Birth Defects and Adverse Pregnancy Outcomes in Hospital-based Birth Surveillance in Eswatini

The Botswana Tsepamo study identified an initial neural tube defect (NTD) safety signal with dolutegravir antiretroviral therapy (ART) exposure at conception. We conducted similar surveillance in 5 hospitals in Eswatini from September 2021 to September 2023 to evaluate the prevalence of birth defects and adverse pregnancy outcomes by maternal HIV status and ART regimen/timing.

Routine pregnancy history and HIV/ART status were collected from clinic records. Women of live or stillborn infants with birth defects consented for interviews and photographs of defects. A medical geneticist reviewed blinded interview data and photographs.

Of 45,836 women with live-born or stillborn infants, 13,577 (29.6%) were living with HIV; 11,581 (86.0%) were receiving ART at conception (84.1% dolutegravir). Overall, birth defects were confirmed in 387 (0.8%) women. Comparing women with and without HIV, there were no significant differences in major defects (0.48% vs. 0.38%) or NTD (0.10% vs. 0.08%). In women with HIV, there were no significant differences between those on dolutegravir versus non-dolutegravir at conception for major defects (0.53% vs. 0.49%) or NTD (0.08% vs. 0.22%). Stillbirths were significantly higher in women with HIV than those without (2.6% vs. 1.9%, P < 0.001), as was low birthweight and preterm delivery (11.8% vs. 10.4%, P < 0.001; 12.5% vs. 10.7%, P < 0.001, respectively). There were no significant differences in outcomes by ART regimen.

While these data from sub-Saharan Africa further strengthen the lack of a NTD safety signal in women with HIV on ART, there remained elevated adverse birth outcomes despite treatment compared to women without HIV.