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

Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexFemale
Age16+
SponsorANRS, Emerging Infectious Diseases

About this trial

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).

Eligibility criteria

Qualifiers

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 ;

Disqualifiers

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);

Trial design

Treatments tested in this trial

  • Fumarate, Tenofovir Disoproxil

Treatment groups

150 Participants
are divided into 1 treatment group