Open-Label Study of Sofusbuvir+Ribavirin With or Without Peginterferon Alfa-2a in Subjects With Chronic HCV Infection Who Participated in Prior Gilead HCV Studies

An Open-Label Study of GS-7977 + Ribavirin With or Without Peginterferon Alfa-2a in Subjects With Chronic HCV Infection Who Participated in Prior Gilead HCV Studies

This study will evaluate the efficacy, safety, and tolerability of sofosbuvir (SOF; GS-7977) in combination with ribavirin (RBV) with or without pegylated interferon (Peg-IFN) in adults with chronic hepatitis C virus (HCV) infection who participated in a prior Gilead HCV study and have not achieved sustained virologic response (SVR).

Study Overview

• Status: Completed
• Conditions: Chronic Hepatitis C
• Intervention / Treatment: Drug: RBV; Drug: SOF; Drug: Peg-IFN

• Study Type: Interventional
• Enrollment (Actual): 534
• Phase: Phase 3

Contacts and Locations

Study Locations

• Australia
  • Australian Capital Territory, Australia, 2605
    • Canberra Hospital
  • Fitzroy, Australia, 3065
    • St. Vincent's Hospital
  • Herston, Australia, QLD 4029
    • Royal Brisbane & Women's Hospital
  • Kogarah, Australia, 2217
    • St George Hospital
  • NSW, Australia, 2050
    • Royal Prince Alfred Hospital, Camperdown
  • Perth Western Australia, Australia, 6000
    • Royal Perth Hospital
  • State of Queensland, Australia, 4102
    • Princess Alexandra Hospital
  • Victoria, Australia, 3128
    • Box Hill Hospital
  • New South Wales
    • Concord, New South Wales, Australia, 2139
      • Concord Repatriation General Hospital
    • Westmead, New South Wales, Australia, 2145
      • Westmead Hospital
  • Queensland
    • Greenslopes, Queensland, Australia, 4120
      • Gallipoli Medical Research Foundation
  • South Australia
    • Adelaide, South Australia, Australia, 5000
      • Royal Adelaide Hospital
  • Victoria
    • Heidelberg, Victoria, Australia, 3084
      • Austin Hospital
    • Melbourne, Victoria, Australia, 3168
      • Monash Medical Centre
  • Western Australia
    • Fremantle, Western Australia, Australia, 6160
      • B2 Clinic
• Austria
  • Graz, Austria, 8036
    • Medizinische Universitat Graz
  • Vienna, Austria, 1090
    • Medizinische Universitat Wien
  • Wien, Austria, 1160
    • Wilhelminenspital
• Canada
  • Vancouver, Canada, BC V5Z 1M9
    • Gordon & Leslie Diamond Health Care Centre
  • Alberta
    • Calgary, Alberta, Canada, T2N 4Z6
      • University of Calgary
    • Edmonton, Alberta, Canada, T6G 2B7
      • University of Alberta Hospital
  • British Columbia
    • Vancouver, British Columbia, Canada, V6Z 2C7
      • Vancouver Infectious Disease Research and Care Centre
    • Vancouver, British Columbia, Canada, V6Z 2K5
      • Gastrointestinal Research Institute (GIRI)
  • Manitoba
    • Winnipeg, Manitoba, Canada, R3A1R9
      • John Buhler Research Center
  • Ontario
    • Toronto, Ontario, Canada, M5T 2S8
      • Toronto Western Hospital
    • Toronto, Ontario, Canada, M6H 3M1
      • Toronto Liver Centre
    • Toronto, Ontario, Canada, M5G 1X5
      • Mount Sinai Hospital
    • Toronto, Ontario, Canada, M5G 2C4
      • Toronto Western Hospital
    • Vaughan, Ontario, Canada, L4L 4Y7
      • Toronto Digestive Diseases Associates, Inc
  • Quebec
    • Montreal, Quebec, Canada, H2X 3J4
      • Hopital St. Luc
• Czech Republic
  • Praha 4, Czech Republic
    • Remedis s.r.o., Nestátní zdravotnické zarízení
• Estonia
  • Tallinn, Estonia, 10617
    • West Tallinn Central Hospital
  • Tartu, Estonia, 51014
    • Tartu University Hospital
• France
  • Clermont-Ferrand, France, 63003
    • CHU Estaing
  • Clermont-Ferrand, France, 63003
    • Centre Hospitalier Universitaire de Clermont-Ferrand
  • Clichy, France, 92110
    • Hôpital Beaujon
  • Creteil Cedex, France, 94010
    • Hopital Henri Mondor
  • Lille, France, 59037
