Treatment of Hepatitis C Infected Substance Abusers within a Community-Based, Outpatient Methadone Maintenance Program

Abstract

Purpose: To demonstrate the feasibility of Hepatitis C virus treatment of HCV-infected substance abusers within a community-based, outpatient methadone maintenance program. Methods: In an effort to expand the treatment options to community-based methadone maintenance pts within a behavioral health agency, an HCV evaluation and treatment program was initiated. After HCV antibody testing and counseling, pts were screened for suitability for IFN-based tx (stable medical/psychiatric/substance abuse disease). These pts received a physician evaluation, lab (± biopsy evaluation), and IFN-based tx with lab monitoring and on-site psychiatric services. Results: Using an intention-to-treat analysis, 15 pts on methadone maintenance therapy started a course of combination tx for chronic HCV liver disease. Demographically pts were 67% male, with mean age of 45, mean baseline ALT of 107, and 73% genotype I with a mean HCV viral load of 2,800,000 IU/ml. Mean biopsy stage was 2.4 with a mean grade of 2.4. All pts had had at least 3 months abstinence from illicit drugs prior to the initiation of tx. 8/15 (53%) had known psychiatric illness; 7 of these were diagnosed with depression. All 15 pts were treated with PEG-IFN and RBV for 24–48 wks dependent on genotype. Only one pt withdrew from tx, due to intolerance of PEG-IFN. 93% of those completing 12 wks of tx (N = 14) had an early virological response (2-log drop in HCV RNA level). Later 3 pts had a recurrence of virus, leading to discontinuation of tx prior to its intended duration. 10 pts completed a full course of tx; 9 of these pts had undetectable HCV RNA (ETR 60%). 6 months post-tx, 5/15 (33%) had a sustained virological response; 2 pts had recurrence of virus, and 2 others pts remain in follow-up. 2 pts with preexisting depression experienced worsening of symptoms; temporary reduction of PEG-IFN dosage successfully reduced depressive symptoms for one of these pts. 3 other pts developed depressive symptoms. Therapy was generally well-tolerated, with side-effects similar to pts who are not on methadone. Upward titration of methadone dosage reduced side-effects in most pts. There were no serious adverse events. Conclusions: HCV-infected pts on methadone therapy can be safely and effectively treated for HCV. Due to the enhanced ability to monitor for psychiatric decompensation and substance abuse relapse, this therapy can be effectively delivered within the setting of a community-based, outpatient methadone maintenance program.