Trial Outcomes & Findings for Study to Evaluate the Pharmacokinetics, Safety, and Antiviral Activity of the Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide (E/C/F/TAF) Single Tablet Regimen (STR) in HIV-1 Infected Antiretroviral Treatment-Naive Adolescents and Virologically Suppressed Children (NCT NCT01854775)

NCT ID: NCT01854775

Last Updated: 2026-01-09

Results Overview

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

• Recruitment status: COMPLETED
• Study phase: PHASE2/PHASE3
• Target enrollment: 129 participants
• Primary outcome timeframe: 0 (pre-dose, ≤ 30 minutes prior to dosing), 5 minutes, 0.25, 0.5, 1, 1.5, 2, 4, 5, 8 and 24 hours post-dose at Week 4
• Results posted on: 2026-01-09

Participant Flow

Participants were enrolled at study sites in South Africa, Thailand, Uganda, United States of America, and Zimbabwe.

155 participants were screened.

Participant milestones

Measure	Cohort 1: Age 12 to < 18 Years and Weight ≥ 35 kg Treatment naive adolescents (12 to \< 18 years of age) with human immunodeficiency virus (HIV) received elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) (150/150/200/10 mg) fixed-dose combination (FDC) tablets, once daily orally with food for 48 weeks. Participants who completed 48 weeks of study treatment had the option to receive E/C/F/TAF in an extension phase of the study until: a) the participant turned 18 years old and E/C/F/TAF was commercially available for adults in the country in which the participant was enrolled; b) age-appropriate E/C/F/TAF became commercially available in participant's country.	Cohort 2: Age 6 to < 12 Years and Weight ≥ 25 kg Children (6 to \< 12 years of age weighing ≥ 25 kg) with HIV who were virologically suppressed received E/C/F/TAF (150/150/200/10 mg) FDC tablets, once daily orally with food for 48 weeks. Participants who completed 48 weeks of study treatment had the option to receive E/C/F/TAF in an extension phase of the study until: a) the participant turned 18 years old and E/C/F/TAF was commercially available for adults in the country in which the participant was enrolled; b) age-appropriate E/C/F/TAF became commercially available in participant's country.	Cohort 3: Age ≥ 2 Years and Weight ≥ 14 to < 25 kg Children (≥ 2 years of age weighing ≥ 14 to \< 25 kg) with HIV who were virologically suppressed received E/C/F/TAF (90/90/120/6 mg) FDC tablets, once daily orally with food for 48 weeks. Participants who attained a weight of ≥ 25 kg during the course of the study were switched to adult E/C/F/TAF (150/150/200/10 mg) tablets administered orally, once daily with food. Participants who completed 48 weeks of study treatment had the option to receive E/C/F/TAF in an extension phase of the study until: a) the participant turned 18 years old and E/C/F/TAF was commercially available for adults in the country in which the participant was enrolled; b) age-appropriate E/C/F/TAF became commercially available in participant's country.
Treatment Phase (48 Weeks) STARTED	50	52	27
Treatment Phase (48 Weeks) COMPLETED	48	51	27
Treatment Phase (48 Weeks) NOT COMPLETED	2	1	0
Extension Phase STARTED	48	50	27
Extension Phase COMPLETED	44	49	27
Extension Phase NOT COMPLETED	4	1	0

Reasons for withdrawal

Measure	Cohort 1: Age 12 to < 18 Years and Weight ≥ 35 kg Treatment naive adolescents (12 to \< 18 years of age) with human immunodeficiency virus (HIV) received elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) (150/150/200/10 mg) fixed-dose combination (FDC) tablets, once daily orally with food for 48 weeks. Participants who completed 48 weeks of study treatment had the option to receive E/C/F/TAF in an extension phase of the study until: a) the participant turned 18 years old and E/C/F/TAF was commercially available for adults in the country in which the participant was enrolled; b) age-appropriate E/C/F/TAF became commercially available in participant's country.	Cohort 2: Age 6 to < 12 Years and Weight ≥ 25 kg Children (6 to \< 12 years of age weighing ≥ 25 kg) with HIV who were virologically suppressed received E/C/F/TAF (150/150/200/10 mg) FDC tablets, once daily orally with food for 48 weeks. Participants who completed 48 weeks of study treatment had the option to receive E/C/F/TAF in an extension phase of the study until: a) the participant turned 18 years old and E/C/F/TAF was commercially available for adults in the country in which the participant was enrolled; b) age-appropriate E/C/F/TAF became commercially available in participant's country.	Cohort 3: Age ≥ 2 Years and Weight ≥ 14 to < 25 kg Children (≥ 2 years of age weighing ≥ 14 to \< 25 kg) with HIV who were virologically suppressed received E/C/F/TAF (90/90/120/6 mg) FDC tablets, once daily orally with food for 48 weeks. Participants who attained a weight of ≥ 25 kg during the course of the study were switched to adult E/C/F/TAF (150/150/200/10 mg) tablets administered orally, once daily with food. Participants who completed 48 weeks of study treatment had the option to receive E/C/F/TAF in an extension phase of the study until: a) the participant turned 18 years old and E/C/F/TAF was commercially available for adults in the country in which the participant was enrolled; b) age-appropriate E/C/F/TAF became commercially available in participant's country.
Treatment Phase (48 Weeks) Withdrew consent	1	1	0
Treatment Phase (48 Weeks) Lost to Follow-up	1	0	0
Extension Phase Pregnancy	1	0	0
Extension Phase Investigator's Discretion	1	0	0
Extension Phase Non-Compliance with study drug	1	0	0
Extension Phase Lost to Follow-up	1	0	0
Extension Phase Withdrew consent	0	1	0

Baseline Characteristics

Study to Evaluate the Pharmacokinetics, Safety, and Antiviral Activity of the Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide (E/C/F/TAF) Single Tablet Regimen (STR) in HIV-1 Infected Antiretroviral Treatment-Naive Adolescents and Virologically Suppressed Children

