In a landmark step toward controlling the HIV epidemic, the U.S. Food and Drug Administration (FDA) has approved injectable lenacapavir for HIV prevention. The decision comes alongside a promising scientific breakthrough: researchers have successfully delivered mRNA into latent HIV-infected cells, potentially paving the way for a future cure.
Lenacapavir, developed by Gilead Sciences, is a long-acting antiretroviral drug administered just twice a year. It demonstrated high efficacy and safety in the PURPOSE 1 and PURPOSE 2 trials conducted in 2024 across varied populations. The World Health Organization (WHO) has welcomed the approval, stating it offers a vital new option for pre-exposure prophylaxis (PrEP) and helps overcome common barriers like daily medication adherence and stigma.
“This regulatory milestone brings us one step closer to expanding access to an innovative HIV prevention option,” said Dr. Meg Doherty, Director of WHO’s Global HIV, Hepatitis, and STI Programmes. WHO is set to release guidelines for lenacapavir use on July 14, 2025, during the International AIDS Conference in Kigali, Rwanda.
In a parallel development, a study published in Nature Communications by scientists at Australia’s Doherty Institute reported a major leap in HIV cure research. Using a newly engineered lipid nanoparticle (LNP X), researchers successfully delivered mRNA into white blood cells harboring dormant HIV—a longstanding obstacle in the cure quest.
The mRNA instructs infected cells to “reveal” the hidden virus, offering a potential pathway for the immune system or additional therapies to attack it. “We’ve never seen anything this effective in exposing latent HIV,” said Dr. Paula Cevaal, co-lead author of the study.
While still in preclinical stages, experts say the technology offers new hope. Dr. Jonathan Stoye, retrovirologist at the Francis Crick Institute, called it “a major potential advance,” though warned more research is needed to determine if revealing the virus is enough to eradicate it completely.
Together, these developments signal renewed momentum in the global fight against HIV—one offering stronger prevention today, and the other, a glimpse at a possible cure tomorrow.
Sources:
- FDA Press Release, June 2025
- WHO Statement on Lenacapavir, June 2025
- Nature Communications, June 2025:
- Interviews via University of Melbourne Media Briefing
