Medical Advocates
 Fosamprenavir (Lexiva/GW433908)
 


 		 Journal Papers, Abstracts, and
Commentaries
General Reports
Pharmacokinetics
Drug/Drug Interactions
 Drug Comparison Studies
 Adverse Events
 Resistance
 Adolescent/Adult Treatment
 Therapeutic Strategies

 		  
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Last Update:  September 16, 2008
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General Reports
     
 
A WEEK IN REVIEW FEATURED REPORT
Evaluation of Sex Differences of Fosamprenavir (With and Without Ritonavir) in HIV-Infected Men
and Women.
Hoffman RM, Umeh OC, Garris C, et al 
HIV Clin Trials. 2007 Nov-Dec;8(6):371-80.
 Abstract
 
A WEEK-IN-REVIEW FEATURED REPORT
Fosamprenavir calcium plus ritonavir for HIV infection.
Torres HA, Arduino RC. 
Expert Rev Anti Infect Ther. 2007 Jun;5(3):349-63.
 Abstract

A WEEK-IN-REVIEW FEATURED REPORT
 Fosamprenavir: Drug Development for Adherence (CE) (July/August).
 Hester EK, Chandler HV, Sims KM, et al
 Ann Pharmacother. 2006 Jun 6;
 Abstract

Fosamprenavir: advancing HIV protease inhibitor treatment options.
 Becker S, Thornton L. 
Expert Opin Pharmacother. 2004 Sep;5(9):1995-2005
Abstract
Pharmacokinetics
     
  A WEEK-IN-REVIEW FEATURED REPORT
Fosamprenavir plus Ritonavir Increased Plasma Ketoconazole and Ritonavir Exposure while
Amprenavir Exposure remained Unchanged.
Wire MB, Ballow CH, Borland J, et al
Antimicrob Agents Chemother. 2007 May 21;
Abstract

 A WEEK-IN-REVIEW FEATURED REPORT
Parallel Monitoring of Plasma and Intraluminal Drug Concentrations in Man After Oral
Administration of Fosamprenavir in the Fasted and Fed State.
 Brouwers J, Tack J, Augustijns P.
Pharm Res. 2007 Apr 19;
Abstract
 
A WEEK-IN-REVIEW FEATURED REPORT
 Interpretation of Genotype and Pharmacokinetics for Resistance to Fosamprenavir/ritonavir-Based
Regimens in Antiretroviral-Experienced Patients (Zephir Study).
Pellegrin I, Breilh D, Coureau G, et al
Antimicrob Agents Chemother. 2007 Feb 12;
Abstract
 
A WEEK-IN-REVIEW FEATURED REPORT
 Plasma Amprenavir Pharmacokinetics and Tolerability following Administration of Fosamprenavir
1400 mg Once Daily on Combination with either 100 mg OR 200 mg of Ritonavir in Healthy
Volunteers
Ruane PJ, Luber AD, Wire MB, et al 
Antimicrob Agents Chemother. 2006 Nov 6;
 Abstract

A WEEK-IN-REVIEW FEATURED REPORT
 Pharmacokinetic and safety evaluation of high-dose combinations of fosamprenavir and ritonavir.
 Shelton MJ, Wire MB, Lou Y, Adamkiewicz B, Min SS. 
Antimicrob Agents Chemother. 2006 Mar;50(3):928-34.
Abstract

Pharmacokinetics and safety of GW433908 and ritonavir, with and without efavirenz, in
healthy volunteers.
 Wire MB, Ballow C, Preston SL, et al
 AIDS. 2004 Apr 2;18(6):897-907.
 Abstract
 
Preclinical pharmacology and pharmacokinetics of GW433908, a water-soluble prodrug of the
human immunodeficiency virus protease inhibitor amprenavir.
 Furfine ES, Baker CT, Hale MR, et al
 Antimicrob Agents Chemother. 2004 Mar;48(3):791-8.
 Abstract
 
Six-week randomized controlled trial to compare the tolerabilities, pharmacokinetics, and antiviral
activities of GW433908 and amprenavir in human immunodeficiency virus type 1-infected patients.
 Wood R, Arasteh K, Stellbrink HJ, et al
 Antimicrob Agents Chemother. 2004 Jan;48(1):116-23.
 Abstract
 
