Trial Outcomes & Findings for Study to Evaluate Switching From an E/C/F/TAF Fixed-Dose Combination (FDC) Regimen or a TDF Containing Regimen to B/F/TAF FDC in Human Immunodeficiency Virus-1 (HIV-1) Infected Participants Aged ≥ 65 Years (NCT NCT03405935)

NCT ID: NCT03405935

Last Updated: 2020-12-01

Results Overview

The percentage of participants with HIV-1 RNA \< 50 copies/mL at Week 24 was analyzed using the snapshot algorithm, which defined a participant's virologic response status using only the viral load at the predefined timepoint within an allowed window of time, along with study drug discontinuation status.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 86 participants
• Primary outcome timeframe: Week 24
• Results posted on: 2020-12-01

Participant Flow

Participants were enrolled at study sites in Europe. The first participant was screened on 01 March 2018. The last study visit occurred on 29 May 2020.

90 participants were screened.

Participant milestones

Measure	B/F/TAF Bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) (50/200/25 mg) fixed-dose combination (FDC) tablet once daily, without regard to food for at least 96 weeks.
Overall Study STARTED	86
Overall Study COMPLETED	78
Overall Study NOT COMPLETED	8

Reasons for withdrawal

Measure	B/F/TAF Bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) (50/200/25 mg) fixed-dose combination (FDC) tablet once daily, without regard to food for at least 96 weeks.
Overall Study Adverse Event	3
Overall Study Death	2
Overall Study Withdrawal by Subject	1
Overall Study Lost to Follow-up	2

Baseline Characteristics

Study to Evaluate Switching From an E/C/F/TAF Fixed-Dose Combination (FDC) Regimen or a TDF Containing Regimen to B/F/TAF FDC in Human Immunodeficiency Virus-1 (HIV-1) Infected Participants Aged ≥ 65 Years

Baseline characteristics by cohort

Measure	B/F/TAF n=86 Participants B/F/TAF (50/200/25 mg) FDC tablet once daily, without regard to food for at least 96 weeks.
Age, Continuous	70 years STANDARD_DEVIATION 3.8 • n=5 Participants
Sex: Female, Male Female	11 Participants n=5 Participants
Sex: Female, Male Male	75 Participants n=5 Participants
Race/Ethnicity, Customized Race · American Indian or Alaska Native	0 Participants n=5 Participants
Race/Ethnicity, Customized Race · Asian	0 Participants n=5 Participants
Race/Ethnicity, Customized Race · Black	1 Participants n=5 Participants
Race/Ethnicity, Customized Race · Native Hawaiian or Pacific Islander	0 Participants n=5 Participants
Race/Ethnicity, Customized Race · White	82 Participants n=5 Participants
Race/Ethnicity, Customized Race · Other	0 Participants n=5 Participants
Race/Ethnicity, Customized Race · Not Permitted	3 Participants n=5 Participants
Race/Ethnicity, Customized Ethnicity · Hispanic or Latino	12 Participants n=5 Participants
Race/Ethnicity, Customized Ethnicity · Not Hispanic or Latino	71 Participants n=5 Participants
Race/Ethnicity, Customized Ethnicity · Not Permitted	3 Participants n=5 Participants
Region of Enrollment Belgium	8 participants n=5 Participants
Region of Enrollment France	28 participants n=5 Participants
Region of Enrollment Italy	22 participants n=5 Participants
Region of Enrollment Spain	27 participants n=5 Participants
Region of Enrollment United Kingdom	1 participants n=5 Participants
Human Immunodeficiency Virus-1 Ribonucleic acid (HIV-1 RNA) Category < 50 copies/mL	84 Participants n=5 Participants
Human Immunodeficiency Virus-1 Ribonucleic acid (HIV-1 RNA) Category ≥ 50 copies/mL	2 Participants n=5 Participants
Cluster of Differentiation 4 (CD4) Cell Count	694 cells/µL STANDARD_DEVIATION 273.6 • n=5 Participants
CD4 Cell Count Category < 50 cells/µL	0 Participants n=5 Participants
CD4 Cell Count Category ≥ 50 to < 200 cells/µL	2 Participants n=5 Participants
CD4 Cell Count Category ≥ 200 to < 350 cells/µL	7 Participants n=5 Participants
CD4 Cell Count Category ≥ 350 to < 500 cells/µL	9 Participants n=5 Participants
CD4 Cell Count Category ≥ 500 cells/µL	68 Participants n=5 Participants
CD4 Percentage	33.4 percentage of lymphocytes STANDARD_DEVIATION 9.24 • n=5 Participants

