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Efficacy and Safety of Sofosbuvir Plus Ribavirin in Adults With Chronic HCV Infection

Sponsor
Gilead Sciences (Industry)
Overall Status
Completed
CT.gov ID
NCT02021643
Collaborator
(none)
687
Enrollment
35
Locations
4
Arms
34.8
Actual Duration (Months)
19.6
Patients Per Site
0.6
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The primary objectives of this study are to evaluate the efficacy, safety and tolerability of treatment with sofosbuvir (SOF)+ ribavirin (RBV), with or without Pegylated interferon alfa (Peg-IFNα-2a/ PEG)) in participants with chronic genotype (GT)-1, 2, 3, and 6 Hepatitis C virus (HCV) infection.

Condition or Disease Intervention/Treatment Phase
Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
687 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Phase 3b, Multicenter, Open-Label, Randomized Study to Investigate the Efficacy and Safety of Sofosbuvir Plus Ribavirin (± Pegylated Interferon) in Subjects With Chronic Genotype 1, 2, 3 and 6 HCV Infection
Actual Study Start Date :
Dec 10, 2013
Actual Primary Completion Date :
Aug 12, 2016
Actual Study Completion Date :
Nov 3, 2016

Arms and Interventions

Arm Intervention/Treatment
Experimental: Sofosbuvir+RBV+PEG 12 weeks

Participants with genotype 1 or 6 will receive sofosbuvir+RBV+Peg-IFNα-2a for 12 weeks.

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

    • Drug: RBV
    Ribavirin (RBV) tablets administered orally in a divided daily dose according to package insert weight-based dosing recommendations (< 75kg = 1000 mg and ≥ 75 kg = 1200 mg)
    Other Names:
  • Ribasphere®

    • Drug: PEG
    Pegylated interferon alfa-2a (Peg-IFNα-2a) 180 µg/0.5 mL pre-filled syringe administered subcutaneously once a week
    Other Names:
  • Pegasys®

    		•
    Experimental: Sofosbuvir+RBV 12 weeks

    Participants with genotype 1, 2 or 6 will receive sofosbuvir+RBV for 12 weeks.

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

    • Drug: RBV
    Ribavirin (RBV) tablets administered orally in a divided daily dose according to package insert weight-based dosing recommendations (< 75kg = 1000 mg and ≥ 75 kg = 1200 mg)
    Other Names:
  • Ribasphere®

    		•
    Experimental: Sofosbuvir+RBV 16 weeks

    Participants with genotype 1, 6 will receive sofosbuvir+RBV for 16 weeks.

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

    • Drug: RBV
    Ribavirin (RBV) tablets administered orally in a divided daily dose according to package insert weight-based dosing recommendations (< 75kg = 1000 mg and ≥ 75 kg = 1200 mg)
    Other Names:
  • Ribasphere®

    		•
    Experimental: Sofosbuvir+RBV 24 Weeks

    Participants with genotype 1, 3, or 6 will receive sofosbuvir+RBV for 24 weeks.

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

    • Drug: RBV
    Ribavirin (RBV) tablets administered orally in a divided daily dose according to package insert weight-based dosing recommendations (< 75kg = 1000 mg and ≥ 75 kg = 1200 mg)
    Other Names:
  • Ribasphere®

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Percentage of Participants With Sustained Virologic Response 12 Weeks After Discontinuation of Therapy (SVR12) [Posttreatment Week 12]

      SVR12 is defined as HCV RNA < the lower limit of quantification (LLOQ; ie, < 25 IU/mL) 12 weeks following the last dose of study drug.

    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 Sustained Virologic Response 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24) [Posttreatment Weeks 4 and 24]

      SVR4 and SVR24 are defined as HCV RNA < LLOQ at 4 and 24 weeks following the last dose of study drug, respectively.

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

      Viral breakthrough was defined as HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ while receiving treatment.

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

      Viral relapse was defined as HCV RNA ≥ LLOQ during the post-treatment period having achieved HCV RNA < LLOQ at end of treatment, confirmed with 2 consecutive values or last available post-treatment measurement.

    4. Change From Baseline in HCV RNA (log10 IU/mL) [Up to 24 weeks]

    Eligibility Criteria

    Criteria

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

    • Willing and able to provide written informed consent

    • HCV RNA ≥ 10^4 IU/mL at screening

    • HCV treatment-naive (HCV genotype 1, 2, 3 or 6), defined as no prior exposure to any interferon (IFN), RBV, or other approved or experimental HCV-specific direct-acting antiviral agent, or HCV treatment-experienced (HCV genotype 1, 2, 3, or 6 only) with medical records that include sufficient detail of prior treatment with IFN to allow for categorization of prior response as either IFN Intolerant, non-responder, or experiences viral breakthrough or relapse

    • HCV infection documented by anti-HCV antibody test, genotyping test, or liver biopsy

    Key Exclusion Criteria:

    • Current or prior history of any clinically-significant illness (other than HCV)

    • Pregnant or nursing female or male with pregnant female partner

    • Chronic liver disease of a non-HCV etiology

    • Infection with hepatitis B virus (HBV) or human immunodeficiency virus (HIV)

    Note: Other protocol defined Inclusion/Exclusion criteria may apply.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Beijing China
    2 Chongqing China
    3 Fujian China
    4 Guangdong China
    5 Guangxi China
    6 Hainan China
    7 Hebei China
    8 Hubei China
    9 Hunan China
    10 Jiangxi China
    11 Jilin China
    12 Jin'an China
    13 Liaoyang China
    14 Shanghai China
    15 Sichuan China
    16 Yunnan China
    17 Zhejiang China
    18 Hong Kong Hong Kong
    19 Sha Tin Hong Kong
    20 Incheon Gyeonggi-do Korea, Republic of
    21 Seongnam-si Gyeonggi-do Korea, Republic of
    22 Ansan-si Korea, Republic of
    23 Bucheon-si Korea, Republic of
    24 Busan Korea, Republic of
    25 Daegu Korea, Republic of
    26 Seoul Korea, Republic of
    27 Chang-hua Taiwan
    28 Kaohsiung Taiwan
    29 Keelung Taiwan
    30 Taichung Taiwan
    31 Tainan Taiwan
    32 Taipei Taiwan
    33 Taoyuan Taiwan
    34 Hanoi Vietnam
    35 Ho Chi Minh City Vietnam

    Sponsors and Collaborators

    • Gilead Sciences

    Investigators

    • Study Director: Gilead Study Director, Gilead Sciences

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Gilead Sciences
    ClinicalTrials.gov Identifier:
    NCT02021643
    Other Study ID Numbers:
    • GS-US-334-0115
    First Posted:
    Dec 27, 2013
    Last Update Posted:
    Feb 20, 2018
    Last Verified:
    Aug 1, 2017
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Infections
    Communicable Diseases
    Hepatitis C
    Sofosbuvir
    Ribavirin

    Study Results

    Participant Flow

    Recruitment Details Participants were enrolled at 61 study sites in Asia. The first participant was screened on 10 December 2013. The last study visit occurred on 03 November 2016.
    Pre-assignment Detail 815 participants were screened.
    Arm/Group Title SOF+PEG+RBV 12 Weeks SOF+RBV 12 Weeks SOF+RBV 16 Weeks SOF+RBV 24 Weeks
    Arm/Group Description Participants with genotype 1 or 6 received Sofosbuvir (Sovaldi®; SOF) 400 mg tablet once daily + Pegylated interferon alfa-2a (PEG) 180 µg/0.5 mL pre-filled syringe administered subcutaneously once a week + ribavirin (RBV) tablets (1000 or 1200 mg daily based on weight) for 12 weeks Participants with genotype 1, 2 or 6 received SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks Participants with genotype 1 or 6 received SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 16 weeks Participants with genotype 1, 3 or 6 received SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 24 weeks
    Period Title: Overall Study
    STARTED 156 290 11 230
    COMPLETED 147 280 11 218
    NOT COMPLETED 9 10 0 12

