Hepatitis C, Chronic, Substance Abuse, Intravenous
Conditions
Brief summary
Previous intravenous drug abusers with chronic hepatitis C who are under substitution therapy (buprenorphine, methadone) will be treated with PegIntron and Rebetol according to the approved European labeling. The study will assess the tolerability, safety and efficacy of the treatment with PegIntron plus Rebetol in this study population. The objective of the study is to collect data on the prevalence of the hepatitis C infections in drug-substituted patients. The study will also compare the feasibility of HCV (Hepatitis C Virus) treatment in patients receiving Subutex® vs other drug substitution pharmacotherapies.
Interventions
BIOLOGICALPegIntron (pegylated interferon alfa-2b; SCH 54031)
PegIntron 1.5 μg/kg/week administered for a minimum of 12 weeks. Patients who achieve early virologic response at Treatment Week 12, will continue PegIntron therapy for a total of 24 weeks for subjects infected with HCV genotype 2 or 3, and for a total of 48 weeks for subjects infected with HCV genotype 1 or 4
Rebetol administered at 10.6 mg/kg/day for a minimum of 12 weeks. Patients who achieve early virologic response at Treatment Week 12, will continue Rebetol therapy for a total of 24 weeks for subjects infected with HCV genotype 2 or 3, and for a total of 48 weeks for subjects infected with HCV genotype 1 or 4
Sponsors
Merck Sharp & Dohme LLC
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Treatment-naïve participants or relapsers to interferon monotherapy * Participants with chronic hepatitis C infection * At least 18 years of age * Must meet the following laboratory criteria: * Platelets \>=100,000/mm\^3 * Neutrophil count \>=1,500/mm\^3 * TSH (thyroid stimulating hormone) within normal limits * Hemoglobin \>=12 g/dL (females); \>=13 g/dL (males) * Ex-intravenous drug abusers who are under stable substitution therapy * Women of childbearing potential must practice adequate contraception and have a routine pregnancy test performed monthly during treatment and for 7 months post-treatment. * Sexually-active participants must be practicing acceptable methods of contraception during the treatment and for 7 months post-treatment
Exclusion criteria
* Any contraindications specified in the SPC (Summary of Product Characteristics) and approved European labeling * Hypersensitivity to the active substance or to any interferons or to any of the excipients * Pregnant women * Women who are breast-feeding * Existence of or history of severe psychiatric condition, in particular severe depression, suicidal ideation or suicide attempt * A history of severe pre-existing cardiac disease, including unstable or uncontrolled cardiac disease in the previous 6 months * Severe debilitating medical conditions, including participants with chronic renal failure or creatinine clearance \<50 mL/min * Coinfection with HIV (Human Immunodeficiency Virus) * Autoimmune hepatitis or history of autoimmune disease * Severe hepatic dysfunction or decompensated cirrhosis of the liver * Pre-existing thyroid disease unless it can be controlled with conventional therapy * Epilepsy and/or compromised central nervous system function
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Drug-substituted Participants Who Achieved Sustained Virological Response (SVR) With PegIntron 1.5 μg/kg/Week and Rebetol (10.6 mg/kg/Day) in Substitution Centers Under Routine Conditions | End of Follow-up (Week 48 or Week 72, depending on genotype) | Participants who achieved SVR (sustained virological response) at the end of treatment (24 weeks for genotypes 2,3 and 48 weeks for genotypes 1,4) were analyzed for sustained response at the end of the follow-up period (24 weeks after end of treatment). SVR is defined as having negative HCV-RNA (hepatitis C virus ribonucleic acid). |
| Number of Participants Who Tolerated Treatment With PegIntron 1.5 mcg/kg/Week + Rebetol 10.6 mg/kg/Week | Assessed at the end of treatment | Tolerability of the treatment was measured by number of participants with complete treatment. |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| PegIntron + Rebetol Baseline measures only available for the 118 participants who completed. | 246 |
| Total | 246 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Inclusion criteria not met | 15 |
| Overall Study | No end of treatment documentation | 37 |
| Overall Study | No follow-up documentation available | 55 |
| Overall Study | Screening failure | 4 |
| Overall Study | Treatment less than 3 months | 17 |
Baseline characteristics
| Characteristic | PegIntron + Rebetol |
|---|---|
| Age, Continuous | 36.64 years STANDARD_DEVIATION 8.39 |
| Region of Enrollment Germany | 246 participants |
| Sex/Gender, Customized Female | 35 participants |
| Sex/Gender, Customized Male | 83 participants |
| Sex/Gender, Customized Unavailable | 128 participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 0 |
| serious Total, serious adverse events | 4 / 246 |
Outcome results
Primary
Number of Drug-substituted Participants Who Achieved Sustained Virological Response (SVR) With PegIntron 1.5 μg/kg/Week and Rebetol (10.6 mg/kg/Day) in Substitution Centers Under Routine Conditions
Participants who achieved SVR (sustained virological response) at the end of treatment (24 weeks for genotypes 2,3 and 48 weeks for genotypes 1,4) were analyzed for sustained response at the end of the follow-up period (24 weeks after end of treatment). SVR is defined as having negative HCV-RNA (hepatitis C virus ribonucleic acid).
Time frame: End of Follow-up (Week 48 or Week 72, depending on genotype)
Population: Participants who achieved SVR at the end of treatment (24 weeks for genotypes 2,3 and 48 weeks for genotypes 1,4)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Participants With Negative HCV-RNA at End of Treatment | Number of Drug-substituted Participants Who Achieved Sustained Virological Response (SVR) With PegIntron 1.5 μg/kg/Week and Rebetol (10.6 mg/kg/Day) in Substitution Centers Under Routine Conditions | Opioid substitution with methadone (n=52) | 49 Participants |
| Participants With Negative HCV-RNA at End of Treatment | Number of Drug-substituted Participants Who Achieved Sustained Virological Response (SVR) With PegIntron 1.5 μg/kg/Week and Rebetol (10.6 mg/kg/Day) in Substitution Centers Under Routine Conditions | Opioid substitution with levo-methadone (n=13) | 10 Participants |
| Participants With Negative HCV-RNA at End of Treatment | Number of Drug-substituted Participants Who Achieved Sustained Virological Response (SVR) With PegIntron 1.5 μg/kg/Week and Rebetol (10.6 mg/kg/Day) in Substitution Centers Under Routine Conditions | No opioid substitution medication (n=9) | 9 Participants |
| Participants With Negative HCV-RNA at End of Treatment | Number of Drug-substituted Participants Who Achieved Sustained Virological Response (SVR) With PegIntron 1.5 μg/kg/Week and Rebetol (10.6 mg/kg/Day) in Substitution Centers Under Routine Conditions | Opioid substitution with buprenorphine (n=26) | 23 Participants |
| Participants With Negative HCV-RNA at End of Treatment | Number of Drug-substituted Participants Who Achieved Sustained Virological Response (SVR) With PegIntron 1.5 μg/kg/Week and Rebetol (10.6 mg/kg/Day) in Substitution Centers Under Routine Conditions | Opioid substitution with other medication (n=1) | 0 Participants |
Primary
Number of Participants Who Tolerated Treatment With PegIntron 1.5 mcg/kg/Week + Rebetol 10.6 mg/kg/Week
Tolerability of the treatment was measured by number of participants with complete treatment.
Time frame: Assessed at the end of treatment
Population: All enrolled participants
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Participants With Negative HCV-RNA at End of Treatment | Number of Participants Who Tolerated Treatment With PegIntron 1.5 mcg/kg/Week + Rebetol 10.6 mg/kg/Week | 118 participants |