Weight Changes and Adverse Pregnancy Outcomes With Dolutegravir- and Tenofovir Alafenamide Fumarate-Containing Antiretroviral Treatment Regimens During Pregnancy and Postpartum.

Journal: Clinical infectious diseases : an official publication of the Infectious Diseases Society of America

Volume: 78

Issue: 6

Year of Publication: 2024

Affiliated Institutions:  Department of Medicine, University of California, Los Angeles, California, USA. Department of Biostatistics, Harvard T.H. Chan School of Public Health, Boston, Massachusetts, USA. UNC Chapel Hill Department of Obstetrics & Gynecology, UNC Project Malawi, Lilongwe, Malawi. FHI , Durham, North Carolina, USA. Wits Reproductive Health and HIV Institute, University of the Witwatersrand, Johannesburg, South Africa. Maternal Adolescent Pediatric Research Branch, Division of AIDS, National Institutes of Health, Rockville, Maryland, USA. National Institute of Child Health and Human Development, National Institutes of Health, Bethesda, Maryland, USA. Frontier Science Foundation, Amherst, New York, USA. University of Zimbabwe-UCSF Collaborative Research Programme, Chitungwiza, Zimbabwe. MUJHU Care Limited, Kampala, Uganda. Baylor College of Medicine Children's Foundation Uganda, Kampala, Uganda. Department of Family Medicine, Centre for the AIDS Programme of Research and University of KwaZulu-Natal, Durban, South Africa. Stellenbosch University, Stellenbosch, South Africa. Perinatal HIV Research Unit, University of the Witwatersrand, Soweto, South Africa. Infectious Diseases Department, Hospital Federal dos Servidores do Estado, Rio de Janeiro, Brazil. Department of Obstetrics and Gynecology, Universidade Federal de Minas Gerais, Belo Horizonte, Brazil. Department of Preventive Medicine, Universidade Federal do Rio de Janeiro, Rio de Janeiro, Brazil. Faculty of Medicine, Siriraj Hospital, Mahidol University, Bangkok, Thailand. Research Institute for Health Sciences, Chiang Mai University, Chiang Mai, Thailand. Byramjee Jeejeebhoy Government Medical College-Johns Hopkins University, Pune, India. Department of Medicine, Beth Israel Deaconess Medical Center, Boston, Massachusetts, USA. Department of Obstetrics and Gynecology, University of North Carolina School of Medicine, Chapel Hill, North Carolina, USA. Department of Medicine, Brigham and Women's Hospital, Boston, Massachusetts, USA. Department of Medicine, Brigham and Women's Hospital and Harvard T.H. Chan School of Public Health, Boston, Massachusetts, USA.

Abstract summary 

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 human immunodeficiency virus (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 Institute of Medicine 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 size for GA (<10th percentile), and a composite of these endpoints.A total of 643 participants were randomized: 217 to the DTG + FTC/TAF, 215 to the DTG + FTC/TDF, and 211 to the EFV/FTC/TDF arm. Baseline medians were as follows: GA, 21.9 weeks; HIV RNA, 903 copies/mL; and CD4 cell count, 466/μL. 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 (hazard ratio, 1.44 [95% confidence interval, 1.04-2.00]) and small size for GA (1.48 [.99-2.22]). More women in the DTG + FTC/TAF arm had a body mass index ≥25 (calculated as weight in kilograms divided by height in meters squared) 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 typically 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.

Authors & Co-authors:  Hoffman Risa M RM Brummel Sean S Ziemba Lauren L Chinula Lameck L McCarthy Katie K Fairlie Lee L Jean-Philippe Patrick P Chakhtoura Nahida N Johnston Ben B Krotje Chelsea C Nematadzira Teacler G TG Nakayiwa Frances F Ndyanabangi Victoria V Hanley Sherika S Theron Gerhard G Violari Avy A João Esau E Correa Mario Dias MD Hofer Cristina Barroso CB Navanukroh Oranich O Aurpibul Linda L Nevrekar Neetal N Zash Rebecca R Shapiro Roger R Stringer Jeffrey S A JSA Currier Judith S JS Sax Paul P Lockman Shahin S

Study Outcome 

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Statistics
Citations :  Ruderman  SA, Crane  HM, Nance  RM, et al.  Brief report: weight gain following ART initiation in ART-naive people living with HIV in the current treatment era. J Acquir Immune Defic Syndr  2021; 86:339–43.
Authors :  29
Identifiers
Doi : 10.1093/cid/ciae001
SSN : 1537-6591
Study Population
Female,Women
Mesh Terms
Humans
Other Terms
HIV;adverse pregnancy outcomes;antepartum weight change;postpartum weight;women's health
Study Design
Randomized Control Trial
Study Approach
Country of Study
Publication Country
United States