Prospective study of a high-intensity interferon-alpha regimen for chronic hepatitis C virus genotype 1b infection

BACKGROUND/AIMS: To evaluate efficacy of high-intensity interferon administration for patients chronically infected with hepatitis C virus genotype 1b, we administered interferon-alpha with different regimens according to viral load. METHODOLOGY: Eighty-eight patients with hepatitis C virus genotype 1b were treated with recombinant interferon alpha-2b. The 70 patients with pretreatment hepatitis C virus RNA concentration > or = 10(6) copies/mL were given 10(7) units of interferon daily for the first 8 weeks and then three times weekly for 16 weeks (group A). The 18 patients with smaller pretreatment hepatitis C virus RNA concentration received the same dose daily for the first 2 weeks and then three times weekly for 14 weeks (group B). We analyzed tolerance of therapy, responses, and long-term outcome in the two groups. RESULTS: Fifteen of 70 patients (21.4%) in group A could not continue treatment and dropped out, while all patients in group B completed the entire course of therapy. The rate of sustained response in group A was 10.0%, being significantly less than in group B (72.2%; p < 0.0001). However, 12 patients in group A showed a biochemical sustained response despite presence of viremia. Long-term outcome did not differ between groups. CONCLUSIONS: Many patients could not tolerate high-intensity therapy, which showed the limitation of tolerance of patients receiving interferon monotherapy. High-intensity therapy could not improve eradication of hepatitis C virus in patients with high pretreatment hepatitis C virus RNA concentration. However, this therapy may increase the rate of sustained biochemical response, improving long-term outcome.