Facilitating next-generation pre-exposure prophylaxis clinical trials using HIV recent infection assays: a consensus statement from the forum HIV prevention trial design project

Detalhes bibliográficos
Autor(a) principal: Parkin, Neil
Data de Publicação: 2023
Outros Autores: Fei, Gao, Grebe, Eduard, Cutrell, Amy, Das, Moupali, Donnell, Deborah, Duerr, Ann, Glidden, David V., Hughes, James P., Murray, Jeffrey, Robertson, Michael N., Zinserling, Joerg, Lau, Joseph, Miller, Veronica
Tipo de documento: Artigo
Idioma: eng
Título da fonte: Repositório Institucional da FIOCRUZ (ARCA)
Texto Completo: https://www.arca.fiocruz.br/handle/icict/57604
Resumo: Forum for Collaborative Research Recency Assay Working Group - Beatriz Grinsztejn. Fundação Oswaldo Cruz. Instituto Nacional de Infectologia Evandro Chagas. Rio de Janeiro, RJ, Brasil.
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spelling Parkin, NeilFei, GaoGrebe, EduardCutrell, AmyDas, MoupaliDonnell, DeborahDuerr, AnnGlidden, David V.Hughes, James P.Murray, JeffreyRobertson, Michael N.Zinserling, JoergLau, JosephMiller, Veronica2023-03-28T15:49:21Z2023-03-28T15:49:21Z2023PARKING, Neil et al. Facilitating next-generation pre-exposure prophylaxis clinical trials using HIV recent infection assays: a consensus statement from the forum HIV prevention trial design project. Clinical Pharmacology & Therapeutics, v. 0, n. 0, p. 1-12, 2023.0009-9236https://www.arca.fiocruz.br/handle/icict/5760410.1002/cpt.2830Forum for Collaborative Research Recency Assay Working Group - Beatriz Grinsztejn. Fundação Oswaldo Cruz. Instituto Nacional de Infectologia Evandro Chagas. Rio de Janeiro, RJ, Brasil.Data First Consulting. Sebastopol, CA, USA.Fred Hutchinson Cancer Research Center. Seattle, WA, USA.Vitalant Research Institute, San Francisco, CA, USA / Edward Grebe Consulting. Cape Town, South Africa.ViiV Healthcare. Research Triangle Park, NC, USA.Gilead Sciences. Foster City, CA, USA.Fred Hutchinson Cancer Research Center. Seattle, WA, USA.Fred Hutchinson Cancer Research Center. Seattle, WA, USA.Edward Grebe Consulting. Cape Town, South Africa.University of Washington. Seattle, WA, USA.Independent Consultant. Washington, DC, USA.Merck & Co., Inc. Kenilworth, NJ, USA.Federal Institute for Drugs and Medical Devices (Bundesinstitut für Arzneimittel und Medizinprodukte, BfArM). Bonn, Germany.Forum for Collaborative Research. Washington, DC, USA.Forum for Collaborative Research. Washington, DC, USA.Standard-of-care HIV pre-exposure prophylaxis (PrEP) is highly efficacious, but uptake of and persistence on a daily oral pill is low in many settings. Evaluation of alternate PrEP products will require innovation to avoid the unpractically large sample sizes in noninferiority trials. We propose estimating HIV incidence in people not on PrEP as an external counterfactual to which on-PrEP incidence in trial subjects can be compared. HIV recent infection testing algorithms (RITAs), such as the limiting antigen avidity assay plus viral load used on specimens from untreated HIV positive people identified during screening, is one possible approach. Its feasibility is partly dependent on the sample size needed to ensure adequate power, which is impacted by RITA performance, the number of recent infections identified, the expected efficacy of the intervention, and other factors. Screening sample sizes to support detection of an 80% reduction in incidence for 3 key populations are more modest, and comparable to the number of participants in recent phase III PrEP trials. Sample sizes would be significantly larger in populations with lower incidence, where the false recency rate is higher or if PrEP efficacy is expected to be lower. Our proposed counterfactual approach appears to be feasible, offers high statistical power, and is nearly contemporaneous with the on-PrEP population. It will be important to monitor the performance of this approach during new product development for HIV prevention. If successful, it could be a model for preventive HIV vaccines and prevention of other infectious diseases.engASCPTFacilitating next-generation pre-exposure prophylaxis clinical trials using HIV recent infection assays: a consensus statement from the forum HIV prevention trial design projectinfo:eu-repo/semantics/publishedVersioninfo:eu-repo/semantics/articleHIVPrEPPreexposure prophylaxis (PrEP)Antiretroviral therapy (ART)info:eu-repo/semantics/openAccessreponame:Repositório Institucional da FIOCRUZ (ARCA)instname:Fundação Oswaldo Cruz (FIOCRUZ)instacron:FIOCRUZORIGINALve_Parkin_Neil_etal_INI_2022.pdfve_Parkin_Neil_etal_INI_2022.pdfapplication/pdf397150https://www.arca.fiocruz.br/bitstream/icict/57604/2/ve_Parkin_Neil_etal_INI_2022.pdfb7dce77e29995f69b39ea9148b9a0b8bMD52LICENSElicense.txtlicense.txttext/plain; charset=utf-82991https://www.arca.fiocruz.br/bitstream/icict/57604/1/license.txt5a560609d32a3863062d77ff32785d58MD51icict/576042023-04-12 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dc.title.en_US.fl_str_mv Facilitating next-generation pre-exposure prophylaxis clinical trials using HIV recent infection assays: a consensus statement from the forum HIV prevention trial design project
