DATABASE ON PTS WHO RECEIVE ORTHOTOPIC LIVER TRANSPLANTATION FOR HEP B

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This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. The purpose of this research study is to establish an observational database to collect pre- and post- orthotopic liver transplant (OLT) information on all patients who receive OLT for hepatitis B at participating centers. Hepatitis B accounts for 4,000-5,000 deaths per year in the United States. Orthotopic liver transplantation offers the only hope for patients who develop end-stage liver disease. The treatment for liver disease is still disputed. Early results with OLT for hepatitis B were poor with recurrence rates of greater than 80%. However, recent studies have found that continuous high dose IV (intravenous) hepatitis B immune globulin (HBIG) can decrease the rate of reinfection to less than 20%. However, high dose HBIG is very expensive (total charges for the first year can exceed $100,000) and the efficacy is low in patients with replicative infection prior to OLT. Lamivudine, an oral treatment was recently approved for hepatitis B and several studies suggest that lamivudine can prevent recurrent hepatitis B post-OLT, however drug resistance develops with long duration of therapy. Because HBIG and lamivudine have different mechanisms of action, combination therapy may be more effective than either agent alone. This study will run concurrently with two other prospective clinical trial which administer different doses and combinations of post-OLT drug therapy for the prevention of hepatitis B. The purpose of this study is the development and maintenance of a observational database to capture data from all patients transplanted for hepatitis B at all participating centers. The database will enable the researchers to address research questions that are not included in either of the focused clinical trials and collect information on patients with hepatitis B that do not qualify or do not consent to participation in either clinical trial. The database will be comprised of three components: 1) retrospective data from a chart review, 2) prospectively collected data, and 3) serum and liver tissue values collected throughout the study. All eligible research subjects will be given an overview of the study and asked to sign the informed consent form to indicate their willingness for participation. Participants will then be monitored during their normal clinic visits. An extra blood or tissue samples may be taken during the usual visits and these samples sent to the PI's lab for analysis.