Hepatitis B Research Network Adult Cohort Study

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