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Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of E/C/F/TAF Fixed Dose Combination (FDC) in HIV-1 Infected Adults on Chronic Hemodialysis

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: NCT02600819
Recruitment Status : Completed
First Posted : November 9, 2015
Results First Posted : October 16, 2018
Last Update Posted : November 5, 2020
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition HIV-1 Infection
Interventions Drug: E/C/F/TAF
Drug: B/F/TAF
Enrollment 55
Recruitment Details Participants were enrolled at study sites in Europe and the United States. The first participant was screened on 14 December 2015. The last study visit occurred on 15 October 2019.
Pre-assignment Details 75 participants were screened.
Arm/Group Title E/C/F/TAF (GEN Phase) E/C/F/TAF to B/F/TAF (BVY OL Extension Phase)
Hide Arm/Group Description Participants received elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) (Genvoya®, GEN) (150/150/200/10 mg) fixed-dose combination (FDC) tablet once daily with food for 96 weeks. At Week 96, participants in the United States (US) who wished to participate in the open-label (OL) rollover extension either discontinued E/C/F/TAF FDC or continued to take E/C/F/TAF FDC for up to 114 weeks. At Week 96 or the end of E/C/F/TAF visit (whichever occurred last), participants were given the option to receive open-label (OL) bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) (Biktarvy®, BVY) (50/200/25 mg) FDC tablet once daily without regard to food for up to 52 weeks.
Period Title: GEN Phase
Started 55 0
Completed 39 0
Not Completed 16 0
Reason Not Completed
Adverse Event             2             0
Death             2             0
Investigator's Discretion             4             0
Non-Compliance with Study Drug             1             0
Withdrew Consent             5             0
Lost to Follow-up             2             0
Period Title: BVY OL Extension Phase
Started 0 [1] 10 [1]
Completed 0 10
Not Completed 0 0
[1]
Only US participants were eligible to roll over into the Extension Phase per the study protocol.
Arm/Group Title E/C/F/TAF (GEN Phase)
Hide Arm/Group Description Participants received elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) (Genvoya®, GEN) (150/150/200/10 mg) fixed-dose combination (FDC) tablet once daily with food for 96 weeks. At Week 96, participants in the United States (US) who wished to participate in the open-label (OL) rollover extension either discontinued E/C/F/TAF FDC or continued to take E/C/F/TAF FDC for up to 114 weeks.
Overall Number of Baseline Participants 55
Hide Baseline Analysis Population Description
The GEN Safety Analysis Set included all participants who received at least 1 dose of GEN.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 55 participants
48  (11.0)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 55 participants
Female
13
  23.6%
Male
42
  76.4%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 55 participants
Hispanic or Latino
8
  14.5%
Not Hispanic or Latino
47
  85.5%
Unknown or Not Reported
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 55 participants
American Indian or Alaska Native
0
   0.0%
Asian
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
45
  81.8%
White
10
  18.2%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
 Number Analyzed 55 participants
United States 46
France 7
Austria 1
Germany 1
HIV-1 RNA Category  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 55 participants
< 50 copies/mL
54
  98.2%
≥ 50 copies/mL
1
   1.8%
Cluster Determinant 4+ (CD4+) Cell Count  
Mean (Standard Deviation)
Unit of measure:  cells/µL
Number Analyzed 55 participants
545  (239.2)
CD4+ Cell Count Categories  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 55 participants
< 50 cells/µL 0
>= 50 to < 200 cells/µL 0
>= 200 to < 350 cells/µL 12
>= 350 to < 500 cells/µL 14
>= 500 cells/µL 29
CD4 Percentage  
Mean (Standard Deviation)
Unit of measure:  Percentage of CD4 cells
Number Analyzed 55 participants
31.5  (9.41)
1.Primary Outcome
Title GEN Phase: Percentage of Participants Experiencing Treatment-Emergent Grade 3 or Higher Adverse Events Up to Week 48
Hide Description Treatment-emergent Adverse Events (TEAE) were defined as AEs with onset dates on or after the study drug start date and no later than 30 days after the permanent discontinuation of the E/C/F/TAF (GEN Phase) study drug or all AEs for participants still on E/C/F/TAF. It also includes the AEs that led to premature discontinuation of E/C/F/TAF study drug. Clinical events and clinically significant laboratory abnormalities were graded according to the GSI Grading Scale for Severity of Adverse Events and Laboratory Abnormalities. Adverse events were graded as Grade 1 (mild), Grade 2 (moderate), Grade 3 (severe), or Grade 4 (life threatening).
