The World Health Organization (WHO) has announced new guidelines today, endorsing the use of injectable lenacapavir (LEN) twice a year as an additional option for pre-exposure prophylaxis (PrEP) in the prevention of HIV, marking a significant policy move that could transform the global response to HIV. These guidelines were unveiled at the 13th International AIDS Society Conference on HIV Science in Kigali, Rwanda.
LEN stands as the first injectable PrEP product designed for biannual administration, providing a highly effective, long-lasting alternative to daily oral medications and other shorter-acting solutions.
With only two doses required each year, LEN represents a major advancement in safeguarding individuals at risk of HIV, especially those who encounter difficulties with daily medication adherence, stigma, or healthcare access.
“Although an HIV vaccine is still not available, lenacapavir is the next best alternative: a long-lasting antiretroviral that trials have shown can prevent nearly all HIV infections among at-risk populations,” stated Dr. Tedros Adhanom Ghebreyesus, WHO Director-General.
“The release of WHO’s new guidelines, in conjunction with the FDA’s recent approval, signifies an essential advancement in extending access to this powerful resource. WHO is dedicated to collaborating with countries and partners to ensure this innovation is delivered to communities quickly and safely.”
These new guidelines arrive at a crucial time, as HIV prevention initiatives stagnate, with 1.3 million new HIV infections projected in 2024, disproportionately affecting key populations such as sex workers, men who have sex with men, transgender individuals, people who inject drugs, incarcerated persons, and children and adolescents.
WHO’s recommendation for LEN marks a pivotal shift towards broadening and diversifying HIV prevention methods, empowering individuals with more options to manage their health in ways that suit their circumstances.
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Simplified testing: a significant barrier eliminated
In conjunction with these guidelines, WHO has advocated for a public health approach to HIV testing that employs HIV rapid tests to facilitate the provision of long-acting injectable PrEP, which includes LEN and cabotegravir (CAB-LA).
This simplified testing guideline eliminates a major access hurdle by doing away with intricate, expensive procedures, allowing for community-based delivery of long-acting PrEP through pharmacies, clinics, and telehealth services.
Next steps: appeal for implementation
LEN is now included with other WHO-recommended PrEP alternatives, such as daily oral PrEP, injectable cabotegravir, and the dapivirine vaginal ring, adding to an expanding toolkit aimed at ending the HIV epidemic.
While access to LEN outside of clinical trials is currently limited, WHO encourages governments, donors, and global health partners to promptly incorporate LEN into national combination HIV prevention strategies, while simultaneously gathering vital data on usage, adherence, and real-world effectiveness.
