Drug Utilization of Boceprevir and Clinical Management of Health Outcomes of Interest in Chronic Hepatitis C Participants (P08518)

Study Overview
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Brief Summary
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This is an observational prospective follow-up study to assess the utilization of boceprevir and the management of pre-specified health outcomes of interest (HOIs) under conditions of routine clinical care in participants with chronic hepatitis C (CHC) genotype 1. As an observational prospective study, this study is not intended to change the participant/physician relationship, nor influence the physician's drug prescription or therapeutic management of the participant. No individual administration of any therapeutic or prophylactic agent is assigned in this protocol, and there are no procedures required as part of this protocol. Physician choice of the drug used to treat the participant is based on clinical judgment alone.

Official Title
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An Observational Post-Authorization Safety Study (PASS) of Victrelis™ (Boceprevir) Among 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: Documented chronic hepatitis C (CHC) genotype-1 infection Untreated or failed previous therapy Initiated a new treatment regimen after the study implementation date at their site Agrees to participate in the study by giving written informed consent Exclusion Criteria: Taking part in a clinical trial or in any study where a participant is receiving care outside of normal clinical practice for Hepatitis C Virus (HCV)

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 |
| --- | --- |
| Boceprevir + PR<br>CHC genotype-1 participants included in study and prescribed boceprevir plus PR as routine clinical management. | |
| Telaprevir + PR<br>CHC genotype-1 participants included in study and prescribed telaprevir plus PR as routine clinical management. | |
| PR Alone<br>CHC genotype-1 participants included in study and prescribed PR alone as routine clinical management. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants Initiating Boceprevir Plus PR Treatment, Telaprevir Plus PR Treatment, or PR Treatment Alone (Drug Utilization Pattern) | The percentage of CHC participants initiating boceprevir plus PR treatment, telaprevir plus PR treatment, or PR treatment alone was determined from a Drug Utilization questionnaire that was administered to physicians using an electronic Case Report Form (eCRF) to collect site level information and reported with 95% confidence intervals. | Up to 37 months | 
| Baseline Characteristics of Participants Initiating Boceprevir Plus PR Treatment, Telaprevir Plus PR Treatment, or PR Treatment Alone: Weight | Baseline mean weight (standard deviation [SD]) in kilograms (Kg) was recorded from the eCRF. | Before initiation of CHC treatment (Week 0 baseline) | 
| Baseline Characteristics of Participants Initiating Boceprevir Plus PR Treatment, Telaprevir Plus PR Treatment, or PR Treatment Alone: Height | Baseline mean height (SD) in centimeters (cm) was recorded from the eCRF. | Before initiation of CHC treatment (Week 0 baseline) | 
| Baseline Characteristics of Participants Initiating Boceprevir Plus PR Treatment, Telaprevir Plus PR Treatment, or PR Treatment Alone: Body Mass Index (BMI) | Baseline mean body mass index (SD) in Kg/m^2 was recorded from the eCRF. | Before initiation of CHC treatment (Week 0 baseline) | 
| Baseline Disease Characteristics of Participants Initiating Boceprevir Plus PR Treatment, Telaprevir Plus PR Treatment, or PR Treatment Alone: Baseline Hepatitis C Virus (HCV) Genotype | Baseline HCV genotype was recorded from the eCRF and the number of participants who were 1a genotype, 1b genotype, or unknown/other was reported. | Before initiation of CHC treatment (Week 0 baseline) | 
| Baseline Disease Characteristics of Participants Initiating Boceprevir Plus PR Treatment, Telaprevir Plus PR Treatment, or PR Treatment Alone: Baseline Viral Load | Participant baseline HCV viral load was recorded from the eCRF and categorized as either Low (<800,000 IU/mL or <2,000,000 RNA copies/mL) or High (≥800,000 IU/mL or ≥2,000,000 RNA copies/mL). | Before initiation of CHC treatment (Week 0 baseline) | 
| Baseline Disease Characteristics of Participants Initiating Boceprevir Plus PR Treatment, Telaprevir Plus PR Treatment, or PR Treatment Alone: Baseline Grade for Child-Pugh Score | The Child-Pugh Score is used to determine the prognosis of chronic liver disease, in particular cirrhosis. It is classified into Classes A (best prognosis) to C (worst prognosis). Child-Pugh scores assessed within 3 months before CHC treatment regimen initiation were recorded from the eCRF, and the number of participants who were Grade A, Grade B, Grade C, not assessed, or unknown whether assessed were reported. | Before initiation of CHC treatment (Week 0 baseline) | 
| Percentage of Anemia Episodes Managed by at Least One Clinical Intervention | Anemia (hemoglobin <10 g/dL) was considered a Health Outcome of Interest (HOI) for this study. Clinical interventions used to manage episodes of anemia in participants could include erythropoiesis stimulating agent (ESA), blood transfusion, drug dose reduction, other treatment, and CHC treatment regimen modifications (drug dose reduction, drug discontinuation, and drug interruption). For this analysis, participants were categorized by CHC treatment group of exposure, and could successively be assigned to different treatment groups of exposure depending on their treatment regimen (treatment groups were not mutually exclusive). The percentage of anemia episodes that were managed by at least one intervention is reported for each CHC treatment exposure group with 95% confidence intervals. | Up to 48 weeks of a treatment regimen | 
| Percentage of Anemia Episodes Managed by Each Clinical Intervention Out of All Managed Anemia Episodes | Clinical interventions used to manage episodes of anemia in participants could include erythropoiesis stimulating agent (ESA), blood transfusion (BT), other treatment (OT), and CHC treatment regimen modifications including drug dose reduction (DDR), drug discontinuation (DD), and drug interruption (DI). Interventions could be used in combination (e.g. ESA plus blood transfusion) and more than one treatment modification could have been performed. For this analysis, participants were categorized by CHC treatment group of exposure, and could successively be assigned to different treatment groups of exposure depending on their treatment regimen (treatment groups were not mutually exclusive). For each CHC treatment exposure group, the percentage of anemia episodes managed by a particular intervention are reported out of the total number of managed anemia episodes with data available for that intervention (i.e. anemia episodes with missing data for an intervention were excluded). | Up to 48 weeks of a treatment regimen | 
| Percentage of Grade 3/4 Neutropenia Episodes Managed by at Least One Clinical Intervention | Grade 3/4 neutropenia (Grade 3: neutrophil count 0.5 - <0.75 × 10^9/L, Grade 4: <0.5 × 10^9/L) was considered a HOI for this study. Clinical interventions used to manage episodes of grade 3/4 neutropenia in participants could include Granulocyte colony-stimulating factor (G-CSF) use and CHC treatment regimen modifications (drug dose reduction, drug discontinuation, and drug interruption). For this analysis, participants were categorized by CHC treatment group of exposure, and could successively be assigned to different treatment groups of exposure depending on their treatment regimen (treatment groups were not mutually exclusive). The percentage of grade 3/4 neutropenia episodes that were managed by at least one intervention is reported for each CHC treatment exposure group with 95% confidence intervals. | Up to 48 weeks of a treatment regimen | 
| Percentage of Grade 3/4 Neutropenia Episodes Managed by Each Clinical Intervention Out of All Managed Episodes | Clinical interventions used to manage episodes of grade 3/4 neutropenia in participants could include Granulocyte colony-stimulating factor (G-CSF) use, other treatment (OT), and CHC treatment regimen modifications including drug dose reduction (DDR), drug discontinuation (DD), and drug interruption (DI). More than one treatment modification could have been performed. For this analysis, participants were categorized by CHC treatment group of exposure, and could successively be assigned to different treatment groups of exposure depending on their treatment regimen (treatment groups were not mutually exclusive). For each CHC treatment exposure group, the percentage of grade 3/4 neutropenia episodes managed by a particular intervention are reported out of the total number of managed grade 3/4 neutropenia episodes with data available for that intervention (i.e. grade 3/4 neutropenia episodes with missing data for an intervention were excluded). | Up to 48 weeks of a treatment regimen | 
