The Safety of Anti-viral Therapy in Preventing HBV MTCT in Pregnant Women After Discontinuation

• Status: Completed
• Trial end date: 2017-12-31
• Target enrollment: 0
• Participant gender: Female

Summary

Mother-to-child transmission (MTCT) is the most common mode of perpetuating chronic hepatitis B virus (HBV) infection in endemic countries. Many studies have demonstrated antepartum anti-viral therapy (AVT) is a advisable option to reduce mother-to-child transmission and the risk of vaccination breakthrough in infants who received passive-active immunoprophylaxis. However, several controversies over antiviral treatment have not been resolved, that is, optimal duration, effect of postpartum therapy, and risk of postpartum alanine aminotransferase (ALT) flare after withdrawal. Will the risk of postpartum hepatitis flares increase after short-term AVT in late pregnancy for maternal HBV infection is discontinued? Is there any correlation between postpartum hepatitis flares and withdrawal time? Will the proportion of postpartum flares be reduced if extending the duration of AVT after delivery? There is an urgent need in this area. This study mainly investigated the safety of antiviral therapy in preventing HBV mother-to-child transmission in pregnant women after discontinuation.

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

Details

• Lead Sponsor: Third Affiliated Hospital, Sun Yat-Sen University
• Treatments: Antiviral Agents; Telbivudine; Tenofovir

Criteria

Inclusion Criteria:

• Gestational age between 24 and 28 weeks

• Detectable serum HBsAg at the Screening visit and at least 6 months prior

• Serum HBV DNA level >1,000,000 IU/mL at Screening visit

• Alanine aminotransferase (ALT) below the upper limit of normal (ULN; 40 IU/mL)

Exclusion Criteria:

• Patient is co-infected with hepatitis A virus, hepatitis C virus, hepatitis delta virus, hepatitis E virus or HIV.

• Patient has a history of antiviral treatment or concurrent treatment with immunomodulators, cytotoxic drugs, or steroids.

• Patient has clinical signs of threatened miscarriage in early pregnancy.

• Patient has evidence of hepatocellular carcinoma or cirrhosis.

• Patient has evidence of fetal deformity by 3-dimensional ultrasound examination.

• Patient has a husband infected with HBV.