Taking medications every day exactly as directed — called adherence — is difficult for some people, particularly those who have chaotic lives and substance abuse problems. To ensure that such people take their treatment, researchers developed Directly Observed Therapy (DOT) programs where medication-taking is observed and confirmed by health care workers. This has been particularly useful in helping to control tuberculosis.
Now researchers in Miami are testing DOT in selected people with HIV/AIDS (PHAs). What's different about the Miami study is that in some cases researchers were able to successfully educate PHAs about the importance of adherence. Moreover, preliminary results from this study suggest that the HIV DOT program may not have to be used life-long.
Researchers at the University of Miami recruited 22 subjects with HIV/AIDS who had never previously used anti-HIV therapy. These subjects were considered by the research team to be at high risk for non-adherence because of the following:
All subjects received a combination of the protease inhibitors amprenavir (Agenerase) 1,200 mg boosted with ritonavir (Norvir) 200 mg taken once daily. They also received 3TC (lamivudine, Epivir) and ddI (Videx) in standard doses, both taken once daily. DOT was supervised by case managers. Subjects were monitored for six months.
Researchers were "impressed" that only 5 of 22 subjects did not complete the six-month study. In the remaining subjects, amprenavir levels in the blood were, on average, about five times greater than levels found in other studies where amprenavir was used without ritonavir.
In subjects for whom data was available, 14 of 16 subjects had achieved a viral load of fewer than 400 copies after six months. At the start of the study, CD4+ cell counts averaged about 24 cells for the group. By the sixth month of the study, the average count had climbed to 157 CD4+ cells. No serious side effects were noted in the study.
Study researchers suggest that by educating subjects, adherence improved over time in most. Whether or not this improvement in medication-taking is sustained remains to be seen. Nonetheless, educational programs such as the one explored in this study are perhaps one of several steps needed in helping to bring anti-HIV therapy to low-income injection drug users.
REFERENCE
Garg V, Brill M, Rodriquiz A, et al. Clinical Pharmacology of amprenavir in highly challenged naïve patients following a once daily HAART regimen under directly observed therapy (DOT). 3rd International Workshop on Clinical Pharmacology of HIV Therapy, 11-13 April 2002, Washington DC. Poster 2.5.
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