HEPATITIS C ANTIVIRAL LONG-TERM TREATMENT TO PREVENT CIRRHOSIS (HALT-C)

本子项目是利用由NIH/NCRR资助的中心赠款提供的资源的众多研究子项目之一。子项目和研究者（PI）可能已经从另一个NIH来源获得了主要资金，因此可以在其他CRISP条目中表示。列出的机构是中心的，不一定是研究者的机构。在美国，丙型肝炎影响了大约400万人，在一些患者中，丙型肝炎会在多年后导致肝硬化和肝癌。干扰素单独或与第二种抗病毒药物利巴韦林联合治疗已被美国食品和药物管理局批准，现在被认为是慢性丙型肝炎的标准治疗方法。干扰素的一种缓释形式，称为聚乙二醇干扰素，在血液中停留一周，比单独使用干扰素效果更好，需要注射的次数更少。目前的研究针对之前接受过治疗但未能清除丙型肝炎的患者，符合入组标准的患者将首先接受聚乙二醇干扰素加利巴韦林的联合治疗。对这种治疗有反应的患者将接受整整一年的治疗。联合治疗24周后无反应者将进入维持治疗的研究。无应答者将被平均分配（通过类似于抛硬币的程序）到使用聚乙二醇干扰素维持（治疗）或不治疗（观察）。治疗组和观察组的随访相同，需要3个月的随访，为期3年半，随访6个月。每次访问将包括病史、检查、生活质量问卷和抽血。肝活检将在初始阶段开始后的2年和4年进行。有些病人会接受食管和胃的内窥镜检查，看是否有静脉曲张、大静脉出血的危险。所遇到的风险可能包括研究药物的副作用，涉及血液样本的获取，以及在第2年和研究结束时的肝脏活检。在整个研究过程中，患者将被要求参加两次筛查访问，外加常规间隔的门诊访问。

This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. Hepatitis C affects about 4 million people in the United States and leads to cirrhosis and liver cancer after many years, in some patients. Treatment with interferon, alone or in combination with a second anti-viral agent ribavirin has been approved by the Food and Drug Administration and is now considered standard therapy for chronic hepatitis C. A slow release form of interferon, called PEG-interferon, remains in the blood stream for one week and gives better results than interferon alone, with fewer injections required. The present study is aimed at patients who have received previous treatment and failed to clear hepatitis C. Patients who meet entry criteria, and are enrolled in the trial, will first be treated with the combination of PEG Interferon plus ribavirin. Responders to this treatment will be given a full one year of therapy. Nonresponders, after 24 weeks of the combination treatment, will be entered into the study of maintenance therapy. Nonresponders will be evenly assigned (by a procedure similar to the toss of a coin) to either maintenance with PEG Interferon (treatment) or no treatment (observation). Follow-up will be identical for the treatment and observation groups and will require 3-monthly visits for 3 1/2 years with 6 months follow-up. Each visit will include history, exam, quality-of-life questionnaire, and blood drawing. Liver biopsies will be performed at two and four years following start of the initial phase. Some patients will undergo endoscopic examination of the esophagus and stomach for varices, large veins at risk for bleed. Risks encountered may include side effects of study medications, that involved in obtaining blood samples, and that of liver biopsy at year 2 and at end of study. Patients will be required to attend two screening visits, plus clinic visits at routine intervals over the entire course of the study.