PrEP works. Investment in more options must continue. Faster, smarter rollout must be a top priority.
Antiretroviral drugs (ARVs) were originally developed to treat people living with HIV. But research has proven that ARVs can also prevent HIV acquisition among individuals who are HIV-negative. This is called pre-exposure prophylaxis, or PrEP, and it’s a vital tool in HIV prevention.
The first daily PrEP pill was approved by the FDA in 2012, but rollout was slow, uncoordinated and poorly planned. Uptake is nowhere near where it should be to address the HIV epidemic. (See the trends in AVAC’s PrEP Tracker). While PrEP won’t be right for everyone at risk, the next generation of products — some entering the market now — must act on the lessons from oral PrEP rollout, by improving coordination and speeding access.
The rollout of injectable cabotegravir (CAB for PrEP) and the dapivirine vaginal ring (DVR), the two latest prevention tools to be proven effective, represents an opportunity to get rollout right.
Approved Options
Research and development for PrEP includes a diversity of products. Early phase development includes patches, gels, douches, implants, films, vaginal and rectal inserts, topical agents, long-acting and short-acting products. Further along in development are a 3-monthly ring, a multi-purpose technology that combines PrEP with a contraceptive that prevents pregnancy, and a longer-acting injectable.
In 2024, Gilead Sciences released findings from the PURPOSE 1 and PURPOSE 2 trials testing lenacapavir (LEN) as HIV prevention. The PURPOSE 1 trial found 100% efficacy in preventing HIV in 5,300 cisgender women in Uganda and South Africa, and the PURPOSE 2 trial showed a 96% reduction in HIV incidence among cisgender men, trans, and non-binary individuals across multiple countries. To learn all about lenacapavir and for all related AVAC resources, click here.
Effective advocacy for smarter, better rollout of approved PrEP products remains essential, along with advocacy for continued investment in developing additional PrEP options.
AVAC supports a range of programs to advance this advocacy. We track the status of rollout and uptake of all approved PrEP products; call for continued investment in R&D for new options; support engagement between researchers, donors, community leaders, government and civil society in the design of trials investigating new PrEP options and the design of programs to deliver PrEP effectively to everyone who needs it; and participate in collaborations to hold decision-makers accountable to commitments on funding, policy and more so that prevention programs rolling out PrEP work in the real world.
Find out more about PrEP access and rollout across the globe at AVAC’s PrEPWatch.
report
In addition to an update on the PrEP pipeline, this issue of PxWire recaps the HIVR4P 2024 conference in Lima, Peru; introduces the People’s Research Agenda; and lists our Prevention Playlist, a wide range of resources to inform your decision making and action.
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In 2024, Gilead Sciences released findings from the PURPOSE 1 and PURPOSE 2 trials testing lenacapavir (LEN) as HIV prevention. This advocates’ primer provides background on the product and trials; a summary of the early findings of PURPOSE 1 & 2; key questions and next steps.
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The timeline for generic LEN for PrEP to come to market is expected to be significantly shorter than for CAB for PrEP. Bioequivalence (BE) testing for LEN, which demonstrates a generic product works in the body in the same way as the originator product, is likely to be six months, vs. the 18 months for CAB for PrEP, because of differences in the drug formulation.
The PURPOSE trials evaluate the safety and efficacy of injectable lenacapavir (LEN), an investigational antiretroviral (ARV) drug being studied as a potential PrEP product. This graphic shows the latest status of all five trials including the groundbreaking results of PURPOSE 1 and PURPOSE 2.
The database allows users to view clinical trials around the world, gaining an understanding of the many developments currently being made in the field of HIV prevention research.
AVAC tracks global PrEP use by conducting quarterly surveys of ongoing oral PrEP demonstration and implementation projects, and collecting data from manufacturers and government agencies. This graphic shows data on PrEP initiations around the globe.
