ILF roundtable: Regulatory pathways and clinical trial design for long-acting PrEP
5 March 2018 (By invitation only)
Tenofovir-based HIV pre-exposure prophylaxis (PrEP) is now recognized as a highly effective tool in the HIV prevention toolbox. However, its increasing availability in a number of settings must not prevent the development of new tools, including long-acting PrEP formulations. Indeed, the concomitant use of PrEP by participants in HIV prevention clinical trials can make it challenging to demonstrate the efficacy (non-inferiority) of new tools.
This roundtable reviewed the latest information on PrEP rollout and provided a state-of-the-art overview of the molecules currently under development as long-acting PrEP and in Phase I, II, and III clinical trials. This set the stage for an engaging, interactive discussion of remaining challenges and promising approaches for long-acting PrEP clinical trials and regulatory approval in adults and youth (including neonatal prophylaxis).
Objectives of the meeting
The main objectives for this discussion were to:
- Provide an update on PrEP R&D, in particular around long-acting PrEP and clinical trial design for regulatory approval in adult and youth populations
- Provide a multi-stakeholder platform for academia, industry, the community and other stakeholders to exchange on existing and foreseen challenges and potential solutions for the development of long-acting PrEP.