Directly Observed Therapy for the Management of HIV-Infected Patients in a Methadone Program

Abstract

The objective of this prospective, observational clinical study was to evaluate the safety and efficacy of once-daily and twice-daily directly observed therapy (DOT) in human immunodeficiency virus (HIV)-infected patients undergoing methadone treatment. Methadone and highly active antiretroviral therapy (HAART) were dispensed daily as DOT, with patients in the twice-daily HAART group self-administering the second dose. Clinical and laboratory end points were monitored, along with the impact of ongoing cocaine use. We studied 54 patients coinfected with HIV and hepatitis C virus. At baseline, the median virus load was 111,000 copies/mL, and the median CD4+ cell count was 165 cells/mm3. After a median of 24 months, 17 of 29 patients in the once-daily HAART group and 18 of 25 in the twice-daily HAART group had virus loads of <400 copies/mL, regardless of ongoing cocaine use. Thirty-two patients required methadone dose adjustment, which was managed without modification of HAART. Treatment-limiting hepatic toxicity was rare. A DOT program of coadministered methadone and HAART can be implemented with good results, even for patients who continue to use cocaine.

Delay in the Initiation of HAART, Poorer Virological Response, and Higher Mortality among HIV-Infected Injecting Drug Users in Spain

“…29 It has been shown that once HAART is initiated, the response is similar among injecting drug users and noninjecting drug users. 2,30 However, most authors have described worse virological responses 31 and, in general, a higher risk of progression to AIDS and death among IDUs. 13,17,31 We have also observed that IDUs show poorer viral suppression responses than other transmission categories after adjustment for viral load and level of CD4 at the onset of treatment, previous AIDS diagnosis, and previous treatment with antiretrovirals.…”

Initiation, Adherence, and Retention in a Randomized Controlled Trial of Directly Administered Antiretroviral Therapy

“…This was likely the result of participants being expelled from the methadone program if they were found to be using illicit drugs (Lucas et al 2007). Although one might expect ongoing heroin and cocaine use to be important predisposing factors, these have not been strongly associated with outcomes (Conway et al 2004;. On the other hand, the enabling factor of participation in a methadone program has improved DAART utilization in other studies (Arnsten et al 2007;Lucas et al 2004Lucas et al , 2006b).…”

“…One strategy to improve adherence in this vulnerable population, adapted from directly observed therapy for tuberculosis control, is directly administered antiretroviral therapy (DAART). Recent data from feasibility pilot studies (Altice et al 2003;Behforouz et al 2004;Conway et al 2004;Greenberg et al 1999;Macalino et al 2004;Mitchell et al 2007;Mitty et al 2005;Tinoco et al 2004;Tyndall et al 2007), case-control evaluations (Lucas et al 2006b), and prospective randomized controlled trials ; Arnsten et al 2007;Macalino et al 2007) support DAART implementation among patients with poor adherence. One randomized controlled trial among inner-city patients did not support DAART (Wohl et al 2006); however, the population studied did not have a previous history of problematic adherence .…”

The Experience of Active Injection Drug Use on Adherence to Antiretroviral Treatment in Aboriginal People Living in Prince George - A Qualitative Perspective.

“…The study results indicated that 34 (65%) of participants achieved HIV viral suppression at the two year follow-up. The study showed that DOT can be successful for even the most difficult to treat -a category that people who use injection drugs fit into (Conway et al, 2004).…”

“…Of the 60 patients, only 4 (6.7%) abstained from illicit drug use for the duration of the study and the study adherence rate was 84.5%. Conway, Prasad, Reynolds, Farley, Jones, et al (2004) conducted a study that evaluated the use of directly observed therapy (DOT) for the management of HAART for patients in a methadone program. The study enrolled 54 patients, of which, 48 (89%) continued to actively use injection drugs throughout the study period.…”