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Open-label Safety Study of E/C/F/TAF (Genvoya®) in HIV-1 Positive Patients With Mild to Moderate Renal Impairment

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ClinicalTrials.gov Identifier: NCT01818596
Recruitment Status : Completed
First Posted : March 26, 2013
Results First Posted : February 18, 2016
Last Update Posted : March 19, 2019
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions HIV
HIV Infections
Intervention Drug: E/C/F/TAF
Enrollment 252
Recruitment Details Participants were enrolled at study sites in North America, Asia, and Europe. The first participant was screened on 27 March 2013. The last Week 24 study visit occurred on 31 July 2014.
Pre-assignment Details 380 participants were screened.
Arm/Group Title Cohort 1 (Treatment-experienced) Cohort 2 (Treatment-naive)
Hide Arm/Group Description Elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (Genvoya®; E/C/F/TAF) (150/150/200/10 mg) fixed-dose combination (FDC) tablet administered orally once daily with food for 144 weeks in antiretroviral treatment (ART)-experienced participants E/C/F/TAF (150/150/200/10 mg) FDC tablet administered orally once daily with food for 144 weeks in ART-naive participants
Period Title: Overall Study
Started 246 6
Completed 0 0
Not Completed 246 6
Reason Not Completed
Enrolled but Not Treated             4             0
Adverse Event             4             0
Withdrew Consent             3             0
Protocol Violation             1             0
Lost to Follow-up             2             0
Still on Study             232             6
Arm/Group Title Cohort 1 (Treatment-experienced) Cohort 2 (Treatment-naive) Total
Hide Arm/Group Description E/C/F/TAF (150/150/200/10 mg) FDC tablet administered orally once daily with food for 144 weeks in ART-experienced participants E/C/F/TAF (150/150/200/10 mg) FDC tablet administered orally once daily with food for 144 weeks in ART-naive participants Total of all reporting groups
Overall Number of Baseline Participants 242 6 248
Hide Baseline Analysis Population Description
Safety Analysis Set: participants were enrolled and received at least 1 dose of study drug
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 242 participants 6 participants 248 participants
58  (9.9) 55  (7.1) 58  (9.8)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 242 participants 6 participants 248 participants
Female
50
  20.7%
0
   0.0%
50
  20.2%
Male
192
  79.3%
6
 100.0%
198
  79.8%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
 Number Analyzed 242 participants 6 participants 248 participants
Asian 34 1 35
American Indian or Alaska Native 1 0 1
Black or African American 44 3 47
Native Hawaiian or Pacific Islander 2 0 2
White 152 2 154
Other 7 0 7
Not Permitted 2 0 2
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
 Number Analyzed 242 participants 6 participants 248 participants
Hispanic or Latino 31 1 32
Not Hispanic or Latino 209 5 214
Not Permitted 2 0 2
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
 Number Analyzed 242 participants 6 participants 248 participants
United States 166 5 171
United Kingdom 5 0 5
Thailand 30 1 31
Spain 13 0 13
Netherlands 2 0 2
Dominican Republic 6 0 6
Mexico 2 0 2
Australia 12 0 12
France 6 0 6
1.Primary Outcome
Title Change From Baseline in the Estimated Glomerular Filtration Rate Calculated by the Cockcroft-Gault Formula (eGFR_CG) at Week 24
Hide Description eGFR is a measurement of the kidney's ability to filter blood.
Time Frame Baseline; Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the Safety Analysis Set (enrolled and received at least 1 dose of study drug) with available data at the respective time point were analyzed.
