10.6%、18.8%、27.0%和34.5%；HBeAg血清学转换分别为3.5%、7.1%、9.0%和13.2%。未出现病毒学突破病例。多因素分析显示，基线时无HBeAg及低血清HBV DNA水平（<8 log₁₀拷贝/mL）是病毒学应答的显著预测因素（P<0.01）。
恩替卡韦治疗初治慢性乙型肝炎患者疗效显著。病毒学应答的预测因素为无HBeAg及低基线HBV DNA水平。
