Nucleoside (Acid) Analogues Treatment in Patients With Normal ALT and Positive HBVDNA.

Study on Therapeutic Effects and Safety of Nucleoside (Acid) Analogues Treatment in Patients With Chronic Hepatitis B With Normal Alanine Aminotransferase and Positive Hepatitis B Virus DNA: a Randomized Controlled Trial

This study is to investigate the clinical efficacy and safety of Nucleoside (acid) analogues treatment in patients with normal Alanine Aminotransferase and positive Hepatitis B virus DNA.

Hepatitis b virus infection has always been a global public health problem that endangers national health. Current clinical guidelines do not recommend antiviral therapy for people with positive hepatitis b-DNA and normal Alanine Aminotransferase, but studies have found that viral replication is associated with an increased risk of cirrhosis and liver tumors. Nucleoside (acid) analogues can effectively inhibit viral reverse transcriptase, reduce HBV viral load in the blood, thereby reducing secondary inflammation, and contribute to liver cell regeneration and disease recovery. And its side effect is small, adverse reaction rate is low, use safety.

Inclusion Criteria:

• Positive hepatitis b surface antigen and hepatitis b antibody > 0.5 year;
• Age from 18 to 65 years old;
• Serum Alanine Aminotransferase(ALT) ≤1×ULN at least 12 weeks;
• Positive Hepatitis b virus(HBV);
• Do not receive nucleotide/nucleoside analogues or interferon treatment in the past half year.

Exclusion Criteria:

• Other active liver diseases;
• Hepatocellular carcinoma or other malignancy;
• Pregnancy or lactation;
• Human immunodeficiency virus infection or congenital immune deficiency diseases; 5.Severe diabetes, autoimmune diseases; 6.Other important organ dysfunctions; 7.Using glucocorticoid; 8.Patients can not follow-up; 9.Investigator considering inappropriate.