Impact of Patient Support by the Medical Staff on Adherence to Therapy With PegIntron Plus Rebetol (Study P04413)

Study Overview
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Brief Summary
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The objective of this study is to assess the impact of participant care and support on treatment adherence. PegIntron pen and Rebetol will be administered to participants with Hepatitis C Virus (HCV) in accordance with approved labeling. Sites will be categorized as providing high vs low level of participant management based on information about the level of participant support and management captured on the site questionnaire. Data on each participant will be collected by a physician on an electronic participant case report form (CRF) and by the participant via a questionnaire. Treatment completion rates will be analyzed based on the high vs low level of participant management. The hypothesis is that Physicians investing more time and effort into participant management achieve higher treatment completion rates among their hepatitis C patients than physicians offering less participant management measures.

Official Title
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Impact of Patient Support From Medical Staff on the Adherence to Therapy With PegIntron Plus Rebetol

Conditions
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Hepatitis C, Chronic Hepatitis C

Intervention / Treatment
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* Biological: PegIntron
* Drug: Rebetol


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Participants with chronic hepatitis C. Those participating in patient assistance programs during therapy for hepatitis C. Exclusion Criteria: Participants who have previously been treatment for hepatitis C (non-naïve) Other exclusion criteria as described in local Summary of Product Characteristics (SPC).
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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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| All participants<br>Each site will be evaluated by a site questionnaire and assigned as either a high or low participant management site. Participants are not randomized to a group. However, treatment completion rates will be evaluated based on the high vs low participant management sites. | Biological: PegIntron<br>* PegIntron (peginterferon alfa-2b) pen administered at a dose and frequency in accordance with approved labeling in Germany<br>* Other names: SCH 54031;Drug: Rebetol<br>* Rebetol (ribavirin) administered at a dose and frequency in accordance with approved labeling in Germany<br>* Other names: SCH 18908;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Biometrical Adherence to Therapy | Adherence was defined as participants receiving at least 80% of the planned PegIntron doses, or at least 80% of the planned Rebetol doses, or participants concluding at least 80% of the planned duration of their treatment, or all three conditions. | Up to 48 weeks for Hepatitis C Virus (HCV) genotype 1 or 4 participants and up to 24 weeks for HCV genotype 2 or 3 | 
| Number of Participants With Adherence to Therapy According to Physician Approximation | Adherence was based on physiciant's clinical judgment. | Up to 48 weeks for HCV genotype 1 or 4 participants and up to 24 weeks for HCV genotype 2 or 3 |