Efficacy and safety of lamivudine on replication of recurrent hepatitis B after cadaveric renal transplantation

Transplantation. 1997 Dec 15;64(11):1624-7. doi: 10.1097/00007890-199712150-00025.

Abstract

Background: The aim of this pilot study was to evaluate the efficacy and the safety of lamivudine therapy in hepatitis B virus (HBV)-positive/DNA-positive renal transplant recipients.

Methods: Six HBV DNA-positive cadaveric renal transplant recipients ranging in age from 49+/-6 years were administered lamivudine, at 100 mg/day for a period of at least 6 months, on a compassionate-use basis. Lamivudine is the (-) enantiomer of 3'-thiacytidine, which is known to be a potent inhibitor of HBV replication. All of the patients but one were on cyclosporine-based immunosuppression.

Results: The mean serum creatinine was 134+/-44 micromol/L. The mean duration of HBV infection was 230+/-54 months (156-288). All of the patients but one had high serum alanine aminotransferase levels (122+/-52 IU/L; range, 45-243). Histological evaluation showed 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 therapy was associated with (i) a normalization of alanine aminotransferase levels in four of five patients when these levels were increased at the beginning (n=5); (ii) a rapid disappearance of HBV DNA from the serum (detected by hybridization) in all of the patients; (iii) the negativity of HBV DNA by polymerase chain reaction in four patients; and (iv) no change in renal function and in proteinuria when present (one patient). Finally, no adverse effects were noted. When lamivudine therapy 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.

Publication types

  • Clinical Trial

MeSH terms

  • Antiviral Agents / therapeutic use*
  • Cyclosporine / therapeutic use
  • Female
  • Hepatitis B / drug therapy*
  • Hepatitis B / transmission
  • Hepatitis B virus / physiology
  • Humans
  • Immunosuppressive Agents / therapeutic use
  • Kidney Transplantation / adverse effects*
  • Lamivudine / therapeutic use*
  • Liver Function Tests
  • Male
  • Middle Aged
  • Pilot Projects
  • Virus Replication

Substances

  • Antiviral Agents
  • Immunosuppressive Agents
  • Lamivudine
  • Cyclosporine