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 Pottage; David Ripin; James F Rooney; Izukanji Sikazwe; Moses Nsubuga; Mitchell Warren; Steven G Deeks; Sunnylands 2019 Working Group

doi:10.1016/S2352-3018(20)30234-4

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

Lancet HIV. 2021 Jan;8(1):e42-e50. doi: 10.1016/S2352-3018(20)30234-4. Epub 2020 Nov 30.

Authors

Sharon R Lewin¹, Timothy Attoye², Cathy Bansbach³, Brian Doehle⁴, Karine Dubé⁵, Mark Dybul⁶, Devi SenGupta⁷, Adam Jiang⁸, Rowena Johnston⁹, Rosanne Lamplough¹⁰, Joseph M McCune⁴, Gary J Nabel¹¹, Thumbi Ndung'u¹², John Pottage¹³, David Ripin¹⁴, James F Rooney⁷, Izukanji Sikazwe¹⁵, Moses Nsubuga¹⁶, Mitchell Warren¹⁷, Steven G Deeks¹⁸; Sunnylands 2019 Working Group

Affiliations

¹ 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: [email protected].
² Department of Global Health, University of Washington, The Bill & Melinda Gates Foundation, Seattle, WA, USA.
³ Bill & Melinda Gates Foundation, Seattle, WA, USA.
⁴ HIV Frontiers, Global Health Innovative Technology Solutions, The Bill & Melinda Gates Foundation, Seattle, WA, USA.
⁵ University North Carolina Gillings School of Global Public Health, Chapel Hill, NC, USA.
⁶ Center for Global Health Practice and Impact, Georgetown University, Washington, DC, USA.
⁷ Gilead Sciences, Foster City, CA, USA.
⁸ McKinsey & Company Secondee at The Bill & Melinda Gates Foundation, Seattle, WA, USA.
⁹ amfAR, The Foundation for AIDS Research, New York City, NY, USA.
¹⁰ International AIDS Society, Geneva, Switzerland.
¹¹ Sanofi Global Research and Development, Cambridge, MA, USA.
¹² 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.
¹³ ViiV Healthcare, Brentford, UK.
¹⁴ Clinton Health Access Initiative, Boston, MA, USA.
¹⁵ Centre for Infectious Disease Research in Zambia, Lusaka, Zambia.
¹⁶ Joint Adherent Brothers & Sisters against AIDS, Kampala, Uganda.
¹⁷ AVAC, New York, NY, USA.
¹⁸ University of California, San Francisco, CA, USA.

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.

Publication types

Research Support, Non-U.S. Gov't
Review

MeSH terms

Antiretroviral Therapy, Highly Active
Combined Modality Therapy
Consensus
Disease Management
Expert Testimony
HIV
HIV Infections / drug therapy
HIV Infections / epidemiology*
HIV Infections / virology
Humans
Public Health Surveillance

Grants and funding

R25 MH067127/MH/NIMH NIH HHS/United States