A supplemental New Drug Application (sNDA) has been submitted to the Food and Drug Administration (FDA) to expand the labeling for Cabenuva (cabotegravir and rilpivirine; ViiV Healthcare) injection to include every 2 months dosing for the treatment of HIV-1 infection. Cabenuva is currently approved as a once monthly dosing regimen.
In January 2021, Cabenuva received FDA approval for the treatment of HIV-1 infection in adults to replace the current antiretroviral regimen in those who are virologically suppressed (HIV-1 RNA <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. Prior to initiation with Cabenuva, an oral-lead in should be used for approximately 1 month to assess the tolerability of cabotegravir and rilpivirine.
The sNDA includes data from the multicenter, randomized, open-label, parallel-group, noninferiority phase 3b ATLAS-2M study (ClinicalTrials.gov: NCT03299049), which compared the efficacy and safety of cabotegravir plus rilpivirine administered intramuscularly every 2 months to a once monthly regimen in 1045 adults with HIV-1 infection. The primary end point was the proportion of patients with plasma HIV-RNA greater than or equal to 50 copies/mL using the FDA Snapshot algorithm at week 48 (intent-to-treat exposed [ITTE] population).
Results showed that the every 2 months dosing regimen was noninferior to the once monthly dosing regimen (proportion of patients with plasma HIV-1 RNA ≥50 copies/mL: 1.7% [n=9/522] vs 1.0% [n=5/523], respectively [adjusted difference: 0.8%; 95% CI, -0.6, 2.2]). Moreover, the study met its key secondary end point with similar rates of virologic suppression between the every 2 months (94.3%; n=492/522) and once monthly dosing regimens (93.5%; n=489/523) (adjusted difference: 0.8%; 95% CI, -2.1, 3.7).
Commenting on the sNDA submission, Kimberly Smith, MD, MPH, Head of Research & Development at ViiV Healthcare, said: “This first-of-its-kind regimen reflects the evolving needs of people living with HIV, and, if this expanded use is approved, could allow adults living with HIV to maintain virologic suppression with 6 dosing days per year.”
ViiV Healthcare submits supplemental New Drug Application to US FDA for expanded use of Cabenuva (cabotegravir, rilpivirine) as an HIV treatment for use every 2-months. [press release]. Research Triangle Park, NC: ViiV Healthcare; February 24, 2021.