EACS2023: 794 Real life data on clinical and laboratory outcomes of long acting cabotegravir and rilpivirine in people with HIV M. Mazzitelli , E. Agostini , L. Sasset , D. Leoni , S. Gardin , N. Presa , C. Putaggio , B. Bragato , S. Parisi , A. Cattelan Infectious and Tropical Diseases Unit, Padua University Hospital, Padua, Italy, Padua University, Padua, Italy General data Abstract category: Antiretroviral therapy – observational studies Abstract body Purpose: Data from clinical trials granted efficacy and safety of long acting (LA) injectable cabotegravir and rilpivirine (JC/R) in people with HIV (PWH). Our objective is to report the preliminary real-life experience with JC/R in our center. Method: All adult PWH who started LAJC/R were prospectively enrolled. We assessed efficacy, safety, tolerability, and, for those who achieved at least 12 weeks of follow-up, changes from baseline in viral, immunological, inflammatory, and metabolic parameters, by using paired Wilcoxon test. Results: Sixty-five PWH were included in this analysis; 73.8% were males, median age was 48 years (IQR:43-56), 63% men having sex with men, median age with HIV was 11 (IQR:6-17) years, 44.6% had multimorbidity, 11% was on polypharmacy, 83.1% received LA on their own request, most commonly switching off from the most TAF/FTC/RPV (35.4%). At week 12 of follow-up, 60 (92.3%) PWH retained the LA regimen with undetectable HIV-RNA. Five PWH (7.7%) discontinued LA JC/R: one for virological failure (with no resistance mutation development and with normal concentration of C/R at the therapeutic drug monitoring, despite obesity), 3 for severe pain (1 after the first and 2 after the second dose),1 for allergic reaction. The most common side effects were pain and myalgia. Proportion of people who did not report any side effects significantly increased from baseline to follow-up (9.2% to 63.3%), table 1. No significant changes in immunological, inflammatory, and metabolic parameters were observed during the follow-up, table 2. Side effects* *= Each person may have experienced more than one After the 1rst dose N= 65 After the 2 dose N=62 After the 3 dose N= 60 None, n (%) 6 (9.2) 24 (38.7) 38 (63.3) Pain, n (%) 39 (60) 21 (33.8) 14 (2.3) Fever, n (%) 4 (6.1) 5 (8) 1 (1.6) Nodules, n (%) 1 (1.5) 3 (4.8) 0 (0) Injection site reaction, n (%) 1 (1.5) 1 (1.6) 0 (0) Insomnia, n (%) 3 (4.6) 0 (0) 0 (0) Irritability, n (%) 1 (1.5) 0 (0) 0 (0) Headache, n (%) 3 (4.6) 2 (3.2) 2 (3.3) Nausea, n (%) 2 (3.1) 1 (1.6) 1 (1.6) Myalgia, n (%) 8 (12.3) 3 (4.8) 5 (8.3) Arthralgia, n (%) 3 (4.6) 3 (4.8) 0 (0) Asthenia, n (%), n (%) 3 (4.6) 2 (3.2) 0 (0) Lameness, n (%) 4 (6.1) 4 (6.4) 0 (0) Allergic reaction, n (%) 1 (1.5) 0 (0) 0 (0) N side effects/patient, median (IQR) 1 (1-2) 0 (0-1) 0 (0-1) Parameter Baseline N= 60 12 week Follow-up N=60 p value CD4+ T cell count, cell/mm , median (IQR) 720 (562-940) 717 (588-868) p>0.05 CD4+/CD8+ ratio, median (IQR) 1.1 (0.9-1.6) 1.1 (0.9-1.4) p>0.05 Neutrophils/lymphocytes ratio, median (IQR) 1.6 (1.3-2.2) 1.6 (1.4-2.2) p>0.05 Hs CRP, mmol/L, median (IQR) 0.7 (0.5-1.8) 0.8 (0.5-1.3) p>0.05 AST, UI/ml, median (IQR) ALT, UI/ml, median (IQR) 28 (24-32) 24 (19-34) 26 (22-30) 23 (18-28) p>0.05 p>0.05 Total Cholesterol, mmol/L, median (IQR) 4.9 (4.3-5.4) 4.9 (4.2-5.5) p>0.05 HDL, mmol/L, median (IQR) 1.4 (1.2-1.7) 1.5 (1.2-1.6) p>0.05 LDL, mmol/L, median (IQR) 2.9 (2.5-3.5) 2.8 (2.4-3.6) p>0.05 Triglycerides mmol/L, median (IQR) 1.22 (0.9.1.6) 1.2 (0.8-1.8) p>0.05 eGFR, ml/min, median (IQR) Serum creatinine mmol/L, median (IQR) 90 (79-102) 84 (76-96) 93 (79-107) 81 (70-97) p>0.05 p>0.05 Body weight, kg, median (IQR) 73 (64-82) 73 (65-80) p>0.05 BMI, median (IQR) 23 (21-26) 24 (22-25) p>0.05 Waist circumference, cm, median (IQR) 90 (83-96) 89 (82-97) p>0.05 Conclusions: In our cohort, including a significant proportion of PWH with multimorbidity, switching to LA demonstrated to be effective, neutral on immunological, inflammatory, and metabolic parameters and to be an option chosen and selected in most cases by PWH preferences. Side effects progressively declines over time, but allergies remain a possibility to be considered. More studies with a longer follow-up are needed to confirm our results. 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 1 1 1 1 1,1 1 1 2 1 1 2 nd rd 3 158 19TH EUROPEAN AIDS CONFERENCE | WARSAW 2023
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