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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| treatment group | Experimental | Pregnant women receiving tenofovir alafenamide 25 mg per day since 26-32 weeks of pregnancy to 2-4 weeks postpartum. |
|
| control group | No Intervention | control group receive no drug, only follow-up |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tenofovir Alafenamide | Drug | Pregnant women receiving tenofovir alafenamide 25 mg per day since 26-32 weeks of pregnancy to 2-4 weeks postpartum. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Child HBsAg 6 mo | Serum status of HBsAg of the infants at 6 months old | 6 months after delivery |
| 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 |
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Inclusion criteria:
Exclusion criteria:
Pregnant women
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mei-Hwei Chang | Contact | +886-2-23123456 | 71701 | changmh@ntu.edu.tw |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Taiwan University Hospital | Recruiting | Taipei | 100 | Taiwan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42349783 | Derived | Wen WH, Liu CJ, Lai MW, Tsai MC, Mu SC, Lee CL, Cheng SW, Hsu JJ, Lin YC, Hu JJ, Shu CT, Lin MW, Yang YJ, Hu KC, Chien RN, Ko SC, Chen YC, Shih JC, Lee CN, Chen HL, Chang MH. Peripartum ALT Flares Predict Earlier Postpartum HBeAg Clearance in Highly Viremic HBV-Infected Women: A Long-term Follow-up Study. JHEP Rep. 2026 Jun 25:101936. doi: 10.1016/j.jhepr.2026.101936. Online ahead of print. | |
| 38456620 |
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| ID | Term |
|---|---|
| D006509 | Hepatitis B |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D018347 | Hepadnaviridae Infections |
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| ID | Term |
|---|---|
| C442442 | tenofovir alafenamide |
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| 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 |
| Derived |
| Chen HL, Lee CN, Chang CH, Lai MW, Tsai MC, Mu SC, Liu CJ, Shih JC, Wen WH, Hu RT, Huang CP, Hu KC, Chen CP, Lee CL, Chien RN, Chang KC, Hsu HY, Lee CC, Ni YH, Chang MH. Tenofovir alafenamide or tenofovir disoproxil fumarate in pregnancy to prevent HBV transmission: Maternal ALT trajectory and infant outcomes. Liver Int. 2024 Jun;44(6):1422-1434. doi: 10.1111/liv.15873. Epub 2024 Mar 8. |
| D004266 |
| DNA Virus Infections |
| D014777 | Virus Diseases |
| D006525 | Hepatitis, Viral, Human |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |