Han G-R, Jiang H-X, Wang C-M, Ding Y, Wang G-J, Yue X, Zhou L, Zhao W
Department of Gynecology and Obstetrics, The Second Affiliated Hospital of the Southeast University, Nanjing, China.
Department of Gynecology and Obstetrics, School of Medicine, Southeast University, Nanjing, China.
J Viral Hepat. 2017 Jun;24(6):514-521. doi: 10.1111/jvh.12670. Epub 2017 Feb 14.
Telbivudine, an FDA pregnancy category B drug, has been found to reduce hepatitis B virus (HBV) perinatal transmission with no safety concerns in infants aged up to 1 year. This study evaluated the long-term efficacy and safety of telbivudine in 214 infants born to 210 pregnant women with chronic hepatitis B infection who were treated with telbivudine during pregnancy (weeks 20-32 of gestation). The infants were followed for up to 5 years after birth. The efficacy endpoint was the rate of perinatal transmission, which was established by HBsAg and HBV DNA levels at 7 and 12 months. Safety endpoints included head circumference, weight, height, congenital abnormality and hospitalization rates. In addition, the Denver Developmental Screening Test was performed in 92 randomly selected infants. None of the 214 infants born to these women were infected with HBV, and all had effective serum hepatitis B surface antibody (HBsAb) levels. Compared with Chinese standard values, there were few differences in the infants' mean head circumference, weight, and height values. No birth defects were diagnosed, and the congenital abnormality rate was 0.934%. Serious adverse events requiring hospitalization occurred in 20 infants (9.35%). The qualified Denver Developmental Screening Test rate in 92 infants was 97.82%, which was comparable to a rate of 92% in normal Chinese children. Thus, treatment with telbivudine during the second or third trimesters of pregnancy safely blocked perinatal transmission of HBV. Infants born to telbivudine-treated mothers showed normal growth and development during long-term follow-up of up to 5 years.
替比夫定是一种美国食品药品监督管理局（FDA）妊娠分级为B级的药物，已被发现可降低乙型肝炎病毒（HBV）的围产期传播，且对1岁以下婴儿无安全问题。本研究评估了替比夫定对210例慢性乙型肝炎感染孕妇所生214例婴儿的长期疗效和安全性，这些孕妇在孕期（妊娠20 - 32周）接受了替比夫定治疗。婴儿出生后随访长达5年。疗效终点是围产期传播率，通过7个月和12个月时的乙肝表面抗原（HBsAg）和HBV DNA水平确定。安全终点包括头围、体重、身高、先天性异常和住院率。此外，对92例随机选择的婴儿进行了丹佛发育筛查测试。这些女性所生的214例婴儿均未感染HBV，且所有婴儿的血清乙肝表面抗体（HBsAb）水平均有效。与中国标准值相比，婴儿的平均头围、体重和身高值差异不大。未诊断出出生缺陷，先天性异常率为0.934%。20例婴儿（9.35%）发生了需要住院治疗的严重不良事件。92例婴儿的丹佛发育筛查测试合格率为97.82%，与中国正常儿童92%的合格率相当。因此，在妊娠中期或晚期使用替比夫定治疗可安全阻断HBV的围产期传播。在长达5年的长期随访中，接受替比夫定治疗的母亲所生婴儿生长发育正常。
