Treatment Interruption Study Halted

The Strategies for Management of Anti-Retroviral Therapy study, also called SMART, was cancelled in January after data showed that people who took breaks from their highly active antiretroviral therapy (HAART) regimens had significantly worse health outcomes than those who remained on HAART continuously.

This international study included over 5,000 participants and attempted to determine whether patients could safely reduce their use of antiretroviral therapy in the hope of minimizing side effects, slowing the development of drug resistance, and preserving future treatment options. An independent Data and Safety Monitoring Board halted the study because patients who interrupted their treatment were found to be twice as likely to progress to AIDS or die. This group also had a higher incidence of cardiovascular, kidney, and liver problems--contrary to the hypothesis that episodic therapy might reduce the rate of adverse events.

"We were surprised to learn that in the short term, episodic antiretroviral therapy carries such an increased risk without evidence of sparing patients the known side effects associated with [antiretroviral therapy]," said Wafaa El- Sadr, MD of Columbia University, one of the study's principal investigators.

However, at the recent Conference on Retroviruses and Opportunistic Infections in Denver, several smaller studies of HAART interruption presented findings that conflict with the SMART trial and indicate that monitored breaks could still help in the control of HIV progression. As a result, some experts continue to argue that the strategy of structured treatment interruptions remains compelling as a way to control side effects, the cost of HAART, and treatment fatigue in people who have taken antiretroviral therapy for long periods.

The San Francisco AIDS Foundation's treatment journal, BETA, is available free of charge at S.F. General Hospital's Ward 86, St. Francis Memorial Hospital's HIVCare, and at www.sfaf.org/beta. Or, for your free copy (in English or Spanish), call (415) 487-8060.