    Baseline Characteristics

    Arm/Group Title SOF+PEG+RBV 12 Weeks (GT 1 and GT6) SOF+RBV 12 Weeks (GT1 and GT6) SOF+RBV 16 Weeks (GT1 and GT6) SOF+RBV 24 Weeks (GT1 and GT6) SOF+RBV 12 Weeks (GT2) SOF+RBV 24 Weeks (GT3) Total
    Arm/Group Description Participants with genotype 1 or 6 received SOF 400 mg tablet once daily + PEG 180 µg/0.5 mL pre-filled syringe administered subcutaneously once a week + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks Participants with genotype 1 or 6 received SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks Participants with genotype 1 or 6 received SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 16 weeks Participants with genotype 1 or 6 received SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 24 weeks Participants with genotype 2 received SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks Participants with genotype 3 received SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 24 weeks Total of all reporting groups
    Overall Participants 155 10 11 104 280 126 686
    Age (years) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [years]
    41
    (12.8)
    43
    (17.2)
    43
    (17.6)
    49
    (13.3)
    53
    (12.3)
    40
    (8.1)
    47
    (13.3)
    Sex: Female, Male (Count of Participants)
    Female
    67
    43.2%
    5
    50%
    2
    18.2%
    61
    58.7%
    160
    57.1%
    56
    44.4%
    351
    51.2%
    Male
    88
    56.8%
    5
    50%
    9
    81.8%
    43
    41.3%
    120
    42.9%
    70
    55.6%
    335
    48.8%
    Race/Ethnicity, Customized (Count of Participants)
    Asian
    155
    100%
    10
    100%
    11
    100%
    104
    100%
    280
    100%
    126
    100%
    686
    100%
    Race/Ethnicity, Customized (Count of Participants)
    Hispanic or Latino
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Not Hispanic or Latino
    151
    97.4%
    10
    100%
    11
    100%
    98
    94.2%
    280
    100%
    126
    100%
    676
    98.5%
    Not Disclosed
    4
    2.6%
    0
    0%
    0
    0%
    6
    5.8%
    0
    0%
    0
    0%
    10
    1.5%
    Region of Enrollment (participants) [Number]
    China
    130
    83.9%
    0
    0%
    0
    0%
    69
    66.3%
    64
    22.9%
    126
    100%
    389
    56.7%
    Hong Kong
    0
    0%
    10
    100%
    11
    100%
    10
    9.6%
    0
    0%
    0
    0%
    31
    4.5%
    South Korea
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    129
    46.1%
    0
    0%
    129
    18.8%
    Taiwan
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    87
    31.1%
    0
    0%
    87
    12.7%
    Vietnam
    25
    16.1%
    0
    0%
    0
    0%
    25
    24%
    0
    0%
    0
    0%
    50
    7.3%
    HCV Genotype (Count of Participants)
    Genotype 1
    108
    69.7%
    7
    70%
    7
    63.6%
    81
    77.9%
    0
    0%
    0
    0%
    203
    29.6%
    Genotype 2
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    280
    100%
    0
    0%
    280
    40.8%
    Genotype 3
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    126
    100%
    126
    18.4%
    Genotype 6
    47
    30.3%
    3
    30%
    4
    36.4%
    23
    22.1%
    0
    0%
    0
    0%
    77
    11.2%
    IL28b Status (Count of Participants)
    CC
    114
    73.5%
    8
    80%
    11
    100%
    74
    71.2%
    237
    84.6%
    102
    81%
    546
    79.6%
    CT
    40
    25.8%
    2
    20%
    0
    0%
    29
    27.9%
    42
    15%
    23
    18.3%
    136
    19.8%
    TT
    1
    0.6%
    0
    0%
    0
    0%
    1
    1%
    1
    0.4%
    1
    0.8%
    4
    0.6%
    HCV RNA (log10 IU/mL) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [log10 IU/mL]
    6.5
    (0.74)
    6.3
    (0.49)
    6.2
    (0.88)
    6.5
    (0.71)
    6.2
    (0.96)
    6.2
    (0.71)
    6.3
    (0.84)
    HCV RNA Category (Count of Participants)
    < 800,000 IU/mL
    21
    13.5%
    2
    20%
    6
    54.5%
    22
    21.2%
    87
    31.1%
    32
    25.4%
    170
    24.8%
    ≥ 800,000 IU/mL
    134
    86.5%
    8
    80%
    5
    45.5%
    82
    78.8%
    193
    68.9%
    94
    74.6%
    516
    75.2%

    Outcome Measures

    1. Primary Outcome
    Title Percentage of Participants With Sustained Virologic Response 12 Weeks After Discontinuation of Therapy (SVR12)
    Description SVR12 is defined as HCV RNA < the lower limit of quantification (LLOQ; ie, < 25 IU/mL) 12 weeks following the last dose of study drug.
    Time Frame Posttreatment Week 12

    Outcome Measure Data

    Analysis Population Description
    Full Analysis Set: participants who enrolled in the study and received at least one dose of study drug.
    Arm/Group Title SOF+PEG+RBV 12 Weeks (GT 1 and GT6) SOF+RBV 12 Weeks (GT1 and GT6) SOF+RBV 16 Weeks (GT1 and GT6) SOF+RBV 24 Weeks (GT1 and GT6) SOF+RBV 12 Weeks (GT2) SOF+RBV 24 Weeks (GT3)
    Arm/Group Description Participants with genotype 1 or 6 received SOF 400 mg tablet once daily + PEG 180 µg/0.5 mL pre-filled syringe administered subcutaneously once a week + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks Participants with genotype 1 or 6 received SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks Participants with genotype 1 or 6 received SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 16 weeks Participants with genotype 1 or 6 received SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 24 weeks Participants with genotype 2 received SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks Participants with genotype 3 received SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 24 weeks
    Measure Participants 155 10 11 104 280 126
    Number (95% Confidence Interval) [percentage of participants]
    95.5
    61.6%
    100
    1000%
    100
    909.1%
    94.2
    90.6%
    96.8
    34.6%
    95.2
    75.6%
    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
    Arm/Group Title SOF+PEG+RBV 12 Weeks SOF+RBV 12 Weeks SOF+RBV 16 Weeks SOF+RBV 24 Weeks
    Arm/Group Description Participants with genotype (GT) 1 or 6 received SOF 400 mg tablet once daily + PEG 180 µg/0.5 mL pre-filled syringe administered subcutaneously once a week + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks Participants with genotype 1, 2 or 6 received SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks Participants with genotype 1 or 6 received SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks Participants with genotype 1, 3 or 6 received SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 24 weeks
    Measure Participants 155 290 11 230
    Count of Participants [Participants]
    1
    0.6%
    1
    10%
    0
    0%
    2
    1.9%
    3. Secondary Outcome
    Title Percentage of Participants With Sustained Virologic Response 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)
    Description SVR4 and SVR24 are defined as HCV RNA < LLOQ at 4 and 24 weeks following the last dose of study drug, respectively.
    Time Frame Posttreatment Weeks 4 and 24

