Sofosbuvir and Ribavirin in Treatment-Naive and Treatment-Experienced Subjects With Chronic Genotype 2 or 3 HCV Infection
- Conditions
- Hepatitis C
- Interventions
- Registration Number
- NCT01682720
- Lead Sponsor
- Gilead Sciences
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 421
- 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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo 12 Weeks (GT2/3) Placebo to match SOF 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. SOF 24 Weeks (GT3) SOF 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. SOF 24 Weeks (GT3) RBV 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. Placebo 12 Weeks (GT2/3) Placebo to match RBV 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. SOF 12 Weeks (GT2/3) SOF 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. SOF 12 Weeks (GT2/3) RBV 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.
- Primary Outcome Measures
Name Time Method Percentage of Participants With Sustained Virologic Response 12 Weeks After Discontinuation of Therapy (SVR12) 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.
Adverse Events Leading to Permanent Discontinuation of Study Drug(s) Up to 24 weeks The percentage of participants experiencing an adverse event leading to permanent discontinuation of study drug(s) was analyzed.
- Secondary Outcome Measures
Name Time Method Percentage of Participants With Sustained Virologic Response at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24) 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.
Percentage of Participants Experiencing Viral Breakthrough or Viral Relapse 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.
Trial Locations
- Locations (77)
Centrum fuer interdisziplinaere Medizin Muenster GmbH
🇩🇪Münster, Germany
Universitatsklinikum
🇩🇪Hamburg, Germany
Wilhelminenspital
🇦🇹Wien, Austria
West Tallinn Central Hospital
🇪🇪Tallin, Estonia
Ospedale Casa Sollievo
🇮🇹San Giovanni Rotondo, Foggia, Italy
Leids Universitair Medisch Centrum
🇳🇱Leiden, Netherlands
Wojewodzki Specjalistyczny Szpital im. W. Bieganskiego
🇵🇱Lodz, Poland
SP ZOZ Wojewodzki Szpital Zakazny w Warszawie
🇵🇱Warszawa, Poland
Southampton University Hospital NHS Trust
🇬🇧Southhampton, Hampshire, United Kingdom
Medizinische Universitat Graz
🇦🇹Graz, Austria
Medizinische Universitat Wien
🇦🇹Wien, Austria
Azienda Ospedaliera di Bologna - Policlinico S. Orsola Malpighi
🇮🇹Bologna, Italy
Hopital de l Archet 2
🇫🇷Nice, France
Hopital Saint Antoine
🇫🇷Paris, France
Asklepios Klinik Sankt Georg H
🇩🇪Hamburg, Germany
Universitaetsklinikum Leipzig
🇩🇪Leipzig, Germany
CHU Estaing
🇫🇷Clermont Ferrand, France
Hopital Beaujon
🇫🇷Clichy Cedex, France
Hopital Saint Eloi
🇫🇷Montpellier, France
Leberstudienzentrum Kiel
🇩🇪Kiel, Germany
Universitaetsklinikum Bonn
🇩🇪Bonn, Germany
JWG-Universität Frankfurt
🇩🇪Frankfurt am Main, Germany
Hopital Saint Joseph
🇫🇷Marseille, Cedex 8, France
Centre Hospitalier Universitaire de Strasbourg
🇫🇷Strasbourg, France
Hopital Pitie Salpetriere
🇫🇷Paris, France
Gastroenterologische Gemeinsch
🇩🇪Herne, Germany
Klinikum der Universität Münch
🇩🇪Munchen, Germany
Tartu University Hospital
🇪🇪Tartu, Estonia
Academisch Medisch Centrum
🇳🇱Amsterdam, Netherlands
Wojewodzki Szpital Specjalistyczny im Dluskeigo
🇵🇱Bialystok, Poland
Karolinska Instituet
🇸🇪Stockholm, Sweden
CHRU de Lille, Hopital Claude Huriez
🇫🇷CHRU Lille, France
Département Hépatogastroentérologie - CHU de Grenoble
🇫🇷Grenoble, France
Hopitaux Universitaires
🇫🇷Paris, Cedex 14, France
Medizinische Klinik IV, Dep. o
🇩🇪Heidelberg, Germany
INMI "Lazzaro Spallanzani" I.R.C.C.S.
🇮🇹Roma, Italy
Heinrich Heine Unversitat
🇩🇪Dusseldorf, Germany
Royal Free Hospital and University College London Hospital
🇬🇧London, United Kingdom
Ospedale S. Annunziata
🇮🇹Florence, Italy
Fondazione IRCCS CA Granada - Ospedale Maggiore Policlinico
🇮🇹Milano, Italy
Azienda Ospedaliera Ospedale Niguarda Cà Granda
🇮🇹Milano, Italy
Sahlgrenska University Hospital
🇸🇪Göteborg, Sweden
Azienda Ospedaliera Universitaria San Giovanni Battista di Torino
🇮🇹Torino, Italy
University of Birmingham
🇬🇧Edgbaston, Birmingham, United Kingdom
Medizinische Hochschule Hannov
🇩🇪Hannover, Germany
North Manchester General Hospital
🇬🇧Crumpsall, Manchester, United Kingdom
UMC St. Radboud - Gastroenterology
🇳🇱Nijmegen, Netherlands
Azienda Ospedaliero Universitaria di Parma
🇮🇹Parma, Italy
Skånes Universitetssjukhus, Lund
🇸🇪Lund, Sweden
The Liver Unit
🇬🇧Paddington, London, United Kingdom
Complejo Hospitalario de Especialidades Virgen de la Victoria
🇪🇸Malaga, Spain
Hospital Universitario Marques
🇪🇸Santander, Spain
Valme Hospital
🇪🇸Sevilla, Spain
Erasmus MC
🇳🇱Rotterdam, Netherlands
Skanes Universitetssjukhus
🇸🇪Malmo, Sweden
Hospital General Universitario de Valencia
🇪🇸Valencia, Spain
Fondazione PTV - Policlinico Tor Vergata
🇮🇹Roma, Italy
Hospital Universitario La Paz
🇪🇸Madrid, Spain
NZOZ Centrum Badan Klinicznych
🇵🇱Wroclaw, Poland
King's College Hospital
🇬🇧Denmark Hill, London, United Kingdom
Nottingham University Hospitals-NHS
🇬🇧Nottingham, United Kingdom
Hospital Puerta de Hierro Maja
🇪🇸Majadahonda, Spain
Chelsea & Westminster Hospital
🇬🇧London, United Kingdom
Ente Ospedaliero Ospedali Galliera
🇮🇹Genova, Italy
University of Padova
🇮🇹Padova, Italy
University of Palermo
🇮🇹Palermo, Italy
CHU de Nancy, Hôpital de Brabois
🇫🇷Vandoeuvre les Nancy, France
Hopital Henri Mondor
🇫🇷Creteil Cedex, France
Groupe Hospitalier Sud - Hôpital Haut-Lévêque - USN
🇫🇷Pessac, France
CHU Pontchaillou - Hématologie Clinique
🇫🇷Rennes Cedex 9, France
Leber- and Studienzentrum am Checkpoint
🇩🇪Berlin, Germany
Praxiszentrum
🇩🇪Freiburg, Baden Wuerttemberg, Germany
Hospital Universitari Vall d'H
🇪🇸Barcelona, Spain
Hospital Carlos III
🇪🇸Madrid, Spain
Hospital Casa de la Maternidad
🇪🇸Barcelona, Spain
Queen Marys University of London
🇬🇧London, United Kingdom
Bristol Royal Infirmary
🇬🇧Bristol, United Kingdom