EACS2023: 205 Efficacy, safety and implementation outcomes of Cabotegravir + Rilpivirine long-acting by country in the Cabotegravir And Rilpivirine Implementation Study in European Locations (CARISEL) C. Jonsson-Oldenbüttel , J. Ghosn , J. Olalla Sierra , M. van der Valk , T. Lutz , L. Belkhir , B. J. van Welzen , K. Hove , M. Ait-Khaled , R. DeMoor , G. Bontempo , C. L. Latham , B. Ngenzi , C. Okoli , C. A. Gutner , S. Iyer , M. Gill , M. Czarnogorski , R. D’Amico , J. van Wyk MVZ München am Goetheplatz, Munich, Germany, MUC Research GmbH, Munich, Germany, Université de Paris, INSERM UMR 1137 IAME, Paris, France, Hôpital Bichat–Claude Bernard, Service de Maladies Infectieuses et Tropicales, AP-HP, Paris, France, Costa del Sol Hospital, Internal Medicine Department, Marbella, Spain, University of Amsterdam, Department of Infectious Diseases, Amsterdam Institute for Infection and Immunity, Amsterdam, Netherlands, Infektio Research, Frankfurt, Germany, Cliniques Universitaires Saint-Luc, Brussels, Belgium, University Medical Center Utrecht, Utrecht, Netherlands, ViiV Healthcare, Brentford, United Kingdom, GSK, Collegeville, United States, ViiV Healthcare, Durham, United States, ViiV Healthcare, Wavre, Belgium, GSK, Bangalore, India, GSK, Brentford, United Kingdom General data Abstract category: Antiretroviral therapy – randomised clinical trials Abstract body Purpose: Cabotegravir + rilpivirine long-acting (CAB+RPV LA) administered every 2 months (Q2M) is indicated for virologically suppressed people living with HIV-1 (PLWH). CARISEL is the first European implementation–effectiveness study evaluating CAB+RPV LA Q2M. This post hoc analysis summarizes clinical and implementation outcomes by country. Method: Data from participants receiving CAB+RPV LA were analyzed by country (Belgium, France, Germany, Spain, and the Netherlands). Endpoints assessed at Month (M) 12 included the proportion of participants with plasma HIV-1 RNA ≥50 and <50 copies/mL (FDA Snapshot), safety and tolerability, treatment satisfaction (HIV Treatment Satisfaction Questionnaire status version [HIVTSQs], range 0–66), and the acceptability of intervention measure (AIM), intervention appropriateness measure (IAM), and feasibility of intervention measure (FIM), of CAB+RPV LA (1–5 Likert scale). Results: Overall, 430 participants received CAB+RPV LA (Belgium, 17% [n=71]; Germany, 13% [n=54]; Spain, 22% [n=96]; France, 40% [n=171]; the Netherlands, 9% [n=38]). Median age (range) was 44 years (22–76), and 25% (n=109) were female (sex at birth). At M12, rates of virologic non-response (HIV-1 RNA ≥50 copies/mL) and suppression (HIV-1 RNA <50 copies/mL) with CAB+RPV LA ranged 0–2% and 81–94%, respectively, across countries (Table 1). Drug-related Grade ≥3 adverse events (AEs) occurred in ≤5% of participants across all countries except France (11% [n=18/171]). AEs leading to treatment withdrawal ranged 6–17% across countries. Mean HIVTSQs total scores increased from baseline (56.9–59.1) to M12 (59.5–62.5) across all countries. Mean intervention-based AIM/IAM/FIM scores were ≥4.5/4.4/4.4 at M12 across countries (Table 2). Table 1. CAB+RPV LA Q2M Key Outcomes at Month 12 Parameter, n (%) Belgium (n=71) Germany (n=54) Spain (n=96) France (n=171) The Netherlands (n=38) HIV-1 RNA level (FDA Snapshot) <50 copies/mL 67 (94) 44 (81) 87 (91) 141 (82) 34 (89) ≥50 copies/mL 0 1 (2)* 1 (1) 1 (<1) 0 No virologic data 4 (6) 9 (17) 8 (8) 29 (17) 4 (11) AE outcomes Any AEs 70 (99) 53 (98) 96 (100) 164 (96) 36 (95) Drug-related AEs 68 (96) 50 (93) 85 (89) 153 (89) 33 (87) Excluding ISRs 34 (48) 6 (11) 30 (31) 69 (40) 17 (45) Grade ≥3 drug-related AEs 1 (1) 1 (2) 3 (3) 18 (11) 2 (5) Excluding ISRs 1 (1) 0 1 (1) 6 (4) 2 (5) AEs leading to treatment withdrawal 4 (6) 9 (17) 6 (6) 19 (11) 4 (11) SAEs 4 (6) 4 (7) 3 (3) 4 (2) 0 Drug-related SAEs excluding ISRs 0 0 0 1 (<1) 0 ISR summary Participants who received ≥1 injection, n (%) 70 (99) 53 (98) 96 (100) 167 (98) 37 (97) Number of injections, n 982 670 1438 2258 496 ISR events, n 447 202 367 700 142 Median duration (IQR), days 3 (2–4) 4 (2–6) 3 (2–6) 4 (3–7) 3 (2–6) Participant withdrawing for injectionrelated reasons, n (% of participants with injections) 2 (3) 8 (15) 6 (6) 7 (4) 2 (5) *Participant met the criterion for confirmed virologic failure (two consecutive plasma HIV-1 RNA levels ≥200 copies/mL). No Grade 5 AEs or deaths were reported. Suicidal ideation, n=1. A single injection could result in more than one ISR. AE, adverse event; CAB, cabotegravir; FDA, U.S. Food and Drug Administration; IQR, interquartile range; ISR, injection site reaction; LA, long-acting; Q2M, every 2 months; RPV, rilpivirine; SAE, serious adverse event. Table 2. Acceptability, Appropriateness, and Feasibility* of CAB+RPV LA Q2M at Month 12 Mean (SD) Belgium (n=71) Germany (n=54) Spain (n=96) France (n=171) The Netherlands (n=38) Acceptability of intervention (CAB+RPV LA) measure (AIM) 4.9 (0.26) 4.7 (0.47) 4.6 (0.97) 4.6 (0.56) 4.5 (0.92) Intervention (CAB+RPV LA) appropriateness measure (IAM) 4.8 (0.48) 4.7 (0.51) 4.5 (1.00) 4.6 (0.65) 4.4 (0.91) Feasibility of intervention (CAB+RPV LA) measure (FIM) 4.7 (0.41) 4.6 (0.53) 4.5 (0.99) 4.6 (0.58) 4.4 (0.88) *Acceptability, appropriateness, and feasibility measures are rated on a 1–5 Likert scale: 1 “completely disagree”; 2 “disagree”; 3 “neither agree nor disagree”; 4 “agree”; 5 “completely agree.” CAB, cabotegravir; LA, long-acting; Q2M, every 2 months; RPV, rilpivirine; SD, standard deviation. Conclusions: CAB+RPV LA demonstrated high efficacy and was well tolerated, with increased participant satisfaction, irrespective of country. High and comparable acceptability, appropriateness, and feasibility of CAB+RPV LA was seen across different countries. These data support CAB+RPV LA as a complete regimen for the maintenance of virologic suppression in PLWH in diverse European healthcare settings. General conditions 1. I confirm that I previewed this abstract and that all information is correct. I accept that the content of this abstract cannot be modified or corrected after the submission deadline and I am aware that it will be published exactly as submitted.: Yes 2. I confirm that the submission of the abstract constitutes my consent to publication (e.g. conference website, programmes, other promotions, etc.). : Yes 3. I herewith confirm that the contact details saved in this system are those of the corresponding author, who will be notified about the status of the abstract. The corresponding author is responsible for informing the other authors about the status of the abstract.: Yes 4. 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