    Outcome Measure Data

    Analysis Population Description
    Full Analysis Set
    Arm/Group Title SOF+PEG+RBV 12 Weeks (GT 1 and GT6) SOF+RBV 12 Weeks (GT1 and GT6) SOF+RBV 16 Weeks (GT1 and GT6) SOF+RBV 24 Weeks (GT1 and GT6) SOF+RBV 12 Weeks (GT2) SOF+RBV 24 Weeks (GT3)
    Arm/Group Description Participants with genotype 1 or 6 received SOF 400 mg tablet once daily + PEG 180 µg/0.5 mL pre-filled syringe administered subcutaneously once a week + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks Participants with genotype 1 or 6 received SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks Participants with genotype 1 or 6 received SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 16 weeks Participants with genotype 1 or 6 received SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 24 weeks Participants with genotype 2 received SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks Participants with genotype 3 received SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 24 weeks
    Measure Participants 155 10 11 104 280 126
    SVR4
    96.8
    62.5%
    100
    1000%
    100
    909.1%
    94.2
    90.6%
    97.5
    34.8%
    97.6
    77.5%
    SVR24
    95.5
    61.6%
    100
    1000%
    90.9
    826.4%
    94.2
    90.6%
    96.8
    34.6%
    95.2
    75.6%
    4. Secondary Outcome
    Title Percentage of Participants With On-Treatment Virologic Failure
    Description Viral breakthrough was defined as HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ while receiving treatment.
    Time Frame Up to 24 weeks

    Outcome Measure Data

    Analysis Population Description
    Full Analysis Set
    Arm/Group Title SOF+PEG+RBV 12 Weeks (GT 1 and GT6) SOF+RBV 12 Weeks (GT1 and GT6) SOF+RBV 16 Weeks (GT1 and GT6) SOF+RBV 24 Weeks (GT1 and GT6) SOF+RBV 12 Weeks (GT2) SOF+RBV 24 Weeks (GT3)
    Arm/Group Description Participants with genotype 1 or 6 received SOF 400 mg tablet once daily + PEG 180 µg/0.5 mL pre-filled syringe administered subcutaneously once a week + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks Participants with genotype 1 or 6 received SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks Participants with genotype 1 or 6 received SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 16 weeks Participants with genotype 1 or 6 received SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 24 weeks Participants with genotype 2 received SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks Participants with genotype 3 received SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 24 weeks
    Measure Participants 155 10 11 104 280 126
    Count of Participants [Participants]
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    1
    0.4%
    0
    0%
    5. Secondary Outcome
    Title Percentage of Participants With Viral Relapse
    Description Viral relapse was defined as HCV RNA ≥ LLOQ during the post-treatment period having achieved HCV RNA < LLOQ at end of treatment, confirmed with 2 consecutive values or last available post-treatment measurement.
    Time Frame Up to Posttreatment Week 24

    Outcome Measure Data

    Analysis Population Description
    Full Analysis Set
    Arm/Group Title SOF+PEG+RBV 12 Weeks (GT 1 and GT6) SOF+RBV 12 Weeks (GT1 and GT6) SOF+RBV 16 Weeks (GT1 and GT6) SOF+RBV 24 Weeks (GT1 and GT6) SOF+RBV 12 Weeks (GT2) SOF+RBV 24 Weeks (GT3)
    Arm/Group Description Participants with genotype 1 or 6 received SOF 400 mg tablet once daily + PEG 180 µg/0.5 mL pre-filled syringe administered subcutaneously once a week + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks Participants with genotype 1 or 6 received SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks Participants with genotype 1 or 6 received SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 16 weeks Participants with genotype 1 or 6 received SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 24 weeks Participants with genotype 2 received SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks Participants with genotype 3 received SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 24 weeks
    Measure Participants 155 10 11 104 280 126
    Count of Participants [Participants]
    7
    4.5%
    0
    0%
    0
    0%
    6
    5.8%
    6
    2.1%
    6
    4.8%
    6. Secondary Outcome
    Title Change From Baseline in HCV RNA (log10 IU/mL)
    Description
    Time Frame Up to 24 weeks

