Hepatitis C Chronic
Conditions
Keywords
Pegylated Interferon, boceprevir, telaprevir
Brief summary
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.
Interventions
None listed
Sponsors
Merck Sharp & Dohme LLC
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Serious Rash Episodes Managed by Each Clinical Intervention Out of All Managed Episodes | 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). |
| Baseline Characteristics of Participants Initiating Boceprevir Plus PR Treatment, Telaprevir Plus PR Treatment, or PR Treatment Alone: Height | Before initiation of CHC treatment (Week 0 baseline) | Baseline mean height (SD) in centimeters (cm) was recorded from the eCRF. |
| Percentage of Participants Initiating Boceprevir Plus PR Treatment, Telaprevir Plus PR Treatment, or PR Treatment Alone (Drug Utilization Pattern) | 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 | Before initiation of CHC treatment (Week 0 baseline) | Baseline mean weight (standard deviation \[SD\]) in kilograms (Kg) was recorded from the eCRF. |
| Baseline Characteristics of Participants Initiating Boceprevir Plus PR Treatment, Telaprevir Plus PR Treatment, or PR Treatment Alone: Body Mass Index (BMI) | 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 Hepatitis C Virus (HCV) Genotype | 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 Disease Characteristics of Participants Initiating Boceprevir Plus PR Treatment, Telaprevir Plus PR Treatment, or PR Treatment Alone: Baseline Viral Load | 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). |
| Baseline Disease Characteristics of Participants Initiating Boceprevir Plus PR Treatment, Telaprevir Plus PR Treatment, or PR Treatment Alone: Baseline Grade for Child-Pugh Score | 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 | 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. |
| Percentage of Anemia Episodes Managed by Each Clinical Intervention Out of All Managed Anemia Episodes | 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 Neutropenia Episodes Managed by at Least One Clinical Intervention | 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. |
| Percentage of Grade 3/4 Neutropenia Episodes Managed by Each Clinical Intervention Out of All Managed Episodes | 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 Grade 3/4 Thrombocytopenia Episodes Managed by at Least One Clinical Intervention | 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 | 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 at Least One Clinical Intervention | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Anemia, Grade 3/4 Neutropenia, Grade 3/4 Thrombocytopenia, and Serious Skin Rash | Up to 48 weeks of treatment | 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. |
Participant flow
Pre-assignment details
Of 713 Chronic Hepatitis C (CHC) participants included in the study, 679 were included in the Analysis Population and 34 were excluded. The Analysis Population comprised participants receiving Boceprevir plus peginterferon and ribavirin (PR), Telaprevir plus PR, or PR alone.
Participants by arm
| Arm | Count |
|---|---|
| Boceprevir + PR CHC genotype-1 participants included in study and prescribed boceprevir plus PR as routine clinical management. | 298 |
| Telaprevir + PR CHC genotype-1 participants included in study and prescribed telaprevir plus PR as routine clinical management. | 307 |
| PR Alone CHC genotype-1 participants included in study and prescribed PR alone as routine clinical management | 74 |
| Total | 679 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Analysis Population | Bad Tolerance to Treatment | 0 | 0 | 2 | 0 |
| Analysis Population | Did Not Meet Inclusion Criteria | 0 | 0 | 3 | 0 |
| Analysis Population | Effectiveness Reason | 0 | 48 | 29 | 12 |
| Analysis Population | Intolerance | 0 | 1 | 0 | 0 |
| Analysis Population | Liver Transplantation | 0 | 0 | 1 | 0 |
| Analysis Population | Lost to Follow-up | 0 | 6 | 6 | 5 |
| Analysis Population | New Contraindication-Alcohol Abuse | 0 | 0 | 0 | 1 |
| Analysis Population | No Social Insurance | 0 | 0 | 1 | 0 |
| Analysis Population | Participant in Jail | 0 | 0 | 1 | 0 |
| Analysis Population | Participant Refuses to Continue Study | 0 | 15 | 17 | 4 |
| Analysis Population | Physician Decision | 0 | 13 | 10 | 9 |
| Analysis Population | Poor Adherence | 0 | 0 | 1 | 0 |
| Analysis Population | Poor Participant Compliance | 0 | 1 | 0 | 0 |
| Analysis Population | Programmed Surgery | 0 | 1 | 0 | 0 |
| Analysis Population | Safety Reason | 0 | 33 | 31 | 8 |
| Screening/Eligibility | Eligibility Criteria Not Met | 33 | 0 | 0 | 0 |
| Screening/Eligibility | Initiated Different CHC Treatment | 1 | 0 | 0 | 0 |
Baseline characteristics
| Characteristic | Boceprevir + PR | Telaprevir + PR | PR Alone | Total |
|---|---|---|---|---|
| Age, Continuous | 51.4 years STANDARD_DEVIATION 10.3 | 50.1 years STANDARD_DEVIATION 10.9 | 46.3 years STANDARD_DEVIATION 11.6 | 50.3 years STANDARD_DEVIATION 10.8 |
| Sex: Female, Male Female | 113 Participants | 102 Participants | 25 Participants | 240 Participants |
| Sex: Female, Male Male | 185 Participants | 205 Participants | 49 Participants | 439 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 178 / 298 | 173 / 307 | 25 / 74 |
| serious Total, serious adverse events | 58 / 298 | 50 / 307 | 8 / 74 |
Outcome results
Primary
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.
Time frame: Before initiation of CHC treatment (Week 0 baseline)
Population: Participants in the Analysis Population (all CHC genotype-1 participants included in study meeting eligibility criteria and receiving boceprevir plus peginterferon and ribavirin (PR), telaprevir plus PR, or PR alone) with available demographic data (BMI).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| All Included Participants | Baseline Characteristics of Participants Initiating Boceprevir Plus PR Treatment, Telaprevir Plus PR Treatment, or PR Treatment Alone: Body Mass Index (BMI) | 26.5 Kg/m^2 | Standard Deviation 5.1 |
| Telaprevir + PR | Baseline Characteristics of Participants Initiating Boceprevir Plus PR Treatment, Telaprevir Plus PR Treatment, or PR Treatment Alone: Body Mass Index (BMI) | 26.5 Kg/m^2 | Standard Deviation 4.8 |
| PR Alone | Baseline Characteristics of Participants Initiating Boceprevir Plus PR Treatment, Telaprevir Plus PR Treatment, or PR Treatment Alone: Body Mass Index (BMI) | 24.7 Kg/m^2 | Standard Deviation 4.2 |
Primary
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.
