Lamivudine Extending Therapy in Chronic Hepatitis B Patients After 3-year of Oral Antiviral Agents

Exclusion Criteria

• •1. Women with ongoing pregnancy or breast feeding
• •2. Therapy with any systemic anti-neoplastic or immunomodulatory treatment (including supraphysiologic doses of steroids and radiation) \*6 months prior to the first dose of study drug
• •3. Any investigational drug \*6 weeks prior to the first dose of study drug
• •4. Co-infection with active hepatitis A, hepatitis C and/or human immunodeficiency virus (HIV)
• •5. Patients who have virological evidence of Lamivudine-associated YMDD mutants.
• •6. Patients who have clinical evidence of liver cirrhosis or hepatocellular carcinoma.
• •7. History or other evidence of a medical condition associated with chronic liver disease other than HCV (e.g., hemochromatosis, autoimmune hepatitis, metabolic liver disease, alcoholic liver disease, toxin exposures)
• •8. Signs or symptoms of hepatocellular carcinoma
• •9. History or other evidence of bleeding from esophageal varices or other conditions consistent with decompensated liver disease
• •10. Neutrophil count \<1500 cells/mm3 or platelet count \<90,000 cells/mm3 at screening
• •11. Serum creatinine level \>1.5 times the upper limit of normal at screening
• •12. History of severe psychiatric disease, especially depression. Severe psychiatric disease is defined as treatment with an antidepressant medication or a major tranquilizer at therapeutic doses for major depression or psychosis, respectively, for at least 3 months at any previous time or any history of the following: a suicidal attempt, hospitalization for psychiatric disease, or a period of disability due to a psychiatric disease
• •13. History of a severe seizure disorder or current anticonvulsant use
• •14. History of immunologically mediated disease, chronic pulmonary disease associated with functional limitation, severe cardiac disease, major organ transplantation or other evidence of severe illness, malignancy, or any other conditions which would make the patient, in the opinion of the investigator, unsuitable for the study
• •15. Evidence of drug abuse (including excessive alcohol consumption) within one year of study entry
• •16. Inability or unwillingness to provide informed consent or abide by the requirements of the study