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Updated Antiretroviral Therapy Guidelines Emphasize Benefits of Early HIV Treatment


The U.S. Department of Health and Human Services has updated itsGuidelines for the Use of Antiretroviral Agents in HIV-1-Infected Adults and Adolescents to reflect findings from the START and TEMPRANO trials demonstrating the clinical benefits of early initiation of antiretroviral therapy (ART) with a pre-treatment CD4 T-cell count above 500 cells/mm3.

Results of the START study were first announced last May and presented in full at the International AIDS Society Conference in July. Trial participants with CD4 counts above 500 cells/mm3 were randomly assigned to either start treatment immediately or to delay therapy until their CD4s fell below 350 cells/mm3 or they developed symptoms of AIDS.

The study showed that people in the immediate treatment group were 57% less likely to experience a combined endpoint of serious AIDS-related events, serious non-AIDS events, and death compared to the deferred therapy group. People treated early not only had a 72% lower risk of AIDS events, but also a 39% reduction in non-AIDS events including cancer.

Findings from the Temprano trial, presented at last year's Conference on Retroviruses and Opportunistic Infections, likewise showed that starting ART at a CD4 count above 500 cells/mm3 reduced the risk of serious illness and death compared to starting treatment later.

Key Changes to the Guidelines

  • The DHHS panel has increased the strength and evidence rating to "A1" for the recommendation that all people diagnosed with HIV should initiate ART regardless of CD4 count.
  • The recommendation to start treatment for patients diagnosed with acute or recent HIV infection has been strengthened, also given a "A1" rating.
  • Although adolescents were not included in START or TEMPRANO, the panel decided the recommendation to treat all HIV patients should include them; the panel recommends that post-puberty adolescents should be treated according to the adult guidelines and pre-puberty children according to the pediatric guidelines.
  • The panel strengthened its emphasis on prompt treatment for older adults living with HIV, as they have a greater risk of serious non-AIDS complications and potentially a blunted immunological response to ART.
  • In November 2015 the panel added the newly approved Genvoya coformulation -- the first regimen to contain the new safer tenofovir alafenamide (TAF) -- as a recommended option for first-line therapy.

The complete updated guidelines are available online at The panel welcomes feedback on the revised guidelines by February 12, 2016 (send to JLIB_HTML_CLOAKING ).



HHS Panel on Antiretroviral Guidelines for Adults and Adolescents. Guidelines for the Use of Antiretroviral Agents in HIV-1-Infected Adults and Adolescents. January 28, 2016.

Other Source

Aidsinfo. Updated HHS Adult and Adolescent Antiretroviral Treatment Guidelines Released. Media advisory. January 28, 2016.