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Start HIV Treatment Regardless of CD4 Count, NIH Funded Study Finds
  Fauci/NIH:"These results support treating everyone irrespective of CD4+ T-cell count.......Jens Lundgren, M.D., of the University of Copenhagen and one of the co-chairs of the START study. "We now have strong evidence that early treatment is beneficial to the HIV-positive person. These results support treating everyone irrespective of CD4+ T-cell count......."The study was rigorous and the results are clear," said INSIGHT principal investigator James D. Neaton, Ph.D., a professor of biostatistics at the University of Minnesota, Minneapolis......the DSMB found 41 instances of AIDS, serious non-AIDS events or death among those enrolled in the study's early treatment group compared to 86 events in the deferred treatment group. The DSMB's interim analysis found risk of developing serious illness or death was reduced by 53 percent among those in the early treatment group, compared to those in the deferred group......START is the first large-scale randomized clinical trial to offer concrete scientific evidence to support the current U.S. HIV treatment guidelines, which recommend that all asymptomatic HIV-infected individuals take antiretrovirals, regardless of CD4+ cell count. Current World Health Organization HIV treatment guidelines recommend that HIV-infected individuals begin antiretroviral therapy when CD4+ cell counts fall to 500 cells/mm3 or less."
START findings highlight treatment divide
By Antigone Barton on May 28, 2015
"It's just more scientific evidence to back what we've been saying for a long time."
Dr. Anthony Fauci, Director, National Institute of Allergy and Infectious Diseases, announcing the conclusion of the START trial, which began in 2011 to assess "the best time for healthy HIV-infected people to begin antiretrovirals."
The announcement from the National Institute of Allergy and Infectious Diseases Wednesday that immediate treatment of HIV infection considerably lessens risks of serious illnesses included the sub-headline that the findings from the international trial "likely will impact treatment guidelines."
Adding conclusive proof of the individual health benefit of treatment access upon diagnosis of HIV, to the public health benefit of greatly lowered transmission risks shown by the HPTN 052 study in 2011, the findings do seem likely to impact treatment guidelines. With additional evidence that earlier antiretroviral treatment initiation also did not result in greater numbers of drug side-effect impacts, the START data make it impossible to ignore that continuing to base treatment initiation on immune cell count is a form of rationing. But whether, how soon, and even how the findings will change practice is another question.


Currently collected and reviewed published guidelines. Credit IAPAC (International Association of Providers of AIDS Care) Click on image to enlarge. The announcement that the study had been halted early was perhaps unexpected. The magnitude of data, showing more than double the incidence of serious illness among participants who started treatment with more damaged immune systems, also may have been unexpected. The conclusion of the trial, that early treatment averts illnesses, however, was not. As NIAID Director Dr. Anthony Fauci reiterated Wednesday when discussing the results, scientific evidence as well as his experience of the last three and a half decades, had already shown the benefits of treatment that the weight of a large-scale randomized study would only confirm. For that reason, the United States, Brazil, Canada, France, Korea, Maldives, the Netherlands, Spain and Thailand have written policies offering antiretroviral treatment initiation upon diagnosis, regardless of immune cell, or CD4, count.
Across the 101 countries whose antiretroviral treatment initiation criteria have been published, collected and reviewed, those nine countries are home to four percent of people living with HIV. Another 43 countries, home to a little more than 50 percent of people living with HIV, have written policies in line with the current World Health Organization recommendations of antiretroviral treatment access for people whose immune cell counts have dropped to, or below 500 per cubic litre of blood, with six considering treatment for people with higher immune cell counts. Another 37 countries have policies reflecting WHO guidelines that were in place between in 2010 and 2013, of not starting treatment until immune cell counts drop to 350 or less - the level at which the group of START participants with more than double the rate of serious illnesses than those who started immediately, began treatment. Finally 12 countries, including Russia have published policies that do not reflect the WHO guidelines upgraded in 2010.
Dr. Fauci acknowledged that countries with the largest numbers of people living with HIV struggling to provide treatment now will be challenged to find the resources to provide earlier treatment to all who need it as the study indicates, but, he added, "at the end of the day there's no doubt that its going to cost less money." While the study results underscore the cost-effectiveness of averting opportunistic illnesses that include tuberculosis and cancers, some of the ways early antiretroviral treatment initiation is cost effective also were already known. In addition to reducing HIV transmissions, treatment policies that do not rely on monitoring CD4 counts for initiation criteria can better use the money to monitor levels of virus - or viral load - and better assess the effectiveness of treatment. The period between when a person is diagnosed with HIV and when he or she is "eligible" for treatment, also has been found to be a time when patients are "lost to care," requiring resources to follow up and bring them back to care, again to avert illnesses and transmissions - and their costs. Like Option B+ - the approach to preventing mother to child HIV transmission that includes immediate access to lifelong antiretroviral treatment to pregnant women with HIV, making treatment available upon diagnosis is simpler and more cost-effective. Countries can make them even more so, as some have, by allowing nurses to initiate antiretroviral treatment, treatment dispensing at a community level, and two to three month routine - and reliable - refills for people in stable condition.
But these savings require investments that the largest international funders of HIV responses appear increasingly unable or unwilling to make. While the U.S. President's Emergency Plan for AIDS Relief has prioritized treatment, the program is struggling to do so under current guidelines, with need growing and funding diminishing. Pledges to the Global Fund's last funding cycle fell short of goals, and needs.
But the alternative raises the specter of the past when what was acknowledged to be necessary was not done, when treatment was available to one side of the world, but not the other.
The United States, the largest funder of HIV treatment worldwide, has acknowledged the preferred standard of care by adopting it. The results of the START trial only add impetus.
START Trial data support starting antiretroviral treatment for HIV as early as possible
By Antigone Barton on May 27, 2015.
An international trial has shown that starting antiretroviral treatment for HIV early significantly lowers risks of serious illnesses, including AIDS, compared to waiting for immune cell counts to drop. The START - Strategic Timing of AntiRetroviral Treatment Clinical trial - which enrolled 4,685 people living with HIV at 215 sites across 35 countries over the last four years found that starting treatment early reduced risks of coming down with a serious illness by 53 percent.
The results, announced today, support U.S. guidelines recommending that immediate treatment be offered to all people diagnosed with HIV. The U.S. is one of only a few countries worldwide to adopt immediate treatment as a standard of care, and very few of the highest burden countries have yet adopted World Health Organization guidelines recommending treatment start when immune cell counts have dropped below 500 per cubic litre of blood, and immediately for pregnant women and children.
Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, which invested $154 million of the $166 million spent by the National Institutes of Health on the study, acknowledged that adopting immediate treatment as a standard of care would be expensive. But he added "at the end of the day, there's no doubt that it's going to cost less money."
Trial participants, whose immune cell counts were above 500, were assigned randomly to beginning treatment immediately or to beginning treatment when immune cell counts had dropped below 350. Among those who began treatment immediately, 41 participants - less than 2 percent - developed serious illnesses over three years. Of those who waited 86 participants developed serious illnesses. A data safety and monitoring board asked that the trial be stopped and that all trial participants be informed of the outcomes and given the opportunity to begin immediate treatment.
While the study confirmed benefits of early antiretroviral treatment that most experts agree on, it also yielded evidence that starting early did not result in more side effects or other adverse outcomes, the study's principal investigator James D. Neaton of the University of Minnesota said.
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