In June 2025, the U.S. Food and Drug Administration (FDA) officially approved Yeztugo (lenacapavir) as the world’s first twice-yearly injection for HIV prevention (PrEP).
Developed by Gilead Sciences, this landmark drug offers long-term protection from HIV with just two subcutaneous shots per year.
The approval is based on extensive clinical trials under the PURPOSE 1 and 2 studies, which showed near-perfect efficacy—zero new infections in cisgender women and only two infections across a broader population of over 2,000 individuals.
This brings its protective rate to approximately 99.9%, making it the most effective and long-acting HIV prevention method available today.
Lenacapavir works by targeting the HIV capsid, a protein shell that encases the virus’s genetic material.
By inhibiting this capsid, the drug prevents HIV from replicating inside human cells.
Unlike daily oral PrEP options like Truvada or Descovy, Yeztugo is designed to overcome common adherence issues by requiring just one injection every six months. This simplifies prevention for at-risk
populations, especially those who struggle with daily medication routines.
While the approval is being hailed as a major victory in the global fight against HIV, access and affordability remain concerns.
The U.S. list price for a year’s supply is expected to be around $28,000, though Gilead has committed to providing generics to 120 low-income countries and producing up to 10 million doses by 2026.
Global health experts see this breakthrough as a turning point that could drastically reduce new HIV infections—if distribution is equitable and timely.
In summary, Yeztugo's approval represents a critical milestone in HIV prevention science, combining exceptional efficacy, convenience, and innovation.
It has the potential to reshape the future of HIV prevention—especially if healthcare systems can ensure widespread access to those most in need.
In June 2025, the U.S. Food and Drug Administration (FDA) officially approved Yeztugo (lenacapavir) as the world’s first twice-yearly injection for HIV prevention (PrEP).
Developed by Gilead Sciences, this landmark drug offers long-term protection from HIV with just two subcutaneous shots per year.
The approval is based on extensive clinical trials under the PURPOSE 1 and 2 studies, which showed near-perfect efficacy—zero new infections in cisgender women and only two infections across a broader population of over 2,000 individuals.
This brings its protective rate to approximately 99.9%, making it the most effective and long-acting HIV prevention method available today.
Lenacapavir works by targeting the HIV capsid, a protein shell that encases the virus’s genetic material.
By inhibiting this capsid, the drug prevents HIV from replicating inside human cells.
Unlike daily oral PrEP options like Truvada or Descovy, Yeztugo is designed to overcome common adherence issues by requiring just one injection every six months. This simplifies prevention for at-risk
populations, especially those who struggle with daily medication routines.
While the approval is being hailed as a major victory in the global fight against HIV, access and affordability remain concerns.
The U.S. list price for a year’s supply is expected to be around $28,000, though Gilead has committed to providing generics to 120 low-income countries and producing up to 10 million doses by 2026.
Global health experts see this breakthrough as a turning point that could drastically reduce new HIV infections—if distribution is equitable and timely.
In summary, Yeztugo's approval represents a critical milestone in HIV prevention science, combining exceptional efficacy, convenience, and innovation.
It has the potential to reshape the future of HIV prevention—especially if healthcare systems can ensure widespread access to those most in need.
