Trials have shown that TDF/FTC as oral PrEP works if taken correctly and consistently. But there’s still a lot to learn about how to deliver oral PrEP.
The safety and efficacy of TDF/FTC is well-established. Policy and program decisions are guided by both data from the original randomized clinical trials as well as newer studies. Demonstration projects, implementation initiatives and national rollout provide information about challenges and opportunities with oral PrEP delivery, and can help optimize services and identify gaps.
Read below to find out more about:
Clinical Trials Evidence
The 2012 US FDA decision and WHO guidance on PrEP demonstration projects were based on data from randomized controlled trials of TDF/FTC and TDF (a generic option). Additional randomized trials since then have added to this evidence base.
Open Label and Demonstration Project Evidence
Concluded and ongoing pilot projects, demonstration projects and open label studies offer insight into how TDF/FTC works in the “real world”—outside of the controlled environment of a clinical trial.
- “Real-World” Effectiveness to Date: Summary table of PrEP demonstration and implementation studies
Findings from National Introduction and Scale-Up
As more countries approve TDF/FTC for prevention (visit AVAC’s Global PrEP Tracker for the latest) and begin to scale up national PrEP programs, there are opportunities to understand how services may be optimized and adapted. Already, many of these programs have provided valuable lessons.