Trial Outcomes & Findings for Switching From a Tenofovir Disoproxil Fumarate (TDF) Containing Regimen to Elvitegravir/Cobicistat/Emtricitabine/ Tenofovir Alafenamide (E/C/F/TAF) Fixed-Dose Combination (FDC) in Virologically-Suppressed, HIV-1 Infected Adults Aged ≥ 60 Years (NCT NCT02616783)
NCT ID: NCT02616783
Last Updated: 2020-03-04
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
167 participants
Primary outcome timeframe
Baseline; Week 48
Results posted on
2020-03-04
Participant Flow
Participants were enrolled at study sites in Europe. The first participant was screened on 22 December 2015. The last study visit occurred on 21 March 2018.
214 participants were screened.
Participant milestones
| Measure |
E/C/F/TAF
Participants switched from tenofovir disoproxil fumarate (TDF) and emtricitabine (FTC) or 3TC plus a third agent to elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) (150/150/200/10 mg) fixed-dose combination (FDC) tablet once daily for 48 weeks.
|
Stay on Baseline Regimen
Participants stayed on current regimen of TDF and FTC (or FTC/TDF) or 3TC plus continuing third agent for 48 weeks.
|
|---|---|---|
|
Overall Study
STARTED
|
111
|
56
|
|
Overall Study
COMPLETED
|
105
|
54
|
|
Overall Study
NOT COMPLETED
|
6
|
2
|
Reasons for withdrawal
| Measure |
E/C/F/TAF
Participants switched from tenofovir disoproxil fumarate (TDF) and emtricitabine (FTC) or 3TC plus a third agent to elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) (150/150/200/10 mg) fixed-dose combination (FDC) tablet once daily for 48 weeks.
|
Stay on Baseline Regimen
Participants stayed on current regimen of TDF and FTC (or FTC/TDF) or 3TC plus continuing third agent for 48 weeks.
|
|---|---|---|
|
Overall Study
Randomized but Not Treated
|
1
|
0
|
|
Overall Study
Adverse Event
|
1
|
0
|
|
Overall Study
Death
|
1
|
0
|
|
Overall Study
Non-Compliance with Study Drug
|
1
|
0
|
|
Overall Study
Protocol Violation
|
1
|
1
|
|
Overall Study
Withdrew Consent
|
1
|
1
|
Baseline Characteristics
The Spine Dual-Energy X-ray Absorptiometry (DXA) Analysis Set included all participants who were randomized into the study, received at least 1 dose of study drug, had non missing screening spine BMD values, and did not have any major protocol violations.
Baseline characteristics by cohort
| Measure |
E/C/F/TAF
n=110 Participants
Participants switched from TDF and FTC or 3TC plus a third agent to E/C/F/TAF (150/150/200/10 mg) FDC tablet once daily for 48 weeks.
|
Stay on Baseline Regimen
n=56 Participants
Participants stayed on current regimen of TDF and FTC (or FTC/TDF) or 3TC plus continuing third agent for 48 weeks.
