Lasting HIV prevention shot headed towards approval
A new injection to prevent HIV is anticipated to be approved by the U.S. Food and Drug Administration (FDA) later this month. The shot, lenacapavir, would be administered twice a year and could be a significant advancement in the fight against HIV if approved. Drugmaker Gilead Sciences tested the shot in a study of women and girls. None of the participants who received the injections contracted HIV. This early success boosted Gilead’s stock by 73% over the past year, as reported by The Wall Street Journal.
"We understand it’s challenging to take a daily tablet for prevention, and we see an extraordinary opportunity here," stated Johanna Mercier, Gilead’s chief commercial officer. Currently, over 400,000 individuals in the United States use tablets for HIV prevention, with Gilead expecting this number to surpass 1 million by the next decade. A survey revealed that 95% of over 500 PrEP users would opt for a long-acting injection over daily pills. Sales of other long-acting options, such as the Apretude shot from GSK, have surged by 63% in the past year.
Despite promising results, Gilead faces challenges in reaching those most in need of HIV prevention. While Black Americans account for 39% of new HIV cases, they only represent 14% of current PrEP users. Stigma and lack of insurance coverage hinder access for many individuals. Gilead is prioritizing reaching underserved groups, with a focus on expanding access through Medicaid to lower-income communities. Some experts are concerned that the new shot may cannibalize existing Gilead products like the daily pill Descovy, which currently holds a significant market share. Gilead aims for the shot to increase the overall usage of PrEP domestically and internationally.
"We’re thinking globally about the public health impact we can achieve," Mercier emphasized. The company is collaborating with governments and health organizations in the U.K. and low-income nations to raise awareness and enhance product availability.
More details: The National Institutes of Health provides additional information on Pre-Exposure Prophylaxis (PrEP). © 2025 HealthDay. All rights reserved.
