Hepatitis B
Conditions
Interventions
Experimental group:Pregnant women will receive TAF treatment (25 mg tablet orally once daily) from 28 weeks of gestation until delivery. Postpartum mothers without an indication for treatment will the
Control group:The mother will receive TDF treatment (300 mg tablet orally once a day) starting at 28 weeks of gestation until delivery. Mothers without treatment indications in the postpartum period w
Sponsors
Guangzhou Eighth People's Hospital
Eligibility
Sex/Gender
Female
Age
20 Years to 40 Years
Inclusion criteria
Inclusion criteria: Eligible patients must meet all of the following criteria: 1. Pregnant women aged between 20 and 40 years. 2. Gestational age between 20 and 28 weeks (screening for potential candidates can start from the 20th week of pregnancy). 3. Clinically diagnosed with compensated stable chronic hepatitis B, with HBsAg persistently positive for more than 6 months, and clinical history, signs, and test results consistent with compensated chronic hepatitis B. 4. HBsAg and HBeAg positive in maternal serum at the time of screening. 5. PCR testing shows maternal serum HBV DNA levels exceeding 200,000 IU/mL. 6. Participants are willing and able to undergo treatment according to the study-designated drug regimen and all other study requirements, and patients agree to strictly use contraception within 28 weeks postpartum. 7. Patients and their husbands (the biological parents of the child) understand the risks and voluntarily participate in the study. The mother must participate voluntarily and sign a written informed consent document before participating in the study.
Exclusion criteria
Exclusion criteria: Patients will not be included in this study if they have any of the following conditions: 1. Creatinine clearance 5 times the upper limit of normal, total bilirubin > 20 mg/L, albumin < 25 g/L, abnormal levels of creatinine or urea nitrogen. 4. Pregnant women with a history of miscarriage, history of giving birth to a child with congenital malformations, or history of fetal infection with hepatitis B virus. 5. The biological father of the fetus has chronic hepatitis B. 6. The investigator assesses that the subject has significant kidney, cardiovascular, pulmonary, or neurological diseases that would affect their participation in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The proportion of infants with hepatitis B infection who tested positive for HBsAg at 28 weeks of age;The proportion of infants with hepatitis B infection who tested positive for HBV DNA;The incidence of congenital malformations in newborns exposed to TAF and TDF between 24-28 weeks of pregnancy and during delivery among different groups;The incidence of congenital defects in newborns exposed to TAF and TDF between 24-28 weeks of pregnancy and during delivery among different groups; | — |
Secondary
| Measure | Time frame |
|---|---|
| In each group, the proportion of mothers with HBV DNA levels below 10^6 copies/mL (or 200,000 IU/mL) at the time of delivery;The proportion of HBeAg negative mothers at 28 weeks postpartum.;The proportion of mothers who are HBeAg negative and have experienced seroconversion by the 28th week postpartum;The proportion of HBsAg negative mothers at 28 weeks postpartum;The proportion of mothers who are HBeAg negative and have experienced seroconversion by the 28th week postpartum;The proportion of HBsAg negative mothers at 28 weeks postpartum.;The proportion of mothers who are HBsAg negative and have experienced seroconversion by the 28th week postpartum;At 28 weeks postpartum, the proportion of mothers with elevated ALT levels (more than 5 times the normal range) with or without related symptoms;At 28 weeks postpartum, the proportion of mothers with significantly elevated ALT levels (more than 10 times the normal range) with or without related symptoms;The proportion of mothers with changes in baseline ALT levels during childbirth.;The proportion of mothers with changes in ALT levels from postpartum week 1 to week 28 (after discontinuation of medication).;Differences in adverse events occurring between the two groups' mothers during the study period (from baseline to 28 weeks postpartum);Adverse events occurring in infants between the two groups (from delivery to 28 weeks postpartum);The proportion of mothers in each group with a significant change in baseline creatinine at postpartum week 28 (greater than baseline by 0.5 mg/dL).;Differences in tolerability of TDF/TAF therapy between groups;The maternal ratio of virological breakthroughs observed in the study;The cumulative incidence of drug-resistant mutations among mothers receiving TDF treatment at 28 weeks postpartum; | — |
Countries
People's Republic of China
Contacts
Public ContactPan Qi'an
Guangzhou Eighth People's Hospital, Guangzhou Medical University
Outcome results
None listed