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Lenacapavir: A Twice-Yearly HIV Prevention Injection Approved by the FDA – Promise and Challenges

Lenacapavir: A Twice-Yearly HIV Prevention Injection Approved by the FDA – Promise and Challenges

Lenacapavir: A Twice-Yearly HIV Prevention Injection Approved by the FDA – Promise and Challenges The Food and Drug Administration (FDA) has approved Gilead Sciences’ lenacapavir as a twice-yearly pre-exposure prophylaxis (PrEP) injection, marking a significant advancement in HIV prevention. This approval follows successful Phase III clinical trials demonstrating a remarkably high efficacy rate, exceeding that of daily PrEP regimens. The drug, marketed under the brand name Yeztugo, achieved a 100% prevention rate in cisgender women and a 99.9% prevention rate…

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Lenacapavir: A Promising HIV Prevention Breakthrough and its Global Accessibility Challenges

Lenacapavir: A Promising HIV Prevention Breakthrough and its Global Accessibility Challenges

Lenacapavir: A Promising HIV Prevention Breakthrough and its Global Accessibility Challenges The recent FDA approval of lenacapavir marks a significant advancement in HIV prevention. This long-acting injectable drug, administered just twice yearly, offers a compelling alternative to daily oral PrEP (pre-exposure prophylaxis) medications like Truvada. Clinical trials, including PURPOSE 1 and PURPOSE 2, demonstrated remarkably high efficacy rates, approaching near-complete protection against HIV infection in diverse populations. These results, hailed as a “Breakthrough of the Year” by Science in 2024,…

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