In a historic milestone for global health, the U.S. Food and Drug Administration (FDA) has approved Gilead Sciences’ groundbreaking HIV prevention injection, Yeztugo HIV shot (lenacapavir). This twice-a-year HIV prevention injection marks the first and only long-acting solution available in the U.S., offering a revolutionary approach to preventing HIV infection with just two doses per year.
Designed to serve individuals at high risk of HIV, Yeztugo transforms how pre-exposure prophylaxis (PrEP) is administered. By eliminating the need for daily pills like Truvada or Descovy, this FDA approved HIV shot is already being hailed as one of the most impactful innovations in HIV prevention since the epidemic began.
“This is a massive public health breakthrough,” said Dr. William Pao, Chief Development Officer at Gilead Sciences. “We’re giving people more freedom, fewer doses, and better protection.”
Why the Yeztugo HIV Shot Is a Game-Changer
The Yeztugo HIV shot is built on a new drug class called capsid inhibitors. By targeting the virus’ core shell, it blocks replication at multiple stages of the HIV lifecycle.
Key advantages include:
- Biannual dosing: Just 2 shots per year, making it the lowest-maintenance PrEP option in history.
- Exceptional efficacy: The PURPOSE 1 and 2 clinical trials showed 99.9% prevention rates—with zero infections in women who received the injection.
- Low side effects: Most adverse events were mild injection-site reactions that resolved on their own.
- Stigma reduction: With no daily medication to manage, users experience less visibility and stigma.
Read the FDA announcement for official details.
Current HIV Prevention Options: What the Yeztugo HIV Shot Improves
Until now, HIV prevention largely relied on:
- Daily oral PrEP (Truvada, Descovy): Up to 99% effective if taken consistently. But in practice, adherence is low due to pill fatigue, stigma, and access barriers. [source]
- Monthly injectables for treatment (Cabenuva): Used for managing existing HIV, not prevention. Require monthly clinical visits. [source]
- ART regimens: One-pill-a-day therapies to treat HIV-positive individuals. Effective, but lifelong.
The drawback of all these solutions is the need for continuous adherence, which many at-risk individuals struggle with.
Gilead HIV Injection Innovation: The Science Behind Lenacapavir
Yeztugo (lenacapavir) is developed by Gilead Sciences, a longtime leader in antiviral research. Originally approved under the brand Sunlenca for HIV treatment in drug-resistant patients, lenacapavir was later adapted as a long-acting PrEP solution.
- Mechanism: It binds to HIV-1 capsid proteins, disrupting nuclear entry and viral assembly—two critical points in HIV’s lifecycle.
- Recognition: Named Science’s 2024 Breakthrough of the Year for its groundbreaking prevention performance.
- First ID’d: Capsid inhibitor potential discovered in 2020; fast-tracked by FDA under Breakthrough Therapy designation.
Trials, Testing & FDA Approval of the Yeztugo HIV Shot
- PURPOSE 1 trial (South Africa, Uganda): Studied cisgender women. Result: Zero infections in the treatment group.
- PURPOSE 2 trial (U.S., LATAM, South Africa): Studied men and gender-diverse individuals. Result: 99.9% efficacy.
- June 18, 2025: Official FDA approval.
Testing involved a lead-in oral dose followed by subcutaneous injections every six months. Safety data showed fewer than 1.2% of users had any notable adverse effects. [source]
Who Is Eligible for the Yeztugo HIV Shot?
- Age: Approved for adults and adolescents weighing 35kg (77 lbs) or more.
- Status: Must be HIV-negative at the time of each injection.
- Risk: Intended for individuals at high risk of sexual acquisition of HIV.
- Monitoring: HIV test required prior to each injection to ensure eligibility and prevent resistance.
Cost, Insurance, and Access to Yeztugo
- Cost: Estimated at $14,109 per dose or $28,218/year.
- Insurance: Expected to be covered under Medicaid and most private insurance as a preventive medication.
- Access support: Gilead has launched copay assistance and donation programs. [source]
- Global licensing: Available royalty-free in 120+ low-income countries via Gilead’s partnerships with PEPFAR and the Global Fund.
Broader Public Health Impact of the Yeztugo HIV Shot
Roughly 1.2 million people in the U.S. are at risk of HIV, yet less than 30% currently use PrEP. This gap is especially wide among Black, Latino, and LGBTQ+ communities. Yeztugo could become a powerful tool to bridge this gap.
By offering discreet, long-lasting protection, this Gilead HIV injection addresses barriers like stigma, cost, and access that have limited current solutions.
“This approval will save lives. It’s one of the biggest wins in HIV prevention since PrEP was introduced,” said Harold Phillips, former White House National AIDS Policy Director.
What’s Next for Gilead’s Long-Acting HIV Prevention Injection?
Gilead is already researching self-injectable and once-a-year versions of lenacapavir, which could expand its reach even further.
Global public health officials are also pushing to ensure equitable rollout, especially in underserved communities. That includes building healthcare infrastructure, awareness campaigns, and reducing racial and economic disparities in HIV prevention access.
Final Thoughts
The FDA approval of Yeztugo is not just a pharmaceutical triumph—it’s a public health revolution. With exceptional efficacy, low maintenance, and broad access potential, this HIV prevention injection could dramatically reduce new infections and reshape the future of HIV care.
For families, individuals, and communities impacted by HIV, this is not just a scientific breakthrough—it’s a symbol of hope, progress, and possibility.
