HIV prevention drug hailed as a 'breakthrough' gets FDA approval

A pharmacist holds a vial of lenacapavir, nan injectable supplier that prevents HIV infection. On June 18, nan FDA approved nan supplier for usage successful nan U.S. Nardus Engelbrecht/AP hide caption

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Nardus Engelbrecht/AP

A supplier pinch nan imaginable to drastically curb nan HIV pandemic conscionable cleared its first regulatory hurdle.

On Wednesday, nan Food and Drug Administration approved lenacapavir for nan prevention of HIV. Clinical proceedings information from past twelvemonth propose conscionable 2 injections a twelvemonth supply near-complete protection against an HIV infection.

"It's a milestone infinitesimal successful nan history of HIV," says Daniel O'Day, president and CEO of Gilead Sciences, which manufactures nan drug, which was already approved to dainty HIV infection. "In our opinion, it's nan champion instrumentality yet successful helping extremity nan HIV pandemic for everyone, everywhere." Others agree. In 2024, Science hailed lenacapavir arsenic its "Breakthrough of nan Year" successful 2024.

The twice-yearly injection offers a much convenient replacement to nan existent modular of attraction for HIV prevention, a regular pill called Truvada. This pre-exposure prophylaxis (PrEP) is 99% effective astatine preventing HIV infection successful objective trials, but immoderate group look important barriers successful taking a regular pill. One study recovered oral PrEP's was only 26% effective successful definite groups, successful portion because of skipped doses.

"Even though nan pills work, nan Achilles bottommost of that strategy is that group were not adhering to taking nan pills arsenic prescribed," says Onyema Ogbuagu, an infectious illness interrogator astatine Yale University.

A twice-a-year curen could scope substantially much people, particularly those who look stigma for taking a regular medication. For instance, researchers recovered that immoderate azygous women successful South Africa opportunity taking a regular pill raises suspicion among their partners.

But nan costs of nan supplier — astir $28,000 a twelvemonth — could value retired many. While Gilead is taking steps to broaden access, nan precocious value coupled pinch nan U.S.'s steep cuts to overseas assistance could forestall group successful countries pinch nan highest HIV load from benefiting.

"Breakthrough of nan year"

Existing PrEP pills artifact an enzyme that nan HIV microorganism uses to transcript its familial worldly and reproduce. Lenacapavir useful a spot differently, targeting nan virus's "capsid protein," which houses its familial material.

Lenacapavir's powerfulness to forestall infection lies successful its expertise to disrupt this capsid, which prevents nan microorganism from replicating for astir six months. That power was demonstrated successful 2 objective trials, called PURPOSE 1 and PURPOSE 2, which were published past twelvemonth successful peer-reviewed journals.

PURPOSE 1 tracked complete 5,000 cisgender women successful South Africa and Uganda starting successful 2021. Not a azygous female who received lenacapavir contracted HIV complete nan course of nan trial. PURPOSE 2 tracked much than 3,200 cisgender men, transgender women and men, and gender non-binary persons, uncovering HIV infections successful conscionable 2 of nan participants who received lenacapavir, an efficacy of 96%.

"The efficacy for lenacapavir is conscionable ridiculously high," says Ogbuagu, who was progressive successful PURPOSE 2. "These are conscionable like, unheard of numbers.

Uncertain access

The FDA's determination makes lenacapavir disposable coming successful nan U.S., which sees astir 31,000 of nan 1.3 cardinal caller HIV infections each twelvemonth worldwide.

While nan FDA's determination has nary base connected entree successful different countries, it does build momentum for different regulatory authorities to o.k. nan drug, says Carmen Pérez Casas, elder strategy lead astatine Unitaid, a United Nations agency that helps trim nan costs of treatments for HIV/AIDS, TB and malaria. European Union support will beryllium particularly important successful enabling support successful low- to middle-income countries, she says, and could hap later this year.

"But support from a regulatory authority of a state doesn't connote that we spot entree to this merchandise yet," says Pérez Casas. Ultimately, that will dangle connected costs and distribution mechanisms, particularly successful debased and middle-income countries.

"For nan moment, countries are paying astir $40 per personification per twelvemonth for oral PrEP," she says. "Anything that diverges drastically from that level of value will really enforce a large accent connected fund lines connected HIV."

In principle, lenacapavir could beryllium manufactured for moreover little than that, according to Andrew Hill, a medicine science interrogator astatine Liverpool University. He and his colleagues calculated that nan supplier could beryllium wide produced for conscionable $25 for nan 2 biannual doses, based connected nan existent manufacturing costs. "That includes a 30% profit margin," he says.

Gilead's database value of $28,000 a twelvemonth is far, acold supra that. "We person made a determination to value successful statement pinch nan existing PrEP options," says O'Day, nan company's CEO, but Gilead is moving connected respective levels to supply lower-cost alternatives.

Gilead signed royalty-free licensing agreements pinch six generic manufactures past year, whom they'll activity pinch to supply lower-cost versions of lenacapavir to 120 lower-income countries pinch a precocious incidence of HIV. Several high-incidence but comparatively higher-income countries for illustration Brazil, Colombia and Mexico, are near retired of that woody and could look higher costs, though nan institution says they're moving pinch specified countries straight connected gradual pricing.

Until those generic manufacturers get up and running, nan institution says it will supply up to 2 cardinal group successful these countries pinch lenacapavir astatine cost, pinch nary profit going to Gilead.

"That looks for illustration a batch of drug, but if location are 1.3 cardinal caller HIV infections each year, and you request to dainty betwixt 40-50 group pinch a preventative supplier to forestall 1 infection, past 2 cardinal is not going to do anything," says Hill. "It's not ample capable to person immoderate important effect connected nan epidemic."

If different countries travel nan FDA's lead, lenacapavir could go progressively disposable successful nan coming months and years. But nan Trump administration's drastic cuts to overseas assistance — including HIV prevention — could limit lenacapavir's eventual reach.

"It's a very difficult situation," says Hill. "Because of nan cuts successful funding, we're going to spot millions of group dice from HIV successful nan adjacent respective years."