Impact of Physician Directed Education on Patient Compliance With Hepatitis C Therapy (OPTIMAL)

• Treatment duration compliance rate [ Time Frame: End of treatment up to treatment week 48 ] [ Designated as safety issue: No ]
  The primary objective will be to define treatment duration compliance rate (calculated as the actual treatment duration in weeks divided by the expected duration in weeks) based on individual patient treatment goals as defined in the OPTIMAL protocol for HCV patients treated with boceprevir, peginterferon and ribavirin for up to 48 weeks. Rates will be reported for HCEEs (Group A) and community sites enrolled in the Program (Group B).
  
  

• Dose exposure [ Time Frame: End of treatment up to treatment week 48 ] [ Designated as safety issue: No ]
  Determination of percent dose exposure (measured by the actual dose of prescribed drug [boceprevir, peginterferon and ribavirin] divided by the expected dose) for HCV patients treated at community sites and at HCEEs
  
  
• Sustained virologic response (SVR) defined as undetectable plasma hepatitis C virus (HCV-RNA) at Follow-up Week 24 [ Time Frame: Follow-up week 24 ] [ Designated as safety issue: No ]
  Determination of the rate of SVR for HCV patients treated with boceprevir, peginterferon and ribavirin at community sites and at HCEEs
  
  
• Quality of life [ Time Frame: Baseline, end of treatment, follow-up week 24 ] [ Designated as safety issue: No ]
  Determination of the quality of life for HCV patients treated with boceprevir, peginterferon and ribavirin at community sites and at HCEEs
  
  
• Number of participants with adverse events [ Time Frame: Throughout entire study, at end of treatment and follow up week 24 ] [ Designated as safety issue: Yes ]
  Description of the adverse events and rate of events of boceprevir, peginterferon and ribavirin in HCV patients treated at community sites and at HCEEs
  
  

The new treatment paradigm for HCV in the era of protease inhibitors will add a level of complexity that was previously not seen with pegylated interferon and ribavirin. In addition to new concepts such as utilization of a lead-in period, compliance with a TID dosing regimen of a third agent, development of resistance, and futility rules and decision points have yet to be assessed in a real life practice setting. The OPTIMAL trial is designed to evaluate the impact of an education program for community sites participating in a CLDF study treating chronic HCV genotype 1 patients. Group A will be comprised of approximately 30 CLDF designated Hepatology Centers of Educational Expertise (HCEE) and Group B will be comprised of approximately 60 community sites. Group A will also deliver the educational program regarding the use of HCV protease inhibitors, and the overall treatment of HCV to approximately two (2) community sites in it's geographic region. Group B will be comprised of community sites that have no previous clinical trial experience with boceprevir or an HCV protease inhibitor. For the purpose of this study, each community site in Group B will be assigned to an HCEE.