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

 - Hepatitis B and hepatitis C can cause liver damage. They can also cause serious illness,
 including liver cancer, and even death. This study will follow people who have hepatitis B or
 hepatitis C. The purpose is to understand more about how these viruses affect the immune
 system over the long term (up to 10 years). The study will also compare how these viruses
 affect people who do and do not have HIV, the virus that causes AIDS.

 Objectives:

 -  To do a long-term study of hepatitis B and hepatitis C infection.

 -  To study the effects of hepatitis B and hepatitis C infection in people do and do not
 have HIV.

 Eligibility:

 - People at least 18 years of age who have hepatitis B or hepatitis C and have a regular
 doctor for their medical care.

 Design:

 -  Participants will be screened with a physical exam and medical history. Those who do not
 have a regular doctor to provide medical care during the study will not be able to take
 part.

 -  Participants will have yearly visits with study researchers for up to 10 years. These
 tests will be done at each visit.

 -  Medical history and physical exam.

 -  Questionnaire (optional) on emotions, sexual behaviors, use of alcohol and drugs, and
 quality of life.

 -  Blood and urine tests, including HIV testing.

 -  Tissue sample collections for those who have had a liver or other tissue biopsy.

 -  Participants may leave the study at any time. They will receive the standard of care
 from their regular doctor throughout the study.
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

 8. Childbearing female must test negative for pregnancy

 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.

 4. Childbearing female with positive pregnancy test

 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.