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
- Conditions
- Hepatitis C Virus Infection
- Interventions
- Other: Ineligible parent treatmentDrug: Other SOF-Based RegimenDrug: LDV/SOF
- Registration Number
- NCT02292706
- Lead Sponsor
- Gilead Sciences
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 1609
- 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
- 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 & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description SOF/VEL+RBV SOF/VEL Participants who were previously treated with SOF/VEL along with RBV will be followed up to 5 years. SOF/VEL/VOX 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. LDV/SOF+RBV Ribavirin Participants who were previously treated with LDV/SOF along with ribavirin will be followed up to 5 years. LDV/SOF+RBV LDV/SOF Participants who were previously treated with LDV/SOF along with ribavirin will be followed up to 5 years. LDV/SOF LDV/SOF Participants who were previously treated with ledipasvir/sofosbuvir (LDV/SOF) will be followed up to 5 years. SOF/VEL SOF/VEL Participants who were previously treated with sofosbuvir/velpatasvir (SOF/VEL) will be followed up to 5 years. Enrolled From Ineligible Parent Treatment Group Ineligible parent treatment Participants were enrolled from ineligible parent treatment group. Other SOF-Based Other SOF-Based Regimen Participants who previously received other SOF based regimen will be followed up to 5 years. SOF/VEL/VOX Ribavirin Participants who were previously treated with sofosbuvir/velpatasvir/voxilaprevir (SOF/VEL/VOX) with or without RBV will be followed up to 5 years. SOF+RBV Sofosbuvir Participants who were previously treated with sofosbuvir (SOF) along with ribavirin (RBV) will be followed up to 5 years. SOF+RBV Ribavirin Participants who were previously treated with sofosbuvir (SOF) along with ribavirin (RBV) will be followed up to 5 years. SOF/VEL+RBV Ribavirin Participants who were previously treated with SOF/VEL along with RBV will be followed up to 5 years.
- Primary Outcome Measures
Name Time Method Percentage of Participants With Any Liver-Associated Events 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.
Percentage of Participants Maintaining Sustained Virologic Response (SVR) at Week 240 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.
Percentage of Participants Who Developed Hepatocellular Carcinoma (HCC) Through Week 240 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.
- Secondary Outcome Measures
Name Time Method Number of Participants With Detectable HCV RNA Due to Re-emergence of Pre-existing Virus Through Week 240 Enrollment up to 240 weeks Number of Participants With Detectable HCV RNA Due to Re-infection Through Week 240 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.
Number of Participants With Detectable HCV Resistance Mutations Through Week 240 Enrollment up to 240 weeks
Trial Locations
- Locations (137)
Gastrointestinal Specialists of Georgia, PC
🇺🇸Marietta, Georgia, United States
North Shore Health Inc.
🇺🇸Manhasset, New York, United States
Asheville Gastroenterology Associates, PA
🇺🇸Asheville, North Carolina, United States
Thomas Jefferson University Hospital
🇺🇸Philadelphia, Pennsylvania, United States
Baylor Endocrine Center
🇺🇸Dallas, Texas, United States
St Georges University of London
🇬🇧London, England, United Kingdom
North Manchester General Hospital
🇬🇧Manchester, England, United Kingdom
Kaiser Permanente Medical Center
🇺🇸Los Angeles, California, United States
Tarrant County ID Associates
🇺🇸Los Angeles, California, United States
Hôpital Beaujon
🇫🇷Clichy, France
Hopital Henri Mondor
🇫🇷Creteil Cedex, France
CHU de Grenoble- Hopital Michallon
🇫🇷Grenoble Cedex 9, France
Azienda Ospedaliera Ospedale Niguarda Cà Granda
🇮🇹Milano, Italy
Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico
🇮🇹Milano, Italy
Northwestern University
🇺🇸Chicago, Illinois, United States
Community Research Initiative of New England
🇺🇸Boston, Massachusetts, United States
Cleveland Clinic Foundation
🇺🇸Cleveland, Ohio, United States
Harborview Medical Center
🇺🇸Seattle, Washington, United States
Indiana University
🇺🇸Indianapolis, Indiana, United States
Indianapolis Gastroenterology Research Foundation
🇺🇸Indianapolis, Indiana, United States
University of Minnesota Medical Center
🇺🇸Minneapolis, Minnesota, United States
Duke University Medical Center
🇺🇸Durham, North Carolina, United States
Orlando Immunology Center
🇺🇸Orlando, Florida, United States
University of Michigan Medical Center
🇺🇸Ann Arbor, Michigan, United States
Henry Ford Health System
🇺🇸Detroit, Michigan, United States
Mayo Clinic
🇺🇸Rochester, Minnesota, United States
Kansas City Research Institute, LLC
🇺🇸Kansas City, Missouri, United States
Hospital Virgen de Valme
🇪🇸Sevilla, Spain
Queen Alexandra Hospital
🇬🇧Portsmouth, United Kingdom
UF Hepatology Research at CTRB
🇺🇸Gainesville, Florida, United States
Minnesota Gastroenterology, PA
🇺🇸Saint Paul, Minnesota, United States
Ochsner Clinic Foundation
🇺🇸New Orleans, Louisiana, United States
Carolinas Medical Center
🇺🇸Charlotte, North Carolina, United States
The Liver Center
🇺🇸Pasadena, California, United States
University of Kansas Medical Center Research Institute, Inc.
