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 continue 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 polymerase 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: Spearman correlation coefficient (rs)=0.726, P=0.0004; DTG + 1 RTI: rs=0.589, P=0.010). In general, no significant 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.

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 / Scutari, R.; Galli, L.; Alteri, C.; Poli, A.; Piermatteo, L.; Bigoloni, A.; Perno, C. F.; Lazzarin, A.; Ceccherini-Silberstein, F.; Castagna, A.; Santoro, M. M.; Gianotti, N.. - In: INTERNATIONAL JOURNAL OF ANTIMICROBIAL AGENTS. - ISSN 0924-8579. - 61:5(2023). [10.1016/j.ijantimicag.2023.106771]

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

Poli A.;Lazzarin A.;Castagna A.;
2023-01-01

Abstract

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 continue 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 polymerase 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: Spearman correlation coefficient (rs)=0.726, P=0.0004; DTG + 1 RTI: rs=0.589, P=0.010). In general, no significant 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.
2023
Droplet digital PCR
Dual-regimen
HIV reservoir
Residual viremia
Single-tablet regimen
Total HIV-DNA
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