    Outcome Measure Data

    Analysis Population Description
    Participants in the Full Analysis Set with available data were analyzed
    Arm/Group Title SOF+PEG+RBV 12 Weeks (GT 1 and GT6) SOF+RBV 12 Weeks (GT1 and GT6) SOF+RBV 16 Weeks (GT1 and GT6) SOF+RBV 24 Weeks (GT1 and GT6) SOF+RBV 12 Weeks (GT2) SOF+RBV 24 Weeks (GT3)
    Arm/Group Description Participants with genotype 1 or 6 received SOF 400 mg tablet once daily + PEG 180 µg/0.5 mL pre-filled syringe administered subcutaneously once a week + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks Participants with genotype 1 or 6 received SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks Participants with genotype 1 or 6 received SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 16 weeks Participants with genotype 1 or 6 received SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 24 weeks Participants with genotype 2 received SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks Participants with genotype 3 received SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 24 weeks
    Measure Participants 155 10 11 104 280 126
    Change at Week 1
    -4.81
    (0.653)
    -4.59
    (0.359)
    -4.36
    (0.560)
    -4.61
    (0.607)
    -4.46
    (0.815)
    -4.52
    (0.695)
    Change at Week 2
    -5.11
    (0.734)
    -4.89
    (0.488)
    -4.79
    (0.858)
    -5.04
    (0.682)
    -4.78
    (1.008)
    -4.86
    (0.706)
    Change at Week 4
    -5.12
    (0.738)
    -4.89
    (0.488)
    -4.82
    (0.880)
    -5.12
    (0.710)
    -4.81
    (1.025)
    -4.87
    (0.713)
    Change at Week 6
    -5.12
    (0.738)
    -4.89
    (0.488)
    -4.82
    (0.880)
    -5.12
    (0.710)
    -4.80
    (1.038)
    -4.87
    (0.713)
    Change at Week 8
    -5.12
    (0.738)
    -4.89
    (0.488)
    -4.82
    (0.880)
    -5.12
    (0.708)
    -4.83
    (0.966)
    -4.87
    (0.713)
    Change at Week 10
    -5.12
    (0.738)
    -4.89
    (0.488)
    -4.82
    (0.880)
    -5.12
    (0.708)
    -4.83
    (0.966)
    -4.87
    (0.713)
    Change at Week 12
    -5.12
    (0.739)
    -4.89
    (0.488)
    -4.82
    (0.880)
    -5.12
    (0.708)
    -4.83
    (0.966)
    -4.84
    (0.779)
    Change at Week 16
    -4.82
    (0.880)
    -5.12
    (0.708)
    -4.87
    (0.713)
    Change at Week 20
    -5.14
    (0.701)
    -4.87
    (0.713)
    Change at Week 24
    -5.14
    (0.701)
    -4.87
    (0.713)

