A major study has concluded that ARV therapy should be given as soon as possible after HIV infection is detected, ending years of debate around this issue.

START Study logo “Timing is everything”

The START study – funded by  by the US National Institute of Health (NIH) – was designed to answer the hotly debated question of weather to start ARV treatment while an individual still has a CD4 count in the ‘normal’ range of 500 cells per cubic millimetre, or should be delayed until it drops below this level. This is a important question as, while the effects of HIV on the immune system are obviously dangerous, the powerful drugs used to treat the infection are not without potentially serious side effects. 

The issue has been debated for so long because of lack of good quality evidence supporting either side. This lack of data has meant that treatment guidelines have differed depending on where you live – current US guidelines recommend immediate commencement of treatment, the WHO recommends treatment only once an individuals CD4 count drops below the ‘normal’ range, and the British HIV Association (BHIVA) recommend treatment should be delayed until a CD4 count of 350 cells per mm3.

START was a randomised, controlled study which took place over 215 different sites, in various countries, and involved over 4,500 newly-diagnosed men and women. It looked at risk of death, developing AIDS-related illnesses such as cancer, and non-AIDS related illnesses such as liver disease. The results were dramatic – patients in the early treatment group were over 50% less likely to die or experience any of the illnesses under investigation.

“We now have clear-cut proof that it is of significantly greater health benefit to an HIV-infected person to start antiretroviral therapy sooner rather than later,” said Anthony S. Fauci, M.D, at the NIH.

Responding to the findings, Dr Rosemary Gillespie, Chief Executive at Terrence Higgins Trust, said:

“This ground-breaking research adds to the growing body of evidence that shows there should be no delay in starting HIV treatment. Early diagnosis and treatment mean that people living with HIV can expect to live long and healthy lives, and can also reduce the chances of HIV being passed on unwittingly”

Big randomised studies like these, spread over many locations, are the absolute gold star in clinical trials. Usually, researchers wait until such studies are concluded before publishing the results or making treatment recommendations. However, sometimes the results are so striking and important that they must be released early to ensure the very best care is given to all. This is exactly what has happened here: According to Fauci, “These findings have global implications for the treatment of HIV”.

The official NIH START page can be found here


  1. […] People are also starting treatment earlier. In 2013 26% of the 5,370 people who started treatment did so with a CD4 count of 500 cells/mm3 or higher, this is more than double the 10% who did the same in 2009. These figures show how both clinicians and people living with HIV have embraced study and trial data that continues to show that Treatment As Prevention (TAsP) is successful at preventing onwards transmission to HIV negative partners (see: PARTNER study), as well as leading to better long-term health for the person taking the treatment – compared to those who start with a CD4 count below 350 (see: START Study). […]


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