Food and drug administration has just approved a preventive HIV drug widely regarded as a breakthrough.
On Wednesday afternoon, the FDA approved the Lenacapavir of Gilead Sciences as a more convenient form of pre-exhibition prophylaxis (Prep). In clinical trials, it was shown that the drug was highly effective in preventing HIV infection when it was taken twice a year. At the same time, proponents are calling for Gilead and the United States officials to ensure that the drug is widely accessible to the public.
“ Preparation is one of the most indispensable tools we have to end the HIV epidemic. Having the option of a twice a year, instead of trusting a daily pill, will make the long -term grip on preparation much easier for many, ” said Kevin Robert Frost, director general of Ampar, the foundations for AIDS research, in a statement provided to Gizmodo. “But this remarkable drug will only be as effective as accessible and affordable.”
The FDA approved for the first time Lenacapavir in 2022 as an antiretroviral treatment for HIV, marketed by the name of Sunlenca. It was the first approved treatment of a new class of drugs for HIV: medicines that are directly addressed to the capsid, or the shell, of the virus. Only this has made Lenacapavir a life breakthrough, as it can potentially treat infections that have become resistant to other drugs. But the greater potential of the drug could result from its vaccine capacity to prevent the virus from gaining a foot in the first place.
One year ago, Gilead liberated The results of his phase III essay for his purpose, which tried a two -year Lenacapavir claim to Cisgenere women. The drug exceeded daily preparation options with a 100%prevention rate. A subsequent judgment too show A 99.9% prevention rate between Cisgenere men, transgender men and women and gender non -binary people. Drug success was so impressive that Science Magazine called It is as a breakthrough in the research of the year. Gilead is too study If a single annual dose can be equally effective.
As monumental as Lenacapavir’s arrival for preparation, its cost could be a problem, especially given Gilead’s reputation. The company has been settling for some time High -growing and often growing list prices for your previous preparation medicine and has it resisted fiercely Attempts from the United States and others to lower these prices (Yet todayThe one -month Truvada supply can cost up to $ 2,000 without insurance). Gilead has also been accused of trying to delay the development of cheaper generics, though they are now; By 2023 the company established a Demand for class action about these allegations.
News NBC informed On Wednesday that the Lenacapavir preparation version, sold with the Yeztuba brand, will be priced at a list of $ 14,109 per injection or $ 2,352 per month. In his announcement of FDA approval, Gilead well -known It is “working closely with insurers, health systems and other payers in order to ensure wide coverage of insurance.” It will also set programs aimed at reducing out -of -pocket costs of Yeztubo up to $ 0 for some eligible people with or without insurance.
The time will need to know if these guarantees will be enough to make the drug widely affordable and accessible to the North -Americans and, eventually, to all others in the world.
“Ampar calls on the Gilead sciences and the United States government to do everything in their power to ensure that so many people who want Lenacapavir can achieve it,” said Frost.
