HIV-infected patients have a much lower risk of developing AIDS if they start taking antiretroviral drugs sooner, which is when their CD4+ T-cell count is higher, according to a news release published online in May by the National Institute of Allergy and Infectious Diseases, part of the National Institutes of Health.
The Strategic Timing of AntiRetroviral Treatment study, a large-scale international clinical trial, began in March 2011 and was conducted by the International Network for Strategic Initiatives in Global HIV Trials at 215 sites in 35 countries.
“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,” NIAID Director Anthony S. Fauci, MD, said in the press release. “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 trial studied 4,685 HIV-infected men and women with a median age of 36. Participants had never taken antiretroviral therapy and were enrolled with CD4+ cell counts in the normal range — above 500 cells per cubic millimeter. About half of participants were randomized to initiate antiretroviral treatment immediately while the other half received treatment when their CD4+ cell count declined to 350 cells/mm3. Researchers followed the participants for a three-year period, measuring a combination of outcomes such as AIDS-related cancer, serious non-AIDS events (major cardiovascular, renal and liver disease and cancer), and death.
Data revealed 41 instances of AIDS, serious non-AIDS events or death among those enrolled in the early treatment group compared to 86 events in the deferred treatment group. The risk of developing serious illness or death was reduced by 53% among those in the early treatment group compared to those in the deferred group, the study reported.
Findings were consistent across geographic regions, and the benefits did not differ based on income level.
“The study was rigorous and the results are clear,” said INSIGHT principal investigator James D. Neaton, PhD, professor of biostatistics at the University of Minnesota, Minneapolis. “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.”
Researchers plan to continue observing participants through December of 2016, according to a Q & A on the trial, published on the website.
Seven sub-studies connected with the START trial include looking at genomics, neurology, arterial elasticity, lung disease, bone density, liver disease and informed consent.
START is the first large-scale randomized clinical trial to give concrete scientific evidence supporting U.S. HIV treatment guidelines, which recommend all asymptomatic HIV-infected patients take antiretrovirals regardless of CD4+ cell count. Current WHO HIV treatment guidelines recommend individuals begin antiretroviral therapy when counts fall to 500 cells/mm3 or less.
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