Olivero Rosemary, Williams Paige L, Sawyer George, Yee Lynn M, Patel Kunjal, Hernandez-Diaz Sonia, Powis Kathleen, Paul Mary, Chadwick Ellen G
Helen DeVos Children's Hospital of Corewell Health, Michigan State University, Grand Rapids, MI.
Center for Biostatistics in AIDS Research, Harvard T. H. Chan School of Public Health, Boston, MA.
AIDS. 2025 Mar 15;39(4):381-386. doi: 10.1097/QAD.0000000000004041. Epub 2024 Oct 14.
OBJECTIVE: Bictegravir is increasingly prescribed as a co-formulated tablet with tenofovir alafenamide and emtricitabine to pregnant persons with HIV (PWH) despite limited pregnancy and birth outcome data. We sought to provide birth outcome data following exposure to bictegravir during pregnancy. DESIGN: We conducted a descriptive analysis of infants born to pregnant PWH 18-45 years of age enrolled in at least one Pediatric HIV/AIDS Cohort Study (PHACS)-affiliated study who received bictegravir for ≥7 days during pregnancy and completed follow-up through delivery. METHODS: The outcomes of interest were gestational age at birth, preterm birth (<37 weeks' gestation), gestational-age adjusted birth weight (BWZ) and length (BLZ) Z -scores, small for gestational age (SGA, birthweight <10th percentile), congenital anomalies, neonatal deaths in the first 28 days of life, and infant HIV status. RESULTS: A total of 177 infants born to 170 unique PWH were exposed to bictegravir for ≥7 days during gestation; 55% were exposed to bictegravir from the time of conception. Median gestational age at birth was 38.1 weeks. The prevalence of preterm birth was 15.8% and SGA was 9.3%. Mean BWZ and BLZ were -0.48 and 0.03. No neonatal deaths or perinatal HIV transmissions were reported. Among 126 infants exposed to first-trimester bictegravir, 7 (5.6%) had major congenital anomalies with no specific pattern suggestive of a syndrome. CONCLUSIONS: These findings provide preliminary data without significant safety concerns for fetal bictegravir exposure in this United States cohort. Comparative data and continued surveillance of outcomes among infants exposed to bictegravir during gestation are warranted.
目的:尽管关于怀孕和出生结局的数据有限,但比克替拉韦越来越多地与替诺福韦艾拉酚胺和恩曲他滨联合制成片剂,用于治疗感染艾滋病毒的孕妇(PWH)。我们试图提供孕期接触比克替拉韦后的出生结局数据。 设计:我们对年龄在18 - 45岁、参加了至少一项儿科艾滋病毒/艾滋病队列研究(PHACS)附属研究的感染艾滋病毒孕妇所生的婴儿进行了描述性分析,这些孕妇在孕期接受比克替拉韦治疗≥7天,并完成了直至分娩的随访。 方法:关注的结局包括出生时的孕周、早产(妊娠<37周)、孕周调整后的出生体重(BWZ)和身长(BLZ)Z评分、小于胎龄儿(SGA,出生体重<第10百分位数)、先天性异常、出生后28天内的新生儿死亡以及婴儿艾滋病毒感染状况。 结果:170名独特的感染艾滋病毒孕妇所生的177名婴儿在孕期接触比克替拉韦≥7天;55%的婴儿从受孕时就开始接触比克替拉韦。出生时的孕周中位数为38.1周。早产患病率为15.8%,小于胎龄儿患病率为9.3%。平均BWZ和BLZ分别为 - 0.48和0.03。未报告新生儿死亡或围产期艾滋病毒传播情况。在126名孕早期接触比克替拉韦的婴儿中,7名(5.6%)有主要先天性异常,无特定模式提示综合征。 结论:这些发现提供了初步数据,表明在美国这一队列中,胎儿接触比克替拉韦没有重大安全问题。有必要进行比较数据研究,并持续监测孕期接触比克替拉韦的婴儿的结局。
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