Genotype assays and third-line ART in resource-limited settings: A simulation and cost-effectiveness analysis of a planned clinical trial

Detalhes bibliográficos
Autor(a) principal: Lorenzana, Sarah B.
Data de Publicação: 2012
Outros Autores: Hughes, Michael D., Grinsztejn, Beatriz, Collier, Ann C., Luz, Paula Mendes, Freedberg, Kenneth A., Wood, Robin, Levison, Julie H., Mugyenyi, Peter N., Salata, Robert, Wallis, Carole L., Weinstein, Milton C., Schooley, Robert T., Walensky, Rochelle P.
Tipo de documento: Artigo
Idioma: eng
Título da fonte: Repositório Institucional da FIOCRUZ (ARCA)
Texto Completo: https://www.arca.fiocruz.br/handle/icict/30056
Resumo: Massachusetts General Hospital. Division of General Medicine. USA.
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spelling Lorenzana, Sarah B.Hughes, Michael D.Grinsztejn, BeatrizCollier, Ann C.Luz, Paula MendesFreedberg, Kenneth A.Wood, RobinLevison, Julie H.Mugyenyi, Peter N.Salata, RobertWallis, Carole L.Weinstein, Milton C.Schooley, Robert T.Walensky, Rochelle P.2018-11-16T13:55:13Z2018-11-16T13:55:13Z2012LORENZANA, S. B. et al. Genotype assays and third-line ART in resource-limited settings: a simulation and cost-effectiveness analysis of a planned clinical trial. AIDS, v. 26, n. 9, p. 1083-1093, 2012.0269-9370https://www.arca.fiocruz.br/handle/icict/3005610.1097/QAD.0b013e32835221ebengGenotype assays and third-line ART in resource-limited settings: A simulation and cost-effectiveness analysis of a planned clinical trialinfo:eu-repo/semantics/publishedVersioninfo:eu-repo/semantics/articleMassachusetts General Hospital. Division of General Medicine. USA.The Harvard School of Public Health. Boston, USA.Fundação Oswaldo Cruz. Instituto Nacional de Infectologia Evandro Chagas. Laboratório de Pesquisa Clínica em DST/AIDS. Rio de Janeiro, RJ, Brasil.University of Washington School of Medicine. Harborview Medical Center. Seattle, USA.Fundação Oswaldo Cruz. Instituto Nacional de Infectologia Evandro Chagas. Laboratório de Pesquisa Clínica em DST/AIDS. Rio de Janeiro, RJ, Brasil.Division of Infectious Disease./ Division of General Medicine./ Massachusetts General Hospital. Divisions of Infectious Disease. Department of Medicine. USA. / The Harvard School of Public Health. Boston, USA.University of Cape Town. Institute of Infectious Disease and Molecular Medicine. Desmond Tutu HIV Centre. Cape Town, South Africa.Division of Infectious Disease./ Brigham and Women’s Hospital; Harvard Medical School. USA.Joint Clinical Research Center. Lubowa Estates, Kampala, Uganda.Case Western Reserve University. School of Medicine. Division of Infectious Diseases. Cleveland, USA.Molecular Pathology. Lancet Laboratories. South Africa.The Harvard School of Public Health. Boston, USA.University of California. Division of Infectious Diseases. San Diego, USA.Division of Infectious Disease./ Division of General Medicine./ Massachusetts General Hospital. Divisions of Infectious Disease. Department of Medicine. USA./ Brigham and Women’s Hospital; Harvard Medical School. USA.Objectives To project the clinical and economic outcomes of a genotype assay for selection of third-line antiretroviral therapy (ART) in resource-limited settings, as per the planned international A5288 trial (MULTI-OCTAVE). Methods We used the Cost-effectiveness of Preventing AIDS Complications (CEPAC)-International Model to compare three strategies for subjects who have failed second-line ART in South Africa: (1) Sustained second-line: no genotype assay, all subjects remain on second-line ART; (2) A5288: genotype to determine the resistance profile and assign an appropriate regimen; or (3) Population-based third-line: no genotype, all subjects switch to a potent third-line regimen. Model inputs are from published data in South Africa. Resistance profiles, ART regimens, and efficacy data were those used for trial planning. Results Projected life expectancy for sustained second-line, A5288, and population-based third-line are 61.1, 103.8, and 104.2 months. Compared to sustained second-line ($12,460), per person lifetime costs increase for the A5288 ($39,250) and population-based ($44,120) strategies. The incremental cost-effectiveness ratio of A5288, compared to sustained second-line, is $7,500/year of life saved (YLS), and for population-based third-line, compared to A5288, is $154,500/YLS. In the A5288 strategy, very late presentation to care, coupled with lengthy delays to obtain the genotype, dramatically reduces 5-yr survival, making the population-based third-line strategy more attractive. Conclusions We project that, while the public health approach to third-line therapy is unaffordable, genotype assays and third-line ART in resource-limited settings will increase survival and be cost-effective compared to the population-based approach, supporting the value of an efficacy studyResource-limited settingAntiretroviral therapyARTACTGA5288GenotypeThird-line ARTCost-effectivenessHIVinfo:eu-repo/semantics/openAccessreponame:Repositório Institucional da FIOCRUZ (ARCA)instname:Fundação Oswaldo Cruz (FIOCRUZ)instacron:FIOCRUZLICENSElicense.txtlicense.txttext/plain; charset=utf-83099https://www.arca.fiocruz.br/bitstream/icict/30056/1/license.txt586c046dcfeef936e32f0323bb9a47c0MD51ORIGINALGenotype assays and third-line_Beatriz_Grinsztejn_INI_LapClin-AIDS_2012.pdfGenotype assays and 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dc.title.pt_BR.fl_str_mv Genotype assays and third-line ART in resource-limited settings: A simulation and cost-effectiveness analysis of a planned clinical trial
title Genotype assays and third-line ART in resource-limited settings: A simulation and cost-effectiveness analysis of a planned clinical trial
spellingShingle Genotype assays and third-line ART in resource-limited settings: A simulation and cost-effectiveness analysis of a planned clinical trial
Lorenzana, Sarah B.
