Trial Outcomes & Findings for Efficacy of Pegetron® Redipen™ Treatment and Treatment Compliance of Patients With Chronic Hepatitis C in Canada (P04423) (NCT NCT00724893)

Results Overview

This is a measure of the number of participants achieving a viral response (negative hepatitis C virus ribonucleic acid \[HCV-RNA\]) at either of the follow-up evaluation time points (12 weeks \[window 10-14 weeks\] or ≥22 weeks after the end of treatment (EOT). Participants with no viral response information were considered viral response "no".

Recruitment status

COMPLETED

Target enrollment

2430 participants

Primary outcome timeframe

Up to 72 weeks

Results posted on

2015-08-14

Participant Flow

Participant milestones

Participant milestones
Measure	Stage 1 Participants Participants with chronic hepatitis C (CHC) receiving PegIFN-2b using Redipen™ formulation (1.5 mcg/kg) once weekly and ribavirin capsules (800-1400 mg) daily according to routine medical practice at participating study sites.	Stage 2 Participants Participants with CHC Genotype 1 receiving PegIFN-2b using Redipen™ formulation (1.5 mcg/kg) once weekly and ribavirin capsules (800-1400 mg) daily according to routine medical practice at participating study sites.
Overall Study STARTED	1302	1128
Overall Study COMPLETED	938	670
Overall Study NOT COMPLETED	364	458

Reasons for withdrawal

Reasons for withdrawal
Measure	Stage 1 Participants Participants with chronic hepatitis C (CHC) receiving PegIFN-2b using Redipen™ formulation (1.5 mcg/kg) once weekly and ribavirin capsules (800-1400 mg) daily according to routine medical practice at participating study sites.	Stage 2 Participants Participants with CHC Genotype 1 receiving PegIFN-2b using Redipen™ formulation (1.5 mcg/kg) once weekly and ribavirin capsules (800-1400 mg) daily according to routine medical practice at participating study sites.
Overall Study Adverse Event	76	142
Overall Study Withdrawal by Subject	0	1
Overall Study Lack of virologic response	94	202
Overall Study Reason not specified	193	7
Overall Study Patient choice	0	26
Overall Study Geographic reasons	0	11
Overall Study Incarceration	0	9
Overall Study Substance abuse	0	3
Overall Study Financial reasons	0	2
Overall Study Assigned shorter treatment	0	2
Overall Study Lost to Follow-up	0	52
Overall Study Unknown, missing data	1	1

Baseline Characteristics

Efficacy of Pegetron® Redipen™ Treatment and Treatment Compliance of Patients With Chronic Hepatitis C in Canada (P04423)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Stage 1 Participants n=1302 Participants Participants with chronic hepatitis C (CHC) receiving PegIFN-2b using Redipen™ formulation (1.5 mcg/kg) once weekly and ribavirin capsules (800-1400 mg) daily according to routine medical practice at participating study sites.	Stage 2 Participants n=1128 Participants Participants with CHC Genotype 1 receiving PegIFN-2b using Redipen™ formulation (1.5 mcg/kg) once weekly and ribavirin capsules (800-1400 mg) daily according to routine medical practice at participating study sites.	Total n=2430 Participants Total of all reporting groups
Age, Customized <25 years	23 Participants n=5 Participants	12 Participants n=7 Participants	35 Participants n=5 Participants
Age, Customized 24 to < 40 years	275 Participants n=5 Participants	217 Participants n=7 Participants	492 Participants n=5 Participants
Age, Customized 40 to < 55 yeats	783 Participants n=5 Participants	671 Participants n=7 Participants	1454 Participants n=5 Participants
Age, Customized >55 years	221 Participants n=5 Participants	228 Participants n=7 Participants	449 Participants n=5 Participants
Sex: Female, Male Female	432 Participants n=5 Participants	346 Participants n=7 Participants	778 Participants n=5 Participants
Sex: Female, Male Male	870 Participants n=5 Participants	782 Participants n=7 Participants	1652 Participants n=5 Participants

PRIMARY outcome

Timeframe: Up to 72 weeks

Population: All participants who took at least one dose of study medication (ITT Population)

This is a measure of the number of participants achieving a viral response (negative hepatitis C virus ribonucleic acid \[HCV-RNA\]) at either of the follow-up evaluation time points (12 weeks \[window 10-14 weeks\] or ≥22 weeks after the end of treatment (EOT). Participants with no viral response information were considered viral response "no".

Outcome measures

Outcome measures
Measure	Stage 1 Participants n=1302 Participants Participants with chronic hepatitis C (CHC) receiving PegIFN-2b using Redipen™ formulation (1.5 mcg/kg) once weekly and ribavirin capsules (800-1400 mg) daily according to routine medical practice at participating study sites.	Stage 2 Participants Participants with CHC Genotype 1 receiving PegIFN-2b using Redipen™ formulation (1.5 mcg/kg) once weekly and ribavirin capsules (800-1400 mg) daily according to routine medical practice at participating study sites.	Stage F2 Participants with Fibrosis Stage F2	Stage F3 Participants with Fibrosis Stage F4	Stage F4 Participants with Fibrosis Stage F4	Unknown Stage Participants with unknown Fibrosis Stage
Number of Participants Achieving Viral Response at Any Evaluation Point (Stage 1)	685 participants	—	—	—	—	—

PRIMARY outcome

Timeframe: Up to 62 weeks

Population: All participants who took at least one dose of study medication (ITT population)

This is a measure of the number of participants achieving a viral response (negative HCV-RNA) at 12 weeks (window 10-14 weeks) after EOT. Participants with no viral response information were considered viral response "no".

Outcome measures

Outcome measures
Measure	Stage 1 Participants n=1302 Participants Participants with chronic hepatitis C (CHC) receiving PegIFN-2b using Redipen™ formulation (1.5 mcg/kg) once weekly and ribavirin capsules (800-1400 mg) daily according to routine medical practice at participating study sites.	Stage 2 Participants Participants with CHC Genotype 1 receiving PegIFN-2b using Redipen™ formulation (1.5 mcg/kg) once weekly and ribavirin capsules (800-1400 mg) daily according to routine medical practice at participating study sites.	Stage F2 Participants with Fibrosis Stage F2	Stage F3 Participants with Fibrosis Stage F4	Stage F4 Participants with Fibrosis Stage F4	Unknown Stage Participants with unknown Fibrosis Stage
Number of Participants Achieving Viral Response at 12 Weeks After EOT (Stage 1)	660 Participants	—	—	—	—	—

PRIMARY outcome

Timeframe: Up to 72 weeks

Population: All participants who took at least one dose of study medication (ITT population)

This is a measure of the number of participants who achieved SVR, defined as HCV-RNA negative at ≥22 weeks after EOT. Participants with no viral response information were considered viral response "no".

Outcome measures

Outcome measures
Measure	Stage 1 Participants n=1302 Participants Participants with chronic hepatitis C (CHC) receiving PegIFN-2b using Redipen™ formulation (1.5 mcg/kg) once weekly and ribavirin capsules (800-1400 mg) daily according to routine medical practice at participating study sites.	Stage 2 Participants Participants with CHC Genotype 1 receiving PegIFN-2b using Redipen™ formulation (1.5 mcg/kg) once weekly and ribavirin capsules (800-1400 mg) daily according to routine medical practice at participating study sites.	Stage F2 Participants with Fibrosis Stage F2	Stage F3 Participants with Fibrosis Stage F4	Stage F4 Participants with Fibrosis Stage F4	Unknown Stage Participants with unknown Fibrosis Stage
Number of Participants Achieving Sustained Viral Response (SVR) (Stage 1)	638 Participants	—	—	—	—	—

PRIMARY outcome

Timeframe: Up to 72 weeks

Population: All participants who took at least one dose of study medication (ITT Population)

SVR was defined as HCV-RNA negative at six months after EOT. Participants with no viral response information were considered viral response "no".

Outcome measures

Outcome measures
Measure	Stage 1 Participants n=1128 Participants Participants with chronic hepatitis C (CHC) receiving PegIFN-2b using Redipen™ formulation (1.5 mcg/kg) once weekly and ribavirin capsules (800-1400 mg) daily according to routine medical practice at participating study sites.	Stage 2 Participants Participants with CHC Genotype 1 receiving PegIFN-2b using Redipen™ formulation (1.5 mcg/kg) once weekly and ribavirin capsules (800-1400 mg) daily according to routine medical practice at participating study sites.	Stage F2 Participants with Fibrosis Stage F2	Stage F3 Participants with Fibrosis Stage F4	Stage F4 Participants with Fibrosis Stage F4	Unknown Stage Participants with unknown Fibrosis Stage
Number of Participants Achieving SVR (Stage 2)	468 participants	—	—	—	—	—

SECONDARY outcome

Timeframe: Up to 48 weeks

Population: All participants who took at least one dose of study medication (ITT Population)

An adverse event is any unfavorable and unintended change in the structure, function, or chemistry of the body whether or not considered related to the study treatment

Outcome measures

Outcome measures
Measure	Stage 1 Participants n=1302 Participants Participants with chronic hepatitis C (CHC) receiving PegIFN-2b using Redipen™ formulation (1.5 mcg/kg) once weekly and ribavirin capsules (800-1400 mg) daily according to routine medical practice at participating study sites.	Stage 2 Participants n=1128 Participants Participants with CHC Genotype 1 receiving PegIFN-2b using Redipen™ formulation (1.5 mcg/kg) once weekly and ribavirin capsules (800-1400 mg) daily according to routine medical practice at participating study sites.	Stage F2 Participants with Fibrosis Stage F2	Stage F3 Participants with Fibrosis Stage F4	Stage F4 Participants with Fibrosis Stage F4	Unknown Stage Participants with unknown Fibrosis Stage
Number of Participants Discontinued From Study Treatment Due to Adverse Events (Stage 1 and Stage 2)	76 participants	142 participants	—	—	—	—

SECONDARY outcome

Timeframe: Up to 72 weeks

Population: Participants in the ITT population with EVR evaluation at Treatment Week 12

Viral response was defined as negative HCV-RNA. EVR was defined as either HCV-RNA detectable with a ≥2 log reduction from baseline or HCV-RNA negative at Treatment Week 12. Participants with no viral response information were considered viral response "no".

Outcome measures

Outcome measures
Measure	Stage 1 Participants n=1213 Participants Participants with chronic hepatitis C (CHC) receiving PegIFN-2b using Redipen™ formulation (1.5 mcg/kg) once weekly and ribavirin capsules (800-1400 mg) daily according to routine medical practice at participating study sites.	Stage 2 Participants Participants with CHC Genotype 1 receiving PegIFN-2b using Redipen™ formulation (1.5 mcg/kg) once weekly and ribavirin capsules (800-1400 mg) daily according to routine medical practice at participating study sites.	Stage F2 Participants with Fibrosis Stage F2	Stage F3 Participants with Fibrosis Stage F4	Stage F4 Participants with Fibrosis Stage F4	Unknown Stage Participants with unknown Fibrosis Stage
Number of Participants Achieving Viral Response at Any Evaluation Point, Excluding Participants Who Discontinued Treatment Prior to Early Virologic Response (EVR) Evaluation (Stage 1)	685 Participants	—	—	—	—	—

SECONDARY outcome

Timeframe: Up to 62 weeks

Population: Participants in the ITT population with EVR evaluation at Treatment Week 12

Viral response was defined as negative HCV-RNA. EVR was defined as either HCV-RNA detectable with a ≥2 log reduction from baseline or HCV-RNA negative at Treatment Week 12. Participants with no viral response information were considered viral response "no".

Outcome measures

Outcome measures
Measure	Stage 1 Participants n=1213 Participants Participants with chronic hepatitis C (CHC) receiving PegIFN-2b using Redipen™ formulation (1.5 mcg/kg) once weekly and ribavirin capsules (800-1400 mg) daily according to routine medical practice at participating study sites.	Stage 2 Participants Participants with CHC Genotype 1 receiving PegIFN-2b using Redipen™ formulation (1.5 mcg/kg) once weekly and ribavirin capsules (800-1400 mg) daily according to routine medical practice at participating study sites.	Stage F2 Participants with Fibrosis Stage F2	Stage F3 Participants with Fibrosis Stage F4	Stage F4 Participants with Fibrosis Stage F4	Unknown Stage Participants with unknown Fibrosis Stage
Number of Participants Achieving Viral Response at 12 Weeks After EOT, Excluding Participants Who Discontinued Prior to EVR Evaluation (Stage 1)	660 Participants	—	—	—	—	—

SECONDARY outcome

Timeframe: Up to 72 weeks

Population: Participants in the ITT population with EVR evaluation at Treatment Week 12

SVR was defined as HCV-RNA negative at ≥22 weeks after EOT. EVR was defined as either HCV-RNA detectable with a ≥2 log reduction from baseline or HCV-RNA negative at Treatment Week 12. Participants with no viral response information were considered viral response "no".

Outcome measures

Outcome measures
Measure	Stage 1 Participants n=1213 Participants Participants with chronic hepatitis C (CHC) receiving PegIFN-2b using Redipen™ formulation (1.5 mcg/kg) once weekly and ribavirin capsules (800-1400 mg) daily according to routine medical practice at participating study sites.	Stage 2 Participants Participants with CHC Genotype 1 receiving PegIFN-2b using Redipen™ formulation (1.5 mcg/kg) once weekly and ribavirin capsules (800-1400 mg) daily according to routine medical practice at participating study sites.	Stage F2 Participants with Fibrosis Stage F2	Stage F3 Participants with Fibrosis Stage F4	Stage F4 Participants with Fibrosis Stage F4	Unknown Stage Participants with unknown Fibrosis Stage
Number of Participants Achieving SVR, Excluding Participants Who Discontinued Prior to EVR Evaluation (Stage 1)	638 Participants	—	—	—	—	—

SECONDARY outcome

Timeframe: Up to 62 weeks

Population: Participants in the ITT population with EVR evaluation at Treatment Week 12 and no missing data

Viral response was defined as negative HCV-RNA; evaluation was done 12 weeks (window 10-14 weeks) after EOT. EVR was defined as either HCV-RNA detectable with a ≥2 log reduction from baseline or HCV-RNA negative at Treatment Week 12. Participants with no viral response information were considered viral response "no".

Outcome measures

Outcome measures
Measure	Stage 1 Participants n=1126 Participants Participants with chronic hepatitis C (CHC) receiving PegIFN-2b using Redipen™ formulation (1.5 mcg/kg) once weekly and ribavirin capsules (800-1400 mg) daily according to routine medical practice at participating study sites.	Stage 2 Participants Participants with CHC Genotype 1 receiving PegIFN-2b using Redipen™ formulation (1.5 mcg/kg) once weekly and ribavirin capsules (800-1400 mg) daily according to routine medical practice at participating study sites.	Stage F2 Participants with Fibrosis Stage F2	Stage F3 Participants with Fibrosis Stage F4	Stage F4 Participants with Fibrosis Stage F4	Unknown Stage Participants with unknown Fibrosis Stage
The Number of Participants Achieving Viral Response at 12 Weeks After EOT, Excluding Participants Who Discontinued Prior to EVR Evaluation and Participants With Missing Data (Stage 1)	679 Participants	—	—	—	—	—

SECONDARY outcome

Timeframe: Up to 72 weeks

Population: Participants in the ITT population with EVR evaluation at Treatment Week 12 and no missing data

SVR was defined as HCV-RNA negative at ≥22 weeks after EOT. EVR was defined as either HCV-RNA detectable with a ≥2 log reduction from baseline or HCV-RNA negative at Treatment Week 12. Participants with no viral response information were considered viral response "no".

Outcome measures

Outcome measures
Measure	Stage 1 Participants n=1037 Participants Participants with chronic hepatitis C (CHC) receiving PegIFN-2b using Redipen™ formulation (1.5 mcg/kg) once weekly and ribavirin capsules (800-1400 mg) daily according to routine medical practice at participating study sites.	Stage 2 Participants Participants with CHC Genotype 1 receiving PegIFN-2b using Redipen™ formulation (1.5 mcg/kg) once weekly and ribavirin capsules (800-1400 mg) daily according to routine medical practice at participating study sites.	Stage F2 Participants with Fibrosis Stage F2	Stage F3 Participants with Fibrosis Stage F4	Stage F4 Participants with Fibrosis Stage F4	Unknown Stage Participants with unknown Fibrosis Stage
The Number of Participants Achieving SVR Excluding Participants Who Discontinued Prior to EVR Evaluation and Participants With Missing Data (Stage 1)	612 participants	—	—	—	—	—

SECONDARY outcome

Timeframe: Up to 62 weeks

Population: All participants who took at least one dose of study medication (ITT population).

Viral response was defined as negative HCV-RNA; evaluation was done 12 weeks (window 10-14 weeks) after EOT. Participants with no viral response information were considered viral response "no". For this analysis participants were grouped by their HCV genotype (Types 1-6); a genotype is a classification based on the differences in the genetic material within the hepatitis virus. Knowing the HCV genotype helps with deciding what type and what duration of treatment will be needed because each genotype demonstrates a different response to treatment in infected individuals.

Outcome measures

Outcome measures
Measure	Stage 1 Participants n=1302 Participants Participants with chronic hepatitis C (CHC) receiving PegIFN-2b using Redipen™ formulation (1.5 mcg/kg) once weekly and ribavirin capsules (800-1400 mg) daily according to routine medical practice at participating study sites.	Stage 2 Participants Participants with CHC Genotype 1 receiving PegIFN-2b using Redipen™ formulation (1.5 mcg/kg) once weekly and ribavirin capsules (800-1400 mg) daily according to routine medical practice at participating study sites.	Stage F2 Participants with Fibrosis Stage F2	Stage F3 Participants with Fibrosis Stage F4	Stage F4 Participants with Fibrosis Stage F4	Unknown Stage Participants with unknown Fibrosis Stage
The Number of Participants Achieving Viral Response at 12 Weeks After EOT by Chronic HCV Genotype (Stage 1) Genotype 5 (n=0)	0 Participants	—	—	—	—	—
The Number of Participants Achieving Viral Response at 12 Weeks After EOT by Chronic HCV Genotype (Stage 1) Genotype 6 (n=2)	2 Participants	—	—	—	—	—
The Number of Participants Achieving Viral Response at 12 Weeks After EOT by Chronic HCV Genotype (Stage 1) Genotype unknown (n=2)	0 Participants	—	—	—	—	—
The Number of Participants Achieving Viral Response at 12 Weeks After EOT by Chronic HCV Genotype (Stage 1) Genotype 1 (n=757)	308 Participants	—	—	—	—	—
The Number of Participants Achieving Viral Response at 12 Weeks After EOT by Chronic HCV Genotype (Stage 1) Genotype 2 (n=172)	129 Participants	—	—	—	—	—
The Number of Participants Achieving Viral Response at 12 Weeks After EOT by Chronic HCV Genotype (Stage 1) Genotype 3 (n=348)	215 Participants	—	—	—	—	—
The Number of Participants Achieving Viral Response at 12 Weeks After EOT by Chronic HCV Genotype (Stage 1) Genotype 4 (n=21)	6 Participants	—	—	—	—	—

SECONDARY outcome

Timeframe: Up to 62 weeks

Population: All participants who took at least one dose of study medication (ITT population)

Viral response was defined as negative HCV-RNA; evaluation was done 12 weeks (window 10-14 weeks) after EOT. Participants with no viral response information were considered viral response "no". Liver fibrosis stage was measured with the METAVIR scoring system (F0=no fibrosis or liver damage, F1 = beginning of liver damage with some slight scarring, F2 = moderate liver damage, scarring advancing in liver and surrounding blood vessels, F3 =significant liver damage, the liver becomes fibrotic \[scarred\] and connects with other scarred areas, and F4 = severe damage \[cirrhosis\] and liver no longer functions properly).

Outcome measures

Outcome measures
Measure	Stage 1 Participants n=1302 Participants Participants with chronic hepatitis C (CHC) receiving PegIFN-2b using Redipen™ formulation (1.5 mcg/kg) once weekly and ribavirin capsules (800-1400 mg) daily according to routine medical practice at participating study sites.	Stage 2 Participants Participants with CHC Genotype 1 receiving PegIFN-2b using Redipen™ formulation (1.5 mcg/kg) once weekly and ribavirin capsules (800-1400 mg) daily according to routine medical practice at participating study sites.	Stage F2 Participants with Fibrosis Stage F2	Stage F3 Participants with Fibrosis Stage F4	Stage F4 Participants with Fibrosis Stage F4	Unknown Stage Participants with unknown Fibrosis Stage
The Number of Participants Achieving Viral Response at 12 Weeks After EOT by Liver Fibrosis Stage (Stage 1) F0 (n=59)	34 Participants	—	—	—	—	—
The Number of Participants Achieving Viral Response at 12 Weeks After EOT by Liver Fibrosis Stage (Stage 1) F1 (n=159)	89 Participants	—	—	—	—	—
The Number of Participants Achieving Viral Response at 12 Weeks After EOT by Liver Fibrosis Stage (Stage 1) F2 (n=216)	95 Participants	—	—	—	—	—
The Number of Participants Achieving Viral Response at 12 Weeks After EOT by Liver Fibrosis Stage (Stage 1) F3 (n=128)	51 Participants	—	—	—	—	—
The Number of Participants Achieving Viral Response at 12 Weeks After EOT by Liver Fibrosis Stage (Stage 1) F4 (n=111)	40 Participants	—	—	—	—	—
The Number of Participants Achieving Viral Response at 12 Weeks After EOT by Liver Fibrosis Stage (Stage 1) Fibrosis stage unknown (n=629)	351 Participants	—	—	—	—	—

SECONDARY outcome

Timeframe: Up to 72 weeks

Population: All participants who took at least one dose of study medication (ITT Population)

SVR was defined as HCV-RNA negative at ≥22 weeks after EOT. Participants with no viral response information were considered viral response "no". Liver fibrosis stage was measured with the METAVIR scoring system (F0=no fibrosis or liver damage, F1 = beginning of liver damage with some slight scarring, F2 = moderate liver damage, scarring advancing in liver and surrounding blood vessels, F3 = significant liver damage, the liver is fibrotic \[scarred\] and connects with other scarred areas, and F4 = severe damage \[cirrhosis\] and liver no longer functions properly).

Outcome measures

Outcome measures
Measure	Stage 1 Participants n=1302 Participants Participants with chronic hepatitis C (CHC) receiving PegIFN-2b using Redipen™ formulation (1.5 mcg/kg) once weekly and ribavirin capsules (800-1400 mg) daily according to routine medical practice at participating study sites.	Stage 2 Participants Participants with CHC Genotype 1 receiving PegIFN-2b using Redipen™ formulation (1.5 mcg/kg) once weekly and ribavirin capsules (800-1400 mg) daily according to routine medical practice at participating study sites.	Stage F2 Participants with Fibrosis Stage F2	Stage F3 Participants with Fibrosis Stage F4	Stage F4 Participants with Fibrosis Stage F4	Unknown Stage Participants with unknown Fibrosis Stage
Number of Participants Achieving SVR by Liver Fibrosis Stage (Stage 1) F0 (n=59)	33 participants	—	—	—	—	—
Number of Participants Achieving SVR by Liver Fibrosis Stage (Stage 1) F1 (n=159)	85 participants	—	—	—	—	—
Number of Participants Achieving SVR by Liver Fibrosis Stage (Stage 1) F2 (n=216)	90 participants	—	—	—	—	—
Number of Participants Achieving SVR by Liver Fibrosis Stage (Stage 1) F3 (n=128)	49 participants	—	—	—	—	—
Number of Participants Achieving SVR by Liver Fibrosis Stage (Stage 1) F4 (n=111)	38 participants	—	—	—	—	—
Number of Participants Achieving SVR by Liver Fibrosis Stage (Stage 1) Fibrosis stage unknown (n=629)	343 participants	—	—	—	—	—

SECONDARY outcome

Timeframe: Up to 72 weeks

Population: All participants who took at least one dose of study medication (ITT Population)

SVR was defined as HCV-RNA negative at ≥22 weeks following EOT. Participants with no viral response information were considered viral response "no". For this analysis participants were grouped by their HCV genotype (Types 1-6); a genotype is a classification based on the differences in the genetic material within the hepatitis virus. Knowing the HCV genotype helps with deciding what type and what duration of treatment will be needed because each genotype demonstrates a different response to treatment in infected individuals.

Outcome measures

Outcome measures
Measure	Stage 1 Participants n=1302 Participants Participants with chronic hepatitis C (CHC) receiving PegIFN-2b using Redipen™ formulation (1.5 mcg/kg) once weekly and ribavirin capsules (800-1400 mg) daily according to routine medical practice at participating study sites.	Stage 2 Participants Participants with CHC Genotype 1 receiving PegIFN-2b using Redipen™ formulation (1.5 mcg/kg) once weekly and ribavirin capsules (800-1400 mg) daily according to routine medical practice at participating study sites.	Stage F2 Participants with Fibrosis Stage F2	Stage F3 Participants with Fibrosis Stage F4	Stage F4 Participants with Fibrosis Stage F4	Unknown Stage Participants with unknown Fibrosis Stage
Number of Participants Achieving SVR by Chronic HCV Genotype (Stage 1) Genotype 1 (n=757)	298 participants	—	—	—	—	—
Number of Participants Achieving SVR by Chronic HCV Genotype (Stage 1) Genotype 2 (n=172)	126 participants	—	—	—	—	—
Number of Participants Achieving SVR by Chronic HCV Genotype (Stage 1) Genotype 3 (n=348)	207 participants	—	—	—	—	—
Number of Participants Achieving SVR by Chronic HCV Genotype (Stage 1) Genotype 4 (n=21)	5 participants	—	—	—	—	—
Number of Participants Achieving SVR by Chronic HCV Genotype (Stage 1) Genotype 5 (n=0)	0 participants	—	—	—	—	—
Number of Participants Achieving SVR by Chronic HCV Genotype (Stage 1) Genotype 6 (n=2)	2 participants	—	—	—	—	—
Number of Participants Achieving SVR by Chronic HCV Genotype (Stage 1) Genotype missing (n=2)	0 participants	—	—	—	—	—

SECONDARY outcome

Timeframe: Up to 72 weeks

Population: All participants who took at least one dose of study medication (ITT Population)

SVR was defined as HCV-RNA negative at ≥22 weeks after EOT. Participants with no viral response information were considered viral response "no". Viral load categories were defined as High (≥100,000 Iu/mL) or Low (\<100,000 Iu/mL).

Outcome measures

Outcome measures
Measure	Stage 1 Participants n=1302 Participants Participants with chronic hepatitis C (CHC) receiving PegIFN-2b using Redipen™ formulation (1.5 mcg/kg) once weekly and ribavirin capsules (800-1400 mg) daily according to routine medical practice at participating study sites.	Stage 2 Participants Participants with CHC Genotype 1 receiving PegIFN-2b using Redipen™ formulation (1.5 mcg/kg) once weekly and ribavirin capsules (800-1400 mg) daily according to routine medical practice at participating study sites.	Stage F2 Participants with Fibrosis Stage F2	Stage F3 Participants with Fibrosis Stage F4	Stage F4 Participants with Fibrosis Stage F4	Unknown Stage Participants with unknown Fibrosis Stage
Number of Participants Achieving SVR by Viral Load (Stage 1) Viral load high (n=836)	353 participants	—	—	—	—	—
Number of Participants Achieving SVR by Viral Load (Stage 1) Viral load low (n=109)	63 participants	—	—	—	—	—
Number of Participants Achieving SVR by Viral Load (Stage 1) Viral load missing (n=357)	222 participants	—	—	—	—	—

SECONDARY outcome

Timeframe: Up to 72 weeks

Population: All participants who took at least one dose of study medication (ITT Population)

SVR was defined as HCV-RNA negative at ≥22 weeks after EOT. Participants with no viral response information were considered viral response "no".

Outcome measures

Outcome measures
Measure	Stage 1 Participants n=1302 Participants Participants with chronic hepatitis C (CHC) receiving PegIFN-2b using Redipen™ formulation (1.5 mcg/kg) once weekly and ribavirin capsules (800-1400 mg) daily according to routine medical practice at participating study sites.	Stage 2 Participants Participants with CHC Genotype 1 receiving PegIFN-2b using Redipen™ formulation (1.5 mcg/kg) once weekly and ribavirin capsules (800-1400 mg) daily according to routine medical practice at participating study sites.	Stage F2 Participants with Fibrosis Stage F2	Stage F3 Participants with Fibrosis Stage F4	Stage F4 Participants with Fibrosis Stage F4	Unknown Stage Participants with unknown Fibrosis Stage
Number of Participants Achieving SVR by Weight (Stage 1) 50 to <64 kg (n=160)	82 participants	—	—	—	—	—
Number of Participants Achieving SVR by Weight (Stage 1) 64 to <75 kg (n=297)	158 participants	—	—	—	—	—
Number of Participants Achieving SVR by Weight (Stage 1) 75 to <85 kg (n=283)	137 participants	—	—	—	—	—
Number of Participants Achieving SVR by Weight (Stage 1) 40 to <50 kg (n=21)	10 participants	—	—	—	—	—
Number of Participants Achieving SVR by Weight (Stage 1) >85 kg (n=541)	251 participants	—	—	—	—	—

SECONDARY outcome

Timeframe: Up to 72 weeks

Population: All participants who took at least one dose of study medication (ITT Population); no participants had Genotype 5

SVR was defined as HCV-RNA negative at ≥22 weeks after EOT. Participants with no viral response information were considered viral response "no". Liver fibrosis stage was measured with the METAVIR scoring system (F0=no fibrosis or liver damage, F1 = beginning of liver damage with some slight scarring, F2 = moderate liver damage, scarring advancing in liver and surrounding blood vessels, F3 =significant liver damage, the liver becomes fibrotic \[scarred\] and connects with other scarred areas, and F4 = severe damage \[cirrhosis\] and liver no longer functions properly). For this analysis participants were grouped by their HCV genotype (Types 1-6); a genotype is a classification based on the differences in the genetic material within the hepatitis virus. Knowing the HCV genotype helps with deciding what type and what duration of treatment will be needed because each genotype demonstrates a different response to treatment in infected individuals.

Outcome measures

Outcome measures
Measure	Stage 1 Participants n=59 Participants Participants with chronic hepatitis C (CHC) receiving PegIFN-2b using Redipen™ formulation (1.5 mcg/kg) once weekly and ribavirin capsules (800-1400 mg) daily according to routine medical practice at participating study sites.	Stage 2 Participants n=159 Participants Participants with CHC Genotype 1 receiving PegIFN-2b using Redipen™ formulation (1.5 mcg/kg) once weekly and ribavirin capsules (800-1400 mg) daily according to routine medical practice at participating study sites.	Stage F2 n=216 Participants Participants with Fibrosis Stage F2	Stage F3 n=128 Participants Participants with Fibrosis Stage F4	Stage F4 n=111 Participants Participants with Fibrosis Stage F4	Unknown Stage n=629 Participants Participants with unknown Fibrosis Stage
Number of Participants Achieving SVR by Chronic HCV Genotype + Liver Fibrosis Stage (Stage 1) Genotype 3 (n=348)	8 participants	13 participants	13 participants	10 participants	9 participants	154 participants
Number of Participants Achieving SVR by Chronic HCV Genotype + Liver Fibrosis Stage (Stage 1) Genotype 4 (n=21)	0 participants	0 participants	0 participants	0 participants	2 participants	3 participants
Number of Participants Achieving SVR by Chronic HCV Genotype + Liver Fibrosis Stage (Stage 1) Genotype 1 (n=757)	21 participants	55 participants	64 participants	28 participants	25 participants	105 participants
Number of Participants Achieving SVR by Chronic HCV Genotype + Liver Fibrosis Stage (Stage 1) Genotype 2 (n=172)	4 participants	17 participants	13 participants	9 participants	2 participants	81 participants
Number of Participants Achieving SVR by Chronic HCV Genotype + Liver Fibrosis Stage (Stage 1) Genotype 6 (n=2)	0 participants	0 participants	0 participants	2 participants	0 participants	0 participants
Number of Participants Achieving SVR by Chronic HCV Genotype + Liver Fibrosis Stage (Stage 1) Unknown Genotype (n=2)	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants

SECONDARY outcome

Timeframe: Up to 72 weeks

Population: All participants who took at least one dose of study medication (ITT Population); no participants had Genotype 5

SVR was defined as HCV-RNA negative at ≥22 weeks after EOT. Participants with no viral response information were considered viral response "no". Viral load categories were defined as High (≥100,000 Iu/mL) or Low (\<100,000 Iu/mL). For this analysis participants were grouped by their HCV genotype (Types 1-6); a genotype is a classification based on the differences in the genetic material within the hepatitis virus. Knowing the HCV genotype helps with deciding what type and what duration of treatment will be needed because each genotype demonstrates a different response to treatment in infected individuals.

Outcome measures

Outcome measures
Measure	Stage 1 Participants n=836 Participants Participants with chronic hepatitis C (CHC) receiving PegIFN-2b using Redipen™ formulation (1.5 mcg/kg) once weekly and ribavirin capsules (800-1400 mg) daily according to routine medical practice at participating study sites.	Stage 2 Participants n=109 Participants Participants with CHC Genotype 1 receiving PegIFN-2b using Redipen™ formulation (1.5 mcg/kg) once weekly and ribavirin capsules (800-1400 mg) daily according to routine medical practice at participating study sites.	Stage F2 n=357 Participants Participants with Fibrosis Stage F2	Stage F3 Participants with Fibrosis Stage F4	Stage F4 Participants with Fibrosis Stage F4	Unknown Stage Participants with unknown Fibrosis Stage
Number of Participants Achieving SVR by Chronic HCV Genotype + Viral Load (Stage 1) Genotype 1 (n=757)	222 participants	42 participants	34 participants	—	—	—
Number of Participants Achieving SVR by Chronic HCV Genotype + Viral Load (Stage 1) Genotype 2 (n=172)	53 participants	4 participants	69 participants	—	—	—
Number of Participants Achieving SVR by Chronic HCV Genotype + Viral Load (Stage 1) Genotype 3 (n=348)	74 participants	14 participants	119 participants	—	—	—
Number of Participants Achieving SVR by Chronic HCV Genotype + Viral Load (Stage 1) Genotype 4 (n=21)	2 participants	3 participants	0 participants	—	—	—
Number of Participants Achieving SVR by Chronic HCV Genotype + Viral Load (Stage 1) Genotype 6 (n=2)	2 participants	0 participants	0 participants	—	—	—
Number of Participants Achieving SVR by Chronic HCV Genotype + Viral Load (Stage 1) Unknown Genotype (n=2)	0 participants	0 participants	0 participants	—	—	—

SECONDARY outcome

Timeframe: Up to 72 weeks

Population: All participants who took at least one dose of study medication (ITT Population); no participants had Genotype 5

SVR was defined as HCV-RNA negative at ≥22 weeks after EOT. Participants with no viral response information were considered viral response "no". For this analysis participants were grouped by their HCV genotype (Types 1-6); a genotype is a classification based on the differences in the genetic material within the hepatitis virus. Knowing the HCV genotype helps with deciding what type and what duration of treatment will be needed because each genotype demonstrates a different response to treatment in infected individuals.

Outcome measures

Outcome measures
Measure	Stage 1 Participants n=21 Participants Participants with chronic hepatitis C (CHC) receiving PegIFN-2b using Redipen™ formulation (1.5 mcg/kg) once weekly and ribavirin capsules (800-1400 mg) daily according to routine medical practice at participating study sites.	Stage 2 Participants n=160 Participants Participants with CHC Genotype 1 receiving PegIFN-2b using Redipen™ formulation (1.5 mcg/kg) once weekly and ribavirin capsules (800-1400 mg) daily according to routine medical practice at participating study sites.	Stage F2 n=297 Participants Participants with Fibrosis Stage F2	Stage F3 n=283 Participants Participants with Fibrosis Stage F4	Stage F4 n=541 Participants Participants with Fibrosis Stage F4	Unknown Stage Participants with unknown Fibrosis Stage
Number of Participants Achieving SVR by Weight + Chronic HCV Genotype (Stage 1) Genotype 1 (n=757)	4 participants	39 participants	76 participants	61 participants	118 participants	—
Number of Participants Achieving SVR by Weight + Chronic HCV Genotype (Stage 1) Genotype 2 (n=172)	5 participants	11 participants	26 participants	26 participants	58 participants	—
Number of Participants Achieving SVR by Weight + Chronic HCV Genotype (Stage 1) Genotype 3 (n=348)	1 participants	31 participants	53 participants	47 participants	75 participants	—
Number of Participants Achieving SVR by Weight + Chronic HCV Genotype (Stage 1) Genotype 4 (n=21)	0 participants	0 participants	2 participants	3 participants	0 participants	—
Number of Participants Achieving SVR by Weight + Chronic HCV Genotype (Stage 1) Genotype 6 (n=2)	0 participants	1 participants	1 participants	0 participants	0 participants	—
Number of Participants Achieving SVR by Weight + Chronic HCV Genotype (Stage 1) Genotype unknown (n=2)	0 participants	0 participants	0 participants	0 participants	0 participants	—

SECONDARY outcome

Timeframe: From Week 10 to Week 14

Population: The EVR analysis population comprised participants with HCV Genotypes 1, 4, and 6 only, who took at least one dose of study medication.

EVR was defined as either HCV-RNA detectable with a ≥2 log reduction from baseline or HCV-RNA negative after 12 weeks of treatment. Participants with no viral response information were considered viral response "no".

Outcome measures

Outcome measures
Measure	Stage 1 Participants n=780 Participants Participants with chronic hepatitis C (CHC) receiving PegIFN-2b using Redipen™ formulation (1.5 mcg/kg) once weekly and ribavirin capsules (800-1400 mg) daily according to routine medical practice at participating study sites.	Stage 2 Participants Participants with CHC Genotype 1 receiving PegIFN-2b using Redipen™ formulation (1.5 mcg/kg) once weekly and ribavirin capsules (800-1400 mg) daily according to routine medical practice at participating study sites.	Stage F2 Participants with Fibrosis Stage F2	Stage F3 Participants with Fibrosis Stage F4	Stage F4 Participants with Fibrosis Stage F4	Unknown Stage Participants with unknown Fibrosis Stage
Number of Participants Achieving EVR (Stage 1)	473 participants	—	—	—	—	—

SECONDARY outcome

Timeframe: Up to 72 weeks

Population: The EVR analysis population comprised participants with HCV Genotypes 1, 4, 5, and 6 who took at least one dose of study medication. No participants had Genotype 5.

EVR was defined as either HCV-RNA detectable with a ≥2 log reduction from baseline or HCV-RNA negative after 12 weeks of treatment. SVR was defined as HCV-RNA negative at ≥22 weeks after EOT. Participants with no viral response information were considered viral response "no".

Outcome measures

Outcome measures
Measure	Stage 1 Participants n=473 Participants Participants with chronic hepatitis C (CHC) receiving PegIFN-2b using Redipen™ formulation (1.5 mcg/kg) once weekly and ribavirin capsules (800-1400 mg) daily according to routine medical practice at participating study sites.	Stage 2 Participants Participants with CHC Genotype 1 receiving PegIFN-2b using Redipen™ formulation (1.5 mcg/kg) once weekly and ribavirin capsules (800-1400 mg) daily according to routine medical practice at participating study sites.	Stage F2 Participants with Fibrosis Stage F2	Stage F3 Participants with Fibrosis Stage F4	Stage F4 Participants with Fibrosis Stage F4	Unknown Stage Participants with unknown Fibrosis Stage
Number of Participants Achieving SVR by EVR Type (Stage 1) EVR by ≥2 log reduction from baseline (n=78)	15 participants	—	—	—	—	—
Number of Participants Achieving SVR by EVR Type (Stage 1) EVR by HCV-RNA negative (n=389)	253 participants	—	—	—	—	—
Number of Participants Achieving SVR by EVR Type (Stage 1) EVR missing (n=6)	2 participants	—	—	—	—	—

SECONDARY outcome

Timeframe: Up to 72 weeks

Population: All participants who took at least one dose of study medication (ITT Population)

SVR was defined as HCV-RNA negative at ≥22 weeks after EOT. Participants with no viral response information were considered viral response "no".

Outcome measures

Outcome measures
Measure	Stage 1 Participants n=1302 Participants Participants with chronic hepatitis C (CHC) receiving PegIFN-2b using Redipen™ formulation (1.5 mcg/kg) once weekly and ribavirin capsules (800-1400 mg) daily according to routine medical practice at participating study sites.	Stage 2 Participants Participants with CHC Genotype 1 receiving PegIFN-2b using Redipen™ formulation (1.5 mcg/kg) once weekly and ribavirin capsules (800-1400 mg) daily according to routine medical practice at participating study sites.	Stage F2 Participants with Fibrosis Stage F2	Stage F3 Participants with Fibrosis Stage F4	Stage F4 Participants with Fibrosis Stage F4	Unknown Stage Participants with unknown Fibrosis Stage
Number of Participants Achieving SVR by Gender (Stage 1) Female (n=432)	241 participants	—	—	—	—	—
Number of Participants Achieving SVR by Gender (Stage 1) Male (n=870)	397 participants	—	—	—	—	—

SECONDARY outcome

Timeframe: Up to 72 weeks

Population: All participants who took at least one dose of study medication (ITT Population)

SVR was defined as HCV-RNA negative at ≥22 weeks after EOT. Participants with no viral response information were considered viral response "no".

Outcome measures

Outcome measures
Measure	Stage 1 Participants n=1302 Participants Participants with chronic hepatitis C (CHC) receiving PegIFN-2b using Redipen™ formulation (1.5 mcg/kg) once weekly and ribavirin capsules (800-1400 mg) daily according to routine medical practice at participating study sites.	Stage 2 Participants Participants with CHC Genotype 1 receiving PegIFN-2b using Redipen™ formulation (1.5 mcg/kg) once weekly and ribavirin capsules (800-1400 mg) daily according to routine medical practice at participating study sites.	Stage F2 Participants with Fibrosis Stage F2	Stage F3 Participants with Fibrosis Stage F4	Stage F4 Participants with Fibrosis Stage F4	Unknown Stage Participants with unknown Fibrosis Stage
Number of Participants Achieving SVR by Race (Stage 1) Asian (n=78)	59 participants	—	—	—	—	—
Number of Participants Achieving SVR by Race (Stage 1) Black (n=18)	9 participants	—	—	—	—	—
Number of Participants Achieving SVR by Race (Stage 1) Caucasian (N=1110)	524 participants	—	—	—	—	—
Number of Participants Achieving SVR by Race (Stage 1) Hispanic (n=11)	4 participants	—	—	—	—	—
Number of Participants Achieving SVR by Race (Stage 1) Other (n=85)	42 participants	—	—	—	—	—

SECONDARY outcome

Timeframe: Up to 72 weeks

Population: All participants who took at least one dose of study medication (ITT Population)

SVR was defined as HCV-RNA negative at ≥22 weeks after EOT. Participants with no viral response information were considered viral response "no".

Outcome measures

Outcome measures
Measure	Stage 1 Participants n=1302 Participants Participants with chronic hepatitis C (CHC) receiving PegIFN-2b using Redipen™ formulation (1.5 mcg/kg) once weekly and ribavirin capsules (800-1400 mg) daily according to routine medical practice at participating study sites.	Stage 2 Participants Participants with CHC Genotype 1 receiving PegIFN-2b using Redipen™ formulation (1.5 mcg/kg) once weekly and ribavirin capsules (800-1400 mg) daily according to routine medical practice at participating study sites.	Stage F2 Participants with Fibrosis Stage F2	Stage F3 Participants with Fibrosis Stage F4	Stage F4 Participants with Fibrosis Stage F4	Unknown Stage Participants with unknown Fibrosis Stage
Number of Participants Achieving SVR by Human Immunodeficiency Virus (HIV) Status (Stage 1) HIV positive (n=11)	3 participants	—	—	—	—	—
Number of Participants Achieving SVR by Human Immunodeficiency Virus (HIV) Status (Stage 1) HIV negative (n=1075)	543 participants	—	—	—	—	—
Number of Participants Achieving SVR by Human Immunodeficiency Virus (HIV) Status (Stage 1) HIV status not done (n=216)	92 participants	—	—	—	—	—

SECONDARY outcome

Timeframe: Up to 48 weeks

Population: All participants who took at least one dose of study medication (ITT Population); no participants had Genotype 5

EOT response was defined as HCV-RNA negative after 24 weeks of treatment in participants with HCV Genotype 2 or 3, and after 48 weeks of treatment in participants with Genotype 1, 4, 5, or 6. If there was no EOT information or if it was marked as "not done" then EOT was set to "no".

