School of Medicine, Tzu Chi University, Hualien, Taiwan.
J Gastroenterol Hepatol. 2013 Jan;28(1):46-50. doi: 10.1111/j.1440-1746.2012.07269.x.
Although entecavir has been shown to have good efficacy and low resistance for the treatment of chronic hepatitis B (CHB), factors associated with a favorable response remain unknown.
This was a retrospective, multicenter study of 248 treatment-naïve hepatitis B e antigen (HBeAg)-positive patients (69.4% male; median age, 39.4 years) treated with entecavir for more than 1 year, and 15.7% of them had cirrhosis at baseline. The primary endpoints were HBeAg loss and/or seroconversion.
The median baseline levels of alanine aminotransferase (ALT) and hepatitis B virus (HBV) DNA were 201 U/L (range, 27-2415 U/L) and 7.6 log(10) IU/mL (range, 2.2-13.18), respectively. The median treatment period was 25.3 months (range, 12-69.6). The rates of ALT normalization at years 1, 2, and 3 were 83.1%, 87.9%, and 94.9%, respectively. The cumulative rates of HBeAg loss at years 1, 2, and 3 were 20.3%, 38.0%, and 48.9%, respectively. The rates of undetectable HBV-DNA at years 1, 2, and 3 were 52.1%, 78.9%, and 82.5%, respectively. Using Cox proportional hazards model, multivariate analysis showed that baseline ALT greater than five times the upper limit of normal, and viral load were independent factors associated with HBeAg loss (hazard ratio: 1.81, and 0.812; 95% confidence interval: 1.062-3.085; 0.7-0.942, respectively).
Entecavir treatment for 3 years can achieve good biochemical and virologic responses in HBeAg-positive CHB patients, but has a modest effect on HBeAg loss and/or seroconversion. In addition, baseline serum ALT and HBV-DNA levels are independent factors associated with favorable treatment responses.
尽管恩替卡韦已被证明对慢性乙型肝炎(CHB)的治疗具有良好的疗效和低耐药性,但与良好应答相关的因素仍不清楚。
这是一项回顾性、多中心研究,纳入了 248 例未经治疗的乙型肝炎 e 抗原(HBeAg)阳性患者(69.4%为男性;中位年龄为 39.4 岁),这些患者接受恩替卡韦治疗超过 1 年,其中 15.7%的患者基线时有肝硬化。主要终点是 HBeAg 丢失和/或血清学转换。
中位基线丙氨酸氨基转移酶(ALT)和乙型肝炎病毒(HBV)DNA 水平分别为 201 U/L(范围,27-2415 U/L)和 7.6 log(10) IU/mL(范围,2.2-13.18)。中位治疗时间为 25.3 个月(范围,12-69.6)。第 1、2 和 3 年时 ALT 正常化的累积率分别为 83.1%、87.9%和 94.9%。第 1、2 和 3 年时 HBeAg 丢失的累积率分别为 20.3%、38.0%和 48.9%。第 1、2 和 3 年时 HBV-DNA 不可检测的累积率分别为 52.1%、78.9%和 82.5%。采用 Cox 比例风险模型进行多变量分析显示,基线 ALT 大于正常值上限的 5 倍和病毒载量是与 HBeAg 丢失相关的独立因素(风险比:1.81 和 0.812;95%置信区间:1.062-3.085;0.7-0.942)。
恩替卡韦治疗 3 年可使 HBeAg 阳性 CHB 患者获得良好的生化和病毒学应答,但对 HBeAg 丢失和/或血清学转换的效果中等。此外,基线血清 ALT 和 HBV-DNA 水平是与良好治疗应答相关的独立因素。