OPTIMUM PATIENT POPULATION AND DOSING REGIMEN FOR TREAMENT OF HEPATITIS C

试图确定人体免疫系统因素对慢性丙型肝炎自然发展及其对干扰素治疗反应的影响。丙型肝炎病毒（HCV）是引起慢性肝炎的最常见的病毒。近40%的慢性肝炎病例继发于慢性HCV。高达77%的HCV感染者最终会发展为肝硬化（瘢痕形成）。这成为肝移植最常见的单一适应症，也被认为是整个西方世界肝癌的主要原因。丙型肝炎病毒的疾病进展不同的人。有些患者会在15年内发展成肝硬化，而有些患者会在20 - 50年内发展成肝硬化，或者根本不发展。 解释这种可变进展速度的可能理论是病毒因素和每个患者的免疫系统工作方式。目前，免疫系统如何识别和应答HCV尚不清楚。这是一项初步研究，将试图确定免疫因素，这可能是重要的进展，慢性丙型肝炎肝硬化和干扰素治疗的调节反应。本研究的受试者必须有慢性丙型肝炎的记录。必须进行肝脏活检，以确定在服用药物之前肝脏中存在多少炎症和/或瘢痕组织。将进行几项血液检查以检查肝脏和其他器官，并进行丙型肝炎测试。如果肝脏内存在慢性肝炎病毒，则受试者将是干扰素治疗的候选者。然后将通过注射给药6个月。结果可能是完全缓解（在治疗结束时酶检测正常）、无缓解或复发缓解（显示初始缓解但在停止治疗后酶升高）。 为了确定受试者的肝脏是否对干扰素有反应，受试者将再进行三次活组织检查。

An attempt to determine the effect of factors of the body's immune system on the natural development of Chronic Hepatitis C and its response to interferon therapy. It is recognized that Hepatitis C virus (HCV) is the most common cause of chronic hepatitis. Nearly 40% of all cases of chronic hepatitis are secondary to chronic HCV. Up to 77% of people with HCV will eventually develop cirrhosis (scarring) of the liver. This becomes the single most common indication for liver transplantation and is also recognized as a major cause of liver cancer throughout the western world. The disease of HCV progresses differently in people. Some patients will develop cirrhosis within 15 years, whereas some develop it within a 20 - 50 year period, or not at all. Possible theories to explain this variable rate of progression are viral factors and the way the immune system works in each patient. At the present time, it is not known how the immune system recognizes and responds to HCV. This is a pilot study which will attempt to identify the immune factors which may be important in the progression of chronic HCV to cirrhosis and in modulating response to interferon therapy. Subjects of this study must have documented chronic hepatitis C. A liver biopsy must be done to determine how much inflammation and/or scar tissue is present in the liver prior to taking the medication. Several blood tests will be done to check the liver and other organs, and a test for Hepatitis C will be done. If the chronic hepatitis virus is present within the liver, the subject will be a candidate for the interferon therapy. The medication will then be administered by injection for six months. The results may be complete response which will bring normal enzyme tests at the end of the therapy, no response, or relapse response which shows an initial response but elevated enzymes after discontinuation of therapy. To determine if the liver of the subject has responded to the interferon, the subject will undergo three more biopsies.