title Facilitating next-generation pre-exposure prophylaxis clinical trials using HIV recent infection assays: a consensus statement from the forum HIV prevention trial design project
spellingShingle Facilitating next-generation pre-exposure prophylaxis clinical trials using HIV recent infection assays: a consensus statement from the forum HIV prevention trial design project
Parkin, Neil
HIV
PrEP
Preexposure prophylaxis (PrEP)
Antiretroviral therapy (ART)
title_short Facilitating next-generation pre-exposure prophylaxis clinical trials using HIV recent infection assays: a consensus statement from the forum HIV prevention trial design project
title_full Facilitating next-generation pre-exposure prophylaxis clinical trials using HIV recent infection assays: a consensus statement from the forum HIV prevention trial design project
title_fullStr Facilitating next-generation pre-exposure prophylaxis clinical trials using HIV recent infection assays: a consensus statement from the forum HIV prevention trial design project
title_full_unstemmed Facilitating next-generation pre-exposure prophylaxis clinical trials using HIV recent infection assays: a consensus statement from the forum HIV prevention trial design project
title_sort Facilitating next-generation pre-exposure prophylaxis clinical trials using HIV recent infection assays: a consensus statement from the forum HIV prevention trial design project
author Parkin, Neil
author_facet Parkin, Neil
Fei, Gao
Grebe, Eduard
Cutrell, Amy
Das, Moupali
Donnell, Deborah
Duerr, Ann
Glidden, David V.
Hughes, James P.
Murray, Jeffrey
Robertson, Michael N.
Zinserling, Joerg
Lau, Joseph
Miller, Veronica
author_role author
author2 Fei, Gao
Grebe, Eduard
Cutrell, Amy
Das, Moupali
Donnell, Deborah
Duerr, Ann
Glidden, David V.
Hughes, James P.
Murray, Jeffrey
Robertson, Michael N.
Zinserling, Joerg
Lau, Joseph
Miller, Veronica
author2_role author
author
author
author
author
author
author
author
author
author
author
author
author
dc.contributor.author.fl_str_mv Parkin, Neil
Fei, Gao
Grebe, Eduard
Cutrell, Amy
Das, Moupali
Donnell, Deborah
Duerr, Ann
Glidden, David V.
Hughes, James P.
Murray, Jeffrey
Robertson, Michael N.
Zinserling, Joerg
Lau, Joseph
Miller, Veronica
dc.subject.en.en_US.fl_str_mv HIV
PrEP
topic HIV
PrEP
Preexposure prophylaxis (PrEP)
Antiretroviral therapy (ART)
dc.subject.en.none.fl_str_mv Preexposure prophylaxis (PrEP)
Antiretroviral therapy (ART)
description Forum for Collaborative Research Recency Assay Working Group - Beatriz Grinsztejn. Fundação Oswaldo Cruz. Instituto Nacional de Infectologia Evandro Chagas. Rio de Janeiro, RJ, Brasil.
publishDate 2023
dc.date.accessioned.fl_str_mv 2023-03-28T15:49:21Z
dc.date.available.fl_str_mv 2023-03-28T15:49:21Z
dc.date.issued.fl_str_mv 2023
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 PARKING, Neil et al. Facilitating next-generation pre-exposure prophylaxis clinical trials using HIV recent infection assays: a consensus statement from the forum HIV prevention trial design project. Clinical Pharmacology & Therapeutics, v. 0, n. 0, p. 1-12, 2023.
dc.identifier.uri.fl_str_mv https://www.arca.fiocruz.br/handle/icict/57604
dc.identifier.issn.en_US.fl_str_mv 0009-9236
dc.identifier.doi.none.fl_str_mv 10.1002/cpt.2830
identifier_str_mv PARKING, Neil et al. Facilitating next-generation pre-exposure prophylaxis clinical trials using HIV recent infection assays: a consensus statement from the forum HIV prevention trial design project. Clinical Pharmacology & Therapeutics, v. 0, n. 0, p. 1-12, 2023.
0009-9236
10.1002/cpt.2830
url https://www.arca.fiocruz.br/handle/icict/57604
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 ASCPT
publisher.none.fl_str_mv ASCPT
dc.source.none.fl_str_mv reponame:Repositório Institucional da FIOCRUZ (ARCA)
instname:Fundação Oswaldo Cruz (FIOCRUZ)
instacron:FIOCRUZ
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instacron_str FIOCRUZ
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reponame_str Repositório Institucional da FIOCRUZ (ARCA)
collection Repositório Institucional da FIOCRUZ (ARCA)
bitstream.url.fl_str_mv https://www.arca.fiocruz.br/bitstream/icict/57604/2/ve_Parkin_Neil_etal_INI_2022.pdf
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