Tenofovir in Late Pregnancy to Prevent Vertical Transmission of Hepatitis B Virus

Summary

Immunoprophylaxis failure of hepatitis B virus (HBV) leading to vertical transmission remains a concern and has been reported in approximately 8-15% of infants born to hepatitis B e antigen (HBeAg) positive mothers with high levels of HBV DNA. Maternal HBV DNA \> 6log10 copies/mL (or \>200,000 IU/mL) is the major risk for the mother-to-child transmission. Prior observational studies have shown that antiviral therapy including lamivudine or telbivudine use during late pregnancy can safely reduce the rate of vertical transmission in this special population compared to untreated patients.

Tenofovir Disoproxil (TDF), a pregnancy category B medication, reduces HBV DNA and normalizes serum alanine aminotransferase (ALT) in chronic hepatitis B patients (CHB) with few adverse effects. Two aspects on tenofovir use in pregnancy will be evaluated prospectively in this study:

1. The data on its tolerability and safety in HBeAg+ pregnant women with HBV DNA \> 6log10 copies/mL (or \> 200,000 IU/mL) during late pregnancy and infants.
2. Its efficacy in the reduction of HBV vertical transmission rate.

Conditions

• Hepatitis B Infection
• Chronic Infection
• Viremia

Interventions

DRUG

TDF treatment

About 100 mothers treated with tenofovir from 30-32 weeks of pregnancy to the week 4 of postpartum, then observed to the end of the study at post-partum week 28, paired infants received standard HBV prophylaxis.

Sponsors & Collaborators

• Gilead Sciences

  collaborator INDUSTRY

• New Discovery LLC

  lead INDUSTRY

Principal Investigators

• Calvin Q Pan, MD · Leading Principle Investigator, Division of Gastroenterology and Hepatology, NYU Langone Medical Center, New York

• Zhongping Duan, MD · Capital Medical University

• Shuqin Zhang, MD · Hepatobiliary Disease Hospital of Jilin Province, Jilin, China

• Erhei Dai, MD · The Fifth Hospital of Shijiazhuang, Shijiazhuang, Hebei, China

• Guorong Han, MD · The Second Affiliated Hospital of the Southeast University, Nanjing, China

• Huaihong Zhang, MD · Nanyang Central Hospital, Nanyang, Henan, China

• Yuming Wang, MD · Southwest Hospital, Chongqing, Chongqing, China

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

20 Years

Max Age

35 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2012-03-01

Primary Completion

2014-04-28

Completion

2018-06-28

Countries

• China

Study Locations