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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

Sponsor
Gilead Sciences (Industry)
Overall Status
Completed
CT.gov ID
NCT01625338
Collaborator
(none)
534
Enrollment
175
Locations
3
Arms
30
Duration (Months)
3.1
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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).

Condition or Disease Intervention/Treatment Phase
Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
534 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
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
Study Start Date :
Jun 1, 2012
Actual Primary Completion Date :
Oct 1, 2014
Actual Study Completion Date :
Dec 1, 2014

Arms and Interventions

Arm Intervention/Treatment
Experimental: SOF+RBV 12 Weeks

SOF+RBV for 12 weeks

Drug: SOF
SOF 400 mg tablet administered orally once daily
Other Names:
  • Sovaldi®
  • GS-7977
  • PSI-7977

    • 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)
    Experimental: SOF+RBV 24 Weeks

    SOF+RBV for 24 weeks

    Drug: SOF
    SOF 400 mg tablet administered orally once daily
    Other Names:
  • Sovaldi®
  • GS-7977
  • PSI-7977

    • 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)
    Experimental: SOF+RBV+Peg-IFN 12 Weeks

    SOF+RBV+Peg-IFN for 12 weeks

    Drug: SOF
    SOF 400 mg tablet administered orally once daily
    Other Names:
  • Sovaldi®
  • GS-7977
  • PSI-7977

    • 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: Peg-IFN
    Peg-IFN 180 μg administered once weekly by subcutaneous injection

    Outcome Measures

    Primary Outcome Measures

    1. Percentage of Participants With Sustained Virologic Response (SVR) 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) at 12 weeks after stopping study treatment.

    2. Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event [Up to 24 weeks]

    Secondary Outcome Measures

    1. Percentage of Participants With SVR at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24) [Posttreatment Weeks 4 and 24]

      SVR4 and SVR 24 were defined as HCV RNA < LLOQ at 4 and 24 weeks after stopping study treatment, respectively.

    2. Percentage of Participants With On-treatment Virologic Failure [Up to 24 weeks]

      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)

    3. Percentage of Participants With Viral Relapse [Up to Posttreatment Week 24]

      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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

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

    Sponsors and Collaborators

    • Gilead Sciences

    Investigators

    • Study Director: Bittoo Kanwar, MD, Gilead Sciences

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Gilead Sciences
    ClinicalTrials.gov Identifier:
    NCT01625338
    Other Study ID Numbers:
    • GS-US-334-0109
    • 2012-000571-16
    First Posted:
    Jun 21, 2012
    Last Update Posted:
    Nov 9, 2015
    Last Verified:
    Oct 1, 2015
    Keywords provided by Gilead Sciences
    HCV genotype 2 (GT-2)
    HCV genotype 3 (GT-3)
    HCV
    Sustained Virologic Response
    Direct Acting Antiviral
    Combination Therapy
    GS-7977
    Ribavirin
    Open Label
    Additional relevant MeSH terms:
    Hepatitis C
    Hepatitis C, Chronic
    Sofosbuvir

    Study Results

    Participant Flow

    Recruitment Details Participants were enrolled at a total of 152 study sites from their prior Gilead study in North America, Europe, Australia, and New Zealand. The first participant was screened on 22 June 2012. The last study visit occurred on 22 December 2014.
    Pre-assignment Detail 585 participants were screened.
    Arm/Group Title SOF+RBV 12 Weeks SOF+RBV 24 Weeks SOF+RBV+Peg-IFN 12 Weeks
    Arm/Group Description Sofosbuvir (SOF) 400 mg tablet once daily + ribavirin (RBV) tablets (1000 or 1200 mg daily based on weight) for 12 weeks SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 24 weeks SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) + pegylated interferon (Peg-IFN) 180 µg administered subcutaneously once weekly for 12 weeks in participants
    Period Title: Overall Study
    STARTED 114 200 220
    COMPLETED 82 156 181
    NOT COMPLETED 32 44 39

