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MedlinePlus Drug Information: Enfuvirtide Injection Enfuvirtide is used in combination with other medications to treat human immunodeficiency virus (HIV) infection in patients who have not responded well enough to other antiviral medications. Enfuvirtide comes as a powder to be mixed with sterile water and injected subcutaneously (under the skin). Gently tap the enfuvirtide vial to loosen the powder. www.nlm.nih.gov /medlineplus/druginfo/medmaster/a603023.html   (1766 words)

Fuzeon Online, Description, Chemistry, Ingredients - Enfuvirtide - RxList Monographs Enfuvirtide is a linear 36-amino acid synthetic peptide with the N-terminus acetylated and the C-terminus is a carboxamide. Enfuvirtide binds to the first heptad-repeat (HR1) in the gp41 subunit of the viral envelope glycoprotein and prevents the conformational changes required for the fusion of viral and cellular membranes. Enfuvirtide exhibited additive to synergistic effects in cell culture assays when combined with individual members of various antiretroviral classes, including lamivudine, zidovudine, indinavir, nelfinavir, and efavirenz. www.rxlist.com /cgi/generic3/fuzeon.htm   (598 words)

AIDS Fact Sheet: Enfuvirtide (Fuzeon) Enfuvirtide was approved in 2003 as a medication against HIV. Enfuvirtide is a new class of antiviral drug. The most common other side effects of enfuvirtide are headache, pain and numbness in feet or legs, dizziness, and loss of sleep. www.aids.org /factSheets/461-Enfuvirtide-Fuzeon.html   (704 words)

Enfuvirtide (T-20): predicting success and modelling survival benefits Enfuvirtide (Fuzeon, formerly T-20) has been evaluated into randomised, comparative studies in which individuals who have been experienced with all three approved drug classes were given a new antiretroviral regimen optimised by the use of resistance testing with or without enfuvirtide in a 2:1 ratio. Subgroup analyses indicated that the benefits of the enfuvirtide were consistently observed in both male and female, white and non-white and all patients that were older and younger than 40 years of age. This information suggests that enfuvirtide is likely to be a highly cost-effective therapy and that it is likely to buy not only years of good quality (due to the prevention of new AIDS defining illnesses) but also time for new treatment options to become available. www.i-base.org.uk /pub/htb/v4/htb4-1/Enfuvirtide.html   (828 words)

enfuvirtide of Augusta, Georgia Enfuvirtide is in the FDA pregnancy category B. This means that it is not expected to be harmful to an unborn baby. Enfuvirtide should not be given as an intravenous (into the vein) or intramuscular (into the muscle) injection. Enfuvirtide is not a cure for HIV or AIDS, and you can still transmit the virus to others during treatment with this medication. www.universityhealth.org /16270.cfm   (1562 words)

Interaction Studies Between Fuzeon & Ritonavir or Ritonavir Boosted Saquinavir Enfuvirtide (Fuzeon trade mark) is an HIV fusion inhibitor, the first drug in a new class of antiretrovirals. Plasma concentrations for enfuvirtide, enfuvirtide metabolite, saquinavir, and ritonavir were measured using validated liquid chromatography tandem mass spectrometry methods. The pharmacokinetics of enfuvirtide are affected to a small extent when coadministered with ritonavir at a dose of 200 mg bid but not when coadministered with a saquinavir-ritonavir combination (1000/100 mg bid). www.natap.org /2004/HIV/062304_02.htm   (382 words)

PI Perspective 36: New Anti-HIV Drugs Receive FDA Approval - October, 2003 While enfuvirtide shows some activity in people resistant to many or all anti-HIV drugs, studies suggest it may be most effective in reducing HIV levels when used with at least one or two drugs that are still active against HIV. Enfuvirtide cannot be made into pill form for oral use and must be taken by injection. Finally, while enfuvirtide appears more potently able to impact HIV when paired with other anti-HIV drugs that are active against a person's virus, it still provides some benefits in true salvage situations, even if it can't be paired with another completely new drug. www.aegis.com /pubs/projinform/2003/PI031002.html   (1813 words)

