A Registry for Participants With Cirrhosis Who Achieve a Sustained Virologic Response Following Treatment With a Sofosbuvir-Based Regimen Without Interferon for Chronic Hepatitis C Infection

December 2, 2022 updated by: Gilead Sciences

A Registry for Subjects With Cirrhosis Who Achieve a Sustained Virologic Response Following Treatment With a Sofosbuvir-Based Regimen Without Interferon for Chronic Hepatitis C Infection

The primary objective of this registry study is to assess the durability of sustained virologic response (SVR) and clinical progression or regression of liver disease including the incidence of hepatocellular carcinoma following SVR in participants with cirrhosis after treatment with a sofosbuvir-based regimen for HCV infection.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

1609

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • New South Wales
      • Camperdown, New South Wales, Australia
        • Royal Prince Alfred Hospital
      • Sydney, New South Wales, Australia
        • Kirby Institute
      • Westmead, New South Wales, Australia
        • Westmead Hospital
    • Queensland
      • Herston, Queensland, Australia
        • Royal Brisbane & Women's Hospital
      • Woolloongabba, Queensland, Australia
        • Princess Alexandra Hospital
    • Victoria
      • Fitzroy, Victoria, Australia
        • St Vincents Hospital Sydney
      • Heidelberg, Victoria, Australia, 3084
        • Austin Health
      • Melbourne, Victoria, Australia
        • Monash Medical Centre Clayton Campus
      • Prahran, Victoria, Australia
        • The Alfred Hospital
    • Western Australia
      • Fremantle, Western Australia, Australia
        • Fiona Stanley Hospital
      • Perth, Western Australia, Australia
        • Royal Perth Hospital
  • Canada
      • Edmonton, Canada, T6G 2B7
        • University of Alberta
    • Alberta
      • Calgary, Alberta, Canada
        • University of Calgary
    • British Columbia
      • Vancouver, British Columbia, Canada
        • GI Research Institute
      • Vancouver, British Columbia, Canada
        • Vancouver Infectious Disease Research and Care Centre
    • Ontario
      • London, Ontario, Canada
        • London Health Sciences Centre - University Campus
      • Toronto, Ontario, Canada
        • University Health Network
    • Quebec
      • Montréal, Quebec, Canada
        • CRCHUM
  • France
      • Bordeaux, France
        • Hôpital Haut Lévêque
      • Clermont Ferrand, France
        • CHU Estaing
      • Clichy, France
        • Hopital Beaujon
      • Creteil Cedex, France
        • Hôpital Henri Mondor
      • Grenoble Cedex 9, France
        • CHU de Grenoble- Hopital Michallon
      • Paris, France
        • Hopital Tenon
      • Paris, France
        • Hôpital de La Croix Rousse
      • Paris, Cedex 14, France
        • Hôpital Cochin
      • Strasbourg, France
        • Hôpitaux Universitaires de Strasbourg
      • Vandoeuvre les Nancy, France
        • CHU de Nancy-Hopital Brabois Adulte
      • Villejuif, France
        • Hopital Paul Brousse
    • Bretagne
      • Rennes, Bretagne, France
        • Hôpital Pontchaillou
    • Ile De France
      • Paris, Ile De France, France
        • Hôpital de la Pitié-Salpêtrière
    • Languedoc-Rousillon
      • Montpellier Cedex 05, Languedoc-Rousillon, France
        • CHU Montpellier - Hopital St. Eloi
    • Limousin
      • Limoges Cedex, Limousin, France
        • Hôpital Universitaire Dupuytren
    • Midi-Pyrenees
      • Toulouse, Midi-Pyrenees, France
        • Hôpital Purpan
    • Provence Alpes Cote D'Azu
      • Nice Cedex 3, Provence Alpes Cote D'Azu, France, 06202
        • Groupe Hospitalier Archet I Et II
    • Provence Alpes Cote D'Azur
      • Marseille Cedex 08, Provence Alpes Cote D'Azur, France
        • Hopital Saint Joseph
  • Germany
      • Frankfurt am Main, Germany
        • Klinikum der Johann Wolfgang Goethe Universitat
      • Hamburg, Germany, 20251
        • Universitätsklinikum Hamburg-Eppendorf
      • Hamburg, Germany
        • Asklepios Klinik St. Georg
      • Koln, Germany
        • Universitätsklinikum Köln
      • Mücheln, Germany
        • Technische Universität München
  • Italy
      • Milano, Italy
        • Azienda Ospedaliera Ospedale Niguarda CA Granda
      • Milano, Italy
        • Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico
      • San Giovanni Rotondo, Italy
        • Ospedale Casa Sollievo Della Sofferenza IRCCS
      • Torino, Italy
        • Azienda Ospedaliera Citta Della Salute E Della Scienza Di Torino
  • New Zealand
    • North Island
      • Auckland, North Island, New Zealand
        • Auckland Clinical Studies Ltd
      • Hamilton, North Island, New Zealand
        • Waikato Hospital
    • South Island
      • Christchurch, South Island, New Zealand
        • Christchurch Hospital
  • Puerto Rico
      • San Juan, Puerto Rico, 00927
        • Fundacion de Investigation de Diego
  • Spain
      • Barcelona, Spain, 08035
        • Hospital Universitario Vall d'Hebron
      • Barcelona, Spain, 08028
        • Hospital Clínic de Barcelona
      • Sevilla, Spain
        • Hospital Virgen de Valme
      • Valencia, Spain
        • Hospital Universitari i Politecnic La Fe de Valencia
    • Madrid
      • Majadahonda, Madrid, Spain
        • Hospital Universitario Puerta de Hierro Majadahonda
  • United Kingdom
      • Portsmouth, United Kingdom
        • Queen Alexandra Hospital
    • England
      • London, England, United Kingdom
        • Barts Health NHS Trust
      • London, England, United Kingdom
        • Kings College Hospital
      • London, England, United Kingdom
        • St Georges University of London
      • Manchester, England, United Kingdom
        • North Manchester General Hospital
      • Nottingham, England, United Kingdom
        • Nottingham University Hospitals NHS Trust
    • Scotland
      • Glasgow, Scotland, United Kingdom
        • Gartnavel General Hospital
  • United States
    • Alabama
      • Birmingham, Alabama, United States
        • University of Alabama at Birmingham
    • California
      • La Jolla, California, United States
        • Scripps Clinic Medical Group
      • Long Beach, California, United States
        • V.A. Long Beach Medical Center
      • Los Angeles, California, United States
        • Cedars Sinai Medical Center
      • Los Angeles, California, United States
        • Kaiser Permanente Medical Center
      • Los Angeles, California, United States
        • Tarrant County ID Associates
      • Pasadena, California, United States
        • The Liver Center
      • Rialto, California, United States
        • Inland Empire Liver Foundation
      • Sacramento, California, United States
        • University of California, Davis Medical Center
      • San Diego, California, United States
        • Kaiser Permanente
      • San Diego, California, United States
        • Medical Associates Research Group
      • San Francisco, California, United States
        • Quest Clinical Research
      • San Francisco, California, United States
        • University of California at San Francisco Medical Center
      • Stanford, California, United States
        • Stanford University
    • Colorado
      • Aurora, Colorado, United States
        • University of Colorado
    • District of Columbia
      • Washington, District of Columbia, United States
        • Georgetown University Medical Center
      • Washington, District of Columbia, United States
        • Whitman-Walker Health
    • Florida
      • Gainesville, Florida, United States
        • UF Hepatology Research at CTRB
      • Jacksonville, Florida, United States
        • Borland-Groover Clinic
      • Miami, Florida, United States
        • University of Miami Miller School of Medicine
      • Orlando, Florida, United States
        • Orlando Immunology Center
      • Tampa, Florida, United States
        • Tampa General Hospital
      • Wellington, Florida, United States
        • South Florida Center of Gastroenterology
    • Georgia
      • Atlanta, Georgia, United States
        • Atlanta Gastroenterology Associates
      • Atlanta, Georgia, United States
        • Atlanta Medical Center
      • Atlanta, Georgia, United States
        • Emory University Hospital Midtown
      • Marietta, Georgia, United States
        • Gastrointestinal Specialists of Georgia, PC
    • Illinois
      • Chicago, Illinois, United States
        • Northwestern University
    • Indiana
      • Indianapolis, Indiana, United States
        • Indiana University
      • Indianapolis, Indiana, United States
        • Indianapolis Gastroenterology Research Foundation
    • Kansas
      • Kansas City, Kansas, United States
        • University of Kansas Medical Center Research Institute, Inc.
    • Louisiana
      • Monroe, Louisiana, United States
        • Delta Research Partners
      • New Orleans, Louisiana, United States
        • Ochsner Clinic Foundation
