Hepatitis C, Hepatitis C, Chronic
Conditions
Brief summary
Enrolled patients will be recruited to two parallel groups during therapy for Hepatitis C. Patients in the first one will receive a patient assistance program, and patients in the second group will not. All patients will receive PegIntron and Rebetol according to label.
Detailed description
Non-Probability Sample, Commercial product used according to EU label.
Interventions
Peginterferon alfa-2b will be administered according to the product's labeling.
Ribavirin will be administered according to the product's labeling.
BEHAVIORALPatient Assistance Program
The patient assistance program includes the following: * Training by physicians or specialized nurses. * Informational materials based on the To beat HCV program. * Management of specific side effects.
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
* According to PegIntron/Rebetol label. * Only HCV genotype 1 infected patients will be enrolled in the study.
Exclusion criteria
* According to PegIntron/Rebetol label.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Number of Participants Who Complete Treatment With PegIntron/Rebetol Therapy for Hepatitis C | At the end of the 48-week treatment period | Participant adherence to therapy was compared between participants treated with PegIntron/Rebetol either with or without a patient assistance program |
| The Number of Participants With a Sustained Virologic Response at 6 Months Post-treatment | Measured at 6 months post-treatment | Sustained virologic response is defined as having an undetectable hepatitis C virus ribonucleic acid (HCV-RNA) at the end of treatment and 6 months post-treatment |
| The Number of Participants Who Relapsed at 6 Months Post-treatment | Measured at end of treatment and 6 months post-treatment | Participants who relapse are defined as having an undetectable HCV-RNA at the end of treatment but detectable HCV-RNA at 6 months post-treatment |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Average Length of Treatment | Maximum 48-week treatment duration | Participant adherence to therapy was compared between participants who received vs not received a patient assistance program in addition to their PegIntron/Rebetol treatment. |
| Average Dosage of PegIntron | Up to 48-week treatment duration | Dosage of PegIntron was expressed in terms of micrograms of PegIntron received per kilogram of participant's body weight per week |
| Average Dosage of Rebetol | Up to 48-week treatment duration | Rebetol dosage was expressed in milligrams per kilogram of body weight per day. |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Treatment and Patient Assistance Program Patient assistance program was provided to the participants treated with PegIntron/Rebetol. The support program consisted of training by physicians or specialized nurses on the significance of treatment compliance, methods for managing adverse events, and correct drug administration, as well as informational materials and assistance in the management of adverse events. | 60 |
| Treatment Alone PegIntron/Rebetol treatment only | 39 |
| Total | 99 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 7 | 0 |
| Overall Study | Lack of Efficacy | 2 | 4 |
| Overall Study | No data available | 0 | 1 |
| Overall Study | Withdrawal by Subject | 0 | 2 |
Baseline characteristics
| Characteristic | Treatment and Patient Assistance Program | Treatment Alone | Total |
|---|---|---|---|
| Age, Continuous | 47 years STANDARD_DEVIATION 12 | 42 years STANDARD_DEVIATION 14 | 45 years STANDARD_DEVIATION 13 |
| Region of Enrollment Poland | 60 participants | 39 participants | 99 participants |
| Sex: Female, Male Female | 25 Participants | 18 Participants | 43 Participants |
| Sex: Female, Male Male | 35 Participants | 21 Participants | 56 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 39 / 60 | 28 / 39 |
| serious Total, serious adverse events | 0 / 60 | 0 / 39 |
Outcome results
Primary
The Number of Participants Who Complete Treatment With PegIntron/Rebetol Therapy for Hepatitis C
Participant adherence to therapy was compared between participants treated with PegIntron/Rebetol either with or without a patient assistance program
Time frame: At the end of the 48-week treatment period
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Treatment and Patient Assistance Program | The Number of Participants Who Complete Treatment With PegIntron/Rebetol Therapy for Hepatitis C | 51 Participants |
| Treatment Alone | The Number of Participants Who Complete Treatment With PegIntron/Rebetol Therapy for Hepatitis C | 32 Participants |
Primary
The Number of Participants Who Relapsed at 6 Months Post-treatment
Participants who relapse are defined as having an undetectable HCV-RNA at the end of treatment but detectable HCV-RNA at 6 months post-treatment
Time frame: Measured at end of treatment and 6 months post-treatment
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Treatment and Patient Assistance Program | The Number of Participants Who Relapsed at 6 Months Post-treatment | 17 Participants |
| Treatment Alone | The Number of Participants Who Relapsed at 6 Months Post-treatment | 4 Participants |
Primary
The Number of Participants With a Sustained Virologic Response at 6 Months Post-treatment
Sustained virologic response is defined as having an undetectable hepatitis C virus ribonucleic acid (HCV-RNA) at the end of treatment and 6 months post-treatment
Time frame: Measured at 6 months post-treatment
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Treatment and Patient Assistance Program | The Number of Participants With a Sustained Virologic Response at 6 Months Post-treatment | 29 Participants |
| Treatment Alone | The Number of Participants With a Sustained Virologic Response at 6 Months Post-treatment | 7 Participants |
Secondary
Average Dosage of PegIntron
Dosage of PegIntron was expressed in terms of micrograms of PegIntron received per kilogram of participant's body weight per week
Time frame: Up to 48-week treatment duration
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment and Patient Assistance Program | Average Dosage of PegIntron | 1.46 micrograms/kg/week | Standard Deviation 0.16 |
| Treatment Alone | Average Dosage of PegIntron | 1.45 micrograms/kg/week | Standard Deviation 0.25 |
Secondary
Average Dosage of Rebetol
Rebetol dosage was expressed in milligrams per kilogram of body weight per day.
Time frame: Up to 48-week treatment duration
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment and Patient Assistance Program | Average Dosage of Rebetol | 12.63 mg/kg/day | Standard Deviation 1.72 |
| Treatment Alone | Average Dosage of Rebetol | 12.01 mg/kg/day | Standard Deviation 2.86 |
Secondary
Average Length of Treatment
Participant adherence to therapy was compared between participants who received vs not received a patient assistance program in addition to their PegIntron/Rebetol treatment.
Time frame: Maximum 48-week treatment duration
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Treatment and Patient Assistance Program | Average Length of Treatment | 2-12 weeks | 6 Participants |
| Treatment and Patient Assistance Program | Average Length of Treatment | 48 weeks and one of the drugs at a dose <80% | 13 Participants |
| Treatment and Patient Assistance Program | Average Length of Treatment | 13-47 weeks | 3 Participants |
| Treatment and Patient Assistance Program | Average Length of Treatment | 48 weeks and both drugs at a dose >=80% | 38 Participants |
| Treatment Alone | Average Length of Treatment | 13-47 weeks | 2 Participants |
| Treatment Alone | Average Length of Treatment | 2-12 weeks | 5 Participants |
| Treatment Alone | Average Length of Treatment | 48 weeks and both drugs at a dose >=80% | 23 Participants |
| Treatment Alone | Average Length of Treatment | 48 weeks and one of the drugs at a dose <80% | 9 Participants |