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May 5, 2010

START Wars

by Tim Horn

HIV experts are at odds regarding an uptick in public policy and advocacy efforts to promote early HIV treatment, in light of the unknowns surrounding its potential benefits and risks. A clinical trial—the 4,000-patient START study—is now under way to explore some of the most pressing questions. But should activists and advocacy groups be waiting for answers?

In December 2009, a panel of government officials, academic researchers and HIV/AIDS activists revised the U.S. Department of Health and Human Services (DHHS) official recommendations for when to start HIV treatment. The new Guidelines for the Use of Antiretroviral Agents in HIV-1-Infected Adults and Adolescents strongly encourage treatment for all people living with HIV with CD4 counts between 350 and 500. Previously, treatment was only advised for patients with CD4 counts of 350 or lower—as remains the recommendation in most other developed nations.

A patchwork of data suggests that starting treatment earlier can benefit the health and longevity of people living with HIV, as it may better defend the immune system, lower the risk of non-AIDS diseases and further reduce the risk of death. It is this research that has sparked tremendous interest in the personal benefits of early antiretroviral (ARV) therapy.

Early treatment may also benefit the greater good of the public health. Some research suggests that undetectable viral loads in a large swath of the HIV population can potentially slow the spread of the virus. In turn, public health officials are considering whether widespread, immediate ARV therapy could be an effective HIV prevention tactic.

Few experts and activists argue that the research supporting early treatment is anything less than encouraging. Where there is less agreement, however, is whether enough sound, scientific research has been conducted to spell out the benefits and risks—the increased (or decreased) likelihood of short- and long-term side effects, adherence challenges and the development of drug resistance, for example—of early treatment and to warrant major changes to public policy. In fact, some of the most experienced and trusted sources of HIV prevention and treatment policy are struggling to make the right call.  

Case in point is Project Inform’s recent switch on where it stands on the issue. On April 13, the prominent San Francisco–based HIV advocacy organization issued a policy statement containing a series of when-to-start recommendations. One in particular seemed to advise treatment at any CD4 cell count. A few weeks later—without acknowledgment or explanation in a revised policy statement—Project Inform changed its position.

In its April 13 policy statement, the organization stated, “Based upon a careful review of currently available data, Project Inform believes that all HIV-positive people who are ready to begin treatment should start before their CD4 counts fall below 500.” This exceeded the start recommendation in the DHHS guidelines, which only promoted treatment when the CD4 cell count is 500 or below, and was more along the lines of a recent San Francisco Department of Public Health (SFDPH) policy recommending immediate treatment for everyone diagnosed with HIV.  

But, in a revised policy statement dated May 2010, they wrote: “Based upon a review of currently available data, Project Infom believes that all HIV-positive people who are ready to begin treatment should start if their CD4 counts fall below 500” [emphasis added]. This put the organization’s position more in line with the DHHS guidelines. 

“Based on feedback and in an effort to be clearer in our positions, we made small changes [to our policy statement] and re-dated it,” said Dana Van Gorder, Project Inform’s executive director. When asked if he cared to elaborate, pointing out that some may consider the CD4 change to the policy statement to be rather significant, Van Gorder simply responded, “No.”

Pages: 1 | 2 | 3 | 4 | 5

Search: START, randomized studies, HIV treatment, antiretroviral therapy, Project Inform, Bob Huff, Mark Milano, Simon Collins, controversy


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