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Title: [Clinical characteristics of hepatic flare and efficacy of antiviral therapy in pregnant women with chronic hepatitis B virus infection].
Author: Ding Y, Sheng QJ, Zhang C, Wu YY, Yuan SY, Xia TT, An ZY, Dou XG.
Journal: Zhonghua Gan Zang Bing Za Zhi; 2019 Feb 20; 27(2):106-111. PubMed ID: 30818914.
Abstract:
Objective: To analyze the clinical characteristics of hepatic flare and evaluate efficacy of antiviral treatment in pregnant women with chronic HBV infection. Methods: A single-center, open-label, prospective study was conducted, and pregnant women with chronic HBV infection were enrolled. Liver function, HBV serum markers and HBV DNA of pregnant women with chronic HBV infection were reviewed during every 4 to 12 weeks of gestation period. The proportion and clinical characteristics of hepatitis flare during pregnancy were observed. Logistic regression analysis was used to predict hepatic flare in pregnant women with chronic HBV infection. Antiviral therapy with telbivudine (LdT) or tenofovir dipivoxil (TDF) was used to treat hepatic flare during pregnancy. Sequential entecavir (ETV) or TDF was applied after the delivery. Treatment course and drug withdrawal in pregnant women with hepatic flare was the same as those of the general patients with chronic hepatitis B. Liver function, HBV serum markers and HBV DNA were measured in pregnant women with hepatic flare at different time points (4, 12, 24 and 52 weeks). A t-test was used to compare the hepatic flare in pregnant women with and without hepatitis group. HBsAg and HBeAg were used to quantify the receiver operating characteristic (ROC) curve of pregnant women with hepatic flare during pregnancy. Area under the ROC curve was used to calculate the optimal cut-off value corresponding to the maximum sensitivity and specificity of the ROC curve. Results: Of the 220 pregnant women with chronic HBV infection, 55 (25%) had hepatitis flare during pregnancy and received antiviral treatment. Among the 55 women with hepatic flare during gestation, 47 (85.46%) had hepatic flare in the mid-second trimester (12-24 weeks); average peak value of alanine aminotransferase (ALT) was 220.62 U/L, and the average peak value of ALT in 32 cases (58.18%) of pregnant women with hepatic flare was between 2-5 × ULN. HBsAg and HBeAg quantification were significantly lower in pregnant women with hepatic flare during pregnancy than with non-hepatitis (t = -3.745, P < 0.001; t = -2.186, P = 0.030). Multivariate logistic regression analysis showed that pregnant women with HBeAg < 3.065 log10 s/co were 7.576 times more likely to have hepatic flare during pregnancy (95% confidence interval: 3.779-15.190). ALT normalization, undetectable HBV DNA levels, HBeAg loss and HBeAg seroconversion in 55 pregnant women with hepatic flare at 52-week treatment was 100% (55/55), 74.55% (41/55), 47.27% (26/55) and 41.82% (23/55), respectively. HBsAg quantification at 52 weeks was significantly lower than baseline HBsAg quantification (3.32 + 0.37) log(10) IU/ml and (3.95 + 0.40) log(10) IU/ml; t = 8.465, P < 0.001). Conclusion: Hepatic flare often occurs in the second trimester of pregnancy in pregnant women with chronic HBV infection and baseline HBeAg quantification is an independent predictor of hepatic flare. HBeAg seroconversion rate increased at 52 weeks after antiviral therapy. 目的： 分析慢性HBV感染孕妇妊娠期肝炎发作的临床特点并评价其抗病毒治疗的疗效。 方法： 单中心、前瞻性、开放性临床研究，慢性HBV感染孕妇妊娠期每4～12周复查肝功能、HBV血清标志物和HBV DNA，观察其妊娠期肝炎发作的比例及临床特点，采用logistic回归分析预测慢性HBV感染孕妇妊娠期肝炎发作。妊娠期肝炎发作孕妇应用替比夫定（LdT）或替诺福韦酯（TDF）抗病毒治疗，分娩后换用恩替卡韦（ETV）或继续应用TDF，治疗时间和停药标准同一般慢性乙型肝炎患者。妊娠期肝炎发作孕妇在治疗不同时间点（4、12、24和52周）检测肝功能、HBV血清标志物和HBV DNA。孕妇妊娠期肝炎发作与无肝炎发作组间比较应用t检验。绘制HBsAg和HBeAg定量对孕妇妊娠期肝炎发作的受试者工作特征（ROC）曲线，计算ROC曲线下面积，找出ROC曲线上敏感度和特异度相加最大时对应的最佳界值。 结果： 220例慢性HBV感染孕妇中，55例（25%）孕妇妊娠期肝炎发作并抗病毒治疗。55例妊娠期肝炎发作孕妇中，47例（85.46%）孕妇在妊娠中期（12～24周）肝炎发作，丙氨酸氨基转移酶（ALT）峰值平均值220.62 U/L；32例（58.18%）孕妇的ALT峰值在2～5×正常值上限。妊娠期肝炎发作孕妇入组时HBsAg和HBeAg定量均显著性低于无肝炎发作孕妇入组时HBsAg和HBeAg定量（t = -3.745，P<0.001；t = -2.186，P = 0.030），多因素logistic回归分析中，入组时HBeAg≤3.065 log(10) s/co孕妇是HBeAg>3.065 log(10) S/CO孕妇发生妊娠期肝炎发作风险的7.576倍（95%可信区间：3.779～15.190）。55例妊娠期肝炎发作孕妇抗病毒治疗52周，ALT复常率、HBV DNA阴转率、HBeAg阴转率和HBeAg血清学转换率分别是100%（55/55）、74.55%（41/55）、47.27%（26/55）和41.82%（23/55）；52周HBsAg定量与基线HBsAg定量比较有明显的下降，分别为（3.32±0.37）log(10) IU/ml和（3.95±0.40） log(10) IU/ml，t =8.465，P<0.001，差异有统计学意义。 结论： 慢性HBV感染孕妇妊娠期肝炎发作多发生在妊娠中期，入组时HBeAg定量是孕妇妊娠期肝炎发作独立的预测因素。妊娠期肝炎发作孕妇抗病毒治疗52周HBeAg血清学转换率高。.

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