KIGALI, July 14, 2025 – The World Health Organization today recommended the use of injectable lenacapavir (administered twice yearly) as an additional pre‑exposure prophylaxis option for HIV prevention.
Announced at the International AIDS Society Conference in Kigali, Rwanda, the decision marks a turning point in HIV prevention strategy.
Lenacapavir, a long‑acting capsid inhibitor branded as Yeztugo in the U.S., received FDA approval on June 18, 2025, following highly effective outcomes in the PURPOSE 1 and PURPOSE 2 clinical trials, which reported nearly 100% protection in diverse populations.
The WHO highlights key benefits of this regimen: fewer clinic visits, greater adherence for populations facing daily-pill challenges, and reduced stigma. The recommendation prioritises high-risk groups—sex workers, men who have sex with men, transgender individuals, people who inject drugs, those in prisons, and adolescents—amid rising prevention needs, with 1.3 million new HIV infections reported in 2024.
Safety data also support lenacapavir use during pregnancy and breastfeeding, showing stable drug levels and no increased risk to infants, aligning with recent FDA and WHO findings.
WHO guidelines recommend pairing injectable PrEP with simplified HIV testing using rapid diagnostic tests to ease access and prevent resistance. Meanwhile, affordability remains a focus: analysis suggests potential production costs could be as low as $25 per person per year, while advocacy groups call for pricing strategies to enhance global access.
Read the full WHO announcement here.