Hepacivirus, Hepatitis C, Chronic
Conditions
Brief summary
Several psychiatric adverse events (eg, depression, fatigue, psychoses, behavior troubles, anxiety, irritability, deteriorated concentration, and insomnia) that are likely to occur during the treatment course with PegIntron plus Rebetol may prompt patients to discontinue their treatment early. The goal of this study is to assess whether a psychotherapy support program may contribute to a better adherence rate.
Detailed description
Enrollment of participants will occur in a sequential order of treatment initiation.
Interventions
BIOLOGICALPeginterferon alfa-2b (PegIntron)
Peginterferon alfa-2b (PegIntron) was administered based on the prescribed dose. The average dose for PegIntron was a weekly injection of 1.5 ± 0.3 μg\^kg\^week
Rebetol was administered orally based on the prescribed dose. The average dose for Rebetol was 950 ± 167.2 mg\^day
BEHAVIORALPsychotherapy support program
Each site has implemented a psychotherapy support program.
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 patients with hepatitis C
Exclusion criteria
* According to the products' labeling
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of Participants Who Complete Treatment With PegIntron/Rebetol Therapy for Hepatitis C When Administered With a Patient Psychotherapy Support Program as Compared to a Group Without a Psychotherapy Support Program. | 12 months after onset of treatment |
Secondary
| Measure | Time frame |
|---|---|
| the Average Length of Treatment for Participants on Treatment for Hepatitis C With PegIntron Pen/Rebetol | 12 months after onset of treatment |
Participant flow
Recruitment details
614 participants were recruited in this study.
Pre-assignment details
Only 568 participants were assigned to treatment as they were foreseen to complete treatment, were consulted, and met inclusion criteria.
Participants by arm
| Arm | Count |
|---|---|
| PegIntron/Rebetol and Psychotherapy Support Program Participants receiving a psychotherapy support program during PegIntron/Rebetol therapy for hepatitis C. | 313 |
| PegIntron/Rebetol Alone (no Psychotherapy) Participants receiving no psychotherapy support program during PegIntron/Rebetol therapy for hepatitis C. | 255 |
| Total | 568 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Alcohol abuse | 0 | 1 |
| Overall Study | Bad tolerance | 5 | 5 |
| Overall Study | Drug addiction | 1 | 0 |
| Overall Study | End planned | 11 | 7 |
| Overall Study | Intercurrent infection | 2 | 0 |
| Overall Study | Multiple reasons | 17 | 12 |
| Overall Study | Other | 6 | 3 |
| Overall Study | Participant not tracked | 33 | 35 |
| Overall Study | Study end | 1 | 3 |
| Overall Study | Virological criterion | 24 | 9 |
| Overall Study | Weight loss | 1 | 3 |
| Overall Study | Withdrawal by Subject | 6 | 9 |
Baseline characteristics
| Characteristic | PegIntron/Rebetol and Psychotherapy Support Program | PegIntron/Rebetol Alone (no Psychotherapy) | Total |
|---|---|---|---|
| Age, Continuous | 45.5 years STANDARD_DEVIATION 10.7 | 48.5 years STANDARD_DEVIATION 11.8 | 46.8 years STANDARD_DEVIATION 11.3 |
| Region of Enrollment France | 313 participants | 255 participants | 568 participants |
| Sex/Gender, Customized Female | 117 participants | 80 participants | 197 participants |
| Sex/Gender, Customized Male | 195 participants | 175 participants | 370 participants |
| Sex/Gender, Customized Unavailable (missing data) | 1 participants | 0 participants | 1 participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 614 |
| serious Total, serious adverse events | 11 / 614 |
Outcome results
Primary
Number of Participants Who Complete Treatment With PegIntron/Rebetol Therapy for Hepatitis C When Administered With a Patient Psychotherapy Support Program as Compared to a Group Without a Psychotherapy Support Program.
Time frame: 12 months after onset of treatment
Population: Participants foreseen to complete treatment, consulted and assigned to treatment were analyzed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| PegIntron/Rebetol and Psychotherapy Support Program | Number of Participants Who Complete Treatment With PegIntron/Rebetol Therapy for Hepatitis C When Administered With a Patient Psychotherapy Support Program as Compared to a Group Without a Psychotherapy Support Program. | 206 Participants |
| PegIntron/Rebetol Alone (no Psychotherapy) | Number of Participants Who Complete Treatment With PegIntron/Rebetol Therapy for Hepatitis C When Administered With a Patient Psychotherapy Support Program as Compared to a Group Without a Psychotherapy Support Program. | 168 Participants |
Secondary
the Average Length of Treatment for Participants on Treatment for Hepatitis C With PegIntron Pen/Rebetol
Time frame: 12 months after onset of treatment
Population: Participants with no missing results.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PegIntron/Rebetol and Psychotherapy Support Program | the Average Length of Treatment for Participants on Treatment for Hepatitis C With PegIntron Pen/Rebetol | 36.1 Weeks | Standard Deviation 16.2 |
| PegIntron/Rebetol Alone (no Psychotherapy) | the Average Length of Treatment for Participants on Treatment for Hepatitis C With PegIntron Pen/Rebetol | 35.3 Weeks | Standard Deviation 17.3 |