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Study to Evaluate Switching From a TDF-Containing Combination Regimen to a TAF-Containing Fixed Dose Combination (FDC) in Virologically-Suppressed, HIV-1 Positive Participants

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ClinicalTrials.gov Identifier: NCT01815736
Recruitment Status : Completed
First Posted : March 21, 2013
Results First Posted : April 14, 2016
Last Update Posted : April 13, 2021
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
Conditions HIV
HIV Infections
Interventions Drug: E/C/F/TAF
Drug: E/C/F/TDF
Drug: EFV/FTC/TDF
Drug: RTV
Drug: ATV
Drug: FTC/TDF
Drug: COBI
Enrollment 1443
Recruitment Details Participants were enrolled at study sites in Dominican Republic, Puerto Rico, North America, South America, Europe, Australia, and Asia. The first participant was screened on 27 March 2013. The last study visit occurred on 01 April 2020.
Pre-assignment Details 1559 participants were screened.
Arm/Group Title E/C/F/TAF Stay on Baseline Treatment Regimen (SBR)
Hide Arm/Group Description

Randomized Phase: Elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) (150/150/200/10 mg) fixed-dose combination (FDC) tablet administered once daily for up to 96 weeks.

Extension Phase: After completing 96 weeks of randomized treatment, all participants were given the opportunity to receive open-label E/C/F/TAF until it became commercially available, or until Gilead elected to terminate the development of E/C/F/TAF.

Randomized Phase: Participants stayed on their baseline emtricitabine (FTC)/tenofovir disoproxil fumarate (TDF)-containing regimen (E/C/F/TDF; efavirenz (EFV)/FTC/TDF; ritonavir (RTV)-boosted atazanavir (ATV)+FTC/TDF; or cobicistat (COBI-boosted ATV+FTC/TDF)) administered according to prescribing information for up to 96 weeks.

Extension Phase: After completing 96 weeks of randomized treatment (SBR), all participants were given the opportunity to receive open-label E/C/F/TAF until it became commercially available, or until Gilead elected to terminate the development of E/C/F/TAF.

Period Title: Randomized Treatment Phase-Up to Week 96
Started 963 480
Completed 914 445
Not Completed 49 35
Reason Not Completed
Withdrew Consent             11             17
Lost to Follow-up             10             9
Investigator's Discretion             11             2
Adverse Event             7             4
Death             4             0
Lack of Efficacy             1             0
Pregnancy             1             0
Participants randomized and never treated             4             3
Period Title: Extension Treatment Phase- After Week 96
Started 905 [1] 424 [2]
Completed 854 398
Not Completed 51 26
Reason Not Completed
Investigator's Discretion             31             15
Lost to Follow-up             13             9
Withdrew Consent             5             1
Adverse Event             1             1
Death             1             0
[1]
9 participants who completed the Randomized Treatment Phase did not continue in the Extension E/C/F/TAF Treatment Phase.
[2]
21 participants who completed the Randomized Treatment Phase did not continue in the Extension E/C/F/TAF Treatment Phase.
Arm/Group Title E/C/F/TAF Stay on Baseline Treatment Regimen (SBR) Total
Hide Arm/Group Description

Randomized Phase: Elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF)(150/150/200/10 mg) fixed-dose combination (FDC) tablet administered once daily for up to 96 weeks.

Extension Phase: After completing 96 weeks of randomized treatment, all participants were given the opportunity to receive open-label E/C/F/TAF until it became commercially available, or until Gilead elected to terminate the development of E/C/F/TAF.

Randomized Phase: Participants stayed on their baseline emtricitabine (FTC)/tenofovir disoproxil fumarate (TDF)-containing regimen (E/C/F/TDF; efavirenz (EFV)/FTC/TDF; ritonavir (RTV)-boosted atazanavir (ATV)+FTC/TDF; or cobicistat (COBI-boosted ATV+FTC/TDF)) administered according to prescribing information for up to 96 weeks.

Extension Phase: After completing 96 weeks of randomized treatment (SBR), all participants were given the opportunity to receive open-label E/C/F/TAF until it became commercially available, or until Gilead elected to terminate the development of E/C/F/TAF.

Total of all reporting groups
Overall Number of Baseline Participants 959 477 1436
Hide Baseline Analysis Population Description
Safety Analysis Set included participants who were randomized and received at least one dose of study drug.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 959 participants 477 participants 1436 participants
41  (10.1) 41  (10.1) 41  (10.1)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 959 participants 477 participants 1436 participants
Female
103
  10.7%
50
  10.5%
153
  10.7%
Male
856
  89.3%
427
  89.5%
1283
  89.3%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Race Number Analyzed 959 participants 477 participants 1436 participants
American Indian or Alaska Native
5
   0.5%
2
   0.4%
7
   0.5%
Asian
59
   6.2%
35
   7.3%
94
   6.5%
Black
169
  17.6%
102
  21.4%
271
  18.9%
Native Hawaiian or Pacific Islander
6
   0.6%
1
   0.2%
7
   0.5%
White
651
  67.9%
314
  65.8%
965
  67.2%
Local regulators did not allow collection of race or ethnicity information
2
   0.2%
1
   0.2%
3
   0.2%
Other
67
   7.0%
22
   4.6%
89
   6.2%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Ethnicity Number Analyzed 959 participants 477 participants 1436 participants
Hispanic or Latino
248
  25.9%
82
  17.2%
330
  23.0%
Not Hispanic or Latino
709
  73.9%
392
  82.2%
1101
  76.7%
Local regulators did not allow collection of race or ethnicity information
2
   0.2%
3
   0.6%
5
   0.3%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 959 participants 477 participants 1436 participants
United States 648 316 964
United Kingdom 14 8 22
Thailand 35 21 56
Portugal 8 2 10
Switzerland 5 4 9
Spain 5 3 8
Canada 51 27 78
Austria 16 8 24
Netherlands 2 3 5
Sweden 1 0 1
Belgium 14 8 22
Brazil 14 5 19
Denmark 1 2 3
Dominican Republic 29 13 42
Italy 13 6 19
Mexico 19 6 25
Australia 38 22 60
France 12 12 24
Germany 34 11 45
HIV-1 RNA Category  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 959 participants 477 participants 1436 participants
< 50 copies/mL
943
  98.3%
466
  97.7%
1409
  98.1%
≥ 50 copies/mL
16
   1.7%
11
   2.3%
27
   1.9%
1.Primary Outcome
Title Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 48
Hide Description The percentage of participants achieving HIV-1 RNA < 50 copies/mL at Week 48 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 48
Hide Outcome Measure Data
Hide Analysis Population Description

Full Analysis Set included participants who were randomized and received at least 1 dose of study drug.

New Drug Application (NDA Data Cut) = participants through the data cut for the E/C/F/TAF NDA; All Participants = participants through the Week 48 Data Cut.

Arm/Group Title E/C/F/TAF Stay on Baseline Treatment Regimen (SBR)
Hide Arm/Group Description:
Elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) (150/150/200/10 mg) FDC tablet administered once daily for up to 96 weeks in the Randomized Phase.
Participants stayed on their baseline emtricitabine (FTC)/tenofovir disoproxil fumarate (TDF)-containing regimen (E/C/F/TDF; efavirenz (EFV)/FTC/TDF; ritonavir (RTV)-boosted atazanavir (ATV)+FTC/TDF; or cobicistat (COBI-boosted ATV+FTC/TDF)) administered according to prescribing information for up to 96 weeks in the Randomized Phase.
Overall Number of Participants Analyzed 959 477
Measure Type: Number
Unit of Measure: percentage of participants
NDA Data Cut Number Analyzed 799 participants 397 participants
95.6 92.9
All Participants Number Analyzed 959 participants 477 participants
97.2 93.1
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection E/C/F/TAF, Stay on Baseline Treatment Regimen (SBR)
Comments NDA Data Cut
Type of Statistical Test Non-Inferiority or Equivalence (legacy)
Comments Null hypothesis: the E/C/F/TAF group was at least 12% worse than the Stay on Baseline Regimen group; alternative hypothesis: the E/C/F/TAF group was less than 12% worse than the in Stay on Baseline Regimen group.
Statistical Test of Hypothesis P-Value 0.051
Comments The p-value for the superiority test used a 2-sided Cochran-Mantel-Haenszel (CMH) test, stratified by prior treatment regimen.
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in percentages
Estimated Value 2.7
Confidence Interval (2-Sided) 95.01%
-0.3 to 5.6
Estimation Comments The difference in percentages and its 95.01% confidence interval (CI) were calculated based on the Mantel-Haenszel (MH) proportion adjusted by the prior treatment regimen.
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection E/C/F/TAF, Stay on Baseline Treatment Regimen (SBR)
Comments All Participants
Type of Statistical Test Non-Inferiority or Equivalence (legacy)
Comments Null hypothesis: the E/C/F/TAF group was at least 12% worse than the Stay on Baseline Regimen group; alternative hypothesis: the E/C/F/TAF group was less than 12% worse than the in Stay on Baseline Regimen group.
Statistical Test of Hypothesis P-Value <0.001
Comments The p-value for the superiority test used a 2-sided Cochran-Mantel-Haenszel (CMH) test, stratified by prior treatment regimen.
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in percentages
Estimated Value 4.1
Confidence Interval (2-Sided) 95%
1.6 to 6.7
Estimation Comments The difference in percentages and its 95% confidence interval (CI) were calculated based on the Mantel-Haenszel (MH) proportion adjusted by the prior treatment regimen.
2.Secondary Outcome
Title Percent Change From Baseline in Hip Bone Mineral Density (BMD) at Week 48
Hide Description Hip BMD was assessed by dual energy x-ray absorptiometry (DXA) scan. BMD is calculated as grams per square centimeter (g/cm^2); the mean (SD) percentage change is presented.
Time Frame Baseline; Week 48
Hide Outcome Measure Data
Hide Analysis Population Description

Participants in the Hip DXA Analysis Set (participants who received ≥ 1 dose of study drug and had nonmissing baseline hip BMD) with available data were analyzed.

