The European Commission has granted marketing authorization for Gilead Sciences' Yeytuo® (lenacapavir), a twice-yearly injectable treatment for HIV prevention, enabling its rollout across the European Union's 27 member states as well as Norway, Iceland, and Liechtenstein. Lenacapavir demonstrated nearly 100% efficacy in clinical trials, marking a scientific milestone in HIV prevention. The U.S. Food and Drug Administration approved the drug in June 2025. Gilead's CEO Daniel O’Day highlighted that the lifetime cost of treating an HIV patient can exceed $1 million, positioning lenacapavir as a potentially cost-effective preventive option. However, access and affordability remain critical concerns, with experts emphasizing the need for appropriate pricing and reimbursement arrangements in each country before patient availability. Despite its proven effectiveness, the largest U.S. prescription drug insurer has not yet included Yeytuo in its commercial plans. Approximately 25,000 new HIV diagnoses occur annually in the EU and European Economic Area, underscoring the necessity for improved prevention methods, especially among vulnerable populations. Meanwhile, global HIV/AIDS response efforts face challenges due to recent funding cuts to programs like PEPFAR, raising concerns about future support and accessibility of treatments like lenacapavir.