Time Frame First Dose Date Up to Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
The GEN Safety Analysis Set included participants who were enrolled and received at least 1 dose of GEN (E/C/F/TAF FDC).
Arm/Group Title E/C/F/TAF (GEN Phase)
Hide Arm/Group Description:
Participants received elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) (Genvoya®, GEN) (150/150/200/10 mg) fixed-dose combination (FDC) tablet once daily with food for 96 weeks. At Week 96, participants in the United States (US) who wished to participate in the open-label (OL) rollover extension either discontinued E/C/F/TAF FDC or continued to take E/C/F/TAF FDC for up to 114 weeks.
Overall Number of Participants Analyzed 55
Measure Type: Number
Unit of Measure: percentage of participants
32.7
2.Secondary Outcome
Title GEN Phase: Percentage of Participants Experiencing Treatment-Emergent Grade 3 or Higher Adverse Events Up to Week 96
Hide Description Treatment-emergent Adverse Events (TEAE) were defined as events that met 1 or both of the following criteria as any AEs with onset dates on or after the study drug start date and no later than 30 days after the permanent discontinuation of the E/C/F/TAF (GEN Phase) study drug for participants who did not participate in the BVY OL extension phase or the day prior to the date of the first B/F/TAF study drug dose for participants who participated in the BVY OL extension phase. It also includes the AEs that led to premature discontinuation of E/C/F/TAF study drug. Clinical events and clinically significant laboratory abnormalities were graded according to the GSI Grading Scale for Severity of Adverse Events and Laboratory Abnormalities. Adverse events were graded as Grade 1 (mild), Grade 2 (moderate), Grade 3 (severe), or Grade 4 (life threatening).
Time Frame First Dose Date Up to Week 96
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the GEN Safety Analysis Set were analyzed.
Arm/Group Title E/C/F/TAF (GEN Phase)
Hide Arm/Group Description:
Participants received elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) (Genvoya®, GEN) (150/150/200/10 mg) fixed-dose combination (FDC) tablet once daily with food for 96 weeks. At Week 96, participants in the United States (US) who wished to participate in the open-label (OL) rollover extension either discontinued E/C/F/TAF FDC or continued to take E/C/F/TAF FDC for up to 114 weeks.
Overall Number of Participants Analyzed 55
Measure Type: Number
Unit of Measure: percentage of participants
43.6
3.Secondary Outcome
Title GEN Phase: Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 24 as Defined by the FDA Snapshot Algorithm
Hide Description The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 24 was analyzed using the snapshot algorithm, which defines a participant'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
The GEN Full Analysis Set included participants who were enrolled and received at least 1 dose of GEN (E/C/F/TAF FDC).
Arm/Group Title E/C/F/TAF (GEN Phase)
Hide Arm/Group Description:
Participants received elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) (Genvoya®, GEN) (150/150/200/10 mg) fixed-dose combination (FDC) tablet once daily with food for 96 weeks. At Week 96, participants in the United States (US) who wished to participate in the open-label (OL) rollover extension either discontinued E/C/F/TAF FDC or continued to take E/C/F/TAF FDC for up to 114 weeks.
Overall Number of Participants Analyzed 55
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
87.3
(75.5 to 94.7)
4.Secondary Outcome
Title GEN Phase: Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 48 as Defined by the FDA Snapshot Algorithm
Hide Description The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 48 was analyzed using the snapshot algorithm, which defines a participant'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 48
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the GEN Full Analysis Set were analyzed.
Arm/Group Title E/C/F/TAF (GEN Phase)
Hide Arm/Group Description:
Participants received elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) (Genvoya®, GEN) (150/150/200/10 mg) fixed-dose combination (FDC) tablet once daily with food for 96 weeks. At Week 96, participants in the United States (US) who wished to participate in the open-label (OL) rollover extension either discontinued E/C/F/TAF FDC or continued to take E/C/F/TAF FDC for up to 114 weeks.
Overall Number of Participants Analyzed 55
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
81.8
(69.1 to 90.9)
5.Secondary Outcome
Title GEN Phase: Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 96 as Defined by the FDA Snapshot Algorithm
Hide Description The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 96 was analyzed using the snapshot algorithm, which defines a participant'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 96
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the GEN Full Analysis Set were analyzed.
Arm/Group Title E/C/F/TAF (GEN Phase)
Hide Arm/Group Description:
Participants received elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) (Genvoya®, GEN) (150/150/200/10 mg) fixed-dose combination (FDC) tablet once daily with food for 96 weeks. At Week 96, participants in the United States (US) who wished to participate in the open-label (OL) rollover extension either discontinued E/C/F/TAF FDC or continued to take E/C/F/TAF FDC for up to 114 weeks.
