EACS2023: 291 Bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) in antiretroviral treatment-naïve (TN) and -experienced (TE) people with HIV (PWH): 3-year effectiveness and safety outcomes in the BICSTaR observational cohort M. Sabranski , M. Vassallo , J. de Wet , A. Rieke , A. Wong , D. Thorpe , T. Cassidy , A. Marongiu , O. Robineau ICH Study Center, Hamburg, Germany, Cannes General Hospital, Department of Infectious Diseases, Cannes, France, Unité de Recherche Clinique Côte d'Azur (UR2CA), Côte d'Azur University, Nice, France, Spectrum Health, Vancouver, Canada, Gemeinschaftsklinikum Mittelrhein, Kemperhof Koblenz, Koblenz, Germany, University of Saskatchewan, Department of Medicine, Regina, Canada, Gilead Sciences Europe Ltd, Stockley Park, Uxbridge, United Kingdom, University of Lille, Lille, France, Gustave Dron Hospital, Infectious Disease Department, Tourcoing, France General data Abstract category: Antiretroviral therapy – observational studies Abstract body Purpose: BICSTaR is an ongoing, multinational, observational, 2-year cohort study evaluating real-world effectiveness and safety of B/F/TAF in PWH. Follow-up has recently been extended for a further 3 years in some countries. We assessed 3-year effectiveness and safety of B/F/TAF, including effectiveness in key groups of PWH. Method: Data were pooled from people enrolled in Germany, France and Canada. Outcomes included virologic effectiveness (HIV‐1 RNA <50 copies/mL; missing data=excluded [M=E] and discontinuation=failure [D=F]), persistence, drug‐related adverse events (DRAEs) and laboratory parameters. Results: 781 (122 TN/659 TE) PWH were included from the main study, of whom 449 (67 TN/382 TE) consented to the extension. Of the TE participants, 68%/18%/14% switched from INSTI-/NNRTI-/PI-based and 50%/34%/14% from TAF-/TDF-/ABCbased regimens, respectively. Baseline characteristics were similar between those not eligible for, and those consenting to, the extension (Table 1). Effectiveness was high at 3 years (M=E/D=F), 97%/76% in TN and 97%/78% in TE participants, with similar rates observed across key groups ( Figure 1). Persistence was 88% during the main study and remained high (81%) for those with 3-year follow-up. There was no reported emergence of resistance to the components of B/F/TAF. DRAEs occurred in 10% (82/781), 2% (15/670) and <1% (1/444) of participants in Years 1, 2 and 3, respectively. Discontinuations due to DRAEs were few (7%). Overall, weight increase (4%) and depression (2%) were the most common DRAEs, leading to discontinuation in 2% and 1% of participants, respectively. Serious DRAEs were rare (0.3%; 2 TE participants with depression). Lipid parameters are shown in Figure 2, and other key outcomes are listed in Table 2. Conclusions: B/F/TAF was associated with high levels of effectiveness at 3 years across all groups, with no emergence of resistance and no new or unexpected safety findings. These real-world data continue to support the broad use of B/F/TAF in clinical practice. Table 1. Baseline characteristics of participants at entry to the main study (N=781) (Data cutoff: August 12, 2022) TN (n=122) TE (n=659) Not eligible for extension phase (n=55) Consented to extension phase (n=67) Not eligible for extension phase (n=277) Consented to extension phase (n=382) Demographics Sex: Male / Female, n (%) Race: White / Black, n (%) Age, years, median (Q1, Q3) Weight, kg, median (Q1, Q3) BMI, kg/m , median (Q1, Q3) Receiving ≥1 concomitant medication(s), n (%) 48 (87) / 7 (13) 39 (72) / 8 (15) 37 (30, 51) 69 (61, 79) 22 (20, 25) 27 (49) 62 (93) / 5 (7) 59 (91) / 4 (6) 40 (32, 50) 72 (67, 83) 24 (22, 27) 30 (45) 233 (84) / 44 (16) 219 (80) / 32 (12) 48 (37, 55) 77 (68, 88) 25 (23, 28) 167 (60) 338 (88) / 44 (12) 318 (84) / 34 (9) 50 (41, 56) 78 (67, 87) 25 (22, 28) 245 (64) HIV viral load >100,000 copies/mL, n (%) 25 (46) 22 (33) 1 (0.4) 1 (0.3) Any ongoing comorbidity, n (%) Neuropsychiatric condition Metabolic disorder Hypertension 29 (53) 7 (13) 12 (22) 7 (13) 36 (54) 16 (24) 13 (19) 4 (6) 193 (70) 86 (31) 81 (29) 56 (20) 310 (81) 128 (34) 140 (37) 77 (20) Late presenter, n (%) CD4 <350 cells/μL and/or ≥1 AIDS-defining event at baseline CD4 <200 cells/μL and/or ≥1 AIDS-defining event at baseline 27 (51) 17 (32) 24 (38) 16 (25) NA NA NA NA ≥1 primary resistance mutation, n (%) 3 (9) 6 (13) 31 (23) 41 (23) Most common primary resistance mutations relevant to B/F/TAF, n (%) NRTI overall / M184V/I INSTI overall / T97A 1 (3) / 0 0 / 0 1 (2) / 0 0 / 0 18 (12) / 9 (6) 0 / 0 23 (12) / 16 (8) 1 (0.6) / 1 (0.6) Includes patients who did not consent, discontinued study/study drug, or were lost-to-follow-up BMI, body mass index; INSTI, integrase strand transfer inhibitor; NA, not applicable; NNRTI, non-nucleoside reverse transcriptase inhibitor; NRTI, nucleoside reverse transcriptase inhibitor; PI, protease inhibitor; Q, quartile; TE, treatment-experienced; TN, treatment-naïve Table 2. Outcomes for those participants who consented to the extension phase, with available data at 3 years (N=449) (Data cutoff: August 12, 2022) Parameter TN (n=67) TE (n=382) CD4 count, cells/μL, median (Q1, Q3) change from baseline +232 (+118, +442) n=52; P<0.001 +44 (-70, +150) n=302; P<0.001 CD4/CD8 ratio, median (Q1, Q3) change from baseline +0.50 (+0.29, +0.75) n=51; P<0.001 +0.06 (-0.03, +0.20) n=268; P<0.001 Weight, kg, median (Q1, Q3) [min, max] change from baseline +4.3 (-0.5, +7.3)[-15.0, +30.8] n=40; P=0.003 +1.7 (-1.0, +4.3)[-48.6, +30.0] n=263; P<0.001 BMI, kg/m , median (Q1, Q3) [min, max] change from baseline +1.5 (-0.1, +2.5)[-5.2, +9.0] n=40; P=0.003 +0.5 (-0.3, +1.5)[-14.9, +8.9] n=263; P<0.001 Weight gain >10% change from baseline, % (n/N) 25 (10/40) 12 (33/265) eGFR, mL/min/1.73 m , median (Q1, Q3) change from baseline -11.37 (-21.88, +0.63) n=36; P=0.011 -4.09 (-11.64, +3.91) n=235; P<0.001 P-values calculated using the Sign test; All participants with data available at baseline and 3 years BMI, body mass index; eGFR, estimated glomerular filtration rate by Cockroft–Gault equation; max, maximum value; min, minimum value; Q, quartile; TE, treatment-experienced; TN, treatment-naïve 1 2,3 4 5 6 7 7 7 8,9 1 2 3 4 5 6 7 8 9 a a 2 a a a a 2 a a 2 a 97
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