Clincosm LogoSign in Get a demo

LEPTON: Efficacy and Safety of Oral Regimens for the Treatment of Chronic HCV Infection

Sponsor
Gilead Sciences (Industry)
Overall Status
Completed
CT.gov ID
NCT02202980
Collaborator
(none)
273
Enrollment
2
Locations
15
Arms
21.2
Actual Duration (Months)
136.5
Patients Per Site
6.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study will evaluate the antiviral efficacy, safety, and tolerability of combination therapy with oral regimens for the treatment of chronic hepatitis C virus (HCV) infection.

Condition or Disease Intervention/Treatment Phase
Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
273 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Phase 2, Multicenter, Open-Label Study to Assess the Efficacy and Safety of Oral Regimens for the Treatment of Chronic HCV Infection
Actual Study Start Date :
Aug 4, 2014
Actual Primary Completion Date :
Mar 16, 2016
Actual Study Completion Date :
May 9, 2016

Arms and Interventions

Arm Intervention/Treatment
Experimental: LDV/SOF+RBV 24 Weeks (Cohort 1 Group 1)

Participants who previously received ledipasvir/sofosbuvir (LDV/SOF) fixed-dose combination (FDC) plus ribavirin (RBV) for ≥ 12 weeks without achieving sustained virologic response at 12 weeks following treatment (SVR12) will receive LDV/SOF+RBV for 24 weeks.

Drug: LDV/SOF
90/400 mg FDC tablet administered orally once daily
Other Names:
  • Harvoni®
  • GS-5885/GS-7977

    • Drug: 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: LDV/SOF+RBV 12 Weeks (Cohort 1 Group 2)

    Participants who previously received a sofosbuvir-based regimen without achieving SVR12 were initially enrolled to receive LDV/SOF+RBV for 12 weeks (excluding participants who previously received LDV/SOF+RBV for ≥ 12 weeks). Participants who did not achieve sustained virologic response at 12 weeks were then moved to Cohort 1 Group 1.

    Drug: LDV/SOF
    90/400 mg FDC tablet administered orally once daily
    Other Names:
  • Harvoni®
  • GS-5885/GS-7977

    • Drug: 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: LDV/SOF 12 Weeks GT2 (Cohort 2 Group 1)

    Participants with genotype 2 (GT2) HCV infection will receive LDV/SOF FDC for 12 weeks.

    Drug: LDV/SOF
    90/400 mg FDC tablet administered orally once daily
    Other Names:
  • Harvoni®
  • GS-5885/GS-7977

    		•
    Experimental: LDV/SOF 8 Weeks GT2 (Cohort 2 Group 2)

    Participants with GT2 HCV infection will receive LDV/SOF FDC for 8 weeks.

    Drug: LDV/SOF
    90/400 mg FDC tablet administered orally once daily
    Other Names:
  • Harvoni®
  • GS-5885/GS-7977

    		•
    Experimental: LDV/SOF 12 Weeks GT1/GT2/GT4 (Cohort 3 Group 1)

    Participants with genotypes 1 (GT1), 2 (GT2), or 4 (GT4) HCV infection and extrahepatic manifestations of chronic HCV infection will receive LDV/SOF FDC for 12 weeks.

    Drug: LDV/SOF
    90/400 mg FDC tablet administered orally once daily
    Other Names:
  • Harvoni®
  • GS-5885/GS-7977

    		•
    Experimental: LDV/SOF+RBV 12 Weeks GT3 (Cohort 3 Group 2)

    Participants with genotype 3 (GT3) HCV infection and extrahepatic manifestations of chronic HCV infection will receive LDV/SOF FDC plus RBV for 12 weeks.

    Drug: LDV/SOF
    90/400 mg FDC tablet administered orally once daily
    Other Names:
  • Harvoni®
  • GS-5885/GS-7977

    • Drug: 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/VEL+VOX 6 Weeks GT1 (Cohort 4)

    Treatment-naive participants with GT1 HCV infection without cirrhosis will receive VOX only on Day 1 followed by sofosbuvir/velpatasvir (SOF/VEL) + voxilaprevir (VOX) for 6 weeks.

    Drug: SOF/VEL
    400/100 mg FDC tablet administered orally once daily
    Other Names:
  • Epclusa®
  • GS-7977/GS-5816

    • Drug: VOX
    100 mg tablet administered orally once daily with food
    Other Names:
  • GS-9857

    		•
    Experimental: SOF/VEL+VOX 4 Weeks GT1 (Cohort 5 Group 1)

    Treatment-naive participants with GT1 HCV infection without cirrhosis will receive SOF/VEL+VOX for 4 weeks.

    Drug: SOF/VEL
    400/100 mg FDC tablet administered orally once daily
    Other Names:
  • Epclusa®
  • GS-7977/GS-5816

    • Drug: VOX
    100 mg tablet administered orally once daily with food
    Other Names:
  • GS-9857

    		•
    Experimental: SOF/VEL+VOX 6 Weeks GT1 (Cohort 5 Group 2)

    Treatment-naive participants with GT1 HCV infection with cirrhosis will receive SOF/VEL+VOX for 6 weeks.

    Drug: SOF/VEL
    400/100 mg FDC tablet administered orally once daily
    Other Names:
  • Epclusa®
  • GS-7977/GS-5816

    • Drug: VOX
    100 mg tablet administered orally once daily with food
    Other Names:
  • GS-9857

    		•
    Experimental: SOF/VEL+VOX 6 Weeks GT3 (Cohort 5 Group 3)

    Treatment-naive participants with GT3 HCV infection with cirrhosis will receive SOF/VEL+VOX for 6 weeks.

    Drug: SOF/VEL
    400/100 mg FDC tablet administered orally once daily
    Other Names:
  • Epclusa®
  • GS-7977/GS-5816

    • Drug: VOX
    100 mg tablet administered orally once daily with food
    Other Names:
  • GS-9857

    		•
    Experimental: SOF/VEL+VOX 8 Weeks GT1 (Cohort 5 Group 4)

    Treatment-experienced participants with GT1 HCV infection with cirrhosis who were previously treated with pegylated interferon (Peg-IFN)+RBV will receive SOF/VEL+VOX for 6 weeks.

    Drug: SOF/VEL
    400/100 mg FDC tablet administered orally once daily
    Other Names:
  • Epclusa®
  • GS-7977/GS-5816

    • Drug: VOX
    100 mg tablet administered orally once daily with food
    Other Names:
  • GS-9857

    		•
    Experimental: SOF/VEL+VOX 8 Weeks GT3 (Cohort 5 Group 5)

    Treatment-experienced participants with GT3 HCV infection with cirrhosis who were previously treated with Peg-IFN+RBV will receive SOF/VEL+VOX for 6 weeks.

    Drug: SOF/VEL
    400/100 mg FDC tablet administered orally once daily
    Other Names:
  • Epclusa®
  • GS-7977/GS-5816

    • Drug: VOX
    100 mg tablet administered orally once daily with food
    Other Names:
  • GS-9857

    		•
    Experimental: SOF/VEL+VOX 8 Weeks GT1 (Cohort 5 Group 6)

    Treatment-experienced participants with GT1 HCV infection with or without cirrhosis who were previously treated with non-structural protein (NS3/4A) protease inhibitor (PI) will receive SOF/VEL+VOX for 6 weeks.

    Drug: SOF/VEL
    400/100 mg FDC tablet administered orally once daily
    Other Names:
  • Epclusa®
  • GS-7977/GS-5816

    • Drug: VOX
    100 mg tablet administered orally once daily with food
    Other Names:
  • GS-9857

    		•
    Experimental: SOF/VEL+VOX 6 Weeks GT1 (Cohort 5 Group 7)

    Treatment-experienced participants with GT1 HCV infection with or without cirrhosis who were previously treated with direct-acting antivirals (DAA) will receive SOF/VEL+VOX for 6 weeks.

    Drug: SOF/VEL
    400/100 mg FDC tablet administered orally once daily
    Other Names:
  • Epclusa®
  • GS-7977/GS-5816

    • Drug: VOX
    100 mg tablet administered orally once daily with food
    Other Names:
  • GS-9857

    		•
    Experimental: SOF/VEL+VOX 8 Weeks GT3 (Cohort 5 Group 8)

    Treatment-experienced participants with GT3 HCV infection with or without cirrhosis who were previously treated with DAA will receive SOF/VEL+VOX for 8 weeks.

    Drug: SOF/VEL
    400/100 mg FDC tablet administered orally once daily
    Other Names:
  • Epclusa®
  • GS-7977/GS-5816

    • Drug: VOX
    100 mg tablet administered orally once daily with food
    Other Names:
  • GS-9857

    		•

    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, 15 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 Virologic Failure [Up to Posttreatment Week 24]

      Virologic failure was defined as: On-treatment virologic failure: 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) Virologic relapse: Confirmed HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA < LLOQ at last on-treatment visit.

    3. Percentage of Participants With HCV RNA < LLOQ While on Treatment by Study Visit [Weeks 1, 2, 4, 6, 8, 12, 16, 20, and 24 (depending on treatment duration; Week 6 data was not collected for Cohorts 1-3)]

    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

    • Chronic HCV infection

    • Cirrhosis determination (liver biopsy may be required)

    • Screening laboratory values within specified limits

    • Males and females of childbearing potential who engage in heterosexual intercourse must agree to use protocol specified method(s) of contraception

    • Specific genotype, prior medical history, or concurrent disease as required by the specific study group

    Key Exclusion Criteria:

    • History of clinically significant illness or any other medical disorder that may interfere with subject treatment, assessment or compliance with the protocol

    • Pregnant or nursing female, or male with pregnant female partner

    • Clinical hepatic decompensation (ie, ascites, encephalopathy or variceal hemorrhage)

    • Use of any prohibited concomitant medications

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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Auckland New Zealand
    2 Christchurch New Zealand

    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:
    NCT02202980
    Other Study ID Numbers:
    • GS-US-337-1468
    First Posted:
    Jul 29, 2014
    Last Update Posted:
    Nov 16, 2018
    Last Verified:
    Nov 1, 2017
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    Yes
    Additional relevant MeSH terms:
    Hepatitis C
    Hepatitis C, Chronic
    Sofosbuvir

    Study Results

    Participant Flow

    Recruitment Details Participants were enrolled at study sites in New Zealand. The first participant was screened on 04 August 2014. The last study visit occurred on 09 May 2016.
    Pre-assignment Detail 349 participants were screened.
    Arm/Group Title LDV/SOF+RBV 24 Weeks (Cohort 1 Group 1) LDV/SOF 12 Weeks GT2 (Cohort 2 Group 1) LDV/SOF 8 Weeks GT2 (Cohort 2 Group 2) LDV/SOF 12 Weeks GT1/GT2/GT4 (Cohort 3 Group 1) LDV/SOF 12 Weeks GT3 (Cohort 3 Group 2) SOF/VEL+VOX 6 Weeks GT1 (Cohort 4) SOF/VEL+VOX 4 Weeks GT1 (Cohort 5 Group 1) SOF/VEL+VOX 6 Weeks GT1 (Cohort 5 Group 2) SOF/VEL+VOX 6 Weeks GT3 (Cohort 5 Group 3) SOF/VEL+VOX 8 Weeks GT1 (Cohort 5 Group 4) SOF/VEL+VOX 8 Weeks GT3 (Cohort 5 Group 5) SOF/VEL+VOX 8 Weeks GT1 (Cohort 5 Group 6) SOF/VEL+VOX 6 Weeks GT1 (Cohort 5 Group 7) SOF/VEL+VOX 8 Weeks GT3 (Cohort 5 Group 8)
    Arm/Group Description Ledipasvir/sofosbuvir (LDV/SOF) (90/400 mg) fixed-dose combination (FDC) + ribavirin (RBV) (1000 or 1200 mg daily based on weight) for 24 weeks in participants who previously received LDV/SOF+RBV for ≥ 12 weeks without achieving sustained virologic response at 12 weeks following treatment (SVR12) LDV/SOF (90/400 mg) for 12 weeks in participants with genotype 2 HCV infection LDV/SOF (90/400 mg) for 8 weeks in participants with genotype 2 HCV infection LDV/SOF (90/400 mg) for 12 weeks in participants with genotypes 1, 2, or 4 HCV infection and extrahepatic manifestations of chronic HCV infection LDV/SOF (90/400 mg) + RBV (1000 or 1200 mg daily based on weight) for 12 weeks in participants with genotype 3 HCV infection and extrahepatic manifestations of chronic HCV infection Voxilaprevir (VOX) 100 mg with food on Day 1, followed by sofosbuvir/velpatasvir (SOF/VEL) (400/100 mg) + VOX 100 mg once daily with food for 6 weeks in treatment-naive participants with genotype 1 HCV infection without cirrhosis SOF/VEL (400/100 mg) + VOX 100 mg once daily with food for 4 weeks in treatment-naive participants with genotype 1 HCV infection without cirrhosis SOF/VEL (400/100 mg) + VOX 100 mg once daily with food for 6 weeks in treatment-naive participants with genotype 1 HCV infection with cirrhosis SOF/VEL (400/100 mg) + VOX 100 mg once daily with food for 6 weeks in treatment-naive participants with genotype 3 HCV infection with cirrhosis SOF/VEL (400/100 mg) + VOX 100 mg once daily with food for 8 weeks in treatment-experienced participants with genotype 1 HCV infection with cirrhosis SOF/VEL (400/100 mg) + VOX 100 mg once daily with food for 8 weeks in treatment-experienced participants with genotype 3 HCV infection with cirrhosis SOF/VEL (400/100 mg) + VOX 100 mg once daily with food for 8 weeks in nonstructural protein (NS3/4A) protease inhibitor (PI)-treatment-experienced participants with genotype 1 HCV infection with or without cirrhosis SOF/VEL (400/100 mg) + VOX 100 mg once daily with food for 6 weeks in direct-acting antiviral (DAA)-treatment-experienced participants with genotype 1 HCV infection with or without cirrhosis SOF/VEL (400/100 mg) + VOX 100 mg once daily with food for 8 weeks in DAA-treatment-experienced participants with genotype 3 HCV infection with or without cirrhosis
    Period Title: Overall Study
    STARTED 14 26 27 32 13 15 15 15 18 17 19 28 30 4
    COMPLETED 13 24 17 28 7 14 4 12 14 17 19 25 19 4
    NOT COMPLETED 1 2 10 4 6 1 11 3 4 0 0 3 11 0

    Baseline Characteristics

    Arm/Group Title LDV/SOF+RBV 24 Weeks (Cohort 1 Group 1) LDV/SOF 12 Weeks GT2 (Cohort 2 Group 1) LDV/SOF 8 Weeks GT2 (Cohort 2 Group 2) LDV/SOF 12 Weeks GT1/GT2/GT4 (Cohort 3 Group 1) LDV/SOF 12 Weeks GT3 (Cohort 3 Group 2) SOF/VEL+VOX 6 Weeks GT1 (Cohort 4) SOF/VEL+VOX 4 Weeks GT1 (Cohort 5 Group 1) SOF/VEL+VOX 6 Weeks GT1 (Cohort 5 Group 2) SOF/VEL+VOX 6 Weeks GT3 (Cohort 5 Group 3) SOF/VEL+VOX 8 Weeks GT1 (Cohort 5 Group 4) SOF/VEL+VOX 8 Weeks GT3 (Cohort 5 Group 5) SOF/VEL+VOX 8 Weeks GT1 (Cohort 5 Group 6) SOF/VEL+VOX 6 Weeks GT1 (Cohort 5 Group 7) SOF/VEL+VOX 8 Weeks GT3 (Cohort 5 Group 8) Total
    Arm/Group Description LDV/SOF (90/400 mg) + RBV (1000 or 1200 mg daily based on weight) for 24 weeks in participants who previously received LDV/SOF+RBV for ≥ 12 weeks without achieving SVR12 LDV/SOF (90/400 mg) for 12 weeks in participants with genotype 2 HCV infection LDV/SOF (90/400 mg) for 8 weeks in participants with genotype 2 HCV infection LDV/SOF (90/400 mg) for 12 weeks in participants with genotypes 1, 2, or 4 HCV infection and extrahepatic manifestations of chronic HCV infection LDV/SOF (90/400 mg) + RBV (1000 or 1200 mg daily based on weight) for 12 weeks in participants with genotype 3 HCV infection and extrahepatic manifestations of chronic HCV infection VOX 100 mg with food on Day 1, followed by SOF/VEL (400/100 mg) + VOX 100 mg once daily with food for 6 weeks in treatment-naive participants with genotype 1 HCV infection without cirrhosis SOF/VEL (400/100 mg) + VOX 100 mg once daily with food for 4 weeks in treatment-naive participants with genotype 1 HCV infection without cirrhosis SOF/VEL (400/100 mg) + VOX 100 mg once daily with food for 6 weeks in treatment-naive participants with genotype 1 HCV infection with cirrhosis SOF/VEL (400/100 mg) + VOX 100 mg once daily with food for 6 weeks in treatment-naive participants with genotype 3 HCV infection with cirrhosis SOF/VEL (400/100 mg) + VOX 100 mg once daily with food for 8 weeks in treatment-experienced participants with genotype 1 HCV infection with cirrhosis SOF/VEL (400/100 mg) + VOX 100 mg once daily with food for 8 weeks in treatment-experienced participants with genotype 3 HCV infection with cirrhosis SOF/VEL (400/100 mg) + VOX 100 mg once daily with food for 8 weeks in NS3/4A PI-treatment-experienced participants with genotype 1 HCV infection with or without cirrhosis SOF/VEL (400/100 mg) + VOX 100 mg once daily with food for 6 weeks in DAA-treatment-experienced participants with genotype 1 HCV infection with or without cirrhosis SOF/VEL (400/100 mg) + VOX 100 mg once daily with food for 8 weeks in DAA-treatment-experienced participants with genotype 3 HCV infection with or without cirrhosis Total of all reporting groups
    Overall Participants 14 26 27 32 13 15 15 15 18 17 19 28 30 4 273
    Age (Count of Participants)
    <=18 years
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Between 18 and 65 years
    13
    92.9%
    24
    92.3%
    25
    92.6%
    29
    90.6%
    13
    100%
    13
    86.7%
    15
    100%
    14
    93.3%
    18
    100%
    16
    94.1%
    18
    94.7%
    26
    92.9%
    29
    96.7%
    4
    100%
    257
    94.1%
    >=65 years
    1
    7.1%
    2
    7.7%
    2
    7.4%
    3
    9.4%
    0
    0%
    2
    13.3%
    0
    0%
    1
    6.7%
    0
    0%
    1
    5.9%
    1
    5.3%
    2
    7.1%
    1
    3.3%
    0
    0%
    16
    5.9%
    Sex: Female, Male (Count of Participants)
    Female
    4
    28.6%
    9
    34.6%
    8
    29.6%
    12
    37.5%
    1
    7.7%
    8
    53.3%
    6
    40%
    4
    26.7%
    8
    44.4%
    3
    17.6%
    4
    21.1%
    9
    32.1%
    6
    20%
    0
    0%
    82
    30%
    Male
    10
    71.4%
    17
    65.4%
    19
    70.4%
    20
    62.5%
    12
    92.3%
    7
    46.7%
    9
    60%
    11
    73.3%
    10
    55.6%
    14
    82.4%
    15
    78.9%
    19
    67.9%
    24
    80%
    4
    100%
    191
    70%
    Ethnicity (NIH/OMB) (Count of Participants)
    Hispanic or Latino
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    1
    6.7%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    1
    0.4%
    Not Hispanic or Latino
    14
    100%
    26
    100%
    27
    100%
    32
    100%
    13
    100%
    15
    100%
    14
    93.3%
    15
    100%
    18
    100%
    17
    100%
    19
    100%
    28
    100%
    30
    100%
    4
    100%
    272
    99.6%
    Unknown or Not Reported
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Race/Ethnicity, Customized (Count of Participants)
    White
    10
    71.4%
    24
    92.3%
    21
    77.8%
    26
    81.3%
    12
    92.3%
    14
    93.3%
    12
    80%
    14
    93.3%
    12
    66.7%
    16
    94.1%
    18
    94.7%
    24
    85.7%
    27
    90%
    3
    75%
    233
    85.3%
    Asian
    2
    14.3%
    2
    7.7%
    5
    18.5%
    1
    3.1%
    0
    0%
    1
    6.7%
    2
    13.3%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    2
    7.1%
    1
    3.3%
    0
    0%
    16
    5.9%
    Native Hawaiian or Other Pacific Islander
    0
    0%
    0
    0%
    1
    3.7%
    3
    9.4%
    1
    7.7%
    0
    0%
    1
    6.7%
    1
    6.7%
    3
    16.7%
    1
    5.9%
    1
    5.3%
    1
    3.6%
    2
    6.7%
    0
    0%
    15
    5.5%
    Other
    2
    14.3%
    0
    0%
    0
    0%
    2
    6.3%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    3
    16.7%
    0
    0%
    0
    0%
    1
    3.6%
    0
    0%
    1
    25%
    9
    3.3%
    HCV genotype (Count of Participants)
    Genotype 1a
    1
    7.1%
    0
    0%
    0
    0%
    28
    87.5%
    0
    0%
    11
    73.3%
    11
    73.3%
    14
    93.3%
    0
    0%
    15
    88.2%
    0
    0%
    24
    85.7%
    23
    76.7%
    0
    0%
    127
    46.5%
    Genotype 1b
    0
    0%
    0
    0%
    0
    0%
    3
    9.4%
    0
    0%
    4
    26.7%
    4
    26.7%
    1
    6.7%
    0
    0%
    2
    11.8%
    0
    0%
    4
    14.3%
    7
    23.3%
    0
    0%
    25
    9.2%
    Genotype 2
    7
    50%
    2
    7.7%
    27
    100%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    36
    13.2%
    Genotype 2a or 2c
    0
    0%
    8
    30.8%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    8
    2.9%
    Genotype 2b
    0
    0%
    16
    61.5%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    16
    5.9%
    Genotype 3
    2
    14.3%
    0
    0%
    0
    0%
    0
    0%
    12
    92.3%
    0
    0%
    0
    0%
    0
    0%
    17
    94.4%
    0
    0%
    19
    100%
    0
    0%
    0
    0%
    4
    100%
    54
    19.8%
    Genotype 3a
    3
    21.4%
    0
    0%
    0
    0%
    0
    0%
    1
    7.7%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    4
    1.5%
    Genotype 4
    0
    0%
    0
    0%
    0
    0%
    1
    3.1%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    1
    0.4%
    Indeterminate
    1
    7.1%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    1
    5.6%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    2
    0.7%
    Cirrhosis Status (Count of Participants)
    Yes
    4
    28.6%
    2
    7.7%
    0
    0%
    9
    28.1%
    10
    76.9%
    0
    0%
    0
    0%
    15
    100%
    18
    100%
    17
    100%
    19
    100%
    11
    39.3%
    5
    16.7%
    2
    50%
    112
    41%
    No
    10
    71.4%
    24
    92.3%
    27
    100%
    23
    71.9%
    3
    23.1%
    15
    100%
    15
    100%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    17
    60.7%
    25
    83.3%
    2
    50%
    161
    59%
    IL28b Status (Count of Participants)
    CC
    7
    50%
    10
    38.5%
    14
    51.9%
    6
    18.8%
    4
    30.8%
    5
    33.3%
    5
    33.3%
    8
    53.3%
    10
    55.6%
    6
    35.3%
    8
    42.1%
    4
    14.3%
    6
    20%
    3
    75%
    96
    35.2%
    CT
    7
    50%
    15
    57.7%
    10
    37%
    18
    56.3%
    6
    46.2%
    8
    53.3%
    10
    66.7%
    7
    46.7%
    6
    33.3%
    9
    52.9%
    9
    47.4%
    21
    75%
    18
    60%
    1
    25%
    145
    53.1%
    TT
    0
    0%
    1
    3.8%
    3
    11.1%
    7
    21.9%
    3
    23.1%
    2
    13.3%
    0
    0%
    0
    0%
    2
    11.1%
    2
    11.8%
    2
    10.5%
    3
    10.7%
    6
    20%
    0
    0%
    31
    11.4%
    HCV RNA Category (Count of Participants)
    < 800,000 IU/mL
    1
    7.1%
    11
    42.3%
    5
    18.5%
    8
    25%
    4
    30.8%
    5
    33.3%
    4
    26.7%
    4
    26.7%
    5
    27.8%
    3
    17.6%
    3
    15.8%
    10
    35.7%
    5
    16.7%
    0
    0%
    68
    24.9%
    ≥ 800,000 IU/mL
    13
    92.9%
    15
    57.7%
    22
    81.5%
    24
    75%
    9
    69.2%
    10
    66.7%
    11
    73.3%
    11
    73.3%
    13
    72.2%
    14
    82.4%
    16
    84.2%
    18
    64.3%
    25
    83.3%
    4
    100%
    205
    75.1%
    Prior HCV Treatment (Count of Participants)
    Treatment-Naive
    0
    0%
    21
    80.8%
    20
    74.1%
    17
    53.1%
    3
    23.1%
    15
    100%
    15
    100%
    15
    100%
    18
    100%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    124
    45.4%
    Treatment-Experienced
    14
    100%
    5
    19.2%
    7
    25.9%
    15
    46.9%
    10
    76.9%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    17
    100%
    19
    100%
    28
    100%
    30
    100%
    4
    100%
    149
    54.6%

