The US Meals and Drug Administration has simply authorized lenacapavir, an injectable type of HIV prevention that’s virtually one hundred pc efficient and requires solely two doses per 12 months. Science journal described the medication crucial scientific advance of 2024.
In scientific trials, lenacapavir proved to be 99.9 % efficient in stopping HIV an infection via sexual transmission in folks weighing greater than 35 kilograms. The drug, an antiretroviral, works not by stimulating an immune response, however by blocking HIV from reproducing throughout its early levels—particularly, by disrupting the operate of the virus’s capsid protein. This occurs as long as the physique receives injections each six months.
Lenacapavir has already been authorized in some international locations as a therapy for HIV in folks with types of the virus which can be immune to different remedies. Nevertheless, previous to this week, its prophylactic use had not been authorized anyplace, making the FDA’s resolution a big new growth within the battle towards the HIV/AIDS epidemic.
The drug is just not the primary drugs that may be taken preemptively to guard towards an HIV an infection: pre-exposure prophylaxis (PrEP) tablets have been already obtainable in lots of international locations, together with the USA. However these have to be taken day-after-day, and making certain ongoing entry to those medicines, and that individuals truly keep in mind to take them, is a identified problem. It’s hoped the long-lasting results of lenacapavir will make it simpler for folks to remain protected towards the virus.
In accordance with its creator, Gilead Sciences, lenacapavir can be marketed below the commerce identify Yeztugo. The corporate has dedicated to manufacturing 10 million doses by 2026.
“It is a historic day within the decades-long battle towards HIV. Yeztugo is without doubt one of the most vital scientific breakthroughs of our time and provides a really actual alternative to assist finish the HIV epidemic,” Daniel O’Day, president and CEO of Gilead, mentioned in an announcement on Wednesday.
Nevertheless, lenacapavir’s worth could also be a barrier to entry. Yeztugo can have an annual record worth of $28,218 per particular person within the US. Winnie Byanyima, government director of of the Joint United Nations Program on HIV/AIDS (UNAIDS), has additionally flagged prior to now that the drug is unaffordable for many individuals in Africa, the place the medication has the potential to have the largest impression. Roughly two-thirds of the folks residing with HIV worldwide stay in sub-Saharan Africa.
Gilead mentioned in an announcement final 12 months that it had been “growing a method to allow broad, sustainable entry globally” to lenacapavir, though the corporate has not but offered detailed info on the way it will do that. One choice could possibly be “voluntary licensing,” the place different corporations are granted permission to supply and promote generic variations of a patented product solely to folks in sure (usually low-income) international locations. Researchers on the College of Liverpool within the UK have calculated {that a} 12 months’s value of lenacapavir could possibly be made obtainable for as little as $25.
This story initially appeared on WIRED en Español and has been translated from Spanish.