Baseline characteristics by cohort

Measure	Cohort 1: Age 12 to < 18 Years and Weight ≥ 35 kg n=50 Participants Treatment naive adolescents (12 to \< 18 years of age) with human immunodeficiency virus (HIV) received elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) (150/150/200/10 mg) fixed-dose combination (FDC) tablets, once daily orally with food for 48 weeks. Participants who completed 48 weeks of study treatment had the option to receive E/C/F/TAF in an extension phase of the study until: a) the participant turned 18 years old and E/C/F/TAF was commercially available for adults in the country in which the participant was enrolled; b) age-appropriate E/C/F/TAF became commercially available in participant's country.	Cohort 2: Age 6 to < 12 Years and Weight ≥ 25 kg n=52 Participants Children (6 to \< 12 years of age weighing ≥ 25 kg) with HIV who were virologically suppressed received E/C/F/TAF (150/150/200/10 mg) FDC tablets, once daily orally with food for 48 weeks. Participants who completed 48 weeks of study treatment had the option to receive E/C/F/TAF in an extension phase of the study until: a) the participant turned 18 years old and E/C/F/TAF was commercially available for adults in the country in which the participant was enrolled; b) age-appropriate E/C/F/TAF became commercially available in participant's country.	Cohort 3: Age ≥ 2 Years and Weight ≥ 14 to < 25 kg n=27 Participants Children (≥ 2 years of age weighing ≥ 14 to \< 25 kg) with HIV who were virologically suppressed received E/C/F/TAF (90/90/120/6 mg) FDC tablets, once daily orally with food for 48 weeks. Participants who attained a weight of ≥ 25 kg during the course of the study were switched to adult E/C/F/TAF (150/150/200/10 mg) tablets administered orally, once daily with food. Participants who completed 48 weeks of study treatment had the option to receive E/C/F/TAF in an extension phase of the study until: a) the participant turned 18 years old and E/C/F/TAF was commercially available for adults in the country in which the participant was enrolled; b) age-appropriate E/C/F/TAF became commercially available in participant's country.	Total n=129 Participants Total of all reporting groups
Age, Continuous	15 years STANDARD_DEVIATION 1.9 • n=8 Participants	10 years STANDARD_DEVIATION 1.2 • n=7 Participants	6 years STANDARD_DEVIATION 1.9 • n=15 Participants	11 years STANDARD_DEVIATION 3.7 • n=42 Participants
Age, Customized 2 to <6 Years	0 Participants n=8 Participants	0 Participants n=7 Participants	11 Participants n=15 Participants	11 Participants n=42 Participants
Age, Customized 6 to <12 Years	0 Participants n=8 Participants	52 Participants n=7 Participants	16 Participants n=15 Participants	68 Participants n=42 Participants
Age, Customized 12 to <18 Years	50 Participants n=8 Participants	0 Participants n=7 Participants	0 Participants n=15 Participants	50 Participants n=42 Participants
Sex: Female, Male Female	28 Participants n=8 Participants	30 Participants n=7 Participants	17 Participants n=15 Participants	75 Participants n=42 Participants
Sex: Female, Male Male	22 Participants n=8 Participants	22 Participants n=7 Participants	10 Participants n=15 Participants	54 Participants n=42 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=8 Participants	0 Participants n=7 Participants	0 Participants n=15 Participants	0 Participants n=42 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	50 Participants n=8 Participants	52 Participants n=7 Participants	27 Participants n=15 Participants	129 Participants n=42 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=8 Participants	0 Participants n=7 Participants	0 Participants n=15 Participants	0 Participants n=42 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=8 Participants	0 Participants n=7 Participants	0 Participants n=15 Participants	0 Participants n=42 Participants
Race (NIH/OMB) Asian	6 Participants n=8 Participants	13 Participants n=7 Participants	3 Participants n=15 Participants	22 Participants n=42 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=8 Participants	0 Participants n=7 Participants	0 Participants n=15 Participants	0 Participants n=42 Participants
Race (NIH/OMB) Black or African American	44 Participants n=8 Participants	37 Participants n=7 Participants	24 Participants n=15 Participants	105 Participants n=42 Participants
Race (NIH/OMB) White	0 Participants n=8 Participants	2 Participants n=7 Participants	0 Participants n=15 Participants	2 Participants n=42 Participants
Race (NIH/OMB) More than one race	0 Participants n=8 Participants	0 Participants n=7 Participants	0 Participants n=15 Participants	0 Participants n=42 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=8 Participants	0 Participants n=7 Participants	0 Participants n=15 Participants	0 Participants n=42 Participants
Region of Enrollment South Africa	3 Participants n=8 Participants	0 Participants n=7 Participants	13 Participants n=15 Participants	16 Participants n=42 Participants
Region of Enrollment Thailand	6 Participants n=8 Participants	13 Participants n=7 Participants	1 Participants n=15 Participants	20 Participants n=42 Participants
Region of Enrollment Uganda	30 Participants n=8 Participants	27 Participants n=7 Participants	8 Participants n=15 Participants	65 Participants n=42 Participants
Region of Enrollment United States	11 Participants n=8 Participants	12 Participants n=7 Participants	3 Participants n=15 Participants	26 Participants n=42 Participants
Region of Enrollment Zimbabwe	0 Participants n=8 Participants	0 Participants n=7 Participants	2 Participants n=15 Participants	2 Participants n=42 Participants

PRIMARY outcome

Timeframe: 0 (pre-dose, ≤ 30 minutes prior to dosing), 5 minutes, 0.25, 0.5, 1, 1.5, 2, 4, 5, 8 and 24 hours post-dose at Week 4

Population: The PK Substudy Analysis Set included all enrolled and treated participants from Part A who had any nonmissing key PK parameters (AUCtau, AUClast, Cmax) from Week 4 intensive PK data for the respective analyte.

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

Outcome measures

Measure

Cohort 1: Age 12 to < 18 Years and Weight ≥ 35 kg n=24 Participants Treatment naive adolescents (12 to \< 18 years of age) with human immunodeficiency virus (HIV) received elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) (150/150/200/10 mg) fixed-dose combination (FDC) tablets, once daily orally with food for 48 weeks. Participants who completed 48 weeks of study treatment had the option to receive E/C/F/TAF in an extension phase of the study until: a) the participant turned 18 years old and E/C/F/TAF was commercially available for adults in the country in which the participant was enrolled; b) age-appropriate E/C/F/TAF became commercially available in participant's country.

