Now Available: Revolutionary HIV Prevention Method in the US - But Access for All Remains a Challenge
HIV prevention breakthrough gains U.S. endorsement - US grants approval for new HIV prevention medication
Here's some exciting news on the frontline of HIV prevention! Just this month, the U.S. Food and Drug Administration (FDA) gave its stamp of approval to lenacapavir, marking it as the first and only long-acting HIV prevention drug available for six-monthly injections, administered twice per year.
In two large clinical trials with over 4,000 participants, this new drug proved to be a game-changer, showing an impressive 99.9% protection rate — comparable to a vaccine. While side effects like reactions at the injection site, headaches, and nausea have been reported, these are relatively mild, given the drug's groundbreaking potential.
However, lenacapavir comes with a hefty price tag of $28,000 (€24,000) per person per year, making it expensive as a preventive measure. You might wonder — is this cost justified? Well, according to experts, the production costs are estimated to be around $40. That's quite a markup!
But wait, there's a silver lining. Gilead — the company behind lenacapavir — has announced licensing agreements with six generic manufacturers to produce and distribute the drug in low-income countries. However, critics argue that millions of people living with HIV in these countries may not reap the benefits of an affordable version of lenacapavir anytime soon.
While lenacapavir undeniably moves the needle forward for HIV prevention technology, equitable access remains at the forefront of the conversation. Stay tuned as the World Health Organization (WHO) plans to release guidelines for lenacapavir on July 14, 2025, during the International AIDS Conference in Kigali. These guidelines and the FDA approval are anticipated to speed up WHO prequalification and facilitate procurement through major donor agencies like the Global Fund. Moreover, the WHO is engaging in partnerships with the European Medicines Agency (EMA) and mechanisms like Medicines 4 All (M4All) to smooth regulatory pathways for countries adopting lenacapavir.
However, the current U.S. pricing is far beyond reach for low-income countries. The good news? Research indicates that generic versions could be manufactured at $25–46 per person per year, potentially even down to $25 if the demand surpasses 5 to 10 million people. This would put the cost of lenacapavir on par with existing oral HIV Pre-Exposure Prophylaxis (PrEP) options. UNAIDS and other stakeholders are calling on Gilead to significantly reduce the price to make it more affordable.
In conclusion, lenacapavir has enormous potential for curbing HIV infection rates, but its reach in low-income countries largely hinges on successful price reductions, generic production, and efficient regulatory and procurement channels. The battle for accessible and affordable lenacapavir is just beginning!
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