A Study of the Effectiveness of Peginterferon Alfa-2a (Pegasys) and Ribavirin Treatment in Slovenian Hepatitis C (HCV) Patients

Study Overview
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Brief Summary
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In this Slovenian, multi-center, observational study, the effectiveness of standard of care Peginterferon alfa-2a + ribavirin treatment in adult patients with chronic hepatitis C (CHC) is examined. Patients were treated for 24- or 48-weeks, as prescribed by the treating physician, followed by a 24-week follow-up period.

Conditions
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Hepatitis C, Chronic

Intervention / Treatment
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* Drug: Peginterferon alfa-2a
* Drug: Ribavirin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male and female patients >/= 18 years Positive test for HCV Effective contraception as specified by the Peginterferon alfa-2a and/or ribavirin labels Exclusion Criteria: Concomitant infection with HIV or hepatitis B Participation in a clinical trial within 30 days prior to study start Any contraindications specified in the Peginterferon alfa-2a and ribavirin product labels

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 |
| --- | --- |
| Peginterferon alfa-2a + Ribavirin<br> | Drug: Peginterferon alfa-2a<br>* Peginterferon alfa-2a according to the standard practice in line with current summaries \nof product characteristics (SPCs)/local labeling.<br>* Other names: Pegasys;Drug: Ribavirin<br>* Ribavirin according to the standard practice in line with current summaries \nof product characteristics (SPCs)/local labeling.<br>* Other names: Copegus;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants Achieving Sustained Virological Response (SVR) According to Genotype and Previous Treatment | SVR was defined as participants with undetectable Hepatitis C virus (HCV) ribonucleic acid (RNA) at 24 weeks after completion of treatment. Undetectable HCV RNA was defined as a single last HCV RNA less than (<) 20 international units per milliliter (IU/mL). SVR was evaluated based on HCV genotype (G1, G2, G3 and G4), participant's interleukin 28B genotype (CC, CT and TT), and previous treatment (treatment naive or previous treatment). | 6 months after the last study drug administration (up to 123.6 weeks) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants With Undetectable HCV RNA | Undetectable HCV RNA=a single last HCV RNA <20 IU/mL | Weeks 4, 12 and at end of treatment (up to 99.6 weeks) | 
| HCV RNA Values |  | Baseline; Weeks 4, 12, end of treatment (up to 99.6 weeks) and 6 months after end of treatment (up to 123.6 weeks) | 
| Thrombocyte Values |  | Baseline; Weeks 4, 12, end of treatment (up to 99.6 weeks) and 6 months after end of treatment (up to 123.6 weeks) | 
| Leukocyte Values |  | Baseline; Weeks 4, 12, end of treatment (up to 99.6 weeks) and 6 months after end of treatment (up to 123.6 weeks) | 
| Hemoglobin Values |  | Baseline; Weeks 4, 12, end of treatment (up to 99.6 weeks) and 6 months after end of treatment (up to 123.6 weeks) | 
| Treatment Duration (in Weeks) With Peginterferon Alfa-2a and Ribavirin |  | Up to 99.6 Weeks |