Hepatitis C, Chronic
Conditions
Brief summary
Participants with Chronic Hepatitis C (CHC) and normal ALT, who have been under treatment with peginterferon alfa-2a and ribavirin for at least 4 weeks, will be enrolled into this non-interventional, open-label study. The primary aim is to evaluate quality of life according to the 36-Item Short-Form Health Survey (SF-36) questionnaire, modified for the Greek population.
Interventions
DRUGPeginterferon alfa-2a
As per treating physician discretion and according to summary of product characteristics.
DRUGRibavirin
As per treating physician discretion and according to summary of product characteristics.
Sponsors
Hoffmann-La Roche
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Serological confirmation of chronic infection by anti-hepatitis C virus (HCV) assay * HCV ribonucleic acid (RNA) positive * CHC with normal transaminases * Compensated liver disease * Non-pregnant and willing to use two contraceptive methods (if fertile) * At least 4 weeks of prior treatment with peginterferon alfa-2a and ribavirin
Exclusion criteria
* Pregnant or lactating women * Co-infection with hepatitis A or B, or human immunodeficiency virus (HIV) * History of seizures or depression * History of autoimmune disease, severe heart or lung disease, or renal failure with reduced creatinine clearance * Uncontrolled thyroid disease * Severe retinopathy * Leukopenia or thrombocytopenia * Bleeding esophageal varices or other evidence of hepatic decompensation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in 36-Item Short-Form Health Survey (SF-36) General Health Domain at End of Treatment (EOT) | Baseline, EOT (up to 48 weeks) | SF-36 is a standardized survey evaluating 8 domains of functional health and wellbeing: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. The score for general health domain was an average of the individual question scores of this domain, which are scaled 0-100 (100=highest level of functioning). Data was reported by status of gender (male and female) and drug addiction (yes and no). |
| Change From Baseline in SF-36 General Health Domain at 24 Weeks After EOT | Baseline, 24 weeks after EOT (up to 72 weeks) | SF-36 is a standardized survey evaluating 8 domains of functional health and wellbeing: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. The score for general health domain was an average of the individual question scores of this domain, which are scaled 0-100 (100=highest level of functioning). Data was reported by status of gender (male and female) and drug addiction (yes and no). |
| Change From Baseline in SF-36 Physical Component Summary (PCS) at EOT | Baseline, EOT (up to 48 weeks) | SF-36 is a standardized survey evaluating 8 aspects of functional health and wellbeing: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. The score for a domain was an average of the individual question scores, which were scaled 0-100 (100=highest level of functioning). Score from physical function, role physical, bodily pain, and general health domains were averaged to calculate PCS. Total score range for PCS was 0-100 (100=highest level of physical functioning). |
| Change From Baseline in SF-36 PCS at 24 Weeks After EOT | Baseline, 24 weeks after EOT (up to 72 weeks) | SF-36 is a standardized survey evaluating 8 aspects of functional health and wellbeing: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. The score for a domain was an average of the individual question scores, which were scaled 0-100 (100=highest level of functioning). Score from physical function, role physical, bodily pain, and general health domains were averaged to calculate PCS. Total score range for PCS was 0-100 (100=highest level of physical functioning). |
| Change From Baseline in SF-36 Mental Component Summary (MCS) at EOT | Baseline, EOT (up to 48 weeks) | SF-36 is a standardized survey evaluating 8 domains of functional health and wellbeing: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. The score for a domain was an average of the individual question scores, which were scaled 0-100 (100=highest level of functioning). Score from mental health, role emotional, social functioning, and vitality domains were averaged to calculate MCS. Total score range for MCS was 0-100 (100=highest level of mental functioning). |