NDA Data Cut = participants through the data cut for the E/C/F/TAF NDA; All Participants = participants through the Week 48 Data Cut.

Arm/Group Title E/C/F/TAF Stay on Baseline Treatment Regimen (SBR)
Hide Arm/Group Description:
Elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) (150/150/200/10 mg) FDC tablet administered once daily for up to 96 weeks in the Randomized Phase.
Participants stayed on their baseline emtricitabine (FTC)/tenofovir disoproxil fumarate (TDF)-containing regimen (E/C/F/TDF; efavirenz (EFV)/FTC/TDF; ritonavir (RTV)-boosted atazanavir (ATV)+FTC/TDF; or cobicistat (COBI-boosted ATV+FTC/TDF)) administered according to prescribing information for up to 96 weeks in the Randomized Phase.
Overall Number of Participants Analyzed 902 452
Mean (Standard Deviation)
Unit of Measure: percentage change
NDA Data Cut Number Analyzed 733 participants 350 participants
1.949  (2.9956) -0.136  (2.9890)
All Participants Number Analyzed 869 participants 428 participants
1.468  (2.7136) -0.340  (2.8280)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection E/C/F/TAF, Stay on Baseline Treatment Regimen (SBR)
Comments NDA Data Cut
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments P-value was from the analysis of variance (ANOVA) model including study treatment and prior treatment regimen as fixed effects.
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in least square means
Estimated Value 2.078
Confidence Interval (2-Sided) 95%
1.697 to 2.459
Estimation Comments Difference in least squares means (LSM) and its 95% CI were from the ANOVA model including treatment and prior treatment regimen as fixed effects.
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection E/C/F/TAF, Stay on Baseline Treatment Regimen (SBR)
Comments All Participants
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments P-value was from the analysis of variance (ANOVA) model including study treatment and prior treatment regimen as fixed effects.
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in least square means
Estimated Value 1.807
Confidence Interval (2-Sided) 95%
1.488 to 2.126
Estimation Comments Difference in least squares means and its 95% CI were from the ANOVA model including treatment and prior treatment regimen as fixed effects.
3.Secondary Outcome
Title Percent Change From Baseline in Spine BMD at Week 48
Hide Description Spine BMD was assessed by DXA scan. BMD is calculated as g/cm^2; the mean (SD) percentage change is presented.
Time Frame Baseline; Week 48
Hide Outcome Measure Data
Hide Analysis Population Description

Participants in the Spine DXA Analysis Set (participants who received ≥ 1 dose of study drug and had nonmissing baseline spine BMD) with available data were analyzed.

NDA Data Cut = participants through the data cut for the E/C/F/TAF NDA; All Participants = participants through the Week 48 Data Cut.

Arm/Group Title E/C/F/TAF Stay on Baseline Treatment Regimen (SBR)
Hide Arm/Group Description:
Elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) (150/150/200/10 mg) FDC tablet administered once daily for up to 96 weeks in the Randomized Phase.
Participants stayed on their baseline emtricitabine (FTC)/tenofovir disoproxil fumarate (TDF)-containing regimen (E/C/F/TDF; efavirenz (EFV)/FTC/TDF; ritonavir (RTV)-boosted atazanavir (ATV)+FTC/TDF; or cobicistat (COBI-boosted ATV+FTC/TDF)) administered according to prescribing information for up to 96 weeks in the Randomized Phase.
Overall Number of Participants Analyzed 912 457
Mean (Standard Deviation)
Unit of Measure: percentage change
NDA Data Cut Number Analyzed 742 participants 356 participants
1.861  (3.0889) -0.110  (3.7415)
All Participants Number Analyzed 881 participants 436 participants
1.557  (3.8441) -0.443  (4.1387)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection E/C/F/TAF, Stay on Baseline Treatment Regimen (SBR)
Comments NDA Data Cut
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments P-value was from the analysis of variance (ANOVA) model including study treatment and prior treatment regimen as fixed effects.
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in least square means
Estimated Value 1.970
Confidence Interval (2-Sided) 95%
1.551 to 2.390
Estimation Comments Difference in least squares means (LSM) and its 95% CI were from the ANOVA model including treatment and prior treatment regimen as fixed effects.
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection E/C/F/TAF, Stay on Baseline Treatment Regimen (SBR)
Comments All Participants
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments P-value was from the analysis of variance (ANOVA) model including study treatment and prior treatment regimen as fixed effects.
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in least square means
Estimated Value 2.000
Confidence Interval (2-Sided) 95%
1.549 to 2.452
Estimation Comments Difference in least squares means (LSM) and its 95% CI were from the ANOVA model including treatment and prior treatment regimen as fixed effects.
4.Secondary Outcome
Title Change From Baseline in Serum Creatinine at Week 48
Hide Description [Not Specified]
Time Frame Baseline; Week 48
Hide Outcome Measure Data
Hide Analysis Population Description

Participants in the Safety Analysis Set (randomized participants who received ≥ 1 dose of study drug) excluding participants with prior treatment of EFV/FTC/TDF.

NDA Data Cut = participants through the data cut for the E/C/F/TAF NDA; All Participants = participants through the Week 48 Data Cut

Arm/Group Title E/C/F/TAF Stay on Baseline Treatment Regimen (SBR)
Hide Arm/Group Description:
Elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) (150/150/200/10 mg) FDC tablet administered once daily for up to 96 weeks in the Randomized Phase.
Participants stayed on their baseline emtricitabine (FTC)/tenofovir disoproxil fumarate (TDF)-containing regimen (E/C/F/TDF; efavirenz (EFV)/FTC/TDF; ritonavir (RTV)-boosted atazanavir (ATV)+FTC/TDF; or cobicistat (COBI-boosted ATV+FTC/TDF)) administered according to prescribing information for up to 96 weeks in the Randomized Phase.
Overall Number of Participants Analyzed 708 352
Mean (Standard Deviation)
Unit of Measure: mg/dL
NDA Data Cut Number Analyzed 545 participants 266 participants
-0.01  (0.117) 0.04  (0.123)
All Participants Number Analyzed 696 participants 330 participants
0.00  (0.115) 0.03  (0.105)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection E/C/F/TAF, Stay on Baseline Treatment Regimen (SBR)
Comments NDA Data Cut
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments P-value was from analysis of covariance (ANCOVA) model including study treatment and prior treatment as fixed effects and baseline serum creatinine as a covariate.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in least square means
Estimated Value -0.05
Confidence Interval (2-Sided) 95%
-0.07 to -0.03
Estimation Comments Difference in least squares means (LSM) and its 95% CI were from the analysis of covariance (ANCOVA) model including study treatment and prior treatment regimen as fixed effects and baseline serum creatinine as a covariate.
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection E/C/F/TAF, Stay on Baseline Treatment Regimen (SBR)
Comments All Participants
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments P-value was from analysis of covariance (ANCOVA) model including study treatment and prior treatment as fixed effects and baseline serum creatinine as a covariate.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in least square means
Estimated Value -0.04
Confidence Interval (2-Sided) 95%
-0.05 to -0.02
Estimation Comments Difference in least squares means (LSM) and its 95% CI were from the analysis of covariance (ANCOVA) model including study treatment and prior treatment regimen as fixed effects and baseline serum creatinine as a covariate.
5.Secondary Outcome
Title Change From Baseline in the Overall EFV-related Symptom Assessment Score at Week 48
Hide Description

The mean (SD) change of the overall EFV-related symptom assessment score is presented. The overall symptom score (ranging from 0 to 20) is the sum of the individual symptom scores ranging from 0 (no symptoms) to 4 (most severe symptoms) from the 5 EFV-related symptom assessments (dizziness, trouble sleeping, impaired concentration, sleepiness, and abnormal or vivid dream). A negative change from baseline indicates improvement.

EFV-Related Symptom Analysis Set: participants who received EFV/FTC/TDF as prior treatment, received at least 1 dose of study drug, and completed EFV-related symptom assessments at the baseline visit and at least 1 postbaseline visit.

Time Frame Baseline; Week 48
Hide Outcome Measure Data
Hide Analysis Population Description

Participants in EFV-Related Symptom Analysis Set with available data were analyzed.

