Preventing Mother-to-child Transmission of Hepatitis B Virus With Tenofovir Alafenamide (TAF)

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the efficacy and safety of Tenofovir alafenamide (TAF) for prevention of mother-to-child transmission of hepatitis B virus among pregnant women with high level HBV DNA.

Detailed Description
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This is a single-arm multicenter, prospective, clinical study, aiming to evaluate the efficacy and safety of Tenofovir alafenamide (TAF) for prevention of mother-to-child transmission of hepatitis B virus among pregnant women with high level HBV DNA. 330 HBV-infected mothers with high level HBV DNA will be enrolled and receive Tenofovir alafenamide (TAF) for prevention of mother-to-child transmission of HBV. Demographic data, antiviral treatment history, pregnancy and labour history, co-morbidity, HBV serologic marker tests, HBV DNA tests, liver function tests, mode of delivery, neonatal characteristics (height, weight, head circumference, Apgar score and any major birth defect), breastfeeding and post vaccination serological test for infants at 7-12 months of age are collected. A mobile health application called SHIELD is used in this study to collect data and provide support for communication between mothers and their doctors. All laboratory test reports, questionnaires and other relevant information are uploaded into SHIELD.

Official Title
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A Prospective, Multi-center, Cohort Study to Evaluate the Efficacy and Safety of Tenofovir Alafenamide (TAF) for Prevention of Mother-to-child Transmission of Hepatitis B Virus Among Pregnant Women With High Level HBV DNA

Conditions
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Hepatitis B, Chronic, Mother to Child Transmission

Intervention / Treatment
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* Drug: antiviral prophylaxis with Tenofovir Alafenamide Fumarate


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Pregnant woman aged 20 to 35 years old 24-26 week of gestation HBsAg positive more than 6 months and HBeAg positive HBV DNA> 200,000 IU/ml Informed consent is signed voluntarily by both husband and wife Good compliance and able to be followed up as planned Exclusion Criteria: Mothers co-infected with HCV and HIV Evidence of decompensated cirrhosis and liver cancer Mothers had other organ lesions which would affect patient compliance and follow-up plan Mothers had history of spontaneous abortion or their children had birth defect or congenital malformation Mothers received antiviral therapy within 6 months Mothers had history of kidney injury, CCr <50ml/min and urine protein test positive (>300mg/L) Mothers had history of other chronic diseases and had to take immunomodulators, cytotoxic drugs or hormonal drugs during pregnancy The infants' biological fathers are infected with HBV Symptoms of threatened abortion during early pregnancy ALT > 1×upper limit of normal (ULN), or TBIL ≥ 1×ULN or glomerular filtration rate (GFR) < 90 ml/min, or Albumin (ALB) < 25 g/L Fetal malformations detected by B-ultrasound during pregnancy Participating in other studies

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 35 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
Intervention Model: Single Group Assignment
Interventional Model Description: This is a single arm study, in which all participants will receive study drug.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: antiviral prophylaxis with Tenofovir Alafenamide Fumarate (TAF)<br>All participants will receive oral Tenofovir Alafenamide Fumarate 25mg, daily, at gestational 27-29 week until delivery. | Drug: antiviral prophylaxis with Tenofovir Alafenamide Fumarate<br>* All participants will receive antiviral prophylaxis with Tenofovir Alafenamide Fumarate for preventing of Mother-to-child transmission of HBV<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of mother-to-child transmission of HBV | the number of HBV-infected infants relative to all participants enrolled or to all participants who complete follow-up | from enrollment to the last infant completes post vaccination serological test (PVST), assessed up to 32 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of birth defect of infants | the number of infants with birth defect relative to all participants enrolled | from enrollment to the last mother delivery, assessed up to 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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hepatitis B virus, mother-to-child transmission, antiviral prophylaxis, Tenofovir Alafenamide