An Observational Post-Authorization Safety Study (PASS) of Victrelis™ (Boceprevir) Among Chronic Hepatitis C Patients

Baseline Disease Characteristics of Participants Initiating Boceprevir Plus PR Treatment, Telaprevir Plus PR Treatment, or PR Treatment Alone: Baseline Hepatitis C Virus (HCV) Genotype

时间窗: Before initiation of CHC treatment (Week 0 baseline)

Baseline HCV genotype was recorded from the eCRF and the number of participants who were 1a genotype, 1b genotype, or unknown/other was reported.

Baseline Characteristics of Participants Initiating Boceprevir Plus PR Treatment, Telaprevir Plus PR Treatment, or PR Treatment Alone: Body Mass Index (BMI)

时间窗: Before initiation of CHC treatment (Week 0 baseline)

Baseline mean body mass index (SD) in Kg/m\^2 was recorded from the eCRF.

Baseline Disease Characteristics of Participants Initiating Boceprevir Plus PR Treatment, Telaprevir Plus PR Treatment, or PR Treatment Alone: Baseline Viral Load

时间窗: Before initiation of CHC treatment (Week 0 baseline)

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).

Percentage of Participants Initiating Boceprevir Plus PR Treatment, Telaprevir Plus PR Treatment, or PR Treatment Alone (Drug Utilization Pattern)

时间窗: Up to 37 months

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.

Baseline Characteristics of Participants Initiating Boceprevir Plus PR Treatment, Telaprevir Plus PR Treatment, or PR Treatment Alone: Weight

时间窗: Before initiation of CHC treatment (Week 0 baseline)

Baseline mean weight (standard deviation \[SD\]) in kilograms (Kg) was recorded from the eCRF.

Baseline Disease Characteristics of Participants Initiating Boceprevir Plus PR Treatment, Telaprevir Plus PR Treatment, or PR Treatment Alone: Baseline Grade for Child-Pugh Score

时间窗: Before initiation of CHC treatment (Week 0 baseline)

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.

Percentage of Anemia Episodes Managed by at Least One Clinical Intervention

时间窗: Up to 48 weeks of a treatment regimen

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.

Baseline Characteristics of Participants Initiating Boceprevir Plus PR Treatment, Telaprevir Plus PR Treatment, or PR Treatment Alone: Height

时间窗: Before initiation of CHC treatment (Week 0 baseline)

Baseline mean height (SD) in centimeters (cm) was recorded from the eCRF.

Percentage of Grade 3/4 Neutropenia Episodes Managed by Each Clinical Intervention Out of All Managed Episodes

时间窗: Up to 48 weeks of a treatment regimen

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).

Percentage of Serious Rash Episodes Managed by at Least One Clinical Intervention

时间窗: Up to 48 weeks of a treatment regimen

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.

Percentage of Anemia Episodes Managed by Each Clinical Intervention Out of All Managed Anemia Episodes

时间窗: Up to 48 weeks of a treatment regimen

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).

Percentage of Grade 3/4 Thrombocytopenia Episodes Managed by at Least One Clinical Intervention

时间窗: Up to 48 weeks of a treatment regimen

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.

Percentage of Grade 3/4 Thrombocytopenia Episodes Managed by Each Clinical Intervention Out of All Managed Episodes

时间窗: Up to 48 weeks of a treatment regimen

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).

Percentage of Serious Rash Episodes Managed by Each Clinical Intervention Out of All Managed Episodes

时间窗: Up to 48 weeks of a treatment regimen

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).

Percentage of Grade 3/4 Neutropenia Episodes Managed by at Least One Clinical Intervention

时间窗: Up to 48 weeks of a treatment regimen

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.