Back to resultsSofosbuvir and Ribavirin in Treatment-Naive and Treatment-Experienced Subjects With Chronic Genotype 2 or 3 HCV Infection
Primary Purpose
Hepatitis C
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
SOF
RBV
Placebo to match SOF
Placebo to match RBV
Sponsored by
About this trial
This is an interventional treatment trial for Hepatitis C focused on measuring HCV, Genotype 2, Genotype 3
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
Sites / Locations
- Medizinische Universitat Graz
- Medizinische Universitat Wien
- Wilhelminenspital
- West Tallinn Central Hospital
- Tartu University Hospital
- CHRU de Lille, Hopital Claude Huriez
- CHU Estaing
- Hopital Beaujon
- Hopital Henri Mondor
- Département Hépatogastroentérologie - CHU de Grenoble
- Hopital Saint Joseph
- Hopital Saint Eloi
- Hopital de l Archet 2
- Hopitaux Universitaires
- Hopital Saint Antoine
- Hopital Pitie Salpetriere
- Groupe Hospitalier Sud - Hôpital Haut-Lévêque - USN
- CHU Pontchaillou - Hématologie Clinique
- Centre Hospitalier Universitaire de Strasbourg
- CHU de Nancy, Hôpital de Brabois
- Praxiszentrum
- Leber- and Studienzentrum am Checkpoint
- Universitaetsklinikum Bonn
- Heinrich Heine Unversitat
- JWG-Universität Frankfurt
- Asklepios Klinik Sankt Georg H
- Universitatsklinikum
- Medizinische Hochschule Hannov
- Medizinische Klinik IV, Dep. o
- Gastroenterologische Gemeinsch
- Leberstudienzentrum Kiel
- Universitaetsklinikum Leipzig
- Klinikum der Universität Münch
- Centrum fuer interdisziplinaere Medizin Muenster GmbH
- Ospedale Casa Sollievo
- Azienda Ospedaliera di Bologna - Policlinico S. Orsola Malpighi
- Ospedale S. Annunziata
- Ente Ospedaliero Ospedali Galliera
- Fondazione IRCCS CA Granada - Ospedale Maggiore Policlinico
- Azienda Ospedaliera Ospedale Niguarda Cà Granda
- University of Padova
- University of Palermo
- Azienda Ospedaliero Universitaria di Parma
- Fondazione PTV - Policlinico Tor Vergata
- INMI "Lazzaro Spallanzani" I.R.C.C.S.
- Azienda Ospedaliera Universitaria San Giovanni Battista di Torino
- Academisch Medisch Centrum
- Leids Universitair Medisch Centrum
- UMC St. Radboud - Gastroenterology
- Erasmus MC
- Wojewodzki Szpital Specjalistyczny im Dluskeigo
- Wojewodzki Specjalistyczny Szpital im. W. Bieganskiego
- SP ZOZ Wojewodzki Szpital Zakazny w Warszawie
- NZOZ Centrum Badan Klinicznych
- Hospital Universitari Vall d'H
- Hospital Casa de la Maternidad
- Hospital Carlos III
- Hospital Universitario La Paz
- Hospital Puerta de Hierro Maja
- Complejo Hospitalario de Especialidades Virgen de la Victoria
- Hospital Universitario Marques
- Valme Hospital
- Hospital General Universitario de Valencia
- Sahlgrenska University Hospital
- Skånes Universitetssjukhus, Lund
- Skanes Universitetssjukhus
- Karolinska Instituet
- University of Birmingham
- Southampton University Hospital NHS Trust
- King's College Hospital
- The Liver Unit
- North Manchester General Hospital
- Bristol Royal Infirmary
- Queen Marys University of London
- Royal Free Hospital and University College London Hospital
- Chelsea & Westminster Hospital
- Nottingham University Hospitals-NHS
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Placebo Comparator
Experimental
Experimental
Arm Label
Placebo 12 Weeks (GT2/3)
SOF 12 Weeks (GT2/3)
SOF 24 Weeks (GT3)
Arm Description
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.
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 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.
Outcomes
Primary Outcome Measures
Percentage of Participants With Sustained Virologic Response 12 Weeks After Discontinuation of Therapy (SVR12)
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)
The percentage of participants experiencing an adverse event leading to permanent discontinuation of study drug(s) was analyzed.
