Poster Presentations

Session Title: VIRAL HEPATITIS - e) HEPATITIS B – CLINICAL (THERAPY, NEW COMPOUNDS, RESISTANCE)
Presentation Date: Apr 25, 2009

A RANDOMIZED DOUBLE-BLIND PLACEBO-CONTROLLED CLINICAL TRIAL ON A CHINESE HERBAL FORMULA (PHYLLANTHUS COMPOUND) IN THE TREATMENT OF CHRONIC HEPATITIS B VIRUS CARRIERS

D.Q. Zhou, J.S. He, G.D. Tong, H. Gao, X.Z. Zhou
Hepatology, Shenzhen Hospital of Traditional Chinese Medicine, Shenzhen, China

Background/ aims: Clinical studies have shown that HBV-infection individuals with ALT values of ＜40-45 IU/mL are at risk of significant liver disease and mortality from related complications, including ALT levels between 20 and 30 IU/mL. Therefore, a considerable numbers of chronic HBV carriers would eventually develop serious complications like liver cirrhosis and hepatocellular carcinoma. Unfortunately, there is no effective therapy approach for these patients for the time being. Chinese herbal Formula has recently shown considerable effects in treating patients who suffer from chronic HBV infection. The aim of this study is to investigate the anti-viral effects of a Chinese Herbal Formula (Phyllanthus Compound) in treating chronic hepatitis B Virus carriers.
Methods: This was a randomized, double-blind, placebo-controlled study. 90 patients enrolled in the study who were satisfied with the following criteria: presence of hepatitis B surface antigen and hepatitis B e antigen, HBV DNA level greater than 7 log₁₀ copies/ml, and normal alanine aminotransferase level (30-40 IU/mL for male, and 20-40 IU/mL for female). They were randomly divided into trial group (n=60) and control group (n=30). During the trial period, patients in both trial group and control group received medication Phyllanthus Compound and a placebo for 48 weeks respectively, 4 capsules per time, 3 times per day.
Result: After treaments, the median decrease in serum HBV DNA levels was 3.4 log₁₀ copies/mL in the trial group and 0.1 log₁₀ copies/mL in the control group (P＜0.01). Serum HBV DNA ＜3log₁₀ copies/mL was observed in 13 of the 60 subjects (21.7%) in the trial group and 1 of the 30 subjects (3.3%) in the placebo group (P＜0.01). The proportion of patients with HBeAg loss was 20% (12/60) and 3.3% (1/30) respectively in the trial group and control group (P＜0.01). The ratio of HBeAg seroconversion to anti-HBe was 15% (9/60) in the trial group and 0% (0/30) in the control group (P＜0.05).
Conclusion: Phyllanthus Compound is effective in inhibiting the copy of hepatitis B virus and increase the ratio of HBeAg seroconversion, which can be used to treat Chronic Hepatitis B Virus carriers.