| Change From Baseline in SF-36 MCS at 24 Weeks After EOT | Baseline, 24 weeks after EOT (up to 72 weeks) | SF-36 is a standardized survey evaluating 8 domains of functional health and wellbeing: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. The score for a domain was an average of the individual question scores, which were scaled 0-100 (100=highest level of functioning). Score from mental health, role emotional, social functioning, and vitality domains were averaged to calculate MCS. Total score range for MCS was 0-100 (100=highest level of mental functioning). |
Countries
Greece
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Chronic Hepatitis C Participants Participants with chronic hepatitis C, who were under treatment with peg-interferon alfa-2a and ribavirin for four weeks, were observed up to 24 weeks after EOT (up to 72 weeks). Peg-interferon alfa-2a and ribavirin were administered as per treating physician discretion and according to summary of product characteristics. | 114 |
| Total | 114 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 14 |
| Overall Study | Poor Compliance | 13 |
| Overall Study | Treatment Failure | 8 |
| Overall Study | Treatment Failure and Poor Compliance | 1 |
Baseline characteristics
| Characteristic | Chronic Hepatitis C Participants |
|---|---|
| Age, Continuous | 46.30 years STANDARD_DEVIATION 13.31 |
| Sex: Female, Male Female | 55 Participants |
| Sex: Female, Male Male | 59 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 27 / 114 |
| serious Total, serious adverse events | 1 / 114 |
Outcome results
Primary
Change From Baseline in 36-Item Short-Form Health Survey (SF-36) General Health Domain at End of Treatment (EOT)
SF-36 is a standardized survey evaluating 8 domains of functional health and wellbeing: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. The score for general health domain was an average of the individual question scores of this domain, which are scaled 0-100 (100=highest level of functioning). Data was reported by status of gender (male and female) and drug addiction (yes and no).
Time frame: Baseline, EOT (up to 48 weeks)
Population: Analysis population included all enrolled participants. Number of participants analyzed = participants with evaluable data. Participants evaluable for Gender = 76; participants evaluable for Drug Addiction = 75. Same participants could be evaluated under Gender and Drug Addiction.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Chronic Hepatitis C Participants | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) General Health Domain at End of Treatment (EOT) | Gender: Male | -3.2 units on a scale | Standard Deviation 24.6 |
| Chronic Hepatitis C Participants | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) General Health Domain at End of Treatment (EOT) | Gender: Female | -3.0 units on a scale | Standard Deviation 29.2 |
| Chronic Hepatitis C Participants | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) General Health Domain at End of Treatment (EOT) | Drug Addiction: Yes | -7.4 units on a scale | Standard Deviation 26.5 |
| Chronic Hepatitis C Participants | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) General Health Domain at End of Treatment (EOT) | Drug Addiction: No | -1.2 units on a scale | Standard Deviation 27.1 |
Comparison: The statistical significance of change from baseline to EOT between gender status (male vs female) was tested using Fisher's exact test.p-value: 0.647Fisher Exact
Comparison: The statistical significance of change from baseline to EOT between drug addiction status (yes vs no) was tested using Fisher's exact test.p-value: 0.373Fisher Exact
Primary
Change From Baseline in SF-36 General Health Domain at 24 Weeks After EOT
SF-36 is a standardized survey evaluating 8 domains of functional health and wellbeing: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. The score for general health domain was an average of the individual question scores of this domain, which are scaled 0-100 (100=highest level of functioning). Data was reported by status of gender (male and female) and drug addiction (yes and no).
