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Safety and Efficacy of LDV/SOF Fixed-Dose Combination (FDC) ± Ribavirin in HCV Genotype 1 Subjects

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01726517
Recruitment Status : Completed
First Posted : November 15, 2012
Results First Posted : November 17, 2014
Last Update Posted : November 16, 2018
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Chronic Hepatitis C Virus
Interventions Drug: LDV/SOF
Drug: RBV
Enrollment 100
Recruitment Details Participants were enrolled at 1 study site in the United States. The first participant was screened on 22 October 2012. The last participant observation was on 13 January 2014.
Pre-assignment Details 116 participants were screened.
Arm/Group Title LDV/SOF 8 Weeks (TN) LDV/SOF+RBV 8 Weeks (TN) LDV/SOF 12 Weeks (TN) LDV/SOF 12 Weeks (TE) LDV/SOF+RBV 12 Weeks (TE)
Hide Arm/Group Description Treatment-naive (TN) participants were randomized to receive ledipasvir (LDV) 90 mg/sofosbuvir (SOF) 400 mg for 8 weeks. Treatment-naive participants were randomized to receive LDV 90 mg/SOF 400 mg plus weight-based ribavirin (RBV) (1000-1200 mg) for 8 weeks. Treatment-naive participants were randomized to receive LDV 90 mg/SOF 400 mg for 12 weeks. Treatment-experienced (TE) participants (had virologic failure following prior therapy with a protease-inhibitor [PI]+pegylated interferon [PEG]+RBV regimen) were randomized to receive LDV 90 mg/SOF 400 mg for 12 weeks. Treatment-experienced participants (had virologic failure following prior therapy with a PI+PEG+RBV regimen) were randomized to receive LDV 90 mg/SOF 400 mg plus weight-based RBV (1000-1200 mg) for 12 weeks.
Period Title: Overall Study
Started 20 21 19 19 21
Completed 20 21 18 19 21
Not Completed 0 0 1 0 0
Reason Not Completed
Withdrawal by Subject             0             0             1             0             0
Arm/Group Title LDV/SOF 8 Weeks (TN) LDV/SOF+RBV 8 Weeks (TN) LDV/SOF 12 Weeks (TN) LDV/SOF 12 Weeks (TE) LDV/SOF+RBV 12 Weeks (TE) Total
Hide Arm/Group Description Treatment-naive participants were randomized to receive LDV 90 mg/SOF 400 mg for 8 weeks. Treatment-naive participants were randomized to receive LDV 90 mg/SOF 400 mg plus weight-based RBV (1000-1200 mg) for 8 weeks. Treatment-naive participants were randomized to receive LDV 90 mg/SOF 400 mg for 12 weeks. Treatment-experienced participants (had virologic failure following prior therapy with a PI+PEG+RBV regimen) were randomized to receive LDV 90 mg/SOF 400 mg for 12 weeks. Treatment-experienced participants (had virologic failure following prior therapy with a PI+PEG+RBV regimen) were randomized to receive LDV 90 mg/SOF 400 mg plus weight-based RBV (1000-1200 mg) for 12 weeks. Total of all reporting groups
Overall Number of Baseline Participants 20 21 19 19 21 100
Hide Baseline Analysis Population Description
Safety Analysis Set: participants received at least 1 dose of study drug
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 20 participants 21 participants 19 participants 19 participants 21 participants 100 participants
48  (10.7) 50  (11.1) 46  (11.6) 54  (6.6) 52  (9.8) 50  (10.4)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants 21 participants 19 participants 19 participants 21 participants 100 participants
Female
6
  30.0%
9
  42.9%
8
  42.1%
4
  21.1%
7
  33.3%
34
  34.0%
Male
14
  70.0%
12
  57.1%
11
  57.9%
15
  78.9%
14
  66.7%
66
  66.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants 21 participants 19 participants 19 participants 21 participants 100 participants
Hispanic or Latino
3
  15.0%
12
  57.1%
9
  47.4%
6
  31.6%
10
  47.6%
40
  40.0%
Not Hispanic or Latino
17
  85.0%
9
  42.9%
10
  52.6%
13
  68.4%
11
  52.4%
60
  60.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants 21 participants 19 participants 19 participants 21 participants 100 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
1
   5.3%
0
   0.0%
1
   1.0%
Asian
1
   5.0%
0
   0.0%
1
   5.3%
0
   0.0%
0
   0.0%
2
   2.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
4
  20.0%
0
   0.0%
1
   5.3%
2
  10.5%
2
   9.5%
9
   9.0%
White
15
  75.0%
21
 100.0%
17
  89.5%
16
  84.2%
19
  90.5%
88
  88.0%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Hepatitis C Virus (HCV) Genotype   [1] 
Measure Type: Number
Unit of measure:  Participants
 Number Analyzed 20 participants 21 participants 19 participants 19 participants 21 participants 100 participants
1a 17 19 17 18 16 87
1b 3 2 2 1 5 13
[1]
Measure Description: There are variations within HCV genotype 1 which are distinct enough to be referred to as genotypes 1a or 1b.
