Safety and Efficacy of Ledipasvir/Sofosbuvir Fixed-Dose Combination in Adults With Chronic HCV and HBV Coinfection

Sponsor
Gilead Sciences (Industry)
Overall Status
Completed
CT.gov ID
NCT02613871
Collaborator
(none)
111
11
1
34.5
10.1
0.3

Study Details

Study Description

Brief Summary

The primary objectives of this study are to determine the antiviral efficacy, safety, and tolerability of ledipasvir/sofosbuvir (LDV/SOF) fixed-dose combination (FDC) in adults with chronic genotype 1 or 2 HCV infection who are coinfected with HBV in Taiwan.

Condition or Disease Intervention/Treatment Phase
Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
111 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Phase 3b Open-Label Study of Ledipasvir/Sofosbuvir Fixed-Dose Combination for 12 Weeks in Subjects With Chronic Genotype 1 or 2 Hepatitis C Virus (HCV) and Hepatitis B Virus (HBV) Coinfection
Actual Study Start Date :
Dec 22, 2015
Actual Primary Completion Date :
Jan 4, 2017
Actual Study Completion Date :
Nov 7, 2018

Arms and Interventions

Arm Intervention/Treatment
Experimental: LDV/SOF

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
  • 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 quantification (LLOQ; 15 IU/mL) at 12 weeks after stopping study treatment.

    2. Percentage of Participants With Any Adverse Event Leading to Permanent Discontinuation of Study Drug [First dose date up to 12 weeks]

    Secondary Outcome Measures

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

      SVR4 was defined as HCV RNA < LLOQ (15 IU/mL) at 4 weeks after stopping study treatment.

    2. Percentage of Participants With HCV RNA < LLOQ While on Treatment [Weeks 1, 2, 4, 8, and 12]

      LLOQ = 15 IU/mL

    3. Percentage of Participants With HCV RNA < LLOQ at Posttreatment Weeks 24, 36, 48, 60, 72, 84, 96, and 108 [Posttreatment Weeks 24, 36, 48, 60, 72, 84, 96, and 108]

      LLOQ = 15 IU/mL

    4. HCV RNA Change From Baseline While on Treatment [Weeks 1, 2, 4, 8, and 12]

    5. Percentage of Participants With Virologic Failure [First dose date up to Posttreatment Week 12]

      Virologic failure was defined as : Breakthrough (confirmed HCV RNA ≥ LLOQ [15 IU/mL] 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), or Relapse (HCV RNA ≥ LLOQ during the post-treatment period having achieved HCV RNA < LLOQ at end of treatment, confirmed with 2 consecutive values or last available post-treatment measurement)

    6. Plasma HBV DNA Change From Baseline While on Treatment [Weeks 1, 2, 4, 8, and 12]

    7. Plasma HBV DNA Change From Baseline at Posttreatment Weeks 4, 12, 24, 36, 48, 60, 72, 84, 96, and 108 [Posttreatment Weeks 4, 12, 24, 36, 48, 60, 72, 84, 96, and 108]

    8. HBsAg Level Change From Baseline While on Treatment [Weeks 1, 2, 4, 8, and 12]

    9. HBsAg Level Change From Baseline at Posttreatment Weeks 4, 12, 24, 36, 48, 60, 72, 84, 96, and 108 [Posttreatment Weeks 4, 12, 24, 36, 48, 60, 72, 84, 96, and 108]

    10. Serum LOXL-2 Level Change From Baseline While on Treatment [Weeks 1, 2, 4, 8, and 12]

    11. Serum LOXL-2 Level Change From Baseline at Posttreatment Weeks 4, 12, and 36 [Posttreatment Weeks 4, 12, and 36]

    12. Percentage of Participants That Required HBV Therapy During the Study [First dose date up to Posttreatment Week 108]

    13. Fibrosis Status as Assessed by Fibroscan Score at Posttreatment Weeks 12, 60, and 108 [Posttreatment Weeks 12, 60, and 108]

      FibroScan is a non-invasive device that assesses the hardness (or stiffness) of the liver using the technique of transient elastography. FibroScan results range from 2.5 kPa to 75 kPa with higher scores indicating greater liver stiffness. Per protocol, cirrhosis status was determined as follows: Presence of cirrhosis = FibroScan result of > 12.5 kPa Absence of cirrhosis = FibroScan result of ≤ 12.5 kPa

    14. Percentage of Participants That Develop Hepatocellular Carcinoma (HCC) During the Study [First dose date up to Posttreatment Week 108]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Key Inclusion Criteria:
    • Individuals ≥ 40 kg in weight with chronic genotype 1 or 2 HCV and HBV coinfection

    • Individuals must not be taking or requiring treatment with HBV antiviral therapy at screening. For participants that are HBV treatment experienced, the most recent treatment must have been completed at least 6 months prior to Day 1.