Overall Number of Participants Analyzed 55
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
54.5
(40.6 to 68.0)
6.Secondary Outcome
Title Pharmacokinetic (PK) Parameter: AUCtau of Elvitegravir (EVG), Cobicistat (COBI), Emtricitabine (FTC), and Tenofovir (TFV)
Hide Description AUCtau is defined as area under the concentration versus time curve over the dosing interval (i.e., concentration of drug over time).
Time Frame 0.5, 1, 2, 3, 4, 6, 8, and 24 hours postdose at or between Week 2 or Week 4
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the PK Substudy Analysis Set (participants who were enrolled into the study, participated in the intensive PK substudy, received at least 1 dose of E/C/F/TAF FDC, and had at least 1 nonmissing plasma PK concentration value for any analyte of interest) with available data were analyzed.
Arm/Group Title E/C/F/TAF (GEN Phase)
Hide Arm/Group Description:
Participants received elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) (Genvoya®, GEN) (150/150/200/10 mg) fixed-dose combination (FDC) tablet once daily with food for 96 weeks. At Week 96, participants in the United States (US) who wished to participate in the open-label (OL) rollover extension either discontinued E/C/F/TAF FDC or continued to take E/C/F/TAF FDC for up to 114 weeks.
Overall Number of Participants Analyzed 11
Mean (Standard Deviation)
Unit of Measure: h*ng/mL
EVG Number Analyzed 10 participants
14284.8  (7790.26)
COBI Number Analyzed 11 participants
10179.5  (6009.28)
FTC Number Analyzed 11 participants
62929.9  (30199.63)
TFV Number Analyzed 10 participants
8715.0  (3432.16)
7.Secondary Outcome
Title PK Parameter: AUClast of EVG, COBI, FTC, Tenofovir Alafenamide (TAF), and TFV
Hide Description AUClast is defined as the area under the concentration versus time curve from time zero to the last observable concentration.
Time Frame 0.5, 1, 2, 3, 4, 6, 8, and 24 hours postdose at or between Week 2 or Week 4
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the PK Substudy Analysis Set with available data were analyzed.
Arm/Group Title E/C/F/TAF (GEN Phase)
Hide Arm/Group Description:
Participants received elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) (Genvoya®, GEN) (150/150/200/10 mg) fixed-dose combination (FDC) tablet once daily with food for 96 weeks. At Week 96, participants in the United States (US) who wished to participate in the open-label (OL) rollover extension either discontinued E/C/F/TAF FDC or continued to take E/C/F/TAF FDC for up to 114 weeks.
Overall Number of Participants Analyzed 12
Mean (Standard Deviation)
Unit of Measure: h*ng/mL
EVG 12857.6  (7894.09)
COBI 9558.7  (5963.16)
FTC 59057.4  (31485.96)
TAF 231.9  (123.46)
TFV 7664.2  (3958.36)
8.Secondary Outcome
Title PK Parameter: Cmax of EVG, COBI, FTC, TAF, and TFV
Hide Description Cmax is defined as the maximum concentration of drug.
Time Frame 0.5, 1, 2, 3, 4, 6, 8, and 24 hours postdose at or between Week 2 or Week 4
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the PK Substudy Analysis Set with available data were analyzed.
Arm/Group Title E/C/F/TAF (GEN Phase)
Hide Arm/Group Description:
Participants received elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) (Genvoya®, GEN) (150/150/200/10 mg) fixed-dose combination (FDC) tablet once daily with food for 96 weeks. At Week 96, participants in the United States (US) who wished to participate in the open-label (OL) rollover extension either discontinued E/C/F/TAF FDC or continued to take E/C/F/TAF FDC for up to 114 weeks.
Overall Number of Participants Analyzed 12
Mean (Standard Deviation)
Unit of Measure: ng/mL
EVG 1258.5  (689.57)
COBI 1370.4  (920.15)
FTC 4875.0  (1981.03)
TAF 246.3  (185.69)
TFV 442.8  (181.03)
9.Secondary Outcome
Title PK Parameter: Ctau of EVG, COBI, FTC, and TFV
Hide Description Ctau is defined as the observed drug concentration at the end of the dosing interval. Ctau has been presented in lieu of Cmin (specified in the protocol) to align with other Gilead studies. This change has no impact on the PK analysis as Ctau and Cmin are equivalent for all analytes.