Time frame: Before initiation of CHC treatment (Week 0 baseline)
Population: Participants in the Analysis Population (all CHC genotype-1 participants included in study meeting eligibility criteria and receiving boceprevir plus peginterferon and ribavirin (PR), telaprevir plus PR, or PR alone) with available demographic data (height).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| All Included Participants | Baseline Characteristics of Participants Initiating Boceprevir Plus PR Treatment, Telaprevir Plus PR Treatment, or PR Treatment Alone: Height | 170.8 centimeters | Standard Deviation 9.8 |
| Telaprevir + PR | Baseline Characteristics of Participants Initiating Boceprevir Plus PR Treatment, Telaprevir Plus PR Treatment, or PR Treatment Alone: Height | 170.8 centimeters | Standard Deviation 8.8 |
| PR Alone | Baseline Characteristics of Participants Initiating Boceprevir Plus PR Treatment, Telaprevir Plus PR Treatment, or PR Treatment Alone: Height | 171.0 centimeters | Standard Deviation 7.5 |
Primary
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.
Time frame: Before initiation of CHC treatment (Week 0 baseline)
Population: Participants in the Analysis Population (all CHC genotype-1 participants included in study meeting eligibility criteria and receiving boceprevir plus peginterferon and ribavirin (PR), telaprevir plus PR, or PR alone) with available demographic data (weight).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| All Included Participants | Baseline Characteristics of Participants Initiating Boceprevir Plus PR Treatment, Telaprevir Plus PR Treatment, or PR Treatment Alone: Weight | 77.7 kilograms (Kg) | Standard Deviation 17.4 |
| Telaprevir + PR | Baseline Characteristics of Participants Initiating Boceprevir Plus PR Treatment, Telaprevir Plus PR Treatment, or PR Treatment Alone: Weight | 77.0 kilograms (Kg) | Standard Deviation 15.5 |
| PR Alone | Baseline Characteristics of Participants Initiating Boceprevir Plus PR Treatment, Telaprevir Plus PR Treatment, or PR Treatment Alone: Weight | 71.7 kilograms (Kg) | Standard Deviation 13.7 |
Primary
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.
Time frame: Before initiation of CHC treatment (Week 0 baseline)
Population: Participants in the Analysis Population (all CHC genotype-1 participants included in study meeting eligibility criteria and receiving boceprevir plus peginterferon and ribavirin (PR), telaprevir plus PR, or PR alone) with available demographic data (Child Pugh score).
| Arm | Measure | Group | Value (NUMBER) | Dispersion |
|---|---|---|---|---|
| All Included Participants | Baseline Disease Characteristics of Participants Initiating Boceprevir Plus PR Treatment, Telaprevir Plus PR Treatment, or PR Treatment Alone: Baseline Grade for Child-Pugh Score | Not Assessed | 169 participants | — |
| All Included Participants | Baseline Disease Characteristics of Participants Initiating Boceprevir Plus PR Treatment, Telaprevir Plus PR Treatment, or PR Treatment Alone: Baseline Grade for Child-Pugh Score | Grade C | 0 participants | — |
| All Included Participants | Baseline Disease Characteristics of Participants Initiating Boceprevir Plus PR Treatment, Telaprevir Plus PR Treatment, or PR Treatment Alone: Baseline Grade for Child-Pugh Score | Grade A | 97 participants | 5.1 |
| All Included Participants | Baseline Disease Characteristics of Participants Initiating Boceprevir Plus PR Treatment, Telaprevir Plus PR Treatment, or PR Treatment Alone: Baseline Grade for Child-Pugh Score | Grade B | 1 participants | — |
| All Included Participants | Baseline Disease Characteristics of Participants Initiating Boceprevir Plus PR Treatment, Telaprevir Plus PR Treatment, or PR Treatment Alone: Baseline Grade for Child-Pugh Score | Unknown whether assessed | 31 participants | — |
| Telaprevir + PR | Baseline Disease Characteristics of Participants Initiating Boceprevir Plus PR Treatment, Telaprevir Plus PR Treatment, or PR Treatment Alone: Baseline Grade for Child-Pugh Score | Grade C | 0 participants | — |
| Telaprevir + PR | Baseline Disease Characteristics of Participants Initiating Boceprevir Plus PR Treatment, Telaprevir Plus PR Treatment, or PR Treatment Alone: Baseline Grade for Child-Pugh Score | Grade A | 61 participants | 4.8 |
| Telaprevir + PR | Baseline Disease Characteristics of Participants Initiating Boceprevir Plus PR Treatment, Telaprevir Plus PR Treatment, or PR Treatment Alone: Baseline Grade for Child-Pugh Score | Grade B | 3 participants | — |
| Telaprevir + PR | Baseline Disease Characteristics of Participants Initiating Boceprevir Plus PR Treatment, Telaprevir Plus PR Treatment, or PR Treatment Alone: Baseline Grade for Child-Pugh Score | Not Assessed | 203 participants | — |
| Telaprevir + PR | Baseline Disease Characteristics of Participants Initiating Boceprevir Plus PR Treatment, Telaprevir Plus PR Treatment, or PR Treatment Alone: Baseline Grade for Child-Pugh Score | Unknown whether assessed | 40 participants | — |
| PR Alone | Baseline Disease Characteristics of Participants Initiating Boceprevir Plus PR Treatment, Telaprevir Plus PR Treatment, or PR Treatment Alone: Baseline Grade for Child-Pugh Score | Unknown whether assessed | 5 participants | — |
| PR Alone | Baseline Disease Characteristics of Participants Initiating Boceprevir Plus PR Treatment, Telaprevir Plus PR Treatment, or PR Treatment Alone: Baseline Grade for Child-Pugh Score | Not Assessed | 39 participants | — |
| PR Alone | Baseline Disease Characteristics of Participants Initiating Boceprevir Plus PR Treatment, Telaprevir Plus PR Treatment, or PR Treatment Alone: Baseline Grade for Child-Pugh Score | Grade A | 30 participants | 4.2 |
| PR Alone | Baseline Disease Characteristics of Participants Initiating Boceprevir Plus PR Treatment, Telaprevir Plus PR Treatment, or PR Treatment Alone: Baseline Grade for Child-Pugh Score | Grade C | 0 participants | — |
| PR Alone | Baseline Disease Characteristics of Participants Initiating Boceprevir Plus PR Treatment, Telaprevir Plus PR Treatment, or PR Treatment Alone: Baseline Grade for Child-Pugh Score | Grade B | 0 participants | — |
Primary
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.
Time frame: Before initiation of CHC treatment (Week 0 baseline)
Population: Participants in the Analysis Population (all CHC genotype-1 participants included in study meeting eligibility criteria and receiving boceprevir plus peginterferon and ribavirin (PR), telaprevir plus PR, or PR alone) with available demographic data (HCV genotype).
| Arm | Measure | Group | Value (NUMBER) | Dispersion |
|---|---|---|---|---|
| All Included Participants | Baseline Disease Characteristics of Participants Initiating Boceprevir Plus PR Treatment, Telaprevir Plus PR Treatment, or PR Treatment Alone: Baseline Hepatitis C Virus (HCV) Genotype | Unknown/Other | 44 participants | — |
| All Included Participants | Baseline Disease Characteristics of Participants Initiating Boceprevir Plus PR Treatment, Telaprevir Plus PR Treatment, or PR Treatment Alone: Baseline Hepatitis C Virus (HCV) Genotype | 1b genotype | 147 participants | — |
| All Included Participants | Baseline Disease Characteristics of Participants Initiating Boceprevir Plus PR Treatment, Telaprevir Plus PR Treatment, or PR Treatment Alone: Baseline Hepatitis C Virus (HCV) Genotype | 1a genotype | 107 participants | 5.1 |
| Telaprevir + PR | Baseline Disease Characteristics of Participants Initiating Boceprevir Plus PR Treatment, Telaprevir Plus PR Treatment, or PR Treatment Alone: Baseline Hepatitis C Virus (HCV) Genotype | Unknown/Other | 39 participants | — |
| Telaprevir + PR | Baseline Disease Characteristics of Participants Initiating Boceprevir Plus PR Treatment, Telaprevir Plus PR Treatment, or PR Treatment Alone: Baseline Hepatitis C Virus (HCV) Genotype | 1a genotype | 120 participants | 4.8 |
| Telaprevir + PR | Baseline Disease Characteristics of Participants Initiating Boceprevir Plus PR Treatment, Telaprevir Plus PR Treatment, or PR Treatment Alone: Baseline Hepatitis C Virus (HCV) Genotype | 1b genotype | 148 participants | — |
| PR Alone | Baseline Disease Characteristics of Participants Initiating Boceprevir Plus PR Treatment, Telaprevir Plus PR Treatment, or PR Treatment Alone: Baseline Hepatitis C Virus (HCV) Genotype | Unknown/Other | 11 participants | — |
| PR Alone | Baseline Disease Characteristics of Participants Initiating Boceprevir Plus PR Treatment, Telaprevir Plus PR Treatment, or PR Treatment Alone: Baseline Hepatitis C Virus (HCV) Genotype | 1b genotype | 30 participants | — |
| PR Alone | Baseline Disease Characteristics of Participants Initiating Boceprevir Plus PR Treatment, Telaprevir Plus PR Treatment, or PR Treatment Alone: Baseline Hepatitis C Virus (HCV) Genotype | 1a genotype | 33 participants | 4.2 |
Primary
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).
Time frame: Before initiation of CHC treatment (Week 0 baseline)
Population: Participants in the Analysis Population (all CHC genotype-1 participants included in study meeting eligibility criteria and receiving boceprevir plus peginterferon and ribavirin (PR), telaprevir plus PR, or PR alone) with available demographic data (viral load).
| Arm | Measure | Group | Value (NUMBER) | Dispersion |
|---|---|---|---|---|
| All Included Participants | Baseline Disease Characteristics of Participants Initiating Boceprevir Plus PR Treatment, Telaprevir Plus PR Treatment, or PR Treatment Alone: Baseline Viral Load | High (≥800,000 IU/mL) | 182 participants | — |
| All Included Participants | Baseline Disease Characteristics of Participants Initiating Boceprevir Plus PR Treatment, Telaprevir Plus PR Treatment, or PR Treatment Alone: Baseline Viral Load | Low (<800,000 IU/mL) | 101 participants | 5.1 |
| All Included Participants | Baseline Disease Characteristics of Participants Initiating Boceprevir Plus PR Treatment, Telaprevir Plus PR Treatment, or PR Treatment Alone: Baseline Viral Load | Unavailable | 15 participants | — |
| Telaprevir + PR | Baseline Disease Characteristics of Participants Initiating Boceprevir Plus PR Treatment, Telaprevir Plus PR Treatment, or PR Treatment Alone: Baseline Viral Load | High (≥800,000 IU/mL) | 197 participants | — |
| Telaprevir + PR | Baseline Disease Characteristics of Participants Initiating Boceprevir Plus PR Treatment, Telaprevir Plus PR Treatment, or PR Treatment Alone: Baseline Viral Load | Low (<800,000 IU/mL) | 94 participants | 4.8 |
| Telaprevir + PR | Baseline Disease Characteristics of Participants Initiating Boceprevir Plus PR Treatment, Telaprevir Plus PR Treatment, or PR Treatment Alone: Baseline Viral Load | Unavailable | 16 participants | — |
| PR Alone | Baseline Disease Characteristics of Participants Initiating Boceprevir Plus PR Treatment, Telaprevir Plus PR Treatment, or PR Treatment Alone: Baseline Viral Load | Low (<800,000 IU/mL) | 35 participants | 4.2 |
| PR Alone | Baseline Disease Characteristics of Participants Initiating Boceprevir Plus PR Treatment, Telaprevir Plus PR Treatment, or PR Treatment Alone: Baseline Viral Load | Unavailable | 0 participants | — |
| PR Alone | Baseline Disease Characteristics of Participants Initiating Boceprevir Plus PR Treatment, Telaprevir Plus PR Treatment, or PR Treatment Alone: Baseline Viral Load | High (≥800,000 IU/mL) | 39 participants | — |
Primary
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.
Time frame: Up to 48 weeks of a treatment regimen
Population: Participants in the Analysis Population (all CHC genotype-1 participants included on study meeting eligibility criteria and treated with boceprevir plus PR, telaprevir plus PR, or PR alone) who experienced at least one episode of anemia. Participants categorized by treatment group of exposure (further described in Arm Description).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| All Included Participants | Percentage of Anemia Episodes Managed by at Least One Clinical Intervention | % Episodes with ≥1 intervention implemented | 79.3 percentage of episodes |
| All Included Participants | Percentage of Anemia Episodes Managed by at Least One Clinical Intervention | % Episodes with no intervention implemented | 20.7 percentage of episodes |
| Telaprevir + PR | Percentage of Anemia Episodes Managed by at Least One Clinical Intervention | % Episodes with no intervention implemented | 27.5 percentage of episodes |
| Telaprevir + PR | Percentage of Anemia Episodes Managed by at Least One Clinical Intervention | % Episodes with ≥1 intervention implemented | 72.5 percentage of episodes |
| PR Alone | Percentage of Anemia Episodes Managed by at Least One Clinical Intervention | % Episodes with no intervention implemented | 30.1 percentage of episodes |
| PR Alone | Percentage of Anemia Episodes Managed by at Least One Clinical Intervention | % Episodes with ≥1 intervention implemented | 69.9 percentage of episodes |
| PR + Boceprevir + Telaprevir Group of Exposure | Percentage of Anemia Episodes Managed by at Least One Clinical Intervention | % Episodes with no intervention implemented | 25.0 percentage of episodes |
| PR + Boceprevir + Telaprevir Group of Exposure | Percentage of Anemia Episodes Managed by at Least One Clinical Intervention | % Episodes with ≥1 intervention implemented | 75.0 percentage of episodes |
Primary
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).
