Title

Adverse pregnancy outcomes following dolutegravir transition among women delivering at surveillance sites in Eswatini

Presenter

Michelle M. Gill

Authors

M.M. Gill¹, P. Khumalo², C. Chouraya², M. Kunene², F. Dlamini², H.J. Hoffman³, A.E. Scheuerle⁴, B. Nhlabatsi⁵, W. Mngometulu⁵, N. Dlamini-Madlopha⁵, N. Mthunzi⁵, L. Mofenson¹

Institutions

¹Elizabeth Glaser Pediatric AIDS Foundation, Washington, United States, ²Elizabeth Glaser Pediatric AIDS Foundation, Mbabane, Eswatini, ³The George Washington University, Department of Biostatistics and Bioinformatics, Washington, United States, ⁴University of Texas Southwestern Medical Center, Dallas, United States, ⁵Eswatini Ministry of Health, Mbabane, Eswatini

BACKGROUND: Dolutegravir (DTG) at conception was initially associated with neural tube defects (NTD) in the Botswana Tsepamo study; the association became nonsignificant with increased exposures. We conducted similar surveillance in Eswatini and describe overall birth outcomes in delivering women by HIV and antiretroviral therapy (ART) status.
METHODS: We surveilled deliveries across five government hospitals serving urban and rural populations in September 2021-September 2022. Routine data on HIV/ART status and pregnancy outcomes were collected from clinic records. Women delivering live/stillborn infants with birth defects were consented for interviews capturing detailed information and birth defect photographs; a medical geneticist conducted blinded review. We used Chi-square tests for comparison of infant outcome by maternal HIV/ART status.
RESULTS: Among 24,830 deliveries, 82.3% (6,218/7,554) of HIV-positive women received DTG-based ART: 4,832 DTG preconception, 1,025 newly initiated on DTG during pregnancy, and 361 unknown regimen at conception but on DTG at delivery; 1,328 women were on non-DTG-based ART preconception (94.0% efavirenz). Major surface birth defects were identified in 0.4% of live/stillbirths with similar rates by HIV and ART status; 19 (17.9%) major birth defects were NTDs, with no difference between HIV-negative and HIV-positive women. Compared to HIV-negative women, HIV-positive women were more likely to have a stillbirth (2.0% vs. 2.7%, respectively, p<0.001) and had slightly higher rates of low birthweight (LBW) (11.8% vs. 13.2%, p=0.004) and preterm delivery (PTD) (10.3% vs. 11.7%, p=0.001). There were no significant differences between HIV-positive women on DTG and non-DTG at conception for NTD (p=0.62), stillbirth (p=0.19), LBW (p=0.35), or PTD (p=0.65).

CONCLUSIONS: With 80% of HIV-positive women receiving DTG-based ART (most at conception), HIV-positive women had slightly higher adverse pregnancy outcomes than HIV-negative women. There was no evidence that DTG preconception had an increased rate of any adverse outcome compared to non-DTG at conception.

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