EACS2023: 878 Real-world data on commercial long-acting intramuscular maintenance therapy with cabotegravir and rilpivirine mirror phase 3 results: findings from a University Hospital in Paris, France V.M. Ferré , A. Serris , Q. Le Hingrat , A. Bachelard , C. Charpentier , M. Exarchopoulos , M. Digumber , F. Damond , F. Louni , B. Phung , R. Landman , Y. Yazdanpanah , D. Descamps , V. Joly , G. Peytavin , J. Ghosn Université Paris Cité, INSERM UMR_1137, IAME; Virology department, Hôpital Bichat-Claude Bernard, AP-HP, Virology department, Paris, France, Université Paris Cité, INSERM UMR_1137 IAME; Infectious Diseases department, Hôpital Bichat-Claude Bernard, AP-HP, Infectious Diseases department, Paris, France, Université Paris Cité, INSERM UMR_1137 IAME; Virology department, Hôpital Bichat-Claude Bernard, AP-HP, Virology department, Paris, France, Infectious Disease Department, Hôpital Bichat-Claude Bernard, Infectious Disease Department, Paris, France, Université Paris Cité, INSERM UMR_1137 IAME; Infectious Disease Department, Hôpital Bichat-Claude Bernard, Infectious Disease Department, Paris, France, Université Paris Cité, INSERM UMR_1137 IAME; Pharmacology Department, Hôpital Bichat-Claude Bernard, Infectious Disease Department, Paris, France General data Abstract category: Antiretroviral therapy – observational studies Abstract body Purpose: Cabotegravir (CAB) and rilpivirine (RPV) is the first long-acting intramuscular (LA-IM) combination approved in maintenance-therapy in PLHIV with plasma HIV-1-RNA< 50c/mL (pVL). The aim of this study was to assess pharmaco-virological outcome and tolerability of LA-IM CAB/RPV in a real-world setting. Method: This single-center study included PLHIV switching for LA-IM CAB/RPV (optional oral lead in (OLI) dose of 30/25mg QD and then 600/900mg Q4W as loading dose and Q8W as maintenance dose) after expert advice from a multidisciplinary committee taking into account the strategy's potential failure factors (Cutrell et al, 2021). The needle length was adjusted according to the BMI (>30kg/m ). CAB and RPV plasma concentrations (Cpl) were interpreted using threshold values of 1,120ng/mL and 32ng/mL, respectively, corresponding to the IQR25% of Cpl at M1 of the pooled phase 3 multivariate data analysis (https://hivfrenchresistance.org). Results: All 127 PLHIV included had pVL<50c/mL before LA-IM CAB/RPV initiation and 78 received an OLI. ARV Cpl at M1 and M3 and during follow-up (median delay 548 days [IQR=218-675]) are presented in the Table. With a median follow-up of 12.8 months [IQR=8.5-26.7], 121/127 (95%) patients maintained virological suppression. pVL blips were observed in 13/127 (10%) PLVIH and not associated with subsequent occurrence of virological failure (VF, two consecutive pVL>200c/Ml or a single pVL>50c/Ml followed by treatment discontinuation). LA-IM CAB-RPV was discontinued in 27/127 (21%) PLVIH: 6 for VF (median pVL 114 c/mL [87-366]), 6 for adverse-effects, 7 PLVIH’s decision and 8 for other reasons. Among the 6 patients experiencing a VF, successful genotypic resistance tests were obtained for 2/6 for RT and 3/6 for integrase, and no emergent resistance-associated mutation was detected. Table: Median (IQR25-75%) Plasma concentrations (Cpl) of Cabotegravir (CAB) and Rilpivirine (RPV at M1 and M3 after first CAB-RPV LA-IM first injection, depending on Oral Lead In (OLI) phase) and during follow-up. PK at M1 post LA-IM (n=65 PLHIV) PK results at M3 post-LA-IM (n=63 PLHIV) Cpl during follow up (n=59 PLHIV) Overall With OLI (n=23) Without OLI (n=42) Overall With OLI (n=23) Without OLI (n=40) Interval between last injection and sampling (Days) 29 [28-32] 29 [28-32] 30 [28-33] 62 [57-63] 62 [56-63] 62 [57-63] 60 [56-63] CAB Cpl (ng/mL) 2202 [1592-4044] 2875 [1470-4685] 2090 [1643-2963] 1842 [1153-2396] 1926 [1191-2592] 1738 [1149-2290] 1822 [1185-2603] p = 0.19 ( Mann-Whitney) p = 0.45 ( Mann-Whitney) Patients with adequate CAB Cpl (>1120 ng/mL) (n, %) 57 (87.7%) 19 (82.6%) 38 (90.5%) 52 (82.5%) 19 (82.6%) 33 (82.5%) 48 (81.4%) p = 0.44 ( Fisher's Exact Test ) p = 1.0 ( Fisher's Exact Test ) RPV Cpl (ng/mL) 53 [37-72] 56 [40-70] 48.5 [34.25-76.5] 47 [35-68] 47 [41-65] 47.5 [30.25-73] 68 [42-107] p = 0.40 ( Mann-Whitney) p = 0.42 ( Mann-Whitney) Patients with adequate RPV Cpl (>32 ng/mL) (n, %) 52 (80.0%) 20 (87.0%) 32 (76.2%) 49 (77.8%) 22 (95.7%) 27 (67.5%) 52 (88.1%) p = 0.35 ( Fisher's Exact Test ) p = 0.01 ( Fisher's Exact Test ) Conclusions: Data from this real-world cohort of PLHIV who received LA-IM CAB-RPV suggest that this regimen is effective and well tolerated, with adequate ARV plasma exposure in most PLVIH (>80%) without any impact of OLI. 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