Data Sheet Enfuvirtide susceptibility for 130 PBMC baseline virus isolates from enfuvirtide treated patients in Phase II clinical studies was determined in a cMAGI cell assay (CCR5 expressing derivative of the Multinuclear Activation of a Galactosidase Indicator cell line). As a peptide, enfuvirtide is expected to undergo catabolism to its constituent amino acids, with subsequent recycling of the amino acids in the body pool. Enfuvirtide was not mutagenic in a series of assays including the Ames bacterial reverse mutation assay, a mammalian cell forward gene mutation assay in AS52 Chinese Hamster ovary cells, nor did it induce micronuclei in an in vivo mouse micronucleus assay. www.medsafe.govt.nz /Profs/Datasheet/f/Fuzeoninj.htm   (4203 words)

MedlinePlus Drug Information: Enfuvirtide (Systemic)   (Site not responding. Last check: 2007-11-03) Enfuvirtide (en-FYOO-vir-tide) is used, in combination with other medicines, in the treatment of the infection caused by the human immunodeficiency virus (HIV). Enfuvirtide will not cure or prevent HIV infection or AIDS; however, it helps keep HIV from reproducing and appears to slow down the destruction of the immune system. Enfuvirtide should be used with caution in pregnant women and should be used only if clearly needed. www.nlm.nih.gov /medlineplus/druginfo/uspdi/500467.html   (1210 words)

Enfuvirtide (Fuzeon, T-20) Enfuvirtide was approved by the FDA in March 2003 for use in adults, and in children ages six and older, with advanced HIV infection. The first agent to be approved in the class of fusion inhibitors, enfuvirtide functions by binding a region of the HIV envelope glycoprotein gp41 and preventing viral fusion with the target cell membrane. Resistance to enfuvirtide may result from one or more of several mutations in gp41.(7) The incidence and significance of specific enfuvirtide mutations is being studied in ongoing Phase II and III trials. hivinsite.ucsf.edu /InSite.jsp?page=ar-drugs&doc=ar-04-01   (1027 words)

CROI: No Interaction Found Between Enfuvirtide and Protease Inhibitors or Rifampicin BOSTON, MA -- February 12, 2003 -- The investigative HIV-1 fusion inhibitor enfuvirtide is well tolerated when co-administered with a protease inhibitor -- saquinavir or ritonavir -- or with the antituberculosis drug rifampicin. Combination of enfuvirtide with any of these drugs did not lead to a clinically relevant interaction and was well tolerated over the duration of the studies, said Mark Boyd, MD, a researcher with the HIV Netherlands Australia Thailand Research Collaboration (HIVNAT), Bangkok, Thailand. To establish the potential for drug-drug interactions between enfuvirtide and common antiretrovirals or other drugs commonly used in treating patients with HIV infection and other comorbidities, Dr. Boyd and colleagues conducted 3 pharmacokinetic interaction studies. www.docguide.com /dg.nsf/PrintPrint/EFECDB8C5961590085256CCB006A909E   (428 words)

Health-Related Quality of Life with Enfuvirtide   (Site not responding. Last check: 2007-11-03) One drawback to enfuvirtide is that it is a drug that must be administered twice daily by subcutaneous injection. To assess the effect of enfuvirtide use on health-related quality of life, researchers gathered information from patients enrolled in two phase III clinical trials (TORO 1 and 2). In this survey of patients, most said that preparing enfuvirtide and injecting it was “easy to perform” and had “little or no impact” on the patients’ daily lives. www.hivandhepatitis.com /recent/quality_of_life/083004_d.html   (496 words)

The Body Pro: Enfuvirtide -- A Review of the First Entry Inhibitor   (Site not responding. Last check: 2007-11-03) They began enfuvirtide treatment with at least two other antivirals that were active, as judged by a resistance test. These analyses show that enfuvirtide tends to work better for people with less-advanced HIV infection -- a conclusion that is similar to most of the findings for other antivirals currently in use. The timing of using enfuvirtide is among the most complex discussions providers must have with patients when dealing with resistance and treatment options. www.thebodypro.com /fuzeon/patients.html   (419 words)

