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

Phase 4

Completed

Conditions: Chronic Hepatitis C
Genotype 1

Registration Number: NCT01405027

Lead Sponsor: Chronic Liver Disease Foundation

Brief Summary: 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: 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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 197

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Treatment Duration Compliance Rate	End of treatment up to treatment week 48	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).

Secondary Outcome Measures

Name	Time	Method
Drug Exposure	End of treatment up to treatment week 48	Total number of patients receiving treatment over specified time intervals.
Determination of the Rate of Sustained Viral Response (SVR) for HCV Patients Treated With Boceprevir, Peginterferon and Ribavirin at Community Sites and at HCEEs.	Follow-up week 24	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.
Short Form Health Survey Measuring Quality of Life Reported at Baseline, End of Treatment, and Follow-up Week 24 (36 Multiple Choice Questions)	Baseline, end of treatment, follow-up week 24	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.
Number of Participants With Adverse Events	Throughout entire study, at end of treatment and follow up week 24	Description of the adverse events and rate of events of boceprevir, peginterferon and ribavirin in HCV patients treated at community sites and at HCEEs

Trial Locations

Locations (43): California Liver Institute
🇺🇸
Beverly Hills, California, United States
Samuel Burstein, MD
🇺🇸
Calabasas, California, United States
William Katkov, MD
🇺🇸
Santa Monica, California, United States
Sutha Sachar, MD
🇺🇸
Torrance, California, United States
Harbor UCLA Medical Professional Group
🇺🇸
Torrance, California, United States
Associates in Gastroenterology
🇺🇸
Colorado Springs, Colorado, United States
South Denver Gastroenterology
🇺🇸
Englewood, Colorado, United States
Bay Area Gastroenterology
🇺🇸
Clearwater, Florida, United States
Digestive Medicine Associates
🇺🇸
Hialeah, Florida, United States
James Johnson, MD
🇺🇸
Lakeland, Florida, United States
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California Liver Institute
🇺🇸Beverly Hills, California, United States