    Adverse Events

    Time Frame Up to 24 Weeks Plus 30 Days
    Adverse Event Reporting Description
    Arm/Group Title SOF+PEG+RBV 12 Weeks SOF+RBV 12 Weeks SOF+RBV 16 Weeks SOF+RBV 24 Weeks
    Arm/Group Description Participants with genotype 1 or 6 received SOF 400 mg tablet once daily + PEG 180 µg/0.5 mL pre-filled syringe administered subcutaneously once a week + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks Participants with genotype 1, 2 or 6 received SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks Participants with genotype 1 or 6 received SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks Participants with genotype 1, 3 or 6 received SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 24 weeks
    All Cause Mortality
    SOF+PEG+RBV 12 Weeks SOF+RBV 12 Weeks SOF+RBV 16 Weeks SOF+RBV 24 Weeks
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total / (NaN) / (NaN) / (NaN) / (NaN)
    Serious Adverse Events
    SOF+PEG+RBV 12 Weeks SOF+RBV 12 Weeks SOF+RBV 16 Weeks SOF+RBV 24 Weeks
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 5/155 (3.2%) 7/290 (2.4%) 0/11 (0%) 4/230 (1.7%)
    Eye disorders
    Angle closure glaucoma 1/155 (0.6%) 0/290 (0%) 0/11 (0%) 0/230 (0%)
    Gastrointestinal disorders
    Colitis ischaemic 0/155 (0%) 1/290 (0.3%) 0/11 (0%) 0/230 (0%)
    Gastritis 1/155 (0.6%) 0/290 (0%) 0/11 (0%) 0/230 (0%)
    Gingival bleeding 0/155 (0%) 0/290 (0%) 0/11 (0%) 1/230 (0.4%)
    Pancreatitis 0/155 (0%) 0/290 (0%) 0/11 (0%) 1/230 (0.4%)
    Vomiting 0/155 (0%) 1/290 (0.3%) 0/11 (0%) 0/230 (0%)
    Hepatobiliary disorders
    Biliary colic 0/155 (0%) 1/290 (0.3%) 0/11 (0%) 0/230 (0%)
    Cholecystitis acute 0/155 (0%) 1/290 (0.3%) 0/11 (0%) 1/230 (0.4%)
    Cholelithiasis 0/155 (0%) 0/290 (0%) 0/11 (0%) 1/230 (0.4%)
    Hepatic lesion 0/155 (0%) 0/290 (0%) 0/11 (0%) 1/230 (0.4%)
    Infections and infestations
    Bronchitis 1/155 (0.6%) 0/290 (0%) 0/11 (0%) 0/230 (0%)
    Injury, poisoning and procedural complications
    Back injury 0/155 (0%) 1/290 (0.3%) 0/11 (0%) 0/230 (0%)
    Concussion 0/155 (0%) 1/290 (0.3%) 0/11 (0%) 0/230 (0%)
    Metabolism and nutrition disorders
    Hypocalcaemia 1/155 (0.6%) 0/290 (0%) 0/11 (0%) 0/230 (0%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Fibroadenoma of breast 0/155 (0%) 0/290 (0%) 0/11 (0%) 1/230 (0.4%)
    Lung neoplasm malignant 0/155 (0%) 1/290 (0.3%) 0/11 (0%) 0/230 (0%)
    Nervous system disorders
    Cerebellar infarction 0/155 (0%) 1/290 (0.3%) 0/11 (0%) 0/230 (0%)
    Cerebral haemorrhage 0/155 (0%) 1/290 (0.3%) 0/11 (0%) 0/230 (0%)
    Cerebral infarction 1/155 (0.6%) 0/290 (0%) 0/11 (0%) 0/230 (0%)
    Other (Not Including Serious) Adverse Events
    SOF+PEG+RBV 12 Weeks SOF+RBV 12 Weeks SOF+RBV 16 Weeks SOF+RBV 24 Weeks
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 145/155 (93.5%) 215/290 (74.1%) 5/11 (45.5%) 177/230 (77%)
    Blood and lymphatic system disorders
    Anaemia 30/155 (19.4%) 22/290 (7.6%) 1/11 (9.1%) 27/230 (11.7%)
    Leukopenia 30/155 (19.4%) 2/290 (0.7%) 0/11 (0%) 6/230 (2.6%)
    Neutropenia 27/155 (17.4%) 0/290 (0%) 0/11 (0%) 3/230 (1.3%)
