Dolutegravir- Versus Efavirenz-Based Treatment in Pregnancy: Impact on Red Blood Cell Folate Concentrations in Pregnant Women and Their Infants.

Autor:	Jacobson DL; Center for Biostatistics in AIDS Research, Harvard T. H. Chan School of Public Health, Boston, Massachusetts., Crider KS; National Center on Birth Defects and Developmental Disabilities, Centers for Disease Control and Prevention, Atlanta, Georgia., DeMarrais P; Center for Biostatistics in AIDS Research, Harvard T. H. Chan School of Public Health, Boston, Massachusetts., Brummel S; Center for Biostatistics in AIDS Research, Harvard T. H. Chan School of Public Health, Boston, Massachusetts., Zhang M; National Center for Environmental Health, Centers for Disease Control and Prevention, Atlanta, Georgia., Pfeiffer CM; National Center for Environmental Health, Centers for Disease Control and Prevention, Atlanta, Georgia., Moore CA; Goldbelt Professional Services, LLC, Chesapeake, Virginia., McCarthy K; FHI 360, Durham, North Carolina., Johnston B; Frontier Science Foundation, Amherst, New York., Mohammed T; Botswana Harvard AIDS Institute Partnership, Gaborone, Botswana., Vhembo T; University of Zimbabwe Clinical Trials Research Centre, Harare, Zimbabwe., Kabugho E; Makarere University-Johns Hopkins University Research Collaboration, Kampala, Uganda., Muzorah GA; Clinical Research site, Baylor-Uganda, Kampala, Uganda., Cassim H; Perinatal HIV Research Unit, Faculty of Health Sciences, University of the Witwatersand, South Africa., Fairlie L; Wits RHI, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa., Machado ES; Instituto de Puericultura e Pediatria Martagão Gesteira, Universidade Federal do Rio de Janeiro, Brazil., Ngocho JS; Kilimanjaro Christian Medical University College, Moshi, Tanzania., Shapiro RL; Department of Immunology and Infectious Diseases, Harvard T. H. Chan School of Public Health, Boston, Massachusetts., Serghides L; University Health Network and Department of Immunology and Institute of Medical Sciences, University of Toronto, Ontario, Canada., Chakhtoura N; Pregnancy and Perinatal Branch, Eunice Kennedy Shriver National Institute of Child Health and Human Development, Bethesda, Maryland., Chinula L; University of North Carolina Project-Malawi, Lilongwe, Malawi., Lockman S; Botswana Harvard Health Partnership, Brigham and Women's Hospital.; Harvard T. H. Chan School of Public Health, Boston, Massachusetts.
Jazyk:	angličtina
Zdroj:	The Journal of infectious diseases [J Infect Dis] 2024 Nov 15; Vol. 230 (5), pp. 1224-1234.
DOI:	10.1093/infdis/jiae308
Abstrakt:	Background: In the International Maternal Pediatric Adolescent AIDS Clinical Trials (IMPAACT) 2010/VESTED study, pregnant women were randomized to initiate dolutegravir (DTG) + emtricitabine (FTC)/tenofovir alafenamide (TAF), DTG + FTC/tenofovir disoproxil fumarate (TDF), or efavirenz (EFV)/FTC/TDF. Methods: We assessed red blood cell (RBC) folate concentrations at maternal study entry and delivery, and infant birth. RBC folate outcomes were (1) maternal change entry to delivery (trajectory), (2) infant, and (3) ratio of infant-to-maternal delivery. Generalized estimating equation models for each log(folate) outcome were fit to estimate adjusted geometric mean ratio (Adj-GMR)/GMR trajectories (Adj-GMRTs) of each arm comparison in 340 mothers and 310 infants. Results: Overall, 90% of mothers received folic acid supplements and 78% lived in Africa. At entry, median maternal age was 25 years, gestational age was 22 weeks, CD4 count was 482 cells/μL, and log10 HIV RNA was 3 copies/mL. Entry RBC folate was similar across arms. Adj-GMRT of maternal folate was 3% higher in the DTG + FTC/TAF versus EFV/FTC/TDF arm (1.03 [95% confidence interval {CI}, 1.00-1.06]). The DTG + FTC/TAF arm had an 8% lower infant-maternal folate ratio (0.92 [95% CI, .78-1.09]) versus EFV/FTC/TDF. Conclusions: Results are consistent, with no clinically meaningful differences between arms for all RBC folate outcomes, and they suggest that cellular uptake of folate and folate transport to the infant do not differ in pregnant women starting DTG- versus EFV-based antiretroviral therapy. Clinical Trials Registration: NCT03048422. Competing Interests: Potential conflicts of interest. P. D. and S. B. have received funds from ViiV/GSK that were paid to Harvard. All other authors report no potential conflicts of interest. All authors have submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest. Conflicts that the editors consider relevant to the content of the manuscript have been disclosed. (© The Author(s) 2024. Published by Oxford University Press on behalf of Infectious Diseases Society of America. All rights reserved. For commercial re-use, please contact reprints@oup.com for reprints and translation rights for reprints. All other permissions can be obtained through our RightsLink service via the Permissions link on the article page on our site—for further information please contact journals.permissions@oup.com.)
Databáze:	MEDLINE
Externí odkaz:	Zobrazit plný text záznamu