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

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 ma...
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Autor*in:	Ushma C. Mehta [verfasserIn] Cari van Schalkwyk [verfasserIn] Prineetha Naidoo [verfasserIn] Arthi Ramkissoon [verfasserIn] Otty Mhlongo [verfasserIn] Niren R. Maharaj [verfasserIn] Niree Naidoo [verfasserIn] Karen Fieggen [verfasserIn] Michael F. Urban [verfasserIn] Shaun Krog [verfasserIn] Alex Welte [verfasserIn] Mukesh Dheda [verfasserIn] Yogan Pillay [verfasserIn] Neil F. Moran [verfasserIn]

Format:	E-Artikel
Sprache:	Englisch

Erschienen:	2019

Schlagwörter:	pharmacovigilance antiretrovirals pregnancy birth outcomes safety birth defect congenital malformations surveillance

Übergeordnetes Werk:	In: Southern African Journal of HIV Medicine - AOSIS, 2016, 20(2019), 1, Seite e1-e12
Übergeordnetes Werk:	volume:20 ; year:2019 ; number:1 ; pages:e1-e12

Links:	Link aufrufen Link aufrufen Link aufrufen Journal toc Journal toc

DOI / URN:	10.4102/sajhivmed.v20i1.971

Katalog-ID:	DOAJ028012755

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100	0		\|a Ushma C. Mehta \|e verfasserin \|4 aut
245	1	0	\|a Birth outcomes following antiretroviral exposure during pregnancy: Initial results from a pregnancy exposure registry in South Africa
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520			\|a 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.
650		4	\|a pharmacovigilance
650		4	\|a antiretrovirals
650		4	\|a pregnancy
650		4	\|a birth outcomes
650		4	\|a safety
650		4	\|a birth defect
650		4	\|a congenital malformations
650		4	\|a surveillance
653		0	\|a Public aspects of medicine
653		0	\|a Infectious and parasitic diseases
700	0		\|a Cari van Schalkwyk \|e verfasserin \|4 aut
700	0		\|a Prineetha Naidoo \|e verfasserin \|4 aut
700	0		\|a Arthi Ramkissoon \|e verfasserin \|4 aut
700	0		\|a Otty Mhlongo \|e verfasserin \|4 aut
700	0		\|a Niren R. Maharaj \|e verfasserin \|4 aut
700	0		\|a Niree Naidoo \|e verfasserin \|4 aut
700	0		\|a Karen Fieggen \|e verfasserin \|4 aut
700	0		\|a Michael F. Urban \|e verfasserin \|4 aut
700	0		\|a Shaun Krog \|e verfasserin \|4 aut
700	0		\|a Alex Welte \|e verfasserin \|4 aut
700	0		\|a Mukesh Dheda \|e verfasserin \|4 aut
700	0		\|a Yogan Pillay \|e verfasserin \|4 aut
700	0		\|a Neil F. Moran \|e verfasserin \|4 aut
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publishDate	2019
allfields	10.4102/sajhivmed.v20i1.971 doi (DE-627)DOAJ028012755 (DE-599)DOAJb1e45fb820ae41adaa89f4c7a30176e7 DE-627 ger DE-627 rakwb eng RA1-1270 RC109-216 Ushma C. Mehta verfasserin aut Birth outcomes following antiretroviral exposure during pregnancy: Initial results from a pregnancy exposure registry in South Africa 2019 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier 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. pharmacovigilance antiretrovirals pregnancy birth outcomes safety birth defect congenital malformations surveillance Public aspects of medicine Infectious and parasitic diseases Cari van Schalkwyk verfasserin aut Prineetha Naidoo verfasserin aut Arthi Ramkissoon verfasserin aut Otty Mhlongo verfasserin aut Niren R. Maharaj verfasserin aut Niree Naidoo verfasserin aut Karen Fieggen verfasserin aut Michael F. Urban verfasserin aut Shaun Krog verfasserin aut Alex Welte verfasserin aut Mukesh Dheda verfasserin aut Yogan Pillay verfasserin aut Neil F. Moran verfasserin aut In Southern African Journal of HIV Medicine AOSIS, 2016 20(2019), 1, Seite e1-e12 (DE-627)521453623 (DE-600)2259791-8 20786751 nnns volume:20 year:2019 number:1 