Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Antiviral Activity of Velpatasvir in Participants With Chronic HCV Infection

Sponsor
Gilead Sciences (Industry)
Overall Status
Completed
CT.gov ID
NCT01740791
Collaborator
(none)
103
10
12
14.6
10.3
0.7

Study Details

Study Description

Brief Summary

The primary objective of the study is to evaluate the safety, tolerability, and antiviral activity of velpatasvir (formerly GS-5816) in HCV treatment naive participants with genotypes 1-6.

Condition or Disease Intervention/Treatment Phase
Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
103 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Phase 1b, Randomized, Double-Blind, Multiple-Dose Ranging Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Antiviral Activity of GS-5816 in Subjects With Chronic Hepatitis C Virus Infection
Actual Study Start Date :
Nov 6, 2012
Actual Primary Completion Date :
Mar 15, 2013
Actual Study Completion Date :
Jan 24, 2014

Arms and Interventions

Arm Intervention/Treatment
Experimental: Velpatasvir 5 mg (GT 1a)

Participants with genotype (GT) 1a HCV infection will receive velpatasvir 5 mg or placebo once daily for 3 days under fasted conditions.

Drug: Velpatasvir
Tablets administered orally
Other Names:
  • GS-5816
  • Drug: Placebo
    Tablets administered orally

    Experimental: Velpatasvir 25 mg (GT 1a)

    Participants with GT 1a HCV infection will receive velpatasvir 25 mg or placebo once daily for 3 days under fasted conditions.

    Drug: Velpatasvir
    Tablets administered orally
    Other Names:
  • GS-5816
  • Drug: Placebo
    Tablets administered orally

    Experimental: Velpatasvir 50 mg (GT 1a)

    Participants with GT 1a HCV infection will receive velpatasvir 50 mg or placebo once daily for 3 days under fasted conditions.

    Drug: Velpatasvir
    Tablets administered orally
    Other Names:
  • GS-5816
  • Drug: Placebo
    Tablets administered orally

    Experimental: Velpatasvir 100 mg (GT 1a)

    Participants with GT 1a HCV infection will receive velpatasvir 100 mg or placebo once daily for 3 days under fasted conditions.

    Drug: Velpatasvir
    Tablets administered orally
    Other Names:
  • GS-5816
  • Drug: Placebo
    Tablets administered orally

    Experimental: Velpatasvir 150 mg (GT 1a)

    Participants with GT 1a HCV infection will receive velpatasvir 150 mg or placebo once daily for 3 days under fasted conditions.

    Drug: Velpatasvir
    Tablets administered orally
    Other Names:
  • GS-5816
  • Drug: Placebo
    Tablets administered orally

    Experimental: Velpatasvir 150 mg (GT 1b)

    Participants with GT 1b HCV infection will receive velpatasvir 150 mg or placebo once daily for 3 days under fasted conditions.

    Drug: Velpatasvir
    Tablets administered orally
    Other Names:
  • GS-5816
  • Drug: Placebo
    Tablets administered orally

    Experimental: Velpatasvir 150 mg (GT 2)

    Participants with GT 2 HCV infection will receive velpatasvir 150 mg or placebo once daily for 3 days under fasted conditions.

    Drug: Velpatasvir
    Tablets administered orally
    Other Names:
  • GS-5816
  • Drug: Placebo
    Tablets administered orally

    Experimental: Velpatasvir 25 mg (GT 3)

    Participants with GT 3 HCV infection will receive velpatasvir 25 mg or placebo once daily for 3 days under fasted conditions.

    Drug: Velpatasvir
    Tablets administered orally
    Other Names:
  • GS-5816
  • Drug: Placebo
    Tablets administered orally

    Experimental: Velpatasvir 50 mg (GT 3)

    Participants with GT 3 HCV infection will receive velpatasvir 50 mg or placebo once daily for 3 days under fasted conditions.

    Drug: Velpatasvir
    Tablets administered orally
    Other Names:
  • GS-5816
  • Drug: Placebo
    Tablets administered orally

    Experimental: Velpatasvir 150 mg (GT 3)

    Participants with GT 3 HCV infection will receive velpatasvir 150 mg or placebo once daily for 3 days under fasted conditions.

    Drug: Velpatasvir
    Tablets administered orally
    Other Names:
  • GS-5816
  • Drug: Placebo
    Tablets administered orally

    Experimental: Velpatasvir 150 mg (GT 4)

    Participants with GT 4 HCV infection will receive velpatasvir 150 mg or placebo once daily for 3 days under fasted conditions.

    Drug: Velpatasvir
    Tablets administered orally
    Other Names:
  • GS-5816
  • Drug: Placebo
    Tablets administered orally

    Experimental: Velpatasvir up to 400 mg (GT 2)

    Participants with GT 2 HCV infection will receive velpatasvir up to 400 mg or placebo once daily for 3 days under fasted conditions.

    Drug: Velpatasvir
    Tablets administered orally
    Other Names:
  • GS-5816
  • Drug: Placebo
    Tablets administered orally

    Outcome Measures

    Primary Outcome Measures

    1. Percentage of Participants Experiencing Treatment Emergent Adverse Events [First dose date up to Day 17 + 2 (Day 19 if Day 17 visit missing)]

      Treatment-emergent adverse events were defined as any new or worsening adverse event that began on or after the date of the first dose of study drug until the Day 17 study visit date + 2 (Day 19 if Day 17 visit missing).

    2. Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities [First dose date up to Day 17 + 2 (Day 19 if Day 17 visit missing)]

      A treatment-emergent laboratory abnormality was defined as an increase of at least 1 abnormality grade from baseline at any postbaseline visit up to the Day 17 visit date + 2 days (or Day 19 if Day 17 visit was missing). The criteria used to grade laboratory results were as follows: Grade 1 (mild), Grade 2 (moderate), or Grade 3 (severe). Graded laboratory abnormalities were defined using the grading scheme defined in protocol (Gilead Sciences, Inc. Grading Scale for Severity of Adverse Events and Laboratory Abnormalities) for analysis purpose.

    3. Antiviral Activity of Velpatasvir as Measured by Change in Plasma HCV RNA From Baseline [Baseline; Days 4, 5, 6, 7, 8, 10, and 17]

      Participants who were genotyped incorrectly but received appropriate treatment for that genotype were included in that treatment group for the efficacy analysis. Data were summarized by treatment and placebo.

    Secondary Outcome Measures

    1. Absolute HCV RNA Level [Baseline; Days 4, 5, 6, 7, 8, 10, and 17]

    2. Number of Participants Achieving Reductions From Baseline in HCV RNA [Baseline; Days 4, 5, 6, 7, 8, 10, and 17]

      Categorical declines from baseline were summarized by the number of participants with a < 1, ≥ 1 to < 2, ≥ 2 to < 3, or ≥ 3 log10 IU/mL decrease in HCV RNA from baseline by treatment (velpatasvir dose/HCV genotype) and placebo at each collection time point through Day 17.

    3. Number of Participants Who Have HCV RNA < Lower Limit of Quantitation (LLOQ) Detected [Days 4, 5, 6, 7, and 8]

      The lower limit of quantitation (LLOQ) detection for HCV RNA levels was 25 IU/mL. HCV detected means calculated HCV RNA level is below LLOQ of the assay.

    4. Plasma HCV RNA Levels by Treatment and IL28B Genotype [Days 4, 5, 6, 7, 8, 10, and 17]

    5. Pharmacokinetic (PK) Parameter of Velpatasvir: AUCinf [0 (predose), 0.5, 1, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 16, and 24 hours postdose at Day 1]

      AUCinf is defined as the concentration of drug extrapolated to infinite time.

    6. PK Parameter of Velpatasvir: AUCtau [0 (predose), 0.5, 1, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 16, and 24 hours postdose at Day 3]

      AUCtau is defined as concentration of drug over time (the area under the concentration verses time curve over the dosing interval).

    7. PK Parameter of Velpatasvir: Cmax [0 (predose), 0.5, 1, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 16, and 24 hours postdose at Day 1 for single dose and Day 3 for multiple dose.]

      Cmax is defined as the maximum observed plasma concentration of drug.

    8. PK Parameter of Velpatasvir: CL/F [0 (predose), 0.5, 1, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 16, and 24 hours postdose at Day 1 for single dose and Day 3 for multiple dose]

      CL/F is defined as the apparent oral clearance following administration of the drug.

    9. PK Parameter of Velpatasvir: Ctau [0 (predose), 0.5, 1, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 16, and 24 hours postdose at Day 3]

      Ctau is defined as the observed drug concentration at the end of the dosing interval.

