Hepatitis C, Chronic
Conditions
Brief summary
In this Slovenian, multi-center, observational study, the effectiveness of standard of care Peginterferon alfa-2a + ribavirin treatment in adult patients with chronic hepatitis C (CHC) is examined. Patients were treated for 24- or 48-weeks, as prescribed by the treating physician, followed by a 24-week follow-up period.
Interventions
DRUGPeginterferon alfa-2a
Peginterferon alfa-2a according to the standard practice in line with current summaries \\nof product characteristics (SPCs)/local labeling.
DRUGRibavirin
Ribavirin according to the standard practice in line with current summaries \\nof product characteristics (SPCs)/local labeling.
Sponsors
Hoffmann-La Roche
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Male and female patients \>/= 18 years * Positive test for HCV * Effective contraception as specified by the Peginterferon alfa-2a and/or ribavirin labels
Exclusion criteria
* Concomitant infection with HIV or hepatitis B * Participation in a clinical trial within 30 days prior to study start * Any contraindications specified in the Peginterferon alfa-2a and ribavirin product labels
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Achieving Sustained Virological Response (SVR) According to Genotype and Previous Treatment | 6 months after the last study drug administration (up to 123.6 weeks) | SVR was defined as participants with undetectable Hepatitis C virus (HCV) ribonucleic acid (RNA) at 24 weeks after completion of treatment. Undetectable HCV RNA was defined as a single last HCV RNA less than (\<) 20 international units per milliliter (IU/mL). SVR was evaluated based on HCV genotype (G1, G2, G3 and G4), participant's interleukin 28B genotype (CC, CT and TT), and previous treatment (treatment naive or previous treatment). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| HCV RNA Values | Baseline; Weeks 4, 12, end of treatment (up to 99.6 weeks) and 6 months after end of treatment (up to 123.6 weeks) | — |
| Thrombocyte Values | Baseline; Weeks 4, 12, end of treatment (up to 99.6 weeks) and 6 months after end of treatment (up to 123.6 weeks) | — |
| Percentage of Participants With Undetectable HCV RNA | Weeks 4, 12 and at end of treatment (up to 99.6 weeks) | Undetectable HCV RNA=a single last HCV RNA \<20 IU/mL |
| Hemoglobin Values | Baseline; Weeks 4, 12, end of treatment (up to 99.6 weeks) and 6 months after end of treatment (up to 123.6 weeks) | — |
| Treatment Duration (in Weeks) With Peginterferon Alfa-2a and Ribavirin | Up to 99.6 Weeks | — |
| Leukocyte Values | Baseline; Weeks 4, 12, end of treatment (up to 99.6 weeks) and 6 months after end of treatment (up to 123.6 weeks) | — |
Countries
Slovenia
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Peginterferon Alfa-2a + Ribavirin Participants received peginterferon alfa-2a and ribavirin according to the standard practice in line with current SPCs/local labeling. | 268 |
| Total | 268 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Change to triple therapy | 4 |
| Overall Study | Enrolled but not treated | 2 |
| Overall Study | Lost to Follow-up | 36 |
| Overall Study | Premature treatment interruption | 11 |
Baseline characteristics
| Characteristic | Peginterferon Alfa-2a + Ribavirin |
|---|---|
| Age, Continuous | 37.7 years STANDARD_DEVIATION 10.1 |
| Sex: Female, Male Female | 71 Participants |
| Sex: Female, Male Male | 197 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 15 / 268 |
| serious Total, serious adverse events | 4 / 268 |
Outcome results
Primary
Percentage of Participants Achieving Sustained Virological Response (SVR) According to Genotype and Previous Treatment
SVR was defined as participants with undetectable Hepatitis C virus (HCV) ribonucleic acid (RNA) at 24 weeks after completion of treatment. Undetectable HCV RNA was defined as a single last HCV RNA less than (\<) 20 international units per milliliter (IU/mL). SVR was evaluated based on HCV genotype (G1, G2, G3 and G4), participant's interleukin 28B genotype (CC, CT and TT), and previous treatment (treatment naive or previous treatment).
