Post-marketing Surveillance of HIV-infected Patients With Chronic Hepatitis C Treated With PegIntron Pen and Rebetol (Study P04584)
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|ClinicalTrials.gov Identifier: NCT00736242|
Recruitment Status : Completed
First Posted : August 15, 2008
Results First Posted : April 8, 2013
Last Update Posted : February 19, 2015
|Condition or disease||Intervention/treatment|
|Chronic Hepatitis C Hepatitis C HIV Infections||Biological: PEG-IFN alfa-2b Drug: RBV|
|Study Type :||Observational|
|Actual Enrollment :||232 participants|
|Official Title:||Treatment of Chronic Hepatitis C in HIV-infected Patients With PegIntron Pen and Rebetol According to German Law (§ 67 Abs 6 AMG)|
|Study Start Date :||December 2005|
|Actual Primary Completion Date :||December 2011|
|Actual Study Completion Date :||December 2011|
PEG-IFN alfa-2b + RBV
Participants received a combination of PEG-IFN alfa-2b plus RBV according to routine clinical practice and locally-approved product recommendations for a minimum of 12 weeks. No investigational medicinal product was provided by the sponsor.
Biological: PEG-IFN alfa-2b
Peginterferon alfa-2b administered subcutaneously at a dose 1.5 ug/kg/week, according to the European Medicines Agency (EMEA)-approved labeling
Ribavirin administered at a dose of 800-1200 mg/day (on a weight-basis) according to the EMEA-approved labeling
- Number of Participants With Sustained Virologic Response (SVR) [ Time Frame: From End of Treatment to 24 weeks post-treatment (up to 72 weeks) ]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 ]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 ]
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) ]
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) ]
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) ]
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) ]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). ]
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.