Pharmacokinetic (PK) Parameter: AUCtau of Elvitegravir (EVG) (Cohort 1)

23840.1 hr*ng/mL Standard Deviation 6076.15

PRIMARY outcome

Timeframe: 0 (pre-dose, ≤ 30 minutes prior to dosing), 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 8, and 24 hours post-dose at Week 4

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

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

Outcome measures

Measure

Cohort 1: Age 12 to < 18 Years and Weight ≥ 35 kg n=22 Participants Treatment naive adolescents (12 to \< 18 years of age) with human immunodeficiency virus (HIV) received elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) (150/150/200/10 mg) fixed-dose combination (FDC) tablets, once daily orally with food for 48 weeks. Participants who completed 48 weeks of study treatment had the option to receive E/C/F/TAF in an extension phase of the study until: a) the participant turned 18 years old and E/C/F/TAF was commercially available for adults in the country in which the participant was enrolled; b) age-appropriate E/C/F/TAF became commercially available in participant's country.

PK Parameter: AUCtau of EVG (Cohort 2)

33813.9 hr*ng/mL Standard Deviation 19536.30

PRIMARY outcome

Timeframe: 0 (pre-dose, ≤ 30 minutes prior to dosing), 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, and 8 hours post-dose at Week 2

Population: The Intensive PK Analysis Set included all enrolled and treated participants who had any nonmissing key PK parameters (AUCtau, AUClast, Cmax) from Week 2 intensive PK data for the respective analyte.

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

Outcome measures

Measure

Cohort 1: Age 12 to < 18 Years and Weight ≥ 35 kg n=24 Participants Treatment naive adolescents (12 to \< 18 years of age) with human immunodeficiency virus (HIV) received elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) (150/150/200/10 mg) fixed-dose combination (FDC) tablets, once daily orally with food for 48 weeks. Participants who completed 48 weeks of study treatment had the option to receive E/C/F/TAF in an extension phase of the study until: a) the participant turned 18 years old and E/C/F/TAF was commercially available for adults in the country in which the participant was enrolled; b) age-appropriate E/C/F/TAF became commercially available in participant's country.

PK Parameter: AUCtau of EVG (Cohort 3)

33245.6 hr*ng/mL Standard Deviation 15499.22

PRIMARY outcome

Timeframe: 0 (pre-dose, ≤ 30 minutes prior to dosing), 5 minutes, 0.25, 0.5, 1, 1.5, 2, 4, 5, 8 and 24 hours post-dose at Week 4

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

AUClast is defined as the concentration of drug from time zero to the last observable concentration, area under the concentration time curve to last observation (AUClast).

Outcome measures

Measure

Cohort 1: Age 12 to < 18 Years and Weight ≥ 35 kg n=24 Participants Treatment naive adolescents (12 to \< 18 years of age) with human immunodeficiency virus (HIV) received elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) (150/150/200/10 mg) fixed-dose combination (FDC) tablets, once daily orally with food for 48 weeks. Participants who completed 48 weeks of study treatment had the option to receive E/C/F/TAF in an extension phase of the study until: a) the participant turned 18 years old and E/C/F/TAF was commercially available for adults in the country in which the participant was enrolled; b) age-appropriate E/C/F/TAF became commercially available in participant's country.

PK Parameter: AUClast of Tenofovir Alafenamide (TAF) (Cohort 1)

188.9 hr*ng/mL Standard Deviation 105.45

PRIMARY outcome

Timeframe: 0 (pre-dose, ≤ 30 minutes prior to dosing), 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 8, and 24 hours post-dose at Week 4

Population: Participants in the PK Substudy Analysis set were analyzed.

AUClast is defined as the concentration of drug from time zero to the last observable concentration.

Outcome measures

Measure

Cohort 1: Age 12 to < 18 Years and Weight ≥ 35 kg n=23 Participants Treatment naive adolescents (12 to \< 18 years of age) with human immunodeficiency virus (HIV) received elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) (150/150/200/10 mg) fixed-dose combination (FDC) tablets, once daily orally with food for 48 weeks. Participants who completed 48 weeks of study treatment had the option to receive E/C/F/TAF in an extension phase of the study until: a) the participant turned 18 years old and E/C/F/TAF was commercially available for adults in the country in which the participant was enrolled; b) age-appropriate E/C/F/TAF became commercially available in participant's country.

PK Parameter: AUClast of TAF (Cohort 2)

332.9 hr*ng/mL Standard Deviation 149.12

PRIMARY outcome

Timeframe: 0 (pre-dose, ≤ 30 minutes prior to dosing), 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, and 8 hours post-dose at Week 2

Population: Participants in the Intensive PK Analysis Set (all enrolled and treated participants who had any nonmissing key PK parameters \[AUCtau, AUClast, Cmax\] from Week 2 intensive PK data for the respective analyte) with available data were analyzed.

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

Outcome measures

Measure

Cohort 1: Age 12 to < 18 Years and Weight ≥ 35 kg n=17 Participants Treatment naive adolescents (12 to \< 18 years of age) with human immunodeficiency virus (HIV) received elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) (150/150/200/10 mg) fixed-dose combination (FDC) tablets, once daily orally with food for 48 weeks. Participants who completed 48 weeks of study treatment had the option to receive E/C/F/TAF in an extension phase of the study until: a) the participant turned 18 years old and E/C/F/TAF was commercially available for adults in the country in which the participant was enrolled; b) age-appropriate E/C/F/TAF became commercially available in participant's country.

PK Parameter: AUCtau of TAF (Cohort 3)

366.4 hr*ng/mL Standard Deviation 144.91

PRIMARY outcome

Timeframe: From first dose date up to Week 24

Population: Participants in the Safety Analysis Set (all participants who received at least 1 dose of study drug) with available data were analyzed.

Treatment-emergent adverse events (TEAEs) were defined as any AEs that begin or worsen on or after the start of study drug through 30 days after the last dose of study drug. The severity was graded based on the Gilead Sciences Grading Scale for Severity of Adverse Events. An AE that met one or more of the following outcomes was classified as serious:

• Fatal
• Life-threatening
• Disabling/incapacitating
• Results in hospitalization or prolongs a hospital stay
• A congenital abnormality
• Other important medical events may also be considered serious AEs if they may require medical or surgical intervention to prevent one of the outcomes listed above.

