Trial Outcomes & Findings for Drug Utilization of Boceprevir and Clinical Management of Health Outcomes of Interest in Chronic Hepatitis C Participants (P08518) (NCT NCT01544582)

Last Updated: 2016-09-16

Results Overview

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.

Recruitment status

COMPLETED

Target enrollment

713 participants

Primary outcome timeframe

Up to 37 months

Results posted on

2016-09-16

Participant Flow

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.

Participant milestones

Participant milestones
Measure	All Included Participants All CHC genotype-1 participants included in study.	Boceprevir + PR CHC genotype-1 participants included in study and prescribed boceprevir plus PR as routine clinical management.	Telaprevir + PR CHC genotype-1 participants included in study and prescribed telaprevir plus PR as routine clinical management.	PR Alone CHC genotype-1 participants included in study and prescribed PR alone as routine clinical management
Screening/Eligibility STARTED	713	0	0	0
Screening/Eligibility Analysis Population	679	0	0	0
Screening/Eligibility COMPLETED	679	0	0	0
Screening/Eligibility NOT COMPLETED	34	0	0	0
Analysis Population STARTED	0	298	307	74
Analysis Population COMPLETED	0	180	205	35
Analysis Population NOT COMPLETED	0	118	102	39

Reasons for withdrawal

Reasons for withdrawal
Measure	All Included Participants All CHC genotype-1 participants included in study.	Boceprevir + PR CHC genotype-1 participants included in study and prescribed boceprevir plus PR as routine clinical management.	Telaprevir + PR CHC genotype-1 participants included in study and prescribed telaprevir plus PR as routine clinical management.	PR Alone CHC genotype-1 participants included in study and prescribed PR alone as routine clinical management
Screening/Eligibility Initiated Different CHC Treatment	1	0	0	0
Screening/Eligibility Eligibility Criteria Not Met	33	0	0	0
Analysis Population Participant Refuses to Continue Study	0	15	17	4
Analysis Population Physician Decision	0	13	10	9
Analysis Population Safety Reason	0	33	31	8
Analysis Population Effectiveness Reason	0	48	29	12
Analysis Population New Contraindication-Alcohol Abuse	0	0	0	1
Analysis Population Lost to Follow-up	0	6	6	5
Analysis Population Bad Tolerance to Treatment	0	0	2	0
Analysis Population Did Not Meet Inclusion Criteria	0	0	3	0
Analysis Population Intolerance	0	1	0	0
Analysis Population Liver Transplantation	0	0	1	0
Analysis Population No Social Insurance	0	0	1	0
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 Participant in Jail	0	0	1	0

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Boceprevir + PR n=298 Participants CHC genotype-1 participants included in study and prescribed boceprevir plus PR as routine clinical management.	Telaprevir + PR n=307 Participants CHC genotype-1 participants included in study and prescribed telaprevir plus PR as routine clinical management.	PR Alone n=74 Participants CHC genotype-1 participants included in study and prescribed PR alone as routine clinical management	Total n=679 Participants Total of all reporting groups
Age, Continuous	51.4 years STANDARD_DEVIATION 10.3 • n=5 Participants	50.1 years STANDARD_DEVIATION 10.9 • n=7 Participants	46.3 years STANDARD_DEVIATION 11.6 • n=5 Participants	50.3 years STANDARD_DEVIATION 10.8 • n=4 Participants
Sex: Female, Male Female	113 Participants n=5 Participants	102 Participants n=7 Participants	25 Participants n=5 Participants	240 Participants n=4 Participants
Sex: Female, Male Male	185 Participants n=5 Participants	205 Participants n=7 Participants	49 Participants n=5 Participants	439 Participants n=4 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	All Included Participants n=679 Participants All CHC genotype-1 participants included in study.	Telaprevir + PR CHC genotype-1 participants included in study and prescribed telaprevir plus PR as routine clinical management.	PR Alone CHC genotype-1 participants included in study and prescribed PR alone as routine clinical management	PR + Boceprevir + Telaprevir Group of Exposure CHC genotype-1 participants included on study that received telaprevir + PR as routine clinical management and then switched to Boceprevir + PR treatment or vice-versa. 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 group was not mutually exclusive). The PR + Boceprevir+Telaprevir Treatment Group of Exposure included 3 participants who were switched from telaprevir + PR to boceprevir + PR, 2 participants who switched from boceprevir + PR to telaprevir + PR, and one participant who switched from boceprevir + PR to telaprevir + PR, and then to boceprevir + PR during follow-up.
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 Interval 40.1 to 47.7	—	—	—
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 Interval 41.4 to 49.0	—	—	—
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 Interval 8.7 to 13.5	—	—	—

PRIMARY outcome

Timeframe: 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).