Outcome measures

Outcome measures
Measure	Stage 1 Participants n=1302 Participants Participants with chronic hepatitis C (CHC) receiving PegIFN-2b using Redipen™ formulation (1.5 mcg/kg) once weekly and ribavirin capsules (800-1400 mg) daily according to routine medical practice at participating study sites.	Stage 2 Participants Participants with CHC Genotype 1 receiving PegIFN-2b using Redipen™ formulation (1.5 mcg/kg) once weekly and ribavirin capsules (800-1400 mg) daily according to routine medical practice at participating study sites.	Stage F2 Participants with Fibrosis Stage F2	Stage F3 Participants with Fibrosis Stage F4	Stage F4 Participants with Fibrosis Stage F4	Unknown Stage Participants with unknown Fibrosis Stage
Number of Participants With End of Treatment (EOT) Response (Stage 1)	800 participants	—	—	—	—	—

SECONDARY outcome

Timeframe: Up to 72 weeks

Population: All participants who took at least one dose of study medication (ITT Population); no participants had Genotype 5

EOT response was defined as HCV-RNA negative after 24 weeks of treatment in participants with HCV-RNA Genotype 2 or 3, and after 48 weeks of treatment in participants with Genotype 1, 4, 5, or 6. If there was no EOT information or if it was marked as "not done" then EOT was set to "no". For this analysis participants were grouped by their HCV genotype (Types 1-6); a genotype is a classification based on the differences in the genetic material within the hepatitis virus. Knowing the HCV genotype helps with deciding what type and what duration of treatment will be needed because each genotype demonstrates a different response to treatment in infected individuals.

Outcome measures

Outcome measures
Measure	Stage 1 Participants n=1302 Participants Participants with chronic hepatitis C (CHC) receiving PegIFN-2b using Redipen™ formulation (1.5 mcg/kg) once weekly and ribavirin capsules (800-1400 mg) daily according to routine medical practice at participating study sites.	Stage 2 Participants Participants with CHC Genotype 1 receiving PegIFN-2b using Redipen™ formulation (1.5 mcg/kg) once weekly and ribavirin capsules (800-1400 mg) daily according to routine medical practice at participating study sites.	Stage F2 Participants with Fibrosis Stage F2	Stage F3 Participants with Fibrosis Stage F4	Stage F4 Participants with Fibrosis Stage F4	Unknown Stage Participants with unknown Fibrosis Stage
Number of Participants With EOT Response by Chronic HCV Genotype (Stage 1) Genotype 1, 4, and 6 (N=780)	405 particpants	—	—	—	—	—
Number of Participants With EOT Response by Chronic HCV Genotype (Stage 1) Genotype 2 and 3 (n=520)	395 particpants	—	—	—	—	—
Number of Participants With EOT Response by Chronic HCV Genotype (Stage 1) Genotype missing (n=2)	0 particpants	—	—	—	—	—

SECONDARY outcome

Timeframe: Week 12

Population: The EVR analysis population comprised participants with HCV genotypes 1, 4, and 6 only, who took at least one dose of study medication; no participants had Genotype 5

EVR was defined as either HCV-RNA detectable with a ≥2 log reduction from baseline or HCV-RNA negative at TW12. Participants with no viral response information were considered viral response "no". For this analysis participants were grouped by their HCV genotype (Types 1-6); a genotype is a classification based on the differences in the genetic material within the hepatitis virus. Knowing the HCV genotype helps with deciding what type and what duration of treatment will be needed because each genotype demonstrates a different response to treatment in infected individuals.

Outcome measures

Outcome measures
Measure	Stage 1 Participants n=780 Participants Participants with chronic hepatitis C (CHC) receiving PegIFN-2b using Redipen™ formulation (1.5 mcg/kg) once weekly and ribavirin capsules (800-1400 mg) daily according to routine medical practice at participating study sites.	Stage 2 Participants Participants with CHC Genotype 1 receiving PegIFN-2b using Redipen™ formulation (1.5 mcg/kg) once weekly and ribavirin capsules (800-1400 mg) daily according to routine medical practice at participating study sites.	Stage F2 Participants with Fibrosis Stage F2	Stage F3 Participants with Fibrosis Stage F4	Stage F4 Participants with Fibrosis Stage F4	Unknown Stage Participants with unknown Fibrosis Stage
Number of Participants With EVR by Selected Chronic HCV Genotypes (Stage 1) Genotype 1 (n=757)	461 Participants	—	—	—	—	—
Number of Participants With EVR by Selected Chronic HCV Genotypes (Stage 1) Genotypes 1,4, and 6 (n=780)	473 Participants	—	—	—	—	—

SECONDARY outcome

Timeframe: Up to 48 weeks

Population: All participants who took at least one dose of study medication (ITT population) and had EOT "yes" and valid EVR evaluation ; no participants had Genotype 5

The relapse rate was calculated with these parameters: EOT "yes", EVR evaluation valid, and ≥22 weeks of follow-up data. There were no imputations for EOT or SVR. Participants with no viral response information were considered viral response "no". For this analysis participants were grouped by their HCV genotype (Types 1-6); a genotype is a classification based on the differences in the genetic material within the hepatitis virus. Knowing the HCV genotype helps with deciding what type and what duration of treatment will be needed because each genotype demonstrates a different response to treatment in infected individuals.

Outcome measures

Outcome measures
Measure	Stage 1 Participants n=598 Participants Participants with chronic hepatitis C (CHC) receiving PegIFN-2b using Redipen™ formulation (1.5 mcg/kg) once weekly and ribavirin capsules (800-1400 mg) daily according to routine medical practice at participating study sites.	Stage 2 Participants Participants with CHC Genotype 1 receiving PegIFN-2b using Redipen™ formulation (1.5 mcg/kg) once weekly and ribavirin capsules (800-1400 mg) daily according to routine medical practice at participating study sites.	Stage F2 Participants with Fibrosis Stage F2	Stage F3 Participants with Fibrosis Stage F4	Stage F4 Participants with Fibrosis Stage F4	Unknown Stage Participants with unknown Fibrosis Stage
Relapse Rate by HCV Genotype (Stage 1) Genotype 1 (n=251)	11.5 Percentage of Participants	—	—	—	—	—
Relapse Rate by HCV Genotype (Stage 1) Genotype 2 (n=123)	3.2 Percentage of Participants	—	—	—	—	—
Relapse Rate by HCV Genotype (Stage 1) Genotype 3 (n=217)	9.7 Percentage of Participants	—	—	—	—	—
Relapse Rate by HCV Genotype (Stage 1) Genotype 4 (n=5)	40.0 Percentage of Participants	—	—	—	—	—
Relapse Rate by HCV Genotype (Stage 1) Genotype 6 (n=2)	0 Percentage of Participants	—	—	—	—	—

SECONDARY outcome

Timeframe: Up to 48 weeks

Population: All participants who took at least one dose of study medication (ITT population); no participants had Genotype 5

An adverse event is any unfavorable and unintended change in the structure, function, or chemistry of the body whether or not considered related to the study treatment. For this analysis participants were grouped by their HCV genotype (Types 1-6); a genotype is a classification based on the differences in the genetic material within the hepatitis virus. Knowing the HCV genotype helps with deciding what type and what duration of treatment will be needed because each genotype demonstrates a different response to treatment in infected individuals.

Outcome measures

Outcome measures
Measure	Stage 1 Participants n=1302 Participants Participants with chronic hepatitis C (CHC) receiving PegIFN-2b using Redipen™ formulation (1.5 mcg/kg) once weekly and ribavirin capsules (800-1400 mg) daily according to routine medical practice at participating study sites.	Stage 2 Participants Participants with CHC Genotype 1 receiving PegIFN-2b using Redipen™ formulation (1.5 mcg/kg) once weekly and ribavirin capsules (800-1400 mg) daily according to routine medical practice at participating study sites.	Stage F2 Participants with Fibrosis Stage F2	Stage F3 Participants with Fibrosis Stage F4	Stage F4 Participants with Fibrosis Stage F4	Unknown Stage Participants with unknown Fibrosis Stage
Number of Participants Discontinued From Study Drug Due to Adverse Events by Chronic HCV Genotype (Stage 1) Genotypes 1, 4, and 6 (n=780)	52 Participants	—	—	—	—	—
Number of Participants Discontinued From Study Drug Due to Adverse Events by Chronic HCV Genotype (Stage 1) Genotype 2 and 3 (n=520)	24 Participants	—	—	—	—	—

SECONDARY outcome

Timeframe: Week 4

Population: The RVR analysis population comprised 388 participants who took at least one dose of study medication and were evaluated for RVR

RVR was defined as undetectable HCV-RNA after 4 weeks of treatment (window of 2 to 6 weeks). Participants with no viral response information were considered viral response "no".

Outcome measures

Outcome measures
Measure	Stage 1 Participants n=388 Participants Participants with chronic hepatitis C (CHC) receiving PegIFN-2b using Redipen™ formulation (1.5 mcg/kg) once weekly and ribavirin capsules (800-1400 mg) daily according to routine medical practice at participating study sites.	Stage 2 Participants Participants with CHC Genotype 1 receiving PegIFN-2b using Redipen™ formulation (1.5 mcg/kg) once weekly and ribavirin capsules (800-1400 mg) daily according to routine medical practice at participating study sites.	Stage F2 Participants with Fibrosis Stage F2	Stage F3 Participants with Fibrosis Stage F4	Stage F4 Participants with Fibrosis Stage F4	Unknown Stage Participants with unknown Fibrosis Stage
Number of Participants Achieving Rapid Virologic Response (RVR) (Stage 2)	56 participants	—	—	—	—	—

SECONDARY outcome

Timeframe: Week 12

Population: All participants who took at least one dose of study medication (ITT Population)

EVR was defined as either HCV-RNA undetectable with a ≥2 log reduction in HCV-RNA from baseline or HCV-RNA undetectable after 12 weeks of treatment. Participants with no viral response information were considered viral response "no".

Outcome measures

Outcome measures
Measure	Stage 1 Participants n=1128 Participants Participants with chronic hepatitis C (CHC) receiving PegIFN-2b using Redipen™ formulation (1.5 mcg/kg) once weekly and ribavirin capsules (800-1400 mg) daily according to routine medical practice at participating study sites.	Stage 2 Participants Participants with CHC Genotype 1 receiving PegIFN-2b using Redipen™ formulation (1.5 mcg/kg) once weekly and ribavirin capsules (800-1400 mg) daily according to routine medical practice at participating study sites.	Stage F2 Participants with Fibrosis Stage F2	Stage F3 Participants with Fibrosis Stage F4	Stage F4 Participants with Fibrosis Stage F4	Unknown Stage Participants with unknown Fibrosis Stage
Number of Participants Achieving EVR (Stage 2)	690 participants	—	—	—	—	—

SECONDARY outcome

Timeframe: Week 4

Population: The RVR analysis population comprised 388 participants who took at least one dose of study medication and were evaluated for RVR

RVR was defined as undetectable HCV-RNA after 4 weeks of treatment (window of 2 to 6 weeks). Participants with no viral response information were considered viral response "no".

