Maternal Screening and Antiviral Therapy in Pregnant Women to Reduce Mother-to-infant Transmission of Hepatitis B Virus

National Taiwan University

Status and phase

Unknown

Phase 4

Conditions

Hepatitis B Virus Infection

Treatments

Drug: Tenofovir Alafenamide

Study type

Interventional

Funder types

Other

Identifiers

NCT03695029

201010078M

Details and patient eligibility

About

To investigate the efficacy of using antiviral therapy in third trimester of pregnancy to reduce mother-to-infant HBV transmission, and to access the safety of such treatment for mothers and infants.

Full description

This is a multi-centered study conducted in 12-16 collaborative hospitals in Taiwan, using tenofovir as antiviral therapy to reduce mother-to-infant transmission. The study group recruited pregnant women at 2nd to 3rd trimester receive tenofovir disoproxil fumurate (TDF) 2011-2018, June, and receive tenofovir alafenamide (TAF) 2018-2021. Control group did not receive antiviral treatment. Both group receive mother and infant follow-up up to 12 months after delivery.

Enrollment

120 estimated patients

Sex

Female

Ages

20 to 40 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Women aged 20-45 years in 28 to 32 weeks of pregnancy
Positive HBsAg and HBeAg
Serum viral load above 6 log10 IU/mL

Exclusion criteria

Major systemic disease of the mother or fetus
Positive anti-HIV or anti-HCV
Under treatment of antiviral therapy
Pregnant woman whose ultrasonographic examination reveals congenital anomaly of the fetus
Pregnant woman whose amniocentesis reveals any genetic abnormality