    Baseline Characteristics

    Arm/Group Title SOF+RBV 12 Weeks SOF+RBV 24 Weeks SOF+RBV+Peg-IFN 12 Weeks Total
    Arm/Group Description SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 24 weeks SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) + Peg-IFN 180 µg administered subcutaneously once weekly for 12 weeks in participants Total of all reporting groups
    Overall Participants 114 200 219 533
    Age (years) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [years]
    53
    (9.6)
    52
    (7.6)
    53
    (10.0)
    53
    (9.1)
    Sex: Female, Male (Count of Participants)
    Female
    54
    47.4%
    50
    25%
    60
    27.4%
    164
    30.8%
    Male
    60
    52.6%
    150
    75%
    159
    72.6%
    369
    69.2%
    Race/Ethnicity, Customized (participants) [Number]
    White
    105
    92.1%
    184
    92%
    187
    85.4%
    476
    89.3%
    Black Or African American
    4
    3.5%
    2
    1%
    20
    9.1%
    26
    4.9%
    Asian
    2
    1.8%
    6
    3%
    8
    3.7%
    16
    3%
    Other
    1
    0.9%
    3
    1.5%
    2
    0.9%
    6
    1.1%
    Not Permitted
    0
    0%
    2
    1%
    2
    0.9%
    4
    0.8%
    American Indian Or Alaska Native
    2
    1.8%
    1
    0.5%
    0
    0%
    3
    0.6%
    Native Hawaiian Or Other Pacific Islander
    0
    0%
    2
    1%
    0
    0%
    2
    0.4%
    Race/Ethnicity, Customized (participants) [Number]
    Hispanic or Latino
    19
    16.7%
    12
    6%
    20
    9.1%
    51
    9.6%
    Not Hispanic or Latino
    95
    83.3%
    187
    93.5%
    197
    90%
    479
    89.9%
    Not Permitted
    0
    0%
    1
    0.5%
    2
    0.9%
    3
    0.6%
    Region of Enrollment (participants) [Number]
    United States
    77
    67.5%
    82
    41%
    121
    55.3%
    280
    52.5%
    United Kingdom
    3
    2.6%
    10
    5%
    8
    3.7%
    21
    3.9%
    Spain
    1
    0.9%
    8
    4%
    2
    0.9%
    11
    2.1%
    New Zealand
    4
    3.5%
    30
    15%
    6
    2.7%
    40
    7.5%
    Canada
    7
    6.1%
    13
    6.5%
    10
    4.6%
    30
    5.6%
    Austria
    1
    0.9%
    2
    1%
    1
    0.5%
    4
    0.8%
    Netherlands
    2
    1.8%
    4
    2%
    4
    1.8%
    10
    1.9%
    Sweden
    2
    1.8%
    5
    2.5%
    3
    1.4%
    10
    1.9%
    Czech Republic
    0
    0%
    0
    0%
    1
    0.5%
    1
    0.2%
    Poland
    0
    0%
    1
    0.5%
    8
    3.7%
    9
    1.7%
    Italy
    3
    2.6%
    7
    3.5%
    4
    1.8%
    14
    2.6%
    Australia
    9
    7.9%
    14
    7%
    19
    8.7%
    42
    7.9%
    France
    2
    1.8%
    10
    5%
    11
    5%
    23
    4.3%
    Germany
    2
    1.8%
    12
    6%
    18
    8.2%
    32
    6%
    Estonia
    1
    0.9%
    2
    1%
    3
    1.4%
    6
    1.1%
    HCV Genotype (participants) [Number]
    Genotype 1
    0
    0%
    2
    1%
    134
    61.2%
    136
    25.5%
    Genotype 2
    62
    54.4%
    10
    5%
    8
    3.7%
    80
    15%
    Genotype 3
    52
    45.6%
    180
    90%
    74
    33.8%
    306
    57.4%
    Genotype 4
    0
    0%
    7
    3.5%
    3
    1.4%
    10
    1.9%
    Indeterminate
    0
    0%
    1
    0.5%
    0
    0%
    1
    0.2%
    Cirrhosis Status (participants) [Number]
    No
    89
    78.1%
    138
    69%
    183
    83.6%
    410
    76.9%
    Yes
    25
    21.9%
    62
    31%
    36
    16.4%
    123
    23.1%
    IL28b Status (participants) [Number]
    CC
    38
    33.3%
    59
    29.5%
    47
    21.5%
    144
    27%
    CT
    61
    53.5%
    103
    51.5%
    127
    58%
    291
    54.6%
    TT
    13
    11.4%
    35
    17.5%
    40
    18.3%
    88
    16.5%
    Missing
    2
    1.8%
    3
    1.5%
    5
    2.3%
    10
    1.9%
    HCV RNA (log10 IU/mL) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [log10 IU/mL]
    6.3
    (0.87)
    6.4
    (0.70)
    6.4
    (0.64)
    6.4
    (0.72)
    HCV RNA Category (participants) [Number]
    < 800,000 IU/mL
    30
    26.3%
    44
    22%
    36
    16.4%
    110
    20.6%
    ≥ 800,000 IU/mL
    84
    73.7%
    156
    78%
    183
    83.6%
    423
    79.4%

