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

丙型肝炎抗病毒长期治疗以预防肝硬化 (HALT-C)

• 批准号: 7719421
• 负责人: Gregory Thomas Everson
• 金额: $ 1.78万
• 依托单位: UNIVERSITY OF COLORADO DENVER
• 依托单位国家: 美国
• 财政年份: 2008
• 资助国家: 美国
• 起止时间: 2008-04-01 至 2008-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7719421
• 关键词: Adverse effects; Affect; Antiviral Agents; Blood; Blood specimen; Chronic Hepatitis C; Cirrhosis; Clinic Visits; Coin; Computer Retrieval of Information on Scientific Projects Database; Enrollment; Esophagus; Funding; Grant; Hemorrhage; Hepatitis; Hepatitis C; Injection of therapeutic agent; Institution; Interferons; Maintenance; Maintenance Therapy; Malignant neoplasm of liver; Patients; Pharmaceutical Preparations; Phase; Procedures; Quality of life; Questionnaires; Recording of previous events; Research; Research Personnel; Resources; Ribavirin; Risk; Screening procedure; Source; Standards of Weights and Measures; Stomach; Stream; United States; United States Food and Drug Administration; United States National Institutes of Health; Varicosity; Veins; Viral; Visit; Week; follow-up; liver biopsy; prevent

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.

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