Hepacivirus, Hepatitis C, Chronic
Conditions
Brief summary
In February 2002, a French Consensus Conference on the management of patients with chronic hepatitis C in France was organized. The jury issued several recommendations on pegylated alpha interferon/ribavirin treatment strategy. Three years after these recommendations, it is of interest to understand the evolution of hepatitis C management in France in real clinical practice. This observational study will permit the identification of patients who are treated and will provide information on the use of PegIntron/ Ribavirin.
Detailed description
To assure a good representation of participants treated for hepatitis C, participants who meet the inclusion criteria will be enrolled on a consecutive basis.
Interventions
BIOLOGICALPeginterferon alfa-2b (SCH 54031)
Peginterferon alfa-2b as monotherapy or in combination with ribavirin will be administered according to the products' labeling.
Peginterferon alfa-2b as monotherapy or in combination with ribavirin will be administered according to the products' labeling.
Sponsors
Merck Sharp & Dohme LLC
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 starting a treatment with PegIntron for the treatment of chronic hepatitis C.
Exclusion criteria
* Concomitant participation in a clinical trial for the treatment of hepatitis C.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The Number of Participants Receiving the Recommended Treatment Duration (24 Weeks for Genotypes 2 and 3 and 48 Weeks for Genotype 1 According to the French 2002 Consensus Meeting). | Physicians will complete a questionnaire at these visits: treatment initiation; 12 and 24 weeks after treatment initiation and 24 weeks after the end of treatment; and 36 and 48 weeks after treatment initiation for participants treated for 48 weeks. |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| PegIntron as Monotherapy or in Combination With Ribavirin Adult participants with chronic hepatitis C treated with PegIntron as monotherapy or in combination with ribavirin. | 789 |
| Total | 789 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 4 |
| Overall Study | Death | 1 |
| Overall Study | Lack of data | 3 |
| Overall Study | Lost to Follow-up | 5 |
| Overall Study | No post-treatment questionnaire | 279 |
| Overall Study | Other | 12 |
| Overall Study | Physician Decision | 7 |
| Overall Study | Untreated | 5 |
| Overall Study | Withdrawal by Subject | 21 |
Baseline characteristics
| Characteristic | PegIntron as Monotherapy or in Combination With Ribavirin |
|---|---|
| Age, Customized | 49 years STANDARD_DEVIATION 12.1 |
| Region of Enrollment France | 789 participants |
| Sex/Gender, Customized Female | 296 participants |
| Sex/Gender, Customized Male | 485 participants |
| Sex/Gender, Customized Unavailable | 8 participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 0 |
| serious Total, serious adverse events | 66 / 789 |
Outcome results
Primary
The Number of Participants Receiving the Recommended Treatment Duration (24 Weeks for Genotypes 2 and 3 and 48 Weeks for Genotype 1 According to the French 2002 Consensus Meeting).
Time frame: Physicians will complete a questionnaire at these visits: treatment initiation; 12 and 24 weeks after treatment initiation and 24 weeks after the end of treatment; and 36 and 48 weeks after treatment initiation for participants treated for 48 weeks.
Population: For the 48 week treatment period, the analysis did not separate Genotype 1 (G1) from Genotype 4 (G4) or others. Of the 789 participants, 8 were excluded from analysis (3 for lack of data; 5 because they were untreated).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| PegIntron as Monotherapy or in Combination With Ribavirin | The Number of Participants Receiving the Recommended Treatment Duration (24 Weeks for Genotypes 2 and 3 and 48 Weeks for Genotype 1 According to the French 2002 Consensus Meeting). | G2, 3 completing 24 weeks of treatment | 160 Participants |
| PegIntron as Monotherapy or in Combination With Ribavirin | The Number of Participants Receiving the Recommended Treatment Duration (24 Weeks for Genotypes 2 and 3 and 48 Weeks for Genotype 1 According to the French 2002 Consensus Meeting). | G 1, 4, others completing 48 weeks of treatment | 195 Participants |