Xu J-H, Song L-W, Li N, Wang S, Zeng Z, Si C-W, Li J, Mao Q, Zhang D-Z, Tang H, Sheng J-F, Chen X-Y, Ning Q, Shi G-F, Xie Q, Yuan Q, Yu Y-Y, Xia N-S
Department of Infectious Diseases, Center for Liver Diseases, Peking University First Hospital, Beijing, China.
State Key Laboratory of Molecular Vaccinology and Molecular Diagnostics, National Institute of Diagnostics and Vaccine Development in Infectious Diseases, School of Public Health, Xiamen University, Xiamen, China.
J Viral Hepat. 2017 Feb;24(2):148-154. doi: 10.1111/jvh.12626. Epub 2016 Nov 28.
Studies regarding the clinical significance of quantitative hepatitis B core antibody (anti-HBc) in patients with chronic hepatitis B receiving first-line nucleos(t)ide analogues is limited. The aim of this study was to determine the performance of anti-HBc as a predictor for hepatitis B e antigen (HBeAg) seroconversion in HBeAg-positive CHB patients treated with entecavir. This was a retrospective cohort study consisting of 139 Chinese patients enrolled in a multicenter clinical trial treated with entecavir or entecavir maleate for up to 240 weeks. Anti-HBc evaluation was conducted for all the available samples using a newly developed double-sandwich anti-HBc immunoassay. At week 240, 35 (25.2%) patients achieved a serological response (HBeAg seroconversion) and these patients at week 240 had significantly higher levels of anti-HBc (P<.01). We defined 4.65 log IU·mL , with a maximum sum of sensitivity and specificity, as the optimal cut-off value of baseline anti-HBc level to predict seroconversion. Patients with baseline anti-HBc ≥4.65 log IU·mL had 28.0% (26/93) and 35.5% (33/93) chance of seroconversion at weeks 144 and 240, respectively. The baseline anti-HBc level was the strongest predictor for seroconversion at week 144 (OR: 5.78, 95% confidence interval [CI]: 2.05-16.34, P=.001). The baseline anti-HBc level was a strong predictor for seroconversion at week 240 (OR: 5.36, 95% CI: 2.17-13.25, P<.001). Hence, baseline anti-HBc titre is a useful predictor of long-term entecavir therapy efficacy in HBeAg-positive CHB patients, which could be used to optimize antiviral therapy.
关于接受一线核苷（酸）类似物治疗的慢性乙型肝炎患者中定量乙型肝炎核心抗体（抗-HBc）临床意义的研究有限。本研究的目的是确定抗-HBc作为接受恩替卡韦治疗的HBeAg阳性慢性乙型肝炎（CHB）患者中乙型肝炎e抗原（HBeAg）血清学转换预测指标的性能。这是一项回顾性队列研究，由139名中国患者组成，这些患者参加了一项多中心临床试验，接受恩替卡韦或马来酸恩替卡韦治疗长达240周。使用新开发的双夹心抗-HBc免疫测定法对所有可用样本进行抗-HBc评估。在第240周时，35名（25.2%）患者实现了血清学应答（HBeAg血清学转换），这些患者在第240周时抗-HBc水平显著更高（P<0.01）。我们将最大灵敏度和特异性之和对应的4.65 log IU·mL定义为预测血清学转换的基线抗-HBc水平的最佳截断值。基线抗-HBc≥4.65 log IU·mL的患者在第144周和第240周时血清学转换的几率分别为28.0%（26/93）和35.5%（33/93）。基线抗-HBc水平是第144周时血清学转换的最强预测指标（比值比：5.78，95%置信区间[CI]：2.05-16.34，P=0.001）。基线抗-HBc水平是第240周时血清学转换的有力预测指标（比值比：5.36，95%CI：2.17-13.25，P<0.001）。因此，基线抗-HBc滴度是HBeAg阳性CHB患者长期恩替卡韦治疗疗效的有用预测指标，可用于优化抗病毒治疗。