IL28b Status   [1] 
Measure Type: Number
Unit of measure:  Participants
 Number Analyzed 20 participants 21 participants 19 participants 19 participants 21 participants 100 participants
CC 4 7 1 2 1 15
CT 12 11 14 13 11 61
TT 4 3 4 4 9 24
[1]
Measure Description: CC, CT, and TT alleles are different forms of the IL28b gene.
HCV RNA (log10 IU/mL)  
Mean (Standard Deviation)
Unit of measure:  Log10 IU/mL
Number Analyzed 20 participants 21 participants 19 participants 19 participants 21 participants 100 participants
6.1  (0.82) 6.0  (0.84) 6.1  (0.79) 6.3  (0.49) 6.2  (0.42) 6.1  (0.69)
HCV RNA Category  
Measure Type: Number
Unit of measure:  Participants
 Number Analyzed 20 participants 21 participants 19 participants 19 participants 21 participants 100 participants
< 800,000 IU/mL 9 7 7 4 5 32
≥ 800,000 IU/mL 11 14 12 15 16 68
Prior HCV Treatment and Response   [1] 
Measure Type: Number
Unit of measure:  Participants
 Number Analyzed 20 participants 21 participants 19 participants 19 participants 21 participants 100 participants
Non-responder to PI boceprevir 0 0 0 9 9 18
Relapse/Breakthrough to PI boceprevir 0 0 0 2 2 4
Non-responder to PI telaprevir 0 0 0 3 6 9
Relapse/Breakthrough to PI telaprevir 0 0 0 5 4 9
[1]
Measure Description: Prior HCV treatment and response was only collected for treatment-experienced participants in the LDV/SOF 12 Weeks (TE) and LDV/SOF+RBV 12 Weeks (TE) groups.
Cirrhosis  
Measure Type: Number
Unit of measure:  Participants
 Number Analyzed 20 participants 21 participants 19 participants 19 participants 21 participants 100 participants
No 20 21 19 8 10 78
Yes 0 0 0 11 11 22
1.Primary Outcome
Title Percentage of Participants With Sustained Virologic Response (SVR) at 12 Weeks After Discontinuation of Therapy (SVR12)
Hide Description SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ; ie, 25 IU/mL) 12 weeks after stopping study treatment.
Time Frame Posttreatment Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set: participants were randomized and received at least 1 dose of study drug
Arm/Group Title LDV/SOF 8 Weeks (TN) LDV/SOF+RBV 8 Weeks (TN) LDV/SOF 12 Weeks (TN) LDV/SOF 12 Weeks (TE) LDV/SOF+RBV 12 Weeks (TE)
Hide Arm/Group Description:
Treatment-naive participants were randomized to receive LDV 90 mg/SOF 400 mg for 8 weeks.
Treatment-naive participants were randomized to receive LDV 90 mg/SOF 400 mg plus weight-based RBV (1000-1200 mg) for 8 weeks.
Treatment-naive participants were randomized to receive LDV 90 mg/SOF 400 mg for 12 weeks.
Treatment-experienced participants (had virologic failure following prior therapy with a PI+PEG+RBV regimen) were randomized to receive LDV 90 mg/SOF 400 mg for 12 weeks.
Treatment-experienced participants (had virologic failure following prior therapy with a PI+PEG+RBV regimen) were randomized to receive LDV 90 mg/SOF 400 mg plus weight-based RBV (1000-1200 mg) for 12 weeks.
Overall Number of Participants Analyzed 20 21 19 19 21
Measure Type: Number
Unit of Measure: percentage of participants
95.0 100.0 94.7 94.7 100.0
2.Primary Outcome
Title Incidence of Adverse Events Leading to Permanent Discontinuation of Study Drug(s)
Hide Description The number of participants experiencing an adverse event leading to permanent discontinuation of study drug(s) was summarized.