    Outcome Measures

    1. Primary Outcome
    Title Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12)
    Description SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ; ie, 25 IU/mL) at 12 weeks after stopping study treatment.
    Time Frame Posttreatment Week 12

    Outcome Measure Data

    Analysis Population Description
    Full Analysis Set: participants who were enrolled and received at least 1 dose of study drug.
    Arm/Group Title SOF+RBV 12 Weeks SOF+RBV 24 Weeks SOF+RBV+Peg-IFN 12 Weeks
    Arm/Group Description SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 24 weeks SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) + Peg-IFN 180 µg administered subcutaneously once weekly for 12 weeks in participants
    Measure Participants 114 200 219
    Number [percentage of participants]
    71.9
    63.1%
    77.5
    38.8%
    82.6
    37.7%
    2. Primary Outcome
    Title Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event
    Description
    Time Frame Up to 24 weeks

    Outcome Measure Data

    Analysis Population Description
    Safety Analysis Set: participants who were enrolled and received at least 1 dose of study drug.
    Arm/Group Title SOF+RBV 12 Weeks SOF+RBV 24 Weeks SOF+RBV+Peg-IFN 12 Weeks
    Arm/Group Description SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 24 weeks SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) + Peg-IFN 180 µg administered subcutaneously once weekly for 12 weeks in participants
    Measure Participants 114 200 219
    Number [percentage of participants]
    0.9
    0.8%
    1.0
    0.5%
    3.7
    1.7%
    3. Secondary Outcome
    Title Percentage of Participants With SVR at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)
    Description SVR4 and SVR 24 were defined as HCV RNA < LLOQ at 4 and 24 weeks after stopping study treatment, respectively.
    Time Frame Posttreatment Weeks 4 and 24

    Outcome Measure Data

    Analysis Population Description
    Full Analysis Set
    Arm/Group Title SOF+RBV 12 Weeks SOF+RBV 24 Weeks SOF+RBV+Peg-IFN 12 Weeks
    Arm/Group Description SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 24 weeks SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) + Peg-IFN 180 µg administered subcutaneously once weekly for 12 weeks in participants
    Measure Participants 114 200 219
    SVR4
    73.7
    64.6%
    81.5
    40.8%
    87.2
    39.8%
    SVR24
    71.9
    63.1%
    76.0
    38%
    82.6
    37.7%
    4. Secondary Outcome
    Title Percentage of Participants With On-treatment Virologic Failure
    Description 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)
    Time Frame Up to 24 weeks

    Outcome Measure Data

    Analysis Population Description
    Full Analysis Set
    Arm/Group Title SOF+RBV 12 Weeks SOF+RBV 24 Weeks SOF+RBV+Peg-IFN 12 Weeks
    Arm/Group Description SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 24 weeks SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) + Peg-IFN 180 µg administered subcutaneously once weekly for 12 weeks in participants
    Measure Participants 114 200 219
    Number [percentage of participants]
    0.9
    0.8%
    0.5
    0.3%
    0
    0%
    5. Secondary Outcome
    Title Percentage of Participants With Viral Relapse
    Description 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.
    Time Frame Up to Posttreatment Week 24

    Outcome Measure Data

    Analysis Population Description
    Participants in the Full Analysis Set with available data were analyzed.
    Arm/Group Title SOF+RBV 12 Weeks SOF+RBV 24 Weeks SOF+RBV+Peg-IFN 12 Weeks
    Arm/Group Description SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 24 weeks SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) + Peg-IFN 180 µg administered subcutaneously once weekly for 12 weeks in participants
    Measure Participants 113 199 219
    Number [percentage of participants]
    25.7
    22.5%
    20.6
    10.3%
    16.4
    7.5%

