评价感染 HIV 个体在第 96 周时继续使用两药方案或换用基于三药整合酶抑制剂方案时的 HIV-DNA 和残余病毒载量水平。
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.
机构信息
Department of Oncology and Hemato-Oncology, University of Milan, Milan, Italy; Multimodal Laboratory Research Department, Children Hospital Bambino Gesù, IRCCS, Rome, Italy.
Infectious Diseases, IRCCS San Raffaele, Milan, Italy.
出版信息
Int J Antimicrob Agents. 2023 May;61(5):106771. doi: 10.1016/j.ijantimicag.2023.106771. Epub 2023 Mar 3.
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/10 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 (r)=0.726, P=0.0004; DTG + 1 RTI: r=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.
目的
在 Be-OnE 研究中，调查经过病毒学抑制的 HIV-1 感染者在 96 周（W96）时的 HIV-DNA 和残余病毒载量（RV）水平。将患者随机分为继续使用二联药物（多替拉韦[DTG]加一种逆转录酶抑制剂[RTI]）或转换为艾维雷韦/考比司他/恩曲他滨/替诺福韦艾拉酚胺（E/C/F/TAF）的三联药物治疗组。
设计
使用液滴数字聚合酶链反应（ddPCR）技术在基线、W48 和 W96 时评估总 HIV-DNA 和 RV。还评估了病毒学-免疫参数之间以及各臂之间和之内的潜在关系。
结果
基线、W48 和 W96 时，中位数（四分位距[IQR]）HIV-DNA 分别为 2247（767-4268）、1587（556-3543）和 1076（512-2345）拷贝/10 CD4+T 细胞；RV 分别为 3（1-5）、4（1-9）和 2（2-4）拷贝/ml，各臂之间无显著差异。在 E/C/F/TAF 臂中，HIV-DNA 和 RV 从基线到 W96 显著降低（HIV-DNA：-285 [-2257；-45]，P=0.010；RV：-1 [-3；0]，P=0.007）。在 DTG+1 RTI 臂中，HIV-DNA 和 RV 水平保持稳定（HIV-DNA：-549 [-2269；+307]，P=0.182；RV：-1 [-3；+1]，P=0.280）。对于 HIV-DNA 和 RV，各臂之间在时间上均无显著变化。发现基线 HIV-DNA 与 W96 时的 HIV-DNA 之间存在正相关（E/C/F/TAF：Spearman 相关系数（r）=0.726，P=0.0004；DTG+1 RTI：r=0.589，P=0.010）。一般而言，在时间上未发现 HIV-DNA、RV 和免疫参数之间存在显著相关性。
结论
在经过病毒学抑制的个体中，与继续使用 DTG+1 RTI 的个体相比，转换为 E/C/F/TAF 臂的个体在 W96 时 HIV-DNA 和 HIV-RNA 水平略有降低。然而，在时间上，两个臂之间 HIV-DNA 和 HIV-RNA 的变化没有显著差异。
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