A Study of Predictors of the Effectiveness of Pegylated Interferon in a Cohort of Participants With Hepatitis C

• Sponsor: Hoffmann-La Roche (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01659567
• Collaborator: (none)
• Enrollment: 516
• Locations: 3
• Actual Duration (Months): 54.5
• Patients Per Site: 172
• Patients Per Site Per Month: 3.2

Study Details

Study Description

Brief Summary

This prospective observational study will investigate predictive values of virological response in pegylated interferon alfa-2a (Pegasys)/ribavirin (Copegus) treatment-naive participants with chronic hepatitis C. Participants will be treated with pegylated interferon alfa-2a and ribavirin as prescribed by the physician. Data will be collected for a maximum of 96 weeks.

Condition or Disease	Intervention/Treatment	Phase
Hepatitis C, Chronic	Drug: Pegylated Interferon Alfa-2a; Drug: Ribavirin

Study Design

• Study Type: Observational
• Actual Enrollment: 516 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Prospective, Observational Study of Predictors of the Effectiveness of Pegylated Interferon in a Cohort of Patients With Hepatitis C in Georgia
• Actual Study Start Date: Apr 6, 2011
• Actual Primary Completion Date: Oct 20, 2015
• Actual Study Completion Date: Oct 20, 2015

Arms and Interventions

Arm

Intervention/Treatment

Chronic Hepatitis C Participants with chronic hepatitis C, treated with pegylated interferon alfa-2a (Pegasys) and ribavirin (Copegus) according to the current standard of care and in line with current summaries of product characteristics/local labelling, will be observed for up to 96 weeks.

Drug: Pegylated Interferon Alfa-2a; Pegylated interferon alfa-2a will be administered according to the current standard of care and in line with current summaries of product characteristics/local labelling.; Other Names: Pegasys ; Drug: Ribavirin; Ribavirin will be administered according to the current standard of care and in line with current summaries of product characteristics/local labelling.; Other Names: Copegus

Outcome Measures

Primary Outcome Measures

1. Percentage of Participants Achieving Sustained Virological Response (SVR) [At 24 weeks after end of treatment (EOT) (up to 96 weeks), where EOT = up to 72 weeks]

   SVR was defined as hepatitis C virus (HCV) ribonucleic acid (RNA) level undetectable (less than [<] 15 international units per milliliter [IU/mL]) 24 weeks after completion of the actual treatment period (measured using the COBAS AmpliPrep [CAP]/ COBAS TaqMan [CTM] test). Percentage of participants achieving SVR was reported.

2. Positive Predictive Value (PPV) of Rapid Viral Response (RVR) on SVR [At 24 weeks after EOT (up to 96 weeks), where EOT = up to 72 weeks]

   RVR was defined as HCV RNA less than or equal to (<=) 25 IU/mL at Week 4 using CAP/CTM test. The percentage of participants with probability that the participant who develops RVR would achieve SVR was termed as PPV of RVR on SVR. SVR was defined as HCV RNA level undetectable (<15 IU/mL) 24 weeks after completion of the actual treatment period (measured using CAP/ CTM test).

3. PPV of Complete Early Viral Response (cEVR) on SVR [At 24 weeks after EOT (up to 96 weeks), where EOT = up to 72 weeks]

   cEVR was defined as HCV RNA <=25 IU/mL at Week 12, but not at Week 4 using CAP/CTM test. The percentage of participants with probability that the participant who develops cEVR would achieve SVR was termed as PPV of cEVR on SVR. SVR was defined as HCV RNA level undetectable (<15 IU/mL) 24 weeks after completion of the actual treatment period (measured using CAP/ CTM test).

Secondary Outcome Measures

1. Odds Ratio (OR) for Impact of Age on SVR [Baseline up to 96 weeks (assessed at Baseline, 24 weeks after EOT [up to 96 weeks], where EOT = up to 72 weeks)]

   The viral response development was assessed using univariate analysis with logistic regression model to calculate OR for impact of age (greater than [>] 42 years versus <=42 years) on SVR. SVR was defined as HCV RNA level undetectable (<15 IU/mL) 24 weeks after completion of the actual treatment period (measured using CAP/ CTM test).

