Last Updated: 2011-01-28 18:16:11 -0400 (Reuters Health)
NEW YORK (Reuters Health) - Hepatitis B prophylaxis may be safely withdrawn after liver transplantation in patients at low risk of hepatitis B virus (HBV) recurrence, researchers from Italy report in the January 18th online issue of the Journal of Hepatology.
Twenty-five of the 30 patients (83.3%) showed no signs of HBV recurrence a median 28.7 months (range, 22-42 months) after withdrawal of prophylaxis.
In an earlier report, these investigators identified a cohort of patients liver transplanted more than 5 years earlier, who were HBeAg-negative and with undetectable HBV-DNA at transplant and had undetectable intrahepatic total and covalently closed circular DNA at follow-up.
This prompted Dr. Ilaria Lenci and colleagues from Tor Vergata University in Rome to investigate whether indefinite continuation of HBV prophylaxis was really necessary in this selected group of 30 patients or whether cautious withdrawal could be attempted.
Lamivudine was used for HBV prophylaxis, which commonly causes side effects that include nausea, vomiting, diarrhea, dizziness and headaches.
Among the other 5 patients in the study, 1 returned to HBsAg-negative status promptly after reinstitution of anti-hepatitis B immunoglobulin (HBIg) treatment, 1 required reinstitution of both HBIg and tenofovir, and 3 had only transient, short-term HBsAg serum positivity and always remained HBV-DNA-negative.
Only the patient who became HBsAg-positive after HBIg withdrawal had HBV DNA in liver tissue obtained after withdrawal of prophylaxis, and this patient was the only one who had active viral replication as evidenced by detectable serum HBV-DNA.
There were no significant predictors of HBV recurrence, including time after liver transplantation and type of maintenance immunosuppression.
"Although preliminary and based on a relatively small number of cases, our findings may have significant implications in relation to the definition of HBV recurrence and the use of new virological tools in this setting, and could be regarded as a proof-of-concept in relation to their clinical relevance," the researchers explain.
"Cautious HBV prophylaxis withdrawal in long-term liver transplant survivors at low risk of HBV recurrence is feasible and safe in clinical practice, is associated with low rate of HBV recurrence after 2 years of follow-up, and results in considerable cost reduction," they conclude.
"Further studies with extended follow-up are needed to evaluate whether these findings may have an impact on the current clinical practice."
SOURCE: http://bit.ly/gluhbK
J Hepatol 2011
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