EACS2023: 922 Effectiveness of injectable long-acting cabotegravir and rilpivirine for the treatment of HIV-1: results from the Dutch ATHENA national observational cohort V. Jongen , F. Wit , A. van Eeden , A. Brouwer , R. Soetekouw , R. El Moussaoui , J. Stalenhoef , K. Sigaloff , T. Mudrikova , J. Gisolf , A. Wensing , M. van der Valk , on behalf of the ATHENA Cohort Study Group Stichting HIV Monitoring, Dutch HIV Monitoring Foundation, Amsterdam, Netherlands, Public Health Service Amsterdam, Department of Infectious Diseases, Amsterdam, Netherlands, Amsterdam University Medical Centers, University of Amsterdam, Department of Infectious Diseases, Amsterdam, Netherlands, DC Klinieken, Amsterdam, Netherlands, Elisabeth Twee Steden Ziekenhuis, Tilburg, Netherlands, Spaarne Ziekenhuis, Haarlem, Netherlands, Maasstad Ziekenhuis, Rotterdam, Netherlands, OLVG, Amsterdam, Netherlands, Amsterdam UMC Location Vrije Universiteit Amsterdam, Department of Internal Medicine, Division of Infectious Diseases, Amsterdam, Netherlands, UMCU, Utrecht, Netherlands, Rijnstate Ziekenhuis, Arnhem, Netherlands General data Abstract category: Antiretroviral therapy – observational studies Abstract body Purpose: Clinical trials have shown long-term effectiveness of long-acting injectable cabotegravir and rilpivirine (CAB/RPV) as maintenance treatment for HIV, but real-world observational data are scarce. We assessed non-inferiority of CAB/RPV compared to a standard triple ARV regimen (tART). Method: We used data from the ATHENA cohort, an ongoing observational nationwide HIV cohort in the Netherlands. For this analysis, we included all individuals who initiated CAB/RPV and had no previous episodes of virological failure (VF) (hereafter cases). Oral lead-in was optional. Individuals using tART (hereafter controls) were matched 2:1 to cases based on timing of clinical visit, mode of HIV transmission, zenith viral load, (nadir) CD4, duration of cART, sex at birth, and age. We assessed the proportion of VF (i.e., ≥1 plasma HIV RNA ≥200 c/mL) among patients with up to 1 year of follow-up, with a non-inferiority margin of 5%. Results: Between February 2018 and November 2022, we included 188 cases and 324 controls. At treatment initiation, 21 (11%) cases and 24 (7%) controls had a BMI≥30kg/m (Table-1). One case (0.5%) had a HIV-1-subtype A1A6; none had resistance to RPV at CAB/RPV initiation. Median follow-up time was 379 days [IQR 337-490]. 23/188 (11%) cases stopped within a year of CAB/RPV initiation. 3/188 (2%) cases (Table-2) and 9/324 (3%) controls experienced VF. One case and three controls resuppressed without changing treatment. Integrase and NNRTI mutations were detected in two cases at the moment of VF (Table-2). For one case the third injection was administered 12 days after the target date. CAB/RPV was non-inferior to tART (risk difference=-1.2 %, 95%CI=-4.0% to 2.5%). Conclusions: In this well characterized population without known risk factors for VF CAB/RPV was non-inferior compared to a standard tART. These results confirm findings from clinical trials for CAB/RPV as a reliably therapeutic option for virally suppressed individuals. 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 4 5 6 7 8 3,9 10 11 10 1,3 1 2 3 4 5 6 7 8 9 10 11 2 174 19TH EUROPEAN AIDS CONFERENCE | WARSAW 2023
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