|
Total
n=166 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
65 Years
STANDARD_DEVIATION 4.6 • n=110 Participants
|
66 Years
STANDARD_DEVIATION 4.9 • n=56 Participants
|
66 Years
STANDARD_DEVIATION 4.7 • n=166 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=110 Participants
|
5 Participants
n=56 Participants
|
19 Participants
n=166 Participants
|
|
Sex: Female, Male
Male
|
96 Participants
n=110 Participants
|
51 Participants
n=56 Participants
|
147 Participants
n=166 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
16 Participants
n=110 Participants
|
8 Participants
n=56 Participants
|
24 Participants
n=166 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
88 Participants
n=110 Participants
|
42 Participants
n=56 Participants
|
130 Participants
n=166 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
6 Participants
n=110 Participants
|
6 Participants
n=56 Participants
|
12 Participants
n=166 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
0 Participants
n=110 Participants
|
1 Participants
n=56 Participants
|
1 Participants
n=166 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
2 Participants
n=110 Participants
|
2 Participants
n=56 Participants
|
4 Participants
n=166 Participants
|
|
Race/Ethnicity, Customized
White
|
103 Participants
n=110 Participants
|
49 Participants
n=56 Participants
|
152 Participants
n=166 Participants
|
|
Race/Ethnicity, Customized
Not Permitted
|
5 Participants
n=110 Participants
|
4 Participants
n=56 Participants
|
9 Participants
n=166 Participants
|
|
Region of Enrollment
Belgium
|
8 Participants
n=110 Participants
|
1 Participants
n=56 Participants
|
9 Participants
n=166 Participants
|
|
Region of Enrollment
Italy
|
36 Participants
n=110 Participants
|
15 Participants
n=56 Participants
|
51 Participants
n=166 Participants
|
|
Region of Enrollment
United Kingdom
|
8 Participants
n=110 Participants
|
3 Participants
n=56 Participants
|
11 Participants
n=166 Participants
|
|
Region of Enrollment
France
|
29 Participants
n=110 Participants
|
23 Participants
n=56 Participants
|
52 Participants
n=166 Participants
|
|
Region of Enrollment
Spain
|
29 Participants
n=110 Participants
|
14 Participants
n=56 Participants
|
43 Participants
n=166 Participants
|
|
HIV-1 RNA Category
< 50 copies/mL
|
109 Participants
n=110 Participants
|
56 Participants
n=56 Participants
|
165 Participants
n=166 Participants
|
|
HIV-1 RNA Category
≥ 50 copies/mL
|
1 Participants
n=110 Participants
|
0 Participants
n=56 Participants
|
1 Participants
n=166 Participants
|
|
CD4+ Cell Count
|
649 cells/µL
STANDARD_DEVIATION 255.6 • n=110 Participants
|
676 cells/µL
STANDARD_DEVIATION 316.5 • n=56 Participants
|
658 cells/µL
STANDARD_DEVIATION 277.0 • n=166 Participants
|
|
CD4+ Cell Count Category
≥ 50 to < 200 cells/µL
|
0 Participants
n=110 Participants
|
2 Participants
n=56 Participants
|
2 Participants
n=166 Participants
|
|
CD4+ Cell Count Category
≥ 200 to < 350 cells/µL
|
12 Participants
n=110 Participants
|
8 Participants
n=56 Participants
|
20 Participants
n=166 Participants
|
|
CD4+ Cell Count Category
≥ 350 to < 500 cells/µL
|
18 Participants
n=110 Participants
|
7 Participants
n=56 Participants
|
25 Participants
n=166 Participants
|
|
CD4+ Cell Count Category
≥ 500 cells/µL
|
80 Participants
n=110 Participants
|
39 Participants
n=56 Participants
|
119 Participants
n=166 Participants
|
|
Spine Bone Mineral Density (BMD)
|
1.036 g/cm^2
STANDARD_DEVIATION 0.1886 • n=109 Participants • The Spine Dual-Energy X-ray Absorptiometry (DXA) Analysis Set included all participants who were randomized into the study, received at least 1 dose of study drug, had non missing screening spine BMD values, and did not have any major protocol violations.
|
1.052 g/cm^2
STANDARD_DEVIATION 0.1789 • n=55 Participants • The Spine Dual-Energy X-ray Absorptiometry (DXA) Analysis Set included all participants who were randomized into the study, received at least 1 dose of study drug, had non missing screening spine BMD values, and did not have any major protocol violations.
|
1.042 g/cm^2
STANDARD_DEVIATION 0.1850 • n=164 Participants • The Spine Dual-Energy X-ray Absorptiometry (DXA) Analysis Set included all participants who were randomized into the study, received at least 1 dose of study drug, had non missing screening spine BMD values, and did not have any major protocol violations.
|
|
Hip BMD
|
0.922 g/cm^2
STANDARD_DEVIATION 0.1332 • n=109 Participants • The Hip DXA Analysis Set included all participants who were randomized into the study, received at least 1 dose of study drug, had non missing screening hip BMD values, and did not have any major protocol violations.
|
0.927 g/cm^2
STANDARD_DEVIATION 0.1346 • n=55 Participants • The Hip DXA Analysis Set included all participants who were randomized into the study, received at least 1 dose of study drug, had non missing screening hip BMD values, and did not have any major protocol violations.
|
0.924 g/cm^2
STANDARD_DEVIATION 0.1332 • n=164 Participants • The Hip DXA Analysis Set included all participants who were randomized into the study, received at least 1 dose of study drug, had non missing screening hip BMD values, and did not have any major protocol violations.
|
PRIMARY outcome
Timeframe: Baseline; Week 48Population: Participants in the Spine DXA Analysis Set with available data were analyzed.
