FDA approves first long-acting injectable treatment for HIV prevention

The preventative measure can be taken as little as six times per year, and has been proven to be more effective than oral medications

A red ribbon is displayed on the North Portico of the White House to recognize World AIDS Day on 1 December, 2021 in Washington. (Getty Images)

The US has approved a long-acting pre-exposure prevention treatment (PrEP), named Apretude, to help people avoid HIV infection.

The FDA announced on Monday that Apretude (cabotegravir extended-release injectable suspension) will be available to at-risk individuals who weigh at least 5.5 stone (more than 77 pounds).

There are currently daily HIV prevention oral medications like Truvada available, but Apretude is a bi-monthly treatment with two initial shots at the beginning of a course (one month apart), and can be given as few as six times per year. Recipients have to test negative for HIV before the drug is administered.

GlaxoSmithKline (GSK) the owners of ViiV Healthcare, which produces the drug, explained that Apretude “demonstrated superior efficacy to a daily oral PrEP option”.

The injectable treatment was given to 7,700 participants across 13 countries. Cisgender men and transgender women who have sex with men were 69 per cent less at risk of getting infected with HIV over taking an oral drug, while cisgender women were 90 per cent less at risk of getting HIV using the injectable drug over an oral drug.

Taking a daily pill to prevent HIV can be a huge burden explained Gabriel Maldonado, from public policy group TruEvolution, people can experience “stigma, fears about accidental disclosure of their medicine, as well as general complications from daily living,” he explained. “Together, these issues may contribute to low rates of PrEP usage and the expansion of the HIV epidemic.”

It’s thought the drug will make a huge difference to those disproportionately affected by HIV, including those in Black/African American and Latinx communities who have sex with men, plus those who are dealing with substance use disorders, depression and poverty.

Women from sub-Saharan Africa are twice as likely to contract HIV as their male counterparts, according to GSK, but so far the US is the only country to approve the use of Apretude.

“We have the tools to end the HIV epidemic through the implementation of effective antiretroviral treatment and HIV prevention,” said Richard Elion, Director of Research at Washington Health Institute. “PrEP has played a vital role in protecting people from acquiring HIV. With the availability of cabotegravir long-acting for PrEP as an injection every two months to prevent HIV, people now have an important new option besides daily medication. This long-acting medication offers more options for prevention, and now providers and patients will be empowered by choices and the ability to choose the approach that is optimal for each individual.” 

Around 38 million people worldwide are living with HIV, some 1.7 million people contract HIV each year. GSK estimates that fewer than 25 per cent of people who are at risk in the US are taking a preventative drug. Apretude will be available from early 2022.