This non-interventional clinical study will be conducted to prospectively collect serial plasma and serum samples from treatment naïve subjects with chronic HCV infection who are initiating sofosbuvir-based therapy. These samples will be used to estimate clinical utility endpoints for the Aptima HCV Quant Dx assay which is used an aid in the management of HCV-infected patients undergoing HCV antiviral therapy.
Study Type
OBSERVATIONAL
Enrollment
352
Sustained viral response based on lower limit of quantitation
Sustained viral response (SVR) is defined as viral load level being below the investigational assay's lower limit of quantitation.
Time frame: 12 weeks post therapy
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