The U.S. Food and Drug Administration (FDA) has designated injectable PrEP as a ‘breakthrough therapy’, according to the drug’s manufacturer.
Designating a treatment as a ‘breakthrough’ means the FDA has been impressed by trial results and will work with a pharmaceutical company to speed up a therapy going through the approval process. It doesn’t mean it’s granted approval just yet.
The announcement comes from ViiV Healthcare, which is majority-owned by GlaxoSmithKline. It’s developed an injectable PrEP treatment called cabotegravir. In recent trials, it compared the injectable PrEP to taking a daily dose of PrEP in tablet form. The injectable PrEP is administered once every eight weeks.
Related: Long-acting PrEP injections show some benefits over daily tablets
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One recent study, published in July, found the injectable PrEP to be 66% more effective at reducing HIV transmission. That study specifically looked at 4,500 transgender women and cisgender gay men who had sex with men.
When taken as directed, daily PrEP medication is highly effective at preventing someone from acquiring HIV. The only issue is that some people can occasionally forget to take their medication, meaning their resistance to HIV will drop.
ViiV said in a press statement, “The Breakthrough Therapy Designation means closer and more frequent collaboration with the FDA to discuss the drug’s development plan and ensure collection of appropriate data needed to support its approval.”
Kimberly Smith, M.D., MPH, Head of Research & Development at ViiV Healthcare, said: “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.
“We are looking forward to working closely with the FDA to make this prevention option available to people at risk of acquiring HIV.”
When asked for a timeline of when they hope the injectable medication might become available, a spokesperson for ViiV told Queerty: “Our intention is to file with the FDA during the first half of 2021, so we would hope for approval sometime in early 2022.”
According to the CDC, there were approximately 38,000 new HIV infections in the United States in 2018. This figure has fallen since the 1980s and 1990s but has remained around the same level since 2014. Gay and bisexual men make up around two-thirds of that figure each year.
In 2019, President Trump pledged to eliminate HIV transmission in the US by 2030. President-Elect Joe Biden said during his campaign for the Presidency that he would strive to end “the HIV/AIDS epidemic by 2025,” and that this would include greater access to PrEP.
Related: 5 ways to get PrEP delivered to your doorstep
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Cam
Covid, 8 months and 2 vaccines. HIV around 45 years, no vaccine but increasingly expensive treatments, now treatments for people who have it AND people who don’t have it.
If suburban moms were getting HIV there would have been a vaccine decades ago.
Kangol2
You know it!
frankcar1965
You obviously do not know how HIV works, its vastly different from covid, HIV mutates so fast that it’s extremely difficult to make a vax that works. It takes three meds just to treat and existing infection. You even need to get a flu vax each year because its mutates to just not as fast. Neither do we have a vax for the common cold.
Openminded
Yeah, kinda ironic that they developed Viagra so one could keep on having sex and potentially spreading HIV way before they developed decent protection to fight off HIV.
Cam
@frankcar1965
So let’s see, HIV supposedly mutates too fast for a vaccine, yet not enough to make the medications against it useless after a few years.
Sorry, but if Republicans in Congress and their voters were being infected at around 150,000 a day the same companies would have had an HIV vaccine ages ago. But it mostly hit gay people in Europe, America, and Asia, and black heterosexuals in Africa, so of course no vaccine. But of COURSE expensive treatments that provide a constant flow of income have been produced since the beginning.
Openminded
I’m confused. Do they mean the injectable is 66% more effective than the current prep pill which is already around, I believe, 90% effective? 66% would make it around 150% effective which is impossible. If it’s only 66% effective, compared to the pills 90%, the fact that you won’t “forget” to take it seems like the issue that should be addressed. Why accept 2/3rds protection from the risk of HIV just because you refuse to be responsible enough to protect yourself and take the pill? I’m glad to help those who try to help themselves, but seriously, it’s not that hard to set a reminder on your phone to take your meds.
IV drug users on Prep pill are around 70% protection rate which would make the injectable claim to be around 116% effective which is, again, impossible. Frankly, I don’t care to see any $ or research wasted on IV drug users problems.
CityguyUSA
Betterr off using condoms. This is only HIV prevention not all the other nasties and I question it’s sudden availability and yes there is a very similar action to HIV and COVID it’s the same underlying infection method.
seaguy
Like we haven’t heard that before. Condoms suck though!