On June 18, 2025, the U.S. Food and Drug Administration (FDA) approved lenacapavir—marketed as Yeztugo—as the first and only twice-yearly injectable HIV prevention treatment. This milestone offers a promising alternative to daily oral PrEP pills, especially for individuals facing challenges with adherence.
What Is Lenacapavir?
Lenacapavir is a capsid inhibitor, a novel class of antiretroviral drugs that disrupts the HIV virus's ability to replicate. Administered subcutaneously, it provides sustained protection against HIV with just two injections per year. In clinical trials, lenacapavir demonstrated a 99.9% efficacy in preventing HIV among participants .
Global Access and Affordability.
Gilead Sciences has signed royalty-free license deals with six generic producers in recognition of the need for broad access, allowing lenacapavir to be produced in 120 low- and lower-middle-income nations. The goal of this program is to increase the medication's accessibility on a global scale.
But in the United States, the list price is about $28,218 per person annually, which has sparked questions about affordability. According to experts, the cost might drop dramatically with more supply and demand, possibly to as low as $25 to $40 per person annually.
Implications for HIV Prevention.
The approval of lenacapavir marks a significant advancement in HIV prevention strategies. Its long-acting formulation addresses common barriers such as daily pill adherence and the stigma associated with daily HIV prevention methods. Organizations like the World Health Organization (WHO) and Unitaid have welcomed this development, emphasizing its potential to reshape HIV prevention efforts, particularly in underserved populations .
Ongoing Challenges.
Despite its promise, several challenges remain:
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Access and Distribution: Ensuring that lenacapavir reaches those most at risk, especially in regions with limited healthcare infrastructure, is crucial.
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Affordability: While licensing agreements aim to reduce costs, the initial high price point may limit access for some populations.
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Ethical Considerations: The effectiveness of lenacapavir raises ethical questions regarding its use in clinical trials for future HIV vaccines .
Conclusion
The approval of lenacapavir represents a significant step forward in the fight against HIV. Its innovative approach to prevention could have a profound impact on global health, provided that access and affordability challenges are addressed. As the world continues to combat the HIV epidemic, advancements like lenacapavir offer hope for a future with fewer new infections and improved quality of life for those at risk.
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