PRIMARY outcome

Timeframe: Week 24

Population: The Full Analysis Set (FAS) included all participants who were enrolled and received at least 1 dose of study drug; and did not have major protocol violations.

The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 24 was analyzed using the snapshot algorithm, which defined a participant's virologic response status using only the viral load at the predefined timepoint within an allowed window of time, along with study drug discontinuation status.

Outcome measures

Measure	B/F/TAF n=86 Participants B/F/TAF (50/200/25 mg) FDC tablet once daily, without regard to food for at least 96 weeks.
Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 24 as Defined by the Food and Drug Administration (FDA)-Defined Snapshot Algorithm	97.7 percentage of participants

SECONDARY outcome

Timeframe: First dose date up to Week 24

Population: The Safety Analysis Set included all participants who were enrolled and received at least 1 dose of study drug.

An AE was any untoward medical occurrence in a clinical study participant administered a medicinal product, which did not necessarily have a causal relationship with the treatment. An AE can therefore be any unfavorable and/or unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. AEs may also included pre- or post-treatment complications that occurred as a result of protocol specified procedures, lack of efficacy, overdose, drug abuse/misuse reports, or occupational exposure. Preexisting events that increased in severity or changed in nature during or as a consequence of participation in the clinical study were also considered AEs.

Outcome measures

Measure	B/F/TAF n=86 Participants B/F/TAF (50/200/25 mg) FDC tablet once daily, without regard to food for at least 96 weeks.
Percentage of Participants Experiencing Adverse Events (AEs) Through Week 24	62.8 percentage of participants

SECONDARY outcome

Timeframe: First dose date Up to Week 48

Population: Participants in the Safety Analysis Set were analyzed.

An AE was any untoward medical occurrence in a clinical study participant administered a medicinal product, which did not necessarily have a causal relationship with the treatment. An AE can therefore be any unfavorable and/or unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. AEs may also included pre- or post-treatment complications that occurred as a result of protocol specified procedures, lack of efficacy, overdose, drug abuse/misuse reports, or occupational exposure. Preexisting events that increased in severity or changed in nature during or as a consequence of participation in the clinical study were also considered AEs.

Outcome measures

Measure	B/F/TAF n=86 Participants B/F/TAF (50/200/25 mg) FDC tablet once daily, without regard to food for at least 96 weeks.
Percentage of Participants Experiencing AEs Through Week 48	81.4 percentage of participants

SECONDARY outcome

Timeframe: First dose date Up to Week 72

Population: Participants in the Safety Analysis Set were analyzed.

An AE was any untoward medical occurrence in a clinical study participant administered a medicinal product, which did not necessarily have a causal relationship with the treatment. An AE can therefore be any unfavorable and/or unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. AEs may also included pre- or post-treatment complications that occurred as a result of protocol specified procedures, lack of efficacy, overdose, drug abuse/misuse reports, or occupational exposure. Preexisting events that increased in severity or changed in nature during or as a consequence of participation in the clinical study were also considered AEs.

Outcome measures

Measure	B/F/TAF n=86 Participants B/F/TAF (50/200/25 mg) FDC tablet once daily, without regard to food for at least 96 weeks.
Percentage of Participants Experiencing AEs Through Week 72	94.2 percentage of participants

SECONDARY outcome

Timeframe: First dose date Up to Week 96

Population: Participants in the Safety Analysis Set were analyzed.

An AE was any untoward medical occurrence in a clinical study participant administered a medicinal product, which did not necessarily have a causal relationship with the treatment. An AE can therefore be any unfavorable and/or unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. AEs may also included pre- or post-treatment complications that occurred as a result of protocol specified procedures, lack of efficacy, overdose, drug abuse/misuse reports, or occupational exposure. Preexisting events that increased in severity or changed in nature during or as a consequence of participation in the clinical study were also considered AEs.

