Pregnancy with chronic viral hepatitis B
Conditions
Interventions
TAF antiviral group:NA
TDF antiviral group:NA
Sponsors
The Third Affiliated Hospital of Guangzhou Medical University
Eligibility
Sex/Gender
Female
Age
20 Years to 40 Years
Inclusion criteria
Inclusion criteria: 1. Between the ages of 20 and 40; 2. HBsAg positive for >= 6 months; 3. 0-24 week of pregnancy; 4. Meets the indications for antiviral therapy in the 2022 version of the guidelines for the prevention and treatment of chronic hepatitis B; 5. It is planned to use TAF or TDF antiviral therapy until the end of delivery or long-term administration, and follow-up will be carried out in this research institution; 6. Signed informed consent for medication;
Exclusion criteria
Exclusion criteria: 1. Previous use of anti-hepatitis B virus drugs (e.g., entecavir, tenofovir, tenofovir alafenol, emintenofovir, adefovir dipoproxil, telbivudine, etc.); 2. Concomitant viral hepatitis A, C, E or other hepatotropic virus infection or AIDS; 3. Concomitant cirrhosis, liver cancer or other chronic liver diseases (e.g., alcoholic liver, autoimmune liver disease, G6PD deficiency, etc.); 4. Patients with heart (such as coronary heart disease, myocardial infarction, heart failure, etc.), lung (such as: lung cancer, chronic obstructive pulmonary disease, tuberculosis, etc.), kidney (such as: renal failure, elevated creatinine, nephritis, nephrotic syndrome, etc.) and other important organ diseases; 5. Chronic diseases such as autoimmune diseases (such as systemic lupus erythematosus, rheumatoid arthritis, anticoagulant antibody syndrome), hypertension, diabetes, thyroid disease, etc; 6. Patients with previous pregnancy complications (such as: gestational hypertension, gestational diabetes, gestational eclampsia, etc.). 7. Those who have had fetal or neonatal growth and development defects in previous pregnancies; 8. Previous or ongoing use of nephrotoxic medications, glucocorticoids, nonsteroidal anti-inflammatory drugs, cytotoxic drugs, or immunomodulators; 9. Premedication ultrasound showed fetal malformations, fetal development abnormalities, placental abnormalities, threatened abortion, etc;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of ALT above normal (>=1 time).; | — |
Secondary
| Measure | Time frame |
|---|---|
| AST;creatinine;blood lipids;Deformity rate;Birth defects;Growth and development data;HBV-DNA;HBsAg, HBeAg;Ultrasound of the liver;HBsAg, HBeAg;HBV-DNA; | — |
Countries
China
Contacts
Public ContactXingfei Pan
The Third Affiliated Hospital of Guangzhou Medical University
Outcome results
None listed