Infectious Disease

FDA makes oral lead-in optional for long-acting injectable HIV regimen

March 24, 2022

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The FDA has approved a label update for Cabenuva that makes the oral lead-in period for the long-acting injectable HIV regimen optional, ViiV Healthcare announced Thursday.

Cabenuva, which includes shots of cabotegravir (ViiV Healthcare) and rilpivirine (Janssen Pharmaceuticals) was first approved in January 2021 and is now available to be taken as few as six time per year by virologically suppressed adults on a stable regimen with no history of prior Treatment failure or resistance to either drug.

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The FDA has approved a label update for Cabenuva that makes the oral lead-in period optional. Source: Adobe Stock.

The FDA’s approval of the label update means it is now optional whether patients take oral versions of the drugs for 1 month to assess their tolerability. Data from the FLAIR trial showed there were similar outcomes for maintenance of virologic suppression, safety, tolerability and pharmacokinetics among people starting cabotegravir and rilpivirine injections with or without the oral lead-in at week 124, ViiV 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 ,” Lynn Baxter, North America head at ViiV Healthcare, said in a press release.

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