Please use this identifier to cite or link to this item: https://www.arca.fiocruz.br/handle/icict/11352
Title: Randomized clinical trial comparing the pharmacokinetics of standard- and increased-dosage lopinavir-ritonavir coformulation tablets in hiv-positive pregnant women
Authors: Oliveira, Marilia Santini
Estrela, Rita de Cássia Elias
Veloso, Valdiléa Gonçalves
Cattani, Vitória Berg
Yanavich, Carolyn
Velasque, Luciane
Torres, Thiago Silva
Marins, Luana Monteiro Spindola
Pilotto, José Henrique
João, Esaú Custódio
Gonçalves, José Carlos Saraiva
Grinsztejn, Beatriz Gilda Jegerhorn
Affilliation: Fundação Oswaldo Cruz. Instituto Nacional de Infectologia Evandro Chagas. Laboratório de Pesquisa Clínica em DST/AIDS. Rio de Janeiro, RJ, Brasil.
Universidade Federal do Rio de Janeiro. Faculdade de Farmácia. Centro de Ciências da Saúde. Laboratório de Farmacometria LabFarma. Rio de Janeiro, RJ, Brasil.
Fundação Oswaldo Cruz. Instituto Nacional de Infectologia Evandro Chagas. Laboratório de Pesquisa Clínica em DST/AIDS. Rio de Janeiro, RJ, Brasil.
Fundação Oswaldo Cruz. Instituto Nacional de Infectologia Evandro Chagas. Laboratório de Pesquisa Clínica em DST/AIDS. Rio de Janeiro, RJ, Brasil.
Children’s Hospital of Los Angeles. Division of Infectious Diseases. Los Angeles, CA, USA.
Universidade Federal do Estado do Rio de Janeiro. Departamento de Matemática. Rio de Janeiro, RJ, Brasil.
Fundação Oswaldo Cruz. Instituto Nacional de Infectologia Evandro Chagas. Laboratório de Pesquisa Clínica em DST/AIDS. Rio de Janeiro, RJ, Brasil.
Fundação Oswaldo Cruz. Instituto Nacional de Infectologia Evandro Chagas. Laboratório de Pesquisa Clínica em DST/AIDS. Rio de Janeiro, RJ, Brasil.
Fundação Oswaldo Cruz. Instituto Oswaldo Cruz. Laboratório de AIDS e Imunologia Molecular. Rio de Janeiro, RJ, Brasil / Hospital Geral de Nova Iguaçu. Nova Iguaçu, RJ, Brasil.
Hospital Federal dos Servidores do Estado. Serviço de Doenças Infecciosas e Parasitárias. Rio de Janeiro, RJ, Brasil.
Universidade Federal do Rio de Janeiro. Faculdade de Farmácia. Centro de Ciências da Saúde. Laboratório de Farmacometria LabFarma. Rio de Janeiro, RJ, Brasil.
Fundação Oswaldo Cruz. Instituto Nacional de Infectologia Evandro Chagas. Laboratório de Pesquisa Clínica em DST/AIDS. Rio de Janeiro, RJ, Brasil.
Abstract: A lopinavir-ritonavir (LPV/r)-based regimen is recommended during pregnancy to reduce the risk of HIV mother-to-child transmission, but the appropriate dose is controversial. We compared the pharmacokinetics of standard and increased LPV/r doses during pregnancy. This randomized, open-label prospective study enrolled 60 pregnant women between gestational weeks 14 and 30. The participants received either the standard dose (400/100 mg twice a day [BID]) or increased dose (600/150 mg BID) of LPV/r tablets during pregnancy and the standard dose for 6 weeks after childbirth. Pharmacokinetics analysis was performed using a high-performance liquid chromatography-tandem mass spectrometry method. Adherent participants who received the standard dose presented minimum LPV concentrations of 4.4, 4.3, and 6.1 g/ml in the second and third trimesters and postpartum, respectively. The increased-dose group exhibited values of 7.9, 6.9, and 9.2 g/ml at the same three time points. Although LPV exposure was significantly higher in the increased-dose group, the standard dose produced therapeutic levels of LPV against wild-type virus in all adherent participants, except one patient in the third trimester; 50%, 37.5%, and 25%, and 0%, 15%, and 0% of the participants in the standard- and increased-dose groups failed to achieve therapeutic levels against resistant viruses during the second and third trimesters and after childbirth, respectively. After 12 weeks of treatment and after childbirth, all adherent participants achieved undetectable HIV viral loads, and their babies (49/54) were uninfected. No serious drug-related adverse events were observed. We conclude that the standard dose is appropriate for use during pregnancy and that an increased dose may be necessary for women harboring resistant HIV. (This study has been registered at ClinicalTrials.gov under registration no. NCT00605098).
Keywords: Pharmacokinetics
HIV
Pregnant Women
Statistical Analysis
DeCS: Farmacocinética
HIV
Gestantes
Análise Estatística
Issue Date: 2014
Publisher: American Society for Microbiology
Citation: OLIVEIRA, Marilia Santini et al. Randomized clinical trial comparing the pharmacokinetics of standard- and increased-dosage lopinavir-ritonavir coformulation tablets in hiv-positive pregnant women. Antimicrobial Agents and Chemotherapy, v. 58, n. 5, p .2884-2893, May 2014.
DOI: 10.1128/AAC.02599-13
ISSN: 0066-4804
Copyright: open access
Appears in Collections:IOC - Artigos de Periódicos
INI - Artigos de Periódicos

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