pages:e1-e12 https://doi.org/10.4102/sajhivmed.v20i1.971 kostenfrei https://doaj.org/article/b1e45fb820ae41adaa89f4c7a30176e7 kostenfrei https://sajhivmed.org.za/index.php/hivmed/article/view/971 kostenfrei https://doaj.org/toc/1608-9693 Journal toc kostenfrei https://doaj.org/toc/2078-6751 Journal toc kostenfrei GBV_USEFLAG_A SYSFLAG_A GBV_DOAJ GBV_ILN_11 GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_31 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_2003 GBV_ILN_2005 GBV_ILN_2009 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2055 GBV_ILN_2111 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 AR 20 2019 1 e1-e12
spelling	10.4102/sajhivmed.v20i1.971 doi (DE-627)DOAJ028012755 (DE-599)DOAJb1e45fb820ae41adaa89f4c7a30176e7 DE-627 ger DE-627 rakwb eng RA1-1270 RC109-216 Ushma C. Mehta verfasserin aut Birth outcomes following antiretroviral exposure during pregnancy: Initial results from a pregnancy exposure registry in South Africa 2019 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier 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. pharmacovigilance antiretrovirals pregnancy birth outcomes safety birth defect congenital malformations surveillance Public aspects of medicine Infectious and parasitic diseases Cari van Schalkwyk verfasserin aut Prineetha Naidoo verfasserin aut Arthi Ramkissoon verfasserin aut Otty Mhlongo verfasserin aut Niren R. Maharaj verfasserin aut Niree Naidoo verfasserin aut Karen Fieggen verfasserin aut Michael F. Urban verfasserin aut Shaun Krog verfasserin aut Alex Welte verfasserin aut Mukesh Dheda verfasserin aut Yogan Pillay verfasserin aut Neil F. Moran verfasserin aut In Southern African Journal of HIV Medicine AOSIS, 2016 20(2019), 1, Seite e1-e12 (DE-627)521453623 (DE-600)2259791-8 20786751 nnns volume:20 year:2019 number:1 pages:e1-e12 https://doi.org/10.4102/sajhivmed.v20i1.971 kostenfrei https://doaj.org/article/b1e45fb820ae41adaa89f4c7a30176e7 kostenfrei https://sajhivmed.org.za/index.php/hivmed/article/view/971 kostenfrei https://doaj.org/toc/1608-9693 Journal toc kostenfrei https://doaj.org/toc/2078-6751 Journal toc kostenfrei GBV_USEFLAG_A SYSFLAG_A GBV_DOAJ GBV_ILN_11 GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_31 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_2003 GBV_ILN_2005 GBV_ILN_2009 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2055 GBV_ILN_2111 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 AR 20 2019 1 e1-e12
allfields_unstemmed	10.4102/sajhivmed.v20i1.971 doi (DE-627)DOAJ028012755 (DE-599)DOAJb1e45fb820ae41adaa89f4c7a30176e7 DE-627 ger DE-627 rakwb eng RA1-1270 RC109-216 Ushma C. Mehta verfasserin aut Birth outcomes following antiretroviral exposure during pregnancy: Initial results from a pregnancy exposure registry in South Africa 2019 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier 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. pharmacovigilance antiretrovirals pregnancy birth outcomes safety birth defect congenital malformations surveillance Public aspects of medicine Infectious and parasitic diseases Cari van Schalkwyk verfasserin aut Prineetha Naidoo verfasserin aut Arthi Ramkissoon verfasserin aut Otty Mhlongo verfasserin aut Niren R. Maharaj verfasserin aut Niree Naidoo verfasserin aut Karen Fieggen verfasserin aut Michael F. Urban verfasserin aut Shaun Krog verfasserin aut Alex Welte verfasserin aut Mukesh Dheda verfasserin aut Yogan Pillay verfasserin aut Neil F. Moran verfasserin aut In Southern African Journal of HIV Medicine AOSIS, 2016 20(2019), 1, Seite e1-e12 (DE-627)521453623 (DE-600)2259791-8 20786751 nnns