Medical Advocates
 Fosamprenavir (Lexiva/GW433908)
 


 		 Journal Papers, Abstracts, and
Commentaries
General Reports
 Safety
Pharmacokinetics
Drug/Drug Interactions
 Drug Comparison Studies
Diagnostics/Monitoring
 Viral Dynamics 
 Adverse Events
 Resistance
 Adolescent/Adult Treatment
 Therapeutic Strategies
 		  
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Last Update:  February 16, 2015
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General Reports
     
 
High viral load, previous fosamprenavir use and more recent HIV diagnosis correlate with darunavir failure in salvage therapy in Sao Paulo, Brazil.
Schöntag M, Tenore S, Ferreira P,  et al
 J Int AIDS Soc. 2012 Nov 11;15(6):18269.
Abstract

Food-dependent disintegration of immediate release fosamprenavir tablets: In vitro
evaluation using magnetic resonance imaging and a dynamic gastrointestinal system.
Brouwers J, Anneveld B, Goudappel GJ,  et a
Eur J Pharm Biopharm. 2011 Feb;77(2):313-9
 Abstract

Food-dependent disintegration of immediate release fosamprenavir tablets: In vitro evaluation
using magnetic resonance imaging and a dynamic gastrointestinal system.
 Brouwers J, Anneveld B, Goudappel GJ, et al
Eur J Pharm Biopharm. 2010 Nov 3.
 Abstract

Effect of boosted fosamprenavir or lopinavir-based combinations on whole-body insulin
sensitivity and lipids in treatment-naive HIV-type-1-positive men.
Randell PA, Jackson AG, Boffito M,  et al
Antivir Ther. 2010;15(8):1125-1132
 Abstract

Electrochemical evaluation and determination of antiretroviral drug fosamprenavir using boron-doped
diamond and glassy carbon electrodes.
Gumustas M, Ozkan SA.
Anal Bioanal Chem. 2009 Dec 10.
 Abstract

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
Safety
     
  Long-Term Safety Study of Fosamprenavir-Containing Regimens in HIV-1-Infected Patients.
Wood R, Gathe JC, Givens N,  et al
 HIV Clin Trials. 2013 Sep-Oct;14(5):183-91
 Abstract

Hepatic Safety Profile of Fosamprenavir-Containing Regimens in HIV-1-Infected Patients With |
or Without Hepatitis B or C Coinfection.
Ha B, Wine B, Rodriguez-Alcantra F, Shaefer M.
HIV Clin Trials. 2012 May-Jun;13(3):171-
 Abstract

Safety of Fosamprenavir in a Cohort of HIV-1-infected Patients with Co-morbidities.
Esposito V, Chiodini P, Viglietti R,  et al 
In Vivo. 2011 Sep-Oct;25(5):813-9.
 Abstract
Pharmacokinetics
     
 
Pharmacokinetics of concurrent administration of fosamprenavir and atazanavir without ritonavir in
human immunodeficiency virus-negative subjects.
McRae M, Clay PG, Anderson PL, Glaros AG.
Pharmacotherapy. 2009 Aug;29(8):937-42.
 Abstract

Steady-State Amprenavir, Tenofovir, and Emtricitabine Pharmacokinetics Before and After
Reducing Ritonavir Boosting of a Fosamprenavir/Tenofovir/Emtricitabine Regimen from 200
mg to 100 mg Once Daily (TELEX II).
Parks DA, Jennings HC, Taylor C, et al 
HIV Clin Trials. 2009 May-Jun;10(3):160-7.
 Abstract

Unboosted fosamprenavir is associated with low drug exposure in HIV-infected patients with
mild-moderate liver impairment resulting from HCV-related cirrhosis.
Gatti F, Nasta P, Loregian A, Puoti M, et al
J Antimicrob Chemother. 2009 Jan 16.
 Abstract
 
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
     
 
Pharmacokinetic Interaction between Maraviroc and Fosamprenavir-Ritonavir: an Open-Label, Fixed-Sequence Study in Healthy Subjects.
Vourvahis M, Plotka A, Mendes da Costa L, et al
Antimicrob Agents Chemother. 2013 Dec;57(12):6158-64.
 Abstract

Pharmacokinetic Interaction between Maraviroc and Fosamprenavir/Ritonavir: An Open-Label. Fixed Sequence Study pm Health Individuals
Vourvahis M, Plotka A, Mendes da Costa L, et al  
Antimicrob Agents Chemother. 2013 Sep 30
 Abstract

Interactions Between Buprenorphine and the Protease Inhibitors Darunavir-Ritonavir and
Fosamprenavir-Ritonavir
Gruber VA, Rainey PM, Moody DE,  et al
Clin Infect Dis. 2011 Nov 18.
 Abstract

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
 
Fosamprenavir/Ritonavir vs Lopinavir
 
  A WEEK-IN-REVIEW FEATURED REPORT
Long-Term Efficacy and Safety of Fosamprenavir plus Ritonavir Versus Lopinavir/Ritonavir
in Combination with Abacavir/Lamivudine over 144 Weeks.
Pulido, Estrada, Baril, Logue, Schewe, et al 
HIV Clin Trials. 2009 Mar-Apr;10(2):76-87
 Abstract
Diagnostics/Monitoring
     
  Stability-Indicating HPLC Method for Determination of Fosamprenavir Calcium.
Chilukuri M, Narayanareddy P, Hussianreddy K.
J Chromatogr Sci. 2013 Jul 25.
 Abstract
Viral Dynamics
     
  A WEEK-IN-REVIEW FEATURED REPORT
Viral response in stable patients switching to fosamprenavir/ritonavir monotherapy (the FONT Study).
Saumoy M, Tiraboschi J, Gutierrez M, Niubó J, et al
HIV Med. 2011 Aug;12(7):438-41.
 Abstract
Adverse Events
     