2. OR for Impact of Gender on SVR [Baseline up to 96 weeks (assessed at Baseline, 24 weeks after EOT [up to 96 weeks], where EOT = up to 72 weeks)]

   The viral response development was assessed using univariate analysis with logistic regression model to calculate OR for impact of gender (male versus female) on SVR. SVR was defined as HCV RNA level undetectable (<15 IU/mL) 24 weeks after completion of the actual treatment period (measured using CAP/ CTM test).

3. OR for Impact of Body Weight on SVR [Baseline up to 96 weeks (assessed at Baseline, 24 weeks after EOT [up to 96 weeks], where EOT = up to 72 weeks)]

   The viral response development was assessed using univariate analysis with logistic regression model to calculate OR for impact of body weight on SVR. SVR was defined as HCV RNA level undetectable (<15 IU/mL) 24 weeks after completion of the actual treatment period (measured using CAP/ CTM test).

4. OR for Impact of Baseline Level of Fibrosis (kPa) on SVR [Baseline up to 96 weeks (assessed at Baseline, 24 weeks after EOT [up to 96 weeks], where EOT = up to 72 weeks)]

   The viral response development was assessed using univariate analysis with logistic regression model to calculate OR for impact of baseline level of fibrosis on SVR. Level of fibrosis was measured in terms of kilopascals (kPa) using elastography. kPa score was categorized in 4 groups: 0 to 6.0; 6.1 to 9.9; 10.0 to 14.5; and 14.6 and above. SVR was defined as HCV RNA level undetectable (<15 IU/mL) 24 weeks after completion of the actual treatment period (measured using CAP/ CTM test).

5. OR for Impact of Baseline Alanine Transaminase (ALT) Level on SVR [Baseline up to 96 weeks (assessed at Baseline, 24 weeks after EOT [up to 96 weeks], where EOT = up to 72 weeks)]

   The viral response development was assessed using univariate analysis with logistic regression model to calculate OR for impact of baseline ALT level (>40 international units per liter [IU/L] versus <=40 IU/L) on SVR. SVR was defined as HCV RNA level undetectable (<15 IU/mL) 24 weeks after completion of the actual treatment period (measured using CAP/ CTM test).

6. OR for Impact of Baseline Viral Load Count on SVR [Baseline up to 96 weeks (assessed at Baseline, 24 weeks after EOT [up to 96 weeks], where EOT = up to 72 weeks)]

   The viral response development was assessed using univariate analysis with logistic regression model to calculate OR for impact of baseline viral load count (>800000 IU/mL versus <=800000 IU/mL) on SVR. SVR was defined as HCV RNA level undetectable (<15 IU/mL) 24 weeks after completion of the actual treatment period (measured using CAP/ CTM test).

7. OR for Impact of Overall Duration of Treatment on SVR [Baseline up to 96 weeks (assessed at Baseline, EOT, 24 weeks after EOT [up to 96 weeks], where EOT = up to 72 weeks)]

   The viral response development was assessed using univariate analysis with logistic regression model to calculate OR for impact of overall duration of treatment on SVR. SVR was defined as HCV RNA level undetectable (<15 IU/mL) 24 weeks after completion of the actual treatment period (measured using CAP/ CTM test).

8. OR for Impact of Duration of Treatment After Achieving RVR on SVR [Baseline up to 96 weeks (assessed at Baseline, Week 4, EOT, 24 weeks after EOT [up to 96 weeks], where EOT = up to 72 weeks)]

   The viral response development was assessed using univariate analysis with logistic regression model to calculate OR for impact of duration of treatment after achieving RVR (>18 weeks versus <=18 weeks) on SVR. RVR was defined as HCV RNA <=25 IU/mL at Week 4 using CAP/CTM test. SVR was defined as HCV RNA level undetectable (<15 IU/mL) 24 weeks after completion of the actual treatment period (measured using CAP/ CTM test).