    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, 15 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 into the study and received at least 1 dose of study drug
    Arm/Group Title LDV/SOF+RBV 24 Weeks (Cohort 1 Group 1) LDV/SOF 12 Weeks GT2 (Cohort 2 Group 1) LDV/SOF 8 Weeks GT2 (Cohort 2 Group 2) LDV/SOF 12 Weeks GT1/GT2/GT4 (Cohort 3 Group 1) LDV/SOF 12 Weeks GT3 (Cohort 3 Group 2) SOF/VEL+VOX 6 Weeks GT1 (Cohort 4) SOF/VEL+VOX 4 Weeks GT1 (Cohort 5 Group 1) SOF/VEL+VOX 6 Weeks GT1 (Cohort 5 Group 2) SOF/VEL+VOX 6 Weeks GT3 (Cohort 5 Group 3) SOF/VEL+VOX 8 Weeks GT1 (Cohort 5 Group 4) SOF/VEL+VOX 8 Weeks GT3 (Cohort 5 Group 5) SOF/VEL+VOX 8 Weeks GT1 (Cohort 5 Group 6) SOF/VEL+VOX 6 Weeks GT1 (Cohort 5 Group 7) SOF/VEL+VOX 8 Weeks GT3 (Cohort 5 Group 8)
    Arm/Group Description LDV/SOF (90/400 mg) + RBV (1000 or 1200 mg daily based on weight) for 24 weeks in participants who previously received LDV/SOF+RBV for ≥ 12 weeks without achieving SVR12 LDV/SOF (90/400 mg) for 12 weeks in participants with genotype 2 HCV infection LDV/SOF (90/400 mg) for 8 weeks in participants with genotype 2 HCV infection LDV/SOF (90/400 mg) for 12 weeks in participants with genotypes 1, 2, or 4 HCV infection and extrahepatic manifestations of chronic HCV infection LDV/SOF (90/400 mg) + RBV (1000 or 1200 mg daily based on weight) for 12 weeks in participants with genotype 3 HCV infection and extrahepatic manifestations of chronic HCV infection VOX 100 mg with food on Day 1, followed by SOF/VEL (400/100 mg) + VOX 100 mg once daily with food for 6 weeks in treatment-naive participants with genotype 1 HCV infection without cirrhosis SOF/VEL (400/100 mg) + VOX 100 mg once daily with food for 4 weeks in treatment-naive participants with genotype 1 HCV infection without cirrhosis SOF/VEL (400/100 mg) + VOX 100 mg once daily with food for 6 weeks in treatment-naive participants with genotype 1 HCV infection with cirrhosis SOF/VEL (400/100 mg) + VOX 100 mg once daily with food for 6 weeks in treatment-naive participants with genotype 3 HCV infection with cirrhosis SOF/VEL (400/100 mg) + VOX 100 mg once daily with food for 8 weeks in treatment-experienced participants with genotype 1 HCV infection with cirrhosis SOF/VEL (400/100 mg) + VOX 100 mg once daily with food for 8 weeks in treatment-experienced participants with genotype 3 HCV infection with cirrhosis SOF/VEL (400/100 mg) + VOX 100 mg once daily with food for 8 weeks in NS3/4A PI-treatment-experienced participants with genotype 1 HCV infection with or without cirrhosis SOF/VEL (400/100 mg) + VOX 100 mg once daily with food for 6 weeks in DAA-treatment-experienced participants with genotype 1 HCV infection with or without cirrhosis SOF/VEL (400/100 mg) + VOX 100 mg once daily with food for 8 weeks in DAA-treatment-experienced participants with genotype 3 HCV infection with or without cirrhosis
    Measure Participants 14 26 27 32 13 15 15 15 18 17 19 28 30 4
    Number (95% Confidence Interval) [percentage of participants]
    92.9
    663.6%
    96.2
    370%
    74.1
    274.4%
    100.0
    312.5%
    76.9
    591.5%
    93.3
    622%
    26.7
    178%
    86.7
    578%
    83.3
    462.8%
    100.0
    588.2%
    100.0
    526.3%
    89.3
    318.9%
    66.7
    222.3%
    100.0
    2500%
    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 into the study and received at least 1 dose of study drug
    Arm/Group Title LDV/SOF+RBV 24 Weeks (Cohort 1 Group 1) LDV/SOF 12 Weeks GT2 (Cohort 2 Group 1) LDV/SOF 8 Weeks GT2 (Cohort 2 Group 2) LDV/SOF 12 Weeks GT1/GT2/GT4 (Cohort 3 Group 1) LDV/SOF 12 Weeks GT3 (Cohort 3 Group 2) SOF/VEL+VOX 6 Weeks GT1 (Cohort 4) SOF/VEL+VOX 4 Weeks GT1 (Cohort 5 Group 1) SOF/VEL+VOX 6 Weeks GT1 (Cohort 5 Group 2) SOF/VEL+VOX 6 Weeks GT3 (Cohort 5 Group 3) SOF/VEL+VOX 8 Weeks GT1 (Cohort 5 Group 4) SOF/VEL+VOX 8 Weeks GT3 (Cohort 5 Group 5) SOF/VEL+VOX 8 Weeks GT1 (Cohort 5 Group 6) SOF/VEL+VOX 6 Weeks GT1 (Cohort 5 Group 7) SOF/VEL+VOX 8 Weeks GT3 (Cohort 5 Group 8)
    Arm/Group Description LDV/SOF (90/400 mg) + RBV (1000 or 1200 mg daily based on weight) for 24 weeks in participants who previously received LDV/SOF+RBV for ≥ 12 weeks without achieving SVR12 LDV/SOF (90/400 mg) for 12 weeks in participants with genotype 2 HCV infection LDV/SOF (90/400 mg) for 8 weeks in participants with genotype 2 HCV infection LDV/SOF (90/400 mg) for 12 weeks in participants with genotypes 1, 2, or 4 HCV infection and extrahepatic manifestations of chronic HCV infection LDV/SOF (90/400 mg) + RBV (1000 or 1200 mg daily based on weight) for 12 weeks in participants with genotype 3 HCV infection and extrahepatic manifestations of chronic HCV infection VOX 100 mg with food on Day 1, followed by SOF/VEL (400/100 mg) + VOX 100 mg once daily with food for 6 weeks in treatment-naive participants with genotype 1 HCV infection without cirrhosis SOF/VEL (400/100 mg) + VOX 100 mg once daily with food for 4 weeks in treatment-naive participants with genotype 1 HCV infection without cirrhosis SOF/VEL (400/100 mg) + VOX 100 mg once daily with food for 6 weeks in treatment-naive participants with genotype 1 HCV infection with cirrhosis SOF/VEL (400/100 mg) + VOX 100 mg once daily with food for 6 weeks in treatment-naive participants with genotype 3 HCV infection with cirrhosis SOF/VEL (400/100 mg) + VOX 100 mg once daily with food for 8 weeks in treatment-experienced participants with genotype 1 HCV infection with cirrhosis SOF/VEL (400/100 mg) + VOX 100 mg once daily with food for 8 weeks in treatment-experienced participants with genotype 3 HCV infection with cirrhosis SOF/VEL (400/100 mg) + VOX 100 mg once daily with food for 8 weeks in NS3/4A PI-treatment-experienced participants with genotype 1 HCV infection with or without cirrhosis SOF/VEL (400/100 mg) + VOX 100 mg once daily with food for 6 weeks in DAA-treatment-experienced participants with genotype 1 HCV infection with or without cirrhosis SOF/VEL (400/100 mg) + VOX 100 mg once daily with food for 8 weeks in DAA-treatment-experienced participants with genotype 3 HCV infection with or without cirrhosis
    Measure Participants 14 26 27 32 13 15 15 15 18 17 19 28 30 4
    Number [percentage of participants]
    7.1
    50.7%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    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: participants who were enrolled into the study and received at least 1 dose of study drug
    Arm/Group Title LDV/SOF+RBV 24 Weeks (Cohort 1 Group 1) LDV/SOF 12 Weeks GT2 (Cohort 2 Group 1) LDV/SOF 8 Weeks GT2 (Cohort 2 Group 2) LDV/SOF 12 Weeks GT1/GT2/GT4 (Cohort 3 Group 1) LDV/SOF 12 Weeks GT3 (Cohort 3 Group 2) SOF/VEL+VOX 6 Weeks GT1 (Cohort 4) SOF/VEL+VOX 4 Weeks GT1 (Cohort 5 Group 1) SOF/VEL+VOX 6 Weeks GT1 (Cohort 5 Group 2) SOF/VEL+VOX 6 Weeks GT3 (Cohort 5 Group 3) SOF/VEL+VOX 8 Weeks GT1 (Cohort 5 Group 4) SOF/VEL+VOX 8 Weeks GT3 (Cohort 5 Group 5) SOF/VEL+VOX 8 Weeks GT1 (Cohort 5 Group 6) SOF/VEL+VOX 6 Weeks GT1 (Cohort 5 Group 7) SOF/VEL+VOX 8 Weeks GT3 (Cohort 5 Group 8)
    Arm/Group Description LDV/SOF (90/400 mg) + RBV (1000 or 1200 mg daily based on weight) for 24 weeks in participants who previously received LDV/SOF+RBV for ≥ 12 weeks without achieving SVR12 LDV/SOF (90/400 mg) for 12 weeks in participants with genotype 2 HCV infection LDV/SOF (90/400 mg) for 8 weeks in participants with genotype 2 HCV infection LDV/SOF (90/400 mg) for 12 weeks in participants with genotypes 1, 2, or 4 HCV infection and extrahepatic manifestations of chronic HCV infection LDV/SOF (90/400 mg) + RBV (1000 or 1200 mg daily based on weight) for 12 weeks in participants with genotype 3 HCV infection and extrahepatic manifestations of chronic HCV infection VOX 100 mg with food on Day 1, followed by SOF/VEL (400/100 mg) + VOX 100 mg once daily with food for 6 weeks in treatment-naive participants with genotype 1 HCV infection without cirrhosis SOF/VEL (400/100 mg) + VOX 100 mg once daily with food for 4 weeks in treatment-naive participants with genotype 1 HCV infection without cirrhosis SOF/VEL (400/100 mg) + VOX 100 mg once daily with food for 6 weeks in treatment-naive participants with genotype 1 HCV infection with cirrhosis SOF/VEL (400/100 mg) + VOX 100 mg once daily with food for 6 weeks in treatment-naive participants with genotype 3 HCV infection with cirrhosis SOF/VEL (400/100 mg) + VOX 100 mg once daily with food for 8 weeks in treatment-experienced participants with genotype 1 HCV infection with cirrhosis SOF/VEL (400/100 mg) + VOX 100 mg once daily with food for 8 weeks in treatment-experienced participants with genotype 3 HCV infection with cirrhosis SOF/VEL (400/100 mg) + VOX 100 mg once daily with food for 8 weeks in NS3/4A PI-treatment-experienced participants with genotype 1 HCV infection with or without cirrhosis SOF/VEL (400/100 mg) + VOX 100 mg once daily with food for 6 weeks in DAA-treatment-experienced participants with genotype 1 HCV infection with or without cirrhosis SOF/VEL (400/100 mg) + VOX 100 mg once daily with food for 8 weeks in DAA-treatment-experienced participants with genotype 3 HCV infection with or without cirrhosis
    Measure Participants 14 26 27 32 13 15 15 15 18 17 19 28 30 4
    SVR4
    92.9
    663.6%
    96.2
    370%
    81.5
    301.9%
    100.0
    312.5%
    76.9
    591.5%
    100.0
    666.7%
    73.3
    488.7%
    86.7
    578%
    88.9
    493.9%
    100.0
    588.2%
    100.0
    526.3%
    92.9
    331.8%
    86.7
    289%
    100.0
    2500%
    SVR24
    92.9
    663.6%
    96.2
    370%
    74.1
    274.4%
    100.0
    312.5%
    76.9
    591.5%
    93.3
    622%
    20.0
    133.3%
    86.7
    578%
    83.3
    462.8%
    100.0
    588.2%
    100.0
    526.3%
    89.3
    318.9%
    66.7
    222.3%
    100.0
    2500%
    4. Secondary Outcome
    Title Percentage of Participants With Virologic Failure
    Description Virologic failure was defined as: On-treatment virologic failure: 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) Virologic relapse: Confirmed HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA < LLOQ at last on-treatment visit.
    Time Frame Up to Posttreatment Week 24

