Hepatitis C, Hepatitis C, Chronic
Conditions
Brief summary
Adherence to the prescribed treatment regimen with PegIntron and Rebetol affects the chance of achieving a sustained virologic response in patients with hepatitis C. The objective of this study is to evaluate the proportion of patients who complete treatment with PegIntron pen and Rebetol while participating in a patient assistance program. The patient assistance program can consist of prophylactic treatment (eg, with growth factors, psychiatric medications) or other interventions (eg, psychotherapy, patient support groups, visiting nurse, nurse telephone calls, educational literature).
Interventions
BIOLOGICALPegIntron pen (peginterferon alfa-2b; SCH 54031)
PegIntron administered in accordance with approved labeling.
Rebetol administered in accordance with approved labeling
Sponsors
Merck Sharp & Dohme LLC
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Treatment-naïve patients with hepatitis C * Patients treated with PegIntron pen and Rebetol * Patients receiving patient assistance program
Exclusion criteria
* Not applicable
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of Subjects Who Completed Treatment. | Assessed at the end of the 48-week treatment. |
Secondary
| Measure | Time frame |
|---|---|
| Average Length of Treatment. | Assessed at the end of treatment. The prescribed treatment duration was 48 weeks. |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| All Treated Patients | 267 |
| Total | 267 |
Baseline characteristics
| Characteristic | All Treated Patients |
|---|---|
| Age, Continuous | 51.35 years STANDARD_DEVIATION 10.11 |
| Region of Enrollment Romania | 267 participants |
| Sex/Gender, Customized Female | 168 participants |
| Sex/Gender, Customized Male | 98 participants |
| Sex/Gender, Customized Missing | 1 participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 124 / 267 |
| serious Total, serious adverse events | 1 / 267 |
Outcome results
Primary
Number of Subjects Who Completed Treatment.
Time frame: Assessed at the end of the 48-week treatment.
Population: All participants
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| All Treated Patients | Number of Subjects Who Completed Treatment. | 218 Participants |
Secondary
Average Length of Treatment.
Time frame: Assessed at the end of treatment. The prescribed treatment duration was 48 weeks.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| All Treated Patients | Average Length of Treatment. | 43.60 weeks | Standard Deviation 21.38 |