Browsing by Author "Bansbach C"

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    Multi-stakeholder consensus on a target product profile for an HIV cure.
    (2021-Jan) Lewin SR; Attoye T; Bansbach C; Doehle B; Dubé K; Dybul M; SenGupta D; Jiang A; Johnston R; Lamplough R; McCune JM; Nabel GJ; Ndung'u T; Pottage J; Ripin D; Rooney JF; Sikazwe I; Nsubuga M; Warren M; Deeks SG
    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.