In a significant advancement for HIV prevention, the Centers for Disease Control and Prevention (CDC) has issued a strong recommendation for Yeztugo (lenacapavir), Gilead Sciences’ long-acting, twice-yearly pre-exposure prophylaxis (PrEP) medication. This endorsement, published in the CDC’s Morbidity and Mortality Weekly Report on September 18, marks a pivotal moment in the effort to expand HIV prevention options across the United States.
Clinical Evidence and CDC Recommendation
The CDC’s PrEP Guidelines Work Group based its recommendation on data from Gilead’s Purpose 1 and Purpose 2 clinical trials. These studies demonstrated exceptional efficacy: 100% protection against HIV in female participants and 96% efficacy in a predominantly male cohort, compared to background HIV incidence rates. These results also supported the FDA’s approval of Yeztugo in June.
The CDC emphasized that Yeztugo has the potential to improve adherence to PrEP regimens, which is a critical factor in effective HIV prevention. By reducing the dosing frequency to just twice a year, Yeztugo may help overcome common barriers to daily or monthly PrEP adherence.
Access Challenges and Advocacy Response
Despite the CDC’s endorsement, access to Yeztugo remains limited. Advocacy groups have raised concerns about insurance coverage, particularly for individuals without health insurance or those relying on Affordable Care Act (ACA) plans.
CVS Health, one of the largest pharmacy benefit managers in the U.S., announced in August that it would not include Yeztugo in its commercial or ACA formularies. The company cited a “careful review of clinical, financial and regulatory considerations.” CVS’s ACA formulary decisions are guided by the U.S. Preventive Services Task Force (USPSTF), which has not yet updated its guidelines to include Yeztugo.
In response, 64 HIV advocacy organizations, including AIDS United and the HIV + Hepatitis Policy Institute, sent a joint letter to CVS Health CEO David Joyner urging the company to reconsider. The letter highlighted that USPSTF recommendations are updated infrequently and do not endorse specific drugs, but rather general categories of preventive care.
Global and Professional Support
Yeztugo has also received support from international and professional bodies. The World Health Organization recently endorsed the drug, and the International Antiviral Society-USA Panel updated its PrEP guidelines to include lenacapavir. These endorsements further validate the drug’s role in global HIV prevention strategies.
Gilead’s Commitment to Access
To address access concerns, Gilead has pledged to provide Yeztugo free of charge to eligible individuals through its Advancing Access medication assistance program. This initiative aims to ensure that uninsured individuals can still benefit from the breakthrough therapy.
Carl Schmid, executive director of the HIV + Hepatitis Policy Institute, underscored the urgency:
“The entire world is excited about this PrEP drug that for the first time resulted in zero infections in clinical trials, and was hailed by Science magazine as the 2024 Breakthrough of the Year. Now we must make sure that everyone who wants it is able to access it.”
Conclusion
Yeztugo represents a major leap forward in HIV prevention, offering a highly effective and convenient option for individuals at risk. While the CDC’s endorsement is a critical milestone, broader access, especially through insurance coverage, remains a key challenge. Continued advocacy and policy updates will be essential to ensure equitable access to this life-saving medication.
