WASHINGTON, D.C. – In a landmark decision, the US Food and Drug Administration approved a twice-yearly injection by Gilead Sciences to prevent HIV, marking a significant advancement in the battle against the virus.
Immediate Impact
The approval of Gilead Sciences’ injection, known as Yeztugo, is being celebrated as a major breakthrough in the fight against HIV. The injection, which needs to be administered only twice a year, could revolutionize pre-exposure prophylaxis (PrEP) strategies by eliminating the need for daily pills.
“This is a historic day in the decades-long fight against HIV,” stated Daniel O’Day, chairman and chief executive of Gilead Sciences, highlighting the potential of Yeztugo to significantly reduce new infections.
Key Details Emerge
Lenacapavir, the active ingredient in Yeztugo, has demonstrated a remarkable ability to prevent HIV transmission. Clinical trials showed a prevention rate of over 99.9 percent among both adults and adolescents, effectively functioning as a potent vaccine.
Clinical Trials:
- Over 2,000 women in sub-Saharan Africa participated, resulting in a 100% reduction in infections.
- A separate trial with over 2,000 men and gender-diverse individuals recorded only two infections, achieving a 99.9% prevention rate.
Reported side effects included injection site reactions, headaches, and nausea. Results from these trials were published in The New England Journal of Medicine, with Science naming lenacapavir its 2024 “Breakthrough of the Year.”
Industry Response
While the scientific community lauds the approval, concerns about the drug’s pricing loom large. The high cost of similar treatments has previously limited their global impact.
Analysts estimate Yeztugo’s US launch price could reach $25,000 per year, though Gilead has yet to confirm pricing details.
Activists are urging Gilead to reduce the price significantly to ensure widespread accessibility. Andrew Hill of Liverpool University emphasized the necessity for affordable pricing, stating, “Even high-income countries will not be able to afford widescale use of lenacapavir at prices above US $20,000 per year.”
What Comes Next
Gilead has taken steps to facilitate global access by signing agreements with six pharmaceutical companies to produce generic versions of the drug in 120 low- and middle-income countries. Additionally, a deal with the Global Fund aims to provide doses for two million people, although funding uncertainties remain due to cuts in the PEPFAR program.
Winnie Byanyima, under-secretary-general of the United Nations, expressed optimism, stating, “Lenacapavir could be the tool we need to bring new infections under control – but only if it is priced affordably and made available to everyone who could benefit.”
Background Context
PrEP drugs have been available for over a decade but have struggled to significantly reduce global HIV infections due to the need for daily administration. Yeztugo’s twice-yearly regimen represents a promising shift in prevention strategies, potentially increasing adherence and accessibility.
The move represents a significant shift from traditional methods and could pave the way for future innovations in HIV prevention and treatment.
Expert Analysis
Experts acknowledge the potential of Yeztugo to change the landscape of HIV prevention, but emphasize the importance of strategic pricing and distribution to maximize its impact. The timing is particularly significant as global health organizations strive to reduce HIV infections worldwide.
As the world watches the rollout of this new treatment, the focus remains on ensuring that it reaches those who need it most, at a price that is sustainable for health systems across the globe.