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

Outcome measures

Outcome measures
Measure	All Included Participants n=280 Participants All CHC genotype-1 participants included in study.	Telaprevir + PR n=280 Participants CHC genotype-1 participants included in study and prescribed telaprevir plus PR as routine clinical management.	PR Alone n=74 Participants CHC genotype-1 participants included in study and prescribed PR alone as routine clinical management	PR + Boceprevir + Telaprevir Group of Exposure CHC genotype-1 participants included on study that received telaprevir + PR as routine clinical management and then switched to Boceprevir + PR treatment or vice-versa. 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 group was not mutually exclusive). The PR + Boceprevir+Telaprevir Treatment Group of Exposure included 3 participants who were switched from telaprevir + PR to boceprevir + PR, 2 participants who switched from boceprevir + PR to telaprevir + PR, and one participant who switched from boceprevir + PR to telaprevir + PR, and then to boceprevir + PR during follow-up.
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	77.0 kilograms (Kg) Standard Deviation 15.5	71.7 kilograms (Kg) Standard Deviation 13.7	—

PRIMARY outcome

Timeframe: Before initiation of CHC treatment (Week 0 baseline)

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

Outcome measures

Outcome measures
Measure	All Included Participants n=254 Participants All CHC genotype-1 participants included in study.	Telaprevir + PR n=238 Participants CHC genotype-1 participants included in study and prescribed telaprevir plus PR as routine clinical management.	PR Alone n=61 Participants CHC genotype-1 participants included in study and prescribed PR alone as routine clinical management	PR + Boceprevir + Telaprevir Group of Exposure CHC genotype-1 participants included on study that received telaprevir + PR as routine clinical management and then switched to Boceprevir + PR treatment or vice-versa. 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 group was not mutually exclusive). The PR + Boceprevir+Telaprevir Treatment Group of Exposure included 3 participants who were switched from telaprevir + PR to boceprevir + PR, 2 participants who switched from boceprevir + PR to telaprevir + PR, and one participant who switched from boceprevir + PR to telaprevir + PR, and then to boceprevir + PR during follow-up.
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	170.8 centimeters Standard Deviation 8.8	171.0 centimeters Standard Deviation 7.5	—

PRIMARY outcome

Timeframe: Before initiation of CHC treatment (Week 0 baseline)

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

Outcome measures

Outcome measures
Measure	All Included Participants n=248 Participants All CHC genotype-1 participants included in study.	Telaprevir + PR n=233 Participants CHC genotype-1 participants included in study and prescribed telaprevir plus PR as routine clinical management.	PR Alone n=61 Participants CHC genotype-1 participants included in study and prescribed PR alone as routine clinical management	PR + Boceprevir + Telaprevir Group of Exposure CHC genotype-1 participants included on study that received telaprevir + PR as routine clinical management and then switched to Boceprevir + PR treatment or vice-versa. 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 group was not mutually exclusive). The PR + Boceprevir+Telaprevir Treatment Group of Exposure included 3 participants who were switched from telaprevir + PR to boceprevir + PR, 2 participants who switched from boceprevir + PR to telaprevir + PR, and one participant who switched from boceprevir + PR to telaprevir + PR, and then to boceprevir + PR during follow-up.
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	26.5 Kg/m^2 Standard Deviation 4.8	24.7 Kg/m^2 Standard Deviation 4.2	—

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	All Included Participants n=298 Participants All CHC genotype-1 participants included in study.	Telaprevir + PR n=307 Participants CHC genotype-1 participants included in study and prescribed telaprevir plus PR as routine clinical management.	PR Alone n=74 Participants CHC genotype-1 participants included in study and prescribed PR alone as routine clinical management	PR + Boceprevir + Telaprevir Group of Exposure CHC genotype-1 participants included on study that received telaprevir + PR as routine clinical management and then switched to Boceprevir + PR treatment or vice-versa. 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 group was not mutually exclusive). The PR + Boceprevir+Telaprevir Treatment Group of Exposure included 3 participants who were switched from telaprevir + PR to boceprevir + PR, 2 participants who switched from boceprevir + PR to telaprevir + PR, and one participant who switched from boceprevir + PR to telaprevir + PR, and then to boceprevir + PR during follow-up.
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	120 participants 4.8	33 participants 4.2	—
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	148 participants	30 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	39 participants	11 participants	—

PRIMARY outcome

Timeframe: 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).

