Long-Term Study of Liver Disease in People With Hepatitis B and/or Hepatitis C With or Without HIV Infection

Chronic viral hepatitis is a major health problem affecting millions globally. The
immunosuppressed population, especially those with HIV infection, remains at particular risk
and the incidence of hepatocellular carcinoma (HCC) is increasing in the US and worldwide,
with high rates in those who are cirrhotic, and is the 10th most common cause of death in the
US.

HIV-hepatitis coinfection is problematic in that HIV patients are currently living longer on
highly active antiretroviral therapy (HAART).. Those who are coinfected with HBV and/or HCV
progress more rapidly to cirrhosis and hepatic failure. Further research on the epidemiology,
optimal screening and new therapeutic approaches in persons with advanced liver disease, in
the setting of effective treatment for viral hepatitis is needed.

The primary objective of the proposed study is to characterize viral liver disease and
factors affecting the natural history of viral liver disease in persons with and without HIV
with an emphasis on those living in the Washington DC metropolitan area. The cohort will be
designed to study research questions with respect to liver disease, disease pathogenesis
using genomics, proteomics, and immunologic disease models. Secondary objectives include
study of the immunopathogenesis of HBV and HCV disease progression in HIV infected subjects.
In addition, this is an invaluable opportunity to determine the prevalence and risk factors
associated with the development of hepatocellular carcinoma, the longterm effects of HCV
clearance with DAAs, along with biomarker profile(s) for diagnosis and outcome. Moreover,
this will serve as a catchment protocol to select appropriate participants for novel HBV and
HCV therapeutic trials.

- INCLUSION CRITERIA:

To be eligible for participation on this protocol, a participant must satisfy all of the
following conditions:

1. Be greater than or equal to 18 years old

2. HBV-infected and/or HCV-infected, or was HCV-infected and successfully treated

3. Willing to undergo genetic testing

4. Willingness to allow study staff to review your medical records between research
visits

5. Willing to have samples stored for future research

6. Must have an identifiable primary care physician

7. Willing to undergo HIV testing

An HBV infected individual is defined as any individual with documentation of the
following:

- Positive Hepatitis B surface antigen within the past 12 months or HBV DNA positive, or
prior documentation if the individual is currently on active therapy

An HCV infected individual is defined as any individual with documentation of the following
in the past:

- Positive HCV antibody and/or positive HCV RNA test (HCV RNA of 2,000 IU/mL or greater)

An HIV infected individual is defined as any individual with documentation of the
following:

- Positive Enzyme Linked Immunosorbent Assay followed by a positive Western Blot or
detectable HIV viral load or HIV viral less than 50 copies/mL with documentation this
individuals is curently on an active HIV antiretroviral regimen.

EXCLUSION CRITERIA:

A participant will be ineligible to participate on this study if any of the following
criteria are met:

1. Unable to comply with research study visits

2. Poor venous access

3. Have any condition that the investigator considers a contraindication to study
participation.

Co-enrollment Guidelines: Participants may be enrolled in other protocols as long as the
amount of research blood drawn does not exceed the acceptable NIH guidelines.