Trial Outcomes & Findings for An Observational Study of Dual and Triple Therapies Based on Pegasys (Peginterferon Alfa-2a) in Patients With Chronic Hepatitis C (NCT NCT01604291)

NCT ID: NCT01604291

Last Updated: 2019-03-14

Results Overview

Recruitment status

COMPLETED

Target enrollment

991 participants

Primary outcome timeframe

Week 24

Results posted on

2019-03-14

Participant Flow

The study was conducted at 21 investigational centers in Israel.

The study was consisted of 3 arms of treatments: 1. Dual therapy: Peginterferon alfa-2a \& Ribavirin; 2. Triple therapy :Peginterferon alfa 2a \& Ribavirin \& Telaprevir; 3. Triple therapy: Peginterferon alfa 2a \& Ribavirin \& Boceprevir

Participant milestones

Participant milestones
Measure	Peginterferon Alfa-2a + Ribavirin Dual Therapy. Dosing and treatment duration of the dual therapy (Peginterferon Alfa-2a + Ribavirin) were at the discretion of the Investigator in accordance with the current local prescribing information.	Peginterferon Alfa-2a + Ribavirin + Telaprevir Triple Therapy. Dosing and treatment duration of the triple therapy (Peginterferon Alfa-2a + Ribavirin + Teleprevir) were at the discretion of the Investigator in accordance with the current local prescribing information.	Peginterferon Alfa-2a + Ribavirin + Boceprevir Triple Therapy. Dosing and treatment duration of the triple therapy (Peginterferon Alfa-2a + Ribavirin + Boceprevir) were at the discretion of the Investigator in accordance with the current local prescribing information.	No Information on Treatment Allocation Participants for which Treatment Allocation Data is Unavailable.
Overall Study STARTED	311	443	193	44
Overall Study COMPLETED	311	443	193	44
Overall Study NOT COMPLETED	0	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

An Observational Study of Dual and Triple Therapies Based on Pegasys (Peginterferon Alfa-2a) in Patients With Chronic Hepatitis C

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Peginterferon Alfa-2a + Ribavirin n=311 Participants Dual Therapy. Dosing and treatment duration of the dual therapy (Peginterferon Alfa-2a + Ribavirin) were at the discretion of the Investigator in accordance with the current local prescribing information.	Peginterferon Alfa-2a + Ribavirin + Telaprevir n=443 Participants Triple Therapy. Dosing and treatment duration of the triple therapy (Peginterferon Alfa-2a + Ribavirin + Teleprevir) were at the discretion of the Investigator in accordance with the current local prescribing information.	Peginterferon Alfa-2a + Ribavirin + Boceprevir n=193 Participants Triple Therapy. Dosing and treatment duration of the triple therapy (Peginterferon Alfa-2a + Ribavirin + Boceprevir) were at the discretion of the Investigator in accordance with the current local prescribing information.	No Information on Treatment Allocation n=44 Participants Participants for which Treatment Allocation Data is Unavailable	Total n=991 Participants Total of all reporting groups
Age, Continuous	44.1 Years STANDARD_DEVIATION 10.6 • n=5 Participants	50.3 Years STANDARD_DEVIATION 11.0 • n=7 Participants	51.1 Years STANDARD_DEVIATION 11.6 • n=5 Participants	48.1 Years STANDARD_DEVIATION 12.0 • n=4 Participants	48.4 Years STANDARD_DEVIATION 11.4 • n=21 Participants
Sex/Gender, Customized Female	101 Participants n=5 Participants	161 Participants n=7 Participants	74 Participants n=5 Participants	9 Participants n=4 Participants	345 Participants n=21 Participants
Sex/Gender, Customized Male	210 Participants n=5 Participants	282 Participants n=7 Participants	118 Participants n=5 Participants	18 Participants n=4 Participants	628 Participants n=21 Participants
Sex/Gender, Customized Unknown	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	17 Participants n=4 Participants	18 Participants n=21 Participants

PRIMARY outcome

Timeframe: Week 24

Population: Modified All Treated (mTRT) Population: includes all participants who had an HCV-RNA result ≥50 IU/mL at their last measurement prior to commencing CHC therapy; had received one of the study's combination therapies; the participants' treatment documentation was sufficient for assignment to treatment groups.

