Different Regimens of Pegylated Interferon and Lamivudine Combination Therapy in Chronic Hepatitis B Patients

Inclusion Criteria: HBsAg positive for at least 6 months prior to screening Serum HBV-DNA > 10^6 copies per ml at screening Serum HBeAg positive at screening Abnormal ALT (1.3-10x upper limit normal) within one month prior to entry Compensated liver disease with the following minimum criteria: Hemoglobin within range & not less than 10% from lower normal limit WBC >= 4,000/mm3 Platelets >= 100,000/mm3 Bilirubin normal (except for Gilbert's disease). Albumin stable and normal Serum creatinine normal or not more than 10% above the upper normal limit Thyroid Stimulating Hormone (TSH) within normal limits (Patients requiring medication to maintain TSH levels in the normal range are eligible if all other inclusion/exclusion criteria are met.) Alfa-fetoprotein in normal range (obtained within the previous year, or if elevated and < 500 ng/ml with a negative ultrasound for hepatocellular carcinoma at screening). Written informed consent Exclusion Criteria: Co-infection with hepatitis C virus and/or HIV Evidence or history of decompensated liver disease Child's B cirrhosis Ascites, bleeding varices, spontaneous encephalopathy Hypersplenism (hemoglobin, white cell count, platelet outside inclusion criteria) Coagulopathy (PT > 13 sec) Any known pre-existing medical condition that could interfere with the patient's participation in and completion of the treatment such as: Pre-existing psychiatric condition, especially severe depression, or a history of severe psychiatric disorder. Patients on anti-depressant therapy are excluded CNS trauma or active seizure disorders requiring medication Poorly controlled diabetes mellitus Immunologically mediated disease (e.g., inflammatory bowel disease (Crohn's disease, ulcerative colitis, idiopathic thrombocytopenic purpura, lupus erythematous, autoimmune hemolytic anemia, scleroderma, severe psoriasis, rheumatoid arthritis). Clinical gout ANA > 1:320 documentation that women of childbearing potential are using contraception. A serum pregnancy test obtained within two weeks prior to initiation of treatment must be negative. Female patients must not be breast feeding. Any known history of hypersensitivity to nucleoside analogues or interferon Previous use of interferon, lamivudine, immunosuppressive drugs or corticosteroid Subjects with clinically significant retinal abnormality Substance abuse, such as alcohol (>80 g/day), iv drugs and inhaled drugs. If the subject has a history of substance abuse, to be considered for inclusion into the protocol, the subject must have abstained from using the abused substance for at least 2 years. Subjects receiving methadone within the past 2 years are also excluded. Subjects not willing to be counseled/abstain from the consumption of alcohol