EACS2023: 366 Real-world retrospective observational study on the use of Doravirine (DOR) based regimens in clinical practice in Europe R. Movahedi , L. Assoumou , A. Pozniak , K. Lacombe , F. Raffi , J. Fox , D. Roberts , C. Fletcher , A. Duffy , L. Levi , J.-M. Molina , DREW Study Group Chelsea and Westminster Hospital, London, United Kingdom, Sorbonne Université, INSERM, Institut Pierre Louis d’Epidémiologie et de Santé Publique, Paris, France, NEAT ID, Brussels, Belgium, Hôpital Saint Antoine, Paris, France, Centre Hospitalier Universitaire de Nantes, Nantes, France, Guy's and St Thomas Hospital, London, United Kingdom, Research Organisation (Kings Cross), London, United Kingdom, Hôpital Saint Louis, Paris, France, Hôpital Lariboisière, Paris, France General data Abstract category: Antiretroviral therapy – observational studies Abstract body Purpose: DREW, a multi-centre observational European study, assessed the use in real-world clinical practice of Doravirine (DOR), a novel NNRTI with a unique resistance profile against most common NNRTI resistant variants. Method: Adults with HIV (PWH) on DOR-based regimen with two fully active NRTIs for >12 months were enrolled retrospectively. Treatment-naïve and stable-switch PWH (VL<50c/ml for >6 months) were eligible. PWH with prior virological failure on NNRTIs or with DOR-associated genotypic resistance mutations were excluded. Viral suppression at 48 weeks was estimated using FDA snapshot method. Results: 399 PWH were included (74.9% male, 40.6% White European), 64 treatment-naïve, 335 stable-switch; 337 (84.5%) PWH had tenofovir disoproxil fumarate and lamivudine in their DOR-based regimen. 142 (42.4%) stable-switch PWH were switched from NNRTI regimens, 138 (41.2%) from INsTI, 57 (17%) from bPI. 148 (44.2%) switched to DOR due to adverse events, 18 (5.4%) had previous virological failure with no resistance mutations. Table 1: Key Baseline Characteristics Overall (N=399) Treatment naïve (N=64) Stable Switch (335) Age, years, median (IQR) 45 (37-54) 38 (31-48) 46 (38-54) Gender, n (%):Female; Male; Transgender 100 (25.1); 299 (74.9); 0 (0) 15 (23.4); 49 (76.6); 0 (0) 85 (25.4); 250 (74.6); 0 (0) Ethnicity, n (%): White European; White mixed; Asian; Black; Other 162 (40.6); 20 (5); 16 (4); 102 (25.6); 99 (24.8) 25 (39.1); 5 (7.8); 2 (3.1); 17 (26.6); 15 (23.4) 137 (40.9); 15 (4.5); 14 (4.2); 85 (25.4); 84 (25.1) Plasma VL log (cp/ml): median (IQR) 1.3 (1.3-1.5) 4.3 (3.6-5) 1.3 (1.3-1.3) Number of years since ART initiation: Median (IQR) 7.3 (3.9-10.9) N/A 7.3 (3.9-10.9) Last antiretroviral therapy before switching to DOR, n (%) [NNRTI; INsTI; bPI] 142 (42.4); 138 (41.2); 57 (17.0) N/A 142 (42.4); 138 (41.2); 57 (17.0) Time in months between most recent resistance test and baseline: No. of individuals with data; Median (IQR) 396; 56.9 (9.8-116) 64; 0.5 (0.2-1) 332; 81 (30.4-125.9) RT Resistance mutations prior to switch – n (%) [NRTI; NNRTI, both] 16 (4.0); 17 (4.3); 2 (0.5) 3(4.7); 1 (1.6); 1 (1.6) 13 (3.9); 16 (4.8); 1 (0.3) Table 2: Outcomes Overall N=399 Treatment naïve N=64 Stable Switch N=335 Kaplan-Meier (KM) estimate: Individuals with discontinuation of DOR regimen or follow-up at week 48 at week 48 (N; % (95% CI) 15; 3.8 (2.3 - 6.2) 3; 4.7 (1.5 - 13.8) 12; 3.6 (2.1 - 6.2) Kaplan-Meier estimate: Proportion of individuals with confirmed virological failure (VL ≥200 copies/mL) at week 48 after initiation of DOR. (N; % (95% CI) 7; 1.9 (0.9 – 3.9) 1; 1.7 (0.2 -11.3) 6; 1.9 (0.9 – 4.2) FDA Snapshot method at week 48: HIV RNA <50 copies/mL – n ( %), (95% CI) 362 (90.7) (87.4 - 93.4) 56 (87.5) (76.8 -94.4) 306 (91.3) (87.8 - 94.1) FDA Snapshot method at week 48: HIV RNA ≥50 copies/mL – n ( %), (95% CI) 13 (3.3) (1.7 - 5.5) 1 (1.6) (0 - 8.4) 12 (3.6) (1.9 - 6.2) FDA Snapshot method at week 48: Discontinuation due adverse events – n ( %), (95% CI) 4 (1.0) (0.3 - 2.5) 0 (0.0) (0.0 - 5.6) 4 (1.2) (0.3 - 3.0) FDA Snapshot method at week 48: Discontinuation for other reasons – n ( %), (95% CI) 9 (2.3) (1.0 - 4.2) 2 (3.1) (0.4 - 10.8) 7 (2.1) (0.8 - 4.3) FDA Snapshot method at week 48: On study but missing data in the window – n ( %), (95% CI) 11 (2.8) (1.4 - 4.9) 5 (7.8) (2.6 - 17.3) 6 (1.8) (0.7 - 3.9) Kaplan-Meier estimate: Proportion of individuals with HIV RNA ≥50 copies/mL at any time during the 48-week of follow-up among switched group - n (%, 95% CI 26, 7.9 (5.5 – 11.4) Proportion of individuals with resistant viruses among participants with confirmed virological failure (HIV RNA VL ≥200 copies/mL) at week 48: 1. No. with resistance genotyping 2. Percentage of resistance– % (95% CI) 1. 4/7 (57.1) 2. 1/4 (25.0) 1. 1/1 (100) 2. 0/1 (0.0) 1. 3/6 (50%) 2. 1/3 (33.3) FDA Snapshot method: at week 48: viral suppression (HIV RNA <50 copies/mL) recorded in 362/399 (90.7%, 95% CI: 87.4-93.4), 13 (3.3%) PWH (95% CI: 1.7 - 5.5) had VL≥50 copies/ml. By week 48, 7 PWH had confirmed virological failure, VL≥200c/ml (KM estimate: 1.9% [0.9 – 3.9]), 1/4 tested had DOR mutations.; 15 PWH (KM estimate: 3.8% [2.3 – 6.2]) discontinued DOR. Reasons given for discontinuation were adverse events (4 PWH), virological failure (2), individual’s decision (2) and other (7). Conclusions: The study demonstrates the real-world effectiveness of Doravirine-containing regimens at maintaining virological control in stable-switch PWH and inducing it in treatment-naïve PWH. 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. I herewith confirm that the contact details saved in this system are those of the corresponding author, who will be notified about the status of the abstract. The corresponding author is responsible for informing the other authors about the status of the abstract.: Yes 4. I agree that all data provided may be used (saved, stored, processed, transmitted and deleted) in compliance with the privacy policy to provide the services described.: Yes 1 2 1,3 2,4 5 6 7 7 7 8,9 8,9 1 2 3 4 5 6 7 8 9 10 109
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