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to Section One | to Arts & Entertainment
posted Friday, May 29, 2015 - Volume 43 Issue 22
Start antiretrovirals immediately after diagnosis, CDC says
Agency halts study because benefits of early treatment already clear
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Start antiretrovirals immediately after diagnosis, CDC says
Agency halts study because benefits of early treatment already clear

by Mike Andrew - SGN Staff Writer

HIV-positive patients should be given antiretrovirals as early as possible, the CDC said May 27.

The agency also said it was halting the largest-ever clinical trial of early HIV treatment because the benefits were already so clear that no further study was necessary. James D. Neaton, a University of Minnesota biostatistician and the principal investigator of the study, made the announcement with CDC's Dr. Anthony Fauci in a telephone news conference.

Although the study had been scheduled to run another year, preliminary data showed that HIV-positive patients who got immediate treatment were 53% less likely to die during the trial or develop a serious HIV-related illness than those who waited.

Immediate treatment also prevents patients from passing the disease on. Several other studies have shown that people taking antiretroviral drugs regularly are more than 90% less likely to infect others, including spouses with whom they have regular unprotected sex.

The START (Strategic Timing of Antiretroviral Treatment) trial enrolled its first patients in 2009 but was not publically announced till 2011. When it was stopped this month, it had followed 4,685 HIV-positive men and women in 35 countries.

HIV-positive participants with counts over 500 were enrolled in the trial. Half were put on drugs immediately, and the other half were not given drugs until their counts reached 350 or they had an HIV-related event, such as a disease that normally becomes serious only in immune-suppressed patients.

An independent safety monitoring board looked at preliminary data two months ago and found that 86 of those in the deferred-treatment group had died, developed AIDS, or suffered a serious non-AIDS event like heart, liver, or kidney disease, or cancer, while only 41 of those in the immediate treatment group had similar health issues.

That 53 percent difference was large enough to recommend stopping the trial, the CDC decided.

The research was designed to settle the dispute about when to begin treatment. At that time, CDC guidelines for American doctors called for starting therapy when a patient's CD4 count fell below 500, while the World Health Organization recommended waiting until it was below 350.

CD4s are white blood cells that act as the immune system's sentinels and are the virus's chief target. At a count below 200, a patient has what used to be termed 'full-blown AIDS' and is at high risk of dying from other opportunistic infections like tuberculosis or Kaposi's sarcoma, or various pneumonias. A normal CD4 count in a healthy person is 500 to 1,200.

In other words, even as late as 2009, mainstream medical opinion was to prescribe antiretrovirals only after patients had suffered considerable deterioration of their immune systems.

But many HIV researchers and activists argued, based on their own observations and smaller studies, that treatment should start immediately. The trial stopped by the CDC May 27 is the first major clinical trial to produce evidence that patients would live longer and be healthier if they received the drugs immediately.

'This is fantastic,' said Dr. Susan P. Buchbinder, director of HIV prevention research for the San Francisco Department of Public Health. Her department began recommending immediate treatment in 2010, and new infections in that city have dropped substantially since then.

'The evidence for this has been building for quite some time, but now it's clear that people should be offered treatment right away and told why it's beneficial,' she said.

New York City has also recommended immediate treatment since 2011, but has not yet achieved San Francisco's level of success.

'Most doctors in [New York City] are starting HIV medications quickly for newly diagnosed patients,' said Dr. Demetre C. Daskalakis, the city health department's assistant commissioner for HIV/AIDS prevention and control.

'With this study, we've answered the question definitively: Treat HIV - it's good for both personal and public health. The release of data from such a powerful source should erase any doubt.'

In the United States, many HIV patients reportedly hesitate to start taking drugs while they feel healthy because they have heard reports of harsh side effects. In fact, the earliest generation of antiretroviral drugs prescribed in the mid-1990s often caused side-effects, with patients reporting rashes, accumulation of belly fat, and loss of feeling in the fingers and feet.

But modern antiretroviral regimens, many based on tenofovir, which was approved in 2001 but took some years to be widely used, have far fewer side effects.

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