Trial Outcomes & Findings for 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 (NCT NCT02600819)

Last Updated: 2020-11-05

Results Overview

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).

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

55 participants

Primary outcome timeframe

First Dose Date Up to Week 48

Results posted on

2020-11-05

Participant Flow

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.

75 participants were screened.

Participant milestones

Participant milestones
Measure	E/C/F/TAF (GEN Phase) 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.	E/C/F/TAF to B/F/TAF (BVY OL Extension Phase) 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.
GEN Phase STARTED	55	0
GEN Phase COMPLETED	39	0
GEN Phase NOT COMPLETED	16	0
BVY OL Extension Phase STARTED	0	10
BVY OL Extension Phase COMPLETED	0	10
BVY OL Extension Phase NOT COMPLETED	0	0

Reasons for withdrawal

Reasons for withdrawal
Measure	E/C/F/TAF (GEN Phase) 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.	E/C/F/TAF to B/F/TAF (BVY OL Extension Phase) 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.
GEN Phase Adverse Event	2	0
GEN Phase Death	2	0
GEN Phase Investigator's Discretion	4	0
GEN Phase Non-Compliance with Study Drug	1	0
GEN Phase Withdrew Consent	5	0
GEN Phase Lost to Follow-up	2	0

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	E/C/F/TAF (GEN Phase) n=55 Participants 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.
Age, Continuous	48 years STANDARD_DEVIATION 11.0 • n=5 Participants
Sex: Female, Male Female	13 Participants n=5 Participants
Sex: Female, Male Male	42 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	8 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	47 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	45 Participants n=5 Participants
Race (NIH/OMB) White	10 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	46 Participants n=5 Participants
Region of Enrollment France	7 Participants n=5 Participants
Region of Enrollment Austria	1 Participants n=5 Participants
Region of Enrollment Germany	1 Participants n=5 Participants
HIV-1 RNA Category < 50 copies/mL	54 Participants n=5 Participants
HIV-1 RNA Category ≥ 50 copies/mL	1 Participants n=5 Participants
Cluster Determinant 4+ (CD4+) Cell Count	545 cells/µL STANDARD_DEVIATION 239.2 • n=5 Participants
CD4+ Cell Count Categories < 50 cells/µL	0 Participants n=5 Participants
CD4+ Cell Count Categories >= 50 to < 200 cells/µL	0 Participants n=5 Participants
CD4+ Cell Count Categories >= 200 to < 350 cells/µL	12 Participants n=5 Participants
CD4+ Cell Count Categories >= 350 to < 500 cells/µL	14 Participants n=5 Participants
CD4+ Cell Count Categories >= 500 cells/µL	29 Participants n=5 Participants
CD4 Percentage	31.5 percentage of CD4 cells STANDARD_DEVIATION 9.41 • n=5 Participants

PRIMARY outcome

Timeframe: First Dose Date Up to Week 48

Population: The GEN Safety Analysis Set included participants who were enrolled and received at least 1 dose of GEN (E/C/F/TAF FDC).

Outcome measures

Outcome measures
Measure	E/C/F/TAF (GEN Phase) n=55 Participants 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.
GEN Phase: Percentage of Participants Experiencing Treatment-Emergent Grade 3 or Higher Adverse Events Up to Week 48	32.7 percentage of participants

SECONDARY outcome

Timeframe: First Dose Date Up to Week 96

Population: Participants in the GEN Safety Analysis Set were analyzed.

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).

Outcome measures

Outcome measures
Measure	E/C/F/TAF (GEN Phase) n=55 Participants 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.
GEN Phase: Percentage of Participants Experiencing Treatment-Emergent Grade 3 or Higher Adverse Events Up to Week 96	43.6 percentage of participants

SECONDARY outcome

Timeframe: Week 24

Population: The GEN Full Analysis Set included participants who were enrolled and received at least 1 dose of GEN (E/C/F/TAF FDC).

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.

Outcome measures

Outcome measures
Measure	E/C/F/TAF (GEN Phase) n=55 Participants 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.
GEN Phase: Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 24 as Defined by the FDA Snapshot Algorithm	87.3 percentage of participants Interval 75.5 to 94.7

SECONDARY outcome

Timeframe: Week 48

Population: Participants in the GEN Full Analysis Set were analyzed.

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.

