Hepatitis C Virus (HCV) is now recognized as the responsible agent in the majority of cases of Non-A Non-B Hepatitis. The potential impact of HCV infection is staggering. It is estimated that 4 million Americans are infected with the virus, and 8-10,000 deaths are attributable to sequelae of HCV infection. Most patients are minimally symptomatic when acutely infected, however, more than 50% of patients develop chronic hepatitis or progress to cirrhosis and 15% develop hepatocellular carcinoma. Several aspects of HCV infection explain its chronicity: 1) the quasi-species nature of HCV infection (simultaneous infection with multiple different genotypes, replication competent and incompetent virus) leads to both antibody production which is not protective, and ineffective response to anti-viral therapy, and 2) because of the relatively asymptomatic nature of infection and the prolonged period before diagnosis, many patients infected with HCV have significant hepatocellular disease when initially diagnosed, and are thus less likely to respond to therapy. It is apparent that the optimum therapy for HCV has not yet been determined. Interferon combined with other medications, high dose and daily dose Interferon, as well as consensus interferon preparations that contain multiple species of interferon have been utilized to treat HCV. Patients with positive serum HCV antibody, elevations of serum ALT and AST greater than 1.5 x normal, HCV RNA greater than 1,000 copies/ml and evidence of injury consistent with HCV infection on biopsy will receive 15mcg of Infergen daily for 4 weeks. Following this induction period, patients will be randomized to receive either 15 mcg or 9 mcg of Infergen every other day. HCV RNA will be checked at 12 weeks. If HCV RNA is positive at week 12, the patient will be removed from the study and offered therapy off protocol. Treated patients will be naive to previous therapy with any interferon preparation. The endpoints of therapy will be normalization of serum transaminases (ALT and AST) at the end of the 24 week post-treatment observation period (week 72), undetectable serum HCV RNA at the end of a 24 week post-observation period (week 72), and improvement in liver histology. This study will determine the effect of treatment with Infergen given daily for a four week induction period followed by an every other day dosing schedule.
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