EACS2023: 588 DoraVIH: Observational study of the reasons for switch to Doravirine-based regimen in patients with virological success and the choice of a treatment correlated to PRO O. Robineau , V. Pourcher , J.-J. Parienti , P. Loubet , C. Palacios , C. Jacomet , J.-C. Lheritier , P. Mariot , L. Slama , B. Spire CH Tourcoing, Tourcoing, France, AP-HP Pitié Salpêtrière, Paris, France, CHU Caen Normandie, Caen, France, CHU Nîmes, Nîmes, France, AP-HP Tenon, Paris, France, CHU Clermont Ferrand, Clermont Ferrand, France, MSD France, Puteaux, France, AP-HP Hôtel-Dieu, Paris, France, INSERM, Marseille, France General data Abstract category: Antiretroviral therapy – observational studies Abstract body Purpose: In France, it is estimated that over 90% of people living with HIV-1 (PLWH) have controlled viral load under an antiretroviral therapy (ART). Few studies focused on reasons for switch in virologically controlled patients. DoraVIH study aims to answer this comparing patients switch to non-Doravirine regimen (non-DOR) versus switching to a Doravirine-based regimen (DOR) and carry out a longitudinal follow-up of this last group. Method: Population: Adults (≥18 years) with HIV-1 infection virologically controlled for at least 6 months before screening, pretreated with stable ART, without previous use of Doravirine and switching to another ART at inclusion. Design: French, multicentric (15 sites), two-step observational study: cross-sectional at inclusion (explore reasons for switch) and prospective 18-month follow-up for DOR-patients (investigate mainly quality of life). Results: Between December 13 and September 21, 2022, 296 PLWH were included (145 DOR and 151 non-DOR). Mean age was 51.5 years and 209 (71%) were men. The BMI at baseline was ≥30 kg/m for 35 (25%) PLWH on DOR and 15 (10%) on other ART (p<0.05). Comorbidities of interest were reported for 181 (61%) participants and 71% received concomitant medications (Table 1). Overall health was assessed by physicians as good to excellent for 245 (94%) participants. Patient-reported outcomes, SF-36 and HIVTSQ10 questionnaires, provide health status and satisfaction with ART, respectively. Treatment simplification, tolerability and drug-drug interactions were the most common reasons for switching (79%) (Table 2). Of the 69 participants with tolerability concerns, 48 (70%) switched to DOR. Among 145 PLWH who switched to DOR, 85% received a fixed dose combination (Figure 1). Table 1. Sociodemographic, clinical characteristics and concomitant medications at baseline (n=296 participants) Body Mass Index (BMI) DOR (n=145) Non-DOR* (n=151) Total (n=296) < 30 kg/m 107 (75%) 128 (90%) 235 (82%) ≥ 30 kg/m 35 (25%) 15 (10%) 50 (18%) Missing data (not taken into account for the calculation of the percentages) 3 8 11 HIV history Median duration (years) from diagnosis of HIV infection to inclusion 17.3 17.3 17.3 from date of first ART to inclusion 14.3 11.8 13.9 from date of previous ART to inclusion 3.6 3.6 3.6 Overall Health Assessment by Physician Excellent 25 (19%) 28 (22%) 53 (20%) Very good 42 (32%) 41 (32%) 83 (32%) Good 60 (46%) 49 (38%) 109 (42%) Fair or poor 4 (3%) 11 (8%) 15 (6%) Missing data 14 22 36 Table 2. Primary outcome: reasons for switching (n=296 participants) Reason for switch DOR (n=145) Non-DOR (n=151) Total (n=296) Treatment simplification 49 (34%) 98 (65%) 147 (50%) Tolerability 48 (33%) 21 (14%) 69 (23%) Drug-drug interactions 12 (8%) 7 (5%) 19 (6%) Financial 2 (1%) 0 (0%) 2 (1%) Pregnancy 1 (1%) 1 (1%) 2 (1%) Prior treatment failure 1 (1%) 0 (0%) 1 (0%) Other 41 (28%) 30 (20%) 71 (24%) Not documented 6 (4%) 6 (4%) 12 (4%) Number of reasons per participant The patient and the physician could select several reasons. The selected reason could be chosen by the patient only, the physician only or both. Not documented 6 (4%) 6 (4%) 12 (4%) One reason 124 (86%) 133 (88%) 257 (87%) Two or more reasons 15 (10%) 12 (8%) 27 (9%) Conclusions: Simplification and tolerance of ART treatment are the two main reasons for switching. Overweight patients were more likely to switch to DOR. Clinical data at M3 and M15-M18 follow-up as well as quality of life will be analyzed at the end of the study. 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 3 4 5 6 7 7 8 9 1 2 3 4 5 6 7 8 9 2 2 2 136 19TH EUROPEAN AIDS CONFERENCE | WARSAW 2023
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