Cancel That 'Holiday'

While the desire by some HIV-positive patients to take 'drug holidays' from their antiretroviral regimens in order to have a break from strict routines, high prescription costs, or med toxicities might seem reasonable, a new study indicates that taking time off antiretrovirals can more than double the risk of disease progression and death. Despite prior small studies that suggested treatment breaks might be an alternative to ongoing regimen adherence, this new study of the large-scale Strategies for Management of Antiretroviral Therapy cohort, which was reported in the November 30 edition of The New England Journal of Medicine, set back researchers' prior hypotheses that treatment breaks might be able to allow longtime patients to preserve some treatment options for later in their disease progression by delaying buildup of resistance to medications. The average CD4 count was lower by 206 for patients in the study arm who took breaks than for those on continuous treatment. Within two months the proportion of participants with interrupted treatment who had viral loads below 400 fell from 71.8% to 6%. And opportunistic infection or death (including death from non-HIV-related illness, such as heart, kidney, or liver disease) occurred in 120 participants in the interrupted-treatment arm versus 47 who had continuous treatment. In January 2006 a previous arm of the study was prematurely halted when its participants began showing higher rates of opportunistic infections and death when compared with the patients who received regular, ongoing therapy. In summarizing the latest results, study cochair Wafaa El-Sadr said, 'Quite unexpectedly our results show that interrupting therapy increases the risk of serious non-AIDS-related events. This is a major lesson learned for designing any HIV treatment trial. It is important to evaluate all causes of death, not just death from AIDS.' Cochair James Keaton added that while treatment might increase the risk of liver, heart, and kidney disease, 'the absence of treatment appears to increase the risk even more.'