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Enfuvirtide [T-20] (Fuzeon)
 
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Last updated:  August 26, 2008
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General Reports
 
 
A WEEK IN REVIEW FEATURED REPORT
Reassessment of enfuvirtide's role in the management of HIV-1 infection.
 Marr P, Walmsley S 
Expert Opin Pharmacother. 2008 Sep;9(13):2349-62.
 Abstract
 
Specific Enfuvirtide-Associated Mutational Pathways In HIV-1 Gp41 Are Significantly
Correlated With an Increase in CD4(+) Cell Count, Despite Virological Failure.
 Svicher V, Aquaro S, D'Arrigo R, et al 
J Infect Dis. 2008 Apr 15
Abstract
 
Mechanism-based model of the pharmacokinetics of enfuvirtide, an HIV fusion inhibitor.
 Mohanty U, Dixit NM. 
J Theor Biol. 2008 Apr 7;251(3):541-51.
 Abstract
 
Enfuvirtide effects on human erythrocytes and lymphocytes functional properties.
 Vieira CR, Castanho M, Saldanha C, Santos NC. 
J Pept Sci. 2008 Jan 14
 Abstract
 
T-20 and T-1249 HIV fusion inhibitors' structure and conformation in solution: a molecular
dynamics study.
 Martins Do Canto AM, Palace Carvalho AJ, Prates Ramalho JP, Loura LM. 
J Pept Sci. 2007 Dec 11
Abstract
 
CCR5 density levels on primary CD4 T cells impact the replication and Enfuvirtide susceptibility
of R5 HIV-1.
 Heredia A, Gilliam B, Devico A, et al 
AIDS. 2007 Jun;21(10):1317-22.
 Abstract
 
A WEEK-IN-REVIEW FEATURED REPORT
Spanish recommendations for proper use of enfuvirtide
 Ribera E, Moreno S, Viciana P, et al
Enferm Infecc Microbiol Clin. 2007 Feb;25(2):131-42.
 Abstract
 
A novel antiretroviral class (fusion inhibitors) in the management of HIV infection.
Present features and future perspectives of enfuvirtide (T-20).
 Manfredi R, Sabbatani S.  
 Curr Med Chem. 2006;13(20):2369-84.
Abstract
 
HIV-1 Coreceptor Use in Triple-Class Treatment-Experienced Patients: Baseline
Prevalence, Correlates, and Relationship to Enfuvirtide Response.
 Melby T, Despirito M, Demasi R,  
J Infect Dis. 2006 Jul 15;194(2):238-46.
 Abstract

Immunological Basis for IgE Hyper-Production in Enfuvirtide-Treated HIV- Positive Patients.
 Burastero SE, Paolucci C, Breda D, et al 
 J Clin Immunol. 2006 Apr 7;
 Abstract
 
Bioanalytical method development and validation for a large peptide HIV fusion inhibitor
(Enfuvirtide, T-20) and its metabolite in human plasma using LC-MS/MS.
 Chang D, Kolis SJ, Linderholm KH, et al 
Pharm Biomed Anal. 2005 Jul 1;38(3):487-96.
 Abstract
 
Enfuvirtide Is Active against HIV Type 1 Group O.
 Poveda E, Barreiro P, Rodes B, Soriano V. 
AIDS Res Hum Retroviruses. 2005 Jun;21(6):583-5
Abstract

Cost-Effectiveness of Enfuvirtide in Treatment-Experienced Patients With Advanced
HIV Disease.
 Sax PE, Losina E, Weinstein MC
 J Acquir Immune Defic Syndr. 2005 May 1;39(1):69-77
 Abstract

Enfuvirtide: the first HIV fusion inhibitor.
 Lazzarin A.  
Expert Opin Pharmacother. 2005 Mar;6(3):453-464.
 Abstract
 
Fuzeon, first of the so-called "fusion inhibitor" drug in new class of AIDS treatments and
its warnings
 Hayashi T
Nippon Rinsho. 2005 Jan;63(1):173-82.
 Abstract
 
