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

• Sponsor: Hoffmann-La Roche (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01604291
• Collaborator: Clalit Health Services (Other)
• Enrollment: 991
• Locations: 21
• Actual Duration (Months): 44.5
• Patients Per Site: 47.2
• Patients Per Site Per Month: 1.1

Study Details

Study Description

Brief Summary

This multi-center, observational study will evaluate the efficacy and safety of dual and triple therapies based on Pegasys (peginterferon alfa-2a) in patients with chronic hepatitis

1. Patients receiving treatment with either Pegasys plus ribavirin or Pegasys plus ribavirin plus telaprevir/boceprevir will be observed for the duration of their treatment and for up to 24 weeks of follow-up.

Condition or Disease	Intervention/Treatment	Phase
Hepatitis C, Chronic

Study Design

• Study Type: Observational
• Actual Enrollment: 991 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Multi-Center, Non-Interventional Study, on the Efficacy of Dual and Triple Therapies Based on Pegylated Interferon Alfa-2a for the Treatment of Chronic Hepatitis C Patients
• Actual Study Start Date: May 28, 2012
• Actual Primary Completion Date: Feb 10, 2016
• Actual Study Completion Date: Feb 10, 2016

Arms and Interventions

Arm	Intervention/Treatment
Cohort

Outcome Measures

Primary Outcome Measures

1. Percentage of Participants With Sustained Viral Response (SVR) at Week 24 [Week 24]

   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.

Secondary Outcome Measures

1. Comparison of SVR at Week 24 [Week 24]

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

2. Number of Participants With SVR at Week 24 According to the Demographic Characteristics [Week 24]

   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.

3. Percentage of Participants With Rapid Virologic Response (RVR) at Week 4 [Week 4]

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

4. Percentage of Participants With Extended RVR [Week 4 and 12 for telaprevir group; Week 8 and 24 for boceprevir group]

   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'.

5. Percentage of Participants With Complete Early Virologic Response (cEVR) [Week 12]

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

6. Percentage of Participants With End of Treatment Response (EoT) [Week 24]

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

7. Percentage of Participants With Virologic Relapse [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.

8. Treatment Duration [Week 48]

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

9. Time to First Dose Modification of Peginterferon Alfa-2a [Week 48]

10. Time to First Dose Modification of Ribavirin [Week 48]

11. Time to First Dose Modification of Telaprevir/Boceprevir [Week 48]

12. Percentage of Participants With Adverse Events (AEs) [Week 48]

    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.

13. Mean Value of Hemoglobin in Participants With Treatment-Induced Anemia [Week 48]

14. Percentage of Participants With Treatment Regimen for HCV Treatment Induced Anemia [Week 48]

15. Percentage of Participants Who Had SVR at Week 24 With Dose Modifications [Week 24]

    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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Adult patients, >/= 18 years of age

• Chronic hepatitis C (all genotypes, naïve or treatment experienced, HCV mono-infected or HCV-HIV co-infected)

• Receiving either dual therapy (Pegasys plus ribavirin) or triple therapy (Pegasys plus ribavirin plus telaprevir/boceprevir)

• No contra-indications to Pegasys and ribavirin therapy or to treatment regimen containing protease inhibitor (telaprevir or boceprevir) as detailed in local Prescribing Information

• Quantitative serum HCV RNA by PCR test before initiation of treatment

Exclusion Criteria:

• Hepatitis A/B co-infection

• Evidence of severe illness, active malignancy, or any other conditions which would make the patient, in the opinion of the investigator, unsuitable for the study