volume:20 year:2019 number:1 pages:e1-e12 https://doi.org/10.4102/sajhivmed.v20i1.971 kostenfrei https://doaj.org/article/b1e45fb820ae41adaa89f4c7a30176e7 kostenfrei https://sajhivmed.org.za/index.php/hivmed/article/view/971 kostenfrei https://doaj.org/toc/1608-9693 Journal toc kostenfrei https://doaj.org/toc/2078-6751 Journal toc kostenfrei GBV_USEFLAG_A SYSFLAG_A GBV_DOAJ GBV_ILN_11 GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_31 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_2003 GBV_ILN_2005 GBV_ILN_2009 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2055 GBV_ILN_2111 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 AR 20 2019 1 e1-e12
allfieldsGer	10.4102/sajhivmed.v20i1.971 doi (DE-627)DOAJ028012755 (DE-599)DOAJb1e45fb820ae41adaa89f4c7a30176e7 DE-627 ger DE-627 rakwb eng RA1-1270 RC109-216 Ushma C. Mehta verfasserin aut Birth outcomes following antiretroviral exposure during pregnancy: Initial results from a pregnancy exposure registry in South Africa 2019 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier 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. pharmacovigilance antiretrovirals pregnancy birth outcomes safety birth defect congenital malformations surveillance Public aspects of medicine Infectious and parasitic diseases Cari van Schalkwyk verfasserin aut Prineetha Naidoo verfasserin aut Arthi Ramkissoon verfasserin aut Otty Mhlongo verfasserin aut Niren R. Maharaj verfasserin aut Niree Naidoo verfasserin aut Karen Fieggen verfasserin aut Michael F. Urban verfasserin aut Shaun Krog verfasserin aut Alex Welte verfasserin aut Mukesh Dheda verfasserin aut Yogan Pillay verfasserin aut Neil F. Moran verfasserin aut In Southern African Journal of HIV Medicine AOSIS, 2016 20(2019), 1, Seite e1-e12 (DE-627)521453623 (DE-600)2259791-8 20786751 nnns volume:20 year:2019 number:1 pages:e1-e12 https://doi.org/10.4102/sajhivmed.v20i1.971 kostenfrei https://doaj.org/article/b1e45fb820ae41adaa89f4c7a30176e7 kostenfrei https://sajhivmed.org.za/index.php/hivmed/article/view/971 kostenfrei https://doaj.org/toc/1608-9693 Journal toc kostenfrei https://doaj.org/toc/2078-6751 Journal toc kostenfrei GBV_USEFLAG_A SYSFLAG_A GBV_DOAJ GBV_ILN_11 GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_31 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_2003 GBV_ILN_2005 GBV_ILN_2009 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2055 GBV_ILN_2111 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 AR 20 2019 1 e1-e12
allfieldsSound	10.4102/sajhivmed.v20i1.971 doi (DE-627)DOAJ028012755 (DE-599)DOAJb1e45fb820ae41adaa89f4c7a30176e7 DE-627 ger DE-627 rakwb eng RA1-1270 RC109-216 Ushma C. Mehta verfasserin aut Birth outcomes following antiretroviral exposure during pregnancy: Initial results from a pregnancy exposure registry in South Africa 2019 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier 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. pharmacovigilance antiretrovirals pregnancy birth outcomes safety birth defect congenital malformations surveillance Public aspects of medicine Infectious and parasitic diseases Cari van Schalkwyk verfasserin aut Prineetha Naidoo verfasserin aut Arthi Ramkissoon verfasserin aut Otty Mhlongo verfasserin aut Niren R. Maharaj verfasserin aut Niree Naidoo verfasserin aut Karen Fieggen verfasserin aut Michael F. Urban verfasserin aut Shaun Krog verfasserin aut Alex Welte verfasserin aut Mukesh Dheda verfasserin aut Yogan Pillay verfasserin aut Neil F. Moran verfasserin aut In Southern African Journal of HIV Medicine AOSIS, 2016 20(2019), 1, Seite e1-e12 (DE-627)521453623 (DE-600)2259791-8 