Penetration of enfuvirtide, tenofovir, efavirenz, and protease inhibitors in the genital tract of
HIV-1-infected men.
Ghosn J, Chaix M-L, Peytavin G,
AIDS. 18(14):1958-1961, September 24, 2004.
Letter
 
Enfuvirtide
 Machala L. .
 Klin Mikrobiol Infekc Lek. 2004 Jun;10(3):114-117
 Abstract
 
Clinical management of treatment-experienced, HIV-infected patients with the fusion
inhibitor  enfuvirtide: consensus recommendations.
 Clotet B, Raffi F, Cooper D, et al.
AIDS. 2004 May 21;18(8):1137-1146.
 Abstract
 
Enfuvirtide: A fusion inhibitor for the treatment of HIV infection.
 Fung HB, Guo Y.
Clin Ther. 2004 Mar;26(3):352-78.
 Abstract
 
Enfuvirtide, a new fusion inhibitor for therapy of human immunodeficiency virus infection.
 Hardy H, Skolnik PR 
Pharmacotherapy. 2004 Feb;24(2):198-211.
 Abstract
 
Enfuvirtide (Fuzeon): the first fusion inhibitor.
 Williams IG.
 Int J Clin Pract. 2003 Dec;57(10):890-7
 Abstract
Enfuvirtide: A Novel Agent for the Treatment of HIV-1 Infection
Duffalo ML, James CW.
Ann Pharmacother. 2003 Oct;37(10):1448-56.
 Abstract
 
Enfuvirtide (T-20): a novel human immunodeficiency virus type 1 fusion inhibitor.
Cervia JS, Smith MA. 
Clin Infect Dis. 2003 Oct 15;37(8):1102-6
 Abstract
 
In Vitro Data
 
 
Susceptibility of HIV-1 non-B subtypes and recombinant variants to Enfuvirtide.
 Holguin A, Faudon JL, Labernardiere JL, Soriano V.
J Clin Virol. 2006 Dec 28;
Abstract
 
Genotypic changes in human immunodeficiency virus type 1 envelope glycoproteins on treatment
with the fusion inhibitor enfuvirtide and their influence on changes in drug susceptibility in vitro.
 Su C, Melby T, Demasi R, Ravindran P, Heilek-Snyder G   .
J Clin Virol. 2006 Jun 7
 Abstract

Favorable Interactions between Enfuvirtide and 1-beta-D-2,6-Diaminopurine
Dioxolane In Vitro.
Tremblay CL, Poulin DL, Hicks JL, et al
Antimicrob Agents Chemother. 2003 Nov;47(11):3644-6.
 Abstract
Diagnostics
 
 
Assay of HIV gp41 amino acid sequence to identify baseline variation and mutation development
in patients with virologic failure on enfuvirtide.
 Loutfy MR, Raboud JM, Montaner JS, et al
Antiviral Res. 2006 Dec 18;
 Abstract
 
Performance of Human Immunodeficiency Virus Type 1 gp41 Assays for Detecting
Enfuvirtide (T-20) Resistance Mutations.
 Marcial M, Lu J, Deeks SG, Ziermann R, Kuritzkes DR.  
J Clin Microbiol. 2006 Sep;44(9):3384-7.
 Abstract

Development and validation of a quantitative assay for the measurement of two HIV-fusion inhibitors,
enfuvirtide and tifuvirtide, and one metabolite of enfuvirtide (M-20) in human plasma by liquid
chromatography-tandem mass spectrometry.
van den Broek I, Sparidans RW, Huitema AD, et al
.J Chromatogr B Analyt Technol Biomed Life Sci 2006 May 16
 Abstract
 
An Improved HPLC Fluorimetric Method for the Determination of Enfuvirtide Plasma Levels in HIV-
Infected Patients.
 D'avolio A, de Requena MS, Ibanez A, et al 
Ther Drug Monit. 2006 Feb;28(1):110-115
 Abstract