Time frame: Up to 48 weeks of a treatment regimen
Population: Participants in the Analysis Population (all CHC genotype-1 participants included on study meeting eligibility criteria and treated with boceprevir plus PR, telaprevir plus PR, or PR alone) who experienced at least one episode of anemia. Participants categorized by treatment group of exposure (further described in Arm Description).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| All Included Participants | Percentage of Anemia Episodes Managed by Each Clinical Intervention Out of All Managed Anemia Episodes | BT (managed episodes=21, 125, 115, 3) | 52.4 percentage of episodes |
| All Included Participants | Percentage of Anemia Episodes Managed by Each Clinical Intervention Out of All Managed Anemia Episodes | DI (managed episodes=19, 111, 91, 3) | 15.8 percentage of episodes |
| All Included Participants | Percentage of Anemia Episodes Managed by Each Clinical Intervention Out of All Managed Anemia Episodes | DDR (managed episodes=19, 111, 91, 3) | 100.0 percentage of episodes |
| All Included Participants | Percentage of Anemia Episodes Managed by Each Clinical Intervention Out of All Managed Anemia Episodes | DD (managed episodes=19, 111, 91, 3) | 26.3 percentage of episodes |
| All Included Participants | Percentage of Anemia Episodes Managed by Each Clinical Intervention Out of All Managed Anemia Episodes | ESA (managed episodes=21, 124, 114, 3) | 52.4 percentage of episodes |
| All Included Participants | Percentage of Anemia Episodes Managed by Each Clinical Intervention Out of All Managed Anemia Episodes | OT (managed episodes=22, 127, 115, 3) | 9.1 percentage of episodes |
| Telaprevir + PR | Percentage of Anemia Episodes Managed by Each Clinical Intervention Out of All Managed Anemia Episodes | DD (managed episodes=19, 111, 91, 3) | 11.7 percentage of episodes |
| Telaprevir + PR | Percentage of Anemia Episodes Managed by Each Clinical Intervention Out of All Managed Anemia Episodes | DI (managed episodes=19, 111, 91, 3) | 3.6 percentage of episodes |
| Telaprevir + PR | Percentage of Anemia Episodes Managed by Each Clinical Intervention Out of All Managed Anemia Episodes | BT (managed episodes=21, 125, 115, 3) | 20.0 percentage of episodes |
| Telaprevir + PR | Percentage of Anemia Episodes Managed by Each Clinical Intervention Out of All Managed Anemia Episodes | OT (managed episodes=22, 127, 115, 3) | 8.7 percentage of episodes |
| Telaprevir + PR | Percentage of Anemia Episodes Managed by Each Clinical Intervention Out of All Managed Anemia Episodes | DDR (managed episodes=19, 111, 91, 3) | 92.8 percentage of episodes |
| Telaprevir + PR | Percentage of Anemia Episodes Managed by Each Clinical Intervention Out of All Managed Anemia Episodes | ESA (managed episodes=21, 124, 114, 3) | 46.0 percentage of episodes |
| PR Alone | Percentage of Anemia Episodes Managed by Each Clinical Intervention Out of All Managed Anemia Episodes | DI (managed episodes=19, 111, 91, 3) | 5.5 percentage of episodes |
| PR Alone | Percentage of Anemia Episodes Managed by Each Clinical Intervention Out of All Managed Anemia Episodes | BT (managed episodes=21, 125, 115, 3) | 24.3 percentage of episodes |
| PR Alone | Percentage of Anemia Episodes Managed by Each Clinical Intervention Out of All Managed Anemia Episodes | DDR (managed episodes=19, 111, 91, 3) | 95.6 percentage of episodes |
| PR Alone | Percentage of Anemia Episodes Managed by Each Clinical Intervention Out of All Managed Anemia Episodes | ESA (managed episodes=21, 124, 114, 3) | 43.9 percentage of episodes |
| PR Alone | Percentage of Anemia Episodes Managed by Each Clinical Intervention Out of All Managed Anemia Episodes | DD (managed episodes=19, 111, 91, 3) | 5.5 percentage of episodes |
| PR Alone | Percentage of Anemia Episodes Managed by Each Clinical Intervention Out of All Managed Anemia Episodes | OT (managed episodes=22, 127, 115, 3) | 2.6 percentage of episodes |
| PR + Boceprevir + Telaprevir Group of Exposure | Percentage of Anemia Episodes Managed by Each Clinical Intervention Out of All Managed Anemia Episodes | DI (managed episodes=19, 111, 91, 3) | 33.3 percentage of episodes |
| PR + Boceprevir + Telaprevir Group of Exposure | Percentage of Anemia Episodes Managed by Each Clinical Intervention Out of All Managed Anemia Episodes | ESA (managed episodes=21, 124, 114, 3) | 66.7 percentage of episodes |
| PR + Boceprevir + Telaprevir Group of Exposure | Percentage of Anemia Episodes Managed by Each Clinical Intervention Out of All Managed Anemia Episodes | BT (managed episodes=21, 125, 115, 3) | 33.3 percentage of episodes |
| PR + Boceprevir + Telaprevir Group of Exposure | Percentage of Anemia Episodes Managed by Each Clinical Intervention Out of All Managed Anemia Episodes | OT (managed episodes=22, 127, 115, 3) | 33.3 percentage of episodes |
| PR + Boceprevir + Telaprevir Group of Exposure | Percentage of Anemia Episodes Managed by Each Clinical Intervention Out of All Managed Anemia Episodes | DDR (managed episodes=19, 111, 91, 3) | 66.7 percentage of episodes |
| PR + Boceprevir + Telaprevir Group of Exposure | Percentage of Anemia Episodes Managed by Each Clinical Intervention Out of All Managed Anemia Episodes | DD (managed episodes=19, 111, 91, 3) | 0.0 percentage of episodes |
Primary
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.
