Hepatitis B Virus Infection
Conditions
Brief summary
To investigate the efficacy of using antiviral therapy in third trimester of pregnancy to reduce mother-to-infant HBV transmission, and to access the safety of such treatment for mothers and infants.
Detailed description
This is a multi-centered study conducted in 12-16 collaborative hospitals in Taiwan, using tenofovir as antiviral therapy to reduce mother-to-infant transmission. The study group recruited pregnant women at 2nd to 3rd trimester receive tenofovir disoproxil fumurate (TDF) 2011-2018, June, and receive tenofovir alafenamide (TAF) 2018-2021. Control group did not receive antiviral treatment. Both group receive mother and infant follow-up up to 12 months after delivery.
Interventions
DRUGTenofovir Alafenamide
Pregnant women receiving tenofovir alafenamide 25 mg per day since 26-32 weeks of pregnancy to 2-4 weeks postpartum.
Sponsors
National Taiwan University Hospital
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
20 Years to 40 Years
Healthy volunteers
No
Inclusion criteria
* Women aged 20-45 years in 28 to 32 weeks of pregnancy * Positive HBsAg and HBeAg * Serum viral load above 6 log10 IU/mL
Exclusion criteria
* Major systemic disease of the mother or fetus * Positive anti-HIV or anti-HCV * Under treatment of antiviral therapy * Pregnant woman whose ultrasonographic examination reveals congenital anomaly of the fetus * Pregnant woman whose amniocentesis reveals any genetic abnormality
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Child HBsAg 6 mo | 6 months after delivery | Serum status of HBsAg of the infants at 6 months old |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Maternal ALT elevation | 6 months after delivery | Rate of postpartum maternal ALT elevation above 2X upper limit of normal within 6 months after delivery |
| Maternal HBeAg-seroconverion | 12 months after delivery | HBeAg-seroconversion rate within 12 months after delivery |
| Child HBsAg 12 mo | 12 months after delivery | Serum status of HBsAg of the infants at 12 months old |
| Materna bone marker | 6 and 12 months post delivery | Maternal bone alkaline phosphatase (ug/L) at 6 and 12 months post delivery |
| Children's growth | 6 and 12 months after birth | Children's growth: height (cm) in Z score at 6 and 12 months after birth |
| Maternal renal | 6 and 12 months post delivery | Maternal serum creatinine (mg/dL) at 6 and 12 months post delivery |
Countries
Taiwan
Contacts
Primary ContactMei-Hwei Chang
Outcome results
None listed