Injectable PrEP receives ‘breakthrough therapy’ designation from FDA
Bimonthly injections were previously found to be more effective than daily pills at preventing HIV transmission
An injectable form of PrEP has been given “breakthrough therapy” designation by the FDA.
PrEP, or pre-exposure prophylaxis, uses antiretroviral therapies designed to combat HIV to help prevent transmission to those without the virus.
The current standard for PrEP is a once-daily pill consisting of a combination of antiretrovirals emtricitabine and tenofovir, manufactured by Gilead Sciences under the brand name Truvada.
But earlier this year GlaxoSmithKline announced that injections of the antiretroviral cabotegravir, administered every two months, were more effective at preventing transmission of HIV than Truvada.
Read More: PrEP injection every two months proves more effective than daily Truvada
Truvada is already up to 99% effective at preventing transmission of the virus, but GSK’s injections were found to be even more effective — 69% more — so much so that clinical trials were stopped early, and those who had been given Truvada were offered bimonthly injections instead.
This week, ViiV Healthcare, which is owned by GSK and developed the injections, announced that the U.S. Food and Drug Administration had granted Breakthrough Therapy Designation for long-acting, injectable cabotegravir.
The designation helps the development of drugs that address serious or life-threatening medical conditions and expedites their review by the FDA.
ViiV will now work more closely with the FDA to plan out the injection’s development, data collection processes, and approval.
“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, M.D., MPH, and Head of Research & Development at ViiV Healthcare, said in a statement.
“Our data from the [clinical] studies show that long-acting cabotegravir is superior to daily oral [Truvada] tablets for HIV prevention,” Smith continued. “We are looking forward to working closely with the FDA to make this prevention option available to people at risk of acquiring HIV.”
ViiV Healthcare’s clinical trials involved 4,600 HIV-negative cisgender men and transgender women who have sex with men in North and South America, Asia, and Africa.
Of those participants, 38 who were taking the daily pill became infected with HIV, while only 12 who received injections every two months became infected.
GSK reported that most (80%) of the participants receiving the injection reported pain or tenderness at the injection site, but only 2% of participants discontinued due to that discomfort or reaction to the injection.
An interim review by the Data and Safety Monitoring Board, an independent organization, found that the bimonthly injections were “highly effective at preventing HIV in the study population,” GSK reported.
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