The Food and Drug Administration approved on Wednesday Gilead’S: Double-fold antiviral injections to prevent HIV – a milestone in which the company and some experts can help bring the world closer to ending decades of epidemics caused by the virus.
However, the launch of an injectable drug, sold under the name Yeztugo, faces a set of potential threats, including the Trump administration’s proposed cuts to federal funding for HIV prevention efforts.
Two groundbreaking clinical trials in 2024 proved that Gilead injections can effectively eliminate new HIV infections when taken every six months. This is a less frequent dose than all existing HIV preventive medications, such as daily tablets and separate injections from Gilead. GSKIt was photographed every other month.
According to the World Health Organization, Yeztugo will be a valuable and much more useful tool to deal with the epidemic that led to around 1.3 million new infectious diseases and contributed to the deaths of 630,000 people in 2023.
Gilead CEO Daniel O’day is seeing 700 new incidents and 100 HIV-related deaths in the US alone. HIV continues to have a disproportionate effect on men of color, gay, bisexuality, and other males who have sex with men and transgender women.
“It’s difficult to overstate the importance of this for global public health,” O’Day said, adding, “As we roll this out around the world, injections really bend the arc of fashion.”
However, the magnitude of the impact also depends on the magnitude of the impact, according to Jeremiah Johnson, executive director of Prep4all, which focuses on expanding access to HIV preventive medications.
Pricing, Access, Efficiency
Lenacapavir, the popular name for Yeztugo, has an annual listing price of $28,218 in the US before insurance, a Gilead spokesperson said in an email. This is consistent with existing branded drugs approved for the same use. This is pre-exposure prophylaxis or PREP that reduces the risk of ingesting HIV.
A month supply of Truvada and Descoby, Gilead’s daily pills are around $2,000 without insurance, and about $24,000 a year. Do one GSK Apretude. This costs about $4,000 before insurance, once a month for the first two months and once a month thereafter.
“We make Yeztugo accessible to anyone who needs it or expects wide range of insurance coverage,” a Gilead spokesman added that existing prevention options have a wide range of insurance coverage.
The company said there is a Copay Savings program for eligible insured patients that could reduce Yeztugo’s out-of-pocket pay to just zero. Gilead also has a program to get free injections for unqualified, uninsured people.
Lenacapavir is already approved for handling HIV under the brand name Sunlenca, which has a price tag of over $42,200 a year. One analysis in 2024 found that the drug could be made for $26 to $40 a year.
Mizuho analysts estimate that Lenacapavir can reach peak sales of around $4 billion worldwide in both HIV prevention and treatment.
O’Day said the company is also working to provide the drug globally for its use because the virus “don’t knows the boundaries.” In October, Gilead granted six generic manufacturers licenses to produce and sell low-cost version injections in 120 low-middle-income countries.
Gilead also pledged to supply dosages to up to 2 million people without profits before these popular versions came to the market, O’Day said.
PREP was available in the form of daily pills for 10 years, but the infections have climbed and remained almost flat in many areas. For many people, it is difficult for many to take consistently for a number of reasons, outside of the inconvenience and stigma in many communities, especially the demographics of white men who have sex with men.
Black Americans account for 39% of new HIV diagnoses, but only 14% of PREP users, while Hispanics account for 31% of new diagnoses, but only 18% of PREP users.
“Unfortunately, there is still a huge amount of stigma and cultural challenges when it comes to HIV prevention,” Gilead chief executive Johanna Mercier said in an interview. “Getting infusions twice a year really gives you the privacy people are looking for.”
She said Gilead aims to ensure that more people, especially those who are not currently using PREP, are aware of the benefits of its convenience and the effectiveness of the company’s injections.
In one stage trial, 99.9% of patients receiving Gilead’s injections were not infected. With only two of the 2,000 patients, it effectively reduced the risk of HIV infection by 96%, and 89% proved to be more effective than Gilead’s daily pill Truvada. In this study, cisgender men, transgender women, transgender men, and non-binary individuals of gender have sex with partners who assigned a man at birth.
Another trial of over 5,000 cisgender women found that approximately 2,000 participants who received Gilead’s injections were free of HIV infection, indicating 100% efficacy.
The proposed federal funding cut poses a threat
In the US, broad insurance coverage is also required to ensure access to an underserved population. According to the HIV+Hepatitis Policy Institute, most preparatory users are under commercial plans. However, the federal Medicaid program is also important to reach low-income communities.
Medicaid is the largest source of insurance coverage for people with the virus in the United States, covering an estimated 40% of non-elderly people with HIV, according to the Health Policy Research Institute KFF. This creates a major potential threat to access HIV treatment and prevention, with Republicans’ proposed funding cuts.
Mercier said for now Gilead believes Medicaid will continue to cover HIV services and support.
“It points to Gilead’s programs for uninsured individuals, with a safety net to ensure that people need or need access for HIV treatment and prevention, as well as Medicaid and other government programs.
However, Johnson of Prep4all said “the entire foundation for HIV prevention in America is under attack at this time.”
Other proposed federal funding cuts could make it difficult to inject Gilead in doctors and patients’ hands, Johnson said. For example, the White House proposed budget for fiscal year 2026 includes deep reductions in several HIV prevention programs, particularly programs running through the CDC.
While some funding flows continue, Johnson said he is doing so “in a way that completely destabilizes the entire HIV prevention field.”
He said that if Congress doesn’t push back the proposed cuts at the White House, HIV infection could rise in many communities, with people currently preparing.
