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

Inclusion Criteria

• •1. Subjects diagnosed of HBeAg positive or negative chronic hepatitis B
• •2. Aged 18 to 70 years old，male or female
• •3. 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.
• •4. 1.3 times the upper normal limit (1.3 × ULN) ≤ alanine aminotransferase (ALT) ≤ 10 × ULN.
• •5. Total serum bilirubin (TBIL) ≤ 2.5 × ULN.
• •6. Prothrombin activity (PTA) ≥ 60% or prothrombin time prolonged than normal ≤ 3 seconds).
• •7. WBC ≥ 3.5 × 109 / L, PLT ≥ 70 × 109 / L, serum albumin (ALB)≥ 35 g / L.
• •8. Creatinine (Cr) ≤ 1.5 × ULN.
• •9. If patients take intermittently with interferon, nucleoside (acid) analogues, α1 thymosin before enrollment with 24 weeks, the time is no more than 12 weeks.
• •10. Patients signed an informed consent form and compliance was good.