ViiV Healthcare announces label update for long-acting HIV treatment

pharmafile | March 25, 2022 | News story | Medical Communications  

The FDA has approved a label update for Cabenuva (cabotegravir, rilpivirine), which makes the oral lead-in with cabotegravir and rilpivirine tablets optional.

Oral cabotegravir and rilpivirine can be taken for a month to assess tolerability to the medicines prior to initiating cabotegravir and rilpivirine injections, but this oral lead-in is now optional following clinical trial data which demonstrated similar safety and efficacy profiles for both initiation methods (with or without the oral lead-in).

Cabenuva is the first and only complete long-acting HIV treatment regimen, and is now approved in the US as a once-monthly or every two-month treatment for HIV-1 in virologically suppressed adults. This contains cabotegravir extended-release injectable suspension in a single-dose vial, and rilpivirine extended-release injectable suspension in a single-dose vial.

This is indicated as a complete regimen for the treatment of HIV-1 infection in adults to replace the current antiretroviral regimen in those who are virologically suppressed on a stable antiretroviral regimen with no history of treatment failure and with no known or suspected resistance to either cabotegravir or rilpivirine.

Lynn Baxter, Head of North America at ViiV Healthcare, said: “Since launching Cabenuva, we have been keenly focused on optimising the user experience for both people living with HIV and healthcare providers. 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.” 

Lina Adams

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