NDA Data Cut = participants through data cut for E/C/F/TAF NDA; All Participants = participants through Week 48 Data Cut

Arm/Group Title E/C/F/TAF Stay on Baseline Treatment Regimen (SBR)
Hide Arm/Group Description:
Elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) (150/150/200/10 mg) FDC tablet administered once daily for up to 96 weeks in the Randomized Phase.
Participants stayed on their baseline emtricitabine (FTC)/tenofovir disoproxil fumarate (TDF)-containing regimen (E/C/F/TDF; efavirenz (EFV)/FTC/TDF; ritonavir (RTV)-boosted atazanavir (ATV)+FTC/TDF; or cobicistat (COBI-boosted ATV+FTC/TDF)) administered according to prescribing information for up to 96 weeks in the Randomized Phase.
Overall Number of Participants Analyzed 239 116
Mean (Standard Deviation)
Unit of Measure: units on a scale
NDA Data Cut Number Analyzed 210 participants 96 participants
-1.6  (3.06) -0.1  (2.43)
All Participants Number Analyzed 224 participants 101 participants
-1.5  (3.06) -0.1  (2.39)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection E/C/F/TAF, Stay on Baseline Treatment Regimen (SBR)
Comments NDA Data Cut
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments The P-value comparing the 2 treatment groups was from the 2-sided Wilcoxon rank sum test.
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection E/C/F/TAF, Stay on Baseline Treatment Regimen (SBR)
Comments All Participants
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments The P-value comparing the 2 treatment groups was from the 2-sided Wilcoxon rank sum test.
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
6.Secondary Outcome
Title Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 96
Hide Description The percentage of participants achieving HIV-1 RNA < 50 copies/mL at Week 96 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 96
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the Full Analysis Set were analyzed.
Arm/Group Title E/C/F/TAF Stay on Baseline Treatment Regimen (SBR)
Hide Arm/Group Description:
Elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) (150/150/200/10 mg) FDC tablet administered once daily for up to 96 weeks in the Randomized Phase.
Participants stayed on their baseline emtricitabine (FTC)/tenofovir disoproxil fumarate (TDF)-containing regimen (E/C/F/TDF; efavirenz (EFV)/FTC/TDF; ritonavir (RTV)-boosted atazanavir (ATV)+FTC/TDF; or cobicistat (COBI-boosted ATV+FTC/TDF)) administered according to prescribing information for up to 96 weeks in the Randomized Phase.
Overall Number of Participants Analyzed 959 477
Measure Type: Number
Unit of Measure: percentage of participants
92.8 89.1
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection E/C/F/TAF, Stay on Baseline Treatment Regimen (SBR)
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence (legacy)
Comments Null hypothesis: The E/C/F/TAF group was at least 12% worse than the Stay on Baseline Regimen group; alternative hypothesis: the E/C/F/TAF group was less than 12% worse than the in Stay on Baseline Regimen group.
Statistical Test of Hypothesis P-Value 0.017
Comments P-value for the superiority test comparing the percentages of virologic success was from the CMH test stratified by the prior treatment regimen (STB, ATR, ATV/boosted+TVD).
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in percentages
Estimated Value 3.7
Confidence Interval (2-Sided) 95%
0.4 to 7.0
Estimation Comments The difference in percentages of virologic success and its 95% CI were calculated based on the MH proportion adjusted by the prior treatment regimen.
7.Secondary Outcome
Title Percentage of Participants With HIV-1 RNA < 20 Copies/mL at Week 48
Hide Description The percentage of participants achieving HIV-1 RNA < 20 copies/mL at Week 48 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 48
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the Full Analysis Set were analyzed. NDA Data Cut = participants through the data cut for the E/C/F/TAF NDA; All Participants = participants through the Week 48 Data Cut.
Arm/Group Title E/C/F/TAF Stay on Baseline Treatment Regimen (SBR)
Hide Arm/Group Description:
Elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) (150/150/200/10 mg) FDC tablet administered once daily for up to 96 weeks in the Randomized Phase.
Participants stayed on their baseline emtricitabine (FTC)/tenofovir disoproxil fumarate (TDF)-containing regimen (E/C/F/TDF; efavirenz (EFV)/FTC/TDF; ritonavir (RTV)-boosted atazanavir (ATV)+FTC/TDF; or cobicistat (COBI-boosted ATV+FTC/TDF)) administered according to prescribing information for up to 96 weeks in the Randomized Phase.
Overall Number of Participants Analyzed 959 477
Measure Type: Number
Unit of Measure: percentage of participants
NDA Data Cut Number Analyzed 799 participants 397 participants
92.2 90.4
All Participants Number Analyzed 959 participants 477 participants
93.5 90.4
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection E/C/F/TAF, Stay on Baseline Treatment Regimen (SBR)
Comments NDA Data Cut
Type of Statistical Test Non-Inferiority or Equivalence (legacy)
Comments Null hypothesis: The E/C/F/TAF group was at least 12% worse than the Stay on Baseline Regimen group; alternative hypothesis: the E/C/F/TAF group was less than 12% worse than the in Stay on Baseline Regimen group.
Statistical Test of Hypothesis P-Value 0.29
Comments P-value for the superiority test comparing the percentages of virologic success was from the CMH test stratified by the prior treatment regimen (STB, ATR, ATV/boosted+TVD).
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in percentages
Estimated Value 1.8
Confidence Interval (2-Sided) 95%
-1.7 to 5.3
Estimation Comments Difference in percentages of virologic success and its 95% CI were calculated based on the MH proportion adjusted by the prior treatment regimen.
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection E/C/F/TAF, Stay on Baseline Treatment Regimen (SBR)
Comments All Participants
Type of Statistical Test Non-Inferiority or Equivalence (legacy)
Comments Null hypothesis: the E/C/F/TAF group was at least 12% worse than the Stay on Baseline Regimen group; alternative hypothesis: the E/C/F/TAF group was less than 12% worse than the in Stay on Baseline Regimen group.
Statistical Test of Hypothesis P-Value 0.031
Comments P-value for the superiority test comparing the percentages of virologic success was from the CMH test stratified by the prior treatment regimen (STB, ATR, ATV/boosted+TVD).
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in percentages
Estimated Value 3.2
Confidence Interval (2-Sided) 95%
0.1 to 6.3
Estimation Comments Difference in percentages of virologic success and its 95% CI were calculated based on the MH proportion adjusted by the prior treatment regimen.
8.Secondary Outcome
Title Percentage of Participants With HIV-1 RNA < 20 Copies/mL at Week 96
Hide Description The percentage of participants achieving HIV-1 RNA < 20 copies/mL at Week 96 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 96
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the Full Analysis Set were analyzed.
Arm/Group Title E/C/F/TAF Stay on Baseline Treatment Regimen (SBR)
Hide Arm/Group Description:
Elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) (150/150/200/10 mg) FDC tablet administered once daily for up to 96 weeks in the Randomized Phase.
Participants stayed on their baseline emtricitabine (FTC)/tenofovir disoproxil fumarate (TDF)-containing regimen (E/C/F/TDF; efavirenz (EFV)/FTC/TDF; ritonavir (RTV)-boosted atazanavir (ATV)+FTC/TDF; or cobicistat (COBI-boosted ATV+FTC/TDF)) administered according to prescribing information for up to 96 weeks in the Randomized Phase.
Overall Number of Participants Analyzed 959 477
Measure Type: Number
Unit of Measure: percentage of participants
90.6 85.3
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection E/C/F/TAF, Stay on Baseline Treatment Regimen (SBR)
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence (legacy)
Comments Null hypothesis: the E/C/F/TAF group was at least 12% worse than the Stay on Baseline Regimen group; alternative hypothesis: the E/C/F/TAF group was less than 12% worse than the in Stay on Baseline Regimen group.
Statistical Test of Hypothesis P-Value 0.003
Comments P-value for the superiority test comparing the percentages of virologic success was from the CMH test stratified by the prior treatment regimen (STB, ATR, ATV/boosted+TVD).
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in percentages
Estimated Value 5.3
Confidence Interval (2-Sided) 95%
1.6 to 9.0
Estimation Comments Difference in percentages of virologic success and its 95% CI were calculated based on the MH proportion adjusted by the prior treatment regimen.
9.Secondary Outcome
Title Change From Baseline in Cluster Determinant 4 (CD4) Cell Count at Week 48
Hide Description The analysis of CD4 cell count included values up to 1 day after the last dose date of randomized study drug.The change from baseline in CD4 cell count for the full analysis set was based on observed data (ie, Missing = Excluded) for the total and by the prior treatment regimen.
Time Frame Baseline; Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the Full Analysis Set with available data were analyzed. NDA Data Cut = participants through the data cut for the E/C/F/TAF NDA; All Participants = participants through the Week 48 Data Cut.
Arm/Group Title E/C/F/TAF Stay on Baseline Treatment Regimen (SBR)
Hide Arm/Group Description:
Elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) (150/150/200/10 mg) FDC tablet administered once daily for up to 96 weeks in the Randomized Phase.
Participants stayed on their baseline emtricitabine (FTC)/tenofovir disoproxil fumarate (TDF)-containing regimen (E/C/F/TDF; efavirenz (EFV)/FTC/TDF; ritonavir (RTV)-boosted atazanavir (ATV)+FTC/TDF; or cobicistat (COBI-boosted ATV+FTC/TDF)) administered according to prescribing information for up to 96 weeks in the Randomized Phase.
Overall Number of Participants Analyzed 959 477
Mean (Standard Deviation)
Unit of Measure: cells/uL
Baseline (NDA Data Cut) Number Analyzed 799 participants 397 participants
712  (267.9) 690  (251.4)
Change at Week 48 (NDA Data Cut) Number Analyzed 773 participants 374 participants
33  (166.6) 27  (160.2)
Baseline (All Participants) Number Analyzed 959 participants 477 participants
701  (261.8) 689  (248.0)
Change at Week 48 (All Participants) Number Analyzed 937 participants 449 participants
35  (164.6) 24  (156.1)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection E/C/F/TAF, Stay on Baseline Treatment Regimen (SBR)
Comments NDA Data Cut: Change at Week 48
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.56
Comments P-values were from the analysis of variance (ANOVA) model including treatment (E/C/F/TAF vs. SBR) and prior treatment regimen (STB, ATR, ATV/boosted+TVD) as fixed effects.
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in least squares means
Estimated Value 6
Confidence Interval (2-Sided) 95%
-14 to 26
Estimation Comments Difference in least squares means (Diff in LSM), and its 95% CI were from the analysis of variance (ANOVA) model including treatment (E/C/F/TAF vs. FTC/TDF+3rd Agent) and prior treatment regimen (STB, ATR, ATV/boosted+TVD) as fixed effects.
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection E/C/F/TAF, Stay on Baseline Treatment Regimen (SBR)
Comments All Participants: Change at Week 48
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.26
Comments P-values were from the analysis of variance (ANOVA) model including treatment (E/C/F/TAF vs. SBR) and prior treatment regimen (STB, ATR, ATV/boosted+TVD) as fixed effects.
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in least squares means
Estimated Value 11
Confidence Interval (2-Sided) 95%
-8 to 29
Estimation Comments Difference in least squares means and its 95% CI were from the analysis of variance (ANOVA) model including treatment (E/C/F/TAF vs.SBR) and prior treatment regimen (STB, ATR, ATV/boosted+TVD) as fixed effects.
10.Secondary Outcome
Title Change From Baseline in CD4 Cell Count at Weeks 96
Hide Description The analysis of CD4 cell count included values up to 1 day after the last dose date of randomized study drug.The change from baseline in CD4 cell count for the full analysis set was based on observed data (ie, Missing = Excluded) for the total and by the prior treatment regimen.
Time Frame Baseline; Week 96
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the Full Analysis Set with available data were analyzed.
Arm/Group Title E/C/F/TAF Stay on Baseline Treatment Regimen (SBR)
Hide Arm/Group Description:
Elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) (150/150/200/10 mg) FDC tablet administered once daily for up to 96 weeks in the Randomized Phase.
Participants stayed on their baseline emtricitabine (FTC)/tenofovir disoproxil fumarate (TDF)-containing regimen (E/C/F/TDF; efavirenz (EFV)/FTC/TDF; ritonavir (RTV)-boosted atazanavir (ATV)+FTC/TDF; or cobicistat (COBI-boosted ATV+FTC/TDF)) administered according to prescribing information for up to 96 weeks in the Randomized Phase.
Overall Number of Participants Analyzed 959 477
Mean (Standard Deviation)
Unit of Measure: cells/uL
Baseline Number Analyzed 959 participants 477 participants
701  (261.8) 689  (248.0)
Change at Week 96 Number Analyzed 892 participants 427 participants
60  (181.6) 42  (158.0)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection E/C/F/TAF, Stay on Baseline Treatment Regimen (SBR)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.074
Comments P-values were from the analysis of variance (ANOVA) model including treatment (E/C/F/TAF vs. SBR) and prior treatment regimen (STB, ATR, ATV/boosted+TVD) as fixed effects.
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in least squares means
Estimated Value 18
Confidence Interval (2-Sided) 95%
-2 to 38
Estimation Comments Difference in least squares means and its 95% CI were from the analysis of variance (ANOVA) model including treatment (E/C/F/TAF vs. SBR) and prior treatment regimen (STB, ATR, ATV/boosted+TVD) as fixed effects.
Time Frame From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Adverse Event Reporting Description

