EACS2023: 234 Bictegravir versus Dolutegravir-based three-drug regimen in the setting of Rapid ART Initiation A. Cervo , M. Menozzi , A. Cozzi-Lepri , M. Digaetano , M.D. Di Trapani , I. Baldisserotto , G. Cuomo , V. Borghi , C. Mussini Clinic of Infectious Diseases, University Hospital of Modena, Modena, Italy, Centre for Clinical Research, Epidemiology, Modelling and Evaluation (CREME), Institute for Global Health, UCL, London, United Kingdom, University of Modena and Reggio Emilia, Modena, Italy General data Abstract category: Antiretroviral therapy – observational studies Abstract body Purpose: We aimed to compare bictegravir (BIC) versus dolutegravir (DTG)-based regimens in people with new diagnosis of HIV (PWH) in the context of rapid ART. Method: All treatment-naïve PWH starting a three-drug regimen with DTG or BIC within 7 days from the basal viro-immunological exams, from 01/01/2017 to 30/06/2022, in Modena(Italy) were included. Virological suppression (VS) and virological failure (VF) were defined as HIV-RNA<50copies/ml within 48 weeks and confirmed HIV-RNA>200copies/ml after VS, respectively. Durability was defined as time to INSTI triple-regimen discontinuation. Kaplain-Meier analysis was used for time to treatment failure (TF)(defined as absence of VS, VF or discontinuation for toxicity); predictors of TF were analyzed by logistic and cox regression. Results: 111 individuals were included, 59% and 41% on DTG and BIC (Figure1). Characteristics are shown in Table1. Median time of ART initiation was 0 day (IQR 0-1). No RAMs at baseline. 43.1% and 21.7% subjects discontinued DTG and BIC-based regimen, respectively(p=0.010) [median time of discontinuation: 9(IQR 3-23) vs 26(IQR 5-41) weeks, (p=0.131)](Table1). Among 95 individuals without discontinuation, 96.3% and 85.0% achieved VS in DTG and BIC group, respectively(p=0.066), but after adjusting for basal HIV-RNA, no difference was found (p=0.205). One subject in each group had VF, without the emergence of new RAM. Time to TF is described in Figure2. Analysis of predictors of TF (n=23) are reported in Table2: no difference between DTG and BIC-group, while HIV-RNA>1.000.000 copies/ml at baseline was associated with TF (aOR 3.41, 95%CI 1.12-1.38, p=0.031; HR 2.37, 95%CI 0.97-5.78, p=0.055). Table 1. Characteristics of treatment-naive individuals with HIV infection in Rapid ART context, stratified by anchor drug baseline regimen (n=111). BIC (N=46) DTG (N=65) p value Female gender, n (%) 14 (30.4%) 11 (16.9%) 0.093 Age (years), median (IQR) 45 (33-54) 40 (32-47) 0.046 Origin, n (%) Italian Non Italian 22 (47.8%) 24 (52.2%) 41 (63.1%) 24 (36.9%) 0.080 AIDS diagnosis, n (%) 12 (26.1%) 18 (27.7%) 0.851 Hospitalization at HIV diagnosis, n (%) 12 (26.1%) 12 (18.5%) 0.336 CD4+ at baseline (cells/mmc), median (IQR) 179 (52-384) 193 (46-472) 0.881 CD4+/CD8+ ratio, median (IQR) 0.24 (0.11-0.48) 0.23 (0.12-0.54) 0.511 HIV RNA at baseline (log10), median (IQR) 5.20 (4.47-5.83) 4.95 (4.35-5.38) 0.169 HIV RNA > 500000 cp/ml, n (%) 15 (32.6%) 12 (18.5%) 0.116 HIV RNA > 1000000 cp/ml, n (%) 9 (19.6%) 8 (12.3%) 0.423 Clade B genotype 16 (34.8%) 30 (46.2%) 0.231 Year of ART start, n (%) 2017-2018 2019 2020 2021 2022 0 (0.0%) 4 (8.8%) 15 (32.6%) 22 (47.8%) 5 (10.8%) 40 (61.5%) 24 (36.9%) 1 (1.6%) 0 (0%) 0 (0%) <0.001 INSTI-based triple regimen discontinuation, n (%) 10 (21.7%) 28 (43.1%) 0.010 Time to discontinuation within 48WFU (weeks), median (IQR) 26 (5-41) 9 (3-23) 0.131 Reason for discontinuation, n (%) Lost to follow-up Toxicity, any Simplified regimen 6 (13.0%) 2 (4.3%) 2 (4.3%) 2 (3.1%) 11 (16.9%) 15 (23.1%) 0.001 Virological Suppression within 48WFU, n (%) 34 (85.0%)* 53 (96.3%)* 0.066 Treatment failure, n (%) 10 (21.7%) 13 (20.0%) 0.503 *Percentage calculated on 40 and 55 patients who were still on three-drug regimen with BIC and DTG, respectively. Abbreviations: AIDS, acquired immunodeficiency syndrome; ART, antiretrovial therapy; BIC, bictegravir; DTG, dolutegravir; INSTI, integrase strand inhibitor; IQR, interquartile range; 48WFU, 48-week follow-up. Table 2. Predictors of treatment failure evaluated using logistic regression and cox regression Univariable analysis Logistic regression Cox regression OR 95% CI P aOR 95%CI P HR 95% CI P DTG vs BIC 0.90 0.35-2.27 0.824 1.00 0.38-2.06 0.999 1.45 0.63-3.35 0.386 HIV RNA at baseline > 1000000 cp/ml 3.41 1.12-10.60 0.030 3.41 1.12-10.38 0.031 2.37 0.97-5.78 0.055 Conclusions: In a real-life rapid ART setting, DTG and BIC-based three-drug regimens were both effective. DTG-based therapy was mainly discontinued in favour of a single tablet regimen. Lower chance of virological suppression by week 48 in BICgroup was confounded by high basal viremia. Indeed, high viral load at baseline was associated with a higher risk of treatment failure. General conditions 1 1 2 1 1 1 1 1 1,3 1 2 3
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