    10. Number of Participants With Nonstructural Protein 5A (NS5A) Resistance Associated Variants (RAVs) at Pretreatment or Postbaseline Timepoints [First dose date up to Day 17]

      The full-length NS5A coding region was analyzed pretreatment (baseline) by deep sequencing using MiSeq for all 70 participants who received velpatasvir and for 8 of 17 participants who received placebo prior to and up to 2 weeks (Day 17) after dosing with velpatasvir. Participants were categorized by velpatasvir dose/HCV genotype and presence or absence of NS5A RAVs.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Key Inclusion Criteria:
    • HCV treatment-naive adult participants (18-65 years of age) with chronic HCV infection and plasma HCV RNA ≥ 5 log10 IU/mL at screening

    • Agree to use protocol defined precautions against pregnancy

    Key Exclusion Criteria:
    • Chronic liver disease of a non-HCV etiology (e.g., hemochromatosis, Wilson's disease, α1 antitrypsin deficiency, cholangitis)

    • Evidence of cirrhosis

    • Evidence of current drug abuse

    • Screening laboratory results outside the protocol specified requirements

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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 West Coast Clinical Trials, LLC Costa Mesa California United States 92626
    2 Avail Clinical Research, LLC DeLand Florida United States 32720
    3 Orlando Clinical Research Center Orlando Florida United States 32809
    4 Kansas City Gastroenterology and Hepatology Kansas City Missouri United States 64131
    5 CRI Worldwide, LLC Marlton New Jersey United States 08053
    6 CRI Worldwide, LLC Philadelphia Pennsylvania United States 19139
    7 New Orleans Center for Clinical Research-Knoxville Knoxville Tennessee United States 37920
    8 Alamo Medical Research San Antonio Texas United States 78215
    9 Charles River Clinical Services Northwest, Inc. Tacoma Washington United States 98418
    10 Fundacion De Investigacion De Diego San Juan Puerto Rico 00927

    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:
    NCT01740791
    Other Study ID Numbers:
    • GS-US-281-0102
    First Posted:
    Dec 4, 2012
    Last Update Posted:
    Dec 16, 2020
    Last Verified:
    Dec 1, 2020
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Gilead Sciences
    Additional relevant MeSH terms:

    Study Results

    Participant Flow

    Recruitment Details Participants were enrolled at study sites in United States. The first participant was screened on 06 November 2012. The last study visit occurred on 24 January 2014.
    Pre-assignment Detail 163 participants were screened. Participants were not enrolled in 'Velpatasvir up to 400 mg genotype (GT) 2' group.
    Arm/Group Title Placebo Velpatasvir 5 mg Velpatasvir 25 mg Velpatasvir 50 mg Velpatasvir 100 mg Velpatasvir 150 mg
    Arm/Group Description Participants with HCV infection received placebo once daily for 3 days under fasted conditions. Participants with HCV infection received velpatasvir 5 mg once daily for 3 days under fasted conditions. Participants with HCV infection received velpatasvir 25 mg once daily for 3 days under fasted conditions. Participants with HCV infection received velpatasvir 50 mg once daily for 3 days under fasted conditions. Participants with HCV infection received velpatasvir 100 mg once daily for 3 days under fasted conditions. Participants with HCV infection received velpatasvir 150 mg once daily for 3 days under fasted conditions.
    Period Title: Overall Study
    STARTED 22 7 17 14 9 34
    COMPLETED 10 4 11 7 6 23
    NOT COMPLETED 12 3 6 7 3 11

    Baseline Characteristics

    Arm/Group Title Placebo Velpatasvir 5 mg Velpatasvir 25 mg Velpatasvir 50 mg Velpatasvir 100 mg Velpatasvir 150 mg Total
    Arm/Group Description Participants with HCV infection received placebo once daily for 3 days under fasted conditions. Participants with HCV infection received velpatasvir 5 mg once daily for 3 days under fasted conditions. Participants with HCV infection received velpatasvir 25 mg once daily for 3 days under fasted conditions. Participants with HCV infection received velpatasvir 50 mg once daily for 3 days under fasted conditions. Participants with HCV infection received velpatasvir 100 mg once daily for 3 days under fasted conditions. Participants with HCV infection received velpatasvir 150 mg once daily for 3 days under fasted conditions. Total of all reporting groups
    Overall Participants 17 4 15 12 8 31 87
    Age (years) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [years]
    46.6
    (11.46)
    44.8
    (15.65)
    45.1
    (11.56)
    46.9
    (10.13)
    47.0
    (8.40)
    49.2
    (9.12)
    47.3
    (10.26)
    Sex: Female, Male (Count of Participants)
    Female
    3
    17.6%
    1
    25%
    3
    20%
    2
    16.7%
    2
    25%
    8
    25.8%
    19
    21.8%
    Male
    14
    82.4%
    3
    75%
    12
    80%
    10
    83.3%
    6
    75%
    23
    74.2%
    68
    78.2%
    Race/Ethnicity, Customized (Count of Participants)
    American Indian or Alaska Native
    0
    0%
    0
    0%
    0
    0%
    1
    8.3%
    0
    0%
    0
    0%
    1
    1.1%
    Black or African American
    6
    35.3%
    0
    0%
    5
    33.3%
    4
    33.3%
    2
    25%
    10
    32.3%
    27
    31%
    White
    11
    64.7%
    4
    100%
    10
    66.7%
    7
    58.3%
    6
    75%
    21
    67.7%
    59
    67.8%
    Race/Ethnicity, Customized (Count of Participants)
    Hispanic or Latino
    8
    47.1%
    1
    25%
    3
    20%
    6
    50%
    2
    25%
    8
    25.8%
    28
    32.2%
    Not Hispanic or Latino
    9
    52.9%
    3
    75%
    12
    80%
    6
    50%
    6
    75%
    23
    74.2%
    59
    67.8%
    HCV RNA (log10 IU/mL) (log10 IU/mL) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [log10 IU/mL]
    6.52
    (0.517)
    6.64
    (0.312)
    6.32
    (0.826)
    6.39
    (0.558)
    6.46
    (0.479)
    6.41
    (0.603)
    6.43
    (0.597)
    HCV Genotype (Count of Participants)
    1a
    10
    58.8%
    4
    100%
    8
    53.3%
    8
    66.7%
    8
    100%
    7
    22.6%
    45
    51.7%
    1b
    2
    11.8%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    8
    25.8%
    10
    11.5%
    2b
    2
    11.8%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    8
    25.8%
    10
    11.5%
    3
    0
    0%
    0
    0%
    1
    6.7%
    0
    0%
    0
    0%
    0
    0%
    1
    1.1%
    3a
    3
    17.6%
    0
    0%
    6
    40%
    4
    33.3%
    0
    0%
    6
    19.4%
    19
    21.8%
    4
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    1
    3.2%
    1
    1.1%
    4a/4c/4d
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    1
    3.2%
    1
    1.1%
    IL28B Genotype (Count of Participants)
    C/C
    7
    41.2%
    2
    50%
    5
    33.3%
    5
    41.7%
    2
    25%
    5
    16.1%
    26
    29.9%
    C/T
    5
    29.4%
    2
    50%
    8
    53.3%
    5
    41.7%
    6
    75%
    18
    58.1%
    44
    50.6%
    T/T
    5
    29.4%
    0
    0%
    2
    13.3%
    2
    16.7%
    0
    0%
    8
    25.8%
    17
    19.5%

    Outcome Measures

    1. Primary Outcome
    Title Percentage of Participants Experiencing Treatment Emergent Adverse Events
    Description Treatment-emergent adverse events were defined as any new or worsening adverse event that began on or after the date of the first dose of study drug until the Day 17 study visit date + 2 (Day 19 if Day 17 visit missing).
    Time Frame First dose date up to Day 17 + 2 (Day 19 if Day 17 visit missing)

    Outcome Measure Data

    Analysis Population Description
    The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug (velpatasvir or placebo). Data were summarized by velpatasvir or placebo.
    Arm/Group Title Placebo Velpatasvir 5 mg Velpatasvir 25 mg Velpatasvir 50 mg Velpatasvir 100 mg Velpatasvir 150 mg
    Arm/Group Description Participants with HCV infection received placebo once daily for 3 days under fasted conditions. Participants with HCV infection received velpatasvir 5 mg once daily for 3 days under fasted conditions. Participants with HCV infection received velpatasvir 25 mg once daily for 3 days under fasted conditions. Participants with HCV infection received velpatasvir 50 mg once daily for 3 days under fasted conditions. Participants with HCV infection received velpatasvir 100 mg once daily for 3 days under fasted conditions. Participants with HCV infection received velpatasvir 150 mg once daily for 3 days under fasted conditions.
    Measure Participants 17 4 15 12 8 31
    Number [percentage of participants]
    17.6
    103.5%
    25.0
    625%
    26.7
    178%
    8.3
    69.2%
    37.5
    468.8%
    29.0
    93.5%
    2. Primary Outcome
    Title Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities
    Description A treatment-emergent laboratory abnormality was defined as an increase of at least 1 abnormality grade from baseline at any postbaseline visit up to the Day 17 visit date + 2 days (or Day 19 if Day 17 visit was missing). The criteria used to grade laboratory results were as follows: Grade 1 (mild), Grade 2 (moderate), or Grade 3 (severe). Graded laboratory abnormalities were defined using the grading scheme defined in protocol (Gilead Sciences, Inc. Grading Scale for Severity of Adverse Events and Laboratory Abnormalities) for analysis purpose.
    Time Frame First dose date up to Day 17 + 2 (Day 19 if Day 17 visit missing)

