Spirulina (FEM-102) Supplement to Chronic Hepatitis B Patients
Spirulina (FEM-102) Supplement to Chronic Hepatitis B Patients
Hepatocellular carcinoma (HCC), listed among lung and breast cancers as the top-ten cancer in
 2016 Taiwan, is the second most prevalent cancer, just one place below colon cancer. Due to
 mass hepatitis B vaccination and the screening and therapeutic plan against hepatitis B and C
 viruses (HBV and HCV, respectively), the incidence of liver cancer drops significantly,
 however, still around twenty out of per hundred thousand population die from liver cancer
 each year. For patients suffering HBV and HCV, the prevention of HCC is a crucial health
 issue.
Hepatocellular carcinoma (HCC), listed among lung and breast cancers as the top-ten cancer in
 2016 Taiwan, is the second most prevalent cancer, just one place below colon cancer. Due to
 mass hepatitis B vaccination and the screening and therapeutic plan against hepatitis B and C
 viruses (HBV and HCV, respectively), the incidence of liver cancer drops significantly,
 however, still around twenty out of per hundred thousand population die from liver cancer
 each year. For patients suffering HBV and HCV, the prevention of HCC is a crucial health
 issue.

 The cause of HCC is mainly related to the hepatitis of HBV or HCV infection and subsequent
 cirrhosis. The population of HBV carrier is over 350 million in the world, three-fourths of
 them live in Asia-Pacific area. Therefore, hepatitis B may be the leading cause of HCC. For
 Taiwanese people born before 1986, the prevalence rate of hepatitis B is extremely high as
 15-20%, and around 80% of HCC patients are also HBV carriers. In the past 20 years, for
 patients suffering with high level of HBV during immune clearance phase, immune residual
 inactive phase, reactivation phase and cirrhosis, our national health insurance cover the
 cost of interferon or other oral anti-virus medicine with defined criteria, dramatically
 lowering the risk of HCC developed from hepatitis B.

 In previous clinical trial, some carriers showed high incidence of HCC when their
 quantitative hepatitis B surface antigen (qHBsAg) is high, especially when it is higher than
 2000 IU/ml. The risk of HCC is still five-fold higher when the serum qHBsAg is above 1000
 IU/ml. Therefore, it's important to explore novel intervention lowering qHBsAg.

 Spirulina, as demonstrated in previous researches in vitro and in animals, can regulate
 immunity, enhance anti-virus activity, lower inflammation response and slower tumor
 progression. Liver function and liver fibrosis is improved by Spirulina as well. In our
 recent clinical trial, hepatitis B patients that received anti-virus medicine orally and was
 supplemented with Spirulina FEM-102 showed lower qHBsAg, reflecting the clearance of cccDNA.
 It might be related to immune modulation against HBV, which is induced by Spirulina.

 Most chronic hepatitis patients do not meet most criteria of intervention according to our
 current guidelines. Since we already confirmed that Spirulina supplement can lower qHBsAg in
 treated patients, in this study we aim to understand whether Spirulina FEM-102, which
 regulate immunity against HBV as shown by the lowered qHBsAg, can lower the risk of HCC
 development of untreated patients.
Inclusion Criteria:

 1. Patients with chronic hepatitis B do not take oral antiviral drugs.

 2. Ages between 20 and 75.

 3. High concentration of qHBsAg. qHBsAg≧1000 IU/ mL

 Exclusion Criteria:

 1. People allergic to seefood.

 2. Pregnancy