APPROACH Study: Quality of Life and Outcomes Assessment in Participants With Chronic Hepatitis C (CHC) Treated With Pegylated Interferon (PEG-IFN) Alfa-2a and Ribavirin

Study Overview
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Brief Summary
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This multi-center, observational study will examine the clinical use and outcomes of pegylated interferon (PEG-IFN) alfa-2a and ribavirin combination (PEGASYS RBV) in participants with chronic hepatitis C (CHC). Study visits will be scheduled for baseline, 12, 24 and 48 weeks after baseline. An additional follow-up visit at week 72 will be required for participants with an HCV genotype other than 2 or 3. Quality of life data will be collected at baseline, and at each follow-up visit.

Official Title
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A Prospective Study of Peginterferon Alfa-2a and Ribavirin: Outcomes Assessment in Chronic Hepatitis C Patients

Conditions
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Hepatitis C, Chronic

Intervention / Treatment
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* Drug: Pegylated interferon (PEG-INF) alfa-2a
* Drug: Ribavirin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Eligible for and scheduled to receive treatment with commercially available PEG-IFN alfa-2a and ribavirin combination Serologic evidence of chronic hepatitis C (CHC) infection Detectable serum hepatitis C virus - ribonucleic acid (HCV-RNA) Negative urine or blood pregnancy test Fertile participants receiving treatment to use two forms of effective contraception during treatment and for 6 months after treatment end Exclusion Criteria: Women with ongoing pregnancy or who are breast feeding, or male partners of women who are pregnant Received any investigational drug less than or equal to (</=) 6 weeks prior to enrollment Moderate hepatic failure [Child-Pugh greater than or equal to (>/=) B] Co-infection with human immunodeficiency virus (HIV) or hepatitis B Autoimmune hepatitis Known hypersensitivity to alfa interferons, E. coli-derived products, polyethylene glycol, ribavirin and/or any ingredient in the formulation or component of PEG-IFN alfa-2a or ribavirin

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 |
| --- | --- |
| Pegylated Interferon (PEG-IFN) alfa-2a and Ribavirin<br>Participants with hepatitis C who were to be treated with combination of pegylated interferon (PEG-IFN) alfa-2a and ribavirin, within 7 days of baseline, with ongoing management at investigator's discretion. | Drug: Pegylated interferon (PEG-INF) alfa-2a<br>* Pegylated interferon (PEG-IFN) alfa-2a will be administered as per investigator's discretion and will be in line with the current product monograph.<br>* Other names: PEGASYS;Drug: Ribavirin<br>* Ribavirin will be administered as per investigator's discretion and will be in line with the current product monograph.<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 with Sustained Virologic Response (SVR) |  | Up to Week 72 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Short Form Health Survey (SF-36) Physical Composite Score |  | Baseline, Week 12, 24, 48 and 72 | 
| Short Form Health Survey (SF-36) Mental Composite Score |  | Baseline, Week 12, 24, 48 and 72 | 
| Percentage of Participants with Adverse Events of Special Interest Leading to Study Medication Discontinuation |  | Up to Week 72 | 
| Percentage of Participants Who Utilized Resources |  | Baseline, Week 12, 24, 48 and 72 |