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Multi-stakeholder consensus on a target product profile for an HIV cure
Sharon R Lewin1, Timothy Attoye2, Cathy Bansbach3
1The 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.
The Lancet. HIV
|December 3, 2020
Summary
Developing an HIV cure is a global priority. Experts agreed on target product profiles for HIV cures, including gene therapies, with an acceptable cure not needing to match antiretroviral therapy safety.
Area of Science:
- Infectious Diseases
- Biotechnology
- Public Health
Background:
- Developing a cure for Human Immunodeficiency Virus (HIV) is a critical global health objective.
- Target product profiles (TPPs) are essential tools in drug development, aligning stakeholders on product requirements.
- Existing HIV treatments, while effective, do not provide a cure, necessitating research into novel therapeutic strategies.
Purpose of the Study:
- To identify and define target product profiles for an HIV cure.
- To explore distinct therapeutic modalities for achieving an HIV cure, including combination therapies, ex-vivo gene therapy, and in-vivo gene therapy.
- To establish consensus among experts on the criteria for an optimal and acceptable HIV cure.
Main Methods:
- Expert consultations, including face-to-face meetings and an online Delphi process, were employed.
- The study involved identifying key criteria for target product profiles for HIV cure interventions.
- A consensus-building approach was used to define the attributes of an acceptable HIV cure.
Main Results:
- A high degree of agreement was reached on the criteria for an optimum target product profile for an HIV cure.
- Three primary therapeutic modalities were identified: combination therapies, ex-vivo gene therapy, and in-vivo gene therapy.
- Consensus indicated that an acceptable HIV cure need not be as safe and effective as current antiretroviral therapy.
Conclusions:
- Target product profiles for HIV cures have been defined, guiding future research and development.
- An intervention curing a significant fraction of adults is considered sufficient for clinical advancement.
- These TPPs will evolve as scientific understanding and therapeutic technologies advance in the field of HIV cure research.
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