Post-marketing Surveillance Study of Ex-intravenous Drug Abusers With Chronic Hepatitis C Treated With PegIntron Plus Rebetol (P04408/MK-4031-261)

Study Overview
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Brief Summary
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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.

Official Title
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Quality Assurance of HCV-therapy With PegIntron® Plus Rebetol® in Drug-substituted Patients - SUPPORT Project Post-Marketing Surveillance Study

Conditions
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Hepatitis C, Chronic, Substance Abuse, Intravenous

Intervention / Treatment
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* Biological: PegIntron (pegylated interferon alfa-2b; SCH 54031)
* Drug: Rebetol (ribavirin; SCH 18908)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| PegIntron + Rebetol<br>There will be a distinction between the patients depending on the type of substitution drug used (secondary parameters). | Biological: PegIntron (pegylated interferon alfa-2b; SCH 54031)<br>* 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<br>* Other names: SCH 54031;Drug: Rebetol (ribavirin; SCH 18908)<br>* 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<br>* Other names: SCH 18908;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | End of Follow-up (Week 48 or Week 72, depending on genotype) | 
| 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. | Assessed at the end of treatment |