Outcome measures

Outcome measures
Measure	All Included Participants n=298 Participants All CHC genotype-1 participants included in study.	Telaprevir + PR n=307 Participants CHC genotype-1 participants included in study and prescribed telaprevir plus PR as routine clinical management.	PR Alone n=74 Participants CHC genotype-1 participants included in study and prescribed PR alone as routine clinical management	PR + Boceprevir + Telaprevir Group of Exposure CHC genotype-1 participants included on study that received telaprevir + PR as routine clinical management and then switched to Boceprevir + PR treatment or vice-versa. 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 group was not mutually exclusive). The PR + Boceprevir+Telaprevir Treatment Group of Exposure included 3 participants who were switched from telaprevir + PR to boceprevir + PR, 2 participants who switched from boceprevir + PR to telaprevir + PR, and one participant who switched from boceprevir + PR to telaprevir + PR, and then to boceprevir + PR during follow-up.
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	197 participants	39 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	94 participants 4.8	35 participants 4.2	—
Baseline Disease Characteristics of Participants Initiating Boceprevir Plus PR Treatment, Telaprevir Plus PR Treatment, or PR Treatment Alone: Baseline Viral Load Unavailable	15 participants	16 participants	0 participants	—

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	All Included Participants n=298 Participants All CHC genotype-1 participants included in study.	Telaprevir + PR n=307 Participants CHC genotype-1 participants included in study and prescribed telaprevir plus PR as routine clinical management.	PR Alone n=74 Participants CHC genotype-1 participants included in study and prescribed PR alone as routine clinical management	PR + Boceprevir + Telaprevir Group of Exposure CHC genotype-1 participants included on study that received telaprevir + PR as routine clinical management and then switched to Boceprevir + PR treatment or vice-versa. 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 group was not mutually exclusive). The PR + Boceprevir+Telaprevir Treatment Group of Exposure included 3 participants who were switched from telaprevir + PR to boceprevir + PR, 2 participants who switched from boceprevir + PR to telaprevir + PR, and one participant who switched from boceprevir + PR to telaprevir + PR, and then to boceprevir + PR during follow-up.
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	0 participants	0 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	203 participants	39 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	40 participants	5 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	61 participants 4.8	30 participants 4.2	—
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	3 participants	0 participants	—

PRIMARY outcome

Timeframe: 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).

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.

Outcome measures

Outcome measures
Measure	All Included Participants n=29 anemia episodes total All CHC genotype-1 participants included in study.	Telaprevir + PR n=178 anemia episodes total CHC genotype-1 participants included in study and prescribed telaprevir plus PR as routine clinical management.	PR Alone n=166 anemia episodes total CHC genotype-1 participants included in study and prescribed PR alone as routine clinical management	PR + Boceprevir + Telaprevir Group of Exposure n=4 anemia episodes total CHC genotype-1 participants included on study that received telaprevir + PR as routine clinical management and then switched to Boceprevir + PR treatment or vice-versa. 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 group was not mutually exclusive). The PR + Boceprevir+Telaprevir Treatment Group of Exposure included 3 participants who were switched from telaprevir + PR to boceprevir + PR, 2 participants who switched from boceprevir + PR to telaprevir + PR, and one participant who switched from boceprevir + PR to telaprevir + PR, and then to boceprevir + PR during follow-up.
Percentage of Anemia Episodes Managed by at Least One Clinical Intervention % Episodes with ≥1 intervention implemented	79.3 percentage of episodes Interval 60.3 to 92.0	72.5 percentage of episodes Interval 65.3 to 78.9	69.9 percentage of episodes Interval 62.3 to 76.7	75.0 percentage of episodes Interval 19.4 to 99.4
Percentage of Anemia Episodes Managed by at Least One Clinical Intervention % Episodes with no intervention implemented	20.7 percentage of episodes Interval 8.0 to 39.7	27.5 percentage of episodes Interval 21.1 to 34.7	30.1 percentage of episodes Interval 23.3 to 37.7	25.0 percentage of episodes Interval 0.6 to 80.6

PRIMARY outcome

Timeframe: 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).

