FDA approves new twice-yearly HIV shot. What to know

USA Today

18-06-2025

FDA approves new twice-yearly HIV shot. What to know
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New COVID booster guidelines set by FDA for healthy adults under 65
The FDA plans to require new clinical trials for approval of annual COVID-19 boosters for healthy Americans under 65.
The Food and Drug Administration on Wednesday approved Gilead's HIV prevention drug lenacapavir, a twice-a-year injectable medication that clinical trials show prevents new infections.
Gilead did not immediately say how much it will charge for the biannual shot, but company officials said it would be comparable to existing HIV prevention drugs.
The drug will be marketed under the name Yeztugo.
Advocates say the long-acting medication is promising because it's more convenient than existing HIV prevention drugs that must be taken daily.
Giving people the option of a twice-a-year injectable is "a game changer, not only for the United States, but around the world," said Carl Schmid, executive director of the HIV+Hepatitis Policy Institute.
Gilead officials lauded the FDA's approval of lenacapavir, which has been studied and developed over nearly two decades.
"We now have a very real opportunity to end the HIV epidemic," said Daniel O'Day, chairman and CEO of Gilead Sciences. "Lenacapavir has shown to be remarkably effective and only needs to be given twice a year, which represents a whole new way of preventing HIV.'
How does lenacapavir compare to other HIV prevention drugs?
Pre-exposure prophylaxis, or PrEP, medications are sold as a daily pill under brand names Truvada and Descovy, as well as generic versions. Another injectable medication, Apretude, is taken every two months after two initial shots taken one month a part.
The overwhelming majority of PrEP users take daily versions, but "it's hard to take a pill every day ... when it's for prevention," said Johanna Mercier, Gilead's chief commercial officer. "So we see adherence levels as low as 50% to 55%," which does not provide adequate protection for at-risk populations.
People are more likely to stay on the medication if they only need to take the medication twice a year, rather than daily oral doses, Mercier said.
What did the lenacapavir studies show?
In one study of women and adolescent girls in sub-Saharan Africa and Uganda, lenacapavir was 100% effective at preventing HIV infections.
A second study reported the twice-a-year injections lowered the HIV infection rate by 96% in groups of cisgender men and gender-diverse people in the U.S., Argentina, Brazil, Mexico, Peru, South Africa and Thailand.
Schmid said the studies show people are much more likely to take the medication as recommended when it's dosed twice a year compared to daily pills.
"This makes it so much easier and better for adherence and also for people who have other challenges in their life like mental health issues, work or stigma, " Schmid said.
Important read: Here's why most at-risk populations don't use HIV prevention drugs
How much will lenacapavir cost?
Mercier said the company intends to price the drug "in line with other branded medicines in this area."
Out-of-pocket costs for uninsured patients who take Truvada and Descovy, which Gilead also markets, can range from $22,000 to $30,000 per year, according to an analysis by GoodRx, which provides pharmacy drug pricing information.
Gilead expects health insurance companies will cover the full cost of lenacapavir as they do for other prevention medications.
The U.S. Preventive Services Task Force, an independent advisory panel of national experts that evaluates medical treatments and services, assigned an "A" rating for PrEP medications when prescribed to adolescents and adults at increased risk of HIV.
Under the Affordable Care Act, that means insurers must cover the full costs of the medication as preventive care.
Still, activists say insurers have charged copays or other cost sharing from required lab tests and medical visits. People must test negative for HIV before starting the medication. While on the treatments, they must take routine tests for HIV, other sexually transmitted infections and kidney health.
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More than 1 million new HIV cases each year
Every year, more than 1 million people globally become newly infected with HIV, according to the World Health Organization.
About 10 million worldwide need to take PrEP to meet global HIV prevention goals, WHO said. About 2.5 million take PrEP, WHO said.
More than 39,000 U.S. residents were diagnosed with HIV in 2023, according to the Centers for Disease Control and Prevention. More than 4,700 deaths in 2023 were attributed to HIV, the virus that weakens the immune system and causes AIDS, the CDC said.
A June study estimated as many as 2.2 million Americans could benefit from HIV prevention medications.
Men account for nearly 80% of new cases, mostly involving gay or bisexual men, the CDC said.
Research shows White patients are far more likely to take PrEP than their Black or Latino counterparts, even though White patients are less likely to get infected with HIV.
Geographically, the South accounts for more than half of new HIV cases.
"We hope to reduce those numbers and potentially get to a day when zero infections are reported," Mercier said.