An Observational Study of Pegasys (Peginterferon Alfa-2a) Plus Ribavirin Based Regimens in Patients With Chronic Hepatitis C With Previous Treatment Failure

Study Overview
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Brief Summary
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This prospective, national, multicenter, observational study will evaluate in routine clinical practice the efficacy and safety of re-treatment with Pegasys (peginterferon alfa-2a) plus ribavirin or regimens containing direct-acting antivirals in participants with chronic hepatitis C who failed previous treatment. Participants will be followed for the duration of their treatment (24, 48 or 72 weeks) and for 24 weeks of follow-up.

Official Title
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Non-interventional, Observational Study on Retreatment of Chronic Hepatitis C Patients Previous Treatment Failure, Using Peginterferon Alfa-2a and Ribavirin Based Regimens

Conditions
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Hepatitis C, Chronic

Intervention / Treatment
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* Drug: Pegylated Interferon alfa-2a
* Drug: Ribavirin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult participants, >/= 18 years of age Participants with chronic hepatitis C who have been previously treated with pegylated interferon, standard interferon, ribavirin No contra-indications to pegylated interferon and ribavirin therapy or to the treatment regimen containing DAAs as detailed in the local label Treatment in line with summary of Product Characteristics/local labeling for Pegasys/ribavirin and DAAs, in particular: Positive serum hepatitis C virus (HCV) ribonucleic acid (RNA) Fertile males and females receiving ribavirin must use two forms of contraception during treatment with Pegasys/ribavirin and until 6 months post-treatment No co-infection with hepatitis B or human immunodeficiency virus (HIV) Exclusion Criteria: History or other evidence of a medical condition associated with chronic liver disease other than chronic hepatitis C History of neurological disease History of severe psychiatric disease Decompensated diabetes History of immunologically mediated disease History of severe cardiac disease History or evidence of severe chronic pulmonary disease Inadequate hematologic function Pregnant or breastfeeding women Male partners of pregnant women

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 alfa-2a<br>Participants with chronic hepatitis C with previous treatment failure received combination therapy with pegylated interferon alfa-2a plus ribavirin or treatment regimens containing direct-acting anti-viral (DAAs) | Drug: Pegylated Interferon alfa-2a<br>* Dosing was at the discretion of the investigator in accordance with local clinical practice and local labelling.<br>* Other names: Peginterferon alfa 2A;Drug: Ribavirin<br>* Dosing was at the discretion of the investigator in accordance with local clinical practice and local labelling.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sustained virological response (SVR) rate, defined as percentage of patients with HCV RNA <50 IU/mL at 24 weeks post completion of treatment (overall and stratified by prior treatment outcome: non-response and relapse) |  | approximately 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of patients with rapid virological response (RVR), defined as HCV RNA <50 IU/mL at Week 4 (overall and stratified by prior treatment outcome: non-response and relapse) |  | approximately 3 years | 
| Percentage of patients with early virological response (EVR), defined as HCV RNA <50 IU/mL or an at least 2-log drop from baseline in HCV RNA at Week 12, but with no RVR (overall and stratified by prior treatment outcome: non-response and relapse) |  | approximately 3 years | 
| Percentage of patients with non-response/relapse/virological breakthrough/virological rebound |  | approximately 3 years | 
| Duration of treatment |  | approximately 3 years | 
| Time to safety-related dose reduction/treatment discontinuation of any of the treatment compounds |  | approximately 3 years | 
| Safety: Incidence of adverse events |  | approximately 3 years |