Department of Infectious Diseases, Hôpital de l'Archet, Nice, France.
HIV Med. 2013 Sep;14(8):509-15. doi: 10.1111/hiv.12041. Epub 2013 May 8.
The aim of the study was to assess whether patients with undetectable viraemia [a negative polymerase chain reaction result (PCR(neg) )] and those with plasma viral load (PVL) < 40 HIV-1 RNA copies/mL but a detectable (positive) PCR signal (PCR(pos) ) had different outcomes in terms of the development of blips and virological failure (VF).
A multicentre observational database analysis was carried out. Data for patients whose highly active antiretroviral therapy (HAART) regime had been unchanged for ≥ 6 months by 1 January 2008, whose first two PVL measurements of 2008 were < 40 copies/mL and who had at least five PVL measurements between 1 January 2008 and 31 December 2010 were extracted from a multicentre observational database of 4928 patients receiving HAART. PVL assays used during this period had a detection threshold of 20 or 40 copies/mL. Undetectable PVL at baseline (BL PCR(neg) ) was defined as PCR(neg) at the first two PVL determinations of 2008. Multivariable Cox regression analysis was performed to investigate factors associated with the occurrence of blips and VF, defined as two consecutive PVL measurements > 40 copies/mL.
Of the 1957 patients included in the study (mean age 47 years; median antiretroviral exposure 10.3 years), 1312 had BL PCR(neg) . Outcome events included 322 blips and 139 VFs, with incidence rates being significantly lower in patients with BL PCR(neg) than in those with BL PCR(pos) [13.0% vs. 23.4% (P < 0.0001) and 5.1% vs. 11.2% (P < 0.0001), respectively]. In multivariable analysis, BL PCR(neg) was associated with a reduced risk of blips [hazard ratio (HR) 0.58; 95% confidence interval (CI) 0.47-0.73; P < 0.0001] and VF (HR 0.44; 95% CI 0.31-0.62; P < 0.0001).
Patients with PCR(neg) had better virological outcomes than those with PVL < 40 copies/mL but detectable viraemia. This suggests that the 'no-signal' information provided by currently commercially available HIV RNA quantification assays should be used routinely.
本研究旨在评估病毒血症不可检测（聚合酶链反应（PCR）阴性结果）的患者和血浆病毒载量（PVL）<40 HIV-1 RNA 拷贝/ml 但检测到（阳性）PCR 信号（PCR（pos））的患者在出现“回升”和病毒学失败（VF）方面的结局是否不同。
进行了一项多中心观察性数据库分析。从一个多中心观察性数据库中提取了 4928 名接受高效抗逆转录病毒治疗（HAART）的患者的数据，这些患者在 2008 年 1 月 1 日之前至少有 6 个月的 HAART 方案未发生变化，其 2008 年的前两次 PVL 测量值<40 拷贝/ml，并且在 2008 年 1 月 1 日至 2010 年 12 月 31 日期间至少有 5 次 PVL 测量值。在此期间使用的 PVL 检测方法的检测下限为 20 或 40 拷贝/ml。基线时不可检测的 PVL（BL PCR（neg））定义为 2008 年前两次 PVL 测定中的 PCR（neg）。采用多变量 Cox 回归分析探讨与“回升”和 VF 发生相关的因素，VF 定义为两次连续的 PVL 测量值>40 拷贝/ml。
在纳入的 1957 例患者（平均年龄 47 岁；中位抗逆转录病毒暴露时间为 10.3 年）中，有 1312 例患者为 BL PCR（neg）。结局事件包括 322 次回升和 139 次 VF，BL PCR（neg）患者的发生率明显低于 BL PCR（pos）患者[分别为 13.0%（95%CI 11.3-14.8）比 23.4%（95%CI 21.2-25.7）和 5.1%（95%CI 3.6-6.8）比 11.2%（95%CI 9.1-13.4），P<0.0001]。多变量分析显示，BL PCR（neg）与“回升”风险降低相关（HR 0.58；95%CI 0.47-0.73；P<0.0001）和 VF（HR 0.44；95%CI 0.31-0.62；P<0.0001）。
PCR（neg）患者的病毒学结局优于 PVL<40 拷贝/ml 但可检测到病毒血症的患者。这表明目前商业上可获得的 HIV RNA 定量检测方法提供的“无信号”信息应常规使用。
