Directly-observed therapy (DOT), where providers watch patients take their medications every day, is often used to improve adherence to a drug regimen, including medications used to treat HIV infection. A modified version of this technique (mDOT) only observes patients during weekdays and focuses on one drug in the regimen. The goal is to ensure that patients just starting HIV therapy adhere to their regimen and continue to do so after mDOT is stopped. A new study, however, has found that such a strategy only produces marginal results. In addition, once mDOT is stopped after 6 months, any benefits to adherence are not sustained.
Researchers randomized 243 patients, who had never before taken HIV medication, into two groups. One group (161 participants) took their HIV medications without any provider supervision. The second group (82 participants) was given mDOT. As part of their antiretroviral therapy regimen, all patients were prescribed lopinavir/ritonavir once daily. Participants in the mDOT group received lopinavir/ritonavir under direct supervision by a care provider during weekdays and self-administered the drug on weekends, holidays, and days in which they could not reach the site. Compared with self-administered therapy participants, a higher proportion of those on mDOT remained on their dose schedule at week 24 (84 versus 78 percent). By week 48, however, the proportions had dropped to 73 percent and 68 percent, respectively.
The difference in adherence level between the two groups at this point was not considered significant. Although the proportion of participants with adequate suppression of HIV at week 24 was higher in the mDOT group, the difference was once again not large enough to be deemed superior to self-administered therapy. Interestingly, after the mDOT was stopped and mDOT participants switched to fully self-administered therapy for the final 24 weeks, there was some evidence that the group originally on mDOT did worse than the group that started and stayed with self-administered therapy. This suggests that changing an individual's adherence support may have detrimental effects.
While participants did accept mDOT and found it appealing, the researchers concluded that mDOT should not be incorporated routinely into HIV care. However, they believe it may be useful in patients with a high risk for nonadherence, particularly those who have failed treatment. Their study was supported in part by the Agency for Healthcare Research and Quality (HS16946).
See "Modified directly observed antiretroviral therapy compared with self-administered therapy in treatment-naive HIV-1-infected patients," by Robert Gross, M.D., M.S.C.E., Camlin Tierney, Ph.D., Andriana Andrade, M.D., M.P.H., and others, in the July 13, 2009, Archives of Internal Medicine 169(13), pp. 1224-1232.
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