FDA Approves Gilead’s Yeztugo® (Lenacapavir) as First Biannual Injectable HIV PrEP
Gilead Sciences, Inc. (Nasdaq: GILD) has announced that the U.S. Food and Drug Administration (FDA) has approved Yeztugo® (lenacapavir) as pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV-1 in adults and adolescents weighing at least 35kg. This milestone makes Yeztugo the first and only twice-yearly injectable HIV prevention option available in the United States.
Daniel O’Day, Chairman and Chief Executive Officer of Gilead Sciences, said:
“This is a historic day in the decades-long fight against HIV. Yeztugo is one of the most important scientific breakthroughs of our time and offers a very real opportunity to help end the HIV epidemic. This is a medicine that only needs to be given twice a year and has shown remarkable outcomes in clinical studies, which means it could transform HIV prevention. Gilead scientists have made it their life’s work to end HIV and now, with the FDA approval of Yeztugo and in collaboration with our many partners, we can help to make that goal a reality.”
Phase 3 Clinical Trials Showed ≥99.9% of Participants Remained HIV-Negative
FDA approval was based on data from Gilead’s Phase 3 PURPOSE 1 and PURPOSE 2 trials. In PURPOSE 1 (NCT04994509), zero HIV infections occurred among 2,134 participants in the Yeztugo group, demonstrating 100% efficacy and superiority compared to once-daily oral Truvada® in cisgender women in sub-Saharan Africa.
In PURPOSE 2 (NCT04925752), only two HIV infections occurred among 2,179 participants, showing ≥99.9% efficacy in a geographically and demographically diverse group that included cisgender men and gender-diverse people. Both trials confirmed superiority to background HIV incidence and established Yeztugo as generally well-tolerated, with no new safety concerns identified.
Carlos del Rio, MD, Distinguished Professor of Medicine at Emory University, said:
“Yeztugo could be the transformative PrEP option we’ve been waiting for—offering the potential to boost PrEP uptake and persistence and adding a powerful new tool in our mission to end the HIV epidemic. A twice-yearly injection could greatly address key barriers like adherence and stigma, which individuals on more frequent PrEP dosing regimens, especially daily oral PrEP, can face. We also know that, in research, many people who need or want PrEP preferred less frequent dosing.”
Tackling Adherence, Stigma, and Low Awareness in HIV Prevention
Despite earlier innovations in PrEP, including Gilead’s own oral options, uptake has remained low. According to CDC data cited by Gilead, only 36% of people eligible for PrEP in 2022 were prescribed it. Disparities persist across gender, race, ethnicity, and region, particularly affecting women, Black and Hispanic populations, and individuals in the U.S. South.
Gilead notes that adherence challenges, stigma, and low awareness continue to limit the impact of existing PrEP options. With a twice-yearly dosing schedule, Yeztugo has the potential to address these barriers more effectively.
U.S. Access Strategy Designed for Broad Coverage and Affordability
Gilead has confirmed it is working closely with insurers, healthcare systems, and payers to ensure broad access to Yeztugo across the U.S. Eligible individuals with commercial insurance may access Yeztugo at low or no out-of-pocket cost through the company’s Advancing Access® Co-Pay Savings Program.
For individuals without insurance, Gilead’s medication assistance program will provide Yeztugo free of charge, subject to eligibility criteria.
Global Regulatory Filings Underway Following U.S. Approval
In addition to FDA approval, Gilead has submitted marketing authorisation applications to regulatory agencies in Europe, Australia, Brazil, Canada, and South Africa. Countries including Argentina, Mexico, and Peru, which rely on FDA approvals, are expected to follow with additional filings.
Yeztugo has not yet been approved for HIV prevention outside of the United States.
Scientific Innovation Recognised as “Breakthrough of the Year”
Lenacapavir, the active compound in Yeztugo, is designed to inhibit HIV at multiple stages of its lifecycle. It is not cross-resistant to other drug classes and is being evaluated in ongoing clinical programs for both prevention and treatment, including long-acting oral and injectable formulations with multiple dosing options. The journal Science named lenacapavir its 2024 “Breakthrough of the Year”.
The multi-stage mechanism of action of lenacapavir is distinguishable from other currently approved classes of antiviral agents. While most antivirals act on just one stage of viral replication, lenacapavir is designed to inhibit HIV at multiple stages of its lifecycle and has no known cross resistance exhibited in vitro to other existing drug classes.
About Gilead Sciences and Its HIV Legacy
For over 35 years, Gilead Sciences has led innovation in HIV treatment and prevention. With 13 HIV medicines developed to date—including the first single-tablet regimen and the first PrEP option—the company continues to drive solutions for those living with and at risk of HIV.
Through ongoing R&D, global partnerships, and access initiatives, Gilead is committed to ending the HIV epidemic for everyone, everywhere.
For more information, visit www.gilead.com.
Lead Image Credits: HIV-1 Virus Particles Transmission electron micrograph of HIV-1 virus particles (orange) from infected H9 cells, produced in cell culture. The particles exhibit two stages of replication: the two “arcs” are immature particles budding from the plasma membrane of the cell, and the center spherical particle is a mature form in extracellular space. Image captured at the NIAID Integrated Research Facility (IRF) in Fort Detrick, Maryland. Credit: NIAID https://www.flickr.com/photos/niaid/53300792933/ – Published on January 25, 2024 – Free to use under the Unsplash License
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