Clinical trial NCT01682720: Sofosbuvir and Ribavirin in Treatment-Naive and Treatment-Experienced Subjects With Chronic Genotype 2 or 3 HCV Infection
Official title: 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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hepatitis C
Keywords: HCV
Genotype 2
Genotype 3
Lead sponsor: Gilead Sciences
Sponsor class: INDUSTRY
First posted: 2012-09-11
Enrollment: 421
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Percentage of Participants With Sustained Virologic Response 12 Weeks After Discontinuation of Therapy (SVR12)
timeFrame: Posttreatment Week 12
measure: Adverse Events Leading to Permanent Discontinuation of Study Drug(s)
timeFrame: Up to 24 weeks
Secondary outcomes:
measure: Percentage of Participants With Sustained Virologic Response at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)
timeFrame: Posttreatment Weeks 4 and 24
measure: Percentage of Participants Experiencing Viral Breakthrough or Viral Relapse
timeFrame: Up to Posttreatment Week 24
Other outcomes:
Locations:
city: Graz
country: Austria
facility: Medizinische Universitat Graz
city: Wien
country: Austria
facility: Medizinische Universitat Wien
city: Wien
country: Austria
facility: Wilhelminenspital
city: Tallin
country: Estonia
facility: West Tallinn Central Hospital
city: Tartu
country: Estonia
facility: Tartu University Hospital
city: CHRU Lille
country: France
facility: CHRU de Lille, Hopital Claude Huriez
city: Clermont Ferrand
country: France
facility: CHU Estaing
city: Clichy Cedex
country: France
facility: Hopital Beaujon
city: Creteil Cedex
country: France
facility: Hopital Henri Mondor
city: Grenoble
country: France
facility: Département Hépatogastroentérologie - CHU de Grenoble
city: Marseille, Cedex 8
country: France
facility: Hopital Saint Joseph
city: Montpellier
country: France
facility: Hopital Saint Eloi
city: Nice
country: France
facility: Hopital de l Archet 2
city: Paris, Cedex 14
country: France
facility: Hopitaux Universitaires
city: Paris
country: France
facility: Hopital Saint Antoine
city: Paris
country: France
facility: Hopital Pitie Salpetriere
city: Pessac
country: France
facility: Groupe Hospitalier Sud - Hôpital Haut-Lévêque - USN
city: Rennes Cedex 9
country: France
facility: CHU Pontchaillou - Hématologie Clinique
city: Strasbourg
country: France
facility: Centre Hospitalier Universitaire de Strasbourg
city: Vandoeuvre les Nancy
country: France
facility: CHU de Nancy, Hôpital de Brabois
city: Freiburg
country: Germany
facility: Praxiszentrum
state: Baden Wuerttemberg
city: Berlin
country: Germany
facility: Leber- and Studienzentrum am Checkpoint
city: Bonn
country: Germany
facility: Universitaetsklinikum Bonn
city: Dusseldorf
country: Germany
facility: Heinrich Heine Unversitat
city: Frankfurt am Main
country: Germany
facility: JWG-Universität Frankfurt
city: Hamburg
country: Germany
facility: Asklepios Klinik Sankt Georg H
city: Hamburg
country: Germany
facility: Universitatsklinikum
city: Hannover
country: Germany
facility: Medizinische Hochschule Hannov
city: Heidelberg
country: Germany
facility: Medizinische Klinik IV, Dep. o
city: Herne
country: Germany
facility: Gastroenterologische Gemeinsch
city: Kiel
country: Germany
facility: Leberstudienzentrum Kiel
city: Leipzig
country: Germany
facility: Universitaetsklinikum Leipzig
city: Munchen
country: Germany
facility: Klinikum der Universität Münch
city: Münster
country: Germany
facility: Centrum fuer interdisziplinaere Medizin Muenster GmbH
city: San Giovanni Rotondo
country: Italy
facility: Ospedale Casa Sollievo
state: Foggia
city: Bologna
country: Italy
facility: Azienda Ospedaliera di Bologna - Policlinico S. Orsola Malpighi
city: Florence
country: Italy
facility: Ospedale S. Annunziata
city: Genova
country: Italy
facility: Ente Ospedaliero Ospedali Galliera
city: Milano
country: Italy
facility: Fondazione IRCCS CA Granada - Ospedale Maggiore Policlinico
city: Milano
country: Italy
facility: Azienda Ospedaliera Ospedale Niguarda Cà Granda
city: Padova
country: Italy
facility: University of Padova
city: Palermo
country: Italy
facility: University of Palermo
city: Parma
country: Italy
facility: Azienda Ospedaliero Universitaria di Parma
city: Roma
country: Italy
facility: Fondazione PTV - Policlinico Tor Vergata
city: Roma
country: Italy
facility: INMI "Lazzaro Spallanzani" I.R.C.C.S.
