(Last updated: January 28, 2016; last reviewed: January 28, 2016)
Revisions to the April 8, 2015, version of the guidelines are largely based on findings from two large, randomized controlled trials that addressed the optimal time to initiate antiretroviral therapy (ART)—START (Strategic Timing of Antiretroviral Therapy) and TEMPRANO. Both studies demonstrated approximately a 50% reduction in morbidity and mortality among HIV-infected individuals with CD4 T lymphocyte cell (CD4) counts >500 cells/mm3 randomized to receive antiretroviral therapy (ART) immediately versus delaying initiation of ART. Key updates related to these studies and other significant changes are highlighted throughout the guidelines.
The following guideline sections include key updates:
Based on the START and TEMPRANO findings, the Panel on Antiretroviral Guidelines for Adults and Adolescents (the Panel) has increased the strength and evidence rating for the recommendation on initiating ART to AI for all HIV-infected patients, regardless of CD4 count. Revisions to this section focus on the data supporting ART for all patients.
Following are the updated recommendations in this section:
The recommendation for initiation of ART in patients diagnosed with acute and recent infection has been strengthened. The changes are highlighted below:
Following are two key updates to this section:
The updated section is focused on the current recommendation to treat all patients regardless of CD4 count. The section emphasizes that ART is especially important for older patients because they have a greater risk of serious non-AIDS complications and potentially a blunted immunologic response to ART.
The list of Recommended regimens for initial ART has been expanded to include elvitegravir/cobicistat/tenofovir alafenamide/emtricitabine for patients with estimated creatinine clearance ≥30 mL/min (AI).
More updates to the What to Start section will be forthcoming in the next revision of these Guidelines (anticipated in May or June 2016), including additional discussion of the newest recommended regimen.