 
FULL-TEXT PDF ARTICLE
 Evaluation of cardiovascular biomarkers in a randomized trial of fosamprenavir/ritonavir vs. efavirenz with abacavir/lamivudine in underrepresented, antiretroviral-naive, HIV-infected patients (SUPPORT): 96-week results.
Kumar P, Dejesus E, Huhn G, et al
BMC Infect Dis. 2013 Jun 7;13(1):269.
Paper

A WEEK-IN-REVIEW FEATURED REPORT
Liver Toxicity of Antiretroviral Combinations Including Fosamprenavir Plus Ritonavir 1400/100 mg
Once Daily in HIV/Hepatitis C Virus-Coinfected Patients.
Merchante N, López-Cortés LF, Delgado-Fernández M,  et al
AIDS Patient Care STDS. 2011 Jun 20.
Abstract

Changes in lipid profiles after switching to a protease inhibitor-containing cART--unfavourable effect of
fosamprenavir in obese patients.
Gyalrong-Steur M, Bogner JR, Seybold
Eur J Med Res. 2011 Feb 24;16(2):85-92
Abstract

A WEEK-IN-REVIEW FEATURED REPORT
Adverse Reactions of Atazanavir, Fosamprenavir and Tipranavir in "Real Life"
 Balayssac E, Autret-Leca E, Jonville-Béra AP, et al
Therapie. 2010 3-4;65(2):121-128.
Abstract

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
     
 
Genotypic resistance analysis of the virological response to fosamprenavir/ritonavir in protease
inhibitor-experienced patients in CONTEXT and TRIAD clinical trials.
Marcelin AG, Flandre P, Molina JM, et al  
Antimicrob Agents Chemother. 2008 Oct 13.
 Abstract
 
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
 
 
Long-term efficacy and safety of once-daily fosamprenavir 1400 mg boosted by ritonavir 100 mg:
the BOLD100 study.
Blick G, Greiger-Zanlungo P, Gretz S,  et al
Int J STD AIDS. 2012 Mar;23(3):e18-e22
 Abstract

Similar Virologic and Immunologic Efficacy With Fosamprenavir Boosted With 100 mg or 200 mg
of Ritonavir in HIV-Infected Patients: Results of the LESS Trial.
Cohen C, Dejesus E, Lamarca A, et al
HIV Clin Trials. 2010 Sep-Oct;11(5):239-47
 Abstract

Impact of low abundance HIV variants on response to ritonavir-boosted atazanavir or
fosamprenavir given once daily with tenofovir/emtricitabine in antiretroviral-naive
HIV-infected patients.
Ross LL, Weinberg WG, DeJesus E,  et al 
AIDS Res Hum Retroviruses. 2010 Apr;26(4):407-17.
 Abstract

Study of Once-Daily Versus Twice-Daily Fosamprenavir plus Ritonavir Administered with
Abacavir/Lamivudine Once Daily in Antiretroviral-Naďve HIV-1-Infected Adult Subjects.
Carosi, Lazzarin, Stellbrink, Moyle, Rugina, et al  
HIV Clin Trials. 2009 Nov-Dec;10(6):356-67
 Abstract

Efficacy and safety of boosted and unboosted atazanavir-containing antiretroviral regimens in real life:
results from a multicentre cohort study.
Giuntini R, Martinelli C, Ricci E, et al  
 HIV Med. 2009 Aug 3.
 Abstract

A WEEK-IN-REVIEW FEATURED REPORT
Fosamprenavir/ritonavir in advanced HIV disease (TRIAD): a randomized study
of high-dose, dual-boosted or standard dose fosamprenavir/ritonavir in HIV-1-infected
patients with antiretroviral resistance.
Molina JM, Ait-Khaled M, Rinaldi R, et al 
J Antimicrob Chemother. 2009 Jun 10
 Abstract

Comparison of once-daily fosamprenavir boosted with either 100 or 200 mg of ritonavir, in combination with
abacavir/lamivudine: 96-week results from COL100758.
Hicks CB, DeJesus E, Sloan LM, et al 
AIDS Res Hum Retroviruses. 2009 Apr;25(4):395-403.
 Abstract

Comparison of Once-Daily Fosamprenavir Boosted with Either 100 or 200 mg of Ritonavir,
in Combination with Abacavir/Lamivudine: 96-Week Results from COL100758.
Hicks CB, Dejesus E, Sloan LM, et al  
 AIDS Res Hum Retroviruses. 2009 Mar 25.
 Abstract
 
Fosamprenavir (GW433908)/ritonavir in HIV-infected patients: efficacy and safety results from the
Spanish Expanded Access Program.
Pérez-Elias MJ, Sánchez-Conde M, Soriano V, et al 
Enferm Infecc Microbiol Clin. 2009 Jan;27(1):28-32
 Abstract
 
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
     
 
A WEEK-IN-REVIEW FEATURED REPORT
Fosamprenavir treatment in a highly active antiretroviral therapy schedule induces a
HCV-RNA decrease and a Th1 network boost in HIV/HCV-coinfected patients.
Perrella A, Sbreglia C, D'Antonio A, et al 
Clin Microbiol Infect. 2009 Jul 20.
 Abstract

Pharmacokinetics of Fosamprenavir plus Ritonavir in HIV-1-infected Adult Subjects
with Hepatic Impairment.
Perez-Elias MJ, Larrousse Morellon M, et al
Antimicrob Agents Chemother. 2009 Aug 10.
 Abstract

Drop in trough blood concentrations of tacrolimus after switching from nelfinavir to fosamprenavir i
n 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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