tetano
Editor, Senior Moderator
Antimicrob Agents Chemother. 2015 Aug 17. pii: AAC.00799-15. [Epub ahead of print]
[h=1]Population Pharmacokinetics of Peramivir in Healthy Volunteers and Influenza Patients.[/h] Matsuo Y[SUP]1[/SUP], Ishibashi T[SUP]1[/SUP], Hollister AS[SUP]2[/SUP], Wajima T[SUP]3[/SUP].
[h=3]Author information[/h]
[h=3]Abstract[/h] Peramivir is an intravenous anti-influenza agent that inhibits viral growth by selectively inhibiting neuraminidase in human influenza A and B virus. To characterize its pharmacokinetics, population pharmacokinetic analysis of peramivir was performed using 3199 plasma concentration data samples from 332 subjects in six clinical studies in Japan and the US, including studies with renal impairment subjects, elderly subjects and influenza patients. A three-compartment model well described the plasma concentration data of peramivir, and creatinine clearance was found to be the most important factor influencing clearance. Age and body weight were also found to be covariates for clearance and volume of distribution[SUB],[/SUB] respectively. No pharmacokinetic difference was found between genders or between Japanese and US subjects. Small pharmacokinetic differences were observed between uninfected subjects and influenza patients (clearance was 18% higher and volume of distribution was 6% lower in influenza patients). Monte-Carlo simulations indicated that single adjusted doses of 1/3- and 1/6-fold for patients with moderate and severe renal impairment, respectively, would give AUCs comparable to that for patients with normal renal function. The population pharmacokinetic model developed for peramivir should be useful for understanding its pharmacokinetic characteristics and for dose adjustment based on renal function.
Copyright ? 2015, American Society for Microbiology. All Rights Reserved.
PMID: 26282420 [PubMed - as supplied by publisher]
[h=1]Population Pharmacokinetics of Peramivir in Healthy Volunteers and Influenza Patients.[/h] Matsuo Y[SUP]1[/SUP], Ishibashi T[SUP]1[/SUP], Hollister AS[SUP]2[/SUP], Wajima T[SUP]3[/SUP].
[h=3]Author information[/h]
[h=3]Abstract[/h] Peramivir is an intravenous anti-influenza agent that inhibits viral growth by selectively inhibiting neuraminidase in human influenza A and B virus. To characterize its pharmacokinetics, population pharmacokinetic analysis of peramivir was performed using 3199 plasma concentration data samples from 332 subjects in six clinical studies in Japan and the US, including studies with renal impairment subjects, elderly subjects and influenza patients. A three-compartment model well described the plasma concentration data of peramivir, and creatinine clearance was found to be the most important factor influencing clearance. Age and body weight were also found to be covariates for clearance and volume of distribution[SUB],[/SUB] respectively. No pharmacokinetic difference was found between genders or between Japanese and US subjects. Small pharmacokinetic differences were observed between uninfected subjects and influenza patients (clearance was 18% higher and volume of distribution was 6% lower in influenza patients). Monte-Carlo simulations indicated that single adjusted doses of 1/3- and 1/6-fold for patients with moderate and severe renal impairment, respectively, would give AUCs comparable to that for patients with normal renal function. The population pharmacokinetic model developed for peramivir should be useful for understanding its pharmacokinetic characteristics and for dose adjustment based on renal function.
Copyright ? 2015, American Society for Microbiology. All Rights Reserved.
PMID: 26282420 [PubMed - as supplied by publisher]