EACS2023: 373 Fostemsavir use in the OPERA cohort: immunologic and virologic response R.K Hsu , L. Brunet , J.S Fusco , C. Henegar , V. Vannappagari , A. Clark , P.C Lackey , G. Pierone Jr. , G.P Fusco NYU Langone Health, New York, United States, AIDS Healthcare Foundation, New York, United States, Epividian, Raleigh, United States, ViiV Healthcare, Durham, United States, Wake Forest University School of Medicine, Winston-Salem, United States, Whole Family Health, Vero Beach, United States General data Abstract category: Antiretroviral therapy – observational studies Abstract body Purpose: Fostemsavir (FTR) is a novel attachment inhibitor approved in the U.S. in July 2020. Real-world immunologic and virologic responses were assessed among individuals starting FTR in the OPERA cohort. Method: Adults with HIV with a first FTR prescription between 2JUL2020 and 1SEP2022 were included. Change in absolute CD4 count or in CD4 percent, as well as the proportion of individuals who either maintained or achieved suppression (viral load <50 copies/mL) were described at 6 months and 12 months after FTR start. Analyses were stratified by viral load (suppressed: <50 copies/mL; viremic: ≥50 copies/mL) and CD4 count (high: ≥350 cells/µL; low: <350 cells/µL) at FTR initiation. Results: Of 181 individuals starting FTR, the majority (64%) were viremic (34% viremic/low CD4, 30% viremic/high CD4), with the remaining suppressed/high CD4 (20%) or suppressed/low CD4 (16%); demographic characteristics varied across groups (Table 1). Suppressed/low CD4 individuals had the largest median increases in CD4 count (6 months: 30 cells/µL [IQR: 9, 66], 12 months: 66 cells/µL [17, 125]; Figure 1) and CD4% (6 months: 1% [IQR: -0.3, 2.8], 12 months: 1.9% [1.3, 3.9]; Figure 2). Regardless of viral load, those with high CD4 counts at initiation experienced the greatest variability in immunologic response compared to those with low CD4 counts (12 months standard deviation range: 170-227 cells/µL vs. 69-90 cells/µL). Virologic control was maintained in most suppressed individuals; nearly half of viremic/high CD4 individuals and a third of viremic/low CD4 individuals achieved suppression at either timepoint (Table 2). Table 1. Demographic and clinical characteristics at fostemsavir start Suppressed & high CD4 (VL <50, CD4 ≥350) N = 37 Suppressed & low CD4 (VL <50, CD4 <350) N = 29 Viremic & high CD4 (VL ≥50, CD4 ≥350) N = 54 Viremic & low CD4 (VL ≥50, CD4 <350) N = 61 Age Median (IQR) 58 (55, 62) 56 (52, 63) 52 (48, 59) 49 (37, 57) Female n (%) ≤5 7 (24) 15 (28) 14 (23) Black Race n (%) 7 (19) ≤5 23 (43) 34 (56) Hispanic Ethnicity n (%) 12 (32) 9 (31) ≤5 13 (21) CD4 cell count (cells/µL) Median (IQR) 585 (453, 749) 186 (139, 257) 511 (404, 683) 110 (56, 234) ≥500, n (%) 24 (65) NA 30 (56) NA <200, n (%) NA 16 (55) NA 38 (62) CD4 percent Median (IQR) 30 (24, 39) 14 (9, 21) 25 (20, 32) 9 (4, 15) ≥29%, n (%) 19 (51) ≤5 16 (30) 0 (0) ≥14% to <29%, n (%) 18 (49) 13 (45) 37 (68) 18 (30) <14%, n (%) 0 (0) 14 (48) ≤5 43 (70) µL, microliter; IQR, interquartile range; mL, milliliters; N, number; NA, not applicable; VL, viral load HIPAA regulations require the masking of cells with 1 to 5 individuals 1,2 3 3 4 4 4 5 6 3 1 2 3 4 5 6 a a a a a a 112 19TH EUROPEAN AIDS CONFERENCE | WARSAW 2023
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