    Outcome Measure Data

    Analysis Population Description
    Full Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
    Arm/Group Title LDV/SOF+RBV 24 Weeks (Cohort 1 Group 1) LDV/SOF 12 Weeks GT2 (Cohort 2 Group 1) LDV/SOF 8 Weeks GT2 (Cohort 2 Group 2) LDV/SOF 12 Weeks GT1/GT2/GT4 (Cohort 3 Group 1) LDV/SOF 12 Weeks GT3 (Cohort 3 Group 2) SOF/VEL+VOX 6 Weeks GT1 (Cohort 4) SOF/VEL+VOX 4 Weeks GT1 (Cohort 5 Group 1) SOF/VEL+VOX 6 Weeks GT1 (Cohort 5 Group 2) SOF/VEL+VOX 6 Weeks GT3 (Cohort 5 Group 3) SOF/VEL+VOX 8 Weeks GT1 (Cohort 5 Group 4) SOF/VEL+VOX 8 Weeks GT3 (Cohort 5 Group 5) SOF/VEL+VOX 8 Weeks GT1 (Cohort 5 Group 6) SOF/VEL+VOX 6 Weeks GT1 (Cohort 5 Group 7) SOF/VEL+VOX 8 Weeks GT3 (Cohort 5 Group 8)
    Arm/Group Description LDV/SOF (90/400 mg) + RBV (1000 or 1200 mg daily based on weight) for 24 weeks in participants who previously received LDV/SOF+RBV for ≥ 12 weeks without achieving SVR12 LDV/SOF (90/400 mg) for 12 weeks in participants with genotype 2 HCV infection LDV/SOF (90/400 mg) for 8 weeks in participants with genotype 2 HCV infection LDV/SOF (90/400 mg) for 12 weeks in participants with genotypes 1, 2, or 4 HCV infection and extrahepatic manifestations of chronic HCV infection LDV/SOF (90/400 mg) + RBV (1000 or 1200 mg daily based on weight) for 12 weeks in participants with genotype 3 HCV infection and extrahepatic manifestations of chronic HCV infection VOX 100 mg with food on Day 1, followed by SOF/VEL (400/100 mg) + VOX 100 mg once daily with food for 6 weeks in treatment-naive participants with genotype 1 HCV infection without cirrhosis SOF/VEL (400/100 mg) + VOX 100 mg once daily with food for 4 weeks in treatment-naive participants with genotype 1 HCV infection without cirrhosis SOF/VEL (400/100 mg) + VOX 100 mg once daily with food for 6 weeks in treatment-naive participants with genotype 1 HCV infection with cirrhosis SOF/VEL (400/100 mg) + VOX 100 mg once daily with food for 6 weeks in treatment-naive participants with genotype 3 HCV infection with cirrhosis SOF/VEL (400/100 mg) + VOX 100 mg once daily with food for 8 weeks in treatment-experienced participants with genotype 1 HCV infection with cirrhosis SOF/VEL (400/100 mg) + VOX 100 mg once daily with food for 8 weeks in treatment-experienced participants with genotype 3 HCV infection with cirrhosis SOF/VEL (400/100 mg) + VOX 100 mg once daily with food for 8 weeks in NS3/4A PI-treatment-experienced participants with genotype 1 HCV infection with or without cirrhosis SOF/VEL (400/100 mg) + VOX 100 mg once daily with food for 6 weeks in DAA-treatment-experienced participants with genotype 1 HCV infection with or without cirrhosis SOF/VEL (400/100 mg) + VOX 100 mg once daily with food for 8 weeks in DAA-treatment-experienced participants with genotype 3 HCV infection with or without cirrhosis
    Measure Participants 14 26 27 32 13 15 15 15 18 17 19 28 30 4
    Number [percentage of participants]
    7.1
    50.7%
    0
    0%
    22.2
    82.2%
    0
    0%
    23.1
    177.7%
    6.7
    44.7%
    73.3
    488.7%
    13.3
    88.7%
    11.1
    61.7%
    0
    0%
    0
    0%
    10.7
    38.2%
    30.0
    100%
    0
    0%
    5. Secondary Outcome
    Title Percentage of Participants With HCV RNA < LLOQ While on Treatment by Study Visit
    Description
    Time Frame Weeks 1, 2, 4, 6, 8, 12, 16, 20, and 24 (depending on treatment duration; Week 6 data was not collected for Cohorts 1-3)

    Outcome Measure Data

    Analysis Population Description
    Participants in the Full Analysis Set with available data were analyzed.
    Arm/Group Title LDV/SOF+RBV 24 Weeks (Cohort 1 Group 1) LDV/SOF 12 Weeks GT2 (Cohort 2 Group 1) LDV/SOF 8 Weeks GT2 (Cohort 2 Group 2) LDV/SOF 12 Weeks GT1/GT2/GT4 (Cohort 3 Group 1) LDV/SOF 12 Weeks GT3 (Cohort 3 Group 2) SOF/VEL+VOX 6 Weeks GT1 (Cohort 4) SOF/VEL+VOX 4 Weeks GT1 (Cohort 5 Group 1) SOF/VEL+VOX 6 Weeks GT1 (Cohort 5 Group 2) SOF/VEL+VOX 6 Weeks GT3 (Cohort 5 Group 3) SOF/VEL+VOX 8 Weeks GT1 (Cohort 5 Group 4) SOF/VEL+VOX 8 Weeks GT3 (Cohort 5 Group 5) SOF/VEL+VOX 8 Weeks GT1 (Cohort 5 Group 6) SOF/VEL+VOX 6 Weeks GT1 (Cohort 5 Group 7) SOF/VEL+VOX 8 Weeks GT3 (Cohort 5 Group 8)
    Arm/Group Description LDV/SOF (90/400 mg) + RBV (1000 or 1200 mg daily based on weight) for 24 weeks in participants who previously received LDV/SOF+RBV for ≥ 12 weeks without achieving SVR12 LDV/SOF (90/400 mg) for 12 weeks in participants with genotype 2 HCV infection LDV/SOF (90/400 mg) for 8 weeks in participants with genotype 2 HCV infection LDV/SOF (90/400 mg) for 12 weeks in participants with genotypes 1, 2, or 4 HCV infection and extrahepatic manifestations of chronic HCV infection LDV/SOF (90/400 mg) + RBV (1000 or 1200 mg daily based on weight) for 12 weeks in participants with genotype 3 HCV infection and extrahepatic manifestations of chronic HCV infection VOX 100 mg with food on Day 1, followed by SOF/VEL (400/100 mg) + VOX 100 mg once daily with food for 6 weeks in treatment-naive participants with genotype 1 HCV infection without cirrhosis SOF/VEL (400/100 mg) + VOX 100 mg once daily with food for 4 weeks in treatment-naive participants with genotype 1 HCV infection without cirrhosis SOF/VEL (400/100 mg) + VOX 100 mg once daily with food for 6 weeks in treatment-naive participants with genotype 1 HCV infection with cirrhosis SOF/VEL (400/100 mg) + VOX 100 mg once daily with food for 6 weeks in treatment-naive participants with genotype 3 HCV infection with cirrhosis SOF/VEL (400/100 mg) + VOX 100 mg once daily with food for 8 weeks in treatment-experienced participants with genotype 1 HCV infection with cirrhosis SOF/VEL (400/100 mg) + VOX 100 mg once daily with food for 8 weeks in treatment-experienced participants with genotype 3 HCV infection with cirrhosis SOF/VEL (400/100 mg) + VOX 100 mg once daily with food for 8 weeks in NS3/4A PI-treatment-experienced participants with genotype 1 HCV infection with or without cirrhosis SOF/VEL (400/100 mg) + VOX 100 mg once daily with food for 6 weeks in DAA-treatment-experienced participants with genotype 1 HCV infection with or without cirrhosis SOF/VEL (400/100 mg) + VOX 100 mg once daily with food for 8 weeks in DAA-treatment-experienced participants with genotype 3 HCV infection with or without cirrhosis
    Measure Participants 14 25 27 32 13 15 15 15 18 17 19 28 30 4
    Week 1
    7.1
    50.7%
    28.0
    107.7%
    7.4
    27.4%
    9.4
    29.4%
    7.7
    59.2%
    26.7
    178%
    26.7
    178%
    26.7
    178%
    16.7
    92.8%
    5.9
    34.7%
    5.3
    27.9%
    7.1
    25.4%
    13.3
    44.3%
    0
    0%
    Week 2
    64.3
    459.3%
    60.0
    230.8%
    40.7
    150.7%
    53.1
    165.9%
    7.7
    59.2%
    66.7
    444.7%
    53.3
    355.3%
    66.7
    444.7%
    88.9
    493.9%
    41.2
    242.4%
    42.1
    221.6%
    60.7
    216.8%
    43.3
    144.3%
    25.0
    625%
    Week 4
    100.0
    714.3%
    92.0
    353.8%
    92.6
    343%
    87.5
    273.4%
    84.6
    650.8%
    100.0
    666.7%
    100.0
    666.7%
    100.0
    666.7%
    100.0
    555.6%
    76.5
    450%
    84.2
    443.2%
    85.7
    306.1%
    93.3
    311%
    100.0
    2500%
    Week 6
    100.0
    714.3%
    100.0
    384.6%
    100.0
    370.4%
    100.0
    312.5%
    94.7
    728.5%
    96.4
    642.7%
    96.7
    644.7%
    100.0
    666.7%
    Week 8
    100.0
    714.3%
    100.0
    384.6%
    96.3
    356.7%
    100.0
    312.5%
    100.0
    769.2%
    100.0
    666.7%
    100.0
    666.7%
    100.0
    666.7%
    100.0
    555.6%
    Week 12
    100.0
    714.3%
    100.0
    384.6%
    100.0
    370.4%
    100.0
    312.5%
    Week 16
    92.9
    663.6%
    Week 20
    92.9
    663.6%
    Week 24
    100.0
    714.3%

    Adverse Events

    Time Frame Up to 24 weeks plus 30 days
    Adverse Event Reporting Description Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
    Arm/Group Title LDV/SOF+RBV 24 Weeks (Cohort 1 Group 1) LDV/SOF 12 Weeks GT2 (Cohort 2 Group 1) LDV/SOF 8 Weeks GT2 (Cohort 2 Group 2) LDV/SOF 12 Weeks GT1/GT2/GT4 (Cohort 3 Group 1) LDV/SOF 12 Weeks GT3 (Cohort 3 Group 2) SOF/VEL+VOX 6 Weeks GT1 (Cohort 4) SOF/VEL+VOX 4 Weeks GT1 (Cohort 5 Group 1) SOF/VEL+VOX 6 Weeks GT1 (Cohort 5 Group 2) SOF/VEL+VOX 6 Weeks GT3 (Cohort 5 Group 3) SOF/VEL+VOX 8 Weeks GT1 (Cohort 5 Group 4) SOF/VEL+VOX 8 Weeks GT3 (Cohort 5 Group 5) SOF/VEL+VOX 8 Weeks GT1 (Cohort 5 Group 6) SOF/VEL+VOX 6 Weeks GT1 (Cohort 5 Group 7) SOF/VEL+VOX 8 Weeks GT3 (Cohort 5 Group 8)
    Arm/Group Description LDV/SOF (90/400 mg) + RBV (1000 or 1200 mg daily based on weight) for 24 weeks in participants who previously received LDV/SOF+RBV for ≥ 12 weeks without achieving SVR12 LDV/SOF (90/400 mg) for 12 weeks in participants with genotype 2 HCV infection LDV/SOF (90/400 mg) for 8 weeks in participants with genotype 2 HCV infection LDV/SOF (90/400 mg) for 12 weeks in participants with genotypes 1, 2, or 4 HCV infection and extrahepatic manifestations of chronic HCV infection LDV/SOF (90/400 mg) + RBV (1000 or 1200 mg daily based on weight) for 12 weeks in participants with genotype 3 HCV infection and extrahepatic manifestations of chronic HCV infection VOX 100 mg with food on Day 1, followed by SOF/VEL (400/100 mg) + VOX 100 mg once daily with food for 6 weeks in treatment-naive participants with genotype 1 HCV infection without cirrhosis SOF/VEL (400/100 mg) + VOX 100 mg once daily with food for 4 weeks in treatment-naive participants with genotype 1 HCV infection without cirrhosis SOF/VEL (400/100 mg) + VOX 100 mg once daily with food for 6 weeks in treatment-naive participants with genotype 1 HCV infection with cirrhosis SOF/VEL (400/100 mg) + VOX 100 mg once daily with food for 6 weeks in treatment-naive participants with genotype 3 HCV infection with cirrhosis SOF/VEL (400/100 mg) + VOX 100 mg once daily with food for 8 weeks in treatment-experienced participants with genotype 1 HCV infection with cirrhosis SOF/VEL (400/100 mg) + VOX 100 mg once daily with food for 8 weeks in treatment-experienced participants with genotype 3 HCV infection with cirrhosis SOF/VEL (400/100 mg) + VOX 100 mg once daily with food for 8 weeks in NS3/4A PI-treatment-experienced participants with genotype 1 HCV infection with or without cirrhosis SOF/VEL (400/100 mg) + VOX 100 mg once daily with food for 6 weeks in DAA-treatment-experienced participants with genotype 1 HCV infection with or without cirrhosis SOF/VEL (400/100 mg) + VOX 100 mg once daily with food for 8 weeks in DAA-treatment-experienced participants with genotype 3 HCV infection with or without cirrhosis
    All Cause Mortality
    LDV/SOF+RBV 24 Weeks (Cohort 1 Group 1) LDV/SOF 12 Weeks GT2 (Cohort 2 Group 1) LDV/SOF 8 Weeks GT2 (Cohort 2 Group 2) LDV/SOF 12 Weeks GT1/GT2/GT4 (Cohort 3 Group 1) LDV/SOF 12 Weeks GT3 (Cohort 3 Group 2) SOF/VEL+VOX 6 Weeks GT1 (Cohort 4) SOF/VEL+VOX 4 Weeks GT1 (Cohort 5 Group 1) SOF/VEL+VOX 6 Weeks GT1 (Cohort 5 Group 2) SOF/VEL+VOX 6 Weeks GT3 (Cohort 5 Group 3) SOF/VEL+VOX 8 Weeks GT1 (Cohort 5 Group 4) SOF/VEL+VOX 8 Weeks GT3 (Cohort 5 Group 5) SOF/VEL+VOX 8 Weeks GT1 (Cohort 5 Group 6) SOF/VEL+VOX 6 Weeks GT1 (Cohort 5 Group 7) SOF/VEL+VOX 8 Weeks GT3 (Cohort 5 Group 8)
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/14 (0%) 0/26 (0%) 0/27 (0%) 0/32 (0%) 0/13 (0%) 0/15 (0%) 0/15 (0%) 0/15 (0%) 0/18 (0%) 0/17 (0%) 0/19 (0%) 0/28 (0%) 0/30 (0%) 0/4 (0%)
    Serious Adverse Events
    LDV/SOF+RBV 24 Weeks (Cohort 1 Group 1) LDV/SOF 12 Weeks GT2 (Cohort 2 Group 1) LDV/SOF 8 Weeks GT2 (Cohort 2 Group 2) LDV/SOF 12 Weeks GT1/GT2/GT4 (Cohort 3 Group 1) LDV/SOF 12 Weeks GT3 (Cohort 3 Group 2) SOF/VEL+VOX 6 Weeks GT1 (Cohort 4) SOF/VEL+VOX 4 Weeks GT1 (Cohort 5 Group 1) SOF/VEL+VOX 6 Weeks GT1 (Cohort 5 Group 2) SOF/VEL+VOX 6 Weeks GT3 (Cohort 5 Group 3) SOF/VEL+VOX 8 Weeks GT1 (Cohort 5 Group 4) SOF/VEL+VOX 8 Weeks GT3 (Cohort 5 Group 5) SOF/VEL+VOX 8 Weeks GT1 (Cohort 5 Group 6) SOF/VEL+VOX 6 Weeks GT1 (Cohort 5 Group 7) SOF/VEL+VOX 8 Weeks GT3 (Cohort 5 Group 8)
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 2/14 (14.3%) 1/26 (3.8%) 2/27 (7.4%) 3/32 (9.4%) 2/13 (15.4%) 0/15 (0%) 0/15 (0%) 0/15 (0%) 0/18 (0%) 0/17 (0%) 2/19 (10.5%) 1/28 (3.6%) 0/30 (0%) 0/4 (0%)
    Cardiac disorders
    Atrial fibrillation 0/14 (0%) 0/26 (0%) 1/27 (3.7%) 0/32 (0%) 0/13 (0%) 0/15 (0%) 0/15 (0%) 0/15 (0%) 0/18 (0%) 0/17 (0%) 0/19 (0%) 1/28 (3.6%) 0/30 (0%) 0/4 (0%)
    Ear and labyrinth disorders
    Meniere's disease 0/14 (0%) 0/26 (0%) 0/27 (0%) 1/32 (3.1%) 0/13 (0%) 0/15 (0%) 0/15 (0%) 0/15 (0%) 0/18 (0%) 0/17 (0%) 0/19 (0%) 0/28 (0%) 0/30 (0%) 0/4 (0%)
    Gastrointestinal disorders
    Gastrooesophageal reflux disease 0/14 (0%) 1/26 (3.8%) 0/27 (0%) 0/32 (0%) 0/13 (0%) 0/15 (0%) 0/15 (0%) 0/15 (0%) 0/18 (0%) 0/17 (0%) 0/19 (0%) 0/28 (0%) 0/30 (0%) 0/4 (0%)
    Nausea 1/14 (7.1%) 0/26 (0%) 0/27 (0%) 0/32 (0%) 0/13 (0%) 0/15 (0%) 0/15 (0%) 0/15 (0%) 0/18 (0%) 0/17 (0%) 0/19 (0%) 0/28 (0%) 0/30 (0%) 0/4 (0%)
    Infections and infestations
    Gastroenteritis 1/14 (7.1%) 0/26 (0%) 0/27 (0%) 0/32 (0%) 0/13 (0%) 0/15 (0%) 0/15 (0%) 0/15 (0%) 0/18 (0%) 0/17 (0%) 0/19 (0%) 0/28 (0%) 0/30 (0%) 0/4 (0%)
    Lower respiratory tract infection 0/14 (0%) 0/26 (0%) 0/27 (0%) 0/32 (0%) 1/13 (7.7%) 0/15 (0%) 0/15 (0%) 0/15 (0%) 0/18 (0%) 0/17 (0%) 0/19 (0%) 0/28 (0%) 0/30 (0%) 0/4 (0%)
    Pneumonia 0/14 (0%) 0/26 (0%) 0/27 (0%) 1/32 (3.1%) 0/13 (0%) 0/15 (0%) 0/15 (0%) 0/15 (0%) 0/18 (0%) 0/17 (0%) 0/19 (0%) 0/28 (0%) 0/30 (0%) 0/4 (0%)
    Injury, poisoning and procedural complications
    Fall 1/14 (7.1%) 0/26 (0%) 0/27 (0%) 0/32 (0%) 0/13 (0%) 0/15 (0%) 0/15 (0%) 0/15 (0%) 0/18 (0%) 0/17 (0%) 0/19 (0%) 0/28 (0%) 0/30 (0%) 0/4 (0%)
    Metabolism and nutrition disorders
    Hyperglycaemia 0/14 (0%) 0/26 (0%) 0/27 (0%) 0/32 (0%) 1/13 (7.7%) 0/15 (0%) 0/15 (0%) 0/15 (0%) 0/18 (0%) 0/17 (0%) 0/19 (0%) 0/28 (0%) 0/30 (0%) 0/4 (0%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Bladder transitional cell carcinoma 0/14 (0%) 0/26 (0%) 0/27 (0%) 0/32 (0%) 0/13 (0%) 0/15 (0%) 0/15 (0%) 0/15 (0%) 0/18 (0%) 0/17 (0%) 1/19 (5.3%) 0/28 (0%) 0/30 (0%) 0/4 (0%)
    Hepatocellular carcinoma 0/14 (0%) 0/26 (0%) 0/27 (0%) 0/32 (0%) 0/13 (0%) 0/15 (0%) 0/15 (0%) 0/15 (0%) 0/18 (0%) 0/17 (0%) 1/19 (5.3%) 0/28 (0%) 0/30 (0%) 0/4 (0%)
    Psychiatric disorders
    Bipolar I disorder 0/14 (0%) 0/26 (0%) 1/27 (3.7%) 0/32 (0%) 0/13 (0%) 0/15 (0%) 0/15 (0%) 0/15 (0%) 0/18 (0%) 0/17 (0%) 0/19 (0%) 0/28 (0%) 0/30 (0%) 0/4 (0%)
    Confusional state 0/14 (0%) 0/26 (0%) 0/27 (0%) 0/32 (0%) 1/13 (7.7%) 0/15 (0%) 0/15 (0%) 0/15 (0%) 0/18 (0%) 0/17 (0%) 0/19 (0%) 0/28 (0%) 0/30 (0%) 0/4 (0%)
    Renal and urinary disorders
    Acute kidney injury 0/14 (0%) 0/26 (0%) 0/27 (0%) 0/32 (0%) 1/13 (7.7%) 0/15 (0%) 0/15 (0%) 0/15 (0%) 0/18 (0%) 0/17 (0%) 0/19 (0%) 0/28 (0%) 0/30 (0%) 0/4 (0%)
    Renal colic 0/14 (0%) 0/26 (0%) 0/27 (0%) 1/32 (3.1%) 0/13 (0%) 0/15 (0%) 0/15 (0%) 0/15 (0%) 0/18 (0%) 0/17 (0%) 0/19 (0%) 0/28 (0%) 0/30 (0%) 0/4 (0%)
    Other (Not Including Serious) Adverse Events
