Q1 · MEDICINE
Review
Author: McCune, Joseph M ; Sikazwe, Izukanji ; Ndung'u, Thumbi ; Ripin, David ; Lewin, Sharon R ; Bansbach, Cathy ; Deeks, Steven G ; Nabel, Gary J ; Warren, Mitchell ; Doehle, Brian ; SenGupta, Devi ; Jiang, Adam ; Dybul, Mark ; Nsubuga, Moses ; Attoye, Timothy ; Johnston, Rowena ; Rooney, James F ; Dubé, Karine ; Lamplough, Rosanne ; Pottage, John
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.