Single dose pharmacokinetics of lamivudine in subjects with impaired renal function and the effect of haemodialysis

Br J Clin Pharmacol. 1998 Jul;46(1):21-7. doi: 10.1046/j.1365-2125.1998.00044.x.


Aims: The purpose of this study was to investigate the pharmacokinetics of a single oral dose of lamivudine administered to subjects with renal impairment and to determine whether lamivudine was dialysable in subjects with severe renal impairment undergoing haemodialysis.

Methods: Twenty-nine subjects were enrolled, nine with normal renal function (creatinine clearance (CL(CR)) 82-117 ml min(-1)), eight with moderately impaired renal function (CL(CR) 25-49 ml min(-1)), six with severe impairment (CL(CR) 13-19 ml min(-1)) and six with severe impairment who were also receiving haemodialysis. After an overnight fast, nondialysis subjects received a single oral dose of lamivudine. Subjects on haemodialysis were given two doses on separate occasions (intra and interdialysis). Blood was obtained before lamivudine administration and at regular intervals to 48 h post dose. Timed urine collections were performed for subjects able to produce urine. Pharmacokinetic parameters were calculated by using standard non compartmental techniques.

Results: Decreasing renal function was associated with reduced lamivudine clearance in a proportional and apparently linear relationship. Lamivudine was well dialysed with an extraction ratio in the order of 50%. However, because lamivudine has a large volume of distribution (approximately 100 1), a haemodialysis session of 4 h did not affect overall exposure to a clinically significant degree in most subjects.

Conclusions: Impaired renal function does require lamivudine dose modification according to the degree of impairment, but no further modification of dose is required for subjects undergoing regular haemodialysis.

MeSH terms

  • Adolescent
  • Adult
  • Aged
  • Female
  • Humans
  • Kidney / drug effects
  • Kidney / physiopathology*
  • Kidney Failure, Chronic / physiopathology
  • Kidney Failure, Chronic / therapy
  • Lamivudine / administration & dosage
  • Lamivudine / pharmacokinetics*
  • Male
  • Middle Aged
  • Renal Dialysis*
  • Reverse Transcriptase Inhibitors / administration & dosage
  • Reverse Transcriptase Inhibitors / pharmacokinetics*


  • Reverse Transcriptase Inhibitors
  • Lamivudine