Multi-stakeholder consensus on a target product profile for an HIV cure.
Journal
The lancet. HIV
ISSN: 2352-3018
Titre abrégé: Lancet HIV
Pays: Netherlands
ID NLM: 101645355
Informations de publication
Date de publication:
01 2021
01 2021
Historique:
received:
14
06
2020
revised:
09
08
2020
accepted:
11
08
2020
pubmed:
4
12
2020
medline:
26
1
2021
entrez:
3
12
2020
Statut:
ppublish
Résumé
Developing a cure for HIV is a global priority. Target product profiles are a tool commonly used throughout the drug development process to align interested parties around a clear set of goals or requirements for a potential product. Three distinct therapeutic modalities (combination therapies, ex-vivo gene therapy, and in-vivo gene therapy) for a target product profile for an HIV cure were identified. Using a process of expert face-to-face consultation and an online Delphi consultation, we found a high degree of agreement regarding the criteria for the optimum target product profile. Although the minimum attributes for a cure were debated, the broad consensus was that an acceptable cure need not be as safe and effective as optimally delivered antiretroviral therapy. An intervention that successfully cured a reasonable fraction of adults would be sufficient to advance to the clinic. These target product profiles will require further discussion and ongoing revisions as the field matures.
Identifiants
pubmed: 33271125
pii: S2352-3018(20)30234-4
doi: 10.1016/S2352-3018(20)30234-4
pmc: PMC7773628
pii:
doi:
Types de publication
Journal Article
Research Support, Non-U.S. Gov't
Review
Langues
eng
Sous-ensembles de citation
IM
Pagination
e42-e50Subventions
Organisme : NIMH NIH HHS
ID : R25 MH067127
Pays : United States
Informations de copyright
Copyright © 2021 The Author(s). Published by Elsevier Ltd. This is an Open Access article under the CC BY 4.0 license. Published by Elsevier Ltd.. All rights reserved.