Arm/Group Title Cohort 1 (Treatment-experienced) Cohort 2 (Treatment-naive)
Hide Arm/Group Description:
E/C/F/TAF (150/150/200/10 mg) FDC tablet administered orally once daily with food for 144 weeks in ART-experienced participants
E/C/F/TAF (150/150/200/10 mg) FDC tablet administered orally once daily with food for 144 weeks in ART-naive participants
Overall Number of Participants Analyzed 242 6
Median (Inter-Quartile Range)
Unit of Measure: mL/min
Baseline (Cohort 1: n=242; Cohort 2: n=6)
55.6
(45.7 to 62.4)
60.2
(45.0 to 63.2)
Change at Week 24 (Cohort 1: n=233; Cohort 2: n=6)
-0.4
(-4.7 to 4.5)
-0.3
(-3.6 to 1.3)
2.Primary Outcome
Title Change From Baseline in eGFR Calculated by the Chronic Kidney Disease Epidemiology Collaboration Method Based on Cystatin C (eGFR_CKD-EPI,cysC) at Week 24
Hide Description eGFR is a measurement of the kidney's ability to filter blood. The eGFR_CKD-EPI,cysC method is adjusted for age and sex.
Time Frame Baseline; Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the Safety Analysis Set with available data at the respective time point were analyzed.
Arm/Group Title Cohort 1 (Treatment-experienced) Cohort 2 (Treatment-naive)
Hide Arm/Group Description:
E/C/F/TAF (150/150/200/10 mg) FDC tablet administered orally once daily with food for 144 weeks in ART-experienced participants
E/C/F/TAF (150/150/200/10 mg) FDC tablet administered orally once daily with food for 144 weeks in ART-naive participants
Overall Number of Participants Analyzed 242 6
Median (Inter-Quartile Range)
Unit of Measure: mL/min/1.73 m^2
Baseline (Cohort 1: n=241; Cohort 2: n=6)
69.7
(55.9 to 82.7)
70.2
(64.0 to 100.8)
Change at Week 24 (Cohort 1: n=231; Cohort 2: n=6)
3.8
(-4.8 to 11.2)
3.9
(-3.3 to 13.2)
3.Primary Outcome
Title Change From Baseline in eGFR Calculated by the CKD-EPI Method Based on Serum Creatinine (eGFR_CKD-EPI,Creatinine) at Week 24
Hide Description eGFR is a measurement of the kidney's ability to filter blood. The eGFR_CKD-EPI,creatinine method is adjusted for age, race, and sex.
Time Frame Baseline; Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the Safety Analysis Set with available data at the respective time point were analyzed.
Arm/Group Title Cohort 1 (Treatment-experienced) Cohort 2 (Treatment-naive)
Hide Arm/Group Description:
E/C/F/TAF (150/150/200/10 mg) FDC tablet administered orally once daily with food for 144 weeks in ART-experienced participants
E/C/F/TAF (150/150/200/10 mg) FDC tablet administered orally once daily with food for 144 weeks in ART-naive participants
Overall Number of Participants Analyzed 242 6
Median (Inter-Quartile Range)
Unit of Measure: mL/min/1.73 m^2
Baseline (Cohort 1: n=242; Cohort 2: n=6)
54.1
(46.0 to 62.8)
54.4
(41.7 to 81.4)
Change at Week 24 (Cohort 1: n=233; Cohort 2: n=6)
-1.8
(-6.1 to 4.9)
-2.6
(-11.1 to -0.9)
4.Secondary Outcome
Title Change From Baseline in Actual GFR (aGFR) of E/C/F/TAF for Participants Enrolled in the PK/PD Substudy
Hide Description aGFR was directly measured using iohexol plasma clearance (CLiohexol).
Time Frame Baseline; Week 2, 4, or 8; Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the Pharmacodynamic (PD) Substudy Analysis Set (enrolled in the pharmacokinetic (PK)/PD substudy, received at least 1 dose of study drug, and had baseline and at least 1 postbaseline assessment for aGFR assessed by CLiohexol) with available data at the respective time point were analyzed.
Arm/Group Title All Participants
Hide Arm/Group Description:
E/C/F/TAF (150/150/200/10 mg) FDC tablet administered orally once daily with food for 144 weeks
Overall Number of Participants Analyzed 32
Mean (Standard Deviation)
Unit of Measure: mL/min
Baseline (n=32) 60.1  (19.06)
Change at Week 2, 4, or 8 (n=32) -0.6  (8.45)
Change at Week 24 (n=30) 1.4  (9.91)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection All Participants
Comments Comparison is made between the baseline value and the value from the Week 2, 4, or 8 visit and presented as a geometric least squares mean (GLSM) ratio with 90% confidence interval (CI).
