Clinical trial NCT05403047: Efficacy of Tenofovir Disoproxil on Mother-to-child Transmission of HBV in Tokombéré, Cameroon in Pregnant Women
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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE4
Conditions: Hepatitis B Virus - Chronic Active
Lead sponsor: ANRS, Emerging Infectious Diseases
Sponsor class: OTHER_GOV
First posted: 2022-06-03
Enrollment: 150
Sex: FEMALE
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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).

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.

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.

Primary outcomes:
measure: Proportion of children with HBsAg positive at 9-12 months of life (W36 - W48) in the study population,
timeFrame: measured between 36 and 48 weeks of life of the child of the mothers included in the study
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: ANRS, Emerging Infectious Diseases
name: Pr Yazdan YAZDANPANAH
role: STUDY_DIRECTOR
References: