“Lenacapavir is a cutting-edge antiretroviral that made headlines in 2024 for preventing HIV with a twice-yearly injection,” reports The Doomslayer.
Now, a recently published study suggests that new formulations of the drug could function similarly with just a single annual injection.
In the study, researchers compared blood samples of participants injected with the once-yearly formulations with blood samples from trials of the earlier twice-yearly formulation. The new formulations produced higher levels of the drug over the entire 56-week period.
Gilead is planning a larger trial of the new formulations to further test their effectiveness, and whether the drug remains safe at the much higher doses required. If successful, the result would be a much more practical version of an already groundbreaking medicine, especially in regions with poor health infrastructure.
Stat News says the “drug could be submitted” to the FDA “for approval in 2027.” This “medicine, if proven effective, would be the closest thing to a vaccine the HIV field has produced in four decades of research.”
Don’t expect this drug to be on the market in 2027. The FDA can take many years to approve medical devices and drugs. The FDA didn’t approve a home test for HIV until 24 years after it first received an application. According to an FDA advisory committee, the test held “the potential to prevent the transmission of more than 4,000 new HIV infections in its first year of use alone.” That means thousands of people likely got infected with AIDS as a result of the delay in approving it. At least a hundred thousand people died waiting years for the FDA to approve beta blockers.
Recent cuts to staffing at the FDA could result in it taking even longer for the FDA to approve new drugs such as Lenacapavir. Some experts have argued that the FDA should only be able to remove unsafe or useless drugs and devices from the market, instead of the FDA having to approve drugs and devices before they can be sold. Requiring approval before they can be sold results in delays of many years before life-saving drugs become available.
Scientists have engineered a virus that steals proteins from the HIV virus, hoping to use it to eliminate AIDS.