Enfuvirtide Penetration of enfuvirtide, tenofovir, efavirenz, and protease inhibitors in the genital tract of Enfuvirtide, a new fusion inhibitor for therapy of human immunodeficiency virus infection. Enfuvirtide, an HIV-1 Fusion Inhibitor, for Drug-Resistant HIV Infection in North and www.medadvocates.org /drugs/enfuvirtide/journal.html   (1015 words)

New drug enfuvirtide shows promise against drug resistant HIV infection CHAPEL HILL -- The new drug enfuvirtide, a member of a new class of medications designed to combat HIV -- the virus that causes AIDS -- shows strong promise in treating drug-resistant cases of the life-threatening infection, a study conducted with patients in North and South America concludes. Patients from 48 hospitals and clinics in the United States, Canada, Mexico and Brazil who had had at least six months of treatment with retroviral drugs or resistance to those drugs or both and also carried at least 5,000 copies of viral RNA per millimeter of plasma participated in the Western trial. Two-thirds of the nearly 500 patients received enfuvirtide plus a regimen of three to five antiretroviral drugs, while the remaining third -- the control group -- received only the antiretrovirals. www.eurekalert.org /pub_releases/2003-05/uonc-nde052803.php   (656 words)

Fuzeon - Drugs & Vitamins - Drug Library - DrugDigest ENFUVIRTIDE (Fuzeon™) is a medicine used to treat HIV, the virus that causes AIDS. When enfuvirtide is given with other anti-HIV medicine it lowers the amount of virus in your blood (the viral load) and increases the number of CD4 cells (or T-cells). After enfuvirtide has been mixed with sterile water, the vial should be stored in a refrigerator at 2—8 degrees C (36—46 degrees F) for up to 24 hours. www.drugdigest.org /DD/DVH/Uses/0,3915,551942|Fuzeon,00.html   (971 words)

Healthopedia.com Drugs Information - Enfuvirtide : Proper Use (Fuzeon) Enfuvirtide can be given by a health care professional. If you will be using enfuvirtide at home, your health care professional will teach you how get the medicine ready for injection and how the injections are to be given. It is important to take enfuvirtide as part of a combination treatment. www.healthopedia.com /drugs/detailed/enfuvirtide/proper-use.html   (675 words)

Clinical guideline for use of enfuvirtide (T20)   (Site not responding. Last check: 2007-11-03) Patients whose current viral load has substantially rebounded or returned to their baseline level when their first used enfuvirtide and who have a strong CD4 count, are likely to have developed or be developing resistance to enfuvirtide. Enfuvirtide is also unlikely to be having antiretroviral activity, and these patients should consider stopping the enfuvirtide in their combination, with close monitoring. Enfuvirtide and Tipranavir have not been studied together as yet. www.bhiva.org /consortium/t20.html   (498 words)

Resistance to enfuvirtide, the first HIV fusion inhibitor -- Greenberg and Cammack 54 (2): 333 -- Journal of ...   (Site not responding. Last check: 2007-11-03) Enfuvirtide is homologous to a segment of the HR2 region of Enfuvirtide (T-20) and T-1249 resistance: observations from Phase II clinical trials of enfuvirtide in combination with oral antiretrovirals (ARVs) and a Phase I/II dose-ranging monotherapy trial of T-1249. Characterization of baseline and treatment-emergent resistance to T-20 (enfuvirtide) observed in phase II clinical trials, substitutions in gp41 amino acids 36-45 and enfuvirtide susceptibility of virus isolates. jac.oxfordjournals.org /cgi/content/full/54/2/333   (5539 words)

AEGiS-Hopkins Report: FDA Approves Enfuvirtide (Fuzeon, ENF, T-20), The First HIV Fusion Inhibitor - May 2003 Enfuvirtide is packaged in a 30-day kit containing: 60 (108 mg) single-use vials of enfuvirtide, 60 vials of sterile water for injection, 60 reconstitution syringes (3 cc), 60 administration syringes (1 cc), and alcohol wipes. However, once enfuvirtide powder has been reconstituted, it must be refrigerated and used within 24 hours. Enfuvirtide binds to the HR1 site in the gp41 subunit of the viral envelope glycoprotein and prevents the conformational change required for viral fusion and entry into cells. www.aegis.com /pubs/jhopkins/2003/JH20030503.html   (886 words)