Time frame: Baseline, 24 weeks after EOT (up to 72 weeks)
Population: Analysis population included all enrolled participants. Number of participants analyzed = participants with evaluable data. Participants evaluable for Gender = 56; participants evaluable for Drug Addiction = 56. Same participants could be evaluated under Gender and Drug Addiction.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Chronic Hepatitis C Participants | Change From Baseline in SF-36 General Health Domain at 24 Weeks After EOT | Gender: Male | 0.3 units on a scale | Standard Deviation 26.3 |
| Chronic Hepatitis C Participants | Change From Baseline in SF-36 General Health Domain at 24 Weeks After EOT | Gender: Female | 15.4 units on a scale | Standard Deviation 25 |
| Chronic Hepatitis C Participants | Change From Baseline in SF-36 General Health Domain at 24 Weeks After EOT | Drug Addiction: Yes | 8.4 units on a scale | Standard Deviation 18.7 |
| Chronic Hepatitis C Participants | Change From Baseline in SF-36 General Health Domain at 24 Weeks After EOT | Drug Addiction: No | 7.6 units on a scale | Standard Deviation 29.1 |
Comparison: The statistical significance of change from baseline to 24 weeks after EOT between gender status (male vs female) was tested using Fisher's exact test.p-value: 0.049Fisher Exact
Comparison: The statistical significance of change from baseline to 24 weeks after EOT between drug addiction status (yes vs no) was tested using Fisher's exact test.p-value: 0.86Fisher Exact
Primary
Change From Baseline in SF-36 MCS at 24 Weeks After EOT
SF-36 is a standardized survey evaluating 8 domains of functional health and wellbeing: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. The score for a domain was an average of the individual question scores, which were scaled 0-100 (100=highest level of functioning). Score from mental health, role emotional, social functioning, and vitality domains were averaged to calculate MCS. Total score range for MCS was 0-100 (100=highest level of mental functioning).
Time frame: Baseline, 24 weeks after EOT (up to 72 weeks)
Population: Analysis population included all enrolled participants. Number of participants analyzed = participants with evaluable data. Participants evaluable for Gender = 56; participants evaluable for Drug Addiction = 56. Same participants could be evaluated under Gender and Drug Addiction.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Chronic Hepatitis C Participants | Change From Baseline in SF-36 MCS at 24 Weeks After EOT | Gender: Male | -3.2 units on a scale | Standard Deviation 27.1 |
| Chronic Hepatitis C Participants | Change From Baseline in SF-36 MCS at 24 Weeks After EOT | Gender: Female | 6.5 units on a scale | Standard Deviation 30.7 |
| Chronic Hepatitis C Participants | Change From Baseline in SF-36 MCS at 24 Weeks After EOT | Drug Addiction: Yes | 4.4 units on a scale | Standard Deviation 26.4 |
| Chronic Hepatitis C Participants | Change From Baseline in SF-36 MCS at 24 Weeks After EOT | Drug Addiction: No | 0.9 units on a scale | Standard Deviation 30.6 |
Comparison: The statistical significance of change from baseline to 24 weeks after EOT between gender status (male vs female) was tested using Fisher's exact test.p-value: 0.184Fisher Exact
Comparison: The statistical significance of change from baseline to 24 weeks after EOT between drug addiction status (yes vs no) was tested using Fisher's exact test.p-value: 0.889Fisher Exact
Primary
Change From Baseline in SF-36 Mental Component Summary (MCS) at EOT
SF-36 is a standardized survey evaluating 8 domains of functional health and wellbeing: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. The score for a domain was an average of the individual question scores, which were scaled 0-100 (100=highest level of functioning). Score from mental health, role emotional, social functioning, and vitality domains were averaged to calculate MCS. Total score range for MCS was 0-100 (100=highest level of mental functioning).
Time frame: Baseline, EOT (up to 48 weeks)
Population: Analysis population included all enrolled participants. Number of participants analyzed = participants with evaluable data. Participants evaluable for Gender = 76; participants evaluable for Drug Addiction = 75. Same participants could be evaluated under Gender and Drug Addiction.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Chronic Hepatitis C Participants | Change From Baseline in SF-36 Mental Component Summary (MCS) at EOT | Gender: Male | -5.10 units on a scale | Standard Deviation 25.9 |
| Chronic Hepatitis C Participants | Change From Baseline in SF-36 Mental Component Summary (MCS) at EOT | Gender: Female | -3.47 units on a scale | Standard Deviation 25.3 |
| Chronic Hepatitis C Participants | Change From Baseline in SF-36 Mental Component Summary (MCS) at EOT | Drug Addiction: Yes | -9.4 units on a scale | Standard Deviation 23.3 |
| Chronic Hepatitis C Participants | Change From Baseline in SF-36 Mental Component Summary (MCS) at EOT | Drug Addiction: No | -2.1 units on a scale | Standard Deviation 26.2 |
Comparison: The statistical significance of change from baseline to EOT between gender status (male vs female) was tested using Fisher's exact test.p-value: 0.72Fisher Exact
Comparison: The statistical significance of change from baseline to EOT between drug addiction status (yes vs no) was tested using Fisher's exact test.p-value: 0.237Fisher Exact
Primary
Change From Baseline in SF-36 PCS at 24 Weeks After EOT
SF-36 is a standardized survey evaluating 8 aspects of functional health and wellbeing: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. The score for a domain was an average of the individual question scores, which were scaled 0-100 (100=highest level of functioning). Score from physical function, role physical, bodily pain, and general health domains were averaged to calculate PCS. Total score range for PCS was 0-100 (100=highest level of physical functioning).
Time frame: Baseline, 24 weeks after EOT (up to 72 weeks)
Population: Analysis population included all enrolled participants. Number of participants analyzed = participants with evaluable data. Participants evaluable for Gender = 56; participants evaluable for Drug Addiction = 56. Same participants could be evaluated under Gender and Drug Addiction.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Chronic Hepatitis C Participants | Change From Baseline in SF-36 PCS at 24 Weeks After EOT | Gender: Male | 0.1 units on a scale | Standard Deviation 27.5 |
| Chronic Hepatitis C Participants | Change From Baseline in SF-36 PCS at 24 Weeks After EOT | Gender: Female | 15.8 units on a scale | Standard Deviation 23.8 |
| Chronic Hepatitis C Participants | Change From Baseline in SF-36 PCS at 24 Weeks After EOT | Drug Addiction: Yes | 6.7 units on a scale | Standard Deviation 17.1 |
| Chronic Hepatitis C Participants | Change From Baseline in SF-36 PCS at 24 Weeks After EOT | Drug Addiction: No | 8.4 units on a scale | Standard Deviation 29.6 |
Comparison: The statistical significance of change from baseline to 24 weeks after EOT between gender status (male vs female) was tested using Fisher's exact test.p-value: 0.052Fisher Exact
Comparison: The statistical significance of change from baseline to 24 weeks after EOT between drug addiction status (yes vs no) was tested using Fisher's exact test.p-value: 0.677Fisher Exact
Primary
Change From Baseline in SF-36 Physical Component Summary (PCS) at EOT
SF-36 is a standardized survey evaluating 8 aspects of functional health and wellbeing: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. The score for a domain was an average of the individual question scores, which were scaled 0-100 (100=highest level of functioning). Score from physical function, role physical, bodily pain, and general health domains were averaged to calculate PCS. Total score range for PCS was 0-100 (100=highest level of physical functioning).
Time frame: Baseline, EOT (up to 48 weeks)
Population: Analysis population included all enrolled participants. Number of participants analyzed = participants with evaluable data. Participants evaluable for Gender = 76; participants evaluable for Drug Addiction = 75. Same participants could be evaluated under Gender and Drug Addiction.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Chronic Hepatitis C Participants | Change From Baseline in SF-36 Physical Component Summary (PCS) at EOT | Gender: Male | -0.7 units on a scale | Standard Deviation 24.6 |
| Chronic Hepatitis C Participants | Change From Baseline in SF-36 Physical Component Summary (PCS) at EOT | Gender: Female | 0.17 units on a scale | Standard Deviation 26.5 |
| Chronic Hepatitis C Participants | Change From Baseline in SF-36 Physical Component Summary (PCS) at EOT | Drug Addiction: Yes | -0.4 units on a scale | Standard Deviation 18.7 |
| Chronic Hepatitis C Participants | Change From Baseline in SF-36 Physical Component Summary (PCS) at EOT | Drug Addiction: No | -0.1 units on a scale | Standard Deviation 27.7 |
Comparison: The statistical significance of change from baseline to EOT between gender status (male vs female) was tested using Fisher's exact test.p-value: 0.921Fisher Exact
Comparison: The statistical significance of change from baseline to EOT between drug addiction status (yes vs no) was tested using Fisher's exact test.p-value: 0.962Fisher Exact