Gilead Sciences, Inc., Foster City, CA, United States.
University of Pittsburgh, Pittsburgh, PA, United States.
J Clin Virol. 2018 Nov;108:50-52. doi: 10.1016/j.jcv.2018.09.003. Epub 2018 Sep 10.
Plasma HIV-1 RNA (viral load, VL) is measured routinely in HIV-infected persons with FDA-approved commercially available assays such as the Cobas-TaqMan HIV-1 Assay v2.0. This assay provides quantification of viremia ≥20 copies/mL. More sensitive methods, able to quantify low-level persistent viremia below the detection limit of commercially available assays, are needed to assess the impact of current HIV cure strategies on viremia.
The novel integrase HIV-1 RNA single-copy assay (iSCA) was evaluated for measurement of low-level persistent viremia in clinical trial samples (n = 151) from subjects participating in Gilead HIV clinical research.
Paired plasma samples from HIV-1-infected patients treated with combination ART were assessed using both HIV-1 Cobas-TaqMan and iSCA; results from the two assays were compared.
Paired Cobas-TaqMan/iSCA data were obtained for 151 HIV-infected adults. Most samples (117/151, 77%) had non-quantifiable Cobas-TaqMan result, either <20 copies/mL ("<20") or "Target Not Detected" (TND). All 117 non-quantified samples were quantified with iSCA and showed higher HIV-1 RNA levels in samples with <20 than TND Cobas-TaqMan results (p < 0.0001).
In this large sample collection from virologically suppressed HIV-infected adults, use of iSCA led to quantification of low-level viremia below the limit of detection of the Cobas-TaqMan assay in all 117 previously non-quantifiable plasma samples. These data confirm the value of the iSCA as a helpful addition to the classical HIV VL assays and its potential for use in HIV cure studies to assess whether experimental interventions alter viremia.
目前已有经美国食品药品监督管理局批准的商业化检测方法（如 Cobas-TaqMan HIV-1 检测 v2.0）可常规检测感染 HIV 的个体的血浆 HIV-1 RNA（病毒载量，VL）。该检测方法可定量检测≥20 拷贝/mL 的病毒血症。为了评估当前 HIV 治愈策略对病毒血症的影响，需要更灵敏的方法来定量检测低于商业化检测方法检测限的低水平持续性病毒血症。
评估新型整合酶 HIV-1 RNA 单拷贝检测（iSCA）在吉利德 HIV 临床研究中接受联合抗逆转录病毒治疗的受试者的临床试验样本（n=151）中检测低水平持续性病毒血症的能力。
采用 HIV-1 Cobas-TaqMan 和 iSCA 检测接受联合 ART 治疗的 HIV-1 感染者的配对血浆样本；比较两种检测方法的结果。
获得了 151 例 HIV 感染成人的配对 Cobas-TaqMan/iSCA 数据。大多数样本（117/151，77%）的 Cobas-TaqMan 检测结果不可定量，要么<20 拷贝/mL（“<20”），要么“未检出靶标”（TND）。所有 117 个不可定量的样本均用 iSCA 进行定量检测，结果显示，与 Cobas-TaqMan 检测的 TND 结果相比，<20 结果的样本 HIV-1 RNA 水平更高（p<0.0001）。
在这项来自病毒学抑制的 HIV 感染者的大型样本集中，使用 iSCA 可在之前所有 117 个不可定量的血浆样本中定量检测 Cobas-TaqMan 检测方法检测限以下的低水平病毒血症。这些数据证实了 iSCA 作为经典 HIV VL 检测方法的有益补充的价值，以及其在 HIV 治愈研究中评估实验干预是否改变病毒血症的潜在用途。
