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DOT — Not Worth the Effort in Treatment-Naive HIV Patients

An open-label, randomized trial failed to show a lasting advantage for modified directly observed antiretroviral therapy over self-administered therapy.

Directly observed therapy (DOT) is the standard of care for tuberculosis (TB). Preliminary studies, mostly in small cohorts and in supervised settings such as prisons, have also shown promise for DOT in managing HIV infection.

In an open-label trial conducted at 23 ACTG sites in the U.S. and 1 site in South Africa, 243 treatment-naive HIV-infected patients (79% men; 35% Latino; 30% black; 33% white) were randomized to receive modified DOT with once-daily lopinavir/ritonavir or self-administered therapy with either once- or twice-daily lopinavir/r. All regimens included FTC and either extended-release d4T or tenofovir. In the DOT group, lopinavir/r treatment was supervised on weekdays and unsupervised on weekends; this group switched to self-administration after 24 weeks.

By week 24, the rate of virologic success (defined as viral load <200 copies/mL) was 91% in the DOT group and 84% in the self-administration group — a difference insufficient to prove the superiority of DOT. At 48 weeks, virologic success rates remained statistically similar between the two groups (72% and 78%, respectively).

Comment: This study took 4 years to enroll patients (necessitating a change in the nucleoside backbone in the middle of the study) and another 3 years to be published. Nonetheless, the findings have a lesson to offer in 2009: HIV is not TB. TB treatment is limited to a year and is usually administered one to three times per week — not daily for life, as HIV medications are. One possible limitation is that like all studies of adherence interventions, this one included only patients who were stable enough psychosocially to provide informed consent for a research study — and they might have been those who were least likely to benefit from DOT. But my message remains unchanged: Instead of wasting time and money trying to supervise patients directly, I'd suggest redirecting efforts and resources toward empowering them to adhere to treatment on their own.

— Helmut Albrecht, MD

Published in Journal Watch HIV/AIDS Clinical Care August 17, 2009

Citation(s):

Gross R et al. Modified directly observed antiretroviral therapy compared with self-administered therapy in treatment-naïve HIV-1–infected patients: A randomized trial. Arch Intern Med 2009 Jul 13; 169:1224.

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• DOTS AND HIV
  satya prasad saka, vishakapatnam, 20 Aug 2009 2:20 AM EST
  Rightly said that TB is not HIV and vice versa. daily administering drugs requires motivation and desire of the patients... [more]