There are currently two daily pills approved and available as oral PrEP. Below are details on each product’s distinct characteristics, approval history, availability, safety and effectiveness. Evidence and resources to learn more are also provided.
The Basics
TDF/FTC combines two drugs, tenofovir disoproxil fumarate and emtricitabine.
- The most widely available.
- Developed by Gilead.
- First approved in 2012.
- Available in 100+ countries and counting.
- Can be used by all populations at risk of HIV.
- Brand name Truvada.
- Available in generic form.
F/TAF combines two drugs, tenofovir alafenamide and emtricitabine.
- First approved in 2019.
- Also developed by Gilead.
- Approvals apply to cisgender men and transgender women only.
- Phase III Purpose I trial is evaluating its use in cisgender women, with results expected in 2027.
- Now available in more than a dozen countries.
- Brand name Descovy.
- No generics available yet.
Effectiveness
- Oral PrEP is highly effective if taken as prescribed.
- Prescribed as a daily pill to be taken during periods when the user may be at risk of HIV.
- It can take up to a week for daily oral PrEP to build up in the bloodstream to a protective level.
- Some populations, including cisgender men and trans and gender-diverse people assigned male at birth who are not taking estradiol-based hormones, have the option of an alternative dosing regimen with TDF/FTC, which is sometimes referred to as “on-demand” or “event-driven” PrEP.
- This dosing regimen involves taking two PrEP pills between two and 24 hours before sex, and then one pill per day for as long as oral PrEP protection is desired and for at least two days after the last potential sexual exposure. See WHO’s PrEP Implementation Tool- Provider Module for more information on oral PrEP dosing options.
- New data among cisgender women suggests that protective levels of PrEP may be reached even if they do not adhere perfectly to a daily regimen of pill taking. More evaluation is needed and currently it is recommended this population take oral PrEP every day to be effective.
- Oral PrEP does not prevent any sexually transmitted infections other than HIV, and does not prevent pregnancy.
Safety
- The safety of TDF/FTC is well-established for a wide variety of populations, including for adolescents and people who are pregnant or lactating.
- TDF/FTC is also safe and effective when taken with hormonal contraceptives and gender-affirming hormone therapy.
- F/TAF has currently only been shown to be safe in individuals who were assigned male at birth.
- Side effects of both TDF/FTC and F/TAF are generally mild and typically resolve in the first month. They include nausea, abdominal cramps and headache.
Where can I access oral PrEP?
To see where oral PrEP is currently approved, visit our country pages. To find a provider near you, see our PrEP Access page.
Evidence and Resources
Click here for a summary of oral PrEP efficacy trial results. Visit AVAC’s Global PrEP Tracker for the latest updates on PrEP uptake by country.
For lessons from the field on what works check out our report Lessons from Oral PrEP Programs and their Implications for Next Generation Prevention, and the following issue briefs that highlight key findings:
- Reframing Risk in the Context of PrEP
- Generating and Sustaining Demand for PrEP
- Simplifying and Improving PrEP Delivery
- Next Generation M&E for Next-Generation PrEP
WHO’s Consolidated Guidelines on HIV Prevention, Testing, Treatment, Service Delivery and Monitoring brings together all the latest WHO recommendations on PrEP, including oral PrEP.
Looking to roll out oral PrEP in your country? The Plan 4 PrEP toolkit guides implementers through the full planning process.
Aidsmap has comprehensive overviews of PrEP products- see here for info on TDF/FTC, and here for F/TAF.
For more oral PrEP resources, see our resource library.