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Update on neural tube defects with antiretoviral exposure in the Tsepamo study, Botswana

Title
Update on neural tube defects with antiretoviral exposure in the Tsepamo study, Botswana
Presenter
Rebecca Zash
Authors
R. Zash * (1), L.B. Holmes (2), M. Diseko (3), D.L. Jacobson (4), G. Mayondi (3), J. Mabuta (3), M. Jackson-Gibson (5), M. Mmalane (3), T. Gaolathe (6), S. Lockman (7), J. Makhema (3), R.L. Shapiro (8)
Institutions
(1) Beth Israel Deaconess Medical Center, Boston, United States, (2) MassGeneral Hospital for Children, Boston, United States, (3) Botswana Harvard AIDS Institute Partnership, Gaborone, Botswana, (4) Harvard TH Chan School of Public Health, Center for Biostatistic for AIDS Research (CBAR), Boston, United States, (5) Northwestern University Feinberg School of Medicine, Chicago, United States, (6) University of Botswana, Gaborone, Botswana, (7) Brigham and Women''s Hospital, Boston, United States, (8) Harvard TH Chan School of Public Health, Boston, United States

BACKGROUND: Prior Tsepamo Study analyses of women receiving dolutegravir from conception demonstrated a modest decline in neural tube defect (NTD) prevalence from March 2019 (0.30%) to April 2020 (0.19%). We report updated data collected through March 2021.
METHODS: The Tsepamo Study conducts birth outcomes surveillance study at government hospitals throughout Botswana, currently covering ~70% of all births. Midwives perform surface examinations of all live births and stillbirths and describe abnormalities. Research assistants photograph major abnormalities after maternal consent, which are reviewed by a birth defects expert blinded to exposures. Prevalence of NTDs was determined by maternal HIV and antiretroviral exposure status (95%CI by Wilson method) and the primary analysis evaluated prevalence differences by exposure status (95%CI by Newcombe method).
RESULTS: Since April 2020, 39,188 additional births were recorded, including 2,269 additional DTG conception exposures. Since August 2014, there have been a total of 191,432 deliveries; 190,982 (99.8%) had an evaluable infant surface exam, with 140 (0.07%, 95% CI 0.06%, 0.09%) NTDs identified (93 with photo, 47 by description only). Among women on dolutegravir at conception, 9/5860 NTDs[RZ1] occurred (0.15%; 95%CI 0.08%, 0.29%): 4 myelomeningoceles, 1 anencephaly, 3 encephaloceles, and 1 iniencephaly. In comparison, NTDs occurred in 22/22,475 (0.10%; 95%CI 0.06%, 0.15%) women delivering on any non-dolutegravir antiretrovirals from conception, 8/13,217 (0.06%; 95%CI 0.03%, 0.12%) on efavirenz from conception, 3/5,535 (0.05%; 95%CI 0.2%, 0.16%) on dolutegravir started in pregnancy, and 97/144,967 (0.07%; 95%CI 0.05, 0.08%) women without HIV. NTD prevalence differed non-significantly between dolutegravir and any non-dolutegravir antiretrovirals from conception (0.06% difference; 95%CI -0.03%, 0.20%).


CONCLUSIONS: The prevalence of NTDs among infants born to women on dolutegravir at conception has declined slightly to 0.15%, a non-significant difference from those exposed to non-dolutegravir antiretrovirals at conception