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.

• hepatitis C treatment
• methadone

ACKNOWLEDGMENTS

The authors thank the National Institute on Drug Abuse (K23 DA022143 RDB) and (K24 DA017072 FLA). Additionally, the authors thank the staff of South Central Rehabilitation Center, which is part of the Cornell Scott-Hill Health Center. Their hard work and dedication was of paramount importance to the success of this project. The author Joseph K. Lim is funded by NIDDK P30-34989.

Declaration of Interest

The authors report no conflicts of interest. The authors alone are responsible for the content and writing of this article.