An update to the 2003 US Department of Health and Human Services treatment guidelines has been issued (click here for full text).
- Definitions of "Preferred" vs "Alternative" regimens are added to define the rationale for the classification of the regimens. It is important to stress that in some cases, based on individual patient characteristics, a regimen listed as an alternative regimen in the table may actually be the preferred regimen for a selected patient.
- Atazanavir has been added as alternative protease inhibitor (PI) in a PI-based regimen.
- Emtricitabine has been added as an alternative nucleoside reverse transcriptase inhibitor (NRTI) in a 2-NRTI backbone.
- Two "triple NRTI" regimens, namely "tenofovir + abacavir + lamivudine" and "tenofovir + didanosine + lamivudine", are added to "Table 13 - Antiretroviral Regimens or Components That Should Not Be Offered At Any Time." This is based on recent studies reporting early virologic failure when these combinations were used as initial antiretroviral combination in treatment-naive patients.
- Other additions/modifications to "Table 13 Antiretroviral Regimens or Components That Should Not Be Offered At Any Time" include:
- "d4T + ddI in pregnancy" - has been changed to "d4T+ddI" due to increased risk of toxicities with this combination; should be used only if benefits outweigh the risks of toxicities
- "atazanavir + indinavir" - potential for additive or worsening hyperbilirubinemia
- "emtricitabine + lamivudine" - similar resistance profile, without additional benefit.
- Additional information on clinical trial data and role of enfuvirtide in patients with virologic failure.