FDA Label Expansion Further Simplifies HIV Treatment with Cabotegravir/Rilpivirine

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A label expansion granted by the US Food and Drug Administration (FDA) to ViiV Healthcare and Johnson & Johnson renders as optional the need for oral initiation of the partnerships’ long-acting injectable HIV treatment cabotegravir/rilpivirine (Cabenuva), allowing patients to start therapy directly with injections.

The announcement was made in a March 24th statement from Viiv.

Cabotegravir/rilpivirine was approved by the FDA in January 2021 as the first long-acting, once-monthly, complete regimen for the treatment of HIV-1 infection in virologically suppressed adults and subsequently granted a first label expansion in February 2022 for administration every 2 months.

“Since launching Cabenuva, we have been keenly focused on optimising the user experience for both people living with HIV and healthcare providers,” said Lynn Baxter, head of North America at ViiV Healthcare in the company statement. The label update underscores the company’s ongoing work to provide innovative treatment options as the needs of the HIV community evolve, she added.

FDA approval of the injectable start to cabotegravir/rilpivirine therapy was based on data from the FLAIR phase III trial Week-124 results. The findings showed similar outcomes in maintenance of virologic suppression, safety, tolerability, and pharmacokinetics in people initiating cabotegravir and rilpivirine injections with or without the oral lead-in.

Patients and/or health care providers can still choose to use oral cabotegravir and rilpivirine for a month to assess tolerability to the combination before starting the injections, but based on the new labeling, it is not required.

Cabotegravir, rilpivirine is indicated as a complete regimen for the treatment of HIV-1 infection in adults as replacement for a current antiretroviral regimen in patients 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.

The components, each in a single-dose vial, are cabotegravir extended-release injectable suspension (ViiV Healthcare) and rilpivirine extended-release injectable suspension (Janssen Sciences Ireland Unlimited Company).