    Adverse Events

    Time Frame Up to 24 weeks plus 30 days
    Adverse Event Reporting Description Safety Analysis Set
    Arm/Group Title SOF+RBV 12 Weeks SOF+RBV 24 Weeks SOF+RBV+Peg-IFN 12 Weeks
    Arm/Group Description SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 24 weeks SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) + Peg-IFN 180 µg administered subcutaneously once weekly for 12 weeks in participants
    All Cause Mortality
    SOF+RBV 12 Weeks SOF+RBV 24 Weeks SOF+RBV+Peg-IFN 12 Weeks
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total / (NaN) / (NaN) / (NaN)
    Serious Adverse Events
    SOF+RBV 12 Weeks SOF+RBV 24 Weeks SOF+RBV+Peg-IFN 12 Weeks
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 4/114 (3.5%) 11/200 (5.5%) 4/219 (1.8%)
    Gastrointestinal disorders
    Abdominal pain 0/114 (0%) 1/200 (0.5%) 0/219 (0%)
    Dysphagia 0/114 (0%) 0/200 (0%) 1/219 (0.5%)
    Haemorrhoidal haemorrhage 0/114 (0%) 1/200 (0.5%) 0/219 (0%)
    Infections and infestations
    Meningitis aseptic 0/114 (0%) 1/200 (0.5%) 0/219 (0%)
    Injury, poisoning and procedural complications
    Ligament rupture 0/114 (0%) 1/200 (0.5%) 0/219 (0%)
    Multiple injuries 0/114 (0%) 1/200 (0.5%) 0/219 (0%)
    Post procedural haemorrhage 1/114 (0.9%) 0/200 (0%) 0/219 (0%)
    Road traffic accident 0/114 (0%) 1/200 (0.5%) 0/219 (0%)
    Musculoskeletal and connective tissue disorders
    Rotator cuff syndrome 0/114 (0%) 1/200 (0.5%) 0/219 (0%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Hepatocellular carcinoma 1/114 (0.9%) 1/200 (0.5%) 0/219 (0%)
    Nervous system disorders
    Headache 0/114 (0%) 1/200 (0.5%) 0/219 (0%)
    Myelitis transverse 1/114 (0.9%) 0/200 (0%) 0/219 (0%)
    Presyncope 0/114 (0%) 1/200 (0.5%) 0/219 (0%)
    Psychiatric disorders
    Affective disorder 0/114 (0%) 1/200 (0.5%) 0/219 (0%)
    Insomnia 0/114 (0%) 1/200 (0.5%) 0/219 (0%)
    Mania 0/114 (0%) 1/200 (0.5%) 0/219 (0%)
    Psychotic disorder 0/114 (0%) 1/200 (0.5%) 0/219 (0%)
    Substance-induced psychotic disorder 0/114 (0%) 0/200 (0%) 1/219 (0.5%)
    Suicide attempt 1/114 (0.9%) 0/200 (0%) 1/219 (0.5%)
    Reproductive system and breast disorders
    Benign prostatic hyperplasia 0/114 (0%) 1/200 (0.5%) 0/219 (0%)
    Respiratory, thoracic and mediastinal disorders
    Chronic obstructive pulmonary disease 0/114 (0%) 0/200 (0%) 1/219 (0.5%)
    Social circumstances
    Social stay hospitalisation 0/114 (0%) 1/200 (0.5%) 0/219 (0%)
    Other (Not Including Serious) Adverse Events
    SOF+RBV 12 Weeks SOF+RBV 24 Weeks SOF+RBV+Peg-IFN 12 Weeks
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 92/114 (80.7%) 167/200 (83.5%) 194/219 (88.6%)
    Blood and lymphatic system disorders
    Anaemia 13/114 (11.4%) 12/200 (6%) 26/219 (11.9%)
    Leukopenia 0/114 (0%) 0/200 (0%) 11/219 (5%)
    Neutropenia 0/114 (0%) 0/200 (0%) 38/219 (17.4%)
    Gastrointestinal disorders
    Abdominal pain 6/114 (5.3%) 7/200 (3.5%) 5/219 (2.3%)
    Diarrhoea 7/114 (6.1%) 14/200 (7%) 28/219 (12.8%)
