The primary composite end point of any serious AIDS-related event, serious non–AIDS-related event, or death from any cause occurred in 42 patients in the immediate-initiation group (1.8%; 0.60 events per 100 person years) vs. 96 patients in deferred-initiation group (4.1%; 1.38 events per 100 person-years), for a hazard ratio of 0.43 (95% CI, 0.30 to 0.62; p<0.001). The risks of a grade 4 event were similar in the two groups, as were the risks of unscheduled hospital admissions. On the basis of an interim analysis, the data and safety monitoring board determined that the study question had been answered and recommended that patients in the deferred-initiation group be offered antiretroviral therapy.
An editorial notes that when to start antiretroviral therapy (ART) in asymptomatic persons has long been debated. This study is one of two published in the New England Journal of Medicines that provides additional evidence to support early initiation by demonstrating its clinical benefits in asymptomatic patients at an early stage of their disease, when CD4+ cell counts are >500cells/mm3. These large trials also showed a minimal or no overall increase in adverse events in patients initiating ART early. The commentator also notes that translating early treatment for all people living with HIV into programmatic implementation by health care services is a daunting prospect, as there was an estimated 36.9 million people living with HIV in 2014, with over 20 million living in Africa. He adds that a key obstacle is the high proportion of people with HIV who are not aware of their HIV status and as treatment scale-up continues, the looming concern is maintaining quality care, including ART adherence, retention in care, and adequate monitoring for treatment failure to avoid drug-resistance. He concludes that converting the new evidence from these two trials into treatment programs for all people living with HIV will require substantial additional resources.