On December 3, 2024, U.S. health officials reported that an injection of lenacapavir, developed for HIV prevention, demonstrated an impressive 99% effectiveness. Administered biannually, this treatment marks a significant advancement in HIV prevention, although it does not provide immunity against the virus, emphasized Vadim Pokrovsky, head of a specialized research department at the Central Research Institute of Epidemiology of Rospotrebnadzor.
The clinical trials, published in the New England Journal of Medicine, involved 3,265 participants who were divided into two groups. One group received lenacapavir injections every six months, while the other took the oral antiretroviral medication Truvada daily. Only two individuals in the lenacapavir group contracted HIV, compared to nine in the Truvada group, highlighting the injection's superior efficacy.
Results from the trial have been submitted to the U.S. Food and Drug Administration (FDA), with hopes for lenacapavir's commercial approval for HIV prevention by 2025. While lenacapavir has been previously used as a treatment for HIV-infected individuals, its application as a preventive measure for those at risk of sexual transmission is a new development.
Pokrovsky reiterated that lenacapavir should not be mistaken for a vaccine, which is designed to induce immune protection. Instead, this injection provides temporary protection against HIV infection for six months. If a subsequent injection is not administered, the risk of infection increases as the drug concentration in the bloodstream diminishes.
Despite its promising results, the high cost of the injection, estimated at around $50,000 per dose, raises concerns about accessibility, particularly in countries like Russia, where the drug may not be available soon due to regulatory and financial barriers.