• Pregnant or breast-feeding women

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Haemek Hospital; Gastroenterology	Afula		Israel	18101
2	Barzilai MC; Gastroenterology	Ashkelon		Israel	78278
3	Soroka Medical Center; Gastroenterology	Beer Sheva		Israel	84105
4	Hillel Yaffe Hospital; Gastroenterology	Hadera		Israel	38100
5	Rambam Medical Center; Gastroenterology - Liver Unit	Haifa		Israel	31096
6	Bnei-Zion Medical Center; Gastroenterology	Haifa		Israel	33394
7	Carmel Hospital; Liver Unit	Haifa		Israel	34362
8	Wolfson Hospital; Gastroenterology Unit	Holon		Israel	58100
9	Shaare Zedek Hospital Liver Unit; Liver Unit	Jerusalem		Israel	91031
10	Hadassah Hospital; Liver Unit	Jerusalem		Israel	91120
11	Meir Medical Center; Liver Unit	Kfar Saba		Israel	44281
12	Western Galilee Hospital - Nahariya	Nahariya		Israel	22100
13	Holy Family Medical Center; Liver Unit	Nazareth		Israel
14	Hasharon Mc; Gastroenterology	Petach Tikva		Israel
15	Beilinson-Rabin Liver Unit; Liver Unit	Petah Tiqwa		Israel
16	Sheba Medical Center; Tel Hashomer	Ramat Gan		Israel	5262100
17	Kaplan Medical Center; Gastroenterology Unit	Rehovot		Israel	76100
18	Rebecca Sieff Medical Center; Liver Unit	Safed		Israel	13110
19	Tel-Aviv Sourasky Medical Center; Liver Unit	Tel Aviv		Israel	6423906
20	Poria Hospital; Gastroenterology	Tiberias		Israel
21	Assaf Harofeh; Gastroenterology	Zerifin		Israel	6093000

Sponsors and Collaborators

• Hoffmann-La Roche
• Clalit Health Services

Investigators

• Study Director: Clinical Trials, Hoffmann-La Roche

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Hoffmann-La Roche
• ClinicalTrials.gov Identifier: NCT01604291
• Other Study ID Numbers: ML28268
• First Posted: May 23, 2012
• Last Update Posted: Mar 14, 2019
• Last Verified: Nov 1, 2018

• Additional relevant MeSH terms: Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Hepatitis

Study Results

Participant Flow

Recruitment Details	The study was conducted at 21 investigational centers in Israel.
Pre-assignment Detail	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

Arm/Group Title	Peginterferon Alfa-2a + Ribavirin	Peginterferon Alfa-2a + Ribavirin + Telaprevir	Peginterferon Alfa-2a + Ribavirin + Boceprevir	No Information on Treatment Allocation
Arm/Group Description	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.	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.	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.	Participants for which Treatment Allocation Data is Unavailable.
Period Title: Overall Study
STARTED	311	443	193	44
COMPLETED	311	443	193	44
NOT COMPLETED	0	0	0	0

Baseline Characteristics

Arm/Group Title	Peginterferon Alfa-2a + Ribavirin	Peginterferon Alfa-2a + Ribavirin + Telaprevir	Peginterferon Alfa-2a + Ribavirin + Boceprevir	No Information on Treatment Allocation	Total
Arm/Group Description	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.	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.	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.	Participants for which Treatment Allocation Data is Unavailable	Total of all reporting groups
Overall Participants	311	443	193	44	991
Age (Years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Years]	44.1 (10.6)	50.3 (11.0)	51.1 (11.6)	48.1 (12.0)	48.4 (11.4)
Sex/Gender, Customized (Count of Participants)
Female	101 32.5%	161 36.3%	74 38.3%	9 20.5%	345 34.8%
Male	210 67.5%	282 63.7%	118 61.1%	18 40.9%	628 63.4%
Unknown	0 0%	0 0%	1 0.5%	17 38.6%	18 1.8%

Outcome Measures

1. Primary Outcome

Title	Percentage of Participants With Sustained Viral Response (SVR) at Week 24
Description	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.
Time Frame	Week 24

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Peginterferon Alfa-2a + Ribavirin	Peginterferon Alfa-2a + Ribavirin + Telaprevir	Peginterferon Alfa-2a + Ribavirin + Boceprevir
Arm/Group Description	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.	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.	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.
Measure Participants	303	442	190
Number (95% Confidence Interval) [Percentage of Participants]	87.2 28%	94.8 21.4%	85.2 44.1%

2. Secondary Outcome

Title	Comparison of SVR at Week 24
Description	SVR at Week 24 is compared by treatment group, type of infection, prior treatments and genotype.
Time Frame	Week 24

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Peginterferon Alfa-2a + Ribavirin	Peginterferon Alfa-2a + Ribavirin + Telaprevir	Peginterferon Alfa-2a + Ribavirin + Boceprevir
Arm/Group Description	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.	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.	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.
Measure Participants	303	442	190
HCV Mono Infection	86.6 27.8%	94.8 21.4%	84.5 43.8%
HIV/HCV Co-Infection	100 32.2%	100 22.6%
Genotype 1	83.8 26.9%	94.9 21.4%	84.4 43.7%
Other Genotypes	88.2 28.4%	100 22.6%
Treatment - Naive	89.7 28.8%	95.5 21.6%	86.7 44.9%
Treatment - Experienced	66.7 21.4%	94.5 21.3%	83.1 43.1%

3. Secondary Outcome

Title	Number of Participants With SVR at Week 24 According to the Demographic Characteristics
Description	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.
Time Frame	Week 24

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	All Participants
Arm/Group Description	Participants who had dual or triple therapy as part of their drug regimen at the discretion of the investigator in accordance with the local prescribing information at the time of the study.
Measure Participants	567
Gender: Male - Achieved SVR 24	316 101.6%
Gender: Male - Did not achieve SVR	33 10.6%
Gender: Female - Achieved SVR 24	198 63.7%
Gender: Female - Did not achieve SVR	20 6.4%
Age - Achieved SVR 24	513 165%
Age - Did not achieve SVR	44 14.1%
Height - Achieved SVR 24	44 14.1%
Height - Did not achieve SVR	44 14.1%
Weight - Achieved SVR 24	44 14.1%
Weight - Did not achieve SVR	44 14.1%
Body Mass Index - Achieved SVR 24	44 14.1%
Body Mass Index - Did not achieve SVR	44 14.1%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Peginterferon Alfa-2a + Ribavirin
	Comments	Correlation between SVR 24 and Gender
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	0.9109
	Comments	The p-value from chi-square is the difference between SVR achieved (yes/no) and dose modifications.
	Method	Chi-squared
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Peginterferon Alfa-2a + Ribavirin
	Comments	Correlation between SVR 24 and Age
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	0.1163
	Comments	A t-test was done to compare SVR participants to non-SVR.
	Method	t-test, 1 sided
	Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Peginterferon Alfa-2a + Ribavirin
	Comments	Correlation between SVR 24 and Height
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	0.9269
	Comments	A t-test was done to compare SVR participants to non-SVR.
	Method	t-test, 1 sided
	Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Peginterferon Alfa-2a + Ribavirin
	Comments	Correlation between SVR 24 and Weight
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	0.3376
	Comments	A t-test was done to compare SVR participants to non-SVR.
	Method	t-test, 1 sided
	Comments

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	Peginterferon Alfa-2a + Ribavirin
	Comments	Correlation between SVR 24 and Body mass index.
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	0.4618
	Comments	A t-test was done to compare SVR participants to non-SVR.
	Method	t-test, 1 sided
	Comments

4. Secondary Outcome

Title	Percentage of Participants With Rapid Virologic Response (RVR) at Week 4
Description	RVR was defined as HCV-RNA <50 IU/mL by Week 4
Time Frame	Week 4

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Peginterferon Alfa-2a + Ribvavirin	Peginterferon Alfa-2a + Ribavirin +Telaprevir	Peginterferon Alfa-2a + Ribavirin + Boceprevir
Arm/Group Description	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.	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	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.
Measure Participants	224	398	156
Number (95% Confidence Interval) [Percentage of Participants]	61.2 19.7%	70.9 16%	21.1 10.9%

5. Secondary Outcome

Title	Percentage of Participants With Extended RVR
Description	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'.
Time Frame	Week 4 and 12 for telaprevir group; Week 8 and 24 for boceprevir group

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Peginterferon Alfa-2a + Ribavirin +Telaprevir	Peginterferon Alfa-2a + Ribavirin + Boceprevir
Arm/Group Description	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.	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.
Measure Participants	355	99
Number (95% Confidence Interval) [Percentage of Participants]	72.7 23.4%	70.7 16%

6. Secondary Outcome

Title	Percentage of Participants With Complete Early Virologic Response (cEVR)
Description	Complete early virologic response (cEVR) was defined as HCV-RNA <50 IU/mL by Week 12
Time Frame	Week 12

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Peginterferon Alfa-2a + Ribvavirin	Peginterferon Alfa-2a + Ribavirin +Telaprevir	Peginterferon Alfa-2a + Ribavirin + Boceprevir
Arm/Group Description	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.	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.	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.
Measure Participants	192	372	158
Number (95% Confidence Interval) [Percentage of Participants]	75.0 24.1%	84.9 19.2%	62.0 32.1%

7. Secondary Outcome

Title	Percentage of Participants With End of Treatment Response (EoT)
Description	End-of-Treatment (EoT) response was defined as HCV-RNA <50 IU/mL by the end of treatment.
Time Frame	Week 24

