Please use this identifier to cite or link to this item: https://www.arca.fiocruz.br/handle/icict/11039
Title: A Comparison of the Pharmacokinetics of Standard and Increased Dosage Lopinavir/Ritonavir Co-formulation Tablets in HIV-positive Pregnant Women: a randomized clinical trial
Authors: Oliveira, Marilia Santini
Estrela, Rita de Cássia Elias
Veloso, Valdiléa
Cattani, Vitória Berg
Yanavich, Carolyn
Velasque, Luciane
Torres, Thiago Silva
Martins, Luana Monteiro Spíndola
Pilotto, José Henrique
João, Esaú Custódio
Gonçalves, José Carlos Saraiva
Grinsztein, Beatriz
Affilliation: Fundação Oswaldo Cruz. Instituto de Pesquisa Clínica Evandro Chagas. Laboratório de Pesquisa Clínica em DST/AIDS. Rio de Janeiro, RJ, Brasil.
Universidade Federal do Rio de Janeiro. Centro de Ciências da Saúde. Faculdade de Farmácia. Laboratório de Farmacometria. Rio de Janeiro, RJ, Brasil.
Fundação Oswaldo Cruz. Instituto de Pesquisa Clínica Evandro Chagas. Laboratório de Pesquisa Clínica em DST/AIDS. Rio de Janeiro, RJ, Brasil.
Fundação Oswaldo Cruz. Instituto de Pesquisa Clínica 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 de Pesquisa Clínica Evandro Chagas. Laboratório de Pesquisa Clínica em DST/AIDS. Rio de Janeiro, RJ, Brasil.
Fundação Oswaldo Cruz. Instituto de Pesquisa Clínica Evandro Chagas. Laboratório de Pesquisa Clínica em DST/AIDS. Rio de Janeiro, RJ, Brasil.
Universidade Federal do Estado do Rio de Janeiro. Departamento de Matemática. Rio de Janeiro, RJ, Brasil.
Hospital Geral de Nova Iguaçu. Nova Iguaçu, RJ, Brasil / Fundação Oswaldo Cruz. Instituto Oswaldo Cruz. Laboratório de AIDS e Imunologia Molecular. Rio de Janeiro, RJ, Brasil.
Universidade Federal do Rio de Janeiro. Centro de Ciências da Saúde. Faculdade de Farmácia. Laboratório de Farmacometria. Rio de Janeiro, RJ, Brasil.
Fundação Oswaldo Cruz. Instituto de Pesquisa Clínica Evandro Chagas. Laboratório de Pesquisa Clínica em DST/AIDS. Rio de Janeiro, RJ, Brasil.
Abstract: 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. Wecompared the pharmacokinetics of standard and increased LPV/r doses during pregnancy. This randomized, open-label prospective study enrolled 60 HIV-infected pregnant women 31 between gestational weeks 14 and 30. Participants received either the standard (400/100 mg BID) or increased dose (600/150 mg BID) of LPV/r tablets during pregnancy and the standard dose for six weeks after childbirth. Pharmacokinetic 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 6.1µg/mL in the second and the third trimesters and postpartum, respectively. The increased dose group exhibited values of 7.9, 6.9 and 9.2 µg/mL at the same timepoints. Although LPV exposure was significantly higher in the increased dose group, the standard 39 dose produced therapeutic levels of LPV against wild-type virus in all adherent participants, except one patient in the third trimester; 50%, 37.5%, 25% and 0%, 15%, 0% of the participants in the standard and increased dose groups, respectively, failed to achieve therapeutic levels against resistant viruses during the second and third trimesters and after childbirth. 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 an increased dose may be necessary for women harboring resistant HIV.
Keywords: Lopinavir/Ritonavir
HIV-positive
Pregnant Women
keywords: Gestantes
Aids
Lopinavir
Ritonavir
Issue Date: 2014
Publisher: American Society for Microbiology
Citation: OLIVEIRA, Marilia Santini et al. A Comparison of the Pharmacokinetics of Standard and Increased Dosage Lopinavir/Ritonavir Co-formulation Tablets in HIV-positive Pregnant Women: a randomized clinical trial. Antimicrob. Agents Chemother., v. 1, p. 1-35, 2014.
DOI: 10.1128/AAC.02599-13
ISSN: 1098-6596
Copyright: open access
Revised document: Não
Publication status: Não publicado
Appears in Collections:INI - Preprint
IOC - Preprint

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