    LDV/SOF+RBV 24 Weeks (Cohort 1 Group 1) LDV/SOF 12 Weeks GT2 (Cohort 2 Group 1) LDV/SOF 8 Weeks GT2 (Cohort 2 Group 2) LDV/SOF 12 Weeks GT1/GT2/GT4 (Cohort 3 Group 1) LDV/SOF 12 Weeks GT3 (Cohort 3 Group 2) SOF/VEL+VOX 6 Weeks GT1 (Cohort 4) SOF/VEL+VOX 4 Weeks GT1 (Cohort 5 Group 1) SOF/VEL+VOX 6 Weeks GT1 (Cohort 5 Group 2) SOF/VEL+VOX 6 Weeks GT3 (Cohort 5 Group 3) SOF/VEL+VOX 8 Weeks GT1 (Cohort 5 Group 4) SOF/VEL+VOX 8 Weeks GT3 (Cohort 5 Group 5) SOF/VEL+VOX 8 Weeks GT1 (Cohort 5 Group 6) SOF/VEL+VOX 6 Weeks GT1 (Cohort 5 Group 7) SOF/VEL+VOX 8 Weeks GT3 (Cohort 5 Group 8)
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 12/14 (85.7%) 15/26 (57.7%) 21/27 (77.8%) 24/32 (75%) 11/13 (84.6%) 12/15 (80%) 13/15 (86.7%) 10/15 (66.7%) 15/18 (83.3%) 15/17 (88.2%) 14/19 (73.7%) 21/28 (75%) 23/30 (76.7%) 3/4 (75%)
    Blood and lymphatic system disorders
    Anaemia 0/14 (0%) 0/26 (0%) 0/27 (0%) 0/32 (0%) 1/13 (7.7%) 0/15 (0%) 0/15 (0%) 0/15 (0%) 0/18 (0%) 0/17 (0%) 0/19 (0%) 0/28 (0%) 0/30 (0%) 0/4 (0%)
    Haemolytic anaemia 0/14 (0%) 0/26 (0%) 0/27 (0%) 0/32 (0%) 2/13 (15.4%) 0/15 (0%) 0/15 (0%) 0/15 (0%) 0/18 (0%) 0/17 (0%) 0/19 (0%) 0/28 (0%) 0/30 (0%) 0/4 (0%)
    Cardiac disorders
    Palpitations 0/14 (0%) 0/26 (0%) 0/27 (0%) 0/32 (0%) 1/13 (7.7%) 0/15 (0%) 0/15 (0%) 0/15 (0%) 0/18 (0%) 0/17 (0%) 0/19 (0%) 0/28 (0%) 0/30 (0%) 0/4 (0%)
    Ear and labyrinth disorders
    Deafness 0/14 (0%) 0/26 (0%) 0/27 (0%) 0/32 (0%) 0/13 (0%) 0/15 (0%) 0/15 (0%) 0/15 (0%) 1/18 (5.6%) 0/17 (0%) 0/19 (0%) 0/28 (0%) 0/30 (0%) 0/4 (0%)
    Ear pain 0/14 (0%) 0/26 (0%) 0/27 (0%) 0/32 (0%) 0/13 (0%) 0/15 (0%) 0/15 (0%) 0/15 (0%) 0/18 (0%) 0/17 (0%) 1/19 (5.3%) 0/28 (0%) 0/30 (0%) 0/4 (0%)
    Tinnitus 0/14 (0%) 0/26 (0%) 0/27 (0%) 0/32 (0%) 0/13 (0%) 0/15 (0%) 0/15 (0%) 2/15 (13.3%) 1/18 (5.6%) 0/17 (0%) 0/19 (0%) 0/28 (0%) 0/30 (0%) 0/4 (0%)
    Eye disorders
    Diplopia 1/14 (7.1%) 0/26 (0%) 0/27 (0%) 0/32 (0%) 0/13 (0%) 0/15 (0%) 0/15 (0%) 0/15 (0%) 0/18 (0%) 0/17 (0%) 0/19 (0%) 0/28 (0%) 0/30 (0%) 0/4 (0%)
    Vision blurred 0/14 (0%) 0/26 (0%) 0/27 (0%) 0/32 (0%) 0/13 (0%) 1/15 (6.7%) 0/15 (0%) 0/15 (0%) 0/18 (0%) 0/17 (0%) 0/19 (0%) 1/28 (3.6%) 0/30 (0%) 0/4 (0%)
    Visual impairment 0/14 (0%) 0/26 (0%) 0/27 (0%) 0/32 (0%) 0/13 (0%) 0/15 (0%) 0/15 (0%) 0/15 (0%) 1/18 (5.6%) 0/17 (0%) 1/19 (5.3%) 0/28 (0%) 0/30 (0%) 0/4 (0%)
    Vitreous detachment 0/14 (0%) 0/26 (0%) 0/27 (0%) 0/32 (0%) 0/13 (0%) 0/15 (0%) 0/15 (0%) 0/15 (0%) 0/18 (0%) 0/17 (0%) 1/19 (5.3%) 0/28 (0%) 0/30 (0%) 0/4 (0%)
    Gastrointestinal disorders
    Abdominal discomfort 0/14 (0%) 1/26 (3.8%) 0/27 (0%) 0/32 (0%) 0/13 (0%) 1/15 (6.7%) 0/15 (0%) 2/15 (13.3%) 0/18 (0%) 0/17 (0%) 0/19 (0%) 0/28 (0%) 1/30 (3.3%) 0/4 (0%)
    Abdominal distension 0/14 (0%) 1/26 (3.8%) 0/27 (0%) 0/32 (0%) 0/13 (0%) 1/15 (6.7%) 0/15 (0%) 0/15 (0%) 0/18 (0%) 0/17 (0%) 0/19 (0%) 0/28 (0%) 1/30 (3.3%) 0/4 (0%)
    Abdominal pain 1/14 (7.1%) 0/26 (0%) 0/27 (0%) 1/32 (3.1%) 0/13 (0%) 0/15 (0%) 0/15 (0%) 0/15 (0%) 0/18 (0%) 0/17 (0%) 0/19 (0%) 2/28 (7.1%) 1/30 (3.3%) 0/4 (0%)
    Abdominal pain lower 0/14 (0%) 0/26 (0%) 0/27 (0%) 0/32 (0%) 0/13 (0%) 0/15 (0%) 0/15 (0%) 0/15 (0%) 1/18 (5.6%) 0/17 (0%) 0/19 (0%) 0/28 (0%) 0/30 (0%) 0/4 (0%)
    Abdominal pain upper 0/14 (0%) 0/26 (0%) 1/27 (3.7%) 0/32 (0%) 0/13 (0%) 0/15 (0%) 0/15 (0%) 0/15 (0%) 0/18 (0%) 1/17 (5.9%) 0/19 (0%) 0/28 (0%) 0/30 (0%) 0/4 (0%)
    Constipation 1/14 (7.1%) 0/26 (0%) 0/27 (0%) 1/32 (3.1%) 0/13 (0%) 1/15 (6.7%) 0/15 (0%) 0/15 (0%) 1/18 (5.6%) 2/17 (11.8%) 0/19 (0%) 0/28 (0%) 0/30 (0%) 0/4 (0%)
    Diarrhoea 0/14 (0%) 2/26 (7.7%) 1/27 (3.7%) 1/32 (3.1%) 0/13 (0%) 3/15 (20%) 2/15 (13.3%) 0/15 (0%) 4/18 (22.2%) 1/17 (5.9%) 0/19 (0%) 6/28 (21.4%) 2/30 (6.7%) 2/4 (50%)
    Dyspepsia 0/14 (0%) 0/26 (0%) 2/27 (7.4%) 0/32 (0%) 0/13 (0%) 0/15 (0%) 0/15 (0%) 0/15 (0%) 1/18 (5.6%) 2/17 (11.8%) 0/19 (0%) 0/28 (0%) 0/30 (0%) 0/4 (0%)
    Flatulence 0/14 (0%) 0/26 (0%) 0/27 (0%) 0/32 (0%) 0/13 (0%) 0/15 (0%) 0/15 (0%) 0/15 (0%) 0/18 (0%) 0/17 (0%) 0/19 (0%) 0/28 (0%) 1/30 (3.3%) 1/4 (25%)
    Gastrooesophageal reflux disease 1/14 (7.1%) 0/26 (0%) 0/27 (0%) 0/32 (0%) 0/13 (0%) 1/15 (6.7%) 0/15 (0%) 0/15 (0%) 1/18 (5.6%) 0/17 (0%) 3/19 (15.8%) 0/28 (0%) 0/30 (0%) 0/4 (0%)
    Glossodynia 1/14 (7.1%) 0/26 (0%) 0/27 (0%) 0/32 (0%) 0/13 (0%) 0/15 (0%) 0/15 (0%) 0/15 (0%) 0/18 (0%) 0/17 (0%) 0/19 (0%) 0/28 (0%) 0/30 (0%) 0/4 (0%)
    Mouth ulceration 0/14 (0%) 0/26 (0%) 0/27 (0%) 0/32 (0%) 0/13 (0%) 2/15 (13.3%) 0/15 (0%) 0/15 (0%) 0/18 (0%) 0/17 (0%) 0/19 (0%) 0/28 (0%) 2/30 (6.7%) 0/4 (0%)
    Nausea 3/14 (21.4%) 4/26 (15.4%) 5/27 (18.5%) 5/32 (15.6%) 1/13 (7.7%) 5/15 (33.3%) 5/15 (33.3%) 3/15 (20%) 3/18 (16.7%) 1/17 (5.9%) 7/19 (36.8%) 3/28 (10.7%) 5/30 (16.7%) 1/4 (25%)
    Retching 0/14 (0%) 0/26 (0%) 0/27 (0%) 0/32 (0%) 0/13 (0%) 0/15 (0%) 0/15 (0%) 0/15 (0%) 1/18 (5.6%) 0/17 (0%) 0/19 (0%) 0/28 (0%) 0/30 (0%) 0/4 (0%)
    Salivary gland enlargement 0/14 (0%) 0/26 (0%) 0/27 (0%) 0/32 (0%) 0/13 (0%) 0/15 (0%) 0/15 (0%) 0/15 (0%) 1/18 (5.6%) 0/17 (0%) 0/19 (0%) 0/28 (0%) 0/30 (0%) 0/4 (0%)
    Toothache 1/14 (7.1%) 0/26 (0%) 1/27 (3.7%) 0/32 (0%) 0/13 (0%) 0/15 (0%) 1/15 (6.7%) 1/15 (6.7%) 0/18 (0%) 1/17 (5.9%) 1/19 (5.3%) 0/28 (0%) 0/30 (0%) 0/4 (0%)
    Vomiting 1/14 (7.1%) 2/26 (7.7%) 1/27 (3.7%) 2/32 (6.3%) 1/13 (7.7%) 1/15 (6.7%) 1/15 (6.7%) 0/15 (0%) 2/18 (11.1%) 1/17 (5.9%) 3/19 (15.8%) 1/28 (3.6%) 0/30 (0%) 0/4 (0%)
    General disorders
    Asthenia 0/14 (0%) 0/26 (0%) 0/27 (0%) 0/32 (0%) 0/13 (0%) 0/15 (0%) 0/15 (0%) 0/15 (0%) 0/18 (0%) 2/17 (11.8%) 0/19 (0%) 0/28 (0%) 0/30 (0%) 0/4 (0%)
    Catheter site erythema 0/14 (0%) 0/26 (0%) 0/27 (0%) 0/32 (0%) 0/13 (0%) 1/15 (6.7%) 0/15 (0%) 0/15 (0%) 0/18 (0%) 0/17 (0%) 0/19 (0%) 0/28 (0%) 0/30 (0%) 0/4 (0%)
    Catheter site pain 0/14 (0%) 0/26 (0%) 0/27 (0%) 0/32 (0%) 0/13 (0%) 0/15 (0%) 1/15 (6.7%) 0/15 (0%) 0/18 (0%) 0/17 (0%) 0/19 (0%) 0/28 (0%) 0/30 (0%) 0/4 (0%)
    Chills 0/14 (0%) 0/26 (0%) 0/27 (0%) 0/32 (0%) 0/13 (0%) 0/15 (0%) 0/15 (0%) 0/15 (0%) 1/18 (5.6%) 0/17 (0%) 0/19 (0%) 0/28 (0%) 0/30 (0%) 0/4 (0%)
    Fatigue 3/14 (21.4%) 6/26 (23.1%) 5/27 (18.5%) 4/32 (12.5%) 2/13 (15.4%) 5/15 (33.3%) 2/15 (13.3%) 2/15 (13.3%) 3/18 (16.7%) 3/17 (17.6%) 2/19 (10.5%) 7/28 (25%) 3/30 (10%) 1/4 (25%)
    Feeling cold 0/14 (0%) 0/26 (0%) 0/27 (0%) 0/32 (0%) 0/13 (0%) 1/15 (6.7%) 0/15 (0%) 0/15 (0%) 0/18 (0%) 0/17 (0%) 0/19 (0%) 0/28 (0%) 0/30 (0%) 0/4 (0%)
    Generalised oedema 0/14 (0%) 0/26 (0%) 0/27 (0%) 0/32 (0%) 1/13 (7.7%) 0/15 (0%) 0/15 (0%) 0/15 (0%) 0/18 (0%) 0/17 (0%) 0/19 (0%) 0/28 (0%) 0/30 (0%) 0/4 (0%)
    Impaired healing 0/14 (0%) 0/26 (0%) 0/27 (0%) 0/32 (0%) 0/13 (0%) 0/15 (0%) 1/15 (6.7%) 0/15 (0%) 0/18 (0%) 0/17 (0%) 0/19 (0%) 0/28 (0%) 0/30 (0%) 0/4 (0%)
    Malaise 0/14 (0%) 0/26 (0%) 0/27 (0%) 1/32 (3.1%) 0/13 (0%) 0/15 (0%) 0/15 (0%) 1/15 (6.7%) 0/18 (0%) 0/17 (0%) 0/19 (0%) 1/28 (3.6%) 2/30 (6.7%) 0/4 (0%)
    Peripheral swelling 0/14 (0%) 0/26 (0%) 0/27 (0%) 2/32 (6.3%) 0/13 (0%) 0/15 (0%) 0/15 (0%) 0/15 (0%) 0/18 (0%) 0/17 (0%) 0/19 (0%) 0/28 (0%) 0/30 (0%) 0/4 (0%)
    Pyrexia 0/14 (0%) 0/26 (0%) 0/27 (0%) 0/32 (0%) 1/13 (7.7%) 0/15 (0%) 0/15 (0%) 0/15 (0%) 0/18 (0%) 0/17 (0%) 0/19 (0%) 0/28 (0%) 0/30 (0%) 0/4 (0%)
    Thirst 0/14 (0%) 0/26 (0%) 0/27 (0%) 0/32 (0%) 0/13 (0%) 0/15 (0%) 0/15 (0%) 0/15 (0%) 0/18 (0%) 0/17 (0%) 1/19 (5.3%) 0/28 (0%) 0/30 (0%) 0/4 (0%)
    Vessel puncture site haematoma 0/14 (0%) 0/26 (0%) 0/27 (0%) 0/32 (0%) 0/13 (0%) 0/15 (0%) 0/15 (0%) 0/15 (0%) 1/18 (5.6%) 0/17 (0%) 0/19 (0%) 0/28 (0%) 0/30 (0%) 0/4 (0%)
    Immune system disorders
    Food allergy 0/14 (0%) 0/26 (0%) 0/27 (0%) 0/32 (0%) 0/13 (0%) 0/15 (0%) 1/15 (6.7%) 0/15 (0%) 0/18 (0%) 0/17 (0%) 0/19 (0%) 0/28 (0%) 0/30 (0%) 0/4 (0%)
    Infections and infestations
