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

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

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 Overview

• Status: Completed
• Conditions: Hepatitis C

• Study Type: Observational
• Enrollment (Actual): 352

Contacts and Locations

Study Locations

• Puerto Rico
  • San Juan, Puerto Rico, 00927
    • Fundacion De Investigacion de Diego
• United States
  • Arkansas
    • North Little Rock, Arkansas, United States, 72117
      • Arkansas Gastroenterology
  • California
    • Bakersfield, California, United States, 93301
      • Franco Felizarta, MD
    • Rialto, California, United States, 92377
      • Inland Empire Liver Foundation
    • San Francisco, California, United States, 94118
      • Kaiser Permanente
    • Upland, California, United States, 91786
      • Empire Clinical Research
    • Ventura, California, United States, 93003
      • Island View Gastroenterology
  • Colorado
    • Englewood, Colorado, United States, 80113
      • South Denver Gastroenterology, PC
  • Connecticut
    • New Haven, Connecticut, United States, 06510
      • Yale School of Medicine
  • Florida
    • Miami, Florida, United States, 33136
      • Schiff Center for Liver Disease
  • Georgia
    • Atlanta, Georgia, United States, 30308
      • Atlanta Gastroenterology Associates
    • Marietta, Georgia, United States, 30060
      • Gastrointestinal Specialists of Georgia
  • Indiana
    • Indianapolis, Indiana, United States, 46237
      • Indianapolis Gastroenterology Research Facility
  • Maryland
    • Annapolis, Maryland, United States, 21401
      • Investigative Clinical Research
    • Baltimore, Maryland, United States, 21202
      • Mercy Medical Center
  • Massachusetts
    • Brockton, Massachusetts, United States, 02302
      • Commonwealth Clinical Studies
    • Springfield, Massachusetts, United States, 01105
      • The Research Institute
  • Missouri
    • Kansas City, Missouri, United States, 64131
      • Kansas City Gastroenterology
  • North Carolina
    • Asheville, North Carolina, United States, 28801
      • Asheville Gastroenterology Associates, PA
    • Durham, North Carolina, United States, 27710
      • Duke University Medical Center
    • Fayetteville, North Carolina, United States, 28304
      • Cumberland Research Associates, LLC
  • Oklahoma
    • Tulsa, Oklahoma, United States, 74104
      • Options Health Research, LLC
  • South Carolina
    • Charleston, South Carolina, United States, 29414
      • Charleston GI Specialists
  • Tennessee
    • Nashville, Tennessee, United States, 37205
      • Nashville Medical Research Institute
    • Nashville, Tennessee, United States, 37211
      • Quality Medical Research, PLLC
  • Texas
    • Austin, Texas, United States, 78705
      • Central Texas Clinical Research
    • Austin, Texas, United States, 78756
      • Austin Center for Clinical Research
    • Houston, Texas, United States, 77030
      • Research Specialists of Texas
    • Houston, Texas, United States, 77030
      • Liver Associates of Texas, P.A.
    • Houston, Texas, United States, 77004
      • Cure C Consortium
    • San Antonio, Texas, United States, 78215
      • The Texas Liver Institute
  • Virginia
    • Lynchburg, Virginia, United States, 24501
      • Infectious Diseases Associates of Central Virginia
    • Norfolk, Virginia, United States, 23502
      • Digestive and Liver Disease Specialists
  • Washington
    • Seattle, Washington, United States, 98104
      • University of Washington

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Study Population

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

Collaborators and Investigators

• Sponsor: Hologic, Inc.
• Investigators: Study Director: Christine Kuslich, Hologic, Inc.

Study record dates

Study Major Dates

• Study Start: February 1, 2014
• Primary Completion (Actual): April 1, 2015
• Study Completion (Actual): December 1, 2015

Study Registration Dates

• First Submitted: February 14, 2014
• First Submitted That Met QC Criteria: February 20, 2014
• First Posted (Estimate): February 21, 2014

Study Record Updates

• Last Update Posted (Estimate): February 4, 2016
• Last Update Submitted That Met QC Criteria: February 2, 2016
• Last Verified: February 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Liver Diseases; Flaviviridae Infections; Hepatitis, Viral, Human; Enterovirus Infections; Picornaviridae Infections; Hepatitis, Chronic; Hepatitis; Hepatitis A; Hepatitis C; Hepatitis C, Chronic
• Other Study ID Numbers: P10433-HCVQPS-01