Low-dose oral interferon-alpha in the treatment of chronic viral hepatitistype B: A double-blind, randomized, placebo-controlled, clinical trial

Objective: To assess the efficacy of low-dose oral human interferon-alpha ( LDO-IFN) (MR-22A) in the treatment of chronic viral hepatitis type B, Methods: One of 4 doses (single tablet: 50 IU, 150 IU, 450 IU, 900 IU) of M R-22A or a single tablet of placebo was administered through the oral mucos a once daily for 24 weeks. Results: At the end of the administration period, the proportion of patient s who had become hepatitis B virus (HBV)-DNA negative was 6 (20.0%) of 30 i n the placebo group, 4 (12.9%) of 31 in the 50-IU group, 6 (18.8%) of 32 in the 150-IU group, 2 (6.9%) of 29 in the 450-IU group, and 4 (16.0%) of 25 in the 900-IU group. The proportion of patients who had become hepatitis B e antigen (HBeAg) negative was 5 (17.9%) of 28, 4 (14.8%) of 27, 5 (16.7%) of 30, 4 (14.8%) of 27, and 1 (5.3%) of 19, respectively. None of the diffe rences were statistically significant between the treatment and placebo gro ups in the proportion of patients who became HBV-DNA negative or HBeAg nega tive. No statistically significant differences were observed in patients gi ven LDO-IFN or placebo in improvement of liver function. Adverse drug react ions were observed in 4(12.5%) of 32 patients in the placebo group, 8 (24.2 %) of 33 in the 50-IU group, 10 (30.3%) of 33 in the 150-IU group, 10 (29.4 %) of 34 in the 450-IU group, and 7 (21.9%) of 32 in the 900-IU group. One patient in the 50-IU group experienced moderate urticaria; all other advers e events were mild. Conclusion: LDO-IFN was not shown to be clinically effective in the treatme nt of chronic viral hepatitis type B with the route of administration, dosi ng levels, and methods of assessment used in this study.