Institut National de la Santé et de la Recherche Médicale, U-773, Centre de Recherche Biomédicale Bichat-Beaujon CRB3, Université Paris VII, Paris, France.
Hepatology. 2010 Apr;51(4):1122-6. doi: 10.1002/hep.23444.
A sustained virologic response (SVR) in patients with chronic hepatitis C receiving pegylated interferon (PEG-IFN) plus ribavirin is defined as undetectable serum HCV-RNA at 24 weeks (W+24) posttreatment follow-up. Viral load outcome in patients with virological relapse (VR) has not been explored. This study evaluated whether the assessment of serum HCV-RNA 12 weeks (W+12) after the end of treatment was as relevant as W+24 to evaluate SVR in 573 patients who received combination PEG-IFN and ribavirin and had a virological response at the end of treatment. Serum HCV-RNA was measured, using a new assay based on transcription-mediated amplification (TMA) with a lowest detection limit of 5-10 IU/mL, at W+12 and W+24 after the end of treatment. VR was defined as reappearance of detectable HCV-RNA at W+24 posttreatment follow-up. The positive predictive value (PPV) of undetectable serum HCV-RNA at W+12 was evaluated to identify patients with SVR, and the viral load outcome was measured in relapse patients. At the W+24 posttreatment follow-up, 408 (71%) patients had an SVR, 181 (71.2%) were treated with PEG-IFNalpha-2a and ribavirin, and 227 (71.1%) were treated with PEG-IFNalpha-2b and ribavirin. At W+12, serum HCV-RNA was undetectable in 409 patients, and 408 patients were SVR (PPV 99.7%, 95% confidence interval 99.1-100). In relapse patients, serum HCV-RNA levels were 5.623 +/- 0.748, 4.979 +/- 0.870, and 5.216 +/- 0.758 log(10) IU/mL at baseline, W+12, and W+24, respectively.
Our results show that the assessment of serum HCV-RNA 12 weeks after the end of treatment, using the highly sensitive TMA assay (PPV 99.7%), is as relevant as after 24 weeks to predict SVR and make decisions on the management of treated patients, suggesting a new definition for SVR.
慢性丙型肝炎患者接受聚乙二醇干扰素（PEG-IFN）加利巴韦林治疗后获得持续病毒学应答（SVR）定义为治疗后 24 周（W+24）时血清 HCV-RNA 不可检测。尚未探讨病毒学复发（VR）患者的病毒载量结果。本研究评估了治疗结束后 12 周（W+12）评估血清 HCV-RNA 是否与 W+24 一样重要，以评估 573 例接受 PEG-IFN 和利巴韦林联合治疗且治疗结束时具有病毒学应答的患者的 SVR。使用基于转录介导扩增（TMA）的新检测方法（最低检测限为 5-10 IU/mL）测量治疗结束后 W+12 和 W+24 时的血清 HCV-RNA。定义为治疗后 W+24 时 HCV-RNA 再次可检测。评估了治疗结束后 12 周时血清 HCV-RNA 不可检测的阳性预测值（PPV），以识别 SVR 患者，并测量复发患者的病毒载量结果。在治疗后 W+24 随访时，408 例（71%）患者获得 SVR，181 例（71.2%）接受 PEG-IFNalpha-2a 和利巴韦林治疗，227 例（71.1%）接受 PEG-IFNalpha-2b 和利巴韦林治疗。在 W+12 时，409 例患者血清 HCV-RNA 不可检测，408 例患者获得 SVR（PPV 99.7%，95%置信区间 99.1-100）。在复发患者中，基线时血清 HCV-RNA 水平分别为 5.623 +/- 0.748、4.979 +/- 0.870 和 5.216 +/- 0.758 log(10) IU/mL，W+12 和 W+24。
我们的结果表明，使用高度敏感的 TMA 检测方法（PPV 99.7%）评估治疗结束后 12 周的血清 HCV-RNA 与 24 周一样重要，可以预测 SVR 并为治疗患者的管理做出决策，提示 SVR 的新定义。
