Patient Compliance During PegIntron and Rebetol Combination Therapy in Chronic Hepatitis C (Study P04690)

Study Overview
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Brief Summary
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Participants will receive PegIntron injection pen (Peginterferon alfa-2b) and Rebetol (Ribavirin) combination therapy as their usual medical treatment. The current study aims to evaluate whether the previously introduced, and now widely accepted and implemented educational program, which represents additional efforts in everyday practice to increase patient compliance, will succeed in achieving adherence rate in treated participants similar to the extent demonstrated by clinical trials.

Official Title
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Patient Compliance During PegIntron (Injection Pen) and Rebetol Combination Therapy in Chronic Hepatitis C

Conditions
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Hepatitis C, Chronic, Hepatitis C

Intervention / Treatment
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* Biological: PegIntron (Peginterferon alfa-2b)
* Drug: Rebetol (Ribavirin)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Before inclusion, all participants must be informed and must give consent for the use of his/her anonymized health data related to his/her treatment with Peginterferon alfa-2b (injection pen) and Ribavirin. Exclusion Criteria: According to Peginterferon alfa-2b/Ribavirin 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 |
| --- | --- |
| Chronic hepatitis C participants<br>Untreated chronic hepatitis C (CHC) participants starting Peginterferon alfa-2b (injection pen) and Ribavirin combination therapy as their usual medical treatment according to the approved dosage/regimen were selected for this study. | Biological: PegIntron (Peginterferon alfa-2b)<br>* Peginterferon alfa-2b (injection pen) administered according to the product's labeling and current practice in Hungary (1.5 micrograms [mcg]/killogram [kg]) for 12 weeks. Those participants whose continued treatment was warranted beyond week 12 based on response received therapy for 24 or 48 weeks depending on the viral genotype.<br>* Other names: SCH 54031;Drug: Rebetol (Ribavirin)<br>* Ribavirin capsules administered according to the product's labeling and current practice in Hungary (weight based daily) for 12 weeks. Those participants whose continued treatment was warranted beyond week 12 based on response received therapy for 24 or 48 weeks depending on the viral genotype.<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 Who Are Triple-80 Compliant | Participants who continued treatment beyond Week 12 (i.e., 24 or 48 weeks depending on the viral genotype) were assessed for triple-80 compliance. Triple-80 compliant, or simply compliant, participants were those that received >= 80% of the planned total doses of both pegylated interferon alfa-2b and ribavirin for >=80% of the duration of the therapy. 3 rates were computed: Compliance with study duration, compliance with pegylated interferon dose, and compliance with ribavirin dose. A participant was defined as triple-80 compliant, if none of the 3 rates as defined above were less than 80. | 24 or 48 Weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants Who Achieved Sustained Virological Response as Assessed at 24-week Post-treatment Follow-up | Sustained virologic response (SVR) was assessed at post-treatment Follow-up Week 24. Day 1 of the Follow-up period was defined as the first day after the last dose day. A participant was considered a sustained responder if the participant had undetectable Hepatitis C virus Ribonucleic acid (HCV-RNA) level (based on qualitative test result) at Follow-up Week 24. If a participant with missing polymerase chain reaction (PCR) data at Follow-up Week 24 had undetectable HCV-RNA level at Follow-up Week 12, the participant was also considered as a sustained responder. | 24 Weeks following completion of 24 or 48 weeks of therapy | 
| Number Of Participants Self-Administering Pegylated Interferon Alfa-2b | Number of participants self-administering Pegylated interferon alfa-2b injection pen. If a participant changed the way he or she administered the injection pen during the course of the study (from self-administering to clinic-administering or the other way around), that participant was also considered as self-administering. | Up to 48 Weeks |