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Peginterferon Alfa-2a + Ribvavirin	Peginterferon Alfa-2a + Ribavirin +Telaprevir	Peginterferon Alfa-2a + Ribavirin + Boceprevir
Arm/Group Description	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.	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.	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.
Measure Participants	286	430	188
Number (95% Confidence Interval) [Percentage of Participants]	86.4 27.8%	81.9 18.5%	76.6 39.7%

8. Secondary Outcome

Title	Percentage of Participants With Virologic Relapse
Description	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.
Time Frame	Week 72

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Peginterferon Alfa-2a + Ribvavirin	Peginterferon Alfa-2a + Ribavirin +Telaprevir	Peginterferon Alfa-2a + Ribavirin + Boceprevir
Arm/Group Description	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.	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.	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.
Measure Participants	286	431	188
Number (95% Confidence Interval) [Percentage of Participants]	0.3 0.1%	0 0%	0 0%

9. Secondary Outcome

Title	Treatment Duration
Description	The average amount of time a treatment was prescribed to participants.
Time Frame	Week 48

Outcome Measure Data

Analysis Population Description

All Enrolled Participants

Arm/Group Title	Peginterferon Alfa-2a + Ribavirin	Peginterferon Alfa-2a + Ribavirin + Telaprevir	Peginterferon Alfa-2a + Ribavirin + Boceprevir
Arm/Group Description	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.	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.	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.
Measure Participants	311	443	193
Peginterferon Alfa-2a Treatment Duration	26.2 (11.5)	34.8 (15.2)	36.1 (14.7)
Ribavirin Treatment Duration	26.2 (11.6)	34.8 (15.2)	36.1 (14.7)
Telaprevir/ Boceprevir Treatment Duration	NA (NA)	11.8 (4.6)	30.6 (14.9)

10. Secondary Outcome

Title	Time to First Dose Modification of Peginterferon Alfa-2a
Time Frame	Week 48

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Peginterferon Alfa-2a + Ribavirin	Peginterferon Alfa-2a + Ribavirin +Telaprevir	Peginterferon Alfa-2a + Ribavirin + Boceprevir
Arm/Group Description	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.	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.	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.
Measure Participants	227	421	187
Mean (Standard Deviation) [Days]	418.5 (9.7)	247.6 (4.1)	328.4 (13.7)

11. Secondary Outcome

Title	Time to First Dose Modification of Ribavirin
Time Frame	Week 48

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Peginterferon Alfa-2a + Ribvavirin	Peginterferon Alfa-2a + Ribavirin +Telaprevir	Peginterferon Alfa-2a + Ribavirin + Boceprevir
Arm/Group Description	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.	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.	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.
Measure Participants	280	168	109
Mean (Standard Deviation) [Days]	NA (NA)	61.4 (3.6)	89.4 (6.8)

12. Secondary Outcome

Title	Time to First Dose Modification of Telaprevir/Boceprevir
Time Frame	Week 48

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Peginterferon Alfa-2a + Ribavirin +Telaprevir	Peginterferon Alfa-2a + Ribavirin + Boceprevir
Arm/Group Description	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.	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.
Measure Participants	416	181
Mean (Standard Deviation) [Days]	124.6 (0.7)	82.3 (0.8)

13. Secondary Outcome

Title	Percentage of Participants With Adverse Events (AEs)
Description	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.
Time Frame	Week 48

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Peginterferon Alfa-2a + Ribavirin	Peginterferon Alfa-2a + Ribavirin + Telaprevir	Peginterferon Alfa-2a + Ribavirin + Boceprevir
Arm/Group Description	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.	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.	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.
Measure Participants	311	445	192
Number [Percentage of Participants]	68.8 22.1%	79.3 17.9%	85.9 44.5%

14. Secondary Outcome

Title	Mean Value of Hemoglobin in Participants With Treatment-Induced Anemia
Time Frame	Week 48

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Peginterferon Alfa-2a + Ribavirin	Peginterferon Alfa-2a + Ribavirin + Telaprevir	Peginterferon Alfa-2a +Ribavirin + Boceprevir
Arm/Group Description	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.	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.	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.
Measure Participants	78	348	219
Mean (Standard Deviation) [Grams per Deciliter (g/dl)]	9.3 (1.6)	9.2 (1.3)	9.5 (1.3)

15. Secondary Outcome

Title	Percentage of Participants With Treatment Regimen for HCV Treatment Induced Anemia
Time Frame	Week 48

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Peginterferon Alfa-2a + Ribvavirin	Peginterferon Alfa-2a + Ribavirin +Telaprevir	Peginterferon Alfa-2a + Ribavirin + Boceprevir
Arm/Group Description	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.	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.	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.
Measure Participants	78	348	219
RVB Dose Reduction	37 11.9%	56.5 12.8%	53.6 27.8%
RBV Temporary Interrupted	2.5 0.8%	4.5 1%	2.3 1.2%
RBV Permanently Interrupted	0 0%	1.4 0.3%	0.9 0.5%
Use of Erythropotin	18.5 5.9%	27.3 6.2%	29.1 15.1%
Blood Transfusion	17.3 5.6%	18.8 4.2%	12.7 6.6%
DAA Permanently Discontinued	0 0%	1.4 0.3%	0.5 0.3%
Peg-IFN a-2a Dose Reduction	2.5 0.8%	1.1 0.2%	5.5 2.8%
No Other Action Done	32.1 10.3%	22.2 5%	25.5 13.2%
Other	6.2 2%	4.8 1.1%	2.7 1.4%

16. Secondary Outcome

Title	Percentage of Participants Who Had SVR at Week 24 With Dose Modifications
Description	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.
Time Frame	Week 24

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	All Participants
Arm/Group Description	Participants who had dual or triple therapy as part of their drug regimen at the discretion of the investigator in accordance with the local prescribing information at the time of the study.
Measure Participants	935
Peginterferon alfa-2a	15.70 5%
Ribavirin	55.56 17.9%
Telaprevir/boceprevir	0.78 0.3%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Peginterferon Alfa-2a + Ribavirin
	Comments	Correlation with dose modification for Peginterferon alfa-2a.
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	0.0463
	Comments
	Method	Chi-squared
	Comments	The p-value from chi-square is the difference between SVR achieved (yes/no) and dose modifications.
Method of Estimation	Estimation Parameter	phi-coefficient
	Estimated Value	-0.0835
	Confidence Interval	() %; to
	Parameter Dispersion	Type: Value:
	Estimation Comments	phi-coefficient is a measure of the degree of association between two binary variables

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Peginterferon Alfa-2a + Ribavirin
	Comments	Correlation with dose modification for Ribavirin.
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	0.2052
	Comments
	Method	Chi-squared
	Comments	The p-value from chi-square is the difference between SVR achieved (yes/no) and dose modifications.
Method of Estimation	Estimation Parameter	phi-coefficient
	Estimated Value	0.0666
	Confidence Interval	() %; to
	Parameter Dispersion	Type: Value:
	Estimation Comments	phi-coefficient is a measure of the degree of association between two binary variables.

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Peginterferon Alfa-2a + Ribavirin
	Comments	Correlation with dose modification for Telaprevir/boceprevir.
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	0.0033
	Comments
	Method	Fisher Exact
	Comments	The p-value from chi-square is the difference between SVR achieved (yes/no) and dose modifications.
Method of Estimation	Estimation Parameter	phi-coefficient
	Estimated Value	-0.1672
	Confidence Interval	() %; to
	Parameter Dispersion	Type: Value:
	Estimation Comments	phi-coefficient is a measure of the degree of association between two binary variables.

