In a major report from the National Institute for Allergy and Infectious Diseases (NIAID) researchers found that early treatment of HIV is linked to a considerably lower risk of developing AIDS. The new data found that when individuals started antiretroviral treatment when their CD4+ count was high they had a significant decrease in developing AIDS and other serious illnesses.
The study called Strategic Timing of Antiretroviral Treatment (known as the START study) was a randomized, study of nearly 5,000 men and women 18 and older in 35 countries and was conducted by the International Network for Strategic Initiatives in Global HIV Trials (INSIGHT). NIAID and the National Institutes for Health provided primary funding to START.
“We now have clear-cut proof that it is of significantly greater health benefit to an HIV-infected person to start antiretroviral therapy sooner rather than later,” said NIAID Director Dr. Anthony S. Fauci. “Moreover, early therapy conveys a double benefit, not only improving the health of individuals but at the same time, by lowering their viral load, reducing the risk they will transmit HIV to others. These findings have global implications for the treatment of HIV. The study which began in 2011, will conclude in 2016, but an independent data and safety board recommended the early release of this information after an interim review of the study data.
The participants were divided into two randomized groups, one to start ART immediately and the other to start treatment only when CD4+ levels dropped below 500 cells per cubic millimeter (the current World Health Organization recommendation). Then participants were followed for three years.
Several health outcomes were measured including AIDS-related major health events, such as AIDS-related cancer, and non-AIDS related major health events, such as liver or kidney disease. The data released in March showed that there were 41 major health events or deaths in the early treatment group compared to 86 major health events in the deferred treatment group. Further analysis showed that risk of developing a serious illness or health event decreased by 53 percent when ART began immediately.
In the U.S., HIV guidelines recommend ART for any asymptomatic HIV-positive person, regardless of CD4+ levels. START is the first large-scale randomized clinical trial to show evidence supporting US guidelines.
“The definitive findings from a randomized trial like START are likely to influence how care is delivered to millions of HIV-positive individuals around the world,” said principle investigator James D. Neaton, professor of biostatistics at the University of Minnesota, Minneapolis.
“Every person living with HIV should have immediate access to life-saving antiretroviral therapy,” said Michel Sidibé, executive director of UNAIDS said in a press release. “Delaying access to HIV treatment under any pretext is denying the right to health.”
UNAIDS reaffirmed also that it encourages starting ART early but that treatment was still a personal decision and still up to the individual.