Document Detail

Enfuvirtide does not require dose adjustment in patients with chronic kidney failure: results of a pharmacokinetic study of enfuvirtide in HIV-1-infected patients with impaired kidney function.
MedLine Citation:
PMID:  18091608     Owner:  NLM     Status:  MEDLINE    
OBJECTIVE: The aim of this study was to examine the influence of kidney disease and hemodialysis on the pharmacokinetics ofenfuvirtide.
DESIGN: An open-label, multicenter, parallel group study of HIV-1-infected patients with varying degrees of kidney dysfunction.
METHODS: A 90-mg dose of enfuvirtide was administered by subcutaneous injection to 3 groups of patients: group A, patients with normal kidney function; group B, patients with chronic kidney disease; and group C, patients with end-stage renal disease (ESRD) requiring dialysis. Patients with ESRD requiring dialysis received the 90-mg dose of enfuvirtide on 2 separate occasions; a dialysis day and a nondialysis day. After each dose, a full 48-hour pharmacokinetic profile was collected and pharmacokinetic parameters were estimated using model-independent techniques.
RESULTS: Enfuvirtide area under the curve (AUCinfinity) and maximum observed enfuvirtide plasma concentration (Cmax) for patients with normal kidney function (group A) was 49.6 microg h/mL and 3.79 microg/mL, respectively. Patients with chronic kidney disease (group B) had higher AUCinfinity (80.3 microg h/mL) and Cmax (5.72 microg/mL), which was similar to patients with ESRD (group C) on both nondialysis days (AUCinfinity 71.1 microg h/mL; Cmax 5.34 microg/mL) and dialysis days (AUCinfinity 66.9 microg h/mL; Cmax 6.31 microg/mL). An average of< 13% of enfuvirtide was removed during the dialysis procedure. The incidence of adverse events was comparable for all study groups.
CONCLUSION: Enfuvirtide exposure observed in patients with ESRD requiring dialysis or chronic kidney disease was slightly higher than in patients with normal kidney function and similar to historical Cmax and AUC values from studies in patients with normal kidney function. Thus, enfuvirtide does not require dosage adjustment in patients with impaired kidney function.
Pablo Tebas; Nicholas Bellos; Christopher Lucasti; Gary Richmond; Eliot Godofsky; Indravadan Patel; Yu-Yuan Chiu; Claire Evans; Lucy Rowell; Miklos Salgo
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Publication Detail:
Type:  Clinical Trial; Comparative Study; Journal Article; Multicenter Study; Research Support, N.I.H., Extramural; Research Support, Non-U.S. Gov't    
Journal Detail:
Title:  Journal of acquired immune deficiency syndromes (1999)     Volume:  47     ISSN:  1525-4135     ISO Abbreviation:  J. Acquir. Immune Defic. Syndr.     Publication Date:  2008 Mar 
Date Detail:
Created Date:  2008-04-09     Completed Date:  2008-04-24     Revised Date:  2013-11-25    
Medline Journal Info:
Nlm Unique ID:  100892005     Medline TA:  J Acquir Immune Defic Syndr     Country:  United States    
Other Details:
Languages:  eng     Pagination:  342-5     Citation Subset:  IM; X    
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MeSH Terms
Area Under Curve
Dose-Response Relationship, Drug
HIV Envelope Protein gp41 / pharmacokinetics*,  therapeutic use
HIV Fusion Inhibitors / pharmacokinetics,  therapeutic use
HIV Infections / drug therapy*,  metabolism
HIV-1 / drug effects*
Kidney / metabolism,  physiopathology
Kidney Failure, Chronic / physiopathology*,  therapy
Metabolic Clearance Rate
Peptide Fragments / pharmacokinetics*,  therapeutic use
Renal Dialysis
Grant Support
Reg. No./Substance:
0/HIV Envelope Protein gp41; 0/HIV Fusion Inhibitors; 0/Peptide Fragments; 19OWO1T3ZE/enfuvirtide

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine

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