HOME HELP FEEDBACK SUBSCRIPTIONS ARCHIVE SEARCH TABLE OF CONTENTS		QUICK SEARCH:   [advanced] Author: Keyword(s): Year:  Vol:  Page:
Sign In to gain access to subscriptions and/or personal tools.

This Article Full Text Full Text (PDF) Alert me when this article is cited Alert me if a correction is posted Citation Map Services Email this article to a friend Similar articles in this journal Similar articles in ISI Web of Science Similar articles in PubMed Alert me to new issues of the journal Download to citation manager Request Permissions Request Reprints Citing Articles Citing Articles via HighWire Citing Articles via ISI Web of Science (1) Citing Articles via Google Scholar Google Scholar Articles by Damle, B. Articles by Petersen, A. Search for Related Content PubMed PubMed Citation Articles by Damle, B. Articles by Petersen, A. Social Bookmarking                   What's this?

Pharmacokinetics of Nelfinavir in Subjects With Hepatic Impairment

From Pfizer Inc, New York, New York (Dr Damle, Dr Hewlett), and La Jolla, California (Dr Hsyu, Dr Becker, Dr Petersen).

HIV-seronegative subjects with hepatic impairment (6 mild, 6 moderate) and 12 matched healthy controls received nelfinavir 1250 mg every 12 hours with food for 2 weeks. Mild impairment did not significantly change nelfinavir or major metabolite (M8) steady-state exposures compared with controls. In subjects with moderate impairment, steady-state area under the plasma concentration time-curve over the dosing interval and maximum observed plasma concentrations were 62% and 22% higher for nelfinavir than for controls, and for M8 were 46% and 35% of control values. With increasing degree of impairment, no trend toward increase in unbound nelfinavir was observed, but there was an increase in unbound M8 levels. Nelfinavir was safe and well tolerated. One subject with moderate impairment was discontinued because of transient leucopenia. Observed changes are unlikely to affect nelfinavir efficacy or markedly influence safety. Dose reduction of nelfinavir does not appear necessary for subjects with mild/moderate impairment. Further long-term evaluations of nelfinavir pharmacokinetics and safety in HIV-seropositive subjects with hepatic impairment may be useful.

Key Words: Pharmacokinetics • nelfinavir • M8 • hepatic function

Address for reprints: Bharat Damle, PhD, Pfizer Global Research & Development, Pfizer Inc, 685 Third Avenue, Mail Stop 685/19/08, New York, NY 10017; e-mail: bharat.damle{at}pfizer.com.

CiteULike    Connotea    Del.icio.us    Digg    Reddit    Technorati    What's this?

This article has been cited by other articles:

				B. Damle, C. Fosser, K. Ito, A. Tran, P. Clax, H. Uderman, and P. Glue Effects of Standard and Supratherapeutic Doses of Nelfinavir on Cardiac Repolarization: A Thorough QT Study J. Clin. Pharmacol., March 1, 2009; 49(3): 291 - 300. [Abstract] [Full Text] [PDF]

				G. Guaraldi, S. Cocchi, A. Motta, S. Ciaffi, M. Codeluppi, S. Bonora, F. Di Benedetto, M. Masetti, M. Floridia, S. Baroncelli, et al. A pilot study on the efficacy, pharmacokinetics and safety of atazanavir in patients with end-stage liver disease J. Antimicrob. Chemother., December 1, 2008; 62(6): 1356 - 1364. [Abstract] [Full Text] [PDF]