The U.S. Food and Drug Administration (FDA) has approved Gilead Sciences’ twice-a-year injectable medication for HIV prevention, a development the company has called a major leap forward in the battle against the virus.
While pre-exposure prophylaxis (PrEP) has been available for over a decade, most options require daily oral dosing, limiting their overall impact on reducing infection rates worldwide.
“This marks a pivotal moment in the long-standing effort to combat HIV,” said Daniel O’Day, CEO and chairman of Gilead, in an official release.
Known commercially as Yeztugo, the newly approved injection uses the drug lenacapavir, which has demonstrated a greater than 99.9% effectiveness in preventing HIV transmission in both adults and adolescents—making it nearly as effective as a vaccine.
The approval was based on two major clinical studies. One included over 2,000 women in sub-Saharan Africa and reported a complete prevention rate—zero infections—outperforming the daily pill Truvada. The second trial, involving more than 2,000 men and gender-diverse participants, showed just two infections, again delivering a 99.9% success rate.
Some of the commonly reported side effects included mild reactions at the injection site, headaches, and nausea.
Researchers published the findings from both studies in The New England Journal of Medicine, and Science magazine named the drug the “Breakthrough of the Year” for 2024.
Cost Concerns Cloud Accessibility
Despite the promising results, concerns about affordability could hinder widespread adoption.
Cabotegravir, another long-acting injectable HIV prevention drug approved in 2021 and administered every two months, costs tens of thousands of dollars annually and has yet to gain traction globally.
Though Gilead has not yet announced a price for Yeztugo, estimates suggest the U.S. launch price may approach $25,000 per year. For comparison, manufacturers currently charge $39,000 per year for lenacapavir as an HIV treatment, although they may lower the price when it’s used for prevention.
Public health advocates are calling on Gilead to significantly lower the cost to ensure global access.
Andrew Hill of Liverpool University warned that even wealthy nations won’t be able to implement lenacapavir broadly if the price exceeds $20,000 per year.His research team calculated that manufacturers could potentially produce the drug for just $25 per person per year.
UN Under-Secretary-General Winnie Byanyima praised the breakthrough and emphasized that lenacapavir could help control the spread of HIV—if Gilead makes it affordable and accessible to everyone who needs it.
To help bridge that gap, Gilead has signed agreements with six pharmaceutical companies to manufacture and distribute generic versions in 120 low- and middle-income countries, pending regulatory approvals.
Recognizing the time needed to ramp up production in those regions, Gilead also entered a separate deal in December with the Global Fund to supply doses for two million people. This effort is backed by partners such as the U.S. President’s Emergency Plan for AIDS Relief (PEPFAR). However, recent budget cuts to PEPFAR under the Trump administration have raised questions about the long-term stability of that initiative.
Read the original article on: Science Alert
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