Hepatitis C Treatment in Underserved Populations

• Sustained virologic response, defined as an undetectable serum HCV RNA level 24 weeks after completion of antiviral therapy. [ Time Frame: 24 weeks after completion of antiviral treatment ] [ Designated as safety issue: No ]
  SVR is measured 24 weeks after completion of antiviral treatment
  
  

• completion of medical and psychiatric evaluation for antiviral therapy [ Time Frame: Patients are expected to complete medical and psychiatric evaluation within 3-6 months but it may take longer in some cases. ] [ Designated as safety issue: No ]
  
• initiation of antiviral therapy [ Time Frame: Patients are expected to initiate antiviral therapy (or decide not to) within 3-6 months but it may take longer in some cases. ] [ Designated as safety issue: No ]
  
• adherence to antiviral therapy [ Time Frame: Weekly up to 48 weeks ] [ Designated as safety issue: No ]
  Adherence is measured weekly during the duration of prescribed antiviral therapy. (Antiviral therapy is prescribed for up to 48 weeks, depending on the patient's characteristics, the regimen, and the response to therapy.)
  
  
• completion of antiviral therapy [ Time Frame: Completion is recorded at the time prescribed antiviral therapy is discontinued, whether that happens when the prescribed duration of therapy is complete or before. (Antiviral therapy is prescribed for up to 48 weeks, depending on the patient.) ] [ Designated as safety issue: No ]
  
• levels of alcohol and illicit drug use [ Time Frame: Weekly up to 96 weeks ] [ Designated as safety issue: No ]
  Measured weekly during antiviral therapy and monthly before and after therapy for the duration of follow-up
  
  
• entry into treatment for substance use [ Time Frame: Monthly up to 24 months ] [ Designated as safety issue: No ]
  Measured monthly from study enrollment through 24 weeks subsequent to completing prescribed course of antiviral therapy
  
  
• entry into treatment for another unaddressed medical or psychiatric condition [ Time Frame: Monthly up to 24 months ] [ Designated as safety issue: No ]
  Measured monthly from study enrollment through 24 weeks subsequent to completing prescribed course of antiviral therapy
  
  
• neuropsychiatric side effects, including depression and hostility/irritability [ Time Frame: Monthly up to 72 weeks ] [ Designated as safety issue: Yes ]
  Measured monthly during prescribed course of antiviral therapy and for 24 weeks thereafter
  
  
• treatment-limiting systemic, hematologic, or other side effects [ Time Frame: Weekly up to 72 weeks ] [ Designated as safety issue: Yes ]
  Measured weekly during prescribed course of antiviral therapy and then monthly or quarterly thereafter (TSH, for example, is measured every 3 months during and after treatment)
  
  
• other adverse events or adverse effects [ Time Frame: Monthly up to 72 weeks ] [ Designated as safety issue: Yes ]
  Measured monthly during prescribed course of antiviral therapy or as patients bring adverse events or effects to attention of physicians or study staff
  
  
• reinfection [ Time Frame: Quarterly up to 10 years ] [ Designated as safety issue: No ]
  Patients are monitored at 3-month intervals for reinfection. This will continue as long as possible after completion of antiviral therapy.
  
  

This study examines the feasibility of integrated treatment for hepatitis C in active IDUs using a client-centered, multidisciplinary model that combines expert care in five domains: (a) antiviral pharmacotherapy for HCV infection; (b) substance abuse treatment; (c) psychiatric evaluation and treatment; (d) primary medical care; and (e) intensive, client-centered, case management. The Weill Cornell Medical College Center for the Study of Hepatitis C collaborates with community-based organizations providing services to injection drug users to provide multidisciplinary, integrated care using a model that combines the resources of culturally appropriate community-based agencies with those of a state-of-the-art tertiary care center.