Multi-stakeholder consensus on a target product profile for an HIV cure

Authors:

• Lewin, Sharon R
• Attoye, Timothy
• Bansbach, Cathy
• Doehle, Brian
• Dubé, Karine
• Dybul, Mark
• SenGupta, Devi
• Jiang, Adam
• Johnston, Rowena
• Lamplough, Rosanne
• McCune, Joseph M
• Nabel, Gary J
• Ndung'u, Thumbi
• Pottage, John
• Ripin, David
• Rooney, James F
• Sikazwe, Izukanji
• Nsubuga, Moses
• Warren, Mitchell
• Deeks, Steven G

Details:

The Lancet HIV, Volume 8, Issue 1, 2021-01-31

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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.