city: Torino
country: Italy
facility: Azienda Ospedaliera Universitaria San Giovanni Battista di Torino
city: Amsterdam
country: Netherlands
facility: Academisch Medisch Centrum
city: Leiden
country: Netherlands
facility: Leids Universitair Medisch Centrum
city: Nijmegen
country: Netherlands
facility: UMC St. Radboud - Gastroenterology
city: Rotterdam
country: Netherlands
facility: Erasmus MC
city: Bialystok
country: Poland
facility: Wojewodzki Szpital Specjalistyczny im Dluskeigo
city: Lodz
country: Poland
facility: Wojewodzki Specjalistyczny Szpital im. W. Bieganskiego
city: Warszawa
country: Poland
facility: SP ZOZ Wojewodzki Szpital Zakazny w Warszawie
city: Wroclaw
country: Poland
facility: NZOZ Centrum Badan Klinicznych
city: Barcelona
country: Spain
facility: Hospital Universitari Vall d'H
city: Barcelona
country: Spain
facility: Hospital Casa de la Maternidad
city: Madrid
country: Spain
facility: Hospital Carlos III
city: Madrid
country: Spain
facility: Hospital Universitario La Paz
city: Majadahonda
country: Spain
facility: Hospital Puerta de Hierro Maja
city: Malaga
country: Spain
facility: Complejo Hospitalario de Especialidades Virgen de la Victoria
city: Santander
country: Spain
facility: Hospital Universitario Marques
city: Sevilla
country: Spain
facility: Valme Hospital
city: Valencia
country: Spain
facility: Hospital General Universitario de Valencia
city: Göteborg
country: Sweden
facility: Sahlgrenska University Hospital
city: Lund
country: Sweden
facility: Skånes Universitetssjukhus, Lund
city: Malmo
country: Sweden
facility: Skanes Universitetssjukhus
city: Stockholm
country: Sweden
facility: Karolinska Instituet
city: Edgbaston
country: United Kingdom
facility: University of Birmingham
state: Birmingham
city: Southhampton
country: United Kingdom
facility: Southampton University Hospital NHS Trust
state: Hampshire
city: Denmark Hill
country: United Kingdom
facility: King's College Hospital
state: London
city: Paddington
country: United Kingdom
facility: The Liver Unit
state: London
city: Crumpsall
country: United Kingdom
facility: North Manchester General Hospital
state: Manchester
city: Bristol
country: United Kingdom
facility: Bristol Royal Infirmary
city: London
country: United Kingdom
facility: Queen Marys University of London
city: London
country: United Kingdom
facility: Royal Free Hospital and University College London Hospital
city: London
country: United Kingdom
facility: Chelsea & Westminster Hospital
city: Nottingham
country: United Kingdom
facility: Nottingham University Hospitals-NHS
Study officials:
affiliation: Gilead Sciences Study Director
name: Rob Hyland, DPhil
role: STUDY_DIRECTOR
References:
citation: Zeuzem S, Dusheiko GM, Salupere R, Mangia A, Flisiak R, Hyland RH, Illeperuma A, Svarovskaia E, Brainard DM, Symonds WT, Subramanian GM, McHutchison JG, Weiland O, Reesink HW, Ferenci P, Hezode C, Esteban R; VALENCE Investigators. Sofosbuvir and ribavirin in HCV genotypes 2 and 3. N Engl J Med. 2014 May 22;370(21):1993-2001. doi: 10.1056/NEJMoa1316145. Epub 2014 May 4.
citation: Younossi ZM, Stepanova M, Sulkowski M, Naggie S, Puoti M, Orkin C, Hunt SL. Sofosbuvir and Ribavirin for Treatment of Chronic Hepatitis C in Patients Coinfected With Hepatitis C Virus and HIV: The Impact on Patient-Reported Outcomes. J Infect Dis. 2015 Aug 1;212(3):367-77. doi: 10.1093/infdis/jiv005. Epub 2015 Jan 12.