The FDA Approves Powerful HIV Prevention Drug
The Food and Drug Administration on Wednesday approved a powerful new drug that provides almost complete protection against HIV infections. The twice-yearly injection, known as lenacapavir, offers near-perfect protection against infection across broad populations and geographies, two clinical trials showed. It’s a promising development, but public health experts are concerned about how widely available the drug will be, considering President Donald Trump has enacted deep cuts to both global and domestic HIV programs since taking office in January.
“We’re on the precipice of now being able to deliver the greatest prevention option we’ve had in 44 years of this epidemic,” said Mitchell Warren, the executive director of AVAC, a global HIV prevention organization. “It’s as if that opportunity is being snatched out of our hands by the policies of the last five months.”
Trump froze all programming and services under PEPFAR, the U.S. government’s global health initiative to treat and prevent HIV and AIDS abroad. Soon after that, the Trump administration
decimated the nation’s domestic HIV prevention programs amid Robert F. Kennedy Jr.’s dramatic takeover of the Department of Health and Human Services. Kennedy quickly shut down several offices within HHS and the Centers for Disease Control and Prevention that had been dedicated to developing HIV prevention strategies and tracking new infections.
Earlier this month, a federal judge blocked several of Trump’s executive orders threatening to pull federal funding from nonprofits that primarily service LGBTQ+ communities, and in particular provide HIV prevention and treatment. But HIV advocates have cautioned that the Trump administration is creating a scenario in which more people would contract HIV and die. Advocates have worried the cuts would exacerbate existing disparities across certain populations, including in particular the high rates of HIV infections among trans women, gay and bisexual men of color, and Black women.
Lenacapavir, which will be sold by Gilead Sciences under the name Yeztugo, could help communities that have long struggled to access HIV prevention medication. It is the second injectable pre-exposure prophylaxis drug on the market; the FDA approved cabotegravir, known as Apretude, in 2021. Unlike daily oral PrEP pills, the injectable option has shown signs of being more effective at preventing the virus and could better serve people who deal with pill fatigue. Roughly 21,000 Americans take injectable Apretude, and 500,000 take daily pills.
Health insurers could decline to cover the drug, or they could impose higher copays than they do on daily pills, Elizabeth Kaplan, the director of health care access at Harvard Law School’s Health Law and Policy Clinic, told NBC News. The Supreme Court is slated to rule in the coming weeks on whether certain forms of preventative health care — including PrEP, as well as cancer screenings and diabetes medication — have to be covered at no cost by insurance plans under the Affordable Care Act.
