On June 18, 2025, the U.S. Food and Drug Administration (FDA) approved lenacapavir, marketed under the name Yeztugo, as the first preventive option against HIV that is administered only twice a year. This marks a major advancement in the field of HIV prevention due to its high efficacy and ease of adherence compared to current daily or monthly medications.
In Phase 3 clinical trials (PURPOSE 1 and 2), the drug demonstrated nearly 99.9% effectiveness in preventing HIV transmission, with side effects limited mainly to mild injection site reactions. The medication received significant praise and was named “Breakthrough of the Year” for 2024 by Science magazine.
Experts believe that a biannual injection could significantly improve patient adherence to HIV prevention, especially among individuals who struggle with daily pill regimens due to social or economic hardships, such as poverty, homelessness, or substance use. This new option may also reduce stigma associated with more visible, frequent PrEP regimens.
Despite the widespread optimism, concerns remain about affordability and access. Yeztugo is expected to cost around $28,000 per year, which could place it out of reach for low-income populations—particularly at a time when public health programs like Medicaid face potential budget cuts.
Nevertheless, Gilead Sciences, the manufacturer, has stated that it is working to ensure broad insurance coverage for the drug, similar to what is currently available for other preventive options like Descovy, which is widely covered at little to no cost to consumers.
In summary, lenacapavir represents a significant step forward in the fight against HIV. If made accessible and affordable through insurance programs, it could be a true “game-changer” in the global effort to end the HIV epidemic.
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