FDA Approves ‘Breakthough’ Drug to Prevent HIV

Food and Drug Administration has just approved a preventive anti-HIV drug, which is widely considered as a breakthrough.

Wednesday afternoon, the FDA approved the Lenacapavir of Gilead’s sciences as a more practical form of pre-exhibition prophylaxis (PREP). In clinical trials, the drug has proven to be very effective in preventing HIV infection when taken twice a year. At the same time, defenders urge Gilead and American officials to ensure that the drug is widely accessible to the public.

“Preparation is one of the most essential tools we have to put an end to the HIV epidemic. Having the option of a twice annual shot, rather than relying on a daily pill, will make long -term accession for much easier preparation for many,” said Kevin Robert Frost, CEO of AMFAR, the foundation of research on AIDS. “But this remarkable drug will not be as effective as accessible and affordable.”

The FDA approved for the first time Lenacapavir in 2022 as an antiretroviral treatment for HIV, marketed under the name of Sunlenca. It was the first approved treatment of a new class of drugs for HIV – drugs that directly target the capside or the shell of the virus. This alone has made Lenacapavir a vital lead because it can potentially treat infections that have become resistant to other drugs. But the greatest potential of the drug could come from its vaccine capacity to prevent the virus from gaining ground in the first place.

A year ago, Gilead released The results of its Phase III test 1 test, which has tested an injection of preparation twice a year of Lenacapavir in women cisgenres. The drug has surpassed daily preparation options with a 100%prevention rate. A later test also watch A 99.9% prevention rate in Cisgenres men, transgender men and women and non -binary people of gender. The success of drugs was so impressive that Science Magazine appointed It is the breakthrough of the search for the year. Gilead is also now to study If only one annual dose can be just as effective.

As monumental as monumental can be for the arrival of Lenacapavir, its cost could pose a problem, in particular given the reputation of Gilead. The company has long settled high and often growing list price for his previous preparation drugs and he has fiercely resistant attempts in the United States and others to reduce these prices (Even todayOne month of the Truvada offer can cost up to $ 2,000 without insurance). Gilead was also accused of having tried to delay the development of cheaper generics, although these exist now; In 2023, the company paid a collective appeal On these allegations.

NBC News reported Wednesday that the PREP version of Lenacapavir, sold under the name of the YezTugo brand, will have a list price of $ 14,109 per injection, or $ 2,352 per month. In his announcement of FDA approval, Gilead declared that he “works in close collaboration with insurers, health systems and other payers in order to ensure large insurance coverage”. It will also establish programs intended to reduce the direct costs of Yeztugo as low as $ 0 for some eligible people with or without insurance.

Time will have to say if these insurances will be sufficient to make drugs largely affordable and accessible to Americans and possibly all others in the world.

“Amfar calls on the sciences of Gilead and the American government to do everything in their power to ensure that many people who want Lenacapavir can get it,” said Frost.