Overview

• Large trials demonstrated lenacapavir’s near-100% effectiveness at preventing HIV, paving the way for U.S. FDA approval in June 2025.
• WHO’s updated guidelines call for immediate integration of the twice-yearly injectable capsid inhibitor into national combination prevention programmes.
• The agency also recommends rapid HIV tests to remove diagnostic barriers and streamline access to the long-acting shot.
• Rwanda is finalizing implementation agreements under new WHO guidance and Kenya aims to issue national rollout protocols by January 2026.
• Pricing debates and generic licensing deals are gaining urgency as funding cuts threaten HIV prevention budgets in low- and middle-income countries.