Original Research

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

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
Southern African Journal of HIV Medicine | Vol 20, No 1 | a971 | DOI: https://doi.org/10.4102/sajhivmed.v20i1.971 | © 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 | This work is licensed under CC Attribution 4.0
Submitted: 19 March 2019 | Published: 30 September 2019

About the author(s)

Ushma C. Mehta, Centre for Infectious Disease Epidemiology and Research (CIDER), School of Public Health and Family Medicine, Faculty of Health Sciences, University of Cape Town, Cape Town, South Africa
Cari van Schalkwyk, South African Centre for Epidemiological Modelling and Analysis, Stellenbosch, South Africa
Prineetha Naidoo, Maternal and Adolescent Child Health Systems (MatCH), School of Public Health, University of the Witwatersrand, Johannesburg, South Africa
Arthi Ramkissoon, Maternal and Adolescent Child Health Systems (MatCH), School of Public Health, University of the Witwatersrand, Johannesburg, South Africa
Otty Mhlongo, KwaZulu-Natal Department of Health, Pietermaritzburg, South Africa
Niren R. Maharaj, Prince Mshiyeni Memorial Hospital, Durban, South Africa
Niree Naidoo, Prince Mshiyeni Memorial Hospital, Durban, South Africa
Karen Fieggen, Division of Human Genetics, Department of Medicine, University of Cape Town, Cape Town, South Africa
Michael F. Urban, Division of Molecular Biology and Human Genetics, Faculty of Medicine and Health Sciences, Stellenbosch University, Cape Town, South Africa
Shaun Krog, VP Health Systems, KwaZulu-Natal, Durban, South Africa
Alex Welte, South African Centre for Epidemiological Modelling and Analysis, Stellenbosch, South Africa
Mukesh Dheda, Programmatic Pharmacovigilance Unit, National Department of Health, Pretoria, South Africa
Yogan Pillay, National Department of Health, Pretoria, South Africa
Neil F. Moran, KwaZulu-Natal Department of Health, Pietermaritzburg, South Africa


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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.


Keywords

pharmacovigilance; antiretrovirals; pregnancy; birth outcomes; safety; birth defect; congenital malformations; surveillance

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