INTRON A MONOTHERAPY VS INTRON A+ RIBAVIRIN FOR TREATMENT OF CHRONIC HEPATITIS C

本研究的主要目的是比较联合治疗（内含子A +利巴韦林）与单独使用干扰素A治疗以前未接受干扰素治疗的慢性丙型肝炎患者的总体活性/有效性和安全性。丙型肝炎几乎占所有输血相关肝炎病例，约占成人散发性急性肝炎所有病例的80%。尽管输血后感染丙型肝炎病毒（HCV）的风险已降至1%以下，尽管随着静脉注射药物相关病例的减少，这种感染的频率已开始下降，但新病例仍在不断发现。在二十年前静脉注射药物的患者中，慢性感染的储存库仍然较大，并且在常规筛查中引起临床注意。在免疫功能正常的成年人中，估计有不到1%的急性乙型肝炎病例进展为慢性肝炎，相比之下，50% - 70%的急性丙型肝炎患者发展为慢性肝炎；即使在那些通过生物化学方法康复的患者中，慢性感染的可能性也很高。因此，慢性肝炎和慢性感染的合并频率接近90%。其他形式的慢性肝炎也是如此，这种疾病通常无症状；然而，潜伏的进展可能会发生。在仅有少量临床和生化异常的情况下，多达20%的慢性输血相关丙型肝炎患者在输血后10年内进展为肝硬化。在肝硬化患者中，患肝细胞癌几十年后存在风险。

The primary objectives of this study are to compare the overall activity/ effectiveness and safety profile of combination therapy (Intron A + ribavirin) with Itron A alone for the treatment of chronic hepatitis C in patients who have not previously been treated with interferon. Hepatitis C accounts for almost all cases of transfusion-associated hepatitis and for approximately 80% of all cases of sporadic acute hepatitis among adults. ALthought the risk of acquiring infection with hepatitis C virus (HCV) after transfution has fallen to under 1% and although the frequency of this infection has begun to decline with a reduction in intravenous drug asociated cases, new cases continue to be discovered. A larger reservoir of chronic infection persists among those who experimented with intravenous drugs two decades ago and come to clinical attention during routine screening. In contrast to the estimated <1% of acoute hepatitis B cases among immunocompetent adults progressing to chronicity, chronic hepatitis develops in 50% - 70% of patients with acute hepatitis C; even among those who recover biochemically, the likelihood for chronic infection is high. Therefore, the combined frequency of both chronic hepatitis and chronic infection approaches 90%. s is true for other forms of chronic hepatitis, this disease if often asymptomatic; yet, insidious progression can occur. In the presence of only minimal clincial and biochemical abnormalities, as many as 20% of patients with chronic transfusion-associated hepatitis C have been observed to progress to cirrhosis within 10 years of transfusion. Among those with cirrhosis, there is a risk after several decades of hepatocellular carcinoma.