Time Frame Baseline to Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Analysis Set
Arm/Group Title LDV/SOF 8 Weeks (TN) LDV/SOF+RBV 8 Weeks (TN) LDV/SOF 12 Weeks (TN) LDV/SOF 12 Weeks (TE) LDV/SOF+RBV 12 Weeks (TE)
Hide Arm/Group Description:
Treatment-naive participants were randomized to receive LDV 90 mg/SOF 400 mg for 8 weeks.
Treatment-naive participants were randomized to receive LDV 90 mg/SOF 400 mg plus weight-based RBV (1000-1200 mg) for 8 weeks.
Treatment-naive participants were randomized to receive LDV 90 mg/SOF 400 mg for 12 weeks.
Treatment-experienced participants (had virologic failure following prior therapy with a PI+PEG+RBV regimen) were randomized to receive LDV 90 mg/SOF 400 mg for 12 weeks.
Treatment-experienced participants (had virologic failure following prior therapy with a PI+PEG+RBV regimen) were randomized to receive LDV 90 mg/SOF 400 mg plus weight-based RBV (1000-1200 mg) for 12 weeks.
Overall Number of Participants Analyzed 20 21 19 19 21
Measure Type: Number
Unit of Measure: participants
0 0 0 0 0
3.Secondary Outcome
Title Percentage of Participants With SVR at 2, 4, 8, and 24 Weeks After Discontinuation of Therapy (SVR2, SVR4, SVR8, and SVR24)
Hide Description SVR2, SVR4, SVR8, and SVR24 was defined as HCV RNA < LLOQ at 2, 4, 8, and 24 weeks following the last dose of study drug, respectively.
Time Frame Posttreatment Weeks 2, 4, 8, and 24
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set
Arm/Group Title LDV/SOF 8 Weeks (TN) LDV/SOF+RBV 8 Weeks (TN) LDV/SOF 12 Weeks (TN) LDV/SOF 12 Weeks (TE) LDV/SOF+RBV 12 Weeks (TE)
Hide Arm/Group Description:
Treatment-naive participants were randomized to receive LDV 90 mg/SOF 400 mg for 8 weeks.
Treatment-naive participants were randomized to receive LDV 90 mg/SOF 400 mg plus weight-based RBV (1000-1200 mg) for 8 weeks.
Treatment-naive participants were randomized to receive LDV 90 mg/SOF 400 mg for 12 weeks.
Treatment-experienced participants (had virologic failure following prior therapy with a PI+PEG+RBV regimen) were randomized to receive LDV 90 mg/SOF 400 mg for 12 weeks.
Treatment-experienced participants (had virologic failure following prior therapy with a PI+PEG+RBV regimen) were randomized to receive LDV 90 mg/SOF 400 mg plus weight-based RBV (1000-1200 mg) for 12 weeks.
Overall Number of Participants Analyzed 20 21 19 19 21
Measure Type: Number
Unit of Measure: percentage of participants
SVR2 100.0 100.0 100.0 94.7 100.0
SVR4 100.0 100.0 100.0 94.7 100.0
SVR8 95.0 100.0 100.0 94.7 100.0
SVR24 95.0 100.0 94.7 94.7 100.0
4.Secondary Outcome
Title Percentage of Participants Experiencing Viral Breakthrough or Viral Relapse
Hide Description
  • Viral breakthrough was defined as HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ while receiving treatment, confirmed with 2 consecutive values (second confirmation value could be posttreatment), or last available on-treatment measurement with no subsequent follow-up values.
  • Viral relapse was defined as HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA < LLOQ at end of treatment, confirmed with 2 consecutive values or last available posttreatment measurement.
Time Frame Baseline to Posttreatment Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title LDV/SOF 8 Weeks (TN) LDV/SOF+RBV 8 Weeks (TN) LDV/SOF 12 Weeks (TN) LDV/SOF 12 Weeks (TE) LDV/SOF+RBV 12 Weeks (TE)
Hide Arm/Group Description:
Treatment-naive participants were randomized to receive LDV 90 mg/SOF 400 mg for 8 weeks.
Treatment-naive participants were randomized to receive LDV 90 mg/SOF 400 mg plus weight-based RBV (1000-1200 mg) for 8 weeks.
Treatment-naive participants were randomized to receive LDV 90 mg/SOF 400 mg for 12 weeks.
Treatment-experienced participants (had virologic failure following prior therapy with a PI+PEG+RBV regimen) were randomized to receive LDV 90 mg/SOF 400 mg for 12 weeks.
Treatment-experienced participants (had virologic failure following prior therapy with a PI+PEG+RBV regimen) were randomized to receive LDV 90 mg/SOF 400 mg plus weight-based RBV (1000-1200 mg) for 12 weeks.