Outcome measures

Outcome measures
Measure	Peginterferon Alfa-2a + Ribavirin n=303 Participants Dual Therapy. Dosing and treatment duration of the dual therapy (Peginterferon Alfa-2a + Ribavirin) were at the discretion of the Investigator in accordance with the current local prescribing information.	Peginterferon Alfa-2a + Ribavirin + Telaprevir n=442 Participants Triple Therapy. Dosing and treatment duration of the triple therapy (Peginterferon Alfa-2a + Ribavirin + Telaprevir) were at the discretion of the Investigator in accordance with the current local prescribing information.	Peginterferon Alfa-2a + Ribavirin + Boceprevir n=190 Participants Triple Therapy. Dosing and treatment duration of the triple therapy (Peginterferon Alfa-2a + Ribavirin +Boceprevir) were at the discretion of the Investigator in accordance with the current local prescribing information.
Percentage of Participants With Sustained Viral Response (SVR) at Week 24	87.2 Percentage of Participants Interval 81.1 to 91.9	94.8 Percentage of Participants Interval 91.6 to 97.1	85.2 Percentage of Participants Interval 77.4 to 91.1

SECONDARY outcome

Timeframe: Week 24

SVR at Week 24 is compared by treatment group, type of infection, prior treatments and genotype.

Outcome measures

Outcome measures
Measure	Peginterferon Alfa-2a + Ribavirin n=303 Participants Dual Therapy. Dosing and treatment duration of the dual therapy (Peginterferon Alfa-2a + Ribavirin) were at the discretion of the Investigator in accordance with the current local prescribing information.	Peginterferon Alfa-2a + Ribavirin + Telaprevir n=442 Participants Triple Therapy. Dosing and treatment duration of the triple therapy (Peginterferon Alfa-2a + Ribavirin + Telaprevir) were at the discretion of the Investigator in accordance with the current local prescribing information.	Peginterferon Alfa-2a + Ribavirin + Boceprevir n=190 Participants Triple Therapy. Dosing and treatment duration of the triple therapy (Peginterferon Alfa-2a + Ribavirin +Boceprevir) were at the discretion of the Investigator in accordance with the current local prescribing information.
Comparison of SVR at Week 24 Treatment - Experienced	66.7 Percentage of Participants Interval 41.0 to 86.7	94.5 Percentage of Participants Interval 90.1 to 97.3	83.1 Percentage of Participants Interval 73.6 to 91.9
Comparison of SVR at Week 24 HCV Mono Infection	86.6 Percentage of Participants Interval 80.3 to 91.5	94.8 Percentage of Participants Interval 91.5 to 97.0	84.5 Percentage of Participants Interval 77.2 to 91.1
Comparison of SVR at Week 24 HIV/HCV Co-Infection	100 Percentage of Participants 100% of participants with HIV/HCV co-infection had a SVR-24 response.	100 Percentage of Participants 100% of participants with HIV/HCV co-infection had a SVR-24 response.	—
Comparison of SVR at Week 24 Genotype 1	83.8 Percentage of Participants Interval 68.0 to 93.8	94.9 Percentage of Participants Interval 91.6 to 97.1	84.4 Percentage of Participants Interval 77.2 to 91.1
Comparison of SVR at Week 24 Other Genotypes	88.2 Percentage of Participants Interval 81.3 to 93.2	100 Percentage of Participants 100% of participants in this arm with other genotypes had a SVR rate.	—
Comparison of SVR at Week 24 Treatment - Naive	89.7 Percentage of Participants Interval 83.6 to 94.1	95.5 Percentage of Participants Interval 89.5 to 98.5	86.7 Percentage of Participants Interval 73.2 to 94.9

SECONDARY outcome

Timeframe: Week 24

Population: Participants who treated for chronic hepatitis C(CHC)with either dual therapy (peginterferon alfa-2a and ribavirin)or triple therapy(peginterferon alfa-2a and ribavirin and telaprevir/boceprevir)for up to 24 weeks thereafter in line with local prescribing information at time of study and for whom demographic baseline characteristics were available.