20786751 nnns volume:20 year:2019 number:1 pages:e1-e12 https://doi.org/10.4102/sajhivmed.v20i1.971 kostenfrei https://doaj.org/article/b1e45fb820ae41adaa89f4c7a30176e7 kostenfrei https://sajhivmed.org.za/index.php/hivmed/article/view/971 kostenfrei https://doaj.org/toc/1608-9693 Journal toc kostenfrei https://doaj.org/toc/2078-6751 Journal toc kostenfrei GBV_USEFLAG_A SYSFLAG_A GBV_DOAJ GBV_ILN_11 GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_31 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_2003 GBV_ILN_2005 GBV_ILN_2009 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2055 GBV_ILN_2111 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 AR 20 2019 1 e1-e12
language	English
source	In Southern African Journal of HIV Medicine 20(2019), 1, Seite e1-e12 volume:20 year:2019 number:1 pages:e1-e12
sourceStr	In Southern African Journal of HIV Medicine 20(2019), 1, Seite e1-e12 volume:20 year:2019 number:1 pages:e1-e12
format_phy_str_mv	Article
institution	findex.gbv.de
topic_facet	pharmacovigilance antiretrovirals pregnancy birth outcomes safety birth defect congenital malformations surveillance Public aspects of medicine Infectious and parasitic diseases
isfreeaccess_bool	true
container_title	Southern African Journal of HIV Medicine
authorswithroles_txt_mv	Ushma C. Mehta @@aut@@ Cari van Schalkwyk @@aut@@ Prineetha Naidoo @@aut@@ Arthi Ramkissoon @@aut@@ Otty Mhlongo @@aut@@ Niren R. Maharaj @@aut@@ Niree Naidoo @@aut@@ Karen Fieggen @@aut@@ Michael F. Urban @@aut@@ Shaun Krog @@aut@@ Alex Welte @@aut@@ Mukesh Dheda @@aut@@ Yogan Pillay @@aut@@ Neil F. Moran @@aut@@
publishDateDaySort_date	2019-01-01T00:00:00Z
hierarchy_top_id	521453623
id	DOAJ028012755
language_de	englisch
fullrecord	<?xml version="1.0" encoding="UTF-8"?><collection xmlns="http://www.loc.gov/MARC21/slim"><record><leader>01000caa a22002652 4500</leader><controlfield tag="001">DOAJ028012755</controlfield><controlfield tag="003">DE-627</controlfield><controlfield tag="005">20230307122554.0</controlfield><controlfield tag="007">cr uuu---uuuuu</controlfield><controlfield tag="008">230226s2019 xx \|\|\|\|\|o 00\| \|\|eng c</controlfield><datafield tag="024" ind1="7" ind2=" "><subfield code="a">10.4102/sajhivmed.v20i1.971</subfield><subfield code="2">doi</subfield></datafield><datafield tag="035" ind1=" " ind2=" "><subfield code="a">(DE-627)DOAJ028012755</subfield></datafield><datafield tag="035" ind1=" " ind2=" "><subfield code="a">(DE-599)DOAJb1e45fb820ae41adaa89f4c7a30176e7</subfield></datafield><datafield tag="040" ind1=" " ind2=" "><subfield code="a">DE-627</subfield><subfield code="b">ger</subfield><subfield code="c">DE-627</subfield><subfield code="e">rakwb</subfield></datafield><datafield tag="041" ind1=" " ind2=" "><subfield code="a">eng</subfield></datafield><datafield tag="050" ind1=" " ind2="0"><subfield code="a">RA1-1270</subfield></datafield><datafield tag="050" ind1=" " ind2="0"><subfield code="a">RC109-216</subfield></datafield><datafield tag="100" ind1="0" ind2=" "><subfield code="a">Ushma C. Mehta</subfield><subfield code="e">verfasserin</subfield><subfield code="4">aut</subfield></datafield><datafield tag="245" ind1="1" ind2="0"><subfield code="a">Birth outcomes following antiretroviral exposure during pregnancy: Initial results from a pregnancy exposure registry in South Africa</subfield></datafield><datafield tag="264" ind1=" " ind2="1"><subfield code="c">2019</subfield></datafield><datafield tag="336" ind1=" " ind2=" "><subfield code="a">Text</subfield><subfield code="b">txt</subfield><subfield code="2">rdacontent</subfield></datafield><datafield tag="337" ind1=" " ind2=" "><subfield code="a">Computermedien</subfield><subfield code="b">c</subfield><subfield code="2">rdamedia</subfield></datafield><datafield tag="338" ind1=" " ind2=" "><subfield code="a">Online-Ressource</subfield><subfield code="b">cr</subfield><subfield code="2">rdacarrier</subfield></datafield><datafield tag="520" ind1=" " ind2=" "><subfield code="a">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. 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callnumber-first	R - Medicine
