STUDIES OF THE NATURAL HISTORY AND TREATMENT OF CHRONIC HEPATITIS C

慢性丙型肝炎的自然史和治疗的研究

• 批准号: 6289821
• 负责人: JAY H. HOOFNAGLE
• 金额: --
• 依托单位: NATIONAL INSTITUTE OF DIABETES AND DIGESTIVE AND KIDNEY DISEASES
• 依托单位国家: 美国
• 资助国家: 美国
• 起止时间: 至
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/6289821
• 关键词: chronic disease /disorder; clinical research; combination chemotherapy; drug screening /evaluation; hepatitis C; hepatitis C virus; human subject; human therapy evaluation; interferon alpha; liver disorder chemotherapy; ribavirin; transaminases; virus RNA

Patients with well-documented chronic hepatitis C are being evaluated to determine the long-term natural history and evaluate therapies of this common form of chronic liver disease. Previous studies have shown that alpha interferon therapy has a short-term beneficial effect in approximately 50 per cent of patients. This response is sustained in approximately 10-15 per cent after stopping interferon. A randomized, placebo-controlled trial of ribavirin showed that a 1 year course of this nucleoside analogue is associated with significant improvement in serum aminotransferase activities and in hepatic lobular necrosis despite unchanged serum levels of HCV RNA. Continous ribavirin therapy for up to 2 years demonstrated the practicality of long term supressive therapy in this disease. A higher sustained response rate occurs with the combination of interferon and Ribavirin. A controlled trial of long term ribavirin immunotherapy is now underway; patients who do not respond to a standard 6-month course of interferon and ribavirin and treated with either ribavirin or placebo immunotherapy and assessed for histologic improvement. Sixty patients have enrolled in this study. The natural history of hepatitis C is evaluated in a study in which patients are monitored for biochemical and virologic tests and underwent repeat liver biopsies after 5 years. Immunological and virological assessment of the serum and liver tissue is focused on elucidating the pathogenesis of disease and the determinants of recovery. - Antiviral/Interferon/Ribavirin/Combination Therapy - Human Subjects

正在评估患有据可查的慢性丙型肝炎的患者，以确定这种常见形式的慢性肝病的长期自然病史并评估疗法。先前的研究表明，α干扰素治疗在大约50％的患者中具有短期有益作用。停止干扰素后，这种反应以约10-15％的速度持续。一项随机的，安慰剂对照试验的利巴韦林试验表明，该核苷类似物的1年过程与血清氨基转移酶活性的显着改善以及尽管血清血清HCV RNA的水平不变，但在血清氨基转移酶活性的显着改善中。最多2年的持续利巴韦林疗法证明了这种疾病中长期崇高治疗的实用性。干扰素和利巴韦林的组合发生较高的持续响应率。长期利巴韦林免疫疗法的对照试验正在进行中；对干扰素和利巴韦林不反应的患者，并接受了利巴韦林或安慰剂免疫疗法的治疗，并评估了组织学改善。六十名患者已入学这项研究。在一项研究中评估了丙型肝炎的自然病史，该研究对患者进行了生化和病毒学检查的监测，并在5年后进行了重复的肝活检。血清和肝组织的免疫学和病毒学评估集中于阐明疾病的发病机理和恢复的决定因素。 - 抗病毒/干扰素/利巴韦林/联合疗法 - 人类受试者