Outcome measures

Outcome measures
Measure	All Included Participants n=23 managed anemia episodes total All CHC genotype-1 participants included in study.	Telaprevir + PR n=129 managed anemia episodes total CHC genotype-1 participants included in study and prescribed telaprevir plus PR as routine clinical management.	PR Alone n=116 managed anemia episodes total CHC genotype-1 participants included in study and prescribed PR alone as routine clinical management	PR + Boceprevir + Telaprevir Group of Exposure n=3 managed anemia episodes total CHC genotype-1 participants included on study that received telaprevir + PR as routine clinical management and then switched to Boceprevir + PR treatment or vice-versa. 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 group was not mutually exclusive). The PR + Boceprevir+Telaprevir Treatment Group of Exposure included 3 participants who were switched from telaprevir + PR to boceprevir + PR, 2 participants who switched from boceprevir + PR to telaprevir + PR, and one participant who switched from boceprevir + PR to telaprevir + PR, and then to boceprevir + PR during follow-up.
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 Interval 60.3 to 92.0	46.0 percentage of episodes Interval 65.3 to 78.9	43.9 percentage of episodes Interval 62.3 to 76.7	66.7 percentage of episodes Interval 19.4 to 99.4
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 Interval 8.0 to 39.7	20.0 percentage of episodes Interval 21.1 to 34.7	24.3 percentage of episodes Interval 23.3 to 37.7	33.3 percentage of episodes Interval 0.6 to 80.6
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	8.7 percentage of episodes	2.6 percentage of episodes	33.3 percentage of episodes
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	92.8 percentage of episodes	95.6 percentage of episodes	66.7 percentage of episodes
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	11.7 percentage of episodes	5.5 percentage of episodes	0.0 percentage of episodes
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	3.6 percentage of episodes	5.5 percentage of episodes	33.3 percentage of episodes

PRIMARY outcome

Timeframe: 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).

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.

Outcome measures

Outcome measures
Measure	All Included Participants n=30 Gr 3/4 neutropenia episodes total All CHC genotype-1 participants included in study.	Telaprevir + PR n=116 Gr 3/4 neutropenia episodes total CHC genotype-1 participants included in study and prescribed telaprevir plus PR as routine clinical management.	PR Alone n=65 Gr 3/4 neutropenia episodes total CHC genotype-1 participants included in study and prescribed PR alone as routine clinical management	PR + Boceprevir + Telaprevir Group of Exposure n=3 Gr 3/4 neutropenia episodes total CHC genotype-1 participants included on study that received telaprevir + PR as routine clinical management and then switched to Boceprevir + PR treatment or vice-versa. 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 group was not mutually exclusive). The PR + Boceprevir+Telaprevir Treatment Group of Exposure included 3 participants who were switched from telaprevir + PR to boceprevir + PR, 2 participants who switched from boceprevir + PR to telaprevir + PR, and one participant who switched from boceprevir + PR to telaprevir + PR, and then to boceprevir + PR during follow-up.
Percentage of Grade 3/4 Neutropenia Episodes Managed by at Least One Clinical Intervention % Episodes with ≥1 intervention implemented	36.7 percentage of episodes Interval 19.9 to 56.1	33.6 percentage of episodes Interval 25.1 to 43.0	18.5 percentage of episodes Interval 9.9 to 30.0	0.0 percentage of episodes Interval 0.0 to 70.8
Percentage of Grade 3/4 Neutropenia Episodes Managed by at Least One Clinical Intervention % Episodes with no intervention implemented	63.3 percentage of episodes Interval 43.9 to 80.1	66.4 percentage of episodes Interval 57.0 to 74.9	81.5 percentage of episodes Interval 70.0 to 90.1	100.0 percentage of episodes Interval 29.2 to 100.0

PRIMARY outcome

Timeframe: 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).

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).