Time frame: 6 months after the last study drug administration (up to 123.6 weeks)
Population: All treated participants were included in the analysis. Here, 'n' specifies the number of participants included in the analysis as per the specified category (genotype or previous treatment).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Peginterferon Alfa-2a + Ribavirin | Percentage of Participants Achieving Sustained Virological Response (SVR) According to Genotype and Previous Treatment | All participants (n=268) | 66 percentage of participants |
| Peginterferon Alfa-2a + Ribavirin | Percentage of Participants Achieving Sustained Virological Response (SVR) According to Genotype and Previous Treatment | G1 (n=104) | 51 percentage of participants |
| Peginterferon Alfa-2a + Ribavirin | Percentage of Participants Achieving Sustained Virological Response (SVR) According to Genotype and Previous Treatment | G2 (n=9) | 67 percentage of participants |
| Peginterferon Alfa-2a + Ribavirin | Percentage of Participants Achieving Sustained Virological Response (SVR) According to Genotype and Previous Treatment | G3 (n=153) | 75 percentage of participants |
| Peginterferon Alfa-2a + Ribavirin | Percentage of Participants Achieving Sustained Virological Response (SVR) According to Genotype and Previous Treatment | G4 (n=2) | 100 percentage of participants |
| Peginterferon Alfa-2a + Ribavirin | Percentage of Participants Achieving Sustained Virological Response (SVR) According to Genotype and Previous Treatment | CC (n=56) | 66 percentage of participants |
| Peginterferon Alfa-2a + Ribavirin | Percentage of Participants Achieving Sustained Virological Response (SVR) According to Genotype and Previous Treatment | CT (n=73) | 66 percentage of participants |
| Peginterferon Alfa-2a + Ribavirin | Percentage of Participants Achieving Sustained Virological Response (SVR) According to Genotype and Previous Treatment | TT (n=25) | 64 percentage of participants |
| Peginterferon Alfa-2a + Ribavirin | Percentage of Participants Achieving Sustained Virological Response (SVR) According to Genotype and Previous Treatment | Treatment-naive (n=238) | 70 percentage of participants |
| Peginterferon Alfa-2a + Ribavirin | Percentage of Participants Achieving Sustained Virological Response (SVR) According to Genotype and Previous Treatment | Pre-treated (n=30) | 30 percentage of participants |
Secondary
HCV RNA Values
Time frame: Baseline; Weeks 4, 12, end of treatment (up to 99.6 weeks) and 6 months after end of treatment (up to 123.6 weeks)
Population: Number of participants analyzed=treated participants with data available for HCV RNA. Here, n specifies number of participants with data available for specified category.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Peginterferon Alfa-2a + Ribavirin | HCV RNA Values | Baseline (n=267) | 3281922 IU/mL | Standard Deviation 6039339 |
| Peginterferon Alfa-2a + Ribavirin | HCV RNA Values | Week 4 (n=262) | 44174 IU/mL | Standard Deviation 192056 |
| Peginterferon Alfa-2a + Ribavirin | HCV RNA Values | Week 12 (n=219) | 21342 IU/mL | Standard Deviation 189967 |
| Peginterferon Alfa-2a + Ribavirin | HCV RNA Values | End of treatment (n=224) | 39436 IU/mL | Standard Deviation 335382 |
| Peginterferon Alfa-2a + Ribavirin | HCV RNA Values | 6 months post treatment (n=195) | 93414 IU/mL | Standard Deviation 852266 |
Secondary
Hemoglobin Values
Time frame: Baseline; Weeks 4, 12, end of treatment (up to 99.6 weeks) and 6 months after end of treatment (up to 123.6 weeks)
Population: Number of participants analyzed=treated participants with data available for hemoglobin. Here, n specifies number of participants with data available for specified category.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Peginterferon Alfa-2a + Ribavirin | Hemoglobin Values | Baseline (n=265) | 147 gram per liter | Standard Deviation 14.4 |
