FDA Approves Groundbreaking Twice-Yearly HIV Prevention Injection: What You Need to Know
The US Food and Drug Administration (FDA) has officially approved a revolutionary new method for HIV prevention – a twice-a-year injection called Yeztugo (lenacapavir). Developed by Gilead Sciences, this long-acting medication offers an exciting alternative to traditional daily pills and frequent injections.
In this post, we break down what this means for public health, who it can help, and why this approval could be a major step forward in the global fight against HIV.
What Is Lenacapavir (Yeztugo)?
Lenacapavir is a long-acting antiretroviral drug originally developed to treat certain HIV infections. It has now been approved in the United States for pre-exposure prophylaxis (PrEP) — a method used to prevent HIV before exposure occurs.
Brand name: Yeztugo
Dosage: Two injections per year (once every six months)
Manufacturer: Gilead Sciences
Approval: FDA approval granted in June 2025
The approval is based on strong clinical trial data showing that just two injections a year can offer near-complete protection against HIV.
Clinical Trial Results: How Effective Is It?
Lenacapavir has delivered remarkable results in global clinical trials.
PURPOSE 2 Trial (for men and nonbinary individuals)
Found a 96% reduction in the risk of HIV infection
Included over 2,180 participants
Only two people became infected during the study
PURPOSE 1 Trial (for women)
Showed 100% efficacy in preventing HIV
All participants who received the injection remained HIV-free
These results make Yeztugo more effective than current daily PrEP pills like Truvada, which already offer high protection when taken consistently.
“This is a milestone moment in the fight against HIV,” said Daniel O’Day, CEO of Gilead Sciences. “With just two doses a year, we can change the course of prevention forever.”
How Does It Work?
Lenacapavir works by entering the bloodstream and blocking HIV from taking hold in the body. According to Dr. Jared Baeten from Gilead Sciences:
“Having the medicine already in your system means if you encounter HIV, the drug can stop the infection before it starts.”
Its bi-annual dosage means people no longer need to remember daily pills or monthly injections, helping overcome adherence issues – a major barrier in traditional HIV prevention.
A Discreet, Empowering Option for Many
This new option is not just medically effective – it’s also socially empowering.
Discreet use: Only two injections a year mean less stigma and more privacy.
Less stress: “Set it and forget it” approach removes daily reminders.
No daily side effects: Minimal adverse reactions, mainly mild injection-site irritation.
“For many people, this could be the private, empowered option that makes HIV prevention workable,” said Dr. Baeten.
Real Stories: Why It Matters
One clinical trial participant, Ian Haddock, described the experience as life-changing.
Faced stigma in his youth about being queer and HIV.
Started taking daily PrEP pills in 2015 but struggled with side effects and consistency.
Enrolled in the PURPOSE 2 trial in 2024 and reported no side effects other than mild irritation at the injection site.
Now plans to continue with lenacapavir long-term.
“It feels like a full-circle moment,” said Haddock, now an HIV awareness advocate and founder of The Normal Anomaly Initiative.
Cost and Availability
Gilead has confirmed that people in the U.S. can start asking healthcare providers about Yeztugo immediately.
First injections may take up to two months to administer, depending on insurance coverage.
List price for PrEP use: Not yet announced.
Cost for treatment use (not prevention): Nearly $45,000 per year without insurance.
A separate study estimated the minimum cost for mass production could fall to as low as $40–$93 per person annually, if voluntary licensing and generic production are adopted.
Source: Journal of Antimicrobial Chemotherapy (November 2024)
Urgent Concern: Budget Cuts Threaten Progress
While the FDA’s approval marks a leap forward, advocates are warning that proposed federal budget cuts could undo this progress.
2026 budget proposal eliminates over $1.5 billion in HIV prevention and research funding.
Cuts impact:
CDC HIV programs
Global HIV initiatives
Surveillance and research efforts
“Now is not the time to pull the rug out from under HIV prevention,” said Carl Schmid from the HIV+Hepatitis Policy Institute. “Such cuts will increase infections and costs.”
What Happens Next?
With lenacapavir now FDA-approved for prevention:
Healthcare providers will begin offering it as a PrEP option.
Awareness campaigns are expected to promote its availability and benefits.
Pricing details will determine how accessible the injection becomes in both the U.S. and globally.
Advocates are hopeful this innovation will drive us closer to ending new HIV infections entirely.
“We now have the opportunity to make HIV history,” said Dr. Baeten. “With testing, treatment, and prevention like this, we can imagine a world without HIV.”
Key Takeaways
Yeztugo (lenacapavir) is the first and only twice-yearly HIV prevention injection.
Offers up to 100% protection in clinical trials.
Reduces barriers like daily pill adherence and stigma.
Expected to transform global HIV prevention efforts.
Calls are growing to protect funding for HIV programs amidst new medical breakthroughs.
Sources