Trial Information

The Natural History of Liver Disease in a Cohort of Participants With Hepatitis B and/or Hepatitis C With or Without HIV Infection

Chronic hepatitis is a major health problem with hepatitis B virus (HBV) affecting upwards
of 350 million people worldwide and over one million in the United States, while hepatitis C
virus (HCV) infects as many as 70-130 million people worldwide, and approximately 4.1
million (1.6% of the US population) in the United States. HBV and HCV are both transmitted
sexually, perinatally and percutaneously, although each virus has differing infectivity
rates depending on the mode of transmission. The immunosuppressed population, especially
those with HIV infection, remains at particular risk given common routes of transmission.
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.

The prevalence rates of HIV in Washington DC are likely 3%. HIV-hepatitis coinfection is
problematic in that HIV patients are currently living longer on highly active antiretroviral
therapy (HAART) but often die of complications from liver disease, including HCC. Those who
are coinfected with HBV and/or HCV progress more rapidly to cirrhosis and hepatic failure.
Treatment for chronic HBV and HCV is limited, even inadequate, especially in those with HIV
and HCV coinfection. Further research on the epidemiology, optimal screening and new
therapeutic approaches in HCC 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 living with and
without HIV in the Washington DC metropolitan area. There are few longitudinal research
cohorts of participants with viral hepatitis and HIV coinfection, especially at integrated
medical care centers. The study, including a participant questionnaire survey and
phlebotomy, will be administered on-site at clinical facilities in the District of Columbia.
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,
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.

The integrated clinics will provide an optimal environment for the adherence and engagement
of medical care and education in decreasing transmission risks of infection. The study will
establish a blood and specimen repository for participants and include a research database
that will be used prospectively to test future hypotheses.