The Food and Drug Administration (FDA) has approved Cabenuva (cabotegravir and rilpivirine, injectable formulation; ViiV Healthcare) as a complete regimen for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adults to replace a current antiretroviral regimen in those who are virologically suppressed on a stable antiretroviral regimen with no history of treatment failure and with no known or suspected resistance to either cabotegravir or rilpivirine. Cabenuva is the first FDA-approved injectable, complete regimen for HIV-infected adults that is administered once a month.

The FDA also approved Vocabria (cabotegravir, tablet formulation; ViiV Healthcare), which should be taken in combination with oral rilpivirine (Edurant) for one month prior to starting treatment with Cabenuva to ensure the medications are well-tolerated before switching to the extended-release injectable formulation.

Approval of Cabenuva is supported by results from 2 clinical trials. Patients in both trials continued to show virologic suppression at the conclusion of each study, and no clinically relevant change from baseline in CD4+ cell counts was observed. Cabenuva should not be used if there is a known previous hypersensitivity reaction to cabotegravir or rilpivirine, or in patients who are not virally suppressed (HIV-1 RNA greater than 50 copies/milliliter). Cabenuva and Vocabria were granted Fast Track and Priority Review designation by the FDA.

Food and Drug Administration (FDA). FDA Approves First Extended-Release, Injectable Drug Regimen for Adults Living with HIV [news release]. January 21, 2021. Available at: click here. Accessed January 22, 2021.