Chronic hepatitis B virus infection
Conditions
Interventions
The prefuvir mesylate group:None
Tenofovir Disoproxil Fumarate Group:None
Sponsors
The Second Affiliated Hospital of Xi'an Jiaotong University
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: (1) All patients gave informed consent to participate in this study and signed the informed consent form; (2) Age range: 18 to 65 years old, gender not restricted; (3) Meet the clinical diagnosis of CHB; (4) At the screening stage, HBsAg remained positive for at least 6 months; (5) Newly diagnosed patients: Newly diagnosed patients who meet the indications for antiviral treatment; Re-treatment patients (treated with NAs for at least 48 weeks): CHB re-treatment patients who have received antiviral treatment but have poor efficacy or have already encountered renal or bone safety issues and need to switch medications.
Exclusion criteria
Exclusion criteria: (1) There is evidence suggesting liver cell carcinoma or serum alpha-fetoprotein (AFP) > 100 g/L; (2) There are obvious signs of liver dysfunction such as ascites, hepatic encephalopathy, rupture and bleeding of esophageal and gastric fundus varices; (3) Platelet count (PLT) 2.5 times the upper limit of normal (ULN); (4) Complicated with active hepatitis caused by hepatitis C or D virus infection, AIDS, autoimmune hepatitis or other reasons; (5) Has a history of allergy to nucleosides or nucleoside analogues; (6) Complicated with severe cardiopulmonary dysfunction, advanced tumors, central nervous system (if there is a history of epilepsy) or other systemic diseases; (7) Complicated with neurological or mental disorders and unable to cooperate or unwilling to cooperate; (8) Pregnant or lactating women or those with a recent fertility plan; (9) Unable to agree or unlikely to complete the 2-year follow-up after being selected.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| HBV DNA negative conversion rate;The reduction in HBV DNA load; | — |
Secondary
| Measure | Time frame |
|---|---|
| The rate of normalization of alanine aminotransferase(ALT);The percentage of subjects with HBeAg seroconversion and serological conversion in the blood serum; | — |
Countries
China
Contacts
Public ContactShuangsuo Dang
The Second Affiliated Hospital of Xi'an Jiaotong University
Outcome results
None listed