Time Frame 0.5, 1, 2, 3, 4, 6, 8, and 24 hours postdose at or between Week 2 or Week 4
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the PK Substudy Analysis Set with available data were analyzed.
Arm/Group Title E/C/F/TAF (GEN Phase)
Hide Arm/Group Description:
Participants received elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) (Genvoya®, GEN) (150/150/200/10 mg) fixed-dose combination (FDC) tablet once daily with food for 96 weeks. At Week 96, participants in the United States (US) who wished to participate in the open-label (OL) rollover extension either discontinued E/C/F/TAF FDC or continued to take E/C/F/TAF FDC for up to 114 weeks.
Overall Number of Participants Analyzed 10
Mean (Standard Deviation)
Unit of Measure: ng/mL
EVG 174.4  (104.36)
COBI 28.9  (34.06)
FTC 1277.3  (756.60)
TFV 264.8  (193.98)
10.Secondary Outcome
Title GEN Phase: Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 96 Using the Missing = Failure (M = F) Approach
Hide Description The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 96 were analyzed using the M = F approach. In this approach, all missing data was treated as HIV-1 RNA ≥ 50 copies/mL.
Time Frame Week 96
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the GEN Full Analysis Set were analyzed.
Arm/Group Title E/C/F/TAF (GEN Phase)
Hide Arm/Group Description:
Participants received elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) (Genvoya®, GEN) (150/150/200/10 mg) fixed-dose combination (FDC) tablet once daily with food for 96 weeks. At Week 96, participants in the United States (US) who wished to participate in the open-label (OL) rollover extension either discontinued E/C/F/TAF FDC or continued to take E/C/F/TAF FDC for up to 114 weeks.
Overall Number of Participants Analyzed 55
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
61.8
(47.7 to 74.6)
11.Secondary Outcome
Title GEN Phase: Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 96 Using the Missing = Excluded (M = E) Approach
Hide Description The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 96 were analyzed using the M = E approach. In this approach, all missing data was excluded in the computation of the proportions.
Time Frame Week 96
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the GEN Full Analysis Set with available data were analyzed.
Arm/Group Title E/C/F/TAF (GEN Phase)
Hide Arm/Group Description:
Participants received elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) (Genvoya®, GEN) (150/150/200/10 mg) fixed-dose combination (FDC) tablet once daily with food for 96 weeks. At Week 96, participants in the United States (US) who wished to participate in the open-label (OL) rollover extension either discontinued E/C/F/TAF FDC or continued to take E/C/F/TAF FDC for up to 114 weeks.
Overall Number of Participants Analyzed 34
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
100.0
(89.7 to 100.0)
12.Secondary Outcome
Title BVY OL Extension Phase: Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 48 Using the M = E Approach
Hide Description The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 48 were analyzed using the M = E approach. In this approach, all missing data was excluded in the computation of the proportions.
Time Frame Week 48 of the BVY OL Extension Phase
Hide Outcome Measure Data
Hide Analysis Population Description
The BVY Full Analysis Set included all participants who were enrolled in the study and received at least 1 dose of BVY (B/F/TAF FDC).
Arm/Group Title E/C/F/TAF to B/F/TAF (BVY OL Extension Phase)
Hide Arm/Group Description:
At Week 96 or the end of E/C/F/TAF visit (whichever occurred last), participants were given the option to receive open-label (OL) bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) (Biktarvy®, BVY) (50/200/25 mg) FDC tablet once daily without regard to food for up to 52 weeks.
Overall Number of Participants Analyzed 10
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
100.0
(69.2 to 100.0)
13.Secondary Outcome
Title GEN Phase: Change From Baseline in Cluster Determinant 4+ (CD4+) Cell Count at Week 96
Hide Description [Not Specified]
Time Frame Baseline; Week 96
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the GEN Full Analysis Set with available data were analyzed.
Arm/Group Title E/C/F/TAF (GEN Phase)
Hide Arm/Group Description:
Participants received elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) (Genvoya®, GEN) (150/150/200/10 mg) fixed-dose combination (FDC) tablet once daily with food for 96 weeks. At Week 96, participants in the United States (US) who wished to participate in the open-label (OL) rollover extension either discontinued E/C/F/TAF FDC or continued to take E/C/F/TAF FDC for up to 114 weeks.
Overall Number of Participants Analyzed 28
Mean (Standard Deviation)
Unit of Measure: cells/µL
-35  (218.3)
14.Secondary Outcome
Title BVY OL Extension Phase: Change From Baseline in CD4+ Cell Count at Week 48
Hide Description [Not Specified]
Time Frame Baseline; Week 48 of the BVY OL Extension Phase
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the BVY Full Analysis Set with available data were analyzed.