Safety Analysis Set included participants who were randomized and received at least one dose of study drug.

For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.

 
Arm/Group Title Randomized Phase: E/C/F/TAF Randomized Phase: Stay on Baseline Treatment Regimen (SBR) Extension Phase: E/C/F/TAF From E/C/F/TAF Extension Phase: E/C/F/TAF From SBR
Hide Arm/Group Description Elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (Genvoya®; EVG/COBI/FTC/TAF; E/C/F/TAF) (150/150/200/10 mg) FDC tablet administered once daily for up to 96 weeks in the Randomized Phase. Participants stayed on their baseline emtricitabine(FTC)/tenofovir disoproxil fumarate (TDF)-containing regimen E/C/F/TDF (Stribild®); efavirenz (EFV)/FTC/TDF (Atripla®); ritonavir (RTV)-boosted atazanavir (ATV)+FTC/TDF; or cobicistat (COBI-boosted ATV+FTC/TDF) administered according to prescribing information for up to 96 weeks in the Randomized Phase. After completing 96 weeks of randomized treatment (E/C/F/TAF), all participants were given the opportunity to receive open-label E/C/F/TAF in the extension phase until it became commercially available, or until Gilead elected to terminate the development of E/C/F/TAF. After completing 96 weeks of randomized treatment (SBR), all participants were given the opportunity to receive open-label E/C/F/TAF in the extension phase until it became commercially available, or until Gilead elected to terminate the development of E/C/F/TAF.
All-Cause Mortality
Randomized Phase: E/C/F/TAF Randomized Phase: Stay on Baseline Treatment Regimen (SBR) Extension Phase: E/C/F/TAF From E/C/F/TAF Extension Phase: E/C/F/TAF From SBR
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   4/963 (0.42%)   0/480 (0.00%)   1/905 (0.11%)   1/424 (0.24%) 
Hide Serious Adverse Events
Randomized Phase: E/C/F/TAF Randomized Phase: Stay on Baseline Treatment Regimen (SBR) Extension Phase: E/C/F/TAF From E/C/F/TAF Extension Phase: E/C/F/TAF From SBR
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   79/959 (8.24%)   39/477 (8.18%)   27/905 (2.98%)   22/424 (5.19%) 
Blood and lymphatic system disorders         
Anaemia  1  1/959 (0.10%)  0/477 (0.00%)  0/905 (0.00%)  0/424 (0.00%) 
Pancytopenia  1  1/959 (0.10%)  0/477 (0.00%)  0/905 (0.00%)  0/424 (0.00%) 
Cardiac disorders         
Acute coronary syndrome  1  1/959 (0.10%)  0/477 (0.00%)  0/905 (0.00%)  0/424 (0.00%) 
Acute myocardial infarction  1  2/959 (0.21%)  1/477 (0.21%)  1/905 (0.11%)  0/424 (0.00%) 
Arrhythmia supraventricular  1  0/959 (0.00%)  0/477 (0.00%)  1/905 (0.11%)  0/424 (0.00%) 
Atrial tachycardia  1  0/959 (0.00%)  0/477 (0.00%)  1/905 (0.11%)  0/424 (0.00%) 
Cardiac arrest  1  0/959 (0.00%)  1/477 (0.21%)  0/905 (0.00%)  0/424 (0.00%) 
Cardiac failure congestive  1  0/959 (0.00%)  1/477 (0.21%)  0/905 (0.00%)  1/424 (0.24%) 
Cardiogenic shock  1  0/959 (0.00%)  1/477 (0.21%)  0/905 (0.00%)  0/424 (0.00%) 
Coronary artery disease  1  2/959 (0.21%)  0/477 (0.00%)  1/905 (0.11%)  0/424 (0.00%) 
Coronary artery insufficiency  1  0/959 (0.00%)  0/477 (0.00%)  0/905 (0.00%)  1/424 (0.24%) 
Myocardial infarction  1  1/959 (0.10%)  2/477 (0.42%)  0/905 (0.00%)  0/424 (0.00%) 
Myocarditis  1  1/959 (0.10%)  0/477 (0.00%)  0/905 (0.00%)  0/424 (0.00%) 
Eye disorders         
Retinal detachment  1  1/959 (0.10%)  0/477 (0.00%)  0/905 (0.00%)  0/424 (0.00%) 
Gastrointestinal disorders         
Abdominal adhesions  1  0/959 (0.00%)  0/477 (0.00%)  1/905 (0.11%)  0/424 (0.00%) 
Abdominal pain  1  3/959 (0.31%)  0/477 (0.00%)  0/905 (0.00%)  2/424 (0.47%) 
Abdominal pain upper  1  0/959 (0.00%)  0/477 (0.00%)  1/905 (0.11%)  0/424 (0.00%) 
Colitis  1  1/959 (0.10%)  0/477 (0.00%)  0/905 (0.00%)  0/424 (0.00%) 
Colitis ulcerative  1  1/959 (0.10%)  0/477 (0.00%)  1/905 (0.11%)  0/424 (0.00%) 
Diarrhoea  1  1/959 (0.10%)  2/477 (0.42%)  1/905 (0.11%)  2/424 (0.47%) 
Diverticular perforation  1  0/959 (0.00%)  1/477 (0.21%)  0/905 (0.00%)  0/424 (0.00%) 
Enteritis  1  1/959 (0.10%)  0/477 (0.00%)  0/905 (0.00%)  0/424 (0.00%) 
Erosive oesophagitis  1  0/959 (0.00%)  1/477 (0.21%)  0/905 (0.00%)  0/424 (0.00%) 
Gastritis  1  0/959 (0.00%)  1/477 (0.21%)  0/905 (0.00%)  0/424 (0.00%) 
Intestinal perforation  1  1/959 (0.10%)  0/477 (0.00%)  0/905 (0.00%)  0/424 (0.00%) 
Large intestine perforation  1  1/959 (0.10%)  0/477 (0.00%)  0/905 (0.00%)  0/424 (0.00%) 
Nausea  1  0/959 (0.00%)  0/477 (0.00%)  0/905 (0.00%)  1/424 (0.24%) 
Rectal haemorrhage  1  0/959 (0.00%)  0/477 (0.00%)  1/905 (0.11%)  1/424 (0.24%) 
Small intestinal obstruction  1  1/959 (0.10%)  0/477 (0.00%)  1/905 (0.11%)  0/424 (0.00%) 
Upper gastrointestinal haemorrhage  1  1/959 (0.10%)  0/477 (0.00%)  0/905 (0.00%)  0/424 (0.00%) 
Vomiting  1  1/959 (0.10%)  0/477 (0.00%)  0/905 (0.00%)  0/424 (0.00%) 
General disorders         
Chest pain  1  1/959 (0.10%)  0/477 (0.00%)  0/905 (0.00%)  2/424 (0.47%) 
Chills  1  0/959 (0.00%)  0/477 (0.00%)  0/905 (0.00%)  1/424 (0.24%) 
Fatigue  1  0/959 (0.00%)  0/477 (0.00%)  0/905 (0.00%)  1/424 (0.24%) 
General physical health deterioration  1  1/959 (0.10%)  0/477 (0.00%)  0/905 (0.00%)  0/424 (0.00%) 
Non-cardiac chest pain  1  2/959 (0.21%)  1/477 (0.21%)  0/905 (0.00%)  0/424 (0.00%) 
Pyrexia  1  0/959 (0.00%)  0/477 (0.00%)  0/905 (0.00%)  2/424 (0.47%) 
Sudden death  1  1/959 (0.10%)  0/477 (0.00%)  0/905 (0.00%)  0/424 (0.00%) 
Systemic inflammatory response syndrome  1  1/959 (0.10%)  0/477 (0.00%)  0/905 (0.00%)  0/424 (0.00%) 
Vascular stent occlusion  1  0/959 (0.00%)  0/477 (0.00%)  0/905 (0.00%)  1/424 (0.24%) 
Hepatobiliary disorders         
Cholecystitis  1  0/959 (0.00%)  1/477 (0.21%)  0/905 (0.00%)  0/424 (0.00%) 
Cholecystitis acute  1  0/959 (0.00%)  1/477 (0.21%)  1/905 (0.11%)  0/424 (0.00%) 
Cholelithiasis  1  0/959 (0.00%)  1/477 (0.21%)  0/905 (0.00%)  0/424 (0.00%) 
Hydrocholecystis  1  0/959 (0.00%)  1/477 (0.21%)  0/905 (0.00%)  0/424 (0.00%) 
Immune system disorders         
Anaphylactic reaction  1  1/959 (0.10%)  0/477 (0.00%)  0/905 (0.00%)  0/424 (0.00%) 
