Hepatitis C, Chronic
Conditions
Brief summary
This prospective, multi-center, observational study will evaluate the efficacy and safety of Pegasys (peginterferon alfa-2a) plus Copegus (ribavirin) in participants with previously untreated chronic hepatitis C, genotype 2, 3, 1 or 4, who are undergoing opioid maintenance therapy. Data will be collected from eligible participants receiving Pegasys and Copegus treatment as prescribed by treating physician and treatment-free follow-up period of 24 weeks.
Interventions
None listed
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
* Adult participants, \>/= 18 years of age * Participants undergoing an opioid maintenance therapy * Serologic evidence of CHC prior to therapy * CHC genotype 2, 3, 1 or 4 * Quantifiable serum hepatitis C (HCV) ribonucleic acid (RNA) * All fertile males and females receiving ribavirin must use two forms of effective contraception during treatment with study drugs and for 7 months after completion of treatment
Exclusion criteria
* Harmful use of psychoactive substances (including excessive alcohol consumption) that precludes successful participation in the study at the discretion of the investigator * Pegylated interferon, standard interferon or ribavirin therapy at any time prior to initiation of the study * Co-infection with hepatitis A, hepatitis B or Human Immunodeficiency Virus (HIV) * Current diagnosis of a major depression or any psychotic disorder
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Sustained Virological Response 24 Weeks After Completing Treatment (SVR24) | 24 weeks after completing treatment, within 3 years, 6 months | SVR24 is defined as percentage of participants with undetectable Hepatitis C virus (HCV) ribonucleic acid (RNA) 24 weeks after completing treatment, using a last observation carried forward (LOCF) approach. Percentage is based on the number of non-missing observations (total). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With End of Treatment Response | at end of treatment, within 3 years, 6 months | A participant was considered to have end of treatment response if there was undetectable HCV RNA after completing treatment, using a LOCF approach. Percentage is based on the number of non-missing observations (total). |
| Percentage of Participants With Virological Relapse | by end of follow-up, within 3 years, 6 months | Virological relapse is defined as no SVR24 in a participant with undetectable HCV RNA at end of treatment who has at least one post-treatment polymerase chain reaction (PCR) result available, using a LOCF approach. Percentage is based on the number of non-missing observations (total). |
| Short Form Health Survey (SF-36) Scores by Visit | at baseline, week 12, end of treatment and end of follow-up within 3 years, 6 months | The SF-36 questionnaire items were scored and transformed according to the SF-36 Health Survey Manual & Interpretation Guide. Summary scores for SF-36 dimensions of physical functioning, role functioning, bodily pain, general health, vitality, social functioning, and mental health were scored on a scale of 0 (worst) to 100 (best), and health transition was scored on a scale of 0 (worst) to 5 (best). Summary SF-36 scores are reported by category and by visit. |
| Percentage of Participants With SVR 12 | 12 weeks after completing treatment, within 3 years, 6 months | SVR 12 is defined as percentage of participants with undetectable HCV RNA 12 weeks after completing treatment, using a LOCF approach. Percentage is based on the number of non-missing observations (total). |
| Beschwerdeliste (BL) Score by Visit | at baseline, week 12, end of treatment and end of follow-up within 3 years, 6 months | The BL questionnaire items were scored by calculating the average response to all answered items. Items can be graded 1=stark (affliction is strong) to 4=gar nicht (not present). The higher the BL score, the less afflictions were present for a participant. Mean scores are presented by visit. |
| Beck Depression Inventory (BDI) Score by Visit | at baseline, week 12, end of treatment and end of follow-up within 3 years, 6 months | The BDI questionnaire items were scored by generating the sum of the responses to all answered items. Each result was categorized into one of four categories: 0-13= no depression or clinically not significant or in remission; 14-19= mild depression; 20-28= moderate depression; or 29-63= severe depression. Mean scores are presented by visit. |
| Fatigue Severity Scale (FSS) Score by Visit | at baseline, week 12, end of treatment and end of follow-up within 3 years, 6 months | The Fatigue Severity Scale (FSS) consists of 9 questions, each answered within a range of 1-7, where lower scores indicate less fatigue in everyday life. The FSS score is the mean of the 9 numbers. Mean scores are presented by visit. |
Countries
Austria
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| All Participants Participants with chronic hepatitis C, Genotype 2, 3, 1 or 4, undergoing an opioid maintenance therapy | 88 |
| Total | 88 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 4 |
| Overall Study | Adverse Event -Patient decision | 3 |
| Overall Study | Lack of Efficacy | 4 |
| Overall Study | Lost to Follow-up | 7 |
| Overall Study | No reason given | 5 |
| Overall Study | Sufficient treatment duration (PCR neg.) | 7 |
| Overall Study | Withdrawal by Subject | 13 |
Baseline characteristics
| Characteristic | All Participants |
|---|---|
| Age, Continuous | 34.6 years STANDARD_DEVIATION 8.5 |
| Region of Enrollment Austria | 88 participants |
| Sex: Female, Male Female | 24 Participants |
| Sex: Female, Male Male | 64 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 60 / 86 |
| serious Total, serious adverse events | 14 / 86 |
Outcome results
Primary
Percentage of Participants With Sustained Virological Response 24 Weeks After Completing Treatment (SVR24)
SVR24 is defined as percentage of participants with undetectable Hepatitis C virus (HCV) ribonucleic acid (RNA) 24 weeks after completing treatment, using a last observation carried forward (LOCF) approach. Percentage is based on the number of non-missing observations (total).
