World-first study finds early HIV treatment halves risk of serious complications

An international study led by UNSW’s Kirby Institute has shown immediate treatment for people diagnosed with HIV can halve their risk of HIV-related serious disease or death.

The study was terminated ahead of schedule after interim results provided conclusive evidence that immediate treatment with antiretroviral therapy (ART) is clinically superior compared to deferred treatment.

The study findings have global implications for the treatment of people living with the virus and will influence global treatment regimens. Approximately 30 million people worldwide are living with HIV with only a third of this group receiving treatment.

The  Strategic Timing of AntiRetroviral Treatment (START) study  enrolled more than 4600 patients in 35 countries including Australia, who had never taken antiretroviral therapy (ART) with a white blood cell count in the normal range (above 500 cells/mm³).

One-half of the participants were randomised to receive antiretroviral treatment immediately and one-half were randomised to receive treatment once their cell count declined to 350 cells/mm³.

Interim results have shown that there is significant benefit from initiating ART before cell counts drop from the normal range.

Current international guidelines generally recommend initiating treatment when the cell count is less than 500 cells/mm³. Until now, there has been a lack of robust evidence to justify treatment at higher cell counts.

USW Professor Sean Emery, co-ordinating investigator of study, said findings show that treatment at all stages of disease extends survival and prevents serious disease complications in people with HIV infection.

“A lot of people with HIV don’t have symptoms, they effectively have a silent clinical presentation, and until now there has been doubt about whether antiretrovirals should be used in those individuals,” Professor Emery said.

Participants will continue to be followed in the next stage of the study that is expected to conclude in late 2016.

Funding for the START trial was provided by the National Institutes for Health (NIH), the National Health and Medical Research Council of Australia (NHMRC), and a number of government organisations based in Europe.

The other international centres involved in the trial are the Medical Research Council (MRC) Clinical Trials Unit at University College London, the Copenhagen HIV Programme at the Rigshospitalet, University of Copenhagen in Denmark and the Veterans Affairs Medical Center affiliated with George Washington University in Washington, DC.

Read the full Kirby Institute media release here.