Collection of Plasma and Serum Samples From Individuals Initiating Sofosbuvir for Chronic Hepatitis C for Testing
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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.
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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:
Treatment naïve men and women ≥18 years of age with chronic HCV infection initiating sofosbuvir-based treatment will be enrolled from medical facilities that may include private and academic family practice, infectious disease, hepatology, gastroenterology, and medical group clinics.
The subject is chronically infected with HCV genotypes 1, 2, 3, 4, 5, and/or 6 as documented in the subject's medical records and is naïve to HCV treatment (treatment naïve).
Chronic HCV (with or without HIV [human immunodeficiency virus] co-infection) will be documented with historical record of:
A positive HCV RNA test result (result generated at least 6 months before the baseline visit)
A HCV genotype test result (result generated at least 6 months before the baseline visit)
A liver biopsy report demonstrating chronic HCV
---The subject is initiating antiviral therapy with a sofosbuvir regimen as indicated below:
Sofosbuvir plus peginterferon and ribavirin for 12 weeks (peginterferon eligible genotype 1, 4, 5, or 6)
Sofosbuvir plus ribavirin for 12 weeks (genotype 2)
Sofosbuvir plus ribavirin for 24 weeks (peginterferon ineligible or unwilling genotype 1 or genotype 3)
The subject is at least 18 years of age at the time of enrollment
Adequate medical records are available for collection of protocol-defined demographics, baseline patient characteristics, medical history, virology and specific laboratory results, and other information to verify enrollment criteria
The subject and/or legally authorized representative is willing and able to provide consent prior to providing a specimen(s)
Subjects with history or evidence of decompensated liver disease
Subjects with severe renal impairment or end stage renal disease
Subjects who are not naïve to HCV therapy with prior exposure to an approved or experimental HCV antiviral therapy
Subject has characteristics that are contraindicated in the FDA approved label for sofosbuvir (eg, subjects with contraindications applicable to peginterferon and/or ribavirin, pregnant woman or men whose female partners are pregnant; Sovaldi Package Insert 2013)
Subject is receiving treatment pre- or post-transplant
Subject is unsuitable for study participation based on the Investigator's decision (eg, unlikely to comply with study visit schedule, significant medical complication)
Participating in another investigational study that the Investigator believes might interfere with the subject's participation in this study