🇺🇸Kansas City, Kansas, United States
Inland Empire Liver Foundation
🇺🇸Rialto, California, United States
Digestive Disease Associates, PA
🇺🇸Catonsville, Maryland, United States
Icahn School of Medicine at Mount Sinai
🇺🇸New York, New York, United States
Cedars Sinai Medical Center
🇺🇸Los Angeles, California, United States
Atlanta Medical Center
🇺🇸Atlanta, Georgia, United States
BIDMC Liver Center
🇺🇸Boston, Massachusetts, United States
South Florida Center of Gastroenterology
🇺🇸Wellington, Florida, United States
Johns Hopkins Hospital/University
🇺🇸Lutherville, Maryland, United States
Whitman-Walker Health
🇺🇸Washington, District of Columbia, United States
V.A. Long Beach Medical Center
🇺🇸Long Beach, California, United States
Kaiser Permanente
🇺🇸San Diego, California, United States
Quest Clinical Research
🇺🇸San Francisco, California, United States
University of Alabama at Birmingham
🇺🇸Birmingham, Alabama, United States
University of California, Davis Medical Center
🇺🇸Sacramento, California, United States
University of Colorado
🇺🇸Aurora, Colorado, United States
Tampa General Hospital
🇺🇸Tampa, Florida, United States
Atlanta Gastroenterology Associates
🇺🇸Atlanta, Georgia, United States
Emory University Hospital Midtown
🇺🇸Atlanta, Georgia, United States
Scripps Clinic Medical Group
🇺🇸La Jolla, California, United States
Medical Associates Research Group
🇺🇸San Diego, California, United States
University of Miami Miller School of Medicine
🇺🇸Miami, Florida, United States
University of California at San Francisco Medical Center
🇺🇸San Francisco, California, United States
Stanford University
🇺🇸Stanford, California, United States
Borland-Groover Clinic
🇺🇸Jacksonville, Florida, United States
Delta Research Partners
🇺🇸Monroe, Louisiana, United States
Georgetown University Medical Center
🇺🇸Washington, District of Columbia, United States
Mercy Medical Center
🇺🇸Baltimore, Maryland, United States
Columbia University Medical Center
🇺🇸New York, New York, United States
New York University Medical Center
🇺🇸New York, New York, United States
ID Care, Inc
🇺🇸Hillsborough, New Jersey, United States
Weill Cornell Medical College
🇺🇸New York, New York, United States
Southwest CARE Center
🇺🇸Santa Fe, New Mexico, United States
Binghamton Gastroenterology Associates, PC
🇺🇸Binghamton, New York, United States
Cumberland Research Associates, LLC
🇺🇸Fayetteville, North Carolina, United States
Saint Louis University
🇺🇸Saint Louis, Missouri, United States
University of Pennsylvania Health System
🇺🇸Philadelphia, Pennsylvania, United States
Royal Prince Alfred Hospital
🇦🇺Camperdown, New South Wales, Australia
St. Luke's Episcopal Hospital
🇺🇸Houston, Texas, United States
Virginia Mason Medical Center
🇺🇸Seattle, Washington, United States
Vancouver Infectious Disease Research and Care Centre
🇨🇦Vancouver, British Columbia, Canada
University Gastroenterology
🇺🇸Providence, Rhode Island, United States
Gastroenterology Center of the MidSouth, P.C.
🇺🇸Germantown, Tennessee, United States
Digestive and Liver Disease Specialists
🇺🇸Norfolk, Virginia, United States
Monash Medical Centre Clayton Campus
🇦🇺Melbourne, Victoria, Australia
Bon Secours St. Mary's Hospital of Richmond
🇺🇸Newport News, Virginia, United States
The Alfred Hospital
🇦🇺Prahran, Victoria, Australia
CRCHUM
🇨🇦Montréal, Quebec, Canada
University of Alberta
🇨🇦Edmonton, Canada
North Texas Research Institute
🇺🇸Dallas, Texas, United States
Royal Brisbane & Women's Hospital
🇦🇺Herston, Queensland, Australia
University of Pittsburgh Medical Center
🇺🇸Pittsburgh, Pennsylvania, United States
The Texas Liver Institute
🇺🇸San Antonio, Texas, United States
Nashville Gastrointestinal Specialists, Inc.
