Efficacy of Antiviral Therapy in Pregnancy in Preventing Vertical Transmission of HBV in Mothers With a High Viral Load

Case-control Study of Antiviral Therapy During Entire and the Third Trimester of Pregnancy in Preventing MTCT of HBV in Mothers With High Serum HBV DNA Load

Mother-to-child transmission (MTCT) is the most common route of hepatitis B virus (HBV) infection. After given standard immunoprophylaxis, MTCT still occurred in some infants born to a HBsAg positive mothers with high HBV DNA load. The main purpose of this study is evaluating the efficacy of methods used in blocking MTCT of HBV in infants born to a HBsAg positive mothers with high serum HBV DNA loads.

Study Overview

• Status: Unknown
• Conditions: Immune Globulin, Prophylaxis, Telbuvidine, Vaccine
• Intervention / Treatment: Drug: telbivudine

Detailed Description

This study contain 600 patients and compose groups as follow: (ⅰ) infants born to a HBsAg positive mothers with high HBV DNA load before delivery receive standard immunoprophylaxis( injection of HBIG 200IU at birth plus HBV vaccine at 0,1 and 6month); (ⅱ) infants born to a HBsAg positive mother with high HBV DNA load before delivery, and based on standard immunoprophylaxis receive addition injection of HBIG 200IU at 1 month after birth; (ⅲ) infants born to a HBsAg positive and high HBV DNA load mothers but treated with antiviral therapy in late pregnancy, receive standard immunoprophylaxis; (ⅳ) infants born to a HBsAg positive mothers treated with antiviral therapy during entire pregnancy for hepatitis receive standard immunoprophylaxis; (ⅴ) infants born to a HBsAg positive mother with serum HBV DNA negative receive standard immunoprophylaxis.

• Study Type: Observational
• Enrollment (Anticipated): 600

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 7 months (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

this study would enroll 600 HBsAg positive mothers, including 240 cases with high serum HBV DNA load during pregnancy, 120 cases treated with antiviral therapy for hepatitis B, 120 cases with HBV DNA negative during pregnancy, 120 cases with high serum HBV DNA but receive antiviral therapy in late of pregnancy, and all of their infants.

Description

Inclusion Criteria:

• infants born to HBsAg positive mother HBsAg positive mother

Exclusion Criteria:

• mothers coinfected HIV or HCV

Study Plan

How is the study designed?

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
telbivudine treated entire pregnancy; mothers in this group were treated with antiviral therapy during entire pregnancy for hepatitis, and their infants receive standard immunoprophylaxis for preventing MTCT of HBV.	Drug: telbivudine; in telbivudine treatment entire pregnancy group, mothers were treated with telbivudine during entire pregnancy for hepatitis B. in telbivudine treatment in late pregnancy group, mothers with high serum HBV DNA load receive telbivudine treatment in late pregnancy for preventing MTCT of HBV.
telbivudine treated in late pregnancy; mothers with high serum HBV DNA load were treated with antiviral therapy in late pregnancy, and their infants receive standard immunoprophylaxis for preventing MTCT of HBV.	Drug: telbivudine; in telbivudine treatment entire pregnancy group, mothers were treated with telbivudine during entire pregnancy for hepatitis B. in telbivudine treatment in late pregnancy group, mothers with high serum HBV DNA load receive telbivudine treatment in late pregnancy for preventing MTCT of HBV.
HBV DNA positive control; infants in this group born to mother with high serum HBV DNA load and receive standard immunoprophylaxis or additional HBIG injection at 1 month after birth for preventing MTCT of HBV.
HBV DNA negative control; infants in this group born to a HBsAg positive and serum HBV DNA negative mothers and receive standard immunoprophylaxis for preventing MTCT of HBV

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
mother-to-child transmission of HBV	HBV infenction in infants at 7 months after birth	7 months

Collaborators and Investigators

• Sponsor: Beijing Ditan Hospital
• Investigators: Principal Investigator: Wei Yi, Beijing Ditan Hospital

Publications and helpful links

General Publications

• Yi W, Li MH, Xie Y, Wu J, Hu YH, Zhang D, Zhang Y, Cao WH. Prospective cohort study on the efficacy and safety of telbivudine used throughout pregnancy in blocking mother-to-child transmission of hepatitis B virus. J Viral Hepat. 2017 Nov;24 Suppl 1:49-56. doi: 10.1111/jvh.12788.

Study record dates

Study Major Dates

• Study Start: August 1, 2012
• Primary Completion (Anticipated): December 1, 2015
• Study Completion (Anticipated): December 1, 2015

Study Registration Dates

• First Submitted: September 29, 2014
• First Submitted That Met QC Criteria: September 29, 2014
• First Posted (Estimate): October 1, 2014

Study Record Updates

• Last Update Posted (Estimate): October 1, 2014
• Last Update Submitted That Met QC Criteria: September 29, 2014
• Last Verified: August 1, 2012

More Information

Terms related to this study

• Keywords: Mother-to-child transmission
• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Antiviral Agents; Nucleic Acid Synthesis Inhibitors; Enzyme Inhibitors; Telbivudine
• Other Study ID Numbers: D121100003912001