    • Maryland
      • Baltimore, Maryland, United States
        • Mercy Medical Center
      • Catonsville, Maryland, United States
        • Digestive Disease Associates, PA
      • Lutherville, Maryland, United States
        • Johns Hopkins Hospital/University
    • Massachusetts
      • Boston, Massachusetts, United States, 02129
        • Community Research Initiative of New England
      • Boston, Massachusetts, United States, 02215
        • BIDMC Liver Center
    • Michigan
      • Ann Arbor, Michigan, United States
        • University of Michigan Medical Center
      • Detroit, Michigan, United States
        • Henry Ford Health System
    • Minnesota
      • Minneapolis, Minnesota, United States
        • University of Minnesota Medical Center
      • Rochester, Minnesota, United States
        • Mayo Clinic
      • Saint Paul, Minnesota, United States
        • Minnesota Gastroenterology, PA
    • Missouri
      • Kansas City, Missouri, United States
        • Kansas City Research Institute, LLC
      • Saint Louis, Missouri, United States
        • Saint Louis University
    • New Jersey
      • Hillsborough, New Jersey, United States, 08844
        • ID Care, Inc
    • New Mexico
      • Santa Fe, New Mexico, United States
        • Southwest CARE Center
    • New York
      • Binghamton, New York, United States
        • Binghamton Gastroenterology Associates, PC
      • Manhasset, New York, United States
        • North Shore Health Inc.
      • New York, New York, United States
        • Columbia University Medical Center
      • New York, New York, United States
        • Icahn School of Medicine at Mount Sinai
      • New York, New York, United States
        • New York University Medical Center
      • New York, New York, United States
        • Weill Cornell Medical College
    • North Carolina
      • Asheville, North Carolina, United States
        • Asheville Gastroenterology Associates, PA
      • Charlotte, North Carolina, United States
        • Carolinas Medical Center
      • Durham, North Carolina, United States
        • Duke University Medical Center
      • Fayetteville, North Carolina, United States
        • Cumberland Research Associates, LLC
    • Ohio
      • Cleveland, Ohio, United States
        • Cleveland Clinic Foundation
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States
        • Thomas Jefferson University Hospital
      • Philadelphia, Pennsylvania, United States
        • University of Pennsylvania Health System
      • Philadelphia, Pennsylvania, United States
        • University of Pittsburgh Medical Center
      • Pittsburgh, Pennsylvania, United States
        • University of Pittsburgh Medical Center
    • Rhode Island
      • Providence, Rhode Island, United States, 02905
        • University Gastroenterology
    • Tennessee
      • Germantown, Tennessee, United States
        • Gastroenterology Center of the Midsouth, P.C.
      • Nashville, Tennessee, United States
        • Vanderbilt University Medical Center
      • Nashville, Tennessee, United States
        • Nashville Gastrointestinal Specialists, Inc.
    • Texas
      • Arlington, Texas, United States
        • The North Texas Clinical Research Institute
      • Dallas, Texas, United States
        • Baylor Endocrine Center
      • Dallas, Texas, United States
        • North Texas Research Institute
      • Houston, Texas, United States
        • St. Luke's Episcopal Hospital
      • San Antonio, Texas, United States
        • The Texas Liver Institute
    • Utah
      • Murray, Utah, United States
        • Intermountain Medical Center
    • Virginia
      • Annandale, Virginia, United States
        • Inova Fairfax Hospital
      • Newport News, Virginia, United States
        • Bon Secours St. Mary's Hospital of Richmond
      • Norfolk, Virginia, United States
        • Digestive and Liver Disease Specialists
    • Washington
      • Seattle, Washington, United States
        • Harborview Medical Center
      • Seattle, Washington, United States
        • Virginia Mason Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Participants with cirrhosis who have achieved an SVR after receiving a SOF-based regimen without interferon (IFN) while participating in a Gilead-sponsored HCV study. In addition, participants with cirrhosis who have achieved SVR after an all-oral SOF-based regimen outside a clinical study may be eligible to enroll in this registry at sites preselected by Gilead.

