Birth outcomes following antiretroviral exposure during pregnancy : initial results from a pregnancy exposure registry in South Africa
Date
2019
Journal Title
Journal ISSN
Volume Title
Publisher
AOSIS
Abstract
Background: In 2013, a pregnancy exposure registry and birth defects surveillance (PER/BDS)
system was initiated in eThekwini District, KwaZulu-Natal (KZN), to assess the impact of
antiretroviral treatment (ART) on birth outcomes.
Objectives: At the end of the first year, we assessed the risk of major congenital malformations
(CM) and other adverse birth outcomes (ABOs) detected at birth, in children born to women
exposed to ART during pregnancy.
Method: Data were collected from women who delivered at Prince Mshiyeni Memorial
Hospital, Durban, from 07 October 2013 to 06 October 2014, using medicine exposure histories
and birth outcomes from maternal interviews, clinical records and neonatal surface
examination. Singleton births exposed to only one ART regimen were included in bivariable
analysis for CM risk and multivariate risk analysis for ABO risk.
Results: Data were collected from 10 417 women with 10 517 birth outcomes (4013 [38.5%]
HIV-infected). Congenital malformations rates in births exposed to Efavirenz during the first
trimester (T1) (RR 0.87 [95% CI 0.12–6.4; p = 0.895]) were similar to births not exposed to ART
during T1. However, T1 exposure to Nevirapine was associated with the increased risk of CM
(RR 9.28 [95% CI 2.3–37.9; p = 0.002]) when compared to the same group. Other ABOs were
more frequent in the combination of HIV/ART-exposed births compared to HIV-unexposed
births (29.9% vs. 26.0%, adjusted RR 1.23 [1.14–1.31; p < 0.001]).
Conclusion: No association between T1 use of EFV-based ART regimens and CM was
observed. Associations between T1 NVP-based ART regimen and CM need further
investigation. HIV- and ART-exposed infants had more ABOs compared to HIV-unexposed
infants.
Description
CITATION: Mehta, U. C. et al. 2019. Birth outcomes following antiretroviral exposure during pregnancy : initial results from a pregnancy exposure registry in South Africa. Southern African Journal of HIV Medicine, 20(1):a971, doi:10.4102/sajhivmed.v20i1.971.
The original publication is available at https://sajhivmed.org.za
The original publication is available at https://sajhivmed.org.za
Keywords
Pharmacovigilance, Congenital malformations, Birth outcomes -- Evaluation -- South Africa -- KwaZulu-Natal, Antiretroviral agents -- Effect on pregnant women, Pregnancy complications, Pregnant women -- Effect of antiretrovirals on, Birth defects -- South Africa -- KwaZulu-Natal
Citation
Mehta, U. C. et al. 2019. Birth outcomes following antiretroviral exposure during pregnancy : initial results from a pregnancy exposure registry in South Africa. Southern African Journal of HIV Medicine, 20(1):a971, doi:10.4102/sajhivmed.v20i1.971.