Long-Lasting HIV Prevention Shot Headed Toward Approval

Follow Drugslib on

Medically reviewed by Carmen Pope, BPharm. Last updated on June 6, 2025.

By I. Edwards HealthDay Reporter

FRIDAY, June 6, 2025 — 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.

Sources

  • The Wall Street Journal, June 5, 2025

    • Disclaimer: Statistical data in medical articles provide general trends and do not pertain to individuals. Individual factors can vary greatly. Always seek personalized medical advice for individual healthcare decisions.

    Source: HealthDay

    Posted : 2025-06-07 06:00

    Read more

    Disclaimer

    Every effort has been made to ensure that the information provided by Drugslib.com is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Drugslib.com information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Drugslib.com does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Drugslib.com's drug information does not endorse drugs, diagnose patients or recommend therapy. Drugslib.com's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners.

    The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Drugslib.com does not assume any responsibility for any aspect of healthcare administered with the aid of information Drugslib.com provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

    Popular Keywords