Browsing by Author "SenGupta D"

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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; HIV Frontiers, Global Health Innovative Technology Solutions, The Bill & Melinda Gates Foundation, Seattle, WA, USA.; Joint Adherent Brothers & Sisters against AIDS, Kampala, Uganda.; University North Carolina Gillings School of Global Public Health, Chapel Hill, NC, USA.; ViiV Healthcare, Brentford, UK.; Sanofi Global Research and Development, Cambridge, MA, USA.; AVAC, New York, NY, USA.; amfAR, The Foundation for AIDS Research, New York City, NY, USA.; The Peter Doherty Institute for Infection and Immunity, The University of Melbourne and Royal Melbourne Hospital, Melbourne, Australia; Department of Infectious Diseases, Alfred Health and Monash University, Melbourne, VIC, Australia; Victorian Infectious Diseases Service, Royal Melbourne Hospital, Melbourne, VIC, Australia. Electronic address: sharon.lewin@unimelb.edu.au.; Bill & Melinda Gates Foundation, Seattle, WA, USA.; McKinsey & Company Secondee at The Bill & Melinda Gates Foundation, Seattle, WA, USA.; Department of Global Health, University of Washington, The Bill & Melinda Gates Foundation, Seattle, WA, USA.; Gilead Sciences, Foster City, CA, USA.; Clinton Health Access Initiative, Boston, MA, USA.; Africa Health Research Institute, Durban, South Africa; HIV Pathogenesis Programme, The Doris Duke Medical Research Institute, University of KwaZulu-Natal, Durban, South Africa; Max Planck Institute for Infection Biology, Berlin, Germany; Ragon Institute of Massachusetts General Hospital, Massachusetts Institute of Technology and Harvard University, Cambridge, MA, USA; Division of Infection and Immunity, University College London, London, UK.; Centre for Infectious Disease Research in Zambia, Lusaka, Zambia.; Center for Global Health Practice and Impact, Georgetown University, Washington, DC, USA.; International AIDS Society, Geneva, Switzerland.; University of California, San Francisco, CA, USA.; CIDRZ; Centre for Infectious Disease Research in Zambia (CIDRZ)
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.