    Bronchitis 0/14 (0%) 0/26 (0%) 0/27 (0%) 1/32 (3.1%) 1/13 (7.7%) 1/15 (6.7%) 0/15 (0%) 0/15 (0%) 0/18 (0%) 0/17 (0%) 1/19 (5.3%) 0/28 (0%) 0/30 (0%) 0/4 (0%)
    Cellulitis 0/14 (0%) 0/26 (0%) 0/27 (0%) 1/32 (3.1%) 0/13 (0%) 0/15 (0%) 0/15 (0%) 0/15 (0%) 0/18 (0%) 1/17 (5.9%) 0/19 (0%) 0/28 (0%) 0/30 (0%) 0/4 (0%)
    Folliculitis 0/14 (0%) 0/26 (0%) 0/27 (0%) 0/32 (0%) 1/13 (7.7%) 0/15 (0%) 0/15 (0%) 0/15 (0%) 0/18 (0%) 0/17 (0%) 0/19 (0%) 0/28 (0%) 0/30 (0%) 0/4 (0%)
    Gastroenteritis 2/14 (14.3%) 2/26 (7.7%) 2/27 (7.4%) 0/32 (0%) 0/13 (0%) 0/15 (0%) 1/15 (6.7%) 1/15 (6.7%) 1/18 (5.6%) 0/17 (0%) 0/19 (0%) 0/28 (0%) 0/30 (0%) 0/4 (0%)
    Gingivitis 0/14 (0%) 0/26 (0%) 0/27 (0%) 0/32 (0%) 0/13 (0%) 1/15 (6.7%) 0/15 (0%) 0/15 (0%) 0/18 (0%) 0/17 (0%) 0/19 (0%) 0/28 (0%) 0/30 (0%) 0/4 (0%)
    Hordeolum 0/14 (0%) 1/26 (3.8%) 0/27 (0%) 0/32 (0%) 0/13 (0%) 0/15 (0%) 0/15 (0%) 1/15 (6.7%) 0/18 (0%) 0/17 (0%) 0/19 (0%) 0/28 (0%) 0/30 (0%) 0/4 (0%)
    Lower respiratory tract infection viral 0/14 (0%) 0/26 (0%) 0/27 (0%) 0/32 (0%) 1/13 (7.7%) 0/15 (0%) 0/15 (0%) 0/15 (0%) 0/18 (0%) 0/17 (0%) 0/19 (0%) 0/28 (0%) 0/30 (0%) 0/4 (0%)
    Nasopharyngitis 0/14 (0%) 0/26 (0%) 0/27 (0%) 0/32 (0%) 0/13 (0%) 0/15 (0%) 0/15 (0%) 0/15 (0%) 1/18 (5.6%) 0/17 (0%) 0/19 (0%) 0/28 (0%) 0/30 (0%) 0/4 (0%)
    Oral candidiasis 0/14 (0%) 0/26 (0%) 0/27 (0%) 0/32 (0%) 0/13 (0%) 0/15 (0%) 0/15 (0%) 0/15 (0%) 0/18 (0%) 0/17 (0%) 1/19 (5.3%) 0/28 (0%) 0/30 (0%) 0/4 (0%)
    Oral herpes 0/14 (0%) 1/26 (3.8%) 0/27 (0%) 0/32 (0%) 0/13 (0%) 0/15 (0%) 1/15 (6.7%) 0/15 (0%) 0/18 (0%) 0/17 (0%) 0/19 (0%) 0/28 (0%) 0/30 (0%) 0/4 (0%)
    Otitis media 0/14 (0%) 0/26 (0%) 0/27 (0%) 0/32 (0%) 0/13 (0%) 0/15 (0%) 0/15 (0%) 0/15 (0%) 0/18 (0%) 1/17 (5.9%) 0/19 (0%) 0/28 (0%) 1/30 (3.3%) 0/4 (0%)
    Paronychia 0/14 (0%) 0/26 (0%) 0/27 (0%) 0/32 (0%) 1/13 (7.7%) 0/15 (0%) 0/15 (0%) 0/15 (0%) 0/18 (0%) 0/17 (0%) 0/19 (0%) 0/28 (0%) 0/30 (0%) 0/4 (0%)
    Pharyngitis 0/14 (0%) 0/26 (0%) 0/27 (0%) 0/32 (0%) 0/13 (0%) 0/15 (0%) 0/15 (0%) 0/15 (0%) 0/18 (0%) 1/17 (5.9%) 0/19 (0%) 0/28 (0%) 0/30 (0%) 0/4 (0%)
    Skin infection 0/14 (0%) 0/26 (0%) 0/27 (0%) 0/32 (0%) 0/13 (0%) 0/15 (0%) 0/15 (0%) 0/15 (0%) 1/18 (5.6%) 0/17 (0%) 0/19 (0%) 0/28 (0%) 0/30 (0%) 0/4 (0%)
    Upper respiratory tract infection 4/14 (28.6%) 4/26 (15.4%) 0/27 (0%) 7/32 (21.9%) 1/13 (7.7%) 0/15 (0%) 2/15 (13.3%) 0/15 (0%) 4/18 (22.2%) 0/17 (0%) 1/19 (5.3%) 4/28 (14.3%) 1/30 (3.3%) 1/4 (25%)
    Urinary tract infection 0/14 (0%) 0/26 (0%) 1/27 (3.7%) 1/32 (3.1%) 0/13 (0%) 0/15 (0%) 1/15 (6.7%) 0/15 (0%) 1/18 (5.6%) 0/17 (0%) 0/19 (0%) 2/28 (7.1%) 0/30 (0%) 0/4 (0%)
    Viral infection 1/14 (7.1%) 0/26 (0%) 0/27 (0%) 0/32 (0%) 0/13 (0%) 0/15 (0%) 1/15 (6.7%) 1/15 (6.7%) 0/18 (0%) 0/17 (0%) 0/19 (0%) 1/28 (3.6%) 3/30 (10%) 0/4 (0%)
    Viral upper respiratory tract infection 0/14 (0%) 0/26 (0%) 0/27 (0%) 1/32 (3.1%) 0/13 (0%) 0/15 (0%) 0/15 (0%) 0/15 (0%) 1/18 (5.6%) 2/17 (11.8%) 2/19 (10.5%) 2/28 (7.1%) 0/30 (0%) 0/4 (0%)
    Wound infection 0/14 (0%) 0/26 (0%) 0/27 (0%) 1/32 (3.1%) 0/13 (0%) 0/15 (0%) 0/15 (0%) 0/15 (0%) 0/18 (0%) 1/17 (5.9%) 0/19 (0%) 0/28 (0%) 0/30 (0%) 0/4 (0%)
    Injury, poisoning and procedural complications
    Animal bite 0/14 (0%) 0/26 (0%) 0/27 (0%) 0/32 (0%) 1/13 (7.7%) 0/15 (0%) 0/15 (0%) 0/15 (0%) 0/18 (0%) 0/17 (0%) 0/19 (0%) 0/28 (0%) 0/30 (0%) 0/4 (0%)
    Arthropod sting 0/14 (0%) 0/26 (0%) 0/27 (0%) 0/32 (0%) 0/13 (0%) 0/15 (0%) 0/15 (0%) 0/15 (0%) 0/18 (0%) 0/17 (0%) 1/19 (5.3%) 0/28 (0%) 0/30 (0%) 0/4 (0%)
    Chemical burn of skin 0/14 (0%) 0/26 (0%) 0/27 (0%) 0/32 (0%) 0/13 (0%) 0/15 (0%) 0/15 (0%) 0/15 (0%) 1/18 (5.6%) 0/17 (0%) 0/19 (0%) 0/28 (0%) 0/30 (0%) 0/4 (0%)
    Contusion 0/14 (0%) 0/26 (0%) 0/27 (0%) 1/32 (3.1%) 0/13 (0%) 0/15 (0%) 0/15 (0%) 0/15 (0%) 0/18 (0%) 2/17 (11.8%) 1/19 (5.3%) 1/28 (3.6%) 0/30 (0%) 0/4 (0%)
    Foreign body in eye 0/14 (0%) 0/26 (0%) 0/27 (0%) 0/32 (0%) 0/13 (0%) 0/15 (0%) 0/15 (0%) 0/15 (0%) 0/18 (0%) 0/17 (0%) 1/19 (5.3%) 0/28 (0%) 0/30 (0%) 0/4 (0%)
    Laceration 0/14 (0%) 1/26 (3.8%) 0/27 (0%) 0/32 (0%) 0/13 (0%) 1/15 (6.7%) 0/15 (0%) 0/15 (0%) 2/18 (11.1%) 1/17 (5.9%) 0/19 (0%) 0/28 (0%) 0/30 (0%) 0/4 (0%)
    Ligament sprain 0/14 (0%) 0/26 (0%) 0/27 (0%) 1/32 (3.1%) 0/13 (0%) 0/15 (0%) 0/15 (0%) 0/15 (0%) 0/18 (0%) 1/17 (5.9%) 1/19 (5.3%) 1/28 (3.6%) 0/30 (0%) 0/4 (0%)
    Muscle strain 1/14 (7.1%) 1/26 (3.8%) 0/27 (0%) 1/32 (3.1%) 0/13 (0%) 0/15 (0%) 0/15 (0%) 1/15 (6.7%) 0/18 (0%) 1/17 (5.9%) 1/19 (5.3%) 1/28 (3.6%) 0/30 (0%) 0/4 (0%)
    Neck injury 0/14 (0%) 0/26 (0%) 0/27 (0%) 0/32 (0%) 0/13 (0%) 0/15 (0%) 0/15 (0%) 0/15 (0%) 1/18 (5.6%) 0/17 (0%) 0/19 (0%) 0/28 (0%) 0/30 (0%) 0/4 (0%)
    Skeletal injury 0/14 (0%) 0/26 (0%) 0/27 (0%) 0/32 (0%) 0/13 (0%) 0/15 (0%) 0/15 (0%) 0/15 (0%) 0/18 (0%) 0/17 (0%) 1/19 (5.3%) 0/28 (0%) 0/30 (0%) 0/4 (0%)
    Skin abrasion 0/14 (0%) 0/26 (0%) 0/27 (0%) 1/32 (3.1%) 0/13 (0%) 0/15 (0%) 0/15 (0%) 0/15 (0%) 0/18 (0%) 1/17 (5.9%) 0/19 (0%) 1/28 (3.6%) 0/30 (0%) 0/4 (0%)
    Thermal burn 0/14 (0%) 0/26 (0%) 0/27 (0%) 0/32 (0%) 0/13 (0%) 1/15 (6.7%) 0/15 (0%) 0/15 (0%) 1/18 (5.6%) 0/17 (0%) 0/19 (0%) 1/28 (3.6%) 0/30 (0%) 0/4 (0%)
    Investigations
    Weight decreased 0/14 (0%) 0/26 (0%) 0/27 (0%) 0/32 (0%) 0/13 (0%) 0/15 (0%) 1/15 (6.7%) 0/15 (0%) 0/18 (0%) 0/17 (0%) 0/19 (0%) 0/28 (0%) 2/30 (6.7%) 0/4 (0%)
    Metabolism and nutrition disorders
    Decreased appetite 0/14 (0%) 0/26 (0%) 0/27 (0%) 0/32 (0%) 0/13 (0%) 0/15 (0%) 1/15 (6.7%) 0/15 (0%) 1/18 (5.6%) 0/17 (0%) 0/19 (0%) 0/28 (0%) 1/30 (3.3%) 0/4 (0%)
    Dehydration 0/14 (0%) 0/26 (0%) 0/27 (0%) 0/32 (0%) 1/13 (7.7%) 0/15 (0%) 0/15 (0%) 0/15 (0%) 0/18 (0%) 0/17 (0%) 0/19 (0%) 0/28 (0%) 0/30 (0%) 0/4 (0%)
    Fluid overload 0/14 (0%) 0/26 (0%) 0/27 (0%) 0/32 (0%) 1/13 (7.7%) 0/15 (0%) 0/15 (0%) 0/15 (0%) 0/18 (0%) 0/17 (0%) 0/19 (0%) 0/28 (0%) 0/30 (0%) 0/4 (0%)
    Hypokalaemia 1/14 (7.1%) 0/26 (0%) 0/27 (0%) 1/32 (3.1%) 0/13 (0%) 0/15 (0%) 0/15 (0%) 0/15 (0%) 0/18 (0%) 0/17 (0%) 0/19 (0%) 0/28 (0%) 0/30 (0%) 0/4 (0%)
    Increased appetite 0/14 (0%) 0/26 (0%) 0/27 (0%) 0/32 (0%) 0/13 (0%) 0/15 (0%) 1/15 (6.7%) 0/15 (0%) 0/18 (0%) 0/17 (0%) 0/19 (0%) 0/28 (0%) 0/30 (0%) 0/4 (0%)
    Musculoskeletal and connective tissue disorders
    Arthralgia 1/14 (7.1%) 1/26 (3.8%) 0/27 (0%) 1/32 (3.1%) 0/13 (0%) 0/15 (0%) 0/15 (0%) 1/15 (6.7%) 0/18 (0%) 0/17 (0%) 2/19 (10.5%) 0/28 (0%) 0/30 (0%) 0/4 (0%)
    Back pain 1/14 (7.1%) 1/26 (3.8%) 2/27 (7.4%) 0/32 (0%) 0/13 (0%) 0/15 (0%) 0/15 (0%) 0/15 (0%) 0/18 (0%) 0/17 (0%) 0/19 (0%) 1/28 (3.6%) 1/30 (3.3%) 0/4 (0%)
    Muscle spasms 1/14 (7.1%) 1/26 (3.8%) 0/27 (0%) 0/32 (0%) 0/13 (0%) 0/15 (0%) 0/15 (0%) 0/15 (0%) 0/18 (0%) 0/17 (0%) 0/19 (0%) 0/28 (0%) 0/30 (0%) 0/4 (0%)
    Musculoskeletal chest pain 1/14 (7.1%) 0/26 (0%) 0/27 (0%) 1/32 (3.1%) 1/13 (7.7%) 0/15 (0%) 0/15 (0%) 0/15 (0%) 0/18 (0%) 0/17 (0%) 0/19 (0%) 1/28 (3.6%) 0/30 (0%) 0/4 (0%)
    Musculoskeletal pain 0/14 (0%) 0/26 (0%) 1/27 (3.7%) 0/32 (0%) 0/13 (0%) 0/15 (0%) 2/15 (13.3%) 0/15 (0%) 0/18 (0%) 0/17 (0%) 0/19 (0%) 1/28 (3.6%) 0/30 (0%) 0/4 (0%)
    Myalgia 2/14 (14.3%) 0/26 (0%) 0/27 (0%) 0/32 (0%) 0/13 (0%) 0/15 (0%) 0/15 (0%) 0/15 (0%) 1/18 (5.6%) 2/17 (11.8%) 0/19 (0%) 3/28 (10.7%) 1/30 (3.3%) 0/4 (0%)
    Neck pain 0/14 (0%) 0/26 (0%) 0/27 (0%) 0/32 (0%) 1/13 (7.7%) 0/15 (0%) 0/15 (0%) 0/15 (0%) 0/18 (0%) 0/17 (0%) 1/19 (5.3%) 1/28 (3.6%) 0/30 (0%) 0/4 (0%)
    Osteoarthritis 1/14 (7.1%) 0/26 (0%) 0/27 (0%) 0/32 (0%) 0/13 (0%) 0/15 (0%) 0/15 (0%) 0/15 (0%) 0/18 (0%) 0/17 (0%) 0/19 (0%) 0/28 (0%) 0/30 (0%) 0/4 (0%)
