Chronic viral hepatitis b
Conditions
Interventions
Entecavir group:On the first day after enrollment, entecavir dispersible tablets were used, 1 tablet/time, once a day, orally.
Interferon group:Long acting interferon (PegIFN -2a) 180ug, once a week, subcutaneous injection, total course of treatment for 48 weeks.
Sequential treatment group:Long acting interferon (PegIFN -2a) 180ug, once a week, subcutaneously injected, changed to entecavir dispersible tablets after 24 weeks, 1 tablet/time, once a day, orally,
Sponsors
Department of Infection, the First Affiliated Hospital of Nanchang University
Eligibility
Sex/Gender
All
Age
18 Years to 50 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18 and <50 years; 2. Patients who meet the diagnostic criteria of chronic viral hepatitis b and need antiviral treatment; 3. Hbeag-positive chronic hepatitis b patients, HBV DNA= 1.0×10^6 copy/mL 4. No previous antiviral treatment; 5. Signing the informed consent.
Exclusion criteria
Exclusion criteria: 1. Pregnant or lactating women; 2. Combined with active liver a, c, d (where appropriate), e and/or HIV infection; 3. Nervous system diseases and abnormal mental state; 4. Contrainuations of IFN treatment (e.g., total bilirubin 10 upper limit of normal value, neutrophil count 5). Child-pugh >5 means that patients will be excluded if: Serum albumin 34 mol/L; Has a history of hepatic encephalopathy; A history of esophageal variceal bleeding; ascites. 7. Patients with symptoms and signs of hepatocellular carcinoma (HCC), AFP>100ng/ml, were excluded, but patients whose AFP remained stable (less than 10% growth) for more than 3 months before the trial were eligible for inclusion. Patients with liver tumors excluded by liver imaging were eligible for inclusion if AFP> was 20 ng/mL but less than or equal to 100 ng/mL. 8. Neutrophil count 1:100. 11. History of severe seizures or current use of anticonvulsants. 12. History of immune diseases (such as inflammatory bowel disease, idiopathic thrombocytopenic purpura, lupus erythematosus, autoimmune hemolytic anemia, scleroderma, rheumatoid arthritis, etc.). 13. A history of chronic lung disease associated with functional limitations. 14. History of severe heart disease (e.g. NYHA function level III or IV, myocardial infarction within 6 months, ventricular tachyarrhythmia requiring continued treatment, unstable angina or other important cardiovascular disease). 15. Other evidence of organ transplantation or of serious disease, malignancy, or any other condition considered inappropriate by the investigator for the purpose of this study. 16. A history of poorly controlled thyroid disease with prescription drugs, elevated thyrotropin accompanied by elevated thyroid peroxidase antibodies, and clinical manifestations of any thyroid disease. 17. History of severe retinopathy or clinically related eye disease (e.g. due to hypertension or diabetes, CMV retinitis, macular degeneration, high myopia). 18. Within the first 6 months of inclusion, patients consumed more than 20g of alcohol per day (female) or 30g per day (male). 19. There was evidence of substance abuse or methadone use in the year prior to study inclusion. 20. Patients who are participating in other trials or have been treated with the study drug during the first 12 weeks of screening. 21. Patients with allergy history to interferon, entecavir and tenofovir esters; In addition to the above exclusion criteria, patients who meet any contraindications in the instructions of the experimental drugs.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| HBV-DNA Turn the negative rate;HBeAg Turn the negative rate;Liver function index;HBVDNA;AFP;blood routine examination; | — |
Countries
China
Contacts
Public ContactWu Xiaoping
Department of Infection, The First Affiliated Hospital of Nanchang University
Outcome results
None listed