Gilead Sciences, Inc. (Nasdaq: GILD) announced that the U.S. Food and Drug Administration (FDA) has approved Yeztugo® (lenacapavir), the first and only twice-yearly injectable HIV-1 capsid inhibitor for pre-exposure prophylaxis (PrEP) in the United States. The FDA approved Yeztugo for adults and adolescents weighing at least 35kg to reduce the risk of sexually acquired HIV.
As per the Gilead Press release, this landmark approval introduces a long-acting PrEP option for people who need or prefer less frequent dosing. Data from Gilead’s PURPOSE 1 and PURPOSE 2 Phase 3 trials show that ≥99.9% of Yeztugo recipients remained HIV-negative, highlighting its strong clinical impact.
A Turning Point in HIV Prevention
Gilead’s Chairman and CEO, Daniel O’Day, emphasized the significance of this approval:
“This is a historic day in the decades-long fight against HIV. Yeztugo represents one of the most important scientific breakthroughs of our time. Its twice-yearly administration and outstanding trial results could truly transform HIV prevention.”
Yeztugo builds on Gilead’s legacy, as the company also developed the first approved PrEP medication back in 2012.
Addressing Gaps in PrEP Access and Adherence
Despite earlier PrEP advancements, CDC data from 2022 show that only 36% of eligible individuals in the U.S. were prescribed PrEP. Usage remains especially low among women, Black and Hispanic communities, and people in the Southern U.S. Barriers such as stigma, daily adherence challenges, and limited awareness continue to hinder PrEP access.
Dr. Carlos del Rio, Distinguished Professor at Emory University School of Medicine, shared:
“Yeztugo could be the game-changer we’ve been waiting for. A twice-yearly injection addresses critical issues like adherence and stigma, and research shows that many people prefer this less frequent dosing option.”
Clinical Trials Show Exceptional Efficacy and Safety
FDA approval is based on data from two pivotal trials:
- PURPOSE 1 (NCT04994509):
In a study of 2,134 cisgender women in sub-Saharan Africa, the Yeztugo group recorded zero HIV infections, demonstrating 100% protection and superiority over daily Truvada® (emtricitabine/tenofovir). - PURPOSE 2 (NCT04925752):
Of 2,179 cisgender men and gender-diverse participants globally, only two HIV infections occurred in the Yeztugo group—confirming 99.9% efficacy.
In both trials, Yeztugo also outperformed background HIV incidence rates and was well-tolerated with no new safety concerns. Results were published in The New England Journal of Medicine, and Science named lenacapavir the 2024 “Breakthrough of the Year.”
Regulatory Milestones and Fast-Track Approvals
Yeztugo received FDA approval through Priority Review and was granted Breakthrough Therapy Designation in October 2024. These designations recognize the drug’s substantial improvement over existing therapies and accelerate its availability to those in need.
Making Yeztugo Accessible: Gilead’s U.S. Access Strategy
Gilead is working closely with insurers, healthcare providers, and payers to ensure broad insurance coverage for Yeztugo. Through its Advancing Access® Co-Pay Savings Program, eligible commercially insured individuals may pay as little as zero dollars out-of-pocket.
For uninsured individuals, Gilead will offer Yeztugo free of charge through its medication assistance program, helping ensure equitable access regardless of insurance status.
Global Expansion Underway
Gilead has initiated regulatory filings in several regions to extend Yeztugo’s reach:
- European Union: Marketing Authorization and EU-M4all applications are under accelerated review by the European Medicines Agency (EMA).
- Other Countries: Applications are underway in Australia, Brazil, Canada, and South Africa.
- Pending Filings: Based on FDA approval, submissions are being prepared for Argentina, Mexico, Peru, and other countries that recognize FDA standards.
These efforts align with Gilead’s global strategy to expand HIV prevention access. The company collaborates closely with health advocates and international agencies.
A New Chapter in HIV Prevention
Yeztugo marks a bold step forward in HIV prevention. It offers a twice-yearly, clinically proven, and well-tolerated option for those most at risk. While HIV remains incurable, innovations like Yeztugo bring the world closer to ending the epidemic.
Gilead remains committed to collaboration, equity, and scientific innovation. It aims to ensure that prevention is within reach for all who need it.
Note: Regulatory authorities outside the United States have not yet approved lenacapavir for HIV prevention. No one has found a cure for HIV or AIDS.