Cabenuva Approval Expanded to Include Every 2 Month Dosing Option for HIV

The Food and Drug Administration (FDA) has approved Cabenuva (cabotegravir and rilpivirine) injection for every 2-month dosing 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 or less), 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. The expanded approval was based on data from the phase 3b ATLAS-2M trial (ClinicalTrials.gov Identifier: NCT03299049), which assessed the noninferior antiviral activity and safety of Cabenuva administered every 2 months vs once monthly over a 48-week treatment period in 1045 adults living with HIV-1.

Results showed that both treatment regimens were similarly effective, as determined by comparing the proportion of patients with plasma HIV-1 RNA greater than or equal to 50 copies/mL at week 48 (adjusted difference, 0.8%, 95% CI, -0.6, 2.2). Rates of virological suppression were also found to be similar in the every 2-month dosing and once-monthly dosing groups (94.3% and 93.5%, respectively).  As for safety, the type and frequency of adverse reactions between groups was observed to be comparable.

“In clinical trials, approximately 9 out of every 10 trial participants preferred long-acting cabotegravir and rilpivirine dosed every 2 months compared to daily oral cabotegravir and rilpivirine taken as the oral lead-in per trial protocol,” said Turner Overton, MD, Professor, Department of Medicine at the University of Alabama at Birmingham and ATLAS-2M primary investigator. “This preference data highlights the meaningful impact long-acting regimens can have on the treatment experience for the HIV community.”

The expanded approval allows for Cabenuva to be injected either monthly or every 2 months. Both dosing options should be discussed with patients prior to starting treatment to determine which dosing frequency would be the most appropriate option. The updated prescribing information provides dosing recommendations for patients who prefer to switch from one dosing regimen to another.

Cabenuva is supplied as 400mg/600mg and 600mg/900mg kits, each containing a single-dose vial of cabotegravir and rilpivirine. To assess the tolerability of cabotegravir and rilpivirine, an oral-lead in should be used for approximately 1 month (at least 28 days) prior to initiating Cabenuva.

References

1. ViiV Healthcare announces US FDA approval of Cabenuva (cabotegravir, rilpivirine) for use every two months, expanding the label of the first and only complete long-acting HIV treatment. News release. February 1, 2022. https://www.businesswire.com/news/home/20220118006212/en/ViiV-Healthcare-Announces-US-FDA-Approval-of-Cabenuva-cabotegravir-rilpivirine-for-Use-Every-Two-Months-Expanding-the-Label-of-the-First-and-Only-Complete-Long-Acting-HIV-Treatment
2. Cabenuva. Package insert. ViiV Healthcare. 2022. Accessed February 2, 2022. https://gskpro.com/content/dam/global/hcpportal/en_US/Prescribing_Information/Cabenuva/pdf/CABENUVA-PI-PIL-IFU2-IFU3.PDF