IAS 2015A new analysis of the major trial that provided gold-standard scientific proof supporting early treatment of HIV has illustrated in greater depth the many benefits of starting antiretrovirals (ARVs) soon after diagnosis and when CD4 counts are high. Researchers presented their findings from the randomized controlled START trial at the 8th International AIDS Society Conference on HIV Pathogenesis, Treatment and Prevention in Vancouver, British Columbia, and also published their study in The New England Journal of Medicine.

The START trial included 4,685 treatment-naive men and women living with HIV in 35 countries, all of whom started the trial with more than 500 CD4 cells. They were randomly assigned to start treatment immediately or to wait until their CD4s dropped to 350 or below, until they developed AIDS or other serious illnesses, or until they met stipulations for beginning ARVs according to local guidelines.

Initial results from the trial were released in May.

Forty-two participants in the early treatment group (1.8 percent) and 96 in the deferred treatment group (4.1 percent) developed AIDS-defining illnesses, serious non-AIDS illnesses (including cardiovascular disease, end-stage kidney disease, liver disease or non-AIDS-defining cancer), or died. This translated to a respective 0.60 and 1.38 occurrences of these outcomes per 100 person-years in the early and deferred treatment groups. Starting treatment early reduced the risk of these outcomes by 57 percent, which  was observed regardless of age, sex, CD4 count upon entry into the study, geographic region, or country income level. Sixty-eight percent of these outcomes occurred in individuals with greater than 500 CD4 cells.

Starting treatment early reduced serious AIDS-defining illnesses by 72 percent and serious non-AIDS illnesses by 39 percent.
There was no difference between the two study arms in the rate of other potentially life-threatening health problems and unscheduled hospitalizations for reasons outside of AIDS. This indicates that early treatment is safe.

“This study conclusively shows that the benefits of early therapy far outweigh any adverse outcomes, and reinforces recommendations to offer immediate antiretroviral therapy to all patients,” Anthony S. Fauci, MD, director of the National Institute of Allergy and Infectious Diseases, said in a press release. “Today’s findings show that early antiretroviral treatment presents no additional risk of serious, non-AIDS-related disease to people taking treatment, but actually confers valuable protection against these illnesses, helping keep HIV-infected people healthier longer.”

To read the press release, click here.

To read the study, click here.