High-dose interferon therapy in patients with chronic hepatitis C: A biochemical and virologic evaluation

Abstract Sixty patients of both sexes with biopsy-proven chronic hepatitis C were randomized to receive recombinant alpha-2b interferon 3 million IU or 10 million IU three times a week for 4 months. A 6-month follow-up period was scheduled for the end of therapy. Eighteen patients (30.0%) had normalized alanine aminotransferase (ALT) levels at the end of therapy and during the follow-up period. Of these, 10 received 3 million IU (33.3%) and 8 (26.7%) received 10 million IU. Twenty-three (38.3%) of the 60 patients relapsed during the follow-up period. No significant difference in relapse rate was observed between the two groups. The overall percentage of nonresponder patients was 31.7%. Treatment was discontinued because of noncompliance and/or side effects in 7 patients (11.7%), 1 in the 3-million IU group and 6 in the 10-million IU group. All patients were positive for hepatitis C virus—RNA at the beginning of the study, and it became undetectable in almost all responder patients. No correlation between viremia and biochemical signs of liver disease was observed in some cases. No virologic differences were found between the two treatment groups. Our study shows that 10 million IU does not increase the response or the relapse rate compared with 3 million IU in the treatment of patients with chronic hepatitis C.