Gilead Sciences, Inc. reported data from the first of two pivotal studies of twice-annual dosing of its capsid inhibitor lenacapavir for HIV pre-exposure prophylaxis (PrEP) on 20 June, showing zero infections in cisgender women and establishing superiority against background incidence of infection and a control group that received Gilead’s daily oral combination therapy Truvada (emtricitabine/tenofovir disoproxil) for PrEP.
Key Takeaways
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Gilead’s capsid inhibitor lenacapavir demonstrated superiority for preventing HIV in a pivotal study testing twice-annual administration in cisgender women.
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Top-line data from the PURPOSE 1 trial yielded zero incidences of infection per 100 person-years for those treated with lenacapavir, which is approved as Sunlenca for HIV salvage therapy
The Foster City, CA-based firm said it anticipates reporting data by late 2024 or early 2025 from a second pivotal trial in the PURPOSE program that, if successful, would enable it to file for approval sometime in 2025. Currently, lenacapavir is approved in the US and EU as Sunlenca for heavily treatment-experienced adults with multidrug-resistant HIV, but the company sees greater economic potential for the product in PrEP as a twice-yearly injectable option
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