Researchers for the Strategic Timing of AntiRetroviral Treatment (START) study have found that individuals infected with HIV are dramatically less likely to develop AIDS and other serious diseases if their treatment is started sooner regardless of CD4+ T-cell counts, a primary measure of how healthy the immune system is.
START is the first major randomized clinical trial to show that starting earlier with antiretroviral treatment is advantageous to all those infected with HIV. Primarily funded by the National Institutes of Health's National Institute of Allergy and Infectious Diseases, the study began in 2011 and was not expected to end until 2016. However, a review conducted by an independent data and safety monitoring board suggested the early release of results.
Aside from providing clear-cut evidence that starting treatment as soon as possible greatly benefits HIV-infected individuals, the study also conveyed that early treatment lowers viral load in an infected person, reducing their risk of transmitting the disease to others, explained Anthony Fauci, M.D., NIAID director.
Carried out by the International Network for Strategic Initiatives in Global HIV Trials, START employed 4,685 subjects at least 18 years old in 215 sites across 35 countries. Those included in the study had never received antiretroviral treatment before and were registered into the study with normal T-cell counts. About half of the subjects were randomly chosen to start receiving treatment immediately while the rest didn't begin getting antiretrovirals until their T-cell counts didn't drop to 350 cells/mm3.
A combination of outcomes was measured by the study, including serious AIDS-related events, serious non-AIDS events and death. According to data from March, the data and safety monitoring board found 41 instances of the stated outcomes among those that are part of START. An interim analysis also revealed that a 53-percent drop was recorded for risks of developing serious complications in subjects part of the group receiving early treatment.
"The study was rigorous and the results are clear," said James D. Neaton, Ph.D., principal investigator for INSIGHT. He added that the definitive results of START will affect how care is provided to millions of people living with HIV around the globe.
START is the first clinical trial to produce concrete proof supporting current guidelines for HIV treatment in the United States, which promotes that all HIV-infected individuals should receive antiretrovirals no matter their T-cell counts. The World Health Organization's current treatment guidelines for HIV recommend that taking antiretrovirals should only start when T-cells drop to 500 cells/mm3 and below.
HIV medications used in START were provided by Merck Sharp & Dohme Corp., Janssen Scientific Affairs, LLC., GlaxoSmithKline/Viiv Healthcare, Gilead Sciences, Bristol-Myers Squibb and AbbVie, Inc.
Photo: Jon Rawlinson | Flickr
