Weight changes and adverse pregnancy outcomes with dolutegravir- and tenofovir alafenamide fumarate-containing antiretroviral treatment regimens during pregnancy and postpartum.

HIV adverse pregnancy outcomes antepartum weight change postpartum weight women's health

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:
05 Jan 2024
Historique:
received: 25 08 2023
revised: 19 11 2023
accepted: 29 12 2023
medline: 5 1 2024
pubmed: 5 1 2024
entrez: 5 1 2024
Statut: aheadofprint

Résumé

We evaluated associations between antepartum weight change and adverse pregnancy outcomes and between antiretroviral therapy (ART) regimens and week-50 postpartum body mass index in IMPAACT 2010. Women with HIV-1 in 9 countries were randomized 1:1:1 at 14-28 weeks gestational age (GA) to start dolutegravir(DTG)+emtricitabine(FTC)/tenofovir alafenamide fumarate(TAF) versus DTG+FTC/tenofovir disoproxil fumarate(TDF) versus efavirenz (EFV)/FTC/TDF. Insufficient antepartum weight gain was defined using IOM guidelines. Cox-proportional hazards regression models were used to evaluate the association between antepartum weight change and adverse pregnancy outcomes: stillbirth (≥20 weeks GA), preterm delivery (<37 weeks GA), small for gestational age (SGA<10th percentile), and a composite of these endpoints. 643 participants were randomized: 217 in DTG+FTC/TAF, 215 in DTG+FTC/TDF, and 211 in EFV/FTC/TDF arms. Baseline medians were: GA 21.9 weeks, HIV RNA 903 copies/mL, CD4 count 466 cells/uL. Insufficient weight gain was least frequent with DTG+FTC/TAF (15.0%) versus DTG+FTC/TDF (23.6%) and EFV/FTC/TDF (30.4%). Women in the DTG+FTC/TAF arm had the lowest rate of composite adverse pregnancy outcome. Low antepartum weight gain was associated with higher hazard of composite adverse pregnancy outcome (HR 1.44, 95%CI 1.04, 2.00) and SGA (HR 1.48, 95%CI 0.99, 2.22). More women in the DTG+FTC/TAF arm had body mass index ≥25 kg/m2 at 50 weeks postpartum (54.7%) versus the DTG+FTC/TDF (45.2%) and EFV/FTC/TDF (34.2%) arms. Antepartum weight gain on DTG regimens was protective against adverse pregnancy outcomes traditionally associated with insufficient weight gain, supportive of guidelines recommending DTG-based ART for women starting ART during pregnancy. Interventions to mitigate postpartum weight gain are needed.

Sections du résumé

BACKGROUND BACKGROUND
We evaluated associations between antepartum weight change and adverse pregnancy outcomes and between antiretroviral therapy (ART) regimens and week-50 postpartum body mass index in IMPAACT 2010.
METHODS METHODS
Women with HIV-1 in 9 countries were randomized 1:1:1 at 14-28 weeks gestational age (GA) to start dolutegravir(DTG)+emtricitabine(FTC)/tenofovir alafenamide fumarate(TAF) versus DTG+FTC/tenofovir disoproxil fumarate(TDF) versus efavirenz (EFV)/FTC/TDF. Insufficient antepartum weight gain was defined using IOM guidelines. Cox-proportional hazards regression models were used to evaluate the association between antepartum weight change and adverse pregnancy outcomes: stillbirth (≥20 weeks GA), preterm delivery (<37 weeks GA), small for gestational age (SGA<10th percentile), and a composite of these endpoints.
RESULTS RESULTS
643 participants were randomized: 217 in DTG+FTC/TAF, 215 in DTG+FTC/TDF, and 211 in EFV/FTC/TDF arms. Baseline medians were: GA 21.9 weeks, HIV RNA 903 copies/mL, CD4 count 466 cells/uL. Insufficient weight gain was least frequent with DTG+FTC/TAF (15.0%) versus DTG+FTC/TDF (23.6%) and EFV/FTC/TDF (30.4%). Women in the DTG+FTC/TAF arm had the lowest rate of composite adverse pregnancy outcome. Low antepartum weight gain was associated with higher hazard of composite adverse pregnancy outcome (HR 1.44, 95%CI 1.04, 2.00) and SGA (HR 1.48, 95%CI 0.99, 2.22). More women in the DTG+FTC/TAF arm had body mass index ≥25 kg/m2 at 50 weeks postpartum (54.7%) versus the DTG+FTC/TDF (45.2%) and EFV/FTC/TDF (34.2%) arms.
CONCLUSIONS CONCLUSIONS
Antepartum weight gain on DTG regimens was protective against adverse pregnancy outcomes traditionally associated with insufficient weight gain, supportive of guidelines recommending DTG-based ART for women starting ART during pregnancy. Interventions to mitigate postpartum weight gain are needed.

