icon_folder.gif   Conference Reports for NATAP  
  9th Conference on Retroviruses and Opportunistic Infections
Seattle, Washington, February, 2002
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Direct Observed Therapy In Methadone and Cocaine Users
Reported by Jules Levin
  Brian Conway from British Columbia, Vancouver, Canada reported on this small study of direct observed therapy (DOT) in patients on a methadone program. Viral load response was not quite as good as seen in clinical trials. Patients abusing cocaine were evaluated in this study.
The treatment of HIV-infected IVDUs presents unique challenges, including co-infection with agents such as HCV, interaction with drugs such as methadone, and the use of strategies used to enhance adherence with often complex highly active antiretroviral therapy (HAART) regimens. Within the context of a methadone maintenance program for heroin users, we have established a directly observed therapy (DOT) program, with HAART being administered once or twice daily by a pharmacist, in conjunction with daily methadone dosing.
The objective of the study was to compare the virologic and immunologic response to therapy in IVDUs receiving initial antiretroviral therapy with two nucleoside analogues with either NVP or a PI regimen either once or twice daily.
This was an observational study of 54 individuals in whom HAART therapy was initiated once or twice daily using a regimen selected by the study physicians. All medication was administered under direct observation along with methadone for the once daily regimen. Those on a twice-daily regimen took the second dose on their own, with adherence verified the next morning. Follow-up (including an ongoing assessment of recreational drug use) occurred at months 1 and 3, then every 3 months, or more frequently if clinically indicated.
A total of 54 patients were enrolled, all with HCV co-infection. The mean CD4 count was 199 [9-1100] and the mean plasma viral load 210,483 [2,900-840,000] copies/mL). 29 patients received once daily (17 NVP/3TC/ddI, 6 RTV/SQV/3TC/ddI, 6 others), and 25 twice daily (7 NNRTI/NRTIs, 13 PI/NRTIs, 5 others) regimens.
Over 23 (3-56) months follow-up, 35/54 (65%) had plasma viral load values below 400 copies/mL. Of those using cocaine >60% of the time 60% (19/32) achieved viral suppression. The authors said these differences were not statistically significant but 40% receiving a once daily regimen vs 60% receiving a twice daily regimen had <50 copies/ml.
Patients on NVP (n=24) compared to PIs (n=25) had similar virologic responses 67 vs.64% <400 copies/mL), 50% for both arms <50 copies/ml. Patients on NVP had a higher CD4 count (469 vs. 293 cells/mm3, p<.05). Despite HCV co-infection, there were two instances of grade 3 hepatic toxicity managed succesfully without sequela.
The authors concluded that directly observed therapy can be successfully undertaken in IVDUs receiving methadone, even if recreational drug use continues. Excellent virologic responses are observed with a variety of regimens, given once or twice daily. Long-term observation fails to demonstrate hepatic toxicity. The apparent immunologic benefit of NVP-based regimens merits further evaluation in comparative multicenter studies, which are planned.