Liver Unit, Department of Internal Medicine, Hospital Universitari Vall d'Hebron, Institut de Recerca (VHIR), Universitat Autònoma de Barcelona, Barcelona, Spain.
Transplantation. 2012 Feb 27;93(4):450-3. doi: 10.1097/TP.0b013e318240e9dd.
The current standard for determining sustained virologic response (SVR) in patients treated for hepatitis C virus (HCV) infection is undetectable serum HCV-RNA 24 weeks after treatment. This study evaluates the value of HCV-RNA determination at 12 weeks posttreatment (W+12) to predict SVR in liver transplant (LT) patients treated with pegylated interferon and ribavirin for recurrent HCV infection.
This study, performed in 2001 to 2010, included HCV-LT patients with an end-of-treatment response (undetectable serum HCV-RNA) and HCV-RNA testing at 12 and 24 weeks posttreatment (W+12/W+24). HCV-RNA was detected with a qualitative polymerase chain reaction assay (detection limit 50 IU/mL) and, when positive, measured by quantitative PCR (detection limit 600 IU/mL) up to 2006. Since 2007, a real-time PCR-based test (detection limit 15 IU/mL) has been used. The positive predictive value (PPV) was defined as the probability that SVR would occur in patients with undetectable HCV-RNA at W+12 and W+24.
Of 162 patients treated during the study period, 57 (35%) had end-of-treatment response and were included. Of these, 45 (79%) had SVR and 12 (21%) had virologic relapse. At W+12, HCV-RNA was undetectable in 45 (79%) patients, all of whom had SVR, yielding a PPV for SVR at W+12 of 100% (95% confidence interval, 75.8%-100%).
Undetectable HCV-RNA at W+12 posttreatment has a high PPV for predicting SVR. HCV-RNA testing to assess SVR at this time point seems as valid as W+24 testing and could be considered for predicting SVR in HCV-LT patients receiving treatment with pegylated interferon and ribavirin.
目前，丙型肝炎病毒（HCV）感染患者治疗后持续病毒学应答（SVR）的标准是治疗结束后 24 周血清 HCV-RNA 不可检测。本研究评估了治疗结束后 12 周（W+12）时 HCV-RNA 测定值预测肝移植（LT）患者接受聚乙二醇干扰素和利巴韦林治疗复发性 HCV 感染的 SVR 的价值。
本研究于 2001 年至 2010 年进行，纳入了治疗结束时应答（血清 HCV-RNA 不可检测）的 HCV-LT 患者，以及治疗结束后 12 周（W+12）和 24 周（W+24）时的 HCV-RNA 检测。采用定性聚合酶链反应检测 HCV-RNA（检测限 50 IU/mL），当为阳性时，采用定量 PCR（检测限 600 IU/mL）检测，直至 2006 年。自 2007 年以来，已使用实时 PCR 检测（检测限 15 IU/mL）。阳性预测值（PPV）定义为 W+12 和 W+24 时 HCV-RNA 不可检测的患者发生 SVR 的概率。
在研究期间接受治疗的 162 例患者中，57 例（35%）有治疗结束时应答并被纳入研究。其中，45 例（79%）获得 SVR，12 例（21%）发生病毒学复发。W+12 时，45 例（79%）患者的 HCV-RNA 不可检测，所有患者均获得 SVR，W+12 时 SVR 的 PPV 为 100%（95%置信区间，75.8%-100%）。
治疗结束后 12 周时 HCV-RNA 不可检测对预测 SVR 具有很高的 PPV。此时进行 HCV-RNA 检测评估 SVR 与 W+24 检测一样有效，可考虑用于预测接受聚乙二醇干扰素和利巴韦林治疗的 HCV-LT 患者的 SVR。