Bioanalytical method development and validation for a large peptide HIV fusion inhibitor (Enfuvirtide,
T-20) and its metabolite in human plasma using LC-MS/MS.
 Chang D, Kolis SJ, Linderholm KH, et al 
Pharm Biomed Anal. 2005 Jul 1;38(3):487-96
 Abstract
Safety
 
  A WEEK-IN-REVIEW FEATURED REPORT
Pharmacokinetics, pharmacodynamics and safety of once-daily versus twice-daily dosing with
enfuvirtide in HIV-infected subjects.
 Thompson M, Dejesus E, Richmond G, et al 
AIDS. 2006 Feb 14;20(3):397-404.
 Abstract
 
A WEEK-IN-REVIEW FEATURED REPORT
Safety of Enfuvirtide in Combination With an Optimized Background of Antiretrovirals in T
reatment-Experienced HIV-1-Infected Adults Over 48 Weeks.
Trottier B, Walmsley S, Reynes J, et al 
J Acquir Immune Defic Syndr. 2005 Dec 1;40(4):413-421.
 Abstract
 
Safety, tolerability, and plasma pharmacokinetics of high-strength formulations
of enfuvirtide (T-20) in treatment-experienced HIV-1-infected patients.
 Wheeler DA, Lalezari JP, Kilby JM et al  
J Clin Virol. 2004 Jun;30(2):183-90
 Abstract

The safety, plasma pharmacokinetics, and antiviral activity of subcutaneous
enfuvirtide (T-20), a peptide inhibitor of gp41-mediated virus fusion, in HIV-infected adults.
 Kilby JM, Lalezari JP, Eron JJ, et al.
AIDS Res Hum Retroviruses 2002 Jul 1;18(10):685-93
 Abstract
 
  A phase II clinical study of the long-term safety and antiviral activity of enfuvirtide-based
antiretroviral therapy.
 Lalezari JP, Eron JJ, Carlson M, et al.
AIDS 2003 Mar 28;17(5):691-698
 Abstract
Pharmacokinetics
 
 
Enfuvirtide cerebrospinal fluid (CSF) pharmacokinetics and potential use in defining CSF HIV-1 origin.
 Price RW, Parham R, Kroll JL, et al  
Antivir Ther. 2008;13(3):369-74.
 Abstract
 
A WEEK IN REVIEW FEATURED REPORT
Pharmacokinetic and pharmacodynamic determinants of early virological response to enfuvirtide-based
regimens in HIV-positive patients.
 Gonzalez de Requena D, Bonora S, Castagna A, et al
 J Antimicrob Chemother. 2008 May 16.
Abstract
 
Mechanism-based model of the pharmacokinetics of enfuvirtide, an HIV fusion inhibitor.
 Mohanty U, Dixit NM.  
J Theor Biol. 2007 Dec 28
Abstract
 
A WEEK-IN-REVIEW FEATURED REPORT
 Pharmacokinetic Bioequivalence of Enfuvirtide Using a Needle-Free Device versus Standard
Needle Administration.
 True AL, Chiu YY, Demasi RA, Stout R, Patel I.
Pharmacotherapy. 2006 Dec;26(12):1679-86.
Abstract
 
Pharmacokinetics of enfuvirtide in patients treated in typical routine clinical settings.
Stocker H, Kloft C, Plock N, et al
Antimicrob Agents Chemother. 2006 Feb;50(2):667-73.
 Abstract
 
A WEEK-IN-REVIEW FEATURED REPORT
Pharmacokinetics, pharmacodynamics and safety of once-daily versus twice-daily dosing with
enfuvirtide in HIV-infected subjects.
 Thompson M, Dejesus E, Richmond G, et al 
AIDS. 2006 Feb 14;20(3):397-404.
 Abstract
 
Population pharmacokinetics and exposure-response relationship of enfuvirtide in treatment-
experienced human immunodeficiency virus type 1-infected patients.
 Mould DR, Zhang X, Nieforth K, et al 
Clin Pharmacol Ther. 2005 Jun;77(6):515-28
 Abstract
 
