US regulators approve a Twice-Yearly shot to prevent H.I.V. infection

By Apoorva Mandavilli,  WASHINGTON United States 

The United States Food and Drug Administration on Wednesday approved a twice-yearly injection that provided a near-perfect shield against H.I.V. infection in clinical trials.

The approval is among the most anticipated developments in the prevention of H.I.V. But it arrives during deep cuts to global health programs that were expected to purchase and distribute the drug in low-income countries.

To what extent the drug, called lenacapavir, can now be rolled out is uncertain.

“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, executive director of the international H.I.V. prevention organization AVAC.

“And it’s as if that opportunity is being snatched out of our hands by the policies of the last five months,” he said.

With much less money available, governments abroad may instead choose to prioritize treatment of the infected.

“We were so excited about the possibilities,” said Dr. Linda-Gail Bekker, who led a clinical trial of the drug. “I don’t think any of us envisaged this year going quite the way it has.”

Lenacapavir, made by Gilead Sciences and to be marketed as Yeztugo, is the second long-acting option for H.I.V. prevention. An alternative, cabotegravir (brand name Apretude), is a shot given every two months and is made by ViiV Healthcare, GSK’s H.I.V. company.

Apretude is given to roughly 21,000 Americans, while daily pills to prevent H.I.V. are taken by nearly 500,000.

Many public health experts believe that the convenience of a twice-yearly injection has the potential to transform the epidemic. In clinical trials, lenacapavir surpassed expectations: Participants given just two shots each year were almost completely protected.

In the United States, more than 39,000 people contracted H.I.V. in 2023. Every newly infected person incurs about $1.1 million in medical care over his or her lifetime, Daniel O’Day, Gilead’s chairman and chief executive officer, said in an interview.

Prevention is “the most cost-effective way of bending the arc of this epidemic,” he added.

Lenacapavir is already sold as a treatment for H.I.V. infections that are resistant to other medications, at roughly $42,000 per patient per year. (Few individuals pay the full cost.)

Lenacapavir taken to prevent H.I.V. infection, a regimen called pre-exposure prophylaxis, or PrEP, will be sold at a list price of $28,218, according to Gilead.

While the price for generic oral pills now is as little as $1 per dose, the other long-term option, Apretude, costs roughly $24,000 per year.

Gilead said most people would not have to pay for the drug, either because of insurance coverage, or through patient assistance programs. But advocacy organizations worry that insurance companies may raise barriers to widespread availability.