Type of Statistical Test Non-Inferiority or Equivalence
Comments 30 subjects with evaluable aGFR (measured by iohexol clearance) in either cohort would provide at least 90% power to show that aGFR change is < 20% after subjects were administered E/C/F/TAF. In this sample size/power computation, it was assumed that the intra-subject variation for aGFR is 0.17 mL/min on natural logarithm scale and a clinical meaningful boundary in aGFR change is 80% to 125%.
Method of Estimation Estimation Parameter Difference in GLSM Ratio
Estimated Value 98.94
Confidence Interval (2-Sided) 90%
93.71 to 104.46
Estimation Comments A parametric analysis of variance model using a mixed-effects model with repeated statement was fitted to the natural logarithm transferred aGFR obtained at postbaseline visits and baseline.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection All Participants
Comments Comparison is made between the baseline value and the value from the Week 24 visit and presented as a GLSM ratio with 90% CI.
Type of Statistical Test Non-Inferiority or Equivalence
Comments 30 subjects with evaluable aGFR (measured by iohexol clearance) in either cohort would provide at least 90% power to show that aGFR change is < 20% after subjects were administered E/C/F/TAF. In this sample size/power computation, it was assumed that the intra-subject variation for aGFR is 0.17 mL/min on natural logarithm scale and a clinical meaningful boundary in aGFR change is 80% to 125%.
Method of Estimation Estimation Parameter Difference in GLSM Ratio
Estimated Value 102.66
Confidence Interval (2-Sided) 90%
97.11 to 108.53
Estimation Comments A parametric analysis of variance model using a mixed-effects model with repeated statement was fitted to the natural logarithm transferred aGFR obtained at postbaseline visits and baseline.
5.Secondary Outcome
Title Percent Change From Baseline in C-type Collagen Sequence (CTX) at Week 24
Hide Description CTX is a biomarker of bone turnover.
Time Frame Baseline; Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the Safety Analysis Set with available data at the respective time point were analyzed.
Arm/Group Title Cohort 1 (Treatment-experienced) Cohort 2 (Treatment-naive)
Hide Arm/Group Description:
E/C/F/TAF (150/150/200/10 mg) FDC tablet administered orally once daily with food for 144 weeks in ART-experienced participants
E/C/F/TAF (150/150/200/10 mg) FDC tablet administered orally once daily with food for 144 weeks in ART-naive participants
Overall Number of Participants Analyzed 226 6
Median (Inter-Quartile Range)
Unit of Measure: percentage change
-3.9
(-15.8 to 10.7)
16.9
(0.0 to 21.7)
6.Secondary Outcome
Title Percent Change From Baseline in Procollagen Type 1 N-terminal Propeptide (P1NP) at Week 24
Hide Description P1NP is a biomarker of bone turnover.
Time Frame Baseline; Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the Safety Analysis Set with available data at the respective time point were analyzed.
Arm/Group Title Cohort 1 (Treatment-experienced) Cohort 2 (Treatment-naive)
Hide Arm/Group Description:
E/C/F/TAF (150/150/200/10 mg) FDC tablet administered orally once daily with food for 144 weeks in ART-experienced participants
E/C/F/TAF (150/150/200/10 mg) FDC tablet administered orally once daily with food for 144 weeks in ART-naive participants
Overall Number of Participants Analyzed 229 6
Median (Inter-Quartile Range)
Unit of Measure: percentage change
-12.98
(-34.48 to 8.86)
6.44
(-5.08 to 47.62)
7.Secondary Outcome
Title Percent Change From Baseline in Retinol Binding Protein (RBP) to Creatinine Ratio (μg/g) at Week 24
Hide Description Urine RBP is a renal biomarker which is used to detect drug-induced kidney injury.
Time Frame Baseline; Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the Safety Analysis Set with available data at the respective time point were analyzed.
Arm/Group Title Cohort 1 (Treatment-experienced) Cohort 2 (Treatment-naive)
Hide Arm/Group Description:
E/C/F/TAF (150/150/200/10 mg) FDC tablet administered orally once daily with food for 144 weeks in ART-experienced participants
E/C/F/TAF (150/150/200/10 mg) FDC tablet administered orally once daily with food for 144 weeks in ART-naive participants
Overall Number of Participants Analyzed 227 6
Median (Inter-Quartile Range)
Unit of Measure: percentage change
-56.2
(-90.0 to -11.8)
68.8
(-37.1 to 72.6)
8.Secondary Outcome
Title Percent Change From Baseline in Urine Beta-2-microglobulin to Creatinine Ratio (μg/g) at Week 24
Hide Description Urine beta-2-microglobulin is a renal biomarker which is used to detect drug-induced kidney injury.
Time Frame Baseline; Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the Safety Analysis Set with available data at the respective time point were analyzed.
Arm/Group Title Cohort 1 (Treatment-experienced) Cohort 2 (Treatment-naive)
Hide Arm/Group Description:
E/C/F/TAF (150/150/200/10 mg) FDC tablet administered orally once daily with food for 144 weeks in ART-experienced participants
E/C/F/TAF (150/150/200/10 mg) FDC tablet administered orally once daily with food for 144 weeks in ART-naive participants
Overall Number of Participants Analyzed 224 6
Median (Inter-Quartile Range)
Unit of Measure: percentage change
-70.7
(-92.6 to -11.1)
-19.5
(-93.0 to 81.3)
9.Secondary Outcome
Title Percentage of Participants Experiencing Adverse Events or Graded Laboratory Abnormalities
Hide Description

Adverse events (AEs) and graded laboratory abnormalities occurring during the E/C/F/TAF treatment period were summarized across the participant population. A participant was counted once if they had a qualifying event.

Data were collected for all participants through the Week 24 visit; additional data are included for participants who had passed the Week 24 visit.
Time Frame Baseline to Week 24 Data Cut (average 42 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Analysis Set
Arm/Group Title Cohort 1 (Treatment-experienced) Cohort 2 (Treatment-naive)
Hide Arm/Group Description:
E/C/F/TAF (150/150/200/10 mg) FDC tablet administered orally once daily with food for 144 weeks in ART-experienced participants
E/C/F/TAF (150/150/200/10 mg) FDC tablet administered orally once daily with food for 144 weeks in ART-naive participants
Overall Number of Participants Analyzed 242 6
Measure Type: Number
Unit of Measure: percentage of participants
Any AE 86.4 83.3
Grade 3 or 4 AE 7.4 0
AE leading to drug discontinuation 3.3 0
Serious AE 10.7 0
Grade 3 or 4 laboratory abnormality 26.4 16.7
10.Secondary Outcome
Title Percentage of Participants Achieving HIV-1 RNA < 50 Copies/mL at Week 24
Hide Description The percentage of participants achieving HIV-1 RNA < 50 Copies/mL at Week 24 was analyzed using the snapshot algorithm, which defines a patient's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status.
Time Frame Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set: participants were enrolled and received at least 1 dose of study drug
Arm/Group Title Cohort 1 (Treatment-experienced) Cohort 2 (Treatment-naive)
Hide Arm/Group Description:
E/C/F/TAF (150/150/200/10 mg) FDC tablet administered orally once daily with food for 144 weeks in ART-experienced participants
E/C/F/TAF (150/150/200/10 mg) FDC tablet administered orally once daily with food for 144 weeks in ART-naive participants
Overall Number of Participants Analyzed 242 6
Measure Type: Number
Unit of Measure: percentage of participants
95.0 83.3
11.Secondary Outcome
Title Pharmacokinetic (PK) Parameter: Cmax of TAF
Hide Description Cmax is defined as the maximum concentration of drug. Blood draws for this outcome may have been at the Week 2, 4, or 8 visit.
Time Frame Predose, and 5 minutes, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 8, and 24 hours postdose
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the PK Substudy Analysis Set (enrolled in the PK/PD substudy, received at least 1 dose of study drug, and for whom steady-state PK parameters were available) with available data were analyzed.
