In what could be a significant step towards ending the HIV epidemic, the US FDA has given the go ahead to the first and only long-acting injectable treatment for pre-exposure prophylaxis (PrEP) of HIV.

Cabotegravir extended-release injectable suspension has been approved for use in adults and adolescents weighing at least 35 kgs (77 lbs) who are at risk of acquiring HIV infection. It is an alternative to daily oral prophylactic drugs.

Dose and administration: Single 600mg injection; two initiation injections are given one month apart, and subsequently every two months. Prior to starting the injectable treatment, oral cabotegravir tablets can be taken for a month to find out tolerability of the drug.

Side effects: Injection site reactions, headache, fever, fatigue, back pain, myalgia, diarrhea, rash, abdominal pain, nausea, vomiting, anorexia, dizziness

Warning and precautions: Hypersensitivity reactions, hepatotoxicity and depressive disorders

The drug also carries a “boxed warning” about using the drug only in persons who test negative for HIV. A negative HIV status before initiating treatment with this drug and before each injection is required to prevent risk of drug resistance. The US FDA has further cautioned that persons who test HIV-positive during the course of treatment should be treated with complete HIV treatment regimen.

Source: US FDA, December 20, 2021