Fontana Robert J, Kleiner David E, Bilonick Richard, Terrault Norah, Afdhal Nezam, Belle Steven H, Jeffers Lennox J, Ramcharran Darmendra, Ghany Marc G, Hoofnagle Jay H
Department of Internal Medicine, University of Michigan, Ann Arbor, MI, USA.
Hepatology. 2006 Oct;44(4):925-35. doi: 10.1002/hep.21335.
Assessment of histological stage is an integral part of disease management in patients infected with the hepatitis C virus (HCV). The aim of this study was to develop a model incorporating objective clinical and laboratory parameters to estimate the probability of severe fibrosis (i.e., Ishak fibrosis > or = 3) in previously untreated African American (AA) and Caucasian American (CA) patients with HCV genotype 1. The Ishak fibrosis scores of 205 CA and 194 AA patients enrolled in the Viral Resistance to Antiviral Therapy of Chronic Hepatitis C study (Virahep-C) were modeled using simple and multiple logistic regression. The model was then validated in an independent cohort of 461 previously untreated patients with HCV. The distribution of fibrosis scores was similar in the AA and CA patients as was the proportion of patients with severe fibrosis (35% vs. 39%, P = .47). After accounting for the number of portal areas in the biopsy, patient age, serum aspartate aminotransferase, alkaline phosphatase, and platelet count were independently associated with severe fibrosis in the overall cohort, and the relationship with fibrosis was similar in both the AA and CA subgroups. The area under the receiver operating characteristic curve (AUROC) of the Virahep-C model (0.837) was significantly better than in other published models (P = .0003). The AUROC of the Virahep-C model was 0.851 in the validation population. In conclusion, a model consisting of widely available clinical and laboratory features predicted severe hepatic fibrosis equally well in AA and CA patients with HCV genotype 1 and was superior to other published models. The excellent performance of the Virahep-C model in an external validation cohort suggests the findings are replicable and potentially generalizable.
组织学分期评估是丙型肝炎病毒（HCV）感染患者疾病管理的一个重要组成部分。本研究的目的是建立一个纳入客观临床和实验室参数的模型，以估计既往未经治疗的1型HCV基因型非裔美国（AA）和高加索美国（CA）患者发生严重纤维化（即Ishak纤维化≥3）的概率。对参加慢性丙型肝炎抗病毒治疗病毒耐药性研究（Virahep-C）的205例CA患者和194例AA患者的Ishak纤维化评分进行了单因素和多因素逻辑回归建模。然后在一个由461例既往未经治疗的HCV患者组成的独立队列中对该模型进行验证。AA患者和CA患者的纤维化评分分布相似，严重纤维化患者的比例也相似（35%对39%，P = 0.47）。在考虑活检中门静脉区域数量后，患者年龄、血清天冬氨酸转氨酶、碱性磷酸酶和血小板计数在整个队列中均与严重纤维化独立相关，且在AA和CA亚组中与纤维化的关系相似。Virahep-C模型的受试者工作特征曲线下面积（AUROC）为0.837，显著优于其他已发表的模型（P = 0.0003）。Virahep-C模型在验证人群中的AUROC为0.851。总之，一个由广泛可用的临床和实验室特征组成的模型在1型HCV基因型的AA和CA患者中对严重肝纤维化的预测效果同样良好，且优于其他已发表的模型。Virahep-C模型在外部验证队列中的出色表现表明这些发现具有可重复性且可能具有普遍性。
