Spotlight: Directly Observed Therapy for HIV Therapy in Corrections: Ready or Not?
A Point and Counterpoint Discussion of the Use of Directly Observed Therapy for HIV Treatment in the Correctional Setting
Dr. Margaret Fischl, director of the Miami AIDS Clinical Research Unit, presented at the CROI (Feb. 7, 2001) her comparison of the outcomes of treatment naive ACTG subjects enrolled in antiretroviral treatment trials conducted both at the Miami AIDS Clinical Research Unit and the Florida state prison (CROI Abstract 528). Within the prison system, inmate-patients are administered antiretrovirals under direct observation (DOT). Fischl examined the viral load responses to study regimens among 50 prisoners receiving their study medications via DOT and 50 AIDS Clinical Research Unit outpatients receiving study medication in the conventional, unobserved way. The two groups were different demographically, with more of the incarcerated patients likely to be African American, Latino, male and to have a history of injection drug use. Further, the patients in prison had lower CD4 cell counts and higher viral loads. After 24 weeks, 90% of the prisoners had viral loads that were below 50 copies/mL while 77% of the free subjects achieved this goal at this time point. These differences in response rates remained out to 90 weeks of follow-up and were highly statistically significant. In general, simpler regimens of three drugs had better response rates than more complex four-agent combinations.
PointBy David A. Wohl, M.D.*, Director, Central Prison Infectious Disease Service, UNC Central Prison Hospital, North Carolina Department of Corrections
Reprinted with permission from the National AIDS Treatment Advocacy Project.
While on the face of it, these results seem to be a resounding endorsement for DOT, several questions lurk. Although all the incarcerated subjects received DOT, it is not clear this was responsible for their excellent responses (above the enviable rates seen among the free patients). There are many confounding factors that could have contributed to the inmates' success including the regimented structure of prison life, the influence of correctional medical staff or just simply having "three hots and a cot" and (relatively) limited access to crack cocaine. The differences between the two groups of patients extend beyond the presence or absence of DOT and, therefore, DOT alone cannot be regarded as the crucial determinant of the observed results. In the North Carolina Department of Corrections, we have found DOT adds nothing to self-administration of antiretrovirals (Wohl DA, Stephenson B, et al. Adherence to Directly Observed Therapy (DOT) of Antiretrovirals in a State Prison System . Infectious Disease Society of America, New Orleans, 2000). In fact, many inmates complain that DOT renders them conspicuous as being HIV-infected as they stand in line for medication and therefore, opt not to present for DOT. Under such conditions, DOT may present an obstacle rather than a path to adherence. Before DOT is used as an intervention to enhance adherence, some prospective investigation on both sides of the barbed wire is warranted beyond this interesting first step.
CounterpointBy David Thomas, M.D.**, Director of Health Services, Florida Department of Corrections
As a co-author of this presentation and the person responsible for all of the Health Services in the Florida Department of Corrections, let me respond to Dr. Wohl's concerns. We strongly agree that medical therapy in isolation (e.g., DOT) may be only one of the contributing factors, and may have reduced opportunities for better diets and illicit drug use. The authors strongly feel that the adherence to medical pharmacotherapeutic regimen is the key reason for improvement. To test this hypothesis, another study is planned of two groups, both of which are incarcerated. In systems that do not use DOT, but have the other realities of prison life, rates of viral load improvement match the community setting. Clearly, there are some situations and conditions where DOT can lead to aversive elements, so the initiation must be done with care and sensitivity. In Florida, we have been using DOT for a long time, and our staff and inmates report they are comfortable with it. Of the 2,700 inmates with HIV, the vast majority are on treatment (2,250). Of the remainder, the overwhelming majority are not captured by the guidelines (and we still use the more aggressive 5-10,000 viral load cut-off for treatment). It is only a small minority who refuse because of direct observed therapy. Most cite other reasons.
HEPP Editor's Note: Clearly, there is a use for DOT in some settings, but its success will vary between facilities. There is an acute need for further study.
*Speaker's Bureau: Abbott Laboratories, GlaxoSmithKline and Merck & Co.
**Consultant & Speaker's Bureau: Agouron Pharmaceuticals, Bristol-Myers Squibb, GlaxoSmithKline, Boehringer-Ingelheim/Roxane Laboratories, Roche Pharmaceuticals, Merck & Co.
This article was provided by Brown Medical School. It is a part of the publication HEPP News.