    • Hôpital Claude Huriez- Service d'Hépato-Gastroentérologie
  • Marseille, France, 13285
    • Hopital Saint Joseph
  • Montpellier, France, 34295
    • Hopital Saint Eloi
  • Nice, France, 06200
    • Service Hepatologie
  • Paris Cedex 12, France, 75571
    • Hopital Saint-Antoine
  • Paris Cedex 13, France, 75651
    • Groupe Hospitalier Pitie-Salpetriere
  • Pessac Cedex, France, 33604
    • Hôpital Haut-Lévêque, CHU Bordeaux
  • Rennes Cedex 9, France, 35033
    • Centre Hospitalier Universitare de Rennes, Hôpital Pontchaillou
  • Strasbourg, France, 67091
    • Centre Hospitalier Universitaire de Strasbourg
  • Vandoeuvre-les-Nancy, France, 54511
    • Hopital de I'Archet 2
• Germany
  • Berlin, Germany, 10969
    • Leber- und Studienzentrum am Checkpoint
  • Berlin, Germany, 13353
    • Campus Virchow Klinikum
  • Bonn, Germany, 53127
    • Universitätsklinikum Bonn
  • Düsseldorf, Germany, 40225
    • Universitatsklinikum Dusseldorf
  • Frankfurt am Main, Germany, 60590
    • Klinikum und Fachbereich Medizin Johann Wolfgang Goethe-Universität Frankfurt am Main
  • Freiburg im Breisgau, Germany, 79098
    • PraxisZentrum für Gastroenterologie und Endokrinologie
  • Hamburg, Germany, 20246
    • Universitatsklinikum Hamburg Eppendorf
  • Hamburg, Germany, 20099
    • Asklepios Klinik Sankt Georg Hamburg
  • Hannover, Germany, 30625
    • Medizinische Hochschule Hannover
  • Heidelberg, Germany, 69120
    • Medizinische Universitätsklinik IV (Krehl Klinik) Abt. Gastroenterologie und Infektionskrankheiten
  • Herne, Germany, 44623
    • Gastroenterologische Gemeinschaftspraxis
  • Kiel, Germany, 24146
    • Leberstudienzentrum Kiel
  • Leipzig, Germany, 04103
    • Universitätsklinikum Leipzig
  • Muenster, Germany, 48143
    • Centrum fur Interdisziplinare Medizin
  • Munich, Germany, 81377
    • Klinikum der Universität München
  • Wurzburg, Germany, 97080
    • Universitatsklinikum Wurzburg
• Italy
  • Florence, Italy, 50011
    • Ospedale S. Annunziata
  • Genoa, Italy, 16128
    • Ente Ospedaliero Ospedali Galliera di Genova
  • Milan, Italy, 20162
    • Azienda Ospedaliera Ospedale Niguarda Ca' Granda
  • Milano, Italy, 20122
    • Fondazione IRCCS CA Granada - Ospedale Maggiore Policlinico
  • Padova, Italy, 35128
    • Azienda Ospedaliera de Padova
  • Parma, Italy, 43126
    • Azienda Ospedaliero Universitaria di Parma
  • Roma, Italy, 00133
    • Fondazione PTV - Policlinico Tor Vergata
  • Rome, Italy, 00149
    • I.N.M.I L. Spallanzani IRCCS
  • Turin, Italy, 10126
    • Azienda Ospedaliero Universitaria S. Giovanni Battista di Torino
  • Foggia
    • San Giovanni Rotonda, Foggia, Italy, 71013
      • Casa Sollievo della Sofferenza Hospital
• Netherlands
  • Amsterdam, Netherlands, 1105 AZ
    • Academisch Medisch Centrum
  • Nijmegen, Netherlands, 6525 GA
    • Radboud University Nijmegen Medical Centre (UMC St Radboud)
  • Rotterdam, Netherlands, 3015 CE
    • Academic Hospital Rotterdam Erasmus Medical Center
• New Zealand
  • Auckland, New Zealand, 11142
    • Auckland City Hospital
  • Christchurch, New Zealand, 8011
    • Christchurch Hospital
  • Dunedin, New Zealand, 9016
    • Dunedin Hospital
  • Hamilton, New Zealand, 3240
    • Waikato Hospital
  • Auckland
    • Grafton, Auckland, New Zealand, 1010
      • Auckland Clinical Studies
  • BOP
    • Tauranga, BOP, New Zealand, 3143
      • Tauranga Hospital
  • WGN
    • Newtown, WGN, New Zealand, 6021
      • Wellington Hospital
• Poland
  • Bialystok, Poland, 15-540
    • Klinika Chorob Zakaznych i Hep
  • Chorzow, Poland, 41-500
    • Oddzial Kliniczny Chorob Zakaznych
  • Lodz, Poland, 91-347
    • WSSzpital im.Dr.Wj.Bieganskieg
  • Myslowice, Poland, 41-400
    • ID Clinic
  • Warsaw, Poland, 01-201
    • Sp Zoz Wojewódzki Szpital
• Puerto Rico
  • San Juan, Puerto Rico, 927
    • Fundacion de Investigacion de Diego
• Spain
