Center for Liver Disease and Transplantation, Columbia University Medical Center, New York, NY 10032, United States.
J Hepatol. 2012 Nov;57(5):953-9. doi: 10.1016/j.jhep.2012.06.031. Epub 2012 Jul 2.
BACKGROUND & AIMS: Fetal safety of antiviral therapies is important given the long-term treatment of women with chronic hepatitis B (CHB) infection who may become pregnant. We analyzed neonatal safety data from the Antiretroviral Pregnancy Registry (APR), the largest safety database in pregnancy for antivirals used for HIV and CHB.
Data were extracted from APR cases prospectively enrolled between 1989 and 2011. Primary outcomes were major birth defects rates with exposure to all antivirals, individual classes, and drugs compared to population-based controls. Relevant to CHB, only lamivudine (LAM) and tenofovir disoproxil fumarate (TDF) had sufficient individual data for review (≥200 cases).
Of 13,711 cases analyzed, the overall birth defect prevalence (2.8%, 95% CI 2.6-3.1%) was comparable to Centers for Disease Control population-based data (2.72%, 2.68-2.76%, p=0.87) and two prospective antiretroviral exposed newborn cohorts (2.8%, 2.5-3.2%, p=0.90 and 1.5%, 1.1-2.0%, p<0.001). The birth defects prevalence between first and second/third trimesters exposure was similar (3.0% vs. 2.7%). No increased risk of major birth defects with LAM or TDF exposure compared to population-based controls was observed. No specific pattern of major birth defects was observed for individual antivirals or overall.
No increased risk of major birth defects including in non-live births was observed for pregnant women exposed to antivirals relevant to CHB treatment overall or to LAM or TDF compared to population-based controls. Continued safety and efficacy reporting on antivirals in pregnancy are essential to inform patients on their risks and benefits during pregnancy.
鉴于慢性乙型肝炎（CHB）感染的女性需要长期治疗，且可能怀孕，因此抗病毒治疗的胎儿安全性非常重要。我们分析了艾滋病病毒和 CHB 治疗中使用的抗病毒药物的最大妊娠安全性数据库——抗逆转录病毒妊娠登记处（APR）的新生儿安全性数据。
数据从 1989 年至 2011 年期间前瞻性入组的 APR 病例中提取。主要结局是所有抗病毒药物、各药物类别和药物暴露组与人群为基础的对照组相比的主要出生缺陷发生率。与 CHB 相关的，只有拉米夫定（LAM）和替诺福韦二吡呋酯（TDF）有足够的个体数据进行审查（≥200 例）。
在分析的 13711 例病例中，整体出生缺陷患病率（2.8%，95%CI 2.6-3.1%）与疾病控制中心人群为基础的数据（2.72%，2.68-2.76%，p=0.87）和两个前瞻性抗逆转录病毒暴露新生儿队列（2.8%，2.5-3.2%，p=0.90 和 1.5%，1.1-2.0%，p<0.001）相似。第一和第二/第三孕期暴露的出生缺陷患病率相似（3.0% vs. 2.7%）。与人群为基础的对照组相比，LAM 或 TDF 暴露与重大出生缺陷的风险增加无关。未观察到个别抗病毒药物或总体的重大出生缺陷的特定模式。
与人群为基础的对照组相比，总体上或 LAM 或 TDF 暴露于治疗 CHB 的抗病毒药物的孕妇，以及非活产的孕妇，未观察到主要出生缺陷的风险增加。在妊娠期间继续报告抗病毒药物的安全性和疗效至关重要，以便告知患者其风险和益处。
