DIRECTLY OBSERVED THERAPY FOR THE TREATMENT OF PEOPLE WITH HUMAN IMMUNODEFICIENCY VIRUS INFECTION: A WORK IN PROGRESS [Mitty JA et al. CID 2002;34:984]: This is a collaborative report from Brown University, Harvard, and Miami summarizing the current state of DOT for management of HIV. The following points are emphasized: Comparison for DOT for Tuberculosis: The comparison shows many similarities and some substantial differences. Both diseases involve a population that is often disenfranchised and DOT is done for the same reasons: to improve health, increase adherence, and reduce resistance. Both also have the advantage of potential linkages to other important facets of health care delivery including counseling, other medical consultation services, social services, substance abuse treatment, etc. Differences include the obvious facts that TB therapy can easily be given 2–3 times/week, the duration is 6–12 months, and there is a public health imperative with legal ramifications. These comparisons are summarized in Table 3.TABLE 3Issues for DOT in HIV: There are several issues that need to be addressed in anyone planning a DOT program. These are summarized as follows: Which populations will benefit? Those with poor adherence are the obvious choice, but often difficult to define. When to start DOT: The primary candidates are considered those “at high risk for poor adherence” despite our difficulty in knowing who they are. How should DOT be implemented? The options are outreach (home) visits, medical clinics or methadone centers. How many doses? The usual options are once-daily dosing or “modified DOT” with one observed and one taken without supervision. Should there be other social services? Yes. Can the frequency of visits be tapered? Possibly. How should these programs be evaluated? The obvious answer is viral load, CD4 cell count, HIVrelated “events,” and cost-effectiveness. Once-daily Dosing: Regimens studied most extensively are ddI plus 3TC combined with efavirenz, nevirapine, or regimens with PI combinations such as ritonavir with saquinavir, indinavir, or amprenavir (Antivir Ther 2000;5:267;Antivir Ther 1998;3:Supplement 4;55;JID 2000;182:599;JAIDS 2000;24:287;AAC 2000;44:2672;JAIDS 2000;25:229). DOT Programs: Rhode Island: The initial program involved an outreach worker who delivered the first of two doses under observation at the patients’ residence. The results at one year for 37 patients who remained in the program that long showed a mean VL decrease of 1.5 log10 c/ml and a median increase in CD4 cell count of 112/mm3. The second trial was one daily dose of ddI (300–400 mg/d) plus 3TC (300 mg/d) combined with efavirenz (600 mg/d) or saquinavir-ritonavir (1600/100 mg). Results with 13 of 25 patients who remained at least six months showed a mean decrease in VL of 2-log10 c/ml. Florida: This is a clinic-based DOT program for salvage therapy with one daily dose or two daily doses with the first given under observation; DOT is provided five days/week. The regimen selected is based on resistance testing. Results at 12–16 weeks for 23 of 44 participants showed 19 (83%) had a VL <1000 c/ml. Miami Department of Corrections: This is based on the report by Fischl et al. of treatment-naïve participants in an ACTG trial. Results at 80 weeks showed 95% of inmates had VL <400 c/ml compared to 75% with self-administered treatment (8th CROI, Chicago, 2001 Abstract 528). Conclusion: The results appeared to be preliminary and inconclusive. One of the major issues is cost-effectiveness. It is noted that an outreach worker costs approximately $25,000/year and can support 10 participants receiving home DOT so the average cost is $2,500/patient/year. The authors suggest that the term DOT be abandoned and replaced with the term “HIV observed therapy” to account for differences compared to the TB DOT programs.
No takes yet. Share an insight, caveat, or question.
A 2002 study studied this question.