9. OR for Impact of Duration of Treatment After Achieving cEVR on SVR [Baseline up to 96 weeks (assessed at Baseline, Weeks 4, 12, EOT, 24 weeks after EOT [up to 96 weeks], where EOT = up to 72 weeks)]

   The viral response development was assessed using univariate analysis with logistic regression model to calculate OR for impact of duration of treatment after achieving cEVR (>11 weeks versus <=11 weeks) on SVR. cEVR was defined as HCV RNA <=25 IU/mL at Week 12, but not at Week 4 using CAP/CTM test. SVR was defined as HCV RNA level undetectable (<15 IU/mL) 24 weeks after completion of the actual treatment period (measured using CAP/ CTM test).

10. OR for Impact of Cumulative Doses of Pegylated Interferon Alfa-2a on SVR [At 24 weeks after EOT (up to 96 weeks), where EOT = up to 72 weeks]

    The viral response development was assessed using univariate analysis with logistic regression model to calculate OR for impact of cumulative doses of pegylated interferon alfa-2a on SVR. SVR was defined as HCV RNA level undetectable (<15 IU/mL) 24 weeks after completion of the actual treatment period (measured using CAP/ CTM test).

11. OR for Impact of Cumulative Doses of Ribavirin on SVR [At 24 weeks after EOT (up to 96 weeks), where EOT = up to 72 weeks]

    The viral response development was assessed using univariate analysis with logistic regression model to calculate OR for impact of cumulative doses of ribavirin on SVR. SVR was defined as HCV RNA level undetectable (<15 IU/mL) 24 weeks after completion of the actual treatment period (measured using CAP/ CTM test).

Eligibility Criteria

Criteria

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

Inclusion Criteria:

• Diagnosis of chronic hepatitis C infection

Exclusion Criteria:

• Co-infection with human immunodeficiency virus (HIV) and/or hepatitis B

• Participants previously treated with pegylated interferon alfa-2a/ribavirin

• Participation in another clinical study within 30 days prior to study start of ML25544

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hepatology Clinic Hepa	Tbilisi		Georgia	0159
2	Infectious Diseases, AIDS and Clinical Immunology Research Center	Tbilisi		Georgia	0160
3	Ltd Mrcheveli	Tbilisi		Georgia	0160

Sponsors and Collaborators

• Hoffmann-La Roche

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: NCT01659567
• Other Study ID Numbers: ML25544
• First Posted: Aug 8, 2012
• Last Update Posted: Oct 3, 2017
• Last Verified: May 1, 2017

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Hepatitis; Interferons; Ribavirin; Interferon-alpha; Interferon alpha-2; Peginterferon alfa-2a

Study Results

Participant Flow

Arm/Group Title	Pegylated Interferon Alfa-2a and Ribavirin
Arm/Group Description	Participants with chronic hepatitis C, treated with pegylated interferon alfa-2a (Pegasys) and ribavirin (copegus) according to the current standard of care and in line with current summaries of product characteristics/local labelling, were observed for up to 96 weeks.
Period Title: Overall Study
STARTED	516
COMPLETED	393
NOT COMPLETED	123

Baseline Characteristics

Arm/Group Title	Pegylated Interferon Alfa-2a and Ribavirin
Arm/Group Description	Participants with chronic hepatitis C, treated with pegylated interferon alfa-2a (Pegasys) and ribavirin (copegus) according to the current standard of care and in line with current summaries of product characteristics/local labelling, were observed for up to 96 weeks.
Overall Participants	516
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	42.12 (10.01)
Sex: Female, Male (Count of Participants)
Female	62 12%
Male	454 88%

Outcome Measures

1. Primary Outcome

Title	Percentage of Participants Achieving Sustained Virological Response (SVR)
Description	SVR was defined as hepatitis C virus (HCV) ribonucleic acid (RNA) level undetectable (less than [<] 15 international units per milliliter [IU/mL]) 24 weeks after completion of the actual treatment period (measured using the COBAS AmpliPrep [CAP]/ COBAS TaqMan [CTM] test). Percentage of participants achieving SVR was reported.
Time Frame	At 24 weeks after end of treatment (EOT) (up to 96 weeks), where EOT = up to 72 weeks

Outcome Measure Data

Analysis Population Description

Analysis population included all treated participants. Here, 'Number of Participants Analyzed' = participants evaluable for this outcome measure.

Arm/Group Title	Pegylated Interferon Alfa-2a and Ribavirin
Arm/Group Description	Participants with chronic hepatitis C, treated with pegylated interferon alfa-2a (Pegasys) and ribavirin (copegus) according to the current standard of care and in line with current summaries of product characteristics/local labelling, were observed for up to 96 weeks.
Measure Participants	225
Number [percentage of participants]	79.1 15.3%

2. Primary Outcome

Title	Positive Predictive Value (PPV) of Rapid Viral Response (RVR) on SVR
Description	RVR was defined as HCV RNA less than or equal to (<=) 25 IU/mL at Week 4 using CAP/CTM test. The percentage of participants with probability that the participant who develops RVR would achieve SVR was termed as PPV of RVR on SVR. SVR was defined as HCV RNA level undetectable (<15 IU/mL) 24 weeks after completion of the actual treatment period (measured using CAP/ CTM test).
Time Frame	At 24 weeks after EOT (up to 96 weeks), where EOT = up to 72 weeks

Outcome Measure Data

Analysis Population Description

Analysis population included all treated participants. Here, 'Number of Participants Analyzed' = participants evaluable for this outcome measure.

Arm/Group Title	Pegylated Interferon Alfa-2a and Ribavirin
Arm/Group Description	Participants with chronic hepatitis C, treated with pegylated interferon alfa-2a (Pegasys) and ribavirin (copegus) according to the current standard of care and in line with current summaries of product characteristics/local labelling, were observed for up to 96 weeks.
Measure Participants	185
Number (95% Confidence Interval) [percentage of participants]	93.1 18%

3. Primary Outcome

Title	PPV of Complete Early Viral Response (cEVR) on SVR
Description	cEVR was defined as HCV RNA <=25 IU/mL at Week 12, but not at Week 4 using CAP/CTM test. The percentage of participants with probability that the participant who develops cEVR would achieve SVR was termed as PPV of cEVR on SVR. SVR was defined as HCV RNA level undetectable (<15 IU/mL) 24 weeks after completion of the actual treatment period (measured using CAP/ CTM test).
Time Frame	At 24 weeks after EOT (up to 96 weeks), where EOT = up to 72 weeks

Outcome Measure Data

Analysis Population Description

Analysis population included all treated participants. Here, 'Number of Participants Analyzed' = participants evaluable for this outcome measure.

Arm/Group Title	Pegylated Interferon Alfa-2a and Ribavirin
Arm/Group Description	Participants with chronic hepatitis C, treated with pegylated interferon alfa-2a (Pegasys) and ribavirin (copegus) according to the current standard of care and in line with current summaries of product characteristics/local labelling, were observed for up to 96 weeks.
Measure Participants	64
Number (95% Confidence Interval) [percentage of participants]	60.3 11.7%

4. Secondary Outcome

Title	Odds Ratio (OR) for Impact of Age on SVR
Description	The viral response development was assessed using univariate analysis with logistic regression model to calculate OR for impact of age (greater than [>] 42 years versus <=42 years) on SVR. SVR was defined as HCV RNA level undetectable (<15 IU/mL) 24 weeks after completion of the actual treatment period (measured using CAP/ CTM test).
Time Frame	Baseline up to 96 weeks (assessed at Baseline, 24 weeks after EOT [up to 96 weeks], where EOT = up to 72 weeks)

Outcome Measure Data

Analysis Population Description

Analysis population included all treated participants. Here, 'Number of Participants Analyzed' = participants evaluable for this outcome measure.

Arm/Group Title	Pegylated Interferon Alfa-2a and Ribavirin
Arm/Group Description	Participants with chronic hepatitis C, treated with pegylated interferon alfa-2a (Pegasys) and ribavirin (copegus) according to the current standard of care and in line with current summaries of product characteristics/local labelling, were observed for up to 96 weeks.
Measure Participants	225
Number (95% Confidence Interval) [odds ratio]	0.21

5. Secondary Outcome

Title	OR for Impact of Gender on SVR
Description	The viral response development was assessed using univariate analysis with logistic regression model to calculate OR for impact of gender (male versus female) on SVR. SVR was defined as HCV RNA level undetectable (<15 IU/mL) 24 weeks after completion of the actual treatment period (measured using CAP/ CTM test).
Time Frame	Baseline up to 96 weeks (assessed at Baseline, 24 weeks after EOT [up to 96 weeks], where EOT = up to 72 weeks)

Outcome Measure Data

Analysis Population Description

Analysis population included all treated participants. Here, 'Number of Participants Analyzed' = participants evaluable for this outcome measure.