Identifiants

pubmed: 38180851
pii: 7511794
doi: 10.1093/cid/ciae001
pii:
doi:

Types de publication

Journal Article

Langues

eng

Sous-ensembles de citation

IM

Subventions

Organisme : NIAID NIH HHS
ID : UM1 AI068616
Pays : United States

Investigateurs

Sharon Nachman (S)
James McIntyre (J)
David P Harrington (DP)
Catherine Hill (C)
Steven Joffe (S)
Alwyn Mwinga (A)
Andrew J Nunn (AJ)
Merlin L Robb (ML)
Haroon Saloojee (H)
Merlin L Robb (ML)
Jonathan Kimmelman (J)
Graeme A Meintjes (GA)
Barbara E Murray (BE)
Stuart Campbell Ray (S)
Haroon Saloojee (H)
Anastasios A Tsiatis (AA)
Paul A Volberding (PA)
David Glidden (D)
Valeria Cavalcanti Rolla (V)
Nahida Chakhtoura (N)
Jeanna Piper (J)
Karin Klingman (K)
Debika Bhattacharya (D)
Patrick Jean-Philippe (P)
Lynne Mofenson (L)
Sean Brummel (S)
Lauren Ziemba (L)
Benjamin Johnston (B)
Chelsea Krotje (C)
Scott McCallister (S)
Jean van Wyk (J)
Mark Mirochnick (M)
Brookie Best (B)
Kevin Robertson (K)
Cheryl Blanchette (C)
Nagawa Jaliaah (N)
Andi Fox (A)
Frances Whalen (F)
Kevin Knowles (K)
William Murtaugh (W)
Mauricio Pinilla (M)
Yao Cheng (Y)
Emmanuel Patras (E)

Informations de copyright

© The Author(s) 2024. Published by Oxford University Press on behalf of Infectious Diseases Society of America. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.

Auteurs

Risa M Hoffman (RM)

Dept of Medicine, University of California, Los Angeles, USA.

Sean Brummel (S)

Harvard T.H. Chan School of Public Health, USA.

Lauren Ziemba (L)

Harvard T.H. Chan School of Public Health, USA.

Lameck Chinula (L)

UNC Chapel Hill Dept OB/GYN, UNC Project Malawi, Malawi.

Katie McCarthy (K)

FHI 360, USA.

Lee Fairlie (L)

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

Patrick Jean-Philippe (P)

Division of AIDS, National Institutes of Health, USA.

Nahida Chakhtoura (N)

National Institute of Child Health and Human Development, National Institutes of Health, USA.

Ben Johnston (B)

Frontier Science Foundation, USA.

Chelsea Krotje (C)

Frontier Science Foundation, USA.

Teacler G Nematadzira (TG)

University of Zimbabwe-UCSF Collaborative Research Programme, Zimbabwe.

Frances Nakayiwa (F)

MUJHU Care Limited, Kampala, Uganda.

Victoria Ndyanabangi (V)

Baylor College of Medicine Children's Foundation Uganda.

Sherika Hanley (S)

Centre for the AIDS Programme of Research and University of KwaZulu-Natal, Department of Family Medicine, South Africa.

Gerhard Theron (G)

Stellenbosch University, South Africa.

Avy Violari (A)

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

Esau João (E)

Hospital Federal dos Servidores do Estado, Brazil.

Mario Dias Correa Junior (MD)

Universidade Federal de Minas Gerais, Brazil.

Cristina Barroso Hofer (CB)

Universidade Federal do Rio de Janeiro, Brazil.

Oranich Navanukroh (O)

Siriraj Hospital, Mahidol University, Thailand.

Linda Aurpibul (L)

Research Institute for Health Sciences, Chiang Mai University, Thailand.

Neetal Nevrekar (N)

Byramjee Jeejeebhoy Government Medical College-Johns Hopkins University, Pune, India.

Rebecca Zash (R)

Beth Israel Deaconess Medical Center, USA.

Roger Shapiro (R)

Harvard T.H. Chan School of Public Health, USA.

Jeffrey S A Stringer (JSA)

University of North Carolina School of Medicine, USA.

Judith S Currier (JS)

Dept of Medicine, University of California, Los Angeles, USA.

Paul Sax (P)

Dept of Medicine, Brigham and Women's Hospital, USA.

Shahin Lockman (S)

Brigham and Women's Hospital and Harvard T.H. Chan School of Public Health, USA.

Classifications MeSH