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shutterstock_184344641A commentary on the START Study

Up until now, the benefits of early HIV treatment before CD4 counts decline have been controversial and inconclusive. On 27 May 2015 the US National Institutes of Health (NIH) halted the largest international study of its kind called START – Strategic Timing of Antiretroviral Treatment – due to overwhelming conclusive evidence that 53% of people enrolled into the early treatment arm of the study (above 500 CD4 cells) were less likely to die or develop AIDS illnesses (and risk death), compared to those in the delayed treatment arm of the study who waited until their CD4 count fell below 350.

This major landmark study demonstrated that early treatment (at high CD4 counts) was beneficial across all populations in the study, and that it conferred substantial reductions in AIDS and serious non-AIDS events, as well as significant reductions in cardiovascular, liver and renal disease, when compared to delaying treatment.

The START study commenced enrolment in 2009 and had followed 4,685 HIV-positive men and women in 35 countries. It was created to settle the long standing debate about when to begin HIV treatment. At that time, the US CDC treatment guidelines (which Australian doctors also follow) recommended starting HIV treatment when a patient’s CD4 count fell below 500 (to 350), while the World Health Organisation recommended waiting until it was below 350.

Dr. Julio S. G. Montaner, Director of the British Columbia Centre for Excellence in HIV/AIDS; and former president of the International AIDS Society, who wrote a seminal 2006 paper in the Lancet arguing that universal antiretroviral treatment was the best way to curb the AIDS epidemic, said the study “confirms what we have been saying for years”.

The ramifications of START will now most certainly imply an alignment shift of local and international treatment guidelines (including the WHO) to recommend treatment to all PLHIV regardless of CD4 count. More data will almost certainly emerge further supporting the benefits of early treatment across other domains of HIV health – including the (now well understood) pro-inflammatory effects of untreated HIV (and CD4 depletion) – which serves only to cause adverse effects on the body. While earlier thresholds for treatment initiation attempted to predict the tipping point between the risk of complications from HIV versus those caused by HIV therapy, the now cleaner and more potent antiretroviral regimens have tilted the balance away from postponing treatment. Now the evidence is in. Although early treatment has been favoured for some time due to observational evidence showing the benefits of early treatment, the large and randomised nature of the START study findings has now set that in concrete. Whilst developed nations have tended to know this for some time now, the greatest challenge following the START study results is to now expand early HIV treatment also in the developing world, to the globe.

The START study has without a doubt confirmed that early treatment of HIV is far more protective to one’s health and well-being than delaying treatment, and to do so significantly outweighs any risk of treatment-related side effects. Additionally, it has become very clear now, through other major empirical research, that HIV treatment also confers substantially reduced infectiousness to others. These things together are important reasons to consider treatment early at high CD4 counts, before CD4 decline.

This important research of our new era brings consistency to the entire world as to the unequivocal best time to start treatment. Now we know there is no benefit in delaying treatment – and we welcome that another barrier to early HIV treatment access has been effectively removed (i.e. the CD4 count). That said, the decision to start, or stop, treatment is still entirely an individual’s right – since treatment guidelines (although based on sound and strong scientific evidence) are not mandatory, just recommended for vastly greater health….and who knows, one day soon, we all live for that one great hope – CURE and NO more treatment at all…

Further reading, discussion and opinion points: