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The Guidelines for the Use of Antiretroviral Agents in HIV-1-Infected Adults and Adolescents are developed by the Panel on Clinical Practices for Treatment of HIV (Panel) and compiled by the Department of Health and Human Services (DHHS).The Guidelines outline the current understanding of how clinicians should use antiretroviral drugs and laboratory testing to treat and manage human immunodeficiency virus type 1 (HIV-1) infection. The Panel, currently led by Drs. John G. Bartlett and H. Clifford Lane,meets monthly via teleconference to review new data and, when deemed necessary, produces revisions or updates. Since the first publication in 1998, 17 versions of the Guidelines have been released; the latest was published on-line at http://aidsinfo.nih.gov on October 10, 2006. Recommendations are based upon analysis of multiple trials and expert opinions. As the many versions of the Guidelines imply, HIV treatment changes very quickly. Drugs and approaches used just one year before are often replaced with newer, better therapies. HIV treatment providers use the Guidelines to improve their practice and to provide their patients with optimal care.

The goals of antiretroviral treatment, as summarized in the Guidelines, are to:

• REDUCE HIV-related morbidity and mortality,
• IMPROVE quality of life,
• RESTORE and PRESERVE immunologic function, and
• MAXIMALLY and durably SUPPRESS viral load.¹

Section I: Overview of HIV Treatment Recommendations for the Treatment-Naive Patient

Upon entering a clinic or private practice, each HIV+ patient should undergo an initial evaluation, with comprehensive physical examination and laboratory workup including CD4⁺ T cell count and viral load tests and often including genotypic resistance testing. Clinicians need to base treatment decisions on the findings of this evaluation, including history, symptoms, and laboratory results. Recommendations regarding this initial evaluation and decisions concerning initiation of treatment have not changed in the last two years.

The Guidelines recommend use of the following indications for initiation of antiretroviral therapy.¹

• Antiretroviral therapy is recommended for all patients with history of an AIDS-defining illness or severe symptoms of HIV infection regardless of CD4⁺ T cell count
• Antiretroviral therapy is also recommended for asymptomatic patients with <200 CD4⁺ T cells/mm³, which is an AIDS-defining finding.
• Asymptomatic patients with CD4⁺ T cell counts of 201-350 cells/mm3 should be offered treatment. • For asymptomatic patients with CD4⁺ T cell of >350 cells/mm3 and plasma HIV RNA >100,000 copies/ml, most experienced clinicians defer therapy but some clinicians may consider initiating treatment.
• Therapy should be deferred for patients with CD4⁺ T cell counts of >350 cells /mm3 and plasma HIV RNA <100,000 copies/mL.

The current indications for treatment are based on clinical data and observational cohorts that have not been recently challenged. Infectious disease specialists concur, based on many randomized clinical trials, that when the CD4⁺ T cell count is <200 cells/mm3, there is a strong correlation with disease progression. For asymptomatic patients with a CD4⁺ T cell count >200 cells/mm3, the Guidelines recommend that clinicians take into consideration other factors such as patient readiness and potential drug toxicities. However, most clinicians choose when to begin treatment based on the findings of clinical trials and observational data of untreated individuals with regular CD4⁺ T cell and HIV RNA level measurements.

The plasma HIV RNA level cut-off for starting treatment of an asymptomatic patient with a CDE+T cell count above 350 cells/mm³ was raised to >100,000 copies/ml in the October 2004 Guidelines, due to the ART Cohort Collaboration study, which included 13 studies from Europe and North America. This study showed that viral load at commencement of therapy was associated with subsequent clinical progression only if it is greater than or equal to 100,000 copies/ml. Additionally, a recent collaborative analysis of three cohort studies showed that patients with baseline viral loads of greater than 100,000 copies/ml had a lower rate of achieving viral suppression than those with less than this number.