Outcome measures

Measure	B/F/TAF n=86 Participants B/F/TAF (50/200/25 mg) FDC tablet once daily, without regard to food for at least 96 weeks.
Percentage of Participants Experiencing AEs Through Week 96	95.3 percentage of participants

SECONDARY outcome

Timeframe: Week 48

Population: Participants in the Full Analysis Set were analyzed.

The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 48 was analyzed using the snapshot algorithm, which defined a participant's virologic response status using only the viral load at the predefined timepoint within an allowed window of time, along with study drug discontinuation status.

Outcome measures

Measure	B/F/TAF n=86 Participants B/F/TAF (50/200/25 mg) FDC tablet once daily, without regard to food for at least 96 weeks.
Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 48 as Defined by the FDA-Defined Snapshot Algorithm	90.7 percentage of participants

SECONDARY outcome

Timeframe: Week 72

Population: Participants in the Full Analysis Set were analyzed.

The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 72 was analyzed using the snapshot algorithm, which defined a participant's virologic response status using only the viral load at the predefined timepoint within an allowed window of time, along with study drug discontinuation status.

Outcome measures

Measure	B/F/TAF n=86 Participants B/F/TAF (50/200/25 mg) FDC tablet once daily, without regard to food for at least 96 weeks.
Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 72 as Defined by the FDA-Defined Snapshot Algorithm	94.2 percentage of participants

SECONDARY outcome

Timeframe: Week 96

Population: Participants in the Full Analysis Set were analyzed.

The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 96 was analyzed using the snapshot algorithm, which defined a participant's virologic response status using only the viral load at the predefined timepoint within an allowed window of time, along with study drug discontinuation status.

Outcome measures

Measure	B/F/TAF n=86 Participants B/F/TAF (50/200/25 mg) FDC tablet once daily, without regard to food for at least 96 weeks.
Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 96 as Defined by the FDA-Defined Snapshot Algorithm	74.4 percentage of participants

SECONDARY outcome

Timeframe: Baseline, Week 24

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

Outcome measures

Measure	B/F/TAF n=84 Participants B/F/TAF (50/200/25 mg) FDC tablet once daily, without regard to food for at least 96 weeks.
Change From Baseline in CD4 Cell Count at Week 24	20 cells/µL Standard Deviation 141.8

SECONDARY outcome

Timeframe: Baseline, Week 48

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

Outcome measures

Measure	B/F/TAF n=76 Participants B/F/TAF (50/200/25 mg) FDC tablet once daily, without regard to food for at least 96 weeks.
Change From Baseline in CD4 Cell Count at Week 48	8 cells/µL Standard Deviation 174.8

SECONDARY outcome

Timeframe: Baseline, Week 72

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

Outcome measures

Measure	B/F/TAF n=78 Participants B/F/TAF (50/200/25 mg) FDC tablet once daily, without regard to food for at least 96 weeks.
Change From Baseline in CD4 Cell Count at Week 72	36 cells/µL Standard Deviation 145.7

SECONDARY outcome

Timeframe: Baseline, Week 96

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

Outcome measures

Measure	B/F/TAF n=59 Participants B/F/TAF (50/200/25 mg) FDC tablet once daily, without regard to food for at least 96 weeks.
Change From Baseline in CD4 Cell Count at Week 96	22 cells/µL Standard Deviation 150.9

SECONDARY outcome

Timeframe: Baseline, Week 24

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

Outcome measures

Measure	B/F/TAF n=84 Participants B/F/TAF (50/200/25 mg) FDC tablet once daily, without regard to food for at least 96 weeks.
Change From Baseline in CD4 Percentage at Week 24	0.1 percentage of lymphocytes Standard Deviation 3.52

SECONDARY outcome

Timeframe: Baseline, Week 48

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

Outcome measures

Measure	B/F/TAF n=76 Participants B/F/TAF (50/200/25 mg) FDC tablet once daily, without regard to food for at least 96 weeks.
Change From Baseline in CD4 Percentage at Week 48	0.1 percentage of lymphocytes Standard Deviation 3.89