Adverse Events

Time Frame	Week 48
Adverse Event Reporting Description	The Safety Analysis population was defined to include only participants who had received at least one dose of a peginterferon alfa-2a plus ribavirin, or a peginterferon alfa-2a plus ribavirin plus telaprevir/boceprevir and had at least one post-baseline safety assessment. 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.
Arm/Group Title	Peginterferon Alfa-2a + Ribavirin		Peginterferon Alfa-2a + Ribavirin +Telaprevir		Peginterferon Alfa-2a + Ribavirin + Boceprevir
Arm/Group Description	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.		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.		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.
All Cause Mortality
	Peginterferon Alfa-2a + Ribavirin		Peginterferon Alfa-2a + Ribavirin +Telaprevir		Peginterferon Alfa-2a + Ribavirin + Boceprevir
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	Peginterferon Alfa-2a + Ribavirin		Peginterferon Alfa-2a + Ribavirin +Telaprevir		Peginterferon Alfa-2a + Ribavirin + Boceprevir
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	24/311 (7.7%)		78/445 (17.5%)		26/192 (13.5%)
Blood and lymphatic system disorders
Anaemia	2/311 (0.6%)		30/445 (6.7%)		5/192 (2.6%)
Febrile Neutropenia	0/311 (0%)		0/445 (0%)		1/192 (0.5%)
Haemolytic Anaemia	1/311 (0.3%)		0/445 (0%)		0/192 (0%)
Leukopenia	0/311 (0%)		0/445 (0%)		1/192 (0.5%)
Neutropenia	0/311 (0%)		0/445 (0%)		2/192 (1%)
Pancytopenia	0/311 (0%)		3/445 (0.7%)		3/192 (1.6%)
Thrombocytopenia	2/311 (0.6%)		2/445 (0.4%)		0/192 (0%)
Cardiac disorders
Atrial Fibrillation	0/311 (0%)		0/445 (0%)		1/192 (0.5%)
Bradycardia	0/311 (0%)		1/445 (0.2%)		0/192 (0%)
Myocardial Infarction	1/311 (0.3%)		0/445 (0%)		0/192 (0%)
Ear and labyrinth disorders
Hearing Impaired	0/311 (0%)		1/445 (0.2%)		0/192 (0%)
Endocrine disorders
Diabetes Mellitus	1/311 (0.3%)		0/445 (0%)		0/192 (0%)
Hypothyroidism	0/311 (0%)		1/445 (0.2%)		0/192 (0%)
Eye disorders
Papilloedema	0/311 (0%)		1/445 (0.2%)		0/192 (0%)
Gastrointestinal disorders
Abdominal Pain	0/311 (0%)		1/445 (0.2%)		0/192 (0%)
Abdominal Pain Upper	0/311 (0%)		1/445 (0.2%)		0/192 (0%)
Diarrhoea	0/311 (0%)		1/445 (0.2%)		0/192 (0%)
Gastrointestinal Perforation	1/311 (0.3%)		0/445 (0%)		0/192 (0%)
Melaena	0/311 (0%)		1/445 (0.2%)		0/192 (0%)
Nausea	0/311 (0%)		2/445 (0.4%)		0/192 (0%)
Pancreatitis Acute	0/311 (0%)		1/445 (0.2%)		0/192 (0%)
Rectal Haemorrhage	0/311 (0%)		2/445 (0.4%)		0/192 (0%)
Small Intestinal Obstruction	1/311 (0.3%)		0/445 (0%)		0/192 (0%)
Vomiting	0/311 (0%)		2/445 (0.4%)		0/192 (0%)
General disorders
Asthenia	0/311 (0%)		5/445 (1.1%)		0/192 (0%)
Chest Pain	2/311 (0.6%)		1/445 (0.2%)		3/192 (1.6%)
Death	4/311 (1.3%)		1/445 (0.2%)		0/192 (0%)
Face Oedema	0/311 (0%)		1/445 (0.2%)		0/192 (0%)
Multi-Organ Failure	0/311 (0%)		1/445 (0.2%)		0/192 (0%)
Pyrexia	5/311 (1.6%)		12/445 (2.7%)		4/192 (2.1%)
Hepatobiliary disorders
Biliary Colic	0/311 (0%)		1/445 (0.2%)		0/192 (0%)
Cholelithiasis	0/311 (0%)		1/445 (0.2%)		0/192 (0%)
