The food and drug administration recently approved a preventive HIV drug widely regarded as a advance.
On Wednesday afternoon, the FDA approved Lenacapavir of Gilead Sciences as a more convenient form of pre-exposure profilaxis (PreP). In clinical trials, the drug proved very effective in preventing HIV infection when taken only twice a year. At the same time, advocates urge Gilead and US officials to ensure that the drug is widely accessible to the public.
“Prep is one of the most indispensable tools we have to end the HIV epidemic. Having the possibility of a double-year shot, instead of relying on a daily pill, will facilitate long-term incorporation for preparation for many,” said Kevin Robert Frost, Director General of Amfar, the foundation for AIDS research, in a statement provided to Gizmodo. “But this remarkable drug will be as effective as it is accessible and accessible.”
The FDA first approved Lenacapavir in 2022 as an anti -finding treatment for HIV, marketed under the name Sunlencan. It was the first approved treatment of a new drug class for HIV – drugs that directly target the capsid, or shell, from the virus. This alone has made Lenacapavir an essential advance, as it can possibly treat infections that have become resistant to other drugs. But the greatest potential of the drug may stem from its vaccine-like ability to prevent the virus ever gaining foot in the first place.
A year ago, Gilead released The results of its target 1 phase III test, which tested a two-year preparation injection of Lenacapavir in cisgender women. The drug has exceeded daily prepoint options with a prevention rate of 100%. Later litigation as well showed 99.9% preventive evidence between cisgender men, transgender men and women, and sexual non-binary individuals. The success of the drug was so impressive that a scientific journal Called it as the research progress of the year. Gilead is also now studying If a single year dose can be equally effective.
As monumental as Lenacapavir’s arrival for Prep, its cost could cause a problem – especially given Gilead’s reputation. The company has long set up High and often growing list prices for its earlier prep -drugs and it has fiercely resisted attempts by the United States and others to lower these prices (Even todayA monthly supply of Truvada can cost up to $ 2,000 without insurance). Gilead has also been accused of trying to delay the development of cheaper generators, although these now exist; In 2023, the company settled a complaint about class activity over these allegations.
NBC News Reported On Wednesday, the Prep version of Lenacapavir, sold under the brand name Yeztugo, will have a list price of $ 14.109 per injection, or $ 2.352 a month. In his announcement of the FDA -approval, Gilead declared that it “works closely with insurers, health systems and other payers with the aim of ensuring wide insurance coverage.” It will also set up programs intended to reduce Yeztugo’s out -of -age costs as low as $ 0 for some eligible people with or without insurance.
Time will have to tell if these assurances will be enough to make the drug widely accessible and accessible to Americans and possibly everyone else in the world.
“Amfar calls on Gilead Sciences and the US government to do everything in their power to make sure that many people who want Lenacapavir can get it,” Frost said.
