EACS2023: 74 Switch to fixed-dose doravirine (100 mg) with islatravir (0.75 mg) once daily in adults with HIV-1 virologically suppressed on antiretroviral therapy: week 96 results of a randomized, open-label, phase 3 trial J.-M. Molina , G. Rizzardini , S. Kassim , A. Afani Saud , A. Calmy , S. Oka , F. Hinestrosa , P. Kumar , P. Tebas , S. Walmsley , A. Grandhi , S. Klopfer , S. Joseph , K. Eves , T. Correll , M.C. Fox , J. Kim St-Louis and Lariboisière Hospitals, APHP, University of Paris, INSERM U944, Paris, France, Department of Infectious Diseases, Hospital Luigi Sacco, Milan, Italy, Desmond Tutu HIV Centre, University of Cape Town, Cape Town, South Africa, Infectious Disease Department, University of Chile, Santiago, Santiago, Chile, HIV/AIDS Unit, Division of Infectious Diseases, Geneva University Hospitals, Geneva, Switzerland, National Center for Global Health and Medicine, AIDS Clinical Center, Tokyo, Japan, Orlando Immunology Center, Orlando, United States, Division of Infectious Diseases, Georgetown University Medical Center, Washington DC, United States, Penn Center for AIDS Research, University of Pennsylvania, Philadelphia, United States, University of Toronto, Department of Medicine, Ontario, Canada, Merck & Co., Inc., Rahway, United States General data Abstract category: Antiretroviral therapy – randomised clinical trials Abstract body Purpose: The once-daily single-tablet regimen containing doravirine (DOR) 100mg, an approved NNRTI, and islatravir (ISL) 0.75mg, an investigational nucleoside reverse transcriptase translocation inhibitor (NRTTI), was non-inferior to continued oral combination ART at week 48 in a phase 3, open-label, switch study (8591A-017, NCT04223778). Week 96 results from this study are presented here. Method: Virologically suppressed adults on stable oral 2- or 3-drug ART for ≥3 months with no history of treatment failure or virologic resistance to DOR were randomized (1:1) to switch to DOR/ISL (Group 1) or continue baseline ART (bART) (Group 2), stratified by bART regimen. Group 2 switched to DOR/ISL at week 48. Efficacy at week 96 was evaluated by FDA Snapshot and Observed Failure (OF) approaches. Adverse events (AE) from weeks 48-96 were summarized. Results: 672 participants (37% female, 27% Black, mean age 45.5 ±11.7 years) were treated with open-label DOR/ISL (Group 1, n=336) or bART (Group 2, n=336). bART was PI-based in 14%, InSTI-based in 52%, and Other (mainly NNRTI-based) in 34%. At week 48, 326 participants switched from bART to DOR/ISL. At week 96, 1.2% in Group 1 and 0.9% in Group 2 had HIV-1 RNA ≥50 copies/mL. Virologic suppression (HIV-1 RNA <50 copies/mL) was maintained in 86.0% and 89.6%, respectively, by FDA Snapshot and in 96.5% and 94.3%, respectively, by OF. No virologic failures (2 consecutive HIV-1 RNA ≥200 copies/mL) occurred. At week 96, mean CD4+ T-cell count remained >700 cells/mm and total lymphocyte count was moderately decreased in both treatment groups (Table). AE profiles were similar (Table) except for higher incidence of infection-related AE in Group 2 (due to higher incidence of COVID-19); no CDC AIDS-defining Category C events occurred. Conclusions: Switching to DOR/ISL (100mg/0.75mg) maintained viral suppression and was generally well tolerated through week 96. No virologic failure was observed 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 11 11 11 1 2 3 4 5 6 7 8 9 10 11 3 192 19TH EUROPEAN AIDS CONFERENCE | WARSAW 2023
RkJQdWJsaXNoZXIy Mzc2ODc=