Peng Cheng-Yuan, Hsieh Tsung-Cheng, Hsieh Tsai-Yuan, Tseng Kuo-Chih, Lin Chih-Lin, Su Tung-Hung, Tseng Tai-Chung, Lin Hans Hsienhong, Wang Chia-Chi, Kao Jia-Horng
School of Medicine, China Medical University, Taichung, Taiwan; Division of Hepatogastroenterology, Department of Internal Medicine, China Medical University Hospital, Taichung, Taiwan.
Institute of Medical Science, Tzu Chi University, Hualien, Taiwan.
J Formos Med Assoc. 2015 Apr;114(4):308-13. doi: 10.1016/j.jfma.2013.10.023. Epub 2013 Dec 5.
BACKGROUND/PURPOSE: To evaluate whether on-treatment HBV-DNA level could predict the treatment response to entecavir in hepatitis B e antigen (HBe)-positive chronic hepatitis B (CHB) patients.
A total of 68 treatment-naïve HBeAg-positive patients (75% male, mean age at 46.6 ± 11.9 years) receiving at least 2 years of entecavir therapy were enrolled. The primary therapeutic endpoint was HBeAg loss. On-treatment complete virological response was defined as serum HBV-DNA < 63 IU/mL.
The median baseline alanine aminotransferase (ALT) and HBV-DNA levels were 199.5 (27-1622) U/L and 7.7 (3.8-13.2) log10 IU/mL, respectively. The median treatment duration was 31.7 (24.3-69.6) months. The rate of HBeAg loss at 2 years was 30.9%. By univariate analysis, on-treatment complete virological response at Month 6 was associated with HBeAg loss at 2 years (p = 0.019). After adjustment for age, sex, cirrhosis, baseline ALT, and HBV-DNA levels, this factor remained significant in multivariate analysis (odds ratio: 4.35; 95% confidence interval: 1.24-15.24, p = 0.021).
On-treatment complete virological response at Month 6 is a favorable factor predictive of HBeAg loss at 2 years of entecavir therapy. Therefore, measurement of serum HBV-DNA level at 6 months of entecavir therapy is optimal to predict HBeAg loss at 2 years of therapy in HBeAg-positive CHB patients.
背景/目的：评估在接受治疗期间的乙肝病毒脱氧核糖核酸（HBV-DNA）水平能否预测e抗原（HBe）阳性慢性乙型肝炎（CHB）患者对恩替卡韦的治疗反应。
共纳入68例初治的HBeAg阳性患者（75%为男性，平均年龄46.6±11.9岁），这些患者接受了至少2年的恩替卡韦治疗。主要治疗终点为HBeAg消失。治疗期间的完全病毒学应答定义为血清HBV-DNA<63国际单位/毫升。
基线丙氨酸氨基转移酶（ALT）和HBV-DNA水平的中位数分别为199.5（27-1622）U/L和7.7（3.8-13.2）log10国际单位/毫升。中位治疗持续时间为31.7（24.3-69.6）个月。2年时HBeAg消失率为30.9%。单因素分析显示，第6个月时治疗期间的完全病毒学应答与2年时HBeAg消失相关（p=0.019）。在对年龄、性别、肝硬化、基线ALT和HBV-DNA水平进行校正后，该因素在多因素分析中仍具有显著性（比值比：4.35；95%置信区间：1.24-15.24，p=0.021）。
第6个月时治疗期间的完全病毒学应答是预测恩替卡韦治疗2年时HBeAg消失的有利因素。因此，在恩替卡韦治疗6个月时检测血清HBV-DNA水平，对于预测HBeAg阳性CHB患者治疗2年时HBeAg消失最为理想。
