Directly Observed Hepatitis C Treatment in Methadone Clinics

Overview

Drug users account for a disproportionately large burden of hepatitis C virus (HCV) infection. However, HCV treatment adherence rates in drug users may be suboptimal in patients who use drugs regularly during HCV treatment. Because HCV treatment is most effective when patients adhere to at least 80% of the prescribed treatment regimen, interventions to improve HCV treatment adherence need to be developed and evaluated. The investigators designed the HCV DOT trial to test the efficacy of two versions of modified directly observed HCV therapy provided on-site at a methadone clinic. The primary objective of this trial is to determine whether enhanced DOT with both pegylated interferon alfa-2a plus ribavirin (PEG/RBV-DOT) is more efficacious than standard DOT with weekly provider-administered pegylated interferon (PEG-DOT) and self-administered ribavirin for increasing adherence and improving HCV treatment outcomes. The investigators hypothesize that PEG/RBV-DOT is associated with increased adherence and rates of sustained viral response compared with PEG-DOT.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: March 2013

Interventions

  • Other: enhanced DOT (both pegylated interferon alfa-2a and ribavirin)
    • Subjects randomized to the PEG/RBV-DOT arm receive weekly provider-administered pegylated interferon alfa-2a injections plus modified directly observed ribavirin therapy. We describe this as modified because ribavirin ingestion is observed at the methadone window three to six days per week based on the participants’ methadone pick-up schedule, and only one of two daily doses is observed.
  • Other: standard DOT (PEG-DOT control arm)
    • Subjects randomized to the Peg-DOT arm receive standard on-site treatment (weekly provider-administered pegylated interferon alfa-2a injections) and self-administered twice-daily oral ribavirin. Subjects in the PEG-DOT arm are dispensed monthly medication bottles of ribavirin, and ingest the ribavirin at home.

Arms, Groups and Cohorts

  • Experimental: enhanced DOT (PEG/RBV-DOT)
    • Subjects randomized to the PEG/RBV-DOT arm receive weekly provider-administered pegylated interferon alfa-2a injections plus modified directly observed ribavirin therapy. We describe this as modified because ribavirin ingestion is observed at the methadone window three to six days per week based on the participants’ methadone pick-up schedule, and only one of two daily doses is observed.
  • Active Comparator: standard DOT (PEG-DOT)
    • Subjects randomized to the Peg-DOT arm receive standard on-site treatment (weekly provider-administered pegylated interferon alfa-2a injections) and self-administered twice-daily oral ribavirin. Subjects in the PEG-DOT arm are dispensed monthly medication bottles of ribavirin, and ingest the ribavirin at home.

Clinical Trial Outcome Measures

Primary Measures

  • Adherence
    • Time Frame: 24 -48 weeks
    • Adherence assessed by pill count, self-report, and medical records.

Secondary Measures

  • sustained viral response (SVR)
    • Time Frame: 24 weeks after treatment completion
  • end of treatment response (ETR)
    • Time Frame: 24 – 48 weeks
  • treatment completion
    • Time Frame: 24 – 48 weeks
    • completion of at least 80% of planned duration of HCV treatment.

Participating in This Clinical Trial

Inclusion Criteria

  • HCV-infected – receive HCV medical care at the methadone clinic – plan to initiate HCV treatment on-site within the next 3 months – psychiatrically stable as determined by HCV treatment provider and/or on-site psychiatrist – attend the methadone clinic between three and six days per week to receive methadone – stable dose fo methadone for two weeks prior to the baseline visit Exclusion Criteria:

  • unable or unwilling to provide informed consent – currently receiving HCV treatment – primary HCV care provider does not agree to their participation in the trial – psychiatrically unstable

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Albert Einstein College of Medicine
  • Collaborator
    • National Institute on Drug Abuse (NIDA)
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Alain Litwin, MD, MPH, Principal Investigator, Albert Einstein College of Medicine

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