Time frame: 24 weeks after completing treatment, within 3 years, 6 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| All Participants | Percentage of Participants With Sustained Virological Response 24 Weeks After Completing Treatment (SVR24) | 83.0 percentage of participants |
Secondary
Beck Depression Inventory (BDI) Score by Visit
The BDI questionnaire items were scored by generating the sum of the responses to all answered items. Each result was categorized into one of four categories: 0-13= no depression or clinically not significant or in remission; 14-19= mild depression; 20-28= moderate depression; or 29-63= severe depression. Mean scores are presented by visit.
Time frame: at baseline, week 12, end of treatment and end of follow-up within 3 years, 6 months
Population: Participants with a viable score at the given time point
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| All Participants | Beck Depression Inventory (BDI) Score by Visit | Baseline (n=50) | 13.7 units on a scale | Standard Deviation 9 |
| All Participants | Beck Depression Inventory (BDI) Score by Visit | Week 12 (n=33) | 18.4 units on a scale | Standard Deviation 11.1 |
| All Participants | Beck Depression Inventory (BDI) Score by Visit | End of treatment (n=33) | 16.9 units on a scale | Standard Deviation 9.4 |
| All Participants | Beck Depression Inventory (BDI) Score by Visit | End of follow-up (n=22) | 11.6 units on a scale | Standard Deviation 10.7 |
Secondary
Beschwerdeliste (BL) Score by Visit
The BL questionnaire items were scored by calculating the average response to all answered items. Items can be graded 1=stark (affliction is strong) to 4=gar nicht (not present). The higher the BL score, the less afflictions were present for a participant. Mean scores are presented by visit.
Time frame: at baseline, week 12, end of treatment and end of follow-up within 3 years, 6 months
Population: Participants with a viable score at the given time point
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| All Participants | Beschwerdeliste (BL) Score by Visit | Baseline (n=59) | 3.1 units on a scale | Standard Deviation 0.5 |
| All Participants | Beschwerdeliste (BL) Score by Visit | Week 12 (n=34) | 2.8 units on a scale | Standard Deviation 0.5 |
| All Participants | Beschwerdeliste (BL) Score by Visit | End of treatment (n=36) | 2.7 units on a scale | Standard Deviation 0.5 |
| All Participants | Beschwerdeliste (BL) Score by Visit | End of follow-up (n=24) | 3.1 units on a scale | Standard Deviation 0.6 |
Secondary
Fatigue Severity Scale (FSS) Score by Visit
The Fatigue Severity Scale (FSS) consists of 9 questions, each answered within a range of 1-7, where lower scores indicate less fatigue in everyday life. The FSS score is the mean of the 9 numbers. Mean scores are presented by visit.
Time frame: at baseline, week 12, end of treatment and end of follow-up within 3 years, 6 months
Population: Participants with a viable score at the given time point
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| All Participants | Fatigue Severity Scale (FSS) Score by Visit | Baseline (n=56) | 4.0 units on a scale | Standard Deviation 1.4 |
| All Participants | Fatigue Severity Scale (FSS) Score by Visit | Week 12 (n=35) | 5.0 units on a scale | Standard Deviation 1.3 |
| All Participants | Fatigue Severity Scale (FSS) Score by Visit | End of treatment (n=37) | 5.0 units on a scale | Standard Deviation 1.4 |
| All Participants | Fatigue Severity Scale (FSS) Score by Visit | End of follow-up (n=24) | 3.8 units on a scale | Standard Deviation 1.8 |
Secondary
Percentage of Participants With End of Treatment Response
A participant was considered to have end of treatment response if there was undetectable HCV RNA after completing treatment, using a LOCF approach. Percentage is based on the number of non-missing observations (total).