| Percentage of Grade 3/4 Thrombocytopenia Episodes Managed by at Least One Clinical Intervention | Grade 3/4 thrombocytopenia (Grade 3: platelet count 25 - <50 × 10^9/L, Grade 4: <25 × 10^9/L) was considered a HOI for this study. Clinical interventions used to manage episodes of grade 3/4 thrombocytopenia in participants could include thrombopoietin, platelet transfusion, other treatment, and CHC treatment regimen modifications (drug dose reduction, drug discontinuation, and drug interruption). For this analysis, participants were categorized by CHC treatment group of exposure, and could successively be assigned to different treatment groups of exposure depending on their treatment regimen (treatment groups were not mutually exclusive). The percentage of grade 3/4 thrombocytopenia episodes that were managed by at least one intervention is reported for each CHC treatment exposure group with 95% confidence intervals. | Up to 48 weeks of a treatment regimen | 
| Percentage of Grade 3/4 Thrombocytopenia Episodes Managed by Each Clinical Intervention Out of All Managed Episodes | Clinical interventions used to manage episodes of grade 3/4 thrombocytopenia in participants could include thrombopoietin (TPO), platelet transfusion (PT), other treatment (OT) , and CHC treatment regimen modifications including drug dose reduction (DDR), drug discontinuation (DD), and drug interruption (DI). For this analysis, participants were categorized by CHC treatment group of exposure, and could successively be assigned to different treatment groups of exposure depending on their treatment regimen (treatment groups were not mutually exclusive). For each CHC treatment exposure group, the percentage of grade 3/4 thrombocytopenia episodes managed by a particular intervention are reported out of the total number of managed grade 3/4 thrombocytopenia episodes with data available for that intervention (i.e. grade 3/4 thrombocytopenia episodes with missing data for an intervention were excluded). | Up to 48 weeks of a treatment regimen | 
| Percentage of Serious Rash Episodes Managed by at Least One Clinical Intervention | Serious rash was considered a HOI for this study and included rash > 50% of body surface area, rash associated with significant systemic symptoms, or rash resulting in hospitalization or urgent care visit. Clinical interventions used to manage episodes of serious rash in participants could include topical corticosteroid use, intravenous (IV) and/or oral corticosteroids, emollients/moisturizers, antihistamines, other treatment, and CHC treatment regimen modifications (drug dose reduction, drug discontinuation, and drug interruption). For this analysis, participants were categorized by CHC treatment group of exposure, and could successively be assigned to different treatment groups of exposure depending on their treatment regimen (treatment groups were not mutually exclusive). The percentage of serious rash episodes that were managed by at least one intervention is reported for each CHC treatment exposure group with 95% confidence intervals. | Up to 48 weeks of a treatment regimen | 
| Percentage of Serious Rash Episodes Managed by Each Clinical Intervention Out of All Managed Episodes | Clinical interventions used to manage episodes of serious rash in participants could include topical corticosteroid (TC), intravenous (IV) and/or oral (PO) corticosteroids (IV/PO CS), emollients/moisturizers (E/M), antihistamines (AH), other treatment (OT), and CHC treatment regimen modifications including drug dose reduction (DDR), drug discontinuation (DD), and drug interruption (DI). For this analysis, participants were categorized by CHC treatment group of exposure, and could successively be assigned to different treatment groups of exposure depending on their treatment regimen (treatment groups were not mutually exclusive). For each CHC treatment exposure group, the percentage of serious rash episodes managed by a particular intervention are reported out of the total number of managed serious rash episodes with data available for that intervention (i.e. serious rash episodes with missing data for an intervention were excluded). | Up to 48 weeks of a treatment regimen | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Anemia, Grade 3/4 Neutropenia, Grade 3/4 Thrombocytopenia, and Serious Skin Rash | The incidence (events per 1000 participant-days) of the protocol-defined HOIs (anemia, grade 3/4 neutropenia, grade 3/4 thrombocytopenia, and serious skin rash) was calculated over the 48-week period following the start of CHC treatment exposure. All protocol-defined HOIs were taken into account (serious and non-serious HOIs). For this analysis, participants were categorized by CHC treatment group of exposure, and could successively be assigned to different treatment groups of exposure depending on their treatment regimen (treatment groups were not mutually exclusive). The incidence per 1000 participant-days of anemia, grade 3/4 neutropenia, grade 3/4 thrombocytopenia, and serious skin rash were reported by CHC treatment group of exposure with 95% confidence intervals. | Up to 48 weeks of treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pegylated Interferon, boceprevir, telaprevir