    • Cirrhosis determination by Fibroscan

    • Screening laboratory values within defined thresholds

    • Use of two effective contraception methods if female or male is of childbearing potential

    Key Exclusion Criteria:
    • Current or prior history of clinically-significant illness or any other major medical disorder that may interfere with individual's treatment, assessment or compliance with the protocol

    • Pregnant or nursing female

    • Infection with human immunodeficiency virus (HIV) or hepatitis delta virus (HDV)

    • Hepatocellular carcinoma (HCC) or other malignancy

    • Current or prior history of clinical hepatic decompensation

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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Changhua Taiwan
    2 Chiayi City Taiwan
    3 Kaohsiung City Taiwan
    4 Kaohsiung Taiwan
    5 Keelung Taiwan
    6 Taichung Taiwan
    7 Tainan City Taiwan
    8 Tainan Taiwan
    9 Taipei City Taiwan
    10 Taipei Taiwan
    11 Taoyuan Taiwan

    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:
    NCT02613871
    Other Study ID Numbers:
    • GS-US-337-1655
    First Posted:
    Nov 25, 2015
    Last Update Posted:
    Mar 6, 2020
    Last Verified:
    Nov 1, 2019
    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:

    Study Results

    Participant Flow

    Recruitment Details Participants were enrolled at study sites in Taiwan. The first participant was screened on 22 December 2015. The last study visit occurred on 07 November 2018.
    Pre-assignment Detail 135 participants were screened.
    Arm/Group Title LDV/SOF FDC
    Arm/Group Description Ledipasvir/sofosbuvir (LDV/SOF) (90/400 mg) fixed-dose combination (FDC) tablet orally once daily for 12 weeks.
    Period Title: Overall Study
    STARTED 111
    COMPLETED 108
    NOT COMPLETED 3

    Baseline Characteristics

    Arm/Group Title LDV/SOF FDC
    Arm/Group Description LDV/SOF (90/400 mg) FDC tablet orally once daily for 12 weeks.
    Overall Participants 111
    Age (years) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [years]
    55
    (9.3)
    Sex: Female, Male (Count of Participants)
    Female
    69
    62.2%
    Male
    42
    37.8%
    Race/Ethnicity, Customized (Count of Participants)
    Asian
    111
    100%
    Race/Ethnicity, Customized (Count of Participants)
    Not Hispanic or Latino
    99
    89.2%
    Not Permitted
    12
    10.8%
    IL28b Status (Count of Participants)
    CC
    85
    76.6%
    CT
    26
    23.4%
    HCV RNA (log10 IU/mL) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [log10 IU/mL]
    5.9
    (0.73)
    HCV RNA Category (Count of Participants)
    < 800,000 IU/mL
    44
    39.6%
    ≥ 800,000 IU/mL
    67
    60.4%
    Cirrhosis status (Count of Participants)
    Absence
    93
    83.8%
    Presence
    18
    16.2%
    Fibroscan Score (kPa) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [kPa]
    9.3
    (7.05)
    Hepatitis B Virus (HBV) DNA (log10 IU/mL) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [log10 IU/mL]
    2.1
    (0.92)
    Plasma HBV DNA (IU/mL) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [IU/mL]
    9423.1
    (69641.90)
    HBsAg (IU/mL) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [IU/mL]
    578.6
    (1113.56)
    Serum Lysyl Oxidase-Like 2 (LOXL-2) Level (pg/mL) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [pg/mL]
    98
    (64.4)
    HCV Genotype (Count of Participants)
    Genotype 1
    1
    0.9%
    Genotype 1a
    3
    2.7%
    Genotype 1b
    64
    57.7%
    Genotype 2
    43
    38.7%

    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 quantification (LLOQ; 15 IU/mL) at 12 weeks after stopping study treatment.
    Time Frame Posttreatment Week 12

    Outcome Measure Data

    Analysis Population Description
    Full Analysis Set included all participants who were enrolled and received at least 1 dose of study drug.
    Arm/Group Title LDV/SOF FDC
    Arm/Group Description LDV/SOF (90/400 mg) FDC tablet orally once daily for 12 weeks.
    Measure Participants 111
    Genotype 1
    100.0
    90.1%
    Genotype 2
    100.0
    90.1%
    Total
    100.0
    90.1%
    2. Primary Outcome
    Title Percentage of Participants With Any Adverse Event Leading to Permanent Discontinuation of Study Drug
    Description
    Time Frame First dose date up to 12 weeks

