Treatment for HIV should begin right at the point of diagnosis. That’s the conclusion of a major international clinical study funded by the National Institutes of Health. The Strategic Timing of AntiRetroviral Treatment (START) study is a randomized clinical trial operating on 215 sites in 35 countries, of which Mayo Clinic is one, funded by the National Institute of Health and conducted by the International Network for Strategic Initiatives in Global HIV Trials (INSIGHT).
Mayo infectious disease specialist and HIV researcher Zelalem Temesgen, M.D., says this is the first clear-cut confirmation that U.S. treatment guidelines should become a global model in the fight against HIV.
Though U.S. policy has been to start patients on antiretroviral treatment (ART) upon diagnosis, some debate has existed in the scientific community due to the lack of hard evidence supporting the benefits of early treatment. According to Dr. Temesgen and Dr. Stacey Rizza, M.D., the principal investigators of the Mayo Clinic trial site, the oft-cited potential risks of reduced quality of life, development of drug resistance, and uncertain long-term toxicities have been made less concerning by other recent medical advancements in HIV treatment, and this study only makes clearer the fact that the benefits dramatically outweigh the risks.
According to the results, individuals who began treatment with high a CD4+ T-cell count (a measurement of immune system health) of 500 cells per cubic millimeter were less likely to develop AIDS or other illnesses – a risk reduced by 53% for patients who were deferred treatment until their CD4+ count was a much lower 350 cells per cubic millimeter (or they had developed AIDS).
Dr. Temesgen hopes that these results will comfort recently-diagnosed patients, as well as inform the decisions of global health organizations and other governments in setting treatment guidelines for this disease. “In the U.S., current guidelines already endorse starting early. But internationally, where resources are less robust, other countries will have to revisit current guidelines [based on these results].”
Though the study is not supposed to conclude until 2016, the findings are clear enough to be released early. They will be officially presented at the International AIDS Society conference in Vancouver in mid-July. Deferred patients will begin ART treatment immediately, and the results will be revisited again in 2016.
The Mayo Clinic HIV Clinic in Rochester, MN is a member of the INSIGHT network and has previously participated in similar, large, landmark HIV studies that have contributed substantially to current knowledge of how to manage HIV infection.