Outcome measures
| Measure |
E/C/F/TAF
n=102 Participants
Participants switched from TDF and FTC or 3TC plus a third agent to E/C/F/TAF (150/150/200/10 mg) FDC tablet once daily for 48 weeks.
|
Stay on Baseline Regimen
n=54 Participants
Participants stayed on current regimen of TDF and FTC (or FTC/TDF) or 3TC plus continuing third agent for 48 weeks.
|
|---|---|---|
|
Percent Change From Baseline to Week 48 in Spine BMD
|
2.237 Percent change
Standard Deviation 3.2727
|
-0.104 Percent change
Standard Deviation 3.3854
|
PRIMARY outcome
Timeframe: Baseline; Week 48Population: Participants in the Hip DXA Analysis Set with available data were analyzed.
Outcome measures
| Measure |
E/C/F/TAF
n=101 Participants
Participants switched from TDF and FTC or 3TC plus a third agent to E/C/F/TAF (150/150/200/10 mg) FDC tablet once daily for 48 weeks.
|
Stay on Baseline Regimen
n=54 Participants
Participants stayed on current regimen of TDF and FTC (or FTC/TDF) or 3TC plus continuing third agent for 48 weeks.
|
|---|---|---|
|
Percent Change From Baseline to Week 48 in Hip BMD
|
1.330 Percent change
Standard Deviation 2.1968
|
-0.726 Percent change
Standard Deviation 3.2069
|
SECONDARY outcome
Timeframe: Baseline; Week 24Population: Participants in the Spine DXA Analysis Set with available data were analyzed.
Outcome measures
| Measure |
E/C/F/TAF
n=104 Participants
Participants switched from TDF and FTC or 3TC plus a third agent to E/C/F/TAF (150/150/200/10 mg) FDC tablet once daily for 48 weeks.
|
Stay on Baseline Regimen
n=54 Participants
Participants stayed on current regimen of TDF and FTC (or FTC/TDF) or 3TC plus continuing third agent for 48 weeks.
|
|---|---|---|
|
Percent Change From Baseline to Week 24 in Spine BMD
|
1.625 Percent change
Standard Deviation 3.2346
|
-0.027 Percent change
Standard Deviation 2.9875
|
SECONDARY outcome
Timeframe: Baseline; Week 24Population: Participants in the Hip DXA Analysis Set with available data were analyzed.
Outcome measures
| Measure |
E/C/F/TAF
n=103 Participants
Participants switched from TDF and FTC or 3TC plus a third agent to E/C/F/TAF (150/150/200/10 mg) FDC tablet once daily for 48 weeks.
|
Stay on Baseline Regimen
n=54 Participants
Participants stayed on current regimen of TDF and FTC (or FTC/TDF) or 3TC plus continuing third agent for 48 weeks.
|
|---|---|---|
|
Percent Change From Baseline to Week 24 in Hip BMD
|
0.808 Percent change
Standard Deviation 1.9084
|
-0.537 Percent change
Standard Deviation 2.7647
|
SECONDARY outcome
Timeframe: Week 24Population: Full Analysis Set included all participants who were randomized into the study, received at least 1 dose of study drug, and did not have any major protocol violations.
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
| Measure |
E/C/F/TAF
n=109 Participants
Participants switched from TDF and FTC or 3TC plus a third agent to E/C/F/TAF (150/150/200/10 mg) FDC tablet once daily for 48 weeks.
|
Stay on Baseline Regimen
n=55 Participants
Participants stayed on current regimen of TDF and FTC (or FTC/TDF) or 3TC plus continuing third agent for 48 weeks.
|
|---|---|---|
|
Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 24 as Defined by the US FDA-Defined Snapshot Algorithm
|
94.5 Percentage of participants
|
100.0 Percentage of participants
|
SECONDARY outcome
Timeframe: Week 48Population: Full Analysis Set included all participants who were randomized into the study, received at least 1 dose of study drug, and did not have any major protocol violations.
