Evaluation of HIV-DNA and residual viremia levels through week 96 in HIV-infected individuals who continue a two-drug or switch to a three-drug integrase strand transfer inhibitor-based regimen

Objectives: To investigate HIV-DNA and residual viremia (RV) levels over 96 weeks (W96) in virologically-suppressed HIV-1-infected individuals enrolled in the Be-OnE Study. Individuals were randomised to con-tinue a two-drug regimen with dolutegravir (DTG) plus one reverse transcriptase inhibitor (RTI) or to switch to elvitegravir/cobicistat/emtricitabine/tenofovir-alafenamide (E/C/F/TAF).Study design: Total HIV-DNA and RV were evaluated at baseline, W48 and W96 using droplet digital poly-merase chain reaction (ddPCR) technique. Potential relationships between viro-immunological parameters and between/within arms were also assessed.Results: Median (interquartile range [IQR]) HIV-DNA was 2247 (767-4268), 1587 (556-3543) and 1076 (512-2345) copies/106 CD4 + T-cells at baseline, W48 and at W96, respectively; RV was 3 (1-5), 4 (1-9) and 2 (2-4) copies/mL, respectively, with no significant differences between arms.A significant reduction in HIV-DNA and RV from baseline to W96 was observed in the E/C/F/TAF arm (HIV-DNA:-285 [-2257;-45], P = 0.010; RV:-1 [-3;0], P = 0.007). In the DTG + 1 RTI arm, HIV-DNA and RV levels remained stable (HIV-DNA:-549 [-2269;+307], P = 0.182; RV:-1 [-3;+1], P = 0.280). For both HIV -DNA and RV, there were no significant changes over time between the arms.A positive correlation was found between baseline HIV-DNA and HIV-DNA at W96 (E/C/F/TAF: Spear-man correlation coefficient (rs) = 0.726, P = 0.0 0 04; DTG + 1 RTI: rs= 0.589, P = 0.010). In general, no signif-icant correlations were found between HIV-DNA, RV and immunological parameters over time.Conclusions: In virologically-suppressed individuals, there was a small reduction in HIV-DNA and HIV -RNA levels from baseline to W96 in individuals who switched to the E/C/F/TAF arm compared with those who remained on DTG + 1 RTI. However, there were no significant differences between the two arms in the changes in HIV-DNA and HIV-RNA over time.(c) 2023 Elsevier Ltd and International Society of Antimicrobial Chemotherapy. All rights reserved.