Arm/Group Title	Pegylated Interferon Alfa-2a and Ribavirin
Arm/Group Description	Participants with chronic hepatitis C, treated with pegylated interferon alfa-2a (Pegasys) and ribavirin (copegus) according to the current standard of care and in line with current summaries of product characteristics/local labelling, were observed for up to 96 weeks.
Measure Participants	225
Number (95% Confidence Interval) [odds ratio]	0.48

6. Secondary Outcome

Title	OR for Impact of Body Weight on SVR
Description	The viral response development was assessed using univariate analysis with logistic regression model to calculate OR for impact of body weight on SVR. SVR was defined as HCV RNA level undetectable (<15 IU/mL) 24 weeks after completion of the actual treatment period (measured using CAP/ CTM test).
Time Frame	Baseline up to 96 weeks (assessed at Baseline, 24 weeks after EOT [up to 96 weeks], where EOT = up to 72 weeks)

Outcome Measure Data

Analysis Population Description

Analysis population included all treated participants.

Arm/Group Title	Pegylated Interferon Alfa-2a and Ribavirin
Arm/Group Description	Participants with chronic hepatitis C, treated with pegylated interferon alfa-2a (Pegasys) and ribavirin (copegus) according to the current standard of care and in line with current summaries of product characteristics/local labelling, were observed for up to 96 weeks.
Measure Participants	516
Number (95% Confidence Interval) [odds ratio]	1.01

7. Secondary Outcome

Title	OR for Impact of Baseline Level of Fibrosis (kPa) on SVR
Description	The viral response development was assessed using univariate analysis with logistic regression model to calculate OR for impact of baseline level of fibrosis on SVR. Level of fibrosis was measured in terms of kilopascals (kPa) using elastography. kPa score was categorized in 4 groups: 0 to 6.0; 6.1 to 9.9; 10.0 to 14.5; and 14.6 and above. SVR was defined as HCV RNA level undetectable (<15 IU/mL) 24 weeks after completion of the actual treatment period (measured using CAP/ CTM test).
Time Frame	Baseline up to 96 weeks (assessed at Baseline, 24 weeks after EOT [up to 96 weeks], where EOT = up to 72 weeks)

Outcome Measure Data

Analysis Population Description

Analysis population included all treated participants. Here, 'Number of Participants Analyzed' = participants evaluable for this outcome measure.

Arm/Group Title	Pegylated Interferon Alfa-2a and Ribavirin
Arm/Group Description	Participants with chronic hepatitis C, treated with pegylated interferon alfa-2a (Pegasys) and ribavirin (copegus) according to the current standard of care and in line with current summaries of product characteristics/local labelling, were observed for up to 96 weeks.
Measure Participants	186
Number (95% Confidence Interval) [odds ratio]	0.53

8. Secondary Outcome

Title	OR for Impact of Baseline Alanine Transaminase (ALT) Level on SVR
Description	The viral response development was assessed using univariate analysis with logistic regression model to calculate OR for impact of baseline ALT level (>40 international units per liter [IU/L] versus <=40 IU/L) on SVR. SVR was defined as HCV RNA level undetectable (<15 IU/mL) 24 weeks after completion of the actual treatment period (measured using CAP/ CTM test).
Time Frame	Baseline up to 96 weeks (assessed at Baseline, 24 weeks after EOT [up to 96 weeks], where EOT = up to 72 weeks)

Outcome Measure Data

Analysis Population Description

Analysis population included all treated participants. Here, 'Number of Participants Analyzed' = participants evaluable for this outcome measure.