Outcome measures

Outcome measures
Measure	All Included Participants n=11 managed neutropenia episodes total All CHC genotype-1 participants included in study.	Telaprevir + PR n=39 managed neutropenia episodes total CHC genotype-1 participants included in study and prescribed telaprevir plus PR as routine clinical management.	PR Alone n=12 managed neutropenia episodes total CHC genotype-1 participants included in study and prescribed PR alone as routine clinical management	PR + Boceprevir + Telaprevir Group of Exposure CHC genotype-1 participants included on study that received telaprevir + PR as routine clinical management and then switched to Boceprevir + PR treatment or vice-versa. 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 group was not mutually exclusive). The PR + Boceprevir+Telaprevir Treatment Group of Exposure included 3 participants who were switched from telaprevir + PR to boceprevir + PR, 2 participants who switched from boceprevir + PR to telaprevir + PR, and one participant who switched from boceprevir + PR to telaprevir + PR, and then to boceprevir + PR during follow-up.
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 Interval 19.9 to 56.1	46.2 percentage of episodes Interval 25.1 to 43.0	75.0 percentage of episodes Interval 9.9 to 30.0	NA percentage of episodes Interval 0.0 to 70.8 There were no managed neutropenia episodes in this arm.
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 Interval 43.9 to 80.1	0.0 percentage of episodes Interval 57.0 to 74.9	0.0 percentage of episodes Interval 70.0 to 90.1	NA percentage of episodes Interval 29.2 to 100.0 There were no managed neutropenia episodes in this arm.
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	87.5 percentage of episodes	80.0 percentage of episodes	NA percentage of episodes There were no managed neutropenia episodes in this arm.
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	12.5 percentage of episodes	0.0 percentage of episodes	NA percentage of episodes There were no managed neutropenia episodes in this arm.
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	8.3 percentage of episodes	20.0 percentage of episodes	NA percentage of episodes There were no managed neutropenia episodes in this arm.

PRIMARY outcome

Timeframe: 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).

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.

Outcome measures

Outcome measures
Measure	All Included Participants n=26 Gr 3/4 thrombocytopenia episodes total All CHC genotype-1 participants included in study.	Telaprevir + PR n=53 Gr 3/4 thrombocytopenia episodes total CHC genotype-1 participants included in study and prescribed telaprevir plus PR as routine clinical management.	PR Alone n=56 Gr 3/4 thrombocytopenia episodes total CHC genotype-1 participants included in study and prescribed PR alone as routine clinical management	PR + Boceprevir + Telaprevir Group of Exposure n=2 Gr 3/4 thrombocytopenia episodes total CHC genotype-1 participants included on study that received telaprevir + PR as routine clinical management and then switched to Boceprevir + PR treatment or vice-versa. 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 group was not mutually exclusive). The PR + Boceprevir+Telaprevir Treatment Group of Exposure included 3 participants who were switched from telaprevir + PR to boceprevir + PR, 2 participants who switched from boceprevir + PR to telaprevir + PR, and one participant who switched from boceprevir + PR to telaprevir + PR, and then to boceprevir + PR during follow-up.
Percentage of Grade 3/4 Thrombocytopenia Episodes Managed by at Least One Clinical Intervention % Episodes with ≥1 intervention implemented	42.3 percentage of episodes Interval 23.4 to 63.1	35.8 percentage of episodes Interval 23.1 to 50.2	32.1 percentage of episodes Interval 20.3 to 46.0	0.0 percentage of episodes Interval 0.0 to 84.2
Percentage of Grade 3/4 Thrombocytopenia Episodes Managed by at Least One Clinical Intervention % Episodes with no intervention implemented	57.7 percentage of episodes Interval 36.9 to 76.6	64.2 percentage of episodes Interval 49.8 to 76.9	67.9 percentage of episodes Interval 54.0 to 79.7	100.0 percentage of episodes Interval 15.8 to 100.0

PRIMARY outcome

Timeframe: 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).