Enfuvirtide Binding Domain Is Highly Conserved in Non-B HIV Type 1 Strains from Cameroon,
West Central Africa.
 Aghokeng AF, Ewane L, Awazi B, et al   
AIDS Res Hum Retroviruses. 2005 May;21(5):430-3
 Abstract
 
Pharmacokinetics, pharmacodynamics and drug interaction potential of enfuvirtide.
 Patel IH, Zhang X, Nieforth K, Salgo M, Buss N.
Clin Pharmacokinet. 2005;44(2):175-86.
 Abstract
 
Safety, tolerability, and plasma pharmacokinetics of high-strength formulations of enfuvirtide
(T-20) in treatment-experienced HIV-1-infected patients.
 Wheeler DA, Lalezari JP, Kilby JM et al  
 J Clin Virol. 2004 Jun;30(2):183-90
 Abstract

The safety, plasma pharmacokinetics, and antiviral activity of subcutaneous enfuvirtide (T-20),
a peptide inhibitor of gp41-mediated virus fusion, in HIV-infected adults.
 Kilby JM, Lalezari JP, Eron JJ, et al.
AIDS Res Hum Retroviruses 2002 Jul 1;18(10):685-93
 Abstract
Drug/Drug Interactions
 
 
A WEEK-IN-REVIEW FEATURED REPORT
Combined tipranavir and enfuvirtide use associated with higher plasma tipranavir concentrations
but not with increased hepatotoxicity: sub-analysis from RESIST.
 Raffi F, Battegay M, Rusconi S, et al 
AIDS. 2007 Sep;21(14):1977-1980.
 Abstract
 
Rapamycin reduces CCR5 density levels on CD4 T cells and this effect results in potentiation of
Enfuvirtide (T-20) against R5 HIV-1 in vitro.
 Heredia A, Gilliam B, Latinovic O, et al 
Antimicrob Agents Chemother. 2007 May 7
 Abstract
 
A WEEK-IN-REVIEW FEATURED REPORT
Unexpected drug-drug interaction between tipranavir/ritonavir and enfuvirtide.
 de Requena DG, Calcagno A, Bonora S, et al 
AIDS. 2006 Oct 3;20(15):1977-1979.
 Abstract
 
Pharmacokinetics, pharmacodynamics and drug interaction potential of enfuvirtide.
 Patel IH, Zhang X, Nieforth K, Salgo M, Buss N.
Clin Pharmacokinet. 2005;44(2):175-86.
 Abstract
 
Lack of Interaction between Enfuvirtide and Ritonavir or Ritonavir-Boosted Saquinavir
in HIV-1-Infected Patients.
 Ruxrungtham K, Boyd M, Bellibas SE, et al    
 J Clin Pharmacol. 2004 Jul;44(7):793-803.
 Abstract
 
Assessment of drug-drug interaction potential of enfuvirtide in human immunodeficiency
virus type 1-infected patients.
 Zhang X, Lalezari JP, Badley AD, et al 
Clin Pharmacol Ther. 2004 Jun;75(6):558-68
 Abstract

Lack of Enzyme-Inducing Effect of Rifampicin on the Pharmacokinetics of Enfuvirtide.
 Boyd MA, Zhang X, Dorr A, et al 
J Clin Pharmacol. 2003 Dec;43(12):1382-1391
 Abstract
Viral Dynamics
 
 
HIV-1-infected patients from the French National Observatory experiencing virological failure while receiving enfuvirtide.
 Descamps D, Assoumou L, Masquelier B, et al 
J Antimicrob Chemother. 2008 Jun 13
 Abstract
 
Susceptibility of HIV Type 1 to the Fusion Inhibitor T-20 Is Reduced on Insertion of Host
Intercellular Adhesion Molecule 1 in the Virus Membrane.
 Beausejour Y, Tremblay MJ. 
J Infect Dis. 2004 Sep 1;190(5):894-902.
 Abstract
 
Immunological and virological study of enfuvirtide-treated HIV-positive patients.
 Barretina J, Blanco J, Bonjoch A, et al 
AIDS. 2004 Aug 20;18(12):1673-82.
Abstract
 
