Cabenuva Label Update Makes Oral Lead-In Dosing Optional

The Food and Drug Administration (FDA) has approved updated labeling for Cabenuva (cabotegravir and rilpivirine) injection making the oral lead-in with cabotegravir and rilpivirine tablets optional.

Cabenuva injection is indicated 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. It is administered as a once-monthly or every-2-month treatment.

The 2-drug co-packaged product combines cabotegravir, an HIV integrase strand transfer inhibitor, and rilpivirine, an HIV non-nucleoside reverse transcriptase inhibitor. Healthcare providers may decide to use an oral lead-in with oral cabotegravir and oral rilpivirine prior to the initiation of Cabenuva to assess the tolerability of cabotegravir and rilpivirine, or opt to proceed directly to injection of Cabenuva without the use of an oral lead-in.

The update was based on data from the phase 3 FLAIR extension phase trial (ClinicalTrials.gov Identifier: NCT02938520), which assessed the efficacy of Cabenuva in patients who switched at week 100 from their current antiretroviral regimen to Cabenuva, with and without an oral lead-in phase. A total of 121 patients chose to initiate treatment with oral lead-in and 111 patients chose direct to injection.

At week 124, results showed that the proportion of patients with HIV-1 RNA greater than or equal to 50 copies/mL was 0.8% for the oral lead-in group and 0.9% for the direct to injection group. The rates of virologic suppression (HIV-1 RNA <50 copies/mL) were similar for the oral lead-in (93%) and direct to injection (99%) groups.

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