SHO-SAIKO-TO for Patients With Chronic Hepatitis C: A Phase II Study

Chronic hepatitis C affects nearly three million Americans. Of these, 15% will develop liver cirrhosis and approximately 5% will progress to hepatocellular carcinoma. Treatment for chronic hepatitis C is limited to interferon-based therapy. Many patients decline or cannot tolerate interferon because of its serious side effects. Sho-saiko-to, an Asian herbal medicine consisting of seven botanicals, has demonstrated anti-fibrotic affect by inhibition of lipid peroxidation in hepatocytes and stellate cells in an animal study. It has also been demonstrated to prevent progression of cirrhosis to hepatocellular carcinoma in human trials. This study is a single arm, single center trial of Sho-saiko-to in patients with chronic active hepatitis from hepatitis C infection who cannot tolerate or who have specific contraindications to interferon therapy. Patients will receive 52 weeks therapy with Sho-saiko-to. Outcome will be assessed by comparing pre- and posttreatment liver biopsies. Patients will be said to respond if they have an improvement of two points or greater on a standard measure of liver histology. If five or more of 25 evaluable patients respond, Sho-saiko-to will be deemed worthy of further testing.

Inclusion criteria

• Chronic hepatitis C diagnosis, with abnormal liver function tests, positive serology for Hepatitis C antibody, positive viremia as indicated by PCR techniques.
• Age 18 or over
• There must be no plans to use interferon in the following 12 months due to EITHER: a specific contraindication to interferon therapy, including but not limited to:history of depression, or other psychiatric disease, history of autoimmune disease,psoriasis, rheumatoid arthritis, history of renal dysfunction, thyroid abnormalities, seizure disorder, depressed blood cell counts, history of asthma OR patient discontinuation of interferon-based therapy prematurely due to intolerable side effects with sustained active viremia OR patient refusal to take interferon
• Patients must be able to understand and sign informed consent.
• Female participants must agree to practice approved methods of birth control (if applicable).

Exclusion criteria

• Coinfection with hepatitis B as defined by a positive Hepatitis B surface antigen (HBsAg) test.
• Coinfection with HIV
• Patients with alcohol intake >40g day
• Patients with recent myocardial infarction or heart failure.
• Concurrent use of Sho-saiko-to, or any of its constituent plants.
• Concurrent use of interferon containing products.
• Use of interferon-based treatment within the past 6 months.
• Women who are pregnant, nursing, or have the potential to becoming pregnant, unless utilizing birth control. A negative pregnancy test must be documented during the screening period for women of childbearing potential.
• History of malignancy, unless there is currently no evidence of disease and patient completed all surgery, radiotherapy and chemotherapy for that disease a minimum of two years previously
• Concurrent life-threatening illness, for which the prognosis is poor.
• Patients with diffusing capacity on pulmonary testing less than 50% of predicted will be excluded.
• Patients with diffusing capacity on pulmonary testing less than 70% of predicted AND total lung capacity less than 80% of predicted will be excluded.