Sensitivity of Human Immunodeficiency Virus Type 1 to Fusion Inhibitors Targeted to the
gp41 First Heptad Repeat Involves Distinct Regions of gp41 and Is Consistently Modulated
by gp120 Interactions with the Coreceptor.
 Derdeyn CA, Decker JM, Sfakianos JN, et al. .
 J Virol 2001 Sep;75(18):8605-8614
 Abstract

 Activation of the formyl peptide receptor by the HIV-derived peptide T-20 suppresses
interleukin-12 p70 production by humanmonocytes.
Braun MC, Wang JM, Lahey E, Rabin RL, Kelsall BL.
 Blood 2001 Jun 1;97(11):3531-3536
 Abstract

Strong in vitro synergy between the fusion inhibitor T-20 and the CXCR4 blocker AMD-3100
 Tremblay CL, Kollmann C, Giguel F, Chou TC, Hirsch MS.
J Acquir Immune Defic Syndr 2000 Oct 1;25(2):99-102
 Abstract
Adverse Events
 
 
Does Iatrogenic Scleroderma due to Injection-Site Reaction to Enfuvirtide Impair Absorption of
the Drug?
 Maggi P, Filotico R, Bonora S, et al 
Clin Drug Investig. 2008;28(5):305-11
 Abstract

Renal failure in a patient treated with atazanavir
Moddel M, Pfammatter R, Varga Z, Keusch G. 
Schweiz Rundsch Med Prax. 2006 Jun 7;95(23):949-51.
 Abstract
 
Pharmacokinetics of enfuvirtide in a patient with impaired renal function.
 Leen C, Wat C, Nieforth K
Clin Infect Dis. 2004 Dec 1;39(11):e119-21.
 Abstract
 
Successful Desensitization to Enfuvirtide after a Hypersensitivity Reaction in an
HIV-1-Infected Man.
 Desimone JA, Ojha A, Pathak R, Cohn J.
Clin Infect Dis. 2004 Nov 15;39(10):e110-2.
 Abstract

Injection site reactions with the HIV-1 fusion inhibitor enfuvirtide.
Ball RA, Kinchelow T.  
J Am Acad Dermatol. 2003 Nov;49(5):826-31
 Abstract
Resistance
 
 
Impact of the Enfuvirtide Resistance Mutation N43D and the Associated Baseline Polymorphism
E137K on Peptide Sensitivity and Six-Helix Bundle Structure.
 Bai X, Wilson KL, Seedorff JE, et al 
Biochemistry. 2008 May 29.
Abstract
 
Association between specific enfuvirtide resistance mutations and CD4 cell response during
enfuvirtide-based therapy.
 Melby TE, Despirito M, Demasi RA, et al  
AIDS. 2007 Nov 30;21(18):2537-9.
Abstract
 
Short Communication: Dynamics of Drug-Resistant HIV-1 in Plasma and Peripheral Blood
Cells in Patients during and after Enfuvirtide Therapy
 Poveda E, Briz V, Paraskevis D, et al
AIDS Res Hum Retroviruses. 2007 Sep;23(9):1078-1082.
 Abstract
 
Transmembrane protein polymorphisms and resistance to T-20 (Enfuvirtide, Fuzeon) in HIV-1
infected therapy-naive seroconverters and AIDS patients under HAART-T-20 therapy.
 Morozov VA, Morozov AV, Schurmann D, et al 
Virus Genes. 2007 Apr 18;
Abstract
 
Interruption of Enfuvirtide in HIV-1-Infected Adults with Incomplete Viral Suppression on an
Enfuvirtide-Based Regimen.
 Deeks SG, Lu J, Hoh R, et al
J Infect Dis. 2007 Feb 1;195(3):387-91.
Abstract
 
A WEEK-IN-REVIEW FEATURED REPORT
Increased Polymorphism in the HR-1 gp41 env Gene Encoding the Enfuvirtide (T20) Target in
HIV-1 Variants Harboring Multiple Antiretroviral Drug Resistance Mutations in the pol Gene.
 Si-Mohamed A, Piketty C, Tisserand P, et al
Acquir Immune Defic Syndr. 2006 Oct 30;
 Abstract
 
