An Observational Study on Dual And Triple Therapies Based on Peginterferon Alfa (e.g. Pegasys) in Patients With Chronic Hepatitis C

Study Overview
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Brief Summary
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This prospective, multicenter, observational cohort study will evaluate the efficacy and safety of pegylated interferon alfa (peginterferon alfa) (e.g. Pegasys) plus ribavirin and treatment regimens containing direct-acting antivirals in participants with chronic hepatitis C who are treatment-naïve or treatment-experienced and HIV HCV co-infected. Data will be collected from participants receiving treatment according to current Summary of Product Characteristics (SPC) and local labeling for the duration of their treatment and a 24-week follow-up.

Official Title
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Non-Interventional Cohort Study on the Utilization and Impact of Dual and Triple Therapies Based on Pegylated Interferon for the Treatment of Chronic Hepatitis C

Conditions
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Hepatitis C, Chronic

Intervention / Treatment
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* Drug: Peg-IFN Alfa-2a
* Drug: Peg-IFN Alfa-2b
* Drug: Ribavirin
* Drug: Boceprevir
* Drug: Telaprevir


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult (according to local legislation) participants Chronic hepatitis C (HCV) Naive or treatment experienced, HIV-HCV co-infected or HCV mono-infected Receiving treatment for HCV with pegylated interferons plus ribavirin or regimens containing direct-acting antivirals (DAA) according to standard of care and in line with current SPC/local labeling Exclusion Criteria: Contraindications according to SPC/local labeling Treatment started >4 weeks before entering study

