Compliance of HCV Genotype 1 Infected Patients Receiving PegIntron/Rebetol and a Patient Assistance Program (Study P04671)

Study Overview
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Brief Summary
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Enrolled patients will be recruited to two parallel groups during therapy for Hepatitis C. Patients in the first one will receive a patient assistance program, and patients in the second group will not. All patients will receive PegIntron and Rebetol according to label.

Detailed Description
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Non-Probability Sample, Commercial product used according to EU label.

Official Title
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Evaluation of Compliance of HCV Genotype 1 Infected Patients Receiving PegIntron / Rebetol in Conjunction With a Patient Assistance Program - Non Interventional Observational Study.

Conditions
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Hepatitis C, Chronic, Hepatitis C

Intervention / Treatment
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* Biological: PegIntron (peginterferon alfa-2b; SCH 54031)
* Drug: Rebetol (ribavirin; SCH 18908)
* Behavioral: Patient Assistance Program


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: According to PegIntron/Rebetol label. Only HCV genotype 1 infected patients will be enrolled in the study. Exclusion Criteria: According to PegIntron/Rebetol label.

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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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Treatment and Patient Assistance Program<br>Patient assistance program was provided to the participants treated with PegIntron/Rebetol. The support program consisted of training by physicians or specialized nurses on the significance of treatment compliance, methods for managing adverse events, and correct drug administration, as well as informational materials and assistance in the management of adverse events. | Biological: PegIntron (peginterferon alfa-2b; SCH 54031)<br>* Peginterferon alfa-2b will be administered according to the product's labeling.<br>* Other names: PegIntron;Drug: Rebetol (ribavirin; SCH 18908)<br>* Ribavirin will be administered according to the product's labeling.<br>* Other names: Rebetol;Behavioral: Patient Assistance Program<br>* The patient assistance program includes the following: Training by physicians or specialized nurses. Informational materials based on the To beat HCV program. Management of specific side effects.<br>* Other names: Support program;|
| Treatment Alone<br>PegIntron/Rebetol treatment only. | Biological: PegIntron (peginterferon alfa-2b; SCH 54031)<br>* Peginterferon alfa-2b will be administered according to the product's labeling.<br>* Other names: PegIntron;Drug: Rebetol (ribavirin; SCH 18908)<br>* Ribavirin will be administered according to the product's labeling.<br>* Other names: Rebetol;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Number of Participants Who Complete Treatment With PegIntron/Rebetol Therapy for Hepatitis C | Participant adherence to therapy was compared between participants treated with PegIntron/Rebetol either with or without a patient assistance program | At the end of the 48-week treatment period | 
| The Number of Participants With a Sustained Virologic Response at 6 Months Post-treatment | Sustained virologic response is defined as having an undetectable hepatitis C virus ribonucleic acid (HCV-RNA) at the end of treatment and 6 months post-treatment | Measured at 6 months post-treatment | 
| The Number of Participants Who Relapsed at 6 Months Post-treatment | Participants who relapse are defined as having an undetectable HCV-RNA at the end of treatment but detectable HCV-RNA at 6 months post-treatment | Measured at end of treatment and 6 months post-treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Average Length of Treatment | Participant adherence to therapy was compared between participants who received vs not received a patient assistance program in addition to their PegIntron/Rebetol treatment. | Maximum 48-week treatment duration | 
| Average Dosage of PegIntron | Dosage of PegIntron was expressed in terms of micrograms of PegIntron received per kilogram of participant's body weight per week | Up to 48-week treatment duration | 
| Average Dosage of Rebetol | Rebetol dosage was expressed in milligrams per kilogram of body weight per day. | Up to 48-week treatment duration |