The FDA Approved a Twice-Yearly HIV Drug, Will it Be Accessible?

On June 18th, the FDA approved Yeztugo (lenacapavir), a medication developed by Gilead Sciences. It is described as an injectable HIV-1 capsid inhibitor as pre-exposure prophylaxis (PrEP) designed to reduce the risk of HIV in adults and adolescents. The bottom line: this is the first and only twice-yearly HIV drug option available in the U.S. for people who need or want PrEP. But will it be available to those who could benefit from it most?

Yeztugo Is More Effective than the Oral PrEP

In clinical trials, the Yeztugo injections were shown to be more effective than the daily oral PrEP medication, Truvada. The first trial resulted in zero infections, with 100% efficacy among 2,134 trial participants who received the Yeztugo injections. The second trial resulted in two HIV infections, and 99.9% of the 2.179 participants did not. The Journal Science named lenacapavir the 2024 Breakthrough Drug of the Year.

HIV is Still a Threat to Our Community

HIV/AIDs is still a serious health threat to our community. While there have been significant advances in treatment, which have resulted in contracting HIV not necessarily equaling death, the rates of infections continue to increase, particularly in the South.

Yeztugo injections could be an opportunity for at-risk individuals in our community to protect themselves because Black Americans account for 39% of new HIV diagnoses overall, but only 14% of PrEP users.

However, when we break things down by region, we gain a clearer understanding. According to the information supplied by AIDSVu, a public resource for HIV surveillance data in partnership with Gilead and Emory University’s Rollins School of Public Health, our HIV numbers are higher in the South and the Midwest at 48% and 42% with PrEP users at rates of 22% and 13%.

Upon further examination, we find that 64% of PrEP users fall within the 25 -44 age range. There is an opportunity for education and outreach around this breakthrough.

The Yeztugo Cost Factor

The list price of Yeztugo is $14,109 per injection. Getting the injection versus the pill may be challenging. Gilead Sciences notes that they are collaborating with insurers, healthcare systems, and other payers to ensure broad coverage. In addition, those with commercial insurance can take advantage of Gilead’s Advancing Access CoPay Savings Program to help reduce out-of-pocket expenses. Therefore, having coverage for this drug will be vital.

However, there may be a potential issue for anyone who is covered under Obamacare. According to NBC News, a pending Supreme Court case related to the Affordable Care Act is up for a decision that could be a barrier for medications that prevent HIV. Currently, PrEP is covered at no cost. Should the court decide against these medications, then they would no longer be free.

The case before the court, however, is not just about HIV medication but all preventative healthcare, from mental health to cardiovascular, cancer, and STI screenings. The ruling could impact more than 150 million Americans.

A Bigger Problem: Access

Poz.com reports that many HIV advocates and organizations are excited about Yeztugo, but are unified in their concerns that this drug may not be accessible to the populations who may need it the most.

Michael Chancley, Communication and Mobilization Director at Prep4All, said, “The stakes couldn’t be higher for communities of color that have yet to significantly benefit from PrEP. “Lenacapavir shows real innovation for cisgender women and other communities facing unique barriers to adhering to a daily pill, but I fear that we may see the same challenges in access that we saw with Apretude which, despite being the first long-acting PrEP available in the U.S., continues to make up only 2% of PrEP scripts.”

In a statement, Kevin Robert Frost, CEO of Amfar, wrote, “PrEP is one of the most indispensable tools we have for ending the HIV epidemic. Having the option of a twice-annual shot, rather than relying on a daily pill, will make long-term adherence to PrEP much easier for many.

But this remarkable drug will only be as effective as it is accessible and affordable. amfAR calls on Gilead Sciences and the U.S. government to do everything in their power to make sure as many people who want lenacapavir can get it,” he continued.

Complicating things further is that domestic funding for HIV is on the chopping block. The President’s 2026 budget request, which includes a 35% cut,  $1.5 billion for domestic HIV funding. This includes closing the CDC HIV Prevention Division to cut $794 million from the budget.

We Remain Hopeful

The drug is just rolling out, so people receiving prescriptions now may not get their first shot for two months. But we remain hopeful that Yeztugo clears some of these necessary hurdles and reaches those who can benefit from it most.

Resources

FDA Approves Yeztugo

Science: The Biggest Science Breakthroughs 2024

AIDSVU Prep for Prep Equity Platform

PrEP4All Statement

AmFar Statement