Outcome measures

Outcome measures
Measure	All Included Participants n=11 managed thrombocytopenia episodes total All CHC genotype-1 participants included in study.	Telaprevir + PR n=19 managed thrombocytopenia episodes total CHC genotype-1 participants included in study and prescribed telaprevir plus PR as routine clinical management.	PR Alone n=18 managed thrombocytopenia episodes total CHC genotype-1 participants included in study and prescribed PR alone as routine clinical management	PR + Boceprevir + Telaprevir Group of Exposure CHC genotype-1 participants included on study that received telaprevir + PR as routine clinical management and then switched to Boceprevir + PR treatment or vice-versa. 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 group was not mutually exclusive). The PR + Boceprevir+Telaprevir Treatment Group of Exposure included 3 participants who were switched from telaprevir + PR to boceprevir + PR, 2 participants who switched from boceprevir + PR to telaprevir + PR, and one participant who switched from boceprevir + PR to telaprevir + PR, and then to boceprevir + PR during follow-up.
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 Interval 23.4 to 63.1	42.1 percentage of episodes Interval 23.1 to 50.2	11.1 percentage of episodes Interval 20.3 to 46.0	NA percentage of episodes Interval 0.0 to 84.2 There were no managed thrombocytopenia episodes in this arm.
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 Interval 36.9 to 76.6	5.3 percentage of episodes Interval 49.8 to 76.9	11.1 percentage of episodes Interval 54.0 to 79.7	NA percentage of episodes Interval 15.8 to 100.0 There were no managed thrombocytopenia episodes in this arm.
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	5.9 percentage of episodes	0.0 percentage of episodes	NA percentage of episodes There were no managed thrombocytopenia episodes in this arm.
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	70.0 percentage of episodes	80.0 percentage of episodes	NA percentage of episodes There were no managed thrombocytopenia episodes in this arm.
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	20.0 percentage of episodes	26.7 percentage of episodes	NA percentage of episodes There were no managed thrombocytopenia episodes in this arm.
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	30.0 percentage of episodes	6.7 percentage of episodes	NA percentage of episodes There were no managed thrombocytopenia episodes in this arm.

PRIMARY outcome

Timeframe: 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).

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.

Outcome measures

Outcome measures
Measure	All Included Participants n=1 serious rash episodes total All CHC genotype-1 participants included in study.	Telaprevir + PR n=7 serious rash episodes total CHC genotype-1 participants included in study and prescribed telaprevir plus PR as routine clinical management.	PR Alone n=27 serious rash episodes total CHC genotype-1 participants included in study and prescribed PR alone as routine clinical management	PR + Boceprevir + Telaprevir Group of Exposure CHC genotype-1 participants included on study that received telaprevir + PR as routine clinical management and then switched to Boceprevir + PR treatment or vice-versa. 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 group was not mutually exclusive). The PR + Boceprevir+Telaprevir Treatment Group of Exposure included 3 participants who were switched from telaprevir + PR to boceprevir + PR, 2 participants who switched from boceprevir + PR to telaprevir + PR, and one participant who switched from boceprevir + PR to telaprevir + PR, and then to boceprevir + PR during follow-up.
Percentage of Serious Rash Episodes Managed by at Least One Clinical Intervention Episodes with ≥1 intervention implemented	100.0 percentage of episodes Interval 2.5 to 100.0	100.0 percentage of episodes Interval 59.0 to 100.0	96.3 percentage of episodes Interval 81.0 to 99.9	—
Percentage of Serious Rash Episodes Managed by at Least One Clinical Intervention Episodes with no intervention implemented	0.0 percentage of episodes Interval 0.0 to 97.5	0.0 percentage of episodes Interval 0.0 to 41.0	3.7 percentage of episodes Interval 0.1 to 19.0	—

PRIMARY outcome

Timeframe: 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).

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).

Outcome measures

Outcome measures
Measure	All Included Participants n=1 managed serious rash episodes total All CHC genotype-1 participants included in study.	Telaprevir + PR n=7 managed serious rash episodes total CHC genotype-1 participants included in study and prescribed telaprevir plus PR as routine clinical management.	PR Alone n=26 managed serious rash episodes total CHC genotype-1 participants included in study and prescribed PR alone as routine clinical management	PR + Boceprevir + Telaprevir Group of Exposure CHC genotype-1 participants included on study that received telaprevir + PR as routine clinical management and then switched to Boceprevir + PR treatment or vice-versa. 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 group was not mutually exclusive). The PR + Boceprevir+Telaprevir Treatment Group of Exposure included 3 participants who were switched from telaprevir + PR to boceprevir + PR, 2 participants who switched from boceprevir + PR to telaprevir + PR, and one participant who switched from boceprevir + PR to telaprevir + PR, and then to boceprevir + PR during follow-up.
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 Interval 2.5 to 100.0	42.9 percentage of episodes Interval 59.0 to 100.0	65.4 percentage of episodes Interval 81.0 to 99.9	—
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 Interval 0.0 to 97.5	28.6 percentage of episodes Interval 0.0 to 41.0	23.1 percentage of episodes Interval 0.1 to 19.0	—
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	28.6 percentage of episodes	23.1 percentage of episodes	—
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	28.6 percentage of episodes	73.1 percentage of episodes	—
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	14.3 percentage of episodes	15.4 percentage of episodes	—
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	0.0 percentage of episodes	11.8 percentage of episodes	—
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	100.0 percentage of episodes	88.2 percentage of episodes	—
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	0.0 percentage of episodes	29.4 percentage of episodes	—

SECONDARY outcome

Timeframe: 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

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.

