Liang Jian, Jiang Man Jun, Deng Xin, Xiao Zhou Xiao
Department of Hepatology, Ruikang Hospital, Guangxi Traditional Chinese Medical University, Nanning, China.
Hepat Mon. 2013 May 23;13(6):e7862. doi: 10.5812/hepatmon.7862. eCollection 2013.
Hepatitis B virus (HBV) infection is a serious global health problem that is associated with huge social and economic costs. Early antiviral drugs, such as interferon-α2b, peginterferon-α2a, lamivudine, and adefovir, all have their limitations (such as low responses or safety concerns) in clinical application. Telbivudine and entecavir are two of the latest nucleotide drugs and both have been shown to have potent viral suppression. However, in patients with hepatitis B e antigen (HBeAg)-positive chronic hepatitis B (CHB), inconsistent results have been generated for efficacy between telbivudine and entecavir. Therefore, evidence-based medical data are required to compare the efficacies, in terms of virological and biochemical responses, and safety between telbivudine and entecavir.
We aimed to compare the early antiviral efficacy and safety of telbivudine and entecavir in the treatment of patients with hepatitis B e antigen (HBeAg)-positive chronic hepatitis B (CHB).
A search for relevant randomized controlled trials (RCTs) on HBeAg-positive CHB patients treated with telbivudine and entecavir for 24 or 52 weeks, published before December 2011, was performed. Primary efficacy endpoint was the cumulative rate of undetectable HBV DNA, and secondary efficacy endpoints included rates of alanine aminotransferase (ALT) normalization, HBeAg disappearance, HBeAg seroconversion and adverse events. Meta-analysis was performed using the Review Manager v5.1.4 software package. We assessed the pooled risk ratios (RRs) and 95% confidence intervals (CIs) using the fixed-or random-effects model.
Six randomized controlled trials (RCTs) involving 555 patients were included. Telbivudine was associated with significantly higher rates of HBeAg disappearance (RR = 1.46, 95% CI: 1.11 - 1.91) and HBeAg seroconversion (RR = 1.76, 95%CI: 1.25-2.48) than entecavir, but had higher adverse events (RR = 2.11, 95%CI: 1.23 - 3.60), compared with entecavir. There was no difference between telbivudine and entecavir in the rate of cumulative undetectable HBV DNA (RR = 0.99, 95% CI: 0.90 - 1.10) and ALT normalization (RR = 0.93, 95% CI: 0.85 - 1.00).
Telbivudine is associated with significantly higher rates of HBeAg disappearance and HBeAg seroconversion than entecavir, whereas entecavir is superior to telbivudine in safety. Both drugs have similar efficacy on rates of cumulative undetectable HBV DNA and ALT normalization.
乙型肝炎病毒（HBV）感染是一个严重的全球健康问题，会带来巨大的社会和经济成本。早期的抗病毒药物，如干扰素-α2b、聚乙二醇干扰素-α2a、拉米夫定和阿德福韦，在临床应用中都有其局限性（如低应答率或安全性问题）。替比夫定和恩替卡韦是两种最新的核苷类药物，均已显示出强效的病毒抑制作用。然而，在乙型肝炎e抗原（HBeAg）阳性的慢性乙型肝炎（CHB）患者中，替比夫定和恩替卡韦之间的疗效结果并不一致。因此，需要循证医学数据来比较替比夫定和恩替卡韦在病毒学和生化应答方面的疗效以及安全性。
我们旨在比较替比夫定和恩替卡韦治疗乙型肝炎e抗原（HBeAg）阳性慢性乙型肝炎（CHB）患者的早期抗病毒疗效和安全性。
检索2011年12月之前发表的关于HBeAg阳性CHB患者接受替比夫定和恩替卡韦治疗24周或52周的相关随机对照试验（RCT）。主要疗效终点是HBV DNA不可检测的累积率，次要疗效终点包括丙氨酸氨基转移酶（ALT）复常率、HBeAg消失率、HBeAg血清学转换率和不良事件。使用Review Manager v5.1.4软件包进行荟萃分析。我们使用固定效应或随机效应模型评估合并风险比（RR）和95%置信区间（CI）。
纳入了6项涉及555例患者的随机对照试验（RCT）。与恩替卡韦相比，替比夫定的HBeAg消失率（RR = 1.46，95%CI：1.11 - 1.91）和HBeAg血清学转换率（RR = 1.76，95%CI：1.25 - 2.48）显著更高，但不良事件发生率更高（RR = 2.11，95%CI：1.23 - 3.60）。替比夫定和恩替卡韦在累积HBV DNA不可检测率（RR = 0.99，95%CI：0.90 - 1.10）和ALT复常率（RR = 0.93，95%CI：0.85 - 1.00）方面没有差异。
与恩替卡韦相比，替比夫定的HBeAg消失率和HBeAg血清学转换率显著更高，而恩替卡韦在安全性方面优于替比夫定。两种药物在累积HBV DNA不可检测率和ALT复常率方面疗效相似。
