Background on the Development and Significance of the New Treatment
The United States has recently approved a new preventive treatment for HIV, which could significantly impact the global fight against AIDS. This development comes after decades of daily oral medication requirements for HIV prevention.
In 2021, the U.S. Food and Drug Administration (FDA) approved the first injectable medication, Apretude by ViiV Healthcare, for HIV prevention. Now, Gilead has introduced Yeztugo, a groundbreaking two-annual-injection treatment.
Who is Gilead and Why is This Relevant?
Gilead Sciences, Inc. is a biopharmaceutical company based in California that specializes in the development of therapies for serious medical conditions, including HIV/AIDS. The company has been a significant player in the global fight against AIDS, with various antiviral treatments under its belt.
The New Treatment: Yeztugo
Yeztugo, developed by Gilead, consists of two annual injections and is available for adults and adolescents weighing at least 35 kilograms.
Clinical Trials and Efficacy
Two large-scale clinical trials demonstrated the efficacy of Yeztugo. The first trial, involving over 2,000 women from sub-Saharan Africa, resulted in a 100% reduction of HIV infections. The second trial, with over 2,000 participants of diverse genders, recorded only two infections, equating to a 99.9% prevention rate.
Reported side effects include injection site reactions, headaches, and nausea.
Recognition and Pricing Concerns
The results of both trials were published in the New England Journal of Medicine, and Science magazine named lenacapavir, Yeztugo’s active ingredient, as the “Advance of the Year” in 2024.
Despite these impressive results, concerns about pricing have emerged. Analysts estimate that the launch price in the U.S. could reach a staggering $25,000 per year.
Accessibility and Affordability
Experts warn that even high-income countries may struggle to implement widespread lenacapavir use at such high prices. Andrew Hill from the University of Liverpool and his team discovered that lenacapavir could be mass-produced and sold for as little as $25 per person annually.
Winnie Byanyima, the UN Under-Secretary-General, praised Gilead for driving this innovation but emphasized the need for affordability and global accessibility.
Gilead’s Initiatives for Global Access
In October, Gilead signed agreements with six pharmaceutical companies to produce and distribute generic versions of Yeztugo in 120 low- and middle-income countries, pending regulatory approval.
Additionally, Gilead partnered with the Global Fund, an international alliance, to acquire doses for two million people. However, uncertainty looms due to budget cuts by the administration of former U.S. President Donald Trump.
