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  18th European AIDS Conference
October 27th-30th, 2021
Online & United Kingdom
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ViiV Healthcare presents positive interim data showing Vocabria (cabotegravir) and Rekambys (rilpivirine) can be implemented successfully in a variety of European healthcare settings
  Issued: London UK 28 October 2021
ViiV Healthcare, the global specialist HIV company majority owned by GlaxoSmithKline plc ("GSK"), with Pfizer Inc. and Shionogi Limited as shareholders, today presented positive interim data from the CARISEL (Cabotegravir and Rilpivirine Implementation Study in European Locations) study, which was initiated and conducted during the COVID-19 pandemic. The study evaluated perspectives of healthcare teams and people living with HIV, through surveys and interviews, around the implementation of Vocabria (cabotegravir injection) and Janssen Pharmaceutical Companies of Johnson & Johnson's Rekambys (rilpivirine long-acting injectable suspension ) administered every 2-months, with data showing that implementation of the long-acting regimen is realistic and achievable in a variety of European healthcare settings.[1],[2],[3] Interim findings were presented at the 18th European AIDS Conference (EACS 2021) being held 27-30 October.
The majority of healthcare teams across Europe agreed or completely agreed that long-acting cabotegravir and rilpivirine was acceptable, appropriate and feasible to implement (mean scores 4.6, 4.1, 4.2, respectively, on a 5-point Likert scale). 1 People living with HIV on the trial were also receptive to the regimen, with 97% feeling it was acceptable to come to clinic for an injection visit every 2-months. 2
Dr Laurence Slama, CARISEL investigator, l'Hôtel Dieu Hospital, Paris, said: "Despite some initial concerns around implementing long-acting cabotegravir and rilpivirine, the CARISEL study interim findings showed that healthcare teams and people living with HIV continued to feel positive about the regimen as the study progressed. These findings were seen across all five European countries in which the study was conducted, suggesting that implementation of this regimen can work well across diverse healthcare systems and settings. It is encouraging to see enthusiasm for this novel regimen for treating HIV among the medical community as well as people who have actually been receiving treatment, and we look forward to seeing the full study results."
Implementation concerns that were identified among healthcare teams at the start of the study reduced markedly when compared to the baseline across all European countries involved once the study began. 1,3 The barriers cited as being the most "moderately" to "extremely concerning" at Month 1 included risk of resistance (36%, compared to 16% at Month 5), enough staffing (34%, compared to 18% at Month 5), and injection pain/soreness (34%, compared to 25% at Month 5). 1 COVID-19 and national lockdowns presented a potential challenge in starting patients on this novel regimen, however, there were few documented COVID-related disruptions for the initiation of the long-acting regimen. [4]
The interim data from CARISEL reinforce 12-month findings from the corresponding CUSTOMIZE study in the US*, presented in July 2021, which showed that the long-acting regimen, dosed monthly, can be successfully implemented into clinical practice in the US, across a variety of clinic types. [5]
Harmony P. Garges, M.D., MPH, Chief Medical Officer at ViiV Healthcare said: "At ViiV Healthcare, we are proud to offer innovative treatment choices that help address the evolving needs of people living with HIV. We are encouraged by the interim data from CARISEL, as it shows that implementation of the first complete long-acting HIV regimen is feasible, with positive sentiment seen across multiple European countries in varied clinical settings. The findings reinforce and are consistent with what we saw in CUSTOMIZE with monthly dosing in the US; that this innovative treatment option dosed every 2-months can also be successfully implemented across Europe."
Additional findings from the interim CARISEL data included:
• Most people living with HIV who started treatment continued to feel positive about the long-acting regimen, with 91% feeling positive at Month 4 vs 84% at Month 1,2
• Healthcare teams also felt positive about the long-acting regimen, with 81% feeling positive at Month 5 1
• Most people living with HIV on the trial agreed or completely agreed that long-acting cabotegravir and rilpivirine was highly acceptable, appropriate and feasible to implement (mean scores of 4.6, 4.6, 4.6 respectively on a 5-point Likert scale) 2
• Most healthcare teams found long-acting cabotegravir and rilpivirine acceptable for people living with HIV citing factors including eliminating worry about carrying and taking HIV pills (44%) 3
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.
*The every 2-month dosing of the long-acting regimen of cabotegravir and rilpivirine is not currently approved in the US. Only the monthly dosing is currently approved by the FDA.
About CARISEL (NCT04399551) [6]
CARISEL is a Phase IIIb, open-label, multicentre, one-year study examining different implementation strategies in a broad range of clinical settings across European countries to identify strategies which best meet the needs in each local context. The study, which involved 437 patient study participants and 70 healthcare team participants from 18 clinics across Spain, France, Netherlands, Belgium, and Germany, assessed the effect of various implementation strategies on the acceptability, appropriateness and feasibility of delivering the new long-acting regimen of cabotegravir and rilpivirine to appropriate people living with HIV.
About Vocabria (cabotegravir injection) and Rekambys (rilpivirine injection) [7],[8] 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: