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Directly Administered Antiretroviral Therapy (DAART): A Literature Review

Directly Administered Antiretroviral Therapy (DAART): A Literature Review. Brian McPhee, BA AIDS Institute New York State Dept. of Health. History of DAART. Directly Administered Antiretroviral Therapy (DAART)- TB Public Health initiatives from India, Hong Kong and the US.

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Directly Administered Antiretroviral Therapy (DAART): A Literature Review

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  1. Directly Administered Antiretroviral Therapy (DAART): A Literature Review Brian McPhee, BA AIDS Institute New York State Dept. of Health

  2. History of DAART • Directly Administered Antiretroviral Therapy (DAART)- TB Public Health initiatives from India, Hong Kong and the US. • TB treatment- 5-9 month regimen w/ perfect adherence. • Purpose- Eradicate organism, prevent resistant TB, prevent transmission.

  3. TB DOT • TB prevention- Must ensure adherence to TB antibiotics. • State agencies given authority to ensure mandatory compliance. • Called Directly Observed Therapy (DOT).

  4. Specifics of TB DOT • A patient with TB takes medication 2 or 3 times per week for 5-9 months. • A health care worker observes the patient taking medication. • DOT can occur in a clinic setting or in the community.

  5. Development of DAART • HIV and TB- Different challenges to public and individual health, yet both require diligent adherence. • Researchers began to explore similar programs for Highly Active Antiretroviral Therapy (HAART). • Models in which patients go to providers or providers go to patients have been developed.

  6. Types of Recent Research • There are various types of studies that have investigated the effectiveness of DAART among a variety of populations. ----------------------------------------------------------- • 1) Descriptive papers • 2) Preliminary studies • 3) Prospective Observational studies • 4) Non-random Comparison studies • 5) Randomized Clinical Trials

  7. Summary of Major Studies

  8. Descriptive Papers • Differences between TB DOT and DAART1: no cure for HIV, dosing frequency, duration of treatment, biology of HIV. • Suggest DAART may have greatest impact on cocaine and methamphetamine substance users.2 12002: Lucas, Flaxner, Moore. “DAART in treatment of HIV infection. AIDS Patient Care. 16(11) 22004: Kresina, Normand, Khalsa et al. Addressing the need for treatment paradigms for drug-abusing patients. Clinical Infectious Diseases. 38(Sup 5)

  9. Qualitative Interest Study • Researchers1 interviewed 47 HIV-positive subjects to determine interest in DAART. • Only 17% choose DAART. • Significant proportion found DAART invasive, impractical, burdensome-Involves meeting with a provider daily. 1Santos, Adeyemi, Tenorio. “Attitudes toward DAART among HIV-positive inpatients in an inner city public hospital.” AIDS Care. Oct 06; 18(7)

  10. Preliminary Pilot Study • Small pilot1: Once-day DAART home delivery in rural Haiti (n=100) and Boston (n>100). • Haiti: 98% retention and decrease in OIs, but no lab data (1999-2004). • Boston: 87% retention, 35.7 mean CD4 count increase, 73% of patients undetectable viral load after 1 year. 12004: Behforouz, Farmer, Mukherjee. “From DOT to Accompagnateurs.” Clinical Infectious Diseases 38(Sup 5)

  11. Preliminary Pilot Study: Brown • Studied1 community based DAART. n=25. • Subjects- used substances and history of failed adherence. • Doses were delivered to the patient daily or less frequently, depending on need. 12004: Macalino, Mitty, Bazerman et al. “MDOT for the treatment of HIV-seropositive substance users.” Clinical Infectious Diseases 38(Sup 5)

  12. Preliminary Pilot Study: Brown • After 1 yr, viral load net decrease 1.9 log copies/mL. CD4 cell percentage increased from 2.6% to 6.8%. • However, very few subjects could maintain DAART 7 days a week: moved, took meds on their own, or discontinued treatment under medical advice.

  13. Vancouver MMTP Prospective Study • Examined once and twice daily DAART among substance users at a methadone clinic1. • Enrolled 54 HIV and HCV co-infected subjects for 24 months, no control group. • 17 out 29 achieved viral suppression in once daily DAART, and 18 of 25 achieved viral suppression with twice daily DAART. 12004: Conway, Prasad, Reynolds et al. “Directly observed therapy for the management of HIV-infected patients in a methadone program.” Clinical Infectious Diseases. 38(Suppl 5).

  14. Vancouver MMTP Prospective Study • Some subjects had ongoing cocaine and heroin use, indicating utility of DAART among active users. • The provision of methadone on-site facilitated DAART encounters with on-site providers. • Results indicate that DAART can be effective among co-infected patients with substance use problems, especially in an MMTP.

  15. Prospective Study: Brown • n = 69 in a community-based DAART program.1 Subjects- documented adherence issues. • Outreach workers delivered medications once daily and tapered visits as needed. • 96% had substance use history, 71% were incarcerated at some point, and 93% were treatment experienced. 12005: Mitty, Macalino, Bazerman et al. “The use of community-based MDOT for the treatment of HIV-infected persons. JAIDS. 39(5).

  16. Prospective Study: Brown • At 6 months, less than half were still receiving visits. Reasons for not receiving visits- medication holidays, hospitalization, incarceration, lost to program and death. • Of those still in the program, mean viral load decreased 2.7 log, from mean baseline 4.8 log. • Paper suggests that DAART is useful among treatment experienced substance users.

  17. Non-randomized Comparative Study: Johns Hopkins • 82 substance users in DAART at a JHU MMTP1. • Enrolled if starting ARVs or were switching due to failure. • Subjects in DAART were observed taking doses on clinic days and self-administered evening and methadone “take home” days. • Subjects were compared to data from other groups in Johns Hopkins HIV Cohort. 12006 Lucas, Mullen, Weidle et al. DAART in methadone clinics is associated with improved HIV treatment outcomes. Clinical Infectious Diseases. 42(1 June).

  18. Non-randomized Comparative Study: Johns HopkinsYear End Results

  19. Non-randomized Comparative Study: Johns Hopkins • DAART participants significantly more likely to achieve viral suppression than each of the 3 comparison groups. • Substance using DAART participants CD4 increase comparable to non-IDU control.

  20. The First Randomized Controlled Trial: Connecticut IDUs • Yale1- The first RCT for DAART • 72 HIV-infected IDUs in New Haven, CT • Randomly assigned to DAART + arm (DAART plus ancillary medical services) or a self-administered HAART arm. 12004: Altice, Mezger, Hodges et al. “Developing a DAART intervention for HIV-infected drug users: Implications for program replication. Clinical Infectious Diseases. 38(Sup 5).

  21. Randomized Controlled Trial: Connecticut IDUs • DAART subjects met counselors once a day during week on a mobile health van. • MEMS caps monitored adherence for both arms. • Counselors addressed other substance, mental and medical issues, referring as needed to ancillary services.

  22. Randomized Controlled Trial: Connecticut IDUs • 85% were antiretroviral experienced. • 76.2% of supervised doses taken. 49.9% of unsupervised doses taken. Baseline- 50% of doses taken. • No reported virologic or immunologic outcomes.

  23. Randomized Controlled Trial: Connecticut IDUs Lessons Learned • Once daily observed regimens most effective, but DAART target pop is treatment experienced, limiting once daily options. • Explored the use of DAART+, which included on-site HIV specialist, drug treatment coordinator, case manager and bilingual outreach workers. • DAART works to ensure adherence among substance users.

  24. Yale Group Expands on DAART+ • Same data (n=72) but virologic outcomes correlated with ancillary service use: medical, case management and substance use services.1 • Virologic success = log decrease or <400. • Virologic success at 6 mos correlated with high case management and medical service use. 12006: Smith-Rohrberg, Mezger, Walton et al. “Impact of enhanced services on virologic outcomes in a DAART trial for HIV-infected drug users.” JAIDS. 43(Sup 1)

  25. Yale Group Expands on DAART+ • DAART fully effective among substance users when ancillary services offered on site. • Utilization of on-site medical and case management services independently associated with improved virologic outcomes. • Proximity to services likely contributed to outcomes but not proven.

  26. A Second RCT: Los Angeles • RCT in LA county1, comparing DAART, intensive adherence case management and standard care control group. • Enrolled 250 subjects from public clinics in LA who were treatment naïve or failed only one regimen. 12006: Wohl, Garland, Valencia. A Randomized trial of DAART and adherence case management intervention. Clinical Infectious Diseases. 42(1 June).

  27. RCT Los Angeles • DAART doses were delivered once daily, 5 days a week, for 6 months. • Majority were male, Latino, and earned less than $10,000 a year. • At baseline, similar proportions of each group had viral suppression. • At 6 months, each group had similar viral suppression and CD4 cell increases.

  28. RCT LA: Results • Viral Suppression by group: DAART 71%, Adherence counseling 80%, Control 74% • No statistical differences in 6 month CD4 cell count changes or self-reported adherence. • The study gave no conclusive evidence that DAART is effective.

  29. Yale Group Responds to LA • Yale- “LA study did not enroll subjects with known problems with adherence.”1 • “LA study should have also looked at viral load reduction, not just number of virally suppressed subjects.” 12006:Smith-Rohrberg, Altice. Letters to editor. Correspondence. Clinical Infectious Diseases. 43(1 Nov).

  30. LA responds to Yale • LA- Chose viral suppression: expected outcome in naïve and second-line patients1 • Subjects: high rates of mental illness, unstable housing, limited social support and missed visits. • Studied effectiveness of DAART in general clinic population w/o prior adherence problems. • DAART mostly effective among patients with known adherence problems, but not in the general population. 12006: Wohl, Witt et al. Letters to editor. Correspondence. Clinical Infectious Diseases. 43(1 Nov).

  31. Yale and LA Studies • Although LA study found DAART ineffective in general pop, useful among substance users. • LA group looks forward to further publication of DAART research.

  32. Summary of Major Studies

  33. DAART- Is it effective? • Narrative papers, preliminary studies, and observational cohort studies: DAART a useful intervention, esp. among substance users. • Yale RCT study: DAART most effective among substance users when combined with ancillary services.

  34. DAART- Is it effective? • LA RCT: DAART no more effective than standard care among patients without prior adherence problems or substance use. • DAART most effective among substance users. • More research should explore the use of DAART among non-substance users with prior adherence problems.

  35. Next Questions • Should DAART be a standard practice? • DAART effective only for substance users? • DAART effective for those with prior adherence problems but not substance users? • How long should DAART programs last? • Mode- delivered, mobile or in clinic?

  36. Further Research • Case management aids DAART effectiveness, but more research needed to explore how. • Proximity to medical care may aid DAART effectiveness, but more research needed to verify and quantify relationship.

  37. Conclusions DAART: Effective among substance users, especially when combined with other medical, case management and substance use services. DAART: May be effective among non-substance users with prior adherence problems, but more RCTs are required to completely evaluate DAART.

  38. Thank You Brian McPhee AIDS Institute NYS Dept. of Health

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