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 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 be randomized in a 2:1 ratio to receive either 9 mcg or 15 mcg of Infergen daily for 48 weeks. HCV RNA will be checked at 30 days. If HCV RNA levels have decreased by 1 log compared to pretreatment levels, patients will continue treatment. If HCV RNA levels are not decreased by 1 log compared to pretreatment levels in patients already receiving 15 mcg daily, patients will continue treatment. At 90 days, HCV RNA levels will be reassessed for all patients. If patients are currently receiving 9 mcg and viremia is present, these patients will increase to 15 mcg daily. If viremia continues in patients already receiving 15 mcg daily, treatment will be discontinued and patients will be offered therapy off protocol. Patients who respond will continue therapy for a total of 48 weeks. Treated patients will have failed previous therapy (relapser or nonresponder) with Interferon alone or Interferon plus Ribavirin. 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. The objective of this study is to compare the effects and safety of different experimental doses of Infergen in patients who have Hepatitis C and failed therapy or relapsed after therapy with Interferon.

National Institute of Health (NIH)
National Center for Research Resources (NCRR)
General Clinical Research Centers Program (M01)
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Tulane University
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