Randomized trial of lamivudine versus hepatitis B immunoglobulin for long-term prophylaxis of hepatitis B recurrence after liver transplantation

Background/Aims: The long-term prophylaxis of hepatitis B after liver trans plantation requires further optimization. In a randomized trial we investig ated a regimen where the initially given hepatitis B immunoglobulin (HBIg) is replaced by long-term lamivudine treatment. Methods: Twenty-four liver transplant recipients (all HBsAg-positive/HBV DN A-negative before transplantation), who had received HBIg for at least 6 mo nths without HBV recurrence, were randomized to receive lamivudine (n = 12) or HBIg (n = 12) for 52 weeks. The efficacy criteria involved seronegativi ty for HBsAg and undetectable HBsAg/ HBcAg in the liver. Results: Twenty-one of 24 patients completed the study without hepatitis B virus (HBV) recurrence (11 on HBIg, ten on lamivudine), while three patient s became HBsAg-positive. Amongst those without HBV recurrence HBV DNA was d etectable only by polymerase chain reaction, intermittently in serum and ly mphocytes, and in liver specimens from six of eight patients receiving HBIg and five of seven receiving lamivudine. YMDD variant was found in four cas es with no viral antigen expression. Eight patients continued lamivudine af ter the study and during an additional 6-22 months remained HBsAg-negative with normal graft function. Conclusions: Substitution of HBIg with lamivudine is effective for preventi on of HBV recurrence in low-risk liver transplant recipients and offers a c onvenient and cost-effective alternative for long-term HBV prophylaxis. (C) 2001 European Association for the Study of the Liver. Published by Elsevie r Science B.V. All rights reserved.