Department of Infectious Diseases and Hepatology, The First Affiliated Hospital of Zhengzhou University, Zhengzhou, Henan, China.
Department of Infectious Diseases, The Second Affiliated Hospital of Xi'an Jiaotong University, Xi'an, Shaanxi, China.
Clin Infect Dis. 2021 Nov 2;73(9):e3324-e3332. doi: 10.1093/cid/ciaa1939.
Few safety and effectiveness results have been published regarding the administration of tenofovir alafenamide fumarate (TAF) during pregnancy for the prevention of mother-to-child transmission (MTCT) of hepatitis B virus (HBV).
In this multicenter prospective observational study, pregnant women with HBV DNA levels higher than 200 000 IU/mL who received TAF or tenofovir disoproxil fumarate (TDF) from gestational weeks 24-35 to delivery were 1:1 enrolled and followed until postpartum month 6. Infants received immunoprophylaxis. The primary endpoint was the safety of mothers and infants. The secondary endpoint was the hepatitis B surface antigen (HBsAg)-positive rate at 7 months for infants.
In total, 116 and 116 mothers were enrolled, and 117 and 116 infants were born, in the TAF and TDF groups, respectively. TAF was well tolerated during a mean treatment duration of 11.0 weeks. The most common maternal adverse event was nausea (19.0%). One (0.9%), 3 (2.6%), and 9 (7.8%) mothers had abnormal alanine aminotransferase levels at delivery and at postpartum months 3 and 6, respectively. The TDF group had safety profiles that were comparable to those of the TAF group. No infants had birth defects in either group. The infants' physical and neurological development at birth and at 7 months in the TAF group were comparable with those in the TDF group. The HBsAg positive rate was 0% at 7 months in all 233 infants.
Antiviral prophylaxis with TAF was determined to be generally safe for both mothers and infants and reduced the MTCT rate to 0%.
在妊娠期间使用替诺福韦艾拉酚胺富马酸酯（TAF）预防乙型肝炎病毒（HBV）母婴传播（MTCT）的安全性和有效性结果鲜有报道。
在这项多中心前瞻性观察性研究中，24-35 孕周时 HBV DNA 水平高于 200000 IU/mL 的 HBV 孕妇按 1:1 比例接受 TAF 或替诺福韦酯（TDF）治疗，直至分娩。婴儿接受免疫预防。主要终点是母婴安全性。次要终点是婴儿 7 个月时 HBsAg 阳性率。
TAF 组和 TDF 组分别有 116 例和 116 例母亲入组，117 例和 116 例婴儿出生。TAF 的平均治疗时间为 11.0 周，耐受性良好。最常见的母亲不良事件是恶心（19.0%）。1（0.9%）例、3（2.6%）例和 9（7.8%）例母亲在分娩时、产后 3 个月和 6 个月时的丙氨酸氨基转移酶水平异常。TDF 组的安全性与 TAF 组相当。两组均无婴儿出生缺陷。TAF 组婴儿的出生时和 7 个月时的身体和神经发育与 TDF 组相当。233 例婴儿的 HBsAg 阳性率在 7 个月时均为 0%。
抗病毒预防治疗用 TAF 对母婴均安全，将 MTCT 率降低至 0%。
