Evidence and Research for Oral PrEP

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.

• Table of Findings by Trial – where they took place, who enrolled, what they found
• Adherence Matters – summary of randomized controlled trial data on the relationship between adherence and efficacy
• PrEP Fact Sheet – includes a narrative description of randomized controlled trials to date

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.

• Designing PrEP Messages That Work for Young Women: Learning from the Jilinde PrEP project in Kenya
• OPTIONS Country Situation Analysis Interim Findings: South Africa

F/TAF as oral PrEP has also been approved for men who have sex with men and transgender women, although data in cisgender women is not yet available.

As a newly approved option for oral PrEP, F/TAF is the most recent addition to the HIV prevention portfolio. Seven years after TDF/FTC (Truvada) was approved by the FDA, there is now another oral PrEP option available for men who have sex with men and transgender women.

Clinical Trials Evidence

The 2019 US FDA decision was based on the results of the phase 3 DISCOVER trial, which compared the safety and efficacy of TDF/FTC to F/TAF in HIV-negative participants, and found F/TAF to be as effective.

• Gilead’s 2019 IAS Presentation of the Results of the DISCOVER Trial.
• AVAC’s factsheet for Gilead’s Phase III DISCOVER trial of daily F/TAF.
• Gilead’s presentation to the Antimicrobial Drugs Advisory Committee and FDA. It showed that daily F/TAF is as safe and effective as daily TDF/FTC for HIV prevention among MSM and transgender populations.
• The FDA’s October announcement of its approval of F/TAF as PrEP excluding those who have “receptive vaginal sex.”
• The FDA’s October supplemental approval directing Gilead to conduct a trial among cisgender women with details and dates on the proposed trial.