A New Option for HIV Prevention
The U.S. Food and Drug Administration has approved lenacapavir for pre-exposure prevention of HIV, a move seen as a major step in the fight against the virus. Administered twice a year, the drug offers near-complete protection, according to clinical data released last year.
The injectable medication, already authorized for HIV treatment, now joins the prevention toolkit, offering a more convenient alternative to daily oral PrEP, such as Truvada.
Better Efficacy Through Simplicity
Unlike daily PrEP pills that can be hard to maintain due to stigma or forgetfulness, lenacapavir requires only two injections per year. In large-scale trials, the drug showed 96–100% efficacy, even among vulnerable populations.
The PURPOSE 1 trial included over 5,000 women in South Africa and Uganda. Not one person contracted HIV while using the drug. The PURPOSE 2 study tracked over 3,000 individuals of various gender identities and recorded only two infections among those using lenacapavir.
The drug works by targeting HIV’s capsid protein, a novel mechanism that blocks the virus from replicating for six months after each dose.
Cost Poses a Barrier to Global Rollout
Despite its success, lenacapavir’s list price in the U.S. is roughly $28,000 per year, raising alarm about affordability—especially in countries hardest hit by the HIV epidemic.
Current oral PrEP costs around $40 per year in many low- and middle-income countries. Unless lenacapavir pricing aligns with that level, experts warn that it will place strain on national HIV prevention budgets.
According to global health experts, even if the drug is approved elsewhere, that doesn’t guarantee access. Broader availability will depend on manufacturing, distribution strategies, and local regulatory approval.
Manufacturing and Licensing for Broader Access
Gilead, the company behind lenacapavir, says it’s taking steps to expand access. The company has signed royalty-free licensing agreements with six generic drugmakers to supply 120 lower-income countries.
To bridge the gap while production ramps up, the firm plans to provide up to 2 million doses at cost, with no profit. However, researchers caution that even this figure may not be enough to meaningfully reduce transmission.
Countries like Brazil, Colombia, and Mexico, not covered by the licensing deal, may face higher prices. Gilead says it is working directly with these nations on tiered pricing models.
Policy and Political Headwinds
Lenacapavir’s future in global HIV prevention may be shaped as much by politics as by science. Although the drug holds great promise, foreign aid cuts could block its path to widespread use.
With the U.S. reducing funding for international HIV programs, organizations warn that millions could remain without access to newer, more effective tools.
Even if the cost of production is low—estimated by some researchers at $25 for two annual doses—the gap between potential and reality remains stark unless more governments and donors support its rollout.
Looking Ahead
Lenacapavir’s approval represents a turning point in HIV prevention science. Its convenience and efficacy set a new benchmark. But until the pricing and policy frameworks catch up, its life-saving impact may remain out of reach for many.
As other regulatory bodies begin evaluating the drug, the world watches to see whether innovation can overcome inequality in global healthcare.