Arm/Group Title All Participants
Hide Arm/Group Description:
E/C/F/TAF (150/150/200/10 mg) FDC tablet administered orally once daily with food for 144 weeks
Overall Number of Participants Analyzed 30
Mean (Standard Deviation)
Unit of Measure: ng/mL
269.8  (180.77)
12.Secondary Outcome
Title PK Parameter: Tmax of TAF
Hide Description Tmax is defined as the time of Cmax. Blood draws for this outcome may have been at the Week 2, 4, or 8 visit.
Time Frame Predose, and 5 minutes, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 8, and 24 hours postdose
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the PK Substudy Analysis Set with available data were analyzed.
Arm/Group Title All Participants
Hide Arm/Group Description:
E/C/F/TAF (150/150/200/10 mg) FDC tablet administered orally once daily with food for 144 weeks
Overall Number of Participants Analyzed 30
Median (Inter-Quartile Range)
Unit of Measure: hours
0.97
(0.50 to 1.98)
13.Secondary Outcome
Title PK Parameter: Clast of TAF
Hide Description Clast is defined as the last observable concentration of drug. Blood draws for this outcome may have been at the Week 2, 4, or 8 visit.
Time Frame Predose, and 5 minutes, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 8, and 24 hours postdose
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the PK Substudy Analysis Set with available data were analyzed.
Arm/Group Title All Participants
Hide Arm/Group Description:
E/C/F/TAF (150/150/200/10 mg) FDC tablet administered orally once daily with food for 144 weeks
Overall Number of Participants Analyzed 30
Mean (Standard Deviation)
Unit of Measure: ng/mL
7.6  (25.73)
14.Secondary Outcome
Title PK Parameter: Tlast of TAF
Hide Description Tlast is defined as the time of Clast. Blood draws for this outcome may have been at the Week 2, 4, or 8 visit.
Time Frame Predose, and 5 minutes, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 8, and 24 hours postdose
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the PK Substudy Analysis Set with available data were analyzed.
Arm/Group Title All Participants
Hide Arm/Group Description:
E/C/F/TAF (150/150/200/10 mg) FDC tablet administered orally once daily with food for 144 weeks
Overall Number of Participants Analyzed 30
Median (Inter-Quartile Range)
Unit of Measure: hours
4.45
(3.82 to 5.00)
15.Secondary Outcome
Title PK Parameter: λz of TAF
Hide Description λz is defined as the terminal elimination rate constant. Blood draws for this outcome may have been at the Week 2, 4, or 8 visit.
Time Frame Predose, and 5 minutes, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 8, and 24 hours postdose
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the PK Substudy Analysis Set with available data were analyzed.
Arm/Group Title All Participants
Hide Arm/Group Description:
E/C/F/TAF (150/150/200/10 mg) FDC tablet administered orally once daily with food for 144 weeks
Overall Number of Participants Analyzed 30
Mean (Standard Deviation)
Unit of Measure: 1/hour
1.764  (1.4521)
16.Secondary Outcome
Title PK Parameter: AUCtau of TAF
Hide Description AUCtau is defined as the concentration of drug over time (area under the plasma concentration versus time curve over the dosing interval). Blood draws for this outcome may have been at the Week 2, 4, or 8 visit.
Time Frame Predose, and 5 minutes, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 8, and 24 hours postdose
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the PK Substudy Analysis Set with available data were analyzed.
Arm/Group Title All Participants
Hide Arm/Group Description:
E/C/F/TAF (150/150/200/10 mg) FDC tablet administered orally once daily with food for 144 weeks
Overall Number of Participants Analyzed 30
Mean (Standard Deviation)
Unit of Measure: ng*h/mL
368.4  (631.20)
17.Secondary Outcome
Title PK Parameter: t1/2 of TAF
Hide Description t1/2 is defined as the estimate of the terminal elimination half-life of the drug. Blood draws for this outcome may have been at the Week 2, 4, or 8 visit.
Time Frame Predose, and 5 minutes, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 8, and 24 hours postdose
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the PK Substudy Analysis Set with available data were analyzed.