Secondary Outcome Measures
Percentage of Participants With Sustained Virologic Response at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)
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
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01682720
Brief Title
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
2. Study Status
Record Verification Date
October 2014
Overall Recruitment Status
Completed
Study Start Date
September 2012 (undefined)
Primary Completion Date
October 2013 (Actual)
Study Completion Date
January 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Gilead Sciences
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatitis C
Keywords
HCV, Genotype 2, Genotype 3
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
421 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Placebo 12 Weeks (GT2/3)
Arm Type
Placebo Comparator
Arm Description
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.
Arm Title
SOF 12 Weeks (GT2/3)
Arm Type
Experimental
Arm Description
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.
Arm Title
SOF 24 Weeks (GT3)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
SOF
Other Intervention Name(s)
Sovaldi®, GS-7977, PSI-7977
Intervention Description
Sofosbuvir (SOF) 400 mg tablet administered orally once daily
Intervention Type
Drug
Intervention Name(s)
RBV
Intervention Description
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)
Intervention Type
Drug
Intervention Name(s)
Placebo to match SOF
Intervention Description
Placebo to match SOF administered orally once daily
Intervention Type
Drug
Intervention Name(s)
Placebo to match RBV
Intervention Description
Placebo to match RBV administered orally in a divided daily dose
Primary Outcome Measure Information:
Title
Percentage of Participants With Sustained Virologic Response 12 Weeks After Discontinuation of Therapy (SVR12)
Description
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.
Time Frame
Posttreatment Week 12
Title
Adverse Events Leading to Permanent Discontinuation of Study Drug(s)
Description
The percentage of participants experiencing an adverse event leading to permanent discontinuation of study drug(s) was analyzed.
Time Frame
Up to 24 weeks
Secondary Outcome Measure Information:
Title
Percentage of Participants With Sustained Virologic Response at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)
Description
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.
Time Frame
Posttreatment Weeks 4 and 24
Title
Percentage of Participants Experiencing Viral Breakthrough or Viral Relapse
Description
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.
Time Frame
Up to Posttreatment Week 24
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rob Hyland, DPhil
Organizational Affiliation
Gilead Sciences Study Director
Official's Role
Study Director
Facility Information:
Facility Name
Medizinische Universitat Graz
City
Graz
ZIP/Postal Code
A-8036
Country
Austria
Facility Name
Medizinische Universitat Wien
City
Wien
ZIP/Postal Code
1090
Country
Austria
Facility Name
Wilhelminenspital
City
Wien
ZIP/Postal Code
1160
Country
Austria
Facility Name
West Tallinn Central Hospital
City
Tallin
ZIP/Postal Code
10617
Country
Estonia
Facility Name
Tartu University Hospital
City
Tartu
ZIP/Postal Code
51014
Country
Estonia
Facility Name
CHRU de Lille, Hopital Claude Huriez
City
CHRU Lille
ZIP/Postal Code
59037
Country
France
Facility Name
CHU Estaing
City
Clermont Ferrand
ZIP/Postal Code
63003
Country
France
Facility Name
Hopital Beaujon
City
Clichy Cedex
ZIP/Postal Code
92110
Country
France
Facility Name
Hopital Henri Mondor
City