Infections and infestations         
Abscess limb  1  0/959 (0.00%)  1/477 (0.21%)  0/905 (0.00%)  0/424 (0.00%) 
Acute hepatitis C  1  1/959 (0.10%)  0/477 (0.00%)  0/905 (0.00%)  0/424 (0.00%) 
Anal abscess  1  1/959 (0.10%)  0/477 (0.00%)  0/905 (0.00%)  0/424 (0.00%) 
Appendiceal abscess  1  0/959 (0.00%)  1/477 (0.21%)  1/905 (0.11%)  0/424 (0.00%) 
Appendicitis  1  3/959 (0.31%)  1/477 (0.21%)  1/905 (0.11%)  1/424 (0.24%) 
Bacterial colitis  1  1/959 (0.10%)  0/477 (0.00%)  0/905 (0.00%)  0/424 (0.00%) 
Bacterial sepsis  1  0/959 (0.00%)  0/477 (0.00%)  0/905 (0.00%)  1/424 (0.24%) 
Bronchitis  1  1/959 (0.10%)  1/477 (0.21%)  1/905 (0.11%)  0/424 (0.00%) 
Cellulitis  1  0/959 (0.00%)  2/477 (0.42%)  2/905 (0.22%)  0/424 (0.00%) 
Chronic sinusitis  1  0/959 (0.00%)  0/477 (0.00%)  0/905 (0.00%)  1/424 (0.24%) 
Conjunctivitis bacterial  1  1/959 (0.10%)  0/477 (0.00%)  0/905 (0.00%)  0/424 (0.00%) 
Diverticulitis  1  0/959 (0.00%)  1/477 (0.21%)  0/905 (0.00%)  0/424 (0.00%) 
Enteritis infectious  1  1/959 (0.10%)  0/477 (0.00%)  0/905 (0.00%)  0/424 (0.00%) 
Epididymitis  1  0/959 (0.00%)  0/477 (0.00%)  0/905 (0.00%)  1/424 (0.24%) 
Erysipelas  1  0/959 (0.00%)  1/477 (0.21%)  0/905 (0.00%)  0/424 (0.00%) 
Gastroenteritis  1  1/959 (0.10%)  0/477 (0.00%)  1/905 (0.11%)  0/424 (0.00%) 
Gonorrhoea  1  1/959 (0.10%)  0/477 (0.00%)  0/905 (0.00%)  0/424 (0.00%) 
H1n1 influenza  1  0/959 (0.00%)  1/477 (0.21%)  0/905 (0.00%)  0/424 (0.00%) 
Hepatitis A  1  1/959 (0.10%)  0/477 (0.00%)  0/905 (0.00%)  0/424 (0.00%) 
Hepatitis syphilitic  1  0/959 (0.00%)  1/477 (0.21%)  0/905 (0.00%)  0/424 (0.00%) 
Influenza  1  0/959 (0.00%)  2/477 (0.42%)  0/905 (0.00%)  0/424 (0.00%) 
Localised infection  1  0/959 (0.00%)  0/477 (0.00%)  0/905 (0.00%)  1/424 (0.24%) 
Meningitis aseptic  1  3/959 (0.31%)  0/477 (0.00%)  0/905 (0.00%)  0/424 (0.00%) 
Meningitis viral  1  0/959 (0.00%)  0/477 (0.00%)  0/905 (0.00%)  1/424 (0.24%) 
Neurosyphilis  1  1/959 (0.10%)  0/477 (0.00%)  0/905 (0.00%)  0/424 (0.00%) 
Osteomyelitis  1  1/959 (0.10%)  2/477 (0.42%)  0/905 (0.00%)  0/424 (0.00%) 
Parasitic gastroenteritis  1  1/959 (0.10%)  0/477 (0.00%)  0/905 (0.00%)  0/424 (0.00%) 
Perineal infection  1  0/959 (0.00%)  1/477 (0.21%)  0/905 (0.00%)  0/424 (0.00%) 
Perirectal abscess  1  0/959 (0.00%)  1/477 (0.21%)  0/905 (0.00%)  0/424 (0.00%) 
Pneumonia  1  5/959 (0.52%)  0/477 (0.00%)  0/905 (0.00%)  2/424 (0.47%) 
Pneumonia legionella  1  0/959 (0.00%)  0/477 (0.00%)  0/905 (0.00%)  1/424 (0.24%) 
Pneumonia mycoplasmal  1  0/959 (0.00%)  0/477 (0.00%)  1/905 (0.11%)  0/424 (0.00%) 
Rectal abscess  1  0/959 (0.00%)  0/477 (0.00%)  0/905 (0.00%)  1/424 (0.24%) 
Reiter's syndrome  1  1/959 (0.10%)  0/477 (0.00%)  0/905 (0.00%)  0/424 (0.00%) 
Scrotal infection  1  0/959 (0.00%)  1/477 (0.21%)  0/905 (0.00%)  0/424 (0.00%) 
Secondary syphilis  1  0/959 (0.00%)  0/477 (0.00%)  0/905 (0.00%)  1/424 (0.24%) 
Sepsis  1  4/959 (0.42%)  1/477 (0.21%)  0/905 (0.00%)  0/424 (0.00%) 
Septic shock  1  1/959 (0.10%)  0/477 (0.00%)  0/905 (0.00%)  0/424 (0.00%) 
Sinusitis  1  2/959 (0.21%)  0/477 (0.00%)  0/905 (0.00%)  0/424 (0.00%) 
Urinary tract infection  1  1/959 (0.10%)  0/477 (0.00%)  0/905 (0.00%)  0/424 (0.00%) 
Viral infection  1  1/959 (0.10%)  0/477 (0.00%)  0/905 (0.00%)  0/424 (0.00%) 
Wound infection  1  0/959 (0.00%)  0/477 (0.00%)  1/905 (0.11%)  0/424 (0.00%) 
Injury, poisoning and procedural complications         
Acetabulum fracture  1  1/959 (0.10%)  0/477 (0.00%)  0/905 (0.00%)  0/424 (0.00%) 
Craniocerebral injury  1  1/959 (0.10%)  0/477 (0.00%)  0/905 (0.00%)  0/424 (0.00%) 
Head injury  1  0/959 (0.00%)  0/477 (0.00%)  1/905 (0.11%)  0/424 (0.00%) 
Hip fracture  1  1/959 (0.10%)  0/477 (0.00%)  0/905 (0.00%)  0/424 (0.00%) 
Maternal exposure during pregnancy  1  0/959 (0.00%)  0/477 (0.00%)  0/905 (0.00%)  1/424 (0.24%) 
Multiple fractures  1  0/959 (0.00%)  0/477 (0.00%)  0/905 (0.00%)  1/424 (0.24%) 
Overdose  1  1/959 (0.10%)  1/477 (0.21%)  0/905 (0.00%)  0/424 (0.00%) 
Post procedural complication  1  1/959 (0.10%)  0/477 (0.00%)  0/905 (0.00%)  0/424 (0.00%) 
Radius fracture  1  1/959 (0.10%)  0/477 (0.00%)  0/905 (0.00%)  0/424 (0.00%) 
Rib fracture  1  0/959 (0.00%)  1/477 (0.21%)  0/905 (0.00%)  0/424 (0.00%) 
Road traffic accident  1  0/959 (0.00%)  0/477 (0.00%)  0/905 (0.00%)  1/424 (0.24%) 
Skin abrasion  1  0/959 (0.00%)  0/477 (0.00%)  1/905 (0.11%)  0/424 (0.00%) 
Skull fracture  1  1/959 (0.10%)  0/477 (0.00%)  0/905 (0.00%)  0/424 (0.00%) 
Wrist fracture  1  0/959 (0.00%)  0/477 (0.00%)  1/905 (0.11%)  0/424 (0.00%) 
Metabolism and nutrition disorders         
Dehydration  1  1/959 (0.10%)  0/477 (0.00%)  0/905 (0.00%)  0/424 (0.00%) 
Musculoskeletal and connective tissue disorders         
Arthritis reactive  1  0/959 (0.00%)  1/477 (0.21%)  0/905 (0.00%)  0/424 (0.00%) 
Intervertebral disc protrusion  1  1/959 (0.10%)  0/477 (0.00%)  0/905 (0.00%)  0/424 (0.00%) 
Osteoarthritis  1  1/959 (0.10%)  0/477 (0.00%)  0/905 (0.00%)  0/424 (0.00%) 
Osteonecrosis  1  1/959 (0.10%)  0/477 (0.00%)  0/905 (0.00%)  0/424 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)         
Bladder cancer  1  0/959 (0.00%)  0/477 (0.00%)  1/905 (0.11%)  0/424 (0.00%) 
Bone cancer metastatic  1  0/959 (0.00%)  0/477 (0.00%)  1/905 (0.11%)  0/424 (0.00%) 
Hodgkin's disease  1  1/959 (0.10%)  1/477 (0.21%)  0/905 (0.00%)  0/424 (0.00%) 
Lung adenocarcinoma stage IV  1  1/959 (0.10%)  0/477 (0.00%)  0/905 (0.00%)  0/424 (0.00%) 
Non-small cell lung cancer  1  1/959 (0.10%)  0/477 (0.00%)  0/905 (0.00%)  0/424 (0.00%) 
Prostate cancer  1  1/959 (0.10%)  0/477 (0.00%)  0/905 (0.00%)  0/424 (0.00%) 
Rectal cancer  1  0/959 (0.00%)  0/477 (0.00%)  1/905 (0.11%)  0/424 (0.00%) 
Squamous cell carcinoma of the tongue  1  0/959 (0.00%)  0/477 (0.00%)  1/905 (0.11%)  0/424 (0.00%) 
Tonsil cancer  1  1/959 (0.10%)  0/477 (0.00%)  0/905 (0.00%)  0/424 (0.00%) 
Nervous system disorders         
