An Observational Study on The Prediction of Adverse Events in Patients With Chronic Hepatitis C Receiving a Long-Acting Interferon Plus Ribavirin (GUARD-C)
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This observational study will assess factors leading to dose reductions/treatment discontinuations and the effect on sustained virological response in patients with chronic hepatitis C receiving a long-acting interferon (e.g. Pegasys/peginterferon alfa-2a) and ribavirin. Data will be collected from each patient for the duration of their treatment and for up to 6 months thereafter.
Correlation between baseline patient characteristics and safety related dose reductions/treatment discontinuations of the long-acting interferon or ribavirin [ Time Frame: 4 years ]
Correlation between safety related dose reductions/treatment discontinuations and sustained virological response (SVR: defined as HCV RNA <50 IU/mL at 24 weeks after completion of treatment) [ Time Frame: 4 years ]
Secondary Outcome Measures :
Correlation of on-treatment factors and dose reduction/treatment discontinuation [ Time Frame: 4 years ]
Correlation between degree of dose reductions/treatment interruptions (percentage of actual exposure/treatment administrations in relation to target exposure) and SVR [ Time Frame: 4 years ]
Comparison of on-treatment virological response (rapid virological response, early virological response) in treatment-naïve and treatment experienced patients [ Time Frame: 4 years ]
Safety: Incidence of adverse events [ Time Frame: 4 years ]
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Layout table for eligibility information
Ages Eligible for Study:
18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Patients with chronic hepatitis C receiving a long-acting interferon plus ribavirin
Adult patients (according to local legislation)
Chronic hepatitis C
Treatment with long-acting interferon plus ribavirin
Quantifiable HCV RNA before initiation of treatment
No contra-indications to long-acting interferon and ribavirin therapy as detailed in the label