START Trial data support starting antiretroviral treatment for HIV as early as possible

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An international trial has shown that starting antiretroviral treatment for HIV early significantly lowers risks of serious illnesses, including AIDS, compared to waiting for immune cell counts to drop. The START — Strategic Timing of AntiRetroviral Treatment clinical trial — which enrolled 4,685 people living with HIV at 215 sites across 35 countries over the last four years found that starting treatment early reduced risks of coming down with a serious illness by 53 percent.

The results, announced today, support U.S. guidelines recommending that immediate treatment be offered to all people diagnosed with HIV. The U.S. is one of only a few countries worldwide to adopt immediate treatment as a standard of care, and very few of the highest burden countries have yet adopted World Health Organization guidelines recommending treatment start when immune cell counts have dropped below 500 per cubic millimeter of blood, and immediately for pregnant women and children.

Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, which invested $154 million of the $166 million spent by the National Institutes of Health on the study, acknowledged that adopting immediate treatment as a standard of care would be expensive. But he added “at the end of the day, there’s no doubt that it’s going to cost less money.”

Trial participants, whose immune cell counts were above 500, were assigned randomly to beginning treatment immediately or to beginning treatment when immune cell counts had dropped below 350. Among those who began treatment immediately, 41 participants — less than 2 percent —  developed serious illnesses over three years. Of those who waited 86 participants developed serious illnesses. A data safety and monitoring board asked that the trial be stopped and that all trial participants be informed of the outcomes and given the opportunity to begin immediate treatment.

While the study confirmed benefits of early antiretroviral treatment that most experts agree on, it also yielded evidence that starting early did not result in more side effects or other adverse outcomes, the study’s principal investigator James D. Neaton of the University of Minnesota said.

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