FDA Approves Long-Lasting Injection for HIV Prevention

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The U.S. Food and Drug Administration (FDA) has approved lenacapavir, a new injectable treatment for HIV prevention that requires only two doses per year. According to Gilead Sciences, the manufacturer, clinical trials demonstrated that lenacapavir is 99.9% effective in preventing HIV transmission among individuals weighing over 35 kilograms. This approval represents a significant advancement in HIV/AIDS prevention, as lenacapavir is the first injectable preventive measure to gain approval in the U.S.

Lenacapavir functions by blocking the virus's reproduction early in the infection process, unlike pre-exposure prophylaxis pills, which require daily consumption. Gilead's CEO, Daniel O’Day, hailed this approval as a historic milestone in combatting HIV. However, potential barriers to access arise due to the drug's annual list price of approximately $28,218 per person. Winnie Byanyima, Executive Director of the Joint United Nations Program on HIV/AIDS, expressed concerns regarding affordability, especially in sub-Saharan Africa, where approximately two-thirds of the global HIV population resides.

To address accessibility, Gilead plans to provide lenacapavir at no profit in 120 high-incidence countries and to issue voluntary licenses allowing local manufacturers to create affordable generic versions.

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