Multi-stakeholder consensus on a target product profile for an HIV cure
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2021-01-01
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The Lancet HIV
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ELSEVIER INC
Melbourne Authors
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Infectious Diseases
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Journal Article
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Lewin, S. R., Attoye, T., Bansbach, C., Doehle, B., Dubé, K., Dybul, M., SenGupta, D., Jiang, A., Johnston, R., Lamplough, R., McCune, J. M., Nabel, G. J., Ndung'u, T., Pottage, J., Ripin, D., Rooney, J. F., Sikazwe, I., Nsubuga, M., Warren, M. & Deeks, S. G. (2021). Multi-stakeholder consensus on a target product profile for an HIV cure. Lancet HIV, 8 (1), pp.e42-e50. https://doi.org/10.1016/S2352-3018(20)30234-4.
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Abstract
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.