FDA Approves Twice-Yearly HIV Prevention Drug

Will Only Work if People Know About & Can Access PrEP

Washington DC… Today, the FDA approved Yeztugo, or lenacapavir as PrEP, a twice-yearly injectable drug providing another long-acting option for people at risk of HIV. In response, Carl Schmid, Executive Director of the HIV+Hepatitis Policy Institute, issued the following statement:

“Today marks a monumental advance in HIV prevention. Congratulations to the many researchers who spent nineteen years to get to today’s approval, backed up by the long-term investment needed to get the drug to market. Long-acting PrEP is now not only effective for up to six months but also improves adherence and will reduce HIV infections—if people are aware of it and payers, including private insurers, cover it without cost-sharing as a preventive service.

“Recent actions by the Trump administration to decimate HIV prevention jeopardize access to preventive measures such as PrEP. In fact, the president’s budget zeroes out all CDC HIV prevention and surveillance funding, hampering our nation’s ability to make people aware of and access new HIV prevention measures. Dismantling these programs means that there will be a weakened public health infrastructure and much less HIV testing, which is needed before a person can take PrEP.

“Private insurers and employers must also immediately cover Yeztugo as a required preventive service, which means that PrEP users should not face any cost-sharing or utilization management barriers. Despite a Grade ‘A’ rating from the USPSTF for PrEP, and supporting federal guidance, PrEP users are still being subjected to unlawful copays and prior authorization. At a time when there is such an emphasis on prevention to avert chronic diseases, we call on federal and state regulators to step up enforcement of the ACA preventive services requirement.  

“The approval of Yeztugo marks another milestone in the now 44-year battle against HIV, an infectious disease that remains a significant public health threat in the U.S and globally. Thanks to medical advances, such as long-acting prevention and new treatment options, more people can protect themselves against HIV and those living with HIV can live longer and healthier lives. We look forward to even more scientific breakthroughs in the future, but as with any public health issue, federal government investment is required. We call on Congress to reject the administration’s proposed budget cuts for HIV prevention and research, so we can further advance our efforts to end HIV.” 

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The approval of Yeztugo is based on the overwhelmingly successful results of two clinical trials: PURPOSE 1, which resulted in zero infections in cisgender women—the first PrEP trial to achieve this—and PURPOSE 2, which evaluated efficacy in men and gender-diverse people. Lenacapavir reduced HIV infections by 100 percent compared to baseline HIV incidence in PURPOSE 1 and by 96 percent in PURPOSE 2. It demonstrated such clear superiority to oral PrEP that both trials were halted early. Science magazine went on to name lenacapavir the 2024 “Breakthrough of the Year.” Its twice-yearly dosing could revolutionize HIV prevention by mitigating adherence challenges, which experts have identified as a critical factor for maximizing PrEP’s impact. 

CDC researchers recently updated modeling that estimates the number of people in the country who can benefit from PrEP. The estimate, which previously was 1.2 million people, is now 2.2 million, an 83 percent increase. The increase underscores the urgent need to redouble efforts to expand access and federal HIV prevention funding. 

While the president’s recently released budget largely maintains funding for HIV treatment and care, in contrast, it retains only about 22 percent of HIV prevention program funding. Though it sustains the Ending the HIV Epidemic (EHE) initiative, including programs to expand PrEP access in community health centers, these wide-ranging cuts decimate the core prevention, surveillance, testing, and education programs in every state across the country.

In addition to coverage requirements by private insurers, due to last year’s National Coverage Determination, Medicare must cover all FDA-approved PrEP drugs without a copay in Medicare Part B.  A January bulletin issued by the federal government discusses the benefits of Medicaid coverage for PrEP in order to prevent HIV.

PrEP is not just a drug, but encompasses provider visits, associated laboratory tests, and ongoing adherence counseling. But first, people must be aware of PrEP and have payers who cover the drugs and these services. Comprehensive federal government action is also needed to ensure that Yeztugo and other tools in the HIV prevention toolkit can reach everyone who needs them, including the uninsured, no matter where they live, or what their race, ethnicity, or gender is. 

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The HIV+Hepatitis Policy Institute is a national, non-profit organization whose mission is to promote quality and affordable healthcare for people living with or at risk of HIV, hepatitis, and other serious and chronic health conditions.