Efficacy of Tenofovir Disoproxil on Mother-to-child Transmission of HBV in Tokombéré, Cameroon in Pregnant Women

Launched by ANRS, EMERGING INFECTIOUS DISEASES · May 28, 2022

Keywords

ClinConnect Summary

This clinical trial is studying the use of a medication called Tenofovir disoproxil fumarate (TDF) to help prevent the transmission of Hepatitis B virus (HBV) from pregnant women to their newborns in Tokombéré, Cameroon. Specifically, it will involve pregnant women who have a high risk of passing the virus to their babies, either because they are HBeAg-positive (a marker indicating active infection) or have a high viral load (more than 200,000 units of the virus in their blood). The women will start taking TDF from the 28th week of pregnancy until six weeks after they give birth. Their babies will also receive a series of vaccinations against hepatitis B to further protect them.

To be eligible for this study, women must be at least 16 years old, be pregnant with a gestation of less than 24 weeks, and test positive for the hepatitis B surface antigen (HBsAg). However, women who are co-infected with HIV, currently receiving treatment for hepatitis B, or have certain health issues will not be able to participate. If selected, participants can expect to take the medication as prescribed and ensure their newborns receive the required vaccinations. This trial aims to see if this treatment can effectively lower the chances of passing HBV to infants, ultimately helping to improve the health of mothers and their babies.

Gender

FEMALE

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.