Outcome measures

Outcome measures
Measure	Stage 1 Participants n=388 Participants Participants with chronic hepatitis C (CHC) receiving PegIFN-2b using Redipen™ formulation (1.5 mcg/kg) once weekly and ribavirin capsules (800-1400 mg) daily according to routine medical practice at participating study sites.	Stage 2 Participants Participants with CHC Genotype 1 receiving PegIFN-2b using Redipen™ formulation (1.5 mcg/kg) once weekly and ribavirin capsules (800-1400 mg) daily according to routine medical practice at participating study sites.	Stage F2 Participants with Fibrosis Stage F2	Stage F3 Participants with Fibrosis Stage F4	Stage F4 Participants with Fibrosis Stage F4	Unknown Stage Participants with unknown Fibrosis Stage
Number of Participants Achieving RVR by Race (Stage 2) Aboriginal peoples/Metis (n=10)	0 participants	—	—	—	—	—
Number of Participants Achieving RVR by Race (Stage 2) Asian (n=19)	6 participants	—	—	—	—	—
Number of Participants Achieving RVR by Race (Stage 2) Black (n=8)	0 participants	—	—	—	—	—
Number of Participants Achieving RVR by Race (Stage 2) Caucasian (n=343)	47 participants	—	—	—	—	—
Number of Participants Achieving RVR by Race (Stage 2) Hispanic (n=1)	0 participants	—	—	—	—	—
Number of Participants Achieving RVR by Race (Stage 2) Other (n=7)	3 participants	—	—	—	—	—

SECONDARY outcome

Timeframe: Week 12

Population: All participants who took at least one dose of study medication (ITT Population)

EVR was defined as either HCV-RNA undetectable with a ≥2 log reduction in HCV-RNA from baseline or HCV-RNA undetectable after 12 weeks of treatment. Participants with no viral response information were considered viral response "no".

Outcome measures

Outcome measures
Measure	Stage 1 Participants n=1128 Participants Participants with chronic hepatitis C (CHC) receiving PegIFN-2b using Redipen™ formulation (1.5 mcg/kg) once weekly and ribavirin capsules (800-1400 mg) daily according to routine medical practice at participating study sites.	Stage 2 Participants Participants with CHC Genotype 1 receiving PegIFN-2b using Redipen™ formulation (1.5 mcg/kg) once weekly and ribavirin capsules (800-1400 mg) daily according to routine medical practice at participating study sites.	Stage F2 Participants with Fibrosis Stage F2	Stage F3 Participants with Fibrosis Stage F4	Stage F4 Participants with Fibrosis Stage F4	Unknown Stage Participants with unknown Fibrosis Stage
Number of Participants Achieving EVR by Race (Stage 2) Aboriginal peoples/Metis (n=13)	6 participants	—	—	—	—	—
Number of Participants Achieving EVR by Race (Stage 2) Asian (n=54)	42 participants	—	—	—	—	—
Number of Participants Achieving EVR by Race (Stage 2) Black (n=20)	8 participants	—	—	—	—	—
Number of Participants Achieving EVR by Race (Stage 2) Caucasian (n=1002)	609 participants	—	—	—	—	—
Number of Participants Achieving EVR by Race (Stage 2) Hispanic (n=4)	4 participants	—	—	—	—	—
Number of Participants Achieving EVR by Race (Stage 2) Other (n=35)	21 participants	—	—	—	—	—

SECONDARY outcome

Timeframe: Up to 72 weeks

Population: All participants who took at least one dose of study medication (ITT Population)

SVR was defined as HCV-RNA negative at six months after EOT. Participants with no viral response information were considered viral response "no".

Outcome measures

Outcome measures
Measure	Stage 1 Participants n=1128 Participants Participants with chronic hepatitis C (CHC) receiving PegIFN-2b using Redipen™ formulation (1.5 mcg/kg) once weekly and ribavirin capsules (800-1400 mg) daily according to routine medical practice at participating study sites.	Stage 2 Participants Participants with CHC Genotype 1 receiving PegIFN-2b using Redipen™ formulation (1.5 mcg/kg) once weekly and ribavirin capsules (800-1400 mg) daily according to routine medical practice at participating study sites.	Stage F2 Participants with Fibrosis Stage F2	Stage F3 Participants with Fibrosis Stage F4	Stage F4 Participants with Fibrosis Stage F4	Unknown Stage Participants with unknown Fibrosis Stage
Number of Participants Achieving SVR by Race (Stage 2) Aboriginal peoples/Metis (n=13)	4 participants	—	—	—	—	—
Number of Participants Achieving SVR by Race (Stage 2) Asians (n=54)	37 participants	—	—	—	—	—
Number of Participants Achieving SVR by Race (Stage 2) Black (n=20)	5 participants	—	—	—	—	—
Number of Participants Achieving SVR by Race (Stage 2) Caucasian (n=1002)	407 participants	—	—	—	—	—
Number of Participants Achieving SVR by Race (Stage 2) Hispanic (n=4)	4 participants	—	—	—	—	—
Number of Participants Achieving SVR by Race (Stage 2) Other (n=35)	11 participants	—	—	—	—	—

SECONDARY outcome

Timeframe: Week 4

Population: Participants who achieved RVR

RVR was defined as undetectable HCV-RNA after four weeks of treatment. SVR was defined as HCV-RNA negative at 24 weeks after EOT. Participants with no viral response information were considered viral response "no".

Outcome measures

Outcome measures
Measure	Stage 1 Participants n=56 Participants Participants with chronic hepatitis C (CHC) receiving PegIFN-2b using Redipen™ formulation (1.5 mcg/kg) once weekly and ribavirin capsules (800-1400 mg) daily according to routine medical practice at participating study sites.	Stage 2 Participants Participants with CHC Genotype 1 receiving PegIFN-2b using Redipen™ formulation (1.5 mcg/kg) once weekly and ribavirin capsules (800-1400 mg) daily according to routine medical practice at participating study sites.	Stage F2 Participants with Fibrosis Stage F2	Stage F3 Participants with Fibrosis Stage F4	Stage F4 Participants with Fibrosis Stage F4	Unknown Stage Participants with unknown Fibrosis Stage
Number of Participants Achieving RVR Who Achieved SVR (Stage 2)	35 participants	—	—	—	—	—

SECONDARY outcome

Timeframe: Week 12

Population: All participants who took at least one dose of study medication and achieved EVR

EVR was defined as either HCV-RNA undetectable with a ≥2 log reduction in HCV-RNA from baseline or HCV-RNA undetectable after 12 weeks of treatment. SVR was defined as HCV-RNA negative at 24 weeks after EOT. Participants with no viral response information were considered viral response "no".

Outcome measures

Outcome measures
Measure	Stage 1 Participants n=690 Participants Participants with chronic hepatitis C (CHC) receiving PegIFN-2b using Redipen™ formulation (1.5 mcg/kg) once weekly and ribavirin capsules (800-1400 mg) daily according to routine medical practice at participating study sites.	Stage 2 Participants Participants with CHC Genotype 1 receiving PegIFN-2b using Redipen™ formulation (1.5 mcg/kg) once weekly and ribavirin capsules (800-1400 mg) daily according to routine medical practice at participating study sites.	Stage F2 Participants with Fibrosis Stage F2	Stage F3 Participants with Fibrosis Stage F4	Stage F4 Participants with Fibrosis Stage F4	Unknown Stage Participants with unknown Fibrosis Stage
Number of Participants Achieving EVR Who Achieved SVR (Stage 2)	399 participants	—	—	—	—	—

SECONDARY outcome

Timeframe: Week 4

Population: The RVR analysis population comprised 388 participants who took at least one dose of study medication and were evaluated for RVR

RVR was defined as undetectable HCV-RNA after four weeks of treatment. SVR was defined as HCV-RNA negative at 24 weeks after EOT. Participants with no viral response information were considered viral response "no". Liver fibrosis stage was measured with the METAVIR scoring system (F0=no fibrosis or liver damage, F1 = beginning of liver damage with some slight scarring, F2 = moderate liver damage, scarring advancing in liver and surrounding blood vessels, F3 =significant liver damage, the liver becomes fibrotic \[scarred\] and connects with other scarred areas , and F4 = severe damage \[cirrhosis\] and liver no longer functions properly).

Outcome measures

Outcome measures
Measure	Stage 1 Participants n=388 Participants Participants with chronic hepatitis C (CHC) receiving PegIFN-2b using Redipen™ formulation (1.5 mcg/kg) once weekly and ribavirin capsules (800-1400 mg) daily according to routine medical practice at participating study sites.	Stage 2 Participants Participants with CHC Genotype 1 receiving PegIFN-2b using Redipen™ formulation (1.5 mcg/kg) once weekly and ribavirin capsules (800-1400 mg) daily according to routine medical practice at participating study sites.	Stage F2 Participants with Fibrosis Stage F2	Stage F3 Participants with Fibrosis Stage F4	Stage F4 Participants with Fibrosis Stage F4	Unknown Stage Participants with unknown Fibrosis Stage
Number of Participants Achieving RVR by Liver Fibrosis Stage (Stage 2) F0 (n=28)	4 participants	—	—	—	—	—
Number of Participants Achieving RVR by Liver Fibrosis Stage (Stage 2) F1 (n=30)	9 participants	—	—	—	—	—
Number of Participants Achieving RVR by Liver Fibrosis Stage (Stage 2) F2 (n=49)	8 participants	—	—	—	—	—
Number of Participants Achieving RVR by Liver Fibrosis Stage (Stage 2) F3 (n=14)	2 participants	—	—	—	—	—
Number of Participants Achieving RVR by Liver Fibrosis Stage (Stage 2) F4 (n=27)	1 participants	—	—	—	—	—
Number of Participants Achieving RVR by Liver Fibrosis Stage (Stage 2) Could not be determined (n=206)	29 participants	—	—	—	—	—
Number of Participants Achieving RVR by Liver Fibrosis Stage (Stage 2) Other (n=34)	3 participants	—	—	—	—	—

SECONDARY outcome

Timeframe: Week 12

Population: All participants who took at least one dose of study medication (ITT Population)

EVR was defined as either HCV-RNA undetectable with a ≥2 log reduction in HCV-RNA from baseline or HCV-RNA undetectable after 12 weeks of treatment.SVR was defined as HCV-RNA negative at 24 weeks after EOT. Participants with no viral response information were considered viral response "no". Liver fibrosis stage was measured with the METAVIR scoring system (F0=no fibrosis or liver damage, F1 = beginning of liver damage with some slight scarring, F2 = moderate liver damage, scarring advancing in liver and surrounding blood vessels, F3 =significant liver damage, the liver becomes fibrotic \[scarred\] and connects with other scarred areas , and F4 = severe damage \[cirrhosis\] and liver no longer functions properly).

