An Observational Study of Dual and Triple Therapies Based on Pegasys (Peginterferon Alfa-2a) in Patients With Chronic Hepatitis C

Study Overview
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Brief Summary
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This multi-center, observational study will evaluate the efficacy and safety of dual and triple therapies based on Pegasys (peginterferon alfa-2a) in patients with chronic hepatitis C. Patients receiving treatment with either Pegasys plus ribavirin or Pegasys plus ribavirin plus telaprevir/boceprevir will be observed for the duration of their treatment and for up to 24 weeks of follow-up.

Official Title
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Multi-Center, Non-Interventional Study, on the Efficacy of Dual and Triple Therapies Based on Pegylated Interferon Alfa-2a for the Treatment of Chronic Hepatitis C Patients

Conditions
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Hepatitis C, Chronic

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult patients, >/= 18 years of age Chronic hepatitis C (all genotypes, naïve or treatment experienced, HCV mono-infected or HCV-HIV co-infected) Receiving either dual therapy (Pegasys plus ribavirin) or triple therapy (Pegasys plus ribavirin plus telaprevir/boceprevir) No contra-indications to Pegasys and ribavirin therapy or to treatment regimen containing protease inhibitor (telaprevir or boceprevir) as detailed in local Prescribing Information Quantitative serum HCV RNA by PCR test before initiation of treatment Exclusion Criteria: Hepatitis A/B co-infection Evidence of severe illness, active malignancy, or any other conditions which would make the patient, in the opinion of the investigator, unsuitable for the study Pregnant or breast-feeding 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 |
| --- | --- |
| Cohort<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants With Sustained Viral Response (SVR) at Week 24 | The overall SVR-24 rate was defined as percentage of participants with Hepatitis C Virus Ribonucleic Acid (HCV-RNA) levels < 50 International Units per MilliLiter (IU/mL) (as measured by Polymerase Chain Reaction (PCR)) at 24 weeks post treatment completion. | Week 24 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of SVR at Week 24 | SVR at Week 24 is compared by treatment group, type of infection, prior treatments and genotype. | Week 24 | 
| Number of Participants With SVR at Week 24 According to the Demographic Characteristics | The overall SVR-24 rate was defined as percentage of participants with Hepatitis C Virus Ribonucleic Acid (HCV-RNA) levels < 50 International Units per MilliLiter (IU/mL) (as measured by Polymerase Chain Reaction (PCR)) at 24 weeks post treatment completion. Number of participants analysed signifies participants who were evaluated for outcome measure. Data for this outcome measure was not summarized for each arm. Hence, data is reported for all participants. | Week 24 | 
| Percentage of Participants With Rapid Virologic Response (RVR) at Week 4 | RVR was defined as HCV-RNA <50 IU/mL by Week 4 | Week 4 | 
| Percentage of Participants With Extended RVR | Extended RVR was defined as HCV-RNA <50 IU/mL at weeks 4 and 12 for participants treated with telaprevir; or at weeks 8 & 24 for participants treated with boceprevir. The assessment was performed in participants who received triple therapy in treatment arms 'Peginterferon Alfa-2a + Ribavirin +Telaprevir' and 'Peginterferon Alfa-2a + Ribavirin + Boceprevir'. | Week 4 and 12 for telaprevir group; Week 8 and 24 for boceprevir group | 
| Percentage of Participants With Complete Early Virologic Response (cEVR) | Complete early virologic response (cEVR) was defined as HCV-RNA <50 IU/mL by Week 12 | Week 12 | 
| Percentage of Participants With End of Treatment Response (EoT) | End-of-Treatment (EoT) response was defined as HCV-RNA <50 IU/mL by the end of treatment. | Week 24 | 
| Percentage of Participants With Virologic Relapse | Virologic relapse was defined as detectable HCV-RNA during the treatment-free follow-up period in participants with HCV-RNA <50 IU/mL at EoT. | Week 72 | 
| Treatment Duration | The average amount of time a treatment was prescribed to participants. | Week 48 | 
| Time to First Dose Modification of Peginterferon Alfa-2a |  | Week 48 | 
| Time to First Dose Modification of Ribavirin |  | Week 48 | 
| Time to First Dose Modification of Telaprevir/Boceprevir |  | Week 48 | 
| Percentage of Participants With Adverse Events (AEs) | Any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Safety analysis included 2 additional participants in arm 'Peginterferon Alfa-2a + Ribavirin + Telaprevir'. The safety parameters were analyzed by the treatment actually received by the participants. | Week 48 | 
| Mean Value of Hemoglobin in Participants With Treatment-Induced Anemia |  | Week 48 | 
| Percentage of Participants With Treatment Regimen for HCV Treatment Induced Anemia |  | Week 48 | 
| Percentage of Participants Who Had SVR at Week 24 With Dose Modifications | Participants with dose modifications who had achieved SVR at Week 24 were reported. Data was collected for all participants who had dose modification of Peginterferon alfa-2a, Ribavirin or Telaprevir/boceprevir in any of the treatment regimen during the study. | Week 24 |