Cabenuva Label Update Makes Oral Lead-In Dosing Optional

Cabenuva injection 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 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 ( 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.

The overall safety profile at week 124 was consistent with that observed at week 48 and when injection therapy with Cabenuva was initiated directly without the oral lead-in phase.

Lynn Baxter, Head of North America at ViiV Healthcare, said: “Today’s label update for the optional oral lead-in provides a streamlined initiation process for the regimen by allowing people to start directly on long-acting injections and underscores ViiV Healthcare’s ongoing commitment to providing innovative treatment options that address the evolving needs of the HIV community.”

Cabenuva is supplied as 400mg/600mg and 600mg/900mg kits, each containing a single-dose vial of cabotegravir and rilpivirine.


  1. ViiV Healthcare announces label update for its long-acting HIV treatment, Cabenuva (cabotegravir, rilpivirine), to be initiated with or without an oral lead-in period. News release. ViiV Healthcare. Accessed March 24, 2022.
  2. Cabenuva. Package insert. ViiV Healthcare; 2022. Accessed March 24, 2022.