Center for Biostatistics in AIDS Research, Harvard T. H. Chan School of Public Health, Boston, Massachusetts.
National Center on Birth Defects and Developmental Disabilities, Centers for Disease Control and Prevention, Atlanta, Georgia.
J Infect Dis. 2024 Nov 15;230(5):1224-1234. doi: 10.1093/infdis/jiae308.
In the International Maternal Pediatric Adolescent AIDS Clinical Trials (IMPAACT) 2010/VESTED study, pregnant women were randomized to initiate dolutegravir (DTG) + emtricitabine (FTC)/tenofovir alafenamide (TAF), DTG + FTC/tenofovir disoproxil fumarate (TDF), or efavirenz (EFV)/FTC/TDF.
We assessed red blood cell (RBC) folate concentrations at maternal study entry and delivery, and infant birth. RBC folate outcomes were (1) maternal change entry to delivery (trajectory), (2) infant, and (3) ratio of infant-to-maternal delivery. Generalized estimating equation models for each log(folate) outcome were fit to estimate adjusted geometric mean ratio (Adj-GMR)/GMR trajectories (Adj-GMRTs) of each arm comparison in 340 mothers and 310 infants.
Overall, 90% of mothers received folic acid supplements and 78% lived in Africa. At entry, median maternal age was 25 years, gestational age was 22 weeks, CD4 count was 482 cells/μL, and log10 HIV RNA was 3 copies/mL. Entry RBC folate was similar across arms. Adj-GMRT of maternal folate was 3% higher in the DTG + FTC/TAF versus EFV/FTC/TDF arm (1.03 [95% confidence interval {CI}, 1.00-1.06]). The DTG + FTC/TAF arm had an 8% lower infant-maternal folate ratio (0.92 [95% CI, .78-1.09]) versus EFV/FTC/TDF.
Results are consistent, with no clinically meaningful differences between arms for all RBC folate outcomes, and they suggest that cellular uptake of folate and folate transport to the infant do not differ in pregnant women starting DTG- versus EFV-based antiretroviral therapy.
NCT03048422.
在国际母婴儿科艾滋病临床试验（IMPAACT）2010/VESTED 研究中，孕妇被随机分配至接受多替拉韦（DTG）+恩曲他滨（FTC）/替诺福韦艾拉酚胺（TAF）、DTG+FTC/替诺福韦二吡呋酯（TDF）或依非韦伦（EFV）+FTC/TDF 治疗。
我们评估了孕妇入组时和分娩时的红细胞（RBC）叶酸浓度以及婴儿的出生时的浓度。RBC 叶酸的结果包括（1）母体从入组到分娩的变化（轨迹）、（2）婴儿以及（3）婴儿与母亲分娩时的比值。在 340 名母亲和 310 名婴儿中，使用广义估计方程模型对每个 log（叶酸）结果进行拟合，以估计每个手臂比较的校正几何平均比（Adj-GMR）/几何均数比（GMR）轨迹（Adj-GMRT）。
总体而言，90%的母亲接受了叶酸补充剂，78%的母亲生活在非洲。入组时，母亲的中位年龄为 25 岁，妊娠周数为 22 周，CD4 计数为 482 个/μL，log10 HIV RNA 为 3 拷贝/mL。入组时的 RBC 叶酸在各手臂间相似。与 EFV/FTC/TDF 组相比，DTG+FTC/TAF 组的母体叶酸 Adj-GMRT 高 3%（1.03[95%置信区间{CI}，1.00-1.06]）。与 EFV/FTC/TDF 组相比，DTG+FTC/TAF 组婴儿与母亲的叶酸比值低 8%（0.92[95%CI，0.78-1.09]）。
结果一致，所有 RBC 叶酸结果在各手臂间均无临床意义上的差异，这表明开始 DTG- 或 EFV 为基础的抗逆转录病毒治疗的孕妇的叶酸细胞摄取和向婴儿的叶酸转运没有差异。
NCT03048422。
