EACS2023: 998 Doravirine plus dolutegravir two-drug regimen as a maintenance ART: results from a French cohort study O. Robineau , R. Palich , C. Allevena , M. Hentzien , A. Becker , C. Genet-Villeger , L. Hocqueloux , C. Duvivier UNiv Lille, Infectious disease, Tourcoing, France, Sorbonne University, Pierre Louis Epidemiology and Public Health Institute (iPLESP), INSERM 1136, Infectious Disease, Paris, France, INSERM EA 1413, CHU de Nantes, Infectious Diseases Department, Nantes, France, CHU de Reims, Infectious Diseases Department, Reims, France, Hospices Civils de Lyon, Infectious Diseases, Lyon, France, CHU de Limoges, Infectious Diseases, Limoges, France, CH d'Orleans, Infectious Diseases, Orleans, France, Paris Cité University, Necker Hospital, AP-HP, Infectious Diseases Department, Necker-Pasteur Infectiology Center ; IHU Imagine, Infectious Diseases, Paris, France General data Abstract category: Antiretroviral therapy – observational studies Abstract body Purpose: Doravirine is the most recent NNRTI, approved for naive and ART experienced people living with HIV (PLWHIV). Its efficacy in two-drug regimens (2-DRs) need to be assessed. We aimed to describe the efficacy and safety of the doravirine/dolutegravir (DOR/DTG) 2-DR as a maintenance ART. Method: An observational study including all virally suppressed (HIV plasma viral load [pVL]<50 copies/mL) adults who initiated DOR/DTG between 1st January 2020 and 31st December 2022, in HIV referring centers participating in the Dat’AIDS French cohort. The primary outcome was the rate of virological failure (VF, two pVL >50 copies/mL) under DOR/DTG during the study period. Secondary outcomes included: reasons to switch to DOR/DTG, rate of treatment discontinuation for nonvirological reasons and reasons to stop DOR/DTG over the study period. Results: Data from 240 PLWH were analyzed. Baseline characteristics are presented in Table-1.. NNRTI-based regimen preceded DOR/DTG strategy in 137/240 (57%) (table 1). The more frequent reasons to switch were simplification and/or reduction in the number of antiretroviral drugs (102/240, 43%), any side effect (49/240, 20%), and drug-drug interaction (32/240, 13%). Median follow-up under DOR/DTG was 403 days (IQR 155-736). VF occurred in 4/240 (2%) patients during the follow-up (figure 1). There was no difference in the CD4 count between the time of DOR/DTG and the end of follow-up (p=0.74). Over the study period, 7/240 patients died (3%), and 39/240 (16%) discontinued the treatment for other reason than a virological failure. These discontinuations appeared during the first three months of treatment for 21/39 (54%). Main reasons for discontinuation were neuropsychiatric disorders (9/39, 23%), simplification (8/39, 21%), and digestive disorders (4/39, 10%). Table 1. Patients’ characteristics at baseline (N= 240). Age, years, median (IQR) 60 (56-67) Male participants, n (%) 164 (70) Transmission group, n (%) - MSM - Heterosexual - Intravenous Drug Users 101 (42) 85 (35) 31 (13) Time from HIV diagnosis, years, median (IQR) 28 (22-33) Time from ART initiation, years, median (IQR) 22 (13-34) Number of lines of ART, median (IQR) 10 (6-14) Nadir CD4 count, cells/mm (IQR) 162 (57.75-270) CD4 count prior to switch, cells/mm (IQR) 646.5 (440.8-840) ART prior DOR/DTG, n (%) 2-drug regimen 3-drug regimen 4-drug regimen monotherapy 131 (54) 79 (33) 22 (9) 6 (3) Reasons for switch n (%) simplification and/or reduction in the number of antiretroviral drugs any side effect drug-drug interaction 102 (43%) 49 (20%) 32 (13%) Conclusions: DOR/DTG maintained a high rate of viral suppression in highly ART-experienced PLWH (98%). Discontinuations were mainly due to side effects. Rate and reason of discontinuation need to be compared to other dual strategies. 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 8 1 2 3 4 5 6 7 8 3 3 191
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