Multi-stakeholder consensus on a target product profile for an HIV cure
Sharon R. Lewin, Timothy Attoye, Cathy Bansbach, Brian Doehle, Karine Dubé, Mark Dybul, Devi SenGupta, Adam Jiang, Rowena Johnston, Rosanne Lamplough, Joseph M. McCune, Gary J. Nabel, Thumbi Ndung’u, John C. Pottage, David H. Brown Ripin, James F. Rooney, Izukanji Sikazwe, Moses Supercharger Nsubuga, Mitchell Warren, Steven G. Deeks
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.