Arm/Group Title	Pegylated Interferon Alfa-2a and Ribavirin
Arm/Group Description	Participants with chronic hepatitis C, treated with pegylated interferon alfa-2a (Pegasys) and ribavirin (copegus) according to the current standard of care and in line with current summaries of product characteristics/local labelling, were observed for up to 96 weeks.
Measure Participants	215
Number (95% Confidence Interval) [odds ratio]	0.12

9. Secondary Outcome

Title	OR for Impact of Baseline Viral Load Count on SVR
Description	The viral response development was assessed using univariate analysis with logistic regression model to calculate OR for impact of baseline viral load count (>800000 IU/mL versus <=800000 IU/mL) on SVR. SVR was defined as HCV RNA level undetectable (<15 IU/mL) 24 weeks after completion of the actual treatment period (measured using CAP/ CTM test).
Time Frame	Baseline up to 96 weeks (assessed at Baseline, 24 weeks after EOT [up to 96 weeks], where EOT = up to 72 weeks)

Outcome Measure Data

Analysis Population Description

Analysis population included all treated participants. Here, 'Number of Participants Analyzed' = participants evaluable for this outcome measure.

Arm/Group Title	Pegylated Interferon Alfa-2a and Ribavirin
Arm/Group Description	Participants with chronic hepatitis C, treated with pegylated interferon alfa-2a (Pegasys) and ribavirin (copegus) according to the current standard of care and in line with current summaries of product characteristics/local labelling, were observed for up to 96 weeks.
Measure Participants	219
Number (95% Confidence Interval) [odds ratio]	1.07

10. Secondary Outcome

Title	OR for Impact of Overall Duration of Treatment on SVR
Description	The viral response development was assessed using univariate analysis with logistic regression model to calculate OR for impact of overall duration of treatment on SVR. SVR was defined as HCV RNA level undetectable (<15 IU/mL) 24 weeks after completion of the actual treatment period (measured using CAP/ CTM test).
Time Frame	Baseline up to 96 weeks (assessed at Baseline, EOT, 24 weeks after EOT [up to 96 weeks], where EOT = up to 72 weeks)

Outcome Measure Data

Analysis Population Description

Analysis population included all treated participants.

Arm/Group Title	Pegylated Interferon Alfa-2a and Ribavirin
Arm/Group Description	Participants with chronic hepatitis C, treated with pegylated interferon alfa-2a (Pegasys) and ribavirin (copegus) according to the current standard of care and in line with current summaries of product characteristics/local labelling, were observed for up to 96 weeks.
Measure Participants	516
Number (95% Confidence Interval) [odds ratio]	1.05

11. Secondary Outcome

Title	OR for Impact of Duration of Treatment After Achieving RVR on SVR
Description	The viral response development was assessed using univariate analysis with logistic regression model to calculate OR for impact of duration of treatment after achieving RVR (>18 weeks versus <=18 weeks) on SVR. RVR was defined as HCV RNA <=25 IU/mL at Week 4 using CAP/CTM test. SVR was defined as HCV RNA level undetectable (<15 IU/mL) 24 weeks after completion of the actual treatment period (measured using CAP/ CTM test).
Time Frame	Baseline up to 96 weeks (assessed at Baseline, Week 4, EOT, 24 weeks after EOT [up to 96 weeks], where EOT = up to 72 weeks)

Outcome Measure Data

Analysis Population Description

Analysis population included all treated participants.

Arm/Group Title	Pegylated Interferon Alfa-2a and Ribavirin
Arm/Group Description	Participants with chronic hepatitis C, treated with pegylated interferon alfa-2a (Pegasys) and ribavirin (copegus) according to the current standard of care and in line with current summaries of product characteristics/local labelling, were observed for up to 96 weeks.
Measure Participants	516
Number (95% Confidence Interval) [odds ratio]	1.04

12. Secondary Outcome

Title	OR for Impact of Duration of Treatment After Achieving cEVR on SVR
Description	The viral response development was assessed using univariate analysis with logistic regression model to calculate OR for impact of duration of treatment after achieving cEVR (>11 weeks versus <=11 weeks) on SVR. cEVR was defined as HCV RNA <=25 IU/mL at Week 12, but not at Week 4 using CAP/CTM test. SVR was defined as HCV RNA level undetectable (<15 IU/mL) 24 weeks after completion of the actual treatment period (measured using CAP/ CTM test).
Time Frame	Baseline up to 96 weeks (assessed at Baseline, Weeks 4, 12, EOT, 24 weeks after EOT [up to 96 weeks], where EOT = up to 72 weeks)

Outcome Measure Data

Analysis Population Description

Analysis population included all treated participants.