Resource-limited setting
Antiretroviral therapy
ART
ACTG
A5288
Genotype
Third-line ART
Cost-effectiveness
HIV
title_short Genotype assays and third-line ART in resource-limited settings: A simulation and cost-effectiveness analysis of a planned clinical trial
title_full Genotype assays and third-line ART in resource-limited settings: A simulation and cost-effectiveness analysis of a planned clinical trial
title_fullStr Genotype assays and third-line ART in resource-limited settings: A simulation and cost-effectiveness analysis of a planned clinical trial
title_full_unstemmed Genotype assays and third-line ART in resource-limited settings: A simulation and cost-effectiveness analysis of a planned clinical trial
title_sort Genotype assays and third-line ART in resource-limited settings: A simulation and cost-effectiveness analysis of a planned clinical trial
author Lorenzana, Sarah B.
author_facet Lorenzana, Sarah B.
Hughes, Michael D.
Grinsztejn, Beatriz
Collier, Ann C.
Luz, Paula Mendes
Freedberg, Kenneth A.
Wood, Robin
Levison, Julie H.
Mugyenyi, Peter N.
Salata, Robert
Wallis, Carole L.
Weinstein, Milton C.
Schooley, Robert T.
Walensky, Rochelle P.
author_role author
author2 Hughes, Michael D.
Grinsztejn, Beatriz
Collier, Ann C.
Luz, Paula Mendes
Freedberg, Kenneth A.
Wood, Robin
Levison, Julie H.
Mugyenyi, Peter N.
Salata, Robert
Wallis, Carole L.
Weinstein, Milton C.
Schooley, Robert T.
Walensky, Rochelle P.
author2_role author
author
author
author
author
author
author
author
author
author
author
author
author
dc.contributor.author.fl_str_mv Lorenzana, Sarah B.
Hughes, Michael D.
Grinsztejn, Beatriz
Collier, Ann C.
Luz, Paula Mendes
Freedberg, Kenneth A.
Wood, Robin
Levison, Julie H.
Mugyenyi, Peter N.
Salata, Robert
Wallis, Carole L.
Weinstein, Milton C.
Schooley, Robert T.
Walensky, Rochelle P.
dc.subject.en.pt_BR.fl_str_mv Resource-limited setting
Antiretroviral therapy
ART
ACTG
A5288
Genotype
Third-line ART
Cost-effectiveness
HIV
topic Resource-limited setting
Antiretroviral therapy
ART
ACTG
A5288
Genotype
Third-line ART
Cost-effectiveness
HIV
description Massachusetts General Hospital. Division of General Medicine. USA.
publishDate 2012
dc.date.issued.fl_str_mv 2012
dc.date.accessioned.fl_str_mv 2018-11-16T13:55:13Z
dc.date.available.fl_str_mv 2018-11-16T13:55:13Z
dc.type.status.fl_str_mv info:eu-repo/semantics/publishedVersion
dc.type.driver.fl_str_mv info:eu-repo/semantics/article
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status_str publishedVersion
dc.identifier.citation.fl_str_mv LORENZANA, S. B. et al. Genotype assays and third-line ART in resource-limited settings: a simulation and cost-effectiveness analysis of a planned clinical trial. AIDS, v. 26, n. 9, p. 1083-1093, 2012.
dc.identifier.uri.fl_str_mv https://www.arca.fiocruz.br/handle/icict/30056
dc.identifier.issn.pt_BR.fl_str_mv 0269-9370
dc.identifier.doi.none.fl_str_mv 10.1097/QAD.0b013e32835221eb
identifier_str_mv LORENZANA, S. B. et al. Genotype assays and third-line ART in resource-limited settings: a simulation and cost-effectiveness analysis of a planned clinical trial. AIDS, v. 26, n. 9, p. 1083-1093, 2012.
0269-9370
10.1097/QAD.0b013e32835221eb
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