Please use this identifier to cite or link to this item: https://www.arca.fiocruz.br/handle/icict/52663
Title: Vaginal Viral Shedding With Undetectable Plasma HIV Viral Load in Pregnant Women Receiving 2 Different Antiretroviral Regimens: A Randomized Clinical Trial
Authors: Frenkel, Lisa M.
Morrison, R. Leavitt
Fuller, Trevon L.
Gouvêa, Maria Isabel
Teixeira, Maria de Lourdes Benamor
Coombs, Robert W.
Shapiro, David E.
Mirochnick, Mark
Hennessey, Roslyn
Whitson, Kyle
Chakhtoura, Nahida
João, Esaú C.
Affilliation: Seattle Children's Research Institute. Center for Global Infectious Disease Research. Seattle, WA, USA / Department of Pediatrics. Seattle, WA, USA / Laboratory Medicine and Pathology. Seattle, WA, USA / University of Washington. Global Health and Medicine. Seattle, WA, USA.
Harvard T. H. Chan School of Public Health. Center for Biostatistics in AIDS Research. Boston, MA, USA.
Hospital Federal dos Servidores do Estado. Departamento de Infectologia. Rio de Janeiro, RJ, Brasil.
Fundação Oswaldo Cruz. Instituto Nacional de Infectologia Evandro Chagas. Rio de Janeiro, RJ, Brasil / Hospital Federal dos Servidores do Estado. Departamento de Infectologia. Rio de Janeiro, RJ, Brasil.
Fundação Oswaldo Cruz. Instituto Nacional de Infectologia Evandro Chagas. Rio de Janeiro, RJ, Brasil / Hospital Federal dos Servidores do Estado. Departamento de Infectologia. Rio de Janeiro, RJ, Brasil.
Laboratory Medicine and Pathology. Seattle, WA, USA.
Harvard T. H. Chan School of Public Health. Center for Biostatistics in AIDS Research. Boston, MA, USA.
Boston University School of Medicine. Department of Pediatrics. Boston, MA, USA.
Westat. Rockville, MD, USA.
Frontier Science. Amherst, NY, USA.
Eunice Kennedy Shriver National Institute of Child Health and Human Development. Maternal and Pediatric Infectious Diseases Branch. Bethesda, MD, USA.
Hospital Federal dos Servidores do Estado. Departamento de Infectologia. Rio de Janeiro, RJ, Brasil.
Abstract: Background: Pregnant women using antiretrovirals (ARVs) may have persistent vaginal viral shedding, which could be associated with sexual and perinatal HIV transmission. However, there are scant data on vaginal viral load (VVL) in pregnant women with undetectable plasma viral load (PVL). Methods: This study was a post hoc analysis of an open-label randomized trial to evaluate the virologic response of 2 ART regimens. The participants were ART-naive women living with HIV initiating ART regimens between 20 and 36 weeks of pregnancy recruited at 19 clinical sites in 6 countries. Participants were randomized to receive 400 mg of raltegravir 2 times a day or 600 mg of efavirenz 4 times a day in addition to 150 mg of lamivudine and 300 mg of zidovudine 2 times a day. VVL and PVL tests were performed at every study visit. The primary outcome measures were HIV-1 PVL and VVL at maternal study week 4 and rates of perinatal HIV transmission. Results: A total of 408 were enrolled, of whom 323 had VVL samples 4 weeks after enrollment and were included in this analysis. Among women with undetectable/nonquantifiable PVL during ART, the overall rate of quantifiable VVL at week 4 was 2.54% (7/275). Of the 275 with nonquantifiable PVL, 99.1% (115/116) and 96.2% (153/159) had nonquantifiable VVL in the efavirenz and raltegravir arms, respectively. None of the 7 women with quantifiable VVL at the week 4 study visit transmitted HIV to their infants. Conclusions: Detectable VVL in pregnant women with undetectable/nonquantifiable PVL while receiving ART was rare and not associated with perinatal HIV transmission
Keywords: Viral load
Vaginal viral shedding
Infectious disease transmission
Vertical
Absorption
Physiological
Issue Date: 2021
Publisher: Wolters Kluwer
Citation: FRENKEL, Lisa M. et al. Brief Report: Vaginal Viral Shedding With Undetectable Plasma HIV Viral Load in Pregnant Women Receiving 2 Different Antiretroviral Regimens: A Randomized Clinical Trial. Journal of acquired immune deficiency syndromes, v. 88, n. 4, p. 361-365, 2021
DOI: 10.1097/QAI.0000000000002771
ISSN: 1525-4135
Copyright: restricted access
Appears in Collections:INI - Artigos de Periódicos
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