Arm/Group Title E/C/F/TAF to B/F/TAF (BVY OL Extension Phase)
Hide Arm/Group Description:
At Week 96 or the end of E/C/F/TAF visit (whichever occurred last), participants were given the option to receive open-label (OL) bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) (Biktarvy®, BVY) (50/200/25 mg) FDC tablet once daily without regard to food for up to 52 weeks.
Overall Number of Participants Analyzed 10
Mean (Standard Deviation)
Unit of Measure: cells/µL
Baseline Number Analyzed 10 participants
581  (146.8)
Change from Baseline at Week 48 Number Analyzed 9 participants
-104  (120.8)
15.Secondary Outcome
Title GEN Phase: Change From Baseline in CD4 Percentage at Week 96
Hide Description [Not Specified]
Time Frame Baseline; Week 96
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the GEN Full Analysis Set with available data were analyzed.
Arm/Group Title E/C/F/TAF (GEN Phase)
Hide Arm/Group Description:
Participants received elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) (Genvoya®, GEN) (150/150/200/10 mg) fixed-dose combination (FDC) tablet once daily with food for 96 weeks. At Week 96, participants in the United States (US) who wished to participate in the open-label (OL) rollover extension either discontinued E/C/F/TAF FDC or continued to take E/C/F/TAF FDC for up to 114 weeks.
Overall Number of Participants Analyzed 28
Mean (Standard Deviation)
Unit of Measure: percentage of CD4 cells
2.8  (6.37)
16.Secondary Outcome
Title BVY OL Extension Phase: Change From Baseline in CD4 Percentage at Week 48
Hide Description [Not Specified]
Time Frame Baseline; Week 48 of the BVY OL Extension Phase
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the BVY Full Analysis Set with available data were analyzed.
Arm/Group Title E/C/F/TAF to B/F/TAF (BVY OL Extension Phase)
Hide Arm/Group Description:
At Week 96 or the end of E/C/F/TAF visit (whichever occurred last), participants were given the option to receive open-label (OL) bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) (Biktarvy®, BVY) (50/200/25 mg) FDC tablet once daily without regard to food for up to 52 weeks.
Overall Number of Participants Analyzed 10
Mean (Standard Deviation)
Unit of Measure: percentage of CD4 cells
Baseline Number Analyzed 10 participants
31.9  (7.37)
Change from Baseline at Week 48 Number Analyzed 9 participants
1.7  (4.39)
Time Frame First dose date up to the last dose date [maximum: 114 Weeks (GEN Phase), 52 Weeks (BVY OL Extension Phase)] plus 30 days
Adverse Event Reporting Description

The GEN Safety Analysis Set included all participants who received at least 1 dose of GEN.

The BVY Safety Analysis Set included all participants who received at least 1 dose of BVY.
 
Arm/Group Title E/C/F/TAF (GEN Phase) E/C/F/TAF to B/F/TAF (BVY OL Extension Phase)
Hide Arm/Group Description Participants received elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) (Genvoya®, GEN) (150/150/200/10 mg) fixed-dose combination (FDC) tablet once daily with food for 96 weeks. At Week 96, participants in the United States (US) who wished to participate in the open-label (OL) rollover extension either discontinued E/C/F/TAF FDC or continued to take E/C/F/TAF FDC for up to 114 weeks. At Week 96 or the end of E/C/F/TAF visit (whichever occurred last), participants were given the option to receive open-label (OL) bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) (Biktarvy®, BVY) (50/200/25 mg) FDC tablet once daily without regard to food for up to 52 weeks.
