FDA Approves Fostemsavir for At-Need Adults with HIV


The indication is granted on the strength of clinical evidence showing 60% of treated patients achieved HIV RNA suppression at 96 weeks.


The US Food and Drug Administration (FDA) has approved fostemsavir (Rukobia) for the treatment of adults living with HIV who cannot be successfully treated with other therapies due to resistance, intolerance or safety considerations.

The therapy from ViiV Healthcare was previously granted Fast Track, Priority Review, and Breakthrough Therapy designations by the FDA.

This newest HIV therapy approval was supported by safety and efficacy findings in a 371-patient clinical trial involving adults with heavy HIV treatment experience and continued high levels of virus as per HIV-RNA.

Investigators treated 272 patients in the main trial arm, with the additional 99 participants receiving fostemsavir in a different trial arm. Nearly three-fourths (71%) of assessed patients had been treated for HIV for 15-plus years. Even more (85%) had been exposed to ≥5 different HIV treatment regimens prior to the trial's start, and 86% had a history of AIDS.

Investigators treated main treatment-cohort patients with either fostemsavir or placebo twice daily for 8 days, plus their failing antiretroviral therapy regimen. On day 8, patients in the treatment arm reported a significantly greater decrease in HIV-RNA levels in their bloodstream versus the placebo arm. All patients were switched or remained on fostemsavir following the day 8 assessment.

At 24 weeks of fostemsavir plus therapy regimen, 53% of patients achieved HIV RNA suppression; that number improved to 60% at 96 weeks.

The most common adverse event reaction to therapy was nausea, while severe adverse reactions included liver enzyme elevations among patients also infected with hepatitis B or C, as well as changes to the immune system.

In a statement accompanying the approval, Jeff Murray, MD, FDA's Center for Drug Evaluation and Research deputy director of the Division of Antivirals, said the indication marks a "new class of antiretroviral medications that may benefit patients who have run out of HIV treatment options."

"The availability of new classes of antiretroviral drugs is critical for heavily treatment-experienced patients living with multidrug resistant HIV infection—helping people living with hard-to-treat HIV who are at greater risk for HIV-related complications, to potentially live longer, healthier lives," Murray said.

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