Dollars and dilemmas: lenacapavir's pricing, patents, and the path to affordability.

Lenacapavir (Yeztugo), the world's first twice-yearly human immunodeficiency virus (HIV) prevention injection, offers transformative potential but faces a critical challenge: affordability. While its production cost is estimated at just $25 per person annually, projections place its market price at over $25,000 in high-income settings, a 1000-fold markup that could restrict access in low- and middle-income countries (LMICs). Gilead's licensing agreements with six generic manufacturers, covering 120 low-income countries, mark a step forward. However, upper middle-income countries with significant HIV burdens remain excluded. Four of these excluded countries namely Argentina, Brazil, Mexico, and Peru that hosted the pivotal PURPOSE-2 trial, due to ongoing high HIV transmission among sexual and gender minorities (SGM) and their historical underrepresentation in HIV clinical trials. This raises serious concerns about post-trial access. Moreover, the licensing terms limit flexibility, restrict generic sales outside designated territories, and omit price caps. Without broader coverage or concrete affordability commitments, millions may be left behind. Patent filings and the absence of a Medicines Patent Pool (MPP) partnership also amplify structural barriers. To meet global HIV targets, lenacapavir's rollout must be guided by equity, not monopoly. The coming year will be decisive and will determine whether this breakthrough becomes a global game-changer or another symbol of structural health inequity.