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

• Number of Participants With Sustained Virologic Response (SVR) [ Time Frame: From End of Treatment to 24 weeks post-treatment (up to 72 weeks) ] [ Designated as safety issue: No ]
  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).
  
  

• Number of Participants With Rapid Virologic Response (RVR) [ Time Frame: At Treatment Week 4 ] [ Designated as safety issue: No ]
  RVR was defined as undetectable serum HCV-RNA at week 4.
  
  
• Number of Participants With Early Virologic Response (EVR) [ Time Frame: From Treatment Week 1 to Treatment Week 12 ] [ Designated as safety issue: No ]

  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.

  
  
• Participant Study Status at End of Follow-up (EOF) [ Time Frame: From EOT to EOF (up to 72 weeks) ] [ Designated as safety issue: No ]

  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.

  
  
• Number of Participants With Hepatitis C Virus (HCV)-RNA Negativity During PEG-IFN Alfa-2b/RBV Treatment [ Time Frame: From the Baseline Visit up to EOF (up to 72 weeks) ] [ Designated as safety issue: No ]

  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.

  
  
• Number of Participants With Human Immunodeficiency Virus (HIV)-RNA Negativity During PEG-IFN Alfa-2b/RBV Treatment [ Time Frame: From the Baseline Visit up to EOF (up to 72 weeks) ] [ Designated as safety issue: No ]

  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

  
  
• Median Cluster of Differentiation 4 (CD4) Cell Count During PEG-IFN Alfa-2b/RBV Treatment [ Time Frame: From the Baseline Visit up to EOF (up to 72 weeks) ] [ Designated as safety issue: No ]
  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.
  
  
• Number of Participants With A Serious Adverse Event (SAE) During PEG-IFN Alfa-2b/RBV Treatment [ Time Frame: From First Participant Visit (12/30/2005) up to 30 days after Last Participant Visit (12/31/2011). ] [ Designated as safety issue: Yes ]
  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.
  
  

In this observational, non-interventional study, the time of enrollment and start of treatment was the sole decision of the physician. No investigational medicinal product was provided by the sponsor.