The US Food and Drug Administration (FDA) has approved use of the vaccine Yeztugo, manufactured by Gilead Sciences, is an anti-HIV drug.
It is noted that the vaccine should be injected twice a year to prevent infection. Its effectiveness in clinical trials involving adults and adolescents was an impressive 99.9%.
The drug, which is commercially available under the brand name Yeztugo, is called lenacapavir. Gilead Sciences has conducted two large clinical trials. The first involved more than 2 thousand women from African countries south of the Sahara Desert. The results demonstrated a 100% reduction in HIV transmission and an advantage over similar Truvada tablets that must be taken daily.
The second trial involved 2,000 men and women. The results showed only two cases of HIV infection, and the prevention rate was 99.9%. At the same time, adverse reactions included irritation and pain at the injection site, headache, and nausea.
However, the current concern is the possible price of the new vaccine. A similar drug, cabotegravir, which must be injected every two months, was approved by the FDA in 2021. It costs tens of thousands of dollars a year and is not yet widely available. Analysts expect the initial price of Yeztugo to be around $25 thousand per year and lower than the current price of a course of treatment with lenacapavir at $39 thousand.
Human rights advocates and researchers are calling on Gilead Sciences to achieve a significant reduction in the price of Yeztugo to overcome the HIV pandemic. Chemist from the University of Liverpool Andrew Hill and his colleagues found, that lenacapavir could be mass-produced and reduce the cost of production to $25.
«Even high-income countries will not be able to afford large-scale use of lenacapavir at prices of more than $20 thousand per year», — emphasizes Andrew Hill.
In October 2025, Gilead signed agreements with six pharmaceutical companies to produce generic versions of the drug in 120 low- and middle-income countries, which should expand access to treatment. However, launching production in these countries will take time. The company also signed an agreement with the Global Fund, which purchased doses for two million people. Meanwhile the cuts to the PEPFAR program by the Donald Trump administration have put the future of this agreement in doubt.
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Research results published in the journal The New England Journal of Medicine
Source: ScienceAlert
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