EACS2023: 599 Safety of cabotegravir/rilpivirine long acting for individuals previously exposed to HBV infection N.B. Bana , L.F. Rezzonico , F. Peracchi , A. Raimondi , C. Moioli , L. Chianura , M. Puoti , R. Rossotti ASST Niguarda Great Metropolitan Hospital, Infectious Diseases Unit, Milan, Italy, University of Milano Bicocca, Milan, Italy, University of Pavia, Pavia, Italy General data Abstract category: Antiretroviral therapy – observational studies Abstract body Purpose: Cryptic, low level HBV replication occurs even in presence of protective anti-HBs titres and tenofovir-containing regimens. Cabotegravir/rilpivirine long-acting (CARLA) is not indicated for people living with HIV with an active HBV co-infection since it does not contain anti-hepatitis active drugs, but studies about its safety among individuals with a previous HBV exposure are missing. Aim of this study is to assess CARLA hepatic safety according to HBV serostatus. Method: Retrospective monocentric observational analysis including individuals who voluntarily switched to injectable CARLA since regimen availability. Demographic, clinical, immuno-virologic and biochemistry data were collected, and FIB-4 score was calculated at each time-point. Study population was stratified according to previous HBV exposure (anti-HBc positive ± anti-HBs positive versus unexposed or vaccinated). Descriptive and non-parametric statistics were used to describe study population and to compare FIB-4 evolution over time. Linear regression analysis was used to describe and predict FIB-4 trajectories. Results: The study enrolled 145 individuals with a maximum follow-up of 364 days (8 drug injections). 40 (27.6%) had a previous exposure to HBV; of them, 6 (4.1%) had an occult HBV infection (OBI). Table 1. Demographic and clinical features of study population Overall (N=145) HBV unexposed (N=105) HBV-exposed (N=40) p Male, n (%) 129 (89.0) 92 (87.6) 37 (92.5) 0.557 Age, years, median (IQR) 46.5 (39.8-54.7) 45.2 (38.0-52.9) 53.8 (47.8-58.8) <0.001 Italian born, n (%) 124 (85.5) 88 (83.8) 36 (90.0) 0.435 Type of risk exposure, n (%) MSM 93 (64.1) 68 (64.8) 25 (62.5) 0.001 MSW/WSM 41 (28.3) 34 (32.4) 7 (17.5) IVDU 10 (6.9) 2 (1.9) 8 (20.0) Other 1 (0.7) 1 (0.9) -- BMI, median (IQR) 24.5 (22.6-27.3) 24.4 (22.5-27.0) 24.6 (22.8-27.7) 0.448 CDC C Stage, n (%) 33 (22.8) 22 (21.0) 11 (27.5) 0.506 Length of infection, years, median (IQR) 10.7 (6.3-17.2) 9.6 (5.9-15.4) 17.3 (8.3-24.6) <0.001 Number of previous therapeutic lines, median (IQR) 3 (2-4) 3 (2-4) 3 (3-7) 0.058 Three-drugs regimens before switch, n (%) 31 (22.1) 86 (81.9) 28 (70.0) 0.054 TXF-containing regimen before switch, n (%) 21 (14.5) 12 (11.4) 9 (22.5) 0.114 XTC-containing regimen before switch, n (%) 107 (73.8) 74 (70.5) 33 (82.5) 0.204 Baseline presence of any NNRTI-related RAMs, n (%) 9 (6.2) 6 (5.7) 3 (7.5) 0.411 Baseline lymphocyte T CD4+, cell/mmc, median (IQR) 799 (557-1,060) 809 (557-1,045) 768 (551-1,065) 0.903 Baseline CD4/CD8 ratio, median (IQR) 0.90 (0.65-1.25) 0.95 (0.66-1.26) 0.85 (0.55-1.10) 0.260 Baseline HIV RNA, n (%) Target not detected 100 (69.0) 77 (73.3) 23 (57.5) 0.093 Below the limit of quantification 23 (15.9) 13 (12.4) 10 (25.0) 20-200 copies/mL 19 (13.1) 14 (13.3) 5 (12.5) 200-1,000 copies/mL 3 (2.0) 1 (1) 2 (5.0) Baseline detectable HIV RNA, copies/mL, median (IQR) 37 (30-68) 35 (25-66) 60 (36-250) 0.242 FIB-4, median (IQR) 0.87 (0.68-1.21) 0.78 (0.64-1.21) 1.03 (0.84-1.29) 0.009 AST, UI/mL, median (IQR) 21 (17-27) 21 (18-28) 20 (17-24) 0.098 ALT, UI/mL, median (IQR) 21 (15-31) 23 (16-35) 20 (15-26) 0.055 Platelet count, x10 cell/mmc, median (IQR) 233 (208-274) 241 (210-283) 227 (196-241) 0.039 IQR: Interquartile range; MSM: Men who have sex with men; MSW: Men who have sex with women; WSM: Women who have sex with men; IVDU: Intravenous drug users; BMI: Body Mass Index; TXF: Tenofovir disoproxil/Tenofovir alafenamide; XTC: Lamivudine/emtricitabine; NNRTI: Non-nucleotide Reverse Transcriptase Inhibitors; RAMs: (drug) Resistance associated mutations; AST: Aspartate amino-transferase; ALT: Alanine amino-transferase Table 1 shows features of study population: HBV-exposed subjects were older, with a longer HIV infection and more commonly intravenous drug users. FIB-4 score at baseline was higher among HBV-exposed (1.03 versus 0.78, p=0.009), who maintained higher values over time but without significant changes at every time-point (Figure 1). Linear regression analysis failed to predict a significant FIB-4 evolution over time within the overall (b=-0.004, CI: -0.183-0.175, p=0.967), the HBVexposed (b=-0.081, 95% CI: -0.440-0.279, p=0.659), and the unexposed population (b=-0.000, 95% CI: -0.180-0.180, p=0.997) (Figure 2). Conclusions: CARLA impact on hepatic profile appeared to be not affected by a previous exposure to HBV, but these results need to be confirmed by a larger sample size and a longer follow-up period. 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 1,3 1,2 1 1 1 1,2 1 1 2 3 9 138 19TH EUROPEAN AIDS CONFERENCE | WARSAW 2023
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