Time frame: Up to 48 weeks of a treatment regimen
Population: Participants in the Analysis Population (all CHC genotype-1 participants included on study meeting eligibility criteria and treated with boceprevir plus PR, telaprevir plus PR, or PR alone) who experienced at least one episode of grade 3/4 neutropenia. Participants categorized by treatment group of exposure (further described in Arm Description).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| All Included Participants | Percentage of Grade 3/4 Neutropenia Episodes Managed by at Least One Clinical Intervention | % Episodes with no intervention implemented | 63.3 percentage of episodes |
| All Included Participants | Percentage of Grade 3/4 Neutropenia Episodes Managed by at Least One Clinical Intervention | % Episodes with ≥1 intervention implemented | 36.7 percentage of episodes |
| Telaprevir + PR | Percentage of Grade 3/4 Neutropenia Episodes Managed by at Least One Clinical Intervention | % Episodes with ≥1 intervention implemented | 33.6 percentage of episodes |
| Telaprevir + PR | Percentage of Grade 3/4 Neutropenia Episodes Managed by at Least One Clinical Intervention | % Episodes with no intervention implemented | 66.4 percentage of episodes |
| PR Alone | Percentage of Grade 3/4 Neutropenia Episodes Managed by at Least One Clinical Intervention | % Episodes with ≥1 intervention implemented | 18.5 percentage of episodes |
| PR Alone | Percentage of Grade 3/4 Neutropenia Episodes Managed by at Least One Clinical Intervention | % Episodes with no intervention implemented | 81.5 percentage of episodes |
| PR + Boceprevir + Telaprevir Group of Exposure | Percentage of Grade 3/4 Neutropenia Episodes Managed by at Least One Clinical Intervention | % Episodes with no intervention implemented | 100.0 percentage of episodes |
| PR + Boceprevir + Telaprevir Group of Exposure | Percentage of Grade 3/4 Neutropenia Episodes Managed by at Least One Clinical Intervention | % Episodes with ≥1 intervention implemented | 0.0 percentage of episodes |
Primary
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).
Time frame: Up to 48 weeks of a treatment regimen
Population: Participants in the Analysis Population (all CHC genotype-1 participants included on study meeting eligibility criteria and treated with boceprevir plus PR, telaprevir plus PR, or PR alone) who experienced at least one episode of grade 3/4 neutropenia. Participants categorized by treatment group of exposure (further described in Arm Description).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| All Included Participants | Percentage of Grade 3/4 Neutropenia Episodes Managed by Each Clinical Intervention Out of All Managed Episodes | DD (managed episodes=8, 24, 5, 0) | 25.0 percentage of episodes |
| All Included Participants | Percentage of Grade 3/4 Neutropenia Episodes Managed by Each Clinical Intervention Out of All Managed Episodes | OT (managed episodes=10, 39, 11, 0) | 0.0 percentage of episodes |
| All Included Participants | Percentage of Grade 3/4 Neutropenia Episodes Managed by Each Clinical Intervention Out of All Managed Episodes | DI (managed episodes=8, 24, 5, 0) | 25.0 percentage of episodes |
| All Included Participants | Percentage of Grade 3/4 Neutropenia Episodes Managed by Each Clinical Intervention Out of All Managed Episodes | DDR (managed episodes=8, 24, 5, 0) | 87.5 percentage of episodes |
| All Included Participants | Percentage of Grade 3/4 Neutropenia Episodes Managed by Each Clinical Intervention Out of All Managed Episodes | G-CSF (managed episodes=11, 39, 12, 0) | 27.3 percentage of episodes |
| Telaprevir + PR | Percentage of Grade 3/4 Neutropenia Episodes Managed by Each Clinical Intervention Out of All Managed Episodes | DDR (managed episodes=8, 24, 5, 0) | 87.5 percentage of episodes |
| Telaprevir + PR | Percentage of Grade 3/4 Neutropenia Episodes Managed by Each Clinical Intervention Out of All Managed Episodes | DD (managed episodes=8, 24, 5, 0) | 12.5 percentage of episodes |
| Telaprevir + PR | Percentage of Grade 3/4 Neutropenia Episodes Managed by Each Clinical Intervention Out of All Managed Episodes | DI (managed episodes=8, 24, 5, 0) | 8.3 percentage of episodes |
| Telaprevir + PR | Percentage of Grade 3/4 Neutropenia Episodes Managed by Each Clinical Intervention Out of All Managed Episodes | OT (managed episodes=10, 39, 11, 0) | 0.0 percentage of episodes |
| Telaprevir + PR | Percentage of Grade 3/4 Neutropenia Episodes Managed by Each Clinical Intervention Out of All Managed Episodes | G-CSF (managed episodes=11, 39, 12, 0) | 46.2 percentage of episodes |
| PR Alone | Percentage of Grade 3/4 Neutropenia Episodes Managed by Each Clinical Intervention Out of All Managed Episodes | DDR (managed episodes=8, 24, 5, 0) | 80.0 percentage of episodes |
| PR Alone | Percentage of Grade 3/4 Neutropenia Episodes Managed by Each Clinical Intervention Out of All Managed Episodes | G-CSF (managed episodes=11, 39, 12, 0) | 75.0 percentage of episodes |
| PR Alone | Percentage of Grade 3/4 Neutropenia Episodes Managed by Each Clinical Intervention Out of All Managed Episodes | OT (managed episodes=10, 39, 11, 0) | 0.0 percentage of episodes |
| PR Alone | Percentage of Grade 3/4 Neutropenia Episodes Managed by Each Clinical Intervention Out of All Managed Episodes | DD (managed episodes=8, 24, 5, 0) | 0.0 percentage of episodes |
| PR Alone | Percentage of Grade 3/4 Neutropenia Episodes Managed by Each Clinical Intervention Out of All Managed Episodes | DI (managed episodes=8, 24, 5, 0) | 20.0 percentage of episodes |
| PR + Boceprevir + Telaprevir Group of Exposure | Percentage of Grade 3/4 Neutropenia Episodes Managed by Each Clinical Intervention Out of All Managed Episodes | DD (managed episodes=8, 24, 5, 0) | NA percentage of episodes |
| PR + Boceprevir + Telaprevir Group of Exposure | Percentage of Grade 3/4 Neutropenia Episodes Managed by Each Clinical Intervention Out of All Managed Episodes | OT (managed episodes=10, 39, 11, 0) | NA percentage of episodes |
| PR + Boceprevir + Telaprevir Group of Exposure | Percentage of Grade 3/4 Neutropenia Episodes Managed by Each Clinical Intervention Out of All Managed Episodes | G-CSF (managed episodes=11, 39, 12, 0) | NA percentage of episodes |
| PR + Boceprevir + Telaprevir Group of Exposure | Percentage of Grade 3/4 Neutropenia Episodes Managed by Each Clinical Intervention Out of All Managed Episodes | DDR (managed episodes=8, 24, 5, 0) | NA percentage of episodes |
| PR + Boceprevir + Telaprevir Group of Exposure | Percentage of Grade 3/4 Neutropenia Episodes Managed by Each Clinical Intervention Out of All Managed Episodes | DI (managed episodes=8, 24, 5, 0) | NA percentage of episodes |
Primary
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.