Arm/Group Title All Participants
Hide Arm/Group Description:
E/C/F/TAF (150/150/200/10 mg) FDC tablet administered orally once daily with food for 144 weeks
Overall Number of Participants Analyzed 30
Median (Inter-Quartile Range)
Unit of Measure: hours
0.43
(0.37 to 0.52)
18.Secondary Outcome
Title PK Parameter: AUCtau of Tenofovir Diphosphate (TFV-DP) in Peripheral Blood Mononuclear Cell (PBMC) for Participants Enrolled in PK/PD Sub-study
Hide Description TFV-DP is an active phosphorylated metabolite of tenofovir alafenamide. AUCtau is defined as the concentration of drug over time (area under the plasma concentration versus time curve over the dosing interval). Blood draws for this outcome may have been at the Week 2, 4, or 8 visit.
Time Frame Predose, and 5 minutes, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 8, and 24 hours postdose
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who were enrolled in the PK/PD substudy, received at least 1 dose of study drug, and for whom the steady-state PK parameter (AUCtau) of TFV-DP was evaluable were analyzed.
Arm/Group Title All Participants
Hide Arm/Group Description:
E/C/F/TAF (150/150/200/10 mg) FDC tablet administered orally once daily with food for 144 weeks
Overall Number of Participants Analyzed 23
Mean (Standard Deviation)
Unit of Measure: µmol*h/L
50.6  (55.75)
Time Frame Baseline to Week 24 Data Cut (average 42 weeks)
Adverse Event Reporting Description Safety Analysis Set: participants were enrolled and received at least 1 dose of study drug
 
Arm/Group Title Cohort 1 (Treatment-experienced) Cohort 2 (Treatment-naive)
Hide Arm/Group Description E/C/F/TAF (150/150/200/10 mg) FDC tablet administered orally once daily with food for 144 weeks in antiretroviral treatment (ART)-experienced participants E/C/F/TAF (150/150/200/10 mg) FDC tablet administered orally once daily with food for 144 weeks in antiretroviral treatment (ART)-naive participants
All-Cause Mortality
Cohort 1 (Treatment-experienced) Cohort 2 (Treatment-naive)
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Cohort 1 (Treatment-experienced) Cohort 2 (Treatment-naive)
Affected / at Risk (%) Affected / at Risk (%)
Total   26/242 (10.74%)   0/6 (0.00%) 
Cardiac disorders     
Acute Myocardial Infarction † 1  3/242 (1.24%)  0/6 (0.00%) 
Cardiac Failure Congestive † 1  1/242 (0.41%)  0/6 (0.00%) 
Palpitations † 1  1/242 (0.41%)  0/6 (0.00%) 
Ventricular Tachycardia † 1  1/242 (0.41%)  0/6 (0.00%) 
Gastrointestinal disorders     
Abdominal Pain † 1  1/242 (0.41%)  0/6 (0.00%) 
Abdominal Pain Upper † 1  1/242 (0.41%)  0/6 (0.00%) 
Infections and infestations     
Acute Hepatitis C † 1  1/242 (0.41%)  0/6 (0.00%) 
Appendicitis † 1  1/242 (0.41%)  0/6 (0.00%) 
Influenza † 1  1/242 (0.41%)  0/6 (0.00%) 
Ophthalmic Herpes Zoster † 1  1/242 (0.41%)  0/6 (0.00%) 
Pneumonia † 1  1/242 (0.41%)  0/6 (0.00%) 
Injury, poisoning and procedural complications     
Spinal Compression Fracture † 1  1/242 (0.41%)  0/6 (0.00%) 
Metabolism and nutrition disorders     
Type 2 Diabetes Mellitus † 1  1/242 (0.41%)  0/6 (0.00%) 
Musculoskeletal and connective tissue disorders     
Arthralgia † 1  1/242 (0.41%)  0/6 (0.00%) 
Osteonecrosis † 1  1/242 (0.41%)  0/6 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Bladder Transitional Cell Carcinoma † 1  1/242 (0.41%)  0/6 (0.00%) 