Ataxia  1  1/959 (0.10%)  0/477 (0.00%)  0/905 (0.00%)  0/424 (0.00%) 
Cauda equina syndrome  1  1/959 (0.10%)  0/477 (0.00%)  0/905 (0.00%)  0/424 (0.00%) 
Cerebral haemorrhage  1  1/959 (0.10%)  0/477 (0.00%)  0/905 (0.00%)  0/424 (0.00%) 
Dizziness  1  0/959 (0.00%)  0/477 (0.00%)  0/905 (0.00%)  1/424 (0.24%) 
Embolic stroke  1  0/959 (0.00%)  1/477 (0.21%)  0/905 (0.00%)  0/424 (0.00%) 
Febrile convulsion  1  1/959 (0.10%)  0/477 (0.00%)  0/905 (0.00%)  0/424 (0.00%) 
Guillain-Barre syndrome  1  1/959 (0.10%)  0/477 (0.00%)  1/905 (0.11%)  0/424 (0.00%) 
Haemorrhagic stroke  1  1/959 (0.10%)  0/477 (0.00%)  0/905 (0.00%)  0/424 (0.00%) 
Headache  1  1/959 (0.10%)  1/477 (0.21%)  0/905 (0.00%)  1/424 (0.24%) 
Memory impairment  1  1/959 (0.10%)  0/477 (0.00%)  0/905 (0.00%)  0/424 (0.00%) 
Migraine  1  1/959 (0.10%)  0/477 (0.00%)  0/905 (0.00%)  0/424 (0.00%) 
Seizure  1  2/959 (0.21%)  0/477 (0.00%)  0/905 (0.00%)  0/424 (0.00%) 
Tension headache  1  0/959 (0.00%)  0/477 (0.00%)  1/905 (0.11%)  0/424 (0.00%) 
Transient ischaemic attack  1  0/959 (0.00%)  1/477 (0.21%)  0/905 (0.00%)  0/424 (0.00%) 
Pregnancy, puerperium and perinatal conditions         
Abortion spontaneous  1  1/959 (0.10%)  0/477 (0.00%)  1/905 (0.11%)  0/424 (0.00%) 
Product Issues         
Device breakage  1  0/959 (0.00%)  0/477 (0.00%)  0/905 (0.00%)  1/424 (0.24%) 
Psychiatric disorders         
Acute psychosis  1  1/959 (0.10%)  0/477 (0.00%)  0/905 (0.00%)  0/424 (0.00%) 
Alcohol abuse  1  1/959 (0.10%)  0/477 (0.00%)  0/905 (0.00%)  0/424 (0.00%) 
Bipolar disorder  1  0/959 (0.00%)  0/477 (0.00%)  1/905 (0.11%)  0/424 (0.00%) 
Depression  1  0/959 (0.00%)  2/477 (0.42%)  0/905 (0.00%)  0/424 (0.00%) 
Drug abuse  1  0/959 (0.00%)  1/477 (0.21%)  0/905 (0.00%)  0/424 (0.00%) 
Hallucination  1  1/959 (0.10%)  0/477 (0.00%)  0/905 (0.00%)  0/424 (0.00%) 
Major depression  1  1/959 (0.10%)  0/477 (0.00%)  0/905 (0.00%)  0/424 (0.00%) 
Mental status changes  1  1/959 (0.10%)  0/477 (0.00%)  0/905 (0.00%)  0/424 (0.00%) 
Substance abuse  1  0/959 (0.00%)  1/477 (0.21%)  0/905 (0.00%)  0/424 (0.00%) 
Substance-induced psychotic disorder  1  2/959 (0.21%)  0/477 (0.00%)  0/905 (0.00%)  0/424 (0.00%) 
Suicidal behaviour  1  1/959 (0.10%)  0/477 (0.00%)  0/905 (0.00%)  0/424 (0.00%) 
Suicidal ideation  1  1/959 (0.10%)  0/477 (0.00%)  0/905 (0.00%)  0/424 (0.00%) 
Suicide attempt  1  4/959 (0.42%)  0/477 (0.00%)  0/905 (0.00%)  0/424 (0.00%) 
Renal and urinary disorders         
Acute kidney injury  1  1/959 (0.10%)  2/477 (0.42%)  1/905 (0.11%)  0/424 (0.00%) 
Bladder disorder  1  1/959 (0.10%)  0/477 (0.00%)  0/905 (0.00%)  0/424 (0.00%) 
Fanconi syndrome acquired  1  0/959 (0.00%)  1/477 (0.21%)  0/905 (0.00%)  0/424 (0.00%) 
Nephrolithiasis  1  0/959 (0.00%)  0/477 (0.00%)  0/905 (0.00%)  1/424 (0.24%) 
Renal colic  1  0/959 (0.00%)  0/477 (0.00%)  1/905 (0.11%)  0/424 (0.00%) 
Reproductive system and breast disorders         
Metrorrhagia  1  1/959 (0.10%)  0/477 (0.00%)  0/905 (0.00%)  0/424 (0.00%) 
Prostatitis  1  0/959 (0.00%)  1/477 (0.21%)  0/905 (0.00%)  1/424 (0.24%) 
Respiratory, thoracic and mediastinal disorders         
Asthma  1  0/959 (0.00%)  1/477 (0.21%)  0/905 (0.00%)  1/424 (0.24%) 
Chronic obstructive pulmonary disease  1  1/959 (0.10%)  0/477 (0.00%)  0/905 (0.00%)  0/424 (0.00%) 
Dyspnoea  1  2/959 (0.21%)  0/477 (0.00%)  1/905 (0.11%)  1/424 (0.24%) 
Non-cardiogenic pulmonary oedema  1  1/959 (0.10%)  0/477 (0.00%)  0/905 (0.00%)  0/424 (0.00%) 
Pleuritic pain  1  0/959 (0.00%)  1/477 (0.21%)  0/905 (0.00%)  0/424 (0.00%) 
Pneumothorax  1  1/959 (0.10%)  0/477 (0.00%)  0/905 (0.00%)  0/424 (0.00%) 
Respiratory failure  1  1/959 (0.10%)  0/477 (0.00%)  0/905 (0.00%)  0/424 (0.00%) 
Skin and subcutaneous tissue disorders         
Subcutaneous emphysema  1  0/959 (0.00%)  1/477 (0.21%)  0/905 (0.00%)  0/424 (0.00%) 
Social circumstances         
Substance use  1  0/959 (0.00%)  1/477 (0.21%)  0/905 (0.00%)  0/424 (0.00%) 
Vascular disorders         
Hypertension  1  0/959 (0.00%)  1/477 (0.21%)  0/905 (0.00%)  0/424 (0.00%) 
Hypertensive crisis  1  0/959 (0.00%)  0/477 (0.00%)  1/905 (0.11%)  0/424 (0.00%) 
Hypotension  1  0/959 (0.00%)  1/477 (0.21%)  0/905 (0.00%)  0/424 (0.00%) 
1
Term from vocabulary, MedDRA (23.0)
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Randomized Phase: E/C/F/TAF Randomized Phase: Stay on Baseline Treatment Regimen (SBR) Extension Phase: E/C/F/TAF From E/C/F/TAF Extension Phase: E/C/F/TAF From SBR
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   620/959 (64.65%)   286/477 (59.96%)   298/905 (32.93%)   144/424 (33.96%) 
Gastrointestinal disorders         
Diarrhoea  1  109/959 (11.37%)  51/477 (10.69%)  40/905 (4.42%)  22/424 (5.19%) 
Nausea  1  56/959 (5.84%)  18/477 (3.77%)  8/905 (0.88%)  13/424 (3.07%) 
General disorders         
Pyrexia  1  48/959 (5.01%)  21/477 (4.40%)  7/905 (0.77%)  6/424 (1.42%) 
Infections and infestations         
Bronchitis  1  69/959 (7.19%)  26/477 (5.45%)  17/905 (1.88%)  13/424 (3.07%) 
Nasopharyngitis  1  96/959 (10.01%)  48/477 (10.06%)  47/905 (5.19%)  20/424 (4.72%) 
Pharyngitis  1  56/959 (5.84%)  14/477 (2.94%)  15/905 (1.66%)  5/424 (1.18%) 
Sinusitis  1  58/959 (6.05%)  31/477 (6.50%)  25/905 (2.76%)  9/424 (2.12%) 
Syphilis  1  63/959 (6.57%)  38/477 (7.97%)  19/905 (2.10%)  9/424 (2.12%) 
Upper respiratory tract infection  1  168/959 (17.52%)  64/477 (13.42%)  67/905 (7.40%)  26/424 (6.13%) 
Musculoskeletal and connective tissue disorders         
Arthralgia  1  78/959 (8.13%)  31/477 (6.50%)  19/905 (2.10%)  8/424 (1.89%) 
Back pain  1  70/959 (7.30%)  33/477 (6.92%)  30/905 (3.31%)  9/424 (2.12%) 
Osteopenia  1  67/959 (6.99%)  25/477 (5.24%)  28/905 (3.09%)  13/424 (3.07%) 
Nervous system disorders         
Headache  1  83/959 (8.65%)  25/477 (5.24%)  18/905 (1.99%)  9/424 (2.12%) 
Psychiatric disorders         
Depression  1  48/959 (5.01%)  30/477 (6.29%)  15/905 (1.66%)  7/424 (1.65%) 
Insomnia  1  58/959 (6.05%)  36/477 (7.55%)  12/905 (1.33%)  8/424 (1.89%) 
