Health Trials

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

ConditionHepatitis B Virus - Chronic Active
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

This trial does not accept healthy volunteers

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

Design model

Single group

Treatments tested in this trial

  • Fumarate, Tenofovir Disoproxil

    Drug

    all participants receive the intervention

Treatment groups

150 Participants
are divided into 1 treatment group
Group A: pregnant woman - tenofovirOther 1 intervention

Trial outcomes

Primary outcomes

1

Proportion of children with HBsAg positive at 9-12 months of life (W36 - W48) in the study population,

Proportion of HBsAg-positive children between 9 and 12 months of age in the study population, assessed by an automated test (mini VIDAS)

Time frame
measured between 36 and 48 weeks of life of the child of the mothers included in the study

Secondary outcomes

1

Proportion of eligible women who accepted the intervention among eligible women offered the intervention (acceptance rate)

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

Time frame
measured from 7 months of pregnancy to 8 weeks postpartum
2

Compliance with treatment

Compliance with treatment, estimated by self-report questionnaire and pill count

Time frame
from 28 weeks of pregnancy to 8 weeks postpartum
3

Progression of viral load

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)

Time frame
measured from 24 weeks of pregnancy until the end of treatment
4

Estimate the protection rate of children with anti-HBs antibody level > 10 mIU/mL

Proportion of children with anti-HBs Ac \> 10 mIU/ml at 9-12 months / total number of children in the study.

Time frame
measured between 36 and 48 weeks of life of the child of the mothers included in the study

Other outcomes

Sponsors and contacts

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ANRS, Emerging Infectious Diseases

Lead sponsor

Source ClinicalTrials.gov
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