Important note: Information in this article was accurate in 2004. The state of the art may have changed since the publication date.
 |
FDA News - October 29, 2004
What's New in the Document?
This guidelines revision represents a major rewriting of the document to improve its organization and readability. The tables are updated with the most current available information. The following major changes have been made to the March 28, 2004 version of the guidelines:
Changes in Recommendations:
For asymptomatic treatment-naïve patients with CD4+ T cell count >350 cells/mm3, the viral load recommendation to defer or to consider therapy has been increased from 55,000 to 100,000 copies/mL. This is based on more recent data supporting HIV RNA level of >100,000 copies/mL being a stronger predictor for disease progression than >55,000 copies/mL, though even at these CD4 and viral load levels, the risk of disease progression is still relatively low. Most experienced clinicians will defer therapy with quarterly clinical and laboratory evaluation.
. stavudine - has been moved from "preferred" to "alternative" due to increasing reports of stavudine-associated toxicities
. tenofovir + lamivudine (or emtricitabine) - is now recommended as a 2-NRTI backbone for both NNRTI- and PI-based regimens. Previously, this recommendation was limited to NNRTI-based regimens only.
. emtricitabine - is now included as an option for part of a preferred or alternative 2-NRTI backbone
Additions to the Guidelines Document:
HIV-infected adolescents
Injection drug users
. Hepatitis B/HIV co-infected patients
. Hepatitis C/HIV co-infected patients
. HIV patients with tuberculosis
Deletion from the Guidelines Document:
Hydroxyurea - Hydroxyurea has been removed from this list as it is the opinion of the Panel that discussions in the guidelines should limit themselves to commentary on FDA-approved agents that are indicated for the treatment of HIV infection. Hydroxyurea, though used by some as adjunctive therapy to antiretroviral agents, is not considered, by itself, an antiretroviral agent, and thus will not be discussed in this guidelines document.
The most current version of this, and other national HIV-related guidelines are always available at http://aidsinfo.nih.gov/
Richard Klein
HIV/AIDS Program Director
Office of Special Health Issues
Food and Drug Administration
041029
FD041003
SOURCE: Food and Drug Administration (FDA).
AEGiS is made possible through unrestricted grants from Boehringer Ingelheim, Elton John AIDS Foundation, 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. .