GENEVA
Around 40 million people across the world are currently living with HIV, a virus that has claimed more than 42 million lives since the beginning of the epidemic.
But for the first time in decades, scientists and public health officials are daring to talk about a realistic path to ending HIV as a public health threat. That hope now carries a name: Lenacapavir.
On June 18, the US Food and Drug Administration approved Yeztugo (Lenacapavir), the world’s first and only twice-yearly injectable medication for pre-exposure prophylaxis (PrEP), marking a major breakthrough in the fight against HIV. Backed by compelling results from the Phase 3 PURPOSE 1 and 2 trials, where more than 99.9% of participants remained HIV-negative, Lenacapavir has quickly emerged as a game-changer.
For Carmen Perez Casas, head of Pandemic Preparedness and Response at Unitaid, the excitement is palpable.
"It is a very, very significant moment," she said. "We knew it (Lenacapavir) was safe to use already. We didn't know if it was so efficient for prevention. The clinical trials...demonstrated that it's really one of the most effective, efficient products that one can have to prevent HIV."
Unlike previous PrEP methods, including daily oral pills and bi-monthly injections, Lenacapavir only requires two subcutaneous injections per year. This feature is particularly important for populations facing adherence challenges.
"There are problems by certain populations to take an oral pill every day," Perez Casas said, explaining such reasons as stigma, logistics or travel.
"Although the oral pill, if taken correctly, is also very efficient, it is not effective, because people cannot use it," she added.
Speed, price critical
Lenacapavir is designed to inhibit HIV at multiple stages of its lifecycle, unlike most antivirals that act on just one stage. It is already approved in multiple countries for the treatment of multi-drug-resistant HIV and is now entering the prevention space with unprecedented speed. That speed is critical.
"This product reaches as many people as possible in the short time frame to have a bite on the epidemic," said Perez Casas, highlighting the upcoming World Health Organization (WHO) guidelines scheduled for release on July 14.
Unitaid, in partnership with WHO, is preparing to support early adopter countries for rollout by the end of 2025.
Yet the success of Lenacapavir depends on more than science. It hinges on equitable access.
The current US list price for Yeztugo is $28,000 per year. Gilead says it's working on making lower-cost versions available, but for many low- and middle-income countries, the price remains a barrier.
"Unless the price is close to the price of the oral tablets for PrEP, it's going to be very difficult," Perez Casas noted. "That is now $40 per person per year. Anything different from that will be a big effort for countries."
Unitaid is already investing in enabling generic production to bring costs down.
"We will be announcing in Kigali interventions that we can support...to ensure that those generic companies can actually launch the product as soon as possible and at the lowest possible cost," she said.
Adding to the challenge is a shift in global funding dynamics. The US President's Emergency Plan for AIDS Relief (PEPFAR) had committed to bringing the drug to 2 million people. But that changed with the new administration.
"They have withdrawn their support," said Perez Casas. "Now we are left with a smaller number of donors."
Still, there’s optimism. Regulatory filings are underway in multiple countries, and WHO's prequalification program could accelerate national approvals. Once national guidelines are in place and funding secured, rollout can begin. But successful adoption will also require political will, robust supply chains, and most importantly, community engagement.
"You need communities to be receiving treatment literacy and participating in generating treatment literacy and awareness so that people can actually use the product," said Perez Casas.
'We can end AIDS' as public health problem
The long-term financial logic of prevention is also compelling.
"For every cohort of 1.3 million people that gets HIV infected, which is what we have now per year, you need to think on the cost of treatment for life," said Perez Casas, noting that adds up to $2 billion.
"If you do the calculations, it's really much worth it to ensure that we are able to focus on Lenacapavir and roll it out," she added.
For Perez Casas, the equation is simple: "We have the tools to end HIV...and also the technologies. The problem is going to be the financial side of things, of course, and whether equitable access is finally clearly on the agenda."
If countries, donors and communities can come together to solve those challenges, the global fight against HIV may finally have a timeline.
"We can end AIDS as a public health problem," she said. "There will be cases, but it doesn't need to be an epidemic. We can control it."