Malignant Neoplasm Of Unknown Primary Site † 1  1/242 (0.41%)  0/6 (0.00%) 
Renal Cell Carcinoma † 1  1/242 (0.41%)  0/6 (0.00%) 
Transitional Cell Carcinoma † 1  1/242 (0.41%)  0/6 (0.00%) 
Nervous system disorders     
Radiculitis Cervical † 1  1/242 (0.41%)  0/6 (0.00%) 
Syncope † 1  2/242 (0.83%)  0/6 (0.00%) 
VIIth Nerve Paralysis † 1  1/242 (0.41%)  0/6 (0.00%) 
Psychiatric disorders     
Drug Dependence † 1  1/242 (0.41%)  0/6 (0.00%) 
Major Depression † 1  1/242 (0.41%)  0/6 (0.00%) 
Suicide Attempt † 1  1/242 (0.41%)  0/6 (0.00%) 
Renal and urinary disorders     
Renal Failure Acute † 1  1/242 (0.41%)  0/6 (0.00%) 
†
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (17.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Cohort 1 (Treatment-experienced) Cohort 2 (Treatment-naive)
Affected / at Risk (%) Affected / at Risk (%)
Total   139/242 (57.44%)   5/6 (83.33%) 
Cardiac disorders     
Supraventricular Extrasystoles † 1  1/242 (0.41%)  1/6 (16.67%) 
Gastrointestinal disorders     
Diarrhoea † 1  21/242 (8.68%)  1/6 (16.67%) 
Gingival Pain † 1  0/242 (0.00%)  1/6 (16.67%) 
Nausea † 1  17/242 (7.02%)  0/6 (0.00%) 
General disorders     
Fatigue † 1  14/242 (5.79%)  1/6 (16.67%) 
Local Swelling † 1  4/242 (1.65%)  1/6 (16.67%) 
Infections and infestations     
Bronchitis † 1  19/242 (7.85%)  0/6 (0.00%) 
Hordeolum † 1  1/242 (0.41%)  1/6 (16.67%) 
Upper Respiratory Tract Infection † 1  17/242 (7.02%)  1/6 (16.67%) 
Investigations     
Cardiac Murmur † 1  1/242 (0.41%)  1/6 (16.67%) 
Electrocardiogram QT Prolonged † 1  0/242 (0.00%)  1/6 (16.67%) 
Electrocardiogram ST-T Change † 1  0/242 (0.00%)  1/6 (16.67%) 
Metabolism and nutrition disorders     
Hyperlipidaemia † 1  2/242 (0.83%)  1/6 (16.67%) 
Musculoskeletal and connective tissue disorders     
Arthralgia † 1  19/242 (7.85%)  1/6 (16.67%) 
Back Pain † 1  15/242 (6.20%)  0/6 (0.00%) 
Osteopenia † 1  19/242 (7.85%)  0/6 (0.00%) 
Osteoporosis † 1  9/242 (3.72%)  1/6 (16.67%) 
Pain In Extremity † 1  16/242 (6.61%)  1/6 (16.67%) 
Tendonitis † 1  1/242 (0.41%)  1/6 (16.67%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Anogenital Warts † 1  0/242 (0.00%)  1/6 (16.67%) 
Nervous system disorders     
Dizziness † 1  14/242 (5.79%)  0/6 (0.00%) 
Headache † 1  17/242 (7.02%)  0/6 (0.00%) 
Somnolence † 1  3/242 (1.24%)  1/6 (16.67%) 
Renal and urinary disorders     
Proteinuria † 1  3/242 (1.24%)  1/6 (16.67%) 
Renal Cyst † 1  13/242 (5.37%)  0/6 (0.00%) 
Skin and subcutaneous tissue disorders     
Pruritus † 1  4/242 (1.65%)  1/6 (16.67%) 
Vascular disorders     
Orthostatic Hypotension † 1  0/242 (0.00%)  1/6 (16.67%) 
†
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (17.0)
Enrollment in Cohort 2 (treatment-naive) was low, which affects the interpretation of the data.
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
Name/Title: Clinical Trial Disclosures
Organization: Gilead Sciences
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT01818596     History of Changes
Other Study ID Numbers: GS-US-292-0112
2013-000516-25 ( EudraCT Number )
First Submitted: March 22, 2013
First Posted: March 26, 2013
Results First Submitted: December 4, 2015
Results First Posted: February 18, 2016
Last Update Posted: March 19, 2019