Hepatitis C, Chronic
Conditions
Brief summary
Although injection drug users represent the majority of new and existing cases of infection with hepatitis C virus (HCV), many lack access to treatment because of concerns about adherence, effectiveness, and reinfection. On the basis of a small but growing body of evidence showing that injection drug users can undergo treatment for HCV infection successfully, the 2002 NIH Consensus Statement on Hepatitis C has recommended that substance users be treated for HCV infection on a case-by-case basis. In this study, all patients will receive pegylated interferon alfa-2b (PegIFN-2b) and ribavirin according to European labeling; one cohort of participants will also be receiving substitution therapy (opioid medicines with long-lasting effects \[methadone + buprenorphine\] or morphine).
Interventions
BIOLOGICALPegylated interferon alfa-2b (PegIFN-2b)
PegIFN-2b administered according to European labeling.
DRUGRibavirin
Ribavirin administered according to European labeling.
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' European labeling
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Who Completed Treatment With PegIFN-2b/Ribavirin | 24 to 48 weeks | For participants with Genotype 1 or 4 completion of treatment was at Week 48; for participants with Genotype 2, 3, or 1 with low viral load or rapid virologic response, completion of therapy was at Week 24. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Who Achieved Sustained Virologic Response (SVR) | 24 weeks after the end of treatment (i.e. 48 or 72 weeks depending on genotype) | SVR was defined as a hepatitis C virus (HCV) ribonucleic acid (RNA) value below the limit of detection by polymerase chain reaction (PCR) analysis. For participants with Genotype 1 or 4 completion of treatment was at Week 48; for participants with Genotype 2, 3, or 1 with low viral load or rapid virologic response, completion of therapy was at Week 24. |
| Number of Participants Who Received Antiviral Treatment Who Were Also on Substitution Therapy | Day 1 | This measure was the number of all of the participants who received antiviral treatment who also received substitution therapy. |
Participant flow
Pre-assignment details
353 participants were enrolled on the study; 348 were treated.
Participants by arm
| Arm | Count |
|---|---|
| PegIFN-2b/Ribavirin With Substitution Therapy Participants in this group received antiviral treatment and substitution therapy (opioid medicines with long-lasting effects \[methadone + buprenorphine\] or morphine) | 90 |
| PegIFN-2b/Ribavirin Without Substitution Therapy Participants in this group received antiviral treatment but did not receive substitution therapy (opioid medicines with long-lasting effects \[methadone + buprenorphine\] or morphine) | 258 |
| Total | 348 |
Baseline characteristics
| Characteristic | PegIFN-2b/Ribavirin With Substitution Therapy | PegIFN-2b/Ribavirin Without Substitution Therapy | Total |
|---|---|---|---|
| Age, Continuous | 32.38 years STANDARD_DEVIATION 9.51 | 42.26 years STANDARD_DEVIATION 12.62 | 39.71 years STANDARD_DEVIATION 12.64 |
| Region of Enrollment Austria | 90 participants | 258 participants | 348 participants |
| Sex: Female, Male Female | 29 Participants | 96 Participants | 125 Participants |
| Sex: Female, Male Male | 61 Participants | 162 Participants | 223 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 18 / 90 | 35 / 258 |
| serious Total, serious adverse events | 1 / 90 | 10 / 258 |
Outcome results
Primary
Number of Participants Who Completed Treatment With PegIFN-2b/Ribavirin
For participants with Genotype 1 or 4 completion of treatment was at Week 48; for participants with Genotype 2, 3, or 1 with low viral load or rapid virologic response, completion of therapy was at Week 24.
Time frame: 24 to 48 weeks
Population: Participants who received at least one dose of PegIFN-2b/ribavirin
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| PegIFN-2b/Ribavirin With Substitution Therapy | Number of Participants Who Completed Treatment With PegIFN-2b/Ribavirin | 56 participants |
| PegIFN-2b/Ribavirin Without Substitution Therapy | Number of Participants Who Completed Treatment With PegIFN-2b/Ribavirin | 150 participants |
Secondary
Number of Participants Who Achieved Sustained Virologic Response (SVR)
SVR was defined as a hepatitis C virus (HCV) ribonucleic acid (RNA) value below the limit of detection by polymerase chain reaction (PCR) analysis. For participants with Genotype 1 or 4 completion of treatment was at Week 48; for participants with Genotype 2, 3, or 1 with low viral load or rapid virologic response, completion of therapy was at Week 24.
Time frame: 24 weeks after the end of treatment (i.e. 48 or 72 weeks depending on genotype)
Population: All treated participants.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| PegIFN-2b/Ribavirin With Substitution Therapy | Number of Participants Who Achieved Sustained Virologic Response (SVR) | 42 participants |
| PegIFN-2b/Ribavirin Without Substitution Therapy | Number of Participants Who Achieved Sustained Virologic Response (SVR) | 111 participants |
Secondary
Number of Participants Who Received Antiviral Treatment Who Were Also on Substitution Therapy
This measure was the number of all of the participants who received antiviral treatment who also received substitution therapy.
Time frame: Day 1
Population: Participants who received at least one dose of antiviral treatment.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| PegIFN-2b/Ribavirin With Substitution Therapy | Number of Participants Who Received Antiviral Treatment Who Were Also on Substitution Therapy | 90 participants |