Drugs to keep people with HIV alive should be given as early as possible – before the virus has weakened their immune system – and not delayed as they are now, according to scientists involved in a major trial.

The Start (Strategic Timing of AntiRetroviral Treatment) trial was stopped because of overwhelming evidence that people with HIV did better if they were put on antiretroviral treatment when their CD4 count (a measure of how well their immune system is functioning) was above 500 rather than 350, as guidelines currently advise in the UK and many other countries.

Anthony S Fauci, director of the National Institute of Allergy and Infectious Diseases, part of the National Institutes of Health which funded the trial of more than 4,600 people, said it was stopped because it became clear that early treatment cut the number of people who died or suffered serious Aids-related illness in half. The trial should have ended in 2016. Those whose treatment was being delayed will now get the drugs immediately.

“These findings clearly demonstrate that starting antiretrovirals sooner rather than later is of considerable benefit to the HIV-infected individual,” Fauci said.

The results are likely to change the way people with HIV are treated all over the world. In both high- and low-income countries, the results were the same: a 53% drop in serious illness and death in those given drugs while their immune systems were more robust.

“I would be surprised if guidelines committees didn’t very seriously look at this and bring it into their calculations,” said Fauci. “[In the US,] if you are infected, you get treated.” That has been based on expert opinion, without evidence from a randomised trial, which is why Start was launched. But in the UK and other countries including most of Europe, treatment is deferred.

There would be financial implications, Fauci acknowledged. “This is going to cost money if you have to go out and treat everyone who is infected,” he said. It would be another motivation for getting resources into programmes such as the Global Fund and Pepfar (the US president’s emergency plan for Aids relief), which provide money for treatment in the poorest countries.

But treating early would be cost-effective, because those who are treated early will not suffer severe illnesses as a result of HIV. “There is no doubt that it is going to be less expensive to treat people early,” he said.

British experts hope that Nice (the National Institute for Health and Care Excellence) will now recommend that anyone with HIV is given the drugs at diagnosis. That would have the great additional benefit of reducing transmission, since it has been shown in gay men that the drugs suppress the virus to the point where people are no longer infectious.

Prof Ab Babiker of the Medical Research Council clinical trials unit at UCL, one of the trial coordinators, said: “We know from previous trials that ART (antiretroviral therapy) reduces the risk of transmission of HIV. The findings from Start clearly demonstrate that early treatment is also of benefit to the individual. This provides a very strong rationale for offering treatment to all HIV-positive individuals as soon as they are diagnosed.”



Dr Alejandro Arenas-Pinto from UCL, the trial’s chief investigator for the UK, said: “Early ART initiation has been advocated by some investigators in the past, but it is the Start trial that provides strong evidence to support the strategy based not only on clinical benefit but also on lack of harm for the individual. The discussion between patients and clinicians on when to start ART would, from now on, be evidence-based.”