    Nausea 22/114 (19.3%) 27/200 (13.5%) 52/219 (23.7%)
    Vomiting 7/114 (6.1%) 7/200 (3.5%) 9/219 (4.1%)
    General disorders
    Asthenia 5/114 (4.4%) 9/200 (4.5%) 19/219 (8.7%)
    Chills 2/114 (1.8%) 3/200 (1.5%) 19/219 (8.7%)
    Fatigue 33/114 (28.9%) 66/200 (33%) 97/219 (44.3%)
    Influenza like illness 6/114 (5.3%) 5/200 (2.5%) 45/219 (20.5%)
    Pain 2/114 (1.8%) 4/200 (2%) 17/219 (7.8%)
    Pyrexia 5/114 (4.4%) 1/200 (0.5%) 27/219 (12.3%)
    Infections and infestations
    Nasopharyngitis 9/114 (7.9%) 22/200 (11%) 4/219 (1.8%)
    Upper respiratory tract infection 7/114 (6.1%) 9/200 (4.5%) 2/219 (0.9%)
    Metabolism and nutrition disorders
    Decreased appetite 3/114 (2.6%) 8/200 (4%) 32/219 (14.6%)
    Musculoskeletal and connective tissue disorders
    Arthralgia 13/114 (11.4%) 21/200 (10.5%) 37/219 (16.9%)
    Back pain 9/114 (7.9%) 11/200 (5.5%) 13/219 (5.9%)
    Muscle spasms 7/114 (6.1%) 17/200 (8.5%) 11/219 (5%)
    Myalgia 8/114 (7%) 9/200 (4.5%) 45/219 (20.5%)
    Nervous system disorders
    Dizziness 4/114 (3.5%) 13/200 (6.5%) 23/219 (10.5%)
    Dysgeusia 3/114 (2.6%) 0/200 (0%) 12/219 (5.5%)
    Headache 15/114 (13.2%) 57/200 (28.5%) 71/219 (32.4%)
    Psychiatric disorders
    Anxiety 6/114 (5.3%) 11/200 (5.5%) 14/219 (6.4%)
    Depression 7/114 (6.1%) 21/200 (10.5%) 14/219 (6.4%)
    Insomnia 18/114 (15.8%) 34/200 (17%) 37/219 (16.9%)
    Irritability 5/114 (4.4%) 27/200 (13.5%) 38/219 (17.4%)
    Respiratory, thoracic and mediastinal disorders
    Cough 11/114 (9.6%) 11/200 (5.5%) 33/219 (15.1%)
    Dyspnoea 6/114 (5.3%) 12/200 (6%) 11/219 (5%)
    Dyspnoea exertional 5/114 (4.4%) 7/200 (3.5%) 13/219 (5.9%)
    Oropharyngeal pain 3/114 (2.6%) 4/200 (2%) 12/219 (5.5%)
    Skin and subcutaneous tissue disorders
    Dry skin 6/114 (5.3%) 14/200 (7%) 17/219 (7.8%)
    Pruritus 15/114 (13.2%) 23/200 (11.5%) 40/219 (18.3%)
    Rash 13/114 (11.4%) 19/200 (9.5%) 35/219 (16%)

    Limitations/Caveats

    There were no limitations affecting the analysis or results.

    More Information

    Certain Agreements

    Principal Investigators are NOT employed by the organization sponsoring the study.

    After conclusion of the study and without prior written approval from Gilead, investigators in this study may communicate, orally present, or publish in scientific journals or other media only after the following conditions have been met: The results of the study in their entirety have been publicly disclosed by or with the consent of Gilead in an abstract, manuscript, or presentation form; or The study has been completed at all study sites for at least 2 years

    Results Point of Contact

    Name/Title Clinical Trial Disclosures
    Organization Gilead Sciences
    Phone
    Email ClinicalTrialDisclosures@gilead.com
    Responsible Party:
    Gilead Sciences
    ClinicalTrials.gov Identifier:
    NCT01625338
    Other Study ID Numbers:
    • GS-US-334-0109
    • 2012-000571-16
    First Posted:
    Jun 21, 2012
    Last Update Posted:
    Nov 9, 2015
    Last Verified:
    Oct 1, 2015