Traditional Chinese Medicine Combined With Entecavir to Treat Refractory Liver Fibrosis in Liver Cirrhosis Due to HBV

Inclusion Criteria:

• Hepatitis B history or more than 6 months history of positive HBsAg

• Within 2 years of Entecavir treatment, HBV-DNA is negative but has not reach theclinical endpoint (HBeAg seroconversion or HBsAg loss in HBeAg-positive patients;HBsAg loss or anti-HBs seroconversion in HBeAg-negative patients)

• Age 18-60

• Ishak fibrosis score of the biopsy within 6 months ≥5, no anti-fibrosis drug was takenwithin 6 months.

• Child-Pugh<7 (Stage A)

• The patient or the patient's guardian agrees to participate the random controlledtrial and sign the Informed Consent Form.

Exclusion Criteria:

• Decompensated liver cirrhosis

• HCC

• Liver histology conforming to other chronic liver diseases, such as moderate or severenon-alcoholic fatty liver disease(more than 1/3 steatosis in liver ), chronichepatitis C, chronic hepatitis D, autoimmune hepatitis, primary biliary cholangitis,primary sclerosing cholangitis, inherited metabolic liver disease, drug or toxicinduced liver injury, parasitic infections, alcoholic liver disease.

• Have psychiatric history or uncontrollable epilepsy patient.

• Uncontrollable diabetic patient

• History of hemoglobin disease (such as alpha- or beta-thalassemia, sickle celldisease, spherocytosis) or patients with toxic or autoimmune hemolytic anemia.

• Severe background disease like chronic respiratory failure, circulatory failure,kidney failure etc.

• In situ organ transplantation (such as liver, kidney, lung and heart) or bone marrowtransplantation and stem cell transplantation.

• Immunocompromised patients: such as HIV infection or take immunosuppressor orGlucocorticoid (such as cyclosporin, azathioprine, adrenocortical hormone) within 3months or chemotherapy drugs (such as cyclophosphamide, ammonia and cancerchemotherapy) and radioactive therapy.

• Gestation or lactation period women and women who plan to get pregnant during thestudy period.

• Patient who are allergy to the experimental drug.

• Using history of other anti-viral drug within 6 months.

• Patients who are participating other trials.

• Other situation where PI thinks the patient should be excluded.