New antiretroviral guidelines issued

The revised Guidelines for the Use of Antiretroviral Agents in HIV-1-Infected Adults and Adolescents was made available in late October by the National Institutes of Health. The revisions were made to improve its organization and readability. The tables are updated with the most current available information. These 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 low. Most experienced clinicians will defer therapy with quarterly clinical and lab evaluation.

  • What to start with?

Stavudine (d4T/Zerit) has moved from "preferred" to "alternative" due to increasing reports of stavudine-associated toxicities. Tenofovir plus lamivudine or emtricitabine now is recommended as a 2-nucleoside reverse transcriptase inhibitor (NRTI) backbone for both non-nucleoside reverse transcriptase inhibitors (NNRTIs) and protease inhibitor-based regimens. Prior, this recommendation was limited to NNRTI-based regimens only. Emtricitabine now is 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 these patient populations have been added:

    — HIV-infected adolescents;
    — injection drug users;
    — hepatitis B/HIV coinfected patients;
    — hepatitis C/HIV coinfected 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 was removed from the list to limit discussions in the guidelines 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 will not be discussed.

The most current version of this and other national HIV-related guidelines are available at