Weight Changes and Adverse Pregnancy Outcomes With Dolutegravir- and Tenofovir Alafenamide Fumarate–Containing Antiretroviral Treatment Regimens During Pregnancy and Postpartum
Author:
Hoffman Risa M1ORCID, Brummel Sean2, Ziemba Lauren2, Chinula Lameck3, McCarthy Katie4, Fairlie Lee5, Jean-Philippe Patrick6, Chakhtoura Nahida7, Johnston Ben8, Krotje Chelsea8, Nematadzira Teacler G9, Nakayiwa Frances10, Ndyanabangi Victoria11, Hanley Sherika12, Theron Gerhard13, Violari Avy14, João Esau15, Correa Mario Dias16, Hofer Cristina Barroso17, Navanukroh Oranich18, Aurpibul Linda19ORCID, Nevrekar Neetal20, Zash Rebecca21, Shapiro Roger2, Stringer Jeffrey S A22, Currier Judith S1ORCID, Sax Paul23, Lockman Shahin24, Nachman Sharon, McIntyre James, Harrington David P, Hill Catherine, Joffe Steven, Mwinga Alwyn, Nunn Andrew J, Robb Merlin L, Saloojee Haroon, Robb Merlin L, Kimmelman Jonathan, Meintjes Graeme A, Murray Barbara E, Ray Stuart Campbell, Saloojee Haroon, Tsiatis Anastasios A, Volberding Paul A, Glidden David, Rolla Valeria Cavalcanti, Piper N C Jeanna, Klingman Karin, Bhattacharya Debika, Mofenson Lynne, McCallister Scott, van Wyk Jean, Mirochnick Mark, Best Brookie, Robertson Kevin, Blanchette Cheryl, Jaliaah Nagawa, Fox Andi, Whalen Frances, Knowles Kevin, Murtaugh William, Pinilla Mauricio, Cheng Yao, Patras Emmanuel, Rooney Jim, Clark Rich, McCallister Scott, van Wyck Jean, Coletti Anne, Purdue Lynette, Frenkel Lisa, Amico K Rivet, Holmes Lewis Ball, Masheto Gaerolwe, Moyo Sikhulile, Momper Jeremiah, Stranix-Chibanda Lynda, Knowles Kevin, Murtaugh William, Whalen Frances, Molepolole Gaborone, Ponatshego Ponego L, Tirelo Lesedi, Nursing Dip, Seme Boitshepo J, Nursing Dip, Modise Georginah O, Raesi Dip Nursingo S, Budu Marian E, Ramogodiri Moakanyi, Oliveira Ricardo Hugo, de Abreu Thalita Fernandes, Pestanha Lorena Macedo, Sidi Leon Claude, Fuller Trevon, Cruz Maria Leticia Santos, Pinto Jorge, Ferreira Flãvia, Romeiro Juliana, Pilotto Jose Henrique, Fernandes Luis Eduardo Barros Costa, Moreira Luiz Felipe, Gomes Ivete Martins, Naik Shilpa, Mave Vidya, Kinikar Aarti, Fairlie Lee, Horne Elizea, Patel Faeezah, Soma-Kasiram Hamisha, Cassim Haseena, Mathiba Sisinyana Ruth, Nyati Mandisa, de Jager Jeanne, Rossouw Magdel, Rossouw Lindie, Desmondarm Alicia Catherine, Gazu Rosemary, Nursing Dip, Govender Vani, Chalermchockcharoenkit Amphan, Thamkhantho Manopchai, Werarak Peerawong, Rungmaitree Supattra, Achalapong Jullapong, Sitiritkawin Lukkana, Cressey Tim R, Sukrakanchana Pra-ornsuda, Tongprasert Fuanglada, Khamrong Chintana, Kiattivej Sopida, Wabwire Deo, Kabugo Enid, Maena Joel, Nagaddya Beatrice, Mid Dip Nus, Sekabira Rogers, Ashaba Justus, Mitchell Charles D, Drada Adriana, Alvarez Grace A, Scott Gwendolyn B, Rathore Mobeen, MahmoudiN Saniyyah, Shabbir Adnan, Maraqa Nizar, Mandima Patricia Fadzayi, Mutambanengwe Mercy, Hons Bpharm, Maonera Suzen, Chanaiwa Vongai, Epi Hons Clin, Matubu Taguma Allen, Tamirepi Kevin, Maturure Sukunena, Mhembere Tsungai, Vhembo Tichaona, Chidemo Tinashe,
Affiliation:
1. Department of Medicine, University of California , Los Angeles, California , USA 2. Department of Biostatistics, Harvard T.H. Chan School of Public Health , Boston, Massachusetts , USA 3. UNC Chapel Hill Department of Obstetrics & Gynecology, UNC Project Malawi , Lilongwe , Malawi 4. FHI 360 , Durham, North Carolina , USA 5. Wits Reproductive Health and HIV Institute, University of the Witwatersrand , Johannesburg , South Africa 6. Maternal Adolescent Pediatric Research Branch, Division of AIDS, National Institutes of Health , Rockville, Maryland , USA 7. National Institute of Child Health and Human Development, National Institutes of Health , Bethesda, Maryland , USA 8. Frontier Science Foundation , Amherst, New York , USA 9. University of Zimbabwe–UCSF Collaborative Research Programme , Chitungwiza , Zimbabwe 10. MUJHU Care Limited , Kampala , Uganda 11. Baylor College of Medicine Children's Foundation Uganda , Kampala , Uganda 12. Department of Family Medicine, Centre for the AIDS Programme of Research and University of KwaZulu-Natal , Durban , South Africa 13. Stellenbosch University , Stellenbosch , South Africa 14. Perinatal HIV Research Unit, University of the Witwatersrand , Soweto , South Africa 15. Infectious Diseases Department, Hospital Federal dos Servidores do Estado , Rio de Janeiro , Brazil 16. Department of Obstetrics and Gynecology, Universidade Federal de Minas Gerais , Belo Horizonte , Brazil 17. Department of Preventive Medicine, Universidade Federal do Rio de Janeiro , Rio de Janeiro , Brazil 18. Faculty of Medicine, Siriraj Hospital, Mahidol University , Bangkok , Thailand 19. Research Institute for Health Sciences, Chiang Mai University , Chiang Mai , Thailand 20. Byramjee Jeejeebhoy Government Medical College–Johns Hopkins University , Pune , India 21. Department of Medicine, Beth Israel Deaconess Medical Center , Boston, Massachusetts , USA 22. Department of Obstetrics and Gynecology, University of North Carolina School of Medicine , Chapel Hill, North Carolina , USA 23. Department of Medicine, Brigham and Women's Hospital , Boston, Massachusetts , USA 24. Department of Medicine, Brigham and Women's Hospital and Harvard T.H. Chan School of Public Health , Boston, Massachusetts , USA
Abstract
Abstract
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
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.
Results
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.
Conclusions
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.
Funder
National Institute of Mental Health National Institutes of Health
Publisher
Oxford University Press (OUP)
Subject
Infectious Diseases,Microbiology (medical)
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