Hepatitis B Research Network Adult Cohort Study

Observational Study of Persons With Hepatitis B Virus Infection in North America (Cohort Study)

The primary purpose of this study is to describe participants with hepatitis B virus (HBV) infection and identify factors that may cause the disease to activate or worsen.

Aims

• Primary Aim:

  o To describe participants with hepatitis B virus (HBV) infection in a prospective cohort in the United States (US) and Canada and identify predictors of disease activation and progression

• Secondary Aims:

  • To describe clinical, virological, and immunological characteristics of participants with HBV in the US and Canada
  • To evaluate changes in HBV infection status and quantitative hepatitis B surface antigen (HBsAg) levels and factors associated with those changes
  • To verify whether a baseline HBsAg below 1,000 IU/mL and HBV DNA below 1,000 IU/mL is an accurate predictor of people who are, or who will become, inactive carriers, defined as people who are HBsAg positive, hepatitis B "e" antigen (HBeAg) negative, have normal Alanine transaminase (ALT) and HBV DNA under 1,000 IU/mL on at least two occasions over a period of at least 6 months
  • To develop a bank of biospecimens (e.g., serum, plasma, DNA, lymphocytes, liver tissue) obtained from participants with HBV infection
  • To identify participants with HBV infection who are potential candidates in one of the treatment studies to be conducted by the Hepatitis B Research Network (HBRN)
  • To describe the natural history of hepatitis B infection in pregnancy including the frequency of, and clinical and virological characteristics associated with, hepatic flares during pregnancy and post-partum.

The study population will be recruited from multi-site clinical centers in the United States and Canada including primary care hospitals and community centers.

Inclusion criteria

• Written informed consent

• At least 18 years of age

• Hepatitis B surface antigen (HBsAg) positive and either:

  • Pregnant
  • Anti-Hepatitis D positive
  • Diagnosed with acute Hepatitis B infection or experiencing a hepatitis flare
  • Immune tolerant or immune active phenotype
  • Potentially eligible for the Immune Regulation and Costimulation in Natural History of Chronic Hepatitis B ancillary study (NCT01298037).

Exclusion Criteria:

• Hepatic decompensation
• Hepatocellular carcinoma (HCC)
• Liver transplantation
• Current hepatitis B antiviral treatment (except pregnant women and patients who are anti-HDV positive)
• Known Human immunodeficiency virus (HIV) co-infection (patients with Hepatitis D (HDV) or Hepatitis C (HCV) co-infection are not excluded).
• Medical or social condition which in the opinion of the investigator will interfere with or prevent follow-up per protocol
• Unable or unwilling to return for follow-up visits