A breakthrough drug in HIV prevention

Although there have been significant advances in HIV treatments and prevention methods over the last few decades, more than 1 million people are still infected by the virus every year, and reducing the number of new infections has largely stalled.

However, a new drug called lenacapavir "might break the impasse," Science writes. Lenacapavir, which is manufactured by Gilead Sciences, was first approved by FDA as a treatment for multi-drug-resistant HIV in 2022. Now, new research suggests that it may be effective in preventing HIV.

Gilead tested lenacapavir, which is given as a twice-yearly injection, in two clinical trials called PURPOSE 1 and PURPOSE 2. In the PURPOSE 1 trial, which included over 5,000 cisgender women and adolescent girls in South Africa and Uganda, none of the participants who received lenacapavir became infected with HIV.

According to Gilead, data from the two trials will be used to support a series of global regulatory filings, which are expected to begin at the end of the year. The company aims to get lenacapavir on the market at some point in 2025.

"It has the potential [to drive down global HIV infection rates], if we can do it right, which means going big and getting it out there," said Linda-Gail Bekker, an infectious disease specialist at the University of Cape Town who led one of the clinical trials for lenacapavir. 

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Ethel Weld, an assistant professor of medicine at the Johns Hopkins University School of Medicine, said the results of the PURPOSE 1 and 2 trials were "a thrilling game changer for HIV prevention." Advocacy groups, such as a People's Medicines Alliance, have expressed similar sentiments about the drug.

Lenacapavir could also be a more manageable alternative to current HIV prevention methods such as oral pre-exposure prophylaxis (PrEP) drugs, which must be taken daily. Research has found significant barriers to taking daily oral PrEP among men who have sex with men, including lack of access, inconvenience, and perceptions that it is unnecessary. Stigma and discrimination against the drug have also made oral PrEP difficult to use in many African countries, which bear the highest disease burden from HIV.

According to Cécile Tremblay, an HIV researcher at the University of Montréal, it's critical for access to lenacapavir to be as widespread as possible.

"The infrastructure needs to be in place to reach at-risk populations and make sure they can access it," Tremblay said. "If everyone at risk could receive this prophylaxis, within a few years it could alter the course of the epidemic. When you substantially decrease the transmission rate, then the epidemic can wane down."

Other health experts agreed. "While we're waiting for the generic companies [to make generic forms of lenacapavir], I feel that places where the lenacapavir trials have been run should have access to this product either from the original company or hopefully in future, from generics companies," Bekker said. "We can't have a world where we don't see this miracle getting into the hands of the people who contributed to this."