    Pain in extremity 0/14 (0%) 1/26 (3.8%) 0/27 (0%) 0/32 (0%) 0/13 (0%) 0/15 (0%) 0/15 (0%) 0/15 (0%) 0/18 (0%) 1/17 (5.9%) 0/19 (0%) 0/28 (0%) 0/30 (0%) 0/4 (0%)
    Synovial cyst 0/14 (0%) 0/26 (0%) 0/27 (0%) 0/32 (0%) 0/13 (0%) 0/15 (0%) 0/15 (0%) 0/15 (0%) 1/18 (5.6%) 0/17 (0%) 0/19 (0%) 0/28 (0%) 0/30 (0%) 0/4 (0%)
    Trigger finger 1/14 (7.1%) 1/26 (3.8%) 0/27 (0%) 0/32 (0%) 0/13 (0%) 0/15 (0%) 0/15 (0%) 0/15 (0%) 0/18 (0%) 0/17 (0%) 0/19 (0%) 0/28 (0%) 0/30 (0%) 0/4 (0%)
    Nervous system disorders
    Balance disorder 0/14 (0%) 0/26 (0%) 0/27 (0%) 0/32 (0%) 0/13 (0%) 0/15 (0%) 0/15 (0%) 0/15 (0%) 1/18 (5.6%) 0/17 (0%) 0/19 (0%) 0/28 (0%) 0/30 (0%) 0/4 (0%)
    Cognitive disorder 0/14 (0%) 0/26 (0%) 0/27 (0%) 0/32 (0%) 0/13 (0%) 0/15 (0%) 0/15 (0%) 0/15 (0%) 0/18 (0%) 0/17 (0%) 1/19 (5.3%) 0/28 (0%) 0/30 (0%) 0/4 (0%)
    Dizziness 0/14 (0%) 0/26 (0%) 0/27 (0%) 0/32 (0%) 1/13 (7.7%) 0/15 (0%) 0/15 (0%) 1/15 (6.7%) 0/18 (0%) 0/17 (0%) 1/19 (5.3%) 2/28 (7.1%) 2/30 (6.7%) 0/4 (0%)
    Dysgeusia 0/14 (0%) 0/26 (0%) 0/27 (0%) 0/32 (0%) 0/13 (0%) 0/15 (0%) 0/15 (0%) 1/15 (6.7%) 0/18 (0%) 1/17 (5.9%) 0/19 (0%) 0/28 (0%) 0/30 (0%) 0/4 (0%)
    Encephalopathy 0/14 (0%) 0/26 (0%) 0/27 (0%) 0/32 (0%) 0/13 (0%) 0/15 (0%) 0/15 (0%) 0/15 (0%) 1/18 (5.6%) 0/17 (0%) 0/19 (0%) 0/28 (0%) 0/30 (0%) 0/4 (0%)
    Head discomfort 0/14 (0%) 0/26 (0%) 0/27 (0%) 0/32 (0%) 0/13 (0%) 0/15 (0%) 0/15 (0%) 0/15 (0%) 0/18 (0%) 1/17 (5.9%) 0/19 (0%) 0/28 (0%) 0/30 (0%) 0/4 (0%)
    Headache 6/14 (42.9%) 6/26 (23.1%) 7/27 (25.9%) 6/32 (18.8%) 1/13 (7.7%) 6/15 (40%) 2/15 (13.3%) 4/15 (26.7%) 6/18 (33.3%) 3/17 (17.6%) 4/19 (21.1%) 5/28 (17.9%) 6/30 (20%) 1/4 (25%)
    Lethargy 1/14 (7.1%) 0/26 (0%) 1/27 (3.7%) 1/32 (3.1%) 0/13 (0%) 0/15 (0%) 0/15 (0%) 0/15 (0%) 0/18 (0%) 0/17 (0%) 0/19 (0%) 0/28 (0%) 2/30 (6.7%) 0/4 (0%)
    Memory impairment 0/14 (0%) 0/26 (0%) 0/27 (0%) 0/32 (0%) 0/13 (0%) 0/15 (0%) 0/15 (0%) 0/15 (0%) 1/18 (5.6%) 0/17 (0%) 0/19 (0%) 0/28 (0%) 0/30 (0%) 0/4 (0%)
    Migraine without aura 0/14 (0%) 0/26 (0%) 0/27 (0%) 0/32 (0%) 0/13 (0%) 0/15 (0%) 0/15 (0%) 0/15 (0%) 1/18 (5.6%) 0/17 (0%) 0/19 (0%) 0/28 (0%) 0/30 (0%) 0/4 (0%)
    Paraesthesia 0/14 (0%) 0/26 (0%) 0/27 (0%) 0/32 (0%) 0/13 (0%) 1/15 (6.7%) 0/15 (0%) 0/15 (0%) 0/18 (0%) 0/17 (0%) 0/19 (0%) 0/28 (0%) 0/30 (0%) 0/4 (0%)
    Presyncope 0/14 (0%) 0/26 (0%) 0/27 (0%) 0/32 (0%) 0/13 (0%) 0/15 (0%) 0/15 (0%) 1/15 (6.7%) 0/18 (0%) 0/17 (0%) 0/19 (0%) 0/28 (0%) 0/30 (0%) 0/4 (0%)
    Syncope 0/14 (0%) 0/26 (0%) 0/27 (0%) 1/32 (3.1%) 0/13 (0%) 1/15 (6.7%) 0/15 (0%) 0/15 (0%) 0/18 (0%) 0/17 (0%) 0/19 (0%) 0/28 (0%) 0/30 (0%) 0/4 (0%)
    Psychiatric disorders
    Affect lability 1/14 (7.1%) 0/26 (0%) 0/27 (0%) 0/32 (0%) 0/13 (0%) 0/15 (0%) 0/15 (0%) 0/15 (0%) 0/18 (0%) 0/17 (0%) 0/19 (0%) 0/28 (0%) 0/30 (0%) 0/4 (0%)
    Depression 0/14 (0%) 0/26 (0%) 0/27 (0%) 0/32 (0%) 1/13 (7.7%) 0/15 (0%) 0/15 (0%) 0/15 (0%) 0/18 (0%) 0/17 (0%) 0/19 (0%) 0/28 (0%) 0/30 (0%) 0/4 (0%)
    Insomnia 2/14 (14.3%) 1/26 (3.8%) 1/27 (3.7%) 0/32 (0%) 0/13 (0%) 0/15 (0%) 0/15 (0%) 1/15 (6.7%) 0/18 (0%) 0/17 (0%) 0/19 (0%) 1/28 (3.6%) 0/30 (0%) 1/4 (25%)
    Irritability 2/14 (14.3%) 1/26 (3.8%) 0/27 (0%) 0/32 (0%) 0/13 (0%) 0/15 (0%) 0/15 (0%) 0/15 (0%) 1/18 (5.6%) 1/17 (5.9%) 0/19 (0%) 0/28 (0%) 0/30 (0%) 0/4 (0%)
    Nightmare 0/14 (0%) 0/26 (0%) 0/27 (0%) 0/32 (0%) 0/13 (0%) 0/15 (0%) 0/15 (0%) 0/15 (0%) 1/18 (5.6%) 0/17 (0%) 0/19 (0%) 0/28 (0%) 0/30 (0%) 0/4 (0%)
    Renal and urinary disorders
    Dysuria 1/14 (7.1%) 0/26 (0%) 0/27 (0%) 1/32 (3.1%) 0/13 (0%) 0/15 (0%) 0/15 (0%) 0/15 (0%) 0/18 (0%) 0/17 (0%) 0/19 (0%) 0/28 (0%) 0/30 (0%) 0/4 (0%)
    Pollakiuria 1/14 (7.1%) 0/26 (0%) 1/27 (3.7%) 1/32 (3.1%) 0/13 (0%) 0/15 (0%) 0/15 (0%) 0/15 (0%) 0/18 (0%) 0/17 (0%) 0/19 (0%) 0/28 (0%) 0/30 (0%) 0/4 (0%)
    Urinary incontinence 0/14 (0%) 0/26 (0%) 0/27 (0%) 0/32 (0%) 0/13 (0%) 0/15 (0%) 0/15 (0%) 1/15 (6.7%) 0/18 (0%) 0/17 (0%) 0/19 (0%) 0/28 (0%) 0/30 (0%) 0/4 (0%)
    Reproductive system and breast disorders
    Dysmenorrhoea 0/14 (0%) 0/26 (0%) 0/27 (0%) 0/32 (0%) 0/13 (0%) 1/15 (6.7%) 0/15 (0%) 0/15 (0%) 0/18 (0%) 0/17 (0%) 0/19 (0%) 0/28 (0%) 0/30 (0%) 0/4 (0%)
    Respiratory, thoracic and mediastinal disorders
    Chronic obstructive pulmonary disease 0/14 (0%) 0/26 (0%) 1/27 (3.7%) 2/32 (6.3%) 0/13 (0%) 0/15 (0%) 0/15 (0%) 0/15 (0%) 0/18 (0%) 0/17 (0%) 0/19 (0%) 0/28 (0%) 0/30 (0%) 0/4 (0%)
    Cough 0/14 (0%) 0/26 (0%) 0/27 (0%) 1/32 (3.1%) 1/13 (7.7%) 0/15 (0%) 0/15 (0%) 0/15 (0%) 0/18 (0%) 0/17 (0%) 1/19 (5.3%) 0/28 (0%) 1/30 (3.3%) 0/4 (0%)
    Epistaxis 0/14 (0%) 0/26 (0%) 0/27 (0%) 1/32 (3.1%) 0/13 (0%) 1/15 (6.7%) 0/15 (0%) 0/15 (0%) 0/18 (0%) 0/17 (0%) 0/19 (0%) 1/28 (3.6%) 0/30 (0%) 0/4 (0%)
    Nasal congestion 0/14 (0%) 0/26 (0%) 0/27 (0%) 0/32 (0%) 1/13 (7.7%) 0/15 (0%) 0/15 (0%) 0/15 (0%) 0/18 (0%) 0/17 (0%) 0/19 (0%) 0/28 (0%) 0/30 (0%) 0/4 (0%)
    Oropharyngeal pain 1/14 (7.1%) 0/26 (0%) 1/27 (3.7%) 2/32 (6.3%) 0/13 (0%) 1/15 (6.7%) 0/15 (0%) 0/15 (0%) 0/18 (0%) 0/17 (0%) 0/19 (0%) 2/28 (7.1%) 0/30 (0%) 0/4 (0%)
    Sinus disorder 0/14 (0%) 0/26 (0%) 0/27 (0%) 0/32 (0%) 0/13 (0%) 0/15 (0%) 0/15 (0%) 0/15 (0%) 1/18 (5.6%) 0/17 (0%) 0/19 (0%) 0/28 (0%) 0/30 (0%) 0/4 (0%)
    Wheezing 0/14 (0%) 0/26 (0%) 0/27 (0%) 0/32 (0%) 0/13 (0%) 0/15 (0%) 0/15 (0%) 0/15 (0%) 0/18 (0%) 0/17 (0%) 0/19 (0%) 0/28 (0%) 0/30 (0%) 1/4 (25%)
    Skin and subcutaneous tissue disorders
    Dry skin 1/14 (7.1%) 1/26 (3.8%) 0/27 (0%) 0/32 (0%) 0/13 (0%) 0/15 (0%) 0/15 (0%) 0/15 (0%) 0/18 (0%) 0/17 (0%) 0/19 (0%) 0/28 (0%) 1/30 (3.3%) 0/4 (0%)
    Eczema 0/14 (0%) 0/26 (0%) 0/27 (0%) 0/32 (0%) 0/13 (0%) 0/15 (0%) 0/15 (0%) 0/15 (0%) 0/18 (0%) 1/17 (5.9%) 0/19 (0%) 0/28 (0%) 0/30 (0%) 0/4 (0%)
    Hyperhidrosis 0/14 (0%) 2/26 (7.7%) 0/27 (0%) 0/32 (0%) 0/13 (0%) 0/15 (0%) 0/15 (0%) 0/15 (0%) 0/18 (0%) 0/17 (0%) 0/19 (0%) 1/28 (3.6%) 0/30 (0%) 0/4 (0%)
    Night sweats 0/14 (0%) 0/26 (0%) 0/27 (0%) 0/32 (0%) 0/13 (0%) 0/15 (0%) 0/15 (0%) 0/15 (0%) 1/18 (5.6%) 0/17 (0%) 0/19 (0%) 0/28 (0%) 0/30 (0%) 0/4 (0%)
    Pruritus 2/14 (14.3%) 0/26 (0%) 0/27 (0%) 0/32 (0%) 0/13 (0%) 0/15 (0%) 0/15 (0%) 1/15 (6.7%) 1/18 (5.6%) 1/17 (5.9%) 0/19 (0%) 0/28 (0%) 1/30 (3.3%) 0/4 (0%)
    Rash 3/14 (21.4%) 3/26 (11.5%) 2/27 (7.4%) 0/32 (0%) 2/13 (15.4%) 0/15 (0%) 0/15 (0%) 0/15 (0%) 1/18 (5.6%) 0/17 (0%) 0/19 (0%) 0/28 (0%) 1/30 (3.3%) 0/4 (0%)
    Rash macular 1/14 (7.1%) 0/26 (0%) 0/27 (0%) 0/32 (0%) 1/13 (7.7%) 0/15 (0%) 0/15 (0%) 0/15 (0%) 0/18 (0%) 0/17 (0%) 0/19 (0%) 0/28 (0%) 0/30 (0%) 0/4 (0%)
    Rash pruritic 2/14 (14.3%) 0/26 (0%) 0/27 (0%) 0/32 (0%) 1/13 (7.7%) 0/15 (0%) 0/15 (0%) 0/15 (0%) 1/18 (5.6%) 0/17 (0%) 0/19 (0%) 0/28 (0%) 0/30 (0%) 0/4 (0%)
    Skin irritation 0/14 (0%) 0/26 (0%) 0/27 (0%) 0/32 (0%) 0/13 (0%) 0/15 (0%) 0/15 (0%) 0/15 (0%) 1/18 (5.6%) 0/17 (0%) 0/19 (0%) 0/28 (0%) 0/30 (0%) 0/4 (0%)
    Urticaria 0/14 (0%) 0/26 (0%) 0/27 (0%) 0/32 (0%) 0/13 (0%) 1/15 (6.7%) 0/15 (0%) 0/15 (0%) 0/18 (0%) 0/17 (0%) 0/19 (0%) 0/28 (0%) 0/30 (0%) 0/4 (0%)
    Vascular disorders
    Haematoma 0/14 (0%) 0/26 (0%) 0/27 (0%) 0/32 (0%) 0/13 (0%) 0/15 (0%) 0/15 (0%) 0/15 (0%) 1/18 (5.6%) 1/17 (5.9%) 0/19 (0%) 0/28 (0%) 0/30 (0%) 0/4 (0%)
    Hypertension 0/14 (0%) 0/26 (0%) 0/27 (0%) 0/32 (0%) 0/13 (0%) 0/15 (0%) 1/15 (6.7%) 0/15 (0%) 0/18 (0%) 0/17 (0%) 0/19 (0%) 0/28 (0%) 0/30 (0%) 0/4 (0%)

    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:
    NCT02202980
    Other Study ID Numbers:
    • GS-US-337-1468
    First Posted:
    Jul 29, 2014
    Last Update Posted:
    Nov 16, 2018
    Last Verified:
    Nov 1, 2017