Long-Lasting HIV Prevention Shot Headed Toward Approval

Key Takeaways

• The U.S. Food and Drug Administration is expected to approve a new HIV shot this month

• A study showed the injection prevented all HIV cases in women and girls

• The drug's maker hopes the new shot will expand HIV prevention across the globe

FRIDAY, June 6, 2025 (HealthDay News) — A new injection to prevent HIV is expected to be approved by the U.S. Food and Drug Administration (FDA) later this month.

If approved, the shot — lenacapavir — would be given twice a year and could be a big step forward in the fight against HIV.

Drugmaker Gilead Sciences tested the shot in a study of women and girls. None of the participants who received the injections got HIV. 

That early success helped boost Gilead’s stock by 73% over the past year, The Wall Street Journal reported.

“We know it’s challenging to take a daily pill for prevention, and we see an incredible opportunity here,” Johanna Mercier, Gilead’s chief commercial officer, said.

Right now, more than 400,000 people in the United States use pills to prevent HIV, The Wall Street Journal added. These medications are referred to as PrEP, short for pre-exposure prophylaxis. 

Gilead expects the number of users to top 1 million by the next decade.

Many people already say they’d prefer a shot over daily pills. In one survey of more than 500 PrEP users, 95% said they would switch to a long-acting injection.

Sales of other long-acting options, like the shot Apretude from GSK, have risen sharply — up 63% in the past year.

Even with strong results, Gilead faces several hurdles.

One is reaching the people who need PrEP the most. Black Americans represent 39% of new HIV cases but only 14% of current PrEP users. 

Many people still face stigma or lack insurance coverage, which can limit access.

Gilead says reaching underserved groups is a top goal. Most current PrEP users have commercial insurance, but Medicaid will be key for expanding access to lower-income communities.

Another concern: Some experts worry the new shot may simply replace current Gilead products, like the daily pill Descovy, which now holds about 40% to 45% of the market.

But Gilead says the shot should help expand the overall number of people using PrEP in both the U.S. and abroad.

“We’re thinking globally about the public health impact we can have,” Mercier said.

The company is working with governments and health groups in the U.K. and low-income countries to raise awareness and make these products more available.

More information

The National Institutes of Health has more on Pre-Exposure Prophylaxis (PrEP).

SOURCE: The Wall Street Journal, June 5, 2025

What This Means For You

A new HIV prevention shot taken just twice a year may become available soon.