Maternal Screening and Antiviral Therapy in Pregnant Women to Reduce Mother-to-infant Transmission of Hepatitis B Virus

Study Overview
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Brief Summary
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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
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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.

Official Title
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Maternal Screening and Antiviral Therapy in Pregnant Women to Reduce Mother-to-infant Transmission of Hepatitis B Virus

Conditions
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Hepatitis B Virus Infection

Intervention / Treatment
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* Drug: Tenofovir Alafenamide


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: treatment group<br>Pregnant women receiving tenofovir alafenamide 25 mg per day since 26-32 weeks of pregnancy to 2-4 weeks postpartum. | Drug: Tenofovir Alafenamide<br>* Pregnant women receiving tenofovir alafenamide 25 mg per day since 26-32 weeks of pregnancy to 2-4 weeks postpartum.<br>|
| No Intervention: control group<br>control group receive no drug, only follow-up | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Child HBsAg 6 mo | Serum status of HBsAg of the infants at 6 months old | 6 months after delivery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Child HBsAg 12 mo | Serum status of HBsAg of the infants at 12 months old | 12 months after delivery | 
| Maternal ALT elevation | Rate of postpartum maternal ALT elevation above 2X upper limit of normal within 6 months after delivery | 6 months after delivery | 
| Maternal HBeAg-seroconverion | HBeAg-seroconversion rate within 12 months after delivery | 12 months after delivery | 
| Maternal renal | Maternal serum creatinine (mg/dL) at 6 and 12 months post delivery | 6 and 12 months post delivery | 
| Materna bone marker | Maternal bone alkaline phosphatase (ug/L) at 6 and 12 months post delivery | 6 and 12 months post delivery | 
| Children's growth | Children's growth: height (cm) in Z score at 6 and 12 months after birth | 6 and 12 months after birth | 
| Children's growth | Children's growth: weight (kg) in Z score at 6 and 12 months after birth | 6 and 12 months after birth |