Hepatitis C virus is an important disease in which 80% of persons with acute infection progress to chronic hepatitis C infection. Our hypothesis is Interferon alfacon-1 therapy administered more frequently or for a longer duration will result in a greater viral response rate (end of treatment) and sustained viral response rate (end of observation) than conventinal interferon therapy in subjects in chronic HCV infection not previously treated with interfon.
Our specific aims are: to compare the efficacy of 9ug interfon-1 administered SC three times per week (TIE) for 72 weeks or 48 weeks, and Interferon alfacon-1 administered SC once daily for 48 weeks. Efficacy is defined by undetectable serum HCV RNA levels 24 weeks following cessatoin of therapy. Serum HCV RNA will be assayed by reverse transcriptase polymerase chain reaction (RT-PCR) analyiss with a sensitivity of < 100 copies/ml. To evaluate the safety and tolerability of 9 ug Interferon alfacon-1 admnistered TIW for 48 and 72 weeks, and the same dosage administered daily for 48 weeks in subjects with chronic HCV infection not previoiusly treated with interferon. To assess response rates of the three groups with respect to undetectable serum HCV RNA and normalization of serum ALT after 12, 24, 48 weeks of treatment. To assess """"""""end of treatment"""""""" response rates of each group as measured by virologic and biochemical response. To assess """"""""end of observation"""""""" response rates as measured by virologic and biochemical response.
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