TOPCHIB: Efficacy of Tenofovir Disoproxil on Mother-to-child Transmission of HBV in Tokombéré, Cameroon in Pregnant Women
Study Details
Study Description
Brief Summary
IIn this study, pregnant women with HBeAg-positive viral hepatitis b or high viral load will receive Tenofovir disoproxil fumarate from the 28th week of amenorrhoea until 6 weeks after delivery. Their newborns will receive the hepatitis B vaccine, starting with one dose at birth and followed by three booster doses, according to the Expanded Programme on Immunisation. The investigators hypothesise that a short course of TDF could greatly reduce the risk of HBV MTCT in pregnant women at high risk of MTCT (HBeAg positive or with high viral load).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 4 |
Detailed Description
This is a prospective, single-arm, open-label, descriptive, phase IV clinical trial in HBsAg and HBeAg positive pregnant women. Eligible pregnant women will receive 245 mg of tenofovir disoproxil fumarate once daily from 28 weeks of pregnancy until 6 weeks after delivery. Newborns will receive the hepatitis B vaccine, starting with one dose at birth, followed by three booster doses, in accordance with the expanded programme of vaccination.
The study aims to show that the addition of maternal antiviral treatment to vaccination at birth followed by three booster doses can be favourably considered in the context where vaccination alone is not sufficient to prevent transmission of the hepatitis B virus from mother to child. A total of 150 pregnant women will be included in the Tokombéré district.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Other: pregnant woman - tenofovir Participants will be started on tenofovir disoproxil fumarate (TDF) 245 mg one tablet per day from week 28 of pregnancy until 6 weeks postpartum. |
Drug: Fumarate, Tenofovir Disoproxil
all participants receive the intervention
Other Names:
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Outcome Measures
Primary Outcome Measures
- Proportion of children with HBsAg positive at 9-12 months of life (W36 - W48) in the study population, [measured between 36 and 48 weeks of life of the child of the mothers included in the study]
Proportion of HBsAg-positive children between 9 and 12 months of age in the study population, assessed by an automated test (mini VIDAS)
Eligibility Criteria
Criteria
Inclusion criteria:
-
Pregnant women with a term of less than 24 weeks of amenorrhea;
-
HBsAg positive ;
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HBeAg positive or HBeAg negative with a high viral load ( > 200 000 UI/ml) ;
-
16 years old or more on the inclusion day ;
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Signature of free and informed consent (for pregnant women aged 16 to 21, the participant's consent as well as the authorization of a parent/adult husband/ legal tutor will be collected) which also includes consent for the children
Exclusion criteria :
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HIV co-infection;
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Women treated for HBV;
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Creatinine clearance <30 ml / min;
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Suspicion of poor monitoring of children's vaccination schedule for HBV (vaccination at birth + boosters);
-
Disease or treatment contraindicating the taking of TDF.
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- ANRS, Emerging Infectious Diseases
Investigators
- Study Director: Pr Yazdan YAZDANPANAH, ANRS, Emerging Infectious Diseases
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- ANRS 12417 TOPCHIB