title: Developing a modified directly observed therapy intervention for hepatitis C treatment in a methadone maintenance program: implications for program replication.
abstract: BACKGROUND
  Hepatitis C virus (HCV) is a prevalent chronic blood-borne infection among opioid-dependent patients on methadone maintenance treatment (MMT). Despite case reports and case-control studies, a randomized controlled trial (RCT) examining HCV treatment adherence in methadone-maintained patients is lacking and was the impetus for this ongoing RCT examining modified directly administered therapy for HCV treatment integrated within a MMT.
  
  
  METHODS
  Subjects were randomized 1:1 to receive HCV treatment as modified directly observed therapy (mDOT) into the MMT program or at a liver specialty clinic as self-administered therapy (SAT). Randomization was stratified based on HIV status and HCV genotype.
  
  
  RESULTS
  Twenty-one subjects to date have enrolled in this pilot study. The mDOT subjects have had greater success in starting treatment and 10 of the 12 mDOT subjects achieved early virologic response (EVR) at week 12 and 6 of those 10 achieved sustained virologic response (SVR). Of the nine SAT subjects, only three achieved EVR at week 12 and only one achieved SVR despite not completing the treatment.
  
  
  CONCLUSIONS
  Hepatitis C treatment can be successfully integrated into a methadone maintenance clinic, and mDOT can be implemented with a methadone clinic's existing nursing and medical staff. Patients struggling with concurrent substance use and mental illness comorbidity may be successfully addressed in such settings and facilitate access to and completion of treatment through the utilization of on-site clinical services for HCV treatment and adherence support with mDOT. The exact importance of site of services and adherence support remains a significant area for future investigation.
authors.affiliation: Yale University AIDS Program, New Haven, CT 06510, USA. robert.bruce@yale.edu
authors.forename: R Douglas
authors.initials: RD
authors.lastname: Bruce
authors.forename: Julie
authors.initials: J
authors.lastname: Eiserman
authors.forename: Angela
authors.initials: A
authors.lastname: Acosta
authors.forename: Ceilia
authors.initials: C
authors.lastname: Gote
authors.forename: Joseph K
authors.initials: JK
authors.lastname: Lim
authors.forename: Frederick L
authors.initials: FL
authors.lastname: Altice
mesh_terms: D000328:Adult; D000998:Antiviral Agents / Q000627:therapeutic use; D023801:Directly Observed Therapy / Q000379:methods* / Q000523:psychology; D005260:Female; D016174:Hepacivirus / Q000187:drug effects; D006526:Hepatitis C / Q000150:complications / Q000188:drug therapy* / Q000821:virology; D006801:Humans; D016898:Interferon-alpha / Q000627:therapeutic use*; D008297:Male; D008691:Methadone / Q000627:therapeutic use*; D008875:Middle Aged; D058850:Opiate Substitution Treatment / Q000379:methods / Q000523:psychology*; D009293:Opioid-Related Disorders / Q000150:complications / Q000188:drug therapy*; D010865:Pilot Projects; D011092:Polyethylene Glycols / Q000627:therapeutic use*; D011994:Recombinant Proteins / Q000627:therapeutic use; D012254:Ribavirin / Q000627:therapeutic use*; D012646:Self Administration / Q000379:methods; D019562:Viral Load / Q000187:drug effects / Q000706:statistics & numerical data; D016903:Drug Monitoring
chemical_list: D000998:Antiviral Agents; D016898:Interferon-alpha; D011994:Recombinant Proteins; D011092:Polyethylene Glycols; D012254:Ribavirin; C100416:peginterferon alfa-2a; D008691:Methadone