Time frame: at end of treatment, within 3 years, 6 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| All Participants | Percentage of Participants With End of Treatment Response | 87.5 percentage of participants |
Secondary
Percentage of Participants With SVR 12
SVR 12 is defined as percentage of participants with undetectable HCV RNA 12 weeks after completing treatment, using a LOCF approach. Percentage is based on the number of non-missing observations (total).
Time frame: 12 weeks after completing treatment, within 3 years, 6 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| All Participants | Percentage of Participants With SVR 12 | 81.8 percentage of participants |
Secondary
Percentage of Participants With Virological Relapse
Virological relapse is defined as no SVR24 in a participant with undetectable HCV RNA at end of treatment who has at least one post-treatment polymerase chain reaction (PCR) result available, using a LOCF approach. Percentage is based on the number of non-missing observations (total).
Time frame: by end of follow-up, within 3 years, 6 months
Population: Participants who completed treatment
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| All Participants | Percentage of Participants With Virological Relapse | 10.6 percentage of participants |
Secondary
Short Form Health Survey (SF-36) Scores by Visit
The SF-36 questionnaire items were scored and transformed according to the SF-36 Health Survey Manual & Interpretation Guide. Summary scores for SF-36 dimensions of physical functioning, role functioning, bodily pain, general health, vitality, social functioning, and mental health were scored on a scale of 0 (worst) to 100 (best), and health transition was scored on a scale of 0 (worst) to 5 (best). Summary SF-36 scores are reported by category and by visit.
Time frame: at baseline, week 12, end of treatment and end of follow-up within 3 years, 6 months
Population: Participants with a viable score at the given time point
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| All Participants | Short Form Health Survey (SF-36) Scores by Visit | Role Functioning - Physical (n=52,34,37,22) | 60.6 units on a scale | Standard Deviation 40.9 |
| All Participants | Short Form Health Survey (SF-36) Scores by Visit | Mental Health (n=52,34,37,22) | 59.1 units on a scale | Standard Deviation 19.2 |
| All Participants | Short Form Health Survey (SF-36) Scores by Visit | Reported Health Transition (n=54,34,37,22) | 3.3 units on a scale | Standard Deviation 1.2 |
| All Participants | Short Form Health Survey (SF-36) Scores by Visit | Bodily Pain (n=53,35,37,22) | 70.8 units on a scale | Standard Deviation 27.7 |
| All Participants | Short Form Health Survey (SF-36) Scores by Visit | General Health (n=50,35,36,22) | 50.9 units on a scale | Standard Deviation 18.9 |
| All Participants | Short Form Health Survey (SF-36) Scores by Visit | Physical Functioning (n=54,34,37,22) | 77.9 units on a scale | Standard Deviation 21.7 |
| All Participants | Short Form Health Survey (SF-36) Scores by Visit | Vitality (n=52,35,37,22) | 42.8 units on a scale | Standard Deviation 21.5 |
| All Participants | Short Form Health Survey (SF-36) Scores by Visit | Social Functioning (n=53,35,37,23) | 69.8 units on a scale | Standard Deviation 27.1 |
| All Participants | Short Form Health Survey (SF-36) Scores by Visit | Role Functioning - Emotional (n=53,34,36,22) | 57.2 units on a scale | Standard Deviation 44 |
| Week 12 | Short Form Health Survey (SF-36) Scores by Visit | Social Functioning (n=53,35,37,23) | 52.5 units on a scale | Standard Deviation 28.6 |
| Week 12 | Short Form Health Survey (SF-36) Scores by Visit | Physical Functioning (n=54,34,37,22) | 63.5 units on a scale | Standard Deviation 25.1 |
