A multicenter study of lamivudine treatment in 33 patients with hepatitis B after liver transplantation

Hepatitis B virus (HBV) infection after liver transplantation (LT) may lead to severe and rapidly progressive graft failure. Antiviral treatment may b e of benefit in selected patients with recurrent hepatitis B post-LT, The a im of this prospective open-label study is to determine the safety and effi cacy of lamivudine in 33 liver transplant recipients with active HBV infect ion. The median time from LT to study enrollment was 51 months, all patient s were hepatitis B surface antigen positive, and 75% and 94% of subjects ha d detectable hepatitis B e antigen (HBeAg) and HBV DNA at entry, respective ly. The median duration of lamivudine treatment on study was 85 weeks, duri ng which time median HBV DNA levels became undetectable by 16 weeks and 9% of patients lost previously detectable HBeAg. Serum alanine aminotransferas e (ALT) levels improved in most patients and normalized in 27% of patients with elevated values pretreatment, Serum bilirubin and albumin levels signi ficantly improved in patients with abnormal values at entry (P < .05), Viro logical breakthrough was detected in 13 subjects after a median of 61 weeks of lamivudine treatment and was confirmed to be caused by YMDD mutants in all patients tested. None of the patients with virological breakthrough sho wed a complete loss of clinical response to lamivudine, Serum ALT and bilir ubin levels in patients with and without virological breakthrough were not significantly different at last study follow-up. Study results show that la mivudine is safe and effective in liver transplant recipients with recurren t hepatitis B, However, the high rate of virological breakthrough with prol onged therapy indicates the need for further studies of combination antivir al therapy in this patient population. Our results and others further estab lish the improving long-term outcomes with LT for patients with hepatitis B through advances in prevention of reinfection, as well as the availability of safe and effective antiviral therapies to treat patients with HBV recur rence.