SECONDARY outcome

Timeframe: Baseline, Week 72

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

Outcome measures

Measure	B/F/TAF n=78 Participants B/F/TAF (50/200/25 mg) FDC tablet once daily, without regard to food for at least 96 weeks.
Change From Baseline in CD4 Percentage at Week 72	-0.1 percentage of lymphocytes Standard Deviation 4.29

SECONDARY outcome

Timeframe: Baseline, Week 96

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

Outcome measures

Measure	B/F/TAF n=59 Participants B/F/TAF (50/200/25 mg) FDC tablet once daily, without regard to food for at least 96 weeks.
Change From Baseline in CD4 Percentage at Week 96	-0.1 percentage of lymphocytes Standard Deviation 4.34

SECONDARY outcome

Timeframe: Week 24

Population: Participants in the Full Analysis Set were analyzed.

The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 24 was analyzed using missing = failure approach. In this approach, all missing data were treated as HIV-1 RNA ≥ 50 copies/mL.

Outcome measures

Measure	B/F/TAF n=86 Participants B/F/TAF (50/200/25 mg) FDC tablet once daily, without regard to food for at least 96 weeks.
Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 24, as Analyzed by Missing = Failure Approach	97.7 percentage of participants

SECONDARY outcome

Timeframe: Week 48

Population: Participants in the Full Analysis Set were analyzed.

The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 48 was analyzed using missing = failure approach. In this approach, all missing data were treated as HIV-1 RNA ≥ 50 copies/mL.

Outcome measures

Measure	B/F/TAF n=86 Participants B/F/TAF (50/200/25 mg) FDC tablet once daily, without regard to food for at least 96 weeks.
Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 48, as Analyzed by Missing = Failure Approach	90.7 percentage of participants

SECONDARY outcome

Timeframe: Week 72

Population: Participants in the Full Analysis Set were analyzed.

The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 72 was analyzed using missing = failure approach. In this approach, all missing data were treated as HIV-1 RNA ≥ 50 copies/mL.

Outcome measures

Measure	B/F/TAF n=86 Participants B/F/TAF (50/200/25 mg) FDC tablet once daily, without regard to food for at least 96 weeks.
Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 72, as Analyzed by Missing = Failure Approach	94.2 percentage of participants

SECONDARY outcome

Timeframe: Week 96

Population: Participants in the Full Analysis Set were analyzed.

The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 96 was analyzed using missing = failure approach. In this approach, all missing data were treated as HIV-1 RNA ≥ 50 copies/mL.

Outcome measures

Measure	B/F/TAF n=86 Participants B/F/TAF (50/200/25 mg) FDC tablet once daily, without regard to food for at least 96 weeks.
Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 96, as Analyzed by Missing = Failure Approach	79.1 percentage of participants

SECONDARY outcome

Timeframe: Week 24

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

The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 24 was analyzed using missing = excluded approach. In this approach, all missing data were excluded in the computation of the percentages (ie, missing data points were excluded from both the numerator and denominator in the computation).

Outcome measures

Measure	B/F/TAF n=84 Participants B/F/TAF (50/200/25 mg) FDC tablet once daily, without regard to food for at least 96 weeks.
Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 24, as Analyzed by Missing = Excluded Approach	100.0 percentage of participants

SECONDARY outcome

Timeframe: Week 48

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

The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 48 was analyzed using missing = excluded approach. In this approach, all missing data were excluded in the computation of the percentages (ie, missing data points were excluded from both the numerator and denominator in the computation).

Outcome measures

Measure	B/F/TAF n=78 Participants B/F/TAF (50/200/25 mg) FDC tablet once daily, without regard to food for at least 96 weeks.
Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 48, as Analyzed by Missing = Excluded Approach	100.0 percentage of participants

SECONDARY outcome

Timeframe: Week 72

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

The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 72 was analyzed using missing = excluded approach. In this approach, all missing data were excluded in the computation of the percentages (ie, missing data points were excluded from both the numerator and denominator in the computation).

