Hepatitis B Virus - Chronic Active
Conditions
Brief summary
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
DRUGFumarate, Tenofovir Disoproxil
all participants receive the intervention
Sponsors
ANRS, Emerging Infectious Diseases
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
16 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of eligible women who accepted the intervention among eligible women offered the intervention (acceptance rate) | measured from 7 months of pregnancy to 8 weeks postpartum | Proportion of women who took TDF continuously from the 7th month of pregnancy to 8 weeks postpartum (for at least 4 months) among women who accepted the intervention |
| Compliance with treatment | from 28 weeks of pregnancy to 8 weeks postpartum | Compliance with treatment, estimated by self-report questionnaire and pill count |
| Progression of viral load | measured from 24 weeks of pregnancy until the end of treatment | Progression of viral load, HBsAg, HBeAg, HBcr and anti-HBe seroconversion in pregnant women during the treatment period (measured at inclusion and at the end of the TDF treatment) |
| Estimate the protection rate of children with anti-HBs antibody level > 10 mIU/mL | measured between 36 and 48 weeks of life of the child of the mothers included in the study | Proportion of children with anti-HBs Ac \> 10 mIU/ml at 9-12 months / total number of children in the study. |
| Assess the clinical and biological tolerance of TDF administration in mothers and children | measured from 28 weeks of pregnancy until the end of treatment | Nature, number, frequency and intensity of adverse events in women; Nature, number, frequency, and intensity of adverse events in mothers and children and whether they are related to TDF use |
| Assess the rate of women requiring extended treatment after delivery | Assess at 12 and 24 weeks postpartum | Proportion of cytolytic or virological rebounds (with detectable viral load) after cessation of treatment estimated by measurement of ALT and HBV viral load at 12 weeks and 24 weeks postpartum when they previously had a non-detectable viral load at 8 weeks postpartum |
| To assess the cost-effectiveness of the intervention (compared to vaccination alone, without hepatitis B immune globulin (Ig-anti HBV)) | To evaluate throughout the study | Incremental cost-effectiveness ratio of the intervention compared to the situation where children receive vaccination only (HBV vaccination at birth + pentavalent) |
Countries
Cameroon
Contacts
CONTACTMaaga DOURWE, MD
PRINCIPAL_INVESTIGATORJean-Pierre ADOUKARA, MD
Hôpital de Tokombéré
Outcome results
None listed