Respiratory, thoracic and mediastinal disorders         
Cough  1  73/959 (7.61%)  31/477 (6.50%)  28/905 (3.09%)  13/424 (3.07%) 
Oropharyngeal pain  1  57/959 (5.94%)  12/477 (2.52%)  10/905 (1.10%)  7/424 (1.65%) 
1
Term from vocabulary, MedDRA (23.0)
Indicates events were collected by systematic assessment
There were no limitations affecting the analysis or results.
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 of Results:
Brown T, Yin MT, Gupta S, Katlama C, et al. Switching from TDF to TAF in HIV-infected adults with low BMD: a pooled analysis. 24th Annual Conference on Retroviruses and Opportunistic Infections (CROI) - CROI Foundation 2017; poster presentation: abstract #683.
Podzamczer D, Viciana P, Rijnders B, Shalit P, et al. Switching from Tenofovir disoproxil fumarate to tenofovir alafenamide in patients with high risk for chronic kidney disease. 8th National Congress of the AIDS Study Group (GESIDA) and Spanish Society of Infectious Diseases and Clinical Microbiology (SEIMC) held jointly with the 9th Teacher Meeting of AIDS Research Network 2016; poster presentation: abstract #P-188.
Orkin C, Rjinders B, Stephan C, McKellar M, et al. Switching from boosted atazanavir (ATV) plus FTC/TDF to a TAF-based single tablet regimen (STR): Week 48 data in virologically suppressed adults. Annual Conference of the British Association for Sexual Health and HIV (BASHH) 2016; poster presentation: abstract # P045.
Mills A, Andrade J, Koenig E, et al. Switching from a tenofovir disoproxil fumarate (TDF)-based regimen to a tenofovir alafenamide (TAF)-based regimen: data in virologically suppressed adults through 48 weeks of treatment. 13th Congress for Infectious Diseases and Tropical Medicine (KIT) 2016; poster presentation: abstract #eP-038.
Overton ET, Shalit P, Crofoot G, Benson P, et al. Switch from TDF regimens to E/C/F/TAF is associated with improved bone mineral density (BMD), decreased serum PTH and decreased bone turnover biomarkers. 56th Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC) held Jointly with the 2016 Annual Meeting on Microbe - American Society for Microbiology (ASM) 2016; poster presentation: abstract #PW-027.
Huhn G, Rijnders B, Thompson M, Tebas P, et al. Switching from TDF to TAF in patients with high risk for CKD. 56th Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC) held Jointly with the 2016 Annual Meeting on Microbe - American Society for Microbiology (ASM) 2016; oral presentation: https://www.natap.org/2016/HIV/062116_01.htm.
Abram M, Margot NA, Cox S, Ram RR, et al. Pooled week-48 analysis of HIV-1 drug resistance in E/C/F/TAF (Genvoya) phase 3 studies. 23rd Annual Conference on Retroviruses and Opportunistic Infections (CROI) - CROI Foundation 2016, poster presentation: abstract #496.
Abram M, Margot NA, Cox S, Ram RR, et al. Pooled week-48 analysis of HIV-1 drug resistance in E/C/F/TAF (Genvoya) phase 3 studies. 25th International HIV Drug Resistance Workshop - Informed Horizons, LLC 2016; poster presentation: abstract #33.
Mills A, Andrade J, Di Perri G, Van Lunzen J, et al. Switching from a tenofovir disoproxil fumarate (TDF)-based regimen to a tenofovir alafenamide (TAF)-based regimen: data in virologically suppressed adults through 48 weeks of treatment. 8th Biennial Conference on HIV Pathogenesis and Treatment and Prevention of the International AIDS Society (IAS) 2015; oral presentation: abstract #TUAB0102.
Shamblaw D, Van Lunzen J, Orkin C, Bloch M, eta al. Switching from Atripla (ATR) to a tenofovir alafenamide (TAF)-based single tablet regimen: week 48 data in virologically suppressed adults. 55th Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC) 2015; oral presentation; https://natap.org/2015/ICAAC/ICAAC_13.htm.
Thompson M, Morales-Ramirez J, Mcdonald C, Rachlis A, et al. Switching from a tenofovir disoproxil fumarate (TDF) to a tenofovir alafenamide (TAF)-based single tablet regimen (STR): Week 48 data in HIV-1 infected virologically suppressed adults. Spring Conference of the Society for Healthcare Epidemiology of America (SHEA) 2015; oral presentation: abstract #725.
Rijnders B, Stephan C, Lazzarin A, Squires K, et al. Switching from ritonavir or cobicistat boosted atazanavir (ATV) plus emtricitabine (FTC)/tenofovir disoproxil fumarate (TDF) to a tenofovir alafenamide (TAF)-based single tablet regimen (STR): week 48 data in virologically suppressed adults. 15th European AIDS Conference (EACS) and 17th International Workshop on Co-morbidities and Adverse Drug Reactions in HIV 2015; poster presentation: abstract #577.
Lutz T, Benson P, Goffard J-C, Haubrich R, et al. Patient reported outcomes (PRO) over 48 weeks in a randomized, open-label trial of patients with HIV switching to coformulated elvitegravir, cobicistat, emtricitabine, and tenofovir alafenamide (E/C/F/TAF). 15th European AIDS Conference (EACS) and 17th International Workshop on Co-morbidities and Adverse Drug Reactions in HIV 2015; poster presentation: abstract #324.
Viciana P, Mills A, Andrade J, Diperri G, et al. Switching from a tenofovir disoproxil fumarate (TDF)-based regimen to a tenofovir alafenamide (TAF)-based regimen: data in virologically suppressed adults through 48 weeks of treatment. 7th National Congress of the AIDS Study Group (GESIDA) and Spanish Society of Infectious Diseases and Clinical Microbiology (SEIMC) held jointly with the 8th Teacher Meeting of AIDS Research Network 2015; oral presentation: abstract #PO-08.
Mills A, Andrade-Villanueva J, DiPerri G, Van Luzen J, et al. Switching from a tenofovir disoproxil fumarate (TDF)-based regimen to a tenofovir alafenamide (TAF)-based regimen: Data in virologically suppressed adults through 48 weeks of treatment. 8th Annual International AIDS Society meeting 2015; oral presentation: abstract #839.
Thompson M, Brar I, Brinson C, Creticos C, et al. Tenofovir alafenamide vs tenofovir DF in women: pooled analysis of 7 clinical trials. Annual Meeting of the American Pharmacists Association (APhA) - Virtual 2020; poster presentation: abstract #209.
