new WHO Guidelines Pave Way for Twice-Yearly HIV Prevention with Lenacapavir
Geneva, Switzerland – November 30, 2025 – A groundbreaking new approach to HIV prevention has been endorsed by the World Health Institution (WHO), offering a potential game-changer in the fight against the global epidemic. The WHO now recommends lenacapavir, an injectable medication administered just twice a year, as pre-exposure prophylaxis (PrEP) for individuals at risk of HIV infection. This marks a notable advancement beyond daily oral PrEP, promising increased convenience and adherence for those seeking to protect themselves.
Despite decades of research, an effective HIV vaccine remains elusive. However, the approval of lenacapavir by both the WHO and the U.S. Food and Drug Management (FDA) represents a major leap forward. The medication functions as a long-acting antiretroviral, effectively preventing infection in nearly all individuals participating in clinical trials. This new guidance aims to dramatically expand access to a powerful tool in preventing new HIV cases, particularly among populations facing significant barriers to consistent healthcare.
lenacapavir operates by inhibiting the viral capsid – the protein shell that encases the HIV genetic material.Unlike many existing antiretroviral drugs that target enzymes crucial for viral replication after infection has begun, lenacapavir disrupts the virus’s ability to even enter human cells. Specifically, it binds to the capsid protein, preventing the virus from uncoating and releasing its genetic material into the host cell. This unique mechanism of action makes it effective against a broad range of HIV variants and offers a different line of defense against drug resistance.
Clinical trials have demonstrated the efficacy of lenacapavir in preventing HIV infection. Studies showed that participants receiving the twice-yearly injections experienced a nearly complete absence of new infections compared to those receiving placebo. This high level of protection,coupled with the reduced dosing frequency,addresses key challenges associated with traditional PrEP regimens – namely,the need for daily adherence and potential side effects.
“Even though we do not yet have a vaccine against HIV, lenacapavir is a very good option,” stated Dr. Tedros Adhanom Ghebreyesus, Director-General of the WHO. “It is a long-acting antiretroviral that, according to trials, prevents infection in almost all people at risk. The publication of the new WHO guidelines,together with the recent approval of the treatment by the FDA,allows us to take a big step forward in expanding access to this powerful tool.”
The WHO’s updated guidelines are expected to influence national HIV prevention programs worldwide,possibly leading to wider implementation of lenacapavir-based PrEP strategies. Further research will focus on optimizing delivery methods and ensuring equitable access to this innovative preventative measure, particularly for vulnerable populations.
