Guidelines for the Use of Antiretroviral Agents in HIV-Infected Adults and Adolescents [http://www.hivatis.org]: The major changes in the guidelines compared to the guideliness from one year ago include the following:

• A more conservative threshold for initiating therapy based on CD4 cell count and viral load.
  
• Additions of lopinavir/ritonavir and indinavir/ritonavir to the list of preferred agents for initial therapy.
  
• The addition of a substantial section dealing with adherence.
  
• An update in all of the tables dealing with drug interactions, doses, PI-PI and PI-NNRTI combinations, and toxicity.

The specific changes with respect to initiation of treatment and the preferred regimens are summarized in the table below:

	Old (1/00)	New (1/01)
Indications to initiate treatment	CD4 <500/mm3 or VL >10,000 c/mL (bDNA) >20,000 c/mL (RT-PCR)	CD4 <350/mm3 or VL >30,000 c/mL (bDNA) >55,000 c/mL (RT-PCR)
Preferred regimens	2 NRTIs + Indinavir Nelfinavir Efavirenz Ritonavir/Saquinavir	2 NRTIs + Indinavir Nelfinavir Efavirenz Ritonavir/Saquinavir Ritonavir/Indinavir Ritonavir/Lopinavir

Comment: A consensus has evolved over the past year that antiretroviral therapy can be initiated later than was previously recommended, based on sparse information to support benefits of early treatment, concerns about adherence and resistance, and ultimately on the risk/benefit ratio. The new guidelines recommend therapy in patients with CD4 counts <350 cells/mm³ or a viral load >30,000 c/mL (bDNA) or >55,000 c/mL (RT-PCR). Patients who meet these criteria have a three-year risk of developing clinically-defined AIDS of >15%. The one exception is the group with a CD4 cell count of 200-350/mm³ and a viral load <20,000 c/mL, who meet criteria for starting therapy but whose risk is lower [Ann Intern Med 1997;126:946]. It should be acknowledged that a CD4 cell count threshold of 200/mm³ is too low, since this has been shown in repeated studies to be inferior. The problem is to define the CD4 cell count above this level that represents an appropriate threshold. Many have commented that practitioners have already become more conservative so that these guidelines are following rather than leading clinical practice. There is also speculation that a we will never know the optimal time to initiate therapy based on viral load and CD4 thresholds . It is clear that these decisions must be individualized, and the guidelines accommodate this need with substantial discussion about the various controversies and variations among patients, providers, and experts. It is expected that most seasoned HIV providers will find the greatest use of the new guidelines to be the tables with updated information about dosing regimens, influence of food, toxicity, drug interactions, and recommendations for PI-PI and PI-NNRTI combinations. Whether right or wrong, whether leading of following, the DHHS guidelines have enjoyed a big reception: The HIV Treatment Information Service (HIVATIS) reported 49,000 downloads in the first 48 hours since they were posted on the web 2/4/01.
posted 2/14/2001

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