AIDSWEEKLY Plus; Monday, June 14, 2004
Staff Medical Writers

The international guidelines are the first to focus solely on optimizing the use of Fuzeon in treatment-experienced HIV patients.

The guidelines provide a framework for physicians in deciding when to include Fuzeon in HIV treatment regimens for their patients. The consensus panel recommends that patients are most likely to experience maximum treatment success when Fuzeon is introduced earlier in the paradigm, after second-line failure as part of a third or fourth antiretroviral regimen. However, the consensus panel agrees that Fuzeon benefits treatment-experienced patients across all sub-groups studied, including those taking few or no other active drugs.

"Because of its unique mechanism of action, Fuzeon is a vitally important option for the increasing number of treatment-experienced patients with HIV drug resistance or intolerance. By providing clear advice on timing of Fuzeon initiation and patient support during therapy, these new consensus guidelines have clarified the place of this drug in current HIV treatment regimens and may enable more treatment-experienced patients to benefit from it," stated Mike Youle, Royal Free Hospital, London.

The guidelines also suggest that as the first of a new class of drugs and a self-injectable antiretroviral, Fuzeon is best used when a training and support program for healthcare professionals and patients is in place. Roche and Trimeris have recently launched two patient support programs, the Outbound Nursing Call program and the Visiting Nurse Support Program. These programs will augment the existing Fuzeon treatment hotline and in-office training efforts by HIV healthcare providers.

The guidelines' consensus group was comprised of nine leading experts from around the world in the area of HIV and several have had direct experience with Fuzeon from both clinical trials and subsequent clinical use. The guidelines were derived from a roundtable discussion supported by funding from Roche.

Fuzeon was granted accelerated approval on the basis of 24-week data by the U.S. Food and Drug Administration in March 2003, and is also approved in the European Union, Switzerland and Canada. Fuzeon leads the first class of anti-HIV drugs with a unique mechanism of action to be introduced in 7 years. Unlike other HIV drugs that work after HIV has entered the human immune cell, Fuzeon works outside the CD4 cell, blocking HIV from entering the cell. For this reason, Fuzeon is effective in treatment-experienced patients who have developed resistance to other anti-HIV drugs, though patients may still develop resistance to Fuzeon.

Fuzeon (enfuvirtide) in combination with other antiretroviral agents is indicated for the treatment of HIV-1 infection in treatment-experienced patients with evidence of HIV-1 replication despite ongoing antiretroviral therapy. This indication is based on analyses of plasma HIV-1 RNA levels and CD4 cell counts in controlled studies of Fuzeon of 24 weeks' duration. Subjects enrolled were treatment-experienced adults; many had advanced disease. There are no studies of Fuzeon in antiretroviral-naive patients. There are no results from controlled trials evaluating the effect of Fuzeon on clinical progression of HIV-1.

This article was prepared by AIDS Weekly editors from staff and other reports.

Reference

Clotet B, Raffi F, Cooper D, et al. "Clinical management of treatment-experienced, HIV-infected patients with the fusion inhibitor enfuvirtide: consensus recommendations", AIDS. 2004 May 21;18(8):1137-1146

PubMED Related articles Search

040614
AW040604

Copyright © 2004 - Charles Henderson, Publisher. All rights Reserved. Permission to reproduce granted to AEGIS by Charles W. Henderson. Authorization to reproduce for personal use granted granted by C. W. Henderson, Publisher, provided that the fee of US$4.50 per copy, per page is paid directly to the Copyright Clearance Center, 27 Congress Street, Salem, Massachusetts 01970, USA. Published by Charles Henderson, Publisher. Editorial & Publishing Office: P.O. Box 5528, Atlanta, GA 30307-0528 / Telephone: (800) 633-4931; Subscription Office: P.O. Box 830409, Birmingham, AL 35283-0409 / FAX: (205) 995-1588 http://www.newsrx.net

AEGiS is made possible through unrestricted grants from Boehringer Ingelheim, Elton John AIDS Foundation, iMetrikus, Inc., John M. Lloyd Foundation, the National Library of Medicine, and donations from users like you. Always watch for outdated information. This article first appeared in 2004. This material is designed to support, not replace, the relationship that exists between you and your doctor.

AEGiS presents published material, reprinted with permission and neither endorses nor opposes any material. All information contained on this website, including information relating to health conditions, products, and treatments, is for informational purposes only. It is often presented in summary or aggregate form. It is not meant to be a substitute for the advice provided by your own physician or other medical professionals. Always discuss treatment options with a doctor who specializes in treating HIV.

Copyright © 1980,2004. AEGiS. All materials appearing on AEGiS are protected by copyright as a collective work or compilation under U.S. copyright and other laws and are the property of AEGiS, or the party credited as the provider of the content.