A new study published today in the New England Journal of Medicine provides convincing evidence of the value of initiating antiretroviral therapy sooner rather than later — even in resource constrained environments.

Until recently, the WHO recommended not initiating treatment until CD4 cell counts fall below 200 per cubic millimeter or when clinical acquired immunodeficiency syndrome (AIDS) developed.  The basic logic behind this treatment strategy is that given that resources are limited, allocate resources to the sickest patients first.

However, over the past few years accumulating evidence from observational studies has suggested that patients who initiate treatment prior to become very sick appeared to have better survival.  While suggestive enough to lead the WHO to release new treatment guidelines last year, the evidence was still just suggestive as it could easily have been that unobserved difference among patients or providers could be driving the results.

The new study was a randomized clinical trial conducted in Haiti.  Both the treatment and control arms had similar baseline levels of CD4 counts and roughly half were randomized to receive early treatment rather than waiting for their CD4 cell levels to fall below 200.  The improvement in mortality was substantial: at 36 months after initiation into the study 98% of the participants in the early-treatment group and 93% in the standard-treatment group were still alive.

This may not sound like a lot as presented here but it translates into about a 75% reduction in the death rate and say we believed that roughly 5 million people have initiated treatment in the developing world, and assuming we can extrapolate the Haiti data to the rest of the world (a big assumption) it could lead to a savings of about 250,000 lives after 3 years and presumably more over time.

The other major finding of the study is that they also looked at the impact of early HIV treatment on tuberculosis related outcomes.  There were half as many cases of tuberculosis in the early initiated group – again a very big effect.

So while these findings really just reaffirm what many have believed for some time, it does now provide convincing evidence that treatment guides should be to treat sooner than later if minimizing mortality is a goal.  This will of course have implications in terms of how limited resources are allocated to treatment  in the developing world.  Since more people now meet clinical guidelines and it will cost more to treat people does that mean who gets priority should be re-evaluated?

Given that there is unlikely to be as large of an increase in funding for HIV programs in the developing world in the coming years, it raises the question that was raised a decade ago when treatment programs were beginning: who should get priority for treatment?  Should those who are most likely to benefit get priority over those who are perhaps too sick to benefit from treatment?  These are difficult questions and there are certainly no easy answers.

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