| Peginterferon Alfa-2a + Ribavirin | Hemoglobin Values | Week 4 (n=260) | 129 gram per liter | Standard Deviation 16 |
| Peginterferon Alfa-2a + Ribavirin | Hemoglobin Values | Week 12 (n=260) | 129 gram per liter | Standard Deviation 16 |
| Peginterferon Alfa-2a + Ribavirin | Hemoglobin Values | End of treatment (n=224) | 122 gram per liter | Standard Deviation 16 |
| Peginterferon Alfa-2a + Ribavirin | Hemoglobin Values | 6 months post treatment (n=198) | 143 gram per liter | Standard Deviation 14 |
Secondary
Leukocyte Values
Time frame: Baseline; Weeks 4, 12, end of treatment (up to 99.6 weeks) and 6 months after end of treatment (up to 123.6 weeks)
Population: Number of participants analyzed=treated participants with data available for leukocyte value. Here, n specifies number of participants with data available for specified category.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Peginterferon Alfa-2a + Ribavirin | Leukocyte Values | Baseline (n=265) | 7.0 billion cells per liter | Standard Deviation 2.1 |
| Peginterferon Alfa-2a + Ribavirin | Leukocyte Values | Week 4 (n=260) | 3.8 billion cells per liter | Standard Deviation 1.4 |
| Peginterferon Alfa-2a + Ribavirin | Leukocyte Values | Week 12 (n=217) | 3.4 billion cells per liter | Standard Deviation 1.4 |
| Peginterferon Alfa-2a + Ribavirin | Leukocyte Values | End of treatment (n=224) | 3.6 billion cells per liter | Standard Deviation 1.8 |
| Peginterferon Alfa-2a + Ribavirin | Leukocyte Values | 6 months post treatment (n=198) | 7.1 billion cells per liter | Standard Deviation 3.5 |
Secondary
Percentage of Participants With Undetectable HCV RNA
Undetectable HCV RNA=a single last HCV RNA \<20 IU/mL
Time frame: Weeks 4, 12 and at end of treatment (up to 99.6 weeks)
Population: All treated participants were included in the analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Peginterferon Alfa-2a + Ribavirin | Percentage of Participants With Undetectable HCV RNA | Week 4 | 64 percentage of participants |
| Peginterferon Alfa-2a + Ribavirin | Percentage of Participants With Undetectable HCV RNA | Week 12 | 21 percentage of participants |
| Peginterferon Alfa-2a + Ribavirin | Percentage of Participants With Undetectable HCV RNA | End of treatment | 79 percentage of participants |
Secondary
Thrombocyte Values
Time frame: Baseline; Weeks 4, 12, end of treatment (up to 99.6 weeks) and 6 months after end of treatment (up to 123.6 weeks)
Population: Number of participants analyzed=treated participants with data available for thrombocyte value. Here, n specifies number of participants with data available for specified category.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Peginterferon Alfa-2a + Ribavirin | Thrombocyte Values | Baseline (n=265) | 206 billion cells per liter | Standard Deviation 62.7 |
| Peginterferon Alfa-2a + Ribavirin | Thrombocyte Values | Week 4 (n=260) | 143 billion cells per liter | Standard Deviation 55 |
| Peginterferon Alfa-2a + Ribavirin | Thrombocyte Values | Week 12 (n=217) | 125 billion cells per liter | Standard Deviation 48 |
| Peginterferon Alfa-2a + Ribavirin | Thrombocyte Values | End of treatment (n=224) | 140 billion cells per liter | Standard Deviation 59 |
| Peginterferon Alfa-2a + Ribavirin | Thrombocyte Values | 6 months post treatment (n=198) | 207 billion cells per liter | Standard Deviation 56 |
Secondary
Treatment Duration (in Weeks) With Peginterferon Alfa-2a and Ribavirin
Time frame: Up to 99.6 Weeks
Population: All treated participants were included.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Peginterferon Alfa-2a + Ribavirin | Treatment Duration (in Weeks) With Peginterferon Alfa-2a and Ribavirin | Peginterferon alfa-2a | 31.0 weeks | Standard Deviation 17.1 |
| Peginterferon Alfa-2a + Ribavirin | Treatment Duration (in Weeks) With Peginterferon Alfa-2a and Ribavirin | Ribavirin | 31.3 weeks | Standard Deviation 17.2 |