title: Directly observed therapy for the treatment of hepatitis C virus infection in current and former injection drug users.
abstract: OBJECTIVE
  There are few studies investigating the treatment of hepatitis C virus (HCV) infection in current and former drug users. With this in mind, we sought to evaluate the antiviral efficacy of interferon alpha-2b (IFN alpha-2b) or pegylated-interferon alpha-2b (PEG-IFN alpha-2b) and ribavirin (RBV) in injection drug users (IDU) enrolled in a directly observed therapy (DOT) program, as measured by sustained virologic response (SVR).
  
  
  METHODS
  Viremic HCV-infected IDU, with alanine aminotransferase (ALT) >1.5x upper limit of normal (ULN) were offered 24-48 week (based on HCV genotype) therapy with RBV (800-1200 mg/day, based on weight) along with IFN alpha-2b (3 million IU thrice weekly) replaced by PEG-IFN alpha-2b (1.5 ìg/kg once weekly) as it became available. All injections were directly observed. The primary endpoint was SVR.
  
  
  RESULTS
  Overall, 40 patients (33 males) received IFN alpha-2b (12) or PEG-IFN alpha-2b (28), 55% with HCV genotypes 2 or 3. Only 14 discontinued therapy, 5 due to toxicity, 6 due to illicit drug use and 3 did not achieve an early virologic response. In an intent-to-treat analysis, the overall SVR was 55% (22/40), 64% (14/22) in subjects with genotypes 2/3. There was no significant difference in response rates among those with >6 (50%) or <or=6 months (64%) drug abstinence (P = 0.51) or among those with (53%) and without (57%) intercurrent drug use (P = 0.99); however, frequent users (n = 9) had a decreased SVR (22%) when compared with occasional users (n = 10, 80%, P = 0.12).
  
  
  CONCLUSIONS
  Treatment of HCV in current and former IDU within a multidisciplinary DOT program can be successfully undertaken, resulting in SVR similar to those in randomized controlled trials.
authors.affiliation: Department of Anesthesiology, Pharmacology and Therapeutics, University of British Columbia, Vancouver, British Columbia, Canada. jgrebely@interchange.ubc.ca
authors.forename: Jason
authors.initials: J
authors.lastname: Grebely
authors.forename: Jesse D
authors.initials: JD
authors.lastname: Raffa
authors.forename: Caite
authors.initials: C
authors.lastname: Meagher
authors.forename: Fiona
authors.initials: F
authors.lastname: Duncan
authors.forename: Krista A
authors.initials: KA
authors.lastname: Genoway
authors.forename: Milan
authors.initials: M
authors.lastname: Khara
authors.forename: Mark
authors.initials: M
authors.lastname: McLean
authors.forename: Annabel
authors.initials: A
authors.lastname: Mead
authors.forename: Mark
authors.initials: M
authors.lastname: Viljoen
authors.forename: Stanley
authors.initials: S
authors.lastname: DeVlaming
authors.forename: Chris
authors.initials: C
authors.lastname: Fraser
authors.forename: Brian
authors.initials: B
authors.lastname: Conway
mesh_terms: D000328:Adult; D000410:Alanine Transaminase / Q000097:blood; D000998:Antiviral Agents / Q000627:therapeutic use; D015415:Biomarkers / Q000097:blood; D001955:British Columbia; D005260:Female; D005838:Genotype; D016174:Hepacivirus / Q000235:genetics; D006526:Hepatitis C / Q000188:drug therapy* / Q000635:transmission*; D006801:Humans; D000077190:Interferon alpha-2; D016898:Interferon-alpha / Q000627:therapeutic use; D008297:Male; D011092:Polyethylene Glycols; D011994:Recombinant Proteins; D015819:Substance Abuse, Intravenous / Q000534:rehabilitation
chemical_list: D000998:Antiviral Agents; D015415:Biomarkers; D000077190:Interferon alpha-2; D016898:Interferon-alpha; D011994:Recombinant Proteins; D011092:Polyethylene Glycols; D000410:Alanine Transaminase; C417083:peginterferon alfa-2b