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
| Measure |
E/C/F/TAF
n=109 Participants
Participants switched from TDF and FTC or 3TC plus a third agent to E/C/F/TAF (150/150/200/10 mg) FDC tablet once daily for 48 weeks.
|
Stay on Baseline Regimen
n=55 Participants
Participants stayed on current regimen of TDF and FTC (or FTC/TDF) or 3TC plus continuing third agent for 48 weeks.
|
|---|---|---|
|
Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 48 as Defined by the US FDA-Defined Snapshot Algorithm
|
93.6 Percentage of participants
|
94.5 Percentage of participants
|
SECONDARY outcome
Timeframe: Baseline; Week 24Population: Participants in the Full Analysis Set with available data were analyzed.
Outcome measures
| Measure |
E/C/F/TAF
n=99 Participants
Participants switched from TDF and FTC or 3TC plus a third agent to E/C/F/TAF (150/150/200/10 mg) FDC tablet once daily for 48 weeks.
|
Stay on Baseline Regimen
n=54 Participants
Participants stayed on current regimen of TDF and FTC (or FTC/TDF) or 3TC plus continuing third agent for 48 weeks.
|
|---|---|---|
|
Change From Baseline in CD4+ Cell Count at Week 24
|
48 cells/μL
Standard Deviation 161.9
|
-4 cells/μL
Standard Deviation 153.9
|
SECONDARY outcome
Timeframe: Baseline; Week 48Population: Participants in the Full Analysis Set with available data were analyzed.
Outcome measures
| Measure |
E/C/F/TAF
n=102 Participants
Participants switched from TDF and FTC or 3TC plus a third agent to E/C/F/TAF (150/150/200/10 mg) FDC tablet once daily for 48 weeks.
|
Stay on Baseline Regimen
n=50 Participants
Participants stayed on current regimen of TDF and FTC (or FTC/TDF) or 3TC plus continuing third agent for 48 weeks.
|
|---|---|---|
|
Change in Baseline in CD4+ Cell Count at Week 48
|
56 cells/μL
Standard Deviation 177.7
|
-1 cells/μL
Standard Deviation 149.1
|
Adverse Events
E/C/F/TAF
Serious events: 10 serious events
Other events: 47 other events
Deaths: 1 deaths
Stay on Baseline Regimen
Serious events: 1 serious events
Other events: 20 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
E/C/F/TAF
n=110 participants at risk
Participants switched from TDF and FTC or 3TC plus a third agent to E/C/F/TAF (150/150/200/10 mg) FDC tablet once daily for 48 weeks.
|
Stay on Baseline Regimen
n=56 participants at risk
Participants stayed on current regimen of TDF and FTC (or FTC/TDF) or 3TC plus continuing third agent for 48 weeks.
