Landmark Trial in South Africa and Uganda Finds Twice Yearly HIV Prevention Injection Safe and Highly Effective

The Gilead Sciences PURPOSE 1 HIV prevention study, which enrolled over 5,300 cisgender adolescent girls and young women ages 16-26 in South Africa and Uganda reported results that a twice-yearly injection of lenacapavir, one of the HIV prevention drugs being studied in the trial, is safe and highly effective with no HIV seen among trial participants who received injectable lenacapavir.

“This is one of the most important results we’ve seen to date in an HIV prevention study,” said Mitchell Warren, AVAC’s executive director. “Adding additional HIV prevention options means more people may find an option that is right for them. Beyond expanded choice, a twice-yearly injection has the potential to transform the way we deliver HIV prevention to people who need and want it most – from an easier to follow regimen for individuals to a decreased burden on healthcare systems that are stretched to the limit.” 

A companion trial, PURPOSE 2, is underway in Argentina, Brazil, Mexico, Peru, South Africa, Thailand and the US, testing twice-yearly lenacapavir for PrEP among cisgender sexual minority men, transgender women, transgender men, and nonbinary people. Results from PURPOSE 2 are expected by early 2025. Additional studies in critical populations, including PURPOSE 3 among cisgender women in the United States and PURPOSE 4 among people who use injection drugs, are also underway. A schematic of the suite of studies is here.

Read AVAC’s Full Press Release