Arm/Group Title	Pegylated Interferon Alfa-2a and Ribavirin
Arm/Group Description	Participants with chronic hepatitis C, treated with pegylated interferon alfa-2a (Pegasys) and ribavirin (copegus) according to the current standard of care and in line with current summaries of product characteristics/local labelling, were observed for up to 96 weeks.
Measure Participants	516
Number (95% Confidence Interval) [odds ratio]	2.77

13. Secondary Outcome

Title	OR for Impact of Cumulative Doses of Pegylated Interferon Alfa-2a on SVR
Description	The viral response development was assessed using univariate analysis with logistic regression model to calculate OR for impact of cumulative doses of pegylated interferon alfa-2a on SVR. SVR was defined as HCV RNA level undetectable (<15 IU/mL) 24 weeks after completion of the actual treatment period (measured using CAP/ CTM test).
Time Frame	At 24 weeks after EOT (up to 96 weeks), where EOT = up to 72 weeks

Outcome Measure Data

Analysis Population Description

Analysis population included all treated participants.

Arm/Group Title	Pegylated Interferon Alfa-2a and Ribavirin
Arm/Group Description	Participants with chronic hepatitis C, treated with pegylated interferon alfa-2a (Pegasys) and ribavirin (copegus) according to the current standard of care and in line with current summaries of product characteristics/local labelling, were observed for up to 96 weeks.
Measure Participants	516
Number (95% Confidence Interval) [odds ratio]	0.99

14. Secondary Outcome

Title	OR for Impact of Cumulative Doses of Ribavirin on SVR
Description	The viral response development was assessed using univariate analysis with logistic regression model to calculate OR for impact of cumulative doses of ribavirin on SVR. SVR was defined as HCV RNA level undetectable (<15 IU/mL) 24 weeks after completion of the actual treatment period (measured using CAP/ CTM test).
Time Frame	At 24 weeks after EOT (up to 96 weeks), where EOT = up to 72 weeks

Outcome Measure Data

Analysis Population Description

Analysis population included all treated participants.

Arm/Group Title	Pegylated Interferon Alfa-2a and Ribavirin
Arm/Group Description	Participants with chronic hepatitis C, treated with pegylated interferon alfa-2a (Pegasys) and ribavirin (copegus) according to the current standard of care and in line with current summaries of product characteristics/local labelling, were observed for up to 96 weeks.
Measure Participants	516
Number (95% Confidence Interval) [odds ratio]	0.99

