American Food The Drug Administration has just approved Lenacapavir, an injectable form of HIV prevention that has an efficiency of almost 100% and requires only two doses per year. science The journal describes the drug as the most important scientific advancement in 2024.
In clinical trials, Lenacapavir has been shown to effectively prevent HIV infection in preventing sexual transmission in people over 35 kg. The drug is an antiretroviral that works not by stimulating an immune response, but by preventing HIV from reproduction in early stages, especially by destroying the function of the virus’s capsid protein. This happens as long as the body receives an injection every six months.
Lenacapavir has been approved in certain countries as a treatment for HIV in a form of virus that is resistant to other therapies. However, its preventive use has not been approved anywhere before this week, making the FDA’s decision a major development in the fight against the HIV/AIDS epidemic.
This drug is not the first drug to prevent HIV infection in advance: in many countries, including the United States, pre-prevention prevention (PREP) pills are already available. However, it is a known challenge to take these daily and ensure that these medications are used continuously and that people actually remember to take them. Hopefully, the lasting effects of Lenacapavir will make it easier for people to protect the virus.
According to its creator Gilead Sciences, Lenacapavir will be sold under the commercial name Yeztugo. The company has pledged to manufacture 10 million doses by 2026.
“This is a historic day in the decades of fighting HIV. Yeztugo is one of the most important scientific breakthroughs of our time and offers a very real opportunity to help end the HIV epidemic,” Gilead President and CEO Daniel O’Day said in a statement Wednesday.
However, the price of Lenacapavir may be a barrier to the passage. In the United States, Yeztugo’s annual salary is $28,218 per person. Winnie Byanyima, executive director of the United Nations Programme for the United Nations Joint HIV/AIDS (UNAIDS), also marked the past that the drug is unbearable for many in Africa, where the drug has the potential to have the greatest impact. About two-thirds of people live in sub-Saharan Africa.
On Wednesday, Gilead released details of a two-part program that “of 120 high-end, resource-limited countries, mainly low- and middle-income countries.” One step would be a “voluntary licensing,” where other companies are licensed to produce and sell common versions of patented products in a certain country. In addition, the company said it plans to “profit unprofitable products without gilead until general manufacturers can fully support the needs of voluntary licensing countries.”
This story originally appeared in wired español and has been translated into Spanish.
BST Updated 6-20-2025: Gilead Science provides detailed information on strategies to access Lenacapavir in low- and middle- and low-income countries.