Outcome measures

Measure	Cohort 1: Age 12 to < 18 Years and Weight ≥ 35 kg n=48 Participants Treatment naive adolescents (12 to \< 18 years of age) with human immunodeficiency virus (HIV) received elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) (150/150/200/10 mg) fixed-dose combination (FDC) tablets, once daily orally with food for 48 weeks. Participants who completed 48 weeks of study treatment had the option to receive E/C/F/TAF in an extension phase of the study until: a) the participant turned 18 years old and E/C/F/TAF was commercially available for adults in the country in which the participant was enrolled; b) age-appropriate E/C/F/TAF became commercially available in participant's country.
Cohort 1: Percentage of Participants With All Treatment-Emergent Adverse Events (AEs) and Treatment-Emergent Serious Adverse Events (SAEs) Any TEAEs	81.3 percentage of participants
Cohort 1: Percentage of Participants With All Treatment-Emergent Adverse Events (AEs) and Treatment-Emergent Serious Adverse Events (SAEs) SAEs	8.3 percentage of participants

PRIMARY outcome

Timeframe: From first dose date up to Week 24

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

TEAEs were defined as any AEs that begin or worsen on or after the start of study drug through 30 days after the last dose of study drug. The severity was graded based on the Gilead Sciences Grading Scale for Severity of Adverse Events. An AE that met one or more of the following outcomes was classified as serious:

• Fatal
• Life-threatening
• Disabling/incapacitating
• Results in hospitalization or prolongs a hospital stay
• A congenital abnormality
• Other important medical events may also be considered serious AEs if they may require medical or surgical intervention to prevent one of the outcomes listed above.

Outcome measures

Measure	Cohort 1: Age 12 to < 18 Years and Weight ≥ 35 kg n=23 Participants Treatment naive adolescents (12 to \< 18 years of age) with human immunodeficiency virus (HIV) received elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) (150/150/200/10 mg) fixed-dose combination (FDC) tablets, once daily orally with food for 48 weeks. Participants who completed 48 weeks of study treatment had the option to receive E/C/F/TAF in an extension phase of the study until: a) the participant turned 18 years old and E/C/F/TAF was commercially available for adults in the country in which the participant was enrolled; b) age-appropriate E/C/F/TAF became commercially available in participant's country.
Cohort 2: Percentage of Participants With All Treatment-Emergent AEs and Treatment-Emergent SAEs Any TEAEs	73.9 percentage of participants
Cohort 2: Percentage of Participants With All Treatment-Emergent AEs and Treatment-Emergent SAEs SAEs	0 percentage of participants

PRIMARY outcome

Timeframe: From first dose date up to Week 24

Population: Participants in the Safety Analysis Set were analyzed.

TEAEs were defined as any AEs that begin or worsen on or after the start of study drug through 30 days after the last dose of study drug. The severity was graded based on the Gilead Sciences Grading Scale for Severity of Adverse Events. An AE that met one or more of the following outcomes was classified as serious:

• Fatal
• Life-threatening
• Disabling/incapacitating
• Results in hospitalization or prolongs a hospital stay
• A congenital abnormality
• Other important medical events may also be considered serious AEs if they may require medical or surgical intervention to prevent one of the outcomes listed above.

Outcome measures

Measure	Cohort 1: Age 12 to < 18 Years and Weight ≥ 35 kg n=27 Participants Treatment naive adolescents (12 to \< 18 years of age) with human immunodeficiency virus (HIV) received elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) (150/150/200/10 mg) fixed-dose combination (FDC) tablets, once daily orally with food for 48 weeks. Participants who completed 48 weeks of study treatment had the option to receive E/C/F/TAF in an extension phase of the study until: a) the participant turned 18 years old and E/C/F/TAF was commercially available for adults in the country in which the participant was enrolled; b) age-appropriate E/C/F/TAF became commercially available in participant's country.
Cohort 3: Percentage of Participants With All Treatment-Emergent AEs and Treatment-Emergent SAEs Any TEAEs	70.4 percentage of participants
Cohort 3: Percentage of Participants With All Treatment-Emergent AEs and Treatment-Emergent SAEs SAEs	3.7 percentage of participants

SECONDARY outcome

Timeframe: 0 (pre-dose, ≤ 30 minutes prior to dosing), 5 minutes, 0.25, 0.5, 1, 1.5, 2, 4, 5, 8 and 24 hours post-dose at Week 4

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

Ctau is defined as the observed drug concentration at the end of the dosing interval.

Outcome measures

Measure	Cohort 1: Age 12 to < 18 Years and Weight ≥ 35 kg n=24 Participants Treatment naive adolescents (12 to \< 18 years of age) with human immunodeficiency virus (HIV) received elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) (150/150/200/10 mg) fixed-dose combination (FDC) tablets, once daily orally with food for 48 weeks. Participants who completed 48 weeks of study treatment had the option to receive E/C/F/TAF in an extension phase of the study until: a) the participant turned 18 years old and E/C/F/TAF was commercially available for adults in the country in which the participant was enrolled; b) age-appropriate E/C/F/TAF became commercially available in participant's country.
PK Parameter: Ctau of EVG, Emtricitabine (FTC), Tenofovir (TFV), and Cobicistat (COBI) (Cohort 1) EVG	300.8 ng/mL Standard Deviation 243.69
PK Parameter: Ctau of EVG, Emtricitabine (FTC), Tenofovir (TFV), and Cobicistat (COBI) (Cohort 1) FTC	102.4 ng/mL Standard Deviation 39.85
PK Parameter: Ctau of EVG, Emtricitabine (FTC), Tenofovir (TFV), and Cobicistat (COBI) (Cohort 1) TFV	10.0 ng/mL Standard Deviation 2.13
PK Parameter: Ctau of EVG, Emtricitabine (FTC), Tenofovir (TFV), and Cobicistat (COBI) (Cohort 1) COBI	25.0 ng/mL Standard Deviation 44.97

SECONDARY outcome

Timeframe: (pre-dose, ≤ 30 minutes prior to dosing), 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 8, and 24 hours post-dose at Week 4

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

Ctau is defined as the observed drug concentration at the end of the dosing interval.

