Hepatitis C, Hepatitis C, Chronic
Conditions
Brief summary
Participants will receive PegIntron injection pen (Peginterferon alfa-2b) and Rebetol (Ribavirin) combination therapy as their usual medical treatment. The current study aims to evaluate whether the previously introduced, and now widely accepted and implemented educational program, which represents additional efforts in everyday practice to increase patient compliance, will succeed in achieving adherence rate in treated participants similar to the extent demonstrated by clinical trials.
Interventions
BIOLOGICALPegIntron (Peginterferon alfa-2b)
Peginterferon alfa-2b (injection pen) administered according to the product's labeling and current practice in Hungary (1.5 micrograms \[mcg\]/killogram \[kg\]) for 12 weeks. Those participants whose continued treatment was warranted beyond week 12 based on response received therapy for 24 or 48 weeks depending on the viral genotype.
Ribavirin capsules administered according to the product's labeling and current practice in Hungary (weight based daily) for 12 weeks. Those participants whose continued treatment was warranted beyond week 12 based on response received therapy for 24 or 48 weeks depending on the viral genotype.
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
* Before inclusion, all participants must be informed and must give consent for the use of his/her anonymized health data related to his/her treatment with Peginterferon alfa-2b (injection pen) and Ribavirin.
Exclusion criteria
* According to Peginterferon alfa-2b/Ribavirin label.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Who Are Triple-80 Compliant | 24 or 48 Weeks | Participants who continued treatment beyond Week 12 (i.e., 24 or 48 weeks depending on the viral genotype) were assessed for triple-80 compliance. Triple-80 compliant, or simply compliant, participants were those that received \>= 80% of the planned total doses of both pegylated interferon alfa-2b and ribavirin for \>=80% of the duration of the therapy. 3 rates were computed: Compliance with study duration, compliance with pegylated interferon dose, and compliance with ribavirin dose. A participant was defined as triple-80 compliant, if none of the 3 rates as defined above were less than 80. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Who Achieved Sustained Virological Response as Assessed at 24-week Post-treatment Follow-up | 24 Weeks following completion of 24 or 48 weeks of therapy | Sustained virologic response (SVR) was assessed at post-treatment Follow-up Week 24. Day 1 of the Follow-up period was defined as the first day after the last dose day. A participant was considered a sustained responder if the participant had undetectable Hepatitis C virus Ribonucleic acid (HCV-RNA) level (based on qualitative test result) at Follow-up Week 24. If a participant with missing polymerase chain reaction (PCR) data at Follow-up Week 24 had undetectable HCV-RNA level at Follow-up Week 12, the participant was also considered as a sustained responder. |
| Number Of Participants Self-Administering Pegylated Interferon Alfa-2b | Up to 48 Weeks | Number of participants self-administering Pegylated interferon alfa-2b injection pen. If a participant changed the way he or she administered the injection pen during the course of the study (from self-administering to clinic-administering or the other way around), that participant was also considered as self-administering. |
Participant flow
Pre-assignment details
A total of 294 participants were enrolled, 2 participants were not treated.
Participants by arm
| Arm | Count |
|---|---|
| Peginterferon Alfa-2b and Ribavirin Previously untreated CHC participants treated with a treatment regimen of 1.5 mcg/kg Peginterferon alfa-2b (injection pen) and weight based daily Ribavirin capsules combination therapy as their usual medical treatment administered according to the product's labeling and current practice in Hungary for 12 weeks. Those participants whose continued treatment was warranted beyond Week 12 based on response received therapy for 24 or 48 weeks depending on the viral genotype. | 294 |
| Total | 294 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 22 |
| Overall Study | Investigator Discontinued | 1 |
| Overall Study | Non-compliance With Protocol | 14 |
| Overall Study | Other | 8 |
| Overall Study | Protocol Defined Clinical Event | 1 |
| Overall Study | Treatment Failure | 41 |
Baseline characteristics
| Characteristic | Peginterferon Alfa-2b and Ribavirin |
|---|---|
| Age, Continuous | 46.7 years STANDARD_DEVIATION 10.8 |
| Sex: Female, Male Female | 165 Participants |
| Sex: Female, Male Male | 129 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 109 / 292 |
| serious Total, serious adverse events | 9 / 292 |
Outcome results
Primary
Number of Participants Who Are Triple-80 Compliant
Participants who continued treatment beyond Week 12 (i.e., 24 or 48 weeks depending on the viral genotype) were assessed for triple-80 compliance. Triple-80 compliant, or simply compliant, participants were those that received \>= 80% of the planned total doses of both pegylated interferon alfa-2b and ribavirin for \>=80% of the duration of the therapy. 3 rates were computed: Compliance with study duration, compliance with pegylated interferon dose, and compliance with ribavirin dose. A participant was defined as triple-80 compliant, if none of the 3 rates as defined above were less than 80.
Time frame: 24 or 48 Weeks
Population: All enrolled participants who received any dose of any medication, had a known viral genotype, and did not discontinue from the study with the status being treatment~failure. Of the 294 enrolled participants, 253 participants started treatment and continued treatment beyond Week 12.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Peginterferon Alfa-2b and Ribavirin | Number of Participants Who Are Triple-80 Compliant | 183 Participants |
Secondary
Number Of Participants Self-Administering Pegylated Interferon Alfa-2b
Number of participants self-administering Pegylated interferon alfa-2b injection pen. If a participant changed the way he or she administered the injection pen during the course of the study (from self-administering to clinic-administering or the other way around), that participant was also considered as self-administering.
Time frame: Up to 48 Weeks
Population: All Participants enrolled.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Peginterferon Alfa-2b and Ribavirin | Number Of Participants Self-Administering Pegylated Interferon Alfa-2b | 291 Participants |
Secondary
Number of Participants Who Achieved Sustained Virological Response as Assessed at 24-week Post-treatment Follow-up
Sustained virologic response (SVR) was assessed at post-treatment Follow-up Week 24. Day 1 of the Follow-up period was defined as the first day after the last dose day. A participant was considered a sustained responder if the participant had undetectable Hepatitis C virus Ribonucleic acid (HCV-RNA) level (based on qualitative test result) at Follow-up Week 24. If a participant with missing polymerase chain reaction (PCR) data at Follow-up Week 24 had undetectable HCV-RNA level at Follow-up Week 12, the participant was also considered as a sustained responder.
Time frame: 24 Weeks following completion of 24 or 48 weeks of therapy
Population: Full Analyses Set: All enrolled participants who received any dose of any medication (Peginterferon or Ribavirin) and had a known viral genotype. Of the 294 enrolled participants, 2 were not treated.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Peginterferon Alfa-2b and Ribavirin | Number of Participants Who Achieved Sustained Virological Response as Assessed at 24-week Post-treatment Follow-up | 66 Participants |