Debate Over Antiretroviral Treatment Interruption Remains After Findings Show Method Increases HIV-Positive Patients' Risk of AIDS, Death

The Washington Post on Tuesday examined the debate surrounding the Strategies for Management of Antiretroviral Therapy trial, which compared daily antiretroviral therapy with a drug-conservation strategy that involved taking medication intermittently and was presented at the 13th Conference on Retroviruses and Opportunistic Infections in Denver on Wednesday. The results of the trial, which was stopped early, show that the strategy increased HIV-positive patients' risk of developing AIDS or dying, the Post reports (Brown, Washington Post, 2/7). The SMART trial, which involved 318 sites in 33 countries, began enrolling patients in January 2002 and included 5,472 HIV-positive participants when the trial was suspended on Jan. 11. SMART trial volunteers were randomly assigned to a daily antiretroviral therapy regimen or an episodic treatment strategy, which called for taking medication only when CD4+ T cell counts dropped below a specific level. Previously, smaller studies indicated that taking monitored breaks from daily antiretroviral treatment might control the progression of HIV while reducing some of the drugs' side effects, as well as lowering costs of the treatment regimens. However, interim studies of the National Institute of Allergy and Infectious Diseases trial conducted last month by the independent Data and Safety Monitoring Board showed that participants who took their medication on an irregular basis were more than twice as likely to experience increased progression of the virus or death compared with those on a daily treatment regimen. Patients taking episodic treatment also were more likely to experience cardiovascular and kidney complications as well as liver disease, all of which also have been related to antiretroviral drug use (Kaiser Daily HIV/AIDS Report, 1/19).

Reaction, Follow Up
Researchers plan to follow patients involved in the SMART trials for a number of years, and some HIV/AIDS advocacy groups last week asked NIH to extend patient monitoring in order to extract more information on episodic treatment strategy. Many physicians and specialists expected that the trial would affirm the positive results of the previous, smaller studies, and some are "struggling to come to terms" with the findings, the Post reports. "We all wanted so much for it to work, but that's how science goes," Mauro Schechter, a professor at Federal University of Rio de Janeiro and head of the trial's Brazil research site, said. "You do the studies to get the answer," Schechter said, adding, "It is not always the answer you like." According to the Post, some HIV/AIDS advocates are concerned that the findings might deter further research into the concept of treatment interruption. Richard Jefferys of the New York-based Treatment Action Group said, "The assumption that people are just going to be on therapy for the rest of their lives is not a practical assumption." Claire Rappoport, a member of the SMART steering committee, said, "I am not ready to throw out the concept of treatment interruptions," adding, "That may not be scientific or rational, but I'm just not there -- and I'm not alone" (Washington Post, 2/7).

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