Target product profile for cell-based and gene-based therapies to achieve a cure for HIV

Sharon R Lewin; Cathy Bansbach; Dominic Kemps; Lauren Mathae; Kumitaa Theva Das; Joseph M McCune; Steven G Deeks; Thumbi Ndung'u; HIV Cure Gene Therapy Target Product Profile Working Group

doi:10.1016/S2352-3018(24)00277-7

Target product profile for cell-based and gene-based therapies to achieve a cure for HIV

Lancet HIV. 2025 Jan 3:S2352-3018(24)00277-7. doi: 10.1016/S2352-3018(24)00277-7. Online ahead of print.

Authors

Sharon R Lewin¹, Cathy Bansbach², Dominic Kemps³, Lauren Mathae⁴, Kumitaa Theva Das⁵, Joseph M McCune⁶, Steven G Deeks⁷, Thumbi Ndung'u⁸; HIV Cure Gene Therapy Target Product Profile Working Group

Affiliations

¹ Department of Infectious Diseases, The University of Melbourne at the Peter Doherty Institute for Infection and Immunity, Melbourne, VIC, Australia. Electronic address: [email protected].
² ChinaCat Enterprises, Gig Harbor, WA, USA.
³ Sommartel, London, UK.
⁴ Center for Global Health Practice and Impact, Georgetown University, Washington, DC, USA.
⁵ Advanced Medical and Dental Institute, Universiti Sains Malaysia, Penang, Malaysia.
⁶ HIV Frontiers, Global Health Accelerator, Bill & Melinda Gates Foundation, Seattle, WA, USA.
⁷ Division of HIV, Infectious Diseases and Global Medicine, University of California, San Francisco, CA, USA.
⁸ Africa Health Research Institute, Durban, South Africa; HIV Pathogenesis Programme, Doris Duke Medical Research Institute, University of KwaZulu-Natal, Durban, South Africa; Ragon Institute of Massachusetts General Hospital, Massachusetts Institute of Technology and Harvard University, Cambridge, MA, USA; University College London, London, UK.

PMID: 39761679
DOI: 10.1016/S2352-3018(24)00277-7

Abstract

This target product profile (TPP) highlights the minimal and optimal characteristics for ex-vivo and in-vivo cell and gene therapy-based products aimed at achieving an HIV cure (ie, durable antiretroviral-free viral control). The need for an effective, safe, scalable, affordable, accessible, and acceptable cure for HIV infection remains a major global priority. The possibilities for cell and gene therapy-based products for an HIV cure are rapidly expanding. In a multi-stakeholder consensus process of clinical experts and civil society, including representatives from low-income and middle-income countries, participants generally agreed on the optimal targets, whereas consensus on the minimal targets was not reached on every parameter. There was less agreement on the minimal targets for ex-vivo than in-vivo therapies given the complexity of ex-vivo interventions. The TTP is planned to be updated at regular intervals. Building a TTP, such as this one, is an important process for stakeholder engagement and aligning ambitions for the development of products that are acceptable to both clinicians and civil society.

Publication types

Review