Outcome measures

Measure	Cohort 1: Age 12 to < 18 Years and Weight ≥ 35 kg n=23 Participants Treatment naive adolescents (12 to \< 18 years of age) with human immunodeficiency virus (HIV) received elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) (150/150/200/10 mg) fixed-dose combination (FDC) tablets, once daily orally with food for 48 weeks. Participants who completed 48 weeks of study treatment had the option to receive E/C/F/TAF in an extension phase of the study until: a) the participant turned 18 years old and E/C/F/TAF was commercially available for adults in the country in which the participant was enrolled; b) age-appropriate E/C/F/TAF became commercially available in participant's country.
PK Parameter: Ctau of EVG, FTC, TFV and COBI (Cohort 2) EVG	370.0 ng/mL Standard Deviation 438.52
PK Parameter: Ctau of EVG, FTC, TFV and COBI (Cohort 2) FTC	114.9 ng/mL Standard Deviation 27.70
PK Parameter: Ctau of EVG, FTC, TFV and COBI (Cohort 2) TFV	15.1 ng/mL Standard Deviation 3.77
PK Parameter: Ctau of EVG, FTC, TFV and COBI (Cohort 2) COBI	96.0 ng/mL Standard Deviation 162.01

SECONDARY outcome

Timeframe: 0 (pre-dose, ≤ 30 minutes prior to dosing), 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, and 8 hours post-dose at Week 2

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

Ctau is defined as the observed drug concentration at the end of the dosing interval.

Outcome measures

Measure	Cohort 1: Age 12 to < 18 Years and Weight ≥ 35 kg n=27 Participants Treatment naive adolescents (12 to \< 18 years of age) with human immunodeficiency virus (HIV) received elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) (150/150/200/10 mg) fixed-dose combination (FDC) tablets, once daily orally with food for 48 weeks. Participants who completed 48 weeks of study treatment had the option to receive E/C/F/TAF in an extension phase of the study until: a) the participant turned 18 years old and E/C/F/TAF was commercially available for adults in the country in which the participant was enrolled; b) age-appropriate E/C/F/TAF became commercially available in participant's country.
PK Parameter: Ctau of EVG, FTC, TFV, and COBI (Cohort 3) TFV	11.4 ng/mL Standard Deviation 2.65
PK Parameter: Ctau of EVG, FTC, TFV, and COBI (Cohort 3) COBI	23.0 ng/mL Standard Deviation 23.02
PK Parameter: Ctau of EVG, FTC, TFV, and COBI (Cohort 3) EVG	277.5 ng/mL Standard Deviation 223.43
PK Parameter: Ctau of EVG, FTC, TFV, and COBI (Cohort 3) FTC	82.5 ng/mL Standard Deviation 26.47

SECONDARY outcome

Timeframe: 0 (pre-dose, ≤ 30 minutes prior to dosing), 5 minutes, 0.25, 0.5, 1, 1.5, 2, 4, 5, 8 and 24 hours post-dose at Week 4

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

Cmax is defined as the maximum concentration of drug.

Outcome measures

Measure	Cohort 1: Age 12 to < 18 Years and Weight ≥ 35 kg n=24 Participants Treatment naive adolescents (12 to \< 18 years of age) with human immunodeficiency virus (HIV) received elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) (150/150/200/10 mg) fixed-dose combination (FDC) tablets, once daily orally with food for 48 weeks. Participants who completed 48 weeks of study treatment had the option to receive E/C/F/TAF in an extension phase of the study until: a) the participant turned 18 years old and E/C/F/TAF was commercially available for adults in the country in which the participant was enrolled; b) age-appropriate E/C/F/TAF became commercially available in participant's country.
PK Parameter: Cmax of EVG, TAF, FTC, TFV, and COBI (Cohort 1) FTC	2265.0 ng/mL Standard Deviation 510.55
PK Parameter: Cmax of EVG, TAF, FTC, TFV, and COBI (Cohort 1) TFV	17.6 ng/mL Standard Deviation 4.18
PK Parameter: Cmax of EVG, TAF, FTC, TFV, and COBI (Cohort 1) COBI	1202.4 ng/mL Standard Deviation 421.21
PK Parameter: Cmax of EVG, TAF, FTC, TFV, and COBI (Cohort 1) EVG	2229.6 ng/mL Standard Deviation 427.93
PK Parameter: Cmax of EVG, TAF, FTC, TFV, and COBI (Cohort 1) TAF	166.8 ng/mL Standard Deviation 107.44

SECONDARY outcome

Timeframe: 0 (pre-dose, ≤ 30 minutes prior to dosing), 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 8, and 24 hours post-dose at Week 4

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

Cmax is defined as the maximum concentration of drug.

Outcome measures

Measure	Cohort 1: Age 12 to < 18 Years and Weight ≥ 35 kg n=23 Participants Treatment naive adolescents (12 to \< 18 years of age) with human immunodeficiency virus (HIV) received elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) (150/150/200/10 mg) fixed-dose combination (FDC) tablets, once daily orally with food for 48 weeks. Participants who completed 48 weeks of study treatment had the option to receive E/C/F/TAF in an extension phase of the study until: a) the participant turned 18 years old and E/C/F/TAF was commercially available for adults in the country in which the participant was enrolled; b) age-appropriate E/C/F/TAF became commercially available in participant's country.
PK Parameter: Cmax of EVG, TAF, FTC, TFV, and COBI (Cohort 2) EVG	3055.2 ng/mL Standard Deviation 1180.90
PK Parameter: Cmax of EVG, TAF, FTC, TFV, and COBI (Cohort 2) TAF	313.3 ng/mL Standard Deviation 191.68
PK Parameter: Cmax of EVG, TAF, FTC, TFV, and COBI (Cohort 2) FTC	3397.4 ng/mL Standard Deviation 916.06
PK Parameter: Cmax of EVG, TAF, FTC, TFV, and COBI (Cohort 2) TFV	26.1 ng/mL Standard Deviation 5.43
PK Parameter: Cmax of EVG, TAF, FTC, TFV, and COBI (Cohort 2) COBI	2079.4 ng/mL Standard Deviation 970.81

SECONDARY outcome

Timeframe: 0 (pre-dose, ≤ 30 minutes prior to dosing), 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, and 8 hours post-dose at Week 2

Population: Participants in the Intensive PK Analysis Set were analyzed.

Cmax is defined as the maximum concentration of drug.

Outcome measures

Measure	Cohort 1: Age 12 to < 18 Years and Weight ≥ 35 kg n=27 Participants Treatment naive adolescents (12 to \< 18 years of age) with human immunodeficiency virus (HIV) received elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) (150/150/200/10 mg) fixed-dose combination (FDC) tablets, once daily orally with food for 48 weeks. Participants who completed 48 weeks of study treatment had the option to receive E/C/F/TAF in an extension phase of the study until: a) the participant turned 18 years old and E/C/F/TAF was commercially available for adults in the country in which the participant was enrolled; b) age-appropriate E/C/F/TAF became commercially available in participant's country.
PK Parameter: Cmax of EVG, TAF, FTC, TFV, and COBI (Cohort 3) EVG	3297.2 ng/mL Standard Deviation 1720.38
PK Parameter: Cmax of EVG, TAF, FTC, TFV, and COBI (Cohort 3) TAF	286.6 ng/mL Standard Deviation 206.97
PK Parameter: Cmax of EVG, TAF, FTC, TFV, and COBI (Cohort 3) FTC	3007.4 ng/mL Standard Deviation 1138.10
PK Parameter: Cmax of EVG, TAF, FTC, TFV, and COBI (Cohort 3) TFV	19.6 ng/mL Standard Deviation 4.72
PK Parameter: Cmax of EVG, TAF, FTC, TFV, and COBI (Cohort 3) COBI	1525.5 ng/mL Standard Deviation 788.12

SECONDARY outcome

Timeframe: 0 (pre-dose, ≤ 30 minutes prior to dosing), 5 minutes, 0.25, 0.5, 1, 1.5, 2, 4, 5, 8 and 24 hours post-dose at Week 4

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

Apparent oral clearance (CL/F) is defined as the apparent clearance of the drug following oral administration.

Outcome measures

Measure	Cohort 1: Age 12 to < 18 Years and Weight ≥ 35 kg n=24 Participants Treatment naive adolescents (12 to \< 18 years of age) with human immunodeficiency virus (HIV) received elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) (150/150/200/10 mg) fixed-dose combination (FDC) tablets, once daily orally with food for 48 weeks. Participants who completed 48 weeks of study treatment had the option to receive E/C/F/TAF in an extension phase of the study until: a) the participant turned 18 years old and E/C/F/TAF was commercially available for adults in the country in which the participant was enrolled; b) age-appropriate E/C/F/TAF became commercially available in participant's country.
PK Parameter: CL/F of EVG and TAF (Cohort 1) EVG	6.7 L/hr Standard Deviation 1.74
PK Parameter: CL/F of EVG and TAF (Cohort 1) TAF	68.6 L/hr Standard Deviation 52.64

SECONDARY outcome

Timeframe: 0 (pre-dose, ≤ 30 minutes prior to dosing), 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 8, and 24 hours post-dose at Week 4

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

CL/F is defined as the apparent clearance of the drug following oral administration.

Outcome measures

Measure	Cohort 1: Age 12 to < 18 Years and Weight ≥ 35 kg n=22 Participants Treatment naive adolescents (12 to \< 18 years of age) with human immunodeficiency virus (HIV) received elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) (150/150/200/10 mg) fixed-dose combination (FDC) tablets, once daily orally with food for 48 weeks. Participants who completed 48 weeks of study treatment had the option to receive E/C/F/TAF in an extension phase of the study until: a) the participant turned 18 years old and E/C/F/TAF was commercially available for adults in the country in which the participant was enrolled; b) age-appropriate E/C/F/TAF became commercially available in participant's country.
PK Parameter: CL/F of EVG and TAF (Cohort 2) EVG	6.3 L/hr Standard Deviation 5.11
PK Parameter: CL/F of EVG and TAF (Cohort 2) TAF	31.9 L/hr Standard Deviation 11.21

SECONDARY outcome

Timeframe: 0 (pre-dose, ≤ 30 minutes prior to dosing), 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, and 8 hours post-dose at Week 2

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

CL/F is defined as the apparent clearance of the drug following oral administration.

Outcome measures

Measure	Cohort 1: Age 12 to < 18 Years and Weight ≥ 35 kg n=24 Participants Treatment naive adolescents (12 to \< 18 years of age) with human immunodeficiency virus (HIV) received elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) (150/150/200/10 mg) fixed-dose combination (FDC) tablets, once daily orally with food for 48 weeks. Participants who completed 48 weeks of study treatment had the option to receive E/C/F/TAF in an extension phase of the study until: a) the participant turned 18 years old and E/C/F/TAF was commercially available for adults in the country in which the participant was enrolled; b) age-appropriate E/C/F/TAF became commercially available in participant's country.
PK Parameter: CL/F of EVG and TAF (Cohort 3) EVG	3.4 L/hr Standard Deviation 1.79
PK Parameter: CL/F of EVG and TAF (Cohort 3) TAF	18.5 L/hr Standard Deviation 6.27

SECONDARY outcome

Timeframe: 0 (pre-dose, ≤ 30 minutes prior to dosing), 5 minutes, 0.25, 0.5, 1, 1.5, 2, 4, 5, 8 and 24 hours post-dose at Week 4

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

Vz/F is defined as the apparent volume of distribution of the drug after oral administration.

Outcome measures

Measure	Cohort 1: Age 12 to < 18 Years and Weight ≥ 35 kg n=24 Participants Treatment naive adolescents (12 to \< 18 years of age) with human immunodeficiency virus (HIV) received elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) (150/150/200/10 mg) fixed-dose combination (FDC) tablets, once daily orally with food for 48 weeks. Participants who completed 48 weeks of study treatment had the option to receive E/C/F/TAF in an extension phase of the study until: a) the participant turned 18 years old and E/C/F/TAF was commercially available for adults in the country in which the participant was enrolled; b) age-appropriate E/C/F/TAF became commercially available in participant's country.
PK Parameter: Vz/F of EVG and TAF (Cohort 1) TAF	49.7 liters Standard Deviation 32.54
PK Parameter: Vz/F of EVG and TAF (Cohort 1) EVG	60.5 liters Standard Deviation 18.77

SECONDARY outcome

Timeframe: 0 (pre-dose, ≤ 30 minutes prior to dosing), 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 8, and 24 hours post-dose at Week 4

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

Vz/F is defined as the apparent volume of distribution of the drug after oral administration.

