New Two-Shot Injection offers Hope in HIV Prevention
The United States has approved a new treatment to prevent HIV that could revolutionize the fight against AIDS.
Medications aimed at preventing the transmission of human immunodeficiency virus have existed for more than a decade, but generally require taking a daily pill.
In 2021, the Food and Drug Administration (FDA) approved the first injectable medicine for this purpose, developed by Viiv Healthcare laboratory.
The new treatment, developed under the Yezugo brand by Gilead Pharmaceutical Laboratory, consists of two annual injections.
It will be available for “adults and adolescents that weigh at least 35 kg,” according to Gilead.
“This is a historic day,” said Daniel O’Day, president and executive director of Gilead.
This medicine, based on the Lenacapavir molecule, is considered a great advance.
Lenacapavir could be the tool we need to control new HIV infections, but only if it has an affordable price.
The Gilead laboratory already markets an antiretroviral treatment since 2022,Sunlenca,developed from the same molecule.
The latter promises unprecedented efficacy and could change the rules of the game against AIDS, according to experts.
It has been shown that Lenacapavir reduces the risk of HIV transmission by more than 99.9% in adults and adolescents, making it functionally similar to a vaccine.
The company conducted two large clinical trials.
The first, in which more than 2,000 women from sub-Saharan Africa participated, resulted in a 100% reduction in infections.
In the second trial,in which more than 2,000 people of diverse gender participated,only two infections were recorded,representing a prevention rate of 99.9%.
Notified side effects include reactions at the injection site, headache, and nausea.
The results of both trials were published in the New England Journal of Medicine, and Science magazine described Lenacapavir as the “advance of the year” in 2024.
Despite these remarkable results, prices could be astronomical.
Although the company has not disseminated them,analysts estimate that the launch price in the united States could amount to $25,000 per year.
Numerous voices have urged the laboratory to make these treatments accessible in poor countries.
“Not even high-income countries may afford the massive use of Lenacapavir at prices greater than US $20,000 per year,” said Andrew Hill, from the University of Liverpool, at the head of a team of chemists and scientists that discovered that it could be produced in mass and sold for only 25 dollars per person per year.
“I congratulate Gilead and his US partners to promote this important innovation,” added Winnie Byanyima, UN Under-Secretary.
“Lenacapavir could be the tool we need to control the new infections, but only if it has an affordable price and is made available to all those who could benefit,” she added.
In October,Gilead signed agreements with six pharmaceutical companies to produce and distribute generic versions of the drug,pending regulatory approval,in 120 low and middle-income countries.
Since the start of production in those countries will take time, the company also announced in December a separate agreement with the World Fund, an international alliance, to acquire doses for two million people.
Though, cuts by the administration of Republican President Donald Trump have generated uncertainty about the future of said agreement.
Frequently Asked questions
- What is Yezugo?
- Yezugo is a new injectable medication used for pre-exposure prophylaxis (PrEP) to prevent HIV infection. It is indeed administered as two injections per year.
- How effective is yezugo?
- Clinical trials have shown that Lenacapavir, the active ingredient in Yezugo, reduces the risk of HIV transmission by more than 99.9%.
- What are the side effects of Yezugo?
- Common side effects include reactions at the injection site, headache, and nausea.
- How does Yezugo compare to daily PrEP pills?
- Yezugo offers a less frequent dosing schedule compared to daily PrEP pills, which may improve adherence and convenience for some individuals.
- How much will Yezugo cost?
- Analysts estimate the annual cost of Yezugo in the united States could be around $25,000, but the actual price has not been officially announced by Gilead.
