Background

Hepatitis B virus (HBV) infection is a significant global health problem and > 42–52% of patients are infected during perinatal period. Tenofovir alafenamide fumarate (TAF) and tenofovir disoproxil fumarate (TDF) have been widely recognized as the main compounds used for antiviral treatment of hepatitis B. The present study evaluated the efficacy and safety of TAF in reducing HBV vertical transmission.

Methods

A total of 72 pregnant women, who met the inclusion criteria, were randomly divided into the TDF (300 mg/day, n = 36) and TAF (25 mg/day, n = 36) groups. Clinical and laboratory data were analyzed and compared between the two groups.

Results

No significant differences in alanine aminotransferase, total bilirubin, blood creatinine and blood urea nitrogen levels were noted between the two groups after treatment. The serum HBV DNA viral load and hepatitis B e antigen (HBeAg) levels of the two groups were significantly decreased following treatment, whereas the difference between the two groups was not statistically significant. The levels of urine retinol-binding protein and β2-microglobulin had no significant change after TAF treatment (p > 0.05), but increased significantly after TDF treatment (p < 0.05). All drug concentrations were undetectable in umbilical cord blood (UCB) and breast milk samples of the TAF group, while the drug concentration of UCB and breast milk samples in the TDF group was 2.98 ± 1.44 and 19.16 ± 15.26 ng/ml, respectively. All infants were tested negative for serum hepatitis B surface antigen, HBV DNA, and HBeAg.

Conclusions

Both TAF and TDF effectively block the mother-to-child transmission of hepatitis B. TAF was superior to TDF with regard to renal safety and breastfeeding.

中文翻译：

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富马酸替诺福韦地索普西和富马酸替诺福韦艾拉酚胺预防母体高病毒载量HBV垂直传播的疗效和安全性

背景

乙型肝炎病毒 (HBV) 感染是一个重要的全球健康问题，超过 42-52% 的患者在围产期受到感染。富马酸替诺福韦艾拉酚胺 (TAF) 和富马酸替诺福韦二吡呋酯 (TDF) 已被广泛认为是用于抗病毒治疗乙型肝炎的主要化合物。本研究评估了 TAF 在减少 HBV 垂直传播方面的有效性和安全性。

方法

将符合纳入标准的72名孕妇随机分为TDF（300mg/天，n  =36）和TAF（25mg/天，n  =36）组。对两组的临床和实验室数据进行分析和比较。

结果

两组治疗后丙氨酸转氨酶、总胆红素、血肌酐和血尿素氮水平无显着差异。治疗后两组血清HBV DNA病毒载量和乙型肝炎e抗原（HBeAg）水平均显着降低，但两组间差异无统计学意义。TAF治疗后尿视黄醇结合蛋白和β2-微球蛋白水平无明显变化（p  > 0.05），但TDF治疗后显着升高（p < 0.05)。TAF组脐带血（UCB）和母乳样品中所有药物浓度均检测不到，而TDF组脐带血和母乳样品的药物浓度分别为2.98±1.44和19.16±15.26ng/ml。所有婴儿的血清乙型肝炎表面抗原、HBV DNA 和 HBeAg 检测均为阴性。

结论

TAF和TDF均有效阻断乙型肝炎母婴传播。TAF在肾脏安全性和母乳喂养方面优于TDF。