INSERM, U-773, Centre de Recherche Biomédicale Bichat-Beaujon CRB3 and Service d'Hépatologie, Hôpital Beaujon, AP-HP, Université Paris 7, 92110 Clichy, France.
J Clin Virol. 2009 Nov;46(3):216-21. doi: 10.1016/j.jcv.2009.08.011. Epub 2009 Sep 12.
Early viral monitoring is essential for the management of treatment outcome in patients with chronic hepatitis C. A variety of commercially available assays are now available to quantify HCV-RNA in routine clinical practice.
Compare the clinical results of 3 commercially available assays to evaluate the positive predictive value (PPV) and the negative predictive value (NPV) of rapid virological response (RVR) at week 4 and early virological response (EVR) at week 12.
287 patients treated with standard care regimen combination therapy were studied. HCV-RNA values measured at baseline, week 4, week 12 with VERSANT HCV 3.0 Assay (bDNA), and VERSANT HCV-RNA Qualitative Assay (TMA) (bDNA/TMA); COBAS Ampliprep/COBAS/TaqMan (CAP/CTM) and Abbott m2000sp extraction/m2000rt amplification system (ART). RVR was defined as undetectable serum HCV-RNA and EVR as a > OR =2 log decline in baseline viral load (BLV).
Median (range) BVLs were: 5.585(2.585-6.816), 5.189(2.792-7.747) and 4.804(2.380-6.580) log(10)IU/ml, with bDNA/TMA, CAP/CTM and ART, respectively (p<0.01); RVR was observed in 22%, 30% and 27% of the patients and PPVs were 97%, 91% and 94% with bDNA/TMA, CAP/CTM and ART, respectively (p=0.317). EVR was observed in 76%, 73% and 67% of the patients and NPVs were 93%, 83% and 79% with bDNA/TMA, CAP/CTM and ART, respectively (p=0.09).
Treatment monitoring should include both detection of serum HCV-RNA at week 4 to predict SVR and at week 12 to predict non-SVR. The value of all 3 assays was similar for evaluating RVR or EVR. Because of viral load discrepancies the same assay should be used throughout patient treatment follow-up.
早期病毒监测对于慢性丙型肝炎患者的治疗结果管理至关重要。目前有多种市售的检测方法可用于常规临床实践中的 HCV-RNA 定量。
比较 3 种市售检测方法的临床结果，评估第 4 周快速病毒学应答（RVR）和第 12 周早期病毒学应答（EVR）的阳性预测值（PPV）和阴性预测值（NPV）。
对接受标准护理联合治疗的 287 例患者进行研究。基线、第 4 周、第 12 周时使用 VERSANT HCV 3.0 检测法（bDNA）和 VERSANT HCV RNA 定性检测法（TMA）（bDNA/TMA）以及 COBAS Ampliprep/COBAS/TaqMan（CAP/CTM）和 Abbott m2000sp 提取/m2000rt 扩增系统（ART）测量 HCV-RNA 值。RVR 定义为血清 HCV-RNA 不可检测，EVR 定义为基线病毒载量（BLV）下降≥2 log。
中位（范围）BLV 分别为 5.585（2.585-6.816）、5.189（2.792-7.747）和 4.804（2.380-6.580）log（10）IU/ml，分别对应 bDNA/TMA、CAP/CTM 和 ART（p<0.01）；分别有 22%、30%和 27%的患者观察到 RVR，bDNA/TMA、CAP/CTM 和 ART 的 PPV 分别为 97%、91%和 94%（p=0.317）。分别有 76%、73%和 67%的患者观察到 EVR，bDNA/TMA、CAP/CTM 和 ART 的 NPV 分别为 93%、83%和 79%（p=0.09）。
治疗监测应包括第 4 周检测血清 HCV-RNA 以预测 SVR 和第 12 周检测以预测非 SVR。所有 3 种检测方法在评估 RVR 或 EVR 方面的价值相似。由于病毒载量存在差异，因此应在整个患者治疗随访过程中使用相同的检测方法。