    Thrombocytopenia 20/155 (12.9%) 0/290 (0%) 0/11 (0%) 3/230 (1.3%)
    Gastrointestinal disorders
    Abdominal pain upper 1/155 (0.6%) 5/290 (1.7%) 1/11 (9.1%) 4/230 (1.7%)
    Constipation 1/155 (0.6%) 2/290 (0.7%) 1/11 (9.1%) 7/230 (3%)
    Diarrhoea 3/155 (1.9%) 7/290 (2.4%) 1/11 (9.1%) 3/230 (1.3%)
    Dyspepsia 1/155 (0.6%) 8/290 (2.8%) 1/11 (9.1%) 0/230 (0%)
    Gastrooesophageal reflux disease 1/155 (0.6%) 4/290 (1.4%) 1/11 (9.1%) 0/230 (0%)
    Gingival pain 0/155 (0%) 1/290 (0.3%) 1/11 (9.1%) 0/230 (0%)
    Nausea 10/155 (6.5%) 14/290 (4.8%) 0/11 (0%) 2/230 (0.9%)
    Vomiting 6/155 (3.9%) 8/290 (2.8%) 1/11 (9.1%) 1/230 (0.4%)
    General disorders
    Asthenia 21/155 (13.5%) 8/290 (2.8%) 0/11 (0%) 9/230 (3.9%)
    Fatigue 24/155 (15.5%) 21/290 (7.2%) 0/11 (0%) 20/230 (8.7%)
    Malaise 0/155 (0%) 3/290 (1%) 2/11 (18.2%) 1/230 (0.4%)
    Non-cardiac chest pain 8/155 (5.2%) 0/290 (0%) 0/11 (0%) 4/230 (1.7%)
    Pain 9/155 (5.8%) 0/290 (0%) 0/11 (0%) 5/230 (2.2%)
    Pyrexia 56/155 (36.1%) 4/290 (1.4%) 0/11 (0%) 10/230 (4.3%)
    Infections and infestations
    Nasopharyngitis 6/155 (3.9%) 21/290 (7.2%) 0/11 (0%) 6/230 (2.6%)
    Upper respiratory tract infection 11/155 (7.1%) 30/290 (10.3%) 2/11 (18.2%) 27/230 (11.7%)
    Investigations
    Alanine aminotransferase increased 10/155 (6.5%) 0/290 (0%) 0/11 (0%) 6/230 (2.6%)
    Blood bilirubin increased 7/155 (4.5%) 7/290 (2.4%) 0/11 (0%) 34/230 (14.8%)
    Haemoglobin decreased 23/155 (14.8%) 9/290 (3.1%) 0/11 (0%) 20/230 (8.7%)
    Neutrophil count decreased 38/155 (24.5%) 1/290 (0.3%) 0/11 (0%) 1/230 (0.4%)
    Platelet count decreased 37/155 (23.9%) 1/290 (0.3%) 0/11 (0%) 2/230 (0.9%)
    Red blood cell count decreased 11/155 (7.1%) 6/290 (2.1%) 0/11 (0%) 16/230 (7%)
    Reticulocyte count increased 13/155 (8.4%) 15/290 (5.2%) 0/11 (0%) 35/230 (15.2%)
    White blood cell count decreased 33/155 (21.3%) 1/290 (0.3%) 0/11 (0%) 0/230 (0%)
    Metabolism and nutrition disorders
    Decreased appetite 9/155 (5.8%) 4/290 (1.4%) 0/11 (0%) 7/230 (3%)
    Musculoskeletal and connective tissue disorders
    Myalgia 20/155 (12.9%) 14/290 (4.8%) 0/11 (0%) 1/230 (0.4%)
    Nervous system disorders
    Dizziness 14/155 (9%) 17/290 (5.9%) 0/11 (0%) 11/230 (4.8%)
    Headache 24/155 (15.5%) 34/290 (11.7%) 0/11 (0%) 14/230 (6.1%)
    Psychiatric disorders
    Insomnia 6/155 (3.9%) 29/290 (10%) 0/11 (0%) 26/230 (11.3%)
    Irritability 1/155 (0.6%) 1/290 (0.3%) 1/11 (9.1%) 1/230 (0.4%)
    Respiratory, thoracic and mediastinal disorders
    Cough 16/155 (10.3%) 18/290 (6.2%) 0/11 (0%) 14/230 (6.1%)
    Oropharyngeal pain 9/155 (5.8%) 7/290 (2.4%) 0/11 (0%) 7/230 (3%)
    Skin and subcutaneous tissue disorders
    Pruritus 2/155 (1.3%) 33/290 (11.4%) 0/11 (0%) 8/230 (3.5%)
    Rash 11/155 (7.1%) 18/290 (6.2%) 0/11 (0%) 10/230 (4.3%)

    Limitations/Caveats

    [Not Specified]

    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:
    NCT02021643
    Other Study ID Numbers:
    • GS-US-334-0115
    First Posted:
    Dec 27, 2013
    Last Update Posted:
    Feb 20, 2018
    Last Verified:
    Aug 1, 2017