The overall SVR-24 rate was defined as percentage of participants with Hepatitis C Virus Ribonucleic Acid (HCV-RNA) levels \< 50 International Units per MilliLiter (IU/mL) (as measured by Polymerase Chain Reaction (PCR)) at 24 weeks post treatment completion. Number of participants analysed signifies participants who were evaluated for outcome measure. Data for this outcome measure was not summarized for each arm. Hence, data is reported for all participants.

Outcome measures

Outcome measures
Measure	Peginterferon Alfa-2a + Ribavirin n=567 Participants Dual Therapy. Dosing and treatment duration of the dual therapy (Peginterferon Alfa-2a + Ribavirin) were at the discretion of the Investigator in accordance with the current local prescribing information.	Peginterferon Alfa-2a + Ribavirin + Telaprevir Triple Therapy. Dosing and treatment duration of the triple therapy (Peginterferon Alfa-2a + Ribavirin + Telaprevir) were at the discretion of the Investigator in accordance with the current local prescribing information.	Peginterferon Alfa-2a + Ribavirin + Boceprevir Triple Therapy. Dosing and treatment duration of the triple therapy (Peginterferon Alfa-2a + Ribavirin +Boceprevir) were at the discretion of the Investigator in accordance with the current local prescribing information.
Number of Participants With SVR at Week 24 According to the Demographic Characteristics Gender: Male - Achieved SVR 24	316 Participants	—	—
Number of Participants With SVR at Week 24 According to the Demographic Characteristics Gender: Male - Did not achieve SVR	33 Participants	—	—
Number of Participants With SVR at Week 24 According to the Demographic Characteristics Gender: Female - Achieved SVR 24	198 Participants	—	—
Number of Participants With SVR at Week 24 According to the Demographic Characteristics Gender: Female - Did not achieve SVR	20 Participants	—	—
Number of Participants With SVR at Week 24 According to the Demographic Characteristics Age - Achieved SVR 24	513 Participants	—	—
Number of Participants With SVR at Week 24 According to the Demographic Characteristics Age - Did not achieve SVR	44 Participants	—	—
Number of Participants With SVR at Week 24 According to the Demographic Characteristics Height - Achieved SVR 24	44 Participants	—	—
Number of Participants With SVR at Week 24 According to the Demographic Characteristics Height - Did not achieve SVR	44 Participants	—	—
Number of Participants With SVR at Week 24 According to the Demographic Characteristics Weight - Achieved SVR 24	44 Participants	—	—
Number of Participants With SVR at Week 24 According to the Demographic Characteristics Weight - Did not achieve SVR	44 Participants	—	—
Number of Participants With SVR at Week 24 According to the Demographic Characteristics Body Mass Index - Achieved SVR 24	44 Participants	—	—
Number of Participants With SVR at Week 24 According to the Demographic Characteristics Body Mass Index - Did not achieve SVR	44 Participants	—	—

SECONDARY outcome

Timeframe: Week 4

Population: mTRT population: participants who had an HCV-RNA result ≥50 IU/mL at their last measurement prior to commencing CHC therapy; had received one of the study's combination therapies; participants' treatment documentation was sufficient for assignment to treatment groups. Number of participants analyzed: participants evaluated for this outcome measure.

RVR was defined as HCV-RNA \<50 IU/mL by Week 4

Outcome measures

Outcome measures
Measure	Peginterferon Alfa-2a + Ribavirin n=224 Participants Dual Therapy. Dosing and treatment duration of the dual therapy (Peginterferon Alfa-2a + Ribavirin) were at the discretion of the Investigator in accordance with the current local prescribing information.	Peginterferon Alfa-2a + Ribavirin + Telaprevir n=398 Participants Triple Therapy. Dosing and treatment duration of the triple therapy (Peginterferon Alfa-2a + Ribavirin + Telaprevir) were at the discretion of the Investigator in accordance with the current local prescribing information.	Peginterferon Alfa-2a + Ribavirin + Boceprevir n=156 Participants Triple Therapy. Dosing and treatment duration of the triple therapy (Peginterferon Alfa-2a + Ribavirin +Boceprevir) were at the discretion of the Investigator in accordance with the current local prescribing information.
Percentage of Participants With Rapid Virologic Response (RVR) at Week 4	61.2 Percentage of Participants Interval 54.4 to 67.6	70.9 Percentage of Participants Interval 66.1 to 75.3	21.1 Percentage of Participants Interval 15.0 to 28.4

SECONDARY outcome

Timeframe: Week 4 and 12 for telaprevir group; Week 8 and 24 for boceprevir group

Population: mTRT population:participants who had an HCV-RNA result ≥50 IU/mL at their last measurement prior to commencing CHC therapy;had received one of study's triple combination therapies;participants' treatment documentation was sufficient for assignment to treatment groups.Number of participants analyzed:participants evaluated for this outcome measure.

Extended RVR was defined as HCV-RNA \<50 IU/mL at weeks 4 and 12 for participants treated with telaprevir; or at weeks 8 \& 24 for participants treated with boceprevir. The assessment was performed in participants who received triple therapy in treatment arms 'Peginterferon Alfa-2a + Ribavirin +Telaprevir' and 'Peginterferon Alfa-2a + Ribavirin + Boceprevir'.

Outcome measures

Outcome measures
Measure	Peginterferon Alfa-2a + Ribavirin n=355 Participants Dual Therapy. Dosing and treatment duration of the dual therapy (Peginterferon Alfa-2a + Ribavirin) were at the discretion of the Investigator in accordance with the current local prescribing information.	Peginterferon Alfa-2a + Ribavirin + Telaprevir n=99 Participants Triple Therapy. Dosing and treatment duration of the triple therapy (Peginterferon Alfa-2a + Ribavirin + Telaprevir) were at the discretion of the Investigator in accordance with the current local prescribing information.	Peginterferon Alfa-2a + Ribavirin + Boceprevir Triple Therapy. Dosing and treatment duration of the triple therapy (Peginterferon Alfa-2a + Ribavirin +Boceprevir) were at the discretion of the Investigator in accordance with the current local prescribing information.
Percentage of Participants With Extended RVR	72.7 Percentage of Participants Interval 67.7 to 77.2	70.7 Percentage of Participants Interval 60.7 to 79.4	—

SECONDARY outcome

Timeframe: Week 12

Complete early virologic response (cEVR) was defined as HCV-RNA \<50 IU/mL by Week 12

Outcome measures

Outcome measures
Measure	Peginterferon Alfa-2a + Ribavirin n=192 Participants Dual Therapy. Dosing and treatment duration of the dual therapy (Peginterferon Alfa-2a + Ribavirin) were at the discretion of the Investigator in accordance with the current local prescribing information.	Peginterferon Alfa-2a + Ribavirin + Telaprevir n=372 Participants Triple Therapy. Dosing and treatment duration of the triple therapy (Peginterferon Alfa-2a + Ribavirin + Telaprevir) were at the discretion of the Investigator in accordance with the current local prescribing information.	Peginterferon Alfa-2a + Ribavirin + Boceprevir n=158 Participants Triple Therapy. Dosing and treatment duration of the triple therapy (Peginterferon Alfa-2a + Ribavirin +Boceprevir) were at the discretion of the Investigator in accordance with the current local prescribing information.
Percentage of Participants With Complete Early Virologic Response (cEVR)	75.0 Percentage of Participants Interval 68.3 to 81.0	84.9 Percentage of Participants Interval 80.9 to 88.4	62.0 Percentage of Participants Interval 54.0 to 69.6

SECONDARY outcome

Timeframe: Week 24

End-of-Treatment (EoT) response was defined as HCV-RNA \<50 IU/mL by the end of treatment.

Outcome measures

Outcome measures
Measure	Peginterferon Alfa-2a + Ribavirin n=286 Participants Dual Therapy. Dosing and treatment duration of the dual therapy (Peginterferon Alfa-2a + Ribavirin) were at the discretion of the Investigator in accordance with the current local prescribing information.	Peginterferon Alfa-2a + Ribavirin + Telaprevir n=430 Participants Triple Therapy. Dosing and treatment duration of the triple therapy (Peginterferon Alfa-2a + Ribavirin + Telaprevir) were at the discretion of the Investigator in accordance with the current local prescribing information.	Peginterferon Alfa-2a + Ribavirin + Boceprevir n=188 Participants Triple Therapy. Dosing and treatment duration of the triple therapy (Peginterferon Alfa-2a + Ribavirin +Boceprevir) were at the discretion of the Investigator in accordance with the current local prescribing information.
Percentage of Participants With End of Treatment Response (EoT)	86.4 Percentage of Participants Interval 81.8 to 90.1	81.9 Percentage of Participants Interval 77.9 to 85.4	76.6 Percentage of Participants Interval 69.9 to 82.4

SECONDARY outcome

Timeframe: Week 72

Virologic relapse was defined as detectable HCV-RNA during the treatment-free follow-up period in participants with HCV-RNA \<50 IU/mL at EoT.

Outcome measures

Outcome measures
Measure	Peginterferon Alfa-2a + Ribavirin n=286 Participants Dual Therapy. Dosing and treatment duration of the dual therapy (Peginterferon Alfa-2a + Ribavirin) were at the discretion of the Investigator in accordance with the current local prescribing information.	Peginterferon Alfa-2a + Ribavirin + Telaprevir n=431 Participants Triple Therapy. Dosing and treatment duration of the triple therapy (Peginterferon Alfa-2a + Ribavirin + Telaprevir) were at the discretion of the Investigator in accordance with the current local prescribing information.	Peginterferon Alfa-2a + Ribavirin + Boceprevir n=188 Participants Triple Therapy. Dosing and treatment duration of the triple therapy (Peginterferon Alfa-2a + Ribavirin +Boceprevir) were at the discretion of the Investigator in accordance with the current local prescribing information.
Percentage of Participants With Virologic Relapse	0.3 Percentage of Participants Interval 0.0 to 1.9	0 Percentage of Participants No participants in this arm suffered a virologic relapse.	0 Percentage of Participants No participants in this arm suffered a virologic relapse.

SECONDARY outcome

Timeframe: Week 48

Population: All Enrolled Participants

The average amount of time a treatment was prescribed to participants.

Outcome measures

Outcome measures
Measure	Peginterferon Alfa-2a + Ribavirin n=311 Participants Dual Therapy. Dosing and treatment duration of the dual therapy (Peginterferon Alfa-2a + Ribavirin) were at the discretion of the Investigator in accordance with the current local prescribing information.	Peginterferon Alfa-2a + Ribavirin + Telaprevir n=443 Participants Triple Therapy. Dosing and treatment duration of the triple therapy (Peginterferon Alfa-2a + Ribavirin + Telaprevir) were at the discretion of the Investigator in accordance with the current local prescribing information.	Peginterferon Alfa-2a + Ribavirin + Boceprevir n=193 Participants Triple Therapy. Dosing and treatment duration of the triple therapy (Peginterferon Alfa-2a + Ribavirin +Boceprevir) were at the discretion of the Investigator in accordance with the current local prescribing information.
Treatment Duration Peginterferon Alfa-2a Treatment Duration	26.2 Weeks Standard Deviation 11.5	34.8 Weeks Standard Deviation 15.2	36.1 Weeks Standard Deviation 14.7
Treatment Duration Ribavirin Treatment Duration	26.2 Weeks Standard Deviation 11.6	34.8 Weeks Standard Deviation 15.2	36.1 Weeks Standard Deviation 14.7
Treatment Duration Telaprevir/ Boceprevir Treatment Duration	NA Weeks Standard Deviation NA Participants in this arm did not receive Telaprevir or Boceprevir	11.8 Weeks Standard Deviation 4.6	30.6 Weeks Standard Deviation 14.9

