Birth outcomes following antiretroviral exposure during pregnancy: Initial results from a pregnancy exposure registry in South Africa

Southern African Journal of HIV Medicine

 
 
Field Value
 
Title Birth outcomes following antiretroviral exposure during pregnancy: Initial results from a pregnancy exposure registry in South Africa
 
Creator Mehta, Ushma C. van Schalkwyk, Cari Naidoo, Prineetha Ramkissoon, Arthi Mhlongo, Otty Maharaj, Niren R. Naidoo, Niree Fieggen, Karen Urban, Michael F. Krog, Shaun Welte, Alex Dheda, Mukesh Pillay, Yogan Moran, Neil F.
 
Subject Public Health, Pharmacovigilance, HIV/AIDS, Maternal and Child health pharmacovigilance; antiretrovirals; pregnancy; birth outcomes; safety; birth defect; congenital malformations; surveillance
Description 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.
 
Publisher AOSIS
 
Contributor USAID-PEPFAR, WHO, South African National Department of Health
Date 2019-09-30
 
Type info:eu-repo/semantics/article info:eu-repo/semantics/publishedVersion — Observational cohort
Format text/html application/epub+zip text/xml application/pdf
Identifier 10.4102/sajhivmed.v20i1.971
 
Source Southern African Journal of HIV Medicine; Vol 20, No 1 (2019); 12 pages 2078-6751 1608-9693
 
Language eng
 
Relation
The following web links (URLs) may trigger a file download or direct you to an alternative webpage to gain access to a publication file format of the published article:

https://sajhivmed.org.za/index.php/hivmed/article/view/971/1641 https://sajhivmed.org.za/index.php/hivmed/article/view/971/1640 https://sajhivmed.org.za/index.php/hivmed/article/view/971/1642 https://sajhivmed.org.za/index.php/hivmed/article/view/971/1639
 
Coverage eThekweni District, Durban South 2013-2014 Pregnant women
Rights Copyright (c) 2019 Ushma C. Mehta, Cari van Schalkwyk, Prineetha Naidoo, Arthi Ramkissoon, Otty Mhlongo, Niren R. Maharaj, Niree Naidoo, Karen Fieggen, Michael F. Urban, Shaun Krog, Alex Welte, Mukesh Dheda, Yogan Pillay, Neil F. Moran https://creativecommons.org/licenses/by/4.0
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