EACS2023: 133 Switch to fixed-dose doravirine/islatravir (100/0.75 mg) once daily in adults with HIV-1 virologically suppressed on bictegravir/emtricitabine/tenofovir alafenamide: week 96 results of a phase 3, randomized, double-blind, non-inferiority trial R. Paredes , A.M. Mills , G. Rizzardini , M. Ramgopal , O. Osiyemi , J.R. Bogner , D. Hagins , J. Reynes , J.K. Rockstroh , A. Carr , F.-H. Su , S.O. Klopfer , T. Correll , M.C. Fox Hospital Universitari Germans Trias i Pujol & irsiCaixa AIDS Research Institute, Barcelona, Spain, Men's Health Foundation, Los Angeles, United States, Hospital Luigi Sacco, Milan, Italy, Midway Immunology and Research Center, Fort Pierce, United States, Triple O Research Institute, West Palm Beach, United States, Department of Medicine IV, LMU University Hospital, LMU Munich, Munich, Germany, Chatham County Health Department, Savannah, United States, Montpellier University Hospital, Montpellier, France, Department of Medicine I, University of Bonn, Bonn, Germany, St. Vincent's Hospital, Sydney, Australia, Merck & Co., Inc., Rahway, United States General data Abstract category: Antiretroviral therapy – randomised clinical trials Abstract body Purpose: Doravirine (DOR)/islatravir (ISL) (100/0.75 mg) was non-inferior to continuing bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) for maintaining viral suppression at week 48 in a double-blind study (8591A-018, NCT04223791). Here we report week 96 results. Method: Adults with no prior treatment failure and HIV-1 RNA <50 copies/mL for ≥3 months on B/F/TAF were randomized (1:1) to switch to DOR/ISL or continue B/F/TAF. Protocol-specified declines (eg, ≥30% reduction) in CD4+ T-cell and/or total lymphocyte (TL) counts confirmed with repeat testing required treatment discontinuation. Efficacy was evaluated by FDA Snapshot in the full analysis set (FAS, all who took ≥1 dose of study drug) and a modified-FAS (mFAS, excluding those who discontinued for declines in cell counts before week 96). Results: 641 participants (mean 47.8 [±12.2] years, 72% male, 75% White) received ≥1 dose of study drug (DOR/ISL n=322; B/F/TAF n=319). At week 96, HIV-1 RNA <50 copies/mL was as follows: FAS, 84.8% on DOR/ISL versus 90.9% on B/F/TAF (difference -6.1%, 95% CI -11.3, -1.1); mFAS (excluding 13 DOR/ISL participants with decreases in cell counts), 88.3% versus 90.9% (difference -2.6%, 95% CI -7.5, 2.2). Two participants on DOR/ISL and one on B/F/TAF developed HIV-1 RNA ≥50 copies/mL. The two participants on DOR/ISL had virologic failure (VF, 2 consecutive HIV-1 RNA ≥200 copies/mL) with undetectable ISL plasma concentrations at VF. Mean CD4+ T-cell and TL counts were lower with DOR/ISL vs B/F/TAF. Total AEs, including infections, were comparable. More on DOR/ISL had treatment-related AEs and discontinuation due to AEs, driven by decreases in CD4+ T-cell and TL counts (Table). Conclusions: Participants switching from B/F/TAF to DOR/ISL (100/0.75mg) maintained viral suppression through week 96. Protocol-specified discontinuation criteria for CD4+ T-cell and/or TL count declines contributed to the efficacy difference between groups in the FAS. Decreases in cell counts accounted for many treatment-related AEs and discontinuations due to AEs with DOR/ISL. 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 9 10 11 11 11 11 1 2 3 4 5 6 7 8 9 10 11 194 19TH EUROPEAN AIDS CONFERENCE | WARSAW 2023
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