Pregnancy Outcomes of Women Conceiving on Antiretroviral Therapy (ART) Compared to Those Commenced on ART During Pregnancy.

Breast Feeding Female HIV Infections / drug therapy Humans Infant, Newborn Infectious Disease Transmission, Vertical Pregnancy Pregnancy Complications, Infectious / drug therapy Pregnancy Outcome Stillbirth
HIV conceiving on ART pregnancy outcomes

Journal

Clinical infectious diseases : an official publication of the Infectious Diseases Society of America
ISSN: 1537-6591
Titre abrégé: Clin Infect Dis
Pays: United States
ID NLM: 9203213

Informations de publication

Date de publication:
15 07 2021
Historique:
received: 10 01 2020
accepted: 17 06 2020
pubmed: 22 6 2020
medline: 5 8 2021
entrez: 22 6 2020
Statut: ppublish

Résumé

Globally, the number of infected women of childbearing age living with human immunodeficiency virus (HIV) and conceiving on antiretroviral therapy (ART) is increasing. Evidence of ART safety at conception and during pregnancy and adverse pregnancy outcomes remains conflicting. The Promoting Maternal and Infant Survival Everywhere (PROMISE) 1077 breastfeeding (BF) and formula feeding (FF) international multisite trials provide an opportunity to examine the impact of ART at conception on pregnancy outcomes with subsequent pregnancies. The PROMISE 1077BF/1077FF trials were designed to address key questions in the management of HIV-infected women who did not meet clinical guidelines for ART treatment during the time of the trials. After the period of risk of mother-to-child transmission was over, women were randomized to either continue or discontinue ART. We compared subsequent pregnancy outcomes of nonbreastfeeding women randomized to continue ART following delivery, or breastfeeding women randomized to continue ART following breastfeeding cessation who conceived while on ART to women randomized to discontinue ART, who restarted ART after pregnancy was diagnosed. Pregnancy outcomes of 939 subsequent pregnancies of 826 mothers were recorded. The intention-to-treat analyses showed increased incidence of low birth weight (<2500 g) for women who conceived while on ART (relative risk, 2.65 [95% confidence interval {CI}, 1.20-5.81]), and also a higher risk of spontaneous abortion, stillbirth, or neonatal death (hazard ratio, 1.40 [95% CI, .99-1.98]) compared to women who restarted ART after they were found to be pregnant during trial follow-up. We found an increased risk for adverse pregnancy outcomes in women conceiving on ART, emphasizing the need for improved obstetric and neonatal care for this group. NCT01061151.

Sections du résumé

BACKGROUND
Globally, the number of infected women of childbearing age living with human immunodeficiency virus (HIV) and conceiving on antiretroviral therapy (ART) is increasing. Evidence of ART safety at conception and during pregnancy and adverse pregnancy outcomes remains conflicting. The Promoting Maternal and Infant Survival Everywhere (PROMISE) 1077 breastfeeding (BF) and formula feeding (FF) international multisite trials provide an opportunity to examine the impact of ART at conception on pregnancy outcomes with subsequent pregnancies.
METHODS
The PROMISE 1077BF/1077FF trials were designed to address key questions in the management of HIV-infected women who did not meet clinical guidelines for ART treatment during the time of the trials. After the period of risk of mother-to-child transmission was over, women were randomized to either continue or discontinue ART. We compared subsequent pregnancy outcomes of nonbreastfeeding women randomized to continue ART following delivery, or breastfeeding women randomized to continue ART following breastfeeding cessation who conceived while on ART to women randomized to discontinue ART, who restarted ART after pregnancy was diagnosed.
RESULTS
Pregnancy outcomes of 939 subsequent pregnancies of 826 mothers were recorded. The intention-to-treat analyses showed increased incidence of low birth weight (<2500 g) for women who conceived while on ART (relative risk, 2.65 [95% confidence interval {CI}, 1.20-5.81]), and also a higher risk of spontaneous abortion, stillbirth, or neonatal death (hazard ratio, 1.40 [95% CI, .99-1.98]) compared to women who restarted ART after they were found to be pregnant during trial follow-up.
CONCLUSIONS
We found an increased risk for adverse pregnancy outcomes in women conceiving on ART, emphasizing the need for improved obstetric and neonatal care for this group.
CLINICAL TRIALS REGISTRATION
NCT01061151.

Identifiants

DOI: 10.1093/cid/ciaa805 PMID: 32564058 PMC: PMC8516506
pubmed: 32564058
pii: 5860458
doi: 10.1093/cid/ciaa805
pmc: PMC8516506
doi:

Banques de données

ClinicalTrials.gov
['NCT01061151']

Types de publication

Journal Article Randomized Controlled Trial Research Support, N.I.H., Extramural Research Support, Non-U.S. Gov't

Langues

eng

Sous-ensembles de citation

IM

Pagination

e312-e320

Subventions

Organisme : NIAID NIH HHS
ID : U01 AI068632
Pays : United States
Organisme : NIMH NIH HHS
ID : R21 MH083308
Pays : United States
Organisme : NIAID NIH HHS
ID : UM1 AI069518
Pays : United States
Organisme : NIAID NIH HHS
ID : UM1 AI069453
Pays : United States
Organisme : NIAID NIH HHS
ID : UM1 AI068632
Pays : United States
Organisme : NIAID NIH HHS
ID : UM1 AI106716
Pays : United States
Organisme : NIAID NIH HHS
ID : UM1 AI069469
Pays : United States
Organisme : NIAID NIH HHS
ID : UM1 AI069530
Pays : United States
Organisme : NIAID NIH HHS
ID : UM1 AI069463
Pays : United States
Organisme : NIAID NIH HHS
ID : UM1 AI068616
Pays : United States

Informations de copyright

© The Author(s) 2020. Published by Oxford University Press for the Infectious Diseases Society of America.

