TREATMENT OF CHRONIC HEPATITIS C W/ COMBINATION OF INTERFERON PLUS

确定慢性丙型肝炎患者复发后，干扰素和利巴韦林联合治疗是否比单独使用干扰素治疗更有效。干扰素-a-2b（内含子-a）是目前唯一被证实对丙型肝炎（HCV）患者有效的药物。在美国，HCV是慢性病毒性肝炎最常见的病因，困扰着近400万人。这些患者在15-30年间有发展为进行性肝损伤和肝硬化的风险。由于干扰素的局限性，人们一致认为需要额外的药物治疗，抗病毒药物利巴铁可能对预防最初对干扰素治疗有反应的患者复发非常有益。先前的研究表明，33-50%接受干扰素治疗的患者对治疗产生了反应。当患者联合使用干扰素和利巴韦林治疗时，停药后复发率从80-90%下降到40-60%。尽管使用这两种药物治疗后，长期持续反应有所改善，但仍有许多未解之谜。本研究的目的是：a)确定在前一个疗程的干扰素治疗后复发的患者在干扰素和利巴韦林联合治疗后是否能达到长期持续缓解；b)确定在干扰素和利巴韦林再次治疗期间获得与病毒感染相关的缓解的患者，在单独使用利巴韦林6个月后，长期持续缓解的比率是否会增加。将有150名患者参加这项研究。他们必须符合有关治疗时间和剂量以及与丙型肝炎病毒有关的其他因素的特定标准。所有患者都将接受干扰素-a-2b治疗，剂量与过去患者获得应答时相同。所有患者都将接受利巴韦林治疗。所有在联合治疗6个月后达到疗效的患者将被随机分为两组，一组继续使用两种药物，另一组继续使用利巴韦林6个月以上。随访24个月或直至复发。

To determine if the treatment of patients with chronic hepatitis C, after they have relapsed, with a combination of interferon and ribavirin, is more effective than treatment with interferon alone. Interferon-a-2b (Intron-A) is the only current medication with proven effective results in patients with hepatitis C (HCV). HCV is the most common cause for chronic viral hepatitis in the United States, plaguing nearly four million people. These patients are at risk for development of progressive liver damage and cirrhosis over a 15-30 year span. Because of the limitations of interferon, it was agreed upon that additional medications are needed and that the ribaviron, an anti-viral agent, may be very beneficial in preventing relapse in patients who initially responded to interferon therapy. Previous studies showed that 33-50% of patients treated with interferons achieved response to therapy. When patients were treated with a combination of interferon and ribavirin, relapse following discontinuation of therapy decreased from 80-90% to 40-60%. Despite the improvement in long term sustained response, following treatment with the two medications, there are many unanswered questions. The aims of this study are a) to determine if patients who relapse following a previous course of interferon therapy can achieve long term sustained response following treatment with the combination of interferon and ribavirin, and b) to determine if patients who achieve response relating to the viral infection during re-treatment with interferon and ribavirin will have an increased rate of long term sustained response when ribavirin is continued alone for an additional six months. There will be 150 patients enrolled into this study. They must meet specific criteria concerning length and dosage of therapy and other factors related to HCV. All patients will be treated with interferon-a-2b at the identical dose as when they achieved response in the past. All patients will be treated with ribavirin. All patients who achieve response after six months of the combination therapy will then be randomized to enter one of two groups, one to continue both medications, and the other to continue only ribavirin for six more months. Follow up will take place for 24 months or until relapse.