This noninterventional, open-label study will observe the safety and tolerability of peginterferon alfa-2a in combination with ribavirin among Austrian participants treated for HCV infection according to routine practice.
Study Type
OBSERVATIONAL
Enrollment
463
180 micrograms subcutaneous weekly for 48 weeks.
1000-1600 mg day orally for 48 weeks.
A.Ö. Krankenhaus Der Barmherzigen Schwestern Ried; Interne Abtl.
Ried-innkreis, Austria
Percentage of Participants With Serious Adverse Events (SAEs) and Adverse Events (AEs)
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability or incapacity; and congenital anomaly. Percentage of participants with AEs included participants affected with both SAEs and non-SAEs.
Time frame: Up to 6 years
Percentage of Participants With End of Treatment Response
Clinical response to the treatment was measured by qualitative negative polymerase chain reaction (PCR). A participant was considered to have and end of treatment response if there was undetectable Hepatitis C Virus (HCV) ribonucleic acid (RNA) after completing treatment. Participants with available PCR results were reported.
Time frame: 12 months
Percentage of Participants With Sustained Virologic Response 24 (SVR24)
Clinical response to the treatment was measured by qualitative negative polymerase chain reaction (PCR). SVR24 is defined as the percentage of participants with undetectable HCV RNA 24 weeks after completing treatment.
Time frame: 18 months
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