FDA Approves Label Update for Cabenuva Long-Acting HIV Treatment

FDA approves label update for Cabenuva that makes the therapy’s oral lead-in with cabotegravir and rilpivirine tablets optional.

The FDA has approved a label update for Cabenuva (cabotegravir, rilpivirine; ViiV Healthcare; Janssen) that makes the therapy’s oral lead-in with cabotegravir and rilpivirine tablets optional. As a result, Cabenuva may or may not be taken orally for a month to evaluate tolerability prior to initiating injections of the medication.1

The decision resulted from clinical data that demonstrated similar safety and efficacy among trial participants who did or did not initiate treatment with the oral lead-in. Cabenuva is intended as a replacement antiretroviral therapy (ART) for virologically suppressed adults (HIV-1 RNA <50 c/ml) with HIV-1 infection.

“Since launching Cabenuva, we have been keenly focused on optimizing the user experience for both people living with HIV and health care providers,” said Lynn Baxter, North American head of ViiV Healthcare, in a press release. “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 the first and only complete long-acting HIV treatment regimen approved in the United States as either a once-monthly or every 2-month treatment for HIV-1 in virologically suppressed adults. The drug is comprised of cabotegravir extended-release injectable suspension in a single-dose vial and rilpivirine extended-release injectable suspension in a single-dose vial.

Cabenuva was co-developed by ViiV Healthcare and Janssen Pharmaceutical Companies of Johnson & Johnson. Cabenuva is intended as a replacement antiretroviral therapy (ART) for virologically suppressed adults (HIV-1 RNA <50 c/ml) with HIV-1 infection.

The FDA approved the injectable combination (cabotegravir 200 mg/mL and rilpivirine 300 mg/mL) as a once-monthly treatment for adults with HIV-1 who are virologically suppressed (HIV-1 RNA ≤ 50 copies/mL [c/mL]) on a stable ART regimen. Eligible patients must have no history of treatment failure and no known or suspected resistance to cabotegravir or rilpivirine. In the phase 2 and 3 randomized trials, researchers showed the monthly injectable combination had comparable results with current daily oral antiretroviral regime.

Eligible patients must have no history of treatment failure and no known or suspected resistance to cabotegravir or rilpivirine.2 In the phase 2 and 3 randomized trials, researchers showed the monthly injectable combination had comparable results with current daily oral antiretroviral regime.2

The FDA recently approved the extended label to be administrated every 2 months based on non-inferiority trial data.3 In the phase 3b study, researchers randomized 1045 participants to receive either cabotegravir 600 mg/rilpivirine 900 mg every 8 weeks or cabotegravir 400 mg/rilpivirine 600 mg every 4 weeks.

The primary endpoint was the proportion of patients with HIV RNA ≥ 50 c/mL at week 48 between 2 groups with a non-inferiority margin of 4%.3 Dosing every 8 weeks and dosing every 4 weeks resulted in similar efficacy.

The researchers identified an RNA ≥ 50 c/mL in 2% of the every 8-weeks group and 1% in the every 4-weeks group. The every 8-weeks group experienced 2% confirmed virological failures (CVF; 2 sequential measures ≥200 c/mL), whereas that figure was 1% in the every 4-weeks group.3

References

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. ViiV Healthcare. [news release]. March 24, 2022. https://www.gsk.com/en-gb/media/press-releases/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/

2. ONCE-MONTHLY CABENUVA CLINICAL TRIAL.Viiv healthcare. https://cabenuvahcp.com/efficacy/atlas-flair/. Accessed March 7, 2022.

3. 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. Viiv healthcare. https://viivhealthcare.com/en-us/media-center/news/press-releases/2022/january/viiv-healthcare-announces-us-fda-approval-of-cabenuva/. Accessed March 7, 2022.