Pharmacokinetics, safety, and tolerability of ribavirin in hemodialysis-dependent patients.
OBJECTIVE
This study describes the pharmacokinetics, safety, and tolerability of ribavirin in hemodialysis-dependent patients.


METHODS
Six adult patients (4 male, 2 female) were recruited from a hemodialysis clinic where they were receiving regular hemodialysis sessions. Patients received a single oral 400-mg dose of ribavirin (2 × 200-mg capsules) after an overnight fast. A 4-h hemodialysis session was performed between 6 and 10 h post-dose. Plasma and urinary concentrations of ribavirin were determined using validated high-performance liquid chromatography/tandem mass spectrometric methods.


RESULTS
Single oral doses of ribavirin 400 mg were safe and well tolerated in this population. Urinary excretion of ribavirin over 48 h was minimal (0.6 mg: approximately 0.14% of the dose). The mean amount removed during the 4-h hemodialysis session (9.6 mg) represented approximately 2.4% of the dose.


CONCLUSIONS
Ribavirin hemodialysis clearance (CLhd = 74.5 ml/min) represented approximately 50% of the renal clearance (CLr) measured in subjects with normal renal function (CLr = 129 ml/min).
Departments of Drug Metabolism, Merck Research Laboratory, Kenilworth, NJ, USA. samir.gupta@merck.com
Samir K
SK
Gupta
Bhavna
B
Kantesaria
Paul
P
Glue
D000328:Adult; D000998:Antiviral Agents / Q000097:blood / Q000493:pharmacokinetics* / Q000652:urine; D005260:Female; D006801:Humans; D007676:Kidney Failure, Chronic / Q000378:metabolism* / Q000628:therapy; D008297:Male; D008875:Middle Aged; D006435:Renal Dialysis; D012254:Ribavirin / Q000097:blood / Q000493:pharmacokinetics / Q000652:urine
D000998:Antiviral Agents; D012254:Ribavirin