Sofosbuvir and Ribavirin in Treatment-Naive and Treatment-Experienced Subjects With Chronic Genotype 2 or 3 HCV Infection

October 8, 2014 updated by: Gilead Sciences

A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Investigate the Efficacy and Safety of GS-7977+Ribavirin for 12 Weeks in Treatment Naive and Treatment Experienced Subjects With Chronic Genotype 2 or 3 HCV Infection.

This study will evaluate the safety, tolerability, and antiviral efficacy of GS-7977 with ribavirin (RBV) in participants with genotype 2 or 3 hepatitis C virus (HCV) infection.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

421

Phase

  • Phase 3

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

  • Austria
      • Graz, Austria, A-8036
        • Medizinische Universität Graz
      • Wien, Austria, 1090
        • Medizinische Universität Wien
      • Wien, Austria, 1160
        • Wilhelminenspital
  • Estonia
      • Tallin, Estonia, 10617
        • West Tallinn Central Hospital
      • Tartu, Estonia, 51014
        • Tartu University Hospital
  • France
      • CHRU Lille, France, 59037
        • CHRU de Lille, Hopital Claude Huriez
      • Clermont Ferrand, France, 63003
        • CHU Estaing
      • Clichy Cedex, France, 92110
        • Hopital Beaujon
      • Creteil Cedex, France, 94000
        • Hôpital Henri Mondor
      • Grenoble, France, 38043
        • Département Hépatogastroentérologie - CHU de Grenoble
      • Marseille, Cedex 8, France, 13008
        • Hopital Saint Joseph
      • Montpellier, France, 34295
        • Hopital Saint Eloi
      • Nice, France, 6202
        • Hopital de l Archet 2
      • Paris, France, 75012
        • Hopital Saint Antoine
      • Paris, France, 75013
        • Hopital Pitie Salpetriere
      • Paris, Cedex 14, France, 75679
        • Hopitaux Universitaires
      • Pessac, France, 33604
        • Groupe Hospitalier Sud - Hôpital Haut-Lévêque - USN
      • Rennes Cedex 9, France, 35033
        • CHU PONTCHAILLOU - Hématologie Clinique
      • Strasbourg, France, 67091
        • Centre Hospitalier Universitaire de Strasbourg
      • Vandoeuvre les Nancy, France, 54511
        • CHU de Nancy, Hôpital de Brabois
  • Germany
      • Berlin, Germany, 10969
        • Leber- and Studienzentrum am Checkpoint
      • Bonn, Germany, 53125
        • Universitaetsklinikum Bonn
      • Dusseldorf, Germany, 40225
        • Heinrich Heine Unversitat
      • Frankfurt am Main, Germany, 60590
        • JWG-Universität Frankfurt
      • Hamburg, Germany, 20099
        • Asklepios Klinik Sankt Georg H
      • Hamburg, Germany, 20246
        • Universitätsklinikum
      • Hannover, Germany, 30625
        • Medizinische Hochschule Hannov
      • Heidelberg, Germany, 69120
        • Medizinische Klinik IV, Dep. o
      • Herne, Germany, 44623
        • Gastroenterologische Gemeinsch
      • Kiel, Germany, 24146
        • Leberstudienzentrum Kiel
      • Leipzig, Germany, 4103
        • Universitaetsklinikum Leipzig
      • Munchen, Germany, 81377
        • Klinikum der Universität Münch
      • Münster, Germany, D-48143
        • Centrum fuer interdisziplinaere Medizin Muenster GmbH
    • Baden Wuerttemberg
      • Freiburg, Baden Wuerttemberg, Germany, 79098
        • Praxiszentrum
  • Italy
      • Bologna, Italy, 40138
        • Azienda Ospedaliera di Bologna - Policlinico S. Orsola Malpighi
      • Florence, Italy, 50011
        • Ospedale S. Annunziata
      • Genova, Italy, 16128
        • Ente Ospedaliero Ospedali Galliera
      • Milano, Italy, 20122
        • Fondazione IRCCS CA Granada - Ospedale Maggiore Policlinico
      • Milano, Italy, 20162
        • Azienda Ospedaliera Ospedale Niguarda CA Granda
      • Padova, Italy, 35100