Description

Key Inclusion Criteria:

  • Willing and able to provide written informed consent
  • Have either previously participated in a Gilead-sponsored HCV study and received a sofosbuvir-containing regimen without interferon OR at pre-selected sites only, have received an all-oral SOF-based regimen outside a clinical study. These individuals must have documentation of the regimen, start and end of treatment dates (month and year), and of having achieved SVR12.
  • Have achieved SVR either in a Gilead-sponsored study, as defined in the treatment protocol OR for individuals who enroll after receiving an all-oral SOF-based regimen outside a clinical study, SVR will be defined as HCV RNA < lower limit of quantification (LLOQ) approximately 12 weeks following last dose of treatment.
  • Have liver cirrhosis, as defined in the treatment protocol, and have not had a liver transplant after receiving a SOF-containing regimen OR individuals who enroll after receiving an all-oral SOF-based regimen outside a clinical study, will have had cirrhosis confirmed prior to initiation of HCV treatment.

Key Exclusion Criteria:

  • Individuals planning to initiate a new course of HCV therapy, including approved products and any investigational agents, during the course of this Registry
  • History of clinically-significant illness or any other major medical disorder that may interfere with the follow-up, assessments, or compliance with the protocol

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
SOF+RBV
Participants who were previously treated with sofosbuvir (SOF) along with ribavirin (RBV) will be followed up to 5 years.
Drug: Ribavirin
Drug: Sofosbuvir
Exposure of interest for participants who received sofosbuvir in a previous Gilead study for chronic HCV infection.
Other Names:
  • Sovaldi®
  • GS-7977
  • PSI-7977
LDV/SOF
Participants who were previously treated with ledipasvir/sofosbuvir (LDV/SOF) will be followed up to 5 years.
Drug: LDV/SOF
Exposure of interest for participants who received LDV/SOF in a previous Gilead study for chronic HCV infection.
Other Names:
  • Harvoni®
LDV/SOF+RBV
Participants who were previously treated with LDV/SOF along with ribavirin will be followed up to 5 years.
Drug: Ribavirin
Drug: LDV/SOF
Exposure of interest for participants who received LDV/SOF in a previous Gilead study for chronic HCV infection.
Other Names:
  • Harvoni®
SOF/VEL
Participants who were previously treated with sofosbuvir/velpatasvir (SOF/VEL) will be followed up to 5 years.
Drug: SOF/VEL
Exposure of interest for participants who received SOF/VEL in a previous Gilead study for chronic HCV infection.
Other Names:
  • Epclusa®
SOF/VEL+RBV
Participants who were previously treated with SOF/VEL along with RBV will be followed up to 5 years.
Drug: Ribavirin
Drug: SOF/VEL
Exposure of interest for participants who received SOF/VEL in a previous Gilead study for chronic HCV infection.
Other Names:
  • Epclusa®
SOF/VEL/VOX
Participants who were previously treated with sofosbuvir/velpatasvir/voxilaprevir (SOF/VEL/VOX) with or without RBV will be followed up to 5 years.
Drug: Ribavirin
Drug: SOF/VEL/VOX
Exposure of interest for participants who received SOF/VEL/VOX in a previous Gilead study for chronic HCV infection.
Other Names:
  • Vosevi®
Other SOF-Based
Participants who previously received other SOF based regimen will be followed up to 5 years.
Drug: Other SOF-Based Regimen

The other SOF-based regimens may have included the following:

  • BMS-790052 (Daclatasvir) + GS-7977 (SOF) with or without RBV
  • LDV/SOF + GS-9669, GS-7977 (SOF) + with or without RBV + TMC-435 (Simeprevir)
  • LDV/SOF + Vedroprevir (VDV), LDV/SOF + GS-9669 (250 mg and 500 mg)
  • LDV/SOF + VDV + RBV
  • Simeprevir + SOF
  • TMC-435 (Simeprevir) + VEL/SOF
Enrolled From Ineligible Parent Treatment Group
Participants were enrolled from ineligible parent treatment group.
Other: Ineligible parent treatment
Participants were enrolled from ineligible parent treatment group.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants Maintaining Sustained Virologic Response (SVR) at Week 240
Time Frame: Week 240
SVR at Week 240 was defined as HCV RNA< lower limit of quantification (LLOQ i.e., 15 or 25 international units per milliliter [IU/mL]) or last available HCV RNA< LLOQ with no subsequent follow-up values at Week 240 after enrollment in this registry study. Percentage of participants who maintained SVR status by Week 240 was estimated using a Kaplan-Meier model.
Week 240
Percentage of Participants With Any Liver-Associated Events
Time Frame: Enrollment up to 240 weeks
The percentage of participants with any liver-associated events since registry start (enrollment) through Week 240 was estimated using a Kaplan-Meier model.
Enrollment up to 240 weeks
Percentage of Participants Who Developed Hepatocellular Carcinoma (HCC) Through Week 240
Time Frame: Enrollment up to 240 weeks
Participants with de novo HCC since registry start were defined as participants who had not been identified with HCC prior to registry start and only had HCC since registry start. The percentage of participants who developed de novo HCC through Week 240 was estimated using a Kaplan-Meier model.
Enrollment up to 240 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With Detectable HCV RNA Due to Re-emergence of Pre-existing Virus Through Week 240
Time Frame: Enrollment up to 240 weeks
Enrollment up to 240 weeks
Number of Participants With Detectable HCV Resistance Mutations Through Week 240
Time Frame: Enrollment up to 240 weeks
Enrollment up to 240 weeks
Number of Participants With Detectable HCV RNA Due to Re-infection Through Week 240
Time Frame: Enrollment up to 240 weeks
Reinfection was defined as HCV RNA > LLOQ on 2 samples collected at least 1 week apart with a different virus than that present prior to treatment baseline in the parent study.
Enrollment up to 240 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Gilead Sciences

Investigators

  • Study Director: Gilead Study Director, Gilead Sciences

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 29, 2014

Primary Completion (Actual)

December 31, 2021

Study Completion (Actual)

December 31, 2021

Study Registration Dates

First Submitted

November 13, 2014

First Submitted That Met QC Criteria

November 13, 2014

First Posted (Estimated)

November 17, 2014

Study Record Updates

Last Update Posted (Actual)

October 4, 2023

Last Update Submitted That Met QC Criteria

December 2, 2022

Last Verified

December 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GS-US-337-1431
  • 2014-001249-26 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Qualified external researchers may request IPD for this study after study completion. For more information, please visit our website at https://www.gileadclinicaltrials.com/transparency-policy/

IPD Sharing Time Frame

18 months after study completion

IPD Sharing Access Criteria

A secured external environment with username, password, and RSA code.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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