The efficacy of a herbal medicine (Mao-to) in combination with intravenous natural interferon-β for patients with chronic hepatitis C, genotype 1b and high viral load: A pilot study

Patients with chronic hepatitis C, with a high serum viral load (≥1Meq/ml) and genotype 1b seem to be resistant to interferon (IFN)therapy. To evaluate the efficacy of a herbal medicine (Mao-to) in combination with natural IFN-β for the treatment of these patients, eighteen Japanese patients were enrolled in this study. Every patient received 6 million units (MU) of IFN-β intravenously daily for 8 weeks. Mao-to was given orally 3-4 times a day during the IFN-β administration, Sixteen of the 18 patients (89%) became negative for serum HCV RNA at the end of treatment, but only 2 of them (11%) remained negative for the virus RNA at 6 months of follow-up. Serum ALT levels normalized in 17 patients (94%) at 2 weeks of follow-up after the cessation of therapy, and 11 patients (61%) retained normal ALT levels for more than 6 months of follow-up. This rate of biochemical response was high as compared with that of therapy with IFN-β alone (19%) in the largest IFN-β trial in Japan. Serum hyaluronic acid levels were decreased significantly from 147.0 ± 110.5 ng/ml to 77.4 ± 67.4 ng/ml in the sustained biochemical response group (P = 0.003). None of the patients needed to interrupt therapy because of side effects of IFN-β. Thus, Mao-to administration together with IFN-β treatment could increase the sustained biochemical response rate, and reduce liver fibrosis.