Overall Number of Participants Analyzed 20 21 19 19 21
Measure Type: Number
Unit of Measure: percentage of participants
Viral breakthrough 0 0 0 0 0
Viral relapse 5.0 0 0 5.3 0
Time Frame Baseline to Week 12 plus 30 days
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title LDV/SOF 8 Weeks (TN) LDV/SOF+RBV 8 Weeks (TN) LDV/SOF 12 Weeks (TN) LDV/SOF 12 Weeks (TE) LDV/SOF+RBV 12 Weeks (TE)
Hide Arm/Group Description Treatment-naive participants were randomized to receive LDV 90 mg/SOF 400 mg for 8 weeks. Treatment-naive participants were randomized to receive LDV 90 mg/SOF 400 mg plus weight-based RBV (1000-1200 mg) for 8 weeks. Treatment-naive participants were randomized to receive LDV 90 mg/SOF 400 mg for 12 weeks. Treatment-experienced participants (had virologic failure following prior therapy with a PI+PEG+RBV regimen) were randomized to receive LDV 90 mg/SOF 400 mg for 12 weeks. Treatment-experienced participants (had virologic failure following prior therapy with a PI+PEG+RBV regimen) were randomized to receive LDV 90 mg/SOF 400 mg plus weight-based RBV (1000-1200 mg) for 12 weeks.
All-Cause Mortality
LDV/SOF 8 Weeks (TN) LDV/SOF+RBV 8 Weeks (TN) LDV/SOF 12 Weeks (TN) LDV/SOF 12 Weeks (TE) LDV/SOF+RBV 12 Weeks (TE)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/--   --/-- 
Hide Serious Adverse Events
LDV/SOF 8 Weeks (TN) LDV/SOF+RBV 8 Weeks (TN) LDV/SOF 12 Weeks (TN) LDV/SOF 12 Weeks (TE) LDV/SOF+RBV 12 Weeks (TE)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/20 (0.00%)   1/21 (4.76%)   1/19 (5.26%)   1/19 (5.26%)   1/21 (4.76%) 
Blood and lymphatic system disorders           
Anaemia † 1  0/20 (0.00%)  0/21 (0.00%)  0/19 (0.00%)  0/19 (0.00%)  1/21 (4.76%) 
Gastrointestinal disorders           
Peptic ulcer † 1  0/20 (0.00%)  0/21 (0.00%)  1/19 (5.26%)  0/19 (0.00%)  0/21 (0.00%) 
Injury, poisoning and procedural complications           
Spinal compression fracture † 1  0/20 (0.00%)  0/21 (0.00%)  0/19 (0.00%)  1/19 (5.26%)  0/21 (0.00%) 
Psychiatric disorders           
Delirium † 1  0/20 (0.00%)  1/21 (4.76%)  0/19 (0.00%)  0/19 (0.00%)  0/21 (0.00%) 
Suicidal ideation † 1  0/20 (0.00%)  0/21 (0.00%)  0/19 (0.00%)  0/19 (0.00%)  1/21 (4.76%) 
†
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA Version 16.0
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
LDV/SOF 8 Weeks (TN) LDV/SOF+RBV 8 Weeks (TN) LDV/SOF 12 Weeks (TN) LDV/SOF 12 Weeks (TE) LDV/SOF+RBV 12 Weeks (TE)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   9/20 (45.00%)   12/21 (57.14%)   8/19 (42.11%)   7/19 (36.84%)   12/21 (57.14%) 
Blood and lymphatic system disorders           
Anaemia † 1  0/20 (0.00%)  2/21 (9.52%)  0/19 (0.00%)  0/19 (0.00%)  6/21 (28.57%) 
Gastrointestinal disorders           
Nausea † 1  2/20 (10.00%)  2/21 (9.52%)  1/19 (5.26%)  0/19 (0.00%)  4/21 (19.05%) 
Abdominal pain † 1  1/20 (5.00%)  1/21 (4.76%)  1/19 (5.26%)  0/19 (0.00%)  1/21 (4.76%) 
Diarrhoea † 1  2/20 (10.00%)  0/21 (0.00%)  0/19 (0.00%)  0/19 (0.00%)  0/21 (0.00%) 
Vomiting † 1  0/20 (0.00%)  2/21 (9.52%)  0/19 (0.00%)  0/19 (0.00%)  0/21 (0.00%) 