Outcome measures

Measure	B/F/TAF n=81 Participants B/F/TAF (50/200/25 mg) FDC tablet once daily, without regard to food for at least 96 weeks.
Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 72, as Analyzed by Missing = Excluded Approach	100.0 percentage of participants

SECONDARY outcome

Timeframe: Week 96

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

The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 96 was analyzed using missing = excluded approach. In this approach, all missing data were excluded in the computation of the percentages (ie, missing data points were excluded from both the numerator and denominator in the computation).

Outcome measures

Measure	B/F/TAF n=68 Participants B/F/TAF (50/200/25 mg) FDC tablet once daily, without regard to food for at least 96 weeks.
Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 96, as Analyzed by Missing = Excluded Approach	100.0 percentage of participants

Adverse Events

B/F/TAF

Serious events: 9 serious events

Other events: 34 other events

Deaths: 2 deaths

Serious adverse events

Measure	B/F/TAF n=86 participants at risk B/F/TAF (50/200/25 mg) FDC tablet once daily, without regard to food for at least 96 weeks.
Cardiac disorders Atrial fibrillation	1.2% 1/86 • Adverse Events: First dose of study drug up to last dose plus 30 days (up to Week 102.9); All-Cause Mortality: First dose date up to Week 102.9 The Safety Analysis Set included all participants who were enrolled and received at least 1 dose of study drug.
Cardiac disorders Cardio-respiratory arrest	1.2% 1/86 • Adverse Events: First dose of study drug up to last dose plus 30 days (up to Week 102.9); All-Cause Mortality: First dose date up to Week 102.9 The Safety Analysis Set included all participants who were enrolled and received at least 1 dose of study drug.
Cardiac disorders Ischaemic cardiomyopathy	1.2% 1/86 • Adverse Events: First dose of study drug up to last dose plus 30 days (up to Week 102.9); All-Cause Mortality: First dose date up to Week 102.9 The Safety Analysis Set included all participants who were enrolled and received at least 1 dose of study drug.
Infections and infestations Anal abscess	1.2% 1/86 • Adverse Events: First dose of study drug up to last dose plus 30 days (up to Week 102.9); All-Cause Mortality: First dose date up to Week 102.9 The Safety Analysis Set included all participants who were enrolled and received at least 1 dose of study drug.
Infections and infestations Covid-19 pneumonia	1.2% 1/86 • Adverse Events: First dose of study drug up to last dose plus 30 days (up to Week 102.9); All-Cause Mortality: First dose date up to Week 102.9 The Safety Analysis Set included all participants who were enrolled and received at least 1 dose of study drug.
Infections and infestations Endocarditis	1.2% 1/86 • Adverse Events: First dose of study drug up to last dose plus 30 days (up to Week 102.9); All-Cause Mortality: First dose date up to Week 102.9 The Safety Analysis Set included all participants who were enrolled and received at least 1 dose of study drug.
Injury, poisoning and procedural complications Intentional overdose	1.2% 1/86 • Adverse Events: First dose of study drug up to last dose plus 30 days (up to Week 102.9); All-Cause Mortality: First dose date up to Week 102.9 The Safety Analysis Set included all participants who were enrolled and received at least 1 dose of study drug.
Nervous system disorders Cerebral haemorrhage	1.2% 1/86 • Adverse Events: First dose of study drug up to last dose plus 30 days (up to Week 102.9); All-Cause Mortality: First dose date up to Week 102.9 The Safety Analysis Set included all participants who were enrolled and received at least 1 dose of study drug.
Nervous system disorders Cerebrovascular accident	1.2% 1/86 • Adverse Events: First dose of study drug up to last dose plus 30 days (up to Week 102.9); All-Cause Mortality: First dose date up to Week 102.9 The Safety Analysis Set included all participants who were enrolled and received at least 1 dose of study drug.
Nervous system disorders Ischaemic stroke	1.2% 1/86 • Adverse Events: First dose of study drug up to last dose plus 30 days (up to Week 102.9); All-Cause Mortality: First dose date up to Week 102.9 The Safety Analysis Set included all participants who were enrolled and received at least 1 dose of study drug.
Psychiatric disorders Alcohol withdrawal syndrome	1.2% 1/86 • Adverse Events: First dose of study drug up to last dose plus 30 days (up to Week 102.9); All-Cause Mortality: First dose date up to Week 102.9 The Safety Analysis Set included all participants who were enrolled and received at least 1 dose of study drug.
Psychiatric disorders Completed suicide	1.2% 1/86 • Adverse Events: First dose of study drug up to last dose plus 30 days (up to Week 102.9); All-Cause Mortality: First dose date up to Week 102.9 The Safety Analysis Set included all participants who were enrolled and received at least 1 dose of study drug.
Psychiatric disorders Depression	1.2% 1/86 • Adverse Events: First dose of study drug up to last dose plus 30 days (up to Week 102.9); All-Cause Mortality: First dose date up to Week 102.9 The Safety Analysis Set included all participants who were enrolled and received at least 1 dose of study drug.
Psychiatric disorders Suicide attempt	1.2% 1/86 • Adverse Events: First dose of study drug up to last dose plus 30 days (up to Week 102.9); All-Cause Mortality: First dose date up to Week 102.9 The Safety Analysis Set included all participants who were enrolled and received at least 1 dose of study drug.
Renal and urinary disorders Renal impairment	1.2% 1/86 • Adverse Events: First dose of study drug up to last dose plus 30 days (up to Week 102.9); All-Cause Mortality: First dose date up to Week 102.9 The Safety Analysis Set included all participants who were enrolled and received at least 1 dose of study drug.
Respiratory, thoracic and mediastinal disorders Acute pulmonary oedema	1.2% 1/86 • Adverse Events: First dose of study drug up to last dose plus 30 days (up to Week 102.9); All-Cause Mortality: First dose date up to Week 102.9 The Safety Analysis Set included all participants who were enrolled and received at least 1 dose of study drug.