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 |
| --- | --- |
| Dual Therapy: Peg-IFN Alfa-2a + Ribavirin<br>Participants with chronic hepatitis C (CHC) receiving dual therapy (pegylated interferon alfa-2a [peg-IFN Alfa-2a] along with ribavirin according to standard of care and in line with local labeling) were followed up for the duration of their treatment and for up to 24 weeks after therapy. | Drug: Peg-IFN Alfa-2a<br>* Peg-IFN Alfa-2a according to standard of care and in line with local labeling.<br>Drug: Ribavirin<br>* Ribavirin according to standard of care and in line with local labeling.<br>|
| Dual Therapy: Peg-IFN Alfa-2b + Ribavirin<br>Participants with CHC receiving dual therapy (pegylated interferon alfa-2b [peg-IFN Alfa-2b] along with ribavirin according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy. | Drug: Peg-IFN Alfa-2b<br>* Peg-IFN Alfa-2b according to standard of care and in line with local labeling.<br>Drug: Ribavirin<br>* Ribavirin according to standard of care and in line with local labeling.<br>|
| Triple Therapy: Boceprevir + Peg-IFN Alfa-2a + Ribavirin<br>Participants with CHC receiving triple therapy (peg-IFN Alfa-2a along with ribavirin and boceprevir according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy. | Drug: Peg-IFN Alfa-2a<br>* Peg-IFN Alfa-2a according to standard of care and in line with local labeling.<br>Drug: Ribavirin<br>* Ribavirin according to standard of care and in line with local labeling.<br>Drug: Boceprevir<br>* Boceprevir according to standard of care and in line with local labeling.<br>|
| Triple Therapy: Boceprevir + Peg-IFN Alfa-2b + Ribavirin<br>Participants with CHC receiving triple therapy (peg-IFN Alfa-2b along with ribavirin and boceprevir according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy. | Drug: Peg-IFN Alfa-2b<br>* Peg-IFN Alfa-2b according to standard of care and in line with local labeling.<br>Drug: Ribavirin<br>* Ribavirin according to standard of care and in line with local labeling.<br>Drug: Boceprevir<br>* Boceprevir according to standard of care and in line with local labeling.<br>|
| Triple Therapy: Telaprevir + Peg-IFN Alfa-2a + Ribavirin<br>Participants with CHC receiving triple therapy (peg-IFN Alfa-2a along with ribavirin and telaprevir according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy. | Drug: Peg-IFN Alfa-2a<br>* Peg-IFN Alfa-2a according to standard of care and in line with local labeling.<br>Drug: Ribavirin<br>* Ribavirin according to standard of care and in line with local labeling.<br>Drug: Telaprevir<br>* Telaprevir according to standard of care and in line with local labeling.<br>|
| Triple Therapy: Telaprevir + Peg-IFN Alfa-2b + Ribavirin<br>Participants with CHC receiving triple therapy (peg-IFN Alfa-2b along with ribavirin and telaprevir according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy. | Drug: Peg-IFN Alfa-2b<br>* Peg-IFN Alfa-2b according to standard of care and in line with local labeling.<br>Drug: Ribavirin<br>* Ribavirin according to standard of care and in line with local labeling.<br>Drug: Telaprevir<br>* Telaprevir according to standard of care and in line with local labeling.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants With Sustained Virological Response at 24 Weeks Post Completion of the Treatment Period (SVR24) | SVR24 rate for dual therapy participants is defined as percentage of participants with hepatitis C virus (HCV) ribonucleic acid (RNA) less than (<) 50 international unit/milliliters (IU/mL) (as measured by a commercially available HCV RNA test with lower limit of detection less than or equal to [<=] 50 IU/mL) at 24 weeks post completion of the treatment period. If a quantitative test was used, the lower limit of quantification had to be <=50 IU/mL. SVR24 for triple therapy participants is defined as percentage of participants with undetectable HCV RNA assessed by a test with lower limit of detection <= 50 IU/mL at 24 weeks post completion of the treatment period. | 24 weeks after end of treatment (up to 118 weeks) | 
| Percentage of Participants With Sustained Virological Response at 12 Weeks Post Completion of the Treatment Period (SVR12) | SVR12 rate for dual therapy participants is defined as percentage of participants with hepatitis C virus (HCV) ribonucleic acid (RNA) less than (<) 50 international unit/milliliters (IU/mL) (as measured by a commercially available HCV RNA test with lower limit of detection less than or equal to [<=] 50 IU/mL) at 12 weeks post completion of the treatment period. If a quantitative test was used, the lower limit of quantification had to be <=50 IU/mL. SVR12 for triple therapy participants is defined as percentage of participants with undetectable HCV RNA assessed by a test with lower limit of detection <= 50 IU/mL at 12 weeks post completion of the treatment period. | 12 weeks after end of treatment (up to 118 weeks) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Virological Response at Various on Treatment Time Points and End of Treatment (EOT) | Virological response (VR) for dual therapy participants is defined as HCV RNA <50 IU/mL as assessed by a qualitative HCV RNA test with a lower limit of detection (LLD) <=50 IU/mL or as assessed by a quantitative test with a lower limit of quantification (LLQ) <=50 IU/mL for all time points concerned. Results of HCV RNA tests with LLD and LLQ >50 IU/mL were considered as non-response. VR for triple therapy participants is defined as undetectable HCV RNA assessed by a test with lower limit of detection <=50 IU/mL (UVR). Results of HCV RNA tests with an LLD >50 IU/mL were considered as non-response for triple therapy participants. | Week 4, 12 and End of treatment (EOT) (up to 96 weeks) | 
| Virological Relapse After End of Treatment | Virological relapse defined as non-virological response (non-VR)/non-undetectable virological response (non-UVR) at the last HCV RNA assessment during the treatment-free follow-up period in participants with VR/UVR at EOT. Here, number of participants analyzed is the participants with end of treatment response (EoT-R) who also had an HCV RNA test at least 12 weeks after EoT or whose last follow-up HCV RNA test showed non-response (HCV RNA >=50 IU/mL). | Up to 24 weeks after EOT (up to 118 weeks) | 
| Virological Breakthrough | Virological breakthrough/rebound defined as non-VR/non-UVR during the treatment period (including end of treatment) in participants with prior VR/UVR or an increase of HCV RNA by >=1 log10 during the treatment period in comparison to the lowest HCV RNA (nadir) previously measured during the treatment period in participants without VR/UVR during the treatment period. Here, Number of participants analyzed is the participants with at least 2 on-treatment HCV RNA assessments (including EoT) or 1 on-treatment HCV RNA assessment (excluding EoT) and response at EoT by backward imputation. | Up to EOT (up to 118 weeks) | 
| Percentage of Participants With Sustained Virological Response (SVR) in Participants With Dose Reductions or Treatment Interruptions | SVR 12 and 24 rates for dual therapy participants are defined as percentage of participants with hepatitis C virus (HCV) ribonucleic acid (RNA) less than (<) 50 international unit/milliliters (IU/mL) (as measured by a commercially available HCV RNA test with lower limit of detection less than or equal to [<=] 50 IU/mL) at 12 or 24 weeks post completion of the treatment period. If a qualitative test was used, then the lower limit of detection has to be <=50 IU/mL. SVR12 and 24 rates for triple therapy participants are defined as percentage of participants with undetectable HCV RNA assessed by a test with lower limit of detection <= 50 IU/mL at 12 or 24 weeks post completion of the treatment period. Here, number of participants analyzed excluded the participants with premature withdrawal due to lack of efficacy or non-safety reasons and participants without dose reductions or interruptions during the first 99 study days. | Up to first 12 weeks of treatment | 
| Percentage of Participants With Very Rapid Virological Response, Rapid Virological Response, Complete Early Virological Response and Partial Early Virological Response (pEVR) During First 12 Weeks | Percentage of participants with very rapid virological response (VRVR) (defined as VR/UVR by study week 2), rapid virological response (RVR) (defined as VR/UVR by study week 4, but no VRVR), complete early virological response (cEVR) (defined as VR/UVR by study week 12, but no VRVR or RVR) and partial early virological response (pEVR) (defined as a 2 log10 drop of HCV RNA by study week 12, but no VRVR, RVR or cEVR) were reported. | Up to 12 weeks | 
| Percentage of Participants Achieving Extended (Rapid) Virological Response (eRVR) | Extended (rapid) virological response (eRVR) defined as UVR at weeks 4 and 12 for telaprevir, and as UVR at weeks 8 and 24 for boceprevir. | Up to 98 weeks | 
| Duration of Overall Treatment | Duration of overall treatment was defined as the time between first and last administration of any study drug, in weeks. | Up to 118 weeks | 
| Percentage of Participants Treated According to Label/Summary of Product Characteristics (SPC) |  | Up to 118 weeks | 
| Percentage of Participants Who Discontinued Treatment With PEG-IFN and Ribavirin (RBV) | Participants who prolonged the treatment period from 72 weeks were not reported. | Up to 72 weeks of treatment | 
| Percentage of Participants Who Discontinued Treatment With Direct-Acting Anti-viral (DAA) | Participants who prolonged the treatment period from 72 weeks were not reported. Participants who discontinued their treatment as planned were included. Here, number of participant analyzed is the total number of participants who received direct-acting anti-viral (DAA). | Up to 72 weeks of treatment | 
| Percentage of Participants With Concomitant Medical Condition at Baseline |  | Baseline | 
| Percentage of Participants With Adverse Events (AE) | An AE was defined as any adverse medical event that occurred after the participant used the investigational medicinal product (IMP) or other intervention behaviors specified by the protocol in the clinical trial regardless of relationship to the study treatment. | Up to 118 weeks |