When to START ART? No Longer a Question

U.S. guidelines recommend starting antiretroviral therapy (ART) in all HIV-infected patients. Until now, however, randomized trials supporting this approach in patients with high CD4-cell counts have been lacking. To address this issue, START trial investigators randomized adults with CD4 counts >500 cells/mm³ to either initiate ART immediately or defer therapy until the count fell to ≤350/mm³. Based on an interim review in May 2015 (NEJM JW Infect Dis Jul 2015), the trial was stopped early; now the results have been published.

START enrolled 4685 patients in 35 countries. The median baseline CD4 count was 651 cells/mm³. In the deferred group, the median CD4 count at ART initiation was 408 cells/mm³. Patients were followed for a mean of 3 ye…