Abdominal distension † 1  1/20 (5.00%)  0/21 (0.00%)  0/19 (0.00%)  0/19 (0.00%)  0/21 (0.00%) 
Cheilitis † 1  0/20 (0.00%)  0/21 (0.00%)  1/19 (5.26%)  0/19 (0.00%)  0/21 (0.00%) 
Constipation † 1  1/20 (5.00%)  0/21 (0.00%)  0/19 (0.00%)  0/19 (0.00%)  0/21 (0.00%) 
Parotid gland enlargement † 1  1/20 (5.00%)  0/21 (0.00%)  0/19 (0.00%)  0/19 (0.00%)  0/21 (0.00%) 
Peptic ulcer † 1  0/20 (0.00%)  0/21 (0.00%)  1/19 (5.26%)  0/19 (0.00%)  0/21 (0.00%) 
General disorders           
Fatigue † 1  0/20 (0.00%)  1/21 (4.76%)  1/19 (5.26%)  0/19 (0.00%)  0/21 (0.00%) 
Infections and infestations           
Upper respiratory tract infection † 1  2/20 (10.00%)  0/21 (0.00%)  1/19 (5.26%)  1/19 (5.26%)  4/21 (19.05%) 
Bronchitis † 1  1/20 (5.00%)  1/21 (4.76%)  0/19 (0.00%)  1/19 (5.26%)  1/21 (4.76%) 
Influenza † 1  2/20 (10.00%)  0/21 (0.00%)  0/19 (0.00%)  0/19 (0.00%)  0/21 (0.00%) 
Urinary tract infection † 1  0/20 (0.00%)  2/21 (9.52%)  0/19 (0.00%)  0/19 (0.00%)  0/21 (0.00%) 
Latent tuberculosis † 1  0/20 (0.00%)  0/21 (0.00%)  0/19 (0.00%)  1/19 (5.26%)  0/21 (0.00%) 
Pharyngitis † 1  0/20 (0.00%)  0/21 (0.00%)  1/19 (5.26%)  0/19 (0.00%)  0/21 (0.00%) 
Pneumonia † 1  0/20 (0.00%)  0/21 (0.00%)  0/19 (0.00%)  1/19 (5.26%)  0/21 (0.00%) 
Investigations           
Blood pressure increased † 1  0/20 (0.00%)  0/21 (0.00%)  1/19 (5.26%)  0/19 (0.00%)  0/21 (0.00%) 
Metabolism and nutrition disorders           
Decreased appetite † 1  0/20 (0.00%)  2/21 (9.52%)  0/19 (0.00%)  1/19 (5.26%)  0/21 (0.00%) 
Musculoskeletal and connective tissue disorders           
Back pain † 1  1/20 (5.00%)  1/21 (4.76%)  1/19 (5.26%)  1/19 (5.26%)  0/21 (0.00%) 
Muscle spasms † 1  1/20 (5.00%)  0/21 (0.00%)  0/19 (0.00%)  0/19 (0.00%)  2/21 (9.52%) 
Nervous system disorders           
Headache † 1  2/20 (10.00%)  3/21 (14.29%)  0/19 (0.00%)  1/19 (5.26%)  1/21 (4.76%) 
Tremor † 1  0/20 (0.00%)  0/21 (0.00%)  0/19 (0.00%)  1/19 (5.26%)  0/21 (0.00%) 
Psychiatric disorders           
Insomnia † 1  0/20 (0.00%)  2/21 (9.52%)  0/19 (0.00%)  0/19 (0.00%)  0/21 (0.00%) 
Respiratory, thoracic and mediastinal disorders           
Cough † 1  0/20 (0.00%)  2/21 (9.52%)  0/19 (0.00%)  0/19 (0.00%)  0/21 (0.00%) 
Skin and subcutaneous tissue disorders           
Dermatitis † 1  1/20 (5.00%)  0/21 (0.00%)  0/19 (0.00%)  0/19 (0.00%)  2/21 (9.52%) 
Pruritus † 1  0/20 (0.00%)  0/21 (0.00%)  0/19 (0.00%)  1/19 (5.26%)  0/21 (0.00%) 
†
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA Version 16.0
[Not Specified]
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

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
Layout table for Results Point of Contact information
Name/Title: Clinical Trial Disclosures
Organization: Gilead Sciences, Inc.
EMail: ClinicalTrialDisclosures@gilead.com
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT01726517    
Other Study ID Numbers: GS-US-337-0118
First Submitted: November 10, 2012
First Posted: November 15, 2012
Results First Submitted: November 7, 2014
Results First Posted: November 17, 2014
Last Update Posted: November 16, 2018