Modified directly observed therapy not linked to significantly improved adherence in patients with HIV

In a study of treatment-naive patients with HIV, modified directly observed antiretroviral therapy provided only marginal benefits over self-administered therapy in adherence levels. Furthermore, the marginal benefits that were observed with modified directly observed therapy were not sustained following discontinuation.

Researchers from the AIDS Clinical Trials Group A5073 Study Team are studying methods to improve medication adherence levels among patients with HIV. For this study, the researchers observed two groups of patients with HIV over a 24-week period; all were treatment-naive at baseline and treated with stavudine or tenofovir with emtricitabine and lopinavir/ritonavir all taken once per day. Patients in the first group (n=82) were treated with modified directly observed antiretroviral therapy given Monday through Friday. Patients in the second group (n=161) were assigned a regimen of self-administered antiretroviral therapy.

At the end of 24 weeks, modified directly observed therapy was associated with greater virologic success than self-administered therapy (0.91 v 0.84). However, the difference between the two therapies (0.07) did not reach the prespecified threshold of 0.075.

The patients were followed for an additional 24 weeks after the end of the 24-week study. The 48-week data showed a decrease in virologic success in both groups of patients. Although the difference in virologic success between the two groups was not statistically significant, there was evidence suggesting that the group formerly receiving directly observed therapy had worse outcomes than the self-administered group after the directly observed therapy was stopped (0.72 v 0.78).

Based on the findings of this study, the researchers recommended that modified directly observed therapy should not be incorporated routinely for treatment-naive patients with HIV.

Gross R et al. Arch Intern Med. 2009;169:1224-1232.