Time frame: Up to 48 weeks of a treatment regimen
Population: Participants in Analysis Population (all CHC genotype-1 participants included on study meeting eligibility criteria and treated with boceprevir plus PR, telaprevir plus PR, or PR alone) who experienced at least one episode of grade 3/4 thrombocytopenia. Participants categorized by treatment group of exposure (further described in Arm Description).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| All Included Participants | Percentage of Grade 3/4 Thrombocytopenia Episodes Managed by at Least One Clinical Intervention | % Episodes with ≥1 intervention implemented | 42.3 percentage of episodes |
| All Included Participants | Percentage of Grade 3/4 Thrombocytopenia Episodes Managed by at Least One Clinical Intervention | % Episodes with no intervention implemented | 57.7 percentage of episodes |
| Telaprevir + PR | Percentage of Grade 3/4 Thrombocytopenia Episodes Managed by at Least One Clinical Intervention | % Episodes with no intervention implemented | 64.2 percentage of episodes |
| Telaprevir + PR | Percentage of Grade 3/4 Thrombocytopenia Episodes Managed by at Least One Clinical Intervention | % Episodes with ≥1 intervention implemented | 35.8 percentage of episodes |
| PR Alone | Percentage of Grade 3/4 Thrombocytopenia Episodes Managed by at Least One Clinical Intervention | % Episodes with ≥1 intervention implemented | 32.1 percentage of episodes |
| PR Alone | Percentage of Grade 3/4 Thrombocytopenia Episodes Managed by at Least One Clinical Intervention | % Episodes with no intervention implemented | 67.9 percentage of episodes |
| PR + Boceprevir + Telaprevir Group of Exposure | Percentage of Grade 3/4 Thrombocytopenia Episodes Managed by at Least One Clinical Intervention | % Episodes with ≥1 intervention implemented | 0.0 percentage of episodes |
| PR + Boceprevir + Telaprevir Group of Exposure | Percentage of Grade 3/4 Thrombocytopenia Episodes Managed by at Least One Clinical Intervention | % Episodes with no intervention implemented | 100.0 percentage of episodes |
Primary
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).
Time frame: Up to 48 weeks of a treatment regimen
Population: Participants in Analysis Population (all CHC genotype-1 participants included on study meeting eligibility criteria and treated with boceprevir plus PR, telaprevir plus PR, or PR alone) who experienced at least one episode of grade 3/4 thrombocytopenia. Participants categorized by treatment group of exposure (further described in Arm Description).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| All Included Participants | Percentage of Grade 3/4 Thrombocytopenia Episodes Managed by Each Clinical Intervention Out of All Managed Episodes | DD (managed episodes=11, 10, 15, 0) | 18.2 percentage of episodes |
| All Included Participants | Percentage of Grade 3/4 Thrombocytopenia Episodes Managed by Each Clinical Intervention Out of All Managed Episodes | PT (managed episodes=10, 19, 18, 0) | 0.0 percentage of episodes |
| All Included Participants | Percentage of Grade 3/4 Thrombocytopenia Episodes Managed by Each Clinical Intervention Out of All Managed Episodes | DI (managed episodes=11, 10, 15, 0) | 0.0 percentage of episodes |
| All Included Participants | Percentage of Grade 3/4 Thrombocytopenia Episodes Managed by Each Clinical Intervention Out of All Managed Episodes | OT (managed episodes=9, 17, 18, 0) | 0.0 percentage of episodes |
| All Included Participants | Percentage of Grade 3/4 Thrombocytopenia Episodes Managed by Each Clinical Intervention Out of All Managed Episodes | DDR (managed episodes=11, 10, 15, 0) | 100.0 percentage of episodes |
| All Included Participants | Percentage of Grade 3/4 Thrombocytopenia Episodes Managed by Each Clinical Intervention Out of All Managed Episodes | TPO (managed episodes=10, 19, 18, 0) | 30.0 percentage of episodes |
| Telaprevir + PR | Percentage of Grade 3/4 Thrombocytopenia Episodes Managed by Each Clinical Intervention Out of All Managed Episodes | PT (managed episodes=10, 19, 18, 0) | 5.3 percentage of episodes |
| Telaprevir + PR | Percentage of Grade 3/4 Thrombocytopenia Episodes Managed by Each Clinical Intervention Out of All Managed Episodes | TPO (managed episodes=10, 19, 18, 0) | 42.1 percentage of episodes |
| Telaprevir + PR | Percentage of Grade 3/4 Thrombocytopenia Episodes Managed by Each Clinical Intervention Out of All Managed Episodes | OT (managed episodes=9, 17, 18, 0) | 5.9 percentage of episodes |
| Telaprevir + PR | Percentage of Grade 3/4 Thrombocytopenia Episodes Managed by Each Clinical Intervention Out of All Managed Episodes | DD (managed episodes=11, 10, 15, 0) | 20.0 percentage of episodes |
| Telaprevir + PR | Percentage of Grade 3/4 Thrombocytopenia Episodes Managed by Each Clinical Intervention Out of All Managed Episodes | DI (managed episodes=11, 10, 15, 0) | 30.0 percentage of episodes |
| Telaprevir + PR | Percentage of Grade 3/4 Thrombocytopenia Episodes Managed by Each Clinical Intervention Out of All Managed Episodes | DDR (managed episodes=11, 10, 15, 0) | 70.0 percentage of episodes |
| PR Alone | Percentage of Grade 3/4 Thrombocytopenia Episodes Managed by Each Clinical Intervention Out of All Managed Episodes | TPO (managed episodes=10, 19, 18, 0) | 11.1 percentage of episodes |
| PR Alone | Percentage of Grade 3/4 Thrombocytopenia Episodes Managed by Each Clinical Intervention Out of All Managed Episodes | PT (managed episodes=10, 19, 18, 0) | 11.1 percentage of episodes |
| PR Alone | Percentage of Grade 3/4 Thrombocytopenia Episodes Managed by Each Clinical Intervention Out of All Managed Episodes | DD (managed episodes=11, 10, 15, 0) | 26.7 percentage of episodes |
| PR Alone | Percentage of Grade 3/4 Thrombocytopenia Episodes Managed by Each Clinical Intervention Out of All Managed Episodes | DDR (managed episodes=11, 10, 15, 0) | 80.0 percentage of episodes |
| PR Alone | Percentage of Grade 3/4 Thrombocytopenia Episodes Managed by Each Clinical Intervention Out of All Managed Episodes | DI (managed episodes=11, 10, 15, 0) | 6.7 percentage of episodes |
| PR Alone | Percentage of Grade 3/4 Thrombocytopenia Episodes Managed by Each Clinical Intervention Out of All Managed Episodes | OT (managed episodes=9, 17, 18, 0) | 0.0 percentage of episodes |
| PR + Boceprevir + Telaprevir Group of Exposure | Percentage of Grade 3/4 Thrombocytopenia Episodes Managed by Each Clinical Intervention Out of All Managed Episodes | DI (managed episodes=11, 10, 15, 0) | NA percentage of episodes |
| PR + Boceprevir + Telaprevir Group of Exposure | Percentage of Grade 3/4 Thrombocytopenia Episodes Managed by Each Clinical Intervention Out of All Managed Episodes | TPO (managed episodes=10, 19, 18, 0) | NA percentage of episodes |
| PR + Boceprevir + Telaprevir Group of Exposure | Percentage of Grade 3/4 Thrombocytopenia Episodes Managed by Each Clinical Intervention Out of All Managed Episodes | PT (managed episodes=10, 19, 18, 0) | NA percentage of episodes |
| PR + Boceprevir + Telaprevir Group of Exposure | Percentage of Grade 3/4 Thrombocytopenia Episodes Managed by Each Clinical Intervention Out of All Managed Episodes | OT (managed episodes=9, 17, 18, 0) | NA percentage of episodes |
| PR + Boceprevir + Telaprevir Group of Exposure | Percentage of Grade 3/4 Thrombocytopenia Episodes Managed by Each Clinical Intervention Out of All Managed Episodes | DDR (managed episodes=11, 10, 15, 0) | NA percentage of episodes |
| PR + Boceprevir + Telaprevir Group of Exposure | Percentage of Grade 3/4 Thrombocytopenia Episodes Managed by Each Clinical Intervention Out of All Managed Episodes | DD (managed episodes=11, 10, 15, 0) | NA percentage of episodes |
Primary
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.