All-Cause Mortality
E/C/F/TAF (GEN Phase) E/C/F/TAF to B/F/TAF (BVY OL Extension Phase)
Affected / at Risk (%) Affected / at Risk (%)
Total   3/55 (5.45%)   0/10 (0.00%) 
Hide Serious Adverse Events
E/C/F/TAF (GEN Phase) E/C/F/TAF to B/F/TAF (BVY OL Extension Phase)
Affected / at Risk (%) Affected / at Risk (%)
Total   36/55 (65.45%)   3/10 (30.00%) 
Blood and lymphatic system disorders     
Anaemia † 1  3/55 (5.45%)  0/10 (0.00%) 
Cardiac disorders     
Acute coronary syndrome † 1  1/55 (1.82%)  0/10 (0.00%) 
Acute myocardial infarction † 1  2/55 (3.64%)  1/10 (10.00%) 
Angina pectoris † 1  1/55 (1.82%)  1/10 (10.00%) 
Bradycardia † 1  2/55 (3.64%)  0/10 (0.00%) 
Cardiac arrest † 1  3/55 (5.45%)  0/10 (0.00%) 
Cardiac failure acute † 1  2/55 (3.64%)  0/10 (0.00%) 
Cardiac failure congestive † 1  1/55 (1.82%)  1/10 (10.00%) 
Coronary artery stenosis † 1  1/55 (1.82%)  0/10 (0.00%) 
Myocardial ischaemia † 1  1/55 (1.82%)  0/10 (0.00%) 
Pericardial effusion † 1  1/55 (1.82%)  0/10 (0.00%) 
Endocrine disorders     
Hyperparathyroidism † 1  1/55 (1.82%)  0/10 (0.00%) 
Gastrointestinal disorders     
Abdominal hernia † 1  1/55 (1.82%)  0/10 (0.00%) 
Abdominal pain † 1  1/55 (1.82%)  0/10 (0.00%) 
Abdominal wall haematoma † 1  0/55 (0.00%)  1/10 (10.00%) 
Colitis ischaemic † 1  1/55 (1.82%)  0/10 (0.00%) 
Gastric ulcer † 1  1/55 (1.82%)  0/10 (0.00%) 
Large intestinal ulcer haemorrhage † 1  1/55 (1.82%)  0/10 (0.00%) 
Oesophagitis † 1  1/55 (1.82%)  0/10 (0.00%) 
Peritoneal haemorrhage † 1  1/55 (1.82%)  0/10 (0.00%) 
General disorders     
Asthenia † 1  1/55 (1.82%)  0/10 (0.00%) 
Chest pain † 1  2/55 (3.64%)  0/10 (0.00%) 
Generalised oedema † 1  1/55 (1.82%)  0/10 (0.00%) 
Non-cardiac chest pain † 1  1/55 (1.82%)  0/10 (0.00%) 
Oedema peripheral † 1  1/55 (1.82%)  0/10 (0.00%) 
Hepatobiliary disorders     
Cholecystitis acute † 1  1/55 (1.82%)  0/10 (0.00%) 
Cholelithiasis † 1  1/55 (1.82%)  0/10 (0.00%) 
Infections and infestations     
Abscess limb † 1  1/55 (1.82%)  0/10 (0.00%) 
Arteriovenous fistula site infection † 1  3/55 (5.45%)  0/10 (0.00%) 
Arthritis bacterial † 1  1/55 (1.82%)  0/10 (0.00%) 
Bronchitis † 1  1/55 (1.82%)  0/10 (0.00%) 
Cellulitis † 1  1/55 (1.82%)  0/10 (0.00%) 
Device related sepsis † 1  1/55 (1.82%)  0/10 (0.00%) 
Endocarditis staphylococcal † 1  1/55 (1.82%)  0/10 (0.00%) 
Escherichia sepsis † 1  1/55 (1.82%)  0/10 (0.00%) 
Gangrene † 1  1/55 (1.82%)  0/10 (0.00%) 
Influenza † 1  1/55 (1.82%)  0/10 (0.00%) 
Intervertebral discitis † 1  1/55 (1.82%)  0/10 (0.00%) 
Localised infection † 1  1/55 (1.82%)  0/10 (0.00%) 
Osteomyelitis † 1  4/55 (7.27%)  0/10 (0.00%) 
Parainfluenzae virus infection † 1  1/55 (1.82%)  0/10 (0.00%) 
Pneumonia † 1  8/55 (14.55%)  1/10 (10.00%) 
Pneumonia respiratory syncytial viral † 1  0/55 (0.00%)  1/10 (10.00%) 
Pyelonephritis † 1  1/55 (1.82%)  0/10 (0.00%) 
Septic shock † 1  1/55 (1.82%)  0/10 (0.00%) 
Staphylococcal bacteraemia † 1  1/55 (1.82%)  0/10 (0.00%) 
Injury, poisoning and procedural complications     
Arteriovenous fistula site haemorrhage † 1  1/55 (1.82%)  0/10 (0.00%) 
Arteriovenous fistula thrombosis † 1  3/55 (5.45%)  0/10 (0.00%) 
