Early ART yields better outcomes in HIV

Early antiretroviral therapy (ART) in individuals with HIV offers better outcomes, particularly in those aged 35 years and younger, in a follow-up analysis of the START trial. Conversely, delayed therapy results in a higher risk of death and serious health issues in this population.

Initiating ART early led to rapid declines in HIV RNA to ≤200 copies/mL. In patients who deferred ART until their CD4 counts were below 350 cells/mm³, there was a 21-percent higher risk of death or serious AIDS-related and non–AIDS-related health consequences in the 5-year period following ART introduction vs those who started ART early (p=0.09). [IDWeek 2022, abstract LB2305]

“Even in patients who had CD4 counts over 500 cells/mm³ at diagnosis, it is better not to delay therapy,” said Dr Abdel Babiker from the University College London in London, UK during his presentation at IDWeek 2022. “The earlier you start ART, the better.”

Normal CD4 count ranges from 500–1,500 cells/mm³. However, the immune compromise caused by HIV is characterized by the loss of CD4 cells. Left untreated, the CD4 cell count declines until it becomes harder for the body to fight off other infections. Rates of HIV-associated complications and death increase as CD4 count declines. 

Worse outcomes for delayed ART

In patients who previously deferred ART in the study, 27 progressed to AIDS and 57 died vs 15 and 47, respectively, in those who started ART early. Non-AIDS-related serious health issues, including cardiovascular disease, end-stage renal disease, decompensated liver disease, and non–AIDS-defining cancer, occurred in 88 patients who delayed therapy and in 76 who started ART early.

What the researchers found striking were the dire outcomes of delayed therapy in patients 35 years and younger. In this age group,  44 patients in the delayed group experienced primary endpoint events vs 19 in the early therapy group (hazard ratio [HR], 0.42, 95 percent confidence interval [CI], 0.24–0.71). These numbers were 69 and 70 in patients older than age 35 (HR, 1.04, 95 percent CI 0.75–1.45; p=0.004).

“People do not actually realize they have HIV until it is too late,” commented Dr Carlos del Rio from Emory University of Medicine in Atlanta, who is unaffiliated with the trial. “We should therefore test for HIV and diagnose these people earlier.”

The original START trial published in 2015 showed that early ART in HIV-positive adults reduced the risk of serious AIDS-related events, serious non-AIDS-related health outcomes, and death by 57 percent. [N Engl J Med 2015; 373:795-807]

The current analysis spanned from January 2016 to December 2021.