The PURPOSE 2 trial was conducted in several countries, including Argentina, Brazil, Mexico, Peru, South Africa, Thailand, and the United States, and involved transgender men, transgender women, and gender-diverse people who have sex with men who were born as male. In the trial, an independent Data Monitoring Committee (DMC) confirmed that the PURPOSE 2 trial achieved its primary endpoint of demonstrating superiority of Lenacapavir over bHIV and Truvada.

“These two Phase 3 results suggest that lenacapavir has the potential to truly transform the way we treat HIV and could be key to ending this epidemic,” said Daniel O’Day, Gilead’s Chairman and Chief Executive Officer.

In addition to the trial results, Gilead is also focused on accessibility of Lenacapavir. The company plans to make Lenacapavir accessible to many countries around the world, especially in countries with high HIV rates and low resources, such as South Africa and Asia, including Thailand, which will help at-risk populations access the drug at an affordable price.

The results of the PURPOSE 1 trial in sub-Saharan African women also showed similar results, giving Gilead sufficient comprehensive data to file for approval of Lenacapavir for future HIV prevention. Applications to regulatory agencies are expected to begin by the end of 2024. If approved, we could see Lenacapavir launched in 2025, the first twice-a-year HIV prevention option in the world!

Gilead is committed to making the drug accessible to the most at-risk groups, especially in countries with high infection rates, and has pledged to work with local authorities and civil society organizations to ensure that the drug is available once it is approved.

In addition, Dr. Onyema Ogbuagu, the principal investigator of PURPOSE 2, added, “The difficulty of taking the drug every day And concerns about social stigma are a major barrier to many people being able to effectively prevent HIV infection. But with Lenacapavir’s impressive trial results and only two injections per year, I believe this is a significant step towards significantly reducing HIV infections.”

Lenacapavir for HIV prevention is still in the experimental phase and has not been proven safe or effective. However, the results of the trial suggest that Lenacapavir may have the potential to change the future of HIV prevention.

Source/Reference: Gilead Sciences, Inc. (2024). Gilead’s Twice-Yearly Lenacapavir for HIV Prevention Reduced HIV Infections by 96% and Demonstrated Superiority to Daily Truvada® in Second Pivotal Phase 3 Trial. Retrieved from Gilead Press Release.