Outcome measures

Outcome measures
Measure	Stage 1 Participants n=1128 Participants Participants with chronic hepatitis C (CHC) receiving PegIFN-2b using Redipen™ formulation (1.5 mcg/kg) once weekly and ribavirin capsules (800-1400 mg) daily according to routine medical practice at participating study sites.	Stage 2 Participants Participants with CHC Genotype 1 receiving PegIFN-2b using Redipen™ formulation (1.5 mcg/kg) once weekly and ribavirin capsules (800-1400 mg) daily according to routine medical practice at participating study sites.	Stage F2 Participants with Fibrosis Stage F2	Stage F3 Participants with Fibrosis Stage F4	Stage F4 Participants with Fibrosis Stage F4	Unknown Stage Participants with unknown Fibrosis Stage
Number of Participants Achieving EVR by Liver Fibrosis Stage (Stage 2) F0 (n=66)	49 participants	—	—	—	—	—
Number of Participants Achieving EVR by Liver Fibrosis Stage (Stage 2) F1 (n=144)	95 participants	—	—	—	—	—
Number of Participants Achieving EVR by Liver Fibrosis Stage (Stage 2) F2 (n=212)	133 participants	—	—	—	—	—
Number of Participants Achieving EVR by Liver Fibrosis Stage (Stage 2) F3 (99)	62 participants	—	—	—	—	—
Number of Participants Achieving EVR by Liver Fibrosis Stage (Stage 2) F4 (n=110)	53 participants	—	—	—	—	—
Number of Participants Achieving EVR by Liver Fibrosis Stage (Stage 2) Could not be determined (n=463)	280 participants	—	—	—	—	—
Number of Participants Achieving EVR by Liver Fibrosis Stage (Stage 2) Other (n=34)	18 participants	—	—	—	—	—

SECONDARY outcome

Timeframe: Up to 72 weeks

Population: All participants who took at least one dose of study medication (ITT Population)

SVR was defined as HCV-RNA negative at 24 weeks after EOT. Participants with no viral response information were considered viral response "no". Liver fibrosis stage was measured with the METAVIR scoring system (F0=no fibrosis or liver damage, F1 = beginning of liver damage with some slight scarring, F2 = moderate liver damage, scarring advancing in liver and surrounding blood vessels, F3 =significant liver damage, the liver becomes fibrotic \[scarred\] and connects with other scarred areas , and F4 = severe damage \[cirrhosis\] and liver no longer functions properly).

Outcome measures

Outcome measures
Measure	Stage 1 Participants n=1128 Participants Participants with chronic hepatitis C (CHC) receiving PegIFN-2b using Redipen™ formulation (1.5 mcg/kg) once weekly and ribavirin capsules (800-1400 mg) daily according to routine medical practice at participating study sites.	Stage 2 Participants Participants with CHC Genotype 1 receiving PegIFN-2b using Redipen™ formulation (1.5 mcg/kg) once weekly and ribavirin capsules (800-1400 mg) daily according to routine medical practice at participating study sites.	Stage F2 Participants with Fibrosis Stage F2	Stage F3 Participants with Fibrosis Stage F4	Stage F4 Participants with Fibrosis Stage F4	Unknown Stage Participants with unknown Fibrosis Stage
Number of Participants Achieving SVR by Liver Fibrosis Score (Stage 2) F0 (n=66)	36 participants	—	—	—	—	—
Number of Participants Achieving SVR by Liver Fibrosis Score (Stage 2) F1 (n=144)	72 participants	—	—	—	—	—
Number of Participants Achieving SVR by Liver Fibrosis Score (Stage 2) F2 (n=212)	94 participants	—	—	—	—	—
Number of Participants Achieving SVR by Liver Fibrosis Score (Stage 2) F3 (n=99)	35 participants	—	—	—	—	—
Number of Participants Achieving SVR by Liver Fibrosis Score (Stage 2) F4 (n=110)	35 participants	—	—	—	—	—
Number of Participants Achieving SVR by Liver Fibrosis Score (Stage 2) Could not be determined (n=463)	187 participants	—	—	—	—	—
Number of Participants Achieving SVR by Liver Fibrosis Score (Stage 2) Other (n=34)	9 participants	—	—	—	—	—

SECONDARY outcome

Timeframe: Week 4

Population: The RVR analysis population comprises 388 participants who took at least one dose of study medication and were evaluated for RVR

RVR was defined as undetectable HCV-RNA after 4 weeks of treatment. Participants with no viral response information were considered viral response "no".

Outcome measures

Outcome measures
Measure	Stage 1 Participants n=388 Participants Participants with chronic hepatitis C (CHC) receiving PegIFN-2b using Redipen™ formulation (1.5 mcg/kg) once weekly and ribavirin capsules (800-1400 mg) daily according to routine medical practice at participating study sites.	Stage 2 Participants Participants with CHC Genotype 1 receiving PegIFN-2b using Redipen™ formulation (1.5 mcg/kg) once weekly and ribavirin capsules (800-1400 mg) daily according to routine medical practice at participating study sites.	Stage F2 Participants with Fibrosis Stage F2	Stage F3 Participants with Fibrosis Stage F4	Stage F4 Participants with Fibrosis Stage F4	Unknown Stage Participants with unknown Fibrosis Stage
Number of Participants Achieving RVR by Weight (Stage 2) 40 to <50 kg (n=3)	0 participants	—	—	—	—	—
Number of Participants Achieving RVR by Weight (Stage 2) 50-<64 kg (n=40)	8 participants	—	—	—	—	—
Number of Participants Achieving RVR by Weight (Stage 2) 64 to <75 kg (n=83)	9 participants	—	—	—	—	—
Number of Participants Achieving RVR by Weight (Stage 2) 75 to <85 kg (n=86)	11 participants	—	—	—	—	—
Number of Participants Achieving RVR by Weight (Stage 2) >=85 kg (n=169)	27 participants	—	—	—	—	—
Number of Participants Achieving RVR by Weight (Stage 2) Weight unknown (n=7)	1 participants	—	—	—	—	—

SECONDARY outcome

Timeframe: Week 12

Population: All participants who took at least one dose of study medication (ITT Population)

EVR was defined as either HCV-RNA undetectable with a ≥2 log reduction in HCV-RNA from baseline or HCV-RNA undetectable after 12 weeks of treatment. Participants with no viral response information were considered viral response "no".

Outcome measures

Outcome measures
Measure	Stage 1 Participants n=1128 Participants Participants with chronic hepatitis C (CHC) receiving PegIFN-2b using Redipen™ formulation (1.5 mcg/kg) once weekly and ribavirin capsules (800-1400 mg) daily according to routine medical practice at participating study sites.	Stage 2 Participants Participants with CHC Genotype 1 receiving PegIFN-2b using Redipen™ formulation (1.5 mcg/kg) once weekly and ribavirin capsules (800-1400 mg) daily according to routine medical practice at participating study sites.	Stage F2 Participants with Fibrosis Stage F2	Stage F3 Participants with Fibrosis Stage F4	Stage F4 Participants with Fibrosis Stage F4	Unknown Stage Participants with unknown Fibrosis Stage
Number of Participants Achieving EVR by Weight (Stage 2) 75 to <85 kg (n=238)	143 participants	—	—	—	—	—
Number of Participants Achieving EVR by Weight (Stage 2) 40 to <50 kg (n=16)	9 participants	—	—	—	—	—
Number of Participants Achieving EVR by Weight (Stage 2) 50 to <64 kg (n=127)	87 participants	—	—	—	—	—
Number of Participants Achieving EVR by Weight (Stage 2) 64 to <75 kg (n=250)	164 participants	—	—	—	—	—
Number of Participants Achieving EVR by Weight (Stage 2) >=85 kg (n=490)	283 participants	—	—	—	—	—
Number of Participants Achieving EVR by Weight (Stage 2) Weight unknown (n=7)	4 participants	—	—	—	—	—

SECONDARY outcome

Timeframe: Up to 72 weeks

Population: All participants who took at least one dose of study medication (ITT Population)

SVR was defined as HCV-RNA negative at 24 weeks after EOT. Participants with no viral response information were considered viral response "no".

Outcome measures

Outcome measures
Measure	Stage 1 Participants n=1128 Participants Participants with chronic hepatitis C (CHC) receiving PegIFN-2b using Redipen™ formulation (1.5 mcg/kg) once weekly and ribavirin capsules (800-1400 mg) daily according to routine medical practice at participating study sites.	Stage 2 Participants Participants with CHC Genotype 1 receiving PegIFN-2b using Redipen™ formulation (1.5 mcg/kg) once weekly and ribavirin capsules (800-1400 mg) daily according to routine medical practice at participating study sites.	Stage F2 Participants with Fibrosis Stage F2	Stage F3 Participants with Fibrosis Stage F4	Stage F4 Participants with Fibrosis Stage F4	Unknown Stage Participants with unknown Fibrosis Stage
Number of Participants Achieving SVR by Weight (Stage 2) 40 to <50 kg (n=16)	6 participants	—	—	—	—	—
Number of Participants Achieving SVR by Weight (Stage 2) 50 to <64 (n=127)	59 participants	—	—	—	—	—
Number of Participants Achieving SVR by Weight (Stage 2) 64 to <75 kg (n=250)	115 participants	—	—	—	—	—
Number of Participants Achieving SVR by Weight (Stage 2) 75 to >85 kg (n=238)	93 participants	—	—	—	—	—
Number of Participants Achieving SVR by Weight (Stage 2) >=85 kg (n=490)	193 participants	—	—	—	—	—
Number of Participants Achieving SVR by Weight (Stage 2) Weight unknown (n=7)	2 participants	—	—	—	—	—

SECONDARY outcome

Timeframe: Week 4

Population: The RVR analysis population comprised 388 participants who took at least one dose of study medication and were evaluated for RVR

RVR was defined as undetectable HCV-RNA after 4 weeks of treatment. SVR was defined as HCV-RNA negative at 24 weeks after EOT. Participants with no viral response information were considered viral response "no". For this analysis participants were grouped by their HCV genotype subcategory (1a or 1b); subcategories are the result of a change in the genetic material in the viruses within the genotype.

