Hepatitis C, Chronic
Conditions
Brief summary
This is a Phase 4, retrospective and observational, multicenter, national (Brazil), open, noncomparative, and nonrandomized study, which does not have visits. This study will be conducted in accordance to Good Clinical Practices. The procedure will be the review of medical records of patients who have already completed 12 weeks of treatment of chronic hepatitis C with peginterferon alfa-2b and ribavirin. This review will take place after the subjects have signed the informed consent form authorizing collection of these data. The collection of data for virological response after Week 12 will be collected prospectively through the review of medical records after the subjects have completed their entire treatment and follow-up period.
Detailed description
This is a Phase 4, retrospective and observational, multicenter, national (Brazil), open, noncomparative, and nonrandomized study, which does not have visits. This study will be conducted in accordance to Good Clinical Practices. The procedure will be the review of medical records of patients who have already completed 12 weeks of treatment of chronic hepatitis C with peginterferon alfa-2b and ribavirin. This review will take place after the subjects have signed the informed consent form authorizing collection of these data. The physician will be filling out the case report form with the information contained in the medical record. Any dose reduction and/or doses not taken during this period will be reported through the case report form. The collection of data for virological response after Week 12 (such as virological response at the end of treatment and sustained virological response after follow-up period) will be collected prospectively through the review of medical records after the subjects have completed their entire treatment and follow-up period.
Interventions
BIOLOGICALPeginterferon alfa-2b
PegIntron 80 μg, PegIntron 100 μg, or PegIntron 120 μg. The duration of the complete treatment and the doses of pegylated interferon alfa 2b should have been prescribed according to local guidelines, and according to the investigating physician's orientation.
DRUGRibavirin
Ribavirin 250 mg. The duration of the complete treatment and the doses of ribavirin should have been prescribed according to local guidelines, and according to the investigating physician's orientation.
Sponsors
Merck Sharp & Dohme LLC
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Must have confirmed his/her willingness in participating in this study, after having been informed of all aspects that are pertinent to his/her decision to participate, by signing and dating the informed consent form (ICF) approved by the Institutional Review Board / Independent Ethics Committee on Research (IRB/IEC). * Adult patients who are 18 years old or above. * Must have diagnosis of chronic hepatitis C confirmed through positive qualitative or quantitative PCR (polymerase chain reaction) performed prior to initiation of the patient's treatment. This result shall be documented in the patient's records. * Must have completed 12 weeks of treatment with peginterferon alfa-2b and ribavirin. * Patients who started treatment for chronic hepatitis C from the year 2008 or later.
Exclusion criteria
* Does not confirm his/her willing in participating in this study or refuses to sign the informed consent form. * Did not start the treatment with peginterferon alfa-2b and ribavirin. * Patients who have less than 12 weeks of treatment with peginterferon alfa-2b and ribavirin.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percent of Participants Who Were Compliant to Treatment in the First 12 Weeks | First 12 weeks of treatment | The participant was considered compliant if he/she had administered 80% of the doses of pegylated interferon alpha 2b and 80% of the doses of ribavirin that were prescribed by the physician in the first 12 weeks of treatment. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percent of Participants Who Achieved Rapid Virologic Response (RVR) | Week 4 | RVR was defined as HCV RNA negative after 4 weeks of treatment. |
| Percent of Participants Who Achieved Early Virologic Response (EVR) | Week 12 | EVR was defined as HCV RNA negative after 12 weeks of treatment. |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| General Peginterferon + Ribavarin Participants received peginterferon alfa-2b and ribavirin according to local labeling guidelines and according to the investigating physician's orientation. | 902 |
| Total | 902 |
Baseline characteristics
| Characteristic | General Peginterferon + Ribavarin |
|---|---|
| Age, Continuous | 49.9 years STANDARD_DEVIATION 9.8 |
| Region of Enrollment Brazil | 902 participants |
| Sex: Female, Male Female | 367 Participants |
| Sex: Female, Male Male | 535 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 658 / 902 |
| serious Total, serious adverse events | 11 / 902 |
Outcome results
Primary
Percent of Participants Who Were Compliant to Treatment in the First 12 Weeks
The participant was considered compliant if he/she had administered 80% of the doses of pegylated interferon alpha 2b and 80% of the doses of ribavirin that were prescribed by the physician in the first 12 weeks of treatment.
Time frame: First 12 weeks of treatment
Population: All enrolled participants
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Naïve Participants | Percent of Participants Who Were Compliant to Treatment in the First 12 Weeks | 98.5 Percent of participants |
| Re-treatment | Percent of Participants Who Were Compliant to Treatment in the First 12 Weeks | 98.5 Percent of participants |
| HIV/Hepatitis C Virus (HCV) Co-infected Participants | Percent of Participants Who Were Compliant to Treatment in the First 12 Weeks | 100.0 Percent of participants |
Secondary
Percent of Participants Who Achieved Early Virologic Response (EVR)
EVR was defined as HCV RNA negative after 12 weeks of treatment.
Time frame: Week 12
Population: Number of participants with data
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Naïve Participants | Percent of Participants Who Achieved Early Virologic Response (EVR) | 67.8 Percent of participants |
| Re-treatment | Percent of Participants Who Achieved Early Virologic Response (EVR) | 46.9 Percent of participants |
| HIV/Hepatitis C Virus (HCV) Co-infected Participants | Percent of Participants Who Achieved Early Virologic Response (EVR) | 33.3 Percent of participants |
Secondary
Percent of Participants Who Achieved Rapid Virologic Response (RVR)
RVR was defined as HCV RNA negative after 4 weeks of treatment.
Time frame: Week 4
Population: Number of participants with data
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Naïve Participants | Percent of Participants Who Achieved Rapid Virologic Response (RVR) | 34.7 Percent of participants |
| Re-treatment | Percent of Participants Who Achieved Rapid Virologic Response (RVR) | 18.8 Percent of participants |
| HIV/Hepatitis C Virus (HCV) Co-infected Participants | Percent of Participants Who Achieved Rapid Virologic Response (RVR) | 0.0 Percent of participants |