SECONDARY outcome

Timeframe: Week 48

Outcome measures

Outcome measures
Measure	Peginterferon Alfa-2a + Ribavirin n=227 Participants Dual Therapy. Dosing and treatment duration of the dual therapy (Peginterferon Alfa-2a + Ribavirin) were at the discretion of the Investigator in accordance with the current local prescribing information.	Peginterferon Alfa-2a + Ribavirin + Telaprevir n=421 Participants Triple Therapy. Dosing and treatment duration of the triple therapy (Peginterferon Alfa-2a + Ribavirin + Telaprevir) were at the discretion of the Investigator in accordance with the current local prescribing information.	Peginterferon Alfa-2a + Ribavirin + Boceprevir n=187 Participants Triple Therapy. Dosing and treatment duration of the triple therapy (Peginterferon Alfa-2a + Ribavirin +Boceprevir) were at the discretion of the Investigator in accordance with the current local prescribing information.
Time to First Dose Modification of Peginterferon Alfa-2a	418.5 Days Standard Deviation 9.7	247.6 Days Standard Deviation 4.1	328.4 Days Standard Deviation 13.7

SECONDARY outcome

Timeframe: Week 48

Outcome measures

Outcome measures
Measure	Peginterferon Alfa-2a + Ribavirin n=280 Participants Dual Therapy. Dosing and treatment duration of the dual therapy (Peginterferon Alfa-2a + Ribavirin) were at the discretion of the Investigator in accordance with the current local prescribing information.	Peginterferon Alfa-2a + Ribavirin + Telaprevir n=168 Participants Triple Therapy. Dosing and treatment duration of the triple therapy (Peginterferon Alfa-2a + Ribavirin + Telaprevir) were at the discretion of the Investigator in accordance with the current local prescribing information.	Peginterferon Alfa-2a + Ribavirin + Boceprevir n=109 Participants Triple Therapy. Dosing and treatment duration of the triple therapy (Peginterferon Alfa-2a + Ribavirin +Boceprevir) were at the discretion of the Investigator in accordance with the current local prescribing information.
Time to First Dose Modification of Ribavirin	NA Days Standard Deviation NA No participants in this arm had their Ribavirin dose modified.	61.4 Days Standard Deviation 3.6	89.4 Days Standard Deviation 6.8

SECONDARY outcome

Timeframe: Week 48

Population: mTRT population:participants who had an HCV-RNA result ≥50 IU/mL at their last measurement prior to commencing CHC therapy;had received 1 of study's triple combination therapies;participants' treatment documentation was sufficient for assignment to treatment groups.Number of participants analyzed:participants evaluated for this outcome measure.

Outcome measures

Outcome measures
Measure	Peginterferon Alfa-2a + Ribavirin n=416 Participants Dual Therapy. Dosing and treatment duration of the dual therapy (Peginterferon Alfa-2a + Ribavirin) were at the discretion of the Investigator in accordance with the current local prescribing information.	Peginterferon Alfa-2a + Ribavirin + Telaprevir n=181 Participants Triple Therapy. Dosing and treatment duration of the triple therapy (Peginterferon Alfa-2a + Ribavirin + Telaprevir) were at the discretion of the Investigator in accordance with the current local prescribing information.	Peginterferon Alfa-2a + Ribavirin + Boceprevir Triple Therapy. Dosing and treatment duration of the triple therapy (Peginterferon Alfa-2a + Ribavirin +Boceprevir) were at the discretion of the Investigator in accordance with the current local prescribing information.
Time to First Dose Modification of Telaprevir/Boceprevir	124.6 Days Standard Deviation 0.7	82.3 Days Standard Deviation 0.8	—

SECONDARY outcome

Timeframe: Week 48

Population: Safety Population. Included only participants who had received at least one dose of peginterferon alfa-2a plus ribavirin or peginterferon alfa-2a plus ribavirin plus telaprevir/boceprevir and had at least one post-baseline safety assessment.

