Drugmaker Gilead has announced that its new, twice-a-year shot of lenacapavir reduced HIV infections by 96% in a Phase 3 clinical trial.
The company will next seek approval from the U.S. Food and Drug Administration (FDA) to market lenacapavir as an HIV treatment.
“With such remarkable outcomes across two Phase 3 studies, lenacapavir has demonstrated the potential to transform the prevention of HIV and help to end the epidemic,” said Daniel O’Day, chairman and CEO of Gilead.
“Now that we have a comprehensive dataset across multiple study populations, Gilead will work urgently with regulatory, government, public health and community partners to ensure that, if approved, we can deliver twice-yearly lenacapavir for PrEP worldwide, for all those who want or need PrEP.”
The company notes that this was the second pivotal Phase 3 trial to demonstrate efficacy of twice-yearly lenacapavir for the investigational use of HIV prevention as PrEP. In June 2024, the PURPOSE 1 trial, studying lenacapavir for PrEP among cisgender women in sub-Saharan Africa, was also unblinded early because it met its key efficacy endpoints.
The company said it believes the data from the PURPOSE 1 and PURPOSE 2 trials will support upcoming regulatory filings so that twice-yearly lenacapavir for PrEP, if approved, can be made available to multiple populations and communities around the world.
If all goes well, Gilead said regulatory approval could support the initial launch of the first and only twice-yearly HIV prevention choice in 2025.