Post-marketing Surveillance of HIV-infected Patients With Chronic Hepatitis C Treated With PegIntron Pen and Rebetol (Study P04584)

SVR was defined as undetectable serum Hepatitis C Virus ribonucleic acid (HCV-RNA) at End of Treatment (EOT) and at the End of Follow-up (EOF).

Time frame: From End of Treatment to 24 weeks post-treatment (up to 72 weeks)

Population: Analysis was performed on all participants in the Efficacy Analysis Set (all participants with HCV-RNA detectable for ≥6 months before the first application of PEG-IFN alfa-2b, Human Immunodeficiency Virus \[HIV\] co-infection, and who had received any amount of PEG-IFN alfa-2b) with documented visits at EOT or at follow-up 24 weeks after EOT.

The CD4 helper T cell count was used to assess participant HIV status and was determined in the laboratory at baseline and during the study course.

Time frame: From the Baseline Visit up to EOF (up to 72 weeks)

Population: Analysis was performed on all participants in the Efficacy Analysis Set (all participants with HCV-RNA detectable for at least 6 months before the first application of PEG-IFN alfa-2b, HIV co-infection, and who had received any amount of PEG-IFN alfa-2b) with data available.

An SAE was any adverse drug/biologic/device experience occurring at any dose that resulted in death, was life-threatening (i.e. placed the participant, in the view of the initial reporter, at immediate risk of death from the AE as it occurred), was a persistent or significant disability/incapacity, required in-patient hospitalization, or prolonged hospitalization, or led to a congenital anomaly or birth defect.

Time frame: From First Participant Visit (12/30/2005) up to 30 days after Last Participant Visit (12/31/2011).

Population: Safety Analysis Set: All participants who received any amount of PEG-IFN alfa-2b. If the application of any PEG-IFN alfa-2b was not certain, the participant was considered part of this set. Participants who were not treated with PEG-IFN alfa-2b were also included in this set providing they did not violate any inclusion or exclusion criterion.

EVR was defined as undetectable serum HCV-RNA at week 12 and/or a ≥2 log decline in HCV-RNA levels at week 12 from baseline.

Time frame: From Treatment Week 1 to Treatment Week 12

Population: Analysis was performed on all participants in the Efficacy Analysis Set (all participants with HCV-RNA detectable for at least 6 months before the first application of PEG-IFN alfa-2b, HIV co-infection, and who had received any amount of PEG-IFN alfa-2b) with a documented visit at Treatment Week 12.

HCV-RNA negativity/positivity was documented at baseline in the medical history (anamnesis), and assessed within the laboratory (lab) at baseline and during treatment by Polymerase Chain Reaction (PCR). HCV-RNA (+) = HCV-RNA positive, HCV-RNA (-) = HCV-RNA negative, HCV-RNA Missing = HCV-RNA data not documented, not applicable, not known, not examined, or missing.

Time frame: From the Baseline Visit up to EOF (up to 72 weeks)

Population: Efficacy Analysis Set: all participants with HCV-RNA detectable for at least 6 months before the first application of PEG-IFN alfa-2b, HIV co-infection, and who had received any amount of PEG-IFN alfa-2b.

HIV-RNA negativity/positivity was documented at baseline in the medical history (anamnesis), and assessed within the laboratory (lab) at baseline and during treatment. HIV-RNA (+) = HIV-RNA positive, HIV-RNA (-) = HIV-RNA negative, HIV-RNA Missing = HIV-RNA data not documented, not applicable, not known, not examined, or missing

Time frame: From the Baseline Visit up to EOF (up to 72 weeks)

Population: Efficacy Analysis Set: all participants with HCV-RNA detectable for at least 6 months before the first application of PEG-IFN alfa-2b, HIV co-infection, and who had received any amount of PEG-IFN alfa-2b.

RVR was defined as undetectable serum HCV-RNA at week 4.

Time frame: At Treatment Week 4

Population: Analysis was performed on all participants in the Efficacy Analysis Set (all participants with HCV-RNA detectable for at least 6 months before the first application of PEG-IFN alfa-2b, HIV co-infection, and who had received any amount of PEG-IFN alfa-2b) with a documented visit at Treatment Week 4

Participant study status was assessed at the End of Follow-up (defined as 24 weeks after the end of treatment) based on serum levels of HCV-RNA. SVR was defined as defined as undetectable serum HCV-RNA at EOT and EOF, Relapse was defined as undetectable HCV-RNA at EOT with detectable HCV-RNA at EOF, and Non-response was defined as a detectable serum HCV-RNA at EOT.

Time frame: From EOT to EOF (up to 72 weeks)

Population: Analysis was performed on all participants in the Efficacy Analysis Set (all participants with HCV-RNA detectable for at least 6 months before the first application of PEG-IFN alfa-2b, with HIV co-infection, and who had received any amount of PEG-IFN alfa-2b) with documented visits at EOT or at follow-up 24 weeks after EOT.