Outcome measures

Outcome measures
Measure	All Included Participants n=394 Participants All CHC genotype-1 participants included in study.	Telaprevir + PR n=298 Participants CHC genotype-1 participants included in study and prescribed telaprevir plus PR as routine clinical management.	PR Alone n=307 Participants CHC genotype-1 participants included in study and prescribed PR alone as routine clinical management	PR + Boceprevir + Telaprevir Group of Exposure n=6 Participants CHC genotype-1 participants included on study that received telaprevir + PR as routine clinical management and then switched to Boceprevir + PR treatment or vice-versa. 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 group was not mutually exclusive). The PR + Boceprevir+Telaprevir Treatment Group of Exposure included 3 participants who were switched from telaprevir + PR to boceprevir + PR, 2 participants who switched from boceprevir + PR to telaprevir + PR, and one participant who switched from boceprevir + PR to telaprevir + PR, and then to boceprevir + PR during follow-up.
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 Interval 0.767 to 1.749	3.302 events per 1000 participant-days Interval 2.76 to 3.918	3.001 events per 1000 participant-days Interval 2.499 to 3.572	5.122 events per 1000 participant-days Interval 1.395 to 13.113
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 Interval 0.86 to 1.899	1.656 events per 1000 participant-days Interval 1.315 to 2.058	0.807 events per 1000 participant-days Interval 0.591 to 1.077	3.195 events per 1000 participant-days Interval 0.659 to 9.337
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 Interval 0.495 to 1.319	0.757 events per 1000 participant-days Interval 0.544 to 1.027	0.596 events per 1000 participant-days Interval 0.413 to 0.832	1.556 events per 1000 participant-days Interval 0.188 to 5.622
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 Interval 0.001 to 0.253	0.117 events per 1000 participant-days Interval 0.047 to 0.242	0.430 events per 1000 participant-days Interval 0.281 to 0.63	0 events per 1000 participant-days Interval 0.0 to 0.0