Creteil Cedex
ZIP/Postal Code
94000
Country
France
Facility Name
Département Hépatogastroentérologie - CHU de Grenoble
City
Grenoble
ZIP/Postal Code
38043
Country
France
Facility Name
Hopital Saint Joseph
City
Marseille, Cedex 8
ZIP/Postal Code
13008
Country
France
Facility Name
Hopital Saint Eloi
City
Montpellier
ZIP/Postal Code
34295
Country
France
Facility Name
Hopital de l Archet 2
City
Nice
ZIP/Postal Code
6202
Country
France
Facility Name
Hopitaux Universitaires
City
Paris, Cedex 14
ZIP/Postal Code
75679
Country
France
Facility Name
Hopital Saint Antoine
City
Paris
ZIP/Postal Code
75012
Country
France
Facility Name
Hopital Pitie Salpetriere
City
Paris
ZIP/Postal Code
75013
Country
France
Facility Name
Groupe Hospitalier Sud - Hôpital Haut-Lévêque - USN
City
Pessac
ZIP/Postal Code
33604
Country
France
Facility Name
CHU Pontchaillou - Hématologie Clinique
City
Rennes Cedex 9
ZIP/Postal Code
35033
Country
France
Facility Name
Centre Hospitalier Universitaire de Strasbourg
City
Strasbourg
ZIP/Postal Code
67091
Country
France
Facility Name
CHU de Nancy, Hôpital de Brabois
City
Vandoeuvre les Nancy
ZIP/Postal Code
54511
Country
France
Facility Name
Praxiszentrum
City
Freiburg
State/Province
Baden Wuerttemberg
ZIP/Postal Code
79098
Country
Germany
Facility Name
Leber- and Studienzentrum am Checkpoint
City
Berlin
ZIP/Postal Code
10969
Country
Germany
Facility Name
Universitaetsklinikum Bonn
City
Bonn
ZIP/Postal Code
53125
Country
Germany
Facility Name
Heinrich Heine Unversitat
City
Dusseldorf
ZIP/Postal Code
40225
Country
Germany
Facility Name
JWG-Universität Frankfurt
City
Frankfurt am Main
ZIP/Postal Code
60590
Country
Germany
Facility Name
Asklepios Klinik Sankt Georg H
City
Hamburg
ZIP/Postal Code
20099
Country
Germany
Facility Name
Universitatsklinikum
City
Hamburg
ZIP/Postal Code
20246
Country
Germany
Facility Name
Medizinische Hochschule Hannov
City
Hannover
ZIP/Postal Code
30625
Country
Germany
Facility Name
Medizinische Klinik IV, Dep. o
City
Heidelberg
ZIP/Postal Code
69120
Country
Germany
Facility Name
Gastroenterologische Gemeinsch
City
Herne
ZIP/Postal Code
44623
Country
Germany
Facility Name
Leberstudienzentrum Kiel
City
Kiel
ZIP/Postal Code
24146
Country
Germany
Facility Name
Universitaetsklinikum Leipzig
City
Leipzig
ZIP/Postal Code
4103
Country
Germany
Facility Name
Klinikum der Universität Münch
City
Munchen
ZIP/Postal Code
81377
Country
Germany
Facility Name
Centrum fuer interdisziplinaere Medizin Muenster GmbH
City
Münster
ZIP/Postal Code
D-48143
Country
Germany
Facility Name
Ospedale Casa Sollievo
City
San Giovanni Rotondo
State/Province
Foggia
ZIP/Postal Code
71013
Country
Italy
Facility Name
Azienda Ospedaliera di Bologna - Policlinico S. Orsola Malpighi
City
Bologna
ZIP/Postal Code
40138
Country
Italy
Facility Name
Ospedale S. Annunziata
City
Florence
ZIP/Postal Code
50011
Country
Italy
Facility Name
Ente Ospedaliero Ospedali Galliera
City
Genova
ZIP/Postal Code
16128
Country
Italy
Facility Name
Fondazione IRCCS CA Granada - Ospedale Maggiore Policlinico
City
Milano
ZIP/Postal Code
20122
Country
Italy
Facility Name
Azienda Ospedaliera Ospedale Niguarda Cà Granda
City
Milano
ZIP/Postal Code
20162
Country
Italy
Facility Name
University of Padova
City
Padova
ZIP/Postal Code
35100
Country
Italy
Facility Name
University of Palermo
City
Palermo
ZIP/Postal Code
90127
Country
Italy
Facility Name
Azienda Ospedaliero Universitaria di Parma
City
Parma
ZIP/Postal Code
43100
Country
Italy
Facility Name
Fondazione PTV - Policlinico Tor Vergata
City
Roma
ZIP/Postal Code
133
Country
Italy
Facility Name
INMI "Lazzaro Spallanzani" I.R.C.C.S.
