Hepatitis C, Hepatitis C, Chronic
Conditions
Brief summary
The goal of this study is to elucidate the reasons why patients with chronic hepatitis C (CHC) would not be considered eligible for antiviral treatment. The study is conducted in common clinical practice at approximately 54 sites in Italy. Patients deemed eligible for antiviral therapy will be treated at the discretion of the physician with either peginterferon alfa-2a or peginterferon alfa-2b, both in combination with ribavirin, in accordance with approved labeling. A secondary objective of this study is to define treatment failure and to evaluate the reasons for treatment discontinuation.
Detailed description
Probability sampling: Consecutive adult patients with chronic hepatitis C in clinical practice at approximately 54 sites in Italy will be included in the study. The decision as to treatment choice falls at the discretion of the treating physician.
Interventions
BIOLOGICALPeginterferon alfa-2b
Peginterferon alfa-2b administered in accordance with approved labeling
DRUGRibavirin
Ribavirin administered in accordance with approved labeling
BIOLOGICALPeginterferon alfa-2a
Peginterferon alfa-2a administered in accordance with approved labeling
Sponsors
Merck Sharp & Dohme LLC
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Willingness to sign an Informed Consent * Male and female patients \>=18 years of age with Chronic Hepatitis C * Not previously treated with Peg-Interferons * Positive for serum hepatitis C virus (HCV)-ribonucleic acid (RNA)
Exclusion criteria
* Previous treatment with peginterferon * Participation in a therapeutic Good Clinical Practice (GCP) clinical study within 30 days prior to study start
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Not Eligible for Antiviral Treatment by Reason for Non-eligibility | Measured at baseline | Investigators recorded their reasons for not prescribing anti-viral treatment. More than one reason leading to non-eligibility could be presented for the same participant. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Discontinued From Treatment by Reason for Discontinuation | 24 weeks after the end of treatment (total of 48 to 72 weeks) | Investigators recorded reasons for treatment discontinuation. |
| Number of Participants With Treatment Failure by Reason for Failure | 24 to 48 weeks | Investigators recorded reasons for treatment failure whether or not treatment was completed. |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Participants With Chronic Hepatitis C (CHC) Peginterferon-naïve participants with CHC seen in general clinical practice in Italy. | 1,118 |
| Total | 1,118 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Excluded - Hepatitis C Virus Negative | 3 |
| Overall Study | Excluded - Prior Use of Peginterferon | 7 |
| Overall Study | Investigator + Participant Decision | 13 |
| Overall Study | Never Started Treatment | 89 |
| Overall Study | Not Eligible for Treatment | 431 |
| Overall Study | Participant Refused Treatment | 89 |
| Overall Study | Physician Decision | 116 |
| Overall Study | Unknown; No Data Sources Available | 9 |
| Overall Study | Withdrawal by Subject | 45 |
Baseline characteristics
| Characteristic | Participants With Chronic Hepatitis C (CHC) |
|---|---|
| Age, Customized 18-29 years | 51 participants |
| Age, Customized 30-39 years | 119 participants |
| Age, Customized 40-49 years | 244 participants |
| Age, Customized 50-59 years | 211 participants |
| Age, Customized 60-69 years | 263 participants |
| Age, Customized 70-79 years | 210 participants |
| Age, Customized ≥80 years | 20 participants |
| Sex: Female, Male Female | 541 Participants |
| Sex: Female, Male Male | 577 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 169 / 500 |
| serious Total, serious adverse events | 6 / 500 |
Outcome results
Primary
Number of Participants Not Eligible for Antiviral Treatment by Reason for Non-eligibility
Investigators recorded their reasons for not prescribing anti-viral treatment. More than one reason leading to non-eligibility could be presented for the same participant.
Time frame: Measured at baseline
Population: 431 of the 1118 participants were determined to be non-eligible for antiviral therapy by Investigator decision.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Participants With Chronic Hepatitis C (CHC) | Number of Participants Not Eligible for Antiviral Treatment by Reason for Non-eligibility | Age | 144 participants |
| Participants With Chronic Hepatitis C (CHC) | Number of Participants Not Eligible for Antiviral Treatment by Reason for Non-eligibility | Mild disease | 77 participants |
| Participants With Chronic Hepatitis C (CHC) | Number of Participants Not Eligible for Antiviral Treatment by Reason for Non-eligibility | Substance abuse history | 17 participants |
| Participants With Chronic Hepatitis C (CHC) | Number of Participants Not Eligible for Antiviral Treatment by Reason for Non-eligibility | Treatment postponed | 7 participants |
| Participants With Chronic Hepatitis C (CHC) | Number of Participants Not Eligible for Antiviral Treatment by Reason for Non-eligibility | Genotype | 2 participants |
| Participants With Chronic Hepatitis C (CHC) | Number of Participants Not Eligible for Antiviral Treatment by Reason for Non-eligibility | Comorbidity | 139 participants |
| Participants With Chronic Hepatitis C (CHC) | Number of Participants Not Eligible for Antiviral Treatment by Reason for Non-eligibility | Liver problems | 41 participants |
| Participants With Chronic Hepatitis C (CHC) | Number of Participants Not Eligible for Antiviral Treatment by Reason for Non-eligibility | Problems with previous treatment | 4 participants |
Secondary
Number of Participants Discontinued From Treatment by Reason for Discontinuation
Investigators recorded reasons for treatment discontinuation.
Time frame: 24 weeks after the end of treatment (total of 48 to 72 weeks)
Population: Reasons for treatment discontinuations were recorded by Investigators for 174 of the 500 treated participants.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Participants With Chronic Hepatitis C (CHC) | Number of Participants Discontinued From Treatment by Reason for Discontinuation | Administrative reason | 5 participants |
| Participants With Chronic Hepatitis C (CHC) | Number of Participants Discontinued From Treatment by Reason for Discontinuation | Virological response | 22 participants |
| Participants With Chronic Hepatitis C (CHC) | Number of Participants Discontinued From Treatment by Reason for Discontinuation | Other reasons | 5 participants |
| Participants With Chronic Hepatitis C (CHC) | Number of Participants Discontinued From Treatment by Reason for Discontinuation | Disease worsening | 3 participants |
| Participants With Chronic Hepatitis C (CHC) | Number of Participants Discontinued From Treatment by Reason for Discontinuation | Side effects | 27 participants |
| Participants With Chronic Hepatitis C (CHC) | Number of Participants Discontinued From Treatment by Reason for Discontinuation | Non response | 44 participants |
| Participants With Chronic Hepatitis C (CHC) | Number of Participants Discontinued From Treatment by Reason for Discontinuation | Adverse effect | 32 participants |
Secondary
Number of Participants With Treatment Failure by Reason for Failure
Investigators recorded reasons for treatment failure whether or not treatment was completed.
Time frame: 24 to 48 weeks
Population: 132 of the 500 treated participants failed treatment per Investigator assessment.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Participants With Chronic Hepatitis C (CHC) | Number of Participants With Treatment Failure by Reason for Failure | Disease relapse | 71 participants |
| Participants With Chronic Hepatitis C (CHC) | Number of Participants With Treatment Failure by Reason for Failure | Non-responder | 61 participants |