FDA approves Gilead HIV prevention injection lenacapavir

Food and Pharmaceutical Administration approved on Wednesday Gilead ‘Antiviral injection twice a year to prevent HIV, a milestone of the company and some experts, can help to approach the end of the epidemic of decades caused by the virus.

However, the initiation of injected drugs to be marketed under the name of Yeztugo is facing a number of potential threats, including the deductions of the Trump administration for HIV prevention efforts.

In 2024, two groundbreaking clinical studies were able to eliminate new HIV infections when Gilead’s injection was taken every six months. This is a dosage of less than all HIV prevention drugs, including daily pills from Gilead and another injection. GSKIt was taken every month.

This makes Yeztugo a valuable and much more suitable tool to appeal to a epidemic that causes around. 1.3 million new infection According to the World Health Organization, in 2023, he contributed to the death of 630,000 people globally.

Gilead CEO Daniel O’da said that only the United States saw death associated with 700 new cases and 100 HIV every week. HIV continues to have a disproportionate effect on color, gay and bisexual men, other men who have sex with men and transgender women.

“It’s hard to exaggerate the importance of global public health,” said O’Day, “the injection will really bend the broadcast of the epidemic as you spread it all over the world.”

However, the size of the effect will depend on how easy it is, Jeremiah Johnson said PreparationAn organization that focuses on expanding access to HIV prevention drugs.

A The supply of the moon Truvada and Descovy, Gilead’s daily pills for preparation, both around $ 2,000 without insuranceThis is about 24,000 dollars a year. Once a month for the first two months and then every two months, a dose of GSK’s apretude Roughly $ 4,000 Before the insurance.

Gilead spokesman, existing prevention options for a wide insurance scope, “Yeztugo’yu need to or want to see the scope of the scope of the wide insurance to make it accessible to everyone.” He said.

The company said that there is a Copay savings program that can reduce the payments from mobile to zero dollars for Yeztugo for the appropriate insured patients. Gilead also has a program for injection of injection for free people for free.

Lenacapavir has already been approved for HIV treatment under the Sunlenca brand, which has a price tag of more than $ 42,200 per year. One analysis In 2024, he found that the drug could be made at a price of 26 to 40 dollars a year.

Mizuho analysts estimate that Lenacapavir can reach the highest sales of approximately $ 4 billion globally for both HIV prevention and treatment.

O’da said that the company also committed to supplying the drug globally for this use because the virus is not “boundaries”. Gilead in October Under licensed six generic manufacturers 120 Producing and selling lower cost versions of injection in low and lower-middle income country.

Gilead also promised to give a dose for up to 2 million people before these generic versions came to the market.

Preparation is present in the form of daily pills for ten years, but infections climbed in many areas or remained roughly flat. Pills can be difficult for many people to take consistently for various reasons, except for the demographic of white men who have sex with men, especially in many communities, in many communities.

Black Americans 39 % According to AIDSVU, a public source for HIV surveillance data from Gilead, in collaboration with the Rollins School of Rollins Public Health, only 14% of the new HIV diagnostic users represent 31% of the new diagnoses, but only 18% of the preparation users represent.

“Unfortunately, when it comes to HIV prevention, there is still a tremendous amount of stigmatization and cultural difficulties,” Gilead’s commercial responsible Johanna Mercier said in an interview. He said. “Taking injection twice a year gives you the privacy that people are looking for.”

Gilead said that more people, especially those who do not use Prep at the moment, are aware of this convenience advantage and the effectiveness of the company’s injection.

In a late stage study, 99.9% of the patients receiving Gilead’s injection did not narrow them with an infection. There were only two cases between more than 2,000 patients, which effectively reduced the risk of HIV infection by 96%, and proved that Gilead was 89% more effective than the daily pill Truvada. The study recorded cisgender men, transsexual women, transsexual men and non -sexy individuals who have sex with assigned partners at birth.

Another essay found more than 5,000 cisgender women found that none of the 2,000 participants injected Gilead’s injection of HIV infections and did not show 100% activity.

In the USA, access to inadequate service population will also require a wide range of insurance. Most preparation users, HIV+Hepatitis Policy Institute. However, the Federal Medicaid program is also very important to reach low -income communities.

Medicaid is the largest insurance scope for people with virus in the USA and an estimated 40% of elderly adults Health Policy Research Organization KFF has HIVs. This makes the proposed financing deductions of Republicans a great threat of potential for HIV treatment and prevention access in Medicaid.

Mercier, as of now Gilead’in Medicaid’in HIV services and support will continue to cover the support, he said.

Pointing to Gilead’s programs for uninsured individuals, “Not only Medicaid and other government programs, but not only Medicaid and other government programs, but also have security networks to ensure that those who require access to both HIV treatment and prevention.” He said.

However, Johnson of Prep4all said that “the whole foundation for HIV prevention in the United States is currently under attack.”

Johnson said other proposed federal financing cuts can make it difficult to take Gilead’s injection into the hands of doctors and patients. For example, the White House Recommended budget for the financial year of 2026 In several HIV prevention programs, it contains deep interruptions, especially to those carried out from CDC.

While some financing flows continue, Johnson said that they did this “in a way that will completely destabilize the entire HIV prevention area”.

Congress, if the White House does not push back the proposed interruptions, the people who are currently prepared “can begin to slide” and HIV infections may rise in many communities, he said.