    Outcome Measure Data

    Analysis Population Description
    Participants in the Safety Analysis Set were analyzed. Data were summarized by dose.
    Arm/Group Title Placebo Velpatasvir 5 mg Velpatasvir 25 mg Velpatasvir 50 mg Velpatasvir 100 mg Velpatasvir 150 mg
    Arm/Group Description Participants with HCV infection received placebo once daily for 3 days under fasted conditions. Participants with HCV infection received velpatasvir 5 mg once daily for 3 days under fasted conditions. Participants with HCV infection received velpatasvir 25 mg once daily for 3 days under fasted conditions. Participants with HCV infection received velpatasvir 50 mg once daily for 3 days under fasted conditions. Participants with HCV infection received velpatasvir 100 mg once daily for 3 days under fasted conditions. Participants with HCV infection received velpatasvir 150 mg once daily for 3 days under fasted conditions.
    Measure Participants 17 4 15 12 8 31
    Grade 1
    41.2
    242.4%
    25.0
    625%
    40.0
    266.7%
    58.3
    485.8%
    62.5
    781.3%
    33.3
    107.4%
    Grade 2
    17.6
    103.5%
    0
    0%
    33.3
    222%
    8.3
    69.2%
    25.0
    312.5%
    33.3
    107.4%
    Grade 3
    11.8
    69.4%
    0
    0%
    13.3
    88.7%
    16.7
    139.2%
    0
    0%
    6.7
    21.6%
    3. Primary Outcome
    Title Antiviral Activity of Velpatasvir as Measured by Change in Plasma HCV RNA From Baseline
    Description Participants who were genotyped incorrectly but received appropriate treatment for that genotype were included in that treatment group for the efficacy analysis. Data were summarized by treatment and placebo.
    Time Frame Baseline; Days 4, 5, 6, 7, 8, 10, and 17

    Outcome Measure Data

    Analysis Population Description
    Participants in the Efficacy Analysis Set (all randomized participants with appropriate genotype who received at least one dose of the study drug (velpatasvir or placebo) and with at least one on-treatment HCV RNA assessment) with available data were analyzed. Data were summarized by treatment (velpatasvir dose/HCV genotype) and placebo.
    Arm/Group Title Placebo Velpatasvir 5 mg (GT 1a) Velpatasvir 25 mg (GT 1a) Velpatasvir 50 mg (GT 1a) Velpatasvir 100 mg (GT 1a) Velpatasvir 150 mg (GT 1a) Velpatasvir 150 mg (GT 1b) Velpatasvir 150 mg (GT 2) Velpatasvir 25 mg (GT 3) Velpatasvir 50 mg (GT 3) Velpatasvir 150 mg (GT 3) Velpatasvir 150 mg (GT 4)
    Arm/Group Description Participants with HCV infection received placebo once daily for 3 days under fasted conditions. Participants with genotype (GT) 1a HCV infection received velpatasvir 5 mg once daily for 3 days under fasted conditions. Participants with GT 1a HCV infection received velpatasvir 25 mg once daily for 3 days under fasted conditions. Participants with GT 1a HCV infection received velpatasvir 50 mg once daily for 3 days under fasted conditions. Participants with GT 1a HCV infection received velpatasvir 100 mg once daily for 3 days under fasted conditions. Participants with GT 1a HCV infection received velpatasvir 150 mg once daily for 3 days under fasted conditions. Participants with GT 1b HCV infection received velpatasvir 150 mg once daily for 3 days under fasted conditions. Participants with GT 2 HCV infection received velpatasvir 150 mg once daily for 3 days under fasted conditions. Participants with GT 3 HCV infection received velpatasvir 25 mg once daily for 3 days under fasted conditions. Participants with GT 3 HCV infection received velpatasvir 50 mg once daily for 3 days under fasted conditions. Participants with GT 3 HCV infection received velpatasvir 150 mg once daily for 3 days under fasted conditions. Participants with GT 4 HCV infection received velpatasvir 150 mg once daily for 3 days under fasted conditions.
    Measure Participants 17 4 8 8 8 7 8 8 7 4 6 2
    Change at Day 4
    -0.005
    (0.3343)
    -3.104
    (0.7348)
    -3.638
    (0.4350)
    -3.338
    (1.3088)
    -3.154
    (1.0089)
    -3.648
    (0.9270)
    -3.848
    (0.4834)
    -4.044
    (0.3671)
    -2.796
    (1.4313)
    -2.382
    (1.5028)
    -2.834
    (0.7608)
    -3.269
    (0.6080)
    Change at Day 5
    -0.018
    (0.2346)
    -1.998
    (0.8305)
    -3.538
    (0.7566)
    -3.123
    (1.5009)
    -3.060
    (1.1098)
    -3.636
    (1.0023)
    -3.955
    (0.3519)
    -4.148
    (0.5841)
    -2.617
    (1.3034)
    -2.130
    (1.4385)
    -2.259
    (1.1488)
    -2.827
    (0.5506)
    Change at Day 6
    -0.037
    (0.2119)
    -1.244
    (0.6135)
    -3.140
    (0.9786)
    -2.704
    (1.5100)
    -2.713
    (1.1206)
    -3.221
    (1.2323)
    -4.021
    (0.3681)
    -4.109
    (0.6408)
    -2.193
    (1.1060)
    -1.737
    (1.3854)
    -1.869
    (1.3270)
    -2.243
    (0.5919)
    Change at Day 7
    -0.003
    (0.1923)
    -1.031
    (0.6112)
    -2.424
    (0.7292)
    -2.184
    (1.5527)
    -2.273
    (1.1753)
    -2.481
    (1.3542)
    -4.205
    (0.4393)
    -3.850
    (0.9630)
    -1.586
    (1.0710)
    -1.742
    (1.3842)
    -1.380
    (1.6686)
    -1.892
    (1.0143)
    Change at Day 8
    0.027
    (0.2740)
    -0.941
    (0.5345)
    -2.074
    (0.7701)
    -1.702
    (1.6152)
    -1.780
    (0.9987)
    -2.544
    (1.5460)
    -4.026
    (0.3155)
    -3.559
    (0.9866)
    -1.025
    (1.1864)
    -1.542
    (1.0593)
    -1.062
    (1.5998)
    -1.478
    (1.1542)
    Change at Day 10
    0.142
    (0.3813)
    -0.679
    (0.4352)
    -1.304
    (1.0374)
    -1.472
    (1.4315)
    -1.143
    (1.2137)
    -2.032
    (1.4388)
    -3.348
    (0.6201)
    -2.918
    (1.1566)
    -0.844
    (0.6967)
    -1.051
    (1.4338)
    -1.198
    (1.0991)
    -0.494
    (0.8933)
    Change at Day 17
    -0.025
    (0.2719)
    -0.135
    (0.3747)
    -0.223
    (0.4236)
    -1.110
    (1.3584)
    -0.801
    (0.7679)
    -0.879
    (0.9231)
    -1.532
    (1.2059)
    -0.886
    (1.3190)
    -0.672
    (0.5003)
    -0.085
    (0.6910)
    -0.225
    (0.4210)
    -0.351
    (0.5914)
    4. Secondary Outcome
    Title Absolute HCV RNA Level
    Description
    Time Frame Baseline; Days 4, 5, 6, 7, 8, 10, and 17

