Overview

• The FDA cleared lenacapavir, sold as Yeztugo, to be administered under the skin every six months as the first long-acting HIV prevention shot.
• Large trials demonstrated nearly 100% efficacy in preventing sexually acquired HIV among adults and adolescents, outperforming daily oral pre-exposure prophylaxis.
• The injectable capsid inhibitor blocks multiple stages of the HIV lifecycle and mandates a negative HIV-1 test before the first dose.
• In trials, participants most commonly reported injection site reactions, headache and nausea as adverse effects.
• Gilead granted royalty-free licenses for generic manufacturing in 120 low- and middle-income countries, but the drug’s steep price and proposed cuts to U.S. prevention funding could constrain access.