A New Era for HIV Prevention: The Promise and Challenge of Injectable Lenacapavir

The Lancet HIV’s July 2025 editorial shines a spotlight on a groundbreaking development in the fight against HIV: the FDA approval of injectable lenacapavir for pre-exposure prophylaxis (PrEP). This twice-yearly injectable, now approved for adults and adolescents over 35kg, represents a significant step forward in long-acting HIV prevention and offers hope for reaching populations previously left behind by traditional oral PrEP approaches.

With WHO set to launch new guidelines at the 2025 International AIDS Conference in Kigali, and The Global Fund partnering with Gilead to supply lenacapavir to low- and middle-income countries, momentum is building. However, the editorial warns that regulatory approval is just the beginning. Without committed funding, equitable pricing, and health system readiness, this promising innovation risks being out of reach for those most in need - particularly in sub-Saharan Africa.

A ten-point framework, proposed in a related Personal View, calls for urgent action to ensure access, scale-up, and price reductions to prevent the mistakes of the past. With the potential to avert up to a third of new infections in high-burden regions over the next decade, the stakes are high and the opportunity is now.

Read the full editorial in The Lancet HIV here