Gilead’s HIV Prevention Injection Lenacapavir Approved By FDA

Introduction to HIV Prevention

The Food and Drug Administration on Wednesday approved Gilead’s twice-yearly antiviral injection for preventing HIV — a milestone that the company and some experts say could help bring the world closer to ending the decades-long epidemic caused by the virus.

The New HIV Prevention Drug

But the launch of the injectable drug, which will be marketed under the name Yeztugo, faces a set of potential threats, including the Trump administration’s proposed cuts to federal funding for HIV prevention efforts. In two groundbreaking clinical trials in 2024, Gilead’s injection proved to be capable of virtually eliminating new HIV infections when taken every six months. That’s a less frequent dosage than for all existing HIV prevention medications, including daily pills from Gilead and another injection, from GSK, taken every other month.

Global Impact of Yeztugo

That makes Yeztugo a valuable and far more convenient tool for addressing an epidemic that led to around 1.3 million new infections and contributed to the deaths of 630,000 people globally in 2023, according to the World Health Organization. The U.S. alone sees 700 new cases and 100 HIV-related deaths each week, Gilead CEO Daniel O’Day said in an interview ahead of the approval. HIV continues to have a disproportionate impact on people of color, gay and bisexual men, other men who have sex with men and transgender women.

Importance of Yeztugo

"It’s hard to overstate the importance of this for global public health," O’Day said, adding that the injection "really will bend the arc of the epidemic as we roll this out across the globe." But the magnitude of its impact will also depend on how easy it is to get, said Jeremiah Johnson, executive director of PrEP4All, an organization focused on expanding access to HIV prevention medications.

Pricing, Access, Efficacy

Lenacapavir, the generic name of Yeztugo, has an annual list price of $28,218 in the U.S. before insurance, a Gilead spokesperson said in an email. That is in line with existing branded medications approved for the same use: pre-exposure prophylaxis, or PrEP, which reduces the risk of getting HIV. A month’s supply of Truvada and Descovy, Gilead’s daily pills for PreP, are both around $2,000 without insurance, which amounts to around $24,000 per year. One dose of GSK’s Apretude, which is taken once monthly for the first two months and then once every other month thereafter, costs roughly $4,000 before insurance.

Ensuring Accessibility

"We are working to make Yeztugo accessible for anyone who needs or wants it and expect to see broad insurance coverage," the Gilead spokesperson said, adding that there is broad insurance coverage for existing prevention options. The company said it has a copay savings program for eligible insured patients that may reduce out-of-pocket payments for Yeztugo to as little as zero dollars. Gilead also has a program for eligible uninsured people to receive the injection for free.

Global Supply and Pricing

Lenacapavir is already approved for treating HIV under the brand name Sunlenca, which has a price tag of more than $42,200 per year. One analysis in 2024 found that the drug could be made for as little as $26 to $40 a year. Mizuho analysts have estimated that lenacapavir could reach peak sales of around $4 billion globally for both HIV prevention and treatment. O’Day said the company is also committed to supplying the drug for that use globally as the virus "knows no boundaries." Gilead in October granted licenses to six generic manufacturers to produce and sell lower-cost versions of the injection in 120 low- and lower-middle-income countries.

Challenges in HIV Prevention

PrEP has been available for a decade in the form of daily pills, but infections have climbed or remained roughly flat in many areas. Pills can be difficult for many people to take consistently for several reasons, including inconvenience and stigma around HIV and PrEP in many communities, particularly outside the demographic of white men who have sex with men. Black Americans account for 39% of new HIV diagnoses but only 14% of PrEP users, while Hispanic people represent 31% of new diagnoses but just 18% of PrEP users, according to AIDSVu, a public resource for HIV surveillance data from Gilead in partnership with Emory University’s Rollins School of Public Health.

Efficacy of Yeztugo

"Unfortunately, there’s still an enormous amount of stigma and cultural challenges when it comes to HIV prevention," Johanna Mercier, Gilead’s chief commercial officer, said in an interview. "Getting a twice-a-year injection really gives you that privacy that people have been looking for." She said Gilead aims to ensure that more people, especially those not currently using PrEP, are aware of that convenience advantage and the efficacy of the company’s injection. In one late-stage trial, 99.9% of patients who took Gilead’s injection did not contract an infection. There were only two cases among more than 2,000 patients, effectively reducing the risk of HIV infection by 96% and proving 89% more effective than Gilead’s daily pill Truvada.

Proposed Federal Funding Cuts

In the U.S., ensuring access to underserved populations will also require broad insurance coverage. Most PrEP users are under commercial plans, according to the HIV+Hepatitis Policy Institute. But the federal Medicaid program is also crucial to reaching lower-income communities. Medicaid is the largest source of insurance coverage for people who have the virus in the U.S., covering an estimated 40% of nonelderly adults who have HIV, according to health policy research organization KFF. That makes Republicans’ proposed funding cuts to Medicaid a huge potential threat to HIV treatment and prevention access.

Conclusion

The approval of Yeztugo is a significant milestone in the fight against HIV, offering a convenient and effective prevention option. However, its impact will depend on accessibility, pricing, and insurance coverage. The proposed federal funding cuts pose a threat to HIV prevention efforts, and it is essential to ensure that these programs continue to receive adequate funding. By addressing the challenges in HIV prevention and ensuring access to Yeztugo, we can work towards ending the HIV epidemic.

FAQs

Q: What is Yeztugo, and how does it work?
A: Yeztugo is a twice-yearly antiviral injection for preventing HIV. It works by reducing the risk of HIV infection when taken every six months.
Q: How effective is Yeztugo in preventing HIV?
A: Yeztugo has been shown to be highly effective in preventing HIV, with a 96% reduction in the risk of HIV infection in clinical trials.
Q: How much does Yeztugo cost, and is it accessible to everyone?
A: The annual list price of Yeztugo is $28,218 in the U.S. before insurance. Gilead has programs in place to make the injection accessible to eligible insured and uninsured patients.
Q: What are the potential threats to the launch of Yeztugo?
A: The proposed federal funding cuts to Medicaid and other HIV prevention programs pose a significant threat to the launch of Yeztugo and its accessibility to underserved populations.
Q: How can we ensure that Yeztugo is accessible to everyone who needs it?
A: It is essential to ensure that Medicaid and other government programs continue to receive adequate funding to support HIV prevention efforts. Additionally, Gilead’s programs for eligible insured and uninsured patients can help make Yeztugo more accessible.