Division of Gastroenterology, Department of Medicine, Montefiore Medical Center, The Albert Einstein College of Medicine, Bronx, NY, USA.
Hepatology. 2010 Apr;51(4):1137-43. doi: 10.1002/hep.23429.
Randomized controlled trials of hepatitis C virus (HCV) therapy with pegylated interferon and ribavirin have demonstrated sustained viral response rates (SVRs) of 54%-63% (efficacy). Treatment results in clinical practice (effectiveness) may not be equivalent. The goal of this study was to assess the effectiveness of HCV treatment with pegylated interferon and ribavirin in a treatment-naïve, human immunodeficiency virus (HIV)-negative, United States urban population with many ethnic minority patients. We evaluated 2,370 outpatients for HCV therapy from 2001 to 2006 in the Faculty Practice of the Albert Einstein College of Medicine or the attending-supervised Montefiore Medical Center Liver Clinic. Care was supervised by one experienced physician under conditions of everyday clinical practice, and appropriate ancillary resources were made available to all patients. Two hundred fifty-five patients were treated with a mean age of 50 years (60% male, 40% female; 58% Hispanic, 20% African American, 9% Caucasian, 13% other; 68% genotype 1, the remainder genotypes 2 or 3). Patients had at least one liver biopsy. Intention-to-treat analysis (ITT) showed SVR in 14% of genotype 1 patients and 37% in genotype 2/3 patients (P < 0.001). SVR was significantly higher in faculty practice (27%) than in clinic patients (15%) by intention-to-treat (P = 0.01) but not per-protocol analysis (46% faculty practice, 34% clinic). 3.3% of 1,656 treatment-naïve, HIV antibody-negative individuals ultimately achieved SVR. Current hepatitis C therapies may sometimes be unavailable to, inappropriate for, and ineffective in United States urban patients. Treatment with pegylated interferon and ribavirin was less effective in this population than is implied by multinational phase III controlled trials. New strategies are needed to care for such patients.
随机对照试验表明，聚乙二醇干扰素和利巴韦林治疗丙型肝炎病毒 (HCV) 的持续病毒学应答率 (SVR) 为 54%-63%（疗效）。但在临床实践中的治疗结果（有效性）可能并不等同。本研究旨在评估聚乙二醇干扰素和利巴韦林治疗未经治疗、人类免疫缺陷病毒 (HIV) 阴性的美国城市人群中，许多少数民族患者的 HCV 治疗的有效性。我们在 2001 年至 2006 年期间，对艾伯特爱因斯坦医学院附属医院或主治医生监督的蒙蒂菲奥里医疗中心肝脏诊所的 2370 名门诊患者进行了 HCV 治疗评估。在日常临床实践的条件下，由一位经验丰富的医生监督治疗，所有患者都可获得适当的辅助资源。255 名患者接受了治疗，平均年龄为 50 岁（60%为男性，40%为女性；58%为西班牙裔，20%为非裔美国人，9%为白种人，13%为其他族裔；68%为基因型 1，其余为基因型 2 或 3）。所有患者都至少进行了一次肝活检。意向治疗分析（ITT）显示基因型 1 患者的 SVR 为 14%，基因型 2/3 患者的 SVR 为 37%（P < 0.001）。按意向治疗（ITT）分析，教员实践中的 SVR 明显高于诊所患者（27%比 15%，P = 0.01），但按方案分析则无显著差异（教员实践中为 46%，诊所中为 34%）。在 1656 名未经治疗、HIV 抗体阴性的个体中，最终有 3.3%达到 SVR。目前的丙型肝炎治疗方法有时可能无法用于、不适合和对美国城市患者无效。与多国 III 期对照试验所暗示的相比，聚乙二醇干扰素和利巴韦林在该人群中的疗效较低。需要新的策略来为这些患者提供治疗。
