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

Boceprevir in Community Practice: Assessing Safety, Efficacy, Compliance and Quality of Life, Impact of an Education Program

The purpose of this study is to evaluate the impact of a physician directed education program on treatment compliance of hepatitis C patients administered triple drug therapy of pegylated interferon, ribavirin and boceprevir.

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.

Inclusion Criteria:

• Chronic Hepatitis C (HCV) genotype 1
• Detectable HCV-RNA within 180 days of screening
• Age ≥ 18 years
• Weight > 40 kg
• Patient and partner(s) must agree to use acceptable methods of contraception
• Written informed consent

Exclusion Criteria:

• Known co-infection with HIV or HBV
• Previous interferon or ribavirin regimen requiring discontinuation for an adverse event considered related to ribavirin and/or interferon
• Currently taking or planning on taking any prohibited medications
• Evidence of decompensated liver disease including the presence of clinical ascites, bleeding varices, or hepatic encephalopathy
• Diabetes and/or hypertension with clinically significant ocular examination findings
• Pre-existing psychiatric condition(s)
• History of severe and uncontrolled psychiatric disorders
• Active alcohol or drug abuse (not including marijuana)
• Pre-existing medical condition that could interfere with the patient's participation in the study
• Chronic obstructive pulmonary disease
• Abnormal lab values