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ViiV HEALTHCARE PRESENTS POSITIVE DATA SHOWING VOCABRIA (CABOTEGRAVIR) AND REKAMBYS (RILPIVIRINE) CAN BE SUCCESSFULLY IMPLEMENTED ACROSS A RANGE OF EUROPEAN HEALTHCARE SETTINGS
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• Healthcare teams from diverse European HIV clinics reported that the implementation of the complete long-acting regimen was acceptable, appropriate, and feasible, with the majority of practices achieving optimal implementation within one to three months
• 81% of people living with HIV who participated in the study reported that the complete long-acting regimen was less stigmatising than daily oral treatment
London, 24 October 2022 - ViiV Healthcare, the global specialist HIV company majority-owned by GSK, with Pfizer and Shionogi as shareholders, today presented findings from the CARISEL study (Cabotegravir And Rilpivirine Implementation Study in European Locations). The study, which evaluated the perspectives of people living with HIV and healthcare teams through surveys and interviews in addition to evaluating clinical effectiveness, demonstrated that ViiV Healthcare's Vocabria (cabotegravir injection) and Janssen Pharmaceutical Companies of Johnson and Johnson's Rekambys (rilpivirine long-acting injectable suspension) was successfully implemented across a range of European healthcare settings.1 The 12-month findings from the implementation study of the first and only complete long-acting regimen for HIV treatment were presented today at the 30th HIV Glasgow Conference being held in Glasgow, Scotland and virtually, from 23 - 26 October.
At 12 months, primary findings from the CARISEL study demonstrated that despite most European clinics having no prior long-acting cabotegravir and rilpivirine experience, there was high acceptability, appropriateness, and feasibility among clinic staff towards its implementation (mean scores ≥ 3.8 on a 5-point Likert scale) as well as the long-acting regimen itself (mean scores ≥ 4.2). Of 70 staff participants in the study, 56% reported optimal implementation within one to three months, with 68% of staff participants believing the time spent in clinic was "very" or "extremely acceptable" 1.
Across the duration of the CARISEL study, people living with HIV also found that long-acting cabotegravir and rilpivirine was highly acceptable, appropriate, and feasible to implement (mean scores ≥ 4.47 on a 5-point Likert scale)1. Long-acting cabotegravir and rilpivirine demonstrated high clinical effectiveness and a low rate of viral failure throughout the duration of the trial.
At Month 12, 373 of 437 (87%) of people living with HIV in the trial maintained viral suppression (HIV-1 RNA <50 copies/mL), and the proportion of participants with HIV-1 RNA ≥50 copies/mL was 0.7% (FDA Snapshot).1
Berend J. van Welzen, M.D., CARISEL Investigator, UMC Utrecht, The Netherlands said: "The findings of the CARISEL study show that long-acting cabotegravir and rilpivirine was not only a highly effective treatment option for people living with HIV with a low rate of viral failure, but that the regimen was also highly acceptable, appropriate, and feasible to implement across a range of European countries and clinics. As healthcare providers and clinics look for real world evidence on the successful implementation of this innovative treatment, the findings of CARISEL provide continued and strong evidence for its applicability across diverse healthcare settings."
Perspectives from healthcare providers and clinical staff from the CARISEL study2
During the CARISEL study, quantitative and qualitative perceptions about the implementation of long-acting cabotegravir and rilpivirine were collected from staff study participants at 18 participating clinics at Month 1 (70 respondents), Month 5 (68 respondents), and Month 12 (62 respondents). At Month 12, quantitative data showed most study staff participants (76%) felt "very" or "extremely positive" about implementing long-acting cabotegravir and rilpivirine, with staff participants believing that the regimen was appropriate for a wide variety of patients including, but not limited to, those who are tired of daily pills, those concerned with disclosure of HIV status, and those who had experienced stress regarding daily pill compliance.
Staff participants were surveyed on their top reported barriers to the implementation of long-acting cabotegravir and rilpivirine following the first month of the CARISEL study. At the conclusion of the study, all top five perceived barriers by staff study participants that were initially reported at Month 1 had markedly decreased by Month 12, including risk of resistance for non-adherent patients (M1 35%, M12 16%), having enough injection administrators on a daily basis (M1 35%, M12 24%), patient injection-related pain/soreness (M1 33%, M12 16%), scheduling around patient holidays (M1 32%, M12 8%), and patients being non-virologically suppressed due to missed dose (M1 30%, M12 15%).
At the conclusion of the study, staff study participants identified several tips for optimising implementation success, including:
• Using techniques to minimise injection discomfort, including slowing the speed of the injection (60%), ensuring that the medication had reached room temperature (57%), and having the patient relax their muscle prior to injection (53%)
• Education about treatment, including information on pain/soreness to discuss with patients before injections, and additional information about medication preparation and injections.
Perspectives from people living with HIV from the CARISEL study3
During the study, 437 virologically suppressed adults living with HIV were enrolled at 18 participating clinical sites, with 379 participants receiving long-acting cabotegravir and rilpivirine and completing questionnaires on the regimen's acceptability, appropriateness, and feasibility through Month 12. People living with HIV also answered questions about facilitators and barriers to treatment, including stigma, pain/discomfort, and treatment preference.
Detailed findings from people living with HIV who participated in the study showed that at Month 12:
• 99% preferred long-acting cabotegravir and rilpivirine compared to daily oral therapy
• 81% agreed that long-acting cabotegravir and rilpivirine was less stigmatising than oral medication
• 78% found the time spent in clinic for their injection visits to be very or extremely acceptable
• 85% found attending appointments every two months to be very or extremely acceptable
• 95% of participants would recommend long-acting cabotegravir and rilpivirine to other people living with HIV
Although 56% of patients noted that injection pain or soreness was the most difficult part of treatment, the mean pain score during the most recent injection at Month 12 was 3 on a 0 ("no pain") to 10 ("extreme pain") scale.
Harmony P. Garges, M.D., MPH, Chief Medical Officer at ViiV Healthcare said: "The need for long-acting cabotegravir and rilpivirine is clear, with 81% of people living with HIV in the study agreeing that the every-two-month regimen was less stigmatising than oral medication and 99% preferring it to daily oral therapy. In addition to developing paradigm-shifting treatment regimens, it's essential that we also study how these medicines are used and implemented in the real world through studies like CARISEL to ensure that all are able to benefit from this innovation. The widespread acceptability and feasibility of this complete long-acting regimen across European countries and healthcare practices reinforces its potential to help address the evolving needs of people living with HIV."
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. Additional findings and analyses from the CARISEL study, which include the potential administration of Vocabria and Rekambys outside of the clinic environment, will be presented at future congresses.
About CARISEL (NCT04399551)
CARISEL is a Phase IIIb, one-year, multicentre implementation-effectiveness trial (open-label single arm switch study for patient study participants), examining different implementation strategies for long-acting cabotegravir and rilpivirine 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)
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.
Link To read full press release
https://viivhealthcare.com/hiv-news-and-media/news/press-releases/2022/october/viiv-healthcare-presents-positive-data-showing-vocabria/
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