Abstract
Lenacapavir is a unique HIV capsid inhibitor that offers an innovative alternative for the treatment of HIV infections resistant to multiple drugs and for pre-exposure prophylaxis (PrEP). This drug, administered subcutaneously every six months, stands out for its proven efficacy in clinical trials, showing 100% effectiveness in cisgender women (Purpose-1) and 96% in diverse populations (Purpose-2). Additionally, it has a favorable safety profile, with mostly mild to moderate adverse effects, such as injection site reactions. Despite its clinical potential, lenacapavir faces challenges related to cost and accessibility. Pharmacoeconomic studies suggest that with mass production and voluntary licensing, its price could be significantly reduced, making it more viable for resource-limited countries. However, recent agreements by Gilead for its generic production exclude middle-income nations such as Mexico, Brazil, and Argentina, where its adoption remains uncertain. Lenacapavir has the potential to transform the landscape of HIV prevention and treatment, particularly for populations with low adherence to daily oral regimens. Nonetheless, its global success will depend on strategies that ensure affordable prices, broader coverage, and equitable access in regions with a high HIV burden.

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Copyright (c) 2025 Ivo Heyerdahl-Viau