Outcome measures

Outcome measures
Measure	Stage 1 Participants n=388 Participants Participants with chronic hepatitis C (CHC) receiving PegIFN-2b using Redipen™ formulation (1.5 mcg/kg) once weekly and ribavirin capsules (800-1400 mg) daily according to routine medical practice at participating study sites.	Stage 2 Participants Participants with CHC Genotype 1 receiving PegIFN-2b using Redipen™ formulation (1.5 mcg/kg) once weekly and ribavirin capsules (800-1400 mg) daily according to routine medical practice at participating study sites.	Stage F2 Participants with Fibrosis Stage F2	Stage F3 Participants with Fibrosis Stage F4	Stage F4 Participants with Fibrosis Stage F4	Unknown Stage Participants with unknown Fibrosis Stage
Number of Participants Achieving RVR by Chronic HCV Genotype 1 Subtype (Stage 2) Genotype 1a (n=147)	17 participants	—	—	—	—	—
Number of Participants Achieving RVR by Chronic HCV Genotype 1 Subtype (Stage 2) Genotype 1b (n=56)	9 participants	—	—	—	—	—
Number of Participants Achieving RVR by Chronic HCV Genotype 1 Subtype (Stage 2) Genotype unknown (n=160)	26 participants	—	—	—	—	—
Number of Participants Achieving RVR by Chronic HCV Genotype 1 Subtype (Stage 2) Genotype mixed (n=11)	1 participants	—	—	—	—	—
Number of Participants Achieving RVR by Chronic HCV Genotype 1 Subtype (Stage 2) Could not be determined (n=14)	3 participants	—	—	—	—	—

SECONDARY outcome

Timeframe: Week 12

Population: All participants who took at least one dose of study medication (ITT Population)

EVR was defined as either HCV-RNA undetectable with a ≥2 log reduction in HCV-RNA from baseline or HCV-RNA undetectable after 12 weeks of treatment.SVR was defined as HCV-RNA negative at 24 weeks after EOT. Participants with no viral response information were considered viral response "no". For this analysis participants were grouped by their HCV genotype subcategory (1a or 1b); subcategories are the result of a change in the genetic material in the viruses within the genotype.

Outcome measures

Outcome measures
Measure	Stage 1 Participants n=1128 Participants Participants with chronic hepatitis C (CHC) receiving PegIFN-2b using Redipen™ formulation (1.5 mcg/kg) once weekly and ribavirin capsules (800-1400 mg) daily according to routine medical practice at participating study sites.	Stage 2 Participants Participants with CHC Genotype 1 receiving PegIFN-2b using Redipen™ formulation (1.5 mcg/kg) once weekly and ribavirin capsules (800-1400 mg) daily according to routine medical practice at participating study sites.	Stage F2 Participants with Fibrosis Stage F2	Stage F3 Participants with Fibrosis Stage F4	Stage F4 Participants with Fibrosis Stage F4	Unknown Stage Participants with unknown Fibrosis Stage
Number of Participants Achieving EVR by Chronic HCV Genotype 1 Subtype (Stage 2) Genotype 1a (n=176)	106 participants	—	—	—	—	—
Number of Participants Achieving EVR by Chronic HCV Genotype 1 Subtype (Stage 2) Genotype 1b (n=74)	51 participants	—	—	—	—	—
Number of Participants Achieving EVR by Chronic HCV Genotype 1 Subtype (Stage 2) Genotype unknown (n=850)	518 participants	—	—	—	—	—
Number of Participants Achieving EVR by Chronic HCV Genotype 1 Subtype (Stage 2) Genotype mixed (n=14)	8 participants	—	—	—	—	—
Number of Participants Achieving EVR by Chronic HCV Genotype 1 Subtype (Stage 2) Could not be determined (n=14)	7 participants	—	—	—	—	—

SECONDARY outcome

Timeframe: Up to 72 weeks

Population: All participants who took at least one dose of study medication (ITT Population)

SVR was defined as HCV-RNA negative at 24 weeks after EOT. Participants with no viral response information were considered viral response "no". For this analysis participants were grouped by their HCV genotype subcategory (1a or 1b); subcategories are the result of a change in the genetic material in the viruses within the genotype.

Outcome measures

Outcome measures
Measure	Stage 1 Participants n=1128 Participants Participants with chronic hepatitis C (CHC) receiving PegIFN-2b using Redipen™ formulation (1.5 mcg/kg) once weekly and ribavirin capsules (800-1400 mg) daily according to routine medical practice at participating study sites.	Stage 2 Participants Participants with CHC Genotype 1 receiving PegIFN-2b using Redipen™ formulation (1.5 mcg/kg) once weekly and ribavirin capsules (800-1400 mg) daily according to routine medical practice at participating study sites.	Stage F2 Participants with Fibrosis Stage F2	Stage F3 Participants with Fibrosis Stage F4	Stage F4 Participants with Fibrosis Stage F4	Unknown Stage Participants with unknown Fibrosis Stage
Number of Participants Achieving SVR by Chronic HCV Genotype 1 Subtype (Stage 2) Genotype 1a (n=176)	58 participants	—	—	—	—	—
Number of Participants Achieving SVR by Chronic HCV Genotype 1 Subtype (Stage 2) Genotype 1b (n=74)	37 participants	—	—	—	—	—
Number of Participants Achieving SVR by Chronic HCV Genotype 1 Subtype (Stage 2) Genotype Unknown (n=850)	364 participants	—	—	—	—	—
Number of Participants Achieving SVR by Chronic HCV Genotype 1 Subtype (Stage 2) Genotype mixed (n=14)	5 participants	—	—	—	—	—
Number of Participants Achieving SVR by Chronic HCV Genotype 1 Subtype (Stage 2) Could not be determined (n=14)	4 participants	—	—	—	—	—

SECONDARY outcome

Timeframe: Week 4

Population: The RVR analysis population comprised 388 participants who took at least one dose of study medication and were evaluated for RVR

RVR was defined as undetectable HCV-RNA after 4 weeks of treatment. Participants with no viral response information were considered viral response "no".

Outcome measures

Outcome measures
Measure	Stage 1 Participants n=388 Participants Participants with chronic hepatitis C (CHC) receiving PegIFN-2b using Redipen™ formulation (1.5 mcg/kg) once weekly and ribavirin capsules (800-1400 mg) daily according to routine medical practice at participating study sites.	Stage 2 Participants Participants with CHC Genotype 1 receiving PegIFN-2b using Redipen™ formulation (1.5 mcg/kg) once weekly and ribavirin capsules (800-1400 mg) daily according to routine medical practice at participating study sites.	Stage F2 Participants with Fibrosis Stage F2	Stage F3 Participants with Fibrosis Stage F4	Stage F4 Participants with Fibrosis Stage F4	Unknown Stage Participants with unknown Fibrosis Stage
Number of Participants Achieving RVR by Gender (Stage 2) Female (n=122)	19 participants	—	—	—	—	—
Number of Participants Achieving RVR by Gender (Stage 2) Male (n=266)	37 participants	—	—	—	—	—

SECONDARY outcome

Timeframe: Week 12

Population: All participants who took at least one dose of study medication (ITT Population)

EVR was defined as either HCV-RNA undetectable with a ≥2 log reduction in HCV-RNA from baseline or HCV-RNA undetectable after 12 weeks of treatment. Participants with no viral response information were considered viral response "no".

Outcome measures

Outcome measures
Measure	Stage 1 Participants n=1128 Participants Participants with chronic hepatitis C (CHC) receiving PegIFN-2b using Redipen™ formulation (1.5 mcg/kg) once weekly and ribavirin capsules (800-1400 mg) daily according to routine medical practice at participating study sites.	Stage 2 Participants Participants with CHC Genotype 1 receiving PegIFN-2b using Redipen™ formulation (1.5 mcg/kg) once weekly and ribavirin capsules (800-1400 mg) daily according to routine medical practice at participating study sites.	Stage F2 Participants with Fibrosis Stage F2	Stage F3 Participants with Fibrosis Stage F4	Stage F4 Participants with Fibrosis Stage F4	Unknown Stage Participants with unknown Fibrosis Stage
Number of Participants Achieving EVR by Gender (Stage 2) Female (n=346)	227 participants	—	—	—	—	—
Number of Participants Achieving EVR by Gender (Stage 2) Male (n=782)	463 participants	—	—	—	—	—

SECONDARY outcome

Timeframe: Up to 72 weeks

Population: All participants who took at least one dose of study medication (ITT Population)

SVR was defined as HCV-RNA negative at 24 weeks after EOT. Participants with no viral response information were considered viral response "no".

Outcome measures

Outcome measures
Measure	Stage 1 Participants n=1128 Participants Participants with chronic hepatitis C (CHC) receiving PegIFN-2b using Redipen™ formulation (1.5 mcg/kg) once weekly and ribavirin capsules (800-1400 mg) daily according to routine medical practice at participating study sites.	Stage 2 Participants Participants with CHC Genotype 1 receiving PegIFN-2b using Redipen™ formulation (1.5 mcg/kg) once weekly and ribavirin capsules (800-1400 mg) daily according to routine medical practice at participating study sites.	Stage F2 Participants with Fibrosis Stage F2	Stage F3 Participants with Fibrosis Stage F4	Stage F4 Participants with Fibrosis Stage F4	Unknown Stage Participants with unknown Fibrosis Stage
Number of Participants Achieving SVR by Gender (Stage 2) Female (n=346)	167 participants	—	—	—	—	—
Number of Participants Achieving SVR by Gender (Stage 2) Male (n=782)	301 participants	—	—	—	—	—

SECONDARY outcome

Timeframe: Week 4

Population: This analysis was not done.

RVR was defined as undetectable HCV-RNA after 4 weeks of treatment (window of 2 to 6 weeks). Participants with no viral response information were considered viral response "no".

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Week 12

Population: This analysis was not done.

EVR was defined as either HCV-RNA undetectable with a ≥2 log reduction in HCV-RNA from baseline or HCV-RNA undetectable after 12 weeks of treatment. Participants with no viral response information were considered viral response "no".

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 72 weeks

Population: This analysis was not done.

SVR was defined as HCV-RNA negative at six months following EOT. Participants with no viral response information were considered viral response "no".

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 72 weeks

Population: Participants who completed the MAQ questionnaire during the study and achieved SVR

Compliance was defined as participants taking ≥80% versus \<80% of their doses; compliance ≥80% was derived from participants who answered "always" or "most of the time" to Questions 4 (How often do you stick to your medication schedule for your Ribavirin?) and 5 (How often do you stick to your medication schedule for your Redipen \[peginterferon\] injections?) of the 6-question compliance questionnaire. Percentages are based on the total number of participants within each compliance category. SVR was defined as HCV-RNA negative at 24 weeks after EOT. Participants with no viral response information were considered viral response "no".

Outcome measures

Outcome measures
Measure	Stage 1 Participants n=314 Participants Participants with chronic hepatitis C (CHC) receiving PegIFN-2b using Redipen™ formulation (1.5 mcg/kg) once weekly and ribavirin capsules (800-1400 mg) daily according to routine medical practice at participating study sites.	Stage 2 Participants Participants with CHC Genotype 1 receiving PegIFN-2b using Redipen™ formulation (1.5 mcg/kg) once weekly and ribavirin capsules (800-1400 mg) daily according to routine medical practice at participating study sites.	Stage F2 Participants with Fibrosis Stage F2	Stage F3 Participants with Fibrosis Stage F4	Stage F4 Participants with Fibrosis Stage F4	Unknown Stage Participants with unknown Fibrosis Stage
Percentage of Compliance for Participants Achieving SVR Based on Medication Adherence Questionnaire (MAQ) (Stage 2) Compliance < 80% (n=10)	40.0 percentage of participants	—	—	—	—	—
Percentage of Compliance for Participants Achieving SVR Based on Medication Adherence Questionnaire (MAQ) (Stage 2) Compliance ≥80% (n=304)	39.1 percentage of participants	—	—	—	—	—

Adverse Events

Stage 1 Participants

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Stage 2 Participants

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Senior Vice President, Global Clinical Development

Merck Sharp & Dohme Corp.

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place