EACS2023: 426 Effectiveness and safety of a generic formulation of dolutegravir in clinical practice in a Latin American cohort: 18-month real-world data D.M. Cecchini , E. Bottaro , B. Bacelar , Á. Tisné , C. Migazzi , S. Diana Menéndez , M. Bergman , I. Cassetti Helios Salud, Buenos Aires, Argentina, Lab. Richmond, Buenos Aires, Argentina General data Abstract category: Antiretroviral therapy – observational studies Abstract body Purpose: Argentina has generic formulations of DTG, but there is no real-world data on its effectiveness and safety. We aim to describe the effectiveness (viral load <50 c/mL), safety, and persistence of a non-coformulated generic DTG associated with nucleoside analogs (NRTI) in clinical practice in Argentina. Method: Retrospective observational study, from 10/2019 to 12/2022. Adult patients who started DTG + NRTI in a reference center were included. Results: 665 patients were included: 538 experienced (81%) and 127 naive (19%). The median (interquartile range) age was 45 years (37–53); 484 (73%) were men. The median viral load in naive patients was 35400 c/mL (11000–133000) and <20 c/mL (<20–44) in experienced patients. Accompanying NRTIs were predominantly 3TC/TDF (73.8% and 48.6% in naive and experienced patients, respectively) and 3TC (9.5% and 32.3%, respectively). In experienced patients, the main reasons for switching to DTG were simplification (43.7%), toxicity of previous antiretrovirals (31.8%), and prevention of toxicity (15.6%). Overall persistence at 6, 12, and 18 months was 99.5%, 97.4%, and 97.5%, respectively. Persistence in naive patients was 100%, 99%, and 98.5%, and in experienced patients it was 99.4%, 97%, and 97.6%, respectively. The effectiveness in naive patients at 6, 12, and 18 months was 85.7%, 93.7%, and 95.2%, respectively, and in experienced patients was 99.2%, 99.3%, and 99%, respectively. There was no virological failure. Discontinuations were 3 (0.6%), 13 (3.3%), and 8 (2.8%) at 6, 12, and 18 months. The most frequent adverse events were renal and metabolic/weight gain-related. Conclusions: Real-world data from this Latin American cohort indicates that generic DTG associated with NRTI was safe and effective in both naive and experienced patients. High rates of treatment persistence were observed despite it not being a single-pill regimen. 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 1 1 1 1 1 2 1 1 2 120 19TH EUROPEAN AIDS CONFERENCE | WARSAW 2023
RkJQdWJsaXNoZXIy Mzc2ODc=