    Outcome Measure Data

    Analysis Population Description
    Participants in the Efficacy Analysis Set with available data were analyzed. Data were summarized by treatment (velpatasvir dose/HCV genotype) and placebo.
    Arm/Group Title Placebo Velpatasvir 5 mg (GT 1a) Velpatasvir 25 mg (GT 1a) Velpatasvir 50 mg (GT 1a) Velpatasvir 100 mg (GT 1a) Velpatasvir 150 mg (GT 1a) Velpatasvir 150 mg (GT 1b) Velpatasvir 150 mg (GT 2) Velpatasvir 25 mg (GT 3) Velpatasvir 50 mg (GT 3) Velpatasvir 150 mg (GT 3) Velpatasvir 150 mg (GT 4)
    Arm/Group Description Participants with HCV infection received placebo once daily for 3 days under fasted conditions. Participants with GT 1a HCV infection received velpatasvir 5 mg once daily for 3 days under fasted conditions. Participants with GT 1a HCV infection received velpatasvir 25 mg once daily for 3 days under fasted conditions. Participants with GT 1a HCV infection received velpatasvir 50 mg once daily for 3 days under fasted conditions. Participants with GT 1a HCV infection received velpatasvir 100 mg once daily for 3 days under fasted conditions. Participants with GT 1a HCV infection received velpatasvir 150 mg once daily for 3 days under fasted conditions. Participants with GT 1b HCV infection received velpatasvir 150 mg once daily for 3 days under fasted conditions. Participants with GT 2 HCV infection received velpatasvir 150 mg once daily for 3 days under fasted conditions. Participants with GT 3 HCV infection received velpatasvir 25 mg once daily for 3 days under fasted conditions. Participants with GT 3 HCV infection received velpatasvir 50 mg once daily for 3 days under fasted conditions. Participants with GT 3 HCV infection received velpatasvir 150 mg once daily for 3 days under fasted conditions. Participants with GT 4 HCV infection received velpatasvir 150 mg once daily for 3 days under fasted conditions.
    Measure Participants 17 4 8 8 8 7 8 8 7 4 6 2
    Baseline
    6.523
    (0.5173)
    6.639
    (0.3123)
    6.461
    (0.6623)
    6.459
    (0.5726)
    6.458
    (0.4785)
    6.335
    (0.5710)
    6.379
    (0.4187)
    6.753
    (0.5857)
    6.150
    (1.0108)
    6.240
    (0.5796)
    6.318
    (0.8151)
    5.734
    (0.2345)
    Day 4
    6.518
    (0.4840)
    3.535
    (0.7588)
    2.823
    (0.7866)
    3.121
    (1.6969)
    3.304
    (1.2823)
    2.687
    (0.8776)
    2.574
    (0.3526)
    2.708
    (0.5823)
    3.151
    (2.0090)
    3.858
    (1.9120)
    3.484
    (0.6784)
    2.465
    (0.8425)
    Day 5
    6.512
    (0.5715)
    4.642
    (0.9016)
    2.922
    (1.0852)
    3.336
    (1.8716)
    3.398
    (1.3325)
    2.699
    (1.0083)
    2.466
    (0.3511)
    2.681
    (0.3893)
    3.329
    (1.8305)
    4.110
    (1.8964)
    4.059
    (1.0186)
    2.907
    (0.7850)
    Day 6
    6.493
    (0.5373)
    5.395
    (0.6898)
    3.321
    (1.3322)
    3.755
    (1.9323)
    3.745
    (1.3213)
    3.104
    (1.2373)
    2.400
    (0.3365)
    2.644
    (0.6568)
    3.753
    (1.6214)
    4.503
    (1.9383)
    4.450
    (1.1943)
    3.491
    (0.8264)
    Day 7
    6.527
    (0.6190)
    5.608
    (0.6929)
    4.036
    (1.1305)
    4.275
    (1.9196)
    4.185
    (1.4107)
    3.862
    (1.4141)
    2.217
    (0.5807)
    2.903
    (0.7639)
    4.361
    (1.4130)
    4.498
    (1.9226)
    4.938
    (1.4707)
    3.842
    (1.2488)
    Day 8
    6.555
    (0.4880)
    5.699
    (0.6305)
    4.387
    (1.1089)
    4.756
    (1.9494)
    4.678
    (1.3233)
    3.791
    (1.5984)
    2.396
    (0.6092)
    3.194
    (0.8402)
    4.922
    (1.3395)
    4.698
    (1.6047)
    5.256
    (1.3141)
    4.256
    (1.3887)
    Day 10
    6.659
    (0.4583)
    5.960
    (0.6104)
    5.156
    (1.3456)
    4.986
    (1.7558)
    5.315
    (1.5130)
    4.319
    (1.6357)
    3.074
    (0.8660)
    3.834
    (1.1710)
    5.103
    (1.1273)
    5.190
    (2.0061)
    5.120
    (0.6140)
    5.240
    (1.1278)
    Day 17
    6.503
    (0.5432)
    6.505
    (0.5615)
    6.237
    (0.6709)
    5.468
    (1.6269)
    5.657
    (1.0148)
    5.455
    (1.2889)
    4.890
    (1.5438)
    5.867
    (1.5443)
    5.275
    (1.1421)
    6.007
    (0.9524)
    6.093
    (0.6451)
    5.383
    (0.8259)
    5. Secondary Outcome
    Title Number of Participants Achieving Reductions From Baseline in HCV RNA
    Description Categorical declines from baseline were summarized by the number of participants with a < 1, ≥ 1 to < 2, ≥ 2 to < 3, or ≥ 3 log10 IU/mL decrease in HCV RNA from baseline by treatment (velpatasvir dose/HCV genotype) and placebo at each collection time point through Day 17.
    Time Frame Baseline; Days 4, 5, 6, 7, 8, 10, and 17

    Outcome Measure Data

    Analysis Population Description
    Participants in the Efficacy Analysis Set were analyzed.
    Arm/Group Title Placebo Velpatasvir 5 mg (GT 1a) Velpatasvir 25 mg (GT 1a) Velpatasvir 50 mg (GT 1a) Velpatasvir 100 mg (GT 1a) Velpatasvir 150 mg (GT 1a) Velpatasvir 150 mg (GT 1b) Velpatasvir 150 mg (GT 2) Velpatasvir 25 mg (GT 3) Velpatasvir 50 mg (GT 3) Velpatasvir 150 mg (GT 3) Velpatasvir 150 mg (GT 4)
    Arm/Group Description Participants with HCV infection received placebo once daily for 3 days under fasted conditions. Participants with GT 1a HCV infection received velpatasvir 5 mg once daily for 3 days under fasted conditions. Participants with GT 1a HCV infection received velpatasvir 25 mg once daily for 3 days under fasted conditions. Participants with GT 1a HCV infection received velpatasvir 50 mg once daily for 3 days under fasted conditions. Participants with GT 1a HCV infection received velpatasvir 100 mg once daily for 3 days under fasted conditions. Participants with GT 1a HCV infection received velpatasvir 150 mg once daily for 3 days under fasted conditions. Participants with GT 1b HCV infection received velpatasvir 150 mg once daily for 3 days under fasted conditions. Participants with GT 2 HCV infection received velpatasvir 150 mg once daily for 3 days under fasted conditions. Participants with GT 3 HCV infection received velpatasvir 25 mg once daily for 3 days under fasted conditions. Participants with GT 3 HCV infection received velpatasvir 50 mg once daily for 3 days under fasted conditions. Participants with GT 3 HCV infection received velpatasvir 150 mg once daily for 3 days under fasted conditions. Participants with GT 4 HCV infection received velpatasvir 150 mg once daily for 3 days under fasted conditions.
    Measure Participants 17 4 8 8 8 7 8 8 7 4 6 2
    Missing HCV RNA
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    1
    1.1%
    0
    NaN
    1
    NaN
    0
    NaN
    0
    NaN
    0
    NaN
    < 1 log10 IU/mL decrease in HCV RNA
    17
    100%
    0
    0%
    0
    0%
    1
    8.3%
    0
    0%
    0
    0%
    0
    0%
    0
    NaN
    1
    NaN
    1
    NaN
    0
    NaN
    0
    NaN
    ≥1 and <2 log10 IU/mL decrease in HCV RNA
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    1
    12.5%
    1
    3.2%
    0
    0%
    0
    NaN
    0
    NaN
    0
    NaN
    1
    NaN
    0
    NaN
    ≥2 and <3 log10 IU/mL decrease in HCV RNA
    0
    0%
    1
    25%
    1
    6.7%
    2
    16.7%
    3
    37.5%
    1
    3.2%
    0
    0%
    0
    NaN
    1
    NaN
    1
    NaN
    3
    NaN
    1
    NaN
    ≥3 log10 IU/mL decrease in HCV RNA
    0
    0%
    3
    75%
    7
    46.7%
    5
    41.7%
    4
    50%
    5
    16.1%
    7
    8%
    8
    NaN
    4
    NaN
    2
    NaN
    2
    NaN
    1
    NaN
    Missing HCV RNA
    2
    11.8%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    1
    1.1%
    2
    NaN
    1
    NaN
    0
    NaN
    0
    NaN
    0
    NaN
    < 1 log10 IU/mL decrease in HCV RNA
    15
    88.2%
    1
    25%
    0
    0%
    1
    8.3%
    0
    0%
    0
    0%
    0
    0%
    0
    NaN
    1
    NaN
    1
    NaN
    1
    NaN
    0
    NaN
    ≥1 and <2 log10 IU/mL decrease in HCV RNA
    0
    0%
    1
    25%
    1
    6.7%
    1
    8.3%
    2
    25%
    0
    0%
    0
    0%
    0
    NaN
    0
    NaN
    0
    NaN
    1
    NaN
    0
    NaN
    ≥2 and <3 log10 IU/mL decrease in HCV RNA
    0
    0%
    2
    50%
    0
    0%
    1
    8.3%
    2
    25%
    2
    6.5%
    0
    0%
    0
    NaN
    2
    NaN
    2
    NaN
    2
    NaN
    1
    NaN
    ≥3 log10 IU/mL decrease in HCV RNA
    0
    0%
    0
    0%
    7
    46.7%
    5
    41.7%
    4
    50%
    5
    16.1%
    7
    8%
    6
    NaN
    3
    NaN
    1
    NaN
    2
    NaN
    1
    NaN
    Missing HCV RNA
    2
    11.8%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    1
    3.2%
    1
    1.1%
    0
    NaN
    1
    NaN
    0
    NaN
    0
    NaN
    0
    NaN
    < 1 log10 IU/mL decrease in HCV RNA
    15
    88.2%
    1
    25%
    0
    0%
    1
    8.3%
    0
    0%
    0
    0%
    0
    0%
    0
    NaN
    1
    NaN
    1
    NaN
    3
    NaN
    0
    NaN
    ≥1 and <2 log10 IU/mL decrease in HCV RNA
    0
    0%
    3
    75%
    1
    6.7%
    2
    16.7%
    2
    25%
    2
    6.5%
    0
    0%
    0
    NaN
    2
    NaN
    1
    NaN
    0
    NaN
    1
    NaN
    ≥2 and <3 log10 IU/mL decrease in HCV RNA
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    2
    25%
    0
    0%
    0
    0%
    1
    NaN
    1
    NaN
    2
    NaN
    1
    NaN
    1
    NaN
    ≥3 log10 IU/mL decrease in HCV RNA
    0
    0%
    0
    0%
    7
    46.7%
    5
    41.7%
    4
    50%
    4
    12.9%
    7
    8%
    7
    NaN
    2
    NaN
    0
    NaN
    2
    NaN
    0
    NaN
    Missing HCV RNA
    2
    11.8%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    2
    6.5%
    1
    1.1%
    0
    NaN
    1
    NaN
    0
    NaN
    0
    NaN
    0
    NaN
    < 1 log10 IU/mL decrease in HCV RNA
    15
    88.2%
    1
    25%
    1
    6.7%
    3
    25%
    2
    25%
    0
    0%
    0
    0%
    0
    NaN
    2
    NaN
    1
    NaN
    3
    NaN
    0
    NaN
    ≥1 and <2 log10 IU/mL decrease in HCV RNA
    0
    0%
    3
    75%
    0
    0%
    0
    0%
    0
    0%
    2
    6.5%
    0
    0%
    0
    NaN
    1
    NaN
    1
    NaN
    1
    NaN
    1
    NaN
    ≥2 and <3 log10 IU/mL decrease in HCV RNA
    0
    0%
    0
    0%
    5
    33.3%
    3
    25%
    3
    37.5%
    0
    0%
    0
    0%
    3
    NaN
    3
    NaN
    2
    NaN
    0
    NaN
    1
    NaN
    ≥3 log10 IU/mL decrease in HCV RNA
    0
    0%
    0
    0%
    2
    13.3%
    2
    16.7%
    3
    37.5%
    3
    9.7%
    7
    8%
    5
    NaN
    0
    NaN
    0
    NaN
    2
    NaN
    0
    NaN
    Missing HCV RNA
    1
    5.9%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    1
    1.1%
    0
    NaN
    1
    NaN
    0
    NaN
    0
    NaN
    0
    NaN
    < 1 log10 IU/mL decrease in HCV RNA
    16
    94.1%
    2
    50%
    1
    6.7%
    3
    25%
    2
    25%
    2
    6.5%
    0
    0%
    0
    NaN
    3
    NaN
    1
    NaN
    4
    NaN
    1
    NaN
    ≥1 and <2 log10 IU/mL decrease in HCV RNA
    0
    0%
    2
    50%
    2
    13.3%
    2
    16.7%
    2
    25%
    0
    0%
    0
    0%
    0
    NaN
    1
    NaN
    1
    NaN
    0
    NaN
    0
    NaN
    ≥2 and <3 log10 IU/mL decrease in HCV RNA
    0
    0%
    0
    0%
    5
    33.3%
    1
    8.3%
    3
    37.5%
    2
    6.5%
    0
    0%
    3
    NaN
    2
    NaN
    2
    NaN
    2
    NaN
    1
    NaN
    ≥3 log10 IU/mL decrease in HCV RNA
    0
    0%
    0
    0%
    0
    0%
    2
    16.7%
    1
    12.5%
    3
    9.7%
    7
    8%
    5
    NaN
    0
    NaN
    0
    NaN
    0
    NaN
    0
    NaN
    Missing HCV RNA
    2
    11.8%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    1
    3.2%
    1
    1.1%
    0
    NaN
    1
    NaN
    0
    NaN
    0
    NaN
    0
    NaN
    < 1 log10 IU/mL decrease in HCV RNA
    15
    88.2%
    3
    75%
    3
    20%
    4
    33.3%
    3
    37.5%
    1
    3.2%
    0
    0%
    0
    NaN
    4
    NaN
    2
    NaN
    3
    NaN
    1
    NaN
    ≥1 and <2 log10 IU/mL decrease in HCV RNA
    0
    0%
    1
    25%
    4
    26.7%
    2
    16.7%
    3
    37.5%
    2
    6.5%
    0
    0%
    2
    NaN
    2
    NaN
    0
    NaN
    1
    NaN
    1
    NaN
    ≥2 and <3 log10 IU/mL decrease in HCV RNA
    0
    0%
    0
    0%
    1
    6.7%
    0
    0%
    2
    25%
    2
    6.5%
    3
    3.4%
    2
    NaN
    0
    NaN
    2
    NaN
    2
    NaN
    0
    NaN
    ≥3 log10 IU/mL decrease in HCV RNA
    0
    0%
    0
    0%
    0
    0%
    2
    16.7%
    0
    0%
    1
    3.2%
    4
    4.6%
    4
    NaN
    0
    NaN
    0
    NaN
    0
    NaN
    0
    NaN
    Missing HCV RNA
    1
    5.9%
    0
    0%
    0
    0%
    1
    8.3%
    0
    0%
    0
    0%
    1
    1.1%
    0
    NaN
    1
    NaN
    1
    NaN
    0
    NaN
    0
    NaN
    < 1 log10 IU/mL decrease in HCV RNA
    16
    94.1%
    4
    100%
    8
    53.3%
    5
    41.7%
    5
    62.5%
    6
    19.4%
    3
    3.4%
    6
    NaN
    5
    NaN
    3
    NaN
    6
    NaN
    2
    NaN
    ≥1 and <2 log10 IU/mL decrease in HCV RNA
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    2
    25%
    0
    0%
    2
    2.3%
    0
    NaN
    1
    NaN
    0
    NaN
    0
    NaN
    0
    NaN
    ≥2 and <3 log10 IU/mL decrease in HCV RNA
    0
    0%
    0
    0%
    0
    0%
    1
    8.3%
    1
    12.5%
    1
    3.2%
    1
    1.1%
    1
    NaN
    0
    NaN
    0
    NaN
    0
    NaN
    0
    NaN
    ≥3 log10 IU/mL decrease in HCV RNA
    0
    0%
    0
    0%
    0
    0%
    1
    8.3%
    0
    0%
    0
    0%
    1
    1.1%
    1
    NaN
    0
    NaN
    0
    NaN
    0
    NaN
    0
    NaN
    6. Secondary Outcome
    Title Number of Participants Who Have HCV RNA < Lower Limit of Quantitation (LLOQ) Detected
    Description The lower limit of quantitation (LLOQ) detection for HCV RNA levels was 25 IU/mL. HCV detected means calculated HCV RNA level is below LLOQ of the assay.
    Time Frame Days 4, 5, 6, 7, and 8

    Outcome Measure Data

    Analysis Population Description
    Participants in the Efficacy Analysis Set were analyzed. Data were summarized by treatment (velpatasvir dose/HCV genotype) and placebo.
    Arm/Group Title Placebo Velpatasvir 5 mg (GT 1a) Velpatasvir 25 mg (GT 1a) Velpatasvir 50 mg (GT 1a) Velpatasvir 100 mg (GT 1a) Velpatasvir 150 mg (GT 1a) Velpatasvir 150 mg (GT 1b) Velpatasvir 150 mg (GT 2) Velpatasvir 25 mg (GT 3) Velpatasvir 50 mg (GT 3) Velpatasvir 150 mg (GT 3) Velpatasvir 150 mg (GT 4)
    Arm/Group Description Participants with HCV infection received placebo once daily for 3 days under fasted conditions. Participants with GT 1a HCV infection received velpatasvir 5 mg once daily for 3 days under fasted conditions. Participants with GT 1a HCV infection received velpatasvir 25 mg once daily for 3 days under fasted conditions. Participants with GT 1a HCV infection received velpatasvir 50 mg once daily for 3 days under fasted conditions. Participants with GT 1a HCV infection received velpatasvir 100 mg once daily for 3 days under fasted conditions. Participants with GT 1a HCV infection received velpatasvir 150 mg once daily for 3 days under fasted conditions. Participants with GT 1b HCV infection received velpatasvir 150 mg once daily for 3 days under fasted conditions. Participants with GT 2 HCV infection received velpatasvir 150 mg once daily for 3 days under fasted conditions. Participants with GT 3 HCV infection received velpatasvir 25 mg once daily for 3 days under fasted conditions. Participants with GT 3 HCV infection received velpatasvir 50 mg once daily for 3 days under fasted conditions. Participants with GT 3 HCV infection received velpatasvir 150 mg once daily for 3 days under fasted conditions. Participants with GT 4 HCV infection received velpatasvir 150 mg once daily for 3 days under fasted conditions.
    Measure Participants 17 4 8 8 8 7 8 8 7 4 6 2
    Day 4 < LLOQ detected
    0
    0%
    0
    0%
    0
    0%
    2
    16.7%
    0
    0%
    1
    3.2%
    0
    0%
    1
    NaN
    1
    NaN
    0
    NaN
    0
    NaN
    0
    NaN
    Day 5 < LLOQ detected
    0
    0%
    0
    0%
    1
    6.7%
    1
    8.3%
    0
    0%
    1
    3.2%
    0
    0%
    0
    NaN
    1
    NaN
    0
    NaN
    0
    NaN
    0
    NaN
    Day 6 < LLOQ detected
    0
    0%
    0
    0%
    1
    6.7%
    0
    0%
    0
    0%
    1
    3.2%
    0
    0%
    0
    NaN
    0
    NaN
    0
    NaN
    0
    NaN
    0
    NaN
    Day 7 < LLOQ detected
    0
    0%
    0
    0%
    0
    0%
    1
    8.3%
    0
    0%
    0
    0%
    0
    0%
    0
    NaN
    0
    NaN
    0
    NaN
    0
    NaN
    0
    NaN
    Day 8 < LLOQ detected
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    1
    3.2%
    0
    0%
    0
    NaN
    0
    NaN
    0
    NaN
    0
    NaN
    0
    NaN
    7. Secondary Outcome
    Title Plasma HCV RNA Levels by Treatment and IL28B Genotype
    Description
    Time Frame Days 4, 5, 6, 7, 8, 10, and 17

    Outcome Measure Data

    Analysis Population Description
    Participants in the Efficacy Analysis Set with available data were analyzed. Data are were summarized by treatment (velpatasvir dose/HCV genotype and placebo) and IL28B genotype (CC and non-CC). Due to the small number of participants in each treatment group, no conclusions can be made on the effect of IL28B genotype on HCV RNA decline.
    Arm/Group Title Placebo (IL28B Genotype CC) Velpatasvir 5 mg (GT 1a) (IL28B Genotype CC) Velpatasvir 25 mg (GT 1a) (IL28B Genotype CC) Velpatasvir 50 mg (GT 1a) (IL28B Genotype CC) Velpatasvir 100 mg (GT 1a) (IL28B Genotype CC) Velpatasvir 150 mg (GT 1a) (IL28B Genotype CC) Velpatasvir 150 mg (GT 1b) (IL28B Genotype CC) Velpatasvir 150 mg (GT 2) (IL28B Genotype CC) Velpatasvir 25 mg (GT 3) (IL28B Genotype CC) Velpatasvir 50 mg (GT 3) (IL28B Genotype CC) Velpatasvir 150 mg (GT 3) (IL28B Genotype CC) Velpatasvir 150 mg (GT 4) (IL28B Genotype CC) Placebo (IL28B Genotype Non-CC) Velpatasvir 5 mg (GT 1a) (IL28B Genotype Non-CC) Velpatasvir 25 mg (GT 1a) (IL28B Genotype Non-CC) Velpatasvir 50 mg (GT 1a) (IL28B Genotype Non-CC) Velpatasvir 100 mg (GT 1a) (IL28B Genotype Non-CC) Velpatasvir 150 mg (GT 1a) (IL28B Genotype Non-CC) Velpatasvir 150 mg (GT 1b) (IL28B Genotype Non-CC) Velpatasvir 150 mg (GT 2) (IL28B Genotype Non-CC) Velpatasvir 25 mg (GT 3) (IL28B Genotype Non-CC) Velpatasvir 50 mg (GT 3) (IL28B Genotype Non-CC) Velpatasvir 150 mg (GT 3) (IL28B Genotype Non-CC) Velpatasvir 150 mg (GT 4) (IL28B Genotype Non-CC)
    Arm/Group Description Participants with HCV infection received placebo once daily for 3 days under fasted conditions. Participants with GT 1a HCV infection received velpatasvir 5 mg once daily for 3 days under fasted conditions. Participants with GT 1a HCV infection received velpatasvir 25 mg once daily for 3 days under fasted conditions. Participants with GT 1a HCV infection received velpatasvir 50 mg once daily for 3 days under fasted conditions. Participants with GT 1a HCV infection received velpatasvir 100 mg once daily for 3 days under fasted conditions. Participants with GT 1a HCV infection received velpatasvir 150 mg once daily for 3 days under fasted conditions. Participants with GT 1b HCV infection received velpatasvir 150 mg once daily for 3 days under fasted conditions. Participants with GT 2 HCV infection received velpatasvir 150 mg once daily for 3 days under fasted conditions. Participants with GT 3 HCV infection received velpatasvir 25 mg once daily for 3 days under fasted conditions. Participants with GT 3 HCV infection received velpatasvir 50 mg once daily for 3 days under fasted conditions. Participants with GT 3 HCV infection received velpatasvir 150 mg once daily for 3 days under fasted conditions. Participants with GT 4 HCV infection received velpatasvir 150 mg once daily for 3 days under fasted conditions. Participants with HCV infection received placebo once daily for 3 days under fasted conditions. Participants with GT 1a HCV infection received velpatasvir 5 mg once daily for 3 days under fasted conditions. Participants with GT 1a HCV infection received velpatasvir 25 mg once daily for 3 days under fasted conditions. Participants with GT 1a HCV infection received velpatasvir 50 mg once daily for 3 days under fasted conditions. Participants with GT 1a HCV infection received velpatasvir 100 mg once daily for 3 days under fasted conditions. Participants with GT 1a HCV infection received velpatasvir 150 mg once daily for 3 days under fasted conditions. Participants with GT 1b HCV infection received velpatasvir 150 mg once daily for 3 days under fasted conditions. Participants with GT 2 HCV infection received velpatasvir 150 mg once daily for 3 days under fasted conditions. Participants with GT 3 HCV infection received velpatasvir 25 mg once daily for 3 days under fasted conditions. Participants with GT 3 HCV infection received velpatasvir 50 mg once daily for 3 days under fasted conditions. Participants with GT 3 HCV infection received velpatasvir 150 mg once daily for 3 days under fasted conditions. Participants with GT 4 HCV infection received velpatasvir 150 mg once daily for 3 days under fasted conditions.
    Measure Participants 7 2 3 2 2 0 1 3 2 3 1 0 10 2 5 6 6 7 7 5 5 1 5 2
    Day 4
    6.473
    (0.4869)
    3.410
    (0.4007)
    2.603
    (0.5255)
    1.762
    (0.5394)
    2.891
    (0.4237)
    2.539
    2.758
    (0.3416)
    2.976
    4.304
    (2.0716)
    3.590
    6.549
    (0.5057)
    3.660
    (1.2265)
    2.955
    (0.9418)
    3.574
    (1.7284)
    3.442
    (1.4747)
    2.687
    (0.8776)
    2.579
    (0.3859)
    2.678
    (0.7295)
    3.186
    (2.2441)
    2.521
    3.463
    (0.7562)
    2.465
    (0.8425)
    Day 5
    6.604
    (0.4842)
    4.578
    (0.6202)
    2.581
    (1.0972)
    1.748
    (0.0110)
    2.996
    (0.4644)
    2.605
    2.689
    (0.5473)
    3.117
    4.620
    (1.9568)
    3.742
    6.450
    (0.6437)
    4.705
    (1.4275)
    3.127
    (1.1484)
    3.865
    (1.8868)
    3.532
    (1.5350)
    2.699
    (1.0083)
    2.443
    (0.3787)
    2.673
    (0.2813)
    3.372
    (2.0433)
    2.577
    4.123
    (1.1255)
    2.907
    (0.7850)
    Day 6
    6.595
    (0.3266)
    5.388
    (0.5909)
    2.740
    (1.2380)
    2.134
    (0.3192)
    3.138
    (0.5754)
    2.801
    2.668
    (0.7974)
    3.813
    5.035
    (1.9842)
    3.653
    6.426
    (0.6525)
    5.403
    (1.0383)
    3.669
    (1.3910)
    4.295
    (1.9510)
    3.947
    (1.4771)
    3.104
    (1.2373)
    2.334
    (0.3139)
    2.629
    (0.6604)
    3.741
    (1.8125)
    2.907
    4.609
    (1.2620)
    3.491
    (0.8264)
    Day 7
    6.563
    (0.3311)
    5.612
    (0.4912)
    3.637
    (0.7489)
    2.988
    (0.7310)
    3.390
    (0.1908)
    3.312
    2.684
    (1.0300)
    4.196
    5.038
    (1.9476)
    3.713
    6.504
    (0.7748)
    5.604
    (1.0949)
    4.276
    (1.3284)
    4.704
    (2.0419)
    4.449
    (1.5628)
    3.862
    (1.4141)
    2.034
    (0.3534)
    3.034
    (0.6583)
    4.394
    (1.5772)
    2.877
    5.183
    (1.5012)
    3.842
    (1.2488)
    Day 8
    6.643
    (0.4611)
    5.744
    (0.7194)
    3.875
    (0.5026)
    3.053
    (1.1852)
    3.867
    (0.3347)
    3.441
    2.913
    (1.0913)
    4.553
    5.123
    (1.6669)
    4.114
    6.503
    (0.5202)
    5.653
    (0.8166)
    4.694
    (1.3082)
    5.324
    (1.8687)
    4.949
    (1.4416)
    3.791
    (1.5984)
    2.222
    (0.4366)
    3.362
    (0.7384)
    4.996
    (1.4838)
    3.423
    5.485
    (1.3293)
    4.256
    (1.3887)
    Day 10
    6.817
    (0.3336)
    6.171
    (0.8102)
    4.369
    (0.3684)
    3.488
    (1.1964)
    4.059
    (0.0027)
    3.948
    3.438
    (1.2872)
    5.061
    5.724
    (2.0787)
    4.754
    6.580
    (0.5065)
    5.750
    (0.5333)
    5.629
    (1.5354)
    5.485
    (1.6832)
    5.733
    (1.5375)
    4.319
    (1.6357)
    2.928
    (0.8495)
    4.073
    (1.1757)
    5.111
    (1.2601)
    3.585
    5.193
    (0.6566)
    5.240
    (1.1278)
    Day 17
    6.601
    (0.3466)
    6.713
    (0.6714)
    6.147
    (1.0166)
    2.949
    4.572
    (0.1838)
    6.953
    5.127
    (1.8225)
    6.744
    5.881
    (1.3108)
    6.621
    6.444
    (0.6440)
    6.297
    (0.5676)
    6.292
    (0.5110)
    5.888
    (1.3019)
    6.019
    (0.8985)
    5.455
    (1.2889)
    4.546
    (1.3663)
    6.311
    (1.3623)
    4.981
    (0.9912)
    6.260
    5.987
    (0.6606)
    5.383
    (0.8259)
    8. Secondary Outcome
    Title Pharmacokinetic (PK) Parameter of Velpatasvir: AUCinf
    Description AUCinf is defined as the concentration of drug extrapolated to infinite time.
    Time Frame 0 (predose), 0.5, 1, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 16, and 24 hours postdose at Day 1

    Outcome Measure Data

    Analysis Population Description
    The PK analysis set included all randomized and treated participants who have evaluable PK profiles for velpatasvir.
    Arm/Group Title Velpatasvir 5 mg Velpatasvir 25 mg Velpatasvir 50 mg Velpatasvir 100 mg Velpatasvir 150 mg
    Arm/Group Description Participants with HCV infection received velpatasvir 5 mg once daily for 3 days under fasted conditions. Participants with HCV infection received velpatasvir 25 mg once daily for 3 days under fasted conditions. Participants with HCV infection received velpatasvir 50 mg once daily for 3 days under fasted conditions. Participants with HCV infection received velpatasvir 100 mg once daily for 3 days under fasted conditions. Participants with HCV infection received velpatasvir 150 mg once daily for 3 days under fasted conditions.
    Measure Participants 4 15 12 8 30
    Mean (Standard Deviation) [h*ng/mL]
    113.8
    (71.61)
    857.9
    (612.23)
    2054.3
    (806.69)
    2727.3
    (1619.74)
    4546.6
    (1757.10)
    9. Secondary Outcome
    Title PK Parameter of Velpatasvir: AUCtau
    Description AUCtau is defined as concentration of drug over time (the area under the concentration verses time curve over the dosing interval).
    Time Frame 0 (predose), 0.5, 1, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 16, and 24 hours postdose at Day 3

    Outcome Measure Data

    Analysis Population Description
    Participants in the PK Analysis Set were analyzed.
    Arm/Group Title Velpatasvir 5 mg Velpatasvir 25 mg Velpatasvir 50 mg Velpatasvir 100 mg Velpatasvir 150 mg
    Arm/Group Description Participants with HCV infection received velpatasvir 5 mg once daily for 3 days under fasted conditions. Participants with HCV infection received velpatasvir 25 mg once daily for 3 days under fasted conditions. Participants with HCV infection received velpatasvir 50 mg once daily for 3 days under fasted conditions. Participants with HCV infection received velpatasvir 100 mg once daily for 3 days under fasted conditions. Participants with HCV infection received velpatasvir 150 mg once daily for 3 days under fasted conditions.
    Measure Participants 4 15 12 8 30
    Mean (Standard Deviation) [h*ng/mL]
    86.4
    (14.32)
    857.5
    (467.74)
    1950.5
    (486.87)
    2745.3
    (1480.47)
    5003.0
    (2371.91)
    10. Secondary Outcome
    Title PK Parameter of Velpatasvir: Cmax
    Description Cmax is defined as the maximum observed plasma concentration of drug.
    Time Frame 0 (predose), 0.5, 1, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 16, and 24 hours postdose at Day 1 for single dose and Day 3 for multiple dose.

    Outcome Measure Data

    Analysis Population Description
    Participants in the PK Analysis Set were analyzed.
    Arm/Group Title Velpatasvir 5 mg Velpatasvir 25 mg Velpatasvir 50 mg Velpatasvir 100 mg Velpatasvir 150 mg
    Arm/Group Description Participants with HCV infection received velpatasvir 5 mg once daily for 3 days under fasted conditions. Participants with HCV infection received velpatasvir 25 mg once daily for 3 days under fasted conditions. Participants with HCV infection received velpatasvir 50 mg once daily for 3 days under fasted conditions. Participants with HCV infection received velpatasvir 100 mg once daily for 3 days under fasted conditions. Participants with HCV infection received velpatasvir 150 mg once daily for 3 days under fasted conditions.
    Measure Participants 4 15 12 8 30
    Day 1 (Single-Dose)
    20.1
    (14.62)
    110.8
    (55.97)
    272.3
    (95.46)
    372.8
    (222.74)
    583.3
    (257.90)
    Day 3 (Multiple-Dose)
    16.2
    (2.34)
    122.9
    (61.38)
    292.4
    (88.77)
    413.9
    (243.66)
    690.1
    (307.04)
    11. Secondary Outcome
    Title PK Parameter of Velpatasvir: CL/F
    Description CL/F is defined as the apparent oral clearance following administration of the drug.
    Time Frame 0 (predose), 0.5, 1, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 16, and 24 hours postdose at Day 1 for single dose and Day 3 for multiple dose

    Outcome Measure Data

    Analysis Population Description
    Participants in the PK Analysis Set were analyzed.
    Arm/Group Title Velpatasvir 5 mg Velpatasvir 25 mg Velpatasvir 50 mg Velpatasvir 100 mg Velpatasvir 150 mg
    Arm/Group Description Participants with HCV infection received velpatasvir 5 mg once daily for 3 days under fasted conditions. Participants with HCV infection received velpatasvir 25 mg once daily for 3 days under fasted conditions. Participants with HCV infection received velpatasvir 50 mg once daily for 3 days under fasted conditions. Participants with HCV infection received velpatasvir 100 mg once daily for 3 days under fasted conditions. Participants with HCV infection received velpatasvir 150 mg once daily for 3 days under fasted conditions.
    Measure Participants 4 15 12 8 30
    Day 1
    61312.2
    (42726.76)
    37170.7
    (16570.51)
    27930.6
    (10689.18)
    49237.5
    (25550.98)
    38011.7
    (14392.55)
    Day 3
    59173.6
    (10490.08)
    34,820.1
    (13217.45)
    27,263.0
    (7367.47)
    53,194.3
    (39618.97)
    37,362.8
    (18382.06)
    12. Secondary Outcome
    Title PK Parameter of Velpatasvir: Ctau
    Description Ctau is defined as the observed drug concentration at the end of the dosing interval.
    Time Frame 0 (predose), 0.5, 1, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 16, and 24 hours postdose at Day 3

    Outcome Measure Data

    Analysis Population Description
    Participants in the PK Analysis Set were analyzed.
    Arm/Group Title Velpatasvir 5 mg Velpatasvir 25 mg Velpatasvir 50 mg Velpatasvir 100 mg Velpatasvir 150 mg
    Arm/Group Description Participants with HCV infection received velpatasvir 5 mg once daily for 3 days under fasted conditions. Participants with HCV infection received velpatasvir 25 mg once daily for 3 days under fasted conditions. Participants with HCV infection received velpatasvir 50 mg once daily for 3 days under fasted conditions. Participants with HCV infection received velpatasvir 100 mg once daily for 3 days under fasted conditions. Participants with HCV infection received velpatasvir 150 mg once daily for 3 days under fasted conditions.
    Measure Participants 4 15 12 8 30
    Mean (Standard Deviation) [ng/mL]
    0.6
    (0.70)
    10.8
    (8.50)
    22.4
    (4.66)
    30.8
    (15.03)
    60.6
    (33.24)
    13. Secondary Outcome
    Title Number of Participants With Nonstructural Protein 5A (NS5A) Resistance Associated Variants (RAVs) at Pretreatment or Postbaseline Timepoints
    Description The full-length NS5A coding region was analyzed pretreatment (baseline) by deep sequencing using MiSeq for all 70 participants who received velpatasvir and for 8 of 17 participants who received placebo prior to and up to 2 weeks (Day 17) after dosing with velpatasvir. Participants were categorized by velpatasvir dose/HCV genotype and presence or absence of NS5A RAVs.
    Time Frame First dose date up to Day 17

