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.
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.
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AVAC welcomes the groundbreaking results of the PURPOSE 2 HIV prevention study of twice-yearly injectable lenacapavir for PrEP among 3,200 cisgender men, transgender men, transgender women, and nonbinary individuals who have sex with partners assigned male at birth. Among more than 2,000 people in the trial who received lenacapavir, there were only two HIV infections.
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As CAB for PrEP is a long-acting, extended-release injection, bioequivalence (BE) testing takes time to determine whether the generic drug functions in the body similarly to the original drug. As shown in this timeline graphic, the BE study (as determined by WHO guidance) is the longest part of the development process for generic CAB. But other steps, such as selecting and licensing generic manufacturers and technology transfer could be done faster.
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In addition to an update on the PrEP pipeline, this issue of PxWire discusses the impact of policies on PrEP uptake, contrasting Uganda’s disastrous Anti-Homosexuality Act with the positive impact of other countries’ comprehensive anti-discrimination policies.
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.
Source: CNN
Source: The Guardian
Source: The Japan Times
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.
This timeline shows the potential time points when the next-generation of HIV prevention options might find their way into new programs.