Adverse Events

Time Frame	Baseline up to 96 weeks
Arm/Group Title	Pegylated Interferon Alfa-2a and Ribavirin
Arm/Group Description	Participants with chronic hepatitis C, treated with pegylated interferon alfa-2a (Pegasys) and ribavirin (copegus) according to the current standard of care and in line with current summaries of product characteristics/local labelling, were observed for up to 96 weeks.
All Cause Mortality
	Pegylated Interferon Alfa-2a and Ribavirin
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Pegylated Interferon Alfa-2a and Ribavirin
	Affected / at Risk (%)	# Events
Total	17/516 (3.3%)
Blood and lymphatic system disorders
Anemia	1/516 (0.2%)
Anemia fourth degree	1/516 (0.2%)
Thrombocytopenia	2/516 (0.4%)
Thrombocytopenia fourth degree	1/516 (0.2%)
Leukopenia	1/516 (0.2%)
Neutropenia	1/516 (0.2%)
Neutropenia fourth degree	6/516 (1.2%)
Hypoalbuminemia	1/516 (0.2%)
Cardiac disorders
Tachyarrhythmia	1/516 (0.2%)
Gastrointestinal disorders
Rectal bleeding	1/516 (0.2%)
Lingual bleeding	1/516 (0.2%)
Infections and infestations
Pneumonia	1/516 (0.2%)
Nervous system disorders
Agitation	1/516 (0.2%)
Respiratory, thoracic and mediastinal disorders
Dyspnea	1/516 (0.2%)
Skin and subcutaneous tissue disorders
Dry skin	1/516 (0.2%)
Other (Not Including Serious) Adverse Events
	Pegylated Interferon Alfa-2a and Ribavirin
	Affected / at Risk (%)	# Events
Total	256/516 (49.6%)
Blood and lymphatic system disorders
Anemia	10/516 (1.9%)
Bilirubinemia	2/516 (0.4%)
Thyrotoxicosis second degree	1/516 (0.2%)
Thrombocytopenia	16/516 (3.1%)
Thrombocytopenia second degree	1/516 (0.2%)
Thrombocytopenia third degree	5/516 (1%)
Leukopenia	5/516 (1%)
Leukopenia second degree	4/516 (0.8%)
Leukopenia third degree	4/516 (0.8%)
Neutropenia	14/516 (2.7%)
Neutropenia second degree	3/516 (0.6%)
Neutropenia third degree	23/516 (4.5%)
Liver enzymes incresed (ALT, AST other)	6/516 (1.2%)
Cardiac disorders
ST elevation	1/516 (0.2%)
Hypertension	3/516 (0.6%)
Hypotension	2/516 (0.4%)
Tachycardia	1/516 (0.2%)
Paresthesia (numbness in hands)	1/516 (0.2%)
Hemorrhoid varicose veins	1/516 (0.2%)
Hyperemia	1/516 (0.2%)
Flushing	1/516 (0.2%)
Ear and labyrinth disorders
Tinnitus	1/516 (0.2%)
Earache	1/516 (0.2%)
Eye disorders
Blurred vision	1/516 (0.2%)
Gastrointestinal disorders
Nausea	5/516 (1%)
Diarrhea	1/516 (0.2%)
Constipation	2/516 (0.4%)
Vomiting	2/516 (0.4%)
Heartburn	1/516 (0.2%)
Abdominal pain upper/epigastric pain	3/516 (0.6%)
Meteorism (flatulence)	2/516 (0.4%)
Ascites	1/516 (0.2%)
General disorders
Fatigue	3/516 (0.6%)
Pyrexia	128/516 (24.8%)
Adynamy	10/516 (1.9%)
General weakness	75/516 (14.5%)
Rigors	2/516 (0.4%)
Sweating - general	1/516 (0.2%)
Immune system disorders
Allergic reactions	8/516 (1.6%)
Autoimmune thyroiditis	2/516 (0.4%)
Metabolism and nutrition disorders
Weight decrease	1/516 (0.2%)
Hyperthyroidism	4/516 (0.8%)
Hypothyroidism	2/516 (0.4%)
Loss of appetite	8/516 (1.6%)
Musculoskeletal and connective tissue disorders
Arthralgia	65/516 (12.6%)
Myalgia	18/516 (3.5%)
Back pain	2/516 (0.4%)
Muscle weakness in legs	1/516 (0.2%)
Nervous system disorders
Headache	31/516 (6%)
Irritability	8/516 (1.6%)
Migraine	1/516 (0.2%)
Dizziness	1/516 (0.2%)
Sexual potency impairment	1/516 (0.2%)
Psychiatric disorders
Anxiety	10/516 (1.9%)
Depression	10/516 (1.9%)
Insomnia	11/516 (2.1%)
Emotional liability	3/516 (0.6%)
Renal and urinary disorders
Pollakiuria	2/516 (0.4%)
Scalding during urination/urine scald	1/516 (0.2%)
Sexual potency impairment	1/516 (0.2%)
Respiratory, thoracic and mediastinal disorders
Cough	9/516 (1.7%)
Bronchitis	1/516 (0.2%)
Pneumonia	1/516 (0.2%)
Flue-like syndrome	15/516 (2.9%)
Sour throat	1/516 (0.2%)
Dyspnea	1/516 (0.2%)
Skin and subcutaneous tissue disorders
Alopecia/hair loss	5/516 (1%)
Itching/pruritus	9/516 (1.7%)
Dry skin	6/516 (1.2%)
Anal itching	1/516 (0.2%)
Rash	4/516 (0.8%)
Herpes rash	1/516 (0.2%)
Left nostril furuncle	1/516 (0.2%)
Sweating - general	1/516 (0.2%)
Dry mouth	3/516 (0.6%)
Toxidermia	1/516 (0.2%)
Sty	1/516 (0.2%)

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.