FDA approved Gilead HIV Prevention Injection Lenacapavir

The Food and Drug Administration approved on Wednesday Gilead 'S Twice annual antiviral injection to prevent HIV-a milestone, of which the company and some experts say that they could come closer to the world to the decades of epidemic caused by the virus.

However, the introduction of the injectable drug, which is marketed under the name Yztugo, sees itself exposed to a number of potential threats, including the proposed cuts of the Trump administration for federal financing for HIV prevention efforts.

In two groundbreaking clinical studies in 2024, Gileads injection was able to remove new HIV infections when they were recorded every six months. This is a less common dosage than for all existing medication for HIV prevention, including the daily pills of Gilead and another injection, of GSKtaken every second month.

This makes Yeztugo a valuable and much more convenient instrument to combat an epidemic that, according to the World Health Organization, led to around 1.3 million new infections in 2023 and contributed to the death of 630,000 people worldwide in 2023.

The United States alone sees 700 new cases and 100 HIV-related deaths per week, Gilead CEO Daniel O'Day said in an interview before approval. HIV still has a disproportionate influence on people with color, gays and bisexual men, other men who have sex with men and transgender women.

“It is difficult to overdo the importance of this for global public health,” said O'Day and added that the injection “will really bend the arc of the epidemic if we work out all over the world.”

However, the extent of its effects also depends on how easy it is to get, said Jeremiah Johnson, Managing Director of Prep4all, an organization that focuses on expanding access to HIV prevention medication.

Prince design, access, effectiveness

Lenacapavir, the generic name of Yeztugo, has an annual list price of USD 28,218 in the USA in front of the insurance company, a Gilead spokesman said in an e -mail. This is in accordance with existing brand medication that has been approved for the same use: prophylaxis or prep before exposure, which reduces the risk of HIV.

A monthly supply with Truvada and Descovy, Gileads daily pills for the preparation, is both around 2,000 US dollars without insurance, which is around 24,000 US dollars a year. A dose of GSK's Apraetude, which is taken once a month in the first two months and then every other month later, costs about 4,000 US dollars in front of the insurance company.

“We are working on making Yeztugo accessible to anyone who needs or would like to, and expect to insure broad insurance coverage,” said the Gilead spokesman and added that there is a wide insurance cover for existing prevention options.

The company announced that it had a Copay savings program for justified insured patients who can reduce payments for Yeztugo to just zero dollars. Gilead also has a program for the beneficiaries of non -insured persons who receive the injection free of charge.

Lenacapavir is already approved for the treatment of HIV under the brand name Sunlenca, which has a price of more than $ 42,200 per year. An analysis in 2024 showed that the medication could be carried out for only 26 to 40 US dollars per year.

Mibuho analysts have estimated that Lenacapavir could achieve a maximum sale of around 4 billion US dollars for both HIV prevention and treatment worldwide.

O'Day said the company was also obliged to deliver the medication globally for this use, since the virus “knows no limits”. In October, Gilead granted six generic manufacturers to produce and sell lower price versions of the injection in 120 countries with lower and lower means of funds.

Gilead also promised to deliver doses for up to 2 million people without profit before these generic versions come onto the market, said O'Day.

Preparation has been available in the form of daily pills for a decade, but infections have risen in many areas or have remained approximately flat. Pillen can be difficult for many people to enter into consistently for several reasons, including inconvenience and stigma in terms of HIV and preparation in many communities, especially outside the demography of the white men who have sex with men.

Black Americans make up 39% of the new HIV diagnoses, but only 14% of the preparatory users, while Hispanic people represent 31% of the new diagnoses, but only 18% of the PREP users, according to AIDSVU, a public resource for HIV surveillance data from Gilead in cooperation with the Rollins School of Public Health at Emory University.

“Unfortunately, there is still an enormous amount of stigmatization and cultural challenges when it comes to HIV prevention,” said Johanna Mercier, Chief Commercial Officer from Gilead in an interview. “A two-year injection really gives them the privacy they searched for.”

She said Gilead wants to make sure that more people, especially those who are currently not using PREP, know this comfort advantage and the effectiveness of the company's injection.

In a study in the late stage, 99.9% of the patients who took Gileads injection did not make any infection. There were only two cases in more than 2,000 patients, which effectively reduces the risk of HIV infection by 96% and 89% more effective than Gileads proves daily pill Truvada. The study included Cisgenden men, transgender women, transgender men and non -binaric genders who have sex with partners who were assigned to men at birth.

Another study with more than 5,000 Cisgender women showed that none of the approximately 2,000 participants who received Gileads injected an HIV infection, which shows a 100% effectiveness.

The proposed federal financing cuts are a threat

In the United States, the guarantee of access to under -sized population groups also requires wide insurance protection. According to the HIV+Hepatitis Policy Institute, most preparation users are under commercial plans. The Federal Medicaid program is also crucial for the achievement of communities with lower incomes.

Medicaid is the largest source of insurance protection for people with the virus in the USA and, according to Health Policy Research Organization KFF, covers an estimated 40% of the non -older adults with HIV. So that the proposed funding reductions of the Republicans for Medicaid into an enormous potential threat to HIV treatment and access to prevention.

Mercier said that Gilead now believes that Medicaid will continue to cover HIV services and support.

“There are fairly incredible programs, not only Medicaid and other government programs that really have security networks to ensure that people who need access to HIV treatment and prevention are set up,” she said, also pointed out to Gilead's programs for people who are not insured.

However, Johnson from Prep4all said that the “entire HIV prevention in America is being attacked at this moment”.

Other proposed cuts in federal financing could make it more difficult to put Gilead's injection into the hands of doctors and patients, said Johnson. For example, the proposed budget of the White House for the 2026 financial year contains profound cuts in several HIV prevention programs, especially those guided by the CDC.

While some financing flows are continued, Johnson said that they “do this in a way that would completely destabilize the entire field of HIV prevention”.

He said that if the congress does not push the proposed cuts of the White House back, the people who are currently preparing could “start slipping” and HIV infections could rise in many communities.