Outcome measures

Measure	Cohort 1: Age 12 to < 18 Years and Weight ≥ 35 kg n=14 Participants Treatment naive adolescents (12 to \< 18 years of age) with human immunodeficiency virus (HIV) received elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) (150/150/200/10 mg) fixed-dose combination (FDC) tablets, once daily orally with food for 48 weeks. Participants who completed 48 weeks of study treatment had the option to receive E/C/F/TAF in an extension phase of the study until: a) the participant turned 18 years old and E/C/F/TAF was commercially available for adults in the country in which the participant was enrolled; b) age-appropriate E/C/F/TAF became commercially available in participant's country.
PK Parameter: Vz/F of EVG and TAF (Cohort 2) EVG	46.8 liters Standard Deviation 36.02
PK Parameter: Vz/F of EVG and TAF (Cohort 2) TAF	28.6 liters Standard Deviation 25.74

SECONDARY outcome

Timeframe: 0 (pre-dose, ≤ 30 minutes prior to dosing), 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, and 8 hours post-dose at Week 2

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

Vz/F is defined as the apparent volume of distribution of the drug after oral administration.

Outcome measures

Measure	Cohort 1: Age 12 to < 18 Years and Weight ≥ 35 kg n=17 Participants Treatment naive adolescents (12 to \< 18 years of age) with human immunodeficiency virus (HIV) received elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) (150/150/200/10 mg) fixed-dose combination (FDC) tablets, once daily orally with food for 48 weeks. Participants who completed 48 weeks of study treatment had the option to receive E/C/F/TAF in an extension phase of the study until: a) the participant turned 18 years old and E/C/F/TAF was commercially available for adults in the country in which the participant was enrolled; b) age-appropriate E/C/F/TAF became commercially available in participant's country.
PK Parameter: Vz/F of EVG and TAF (Cohort 3) EVG	28.5 liters Standard Deviation 28.30
PK Parameter: Vz/F of EVG and TAF (Cohort 3) TAF	16.3 liters Standard Deviation 11.07

SECONDARY outcome

Timeframe: 0 (pre-dose, ≤ 30 minutes prior to dosing), 5 minutes, 0.25, 0.5, 1, 1.5, 2, 4, 5, 8 and 24 hours post-dose at Week 4

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

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

Outcome measures

Measure	Cohort 1: Age 12 to < 18 Years and Weight ≥ 35 kg n=24 Participants Treatment naive adolescents (12 to \< 18 years of age) with human immunodeficiency virus (HIV) received elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) (150/150/200/10 mg) fixed-dose combination (FDC) tablets, once daily orally with food for 48 weeks. Participants who completed 48 weeks of study treatment had the option to receive E/C/F/TAF in an extension phase of the study until: a) the participant turned 18 years old and E/C/F/TAF was commercially available for adults in the country in which the participant was enrolled; b) age-appropriate E/C/F/TAF became commercially available in participant's country.
PK Parameter: AUCtau of FTC, TFV, and COBI (Cohort 1) FTC	14424.4 hr*ng/mL Standard Deviation 3452.88
PK Parameter: AUCtau of FTC, TFV, and COBI (Cohort 1) TFV	287.6 hr*ng/mL Standard Deviation 54.09
PK Parameter: AUCtau of FTC, TFV, and COBI (Cohort 1) COBI	8240.8 hr*ng/mL Standard Deviation 2972.94

SECONDARY outcome

Timeframe: 0 (pre-dose, ≤ 30 minutes prior to dosing), 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 8, and 24 hours post-dose at Week 4

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

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

Outcome measures

Measure	Cohort 1: Age 12 to < 18 Years and Weight ≥ 35 kg n=23 Participants Treatment naive adolescents (12 to \< 18 years of age) with human immunodeficiency virus (HIV) received elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) (150/150/200/10 mg) fixed-dose combination (FDC) tablets, once daily orally with food for 48 weeks. Participants who completed 48 weeks of study treatment had the option to receive E/C/F/TAF in an extension phase of the study until: a) the participant turned 18 years old and E/C/F/TAF was commercially available for adults in the country in which the participant was enrolled; b) age-appropriate E/C/F/TAF became commercially available in participant's country.
PK Parameter: AUCtau of FTC, TFV, and COBI (Cohort 2) FTC	20629.2 hr*ng/mL Standard Deviation 3906.01
PK Parameter: AUCtau of FTC, TFV, and COBI (Cohort 2) TFV	440.2 hr*ng/mL Standard Deviation 92.13
PK Parameter: AUCtau of FTC, TFV, and COBI (Cohort 2) COBI	15890.7 hr*ng/mL Standard Deviation 8208.78

SECONDARY outcome

Timeframe: 0 (pre-dose, ≤ 30 minutes prior to dosing), 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, and 8 hours post-dose at Week 2

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

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

Outcome measures

Measure	Cohort 1: Age 12 to < 18 Years and Weight ≥ 35 kg n=27 Participants Treatment naive adolescents (12 to \< 18 years of age) with human immunodeficiency virus (HIV) received elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) (150/150/200/10 mg) fixed-dose combination (FDC) tablets, once daily orally with food for 48 weeks. Participants who completed 48 weeks of study treatment had the option to receive E/C/F/TAF in an extension phase of the study until: a) the participant turned 18 years old and E/C/F/TAF was commercially available for adults in the country in which the participant was enrolled; b) age-appropriate E/C/F/TAF became commercially available in participant's country.
PK Parameter: AUCtau of FTC, TFV, and COBI (Cohort 3) FTC	19468.1 hr*ng/mL Standard Deviation 5635.74
PK Parameter: AUCtau of FTC, TFV, and COBI (Cohort 3) TFV	334.9 hr*ng/mL Standard Deviation 76.77
PK Parameter: AUCtau of FTC, TFV, and COBI (Cohort 3) COBI	14485.2 hr*ng/mL Standard Deviation 7166.10

SECONDARY outcome

Timeframe: Week 24

Population: The Full analysis set included all participants who were enrolled in the study and had received at least 1 dose of study drug.

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

Cohort 1: Age 12 to < 18 Years and Weight ≥ 35 kg n=50 Participants Treatment naive adolescents (12 to \< 18 years of age) with human immunodeficiency virus (HIV) received elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) (150/150/200/10 mg) fixed-dose combination (FDC) tablets, once daily orally with food for 48 weeks. Participants who completed 48 weeks of study treatment had the option to receive E/C/F/TAF in an extension phase of the study until: a) the participant turned 18 years old and E/C/F/TAF was commercially available for adults in the country in which the participant was enrolled; b) age-appropriate E/C/F/TAF became commercially available in participant's country.

