Record-Breaking: FDA approves new HIV prevention injection

In what experts are calling a watershed moment in global health, the U.S. Food and Drug Administration (FDA) has approved Yeztugo, a powerful twice-yearly injection from pharmaceutical giant Gilead Sciences designed to prevent HIV infections.

The injectable antiviral—known generically as Lenacapavir—is taken just once every six months, a major step forward from the daily pills or bi-monthly shots currently in use.

“This really will bend the arc of the epidemic,” said Gilead CEO Daniel O’Day, ahead of the FDA’s green light.

A true breakthrough

The approval follows two landmark clinical trials in 2024, which showed Yeztugo to be virtually 100% effective in preventing new HIV infections when administered on schedule.

The FDA’s decision puts Yeztugo in the spotlight as the most convenient and long-acting HIV prevention tool available to date, potentially transforming the global fight against HIV/AIDS.

According to the World Health Organization, over 1.3 million people were newly infected with HIV in 2023, with 630,000 deaths recorded.

In the U.S. alone, 700 new infections and 100 deaths are reported every single week.

Despite its medical promise, Yeztugo faces policy and access challenges, including proposed cuts to U.S. HIV prevention funding under the Trump administration.

Advocates warn these cuts could hinder the drug’s rollout to vulnerable populations.

“The real test is access,” said Jeremiah Johnson, Executive Director of PrEP4All, a nonprofit advocating for equitable HIV prevention.

Groups most affected by HIV—people of color, gay and bisexual men, transgender women, and other marginalized communities—remain at the forefront of the epidemic. Making sure Yeztugo reaches them will be key to its success.

Cost and Coverage

Gilead has set Yeztugo’s list price at $28,218 annually in the U.S.—comparable to other pre-exposure prophylaxis (PrEP) options.

For comparison:

Truvada and Descovy, Gilead’s daily oral PrEP pills, cost about $2,000/month, or roughly $24,000 a year without insurance.

GSK’s Apretude, a bimonthly injection, is $4,000 per dose before insurance.

However, Gilead insists affordability will not be a barrier. The company offers:

• Copay programs that can reduce costs to zero for insured patients.
• A no-cost program for uninsured individuals who qualify
• Broad insurance coverage similar to existing PrEP drug.

“We are committed to ensuring Yeztugo is accessible for everyone who needs it,” a Gilead spokesperson said.

Yeztugo is not entirely new.

Lenacapavir is already FDA-approved for HIV treatment under the brand name Sunlenca, which costs over $42,000 per year.

This dual role strengthens Gilead’s grip on the HIV prevention and treatment landscape.

Public health experts see Yeztugo as the most significant development in HIV prevention in decades.

With wide adoption and continued funding, the injection could finally put the world on a path to ending new HIV transmissions.

But access remains the critical question.

“It’s a historic leap forward,” said Johnson. “Now let’s make sure it reaches the people who need it most.”

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