Joint dislocation † 1  1/55 (1.82%)  0/10 (0.00%) 
Tendon rupture † 1  0/55 (0.00%)  1/10 (10.00%) 
Vascular access site haemorrhage † 1  0/55 (0.00%)  1/10 (10.00%) 
Metabolism and nutrition disorders     
Fluid overload † 1  4/55 (7.27%)  0/10 (0.00%) 
Hyperkalaemia † 1  6/55 (10.91%)  1/10 (10.00%) 
Hyponatraemia † 1  1/55 (1.82%)  0/10 (0.00%) 
Musculoskeletal and connective tissue disorders     
Cervical spinal stenosis † 1  1/55 (1.82%)  1/10 (10.00%) 
Muscular weakness † 1  1/55 (1.82%)  0/10 (0.00%) 
Spinal stenosis † 1  0/55 (0.00%)  1/10 (10.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Prostate cancer † 1  1/55 (1.82%)  0/10 (0.00%) 
Nervous system disorders     
Dizziness † 1  1/55 (1.82%)  0/10 (0.00%) 
Headache † 1  1/55 (1.82%)  0/10 (0.00%) 
Seizure † 1  1/55 (1.82%)  0/10 (0.00%) 
Syncope † 1  3/55 (5.45%)  0/10 (0.00%) 
Renal and urinary disorders     
Azotaemia † 1  2/55 (3.64%)  0/10 (0.00%) 
End stage renal disease † 1  3/55 (5.45%)  0/10 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Acute pulmonary oedema † 1  1/55 (1.82%)  0/10 (0.00%) 
Acute respiratory failure † 1  1/55 (1.82%)  0/10 (0.00%) 
Asthma † 1  1/55 (1.82%)  0/10 (0.00%) 
Chronic obstructive pulmonary disease † 1  1/55 (1.82%)  0/10 (0.00%) 
Dyspnoea † 1  1/55 (1.82%)  1/10 (10.00%) 
Epistaxis † 1  1/55 (1.82%)  0/10 (0.00%) 
Productive cough † 1  1/55 (1.82%)  0/10 (0.00%) 
Pulmonary embolism † 1  1/55 (1.82%)  0/10 (0.00%) 
Pulmonary oedema † 1  1/55 (1.82%)  0/10 (0.00%) 
Respiratory distress † 1  1/55 (1.82%)  0/10 (0.00%) 
Respiratory failure † 1  1/55 (1.82%)  0/10 (0.00%) 
Skin and subcutaneous tissue disorders     
Diabetic foot † 1  1/55 (1.82%)  0/10 (0.00%) 
Penile ulceration † 1  1/55 (1.82%)  0/10 (0.00%) 
Skin ulcer † 1  0/55 (0.00%)  1/10 (10.00%) 
Surgical and medical procedures     
Renal transplant † 1  1/55 (1.82%)  0/10 (0.00%) 
Vascular disorders     
Deep vein thrombosis † 1  1/55 (1.82%)  0/10 (0.00%) 
Diabetic microangiopathy † 1  1/55 (1.82%)  0/10 (0.00%) 
Hypertension † 1  3/55 (5.45%)  0/10 (0.00%) 
Hypertensive emergency † 1  2/55 (3.64%)  1/10 (10.00%) 
Hypertensive urgency † 1  1/55 (1.82%)  1/10 (10.00%) 
Hypotension † 1  3/55 (5.45%)  0/10 (0.00%) 
Subclavian vein stenosis † 1  1/55 (1.82%)  0/10 (0.00%) 
1
Term from vocabulary, MedDRA 22.0
†
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
E/C/F/TAF (GEN Phase) E/C/F/TAF to B/F/TAF (BVY OL Extension Phase)
Affected / at Risk (%) Affected / at Risk (%)
Total   41/55 (74.55%)   10/10 (100.00%) 
Blood and lymphatic system disorders     
Anaemia † 1  4/55 (7.27%)  0/10 (0.00%) 
Cardiac disorders     
Bradycardia † 1  0/55 (0.00%)  1/10 (10.00%) 
Ear and labyrinth disorders     
Ear pain † 1  1/55 (1.82%)  1/10 (10.00%) 
Eye disorders     
Cataract † 1  1/55 (1.82%)  1/10 (10.00%) 
Diplopia † 1  0/55 (0.00%)  1/10 (10.00%) 
Eye pain † 1  0/55 (0.00%)  1/10 (10.00%) 
Eye pruritus † 1  0/55 (0.00%)  1/10 (10.00%) 
Scleral hyperaemia † 1  0/55 (0.00%)  1/10 (10.00%) 
Vision blurred † 1  1/55 (1.82%)  1/10 (10.00%) 
Gastrointestinal disorders     
Abdominal pain lower † 1  0/55 (0.00%)  1/10 (10.00%) 
