Hepatitis C
Conditions
Brief summary
This noninterventional, open-label study will observe the safety and tolerability of peginterferon alfa-2a in combination with ribavirin among Austrian participants treated for HCV infection according to routine practice.
Interventions
DRUGPeginterferon alfa-2a
180 micrograms subcutaneous weekly for 48 weeks.
DRUGRibavirin
1000-1600 mg day orally for 48 weeks.
Sponsors
Hoffmann-La Roche
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Ongoing treatment with peginterferon alfa-2a and ribavirin at the discretion of the prescribing physician * HCV infection
Exclusion criteria
* None specified
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Serious Adverse Events (SAEs) and Adverse Events (AEs) | Up to 6 years | An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability or incapacity; and congenital anomaly. Percentage of participants with AEs included participants affected with both SAEs and non-SAEs. |
| Percentage of Participants With End of Treatment Response | 12 months | Clinical response to the treatment was measured by qualitative negative polymerase chain reaction (PCR). A participant was considered to have and end of treatment response if there was undetectable Hepatitis C Virus (HCV) ribonucleic acid (RNA) after completing treatment. Participants with available PCR results were reported. |
| Percentage of Participants With Sustained Virologic Response 24 (SVR24) | 18 months | Clinical response to the treatment was measured by qualitative negative polymerase chain reaction (PCR). SVR24 is defined as the percentage of participants with undetectable HCV RNA 24 weeks after completing treatment. |
Countries
Austria
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Participants With Hepatitis C All participants were treated with Peginterferon alfa-2a+Ribavirin (Pegasys/Copegus) according to the summary of product characteristics and to the investigator's discretion. The daily recommended dose for Pegasys, for the treatment of chronic Hepatitis C, was 180 micrograms once weekly by subcutaneous administration. Copegus was administered orally in doses according to the physician's decision (depending on the participant's weight and genotype). All participants were observed for 12 months. | 463 |
| Total | 463 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 7 |
| Overall Study | End-of-treatment visit not attended | 17 |
| Overall Study | Lack of Efficacy | 31 |
| Overall Study | Lost to Follow-up | 9 |
| Overall Study | Other | 22 |
| Overall Study | Withdrawal by Subject | 18 |
Baseline characteristics
| Characteristic | Participants With Hepatitis C |
|---|---|
| Age, Continuous | 41.0 years STANDARD_DEVIATION 13.3 |
| Sex/Gender, Customized Female | 151 participants |
| Sex/Gender, Customized Male | 310 participants |
| Sex/Gender, Customized Missing | 2 participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 148 / 463 |
| serious Total, serious adverse events | 18 / 463 |
Outcome results
Primary
Percentage of Participants With End of Treatment Response
Clinical response to the treatment was measured by qualitative negative polymerase chain reaction (PCR). A participant was considered to have and end of treatment response if there was undetectable Hepatitis C Virus (HCV) ribonucleic acid (RNA) after completing treatment. Participants with available PCR results were reported.
Time frame: 12 months
Population: All participants who were enrolled in the study. N (Number of participants analysed)=participants who were evaluable for this measure.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Participants With Hepatitis C | Percentage of Participants With End of Treatment Response | Participants with negative PCR | 83.8 percentage of participants |
| Participants With Hepatitis C | Percentage of Participants With End of Treatment Response | Participants with positive PCR | 9.7 percentage of participants |
Primary
Percentage of Participants With Serious Adverse Events (SAEs) and Adverse Events (AEs)
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability or incapacity; and congenital anomaly. Percentage of participants with AEs included participants affected with both SAEs and non-SAEs.
Time frame: Up to 6 years
Population: All participants who were enrolled in the study.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Participants With Hepatitis C | Percentage of Participants With Serious Adverse Events (SAEs) and Adverse Events (AEs) | AEs | 44.28 percentage of participants |
| Participants With Hepatitis C | Percentage of Participants With Serious Adverse Events (SAEs) and Adverse Events (AEs) | SAEs | 3.9 percentage of participants |
Primary
Percentage of Participants With Sustained Virologic Response 24 (SVR24)
Clinical response to the treatment was measured by qualitative negative polymerase chain reaction (PCR). SVR24 is defined as the percentage of participants with undetectable HCV RNA 24 weeks after completing treatment.
Time frame: 18 months
Population: All participant who were enrolled in the study. N=number of participants evaluable for this measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Participants With Hepatitis C | Percentage of Participants With Sustained Virologic Response 24 (SVR24) | 26.6 percentage of participants |