Time frame: Up to 37 months
Population: Analysis Population: All CHC genotype-1 participants included in study meeting eligibility criteria and receiving boceprevir plus peginterferon and ribavirin (PR), telaprevir plus PR, or PR alone.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| All Included Participants | Percentage of Participants Initiating Boceprevir Plus PR Treatment, Telaprevir Plus PR Treatment, or PR Treatment Alone (Drug Utilization Pattern) | Initiating Boceprevir + PR Treatment | 43.9 percentage of participants |
| All Included Participants | Percentage of Participants Initiating Boceprevir Plus PR Treatment, Telaprevir Plus PR Treatment, or PR Treatment Alone (Drug Utilization Pattern) | Initiating Telaprevir + PR Treatment | 45.2 percentage of participants |
| All Included Participants | Percentage of Participants Initiating Boceprevir Plus PR Treatment, Telaprevir Plus PR Treatment, or PR Treatment Alone (Drug Utilization Pattern) | Initiating PR Treatment Alone | 10.9 percentage of participants |
Primary
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.
Time frame: Up to 48 weeks of a treatment regimen
Population: Participants in the Analysis Population (all CHC genotype-1 participants included on study meeting eligibility criteria and treated with boceprevir plus PR, telaprevir plus PR, or PR alone) who experienced at least one episode of serious rash. Participants categorized by treatment group of exposure (further described in Arm Description).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| All Included Participants | Percentage of Serious Rash Episodes Managed by at Least One Clinical Intervention | Episodes with ≥1 intervention implemented | 100.0 percentage of episodes |
| All Included Participants | Percentage of Serious Rash Episodes Managed by at Least One Clinical Intervention | Episodes with no intervention implemented | 0.0 percentage of episodes |
| Telaprevir + PR | Percentage of Serious Rash Episodes Managed by at Least One Clinical Intervention | Episodes with ≥1 intervention implemented | 100.0 percentage of episodes |
| Telaprevir + PR | Percentage of Serious Rash Episodes Managed by at Least One Clinical Intervention | Episodes with no intervention implemented | 0.0 percentage of episodes |
| PR Alone | Percentage of Serious Rash Episodes Managed by at Least One Clinical Intervention | Episodes with ≥1 intervention implemented | 96.3 percentage of episodes |
| PR Alone | Percentage of Serious Rash Episodes Managed by at Least One Clinical Intervention | Episodes with no intervention implemented | 3.7 percentage of episodes |
Primary
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).
Time frame: Up to 48 weeks of a treatment regimen
Population: Participants in the Analysis Population (all CHC genotype-1 participants included on study meeting eligibility criteria and treated with boceprevir plus PR, telaprevir plus PR, or PR alone) who experienced at least one episode of serious rash. Participants categorized by treatment group of exposure (further described in Arm Description).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| All Included Participants | Percentage of Serious Rash Episodes Managed by Each Clinical Intervention Out of All Managed Episodes | TC (managed episodes =1, 7, 26) | 100.0 percentage of episodes |
| All Included Participants | Percentage of Serious Rash Episodes Managed by Each Clinical Intervention Out of All Managed Episodes | IV/PO CS (managed episodes =1, 7, 26) | 0.0 percentage of episodes |
| All Included Participants | Percentage of Serious Rash Episodes Managed by Each Clinical Intervention Out of All Managed Episodes | E/M (managed episodes =1, 7, 26) | 100.0 percentage of episodes |
| All Included Participants | Percentage of Serious Rash Episodes Managed by Each Clinical Intervention Out of All Managed Episodes | AH (managed episodes =1, 7, 26) | 100.0 percentage of episodes |
| All Included Participants | Percentage of Serious Rash Episodes Managed by Each Clinical Intervention Out of All Managed Episodes | OT (managed episodes =1, 7, 26) | 0.0 percentage of episodes |
| All Included Participants | Percentage of Serious Rash Episodes Managed by Each Clinical Intervention Out of All Managed Episodes | DDR (managed episodes =1, 3, 17) | 0.0 percentage of episodes |
| All Included Participants | Percentage of Serious Rash Episodes Managed by Each Clinical Intervention Out of All Managed Episodes | DD (managed episodes =1, 3, 17) | 100.0 percentage of episodes |
| All Included Participants | Percentage of Serious Rash Episodes Managed by Each Clinical Intervention Out of All Managed Episodes | DI (managed episodes =1, 3, 17) | 0.0 percentage of episodes |
| Telaprevir + PR | Percentage of Serious Rash Episodes Managed by Each Clinical Intervention Out of All Managed Episodes | E/M (managed episodes =1, 7, 26) | 28.6 percentage of episodes |
| Telaprevir + PR | Percentage of Serious Rash Episodes Managed by Each Clinical Intervention Out of All Managed Episodes | DD (managed episodes =1, 3, 17) | 100.0 percentage of episodes |
| Telaprevir + PR | Percentage of Serious Rash Episodes Managed by Each Clinical Intervention Out of All Managed Episodes | AH (managed episodes =1, 7, 26) | 28.6 percentage of episodes |
| Telaprevir + PR | Percentage of Serious Rash Episodes Managed by Each Clinical Intervention Out of All Managed Episodes | OT (managed episodes =1, 7, 26) | 14.3 percentage of episodes |
| Telaprevir + PR | Percentage of Serious Rash Episodes Managed by Each Clinical Intervention Out of All Managed Episodes | DDR (managed episodes =1, 3, 17) | 0.0 percentage of episodes |
