Food and Drug Administration Wednesday approved Gilead ‘The antiviral injection twice a year for HIV prevention – an important step which, according to the company and certain experts, could help bring the world closer to the end of the decades caused by the virus.
But the launch of the injectable drug, which will be marketed under the name of Yeztugo, faces a set of potential threats, including the reductions proposed by the Trump administration with federal funding for HIV prevention efforts.
In two revolutionary clinical trials in 2024, the injection of Gilead turned out to eliminate the new HIV infections practically when taken every six months. It is a less frequent dose than for all existing HIV prevention drugs, including the daily pills of Gilead and another injection, of GSKtaken every two months.
This makes Yeztugo a precious and much more practical tool to combat an epidemic that has 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.
The United States alone sees 700 new cases and 100 deaths related to HIV each week, said Gilead CEO Daniel O’Day, in an interview before approval. HIV continues to have a disproportionate impact on people of color, gay and bisexual men, other men who have sex with transgender men and women.
“It is difficult to overestimate the importance of this for global public health,” said O’Day, adding that the injection “will really fold the arc of the epidemic while we deploy this around the world”.
But the extent of its impact will also depend on the ease of obtaining, said Jeremiah Johnson, Executive Director of PREP4All, an organization focused on expanding access to drug prevention drugs.
Price, access, efficiency
Lenacapavir, the generic name of Yeztugo, has an annual list price of $ 28,218 in the United States before insurance, said a spokesperson for Gilead in an email. This complies with the existing brand drugs approved for the same use: pre-exhibition prophylaxis, or prep, which reduces the risk of obtaining HIV.
The offer of a month of Truvada and Descovy, the daily pills of Gilead for the preparation, are both of around $ 2,000 without insurance, which represents about $ 24,000 per year. A dose of GSK’s lenses, which is taken once monthly for the first two months, then once every two months afterwards, costs around $ 4,000 before insurance.
“We are working to make Yeztugo accessible to all those who need it or wish it and we are waiting to see wide insurance coverage,” said Gilead spokesperson, adding that there is a wide insurance coverage for existing prevention options.
The company said it had a copamentation savings program for eligible insured patients who could reduce payments during the pocket for Yeztugo to as little as zero dollar. Gilead also has a program for eligible people who are not guaranteed to receive injection for free.
Lenacapavir is already approved for the treatment of HIV under the Sunlenca brand, which has a price of more than $ 42,200 per year. An analysis in 2024 revealed that the drug could be done for as little as $ 26 to $ 40 per year.
Mizuho analysts estimated that Lenacapavir could reach cutting -edge sales of around $ 4 billion worldwide for HIV prevention and treatment.
O’Day said the company has also committed to providing the drug for this global use because the virus “knows no borders”. Gilead in October granted licenses to six generic manufacturers to produce and sell versions at lower cost of injection in 120 medium and low income countries.
Gilead also promised to provide doses of up to 2 million people without profit before these generic versions arrived on the market, said O’Day.
The preparation has been available for a decade in the form of daily pills, but infections are climbed or have been roughly flat in many regions. Pills can be difficult for many people to be consistent for several reasons, including drawbacks and stigma around HIV and preparation in many communities, especially outside the demography of white men who have sex with men.
Blacks American represent 39% of HIV diagnoses, but only 14% of PREP users, while Hispanics represent 31% of new diagnoses, but only 18% of PREP users, according to AIDSVU, a public resource for Gilead HIV monitoring data in partnership with the Rollins School of Public Health Health.
“Unfortunately, there is still a huge stigma and cultural challenges with regard to HIV prevention,” said Johanna Mercier, Commercial Director of Gilead, in an interview. “Getting an injection twice a year really gives you this privacy that people are looking for.”
She said Gilead aims to ensure that more people, especially those who do not currently use preparation, are aware of this convenience advantage and the effectiveness of the company’s injection.
In an advanced stage test, 99.9% of patients who injected Gilead did not contract an infection. There were only two cases among more than 2,000 patients, which effectively reduces the risk of HIV infection by 96% and was 89% more efficient than the daily pill of Gilead. The study recruited cisgenres men, transgender women, transgender men and non -binary people who have sex with partners assigned to birth.
Another test, out of more than 5,000 Cisgenres women, revealed that none of the approximately 2,000 participants who received the injection of Gilead had contracted a HIV infection, demonstrating 100%efficiency.
Proposed federal financing cuts represent a threat
In the United States, guaranteeing access to poorly served populations will also require wide insurance coverage. Most of the preparation users are in commercial plans, according to HIV + Hepatitis Policy Institute. But the Federal Medicaid program is also crucial to reaching low -income communities.
Medicaid is the greatest source of insurance coverage for people who have the virus in the United States, covering around 40% of unmulate adults who have HIV, according to the research organization on KFF health policy. This makes funding reductions proposed by the Republicans in Medicaid a huge potential threat to the treatment of HIV and access to prevention.
Mercier has said that, to date, Gilead believes that Medicaid will continue to cover the services and support of HIV.
“There are quite incredible programs, not just Medicaid and other government programs, which really have safety nets to ensure that people who need or who want access, both for the treatment and prevention of HIV, are created,” she said, also pointing to gilead programs for unhealthy people.
But Johnson de Prép4all said that “the entire HIV prevention foundation in America was attacked at the moment”.
Other federal financing cuts proposed could make it more difficult to set up the injection of Gilead in the hands of doctors and patients, said Johnson. For example, the proposed budget of the White House for exercise 2026 includes deep cuts with several HIV prevention programs, in particular those managed by the CDC.
While some funding flows continue, Johnson said they were doing it “in a way that would completely destabilize the whole field of HIV prevention”.
He said that if the congress did not postpone the proposed cuts of the White House, people who are currently taking preparations “could start to slip” and that HIV infections could increase in many communities.