Tenofovir As Prevention Of Hepatitis b Mother-to-child Transmission

• Status: Unknown status
• Trial end date: 2020-03-31
• Target enrollment: 0
• Participant gender: Female

Summary

The World Health Organization recommends that all high endemic countries for HBV infection based their mother to child transmission prevention strategies on vaccination of all children and administration of immunoglobulins (HBIG) to infants born to infected mothers in the first 24 hours after birth. Lack of access to antenatal screening and to HBIG significantly results in failure of this strategy in many countries. Moreover, despite sero-vaccination, 10 to 15% of infants of mothers that are positive for HBsAg and HBeAg are still infected, as high levels of HBV replication occurring in the third quarter of pregnancy act as a major risk factor.

The objective of this study is to assess the effectiveness of an operational strategy to prevent HBV mother-to-child transmission (MTCT) in Cambodia based on the use of rapid tests HBs Ag and HBe Ag to screen HBV infection and a treatment by TDF for patients with a positive HBeAg test with a "test and treat" strategy for those seen for Antenatal Care (ANC) from 24 weeks of amenorrhea. In all cases, vaccination of the newborn will be carried out according to the national protocol in Cambodia i.e. 4 injections at 24 hours, 6, 10 and 14 weeks of age.

A phase IV multicenter observational and interventional non randomized prospective study will be conducted in 4 maternity in Cambodia.

The primary outcome will be the proportion of active HBV infection in new-born at 6 months of life estimated by HBs Ag positivity.

The study will aim to document the acceptability and the operational implementation of the study using rapid tests usable in all health centers and a drug available in all the country thanks to HIV national program. The results will be helpful for Cambodian government in order to implement guidelines and algorithm follow-up for HBV-infected pregnant women.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: ANRS, Emerging Infectious Diseases; French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)
• Treatments: Tenofovir

Criteria

Inclusion Criteria:

• >= 18 years old the day of inclusion

• Pregnancy

• Positive HBs Ag

• Informed consent obtained with information sheet given and explained and the consent form signed by the participant of the project investigator at the latest the day of the inclusion

Exclusion Criteria:

• Women refusing HBs Ag test

• HIV co-infection

• HCV co-infection

• HBV treatment ongoing at the day of inclusion

• Creatinine clearance < 30 mL/min

• Severe gravidic disease present at inclusion involving life threatening to the mother and/or the child

• Evidence of pre-existing fetal anomalies incompatible with the child's life

• Imminent child's birth defined as cervix dilatation up to 7 centimeters

• Intention to deliver in a maternity not linked to the study

• Any concomitant medical condition that, according to the clinical site investigator would contraindicate participation in the study.

• Concurrent participation in any other clinical trial without written agreement of the two study teams