Any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Safety analysis included 2 additional participants in arm 'Peginterferon Alfa-2a + Ribavirin + Telaprevir'. The safety parameters were analyzed by the treatment actually received by the participants.

Outcome measures

Outcome measures
Measure	Peginterferon Alfa-2a + Ribavirin n=311 Participants Dual Therapy. Dosing and treatment duration of the dual therapy (Peginterferon Alfa-2a + Ribavirin) were at the discretion of the Investigator in accordance with the current local prescribing information.	Peginterferon Alfa-2a + Ribavirin + Telaprevir n=445 Participants Triple Therapy. Dosing and treatment duration of the triple therapy (Peginterferon Alfa-2a + Ribavirin + Telaprevir) were at the discretion of the Investigator in accordance with the current local prescribing information.	Peginterferon Alfa-2a + Ribavirin + Boceprevir n=192 Participants Triple Therapy. Dosing and treatment duration of the triple therapy (Peginterferon Alfa-2a + Ribavirin +Boceprevir) were at the discretion of the Investigator in accordance with the current local prescribing information.
Percentage of Participants With Adverse Events (AEs)	68.8 Percentage of Participants	79.3 Percentage of Participants	85.9 Percentage of Participants

SECONDARY outcome

Timeframe: Week 48

Outcome measures

Outcome measures
Measure	Peginterferon Alfa-2a + Ribavirin n=78 Participants Dual Therapy. Dosing and treatment duration of the dual therapy (Peginterferon Alfa-2a + Ribavirin) were at the discretion of the Investigator in accordance with the current local prescribing information.	Peginterferon Alfa-2a + Ribavirin + Telaprevir n=348 Participants Triple Therapy. Dosing and treatment duration of the triple therapy (Peginterferon Alfa-2a + Ribavirin + Telaprevir) were at the discretion of the Investigator in accordance with the current local prescribing information.	Peginterferon Alfa-2a + Ribavirin + Boceprevir n=219 Participants Triple Therapy. Dosing and treatment duration of the triple therapy (Peginterferon Alfa-2a + Ribavirin +Boceprevir) were at the discretion of the Investigator in accordance with the current local prescribing information.
Mean Value of Hemoglobin in Participants With Treatment-Induced Anemia	9.3 Grams per Deciliter (g/dl) Standard Deviation 1.6	9.2 Grams per Deciliter (g/dl) Standard Deviation 1.3	9.5 Grams per Deciliter (g/dl) Standard Deviation 1.3

