Treatment of Chronic Hepatitis C With Pegylated Interferon and Ribavirin in Participants With/Without Substitution Therapy (P05255)
- Conditions
- Hepatitis C, Chronic
- Interventions
- Biological: Pegylated interferon alfa-2b (PegIFN-2b)
- Registration Number
- NCT00725751
- Lead Sponsor
- Merck Sharp & Dohme LLC
- 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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 353
- Adult patients with hepatitis C
- According to the products' European labeling
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description PegIFN-2b/ribavirin without substitution therapy Pegylated interferon alfa-2b (PegIFN-2b) Participants in this cohort received antiviral treatment but did not receive substitution therapy (opioid medicines with long-lasting effects \[methadone + buprenorphine\] or morphine) PegIFN-2b/ribavirin with substitution therapy Pegylated interferon alfa-2b (PegIFN-2b) Participants in this cohort received antiviral treatment and substitution therapy (opioid medicines with long-lasting effects \[methadone + buprenorphine\] or morphine) PegIFN-2b/ribavirin with substitution therapy Ribavirin Participants in this cohort received antiviral treatment and substitution therapy (opioid medicines with long-lasting effects \[methadone + buprenorphine\] or morphine) PegIFN-2b/ribavirin without substitution therapy Ribavirin Participants in this cohort received antiviral treatment but did not receive substitution therapy (opioid medicines with long-lasting effects \[methadone + buprenorphine\] or morphine)
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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.