EACS2023: 648 3-year outcomes for Dolutegravir (DTG) + Lamivudine (3TC) in ART-naive and pre-treated people living with HIV-1 (PLHIV) in Germany: real-world data from the German URBAN cohort S. Noe , S. Scholten , C. Wyen , M. Sabranski , N. Postel , O. Degen , D. Beer , K. Ummard-Berger , B. Westermayer , K.M. Dymek , J. Scherzer MVZ München am Goetheplatz, Munich, Germany, Praxis Hohenstaufenring, Cologne, Germany, Praxis Ebertplatz, Cologne, Germany, ICH Study Center, Hamburg, Germany, Prinzmed, Munich, Germany, Universitätsklinikum HamburgEppendorf, Hamburg, Germany, Praxis Dr. H. Knechten, Aachen, Germany, UBN/Praxis, Berlin, Germany, GSK, Munich, Germany, ViiV Healthcare, Munich, Germany General data Abstract category: Antiretroviral therapy – observational studies Abstract body Purpose: Although clinical trials have assessed DTG+3TC for first-line therapy and maintenance of virologic suppression, clinical practice observations can complement these data in more diverse populations. The URBAN study provides real-world data on effectiveness, tolerability, metabolic parameters, and patient-reported outcomes (PROs) in PLHIV using DTG+3TC. We present Year 3 results. Method: URBAN is a prospective, non-interventional, multi-center, 3-year German cohort study in ART-naive and pre-treated PLHIV receiving DTG+3TC. The primary endpoint was proportion of PLHIV with virologic suppression (viral load [VL] <50 or 50-200 c/mL with subsequent VL <50 c/mL within 120 days; discontinuation = failure) at 3-year follow-up. Lipid and liver parameter changes were assessed. PROs were assessed via HIV Treatment Satisfaction Questionnaire, status version (HIV-TSQs) and HIV Symptom Distress Module (HIV-SDM). Results: Of 366 PLHIV, median baseline age was 47 years; 93.2% were male (Table 1). Overall, 332/366 (90.7%) PLHIV were eligible for the primary analysis; PLHIV with missing data (n=8) or lost to follow-up (n=26) were excluded. Year 3 virologic suppression rates were 83.0% for pre-treated and 77.8% for ART-naive PLHIV (Figure 1). Overall, 6/332 (1.8%) PLHIV discontinued DTG+3TC for virologic reasons at investigator’s discretion with VL ≥50 c/mL (n=5 pre-treated, n=1 ART-naive); no emergent resistance was reported. Median (IQR) weight change from baseline at Year 3 was 2.0 kg (−1.0, 6.0; n=131) in pre-treated and 5.0 kg (1.0-10.0; n=13) in ART-naive PLHIV. Lipid and liver parameter changes from baseline were minimal (Figure 2). Pre-treated PLHIV who completed baseline and Year 3 questionnaires had statistically significantly increased HIV-TSQs scores; HIV-SDM scores remained stable (Table 2). Table 1. Demographics and Baseline Characteristics Parameter ART-naive PLHIV (N=31) Pre-treated PLHIV (N=335) Age, median (range), y 35 (21-55) 49 (22-82) ≥50 y, n (%) 5 (16.1) 155 (46.3) Sex, male, n (%) 30 (96.8) 311 (92.8) Weight, median (IQR), kg 68 (65-82) 79 (70-91) BMI, median (IQR), kg/m 23 (21-25) 25 (23-28) HIV-1 RNA, median (IQR), c/mL 37,200 (5100-70,700) 19 (0-39) <50 c/mL, n (%) <200 c/mL, n (%) >100,000 c/mL, n (%) 0 2 (6.5) 3 (9.7) 324 (96.7) 331 (98.8) 1 (0.3) CD4+ cell count, median (IQR), cells/mm 456 (328-664) 748 (549-940) <200 cells/mm , n (%) 4 (12.9) 2 (0.6) Time since HIV diagnosis, median (IQR), y 0 (0-0) 10 (5-16) Time on ART, median (IQR), y NA 7 (4-13) Most common (≥5%) prior ART regimens, n (%) NA DTG/3TC/ABC DTG + FTC/TAF BIC/FTC/TAF DTG + FTC/TDF EVG/COBI/FTC/TAF 148 (44.2) 42 (12.5) 25 (7.5) 20 (6.0) 17 (5.1) Most common comorbidities (>10%), n (%) Depression (acute or status post) Hypertension Lipidemia disorder Chronic kidney insufficiency Insomnia 3 (9.7) 1 (3.2) 1 (3.2) 0 2 (6.5) 114 (34.0) 85 (25.4) 45 (13.4) 40 (11.9) 35 (10.4) ABC, abacavir; BIC, bictegravir; COBI, cobicistat; DTG, dolutegravir; EVG, elvitegravir; FTC, emtricitabine; NA, not applicable; TAF, tenofovir alafenamide; 3TC, lamivudine; TDF, tenofovir disoproxil fumarate. Relevant concomitant diseases according to ICD-10 chapter (per participant total, multiple answers possible). Table 2. HIV-TSQs and HIV-SDM Scores for Pre-treated PLHIV Completing Both Baseline and Year 3 Questionnaires Pre-treated, n Baseline total score, mean (SD) Year 3 total score, mean (SD) Year 3 change from baseline, mean (SD) P value (Wilcoxon signed rank test) HIV-TSQs 165 54.2 (7.5) 56.4 (6.5) 2.2 (8.9) <0.0001 HIV-SDM 165 14.2 (12.2) 14.3 (12.4) 0.1 (9.6) 0.7607 HIV-SDM, HIV Symptom Distress Module; HIV-TSQs, HIV Treatment Satisfaction Questionnaire, status version; PRO, patient-reported outcome. Due to small sample size, PROs in ART-naive PLHIV were not analyzed for statistically significant differences from baseline: HIV-TSQs scores were not assessed at baseline in ART-naive PLHIV, and mean (SD) HIV-TSQs score at Year 3 was 58.9 (2.0; n=12); mean (SD) HIV-SDM score decreased from 10.8 (10.1) at baseline to 7.6 (8.7; n=10) at Year 3. 1 2 3 4 5 6 7 8 9 10 10 1 2 3 4 5 6 7 8 9 10 2 3 3 a a a b c a b
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