Caniglia Ellen C, Patel Kunjal, Huo Yanling, Williams Paige L, Kapetanovic Suad, Rich Kenneth C, Sirois Patricia A, Jacobson Denise L, Hernandez-Diaz Sonia, Hernán Miguel A, Seage George R
aHarvard T.H. Chan School of Public Health, Boston, Massachusetts bDepartment of Psychiatry and Behavioral Sciences, University of Southern California Keck School of Medicine, Los Angeles, California cNational Institutes of Health, National Institute of Mental Health, Bethesda, Maryland dUniversity of Illinois at Chicago College of Medicine, Chicago, Illinois eTulane University School of Medicine, New Orleans, Louisiana fHarvard-MIT Division of Health Sciences and Technology, Boston, Massachusetts, USA.
AIDS. 2016 May 15;30(8):1267-78. doi: 10.1097/QAD.0000000000001052.
To evaluate the safety of in-utero exposure to atazanavir and neurodevelopment in perinatally HIV-exposed but uninfected (PHEU) infants.
Prospective cohort study of mother-PHEU infant pairs in the Surveillance Monitoring for ART Toxicities protocol of the Pediatric HIV/AIDS Cohort Study.
Pregnant women living with HIV who initiated an antiretroviral regimen during pregnancy were followed from the date of antiretroviral initiation. Women were classified according to whether the antiretroviral regimen contained atazanavir and the trimester of antiretroviral initiation. Neurodevelopment at 9-15 months was evaluated using the Bayley Scales of Infant and Toddler Development-Third Edition (Bayley-III). We estimated mean differences for the five Bayley-III domains for atazanavir-containing regimens versus all other regimens. Models included baseline covariates and adjustment for failure to complete the Bayley-III using inverse probability weighting.
PHEU infants were exposed in utero to atazanavir-containing (n = 167) and nonatazanavir-containing (n = 750) antiretroviral regimens. The adjusted mean differences (95% confidence interval) in Bayley-III domain scores for initiating an atazanavir-containing regimen in the first trimester were: cognitive, -1.5 (-6.2, 3.2); language, -3.3 (-7.6, 1.0); motor, -2.9 (-7.7, 1.9); social-emotional, 0.1 (-6.2, 6.4); and adaptive behavior, -0.1 (-4.3, 4.0). The mean differences for the second or third trimester were: cognitive, 0.4 (-3.2, 4.0); language, -3.4 (-6.2, -0.5); motor, 0.3 (-2.9, 3.4); social-emotional, -5.9 (-9.4, -2.3); and adaptive behavior, -2.5 (-5.9, 0.8).
In-utero exposure to atazanavir-containing regimens compared with non-atazanavir-containing regimens may adversely affect language and social-emotional development in PHEU infants during the first year of life, but the absolute difference is small.
评估宫内暴露于阿扎那韦对围产期暴露于HIV但未感染（PHEU）婴儿神经发育的安全性。
在儿科HIV/艾滋病队列研究的抗逆转录病毒治疗毒性监测方案中，对母婴PHEU婴儿对进行前瞻性队列研究。
对孕期开始抗逆转录病毒治疗方案的HIV感染孕妇从开始抗逆转录病毒治疗之日起进行随访。根据抗逆转录病毒治疗方案是否包含阿扎那韦以及开始抗逆转录病毒治疗的孕期对妇女进行分类。使用贝利婴幼儿发展量表第三版（Bayley-III）评估9至15个月时的神经发育情况。我们估计了含阿扎那韦治疗方案与所有其他治疗方案在Bayley-III五个领域的平均差异。模型包括基线协变量，并使用逆概率加权法对未完成Bayley-III的情况进行调整。
PHEU婴儿在宫内暴露于含阿扎那韦（n = 167）和不含阿扎那韦（n = 750）的抗逆转录病毒治疗方案。孕早期开始含阿扎那韦治疗方案时，Bayley-III领域得分的调整后平均差异（95%置信区间）为：认知，-1.5（-6.2，3.2）；语言，-3.3（-7.6，1.0）；运动，-2.9（-7.7，1.9）；社会情感，0.1（-6.2，6.4）；适应行为，-0.1（-4.3，4.0）。孕中期或孕晚期的平均差异为：认知，0.4（-3.2，4.0）；语言，-3.4（-6.2，-0.5）；运动，0.3（-2.9，3.4）；社会情感，-5.9（-9.4，-2.3）；适应行为，-2.5（-5.9，0.8）。
与不含阿扎那韦的治疗方案相比，宫内暴露于含阿扎那韦的治疗方案可能会对PHEU婴儿出生后第一年的语言和社会情感发育产生不利影响，但绝对差异较小。