  • Barcelona, Spain, 8035
    • Hospital Vall d'Hebron
  • Barcelona, Spain, 08036
    • Hospital Casa de la Maternidad
  • Madrid, Spain, 28029
    • Hospital Carlos III
  • Majadahonda, Spain, 28220
    • Hospital Puerta de Hierro Majadahonda
  • Malaga, Spain, 29010
    • Hospital Clínico Universitario Virgen de la Victoria
  • Sevilla, Spain, 41014
    • Hospital Universitario Nuestra Señora de Valme
  • Valencia, Spain, 46010
    • Hospital General Universitario de Valencia
• Sweden
  • Göteborg, Sweden, 41685
    • Sahlgrenska University Hospital
  • Malmo, Sweden, 20502
    • Skånes Universitetssjukhus, Malmö
  • Stockholm, Sweden, 141 86
    • Karolinska University Hospital Huddinge
• United Kingdom
  • Birmingham, United Kingdom, B15 2TH
    • University of Birmingham
  • Hampshire, United Kingdom, SO16 6YD
    • Southampton University Hospital
  • London, United Kingdom, SE5 9RS
    • King's College Hospital
  • London, United Kingdom, SW10 9NH
    • Chelsea and Westminster Hospital NHS Foundation Trust
  • London, United Kingdom, E1 1BB
    • London Royal Hospital, GHU
  • London, United Kingdom, UK NW3 2QG
    • Royal Free Hospital and University College London Hospital
  • Manchester, United Kingdom, M8 5RB
    • North Manchester General Hospital
  • Nottingham, United Kingdom, NG7 2UH
    • Nottingham University Hospitals-NHS
  • London
    • Paddington, London, United Kingdom, W2 1NY
      • The Liver Unit
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35294
      • University of Alabama at Birmingham
  • California
    • Bakersfield, California, United States, 93301
      • Franco Felizarta, MD
    • Colton, California, United States, 92324
      • Arrowhead Regional Medical Center
    • Coronado, California, United States, 92118
      • Southern California Transplantation Institute, Research Foundation Liver Center
    • La Mesa, California, United States, 91942
      • eStudy Site
    • Los Angeles, California, United States, 90027
      • Kaiser Permanente
    • Los Angeles, California, United States, 90048
      • California Liver Institute
    • Los Angeles, California, United States, 90069
      • Anthony Mills MD, Inc.
    • Los Angeles, California, United States, 90036
      • Lightsource Medical/Peter J. Ruane MD, Inc.
    • Oceanside, California, United States, 92056
      • eStudySite
    • Sacramento, California, United States, 95817
      • University of California Davis Medical Center
    • San Diego, California, United States, 92123
      • Medical Associates Research Group
    • San Diego, California, United States, 92103
      • University of California
    • San Diego, California, United States, 92154
      • Kaiser Permanente
    • San Diego, California, United States, 92105
      • Resarch and Education, Inc.
    • San Francisco, California, United States, 94115
      • Quest Clinical Research
  • Colorado
    • Aurora, Colorado, United States, 80045
      • University of Colorado Hospital
    • Englewood, Colorado, United States, 80113
      • South Denver Gastroenterology, PC
  • District of Columbia
    • Washington, District of Columbia, United States, 20009
      • Whitman-Walker Health
  • Florida
    • Bradenton, Florida, United States, 34209
      • Pointe West Infectious Diseases d/b/a Bach and Godofsky Infectious Diseases
    • Gainesville, Florida, United States, 32610
      • University of Florida
    • Jacksonville, Florida, United States, 32256
      • Borland-Groover Clinic
    • Miami, Florida, United States, 33136
      • University of Miami Center for Liver Diseases
    • Orlando, Florida, United States, 32803
      • Orlando Immunology Center
    • Orlando, Florida, United States, 32806
      • Internal Medicine Specialists
    • Trinity, Florida, United States, 34655
      • Advanced Research Institute
    • Wellington, Florida, United States, 33414
