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The FDA has okayed allowing patients to start treatment with the injection instead of having a lead in with the oral version.
The FDA approved a label update for ViiV Healthcare’s popular HIV-1 treatment Cabenuva (cabotegravir, rilpivirine), making the oral lead-in with cabotegravir and rilpivirine tablets optional.
Cabenuva is the only complete long-acting HIV treatment regimen, ViiV, which is majority owned by GlaxoSmithKline with Pfizer and Shionogi as shareholders, said in a news release.
Oral cabotegravir and rilpivirine can be taken for a month to assess tolerability to the medicines prior to initiating cabotegravir and rilpivirine injections, a regimen co-developed as part of a collaboration with the Janssen Pharmaceutical Companies of Johnson & Johnson, ViiV said.
But this oral lead-in is now optional after clinical trial data demonstrated similar safety and efficacy profiles for both initiation methods (with or without the oral lead-in).
“Since launching Cabenuva, we have been keenly focused on optimizing the user experience for both people living with HIV and healthcare providers,” Lynn Baxter, head of North America at ViiV Healthcare, said 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.”
The FDA label update is based on the FLAIR phase 3 trial Week-124 results, which showed there were similar outcomes regarding maintenance of virologic suppression, safety, tolerability, and pharmacokinetics in people starting cabotegravir and rilpivirine injections with or without the oral lead-in, ViiV said.
Cabenuva 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.
The complete regimen combines the integrase strand transfer inhibitor (INSTI) cabotegravir, developed by ViiV Healthcare, with rilpivirine, a non-nucleoside reverse transcriptase inhibitor developed by Janssen Sciences Ireland Unlimited Company.
Rilpivirine is approved in the United States as a 25 mg tablet taken once daily to treat HIV-1, in combination with other antiretroviral agents in antiretroviral treatment-naïve patients 12 years of age and older.