Hepatitis	1/311 (0.3%)		0/445 (0%)		0/192 (0%)
Jaundice	1/311 (0.3%)		1/445 (0.2%)		0/192 (0%)
Infections and infestations
Appendicitis	2/311 (0.6%)		0/445 (0%)		0/192 (0%)
Bacteraemia	0/311 (0%)		0/445 (0%)		1/192 (0.5%)
Cellulitis	1/311 (0.3%)		0/445 (0%)		2/192 (1%)
Cryptococcal Fungaemia	0/311 (0%)		1/445 (0.2%)		0/192 (0%)
Diabetic Foot Infection	0/311 (0%)		0/445 (0%)		1/192 (0.5%)
Ear Infection	0/311 (0%)		0/445 (0%)		1/192 (0.5%)
Furuncle	0/311 (0%)		1/445 (0.2%)		0/192 (0%)
Gastroenteritis	0/311 (0%)		2/445 (0.4%)		1/192 (0.5%)
Infection	1/311 (0.3%)		0/445 (0%)		0/192 (0%)
Pneumonia	2/311 (0.6%)		1/445 (0.2%)		3/192 (1.6%)
Salmonella Bacteraemia	0/311 (0%)		1/445 (0.2%)		0/192 (0%)
Septic Shock	0/311 (0%)		1/445 (0.2%)		0/192 (0%)
Tuberculosis	1/311 (0.3%)		0/445 (0%)		0/192 (0%)
Upper Respiratory Tract Infection	1/311 (0.3%)		0/445 (0%)		0/192 (0%)
Urinary Tract Infection	1/311 (0.3%)		1/445 (0.2%)		0/192 (0%)
Urosepsis	0/311 (0%)		0/445 (0%)		1/192 (0.5%)
Injury, poisoning and procedural complications
Thermal Burn	0/311 (0%)		0/445 (0%)		1/192 (0.5%)
Investigations
Haemoglobin Decreased	0/311 (0%)		2/445 (0.4%)		0/192 (0%)
Metabolism and nutrition disorders
Hypoglycaemia	0/311 (0%)		0/445 (0%)		1/192 (0.5%)
Musculoskeletal and connective tissue disorders
Back Pain	0/311 (0%)		0/445 (0%)		1/192 (0.5%)
Gout	0/311 (0%)		1/445 (0.2%)		0/192 (0%)
Neck Pain	0/311 (0%)		1/445 (0.2%)		0/192 (0%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma Pancreas	1/311 (0.3%)		0/445 (0%)		0/192 (0%)
Nervous system disorders
Dizziness	0/311 (0%)		1/445 (0.2%)		2/192 (1%)
Paraesthesia	0/311 (0%)		0/445 (0%)		1/192 (0.5%)
Polyneuropathy	0/311 (0%)		0/445 (0%)		1/192 (0.5%)
Spinal Cord Compression	0/311 (0%)		1/445 (0.2%)		0/192 (0%)
Syncope	0/311 (0%)		4/445 (0.9%)		1/192 (0.5%)
Tremor	0/311 (0%)		1/445 (0.2%)		0/192 (0%)
Pregnancy, puerperium and perinatal conditions
Pregnancy	0/311 (0%)		2/445 (0.4%)		1/192 (0.5%)
Psychiatric disorders
Anxiety Disorder	0/311 (0%)		1/445 (0.2%)		0/192 (0%)
Major Depression	0/311 (0%)		1/445 (0.2%)		0/192 (0%)
Psychotic Disorder	0/311 (0%)		1/445 (0.2%)		0/192 (0%)
Schizophrenia	0/311 (0%)		1/445 (0.2%)		0/192 (0%)
Suicide Attempt	0/311 (0%)		1/445 (0.2%)		0/192 (0%)
Renal and urinary disorders
Acute Kidney Injury	0/311 (0%)		1/445 (0.2%)		1/192 (0.5%)
Calculus Urethal	1/311 (0.3%)		0/445 (0%)		0/192 (0%)
Oliguria	0/311 (0%)		0/445 (0%)		1/192 (0.5%)
Renal Colic	0/311 (0%)		1/445 (0.2%)		0/192 (0%)
Renal Failure	0/311 (0%)		1/445 (0.2%)		0/192 (0%)
Reproductive system and breast disorders
Testicular Pain	0/311 (0%)		1/445 (0.2%)		0/192 (0%)
Respiratory, thoracic and mediastinal disorders
Acute Bronchitis	1/311 (0.3%)		0/445 (0%)		0/192 (0%)
Bronchitis	1/311 (0.3%)		0/445 (0%)		0/192 (0%)
Cough	0/311 (0%)		2/445 (0.4%)		0/192 (0%)
Dyspnoea	0/311 (0%)		3/445 (0.7%)		2/192 (1%)
Pneumonitis	0/311 (0%)		1/445 (0.2%)		0/192 (0%)
Pneumothorax	0/311 (0%)		1/445 (0.2%)		0/192 (0%)
Skin and subcutaneous tissue disorders
Dermatitis	0/311 (0%)		0/445 (0%)		1/192 (0.5%)
