On 20th December 2021, the U.S. Food and Drug Administration (FDA) announced its first approval of a long-acting HIV prevention medication. Developed by ViiV Healthcare, the medicine is long-acting cabotegravir injected once every two months.
This will provide an alternative to daily pills for HIV prevention, such as Truvada and Descovy. These pills are up to 99% effective at preventing the sexual transmission of HIV, but must be taken every day to be that effective, according to the Centers for Disease Control and Prevention (CDC).
FDA approved Apretude (cabotegravir extended-release injectable suspension) for use in at-risk adults and adolescents weighing at least 35 kilograms (77 pounds) for pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV.
Apretude is given first as two initiation injections administered one month apart, and then every two months thereafter. Patients can either start their treatment with Apretude or take oral cabotegravir (Vocabria) for four weeks to assess how well they tolerate the drug.
Developed by ViiV Healthcare, the medicine is long-acting cabotegravir injected once every two months.The National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, thanks and congratulates everyone who led, conducted and participated in the research that led to this important development.
Apretude includes a boxed warning to not use the drug unless a negative HIV test is confirmed. It must only be prescribed to individuals confirmed to be HIV-negative immediately prior to starting the drug and before each injection to reduce the risk of developing drug resistance.
Drug-resistant HIV variants have been identified in people with undiagnosed HIV when they use Apretude for HIV PrEeP. Individuals who become infected with HIV while receiving Apretude for PrEP must transition to a complete HIV treatment regimen. The drug labeling also includes warnings and precautions regarding hypersensitivity reactions, hepatotoxicity (liver damage) and depressive disorders.
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