Overview

• The FDA approved lenacapavir (Yeztugo) on June 19 as the first long-acting injectable for HIV prevention administered every six months.
• Large clinical trials demonstrated nearly 100 percent efficacy, showing superior protection compared with daily oral PrEP medications such as Truvada.
• Gilead has set a US list price of $28,218 per person per year, prompting concerns about affordability even in wealthier healthcare systems.
• Agreements with six generic manufacturers will supply two million doses at no profit to 120 low-income countries, primarily in Africa, Southeast Asia and the Caribbean.
• Health experts warn that recent federal funding cuts and high prices could limit uptake and urge pricing closer to $25–$40 per person annually to ensure broad impact.