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Pharmacokinetics of Maribavir, a Novel Oral Anticytomegalovirus Agent, in Subjects With Varying Degrees of Renal Impairment

From Hennepin County Medical Center, Minneapolis, Minnesota (Dr Swan); New Orleans Center for Clinical Research, New Orleans, Louisiana (Dr Smith); Orlando Clinical Research Center, Orlando, Florida (Dr Marbury); and ViroPharma Incorporated, Exton, Pennsylvania (Ms Schumacher, Ms Dougherty, Dr Mico, Dr Villano).

The effect of renal function on the pharmacokinetics of maribavir, a novel anticytomegalovirus agent, was evaluated in 12 adults with normal renal function (creatinine clearance [CrCl] >80 mL/min) and 19 adults with renal impairment classified as mild (n = 5), moderate (n = 5), or severe (n = 9), as measured by CrCl 50-80, 30-49, and <30 mL/min, respectively. After a single oral dose of maribavir 400 mg, the pharmacokinetics of maribavir, based on total and unbound plasma concentrations, showed no statistically significant difference between subjects with normal renal function and subjects with mild/moderate or severe renal impairment. Renal impairment was associated with an increase in area under the plasma concentration-time curve (AUC) values for an inactive metabolite of maribavir, VP 44469. Results were consistent with those of previous studies, which showed that very little maribavir was excreted unchanged in urine, whereas about 22% of an oral dose of maribavir is recovered in urine as VP 44469.

Key Words: Maribavir • renal insufficiency • cytomegalovirus • pharmacokinetics

Address for reprints: Address for correspondence: Stephen A. Villano, MD, ViroPharma Incorporated, 397 Eagleview Boulevard, Exton, PA 19341; e-mail: stephen.villano{at}viropharma.com.

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