Key Points:
WHO has approved Gilead's twice-dosed injectable drug, lenacapavir, as an HIV prevention drug.
The drug was almost perfect in trials, a massive step forward in HIV prevention science.
WHO is calling for rapid introduction into national health programs, particularly in high-risk groups.
Key Background:
At a period when HIV prevention has plateaued worldwide, WHO's support of lenacapavir is science and strategic progress. There were an estimated 1.3 million new HIV cases worldwide in 2024 alone that highlight the necessity of new prevention tools as an immediate priority. Classic PrEP options—essentially daily oral medication—have been stigmatised, hard to access, and plagued by vigilance to adhere.
The benefit of lenacapavir is its twice-yearly long-acting injection, which is simpler to administer to patients with difficulty with daily compliance. In clinical trials, nearly complete prevention of HIV transmission occurred in individuals at high risk. These outcomes have prompted WHO officials to think of the drug as a game-changer in the fight against HIV worldwide.
In addition to the lenacapavir prescription, WHO also updated its HIV testing guidance, calling for increased use of streamlined rapid testing. All the updates are planned to reduce barriers to access and decentralize so that non-traditional places like pharmacies, mobile clinics, and telehealth platforms will be able to do more to deliver.
The populations that will gain the most from lenacapavir also carry disproportionate HIV burdens. These are the sex workers, men who have sex with men, trans individuals, injectors of drugs, prisoners, and young people. WHO reiterated that these populations are subject to system-level discrimination and structural barriers that deny them prevention and care.
To further increase access to lenacapavir in the poorer nations, Gilead has collaborated with the Global Fund to provide the drug at cost to a minimum of two million people for three years. Gilead is also granting licensing agreements to facilitate follow-on generic manufacturing, which will expand access in the longer term.
Global health agencies like UNAIDS have been guided by WHO as a key move towards further improving HIV prevention activities. Humanitarian medical agencies like Médecins Sans Frontières cautioned, however, that there must be true commitment to affordability and fair access, particularly to those countries whose health systems are weak or behind schedule.
Generally, inclusion of lenacapavir in WHO guidelines is a move in the right direction but its effect will be determined by how widely and how quickly it is adopted worldwide. It is a landmark that will transform HIV prevention if supported by policy, investment, and financing in infrastructure support.