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Makers of once-every-six-months HIV treatment file for FDA approval

A health professional prepares an injection
(Photo: Shutterstock)

Pharma giant Gilead has applied for FDA approval for a new HIV treatment that only needs to be injected every six months.

The treatment is called Lenacapavir. If approved, it would be the first so-called HIV capsid inhibitor that gets approval. It has been developed specifically for those with HIV who have tried other treatments and have developed resistance to some of their medications.

In trials, when Lenacapavir was given to these patients, the vast majority saw their viral load fall back to undetectable levels.

“Lenacapavir is an important breakthrough innovation with the potential to be transformative for people living with multidrug-resistant HIV who have very limited treatment options,” Gilead Chief Medical Officer Merdad Parsey, MD, PhD, said in a news release.

“The filing moves us one step closer to providing an innovative treatment option that helps to address barriers to achieving viral suppression and meet the unmet needs of people living with multidrug-resistant HIV.”

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In May 2019, the FDA granted Breakthrough Therapy Designation for the development of Lenacapavir for the treatment of HIV-1 infection “in heavily treatment-experienced patients with multi-drug resistance in combination with other antiretroviral drugs”.

In other words, because the health of these individuals is at risk because their treatment options are dwindling, the FDA gave Gilead the greenlight to speed up the development process.

Subsequent trials have been successful and Gilead now wants full approval to begin marketing the drug. However, although Lenacapavir is currently aimed at those with multi-drug resistance, Gilead has indicated that it would look at widening the drug’s scope of use, including the general HIV population.

Last year, the company also indicated it was looking at conducting trials into using Lenacapavir as a form of long-acting PrEP. Gilead already makes Truvada and Descovy.

Earlier this year, the FDA granted approval to the first once-a-month injectable HIV treatment, Cabenuva. That drug is aimed at the general HIV population and is already freeing up some patients from having to adhere to a daily pill regimen.

Related: HIV-positive man shares joy at taking his last HIV-medication pill