Outcome measures

Outcome measures
Measure	E/C/F/TAF (GEN Phase) n=55 Participants 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.
GEN Phase: Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 48 as Defined by the FDA Snapshot Algorithm	81.8 percentage of participants Interval 69.1 to 90.9

SECONDARY outcome

Timeframe: Week 96

Population: Participants in the GEN Full Analysis Set were analyzed.

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.

Outcome measures

Outcome measures
Measure	E/C/F/TAF (GEN Phase) n=55 Participants 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.
GEN Phase: Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 96 as Defined by the FDA Snapshot Algorithm	54.5 percentage of participants Interval 40.6 to 68.0

SECONDARY outcome

Timeframe: 0.5, 1, 2, 3, 4, 6, 8, and 24 hours postdose at or between Week 2 or Week 4

Population: 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.

AUCtau is defined as area under the concentration versus time curve over the dosing interval (i.e., concentration of drug over time).

Outcome measures

Outcome measures
Measure	E/C/F/TAF (GEN Phase) n=11 Participants 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.
Pharmacokinetic (PK) Parameter: AUCtau of Elvitegravir (EVG), Cobicistat (COBI), Emtricitabine (FTC), and Tenofovir (TFV) EVG	14284.8 h*ng/mL Standard Deviation 7790.26
Pharmacokinetic (PK) Parameter: AUCtau of Elvitegravir (EVG), Cobicistat (COBI), Emtricitabine (FTC), and Tenofovir (TFV) COBI	10179.5 h*ng/mL Standard Deviation 6009.28
Pharmacokinetic (PK) Parameter: AUCtau of Elvitegravir (EVG), Cobicistat (COBI), Emtricitabine (FTC), and Tenofovir (TFV) FTC	62929.9 h*ng/mL Standard Deviation 30199.63
Pharmacokinetic (PK) Parameter: AUCtau of Elvitegravir (EVG), Cobicistat (COBI), Emtricitabine (FTC), and Tenofovir (TFV) TFV	8715.0 h*ng/mL Standard Deviation 3432.16

SECONDARY outcome

Timeframe: 0.5, 1, 2, 3, 4, 6, 8, and 24 hours postdose at or between Week 2 or Week 4

Population: Participants in the PK Substudy Analysis Set with available data were analyzed.

AUClast is defined as the area under the concentration versus time curve from time zero to the last observable concentration.

Outcome measures

Outcome measures
Measure	E/C/F/TAF (GEN Phase) n=12 Participants 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.
PK Parameter: AUClast of EVG, COBI, FTC, Tenofovir Alafenamide (TAF), and TFV EVG	12857.6 h*ng/mL Standard Deviation 7894.09
PK Parameter: AUClast of EVG, COBI, FTC, Tenofovir Alafenamide (TAF), and TFV COBI	9558.7 h*ng/mL Standard Deviation 5963.16
PK Parameter: AUClast of EVG, COBI, FTC, Tenofovir Alafenamide (TAF), and TFV FTC	59057.4 h*ng/mL Standard Deviation 31485.96
PK Parameter: AUClast of EVG, COBI, FTC, Tenofovir Alafenamide (TAF), and TFV TAF	231.9 h*ng/mL Standard Deviation 123.46
PK Parameter: AUClast of EVG, COBI, FTC, Tenofovir Alafenamide (TAF), and TFV TFV	7664.2 h*ng/mL Standard Deviation 3958.36

SECONDARY outcome

Timeframe: 0.5, 1, 2, 3, 4, 6, 8, and 24 hours postdose at or between Week 2 or Week 4

Population: Participants in the PK Substudy Analysis Set with available data were analyzed.

Cmax is defined as the maximum concentration of drug.

Outcome measures

Outcome measures
Measure	E/C/F/TAF (GEN Phase) n=12 Participants 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.
PK Parameter: Cmax of EVG, COBI, FTC, TAF, and TFV EVG	1258.5 ng/mL Standard Deviation 689.57
PK Parameter: Cmax of EVG, COBI, FTC, TAF, and TFV COBI	1370.4 ng/mL Standard Deviation 920.15
PK Parameter: Cmax of EVG, COBI, FTC, TAF, and TFV FTC	4875.0 ng/mL Standard Deviation 1981.03
PK Parameter: Cmax of EVG, COBI, FTC, TAF, and TFV TAF	246.3 ng/mL Standard Deviation 185.69
PK Parameter: Cmax of EVG, COBI, FTC, TAF, and TFV TFV	442.8 ng/mL Standard Deviation 181.03

SECONDARY outcome

Timeframe: 0.5, 1, 2, 3, 4, 6, 8, and 24 hours postdose at or between Week 2 or Week 4

Population: Participants in the PK Substudy Analysis Set with available data were analyzed.

