EACS2023: 134 Renal safety parameters of doravirine/islatravir (100/0.75 mg) vs bictegravir/emtricitabine/tenofovir alafenamide once-daily as initial HIV-1 treatment: week 48 results from a randomized, double-blind phase 3 trial F.A. Post , G. Di Perri , D. Cunningham , C. Mussini , J.K. Rockstroh , T.A. Correll , C.J. McMullan , M. Karten , Y. Zhang , K. Squires , M.C. Fox , M. Pisculli King's College Hospital NHS Foundation Trust, London, United Kingdom, University of Torino, Torino, Italy, Pueblo Family Physicians, Phoenix, United States, University of Modena and Reggio Emilia, Modena, Italy, University Hospital Bonn, Department of Medicine I, Bonn, Germany, Merck & Co., Inc., Rahway, United States General data Abstract category: Antiretroviral therapy – randomised clinical trials Abstract body Purpose: Most antiretrovirals affect renal function. This post-hoc analysis evaluated renal safety parameters after 48 weeks in a non-inferiority trial of doravirine (DOR)/islatravir (ISL) (100/0.75 mg) vs bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) for initial treatment of HIV-1 (MK8591A-020, NCT04233879). Method: Previously untreated adults with HIV-1 were randomized 1:1 to once-daily oral DOR/ISL (100/0.75 mg) or B/F/TAF, stratified by screening CD4+ T-cell count (</≥200 cells/mm ) and HIV‐1 RNA (≤/>100,000 copies/mL). Participants with a creatinine clearance ≤30 mL/min were excluded. Renal safety parameters were assessed, including estimated glomerular filtration rate (eGFR) using the CKD-Epi Cystatin-C equation to avoid reliance on creatinine-based eGFR which is confounded by variable inhibition of renal creatinine secretion by antiretroviral agents. Results: 597 participants were randomized and treated: DOR/ISL (100/0.75 mg) n=298, B/F/TAF n=299. Median age was 32 (18-77) years, with 87% between 18-49 years old. 75% of participants were male, 29% were African American, 20% had pretreatment CD4+ T cell count <200 cells/mm , and 20% had pre-treatment HIV-1 RNA >100,000 copies/mL. A greater decline in eGFR-creatinine in the B/F/TAF group was observed. There were comparable improvements in eGFR-cystatin C. No differences in mean change from baseline between groups were observed for urine albumin/creatinine ratio or urine retinol-binding protein/creatinine ratio at 48 weeks (Table). Renal and urinary adverse events (RUAEs) occurred in 3.7% vs 5.4% of participants, respectively. No participants in the DOR/ISL group discontinued treatment due to a RUAE. One participant in the B/F/TAF group experienced serious acute kidney injury and discontinued treatment. Conclusions: Overall, initial treatment of HIV-1 with DOR/ISL (100/0.75 mg) did not adversely impact renal function as compared to B/F/TAF after 48 weeks. 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 6 6 6 6 6 6 1 2 3 4 5 6 3 3 195
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