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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
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US FDA approval of updated label streamlines the initiation process for the first and only complete long-acting HIV treatment by allowing people to start directly with injections
London, 24 March 2022 - ViiV Healthcare, the global specialist HIV company majority owned by GlaxoSmithKline plc ("GSK"), with Pfizer Inc. and Shionogi Limited as shareholders, today announced that the US Food and Drug Administration (FDA) approved a label update for Cabenuva (cabotegravir, rilpivirine) making 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, a regimen co-developed as part of a collaboration with the Janssen Pharmaceutical Companies of Johnson & Johnson, 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).1, 2
Cabenuva is the first and only complete long-acting HIV treatment regimen and is approved in the US as a once-monthly or every-two-month treatment for HIV-1 in virologically suppressed adults.1 It contains ViiV Healthcare's cabotegravir extended-release injectable suspension in a single-dose vial and rilpivirine extended-release injectable suspension in a single-dose vial, a product of Janssen Sciences Ireland Unlimited Company, one of the Janssen Pharmaceutical Companies of Johnson & Johnson.
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."
This US FDA approval is based on the FLAIR phase III 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.2
About Cabenuva (cabotegravir, rilpivirine)
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 (HIV-1 RNA <50 c/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 complete regimen combines the integrase strand transfer inhibitor (INSTI) cabotegravir, developed by ViiV Healthcare, with rilpivirine, a non-nucleoside reverse transcriptase inhibitor (NNRTI) developed by Janssen Sciences Ireland Unlimited Company. Rilpivirine is approved in the US as a 25mg tablet taken once a day to treat HIV-1 in combination with other antiretroviral agents in antiretroviral treatment-naïve patients 12 years of age and older and weighing at least 35kg with a viral load ≤100,000 HIV RNA c/ml.
INSTIs inhibit HIV replication by preventing the viral DNA from integrating into the genetic material of human immune cells (T-cells). This step is essential in the HIV replication cycle and is also responsible for establishing chronic disease. Rilpivirine is an NNRTI that works by interfering with an enzyme called reverse transcriptase, which stops the virus from multiplying.
Trademarks are owned by or licensed to the ViiV Healthcare group of companies.
Important Safety Information for Cabenuva (cabotegravir 200mg/mL; rilpivirine 300mg/mL) extended-release injectable suspensions
Cabenuva is indicated as a complete regimen for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adults to replace the current antiretroviral regimen in those who are virologically suppressed (HIV-1 RNA less than 50 copies per ml) on a stable antiretroviral regimen with no history of treatment failure and with no known or suspected resistance to either cabotegravir or rilpivirine.
CONTRAINDICATIONS
• Do not use Cabenuva in patients with previous hypersensitivity reaction to cabotegravir or rilpivirine
• Do not use Cabenuva in patients receiving carbamazepine, oxcarbazepine, phenobarbital, phenytoin, rifabutin, rifampin, rifapentine, systemic dexamethasone (>1 dose), and St John's wort
WARNINGS AND PRECAUTIONS
Full press release:
https://viivhealthcare.com/hiv-news-and-media/news/press-releases/2022/march/viiv-healthcare-announces-label-update-for-its-long-acting-hiv/
References
1. Cabenuva (cabotegravir, rilpivirine) Prescribing Information. US Approval March 2022.
2. D'Amico R, Orkin C, Morell EB, et al. Safety and efficacy of cabotegravir + rilpivirine long-acting with and without oral lead-in: FLAIR Week 124 results. Presented at HIV Glasgow 2020.
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