Overview

• Lenacapavir (Yeztugo) received FDA approval on June 18 for use as two subcutaneous injections every six months in adults and adolescents weighing at least 35 kg.
• Phase 3 trials reported 100 percent prevention of HIV infections among women and adolescent girls in sub-Saharan Africa and Uganda and a 96 percent reduction in diverse cohorts across the Americas and South Africa.
• Gilead Sciences set a U.S. list price of $28,218 per year and granted royalty-free licenses to six manufacturers to produce low-cost generic versions for 120 low- and middle-income countries.
• Proposed cuts to Medicaid and federal HIV prevention programs threaten to hamper distribution and access, particularly for uninsured and vulnerable populations.
• The shot’s high efficacy raises ethical challenges for future HIV vaccine trials, and Gilead is already developing a once-a-year injectable formulation to improve long-term adherence.