    Outcome Measure Data

    Analysis Population Description
    Safety Analysis Set included participants who received at least 1 dose of study drug.
    Arm/Group Title LDV/SOF FDC
    Arm/Group Description LDV/SOF (90/400 mg) FDC tablet orally once daily for 12 weeks.
    Measure Participants 111
    Number [percentage of participants]
    0.0
    0%
    3. Secondary Outcome
    Title Percentage of Participants With SVR at 4 Weeks After Discontinuation of Therapy (SVR4)
    Description SVR4 was defined as HCV RNA < LLOQ (15 IU/mL) at 4 weeks after stopping study treatment.
    Time Frame Posttreatment Week 4

    Outcome Measure Data

    Analysis Population Description
    Participants in Full Analysis Set were analyzed.
    Arm/Group Title LDV/SOF FDC
    Arm/Group Description LDV/SOF (90/400 mg) FDC tablet orally once daily for 12 weeks.
    Measure Participants 111
    Number (95% Confidence Interval) [percentage of participants]
    100.0
    90.1%
    4. Secondary Outcome
    Title Percentage of Participants With HCV RNA < LLOQ While on Treatment
    Description LLOQ = 15 IU/mL
    Time Frame Weeks 1, 2, 4, 8, and 12

    Outcome Measure Data

    Analysis Population Description
    Participants in Full Analysis Set were analyzed.
    Arm/Group Title LDV/SOF FDC
    Arm/Group Description LDV/SOF (90/400 mg) FDC tablet orally once daily for 12 weeks.
    Measure Participants 111
    Week 1
    33.3
    30%
    Week 2
    82.0
    73.9%
    Week 4
    100.0
    90.1%
    Week 8
    100.0
    90.1%
    Week 12
    100.0
    90.1%
    5. Secondary Outcome
    Title Percentage of Participants With HCV RNA < LLOQ at Posttreatment Weeks 24, 36, 48, 60, 72, 84, 96, and 108
    Description LLOQ = 15 IU/mL
    Time Frame Posttreatment Weeks 24, 36, 48, 60, 72, 84, 96, and 108

    Outcome Measure Data

    Analysis Population Description
    Participants in Full Analysis Set with available data were analyzed.
    Arm/Group Title LDV/SOF FDC
    Arm/Group Description LDV/SOF (90/400 mg) FDC tablet orally once daily for 12 weeks.
    Measure Participants 111
    Posttreatment Week 24
    100
    90.1%
    Posttreatment Week 36
    100
    90.1%
    Posttreatment Week 48
    100
    90.1%
    Posttreatment Week 60
    100
    90.1%
    Posttreatment Week 72
    100
    90.1%
    Posttreatment Week 84
    100
    90.1%
    Posttreatment Week 96
    100
    90.1%
    Posttreatment Week 108
    100
    90.1%
    6. Secondary Outcome
    Title HCV RNA Change From Baseline While on Treatment
    Description
    Time Frame Weeks 1, 2, 4, 8, and 12

    Outcome Measure Data

    Analysis Population Description
    Participants in Full Analysis Set were analyzed.
    Arm/Group Title LDV/SOF FDC
    Arm/Group Description LDV/SOF (90/400 mg) FDC tablet orally once daily for 12 weeks.
    Measure Participants 111
    Change at Week 1
    -4.14
    (0.551)
    Change at Week 2
    -4.63
    (0.702)
    Change at Week 4
    -4.73
    (0.727)
    Change at Week 8
    -4.73
    (0.727)
    Change at Week 12
    -4.73
    (0.727)
    7. Secondary Outcome
    Title Percentage of Participants With Virologic Failure
    Description Virologic failure was defined as : Breakthrough (confirmed HCV RNA ≥ LLOQ [15 IU/mL] 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), or Relapse (HCV RNA ≥ LLOQ during the post-treatment period having achieved HCV RNA < LLOQ at end of treatment, confirmed with 2 consecutive values or last available post-treatment measurement)
    Time Frame First dose date up to Posttreatment Week 12

    Outcome Measure Data

    Analysis Population Description
    Participants in Full Analysis Set were analyzed.
    Arm/Group Title LDV/SOF FDC
    Arm/Group Description LDV/SOF (90/400 mg) FDC tablet orally once daily for 12 weeks.
    Measure Participants 111
    Number [percentage of participants]
    0
    0%
    8. Secondary Outcome
    Title Plasma HBV DNA Change From Baseline While on Treatment
    Description
    Time Frame Weeks 1, 2, 4, 8, and 12

