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FDA approves first long-acting HIV medication: a monthly injection

A health professional prepares an injection
(Photo: Shutterstock)

The FDA in the US has approved the first, long-acting, monthly injection treatment for HIV, replacing the need for some to take daily pills.

The two-shot combo is called Cabenuva, and it comes from the pharmaceutical company, Viiv Healthcare, which is owned by GlaxoSmithKline.

Cabenuva consists of two injections: rilpivirine, commonly sold as Edurant by Janssen, and a new drug, cabotegravir, from ViiV Healthcare. They’re administered as intramuscular injections in your buttocks.

The FDA granted its approval last Thursday (January 21).

Cabenuva - injectable HIV treatment
Cabenuva (Photo: ViiV Healthcare)

ViiV has also developed a pill form of cabotegravir. Those wanting to switch to injections will need to take the cabotegravir pill for a month beforehand to ensure good tolerance to the drug.

Although the drugs will initially be administered once a month, the company is also trialing the medication for administration every two months, but that’s not been approved by the FDA as yet.

The company says the price of the injections ($5,940 for an initial, higher dose and $3,960 per month afterward) was comparable to the cost of the pill versions.

Related: FDA says injectable PrEP a ‘breakthrough’ therapy as it pends approval

Many people on daily medication have expressed a preference for the idea of a monthly injection. One man, an international lawyer who often has to travel to countries that do not allow entry to people with HIV, told the NY Times, he’d previously always “had this fear of being stopped at customs.”

Health experts also think a monthly injection could be of benefit to those who struggle with a daily pill regime, such as those with substance use or mental health issues.

Lynn Baxter, Head of North America, ViiV Healthcare, said in a statement: “Today’s FDA approval of Cabenuva represents a shift in the way HIV is treated, offering people living with HIV a completely new approach to care. Cabenuva reduces the treatment dosing days from 365 days to 12 days per year.”

The medication was trialed on people who were already taking a daily pill and had an undetectable viral load, so it may not be suitable for those who have just been diagnosed or have an elevated viral load.

ViiV will start shipping the medication to wholesalers in February.

ViiV is also seeking approval for cabotegravir to be approved as a form of PrEP. From studies, it has found that an injection of the drug every two months acts just as well as a daily PrEP tablet.

Related: Long-acting PrEP injections show some benefits over daily tablets