| Week 12 | Short Form Health Survey (SF-36) Scores by Visit | Mental Health (n=52,34,37,22) | 49.4 units on a scale | Standard Deviation 19.8 |
| Week 12 | Short Form Health Survey (SF-36) Scores by Visit | General Health (n=50,35,36,22) | 46.1 units on a scale | Standard Deviation 18.6 |
| Week 12 | Short Form Health Survey (SF-36) Scores by Visit | Role Functioning - Physical (n=52,34,37,22) | 32.4 units on a scale | Standard Deviation 37.7 |
| Week 12 | Short Form Health Survey (SF-36) Scores by Visit | Role Functioning - Emotional (n=53,34,36,22) | 31.4 units on a scale | Standard Deviation 37.6 |
| Week 12 | Short Form Health Survey (SF-36) Scores by Visit | Reported Health Transition (n=54,34,37,22) | 3.6 units on a scale | Standard Deviation 1.2 |
| Week 12 | Short Form Health Survey (SF-36) Scores by Visit | Vitality (n=52,35,37,22) | 26.1 units on a scale | Standard Deviation 19.3 |
| Week 12 | Short Form Health Survey (SF-36) Scores by Visit | Bodily Pain (n=53,35,37,22) | 58.7 units on a scale | Standard Deviation 29.3 |
| End of Treatment | Short Form Health Survey (SF-36) Scores by Visit | Role Functioning - Physical (n=52,34,37,22) | 24.3 units on a scale | Standard Deviation 37 |
| End of Treatment | Short Form Health Survey (SF-36) Scores by Visit | Bodily Pain (n=53,35,37,22) | 52.5 units on a scale | Standard Deviation 27.8 |
| End of Treatment | Short Form Health Survey (SF-36) Scores by Visit | General Health (n=50,35,36,22) | 50.5 units on a scale | Standard Deviation 18.7 |
| End of Treatment | Short Form Health Survey (SF-36) Scores by Visit | Social Functioning (n=53,35,37,23) | 48.0 units on a scale | Standard Deviation 27.4 |
| End of Treatment | Short Form Health Survey (SF-36) Scores by Visit | Physical Functioning (n=54,34,37,22) | 62.7 units on a scale | Standard Deviation 22.3 |
| End of Treatment | Short Form Health Survey (SF-36) Scores by Visit | Role Functioning - Emotional (n=53,34,36,22) | 31.5 units on a scale | Standard Deviation 36.5 |
| End of Treatment | Short Form Health Survey (SF-36) Scores by Visit | Vitality (n=52,35,37,22) | 33.9 units on a scale | Standard Deviation 20.2 |
| End of Treatment | Short Form Health Survey (SF-36) Scores by Visit | Mental Health (n=52,34,37,22) | 51.7 units on a scale | Standard Deviation 22.4 |
| End of Treatment | Short Form Health Survey (SF-36) Scores by Visit | Reported Health Transition (n=54,34,37,22) | 3.2 units on a scale | Standard Deviation 1.5 |
| End of Follow-up | Short Form Health Survey (SF-36) Scores by Visit | Reported Health Transition (n=54,34,37,22) | 2.0 units on a scale | Standard Deviation 1.2 |
| End of Follow-up | Short Form Health Survey (SF-36) Scores by Visit | Role Functioning - Physical (n=52,34,37,22) | 70.5 units on a scale | Standard Deviation 39.1 |
| End of Follow-up | Short Form Health Survey (SF-36) Scores by Visit | Bodily Pain (n=53,35,37,22) | 75.4 units on a scale | Standard Deviation 29.7 |
| End of Follow-up | Short Form Health Survey (SF-36) Scores by Visit | General Health (n=50,35,36,22) | 65.4 units on a scale | Standard Deviation 19.3 |
| End of Follow-up | Short Form Health Survey (SF-36) Scores by Visit | Vitality (n=52,35,37,22) | 48.6 units on a scale | Standard Deviation 20 |
| End of Follow-up | Short Form Health Survey (SF-36) Scores by Visit | Social Functioning (n=53,35,37,23) | 72.3 units on a scale | Standard Deviation 32.6 |
| End of Follow-up | Short Form Health Survey (SF-36) Scores by Visit | Role Functioning - Emotional (n=53,34,36,22) | 69.7 units on a scale | Standard Deviation 37 |
| End of Follow-up | Short Form Health Survey (SF-36) Scores by Visit | Mental Health (n=52,34,37,22) | 67.2 units on a scale | Standard Deviation 25.7 |
| End of Follow-up | Short Form Health Survey (SF-36) Scores by Visit | Physical Functioning (n=54,34,37,22) | 76.1 units on a scale | Standard Deviation 26.5 |