Prevention of Recurrent Hepatitis B After Liver Transplantation
Status:
Completed
Trial end date:
2007-11-01
Target enrollment:
0
Participant gender:
All
Summary
Hepatitis B accounts for approximately 5000 deaths per year in the United States. Liver
transplantation offers the only hope for patients who develop end-stage liver disease. Early
results of liver transplantation for hepatitis B were poor with recurrence rate of 80% and
1-year survival of only 50%. Recent studies found that preventive therapy using hepatitis B
immune globulin (HBIG) or antiviral medications such as lamivudine can reduce the recurrence
rate to roughly 30% with accompanying improvement in survival. However, HBIG when given as
intravenous infusion in high doses is very expensive, while long-term use of lamivudine is
associated with drug resistance. Some studies found that preventive therapy using both HBIG
and lamivudine may decrease recurrence rate to less than 10% but the dose and duration of
HBIG needed when used in combination with lamivudine is not clear. Adefovir, a new antiviral
medication, is effective against lamivudine resistant hepatitis B but its role in liver
transplantation is uncertain because of the risk of kidney damage. Many studies showed that
the risk of recurrent hepatitis B is related to the viral load before transplant. Thus, it
may be possible to tailor the preventive therapy according to the risk. The aim of this study
is to establish the most cost-effective preventive therapy for recurrent hepatitis B after
liver transplantation.
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)