    Outcome Measure Data

    Analysis Population Description
    Participants in Full Analysis Set with available data were analyzed.
    Arm/Group Title LDV/SOF FDC
    Arm/Group Description LDV/SOF (90/400 mg) FDC tablet orally once daily for 12 weeks.
    Measure Participants 111
    Change at Week 1
    -0.06
    (0.237)
    Change at Week 2
    0.08
    (0.366)
    Change at Week 4
    0.37
    (0.705)
    Change at Week 8
    0.51
    (0.906)
    Change at Week 12
    0.24
    (0.746)
    9. Secondary Outcome
    Title Plasma HBV DNA Change From Baseline at Posttreatment Weeks 4, 12, 24, 36, 48, 60, 72, 84, 96, and 108
    Description
    Time Frame Posttreatment Weeks 4, 12, 24, 36, 48, 60, 72, 84, 96, and 108

    Outcome Measure Data

    Analysis Population Description
    Participants in Full Analysis Set with available data were analyzed.
    Arm/Group Title LDV/SOF FDC
    Arm/Group Description LDV/SOF (90/400 mg) FDC tablet orally once daily for 12 weeks.
    Measure Participants 111
    Change at Posttreatment Week 4
    0.49
    (0.727)
    Change at Posttreatment Week 12
    0.66
    (0.955)
    Change at Posttreatment Week 24
    0.56
    (1.036)
    Change at Posttreatment Week 36
    0.67
    (1.190)
    Change at Posttreatment Week 48
    0.68
    (1.269)
    Change at Posttreatment Week 60
    0.70
    (1.399)
    Change at Posttreatment Week 72
    0.55
    (1.131)
    Change at Posttreatment Week 84
    0.50
    (1.008)
    Change at Posttreatment Week 96
    0.41
    (0.963)
    Change at Posttreatment Week 108
    0.38
    (0.923)
    10. Secondary Outcome
    Title HBsAg Level Change From Baseline While on Treatment
    Description
    Time Frame Weeks 1, 2, 4, 8, and 12

    Outcome Measure Data

    Analysis Population Description
    Participants in Full Analysis Set with available data were analyzed.
    Arm/Group Title LDV/SOF FDC
    Arm/Group Description LDV/SOF (90/400 mg) FDC tablet orally once daily for 12 weeks.
    Measure Participants 111
    Change at Week 1
    -0.14
    (0.184)
    Change at Week 2
    -0.18
    (0.181)
    Change at Week 4
    -0.25
    (0.185)
    Change at Week 8
    -0.41
    (0.234)
    Change at Week 12
    -0.47
    (0.266)
    11. Secondary Outcome
    Title HBsAg Level Change From Baseline at Posttreatment Weeks 4, 12, 24, 36, 48, 60, 72, 84, 96, and 108
    Description
    Time Frame Posttreatment Weeks 4, 12, 24, 36, 48, 60, 72, 84, 96, and 108

    Outcome Measure Data

    Analysis Population Description
    Participants in Full Analysis Set with available data were analyzed.
    Arm/Group Title LDV/SOF FDC
    Arm/Group Description LDV/SOF (90/400 mg) FDC tablet orally once daily for 12 weeks.
    Measure Participants 111
    Change at Posttreatment Week 4
    -0.16
    (0.347)
    Change at Posttreatment Week 12
    -0.01
    (0.338)
    Change at Posttreatment Week 24
    -0.02
    (0.405)
    Change at Posttreatment Week 36
    -0.07
    (0.484)
    Change at Posttreatment Week 48
    -0.10
    (0.526)
    Change at Posttreatment Week 60
    -0.16
    (0.664)
    Change at Posttreatment Week 72
    -0.20
    (0.619)
    Change at Posttreatment Week 84
    -0.25
    (0.608)
    Change at Posttreatment Week 96
    -0.32
    (0.618)
    Change at Posttreatment Week 108
    -0.37
    (0.658)
    12. Secondary Outcome
    Title Serum LOXL-2 Level Change From Baseline While on Treatment
    Description
    Time Frame Weeks 1, 2, 4, 8, and 12

    Outcome Measure Data

    Analysis Population Description
    Participants in Full Analysis Set with available data were analyzed.
    Arm/Group Title LDV/SOF FDC
    Arm/Group Description LDV/SOF (90/400 mg) FDC tablet orally once daily for 12 weeks.
    Measure Participants 111
    Change at Week 1
    -2
    (29.4)
    Change at Week 2
    -6
    (26.9)
    Change at Week 4
    -15
    (27.8)
    Change at Week 8
    -22
    (36.6)
    Change at Week 12
    -27
    (36.0)
    13. Secondary Outcome
    Title Serum LOXL-2 Level Change From Baseline at Posttreatment Weeks 4, 12, and 36
    Description
    Time Frame Posttreatment Weeks 4, 12, and 36

    Outcome Measure Data

    Analysis Population Description
    Participants in Full Analysis Set were analyzed.
    Arm/Group Title LDV/SOF FDC
    Arm/Group Description LDV/SOF (90/400 mg) FDC tablet orally once daily for 12 weeks.
    Measure Participants 111
    Change at Posttreatment Week 4
    -30
    (45.0)
    Change at Posttreatment Week 12
    -32
    (51.8)
    Change at Posttreatment Week 36
    -41
    (53.0)
    14. Secondary Outcome
    Title Percentage of Participants That Required HBV Therapy During the Study
    Description
    Time Frame First dose date up to Posttreatment Week 108

    Outcome Measure Data

    Analysis Population Description
    Participants in Full Analysis Set were analyzed.
    Arm/Group Title LDV/SOF FDC
    Arm/Group Description LDV/SOF (90/400 mg) FDC tablet orally once daily for 12 weeks.
    Measure Participants 111
    Number [percentage of participants]
    7.2
    6.5%
    15. Secondary Outcome
    Title Fibrosis Status as Assessed by Fibroscan Score at Posttreatment Weeks 12, 60, and 108
    Description FibroScan is a non-invasive device that assesses the hardness (or stiffness) of the liver using the technique of transient elastography. FibroScan results range from 2.5 kPa to 75 kPa with higher scores indicating greater liver stiffness. Per protocol, cirrhosis status was determined as follows: Presence of cirrhosis = FibroScan result of > 12.5 kPa Absence of cirrhosis = FibroScan result of ≤ 12.5 kPa
    Time Frame Posttreatment Weeks 12, 60, and 108

    Outcome Measure Data

    Analysis Population Description
    Participants in Full Analysis Set with available data were analyzed.
    Arm/Group Title LDV/SOF FDC
    Arm/Group Description LDV/SOF (90/400 mg) FDC tablet orally once daily for 12 weeks.
    Measure Participants 111
    Posttreatment Week 12
    8.0
    (7.01)
    Posttreatment Week 60
    7.2
    (4.99)
    Posttreatment Week 108
    7.1
    (4.79)
    16. Secondary Outcome
    Title Percentage of Participants That Develop Hepatocellular Carcinoma (HCC) During the Study
    Description
    Time Frame First dose date up to Posttreatment Week 108

    Outcome Measure Data

    Analysis Population Description
    Participants in Full Analysis Set were analyzed.
    Arm/Group Title LDV/SOF FDC
    Arm/Group Description LDV/SOF (90/400 mg) FDC tablet orally once daily for 12 weeks.
    Measure Participants 111
    Number [percentage of participants]
    0.0
    0%

    Adverse Events

    Time Frame Adverse Events: First dose date up to 12 weeks plus 30 days; All-Cause Mortality: First dose date up to maximum 3 years
    Adverse Event Reporting Description Safety Analysis Set included participants who received at least 1 dose of study drug.
    Arm/Group Title LDV/SOF FDC
    Arm/Group Description LDV/SOF (90/400 mg) FDC tablet orally once daily for 12 weeks.
    All Cause Mortality
    LDV/SOF FDC
    Affected / at Risk (%) # Events
    Total 2/111 (1.8%)
    Serious Adverse Events
    LDV/SOF FDC
    Affected / at Risk (%) # Events
    Total 4/111 (3.6%)
    Gastrointestinal disorders
    Duodenal ulcer 1/111 (0.9%)
    Injury, poisoning and procedural complications
    Meniscus injury 1/111 (0.9%)
    Post procedural haemorrhage 1/111 (0.9%)
    Nervous system disorders
    Optic neuritis 1/111 (0.9%)
    Other (Not Including Serious) Adverse Events
    LDV/SOF FDC
    Affected / at Risk (%) # Events
    Total 24/111 (21.6%)
    General disorders
    Fatigue 8/111 (7.2%)
    Infections and infestations
    Upper respiratory tract infection 9/111 (8.1%)
    Nervous system disorders
    Headache 11/111 (9.9%)

    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:
    NCT02613871
    Other Study ID Numbers:
    • GS-US-337-1655
    First Posted:
    Nov 25, 2015
    Last Update Posted:
    Mar 6, 2020
    Last Verified:
    Nov 1, 2019