Chronic Hepatitis C, Hepatitis C
Conditions
Brief summary
The objective of this study is to assess the impact of participant care and support on treatment adherence. PegIntron pen and Rebetol will be administered to participants with Hepatitis C Virus (HCV) in accordance with approved labeling. Sites will be categorized as providing high vs low level of participant management based on information about the level of participant support and management captured on the site questionnaire. Data on each participant will be collected by a physician on an electronic participant case report form (CRF) and by the participant via a questionnaire. Treatment completion rates will be analyzed based on the high vs low level of participant management. The hypothesis is that Physicians investing more time and effort into participant management achieve higher treatment completion rates among their hepatitis C patients than physicians offering less participant management measures.
Interventions
Sponsors
Merck Sharp & Dohme LLC
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Participants with chronic hepatitis C. Those participating in patient assistance programs during therapy for hepatitis C.
Exclusion criteria
* Participants who have previously been treatment for hepatitis C (non-naïve) Other
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Biometrical Adherence to Therapy | Up to 48 weeks for Hepatitis C Virus (HCV) genotype 1 or 4 participants and up to 24 weeks for HCV genotype 2 or 3 | Adherence was defined as participants receiving at least 80% of the planned PegIntron doses, or at least 80% of the planned Rebetol doses, or participants concluding at least 80% of the planned duration of their treatment, or all three conditions. |
| Number of Participants With Adherence to Therapy According to Physician Approximation | Up to 48 weeks for HCV genotype 1 or 4 participants and up to 24 weeks for HCV genotype 2 or 3 | Adherence was based on physiciant's clinical judgment. |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| All Participants Each site will be evaluated by a site questionnaire and assigned as either a high or low participant management site. Participants are not randomized to a group. However, treatment completion rates will be evaluated based on the high vs low participant management sites. | 746 |
| Total | 746 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Not completed on time | 328 |
Baseline characteristics
| Characteristic | All Participants |
|---|---|
| Age, Continuous | 42.3 years STANDARD_DEVIATION 11.44 |
| Region of Enrollment Germany | 746 participants |
| Sex: Female, Male Female | 297 Participants |
| Sex: Female, Male Male | 449 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 332 / 746 |
| serious Total, serious adverse events | 27 / 746 |
Outcome results
Primary
Number of Participants With Adherence to Therapy According to Physician Approximation
Adherence was based on physiciant's clinical judgment.
Time frame: Up to 48 weeks for HCV genotype 1 or 4 participants and up to 24 weeks for HCV genotype 2 or 3
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| All Participants | Number of Participants With Adherence to Therapy According to Physician Approximation | PegIntron | 615 Participants |
| All Participants | Number of Participants With Adherence to Therapy According to Physician Approximation | Rebetol | 604 Participants |
Primary
Number of Participants With Biometrical Adherence to Therapy
Adherence was defined as participants receiving at least 80% of the planned PegIntron doses, or at least 80% of the planned Rebetol doses, or participants concluding at least 80% of the planned duration of their treatment, or all three conditions.
Time frame: Up to 48 weeks for Hepatitis C Virus (HCV) genotype 1 or 4 participants and up to 24 weeks for HCV genotype 2 or 3
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| All Participants | Number of Participants With Biometrical Adherence to Therapy | PegIntron + Rebetol | 406 Participants |
| All Participants | Number of Participants With Biometrical Adherence to Therapy | PegIntron | 415 Participants |
| All Participants | Number of Participants With Biometrical Adherence to Therapy | Rebetol | 413 Participants |