富马酸丙酚替诺福韦对高病毒载量慢性乙型肝炎病毒感染母婴阻断的分析

Tenofovir alafenamide in prevention of hepatitis B virus transmission in mothers with high viral load

目的对比富马酸丙酚替诺福韦(TAF)、富马酸替诺福韦二吡呋酯(TDF)用于慢性乙肝病毒(HBV)感染的高病毒载量母婴阻断有效性及安全性。方法前瞻性选取高病毒载量孕妇116例,分为TAF组(56例)和TDF组(60例),在第24~28孕周开始服药,两组均分别在24~28孕周、32~36孕周及分娩时检测HBV DNA、HBsAg和HBeAg,新生儿分别在出生时、7月龄时检测HBV DNA、HBsAg和HBeAg。结果分娩时两组孕妇血清HBV DNA降至2.0×10~5 IU/mL以下的病例数,TAF组占92.9%,TDF组占95%;TAF组57例新生儿(1例为双胞胎),出生时HBsAg阳性4例,占7.01%,HBV DNA阳性1例,占1.75%,TDF组60例新生儿,出生时HBsAg阳性2例,占3.33%,HBV DNA均阴性。两组新生儿7月龄时HBsAg、HBV DNA均阴性,均产生抗HBs,阻断成功率100%,两组孕妇均未见明显不良反应,新生儿出生时、28、48、96周均未见明显生长发育障碍。结论TAF用于慢性HBV感染的高病毒载量的母婴阻断有效且安全。

Objective To investigate the efficacy and safety of Tenofovir alafenamide(TAF)and Tenofovir disoproxil fumarate(TDF)therapy for blocking vertical transmission of HBV in mothers infected with chronic high viral load.Methods A total of 116 pregnant women with high viral load were prospectively selected,divided into TAF group(56 cases)and TDF group(60 cases),and the drug was started at 24-28 gestational weeks,and HBV DNA,HBsAg and HBeAg were detected at 24-28,32-36 gestational weeks and delivery in both groups.For neonates at birth and 7 months of age,HBV DNA,HBsAg,and HBeAg were detected.Results At delivery,for 92.9%in the TAF group and 95%in the TDF group,the serum HBV DNA decreased to less than 2.0×105 IU/ml.In the TAF group,there were 57 neonates(1 case had a twin),4 cases(7.01%)were HBsAg positive at birth,1 case was HBV DNA positive,accounting for 1.75%.For the 60 neonates in the TDF group,2 cases(3.33%)were HBsAg positive at birth,and HBV DNA was all negative.When the neonates grew to 7 months of age,both the two groups were negative for HBsAg and HBV DNA,and Anti-HBs all were positive,the blocking success rate was 100%.No obvious adverse reactions were found in the mothers in the two groups,and there were no obvious growth and development disorders at birth,28,48,96 weeks for the neonates.Conclusion TAF therapy was well tolerated for highly viraemic mothers and effectively blocked the transmission of HBV.There were no safety concerns during the postpartum follow-up.