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).
Study Type
OBSERVATIONAL
Enrollment
353
PegIFN-2b administered according to European labeling.
Ribavirin administered according to European labeling.
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
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)
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
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