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FDA clears first-in-class HIV-1 treatment


Drug helps with heavily-treatment experienced (HTE) adults with multidrug-resistant HIV-1 infection.

FDA recently okayed a first-in-class treatment for HIV-1: fostemsavir (Rukobia, ViiV Healthcare).

Rukobia, available in 600 mg extended-release tablets, is a novel attachment inhibitor for the treatment of HIV-1 infection for use in combination with other antiretroviral (ARV) therapies in heavily treatment-experienced (HTE) adults with multidrug-resistant HIV-1 infection, who are failing their current ARV regimen due to resistance, intolerance or safety considerations, ViiV said in a press release.

Related: Gilead snags approval for second HIV-1 prevention drug

“This approval marks a new class of antiretroviral medications that may benefit patients who have run out of HIV treatment options,” said Jeff Murray, MD, deputy director of the Division of Antivirals in the FDA’s Center for Drug Evaluation and Research, in a separate FDA press release.

“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 added.

While significant advances over the past few decades have dramatically improved HIV treatment and for many, HTE adults — which account for approximately 6% of adults living with HIV who are on treatment — have little to no options left due to resistance, tolerability or safety considerations, ViiV said.

Related: FDA clears first 2-drug HIV-1 regimen

“There is a small group of heavily treatment-experienced adults living with HIV who are not able to maintain viral suppression with currently available medication and, without effective new options, are at great risk of progressing to AIDS,” said Deborah Waterhouse, CEO of ViiV Healthcare. “The approval of Rukobia is a culmination of incredibly complex research, development, and manufacturing efforts to ensure we leave no person living with HIV behind.”

The approval was supported by data from the phase 3 BRIGHTE study, which evaluated the safety and efficacy of Rukobia in combination with optimized background therapy (OBT) in HTE adults living with multidrug-resistant HIV, many of whom had advanced HIV disease at study entry.

In the randomized cohort, 60% of individuals who received Rukobia in addition to an investigator-selected OBT achieved undetectable HIV viral load and clinically meaningful improvements to CD4+ T-cell count through Week 96.

Rukobia was approved under the FDA’s Fast Track and Breakthrough Therapy Designations.

Read more: New HIV-1 treatments join crowded market

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