Efficacy and Safety of Entecavir Maleate Tablets in Chinese Patients With Hepatitis B

Inclusion criteria

• Subjects diagnosed of HBeAg positive or negative chronic hepatitis B
• Aged 18 to 70 years old，male or female
• Patients with previously HBsAg-positive, HBeAg-positive for 24 weeks, HBV-DNA> 105copies/ml. HBeAg-negative for 24 weeks or more, HBV-DNA> 105 copies/ml.
• 1.3 times the upper normal limit (1.3 × ULN) ≤ alanine aminotransferase (ALT) ≤ 10 × ULN.
• Total serum bilirubin (TBIL) ≤ 2.5 × ULN.
• Prothrombin activity (PTA) ≥ 60% or prothrombin time prolonged than normal ≤ 3 seconds).
• WBC ≥ 3.5 × 109 / L, PLT ≥ 70 × 109 / L, serum albumin (ALB)≥ 35 g / L.
• Creatinine (Cr) ≤ 1.5 × ULN.
• If patients take intermittently with interferon, nucleoside (acid) analogues, α1 thymosin before enrollment with 24 weeks, the time is no more than 12 weeks.
• Patients signed an informed consent form and compliance was good.

Exclusion criteria

• Patients were infected with other viruses as HAV, HCV, HDV, HEV, CMV, EBV, HIV etc.
• Patients with cirrhosis or liver cancer.
• Patients have participated in another therapeutic clinical trial in 3 months.
• Granulocyte count <1.5 × 109 / L, hemoglobin (HB)<100g / L, sera alpha-fetoprotein(AFP)> 100μg / L, patients' B ultrasonography pointed space-occupying lesions.
• Patients with severe heart, kidney, endocrine hematopoietic system and neuropsychiatric diseases.
• Patients with metabolic or autoimmune diseases such as systemic lupus erythematosus.
• Pregnant woman, lactating women or those who wre allergic for study drug.