SECONDARY outcome

Timeframe: Week 48

Outcome measures

Outcome measures
Measure	Peginterferon Alfa-2a + Ribavirin n=78 Participants Dual Therapy. Dosing and treatment duration of the dual therapy (Peginterferon Alfa-2a + Ribavirin) were at the discretion of the Investigator in accordance with the current local prescribing information.	Peginterferon Alfa-2a + Ribavirin + Telaprevir n=348 Participants Triple Therapy. Dosing and treatment duration of the triple therapy (Peginterferon Alfa-2a + Ribavirin + Telaprevir) were at the discretion of the Investigator in accordance with the current local prescribing information.	Peginterferon Alfa-2a + Ribavirin + Boceprevir n=219 Participants Triple Therapy. Dosing and treatment duration of the triple therapy (Peginterferon Alfa-2a + Ribavirin +Boceprevir) were at the discretion of the Investigator in accordance with the current local prescribing information.
Percentage of Participants With Treatment Regimen for HCV Treatment Induced Anemia RVB Dose Reduction	37 Percentage of Participants	56.5 Percentage of Participants	53.6 Percentage of Participants
Percentage of Participants With Treatment Regimen for HCV Treatment Induced Anemia RBV Temporary Interrupted	2.5 Percentage of Participants	4.5 Percentage of Participants	2.3 Percentage of Participants
Percentage of Participants With Treatment Regimen for HCV Treatment Induced Anemia RBV Permanently Interrupted	0 Percentage of Participants	1.4 Percentage of Participants	0.9 Percentage of Participants
Percentage of Participants With Treatment Regimen for HCV Treatment Induced Anemia Use of Erythropotin	18.5 Percentage of Participants	27.3 Percentage of Participants	29.1 Percentage of Participants
Percentage of Participants With Treatment Regimen for HCV Treatment Induced Anemia Blood Transfusion	17.3 Percentage of Participants	18.8 Percentage of Participants	12.7 Percentage of Participants
Percentage of Participants With Treatment Regimen for HCV Treatment Induced Anemia DAA Permanently Discontinued	0 Percentage of Participants	1.4 Percentage of Participants	0.5 Percentage of Participants
Percentage of Participants With Treatment Regimen for HCV Treatment Induced Anemia Peg-IFN a-2a Dose Reduction	2.5 Percentage of Participants	1.1 Percentage of Participants	5.5 Percentage of Participants
Percentage of Participants With Treatment Regimen for HCV Treatment Induced Anemia No Other Action Done	32.1 Percentage of Participants	22.2 Percentage of Participants	25.5 Percentage of Participants
Percentage of Participants With Treatment Regimen for HCV Treatment Induced Anemia Other	6.2 Percentage of Participants	4.8 Percentage of Participants	2.7 Percentage of Participants

SECONDARY outcome

Timeframe: Week 24

Population: mTRT population: includes all participants who had an HCV-RNA result ≥50 IU/mL at their last measurement prior to commencing CHC therapy; had received one of the study's combination therapies; the participants' treatment documentation was sufficient for assignment to treatment groups.

Participants with dose modifications who had achieved SVR at Week 24 were reported. Data was collected for all participants who had dose modification of Peginterferon alfa-2a, Ribavirin or Telaprevir/boceprevir in any of the treatment regimen during the study.

Outcome measures

Outcome measures
Measure	Peginterferon Alfa-2a + Ribavirin n=935 Participants Dual Therapy. Dosing and treatment duration of the dual therapy (Peginterferon Alfa-2a + Ribavirin) were at the discretion of the Investigator in accordance with the current local prescribing information.	Peginterferon Alfa-2a + Ribavirin + Telaprevir Triple Therapy. Dosing and treatment duration of the triple therapy (Peginterferon Alfa-2a + Ribavirin + Telaprevir) were at the discretion of the Investigator in accordance with the current local prescribing information.	Peginterferon Alfa-2a + Ribavirin + Boceprevir Triple Therapy. Dosing and treatment duration of the triple therapy (Peginterferon Alfa-2a + Ribavirin +Boceprevir) were at the discretion of the Investigator in accordance with the current local prescribing information.
Percentage of Participants Who Had SVR at Week 24 With Dose Modifications Peginterferon alfa-2a	15.70 percentage of participants	—	—
Percentage of Participants Who Had SVR at Week 24 With Dose Modifications Ribavirin	55.56 percentage of participants	—	—
Percentage of Participants Who Had SVR at Week 24 With Dose Modifications Telaprevir/boceprevir	0.78 percentage of participants	—	—

Adverse Events

Peginterferon Alfa-2a + Ribavirin

Serious events: 24 serious events

Other events: 208 other events

Deaths: 0 deaths

Peginterferon Alfa-2a + Ribavirin +Telaprevir

Serious events: 78 serious events

Other events: 338 other events

Deaths: 0 deaths

Peginterferon Alfa-2a + Ribavirin + Boceprevir

Serious events: 26 serious events

Other events: 161 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Additional Information

Medical Communications

Hoffmann-La Roche

Phone: 800-821-8590

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the study but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
Publication restrictions are in place

Restriction type: OTHER