An Observational Study of Peginterferon Alfa-2a Plus Ribavirin for Hepatitis C Virus (HCV) Infection in Austria

Study Overview
=================
Brief Summary
-----------------
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.

Official Title
-----------------
A Non-Interventional Trial of Pegasys/Copegus in HCV Patients for 12 Months

Conditions
-----------------
Hepatitis C

Intervention / Treatment
-----------------
* Drug: Peginterferon alfa-2a
* Drug: Ribavirin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Ongoing treatment with peginterferon alfa-2a and ribavirin at the discretion of the prescribing physician HCV infection Exclusion Criteria: None specified
Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Participants With Hepatitis C<br>All participants were treated with Peginterferon alfa-2a+Ribavirin (Pegasys/Copegus) according to the summary of product characteristics and to the investigator's discretion. The daily recommended dose for Pegasys, for the treatment of chronic Hepatitis C, was 180 micrograms once weekly by subcutaneous administration. Copegus was administered orally in doses according to the physician's decision (depending on the participant's weight and genotype). All participants were observed for 12 months. | Drug: Peginterferon alfa-2a<br>* 180 micrograms subcutaneous weekly for 48 weeks.<br>* Other names: Pegasys;Drug: Ribavirin<br>* 1000-1600 mg day orally for 48 weeks.<br>* Other names: Copegus;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | 18 months |