A DOSE-DEPENDENT CONTROLLED TRIAL OF HUMAN LYMPHOBLASTOID INTERFERON-ALPHA FOR GENOTYPE 1B CHRONIC HEPATITIS-C ASSOCIATED WITH HIGH HCV-RNALEVELS

The efficacy of interferon (IFN) therapy against hepatitis C is greatl y affected by viral factors such as the level of viremia and the HCV g enotype. The prognosis of those with high serum HCV-RNA levels in geno type Ib is poor. In the present report, we carried out a randomized co ntrolled study of two IFN doses for patients with genotype Ib chronic hepatitis C whose serum HCV-RNA levels were at least 10(6) copies/ml a s determined by multicyclic polymerase chain reaction (PCR) assay. The se patients were randomly divided into two groups. Group A received 6 million units (MIU) of IFN 6 days per week for 8 weeks, followed by th e same dose 3 days per week for 16 weeks (total IFN dose: 576 MIU). Gr oup B received 6 MIU of IFN 6 days per week for 2 weeks, followed by t he same dose 3 days per week for 22 weeks (total IFN dose: 480 MIU). T he number of complete responders was four of 24 (16.6%) in group A and three of 20 (15.0%) in group B. There was no significant difference b etween the groups. On the basis of these findings, it appears that the re is no advantage in lengthening the initial period of consecutive IF N administration to 8 weeks or in increasing the total dose bq 100 MIU for those with genotype Ib hepatitis C and high virus levels. (C) 199 7 Elsevier Science Ireland Ltd.