American Family Physician: FDA approvals. for acromegaly treatment; enfuvirtide for HIV treatment - pegvisomant ... Enfuvirtide is the first in a new class of medications called fusion inhibitors. Because HIV infection must be treated with a combination of medications to be effective, enfuvirtide can be used as part of a medication regimen in patients for whom there are limited options. Local skin reactions from enfuvirtide injections are common, occur in almost all patients, and may be painful. www.findarticles.com /p/articles/mi_m3225/is_12_67/ai_102862891   (483 words)

Fuzeon Resistance Enfuvirtide (T-20), the twice-daily injectable antiretroviral that stops HIV from fusing to CD4 cells, poses difficult treatment decisions for people with highly drug-resistant virus. Characterization of determinants of genotypic and phenotypic resistance to enfuvirtide in baseline and on-treatment HIV-1 isolates. Interruption of enfuvirtide in patients with enfuvirtide resistance. www.natap.org /2005/Euro/euro_2.htm   (1643 words)

TAG: Position Paper on Fuzeon brand enfuvirtide (T-20) Lack of influence of gp41 antibodies that cross-react with enfuvirtide on the efficacy and safety of enfuvirtide in TORO 1 and TORO 2 phase III trials. Analysis of baseline enfuvirtide (T20) susceptibility and co-receptor tropism in two phase III study populations. Enfuvirtide, an HIV-1 Fusion Inhibitor, for Drug-Resistant HIV Infection in North and South America. www.aidsinfonyc.org /tag/activism/fuzeonpp.html   (5200 words)

HIV Report May 2003: FDA Approves Enfuvirtide   (Site not responding. Last check: 2007-11-03) Enfuvirtide is difficult to manufacture, and it is expected that initial demand will exceed supply. Enfuvirtide may sometimes take up to 45 minutes to go into solution and needs to be prepared aseptically. Patients or their caregivers will need to be trained on several key issues: how to mix the product and prepare their dose, the proper way to inject the dose in order to minimize injection site reactions, and the proper disposal of syringes and preparation supplies. www.hopkins-aids.edu /publications/report/may03_1.html   (2073 words)

Antibody no bar to enfuvirtide's anti-HIV effect   (Site not responding. Last check: 2007-11-03) Enfuvirtide is a synthetic peptide based on a motif within gp41 that regulates the binding of HIV-1 to host-cell membranes. Subjects were randomized to receive 90 mg enfuvirtide subcutaneously twice daily in combination with optimized background treatment or to optimized background treatment alone. In 78% of enfuvirtide patients, levels fell by at least 30%. www.aidsmeds.com /news/20040107clin002.html   (387 words)

The Body: Enfuvirtide Benefits Persist for at Least 2 Years Enfuvirtide -- the first and still the only available agent in the new, fourth class of antivirals called entry inhibitors -- is targeted for people who have triple-class experience and are no longer responding to their current regimen. In addition, at week 48, all of those on the control arm were offered the chance to add enfuvirtide to their regimen. Additional analyses are ongoing to further define the optimal timing for starting enfuvirtide, with particular focus on the diminished success observed if enfuvirtide use is delayed to the "next" switch in antivirals; these analyses are expected to be presented at this and other upcoming meetings. www.thebody.com /confs/aids2004/cohen1.html?m55h   (848 words)

CROI: Enfuvirtide Does Not Cause Lipid Complications in Patients with Human Immunodeficiency Virus The trials showed that enfuvirtide, known originally as T-20 and now sold as Fuzeon, was effective in treating HIV infection, especially in patients who were unable to control viral levels on their current antiretroviral regimens. Chung said that the scans and other studies showed that the use of enfuvirtide did not cause any exacerbation of the lipid aberrations that are frequently seen among patients using antiretroviral agents for long periods. The changes in laboratory parameters among patients on enfuvirtide and those on just optimal background therapy were also similar, Dr. Chung said. www.docguide.com /dg.nsf/PrintPrint/4EE859302C7B2E8885256E38005CDBD5   (477 words)

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