Diabetic Foot	0/311 (0%)		0/445 (0%)		1/192 (0.5%)
Folliculitis	0/311 (0%)		1/445 (0.2%)		0/192 (0%)
Pruritus	0/311 (0%)		1/445 (0.2%)		0/192 (0%)
Rash	0/311 (0%)		8/445 (1.8%)		0/192 (0%)
Skin Lesion	0/311 (0%)		1/445 (0.2%)		0/192 (0%)
Surgical and medical procedures
Renal Stone Removal	1/311 (0.3%)		0/445 (0%)		0/192 (0%)
Vena Cava Filter Removal	0/311 (0%)		0/445 (0%)		1/192 (0.5%)
Vascular disorders
Hypertension	0/311 (0%)		1/445 (0.2%)		0/192 (0%)
Hypotension	0/311 (0%)		0/445 (0%)		1/192 (0.5%)
Other (Not Including Serious) Adverse Events
	Peginterferon Alfa-2a + Ribavirin		Peginterferon Alfa-2a + Ribavirin +Telaprevir		Peginterferon Alfa-2a + Ribavirin + Boceprevir
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	208/311 (66.9%)		338/445 (76%)		161/192 (83.9%)
Blood and lymphatic system disorders
Anemia	44/311 (14.1%)		162/445 (36.4%)		96/192 (50%)
Leukopenia	16/311 (5.1%)		22/445 (4.9%)		15/192 (7.8%)
Neutropenia	27/311 (8.7%)		33/445 (7.4%)		40/192 (20.8%)
Thrombocytopenia	26/311 (8.4%)		43/445 (9.7%)		24/192 (12.5%)
Ear and labyrinth disorders
Vertigo	23/311 (7.4%)		29/445 (6.5%)		16/192 (8.3%)
Gastrointestinal disorders
Abdominal Pain	16/311 (5.1%)		28/445 (6.3%)		14/192 (7.3%)
Anorectal Discomfort	0/311 (0%)		27/445 (6.1%)		2/192 (1%)
Constipation	12/311 (3.9%)		22/445 (4.9%)		12/192 (6.3%)
Diarrhoea	17/311 (5.5%)		31/445 (7%)		24/192 (12.5%)
Nausea	40/311 (12.9%)		59/445 (13.3%)		34/192 (17.7%)
Proctalgia	6/311 (1.9%)		27/445 (6.1%)		8/192 (4.2%)
Vomiting	17/311 (5.5%)		25/445 (5.6%)		12/192 (6.3%)
General disorders
Asthenia	116/311 (37.3%)		169/445 (38%)		85/192 (44.3%)
Pallor	5/311 (1.6%)		24/445 (5.4%)		13/192 (6.8%)
Pyrexia	47/311 (15.1%)		60/445 (13.5%)		44/192 (22.9%)
Investigations
Weight Decreased	29/311 (9.3%)		40/445 (9%)		14/192 (7.3%)
Metabolism and nutrition disorders
Decreased Appetite	51/311 (16.4%)		66/445 (14.8%)		27/192 (14.1%)
Musculoskeletal and connective tissue disorders
Arthralgia	29/311 (9.3%)		26/445 (5.8%)		12/192 (6.3%)
Back Pain	25/311 (8%)		26/445 (5.8%)		11/192 (5.7%)
Myalgia	29/311 (9.3%)		37/445 (8.3%)		23/192 (12%)
Nervous system disorders
Dizziness	8/311 (2.6%)		23/445 (5.2%)		9/192 (4.7%)
Dysgeusia	23/311 (7.4%)		32/445 (7.2%)		42/192 (21.9%)
Headache	55/311 (17.7%)		49/445 (11%)		26/192 (13.5%)
Psychiatric disorders
Depressed Mood	33/311 (10.6%)		32/445 (7.2%)		14/192 (7.3%)
Insomnia	20/311 (6.4%)		18/445 (4%)		10/192 (5.2%)
Nervousness	48/311 (15.4%)		34/445 (7.6%)		16/192 (8.3%)
Sleep Disorder	31/311 (10%)		27/445 (6.1%)		14/192 (7.3%)
Respiratory, thoracic and mediastinal disorders
Cough	25/311 (8%)		46/445 (10.3%)		21/192 (10.9%)
Dyspnoea	20/311 (6.4%)		28/445 (6.3%)		16/192 (8.3%)
Skin and subcutaneous tissue disorders
Alopecia	16/311 (5.1%)		39/445 (8.8%)		19/192 (9.9%)
Dry Skin	16/311 (5.1%)		25/445 (5.6%)		12/192 (6.3%)
Pruritus	41/311 (13.2%)		133/445 (29.9%)		44/192 (22.9%)
Rash	43/311 (13.8%)		124/445 (27.9%)		33/192 (17.2%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

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.