A second daily pill for PrEP was approved in 2019, using a drug combination of tenofovir and alafenamide and emtricitabine, known as F/TAF, brand name Descovy. To date its approval is restricted to men who have sex with men and transgender women. Data in cisgender women is not yet available, but is expected from an ongoing trial known as Purpose 1, which is also testing the efficacy of an injectable PrEP using the drug lenacapavir.
Prevention options that mitigate or eliminate barriers to access are essential. Key populations, including men who have sex with men (MSM), transgender women (TGW), female sex workers (FSW), and adolescent girls and young women (AGYW) need effective options that work and fit into their lives. Each HIV prevention option has unique characteristics, and individuals may prefer a particular PrEP method for any number of reasons. Ensuring informed choice is key.
Oral PrEP is another strategy to help reduce HIV risk. For some people it will be the right one; for others, it will be injectable cabotegravir for PrEP or the dapivirine vaginal ring (the PrEP ring); for another, a non ARV-based approach will be right. Research and development have created new options; now advocacy is needed to make them viable choices for people who need and want them.
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 2019 announcement of its approval of F/TAF as PrEP excluding those who have “receptive vaginal sex.”
- The FDA’s October 2019 supplemental approval directing Gilead to conduct a trial among cisgender women with details and dates on the proposed trial.
The Purpose 1 trial is ongoing in 23 sites across South Africa and Uganda. It is studying the efficacy of both long-acting injectable lenacapavir and a daily oral F/TAF among young women aged 16-25 years. Enrolling adolescents is new for Gilead’s large-scale adult trials, and the research team is working with the Global Community Advisory Group (GCAG) on engagement with this important population.
The PrEPVacc trial is simultaneously testing experimental HIV vaccines and oral PrEP against a placebo. Participants are randomized to receive one of two experimental vaccines, which have both been tested before but did not advance to late-stage trials on their own. PrEPVacc is evaluating if they work better in combination. Participants are also randomized to receive one of two types of daily oral PrEP: TDF/FTC or F/TAF. Participants receive the daily oral PrEP over weeks 0–26; vaccine injections are received over weeks 0–48. This Phase IIb trial is enrolling 1,668 men and women, aged 18-40, from Mozambique, South Africa, Tanzania, and Uganda.
Findings from National Introduction and Scale-Up
Visit AVAC’s Global PrEP Tracker for the latest updates to PrEP uptake by country.