| Telaprevir + PR | Percentage of Serious Rash Episodes Managed by Each Clinical Intervention Out of All Managed Episodes | TC (managed episodes =1, 7, 26) | 42.9 percentage of episodes |
| Telaprevir + PR | Percentage of Serious Rash Episodes Managed by Each Clinical Intervention Out of All Managed Episodes | IV/PO CS (managed episodes =1, 7, 26) | 28.6 percentage of episodes |
| Telaprevir + PR | Percentage of Serious Rash Episodes Managed by Each Clinical Intervention Out of All Managed Episodes | DI (managed episodes =1, 3, 17) | 0.0 percentage of episodes |
| PR Alone | Percentage of Serious Rash Episodes Managed by Each Clinical Intervention Out of All Managed Episodes | E/M (managed episodes =1, 7, 26) | 23.1 percentage of episodes |
| PR Alone | Percentage of Serious Rash Episodes Managed by Each Clinical Intervention Out of All Managed Episodes | IV/PO CS (managed episodes =1, 7, 26) | 23.1 percentage of episodes |
| PR Alone | Percentage of Serious Rash Episodes Managed by Each Clinical Intervention Out of All Managed Episodes | TC (managed episodes =1, 7, 26) | 65.4 percentage of episodes |
| PR Alone | Percentage of Serious Rash Episodes Managed by Each Clinical Intervention Out of All Managed Episodes | AH (managed episodes =1, 7, 26) | 73.1 percentage of episodes |
| PR Alone | Percentage of Serious Rash Episodes Managed by Each Clinical Intervention Out of All Managed Episodes | DD (managed episodes =1, 3, 17) | 88.2 percentage of episodes |
| PR Alone | Percentage of Serious Rash Episodes Managed by Each Clinical Intervention Out of All Managed Episodes | DDR (managed episodes =1, 3, 17) | 11.8 percentage of episodes |
| PR Alone | Percentage of Serious Rash Episodes Managed by Each Clinical Intervention Out of All Managed Episodes | OT (managed episodes =1, 7, 26) | 15.4 percentage of episodes |
| PR Alone | Percentage of Serious Rash Episodes Managed by Each Clinical Intervention Out of All Managed Episodes | DI (managed episodes =1, 3, 17) | 29.4 percentage of episodes |
Secondary
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.
Time frame: Up to 48 weeks of treatment
Population: Participants in Analysis Population (CHC genotype-1 participants meeting eligibility criteria and treated with boceprevir+PR, telaprevir+PR, or PR alone) with available data who did not already experience HOI during 3 months preceding CHC treatment regimen. Participants categorized by treatment group of exposure further described in Arm Description
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| All Included Participants | Incidence of Anemia, Grade 3/4 Neutropenia, Grade 3/4 Thrombocytopenia, and Serious Skin Rash | Serious Rash (n=394, 298, 307, 6) | 0.045 events per 1000 participant-days |
| All Included Participants | Incidence of Anemia, Grade 3/4 Neutropenia, Grade 3/4 Thrombocytopenia, and Serious Skin Rash | Grade 3/4 Neutropenia (n=394, 297, 307, 5) | 1.305 events per 1000 participant-days |
| All Included Participants | Incidence of Anemia, Grade 3/4 Neutropenia, Grade 3/4 Thrombocytopenia, and Serious Skin Rash | Anemia (n=391, 296, 306, 6) | 1.185 events per 1000 participant-days |
| All Included Participants | Incidence of Anemia, Grade 3/4 Neutropenia, Grade 3/4 Thrombocytopenia, and Serious Skin Rash | Grade 3/4 Thrombocytopenia (n=390, 295, 304, 6) | 0.835 events per 1000 participant-days |
| Telaprevir + PR | Incidence of Anemia, Grade 3/4 Neutropenia, Grade 3/4 Thrombocytopenia, and Serious Skin Rash | Serious Rash (n=394, 298, 307, 6) | 0.117 events per 1000 participant-days |
| Telaprevir + PR | Incidence of Anemia, Grade 3/4 Neutropenia, Grade 3/4 Thrombocytopenia, and Serious Skin Rash | Anemia (n=391, 296, 306, 6) | 3.302 events per 1000 participant-days |
| Telaprevir + PR | Incidence of Anemia, Grade 3/4 Neutropenia, Grade 3/4 Thrombocytopenia, and Serious Skin Rash | Grade 3/4 Neutropenia (n=394, 297, 307, 5) | 1.656 events per 1000 participant-days |
| Telaprevir + PR | Incidence of Anemia, Grade 3/4 Neutropenia, Grade 3/4 Thrombocytopenia, and Serious Skin Rash | Grade 3/4 Thrombocytopenia (n=390, 295, 304, 6) | 0.757 events per 1000 participant-days |
| PR Alone | Incidence of Anemia, Grade 3/4 Neutropenia, Grade 3/4 Thrombocytopenia, and Serious Skin Rash | Anemia (n=391, 296, 306, 6) | 3.001 events per 1000 participant-days |
| PR Alone | Incidence of Anemia, Grade 3/4 Neutropenia, Grade 3/4 Thrombocytopenia, and Serious Skin Rash | Grade 3/4 Neutropenia (n=394, 297, 307, 5) | 0.807 events per 1000 participant-days |
| PR Alone | Incidence of Anemia, Grade 3/4 Neutropenia, Grade 3/4 Thrombocytopenia, and Serious Skin Rash | Grade 3/4 Thrombocytopenia (n=390, 295, 304, 6) | 0.596 events per 1000 participant-days |
| PR Alone | Incidence of Anemia, Grade 3/4 Neutropenia, Grade 3/4 Thrombocytopenia, and Serious Skin Rash | Serious Rash (n=394, 298, 307, 6) | 0.430 events per 1000 participant-days |
| PR + Boceprevir + Telaprevir Group of Exposure | Incidence of Anemia, Grade 3/4 Neutropenia, Grade 3/4 Thrombocytopenia, and Serious Skin Rash | Grade 3/4 Thrombocytopenia (n=390, 295, 304, 6) | 1.556 events per 1000 participant-days |
| PR + Boceprevir + Telaprevir Group of Exposure | Incidence of Anemia, Grade 3/4 Neutropenia, Grade 3/4 Thrombocytopenia, and Serious Skin Rash | Anemia (n=391, 296, 306, 6) | 5.122 events per 1000 participant-days |
| PR + Boceprevir + Telaprevir Group of Exposure | Incidence of Anemia, Grade 3/4 Neutropenia, Grade 3/4 Thrombocytopenia, and Serious Skin Rash | Grade 3/4 Neutropenia (n=394, 297, 307, 5) | 3.195 events per 1000 participant-days |
| PR + Boceprevir + Telaprevir Group of Exposure | Incidence of Anemia, Grade 3/4 Neutropenia, Grade 3/4 Thrombocytopenia, and Serious Skin Rash | Serious Rash (n=394, 298, 307, 6) | 0 events per 1000 participant-days |