Maternal Antiviral Treatment and Infants Immunoprophylaxis in the Prevention of Mother-to-child Transmission

Maternal Nucleos(t)Ide Analogue Use and Infants Immunoprophylaxis to Eliminate Hepatitis B Infection in the Real World Setting

The effective control of nucleos(t)ide analogues for patients infected with hepatitis B has significantly curbed the horizontal transmission of hepatitis B. However, the vertical transmission remains a serious threat to public health for directly increasing the burden of hepatitis B worldwide with the transmission rate up to 80 to 90% among high HBV DNA level if untreated. Currently, the effective prevention of mother-to-child transmission is credited to the implement of HBV vaccination and hepatitis B virus immunoglobin. To leave nobody behind, a growing body of evidence has been yielded to support the use of nucleos(t)ide analogues in the mothers during the late pregnancy. However, the clinical practice can be more complex. Therefore, investigators aim to assess the effectiveness of maternal antiviral therapy and different infants immunoprophylaxis strategy in the prevention of chronic hepatitis infection among children whose mothers were infected with chronic hepatitis B infection in the real world setting.

Study Overview

• Status: Completed
• Conditions: Hepatitis B
• Intervention / Treatment: Drug: nucleos(t)ide analogue

Detailed Description

From 2011 to 2017, the investigators consecutively enrolled the pregnant women with chronic hepatitis B infection who were less than 28 weeks pregnant and not treated with nucleos(t)ide analogues during pregnancy. The investigators recommended those pregnant women with HBV DNA > 2*10^6 IU/ml to receive nucleos(t)ide analogues from 28 weeks of pregnancy to delivery. Patients who agreed the antiviral treatment would assigned to the treatment group and those who declined it were assigned to the control group with high HBV DNA level. Meanwhile, those pregnant women with HBV DNA < 2*10^6 IU/ml was assigned as the control group with low HBV DNA level. All infants would be instructed to receive hepatitis B vaccine and hepatitis B virus immunoglobulin within 24 hours after birth, defined as the standard immunoprophylaxis strategy and encouraged to receive immunoprophylaxis within 2 hours after birth, defined as the aggressive immunoprophylaxis strategy. Umbilical cord blood were collected to determine the HBV serological markers and HBV DNA level. Children were followed every three to four years until December 2018.

• Study Type: Observational
• Enrollment (Actual): 233

Contacts and Locations

Study Locations

• China
  • Jiangsu
    • Suzhou, Jiangsu, China, 215400
      • The First People's Hospital of Taicang

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

In the real-world setting, we recruited consecutively HBsAg positive women who were less than 28 weeks pregnant and underwent routine testing for HBV at the Department of Infectious Diseases of Taicang First People's Hospital at least twice during pregnancy. Patients were excluded from participation if they had been treated with antiviral drugs during pregnancy. Additional exclusion criteria were drug hypersensitivity, abnormal renal laboratory results, coinfection with human immunodeficiency virus or other human hepatitis viruses.

Description

Inclusion Criteria:

• HBsAg positive women who were less than 28 weeks pregnant and underwent routine testing for HBV at the Department of Infectious Diseases of Taicang First People's Hospital at least twice during pregnancy

Exclusion Criteria:

• women treated with antiviral drugs during pregnancy.
• drug hypersensitivity;
• abnormal renal laboratory results;
• coinfection with human immunodeficiency virus or other human hepatitis viruses.

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
The treatment group; Pregnant women with high HBV DNA level > 2*10^6 IU/ml who agree to receive the antiviral treatment during the late pregnancy.	Drug: nucleos(t)ide analogue; Pregnant women in this group agree to receive nucleos(t)ide analogue (tenofovir or telbivudine) daily from the 28 weeks of pregnancy to delivery.
The control group with high HBV DNA level; Pregnant women with high HBV DNA level > 2*10^6 IU/ml who decline to receive the antiviral treatment during the late pregnancy.
The control group with low HBV DNA level; Pregnant women with high HBV DNA level < 2*10^6 IU/ml

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The proportion of children who developed chronic HBV infection between the treatment group and two control groups in the real-world setting.	We compare the proportion of children with chronic HBV born to mothers from three groups in the real life setting	December, 2018

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
the proportion of children who developed chronic HBV infection between the treatment group and two control groups among infants who followed the standardized immunoprophylaxis strategy	We compare the proportion of children with chronic HBV born to mothers from three groups who followed the standardized immunoprophylaxis strategy	December, 2018
the proportion of children who developed chronic HBV infection between the treatment group and two control groups among infants who followed the aggressive immunoprophylaxis strategy	We compare the proportion of children with chronic HBV born to mothers from three groups who followed the aggressive immunoprophylaxis strategy	December, 2018
The proportion of children with detectable HBV DNA and HBsAg in umbilical cord blood	We compare the proportion of children with detectable HBV DNA and HBsAg in umbilical cord blood born to mothers from three groups	At delivery
The HBV DNA level of mothers among three groups	We compare the HBV DNA level of mothers among three groups within one week before delivery.	Within one week before delivery.

Collaborators and Investigators

• Sponsor: Huashan Hospital
• Investigators: Study Director: Yonglan Pu, The First People's Hospital of Taicang

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 1, 2011
• Primary Completion (ACTUAL): December 30, 2018
• Study Completion (ACTUAL): December 30, 2018

Study Registration Dates

• First Submitted: June 5, 2019
• First Submitted That Met QC Criteria: June 5, 2019
• First Posted (ACTUAL): June 6, 2019

Study Record Updates

• Last Update Posted (ACTUAL): June 12, 2019
• Last Update Submitted That Met QC Criteria: June 10, 2019
• Last Verified: June 1, 2019

More Information

Terms related to this study

• Keywords: hepatitis B; antiviral treatment; mother-to-children transmission; immunoprophylaxis
• Additional Relevant MeSH Terms: Digestive System Diseases; RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Liver Diseases; Hepatitis, Viral, Human; Hepadnaviridae Infections; DNA Virus Infections; Enterovirus Infections; Picornaviridae Infections; Hepatitis B; Hepatitis; Hepatitis A
• Other Study ID Numbers: RWD-0

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No