Specific mutations in HIV-1 gp41 are associated with immunological success in HIV-1-infected
patients receiving enfuvirtide treatment.
 Aquaro S, D'Arrigo R, Svicher V, et al 
J Antimicrob Chemother. 2006 Aug 5;
 Abstract
 
A WEEK-IN-REVIEW FEATURED REPORT
Rapid Emergence of Enfuvirtide Resistance in HIV-1-Infected Patients: Results of a Clonal Analysis
 .Lu J, Deeks SG, Hoh R,
 J Acquir Immune Defic Syndr. 2006 Jul 31;
 Abstract
 
A WEEK-IN-REVIEW FEATURED REPORT
Characterization of Envelope Glycoprotein gp41 Genotype and Phenotypic Susceptibility to
Enfuvirtide at Baseline and on Treatment in the Phase III Clinical Trials TORO-1 and TORO-2.
 Melby T, Sista P, Demasi R, et al
AIDS Res Hum Retroviruses. 2006 May;22(5):375-85
 Abstract
 
A WEEK-IN-REVIEW FEATURED REPORT
Long-term monitoring of genotypic and phenotypic resistance to T20 in treated patients infected
with HIV-1.
 Perez-Alvarez L, Carmona R, Ocampo A, et al  
J Med Virol. 2005 Dec 21;78(2):141-147
Abstract
 
A WEEK-IN-REVIEW FEATURED REPORT
Dynamics of enfuvirtide resistance in HIV-infected patients during and after long-term enfuvirtide
salvage therapy.
Poveda E, Rodes B, Lebel-Binay S, et al
J Clin Virol. 2005 Dec;34(4):295-301.
 Abstract
 
Enfuvirtide resistance mutations: impact on human immunodeficiency virus envelope
function, entry inhibitor sensitivity, and virus neutralization.
 Reeves JD, Lee FH, Miamidian JL,et al 
J Virol. 2005 Apr;79(8):4991-9.
 Abstract
 
Natural resistance-associated mutations to Enfuvirtide (T20) and polymorphisms in
the gp41region of different HIV-1 genetic forms from T20 naive patients.
Carmona R, Perez-Alvarez L, Munoz M, et al
J Clin Virol. 2005 Mar;32(3):248-53
 Abstract
 
Emergence and evolution of enfuvirtide resistance following long-term therapy involves
heptad repeat 2 mutations within gp41.
Xu L, Pozniak A, Wildfire A, Stanfield-Oakley SA. et al  
Antimicrob Agents Chemother. 2005 Mar;49(3):1113-9.
 Abstract
 
Emergence of a Drug-Dependent Human Immunodeficiency Virus Type 1 Variant during
Therapy with theT20 Fusion Inhibitor.
 Baldwin CE, Sanders RW, Deng Y, et al
J Virol. 2004 Nov;78(22):12428-37.
 Abstract
 
Genotype and Phenotype Patterns of Human Immunodeficiency Virus Type 1 Resistance
to Enfuvirtide during Long-Term Treatment.
 Menzo S, Castagna A, Monachetti A, et al
Antimicrob Agents Chemother. 2004 Sep;48(9):3253-9.
 Abstract
 
Evolution of genotypic and phenotypic resistance to Enfuvirtide in HIV-infected patients
experiencing
prolonged virologic failure.
 Poveda E, Rodes B, Labernardiere JL, et a;  
J Med Virol. 2004 Sep;74(1):21-8.
 Abstract
 
Resistance to enfuvirtide, the first HIV fusion inhibitor.
Greenberg ML, Cammack N.
J Antimicrob Chemother. 2004 Jul 1
 Abstract
 
Relative replicative fitness of human immunodeficiency virus type 1 mutants resistant
to enfuvirtide (T-20).
 Lu J, Sista P, Giguel F, Greenberg M, Kuritzkes DR.
 J Virol.