US FDA Accepts Gilead’s New Weekly Pill for HIV Prevention

Dr. Rachel Mendez MD, Medical Science Writer

✨ Why this is good news

HIV is a virus that weakens the immune system, and prevention options currently require daily pills or frequent injections.

First weekly oral prevention.Before, people at risk of HIV had to take a daily pill or get a twice-yearly shot. This new weekly pill, Yeztugo, offers a middle ground that is far less frequent than daily dosing but still oral and self-administered.
Proven in diverse populations.The PURPOSE 1 and PURPOSE 2 trials showed high efficacy across cisgender women, cisgender men and gender-diverse people globally. This means the option works for a wide range of individuals, not just one group.
Convenient 300 mg tablet.Instead of remembering a pill every day or scheduling a medical visit for an injection, patients would only need to take one tablet per week. This simplicity could improve adherence and reduce gaps in protection.
FDA acceptance moves it forward.The FDA accepting the application means the drug is now officially under review for approval. If granted, this would give patients a new long-acting oral choice that currently does not exist in the market.

The U.S. Food and Drug Administration has accepted a new drug application for a once-weekly oral pill that could become the first long-acting option for HIV prevention taken by mouth. The move brings Gilead Sciences’ Yeztugo (lenacapavir) one step closer to offering people at risk of HIV a convenient alternative to daily pills or twice-yearly injections.

The application is based on data from the PURPOSE 1 and PURPOSE 2 clinical trials, which showed high efficacy across diverse global populations, including cisgender women, cisgender men and gender-diverse people. If approved, the 300-mg tablet would be taken once a week as pre-exposure prophylaxis (PrEP), a strategy that reduces the risk of sexually acquired HIV. Currently, lenacapavir is already approved as a twice-yearly injection for PrEP and as a treatment for multi-drug-resistant HIV in combination with other antiretrovirals.

The oral tablet is already used as part of the Yeztugo regimen for an initial loading dose and as a bridge therapy when injections are delayed. The new once-weekly formulation would mark a significant step forward, offering a middle ground between daily pills and long-acting shots. Gilead’s chief medical officer noted that HIV prevention is not one-size-fits-all, and that a weekly pill would provide more choice for people who need or want PrEP. The therapy remains investigational for this use and is not yet approved anywhere globally.

A Broader Push for Long-Acting HIV Options

Lenacapavir is being studied across multiple ongoing and planned clinical trials as part of Gilead’s broader HIV prevention and treatment research program. The goal is to offer both long-acting oral and injectable options with several dosing frequencies, helping to address the individual needs and preferences of people and communities affected by HIV. There is currently no cure for HIV or AIDS, but these advances aim to make prevention more accessible and flexible.

The FDA is expected to complete its review in the coming months. If approved, once-weekly oral Yeztugo could become a groundbreaking tool in the fight against HIV, giving patients a powerful new way to stay protected with just one pill a week.

This article is for informational purposes only and does not constitute medical advice. The information presented is based on published research and official announcements. Always consult a qualified healthcare professional before making any medical decisions.