      • South Florida Center of Gastroenterology, PA.
  • Georgia
    • Atlanta, Georgia, United States, 30309
      • Digestive Healthcare of Georgia
    • Atlanta, Georgia, United States, 30308
      • Atlanta Gastroenterology Associates, LLC
    • Marietta, Georgia, United States, 30060
      • Gastointestinal Specialists of Georgia, PC
  • Indiana
    • Indianapolis, Indiana, United States, 46237
      • Indianapolis Gastroenterology Research Foundation
  • Maryland
    • Baltimore, Maryland, United States, 21229
      • Digestive Disease Associates, PA
    • Lutherville, Maryland, United States, 21093
      • Johns Hopkins University
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • Beth Israel Deaconess Medical Center
    • Boston, Massachusetts, United States, 02114
      • Massachusetts General Hospital
    • Springfield, Massachusetts, United States, 01105
      • Infectious Disease and The Research Institute
  • Michigan
    • Detroit, Michigan, United States, 48202
      • Henry Ford Health System
    • Novi, Michigan, United States, 48377
      • Orlando Clinical
  • Minnesota
    • St. Paul, Minnesota, United States, 55114
      • Minnesota Gastroenterology, P.A.
  • Missouri
    • Kansas City, Missouri, United States, 64131
      • Kansas City Gastroenterology and Hepatology
  • New Jersey
    • Hillsborough, New Jersey, United States, 08844
      • ID Care, Inc.
    • Township, New Jersey, United States, 08234
      • AGA Clinical Research Associates, LLC
    • Vineland, New Jersey, United States, 08360
      • The Gastroenterology Group of South Jersey
  • New York
    • Binghamton, New York, United States, 13903
      • Binghamton Gastroenterology Associates, PC
    • Manhasset, New York, United States, 11030
      • North Shore University Hospital
    • New York, New York, United States, 10029
      • Mount Sinai School of Medicine
    • New York, New York, United States, 10021
      • Weill Cornell Medical College
  • North Carolina
    • Asheville, North Carolina, United States, 28801
      • Clinical Study Center of Asheville, LLC
    • Chapel Hill, North Carolina, United States, 27599
      • University of North Carolina
    • Durham, North Carolina, United States, 27710
      • Duke University Medical Center
    • Statesville, North Carolina, United States, 28677
      • Carolinas Center For Liver Disease
    • Winston Salem, North Carolina, United States, 27103
      • Digestive Health Specialists, PA
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Hospital of the University of Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15261
      • University of Pittsburgh
  • Rhode Island
    • Providence, Rhode Island, United States, 02905
      • University Gastroenterology
  • Tennessee
    • Germantown, Tennessee, United States, 38138
      • Gastro One
    • Germantown, Tennessee, United States, 38138
      • Memphis Gastroenterology Group, PC
    • Nashville, Tennessee, United States, 37211
      • Nashville Medical Research Institute
  • Texas
    • Arlington, Texas, United States, 76012
      • Texas Clinical Research Institute, LLC
    • Dallas, Texas, United States, 75246
      • Annette C. and Harold C. Simmons Transplant Center
    • Houston, Texas, United States, 77030
      • Research Specialists of Texas
    • San Antonio, Texas, United States, 78215
      • Alamo Medical Research
  • Virginia
    • Fairfax, Virginia, United States, 22031
      • Metropolitan Research
    • Falls Church, Virginia, United States, 22042
      • Inova Fairfax Hospital
    • Newport News, Virginia, United States, 23602
      • Bon Secours Saint Mary's Hospital of Richmond
    • Norfolk, Virginia, United States, 23502
      • Digestive and Liver Disease Specialists
  • Washington
    • Seattle, Washington, United States, 98111
      • Virginia Mason Medical Center