City
Roma
ZIP/Postal Code
149
Country
Italy
Facility Name
Azienda Ospedaliera Universitaria San Giovanni Battista di Torino
City
Torino
ZIP/Postal Code
10126
Country
Italy
Facility Name
Academisch Medisch Centrum
City
Amsterdam
ZIP/Postal Code
1105 AZ
Country
Netherlands
Facility Name
Leids Universitair Medisch Centrum
City
Leiden
ZIP/Postal Code
2300 RC
Country
Netherlands
Facility Name
UMC St. Radboud - Gastroenterology
City
Nijmegen
ZIP/Postal Code
6500 HB
Country
Netherlands
Facility Name
Erasmus MC
City
Rotterdam
ZIP/Postal Code
3015 CE
Country
Netherlands
Facility Name
Wojewodzki Szpital Specjalistyczny im Dluskeigo
City
Bialystok
ZIP/Postal Code
15-540
Country
Poland
Facility Name
Wojewodzki Specjalistyczny Szpital im. W. Bieganskiego
City
Lodz
ZIP/Postal Code
91-347
Country
Poland
Facility Name
SP ZOZ Wojewodzki Szpital Zakazny w Warszawie
City
Warszawa
ZIP/Postal Code
01-201
Country
Poland
Facility Name
NZOZ Centrum Badan Klinicznych
City
Wroclaw
ZIP/Postal Code
50-349
Country
Poland
Facility Name
Hospital Universitari Vall d'H
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
Hospital Casa de la Maternidad
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Facility Name
Hospital Carlos III
City
Madrid
ZIP/Postal Code
28029
Country
Spain
Facility Name
Hospital Universitario La Paz
City
Madrid
ZIP/Postal Code
28046
Country
Spain
Facility Name
Hospital Puerta de Hierro Maja
City
Majadahonda
ZIP/Postal Code
28222
Country
Spain
Facility Name
Complejo Hospitalario de Especialidades Virgen de la Victoria
City
Malaga
ZIP/Postal Code
29071
Country
Spain
Facility Name
Hospital Universitario Marques
City
Santander
ZIP/Postal Code
39008
Country
Spain
Facility Name
Valme Hospital
City
Sevilla
ZIP/Postal Code
41014
Country
Spain
Facility Name
Hospital General Universitario de Valencia
City
Valencia
ZIP/Postal Code
46014
Country
Spain
Facility Name
Sahlgrenska University Hospital
City
Göteborg
ZIP/Postal Code
41685
Country
Sweden
Facility Name
Skånes Universitetssjukhus, Lund
City
Lund
ZIP/Postal Code
22185
Country
Sweden
Facility Name
Skanes Universitetssjukhus
City
Malmo
ZIP/Postal Code
20502
Country
Sweden
Facility Name
Karolinska Instituet
City
Stockholm
ZIP/Postal Code
14186
Country
Sweden
Facility Name
University of Birmingham
City
Edgbaston
State/Province
Birmingham
ZIP/Postal Code
B15 2TH
Country
United Kingdom
Facility Name
Southampton University Hospital NHS Trust
City
Southhampton
State/Province
Hampshire
ZIP/Postal Code
SO41 3QP
Country
United Kingdom
Facility Name
King's College Hospital
City
Denmark Hill
State/Province
London
ZIP/Postal Code
SE5 9RS
Country
United Kingdom
Facility Name
The Liver Unit
City
Paddington
State/Province
London
ZIP/Postal Code
W2 1NY
Country
United Kingdom
Facility Name
North Manchester General Hospital
City
Crumpsall
State/Province
Manchester
ZIP/Postal Code
M8 5RB
Country
United Kingdom
Facility Name
Bristol Royal Infirmary
City
Bristol
ZIP/Postal Code
BS2 8HW
Country
United Kingdom
Facility Name
Queen Marys University of London
City
London
ZIP/Postal Code
E1 2AT
Country
United Kingdom
Facility Name
Royal Free Hospital and University College London Hospital
City
London
ZIP/Postal Code
NW3 2PF
Country
United Kingdom
Facility Name
Chelsea & Westminster Hospital
City
London
ZIP/Postal Code
SW109NH
Country
United Kingdom
Facility Name
Nottingham University Hospitals-NHS
City
Nottingham
ZIP/Postal Code
NG7 2UH
Country
United Kingdom
12. IPD Sharing Statement
Citations:
PubMed Identifier
24795201
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.
Results Reference
result
PubMed Identifier
25583164
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.
Results Reference
derived
Learn more about this trial
Sofosbuvir and Ribavirin in Treatment-Naive and Treatment-Experienced Subjects With Chronic Genotype 2 or 3 HCV Infection
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