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The Food and Drug Administration has approved Yeztugo, a groundbreaking HIV prevention shot by Gilead Sciences, marking what many advocates are calling a historic advance in the decades-long battle to end HIV transmission.
Delivered just twice a year, Yeztugo (generic name lenacapavir) nearly eliminated new HIV infections in clinical trials, offering a promising alternative to daily pills like Truvada. Its approval comes with high expectations—and steep challenges.
“This is the single best opportunity in 44 years of HIV prevention,” said Mitchell Warren, executive director of AVAC, an HIV advocacy group.
A Game-Changer in HIV Prevention
Yeztugo is the first long-acting injectable PrEP (pre-exposure prophylaxis) that requires only two injections per year, dramatically simplifying prevention for people at risk of HIV who struggle with daily pill adherence.
In clinical trials, Yeztugo reduced HIV risk by 89% compared to Truvada, and no women in a sub-Saharan Africa trial contracted HIV while on the drug. Experts hope it can close racial and socioeconomic gaps in access to effective HIV prevention.
“If it’s available easily and at low or no cost to uninsured or underinsured people,” said Dr. Susanne Doblecki-Lewis, site lead for the lenacapavir trial, “this could reduce disparities. But barriers like copays or prior authorization could worsen them.”
Political and Financial Roadblocks
Despite its medical promise, Yeztugo faces steep policy and cost-related hurdles.
The price tag—$14,109 per injection—has raised concern among insurers, many of whom may continue prioritizing older, cheaper generics like Truvada, which can cost as little as $30 per month. Access could further be restricted if a pending Supreme Court decision undercuts the ACA’s requirement for preventive service coverage, including PrEP.
Meanwhile, the Trump administration’s proposed 2026 budget slashes domestic HIV funding by 35% and seeks to dismantle the CDC’s HIV-prevention division entirely. Experts warn this could derail progress in promoting and delivering Yeztugo to the people who need it most.
Uptake May Be Slow Despite Need
Although PrEP use has expanded—with 200,000 monthly users in 2023, according to CDC estimates—it still falls far short of the 1.5 million gay and bisexual men in the U.S. who are good candidates for it. Uptake among Black and Latino men remains disproportionately low, a gap Yeztugo may help address—if access is equitable.
Previous long-acting options like Apretude, a bimonthly injection, have struggled with adoption due to the need for frequent clinic visits. Experts are hopeful that Yeztugo’s six-month dosage could overcome similar hurdles.
A Push for Equitable Distribution
Gilead says it’s working to make Yeztugo broadly accessible. The company will offer up to $7,200 annually in co-pay assistance and free access for qualifying uninsured individuals. Telehealth provider Mistr has already begun preparing to offer the injection through a network of urban LGBTQ+ clinics and storefronts.
“We’re ready,” said Tristan Schukraft, CEO of Mistr. “This is the future of HIV prevention, and we want it to be accessible.”
But advocates warn that continued cuts to the National Institutes of Health and CDC threaten the research and outreach infrastructure needed to implement new PrEP methods effectively. Many canceled HIV research grants under the Trump administration were ruled “arbitrary and capricious” by a federal judge just this week, but future funding remains uncertain.
What Comes Next?
The FDA’s approval of Yeztugo represents a monumental leap forward—but whether it leads to a meaningful drop in HIV transmission depends on a complex mix of policy, pricing, and public health priorities.
“The science is there,” said Mark Zandi, chief economist at Moody’s Analytics. “The question is whether the systems we have in place will let us use it to its full potential.”
As the United States navigates political battles and budget threats, the promise of finally curbing HIV infections may rest not on medicine alone, but on access, equity, and will.