Pharmacokinetics of GW433908, a prodrug of amprenavir, in healthy male volunteers.
Falcoz C, Jenkins JM, Bye C, et al
J Clin Pharmacol 2002 Aug;42(8):887-98
 Abstract
Drug/Drug Interactions
     
 
A WEEK IN REVIEW FEATURED REPORT
Pharmacokinetics and pharmacodynamics of methadone enantiomers after coadministration
with fosamprenavir-ritonavir in opioid-dependent subjects.
Cao YJ, Smith PF, Wire MB, Lou Y, et al 
Pharmacotherapy. 2008 Jul;28(7):863-74.
 Abstract
 
Effects of Atazanavir/Ritonavir or Fosamprenavir/Ritonavir on the Pharmacokinetics of Rosuvastatin.
 Busti AJ, Bain AM, Hall RG 2nd, et al  
J Cardiovasc Pharmacol. 2008 May 29.
 Abstract
 
Pharmacokinetic Interaction between Fosamprenavir/Ritonavir and Rifabutin in
Healthy Subjects.
Ford SL, Chen YC, Lou Y, et al 
Antimicrob Agents Chemother. 2007 Dec 3
Abstract
 
Amprenavir and lopinavir pharmacokinetics following coadministration of amprenavir or
fosamprenavir with lopinavir/ritonavir, with or without efavirenz.
Pham PA, Hendrix CW, Barditch-Crovo P, et al
Antivir Ther. 2007;12(6):963-9.
Abstract
 
Fosamprenavir/ritonavir plus tenofovir does not affect amprenavir pharmacokinetics: no effect of
tenofovir.
Kurowski M, Walli RK, Breske A, et al 
AIDS. 2007 Jun;21(10):1368-70.
Abstract
 
Interaction between Fosamprenavir, with and without Ritonavir, and Nevirapine in Human
Immunodeficiency Virus-Infected Subjects.
Dejesus E, Piliero PJ, Summers K, et al
Antimicrob Agents Chemother. 2006 Sep;50(9):3157-9
 Abstract
 
A WEEK-IN-REVIEW FEATURED REPORT
 Dose Separation Does Not Overcome the Pharmacokinetic Interaction between Fosamprenavir and
Lopinavir/Ritonavir.
Corbett AH, Patterson KB, Tien HC, et al 
Antimicrob Agents Chemother. 2006 Aug;50(8):2756-61.
 Abstract
 
Ritonavir Increases Plasma Amprenavir (APV) Exposure to a Similar Extent when Coadministered
with either Fosamprenavir or APV.
 Wire MB, Baker KL, Jones LS, et al  
 Antimicrob Agents Chemother. 2006 Apr;50(4):1578-80.
 Abstract
 
Effects of esomeprazole on the pharmacokinetics of atazanavir and fosamprenavir in a patient with
human immunodeficiency virus infection.
 Kiser JJ, Lichtenstein KA, Anderson PL, Fletcher CV.  
Pharmacotherapy. 2006 Apr;26(4):511-4.
Abstract
 
Combining fosamprenavir with lopinavir/ritonavir substantially reduces amprenavir
and lopinavir exposure: ACTG protocol A5143 results.
 Kashuba AD, Tierney C, Downey GF,
AIDS. 2005 Jan 28;19(2):145-152.
 Abstract
 
Effect of antacids and ranitidine on the single-dose pharmacokinetics of fosamprenavir.
 Ford SL, Wire MB, Lou Y,
Antimicrob Agents Chemother. 2005 Jan;49(1):467-9.
 Abstract
 
Drug Comparison Studies
     
Fosamprenavir vs Atazanavir
 
  FULL TEXT PDF ARTICLE
 Fosamprenavir or atazanavir once daily boosted with ritonavir 100mg, plus
tenofovir/emtricitabine, for the initial treatment of HIV infection: 48-week results of ALERT
 Smith KY, Weinberg WG, Dejesus E, et al
 AIDS Res Ther. 2008 Mar 28;5(1):5
Paper
Viral Dynamics
     
Adverse Events
     
  A WEEK-IN-REVIEW FEATURED REPORT
Amprenavir and ritonavir plasma concentrations in HIV-infected patients treated with
fosamprenavir/ritonavir with various degrees of liver impairment.
Seminari E, De Bona A, Gentilini G, et al
J Antimicrob Chemother. 2007 Aug 7;
Abstract
Resistance
     