🇺🇸Nashville, Tennessee, United States
Vanderbilt University Medical Center
🇺🇸Nashville, Tennessee, United States
Intermountain Medical Center
🇺🇸Murray, Utah, United States
Royal Perth Hospital
🇦🇺Perth, Western Australia, Australia
Austin Health
🇦🇺Heidelberg, Victoria, Australia
University Health Network
🇨🇦Toronto, Ontario, Canada
The North Texas Clinical Research Institute
🇺🇸Arlington, Texas, United States
St Vincents Hospital Sydney
🇦🇺Fitzroy, Victoria, Australia
INOVA Fairfax Hospital
🇺🇸Annandale, Virginia, United States
Kirby Institute
🇦🇺Sydney, New South Wales, Australia
Westmead Hospital
🇦🇺Westmead, New South Wales, Australia
Princess Alexandra Hospital
🇦🇺Woolloongabba, Queensland, Australia
Hopital de La Pitié-Salpêtrière
🇫🇷Paris, Ile De France, France
CHU Montpellier - Hopital St. Eloi
🇫🇷Montpellier Cedex 05, Languedoc-Rousillon, France
Hôpital Universitaire Dupuytren
🇫🇷Limoges Cedex, Limousin, France
Hopital Purpan
🇫🇷Toulouse, Midi-Pyrenees, France
Hopital Saint Joseph
🇫🇷Marseille Cedex 08, Provence Alpes Cote D'Azur, France
Groupe Hospitalier Archet I Et II
🇫🇷Nice Cedex 3, Provence Alpes Cote D'Azu, France
Hopital Haut Leveque
🇫🇷Bordeaux, France
CHU Estaing
🇫🇷Clermont Ferrand, France
Hopital Cochin
🇫🇷Paris, Cedex 14, France
Hôpitaux Universitaires de Strasbourg
🇫🇷Strasbourg, France
CHU de Nancy-Hopital Brabois Adulte
🇫🇷Vandoeuvre les Nancy, France
Hôpital Paul Brousse
🇫🇷Villejuif, France
Klinikum der Johann Wolfgang Goethe Universitat
🇩🇪Frankfurt am Main, Germany
Universitatsklinikum Koln
🇩🇪Koln, Germany
Technische Universität München
🇩🇪Mücheln, Germany
London Health Sciences Centre - University Campus
🇨🇦London, Ontario, Canada
Hôpital Pontchaillou
🇫🇷Rennes, Bretagne, France
Fiona Stanley Hospital
🇦🇺Fremantle, Western Australia, Australia
Hopital Tenon
🇫🇷Paris, France
Hôpital de la Croix Rousse
🇫🇷Paris, France
Universitätsklinikum Hamburg-Eppendorf
🇩🇪Hamburg, Germany
Asklepios Klinik St. Georg
🇩🇪Hamburg, Germany
Kings College Hospital
🇬🇧London, England, United Kingdom
Ospedale Casa Sollievo Della Sofferenza IRCCS
🇮🇹San Giovanni Rotondo, Italy
Azienda Ospedaliera Città della Salute e della Scienza di Torino
🇮🇹Torino, Italy
Auckland Clinical Studies Ltd
🇳🇿Auckland, North Island, New Zealand
Waikato Hospital
🇳🇿Hamilton, North Island, New Zealand
Christchurch Hospital
🇳🇿Christchurch, South Island, New Zealand
Fundacion de Investigation de Diego
🇵🇷San Juan, Puerto Rico
Barts Health NHS Trust
🇬🇧London, England, United Kingdom
Gartnavel General Hospital
🇬🇧Glasgow, Scotland, United Kingdom
Hospital Universitario Puerta de Hierro Majadahonda
🇪🇸Majadahonda, Madrid, Spain
Nottingham University Hospitals NHS Trust
🇬🇧Nottingham, England, United Kingdom
Hospital Universitari i Politecnic La Fe de Valencia
🇪🇸Valencia, Spain
Hospital Clinic de Barcelona
🇪🇸Barcelona, Spain
Hospital Universitario Vall d'Hebron
🇪🇸Barcelona, Spain
University of Calgary
🇨🇦Calgary, Alberta, Canada
GI Research Institute
🇨🇦Vancouver, British Columbia, Canada