Innovative Long-Acting HIV Prevention Shot Nearing Regulatory Approval

A groundbreaking HIV prevention injection, known as lenacapavir, is anticipated to receive approval from the U.S. Food and Drug Administration (FDA) later this month. If approved, this long-acting shot would be administered biannually, potentially revolutionizing HIV prevention strategies. The medication has demonstrated promising results, especially in a study involving women and girls, where none of the participants who received lenacapavir contracted HIV, showcasing its high efficacy.

This success has significantly impacted Gilead Sciences, the pharmaceutical company behind the vaccine, leading to a 73% rise in its stock value over the past year. Johanna Mercier, Gilead’s chief commercial officer, highlighted the importance of such innovations, noting the challenges associated with daily pill regimens and emphasizing the opportunity for a long-lasting injectable alternative.

Currently, over 400,000 individuals in the United States rely on daily oral medication for HIV prevention, known as pre-exposure prophylaxis (PrEP), with Gilead projecting this number to surpass one million in the next decade. Surveys reveal a strong preference among users for injectable options, with 95% of over 500 PrEP users expressing willingness to switch from daily pills to a long-acting injection.

Sales of other long-acting PrEP options like GSK’s Apretude have also seen a significant increase, up 63% over the past year. However, Gilead faces key challenges, notably reaching underserved populations. Despite Black Americans accounting for 39% of new HIV cases, they represent just 14% of current PrEP users. Barriers such as stigma and lack of insurance further hinder access, with expanding Medicaid coverage seen as a critical step.

Moreover, some experts express concerns that the new injection might displace existing products like Descovy, which currently holds substantial market share. Nonetheless, Gilead aims to broaden the overall use of PrEP globally, working with governments and health organizations in the UK and low-income countries to raise awareness and improve distribution.

This development signals a significant advancement in HIV prevention, with potential to increase accessibility and adherence, reducing new infections worldwide. For more information on pre-exposure prophylaxis, refer to the National Institutes of Health.

[source: https://medicalxpress.com/news/2025-06-hiv-shot.html]