    Outcome Measure Data

    Analysis Population Description
    Participants in the efficacy analysis set who were sequenced at pre-treatment or post baseline treatment were analyzed.
    Arm/Group Title Placebo Velpatasvir 5 mg (GT 1a) Velpatasvir 25 mg (GT 1a) Velpatasvir 50 mg (GT 1a) Velpatasvir 100 mg (GT 1a) Velpatasvir 150 mg (GT 1a) Velpatasvir 150 mg (GT 1b) Velpatasvir 150 mg (GT 2) Velpatasvir 25 mg (GT 3) Velpatasvir 50 mg (GT 3) Velpatasvir 150 mg (GT 3) Velpatasvir 150 mg (GT 4)
    Arm/Group Description Participants with HCV infection received placebo once daily for 3 days under fasted conditions. Participants with GT 1a HCV infection received velpatasvir 5 mg once daily for 3 days under fasted conditions. Participants with GT 1a HCV infection received velpatasvir 25 mg once daily for 3 days under fasted conditions. Participants with GT 1a HCV infection received velpatasvir 50 mg once daily for 3 days under fasted conditions. Participants with GT 1a HCV infection received velpatasvir 100 mg once daily for 3 days under fasted conditions. Participants with GT 1a HCV infection received velpatasvir 150 mg once daily for 3 days under fasted conditions. Participants with GT 1b HCV infection received velpatasvir 150 mg once daily for 3 days under fasted conditions. Participants with GT 2 HCV infection received velpatasvir 150 mg once daily for 3 days under fasted conditions. Participants with GT 3 HCV infection received velpatasvir 25 mg once daily for 3 days under fasted conditions. Participants with GT 3 HCV infection received velpatasvir 50 mg once daily for 3 days under fasted conditions. Participants with GT 3 HCV infection received velpatasvir 150 mg once daily for 3 days under fasted conditions. Participants with GT 4 HCV infection received velpatasvir 150 mg once daily for 3 days under fasted conditions.
    Measure Participants 8 4 8 8 8 7 8 8 7 4 6 2
    Number of participants sequenced pretreatment
    8
    47.1%
    4
    100%
    8
    53.3%
    8
    66.7%
    8
    100%
    7
    22.6%
    8
    9.2%
    8
    NaN
    7
    NaN
    4
    NaN
    6
    NaN
    2
    NaN
    Number of participants with RAVs at pretreatment
    2
    11.8%
    0
    0%
    2
    13.3%
    3
    25%
    3
    37.5%
    2
    6.5%
    1
    1.1%
    4
    NaN
    2
    NaN
    1
    NaN
    2
    NaN
    2
    NaN
    Number of participants sequenced at postbaseline
    2
    11.8%
    4
    100%
    8
    53.3%
    7
    58.3%
    8
    100%
    6
    19.4%
    6
    6.9%
    8
    NaN
    6
    NaN
    4
    NaN
    6
    NaN
    2
    NaN
    Number of participants with RAVs at postbaseline
    0
    0%
    4
    100%
    7
    46.7%
    6
    50%
    8
    100%
    6
    19.4%
    6
    6.9%
    7
    NaN
    6
    NaN
    4
    NaN
    6
    NaN
    2
    NaN

    Adverse Events

    Time Frame Adverse Events: First dose date up to Day 17 + 2 (Day 19 if Day 17 visit missing); All-Cause Mortality: First dose date up to Week 48
    Adverse Event Reporting Description The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug (velpatasvir or placebo). Data were summarized by velpatasvir and placebo.
    Arm/Group Title Placebo Velpatasvir 5 mg Velpatasvir 25 mg Velpatasvir 50 mg Velpatasvir 100 mg Velpatasvir 150 mg
    Arm/Group Description Participants with HCV infection received placebo once daily for 3 days under fasted conditions. Participants with HCV infection received velpatasvir 5 mg once daily for 3 days under fasted conditions. Participants with HCV infection received velpatasvir 25 mg once daily for 3 days under fasted conditions. Participants with HCV infection received velpatasvir 50 mg once daily for 3 days under fasted conditions. Participants with HCV infection received velpatasvir 100 mg once daily for 3 days under fasted conditions. Participants with HCV infection received velpatasvir 150 mg once daily for 3 days under fasted conditions.
    All Cause Mortality
    Placebo Velpatasvir 5 mg Velpatasvir 25 mg Velpatasvir 50 mg Velpatasvir 100 mg Velpatasvir 150 mg
    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 0/17 (0%) 0/4 (0%) 0/15 (0%) 0/12 (0%) 0/8 (0%) 0/31 (0%)
    Serious Adverse Events
    Placebo Velpatasvir 5 mg Velpatasvir 25 mg Velpatasvir 50 mg Velpatasvir 100 mg Velpatasvir 150 mg
    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 0/17 (0%) 0/4 (0%) 0/15 (0%) 0/12 (0%) 0/8 (0%) 0/31 (0%)
    Other (Not Including Serious) Adverse Events
    Placebo Velpatasvir 5 mg Velpatasvir 25 mg Velpatasvir 50 mg Velpatasvir 100 mg Velpatasvir 150 mg
    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 3/17 (17.6%) 1/4 (25%) 4/15 (26.7%) 1/12 (8.3%) 3/8 (37.5%) 6/31 (19.4%)
    Eye disorders
    Dry eye 0/17 (0%) 0/4 (0%) 1/15 (6.7%) 0/12 (0%) 0/8 (0%) 0/31 (0%)
    Eye irritation 0/17 (0%) 0/4 (0%) 1/15 (6.7%) 0/12 (0%) 0/8 (0%) 0/31 (0%)
    Gastrointestinal disorders
    Abdominal pain upper 0/17 (0%) 0/4 (0%) 1/15 (6.7%) 0/12 (0%) 0/8 (0%) 0/31 (0%)
    Constipation 0/17 (0%) 0/4 (0%) 1/15 (6.7%) 0/12 (0%) 1/8 (12.5%) 0/31 (0%)
    Diarrhoea 0/17 (0%) 0/4 (0%) 1/15 (6.7%) 1/12 (8.3%) 0/8 (0%) 0/31 (0%)
    Faeces discoloured 0/17 (0%) 0/4 (0%) 1/15 (6.7%) 0/12 (0%) 0/8 (0%) 0/31 (0%)
    Flatulence 0/17 (0%) 0/4 (0%) 1/15 (6.7%) 0/12 (0%) 0/8 (0%) 0/31 (0%)
    Gingival bleeding 1/17 (5.9%) 0/4 (0%) 0/15 (0%) 0/12 (0%) 0/8 (0%) 0/31 (0%)
    Nausea 0/17 (0%) 0/4 (0%) 0/15 (0%) 1/12 (8.3%) 0/8 (0%) 2/31 (6.5%)
    Vomiting 0/17 (0%) 0/4 (0%) 1/15 (6.7%) 1/12 (8.3%) 0/8 (0%) 1/31 (3.2%)
    Infections and infestations
    Gastroenteritis 0/17 (0%) 0/4 (0%) 0/15 (0%) 0/12 (0%) 1/8 (12.5%) 0/31 (0%)
    Injury, poisoning and procedural complications
    Contusion 1/17 (5.9%) 0/4 (0%) 0/15 (0%) 0/12 (0%) 0/8 (0%) 0/31 (0%)
    Fibula fracture 1/17 (5.9%) 0/4 (0%) 0/15 (0%) 0/12 (0%) 0/8 (0%) 0/31 (0%)
    Nervous system disorders
    Headache 0/17 (0%) 1/4 (25%) 0/15 (0%) 0/12 (0%) 1/8 (12.5%) 4/31 (12.9%)
    Syncope 1/17 (5.9%) 0/4 (0%) 0/15 (0%) 0/12 (0%) 0/8 (0%) 0/31 (0%)
    Respiratory, thoracic and mediastinal disorders
    Asthma 0/17 (0%) 0/4 (0%) 1/15 (6.7%) 0/12 (0%) 0/8 (0%) 0/31 (0%)
    Cough 0/17 (0%) 0/4 (0%) 0/15 (0%) 0/12 (0%) 1/8 (12.5%) 1/31 (3.2%)
    Skin and subcutaneous tissue disorders
    Dermatitis contact 0/17 (0%) 0/4 (0%) 1/15 (6.7%) 0/12 (0%) 0/8 (0%) 0/31 (0%)
    Rash pruritic 0/17 (0%) 0/4 (0%) 0/15 (0%) 1/12 (8.3%) 0/8 (0%) 0/31 (0%)
    Vascular disorders
    Hypertension 1/17 (5.9%) 0/4 (0%) 0/15 (0%) 0/12 (0%) 0/8 (0%) 1/31 (3.2%)

    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 Gilead Clinical Study Information Center
    Organization Gilead Sciences
    Phone 1-833-445-3230 (GILEAD-0)
    Email GileadClinicalTrials@gilead.com
    Responsible Party:
    Gilead Sciences
    ClinicalTrials.gov Identifier:
    NCT01740791
    Other Study ID Numbers:
    • GS-US-281-0102
    First Posted:
    Dec 4, 2012
    Last Update Posted:
    Dec 16, 2020
    Last Verified:
    Dec 1, 2020