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

• Infection with HCV
• Must have participated in a prior Gilead HCV study
• Use of highly effective contraception methods if female of childbearing potential or sexually active male

• Eligible patients include those in the following

  • received placebo or Peg-IFN+RBV in a control arm

  • previously participated in a Gilead-sponsored HCV study and did not attain sustained virologic response 24 weeks after discontinuation of therapy (SVR24) on a regimen containing:

    • Sofosbuvir+RBV
    • Peg-IFN and/or RBV in combination with one or more Gilead investigational direct-acting agents

Exclusion Criteria:

• Pregnant or nursing female or male with pregnant female partner
• Current or prior history of clinical hepatic decompensation
• Infection with hepatitis B virus (HBV) or human immunodeficiency virus (HIV)
• Chronic use of systemically administered immunosuppressive agents
• Active drug abuse
• Use of any prohibited concomitant medications

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: SOF+RBV 24 Weeks; SOF+RBV for 24 weeks	Drug: RBV; RBV tablets administered orally in a divided daily dose according to package insert weight-based dosing recommendations (< 75 kg = 1000 mg and ≥ 75 kg = 1200 mg); Drug: SOF; SOF 400 mg tablet administered orally once daily; Other Names: Sovaldi®; GS-7977; PSI-7977
Experimental: SOF+RBV 12 Weeks; SOF+RBV for 12 weeks	Drug: RBV; RBV tablets administered orally in a divided daily dose according to package insert weight-based dosing recommendations (< 75 kg = 1000 mg and ≥ 75 kg = 1200 mg); Drug: SOF; SOF 400 mg tablet administered orally once daily; Other Names: Sovaldi®; GS-7977; PSI-7977
Experimental: SOF+RBV+Peg-IFN 12 Weeks; SOF+RBV+Peg-IFN for 12 weeks	Drug: RBV; RBV tablets administered orally in a divided daily dose according to package insert weight-based dosing recommendations (< 75 kg = 1000 mg and ≥ 75 kg = 1200 mg); Drug: SOF; SOF 400 mg tablet administered orally once daily; Other Names: Sovaldi®; GS-7977; PSI-7977; Drug: Peg-IFN; Peg-IFN 180 μg administered once weekly by subcutaneous injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event		Up to 24 weeks
Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12)	SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ; ie, 25 IU/mL) at 12 weeks after stopping study treatment.	Posttreatment Week 12

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants With SVR at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)	SVR4 and SVR 24 were defined as HCV RNA < LLOQ at 4 and 24 weeks after stopping study treatment, respectively.	Posttreatment Weeks 4 and 24
Percentage of Participants With On-treatment Virologic Failure	On-treatment virologic failure was defined as; Breakthrough (confirmed HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ while on treatment), or; Rebound (confirmed > 1 log10 IU/mL increase in HCV RNA from nadir while on treatment), or; Non-response (HCV RNA persistently ≥ LLOQ through 8 weeks of treatment)	Up to 24 weeks
Percentage of Participants With Viral Relapse	Viral relapse was defined as HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA < LLOQ at end of treatment, confirmed with 2 consecutive values or last available posttreatment measurement.	Up to Posttreatment Week 24

Collaborators and Investigators

• Sponsor: Gilead Sciences

Study record dates

Study Major Dates

• Study Start: June 1, 2012
• Primary Completion (Actual): October 1, 2014
• Study Completion (Actual): December 1, 2014

Study Registration Dates

• First Submitted: June 7, 2012
• First Submitted That Met QC Criteria: June 19, 2012
• First Posted (Estimate): June 21, 2012

Study Record Updates

• Last Update Posted (Estimate): November 9, 2015
• Last Update Submitted That Met QC Criteria: October 9, 2015
• Last Verified: October 1, 2015

More Information

Terms related to this study

• Keywords: HCV; Sustained Virologic Response; Combination Therapy; Ribavirin; Open Label; Direct Acting Antiviral; GS-7977; HCV genotype 3 (GT-3); HCV genotype 2 (GT-2)
• 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; Hepatitis, Chronic; Hepatitis; Hepatitis C; Hepatitis C, Chronic; Anti-Infective Agents; Antiviral Agents; Sofosbuvir
• Other Study ID Numbers: GS-US-334-0109; 2012-000571-16 (EudraCT Number)