Developing a modified directly observed therapy intervention for hepatitis C treatment in a methadone maintenance program: implications for program replication

Am J Drug Alcohol Abuse. 2012 May;38(3):206-12. doi: 10.3109/00952990.2011.643975. Epub 2012 Jan 13.

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.

Publication types

  • Randomized Controlled Trial
  • Research Support, N.I.H., Extramural

MeSH terms

  • Adult
  • Antiviral Agents / therapeutic use
  • Directly Observed Therapy / methods*
  • Directly Observed Therapy / psychology
  • Female
  • Hepacivirus / drug effects
  • Hepatitis C / complications
  • Hepatitis C / drug therapy*
  • Hepatitis C / virology
  • Humans
  • Interferon-alpha / therapeutic use*
  • Male
  • Medication Adherence / statistics & numerical data
  • Methadone / therapeutic use*
  • Middle Aged
  • Opiate Substitution Treatment / methods
  • Opiate Substitution Treatment / psychology*
  • Opioid-Related Disorders / complications
  • Opioid-Related Disorders / drug therapy*
  • Pilot Projects
  • Polyethylene Glycols / therapeutic use*
  • Recombinant Proteins / therapeutic use
  • Ribavirin / therapeutic use*
  • Self Administration / methods
  • Viral Load / drug effects
  • Viral Load / statistics & numerical data

Substances

  • Antiviral Agents
  • Interferon-alpha
  • Recombinant Proteins
  • Polyethylene Glycols
  • Ribavirin
  • peginterferon alfa-2a
  • Methadone