Collection of Plasma and Serum Samples From Individuals Initiating Sofosbuvir for Chronic Hepatitis C for Testing

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

Official Title
-----------------
Collection of Plasma and Serum Samples From Individuals Initiating Therapy With Sofosbuvir for Chronic Hepatitis C Virus Infection for the Clinical Evaluation of the Aptima HCV Quant Dx Assay

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 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) Exclusion Criteria: 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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Study Population<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 12 weeks post therapy |