Other adverse events

Measure	B/F/TAF n=86 participants at risk B/F/TAF (50/200/25 mg) FDC tablet once daily, without regard to food for at least 96 weeks.
Gastrointestinal disorders Diarrhoea	7.0% 6/86 • Adverse Events: First dose of study drug up to last dose plus 30 days (up to Week 102.9); All-Cause Mortality: First dose date up to Week 102.9 The Safety Analysis Set included all participants who were enrolled and received at least 1 dose of study drug.
Infections and infestations Bronchitis	11.6% 10/86 • Adverse Events: First dose of study drug up to last dose plus 30 days (up to Week 102.9); All-Cause Mortality: First dose date up to Week 102.9 The Safety Analysis Set included all participants who were enrolled and received at least 1 dose of study drug.
Infections and infestations Nasopharyngitis	8.1% 7/86 • Adverse Events: First dose of study drug up to last dose plus 30 days (up to Week 102.9); All-Cause Mortality: First dose date up to Week 102.9 The Safety Analysis Set included all participants who were enrolled and received at least 1 dose of study drug.
Infections and infestations Urinary tract infection	5.8% 5/86 • Adverse Events: First dose of study drug up to last dose plus 30 days (up to Week 102.9); All-Cause Mortality: First dose date up to Week 102.9 The Safety Analysis Set included all participants who were enrolled and received at least 1 dose of study drug.
Musculoskeletal and connective tissue disorders Arthralgia	9.3% 8/86 • Adverse Events: First dose of study drug up to last dose plus 30 days (up to Week 102.9); All-Cause Mortality: First dose date up to Week 102.9 The Safety Analysis Set included all participants who were enrolled and received at least 1 dose of study drug.
Nervous system disorders Sciatica	5.8% 5/86 • Adverse Events: First dose of study drug up to last dose plus 30 days (up to Week 102.9); All-Cause Mortality: First dose date up to Week 102.9 The Safety Analysis Set included all participants who were enrolled and received at least 1 dose of study drug.
Vascular disorders Hypertension	9.3% 8/86 • Adverse Events: First dose of study drug up to last dose plus 30 days (up to Week 102.9); All-Cause Mortality: First dose date up to Week 102.9 The Safety Analysis Set included all participants who were enrolled 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: GileadClinicalTrials@gilead.com

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