Références

JAMA Pediatr. 2017 Oct 2;171(10):e172222
pubmed: 28783807
BMC Pregnancy Childbirth. 2015 Oct 08;15:246
pubmed: 26450602
N Engl J Med. 2015 Aug 27;373(9):795-807
pubmed: 26192873
J Infect Dis. 2016 Apr 1;213(7):1051-4
pubmed: 26265779
J Acquir Immune Defic Syndr. 2018 Apr 1;77(4):383-392
pubmed: 29239901
AIDS. 2007 Mar 12;21(5):607-15
pubmed: 17314523
PLoS One. 2018 Jul 18;13(7):e0199555
pubmed: 30020964
Lancet. 2013 Aug 3;382(9890):417-425
pubmed: 23746775
Clin Infect Dis. 2019 Jan 7;68(2):273-279
pubmed: 29868833
Clin Infect Dis. 2018 May 2;66(10):1487-1491
pubmed: 29324994
BMC Pregnancy Childbirth. 2016 Feb 11;16:35
pubmed: 26867536
N Engl J Med. 2016 Nov 3;375(18):1726-1737
pubmed: 27806243
PLoS One. 2017 May 10;12(5):e0176009
pubmed: 28489856
Lancet Glob Health. 2018 Jul;6(7):e804-e810
pubmed: 29880310
J Infect Dis. 2012 Dec 1;206(11):1695-705
pubmed: 23066160
Lancet HIV. 2017 Jan;4(1):e21-e30
pubmed: 27864000
JAMA. 2018 Nov 27;320(20):2077-2078
pubmed: 30422300
Lancet HIV. 2016 Jan;3(1):e33-48
pubmed: 26762992

Auteurs

Gerhard Theron (G)

Department of Obstetrics and Gynaecology, Stellenbosch University, Cape Town, South Africa.

Sean Brummel (S)

Harvard T. H. Chan School of Public Health, Center for Biostatistics in AIDS Research, Boston, Massachusetts, USA.

Lee Fairlie (L)

Wits Reproductive Health and HIV Institute, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.

Mauricio Pinilla (M)

Harvard T. H. Chan School of Public Health, Center for Biostatistics in AIDS Research, Boston, Massachusetts, USA.

Katie McCarthy (K)

FHI 360, Durham, North Carolina, USA.

Maxensia Owor (M)

Makerere University - Johns Hopkins University Research Collaboration Research Collaboration, Kampala, Uganda.

Lameck Chinula (L)

Division of Global Women's Health, Department of Obstetrics and Gynaecology, UNC Project-Malawi Common Reporting Standard, University of North Carolina at Chapel Hill, Lilongwe, Malawi.

Bonus Makanani (B)

College of Medicine, Johns Hopkins Research Project, Blantyre, Malawi.

Avy Violari (A)

Perinatal HIV Research Unit, University of the Witwatersrand, Johannesburg, South Africa.

Dhayendre Moodley (D)

Centre for AIDS Research in South Africa and Department of Obstetrics and Gynecology, School of Clinical Medicine, University of KwaZulu Natal, Durban, South Africa.

Nahida Chakhtoura (N)

Maternal and Pediatric Infectious Disease Branch, Eunice Kennedy Shriver National Institute of Child Health and Human Development, National Institutes of Health, Bethesda, Maryland, USA.

Renee Browning (R)

National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, Maryland, USA.

Risa Hoffman (R)

Division of Infectious Diseases, David Geffen School of Medicine, University of California, Los Angeles, California, USA.

Mary Glenn Fowler (MG)

Johns Hopkins University, Department of Pathology, Baltimore, Maryland, USA.

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Classifications MeSH

questionsmedicales.fr › Phénomènes physiologiques › Alimentation et nutrition › Phénomènes physiologiques nutritionnels › Comportement alimentaire › Allaitement naturel › Pregnancy Outcomes of Women Conceiving on...
questionsmedicales.fr › Maladies du système immunitaire › Déficits immunitaires › Infections à VIH › Pregnancy Outcomes of Women Conceiving on...
questionsmedicales.fr › Eucaryotes › Animaux › Chordés › Vertébrés › Mammifères › Eutheria › Primates › Haplorhini › Catarrhini › Hominidae › Humains › Pregnancy Outcomes of Women Conceiving on...
questionsmedicales.fr › Personnes › Tranches d'âge › Nourrisson › Nouveau-né › Pregnancy Outcomes of Women Conceiving on...
questionsmedicales.fr › Environnement et santé publique › Santé publique › Transmission de maladie infectieuse › Transmission verticale de maladie infectieuse › Pregnancy Outcomes of Women Conceiving on...
questionsmedicales.fr › Phénomènes physiologiques des appareils urinaire et reproducteur › Phénomènes physiologiques de la reproduction › Reproduction › Grossesse › Pregnancy Outcomes of Women Conceiving on...
questionsmedicales.fr › Maladies urogénitales › Maladies de l'appareil urogénital féminin et complications de la grossesse › Complications de la grossesse › Complications infectieuses de la grossesse › Pregnancy Outcomes of Women Conceiving on...
questionsmedicales.fr › Phénomènes physiologiques des appareils urinaire et reproducteur › Phénomènes physiologiques de la reproduction › Reproduction › Grossesse › Issue de la grossesse › Pregnancy Outcomes of Women Conceiving on...
questionsmedicales.fr › Phénomènes physiologiques des appareils urinaire et reproducteur › Phénomènes physiologiques de la reproduction › Reproduction › Grossesse › Issue de la grossesse › Mortinatalité › Pregnancy Outcomes of Women Conceiving on...