EFFICACY AND SAFETY OF LAMIVUDINE ON REPLICATION OF RECURRENT HEPATITIS-B AFTER CADAVERIC RENAL-TRANSPLANTATION

Background. The aim of this pilot study was to evaluate the efficacy a nd the safety of lamivudine therapy in hepatitis B virus (HBV)-positiv e/DNA-positive renal transplant recipients, Methods. Six HBV DNA-posit ive cadaveric renal transplant recipients ranging in age from 49+/-6 y ears were administered lamivudine, at 100 mg/day for a period of at le ast 6 months, on a compassionate-use basis, Lamivudine is the (-) enan tiomer of 3'-thiacytidine, which is known to be a potent inhibitor of HBV replication, All of the patients but one were on cyclosporine-base d immunosuppression. Results. The mean serum creatinine was 134+/-44 m u mol/L. The mean duration of HBV infection was 230+/-54 months (156-2 88). All of the patients but one had high serum alanine aminotransfera se levels (122+/-52 IU/L; range, 45-243). Histological evaluation show ed the presence of either chronic active hepatitis (n=4) or cirrhosis (n=2). All of the patients but one were hepatitis B e antigen negative /hepatitis B e antibody positive, but none were coinfected with either hepatitis C virus or hepatitis D virus. Conclusions. Lamivudine thera py was associated with (i) a normalization of alanine aminotransferase levels in four of five patients when these levels were increased at t he beginning (n=5); (ii) a rapid disappearance of HBV DNA from the ser um (detected by hybridization) in all of the patients; (iii) the negat ivity of HBV DNA by polymerase chain reaction in four patients; and (i v) no change in renal function and in proteinuria when present (one pa tient), Finally, no adverse effects were noted. When lamivudine therap y was stopped for four patients after 6 months, it was associated with a biochemical and virological relapse within the weeks that followed. Lamivudine therapy was therefore resumed for these patients.