A major international HIV treatment trial coordinated by the Kirby Institute at UNSW in partnership with three other international research centres has been terminated ahead of schedule after interim results provided conclusive evidence that immediate treatment of HIV is clinically superior compared with deferred treatment among people with HIV infection and early disease.
Professor Sean Emery, coordinating investigator of the START study from the Kirby Institute said in a media release earlier today, “These findings have global implications for the treatment of people living with HIV”
“As a result of this trial, we now know that treatment at all stages of disease extends survival and prevents serious disease complications in people with HIV infection. Together with data from previous studies showing reduced risk of HIV transmission among people on ART, these new findings support treatment for everyone with HIV,” said Professor Emery.
The recommendation to stop the study was based on an interim analysis that showed the following:
- Risk of serious AIDS events and deaths due to non-AIDS events including major cardiovascular events, renal and liver disease and cancer was reduced by more than 50% among those in the early treatment group compared to those in the deferred group.
- Reductions due to early treatment were seen in both serious AIDS and serious non-AIDS events; the effect of early treatment on AIDS was greater than non-AIDS events.
- Safety outcomes (e.g., serious adverse event) were similar in the two groups.
- Findings were consistent across a number of pre-specified subgroups, including geographic region.
This is yet another example of the incredibly important role of investigator-led clinical trials in providing concrete evidence to support critical decisions made by patients, doctors and policymakers everyday across our health system. Our congratulations to the START Study Investigators and all who have played a part in delivering this major international breakthrough in the treatment of HIV infection.
For more information check out The Kirby Institute's media release