The US Food and Drug Administration (FDA) approved on June 18 the first HIV prevention medications that need to be taken only twice a year. People at high risk of HIV infection can now receive an injection – lenacapavir, sold under the brand name Yeztugo – just once every six months, writes UNN, citing Time.
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The approval, it is noted, is an important milestone in the fight against HIV and could change the epidemic. While antiretroviral treatments have helped millions of people suppress the virus to undetectable levels, thus preventing them from spreading it to others, and have also allowed HIV-negative people to maintain their status when used for infection prevention, the daily pill regimen means adherence, and therefore effectiveness, is often not as strong as it could be, the publication notes.
In two studies, scientists from Gilead, which developed lenacapavir, showed that the drug is 96% effective in protecting cisgender women from HIV infection compared to daily oral pills (so-called PrEP, short for pre-exposure prophylaxis). In men who have sex with men and people of various gender identities, the drug proved to be 100% effective, the publication writes.
"Lenacapavir, used alone for prevention, is a huge breakthrough," says Dr. David Ho, a professor of microbiology, immunology, and medicine at Columbia University, who first combined HIV drugs to suppress the virus and its ability to mutate, becoming resistant to treatment. "Its potential in curbing the epidemic is huge."
But advocacy groups and global AIDS organizations express concerns about whether this potential will be fully realized, given the recent cuts to US-supported HIV treatment and prevention programs worldwide.
Lenacapavir was approved by the FDA in 2022 for the treatment of people with HIV whose virus had become resistant to other antiviral drugs. While developing this treatment, Gilead scientists noticed that lenacapavir has two important properties that could make it potentially useful for HIV prevention as well: its ability to remain in the body longer than other antiviral drugs, and its ability to interfere with multiple stages of the process the virus uses to replicate. Lenacapavir is not an HIV vaccine, but its effect in preventing infection is analogous to one, the publication writes.