EACS2023: 131 Cabotegravir + Rilpivirine long-acting efficacy and safety outcomes by sex at birth, age and race: a subgroup analysis of the CARISEL study J. Ghosn , L. Hocqueloux , M. José Crusells-Canales , L. Belkhir , C. Jonsson-Oldenbüttel , T. Lutz , M. van der Valk , B. J. van Welzen , K. Hove , M. Ait-Khaled , R. DeMoor , G. Bontempo , C. L. Latham , C. A. Gutner , S. Iyer , M. Gill , R. D’Amico , J. van Wyk , M. Czarnogorski Université de Paris, INSERM UMR 1137 IAME, Paris, France, Hôpital Bichat–Claude Bernard, Service de Maladies Infectieuses et Tropicales, AP-HP, Paris, France, CHU d’Orléans, Service des Maladies Infectieuses et Tropicales, Paris, France, Hospital Clínico Universitario Lozano Blesa, Zaragosa, Spain, Cliniques Universitaires Saint-Luc, Université Catholique de Louvain, AIDS Reference Center, Department of Internal Medicine, Brussels, Belgium, MUC Research GmbH, Munich, Germany, MVZ München am Goetheplatz, Munich, Germany, Infektiologikum, Frankfurt, Germany, University of Amsterdam, Department of Infectious Diseases, Institute for Infection and Immunity, Amsterdam, Netherlands, University Medical Center Utrecht, Department of Infectious Diseases, Utrecht, Netherlands, ViiV Healthcare, Brentford, United Kingdom, GSK, Collegeville, United States, ViiV Healthcare, Durham, United States, GSK, Bangalore, India, GSK, Brentford, United Kingdom General data Abstract category: Antiretroviral therapy – randomised clinical trials Abstract body Purpose: Cabotegravir+rilpivirine (CAB+RPV) is the only complete long-acting (LA) every 2 months (Q2M) regimen for maintaining HIV-1 virologic suppression. With this new treatment modality, there is continued interest in evaluating clinical outcomes across different regional and demographic contexts. We present efficacy and safety outcomes within key demographic subgroups of the CARISEL (NCT04399551) study. Method: CARISEL is a Phase 3b, multicenter, open-label, hybrid type III implementation–effectiveness study assessing strategies to support the implementation of CAB+RPV LA across European locations (Belgium, France, Germany, Spain, the Netherlands). Data from participants receiving CAB+RPV LA Q2M were analyzed by sex at birth, age, and race. Endpoints assessed at Month (M) 12 included the proportion of participants with plasma HIV-1 RNA ≥50 copies/mL and HIV-1 RNA <50 copies/mL (Snapshot algorithm), safety, and tolerability. Results: Overall, 430 participants received CAB+RPV LA Q2M; 25% were female, 30% were aged ≥50 years, 18% identified as Black. Few participants were in the Asian and other races subgroups (both n=9). At M12, rates of virologic non-response (HIV-1 RNA ≥50 copies/mL) and suppression (HIV-1 RNA <50 copies/mL) ranged from 0–1% and 78–100%, respectively, across subgroups (Table). Adverse events (AEs) were comparable between subgroups. Excluding injection site reactions (ISRs), drug-related AEs occurred in 36% (n=156/430) of participants, ranging from 22–56% across subgroups (Table). One (<1%) drug-related serious AE leading to discontinuation occurred (suicidal ideation); the participant was male, aged <50 years, and Asian. No fatal AEs occurred. The proportion of participants discontinuing treatment due to ISRs was low and comparable between subgroups, ranging from 0–9%. Sex at birth Age (years) Race Female (n=109) Male (n=321) <50 (n=301) ≥50 (n=129) White (n=336) Black (n=76) Asian (n=9) Other races (n=9) Outcome, n (%) HIV-1 RNA level (Snapshot analysis) <50 copies/mL 92 (84) 281 (88) 262 (87) 111 (86) 295 (88) 62 (82) 7 (78) 9 (100) ≥50 copies/mL* 1 (<1) 2 (<1) 2 (<1) 1 (<1) 2 (<1) 1 (1) 0 0 No virologic data 16 (15) 38 (12) 37 (12) 17 (13) 39 (12) 13 (17) 2 (22) 0 AE outcomes Any AEs 105 (96) 314 (98) 294 (98) 125 (97) 331 (99) 71 (93) 8 (89) 9 (100) Any Grade ≥3 AEs 12 (11) 37 (12) 36 (12) 13 (10) 37 (11) 9 (12) 3 (33) 0 Drug-related AEs 98 (90) 291 (91) 276 (92) 113 (88) 308 (92) 64 (84) 8 (89) 9 (100) Excluding ISRs 41 (38) 115 (36) 105 (35) 51 (40) 131 (39) 17 (22) 5 (56) 3 (33) Grade ≥3 drug-related AEs 5 (5) 20 (6) 17 (6) 8 (6) 19 (6) 5 (7) 1 (11) 0 AEs leading to treatment withdrawal 10 (9) 32 (10) 26 (9) 16 (12) 32 (10) 7 (9) 3 (33) 0 Injection-related reasons for withdrawal (% of participants with injections) 7 (6) 18 (6) 13 (4) 12 (9) 19 (6) 6 (8) 0 0 SAEs 4 (4) 11 (3) 11 (4) 4 (3) 12 (4) 1 (1) 2 (22) 0 Drug-related SAEs excluding ISRs 0 1 (<1) 1 (<1) 0 0 0 1 (11) 0 *One participant met the CVF criterion (two consecutive plasma HIV-1 RNA levels ≥200 copies/mL). The participant was female, aged ≥50 years, and White (at baseline: HIV-1 subtype G; BMI of 29 kg/m ; presence of an RPV RAM [E138A] and no INSTI RAMs [both assessed retrospectively]). All AEs include ISRs unless specified. None of the SAEs were fatal. Suicidal ideation, n=1. AE, adverse event; CAB, cabotegravir; CVF, confirmed virologic failure; INSTI, integrase strand transfer inhibitor; ISR, injection site reaction; LA, long-acting; Q2M, every 2 months; RAM, resistance-associated mutation; RPV, rilpivirine; SAE, serious adverse event. Conclusions: By design, the CARISEL study enrolled a diverse set of participants broadly representative of people living with HIV in Europe. CAB+RPV LA Q2M was well tolerated and highly effective in maintaining virologic suppression irrespective of sex at birth, age, or race. 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. I agree that all data provided may be used (saved, stored, processed, transmitted and deleted) in compliance with the privacy policy to provide the services described.: Yes 1,2 3 4 5 6,7 8 9 10 11 11 12 13 13 13 14 15 13 11 13 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 † ‡ § 2 † ‡ § 193
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