Stellbrink H, Gandhi-Patel B, Zhong L, Das M, et al. Safety and efficacy of switching from tenofovir disoproxil fumarate to tenofovir alafenamide in people with HIV aged 50 years and older. Annual Meeting of the American Pharmacists Association (APhA) - Virtual 2020; poster presentation: abstract #205.
Stellbrink H-J, Post FA, Podzamczer D, Arribas J, et al. Safety and efficacy of switching from tenofovir disoproxil fumarate to tenofovir alafenamide in people with HIV aged 50 years and older. 15th Congress on Infectious Diseases and Tropical Medicine - German Society for Infectious Diseases (DPID) held jointly with the 29th Annual Meeting of the German Society for Pediatric Infectiology (DGPI) 2020; poster presentation: abstract #A-343.
Stellbrink H-J, Post FA, Podzamczer D, Arribas J, et al. Safety and efficacy of switching from tenofovir disoproxil fumarate to tenofovir alafenamide in people with HIV aged 50 years and older. 17th European AIDS Conference of the European AIDS Clinical Society (EACS) 2019; poster presentation: abstract #PE9-50.
Pepperrell T, Hughes S, Gotham D, Pozniak A, et al. Tenofovir alafenamide versus tenofovir disoproxil fumarate - is there a true difference in safety? 17th European AIDS Conference of the European AIDS Clinical Society (EACS) 2019; poster presentation: abstract #PE3-8.
Thompson M, Brar I, Brinson C, Creticos C, et al. Tenofovir alafenamide vs. tenofovir DF in women: pooled analysis of 7 clinical trials. 9th Edition International Workshop on HIV and Women - Virology Education 2019; poster presentation: abstract #21.
Dejesus E, Federico Andrade Villanueva J, Ramon Arribas Lopez J, Brinson C, et al. Tenofovir alafenamide (TAF) versus tenofovir disoproxil fumarate (TDF) in hispanic/latinx and black participants: efficacy, bone and renal safety results from a pooled analysis of 7 clinical trials. IDWeek Meeting of the Infectious Diseases Society of America (IDSA) 2019; poster presentation: abstract #318.
Walmsley S, Andany N, Brar I, Brinson C, et al. Tenofovir alafenamide VS tenofovir DF in women: pooled analysis of 7 clinical trials. 28th Annual Canadian Conference on HIV/AIDS Research - Canadian Association for HIV Research (CAHR) 2019; poster presentation: abstract #CSP9.04.
Hermansson L, Price RW, Yilmaz A, Nilsson S, et al. Effect on plasma NFL, a marker or neuronal injury, after switching from TDF to TAF. Annual Conference on Retroviruses and Opportunistic Infections (CROI) - CROI Foundation 2019; oral presentation: abstract #127.
Thompson M, Brar I, Brinson C, Creticos C, et al. Tenofovir alafenamide VS tenofovir DF in women: pooled analysis of 7 clinical trials. Annual Conference on Retroviruses and Opportunistic Infections (CROI) - CROI Foundation 2019; poster presentation: abstract #519.
Orkin C, Castelli F, Yazdanpanah Y, Rockstroh J, et al. Cardiovascular disease risk assessments and fasting lipid changes in virologically suppressed patients randomized to switch to tenofovir alafenamide versus continuing tenofovir disoproxil fumarate. 22nd International AIDS Conference - International AIDS Society 2018; poster presentation: abstract #TUPEB104.
Brown TT, Yin MT, Gupta SK, Short WR, et al. Combined effects of bisphosphonates & TDF->TAF switch in HIV+ adults with low BMD. Annual Conference on Retroviruses and Opportunistic Infections (CROI) - CROI Foundation 2018; poster presentation: abstract #724.
Goldstein D, Ward D, Brinson C, Crofoot G, et al. Week 96 efficacy and safety of tenofovir alafenamide (TAF) versus tenofovir disoproxil fumarate (TDF) in older, HIV-Infected virologically-suppressed adults. Annual Meeting of the American Geriatrics Society (AGS) 2017; poster presentation: abstract #A90.
Ward D, Thompson M, Goldstein D, Brinson C, et al. Week 96 efficacy and safety of tenofovir alafenamide (TAF) versus tenofovir disoproxil fumarate (TDF) in older, HIV-infected treatment-naïve adults. Annual Meeting of the American Geriatrics Society (AGS) 2017; poster presentation: abstract #A91.
Choe S, Podzamvzer D, Tashima K, McNicholl I, and McCallister S. Utilizing phase 3 clinical trial data to assess adverse event (AE) frequency of a potentially interacting medication (PIM) amlodipine with elvitegravir/cobicistat (EVG/COBI). Midyear Clinical Meeting of the American Society of Health-System Pharmacists (ASHP) 2017; poster presentation: abstract #7-068.
Yin M, Gupta S, Nguyen-Cleary T, Mora M, and Das M. Switching from TDF to TAF in HIV-infected adults with low BMD: A pooled analysis. Congress on HIV and Hepatitis in the Americas - ViiV Healthcare UK Limited 2017; poster presentation: abstract #P021.
Podzamczer D, Tashima K, Daar E, McGowan J, et al. Utilizing phase 3 clinical trial data to assess adverse event (AE) frequency of a potentially interacting medication (PIM) amlodipine with elvitegravir/cobicistat (EVG/COBI). International Congress of Drug Therapy in HIV Infection - International AIDS Society 2016; poster presentation: abstract #P314.
Dejesus E, Haas B, Segal-Maurer S, Ramgopal M, et al. Superior efficacy and improved renal and bone safety after switching from a tenofovir disoproxil fumarate (TDF) regimen to a tenofovir alafenamide (TAF) based regimen through 96 weeks (W96) of treatment. 56th Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC) held Jointly with the 2016 Annual Meeting on Microbe - American Society for Microbiology (ASM) 2016; poster presentation: abstract # LB-087.
Viciana P, Rijnders B, Shalit P, Liu Y et al. Cambio desde TDF a TAF en pacientes en alto riesgo de erc. 18th Congress of the Andalusian Society of Infectious Diseases (SAID) 2016; poster presentation: abstract #P-070.
Layout table for additonal information
Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT01815736    
Other Study ID Numbers: GS-US-292-0109
2012-005114-20 ( EudraCT Number )
First Submitted: March 19, 2013
First Posted: March 21, 2013
Results First Submitted: March 15, 2016
Results First Posted: April 14, 2016
Last Update Posted: April 13, 2021