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ViiV Healthcare announces European Commission Decision for Vocabria (cabotegravir) and Rekambys (rilpivirine) injections to be initiated with or without an oral lead-in period for the long-acting treatment of HIV
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Healthcare professionals and people living with HIV now have the choice of starting long-acting treatment with the oral initiation phase or starting injections directly
London, 28 October 2021 - ViiV Healthcare, the global specialist HIV company majority owned by GlaxoSmithKline plc ("GSK"), with Pfizer Inc. and Shionogi Limited as shareholders, announced that the European Commission has granted a decision to update the Summary of Product Characteristics (SmPC) for Vocabria (cabotegravir injections and tablets) and The Janssen Pharmaceutical Companies of Johnson & Johnson's Rekambys (rilpivirine long-acting injectable suspension) giving healthcare professionals and people living with HIV the option to start with injections, without the need for an oral lead-in of cabotegravir and rilpivirine. Oral cabotegravir and rilpivirine can be taken for a month to assess tolerability to the medicines, which is now optional with the SmPC update. The data showed that both initiation routes have similar safety and efficacy profiles.1,2
Harmony P. Garges, M.D., MPH, Chief Medical Officer at ViiV Healthcare said: "Being able to initiate cabotegravir and rilpivirine injections without an oral lead-in simplifies the initiation experience for both healthcare professionals and people living with HIV, meaning that they can start long-acting therapy sooner. People living with HIV can experience a range of challenges with daily oral antiretroviral therapy, including daily reminders of HIV and the fear of disclosing their HIV status. We are pleased that with this decision, they now have a choice of switching from their current oral therapy to a long-acting injectable therapy without having to transition through an oral lead-in. At ViiV Healthcare, we are proud to be able to offer innovative choices that meet the changing needs of people living with HIV."
The decision from the European Commission was based on the phase III FLAIR clinical trial Week 124 results, and supported by extensive safety and tolerability data from Phase II and Phase III studies of oral cabotegravir and rilpivirine, prior to intramuscular injections, where no safety signals that would require the use of an oral lead-in were identified.3 Administration of cabotegravir and rilpivirine injections without the oral lead-in was investigated as part of an extension to the Phase III FLAIR clinical trial, with results showing that there were no meaningful differences in 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
ViiV Healthcare's cabotegravir in combination with Janssen Pharmaceutical Companies of Johnson & Johnson's rilpivirine was co-developed as part of a collaboration with Janssen and builds on ViiV Healthcare's industry-leading portfolio that is centred on delivering innovative medicines for the HIV community.
About Vocabria (cabotegravir injection) and Rekambys (rilpivirine injection)1,3
Cabotegravir injection used in combination with rilpivirine injection is a complete long-acting regimen dosed monthly or every 2-months, for the treatment of HIV-1 in adults who are virologically suppressed (HIV-1 RNA <50 copies/mL) on a stable antiretroviral regimen without present or past evidence of viral resistance to, and no prior virological failure with agents of the NNRTI and INI class. Cabotegravir and rilpivirine injections are administered as two intramuscular (IM) injections in the buttocks by a healthcare professional at the same appointment.
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 UC, one of the Janssen Pharmaceutical Companies of Johnson & Johnson.
INSTIs, like cabotegravir, 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 infection. Rilpivirine is an NNRTI that works by interfering with an enzyme called reverse transcriptase, which in turn stops the virus from multiplying.
Trademarks are owned by or licensed to the ViiV Healthcare group of companies.
full press release -
https://viivhealthcare.com/en-gb/media/press-releases/2021/october/viiv-healthcare-announces-european-commission-decision/
References
1. Vocabria EU Summary of Product Characteristics. Available at: https://www.ema.europa.eu/en/documents/product-information/vocabria-epar-product-information_en.pdf. Last accessed October 2021.
2. Rekambys EU Summary of Product Characteristics. Available at: https://www.ema.europa.eu/en/documents/product-information/rekambys-epar-product-information_en.pdf Last access October 2021
3. 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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