EACS2023: 992 DOLAM-500: Efficacy and safety of Dolutegravir (DTG) plus Lamivudine (3TC) in ART-naive PLWH with baseline viral load ≥500.000 copies/ml A. Inan , S. Akhan , B. Kaya , A. Kılınç Toker , Y. Taşova , I. Karaoglan , P. Sarlak , S. Nazik , İ. Akbulut , M.K. Celen , S.A. Nemli , D. Inan , DOLAM-500 Study Group Saglik Bilimleri University, Infectious Diseases, Istanbul, Turkey, Kocaeli University, Kocaeli, Turkey, Saglik Bilimleri University, Istanbul, Turkey, Saglik Bilimleri University, Kayseri, Turkey, Çukurova University, Adana, Turkey, Gazıantep University, Gaziantep, Turkey, Saglik Bilimleri University, Konya, Turkey, Sutçu Imam University, Kahramanmaraş, Turkey, Saglik Bilimleri University, İzmir, Turkey, Dicle University, Diyarbakır, Turkey, Katip Celebi University, İzmir, Turkey, Akdeniz University, Antalya, Turkey General data Abstract category: Antiretroviral therapy – observational studies Abstract body Purpose: Dual ART with DTG/3TC is recommended for PLWH presenting with HIV RNA levels below 500.000 copies/mL. There is a scarcity of data on DTG/3TC efficacy in PLWH presenting with higher viral loads. Here, we evaluated the efficacy and safety of the DTG+3TC in ART-naïve PLWH presenting with HIV viral load ≥ 500,000 copies/ml. Method: This retrospective, multicenter, observational, real-life study, recruited PLWH aged >18 years, with baseline viral load ≥500,000 copies/mL, initiated ART with DTG+ 3TC regimen and completed at least 24-weeks of follow-up. The primary endpoint was the proportion of patients with HIV RNA below 50 copies/mL at week 48. Results: 56 patients were included from 15 HIV centers in Turkey. 92.8% were male, the median age was 37 years, the median BL CD4+cell count was 330 cells/mm and the median BL HIV-1 RNA was 1,023,000 copies/mL. Baseline resistance testing was available in 27(48.2%) and no resistance mutation was detected.16 patients did not reach the 48th week of follow up and 2 did not appear for the 48th week of follow-up. HIV-1 RNA suppressed(<50 copies/mL) in 46 of 56(82.1%) and 35 of 38(92.1%) PLWH at week 24 and 48,respectively. The rate of drug-related side effects was low(7.1%); including 3 nausea and one pruritus. No serious drug-related side effects requiring drug discontinuation were observed. Table1: Baseline characteristics of the patients and reasons for DTG+3TC as first line therapy Median (range) age , years 37 (21-85) Female % 7.2 Median (range) CD4 cells/mm 330 (25-982) Median (range) HIV-1 RNA copies/mL 1.023.000 (500.000- 55.549.410) CD4/CD8 mean ±SD 0.32± 0.28 HBV/HCV coinfection 0 Underlying diseases/conditions n(%) Cardiovascular disease Chronic renal failure Osteopenia/osteoporosis Diabetes mellitus Hypertension Obesity Smoking Dyslipidemia Family history of CVD 4 (7.1) 2 (3.5) 4 (7.1) 7 (12.5) 9 (16.0) 5(8.9) 31(55.3) 18 (32.1) 18(32.1) Reasons of DTG/LAM therapy n(%) Patient’s request/toxicity concern Provider’s choise Osteopenia/osteoporosis Polypharmacy/drug-drug interaction CRF or renal function tests abnormalities 23(41.0) 17(30.3) 4 (7.1) 8 (14.2) 4(7.1) Table 2: Virologic outcomes at w24 and w48 in patients with baseline HIV RNA≥500,000 copies/mL Baseline HIV-1 RNA copies/mL N W24 W48 Total 56 N HIV-1 RNA <50 copies /mL HIV-1 RNA ≥ 50 copies/mL No data 56 46 10 0 38* 35 3 2** 500.000- 1.000.000 28 N HIV-1 RNA <50 copies/mL HIV-1 RNA ≥ 50 copies/mL No data 28 23 5 0 17* 17 0 1** 1.000.000 - 2.000.000 15 N HIV-1 RNA <50 copies/mL HIV-1 RNA ≥ 50 copies/mL No data 15 14 1 0 9* 8 1 0 2.000.000- 3.000.000 5 N HIV-1 RNA <50 copies/mL HIV-1 RNA ≥ 50 copies/mL No data 5 4 1 0 4* 3 1 0 >3.000.000 8 N HIV-1 RNA <50 copies/mL HIV-1 RNA ≥ 50 copies/mL No data 8 5 3 0 8 7 1 1** Baseline CD4 ( cells/mm ) mean ±SD N W24 W48 375,9 ± 209.7 56 N CD4 mean ±SD 56 624.1 ± 307.4 38 721.1 ± 339.8 *Some patients did not reach the 48th week of follow up(totally 16 patients) **The patients who did not appear for the 48th week of follow-up( totally 2 patients). Conclusions: The preliminary results of our ongoing study reveal that the DTG+3TC dual ART regimen may be effective and tolerable as first-line therapy in patients with baseline viral load ≥500,000 copies/mL. 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 12 1 2 3 4 5 6 7 8 9 10 11 12 3 3 3 190 19TH EUROPEAN AIDS CONFERENCE | WARSAW 2023
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