In-utero exposure to INSTI-based ART regimens not a hazard to infant neurodevelopment

05 Dec 2025
In-utero exposure to INSTI-based ART regimens not a hazard to infant neurodevelopment

Infants exposed to antiretroviral treatment (ART) regimens containing integrase strand transfer inhibitors (INSTIs) in utero seem to fare as well as their nonexposed peers in terms of neurodevelopment, as reported in a study.

The study included 1,006 uninfected infants born to women with HIV. These children underwent neurodevelopmental assessments at 1 year of age using the Bayley Scales of Infant and Toddler Development–3rd Edition (Bayley-III). Outcomes of interest included Bayley-III cognitive, language, and motor development domain scores.

Of the mothers, 125 (12.4 percent) had perinatally acquired HIV. The mean maternal age at delivery was 30.3 years. Of the infants, 306 were exposed in utero to an initial INSTI-based maternal ART regimen, 473 to a protease inhibitor (PI)-based regimen, and 227 to a non-nucleoside reverse transcriptase inhibitor (NNRTI)-based regimen; more than half (52.8 percent) were exposed from conception.

Overall, mean scores for cognitive (101.7), language (95.5), and motor development (96.4) domains were close to reference standards (100). Bayley-III cognitive, language, or motor development domain scores did not significantly differ between infants exposed to INSTI-based regimens and those exposed to PI-based regimens.

However, INSTI-exposed infants had slightly lower mean scores for cognitive (adjusted mean difference, −2.94, 95 percent confidence interval [CI], −5.47 to −0.41), language (adjusted mean difference, −1.96, 95 percent CI, −4.50 to 0.57), and motor development (adjusted mean difference, −1.60, 95 percent CI, −4.15 to 0.94) domains compared with NNRTI-exposed infants. Larger differences were seen among infants whose mothers initiated ART during pregnancy.

The present data support continued inclusion of INSTIs in first-line regimens for pregnant women with HIV.

JAMA Netw Open 2025;8:e2545652