US regulator approves the first injectable PrEP to prevent HIV

food and drugs administration
Images: Piyapong Sayduang/Pexels, NIAID/Flickr

The US Food and Drug Administration has approved the first injectable medication for pre-exposure prophylaxis (PrEP) to reduce the risk of HIV transmission.

The regulator has approved ViiV Healthcare’s Apretude, a long-acting injection every two months for adults and teenagers at risk of contracting the virus.

The shot would replaces oral PrEP pills, which experts say is an important development in the fight against HIV.

The long-acting injectable PrEP is two shots of the medication one month apart first, then an injection every two months after that to protect against HIV.

Patients can also choose to trial the medication in an oral pill form for four weeks before the injection.

The FDA has touted the Apretude injections as an important tool in ending HIV transmission.

According to the Centers for Disease Control and Prevention, in 2020 PrEP was recommended for 1.2 million Americans. However only around 25% were prescribed it.

The FDA said the medication “requires high levels of adherence to be effective and certain high-risk individuals and groups.”

“Young men who have sex with men, are less likely to adhere to daily medication,” the regulator said.

“Other interpersonal factors, such as substance use disorders, depression, poverty and efforts to conceal medication also can impact adherence.

“It’s hoped that the availability of a long-acting injectable PrEP option will increase PrEP uptake and adherence in these groups.”

Trials show effectiveness of injectable PrEP

Two clinical trials compared Apretude with Truvada, the daily pill for PreP. The trials found significantly lower HIV risk in people who got the injection, the FDA said.

The risk was 69% lower in the first trial, of HIV-negative cisgender men and transgender women who have sex with men.

And the risk was 90% lower in the second trial, which involved cisgender women.

Long-acting injectables are also transforming HIV treatment, as well as prevention.

In January, the FDA in the US also approved ViiV Healthcare’s Cabenuva, the first injectable HIV regimen.

Experts urge Australians to catch up on HIV testing

In Australia, the federal government added oral PrEP pills to the Pharmaceutical Benefits Scheme in 2018.

Australian experts credit the medication with dramatic declines in HIV transmission as a result.

According to Kirby Institute data, as of March 2019, 62,200 Australians were eligible for PrEP. An estimated 23,020 people were accessing the medication.

Recently, experts urged all Australians at risk of HIV to catch on HIV testing and prophylaxis after a dramatic drop due to the pandemic.

This month, HIV self-test kits are going on sale for the first time at select Australian pharmacies.

The kits, produced by Atomo Diagnostics, are the first and only ones of their type approved by Australia’s Therapeutic Goods Administration.

They are first going on sale at Serafim’s pharmacy in Sydney’s Taylor Square and Western Australia’s 777 pharmacy network.

More pharmacies around the country will also start selling the self-test kits in 2022.

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1 Comment

  1. Peter Turner
    24 December 2021

    I am on PreP. My chemist places it in my Webster Pack along with all of my other medications and I take it every morning. No problems.

    Given the choice of a once a day pill or an injection every 2 months I think I’ll take the oral pills thank you very much. I’m sure I would forget when the injection was due anyway….lol!!

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