Chronic hepatitis B
Conditions
Interventions
Chronic hepatitis B with entecavir treatment group:None
Group for chronic hepatitis B with amitinofovir tablet treatment:None
Sponsors
Beijing Ditan Hospital, Capital Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Age between 18 and 65 years; 2. Meets the diagnostic criteria for chronic hepatitis B according to the "Guidelines for the Prevention and Treatment of Chronic Hepatitis B" from 2015, 2019, and 2022; 3. Patients who initiated entecavir antiviral therapy after January 1, 2017, or who will initiate amivudine antiviral therapy between July 1, 2023, and June 30, 2025; 4. Able to participate in long-term follow-up; 5. Signed informed consent; 6. According to the 2022 version of the Chinese guidelines for the diagnosis and treatment of hepatitis B, include chronic hepatitis B patients who are HBsAg positive and have HBV DNA levels below the detection limit. In subsequent analyses, subgroup analyses can be conducted, and past cases can be matched using propensity scores.
Exclusion criteria
Exclusion criteria: 1. Chronic liver diseases not caused by HBV, such as HCV infection, alcoholic liver disease, severe fatty liver, drug-induced liver injury, autoimmune liver disease, and genetic metabolic liver disease; 2. Patients allergic to Entecavir, Ametenofovir, or their components, and those taking Entecavir doses >= 1.0 mg; 3. Patients resistant to Lamivudine and Telbivudine; 4. Patients with grade 3 or higher hepatic encephalopathy or active variceal bleeding; 5. Patients with chronic liver failure or acute-on-chronic liver failure; 6. Child-Pugh score greater than 12; 7. Patients who have undergone splenectomy with devascularization, extensive portal vein thrombosis, or TIPS treatment; 8. Creatinine levels 1.5 times above the upper normal limit at screening; 9. Patients with malignant tumors (excluding those cured, including primary liver cancer); 10. Patients with severe diseases of important organs such as the heart, lungs, kidneys, brain, or blood; 11. Patients with severe mental illnesses such as depression, mania, epilepsy, or schizophrenia; 12. Pregnant and breastfeeding women; 13. Patients with poor compliance who cannot meet follow-up requirements; 14. Patients deemed unsuitable for participation in the study by the researchers.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Virological Response Rate of Chronic Hepatitis B Patients Treated with Ametenofovir Tablets for 48 Weeks; | — |
Secondary
| Measure | Time frame |
|---|---|
| Virological Response Rate of Chronic Hepatitis B Patients Treated with Ametenofovir Tablets for 96 Weeks;Changes in Liver Biochemical, Blood Lipid, Bone, and Renal Safety Indicators at Week 48 and Week 96 of Antiviral Treatment;Changes in Effective Albumin Levels in Hepatitis B Virus-Infected Patients at Different Clinical Stages (Chronic Hepatitis B, Compensated Cirrhosis, Decompensated Cirrhosis, etc.);Incidence of Liver-Related Events and Changes in Child-Pugh and MELD Scores at Week 48 and Week 96 of Antiviral Treatment with Entecavir and Ametenofovir Tablets in the Subgroup of Hepatitis B Cirrhosis Decompensated Patients; | — |
Countries
China
Contacts
Public ContactWen Xie
Beijing Ditan Hospital, Capital Medical University
Outcome results
None listed