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The risk of vertical HBV transmission is related to HBV DNA level in pregnant women, around 30% in women with HBV DNA above 1, 000 000 I.U/mL despite serovaccination of newborns. Using tenofovir DF during the last trimester of pregnancy allows to reduce the risk, but data from Western countries are needed.
The prevalence of HBs Ag carriage in pregnant women varies in France, according to the native country, with higher rates in those originating from sub-Saharan Africa and Asia (5 to 8% in Parisian area). The level of HBV DNA varies according to HBe status and geographical origin, and is strongly predictive of the risk of HBV mother-to-child transmission (MTCT). The rate of vertical transmission (Yuan J et al. J Viral Hepatitis 2006) was 0% in newborns to mothers with HBV DNA less than 100,000 copies/mL and up to more than 40% in newborns to mothers with HBV DNA above 8 Log10 copies/mL, despite serovaccination at birth, thus justifying the use of tenofovir DF during the last trimester of pregnancy in highly viraemic pregnant women, as mentionned in EASL 2012 Guidelines. Data are needed concerning the results of this strategy in western countries, justifying this prospective study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| tenofovir | Other | tenofovir DF one pill (245 mg) per day from week 28 of pregnancy to week 12 after birth |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tenofovir DF | Drug | Tenofovir DF will be started at week 28 of pregnancy and stopped or not, according to the physician's decision, at week 12 after birth |
|
| Measure | Description | Time Frame |
|---|---|---|
| Rate of chronically infected (positive HBs Ag) children born from mothers with HBV DNA above 100, 000 I.U/mL being given tenofovir during the last trimester of pregnancy. | At 9 months after birth |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pierre O SELLIER, MD, PhD | Hopital Lariboisiere, Paris, France | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hopital Lariboisiere | Paris | 75475 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27879486 | Derived | Sellier PO, Maylin S, Bercot B, Chopin D, Lopes A, Simoneau G, Evans J, Delcey V, Benifla JL, Simon F, Bergmann JF. Prospective interventional study of tenofovir in pregnancy to prevent vertical transmission of hepatitis B in highly viremic women. Eur J Gastroenterol Hepatol. 2017 Mar;29(3):259-263. doi: 10.1097/MEG.0000000000000793. |
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| ID | Term |
|---|---|
| D000068698 | Tenofovir |
| ID | Term |
|---|---|
| D063065 | Organophosphonates |
| D009943 | Organophosphorus Compounds |
| D009930 | Organic Chemicals |
| D000225 | Adenine |
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| D011687 |
| Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |