A Comparison of the Pharmacokinetics of Standard and Increased Dosage Lopinavir/Ritonavir Co-formulation Tablets in HIV-positive Pregnant Women: a randomized clinical trial

Detalhes bibliográficos
Autor(a) principal: Oliveira, Marilia Santini
Data de Publicação: 2014
Outros Autores: Estrela, Rita de Cássia Elias, Veloso, Valdiléa G., 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
Tipo de documento: Artigo
Idioma: eng
Título da fonte: Repositório Institucional da FIOCRUZ (ARCA)
Texto Completo: https://www.arca.fiocruz.br/handle/icict/11039
Resumo: Fundação Oswaldo Cruz. Instituto de Pesquisa Clínica Evandro Chagas. Laboratório de Pesquisa Clínica em DST/AIDS. Rio de Janeiro, RJ, Brasil.
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spelling Oliveira, Marilia SantiniEstrela, Rita de Cássia EliasVeloso, Valdiléa G.Cattani, Vitória BergYanavich, CarolynVelasque, LucianeTorres, Thiago SilvaMartins, Luana Monteiro SpíndolaPilotto, José HenriqueJoão, Esaú CustódioGonçalves, José Carlos SaraivaGrinsztein, Beatriz2015-07-01T12:12:29Z2015-07-01T12:12:29Z2014OLIVEIRA, 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. Antimicrobial Agents and Chemotherapy, v. 1, p. 1-35, 2014.1098-6596https://www.arca.fiocruz.br/handle/icict/1103910.1128/AAC.02599-13engAmerican Society for MicrobiologyGestantesAidsLopinavirRitonavirLopinavir/RitonavirHIV-positivePregnant WomenA Comparison of the Pharmacokinetics of Standard and Increased Dosage Lopinavir/Ritonavir Co-formulation Tablets in HIV-positive Pregnant Women: a randomized clinical trialinfo:eu-repo/semantics/publishedVersioninfo:eu-repo/semantics/articleFundação 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.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.NãoNão publicadoinfo:eu-repo/semantics/openAccessreponame:Repositório Institucional da FIOCRUZ (ARCA)instname:Fundação Oswaldo Cruz (FIOCRUZ)instacron:FIOCRUZLICENSElicense.txttext/plain1914https://www.arca.fiocruz.br/bitstream/icict/11039/1/license.txt7d48279ffeed55da8dfe2f8e81f3b81fMD51ORIGINALesau_joaoetal_IOC_2014.pdfapplication/pdf710059https://www.arca.fiocruz.br/bitstream/icict/11039/2/esau_joaoetal_IOC_2014.pdfb9e7e1c8a324a8e046c8813a7b6ba2d5MD52TEXTesau_joaoetal_IOC_2014.pdf.txtesau_joaoetal_IOC_2014.pdf.txtExtracted texttext/plain55224https://www.arca.fiocruz.br/bitstream/icict/11039/3/esau_joaoetal_IOC_2014.pdf.txt2d2e94474c3d0bd76861246a4c4755c4MD53icict/110392023-03-30 22:51:05.688oai:www.arca.fiocruz.br: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ório InstitucionalPUBhttps://www.arca.fiocruz.br/oai/requestrepositorio.arca@fiocruz.bropendoar:21352023-03-31T01:51:05Repositório Institucional da FIOCRUZ (ARCA) - Fundação Oswaldo Cruz (FIOCRUZ)false
dc.title.pt_BR.fl_str_mv A Comparison of the Pharmacokinetics of Standard and Increased Dosage Lopinavir/Ritonavir Co-formulation Tablets in HIV-positive Pregnant Women: a randomized clinical trial
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
spellingShingle A Comparison of the Pharmacokinetics of Standard and Increased Dosage Lopinavir/Ritonavir Co-formulation Tablets in HIV-positive Pregnant Women: a randomized clinical trial
Oliveira, Marilia Santini
Gestantes
Aids
Lopinavir
Ritonavir
Lopinavir/Ritonavir
HIV-positive
Pregnant Women
title_short A Comparison of the Pharmacokinetics of Standard and Increased Dosage Lopinavir/Ritonavir Co-formulation Tablets in HIV-positive Pregnant Women: a randomized clinical trial
title_full A Comparison of the Pharmacokinetics of Standard and Increased Dosage Lopinavir/Ritonavir Co-formulation Tablets in HIV-positive Pregnant Women: a randomized clinical trial
title_fullStr A Comparison of the Pharmacokinetics of Standard and Increased Dosage Lopinavir/Ritonavir Co-formulation Tablets in HIV-positive Pregnant Women: a randomized clinical trial
title_full_unstemmed A Comparison of the Pharmacokinetics of Standard and Increased Dosage Lopinavir/Ritonavir Co-formulation Tablets in HIV-positive Pregnant Women: a randomized clinical trial
title_sort A Comparison of the Pharmacokinetics of Standard and Increased Dosage Lopinavir/Ritonavir Co-formulation Tablets in HIV-positive Pregnant Women: a randomized clinical trial
author Oliveira, Marilia Santini
author_facet Oliveira, Marilia Santini
Estrela, Rita de Cássia Elias
Veloso, Valdiléa G.
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
author_role author
author2 Estrela, Rita de Cássia Elias
Veloso, Valdiléa G.
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
author2_role author
author
author
author
author
author
author
author
author
author
author
dc.contributor.author.fl_str_mv Oliveira, Marilia Santini
Estrela, Rita de Cássia Elias
Veloso, Valdiléa G.
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
dc.subject.other.pt_BR.fl_str_mv Gestantes
Aids
Lopinavir
Ritonavir
topic Gestantes
Aids
Lopinavir
Ritonavir
Lopinavir/Ritonavir
HIV-positive
Pregnant Women
dc.subject.en.pt_BR.fl_str_mv Lopinavir/Ritonavir
HIV-positive
Pregnant Women
description Fundação Oswaldo Cruz. Instituto de Pesquisa Clínica Evandro Chagas. Laboratório de Pesquisa Clínica em DST/AIDS. Rio de Janeiro, RJ, Brasil.
publishDate 2014
dc.date.issued.fl_str_mv 2014
dc.date.accessioned.fl_str_mv 2015-07-01T12:12:29Z
dc.date.available.fl_str_mv 2015-07-01T12:12:29Z
dc.type.status.fl_str_mv info:eu-repo/semantics/publishedVersion
dc.type.driver.fl_str_mv info:eu-repo/semantics/article
format article
status_str publishedVersion
dc.identifier.citation.fl_str_mv 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. Antimicrobial Agents and Chemotherapy, v. 1, p. 1-35, 2014.
dc.identifier.uri.fl_str_mv https://www.arca.fiocruz.br/handle/icict/11039
dc.identifier.issn.pt_BR.fl_str_mv 1098-6596
dc.identifier.doi.pt_BR.fl_str_mv 10.1128/AAC.02599-13
identifier_str_mv 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. Antimicrobial Agents and Chemotherapy, v. 1, p. 1-35, 2014.
1098-6596
10.1128/AAC.02599-13
url https://www.arca.fiocruz.br/handle/icict/11039
dc.language.iso.fl_str_mv eng
language eng
dc.rights.driver.fl_str_mv info:eu-repo/semantics/openAccess
eu_rights_str_mv openAccess
dc.publisher.none.fl_str_mv American Society for Microbiology
publisher.none.fl_str_mv American Society for Microbiology
dc.source.none.fl_str_mv reponame:Repositório Institucional da FIOCRUZ (ARCA)
instname:Fundação Oswaldo Cruz (FIOCRUZ)
instacron:FIOCRUZ
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collection Repositório Institucional da FIOCRUZ (ARCA)
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