Long-Term Study of Liver Disease in People With Hepatitis B and/or Hepatitis C With or Without HIV Infection
Condition: Hepatitis B; Hepatitis C; HIV-HCV Co-Infection
MeSH terms: Infections; Communicable Diseases; Hepatitis A; Hepatitis C; HIV Infections; Hepatitis B; Coinfection; Hepatitis; Liver Diseases
Study type: Observational

Summary: 
      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....
    

Detailed description: 
      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.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        NIH NIAID Outpatient Clinic 8 Participants, local Washington DC Primary Clinics, and
        formerly the Washington DC VA Clnic
      
Keywords: Viral Hepatitis; Acquired Immunodeficiency Syndrome (AIDS); Hepatocellular Carcinoma; HIV-HCV Co-Infection; Liver Neoplasms; Natural History