The Study of Short-range Antiviral Treatment During Pregnancy to Block Mother-to-child Transmission of Hepatitis B Virus and Withdrawal Time

Capital Medical University

Status: Unknown

Conditions: Chronic Hepatitis B

Treatments: Drug: Tenofovir Disoproxil Fumarate

Study type: Observational

Funder types: Other

Identifiers

NCT03209908

XMLX201706-1

Details and patient eligibility

About

Pregnant women carry high HBV DNA loads before delivery, which is the most important factor leading to mother-to-child transmission of HBV. Nucleoside analogue antiviral treatment during late pregnancy can significantly reduce the incidence of HBV MTCT, but security problems of using NA treatment during pregnancy has not been eliminated, Therefore, the aim of our study is to explore the effect of starting to use Tenofovir Disoproxil Fumarate(TDF) antiviral treatment from the 32 weeks of gestation to block mother-to-child transmission of hepatitis B virus(HBV MTCT).

Full description

HBV MTCT is the important reason to keep high prevalence of chronic HBV infection in China; high HBV DNA loads of Pregnant women before delivery is the most important factor resulting in mother-to-child transmission of HBV, therefore, how to drop HBV DNA levels of pregnant women before delivery to the level that can markedly decrease the rate of HBV MTCT on the base of HBIG combined hepatitis b vaccine injection for newborns, which is the most important method to improve HBV MTCT. Although Nucleoside analogue antiviral treatment during late pregnancy can dramatically reduce the rate of HBV MTCT, security problems of NA treatment during pregnancy has not been demonstrated, On account of the above problems, our study is to investigate the effect of starting to use Tenofovir Disoproxil Fumarate(TDF) antiviral treatment from the 32 weeks of gestation to block mother-to-child transmission of hepatitis B virus(HBV MTCT).

Enrollment: 380 estimated patients

Sex: Female

Ages: 20 to 35 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Pregnant women who were chronic hepatitis B and had achieved HBeAg positive and HBV DNA > 106 copies/ml

Exclusion criteria

• Active consumption of alcohol and/or drugs
• Co-infection with human immunodeficiency virus, hepatitis C virus, or hepatitis D virus, HIV, etc.
• History of autoimmune hepatitis
• Psychiatric disease
• Evidence of neoplastic diseases of the liver
• without gestational hypertension, premature rupture of membranes, antepartum haemorrhage diseases or amniotic fluid piercing history during pregnancy.

Trial design

380 participants in 2 patient groups

control group

Description:

In this group, pregnant women with HBsAg/HBeAg positive and HBV DNA \> 106 copies/ml don not use any antiviral drugs during pregnancy.

experimental group

Description:

pregnant women with HBsAg/HBeAg positive and HBV DNA \> 106 copies/ml start to use Tenofovir Disoproxil Fumarate(TDF) antiviral treatment from the 32 weeks of gestation to block mother-to-child transmission of hepatitis B virus.

Treatment:

Drug: Tenofovir Disoproxil Fumarate