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. 2024 Sep 1;38(11):1686-1695.
doi: 10.1097/QAD.0000000000003955. Epub 2024 Jun 11.

First-trimester exposure to newer antiretroviral agents and congenital anomalies in a US cohort

Kelly Fung  1 , Sonia Hernandez-Diaz  1 , Rebecca Zash  2 , Ellen G Chadwick  3 , Russell B Van Dyke  4 , Carly Broadwell  5 , Jennifer Jao  3 , Kathleen Powis  6   7 , Lynn M Yee  8 , Paige L Williams  1   5   9 ; Pediatrics HIV/AIDS Cohort Study (PHACS)
Affiliations

First-trimester exposure to newer antiretroviral agents and congenital anomalies in a US cohort

Kelly Fung et al. AIDS. .

Abstract

Objective: To characterize associations of exposure to newer antiretroviral medications in the first trimester with congenital anomalies among infants born to persons with HIV in the United States.

Design: Longitudinal cohort of infants born 2012-2022 to pregnant persons with HIV enrolled in the Surveillance Monitoring for ART Toxicities (SMARTT) study.

Methods: First-trimester exposures to newer antiretrovirals (ARVs) were abstracted from maternal medical records. Trained site staff conducted physical exams and abstracted congenital anomalies from infant medical records. Investigators classified anomalies using the Metropolitan Atlanta Congenital Defects Program classification system. The prevalence of major congenital anomalies identified by age one year was estimated for infants exposed and unexposed to each ARV. Generalized estimating equation models were used to estimate the odds ratio (OR) of major congenital anomalies for each ARV exposure, adjusting for potential confounders.

Results: Of 2034 infants, major congenital anomalies were identified in 135 [6.6%; 95% confidence interval (CI): 5.6-7.8%]. Cardiovascular ( n = 43) and musculoskeletal ( n = 37) anomalies were the most common. Adjusted ORs (95% CI) of congenital anomalies were 1.03 (0.62-1.72) for darunavir, 0.91 (0.46-1.81) for raltegravir, 1.04 (0.58-1.85) for rilpivirine, 1.31 (0.71-2.41) for elvitegravir, 0.76 (0.37-1.57) for dolutegravir, and 0.34 (0.05-2.51) for bictegravir, compared to those unexposed to each specific ARV. Findings were similar after adjustment for nucleoside/nucleotide backbones.

Conclusions: The odds of congenital anomalies among infants with first-trimester exposure to newer ARVs did not differ substantially from those unexposed to these specific ARVs, which is reassuring. Continued evaluation of these ARVs with larger studies will be needed to confirm these findings.

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Conflict of interest statement

SHD reports a grant to her institution from Takeda for unrelated topics and consultation for Moderna, UCB, and J&J for unrelated topics. The other authors do not have conflicts of interest to declare.

Figures

Figure 1:
Figure 1:. Adjusted Associations for First-Trimester ARV Exposure and Occurrence of at Least One Major Congenital Anomaly (N=2034)
ORs adjusted for infant birth year, maternal age at delivery, pre-pregnancy body mass index (BMI) category, pregestational diabetes, and first-trimester alcohol use Abbreviations: ARV (antiretroviral), BIC (bictegravir), DRV (darunavir), DTG (dolutegravir), EVG (elvitegravir), RAL (raltegravir), RPV (rilpivirine)
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