“FDA Approves Yeztugo: New HIV Prevention Injection with 99.9% Efficacy”

Yeztugo – Lenacapavir: Revolutionary New Drug Offers 99.9% Protection Against HIV

Introduction
In a major step forward in the fight against HIV, the U.S. Food and Drug Administration (FDA) has approved Yeztugo, a twice-yearly injection developed by Gilead Sciences. This new drug, scientifically known as lenacapavir, has shown a 99.9% effectiveness rate in preventing HIV transmission, offering new hope in the global battle against the virus.

What Is Yeztugo and How Does It Work?

Yeztugo (lenacapavir) is a long-acting HIV prevention injection designed to be administered only twice a year. This makes it far more convenient than daily oral PrEP (Pre-Exposure Prophylaxis) pills like Truvada, which have been the standard until now.

Key Benefits:

  • Only two doses required per year
  • Over 99.9% effectiveness
  • Suitable for adults and adolescents

This injectable PrEP could revolutionize HIV prevention, functioning much like a vaccine in its preventive ability.

Clinical Trials: Outstanding Results

Gilead conducted two major clinical trials involving more than 4,000 participants:

  • Trial 1: Over 2,000 women in sub-Saharan Africa
    100% reduction in HIV infections
  • Trial 2: Over 2,000 men and gender-diverse individuals
    9% effectiveness, only 2 infections reported

Both trials demonstrated that Yeztugo outperformed daily PrEP pills like Truvada. Side effects were minimal and included mild injection site reactions, headaches, and nausea.

These results were published in The New England Journal of Medicine, and Science named lenacapavir its 2024 “Breakthrough of the Year.”

Cost Concerns: A Major Barrier

Despite its promise, the high projected cost of Yeztugo could limit its accessibility. While Gilead has not revealed the official price, analysts estimate a launch cost of $25,000 per year in the U.S.
For comparison:

  • Lenacapavir as HIV treatment: $39,000 annually
  • Cabotegravir (older PrEP injection): Tens of thousands of dollars per year

Expert Warnings:

“Even high-income countries will not be able to afford widescale use of lenacapavir at prices above $20,000,” said Dr. Andrew Hill of Liverpool University.

His research indicates the drug could be mass-produced for as little as $25 per person per year.

Global Access Plans

To address these concerns, Gilead has partnered with six pharmaceutical companies to manufacture and distribute generic versions of lenacapavir in 120 low- and middle-income countries, once regulatory approvals are granted.

Additionally, Gilead has signed a separate agreement with the Global Fund to supply two million doses. This initiative involves:

  • Global Fund
  • S. President’s Emergency Plan for AIDS Relief (PEPFAR)
  • United Nations partners

However, recent budget cuts to PEPFAR under former President Donald Trump have created uncertainty around the future of this global supply plan.

What This Means for HIV Prevention

This FDA approval marks a historic advancement in HIV prevention, with the potential to dramatically reduce new infections, especially in communities with limited access to daily medication.

According to UN’s Winnie Byanyima:

“Lenacapavir could be the tool we need to bring new infections under control – but only if it is priced affordably and made available to everyone who could benefit.”

Final Thoughts

The approval of Yeztugo is a milestone in the global fight against HIV. While the drug’s medical effectiveness is undeniable, its success will depend heavily on global affordability and access.

Call to Action

Stay informed. Support equitable access to HIV prevention. Share this news to spread awareness.
To learn more about HIV prevention options or to find local PrEP resources, visit HIV.gov or speak to a healthcare provider today.

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