Enfuvirtide

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Enfuvirtide [T-20] (Fuzeon)

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Last Update: June 25, 2008
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New and Noteworthy

June 2008

A randomized study to evaluate injection site reactions using three different enfuvirtide delivery mechanisms
(the OPTIONS study).
Boyd MA, Truman M, Hales G, et al Antivir Ther. 2008;13(3):449-53.

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.

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

An Open-Label Safety Study of Enfuvirtide Injection with a Needle-Free Injection Device or Needle/Syringe:
The Biojector 2000 Open-Label Safety Study (BOSS).
Lalezari JP, Saag M, Walworth C, Larson P. AIDS Res Hum Retroviruses. 2008 May 28.

May 2008

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.

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 alJ Antimicrob Chemother. 2008 May 16.

A WEEK IN REVIEW FEATURED REPORT
Efficacy and Safety of 48 Weeks of Enfuvirtide 180 mg Once-Daily Dosing Versus 90 mg Twice-Daily Dosing
in HIV-Infected Patients.
Wright D, Rodriguez A, Godofsky E, et al HIV Clin Trials. 2008 Mar-Apr;9(2):73-82

Patients' Perception and Effectiveness of a Treatment Containing Enfuvirtide When Used in HIV-Infected Patients Without Very
Advanced Disease.
Wright , Del Pozo , Fernández-Guerrero , et al HIV Clin Trials. 2008 Mar-Apr;9(2):83-90.

FDA Fuzeon Warnings/Label Changes

FULL-TEXT DOCUMENT
Additions to the Fuzeon (Enfuvirtide) for Injection Product Label
US FDA January 31, 2007

Perinatal Data

Guidelines and Recommendations

     United States
          Internet Documents

FULL TEXT PDF DOCUMENT
Public Health Service Task Force Recommendations for Use of Antiretroviral Drugs
in Pregnant HIV-Infected Women for Maternal Health and Interventions to Reduce
Perinatal HIV Transmission in the United States.
Perinatal HIV Guidelines Working Group.
November 2, 2007
Guidelines

FULL TEXT PDF DOCUMENT
Safety and Toxicity of Individual Antiretroviral Agents in Pregnancy
Perinatal HIV Guidelines Working Group.
November 2, 2007
Guidelines

Journal Papers, Abstracts and Commentates

Placental transfer of enfuvirtide in the ex vivo human placenta perfusion model.
Ceccaldi PF, Ferreira C, Gavard L, et al
Am J Obstet Gynecol. 2008 Jan 31
Abstract

E nfuvirtide prescription at the end of pregnancy to a multi-treated HIV-infected woman with
virological breakthrough.
Meyohas M-C, Lacombe M, Carbonne B, et al
AIDS. 18(14):1966-1968, September 24, 2004.
Letter

         Conference Reports, Abstracts, and Posters

POSTER
Use of Enfuvirtide in HIV⁺ Pregnant Women
A Haberl, R Linde, A Reitter, et al
PDF Poster     Abstract

Terumo SurGuard2

          Internet Documents

PDF FACT SHEET
Fact Sheet: New Safety Syringe in Fuzeon Convenience Kit
Roche/ Trimeris
October 2005

Biojector

News

PDF NEWS RELEASE
FDA Issues Approvable Letter for Biojector Needle-Free Injection Device for FUZEON
Roche/ Trimeris
November 23, 2005
News Release

Journal Papers, Abstracts and Commentates

An Open-Label Safety Study of Enfuvirtide Injection with a Needle-Free Injection Device or Needle/Syringe:
The Biojector 2000 Open-Label Safety Study (BOSS).
Lalezari JP, Saag M, Walworth C, Larson P.
AIDS Res Hum Retroviruses. 2008 May 28.
Abstract

A WEEK-IN-REVIEW FEATURED REPORT
Enfuvirtide plasma levels and injection site reactions using a needle-free
gas-powered injection system (Biojector).
Harris M, Joy R, Larsen G, Valyi M, et al
AIDS. 2006 Mar 21;20(5):719-23.
Abstract

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