Food and medication administration approved Wednesday Gilead 'S Antiviral injection twice a year to prevent HIV, a milestone that the company and some experts say it could help bring the world closer to finish the decades epidemic caused by the virus.
But the launch of the injectable drug, which will be marketed under the name of Yezugo, faces a set of potential threats, including the cuts proposed by the Trump administration to federal funds for HIV prevention efforts.
In two innovative clinical trials last year, Gilead's injection proved to be able to virtually eliminate new HIV infections when taken every six months. Patients take it less frequently than all existing HIV prevention medications, including Gilead's daily pills and another injection of GSK received every two months.
That makes Yeztugo a valuable tool and much more convenient to address an epidemic that led to around 1.3 million new infections and contributed to the death of 630,000 people worldwide in 2023, according to the World Health Organization.
Only the United States sees 700 new cases and 100 deaths related to HIV every week, said the CEO of Gilead, Daniel O'Day, in an interview before approval. HIV continues to have a disproportionate impact on people of color, homosexual and bisexual men, other men who have sex with transgender men and women.
“It is difficult to exaggerate the importance of this for global public health,” O'Day said, adding that the injection “will really bend the epidemic's arch as we go out throughout the world.”
But the magnitude of its impact will also depend on how easy it is, said Jeremiah Johnson, executive director of Prep4all, an organization focused on expanding access to HIV prevention medications.
Prices, access, efficacy
Lenacapavir, Yeztugo's generic name, has an annual list price of $ 28,218 in the USA. Before insurance, said a Gilead spokesman in an email. That is in line with existing brand medications approved for the same use: prophylaxis prior to exposure, or preparation, which reduces the risk of obtaining HIV.
The supply of a month of Truvada and Decovy, the daily pills of Gilead for the preparation, cost around $ 2,000 without insurance, which amounts to around $ 24,000 per year. A dose of GSK's apprehension, which is taken once monthly during the first two months and, once every two months, costs approximately $ 4,000 before insurance.
“We are working for Yezugo to be accessible to anyone who needs or wants and we hope to see wide insurance coverage,” said Gilead spokesman, adding that there is a wide insurance coverage for existing prevention options.
The company said it has a copayment savings program for eligible insurance patients who can reduce pocket payments for yeztugo to only zero dollars. Gilead also has a program for eligible people without insurance to receive injection for free.
Lenacapavir is already approved to treat HIV under the Sunlenca brand, which is priced at more than $ 42,200 per year. An analysis in 2024 found that the medicine could be done for only $ 26 to $ 40 a year.
Mizuho analysts have estimated that Lenacapavir could reach maximum sales of around $ 4 billion worldwide both for HIV prevention and treatment.
O'Day said that the company is also committed to supplying the medication for that use worldwide, since the virus “does not know the limits.” In October, Gilead gave licenses to six generic manufacturers to produce and sell versions of lower injection cost in 120 low and low middle income countries.
Gilead also promised to supply doses for up to 2 million people without profits before these generic versions reach the market, O'Day said.
Prep has been available for a decade in the form of daily pills, but infections have risen or remained in many areas. Pills can be difficult for many people to constantly take for several reasons, including inconveniences and stigma around HIV and preparation in many communities, particularly outside the demography of white men who have sex with men.
Black Americans represent 39% of the new HIV diagnoses, but only 14% of preparation users, while Hispanic people represent 31% of the new diagnoses but only 18% of preparation users, according to AIDSVU.
“Unfortunately, there is still a huge amount of stigma and cultural challenges when it comes to HIV prevention,” said Johanna Mercier, Gilead's commercial director, in an interview. “Getting an injection twice a year really gives you that privacy that people have been looking for.”
She said that Gilead aims to ensure that more people, especially those who do not currently use, are aware of that advantage of the convenience and efficacy of the company's injection.
In a late stage, 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 demonstrating 89% more effective than Gilead Truvada's daily pill. The study enrolled cisgenero men, transgender women, transgender men and non -binary people who have sex with couples assigned to men at birth.
Another judgment on Cisgender's women found that none of the participants who received the injection of Gilead contracted an HIV infection, which demonstrated a 100%efficacy.
The proposed republican fund cuts represent a threat
In the United States, guaranteeing access to unattended populations will also require wide insurance coverage. Although most preparation users are under commercial plans, the Federal Medicaid program is also crucial to reach low -income communities.
Medicaid is the largest source of insurance coverage for people who have the virus in the US. That makes the clippings proposed to Republicans to Medicaid a great potential threat to the treatment of HIV and access to prevention.
Mercier said that, from now on, Gilead believes that Medicaid will continue to cover the services and support of HIV.
“There are quite incredible programs, not only Medicaid and other government programs, which really have security networks to ensure that people who need or want access, both for the treatment of HIV and for prevention, are created,” he said, also pointing to Gilead's programs for people without insurance.
But Johnson de Prep4all said the “Complete Base for HIV prevention in the United States is under attack at this time.”
Other proposed federal fund cuts could hinder Gilead's injection into the hands of doctors and patients, said Johnson. For example, the budget proposed by the White House for fiscal year 2026 includes deep cuts to several HIV prevention programs, particularly those carried out through CDC.
While some financing currents continue, Johnson said they are doing it “in a way that would completely destabilize the entire field of HIV prevention.”
He said that if Congress does not retreat the proposed cuts, people who currently take the preparation “could begin to slide” and HIV infections could increase in many communities.
