America is on the brink of approving a long-acting HIV prevention medication that is easier to take than daily PrEP.
On 23 September, the US Food and Drug Administration (FDA) gave cabotegravir priority review status.
This means the drug will undergo a review period of six months as opposed to the usual 10.
Cabotegravir, commercially known as Cabenuva, is a long-acting version of pre-exposure prophylaxis (PrEP) and is made by ViiV Healthcare.
If approved, the drug would make history by becoming the first of its kind on the market.
Unlike oral PrEP, which is typically taken once a day, patients would receive a monthly injection to prevent the contraction of HIV.
According to Fierce Pharma, late-stage clinical trials of men who have sex with men, cisgender women and transgender women have boosted “optimism” for the drug’s success.
It comes after a year of delays for ViiV Healthcare, which is majority-owned by GlaxoSmithKline, whose manufacturing delays have slowed the process despite the FDA approving cabotegravir in November 2020.
In May 2021, GlaxoSmithKline conducted a study of over 4,500 cis men who have sex with men and trans women who have sex with men.
They found that the drug was not only safe, but that it was more effective than Truvada (the most commonly available form of oral PrEP), though it is unclear if it was able to prevent intravenous infection.
After the release of the results, Shannon Hader, the Deputy Executive Director of the Joint United Nations Program on HIV/AIDS, called the findings a “breakthrough that will have a significant impact on the lives of gay men and other men who have sex with men and transgender women when they are at higher risk of HIV infection.”
HIV transmission could be drastically reduced if long-acting forms of PrEP are rolled out, something which would also be assisted by companies trying to develop vaccines against the virus.
Given that America does not have universal healthcare like the UK, it remains unclear how expensive these medications will be or if insurance will cover the costs of them should they arrive on the market.
A decision on cabotegravir from the FDA could come as soon as January 2022. Clinical trials on Moderna’s HIV vaccine are expected to end in spring 2023.
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