Constipation † 1  2/55 (3.64%)  1/10 (10.00%) 
Diarrhoea † 1  5/55 (9.09%)  0/10 (0.00%) 
Gastritis † 1  3/55 (5.45%)  0/10 (0.00%) 
Nausea † 1  13/55 (23.64%)  1/10 (10.00%) 
Oesophagitis † 1  0/55 (0.00%)  1/10 (10.00%) 
Vomiting † 1  3/55 (5.45%)  0/10 (0.00%) 
General disorders     
Chest pain † 1  3/55 (5.45%)  0/10 (0.00%) 
Malaise † 1  1/55 (1.82%)  1/10 (10.00%) 
Oedema peripheral † 1  6/55 (10.91%)  0/10 (0.00%) 
Peripheral swelling † 1  3/55 (5.45%)  0/10 (0.00%) 
Infections and infestations     
Nasopharyngitis † 1  1/55 (1.82%)  1/10 (10.00%) 
Rhinovirus infection † 1  0/55 (0.00%)  1/10 (10.00%) 
Upper respiratory tract infection † 1  4/55 (7.27%)  0/10 (0.00%) 
Injury, poisoning and procedural complications     
Contusion † 1  0/55 (0.00%)  1/10 (10.00%) 
Face injury † 1  0/55 (0.00%)  1/10 (10.00%) 
Hand fracture † 1  0/55 (0.00%)  1/10 (10.00%) 
Procedural haemorrhage † 1  0/55 (0.00%)  1/10 (10.00%) 
Procedural pain † 1  3/55 (5.45%)  0/10 (0.00%) 
Investigations     
Electrocardiogram QT prolonged † 1  3/55 (5.45%)  0/10 (0.00%) 
Metabolism and nutrition disorders     
Hyperkalaemia † 1  8/55 (14.55%)  1/10 (10.00%) 
Musculoskeletal and connective tissue disorders     
Arthralgia † 1  5/55 (9.09%)  0/10 (0.00%) 
Back pain † 1  4/55 (7.27%)  1/10 (10.00%) 
Musculoskeletal chest pain † 1  2/55 (3.64%)  1/10 (10.00%) 
Myalgia † 1  2/55 (3.64%)  1/10 (10.00%) 
Pain in extremity † 1  6/55 (10.91%)  0/10 (0.00%) 
Nervous system disorders     
Headache † 1  4/55 (7.27%)  1/10 (10.00%) 
Product Issues     
Thrombosis in device † 1  0/55 (0.00%)  1/10 (10.00%) 
Psychiatric disorders     
Anxiety † 1  3/55 (5.45%)  0/10 (0.00%) 
Depression † 1  3/55 (5.45%)  0/10 (0.00%) 
Insomnia † 1  1/55 (1.82%)  1/10 (10.00%) 
Reproductive system and breast disorders     
Acquired phimosis † 1  0/55 (0.00%)  1/10 (10.00%) 
Balanoposthitis † 1  2/55 (3.64%)  1/10 (10.00%) 
Respiratory, thoracic and mediastinal disorders     
Cough † 1  9/55 (16.36%)  1/10 (10.00%) 
Dyspnoea † 1  4/55 (7.27%)  1/10 (10.00%) 
Nasal congestion † 1  3/55 (5.45%)  1/10 (10.00%) 
Rhinitis allergic † 1  0/55 (0.00%)  1/10 (10.00%) 
Skin and subcutaneous tissue disorders     
Hidradenitis † 1  1/55 (1.82%)  1/10 (10.00%) 
Neurodermatitis † 1  0/55 (0.00%)  1/10 (10.00%) 
Skin ulcer † 1  0/55 (0.00%)  1/10 (10.00%) 
Vascular disorders     
Hypertension † 1  2/55 (3.64%)  2/10 (20.00%) 
Hypotension † 1  3/55 (5.45%)  0/10 (0.00%) 
Superior vena cava stenosis † 1  0/55 (0.00%)  1/10 (10.00%) 
1
Term from vocabulary, MedDRA 22.0
†
Indicates events were collected by systematic assessment
[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: Gilead Clinical Study Information Center
Organization: Gilead Sciences
Phone: 1-833-445-3230 (GILEAD-0)
EMail: GileadClinicalTrials@gilead.com
Publications:
Layout table for additonal information
Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT02600819    
Other Study ID Numbers: GS-US-292-1825
2015-002713-30 ( EudraCT Number )
First Submitted: November 6, 2015
First Posted: November 9, 2015
Results First Submitted: September 21, 2018
Results First Posted: October 16, 2018
Last Update Posted: November 5, 2020