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START Trial demonstrates importance of early treatment – Who Will Pay?

June 10, 2015

Position paper

On May 27th, 2015, the U.S. National Institute of Health released an article stating that the START Trial, short for Strategic Timing of Starting Antiretroviral Treatment, was stopped more than a year early after strongly conclusive findings made completing the trial unethical.  The trial separated 4,685 enrolled HIV-positive men and women into two study groups: one in which antiretroviral treatment was started immediately – despite all of the patients having a CD4+ cell count above 500 – and the other in which treatment was not started until the patient’s CD4+ cell counts fell below 350 or the patient experienced an AIDS-related event.  The results that halted the continuation of the trial found that there was a 53% decreased risk of experiencing AIDS, serious non-AIDS events, or death among those enrolled in the early treatment group compared to those in the deferred treatment group (http://www.nih.gov/news/health/may2015/niaid-27.htm).

Based on these findings, federal health officials in the U.S.A. have issued new recommendations to immediately initiate antiretroviral treatment as soon as a person tests positive.  The START Trial has made it very clear that initiating treatment as early as the time of diagnosis of HIV infection, as opposed to the current WHO guidelines of a CD4+ cell count of 350, has profound benefits for patients’ health.  But this recommendation raises serious issues about funding.  Of the roughly 35 million people estimated to be living with HIV globally, less than 14 million are on treatment and, according to the New York Times, access to treatment for all people currently infected would be an endeavor that would cost approximately US$20 billion (http://www.nytimes.com/2015/05/31/opinion/sunday/treating-hiv-patients-before-they-get-sick.html?_r=1).  Despite this hefty cost, AIDS officials are lauding the finding as the discovery that will finally put more money into treatment.  They are also praising its potential for prevention, as those on regular treatment are 90% less likely to infect others (http://www.nytimes.com/2015/05/28/health/hiv-treatment-should-start-with-diagnosis-us-health-officials-say.html).

Findings from the START Trial clearly document the fact that access to antiretroviral treatment can significantly lower an HIV-positive person’s chance of infecting another person, transitioning to AIDS, getting seriously ill, and ultimately dying.  In light of this, it is no wonder that public health officials, including the executive director of UNAIDS, Michel Sidibé, are considering the START trial results a “defining moment” (http://www.nytimes.com/2015/05/28/health/hiv-treatment-should-start-with-diagnosis-us-health-officials-say.html).  Unfortunately, the problem never will be that simple.

In spite of the scientific evidence, and widespread official recognition of the fact that starting treatment earlier for people living with HIV could have a major impact on ending the epidemic, there is little chance that this can be achieved given the reality of a trending decrease in financial resources and commitments for responding to the epidemic globally.  The U.S.A. is the largest contributor to all HIV and AIDS funding but the projected budget for the 2016 fiscal year is $31.7 billion, with only $6.3 billion for global spending – a 3.7% decrease from 2015.  Of the U.S. global funding for HIV and AIDS, only $1.1 billion will go towards the Global Fund, an 18% ($244 million) decrease from 2015.  In addition to the decline of U.S. contribution to the Global Fund, international funding from the other donor governments started to plateau in 2008 at around $8.7 billion.  Between 2011 and 2013, international funding continued to decrease to as low as $8.1 billion in 2013 (https://kaiserfamilyfoundation.files.wordpress.com/2014/07/7347-10-financing-the-response-to-hiv-in-low-and-middle-income-countries.pdf).  This highlights the lack of global financial commitment, not just from the U.S.A. (http://kff.org/global-health-policy/fact-sheet/u-s-federal-funding-for-hivaids-the-presidents-fy-2016-budget-request/).

Given the current lack of adequate funding, the scientific evidence from the START Trial and amended WHO recommendations to initiate antiretroviral treatment at the time of diagnosis will not be enough to get treatment to the other 21 million people who are infected but have no access to treatment.  In order to increase treatment access, a complex combination of changes needs to be made: global funding must increase, global priorities must refocus on HIV treatment and prevention, health systems in low and middle income countries must also be strengthened, and societal prejudice against those living with HIV (which is also driven by homophobia, classism, racism and gender inequality) must be addressed.  None of these challenges are easy.  They all point out the difference between what policy makers are saying about HIV and AIDS and the reality of a global epidemic that is still out of control.

International organizations and global leaders talk about this “end of AIDS” as a realistic future for 2030.  But the reality is that less than half of the people who are infected with HIV are currently receiving treatment due to funding constraints caused by a combination of the global economic crisis and AIDS backlash (criticism that AIDS is receiving far more than its fair share of global funding compared to other diseases).  This theme of the “end of AIDS” by 2030 has been popular since 2011, yet global spending on HIV and AIDS has consistently decreased.  If the world is ever to succeed in truly ending the epidemic, we must confront the disparity between scientific findings, policy recommendations and guidelines, and the dwindling donor commitment to funding an effective response to the epidemic.  As policymakers know very well, talk is cheap.  It is time for action.

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