FDA Approval Opens New Era for HIV Prevention: Meet Yeztugo

Twice yearly shot offers hope and convenience in HIV prevention.


A bold step forward: Twice yearly HIV prevention is here

If you’ve ever felt overwhelmed by the idea of taking daily medication or struggled to keep up with appointments, you’re not alone. For many, sticking to a daily or even monthly schedule for HIV prevention has been a challenge. This challenge sometimes leads to missed doses and increased risk. But a new chapter is unfolding.

On June 18, 2025, the U.S. Food and Drug Administration (FDA) approved Gilead’s Yeztugo, also known as lenacapavir, as the first and only twice yearly injectable option for pre-exposure prophylaxis (PrEP) against HIV. This isn’t just another medicine; it’s a milestone that challenges our assumptions about what’s possible in HIV prevention.

Why Yeztugo matters

As an educator, I believe that understanding the why behind medical advances is just as important as the what. Here’s what sets Yeztugo apart:

  • Convenience: Two injections a year. That’s it. No daily pills, no monthly appointments. Just a simple schedule that fits real lives.
  • Preference: In clinical trials, more than 75% of participants said they preferred the twice yearly shot over daily medication. Many reported feeling safer and more confident they wouldn’t miss a dose.
  • Inclusivity: The pivotal PURPOSE trials didn’t just test Yeztugo in the “average” patient. Pregnant and lactating women, adolescents, and young people, groups often left out of such research, were front and center. And the results? Consistent protection and good tolerance across all groups.

Adaptability: Special dosing adjustments were explored for people who take other medications, like tuberculosis treatments or cholesterol lowering drugs, a thoughtful nod to the reality that prevention doesn’t happen in a vacuum.

The science, simplified

Yeztugo works differently from most HIV preventatives. Instead of targeting the virus at a single stage, lenacapavir blocks HIV at multiple points in its life cycle, making it a powerful safeguard, even for those at higher risk.

Of course, no prevention is perfect. Individuals must be HIV-negative before starting Yeztugo, and regular testing is essential before each injection. This is not an “inject and forget” solution, but it’s a significant leap toward making prevention more accessible for everyone.

Reflect and discuss

Pausing for a moment, how might twice yearly PrEP reshape your approach (or your community’s approach) to HIV prevention? If you’re a healthcare provider, educator, or advocate, what could you do to raise awareness of new options like Yeztugo? Are there barriers (cost, stigma, access) that still need addressing?

Taking action: What’s next?

  • Learn more: If you or someone you know could benefit from PrEP, talk to a healthcare provider about whether Yeztugo might be an option.
  • Stay informed: Follow the latest recommendations and research. Science and policy move quickly.
  • Start the conversation: Share what you’ve learned. Sometimes, a single conversation can change a life.

Looking ahead

Yeztugo’s approval is more than a scientific achievement, it’s a signal that HIV prevention can, and must, meet people where they are. As we continue to challenge old thinking and demand better from our health systems, let’s hold onto this hope: bold innovations, paired with education and compassion, really can move us closer to ending HIV for good.

Curious to learn more? Read about the data and clinical trials here.


  1. U.S. Food and Drug Administration. FDA approves first twice-yearly injectable for HIV pre-exposure prophylaxis (PrEP): Lenacapavir (Yeztugo). Published June 18, 2025. Accessed August 19, 2025. https://www.fda.gov/news-events/press-announcements
  2. Gilead Sciences. Gilead announces FDA approval of Yeztugo™ (lenacapavir) for HIV prevention. Press release. Published June 18, 2025. Accessed August 19, 2025. https://www.gilead.com/news
  3. Loftus P. FDA approves powerful twice-yearly treatment to prevent HIV. Wall Street Journal. June 18, 2025. Accessed August 19, 2025. https://www.wsj.com/health/pharma/fda-approves-powerful-twice-yearly-treatment-to-prevent-hiv-df628df8
  4. ClinicalTrials.gov. The PURPOSE 1 and PURPOSE 2 studies: Lenacapavir for HIV prevention. Bethesda, MD: National Library of Medicine. Updated 2025. Accessed August 19, 2025. https://clinicaltrials.gov

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