Advocates' perspectives on an efficacy trial of F/TAF as PrEP for women


BACKGROUND: The October 2019 FDA approval of F/TAF (Descovy) as daily oral PrEP excluded individuals at risk of HIV infection from receptive vaginal sex, and required Gilead, the product's developer, conduct an efficacy trial in cisgender women. Gilead plans to conduct the Descovy for PrEP (D4P) trial in women in sub-Saharan Africa, using background HIV incidence from previous trials, including ECHO, to estimate efficacy.
Given scrutiny around the clinical development of F/TAF, AVAC, Advocacy for Prevention of HIV/AIDS (APHA) and International Community of Women living with HIV Eastern Africa (ICW-EA) convened independent civil society consultations to engage with Gilead and inform the design of the D4P protocol.
METHODS: APHA and ICW-EA, in collaboration with AVAC, led engagement with civil society stakeholders in South Africa and Uganda, respectively, through the following activities:
'¢ Series of six consultations with approximately 100 advocates, to build research literacy and discuss advocacy concerns;
'¢ Online survey to gather perspectives and consolidate positions and priorities;
'¢ Direct consultation with Gilead.
All activities were conducted virtually in light of COVID-19.
RESULTS: The quantitative survey revealed diverse perspectives, especially those related to inclusion of pregnant and breastfeeding women, providing important nuance in discussions with Gilead.
Feedback centered around:
'¢ Safety profile of F/TAF among adolescents and pregnant and breastfeeding women and possibilities of including these population in the trial;
'¢ Size, color and packaging of the pill;
'¢ Standard of prevention, reproductive health package, adherence counselling and social-behavioural support during the trial;
'¢ Post-trial access to PrEP;
'¢ Efficacy calculations based on ECHO incidence, given the unknown impacts of COVID-19 on HIV rates, and that Uganda was not an ECHO country;
'¢ Sustained and diverse stakeholder and community engagement throughout the trial life-cycle, ensuring local relevance and acceptance;
'¢ Framing F/TAF as an additional, rather than a 'better', PrEP option to TDF/FTC.
CONCLUSIONS: Advocates' input informed the D4P protocol and Gilead's ongoing negotiations with regulatory agencies. Engagement should be sustained to ensure stakeholder support and ownership of the trial, results, and product introduction.

The process provides a model for robust engagement of advocates with product developers around complex, next-generation prevention trials.