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.

Outcome measures

Outcome measures
Measure	E/C/F/TAF (GEN Phase) n=10 Participants 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.
PK Parameter: Ctau of EVG, COBI, FTC, and TFV EVG	174.4 ng/mL Standard Deviation 104.36
PK Parameter: Ctau of EVG, COBI, FTC, and TFV COBI	28.9 ng/mL Standard Deviation 34.06
PK Parameter: Ctau of EVG, COBI, FTC, and TFV FTC	1277.3 ng/mL Standard Deviation 756.60
PK Parameter: Ctau of EVG, COBI, FTC, and TFV TFV	264.8 ng/mL Standard Deviation 193.98

SECONDARY outcome

Timeframe: Week 96

Population: Participants in the GEN Full Analysis Set were analyzed.

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.

Outcome measures

Outcome measures
Measure	E/C/F/TAF (GEN Phase) n=55 Participants 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.
GEN Phase: Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 96 Using the Missing = Failure (M = F) Approach	61.8 percentage of participants Interval 47.7 to 74.6

SECONDARY outcome

Timeframe: Week 96

Population: Participants in the GEN Full Analysis Set with available data were analyzed.

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.

Outcome measures

Outcome measures
Measure	E/C/F/TAF (GEN Phase) n=34 Participants 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.
GEN Phase: Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 96 Using the Missing = Excluded (M = E) Approach	100.0 percentage of participants Interval 89.7 to 100.0

SECONDARY outcome

Timeframe: Week 48 of the BVY OL Extension Phase

Population: 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).

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.

Outcome measures

Outcome measures
Measure	E/C/F/TAF (GEN Phase) n=10 Participants 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.
BVY OL Extension Phase: Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 48 Using the M = E Approach	100.0 percentage of participants Interval 69.2 to 100.0

SECONDARY outcome

Timeframe: Baseline; Week 96

Population: Participants in the GEN Full Analysis Set with available data were analyzed.

Outcome measures

Outcome measures
Measure	E/C/F/TAF (GEN Phase) n=28 Participants 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.
GEN Phase: Change From Baseline in Cluster Determinant 4+ (CD4+) Cell Count at Week 96	-35 cells/µL Standard Deviation 218.3

SECONDARY outcome

Timeframe: Baseline; Week 48 of the BVY OL Extension Phase

Population: Participants in the BVY Full Analysis Set with available data were analyzed.

Outcome measures

Outcome measures
Measure	E/C/F/TAF (GEN Phase) n=10 Participants 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.
BVY OL Extension Phase: Change From Baseline in CD4+ Cell Count at Week 48 Baseline	581 cells/µL Standard Deviation 146.8
BVY OL Extension Phase: Change From Baseline in CD4+ Cell Count at Week 48 Change from Baseline at Week 48	-104 cells/µL Standard Deviation 120.8

SECONDARY outcome

Timeframe: Baseline; Week 96

Population: Participants in the GEN Full Analysis Set with available data were analyzed.

Outcome measures

Outcome measures
Measure	E/C/F/TAF (GEN Phase) n=28 Participants 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.
GEN Phase: Change From Baseline in CD4 Percentage at Week 96	2.8 percentage of CD4 cells Standard Deviation 6.37

SECONDARY outcome

Timeframe: Baseline; Week 48 of the BVY OL Extension Phase

Population: Participants in the BVY Full Analysis Set with available data were analyzed.

Outcome measures

Outcome measures
Measure	E/C/F/TAF (GEN Phase) n=10 Participants 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.
BVY OL Extension Phase: Change From Baseline in CD4 Percentage at Week 48 Baseline	31.9 percentage of CD4 cells Standard Deviation 7.37
BVY OL Extension Phase: Change From Baseline in CD4 Percentage at Week 48 Change from Baseline at Week 48	1.7 percentage of CD4 cells Standard Deviation 4.39

Adverse Events

E/C/F/TAF (GEN Phase)

Serious events: 36 serious events

Other events: 41 other events

Deaths: 3 deaths

E/C/F/TAF to B/F/TAF (BVY OL Extension Phase)

Serious events: 3 serious events

Other events: 10 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Additional Information

Gilead Clinical Study Information Center

Gilead Sciences

Phone: 1-833-445-3230 (GILEAD-0)

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee 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
Publication restrictions are in place

Restriction type: OTHER