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    START Trial Stopped

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    A much-awaited international trial investigating the effect of early initiation of ART in people living with HIV was stopped when clear evidence of benefit emerged.

    28 May 2015

    The sector has been eagerly awaiting the results of the Strategic Timing of Antiretroviral Treatment (START) trial about the efficacy of earlier initiation of antiretroviral treatment. The NIH announced today that the trial has been terminated early after an interim review found a clear benefit for commencing treatment at CD4+ counts above 500 compared with delaying until CD4+ falls below 350.

    There is still considerable detail to be unpicked and we anticipate START and its sub-studies contributing to the clinical program at the IAS Pathogenesis meeting in Vancouver in July. Details from the START Team, the Kirby Institute and a number of commentary sites are below.

    Detail from the analyses and a number of sub studies may provide a more detailed understanding of this data. There were 41 endpoints reached in the treatments arm (AIDS, serious non-AIDS events and death) compared to 86 in the deferred treatment group. This is a stark 53 per cent increase in events in the deferred group.

    START provides the rigorous randomised controlled trial data to support guidelines recommending earlier treatment initiation. It also indicates that the benefits associated with early treatment significantly outweigh the harms. These findings were consistent across economic settings.

    There is now firm evidence that early initiation of therapy confers benefit over delayed initiation of therapy. Earlier initiation of therapy in people living with HIV can now be confidently recommended

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