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 the most vital scientific advance of 2024.
In scientific trials, lenacapavir proved to be 99.9 p.c efficient in stopping HIV an infection by 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 phases—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 might be immune to different remedies. Nevertheless, previous to this week, its prophylactic use had not been authorized wherever, making the FDA’s choice a big new growth within the combat in opposition to the HIV/AIDS epidemic.
The drug isn’t the primary drugs that may be taken preemptively to guard in opposition to 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 by day, and making certain ongoing entry to those medicines, and that individuals truly bear 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 in opposition to the virus.
Based on its creator, Gilead Sciences, lenacapavir can be marketed below the commerce identify Yeztugo. The corporate has dedicated to manufacturing 10 million doses by 2026.
“This can be a historic day within the decades-long combat in opposition to HIV. Yeztugo is likely one of the most vital scientific breakthroughs of our time and presents a really actual alternative to assist finish the HIV epidemic,” Daniel O’Day, president and CEO of Gilead, mentioned in a assertion on Wednesday.
Nevertheless, lenacapavir’s worth could also be a barrier to entry. Yeztugo may have an annual checklist worth of $28,218 per particular person within the US. Winnie Byanyima, govt 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 most important impression. Roughly two-thirds of the folks residing with HIV worldwide reside in sub-Saharan Africa.
Gilead mentioned in a assertion final 12 months that it had been “creating a technique 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 possibility may very well be “voluntary licensing,” the place different corporations are granted permission to provide and promote generic variations of a patented product completely 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 price of lenacapavir may very well be made obtainable for as little as $25.
This story initially appeared on WIRED en Español and has been translated from Spanish.
