Previous studies have established that early treatment of HIV dramatically reduces the odds of spreading the infection to a sexual partner. The START trial provides evidence that early therapy benefits a patient's own health.
The Strategic Timing of Anti-Retroviral Treatment (START) trial was stopped a year early when it became obvious that immediate treatment of HIV patients at a CD4 cell count of 500 cells/Î¼L or higher was superior to deferring ART until the CD4 cell count decreased to 350 cells/Î¼L or until AIDS develops, according to an Associated Press report.
Previous studies have established that early treatment dramatically reduces the odds of spreading HIV to a sexual partner. Now there is evidence that a patient's own health benefits by starting early therapy.
Anthony Fauci, MD, director of the National Institutes of Health (NIH) National Institute of Allergy and Infectious Diseases, which funded the study, said the study offers "another reason why we should be more aggressive" in getting people tested and treated. "It tells you that you will benefit from therapy at whatever your CD4 count is," he said.
START, an open-label multinational trial, included 4,685 participants. It was the largest ongoing ART trial, and was planned to be completed by the end of 2016.
Researchers tracked deaths, the development of AIDS-related illnesses, and the development of serious non-AIDS events, such as cancer, heart disease, kidney disease, or liver disease. Over about 3 years, the risk of serious illness or death was reduced by 53% in the early treatment group, according to the NIH.
The actual numbers of worse outcomes in both groups were very low because patients were so healthy when they enrolled in the study. There were 41 cases in the early-treatment group compared with 86 cases in the group that delayed treatment until their CD4 count dropped to near 350 cells/Î¼L.
“Current HIV treatment guidelines vary considerably on when to start treatment, and reliance on expert opinion in the past has often underestimated the risks of treatment and overestimated the benefits of earlier initiation of ART,” noted the authors of a study in the April 2015 HIV Medicine that provided a community perspective on the START trial.
In the US, ART is recommended regardless of CD4 cell count. The World Health Organization now recommends starting ART at a CD4 cell count of 500 cells/Î¼L, while the threshold for the UK and South Africa remains at 350 cells/Î¼L.
“Evidence from randomized clinical trials shows that the threshold must be set higher than 250 cells/Î¼L. Data become less clear at levels above 350 cells/Î¼L,” they write.
The authors noted that the patients’ CD4 cell counts at study entry were higher than the estimate used in the original calculations of sample size. Therefore, “this enables START to answer the primary hypothesis with fewer clinical events than originally calculated,” they write.
Baseline data show that the majority of patients included in the study were those who were recently diagnosed with HIV and still in relatively early infection. The median time from diagnosis was 1 year and about one-quarter of participants had been diagnosed within 4 months before entering START, showing that many people found the option of early treatment an acceptable one, the authors noted.