author	Ushma C. Mehta
spellingShingle	Ushma C. Mehta misc RA1-1270 misc RC109-216 misc pharmacovigilance misc antiretrovirals misc pregnancy misc birth outcomes misc safety misc birth defect misc congenital malformations misc surveillance misc Public aspects of medicine misc Infectious and parasitic diseases Birth outcomes following antiretroviral exposure during pregnancy: Initial results from a pregnancy exposure registry in South Africa
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topic_title	RA1-1270 RC109-216 Birth outcomes following antiretroviral exposure during pregnancy: Initial results from a pregnancy exposure registry in South Africa pharmacovigilance antiretrovirals pregnancy birth outcomes safety birth defect congenital malformations surveillance
topic	misc RA1-1270 misc RC109-216 misc pharmacovigilance misc antiretrovirals misc pregnancy misc birth outcomes misc safety misc birth defect misc congenital malformations misc surveillance misc Public aspects of medicine misc Infectious and parasitic diseases
topic_unstemmed	misc RA1-1270 misc RC109-216 misc pharmacovigilance misc antiretrovirals misc pregnancy misc birth outcomes misc safety misc birth defect misc congenital malformations misc surveillance misc Public aspects of medicine misc Infectious and parasitic diseases
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title	Birth outcomes following antiretroviral exposure during pregnancy: Initial results from a pregnancy exposure registry in South Africa
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title_full	Birth outcomes following antiretroviral exposure during pregnancy: Initial results from a pregnancy exposure registry in South Africa
author_sort	Ushma C. Mehta
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author_browse	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
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title_sort	birth outcomes following antiretroviral exposure during pregnancy: initial results from a pregnancy exposure registry in south africa
callnumber	RA1-1270
title_auth	Birth outcomes following antiretroviral exposure during pregnancy: Initial results from a pregnancy exposure registry in South Africa
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.
abstractGer	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.
abstract_unstemmed	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.
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title_short	Birth outcomes following antiretroviral exposure during pregnancy: Initial results from a pregnancy exposure registry in South Africa
url	https://doi.org/10.4102/sajhivmed.v20i1.971 https://doaj.org/article/b1e45fb820ae41adaa89f4c7a30176e7 https://sajhivmed.org.za/index.php/hivmed/article/view/971 https://doaj.org/toc/1608-9693 https://doaj.org/toc/2078-6751
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author2	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
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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. 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