Efficacy of Tenofovir Disoproxil on Mother-to-child Transmission of HBV in Tokombéré, Cameroon in Pregnant Women
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Fumarate, Tenofovir Disoproxil.
- Who it may be relevant to
- Registry conditions: Hepatitis B Virus - Chronic Active. Basic parameters: from 16 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Cameroon
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Efficacy of Tenofovir Disoproxil on Mother-to-child Transmission of HBV in Tokombéré, Cameroon in Pregnant Women Infected With Hepatitis B Virus (HBeAg Positive or With a High Viral Load) and Whose Newborns Had Been Vaccinated at Birth
Overview
Pregnant women with HBeAg-positive viral hepatitis b or high viral load will receive Tenofovir disoproxil fumarate (TDF) 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).
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.
Interventions
- Drug Fumarate, Tenofovir Disoproxil
all participants receive the intervention
Primary outcome measures
- Proportion of children with HBsAg positive at 9-12 months of life (W36 - W48) in the study population, [Time frame: measured between 36 and 48 weeks of life of the child of the mothers included in the study]
Secondary outcome measures (7)
- Proportion of eligible women who accepted the intervention among eligible women offered the intervention (acceptance rate) [Time frame: measured from 7 months of pregnancy to 8 weeks postpartum]
- Compliance with treatment [Time frame: from 28 weeks of pregnancy to 8 weeks postpartum]
- Progression of viral load [Time frame: measured from 24 weeks of pregnancy until the end of treatment]
- Estimate the protection rate of children with anti-HBs antibody level > 10 mIU/mL [Time frame: measured between 36 and 48 weeks of life of the child of the mothers included in the study]
- Assess the clinical and biological tolerance of TDF administration in mothers and children [Time frame: measured from 28 weeks of pregnancy until the end of treatment]
- Assess the rate of women requiring extended treatment after delivery [Time frame: Assess at 12 and 24 weeks postpartum]
- To assess the cost-effectiveness of the intervention (compared to vaccination alone, without hepatitis B immune globulin (Ig-anti HBV)) [Time frame: To evaluate throughout the study]
Eligibility criteria
Inclusion criteria
- Pregnant women with a term of less than 24 weeks of amenorrhea;
- HBsAg positive ;
- HBeAg positive or HBeAg negative with a high viral load ( > 200 000 UI/ml) ;
- 16 years old or more on the inclusion day ;
- 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
- HIV co-infection;
- Women treated for HBV;
- Creatinine clearance <30 ml / min;
- Suspicion of poor monitoring of children's vaccination schedule for HBV (vaccination at birth + boosters);
- Disease or treatment contraindicating the taking of TDF.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Prevention
Study locations
Cameroon · 1 center
- Hôpital Privé de Tokombéré — Tokonbéré
Identifiers
NCT: NCT05403047 · ANRS 12417 TOPCHIB