Kessler H H, Pierer K, Santner B I, Vellimedu S K, Stelzl E, Marth E, Fickert P, Stauber R E
Division of Clinical Molecular Diagnostics, Karl-Franzens-University, Graz, Austria.
J Hum Virol. 1998 Jul-Aug;1(5):314-9.
To define the usefulness of molecular parameters in patients with chronic hepatitis C who are undergoing antiviral therapy. Anti-hepatitis C virus (HCV) treatment was monitored by determination of serum HCV load and by presence of HCV RNA in peripheral blood mononuclear cells (PBMCs).
STUDY DESIGN/METHODS: Fifty-one patients with chronic hepatitis C undergoing antiviral therapy with interferon-alpha plus ribavirin were studied. Serum HCV RNA load was tested with a quantitative assay (Amplicor HCV Monitor Test) before, during, and up to 12 months after end of treatment. If HCV RNA was not detectable, serum samples were subsequently tested with a qualitative assay (Cobas Amplicor HCV Test) and corresponding ethylenediaminetetraacetic acid (EDTA)-treated blood was checked for presence of HCV RNA in peripheral blood mononuclear cells (PBMCs). Sustained virologic response was defined by loss of HCV RNA 12 months after the end of treatment.
Four patients (7.8%) were found to be sustained virologic responders, 17 (33.3%) were transient virologic responders, and 30 (58.8%) were virologic nonresponders. No significant difference was found in the median pretreatment serum HCV RNA load between sustained virologic responders, transient virologic responders, and virologic nonresponders. At 1 month after start of therapy, HCV RNA was not detectable with both the serum and the PBMC assay in 12 (23.5%) of 51 patients. Four remained HCV RNA-negative until 12 months after the end of treatment. In 14 of 17 transient virologic responders, reappearance of HCV RNA was detected earlier in PBMCs than in serum.
Based on these results in 51 patients, quantitation of baseline serum HCV RNA does not appear to be a decisive factor to the management of the individual patient. Early assessment of serum HCV RNA level after start of anti-viral treatment seems to be of major importance to identify virologic nonresponders. Reappearance of HCV RNA may be demonstrated earlier in PBMCs than in serum.
确定分子参数在接受抗病毒治疗的慢性丙型肝炎患者中的作用。通过测定血清丙型肝炎病毒（HCV）载量以及外周血单个核细胞（PBMC）中HCV RNA的存在情况来监测抗HCV治疗。
研究设计/方法：对51例接受α干扰素联合利巴韦林抗病毒治疗的慢性丙型肝炎患者进行研究。在治疗前、治疗期间以及治疗结束后长达12个月，采用定量检测法（Amplicor HCV监测检测）检测血清HCV RNA载量。如果检测不到HCV RNA，则随后用定性检测法（Cobas Amplicor HCV检测）检测血清样本，并检查相应的乙二胺四乙酸（EDTA）处理血液中PBMC中HCV RNA的存在情况。持续病毒学应答定义为治疗结束后12个月时HCV RNA消失。
发现4例患者（7.8%）为持续病毒学应答者，17例（33.3%）为短暂病毒学应答者，30例（58.8%）为病毒学无应答者。持续病毒学应答者、短暂病毒学应答者和病毒学无应答者治疗前血清HCV RNA载量中位数无显著差异。治疗开始后1个月，51例患者中有12例（23.5%）血清和PBMC检测均未检测到HCV RNA。4例患者直至治疗结束后12个月仍保持HCV RNA阴性。在17例短暂病毒学应答者中的14例中，PBMC中HCV RNA的重新出现比血清中更早被检测到。
基于这51例患者的结果，基线血清HCV RNA定量似乎不是个体患者管理的决定性因素。抗病毒治疗开始后早期评估血清HCV RNA水平对于识别病毒学无应答者似乎至关重要。HCV RNA的重新出现可能在PBMC中比在血清中更早被证实。
