The Food and Drug Administration (FDA) has approved Cabenuva (cabotegravir and rilpivirine; ViiV Healthcare) injection for the treatment of HIV-1 infection in adults to replace the current antiretroviral regimen in those who are virologically suppressed (HIV-1 RNA less than 50 copies/mL) 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 a 2-drug co-packaged product that combines cabotegravir, an HIV integrase strand transfer inhibitor, and rilpivirine, an HIV non-nucleoside reverse transcriptase inhibitor. Prior to initiation with Cabenuva, an oral-lead in should be used for approximately 1 month (at least 28 days) to assess the tolerability of cabotegravir and rilpivirine.
The approval was based on data from 2 randomized, open-label, parallel-group phase 3 trials (ATLAS and FLAIR) that evaluated the efficacy and safety of Cabenuva in 1182 HIV-infected adults who were virologically suppressed (HIV-1 RNA less than 50 copies/mL) prior to initiation. Results showed that treatment with Cabenuva administered intramuscularly every 4 weeks was noninferior to a standard of care daily oral 3-drug regimen in maintaining viral suppression (primary end point). In both studies, virologic suppression rates (HIV-1 RNA less than 50 copies/mL) were found to be similar between the 2 treatment arms at week 48.
Regarding safety, the most common adverse reactions reported with Cabenuva include injection site reactions, pyrexia, fatigue, headache, musculoskeletal pain, nausea, sleep disorders, dizziness and rash.
“Currently, the standard of care for patients with HIV includes patients taking daily pills to adequately manage their condition. This approval will allow some patients the option of receiving once-monthly injections in lieu of a daily oral treatment regimen,” said John Farley, MD, MPH, director of the Office of Infectious Diseases in the FDA’s Center for Drug Evaluation and Research.
The FDA has also approved Vocabria (cabotegravir; ViiV Healthcare) tablets, in combination with oral rilpivirine (Edurant; Janssen), for short-term treatment of HIV-1 infection in adults who are virologically stable and suppressed, for use as an oral lead-in to assess tolerability of cabotegravir for 1 month prior to initiation with Cabenuva.
Cabenuva will be supplied as 400mg/600mg and 600mg/900mg kits, each containing a single-dose vial of cabotegravir and rilpivirine. Vocabria will be supplied as 30mg tablets of cabotegravir in 30-count bottles.
The Company expects to begin shipping both products in February 2021.
1. FDA approves first extended-release, injectable drug regimen for adults living with HIV. [press release]. Silver Springs, MD: US Food and Drug Administration; January 21, 2021.
2. ViiV Healthcare announces FDA approval of Cabenuva (cabotegravir, rilpivirine), the first and only complete long-acting regimen for HIV treatment. [press release]. London, England: ViiV Healthcare; January 21, 2021.
3. Cabenuva [package insert]. Research Triangle Park, NJ: ViiV Healthcare; 2021.
4. Vocabria [package insert]. Research Triangle Park, NJ: ViiV Healthcare; 2021.