START says start

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02 Jun 2015

A major international trial coordinated by the Kirby Institute at UNSW has been halted ahead of schedule after results provided “rock solid evidence” that immediate treatment of HIV has “a highly significant benefit” for people infected with the virus.

The Strategic Timing of AntiRetroviral Treatment (START) study findings will have “global implications for the treatment of people living with HIV”, said coordinating investigator Professor Sean Emery. “As a result of this trial we now know that treatment at all stages of disease extends survival and prevents serious complications in people with HIV infection,” he added.

Current international guidelines generally recommend PLHIV start treatment when their CD4 count falls below 500. The START study corroborates earlier evidence justifying treatment at higher counts. “Many researchers, clinicians and advocates have held this view,” said Robert Mitchell, president of the National Association of People with HIV Australia (NAPWHA), “but the evidence to support it came mostly from smaller studies and expert opinion. It was argued that we lacked a large, definitive, randomised clinical study to prove the early treatment strategy. So START has provided that.”

NAPWHA has been involved in the START study from its beginning in 2009, with former executive director Jo Watson serving on the international coordinating group. “Once again, through our participation in START, Australia has shown remarkable global leadership in HIV research,” said Mitchell.

Carried out at 215 sites in 35 countries, START is the first study to examine the initiation of antiretroviral therapy (ART) for HIV- positive individuals with normal CD4 counts (500-plus). The study enrolled 4,685 participants who had never taken ART before. One half of participants began treatment immediately, while the other half commenced treatment once their count fell to 350.

Interim analysis shows the risk of serious AIDS events, and deaths due to non-AIDS events including major cardiovascular episodes, renal and liver disease, and cancer was reduced by more than 50 percent among the early treatment cohort compared to those in the deferred group. All study participants will now be offered treatment and will continue to be followed in the next stage of the study which is expected to conclude in 2016. “We would like to thank the thousands of HIV-positive participants who have contributed to a finding that will impact treatment guidelines around the world,” said Emery.

Read more here.

NAPWHA's full response here.

BY CHRISTOPHER KELLY