Pharmacoeconomic Study Assessing the Cost of Chronic Hepatitis C Treatment With Peginterferon Alfa-2b (PegIntron) and Ribavirin (Rebetol) in the Czech Republic (Study P04588)(COMPLETED)

Study Overview
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Brief Summary
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The objective of the study is to evaluate the costs associated with peginterferon alfa-2b (PegIntron) plus ribavirin (Rebetol) treatment for chronic hepatitis C in the Czech Republic. Only costs associated with rescue medication, concomitant therapy, disease monitoring, and medical intervention costs recognized by the treating institution as treatment-related expenses will be included in the analysis. The study will also evaluate the correlation between hepatitis C virus (HCV) therapy-related costs with ribavirin dosing and participant history.

Official Title
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Cost of Treatment of Chronic Hepatitis C Using Combination of Peginterferon α-2b Plus Ribavirin

Conditions
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Hepatitis C, Chronic, Hepatitis C

Intervention / Treatment
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* Biological: peginterferon alfa-2b
* Drug: ribavirin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Participants with chronic hepatitis C At least 18 years old Eligibility determined based on the diagnosis and medical judgment only. Exclusion Criteria: None

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-2b and ribavirin<br>All participants included in the study | Biological: peginterferon alfa-2b<br>* Peginterferon alfa-2b administered in accordance with approved labeling, ie, 1.5 μg/kg weekly SC for 48 weeks for participants with hepatitis C virus (HCV) genotype 1 or for 24 weeks for participants with HCV genotype 2, 3.<br>* Other names: peginterferon α-2b;Drug: ribavirin<br>* Ribavirin administered in accordance with approved labeling, ie, 800 mg/day for participants <65 kg, 1000 mg/day for participants >65 to <85 kg, and 1200 mg/day for participants >=85 kg, administered orally for 48 weeks for participants with HCV genotype 1 or for 24 weeks for participants with HCV genotype 2, 3.<br>* Other names: Rebetol;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Average Cost Per Participant With Sustained Virologic Response (SVR) Stratified by Weight Category | SVR is defined as undetectable HCV ribonucleic acid (RNA) six months after the end of treatment. Cost per participant with SVR was calculated as a ratio of the total costs for all participants and the number of participants with SVR in the given group. All costs were adjusted for inflation to 2010 values. | From enrollment up to 48 weeks for participants with hepatitis C virus (HCV) genotype 1, and from enrollment up to 24 weeks for participants with HCV genotypes 2 and 3 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Average Cost Per Participant With SVR Stratified by Ribavirin Dosage | SVR is defined as undetectable HCV ribonucleic acid (RNA) six months after the end of treatment. Cost per participant with SVR was calculated as a ratio of the total costs for all participants and the number of participants with SVR in the given group. All costs were adjusted for inflation to 2010 values. | From enrollment up to 48 weeks for participants with HCV genotype 1, and from enrollment up to 24 weeks for participants with HCV genotypes 2 and 3 | 
| Average Cost Per Participant With SVR Stratified by Prior Treatment Status | SVR is defined as undetectable HCV ribonucleic acid (RNA) six months after the end of treatment. Cost per participant with SVR was calculated as a ratio of the total costs for all participants and the number of participants with SVR in the given group. All costs were adjusted for inflation to 2010 values. | From enrollment up to 48 weeks for participants with HCV genotype 1, and from enrollment up to 24 weeks for participants with HCV genotypes 2 and 3 |