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For Consumers

Availability of Revised HIV Treatment Guidelines

Revised "Guidelines for the Use of Antiretroviral Agents in HIV-1-Infected Adults and Adolescents" become available today (October 29, 2004) on the website.

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:

  • When to start?
    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.
  • What to start with?
    • 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:

  • Special Populations section - discussions on special considerations for antiretroviral therapy in the following patient populations are added to this document:
    • HIV-infected adolescents
    • Injection drug users
    • Hepatitis B/HIV co-infected patients
    • Hepatitis C/HIV co-infected patients
    • HIV patients with tuberculosis
  • Discussion on Discontinuation or Interruption of Antiretroviral Therapy
  • Table 3a - " Probability of progressing to AIDS or death according to CD4 cell count, viral load, and sociodemographic factors -- reproduced with permission from Lancet 2002.
  • Table 3b - " Predicted 6-month risk of AIDS according to age and current CD4 cell count and viral load, based on a Poisson regression model" - reproduced with permission from AIDS 2004.
  • Table 7 - " A compilation of 48-week treatment outcome data from selected clinical trials of combination antiretroviral therapy in treatment-naïve individuals"
  • Tables 16 a-c - New tables on " Antiretroviral therapy associated adverse effects and management recommendations"

Deletion from the Guidelines Document:

  • What not to use?
    • 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

Richard Klein
HIV/AIDS Program Director
Office of Special Health Issues
Food and Drug Administration

Page Last Updated: 08/01/2014
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