The recently published INSIGHT trial showed that starting HIV therapy earlier rather than later has benefit for patients 1. This should not come as a surprise considering the excellent suppressive power of current triple regimens. The trial which enrolled 4685 HIV infected patients was stopped prematurely when an interim analysis showed (with an impressive P-value) that outcomes were statistically improved, in a clinically meaningful manner, by starting therapy early irrespective of CD4 count.
Current practice which delays treatment until the CD4 count drops to 350 will almost certainly be replaced soon with this new regimen which makes every HIV positive patient a candidate for treatment at the time of diagnosis.
It also brings to mind the Pareto’s principle – also known as the 80/20 rule: we pay a very high price to squeeze out the last 20% of benefit with our therapies, be that cholesterol-lowering with statins or viral load suppression in HIV.
Let us review the situation in an unbiased fashion. The benefits of early treatment initiation in terms of ‘serious clinical problems averted’ (see list below) seem real. The study findings are internally consistent all showing a similar positive trend in subset analyses favoring early initiation of HAART.
Now, stepping out of the ivory tower of science and looking at the cost consequences, we can make some crude estimates:
- In this study, the number ‘needed to treat’ (NNT) was approx. 43; in other words, one would have to treat this many patients for 1 to benefit from the intervention;
- An effective therapy is available which costs at least $20-25k per year [2, 3]; it would now be given on average 3 years earlier than with current practice.
Hence, the costs for 1 ‘serious clinical problem averted’ is
$ 20k x 3 years x 43 patients = $ 2.56 mio
Clearly, there are indirect benefits like reduced transmission of HIV which we did not factor in. However, on the flip side, we also chose to disregard the additional costs from doctor visits, drug monitoring, and labs like VL and CD4 level determinations which patients incur while on therapy during an extra 3 years.
Importantly, the number of deaths averted from any cause was 9; there were 12 in the early treatment and 21 occurred in the delayed treatment groups (P=0.13).
Besides the clinical results we are interested in the financial aspects and the societal consequences of the INSIGHT study. We are interested your esteemed opinion.
Here is today’s question we ask you to vote on:
Health progress and the R&D it required comes at a cost. Society and Health Care providers are now routinely asked to pay premium prices for better medicines. In your opinion, given the results of the INSIGHT study , is the cost of an earlier HIV treatment justified? [poll id=”4″]
Independent of your vote, we all can agree that an ounce invested in prevention stands to reap huge long-term cost savings. Research into HIV vaccines and curative approaches should be a top priority as it would have a tremendous impact on health care spending.
Here the LIST of SERIOUS PROBLEMS AVERTED from the INSIGHT STUDY:
- Death from any cause
- AIDS-defining event
- Myocardial infarction, coronary revascularization or stroke
- end-stage renal disease or renal transplant
- decompensated liver disease
Here some more FACTS about HIV / AIDS:
- HIV incidence of new cases for the US is approx. 50,000 patients / year. These plus all HIV positive patients currently untreated are now eligible for HIV therapy.
- According to The Kaiser Family Foundation, Medicaid spending on HIV totalled $5.3 billion, which is a third of all federal HIV funding – in 2012.[2] The Ryan White Act provides additional billions of funding: $2.3 billion were requested in the Budget for 2015.
- None of the existing programs cover all the uninsured that are candidates for delayed therapy, let alone for immediate therapy.
References:
[1] The INSIGHT START Study Group, NEJM July 20, 2015
[2] http://www.avert.org/hiv-treatment-usa.htm
[3] The actual cost of a triple regimen of Prezista, Truvada, and Norvir amounts to $3000/month, or $36k/year.
