A double-blind randomized controlled study to evaluate the efficacy of low-dose oral interferon-alpha in preventing hepatitis C relapse

Abstract

Low-dose oral interferon could exert immune-modulating effects in human. We conducted a clinical trial to investigate the efficacy of oral interferon-alpha in preventing hepatitis C relapse. Totally 169 genotype 1b chronic hepatitis C patients having achieved end-of-therapy virological clearance were randomized to receive interferon-alpha lozenge 500 IU/day (n=59), 1,500 IU/day (n=53), or placebo (n=57) for 24 weeks. Overall, no significant differences were found for the relapse rates in the 3 groups (P>0.05). However, in patients with fibroindex 1.4-1.7, relapse occurred in 1/12 (8.3%) 500 IU-group patients versus 9/21 (42.9%) patients of the other groups (P=0.05). In 158 patients receiving at least 4 weeks of oral interferon, significantly higher platelet count was found at the end of trial in the 500 IU group (P=0.003). In thrombocytopenic patients, a significantly expedited recovery of platelet count was found in the 500 IU group (P=0.002). No drug-related severe adverse events were reported. In conclusion, at 500 IU/day, oral interferon exerted a borderline suppression effect of virological relapse in chronic hepatitis C patients with mild liver fibrosis. Additionally, it significantly expedited platelet count recovery after the end of peginterferon therapy.

Trial registration: ClinicalTrials.gov NCT00695019.

Figures

FIG. 1.

Clinical trial design. Hepatitis C patients infected with genotype 1b and received pegylated interferon plus ribavirin (P+R) treatment were included, provided that virological clearance was achieved at the end of therapy. Oral interferon was given for 24 weeks (low dose 500 IU/day, high dose 1,500 IU/day, or placebo) followed by 24 weeks of follow-up.

FIG. 2.

Progressive increase of platelet count in patients receiving at least 4 weeks of oral interferon. Black circle, low dose 500 IU/day; purple triangle, high dose 1,500 IU/day; blue diamond, placebo. Vertical lines, standard deviation.