|
|---|---|---|
|
Cardiac disorders
Acute coronary syndrome
|
0.91%
1/110 • Up to 48 weeks plus 30 days
Safety Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
1.8%
1/56 • Up to 48 weeks plus 30 days
Safety Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
|
Cardiac disorders
Cardiac arrest
|
0.91%
1/110 • Up to 48 weeks plus 30 days
Safety Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
0.00%
0/56 • Up to 48 weeks plus 30 days
Safety Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.91%
1/110 • Up to 48 weeks plus 30 days
Safety Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
0.00%
0/56 • Up to 48 weeks plus 30 days
Safety Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
|
Infections and infestations
Escherichia sepsis
|
0.91%
1/110 • Up to 48 weeks plus 30 days
Safety Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
0.00%
0/56 • Up to 48 weeks plus 30 days
Safety Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
|
Infections and infestations
Pneumonia
|
0.91%
1/110 • Up to 48 weeks plus 30 days
Safety Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
0.00%
0/56 • Up to 48 weeks plus 30 days
Safety Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
|
Infections and infestations
Sepsis
|
0.91%
1/110 • Up to 48 weeks plus 30 days
Safety Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
0.00%
0/56 • Up to 48 weeks plus 30 days
Safety Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.91%
1/110 • Up to 48 weeks plus 30 days
Safety Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
0.00%
0/56 • Up to 48 weeks plus 30 days
Safety Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
0.91%
1/110 • Up to 48 weeks plus 30 days
Safety Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
0.00%
0/56 • Up to 48 weeks plus 30 days
Safety Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis
|
0.91%
1/110 • Up to 48 weeks plus 30 days
Safety Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
0.00%
0/56 • Up to 48 weeks plus 30 days
Safety Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colorectal cancer
|
0.91%
1/110 • Up to 48 weeks plus 30 days
Safety Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
0.00%
0/56 • Up to 48 weeks plus 30 days
Safety Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatocellular carcinoma
|
0.91%
1/110 • Up to 48 weeks plus 30 days
Safety Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
0.00%
0/56 • Up to 48 weeks plus 30 days
Safety Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
|
Nervous system disorders
Loss of consciousness
|
0.91%
1/110 • Up to 48 weeks plus 30 days
Safety Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
0.00%
0/56 • Up to 48 weeks plus 30 days
Safety Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
|
Nervous system disorders
Neuritis cranial
|
0.91%
1/110 • Up to 48 weeks plus 30 days
Safety Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
0.00%
0/56 • Up to 48 weeks plus 30 days
Safety Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
|
Nervous system disorders
Syncope
|
0.91%
1/110 • Up to 48 weeks plus 30 days
Safety Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
0.00%
0/56 • Up to 48 weeks plus 30 days
Safety Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.91%
1/110 • Up to 48 weeks plus 30 days
Safety Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
0.00%
0/56 • Up to 48 weeks plus 30 days
Safety Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
|
Renal and urinary disorders
Renal colic
|
0.91%
1/110 • Up to 48 weeks plus 30 days
Safety Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
0.00%
0/56 • Up to 48 weeks plus 30 days
Safety Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
|
Reproductive system and breast disorders
Prostatomegaly
|
0.91%
1/110 • Up to 48 weeks plus 30 days
Safety Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
0.00%
0/56 • Up to 48 weeks plus 30 days
Safety Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
Other adverse events
| Measure |
E/C/F/TAF
n=110 participants at risk
Participants switched from TDF and FTC or 3TC plus a third agent to E/C/F/TAF (150/150/200/10 mg) FDC tablet once daily for 48 weeks.
|
Stay on Baseline Regimen
n=56 participants at risk
Participants stayed on current regimen of TDF and FTC (or FTC/TDF) or 3TC plus continuing third agent for 48 weeks.
|
|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
7.3%
8/110 • Up to 48 weeks plus 30 days
Safety Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
3.6%
2/56 • Up to 48 weeks plus 30 days
Safety Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
|
Infections and infestations
Bronchitis
|
3.6%
4/110 • Up to 48 weeks plus 30 days
Safety Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
10.7%
6/56 • Up to 48 weeks plus 30 days
Safety Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
|
Infections and infestations
Nasopharyngitis
|
10.9%
12/110 • Up to 48 weeks plus 30 days
Safety Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
5.4%
3/56 • Up to 48 weeks plus 30 days
Safety Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
|
Infections and infestations
Urinary tract infection
|
3.6%
4/110 • Up to 48 weeks plus 30 days
Safety Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
5.4%
3/56 • Up to 48 weeks plus 30 days
Safety Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Vitamin D deficiency
|
6.4%
7/110 • Up to 48 weeks plus 30 days
Safety Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
7.1%
4/56 • Up to 48 weeks plus 30 days
Safety Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
5.5%
6/110 • Up to 48 weeks plus 30 days
Safety Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
7.1%
4/56 • Up to 48 weeks plus 30 days
Safety Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
8.2%
9/110 • Up to 48 weeks plus 30 days
Safety Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
3.6%
2/56 • Up to 48 weeks plus 30 days
Safety Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
5.5%
6/110 • Up to 48 weeks plus 30 days
Safety Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
0.00%
0/56 • Up to 48 weeks plus 30 days
Safety Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
|
Vascular disorders
Hypertension
|
6.4%
7/110 • Up to 48 weeks plus 30 days
Safety Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
1.8%
1/56 • Up to 48 weeks plus 30 days
Safety Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
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