EACS2023: 618 Bictegravir/Emtricitabine/Tenofovir Alafenamide use significantly improves CD4/CD8 ratio in women living with HIV over a 48-week treatment, with good safety and effectiveness M. Ceccarelli , A. Colpani , B.M. Celesia , G. Pantò , A. Albanese , E. Venanzi Rullo , M.C. Frasca , M.S. Paternò Raddusa , A. De Vito , A.E. Campanella , L. Santoro , Y. Russotto , L. Todaro , M. Coco , S.A. Sofia , C. Micali , A. Marino , G.F. Pellicanò , C. Iacobello , A. Montineri , B.S. Cacopardo , G. Madeddu , G. Nunnari "Kore" University of Enna, School of Medicine and Surgery, Enna, Italy, "Umberto I" Hospital, Unit of Infectious Diseases, Enna, Italy, University of Messina, Department of Biomedical and Dental Sciences and of Morphological and Functional Imaging, Messina, Italy, University of Sassari, Department of Medical, Surgical, and Experimental Sciences, Sassari, Italy, "Garibaldi" Hospital, Unit of Infectious Diseases, Catania, Italy, "Cannizzaro" Hospital, Unit of Infectious Diseases, Catania, Italy, "Papardo" Hospital, Unit of Infectious Diseases, Messina, Italy, University of Messina, Department of Clinical and Experimental Medicine, Messina, Italy, "G. Martino" University Hospital, Unit of Infectious Diseases, Messina, Italy, "G. Rodolico - S. Marco" University Hospital, Unit of Infectious Diseases, Catania, Italy, University of Catania, Department of Clinical and Experimental Medicine, Catania, Italy, University of Catania, Department of Biomedical and Biotechnological Sciences, Catania, Italy, University of Messina, "G. Barresi" Department of Human Adult and Pediatric Pathology, Messina, Italy General data Abstract category: Antiretroviral therapy – observational studies Abstract body Purpose: Bictegravir/Emtricitabine/Tenofovir Alafenamide (B/F/TAF) has been available for more than five years; however, data about its safety and effectiveness in women living with HIV (WLWH) are lacking. This study aims to fill this knowledge-gap about safety and effectiveness of B/F/TAF in a real-life setting. Method: We retrospectively collected data about viro-immunological and metabolic parameters at baseline and after 48 weeks of the WLWH in follow-up in Eastern Sicily and Northern Sardinia. All treatments were started during the period September 2019-December 2021. Results: We collected data about 87 WLWH, 12 naïve (13.8%) and 75 experienced (86.2%) ones. Median age was 50.63 years (IQR 41.5-56.7), with no significant differences between naïve and experienced WLWH ( p = 0.087). 69.9% of the experienced WLWH were on a 3DR and 72.6% were already on INSTIs. 63.0% switched from their previous regimens as a simplification, while in 12.4% of the cases it was a pre-emptive switch. Table 1 summarizes the characteristics of the population. Count Percentage Substance abuse Active smoker Injection Drug User Alcohol Abuse 28 8 12 32.1 9.2 13.8 Comorbidities Hypertension Dyslipidemia Cancer Diabetes Osteoporosis Hypothyroïdism Psychiatric disorders 14 27 5 2 4 6 18 16.1 31.0 5.7 2.3 4.6 6.9 20.7 Not ART drugs Statins Anti-hypertensive Metformin Vitamin D Antidepressants Antipsychotics Other 12 10 1 16 14 4 21 13.8 11.5 1.1 18.4 16.7 4.6 24.1 AIDS defining comorbidities Esophageal candidiasis Invasive cervical cancer Pneumocystis carinii pneumoniae Lymphoma Mycobacterium avium complex Progressive Multifocal Leukoencephalopathy Other 16 5 5 1 1 2 12 18.4 5.7 5.7 1.1 1.1 2.3 13.8 B/F/TAF showed high effectiveness in naïve WLWH at 48 weeks, leading to significant decrease in pVL ( p = 0.002) and improvement of CD4+ T-cell count ( p = 0.004). Both in naïve and experienced WLWH we highlighted a significant improvement of CD4/CD8 ratio ( p = 0.002 and 0.007 respectively). Table 2 summarizes our findings in naïve and experienced WLWH. Baseline (median, IQR) 48 weeks (median, IQR) p value Naïve WLWH (n = 12) CD4+ T-cell count (cells/µL) CD8+ T-cell count (cells/µL) CD4/CD8 ratio pVL (cps/mL) Triglycerides (mg/dL) Total cholesterol (mg/dL) HDL cholesterol (mg/dL) LDL cholesterol (mg/dL) Creatinine (mg/dL) eGFR (mL/min/1.73m ) AST (IU/L) ALT (IU/L) Glycemia (mg/dL) Weight (kg) BMI (kg/m ) 203 (110-292) 731 (571-1105) 0.17 (0.12-0.42) 74,800 (16,750-148,000) 74 (71-79) 161 (147-176) 45 (37-51) 102 (88-115) 0.70 (0.67-0.73) 117 (112-121) 25 (23-27) 16 (15-21) 86 (84-89) 60.2 (56.6-67.2) 23.3 (22.5-25.2) 414 (286-510) 719 (557-983) 1.03 (0.54-1.34) 15 (2-38) 98 (71-130) 174 (154-185) 51 (48-62) 112 (88-115) 0.80 (0.77-0.85) 99 (94-108) 20 (18-22) 16 (14-21) 81 (79-84) 60.5 (57.7-68.0) 23.4 (23.3-23.6) 0.004* 0.625 0.002* 0.002* 0.164 0.074 0.360 0.148 0.006* 0.010* 0.176 0.866 0.345 0.098 > 0.999 Experienced WLWH (n = 75) CD4+ T-cell count (cells/µL) CD8+ T-cell count (cells/µL) CD4/CD8 ratio pVL (cps/mL) Triglycerides (mg/dL) Total cholesterol (mg/dL) HDL cholesterol (mg/dL) LDL cholesterol (mg/dL) Creatinine (mg/dL) eGFR (mL/min/1.73m ) AST (IU/L) ALT (IU/L) Glycemia (mg/dL) Weight (kg) BMI (kg/m ) 673 (418-873) 668 (506-985) 0.82 (0.39-1.29) < LoD (TND-53) 87 (66-164) 215 (164-237) 53 (45-66) 122 (102-150) 0.74 (0.65-0.86) 105 (80-114) 25 (19-30) 19 (14-27) 87 (81-96) 58.4 (53.6-67.0) 22.7 (19.2-26.1) 697 (477-928) 685 (508-995) 1.03 (0.54-1.34) < LoD (TND-29) 98 (71-130) 187 (165-225) 56 (44-65) 112 (89-145) 0.80 (0.70-0.88) 98 (80-107) 23 (18-29) 20 (14-31) 87 (77-93) 62.5 (53.9-69.3) 24.0 (21.6-28.7) 0.058 0.891 0.007* 0.225 0.091 0.162 0.525 0.217 0.103 0.138 0.344 0.326 0.721 > 0.999 0.441 Conclusions: B/F/TAF is an effective and potent regimen in WLWH after 48 weeks of treatment. A significant improvement of CD4/CD8 ratio was observed both in naïve and experienced WLWH. This could indicate a positive effect of B/F/TAF on inflammation in WLWH. In naïve WLWH, but not in experienced ones, we observed a slight increase in serum creatinine. Bictegravir is metabolized through OCT2, which mediates creatinine tubular secretion; therefore, this increase is considered cosmetic, with no clinical significance. We did not observe any significant effect on weight and BMI. 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. 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