 
Clinically validated mutation scores for HIV-1 resistance to fosamprenavir/ritonavir.
 Masquelier B, Assoumou KL, Descamps D, et al
J Antimicrob Chemother. 2008 Apr 4
 Abstract
 
A WEEK-IN-REVIEW FEATURED REPORT
 Interpretation of Genotype and Pharmacokinetics for Resistance to Fosamprenavir/ritonavir-Based
Regimens in Antiretroviral-Experienced Patients (Zephir Study).
 Pellegrin I, Breilh D, Coureau G, et al
Antimicrob Agents Chemother. 2007 Feb 12;
Abstract
Adolescent/Adult Indications
 
 
Efficacy and tolerability of a fosamprenavir-ritonavir-based versus a lopinavir-ritonavir-based
antiretroviral treatment in 82 therapy-nayive patients with HIV-1 infection.
Calza L, Manfredi R, Pocaterra D, Chiodo F
Int J STD AIDS. 2008 Aug;19(8):541-4.
Abstract
 
A WEEK IN REVIEW FEATURED REPORT
FULL TEXT PDF ARTICLE
 Fosamprenavir or atazanavir once daily boosted with ritonavir 100mg, plus
tenofovir/emtricitabine, for the initial treatment of HIV infection: 48-week results of ALERT
Smith KY, Weinberg WG, Dejesus E, et al
AIDS Res Ther. 2008 Mar 28;5(1):5
Abstract
 
Impact of nevirapine or efavirenz co-administration on ritonavir-boosted amprenavir
pharmacokinetics in HIV-infected patients.
Dailly E, Raffi F, Biron C, et al
 Fundam Clin Pharmacol. 2008 Feb;22(1):101-4
 Abstract
 
Combined use of paroxetine and fosamprenavir/ritonavir: an interaction study in healthy subjects.
van der Lee MJ, Blenke AA, Rongen GA,.et al
Antimicrob Agents Chemother. 2007 Sep 10;
 Abstract
 
Liver function parameters in HIV/HCV co-infected patients treated with amprenavir and ritonavir
and correlation with plasma levels.
Spagnuolo V, Gentilini G, De Bona A, et al
New Microbiol. 2007 Jul;30(3):279-82.
 Abstract
 
A WEEK-IN-REVIEW FEATURED REPORT
 The KLEAN study of fosamprenavir-ritonavir versus lopinavir-ritonavir, each in combination with
abacavir-lamivudine, for initial treatment of HIV infection over 48 weeks: a randomised non-inferiority
trial.
Eron J Jr, Yeni P, Gathe J Jr, et al 
Lancet. 2006 Aug 5;368(9534):476-82.
Abstract
 Also refer to Head-to-Head Study Comparing LEXIVA (fosamprenavir calcium) to Kaletra Presented at IAC 2006 and Published in The Lancet
GlaxoSmithKline  August 17, 2006
News Release
 
Long-Term (120-Week) antiviral efficacy and tolerability of fosamprenavir/ritonavir once daily in
therapy-naive patients with HIV-1 infection: An uncontrolled, open-label, single-arm follow-on
study.
Gathe JC Jr, Wood R, Sanne I, et al 
Clin/ Ther. 2006 May;28(5):745-54
 Abstract
 
SOLO: 48-week efficacy and safety comparison of once-daily fosamprenavir /ritonavir versus
twice-daily nelfinavir in naive HIV-1-infected patients.
Gathe JC Jr, Ive P, Wood R, et al
AIDS. 2004 Jul 23;18(11):1529-1537.
 Abstract
 
GW433908/ritonavir once daily in antiretroviral therapy-naive HIV-infected patients: absence
of protease resistance at 48 weeks.
MacManus S, Yates PJ, Elston RCm et al
AIDS. 2004 Mar 5;18(4):651-5.
 Abstract
 
The NEAT study: a 48-week open-label study to compare the antiviral efficacy and safety of
W433908 versus nelfinavir in antiretroviral therapy-naive HIV-1-infected patients.
 Rodriguez-French A, Boghossian J, et al
 J Acquir Immune Defic Syndr. 2004 Jan 1;35(1):22-32.
 Abstract
 
Therapeutic Strategies
     
  Drop in trough blood concentrations of tacrolimus after switching from nelfinavir to fosamprenavir in four HIV-infected
liver transplant patients
Pea F, Tavio M, Pavan F, Londero A. 
Antivir Ther. 2008;13(5):739-42.
 Abstract

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