Adverse Events

Boceprevir + PR

Serious events: 58 serious events

Other events: 178 other events

Deaths: 0 deaths

Telaprevir + PR

Serious events: 50 serious events

Other events: 173 other events

Deaths: 0 deaths

PR Alone

Serious events: 8 serious events

Other events: 25 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	Boceprevir + PR n=298 participants at risk CHC genotype-1 participants included in study and prescribed boceprevir plus PR as routine clinical management.	Telaprevir + PR n=307 participants at risk CHC genotype-1 participants included in study and prescribed telaprevir plus PR as routine clinical management.	PR Alone n=74 participants at risk CHC genotype-1 participants included in study and prescribed PR alone as routine clinical management
Blood and lymphatic system disorders Anaemia	44.6% 133/298 • Number of events 184 • Up to 14 days following a 48-week treatment regimen (up to 50 weeks) AEs reported for Analysis Population by CHC treatment arms (mutually exclusive). Nonserious AEs (NSAEs) that were non-HOIs were not actively solicited on this study, however spontaneous drug-related NSAEs were collected and reported. As prespecified by the protocol, AEs were not collected for the PR Alone Arm until after amendment 3 (6/18/2013).	42.3% 130/307 • Number of events 173 • Up to 14 days following a 48-week treatment regimen (up to 50 weeks) AEs reported for Analysis Population by CHC treatment arms (mutually exclusive). Nonserious AEs (NSAEs) that were non-HOIs were not actively solicited on this study, however spontaneous drug-related NSAEs were collected and reported. As prespecified by the protocol, AEs were not collected for the PR Alone Arm until after amendment 3 (6/18/2013).	12.2% 9/74 • Number of events 13 • Up to 14 days following a 48-week treatment regimen (up to 50 weeks) AEs reported for Analysis Population by CHC treatment arms (mutually exclusive). Nonserious AEs (NSAEs) that were non-HOIs were not actively solicited on this study, however spontaneous drug-related NSAEs were collected and reported. As prespecified by the protocol, AEs were not collected for the PR Alone Arm until after amendment 3 (6/18/2013).
Blood and lymphatic system disorders Neutropenia	29.9% 89/298 • Number of events 130 • Up to 14 days following a 48-week treatment regimen (up to 50 weeks) AEs reported for Analysis Population by CHC treatment arms (mutually exclusive). Nonserious AEs (NSAEs) that were non-HOIs were not actively solicited on this study, however spontaneous drug-related NSAEs were collected and reported. As prespecified by the protocol, AEs were not collected for the PR Alone Arm until after amendment 3 (6/18/2013).	16.0% 49/307 • Number of events 70 • Up to 14 days following a 48-week treatment regimen (up to 50 weeks) AEs reported for Analysis Population by CHC treatment arms (mutually exclusive). Nonserious AEs (NSAEs) that were non-HOIs were not actively solicited on this study, however spontaneous drug-related NSAEs were collected and reported. As prespecified by the protocol, AEs were not collected for the PR Alone Arm until after amendment 3 (6/18/2013).	14.9% 11/74 • Number of events 13 • Up to 14 days following a 48-week treatment regimen (up to 50 weeks) AEs reported for Analysis Population by CHC treatment arms (mutually exclusive). Nonserious AEs (NSAEs) that were non-HOIs were not actively solicited on this study, however spontaneous drug-related NSAEs were collected and reported. As prespecified by the protocol, AEs were not collected for the PR Alone Arm until after amendment 3 (6/18/2013).
Blood and lymphatic system disorders Thrombocytopenia	17.8% 53/298 • Number of events 67 • Up to 14 days following a 48-week treatment regimen (up to 50 weeks) AEs reported for Analysis Population by CHC treatment arms (mutually exclusive). Nonserious AEs (NSAEs) that were non-HOIs were not actively solicited on this study, however spontaneous drug-related NSAEs were collected and reported. As prespecified by the protocol, AEs were not collected for the PR Alone Arm until after amendment 3 (6/18/2013).	12.1% 37/307 • Number of events 56 • Up to 14 days following a 48-week treatment regimen (up to 50 weeks) AEs reported for Analysis Population by CHC treatment arms (mutually exclusive). Nonserious AEs (NSAEs) that were non-HOIs were not actively solicited on this study, however spontaneous drug-related NSAEs were collected and reported. As prespecified by the protocol, AEs were not collected for the PR Alone Arm until after amendment 3 (6/18/2013).	13.5% 10/74 • Number of events 15 • Up to 14 days following a 48-week treatment regimen (up to 50 weeks) AEs reported for Analysis Population by CHC treatment arms (mutually exclusive). Nonserious AEs (NSAEs) that were non-HOIs were not actively solicited on this study, however spontaneous drug-related NSAEs were collected and reported. As prespecified by the protocol, AEs were not collected for the PR Alone Arm until after amendment 3 (6/18/2013).
Skin and subcutaneous tissue disorders Rash	3.4% 10/298 • Number of events 11 • Up to 14 days following a 48-week treatment regimen (up to 50 weeks) AEs reported for Analysis Population by CHC treatment arms (mutually exclusive). Nonserious AEs (NSAEs) that were non-HOIs were not actively solicited on this study, however spontaneous drug-related NSAEs were collected and reported. As prespecified by the protocol, AEs were not collected for the PR Alone Arm until after amendment 3 (6/18/2013).	9.8% 30/307 • Number of events 31 • Up to 14 days following a 48-week treatment regimen (up to 50 weeks) AEs reported for Analysis Population by CHC treatment arms (mutually exclusive). Nonserious AEs (NSAEs) that were non-HOIs were not actively solicited on this study, however spontaneous drug-related NSAEs were collected and reported. As prespecified by the protocol, AEs were not collected for the PR Alone Arm until after amendment 3 (6/18/2013).	0.00% 0/74 • Up to 14 days following a 48-week treatment regimen (up to 50 weeks) AEs reported for Analysis Population by CHC treatment arms (mutually exclusive). Nonserious AEs (NSAEs) that were non-HOIs were not actively solicited on this study, however spontaneous drug-related NSAEs were collected and reported. As prespecified by the protocol, AEs were not collected for the PR Alone Arm until after amendment 3 (6/18/2013).

Additional Information

Senior Vice President, Global Clinical Development

Merck Sharp & Dohme Corp.

Phone: 1-800-672-6372

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee The Sponsor must have the opportunity to review all proposed abstracts, manuscripts or presentations regarding this study 60 days prior to submission for publication/presentation. Any information identified by the Sponsor as confidential must be deleted prior to submission. Sponsor review can be expedited to meet publication timelines.
Publication restrictions are in place

Restriction type: OTHER