Department of Medicine and Clinical Oncology, Graduate School of Medicine, Chiba University, Chiba, Japan.
J Viral Hepat. 2011 Jul;18(7):e292-7. doi: 10.1111/j.1365-2893.2010.01409.x. Epub 2010 Dec 3.
Extremely low levels of serum hepatitis C virus (HCV) RNA can be detected by COBAS TaqMan HCV test. To investigate whether the COBAS TaqMan HCV test is useful for measuring rapid virological response (RVR) and early virological response (EVR) to predict sustained virological response (SVR), we compared the virological response to PEG-IFN-alfa 2a plus RBV in 76 patients infected with HCV genotype 1 when undetectable HCV RNA by the COBAS TaqMan HCV test was used, with those when below 1.7 log IU/mL HCV RNA by COBAS TaqMan HCV test was used, which corresponded to the use of traditional methods. Among the 76 patients, 28 (36.8%) had SVR, 13 (17.1%) relapsed, 19 (25.0%) did not respond, and 16 (21.0%) discontinued the treatment due to side effects. The positive predictive values for SVR based on undetectable HCV RNA by COBAS TaqMan HCV test at 24 weeks after the end of treatment [10/10 (100%) at week 4, 21/23 (91.3%) at week 8 and 26/33 (78.7%) at week 12] were superior to those based on <1.7 log IU/mL HCV RNA [17/19 (89.4%) at week 4, 27/38 (71.0%) at week 8, and 27/43 (62.7%) at week 12]. The negative predictive values for SVR based on <1.7 log IU/mL HCV RNA by COBAS TaqMan HCV test [46/57 (80.7%) at week 4, 37/38 (97.3%) at week 8, and 32/33 (96.9%) at week 12] were superior to those based on undetectable HCV RNA [48/66 (72.7%) at week 4, 46/53 (86.7%) at week 8, and 41/43 (95.3%) at week 12]. The utilization of both undetectable RNA and <1.7 log IU/mL HCV RNA by COBAS TaqMan HCV test is useful and could predict SVR and non-SVR patients with greater accuracy.
COBAS TaqMan HCV 检测可检测到极低水平的血清丙型肝炎病毒 (HCV) RNA。为了研究 COBAS TaqMan HCV 检测是否可用于测量快速病毒学应答 (RVR) 和早期病毒学应答 (EVR) 以预测持续病毒学应答 (SVR)，我们比较了在使用 COBAS TaqMan HCV 检测无法检测到 HCV RNA 的情况下，76 例感染 HCV 基因型 1 的患者接受 PEG-IFN-alfa 2a 加 RBV 治疗的病毒学应答情况，以及在使用 COBAS TaqMan HCV 检测 HCV RNA 低于 1.7 log IU/mL 的情况下的病毒学应答情况，这两种情况对应于传统方法的使用。在这 76 例患者中，28 例 (36.8%) 获得 SVR，13 例 (17.1%) 复发，19 例 (25.0%) 无应答，16 例 (21.0%) 因副作用而停止治疗。在治疗结束后 24 周时，基于 COBAS TaqMan HCV 检测无法检测到 HCV RNA 的 SVR 阳性预测值[第 4 周时 10/10 (100%)，第 8 周时 21/23 (91.3%)，第 12 周时 26/33 (78.7%)]优于基于 <1.7 log IU/mL HCV RNA 的 SVR 阳性预测值[第 4 周时 17/19 (89.4%)，第 8 周时 27/38 (71.0%)，第 12 周时 27/43 (62.7%)]。在治疗结束后 24 周时，基于 COBAS TaqMan HCV 检测 <1.7 log IU/mL HCV RNA 的 SVR 阴性预测值[第 4 周时 46/57 (80.7%)，第 8 周时 37/38 (97.3%)，第 12 周时 32/33 (96.9%)]优于基于 COBAS TaqMan HCV 检测无法检测到 HCV RNA 的 SVR 阴性预测值[第 4 周时 48/66 (72.7%)，第 8 周时 46/53 (86.7%)，第 12 周时 41/43 (95.3%)]。使用 COBAS TaqMan HCV 检测无法检测到 HCV RNA 和 <1.7 log IU/mL HCV RNA 均有助于提高 SVR 和非 SVR 患者的预测准确性。
