Overview

• The FDA cleared lenacapavir (Yeztugo) on June 18 for adults and adolescents at risk of HIV after two annual injections showed nearly 100% efficacy in large-scale trials.
• Gilead will offer Yeztugo in the US at a list price of $28,218 per year while partnering with manufacturers to supply lower-cost generics across over 100 low- and middle-income nations.
• Independent analyses estimate that lenacapavir could be produced for as little as $25 to $46 per patient annually, underscoring a stark contrast with its planned US price.
• Health advocates led by Onusida director Winnie Byanyima have urged Gilead to reduce costs and expand production to ensure access in regions such as sub-Saharan Africa where HIV remains prevalent.
• As part of the capsid inhibitor class, lenacapavir builds on Gilead’s earlier Sunlenca therapy and represents a major advance in both HIV prevention and treatment strategies.