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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Chronic Hepatitis C, Genotype 1

Intervention / Treatment
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* Procedure: Educational Intervention
* Other: Patient education and management skills training


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Group A - HCEE<br>Group A - CLDF Hepatology Centers of Educational Expertise (HCEE) are hepatologists experienced in educating health professionals about current developments in the management of chronic liver disease and with clinical trial experience using an HCV protease inhibitor. HCEE investigators provided patient education and management skills training during four (4) educational interventions to Community Site investigators. | Other: Patient education and management skills training<br>* Community sites received patient education and management skills training by HCEE investigators during four (4) educational interventions.The CLDF (Sponsor) intends to evaluate the effectiveness of the HCEE led educational interventions in improving a community site's HCV therapeutic management skills and patient outcomes.<br>* Other names: Ribavirin;|
| Other: Group B - Community Sites<br>Group B - community physicians treating HCV but without clinical trial experience with an HCV protease inhibitor received patient education and management skills training from Hepatology Centers of Educational Expertise (HCEEs) during four (4) educational interventions. | Procedure: Educational Intervention<br>* Receive patient education and management skills training from Hepatology Centers of Educational Expertise (HCEE) during four (4) educational interventions.The CLDF (Sponsor) intends to evaluate the effectiveness of the HCEE led educational interventions in improving a community site's HCV therapeutic management skills and patient outcomes.<br>* Other names: Ribavirin;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Treatment Duration Compliance Rate | 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). | End of treatment up to treatment week 48 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Drug Exposure | Total number of patients receiving treatment over specified time intervals. | End of treatment up to treatment week 48 | 
| Determination of the Rate of Sustained Viral Response (SVR) for HCV Patients Treated With Boceprevir, Peginterferon and Ribavirin at Community Sites and at HCEEs. | Rate of SVR was defined as the percentage of participants with HCV-RNA undetectable at follow-up Week 24. All percentages were based on the total number of participants originally randomized/enrolled to that particular arm. | Follow-up week 24 | 
| Short Form Health Survey Measuring Quality of Life Reported at Baseline, End of Treatment, and Follow-up Week 24 (36 Multiple Choice Questions) | Determination of the quality of life for HCV patients treated with boceprevir, peginterferon and ribavirin at community sites and at HCEEs. Patient scores per subscale (8) were obtained by subtracting the lowest possible raw score from the actual raw score x 100, divided by the lowest possible raw score subtracted from the highest possible raw score. Subscale scores were averaged (with standard deviation) for Group A and Group B. Composite Scores are standardized to the general US population having a mean of 50 and a standard deviation of 10. Higher score = improved quality of life. | Baseline, end of treatment, follow-up week 24 | 
| Number of Participants With Adverse Events | Description of the adverse events and rate of events of boceprevir, peginterferon and ribavirin in HCV patients treated at community sites and at HCEEs | Throughout entire study, at end of treatment and follow up week 24 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HCV, Genotype1, Naive, Partial responder, Relapser