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

• Status: Not yet recruiting
• Trial end date: 2025-10-01
• Target enrollment: 0
• Participant gender: Female

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).

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: ANRS, Emerging Infectious Diseases
• Treatments: Tenofovir

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.