EU Approves Gilead’s New HIV Prevention Injection: What It Means

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Table of Contents

1. What Is Yeytuo and How Does It Work?
2. Why the EU Approval Is a Major Milestone
3. The Promise of Twice-Yearly PrEP
4. Concerns Over Cost and Access
5. Conclusion
6. FAQs

What Is Yeytuo and How Does It Work?

On August 26, 2025, the European Commission officially approved Gilead Sciences’ long-acting injectable HIV prevention drug, Yeytuo, marking a groundbreaking shift in global PrEP (pre-exposure prophylaxis) strategies. Known generically as lenacapavir, this drug is administered as an injection just twice a year—offering a convenient alternative to daily pills like Truvada or Descovy.

Lenacapavir blocks HIV at multiple stages of its life cycle, reducing the risk of infection to nearly zero when taken consistently. With only two injections per year, it significantly reduces the burden of adherence, especially for people who face challenges with daily medications.

Why the EU Approval Is a Major Milestone

The European approval follows the United States’ green light in June 2025, where the drug is sold under the brand name Yeztugo. This rapid regulatory progress highlights global urgency to expand access to more effective and user-friendly HIV prevention options.

Public health officials in Europe have welcomed the decision, emphasizing that long-acting PrEP options like Yeytuo could reduce new HIV infections among high-risk populations, especially in groups with historically low PrEP uptake.

The European Medicines Agency (EMA) reviewed substantial data showing 100% efficacy among study participants who adhered to the biannual injection schedule.

The Promise of Twice-Yearly PrEP

For people living in fear of HIV exposure, a twice-yearly injection could be life-changing. It minimizes the stigma of having to carry or take daily pills and reduces missed doses. According to Gilead, this could particularly benefit populations such as:

  • LGBTQ+ individuals facing healthcare discrimination
  • Adolescents and young adults with inconsistent routines
  • People in low-income or rural areas with limited pharmacy access

By simplifying prevention, Yeytuo has the potential to reshape global HIV management and boost PrEP coverage.

Concerns Over Cost and Access

Despite the promise, concerns remain. The cost of lenacapavir in the U.S. is around $28,000 annually, and it’s unclear whether European pricing will be significantly lower. Gilead has pledged to work with governments and global health organizations, including The Global Fund, to expand access in low- and middle-income countries.

However, major U.S. pharmacy benefit managers like CVS Health have excluded Yeztugo from their coverage plans, citing high costs. Activists fear this pattern could repeat in Europe, limiting the reach of what should be a public health breakthrough.

Organizations are calling for transparent pricing, subsidized access programs, and wider insurance support to ensure Yeytuo doesn’t become a drug only accessible to the privileged few.

Conclusion

The European Union’s approval of Gilead’s long-acting PrEP injection is a hopeful step in the global fight against HIV. Yeytuo’s convenience, backed by impressive clinical results, could help break down barriers to prevention for many at risk.

But the promise of this innovation depends on equitable access. As global health systems weigh cost against benefit, the next challenge is ensuring that no one is left behind in the race to end HIV.

Talk to a healthcare provider to see if long-acting PrEP is the right option for you.

FAQs

What is Yeytuo?
Yeytuo is the European brand name for lenacapavir, a long-acting injection for HIV prevention administered every six months.

How effective is Gilead’s new injection?
Clinical trials showed 100% efficacy among individuals who adhered to the injection schedule.

Is Yeytuo available in the United States?
Yes. It was approved by the FDA in June 2025 under the brand name Yeztugo.

Who should consider using this injection?
It’s recommended for people at high risk of HIV exposure, particularly those who struggle with daily pill adherence.

Will insurance cover the cost of Yeytuo?
Insurance coverage varies. In the U.S., CVS Health does not cover it, and EU pricing details are still being finalized.

This content is not medical advice. For any health issues, always consult a healthcare professional. In an emergency, call 911 or your local emergency services.

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