FDA Grants Breakthrough Therapy Designation For Long-Acting Cabotegravir As HIV PrEP

By Jeff Craven /alert Contributor
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FDA has granted the long-acting injectable cabotegravir Breakthrough Designation Therapy for HIV pre-exposure prophylaxis, according to a recent announcement released by ViiV Healthcare.

“New medicines that decrease the risk of HIV acquisition in at-risk populations are an essential tool to help us end the global HIV epidemic,” Kimberly Smith, MD, MPH, Head of Research & Development at ViiV Healthcare, stated in a press release.


The Breakthrough Designation Therapy was granted based on results from the randomized, double-blinded, multicenter, phase 2b/3 HPTN 083 trial, where 4,566 cisgender men and transgender women without HIV in Argentina, Brazil, Peru, the United States, South Africa, Thailand and Vietnam received long-acting, injectable cabotegravir every 8 weeks, or daily oral tablets of emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) at doses of 200 mg or 300 mg. The participants were expected to receive up 3 years of unblinded study medication. In the final analysis of the trial, which was presented at the 23rd International AIDS Conference in July, researchers found long-acting cabotegravir was 66% more effective at preventing HIV (HIV incidence, 0.41%; 95% confidence interval, 0.22-0.69%) than oral FTC/TDF tablets taken daily (HIV incidence, 1.22%; 95% CI, 0.87-1.67%).

A phase 3 double-blinded safety and efficacy study, HPTN 084, which evaluated long-acting cabotegravir administered every 8 weeks and daily oral FTC/TDF tablets at doses of 200 mg or 300 mg in 3,223 women in Botswana, Kenya, Malawi, South Africa, Eswatini, Uganda and Zimbabwe at risk for becoming infected with HIV, was unblinded after an independent data safety monitoring board determined the cabotegravir intervention was more effective.

“Our data from the HPTN 083 and 084 studies show that long-acting cabotegravir is superior to daily oral FTC/TDF tablets for HIV prevention. We are looking forward to working closely with the FDA to make this prevention option available to people at risk of acquiring HIV,” Dr. Smith said. 

In a press release, ViiV Healthcare said both HPTN 083 and HPTN 084 will be used for future regulatory submissions. Currently, long-acting cabotegravir is not an approved or licensed treatment in the United States or internationally for HIV prevention.


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