Page 362 - SAHCS HIVMed Journal Vol 20 No 1 2019

Southern African Journal of HIV Medicine
ISSN: (Online) 2078-6751, (Print) 1608-9693
Page 1 of 12 Original Research

Birth outcomes following antiretroviral exposure

during pregnancy: Initial results from a pregnancy

exposure registry in South Africa

Authors: Background: In 2013, a pregnancy exposure registry and birth defects surveillance (PER/BDS)
Ushma C. Mehta 1 system was initiated in eThekwini District, KwaZulu-Natal (KZN), to assess the impact of
Cari van Schalkwyk 2
Prineetha Naidoo 3 antiretroviral treatment (ART) on birth outcomes.
Arthi Ramkissoon 3 Objectives: At the end of the first year, we assessed the risk of major congenital malformations
Otty Mhlongo 4
Niren R. Maharaj 5 (CM) and other adverse birth outcomes (ABOs) detected at birth, in children born to women
Niree Naidoo 5 exposed to ART during pregnancy.
Karen Fieggen 6
Michael F. Urban Method: Data were collected from women who delivered at Prince Mshiyeni Memorial
7
Shaun Krog Hospital, Durban, from 07 October 2013 to 06 October 2014, using medicine exposure histories
8
Alex Welte 2 and birth outcomes from maternal interviews, clinical records and neonatal surface
Mukesh Dheda
9
10
Yogan Pillay examination. Singleton births exposed to only one ART regimen were included in bivariable
Neil F. Moran 4 analysis for CM risk and multivariate risk analysis for ABO risk.
Affiliations: Results: Data were collected from 10 417 women with 10 517 birth outcomes (4013 [38.5%]
1 Centre for Infectious Disease HIV-infected). Congenital malformations rates in births exposed to Efavirenz during the first
Epidemiology and Research trimester (T1) (RR 0.87 [95% CI 0.12–6.4; p = 0.895]) were similar to births not exposed to ART
(CIDER), School of Public during T1. However, T1 exposure to Nevirapine was associated with the increased risk of CM
Health and Family Medicine,
Faculty of Health Sciences, (RR 9.28 [95% CI 2.3–37.9; p = 0.002]) when compared to the same group. Other ABOs were
University of Cape Town, more frequent in the combination of HIV/ART-exposed births compared to HIV-unexposed
Cape Town, South Africa births (29.9% vs. 26.0%, adjusted RR 1.23 [1.14–1.31; p < 0.001]).
2 South African Centre for Conclusion: No association between T1 use of EFV-based ART regimens and CM was
Epidemiological Modelling observed. Associations between T1 NVP-based ART regimen and CM need further
and Analysis, Stellenbosch, investigation. HIV- and ART-exposed infants had more ABOs compared to HIV-unexposed
South Africa
infants.
3 Maternal and Adolescent Keywords: pharmacovigilance; antiretrovirals; pregnancy; birth outcomes; safety; birth defect;
Child Health Systems
(MatCH), School of Public congenital malformations; surveillance.
Health, University of the
Witwatersrand, Johannesburg,
South Africa Introduction
4 KwaZulu-Natal Department Despite improvements in recent years, maternal and infant mortality rates in South Africa remain
of Health, Pietermaritzburg, unacceptably high. HIV/AIDS (complicated by Tuberculosis and pneumonia), haemorrhage and
South Africa hypertension account for more than two-thirds of the avoidable maternal deaths. The early
1
initiation of antiretroviral therapy (ART) in pregnant women and women of child-bearing age has
5 Prince Mshiyeni Memorial 2
Hospital, Durban, well-described benefits and has become standard practice in South Africa. In 2013, the World
South Africa Health Organization (WHO) recommended the initiation of lifelong antiretroviral treatment for
pregnant women diagnosed with HIV during pregnancy, regardless of CD4 cell count or clinical
6 Division of Human Genetics, stage (Option B+). This approach was adopted by the South African National Department of
3
Department of Medicine, Health (NDoH) in April in the same year. However, various reports have suggested that
4
University of Cape Town,
Cape Town, South Africa antiretroviral therapy may increase the risk of adverse birth outcomes (ABOs), including preterm
7 Division of Molecular Biology and Human Genetics, Faculty of Medicine and Health Sciences, Stellenbosch University, Cape Town,
South Africa
8 VP Health Systems, KwaZulu-Natal, Durban, South Africa
9 Programmatic Pharmacovigilance Unit, National Department of Health, Pretoria, South Africa
10 National Department of Health, Pretoria, South Africa
Read online: Corresponding author: Ushma Mehta, [email protected]
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Scan this QR Dates: Received: 19 Mar. 2019 |Accepted: 04 May 2019 |Published: 30 Sept. 2019
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