        • University of Padova
      • Palermo, Italy, 90127
        • University of Palermo
      • Parma, Italy, 43100
        • Azienda Ospedaliero Universitaria di Parma
      • Roma, Italy, 133
        • Fondazione PTV - Policlinico Tor Vergata
      • Roma, Italy, 149
        • INMI "Lazzaro Spallanzani" I.R.C.C.S.
      • Torino, Italy, 10126
        • Azienda Ospedaliera Universitaria San Giovanni Battista di Torino
    • Foggia
      • San Giovanni Rotondo, Foggia, Italy, 71013
        • Ospedale Casa Sollievo
  • Netherlands
      • Amsterdam, Netherlands, 1105 AZ
        • Academisch Medisch Centrum
      • Leiden, Netherlands, 2300 RC
        • Leids Universitair Medisch Centrum
      • Nijmegen, Netherlands, 6500 HB
        • UMC St. Radboud - Gastroenterology
      • Rotterdam, Netherlands, 3015 CE
        • Erasmus MC
  • Poland
      • Bialystok, Poland, 15-540
        • Wojewodzki Szpital Specjalistyczny im Dluskeigo
      • Lodz, Poland, 91-347
        • Wojewodzki Specjalistyczny Szpital im. W. Bieganskiego
      • Warszawa, Poland, 01-201
        • SP ZOZ Wojewodzki Szpital Zakazny w Warszawie
      • Wroclaw, Poland, 50-349
        • NZOZ Centrum Badan Klinicznych
  • Spain
      • Barcelona, Spain, 08035
        • Hospital Universitari Vall d'H
      • Barcelona, Spain, 08036
        • Hospital Casa de la Maternidad
      • Madrid, Spain, 28046
        • Hospital Universitario La Paz
      • Madrid, Spain, 28029
        • Hospital Carlos III
      • Majadahonda, Spain, 28222
        • Hospital Puerta de Hierro Maja
      • Malaga, Spain, 29071
        • Complejo Hospitalario de Especialidades Virgen de la Victoria
      • Santander, Spain, 39008
        • Hospital Universitario Marques
      • Sevilla, Spain, 41014
        • Valme Hospital
      • Valencia, Spain, 46014
        • Hospital General Universitario de Valencia
  • Sweden
      • Göteborg, Sweden, 41685
        • Sahlgrenska University Hospital
      • Lund, Sweden, 22185
        • Skånes universitetssjukhus, Lund
      • Malmo, Sweden, 20502
        • Skanes universitetssjukhus
      • Stockholm, Sweden, 14186
        • Karolinska Instituet
  • United Kingdom
      • Bristol, United Kingdom, BS2 8HW
        • Bristol Royal Infirmary
      • London, United Kingdom, E1 2AT
        • Queen Marys University of London
      • London, United Kingdom, NW3 2PF
        • Royal Free Hospital and University College London Hospital
      • London, United Kingdom, SW109NH
        • Chelsea & Westminster Hospital
      • Nottingham, United Kingdom, NG7 2UH
        • Nottingham University Hospitals-NHS
    • Birmingham
      • Edgbaston, Birmingham, United Kingdom, B15 2TH
        • University of Birmingham
    • Hampshire
      • Southhampton, Hampshire, United Kingdom, SO41 3QP
        • Southampton University Hospital NHS Trust
    • London
      • Denmark Hill, London, United Kingdom, SE5 9RS
        • King's College Hospital
      • Paddington, London, United Kingdom, W2 1NY
        • The Liver Unit
    • Manchester
      • Crumpsall, Manchester, United Kingdom, M8 5RB
        • North Manchester General Hospital

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

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age > 18 with chronic genotype 2 or 3 HCV infection
  • HCV RNA > 10,000 IU/mL at screening
  • Subjects must be treatment naive or treatment experienced
  • Presence or absence of cirrhosis; a liver biopsy may be required
  • Healthy according to medical history and physical examination with the exception of HCV diagnosis
  • Agree to use two forms of highly effective contraception for the duration of the study and 6 months after the last dose of study medication

Exclusion Criteria:

  • Prior use of any other inhibitor of the HCV NS5B Polymerase
  • History of any other clinically significant chronic liver disease
  • Evidence of or history of decompensated liver disease
  • HIV or chronic hepatitis B virus (HBV) infection
  • Hepatocellular carcinoma (HCC) or other malignancy (with exception of certain resolved skin cancers)
  • Chronic use of immunosuppressive agents or immunomodulatory agents
  • History or current evidence of any condition, therapy, laboratory abnormality or other circumstance that might confound the results of the study, or interfere with the subject's participation for the full duration of the study or not be in the best interest of the subject in the opinion of the investigator

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

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo 12 Weeks (GT2/3)
Placebo to match SOF + weight-based RBV (1000-1200 mg as 200 mg tablets in a divided daily dose) for 12 weeks in participants with genotype 2 or 3 HCV infection.
Drug: Placebo to match SOF
Placebo to match SOF administered orally once daily
Drug: Placebo to match RBV
Placebo to match RBV administered orally in a divided daily dose
Experimental: SOF 12 Weeks (GT2/3)
Placebo to match SOF + weight-based RBV (1000-1200 mg as 200 mg tablets in a divided daily dose) for 12 weeks in participants with genotype 2 or 3 HCV infection.
Drug: SOF
Sofosbuvir (SOF) 400 mg tablet administered orally once daily
Other Names:
  • Sovaldi®
  • GS-7977
  • PSI-7977
Drug: RBV
Ribavirin (RBV) 200 mg 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)
Experimental: SOF 24 Weeks (GT3)
SOF 400 mg tablet once daily + weight-based RBV (1000-1200 mg as 200 mg tablets in a divided daily dose) for 24 weeks in participants with genotype 3 HCV infection.
Drug: SOF
Sofosbuvir (SOF) 400 mg tablet administered orally once daily
Other Names:
  • Sovaldi®
  • GS-7977
  • PSI-7977
Drug: RBV
Ribavirin (RBV) 200 mg 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants With Sustained Virologic Response 12 Weeks After Discontinuation of Therapy (SVR12)
Time Frame: Posttreatment Week 12
SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ, ie, < 25 IU/mL) 12 weeks following the last dose of study drug. Data for this outcome measure was not collected for the Placebo 12 Weeks (GT2/3) group.
Posttreatment Week 12
Adverse Events Leading to Permanent Discontinuation of Study Drug(s)
Time Frame: Up to 24 weeks
The percentage of participants experiencing an adverse event leading to permanent discontinuation of study drug(s) was analyzed.
Up to 24 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants With Sustained Virologic Response at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)
Time Frame: Posttreatment Weeks 4 and 24
SVR4 and SVR24 was defined as HCV RNA < LLOQ at 4 and 24 weeks following the last dose of study drug, respectively. Data for this outcome measure was not collected for the Placebo 12 Weeks (GT2/3) group.
Posttreatment Weeks 4 and 24
Percentage of Participants Experiencing Viral Breakthrough or Viral Relapse
Time Frame: Up to Posttreatment Week 24

Viral breakthrough was defined as having confirmed detectable HCV RNA levels (HCV RNA > LLOQ) after having previously had undetectable HCV RNA levels (HCV RNA < LLOQ) while on treatment.

Viral relapse was defined as having achieved undetectable HCV RNA levels (HCV RNA < LLOQ) at end of treatment, but did not achieve an SVR.

Data for this outcome measure was not collected for the Placebo 12 Weeks (GT2/3) group.
Up to Posttreatment Week 24

Collaborators and Investigators

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

Sponsor

Gilead Sciences

Investigators

  • Study Director: Rob Hyland, DPhil, Gilead Sciences Study Director

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

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

September 1, 2012

Primary Completion (Actual)

October 1, 2013

Study Completion (Actual)

January 1, 2014

Study Registration Dates

First Submitted

September 5, 2012

First Submitted That Met QC Criteria

September 6, 2012

First Posted (Estimate)

September 11, 2012

Study Record Updates

Last Update Posted (Estimate)

October 9, 2014

Last Update Submitted That Met QC Criteria

October 8, 2014

Last Verified

October 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GS-US-334-0133
  • 2012-001942-16 (EudraCT Number)

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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