Cohort 1: Percentage of Participants With Plasma HIV-1 RNA < 50 Copies/mL at Week 24, as Defined by the FDA Snapshot Analysis

90.0 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 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

Cohort 1: Age 12 to < 18 Years and Weight ≥ 35 kg n=50 Participants Treatment naive adolescents (12 to \< 18 years of age) with human immunodeficiency virus (HIV) received elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) (150/150/200/10 mg) fixed-dose combination (FDC) tablets, once daily orally with food for 48 weeks. Participants who completed 48 weeks of study treatment had the option to receive E/C/F/TAF in an extension phase of the study until: a) the participant turned 18 years old and E/C/F/TAF was commercially available for adults in the country in which the participant was enrolled; b) age-appropriate E/C/F/TAF became commercially available in participant's country.

Cohort 1: Percentage of Participants With Plasma HIV-1 RNA < 50 Copies/mL at Week 48, as Defined by the FDA Snapshot Analysis

92.0 percentage of participants

SECONDARY outcome

Timeframe: Week 24

Population: Participants in the Full Analysis Set were analyzed.

The percentage of participants with HIV-1 RNA < 400 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

Cohort 1: Age 12 to < 18 Years and Weight ≥ 35 kg n=50 Participants Treatment naive adolescents (12 to \< 18 years of age) with human immunodeficiency virus (HIV) received elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) (150/150/200/10 mg) fixed-dose combination (FDC) tablets, once daily orally with food for 48 weeks. Participants who completed 48 weeks of study treatment had the option to receive E/C/F/TAF in an extension phase of the study until: a) the participant turned 18 years old and E/C/F/TAF was commercially available for adults in the country in which the participant was enrolled; b) age-appropriate E/C/F/TAF became commercially available in participant's country.

Cohort 1: Percentage of Participants With Plasma HIV-1 RNA < 400 Copies/mL at Week 24, as Defined by the FDA Snapshot Analysis

94.0 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 < 400 Copies/mL at Weeks 24 and 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

Cohort 1: Age 12 to < 18 Years and Weight ≥ 35 kg n=50 Participants Treatment naive adolescents (12 to \< 18 years of age) with human immunodeficiency virus (HIV) received elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) (150/150/200/10 mg) fixed-dose combination (FDC) tablets, once daily orally with food for 48 weeks. Participants who completed 48 weeks of study treatment had the option to receive E/C/F/TAF in an extension phase of the study until: a) the participant turned 18 years old and E/C/F/TAF was commercially available for adults in the country in which the participant was enrolled; b) age-appropriate E/C/F/TAF became commercially available in participant's country.

Cohort 1: Percentage of Participants With Plasma HIV-1 RNA < 400 Copies/mL at Week 48, as Defined by the FDA Snapshot Analysis

94.0 percentage of participants

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 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

Cohort 1: Age 12 to < 18 Years and Weight ≥ 35 kg n=52 Participants Treatment naive adolescents (12 to \< 18 years of age) with human immunodeficiency virus (HIV) received elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) (150/150/200/10 mg) fixed-dose combination (FDC) tablets, once daily orally with food for 48 weeks. Participants who completed 48 weeks of study treatment had the option to receive E/C/F/TAF in an extension phase of the study until: a) the participant turned 18 years old and E/C/F/TAF was commercially available for adults in the country in which the participant was enrolled; b) age-appropriate E/C/F/TAF became commercially available in participant's country.

Cohort 2: Percentage of Participants With Plasma HIV-1 RNA < 50 Copies/mL at Week 24, as Defined by the FDA Snapshot Analysis

100.0 percentage of participants Interval 93.2 to 100.0

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 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

Cohort 1: Age 12 to < 18 Years and Weight ≥ 35 kg n=52 Participants Treatment naive adolescents (12 to \< 18 years of age) with human immunodeficiency virus (HIV) received elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) (150/150/200/10 mg) fixed-dose combination (FDC) tablets, once daily orally with food for 48 weeks. Participants who completed 48 weeks of study treatment had the option to receive E/C/F/TAF in an extension phase of the study until: a) the participant turned 18 years old and E/C/F/TAF was commercially available for adults in the country in which the participant was enrolled; b) age-appropriate E/C/F/TAF became commercially available in participant's country.

Cohort 2: Percentage of Participants With Plasma HIV-1 RNA < 50 Copies/mL at Week 48, as Defined by the FDA Snapshot Analysis

98.1 percentage of participants Interval 89.7 to 100.0

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 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

Cohort 1: Age 12 to < 18 Years and Weight ≥ 35 kg n=27 Participants Treatment naive adolescents (12 to \< 18 years of age) with human immunodeficiency virus (HIV) received elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) (150/150/200/10 mg) fixed-dose combination (FDC) tablets, once daily orally with food for 48 weeks. Participants who completed 48 weeks of study treatment had the option to receive E/C/F/TAF in an extension phase of the study until: a) the participant turned 18 years old and E/C/F/TAF was commercially available for adults in the country in which the participant was enrolled; b) age-appropriate E/C/F/TAF became commercially available in participant's country.

Cohort 3: Percentage of Participants With Plasma HIV-1 RNA < 50 Copies/mL at Week 24, as Defined by the FDA Snapshot Analysis

96.3 percentage of participants Interval 81.0 to 99.9

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 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

Cohort 1: Age 12 to < 18 Years and Weight ≥ 35 kg n=27 Participants Treatment naive adolescents (12 to \< 18 years of age) with human immunodeficiency virus (HIV) received elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) (150/150/200/10 mg) fixed-dose combination (FDC) tablets, once daily orally with food for 48 weeks. Participants who completed 48 weeks of study treatment had the option to receive E/C/F/TAF in an extension phase of the study until: a) the participant turned 18 years old and E/C/F/TAF was commercially available for adults in the country in which the participant was enrolled; b) age-appropriate E/C/F/TAF became commercially available in participant's country.

Cohort 3: Percentage of Participants With Plasma HIV-1 RNA < 50 Copies/mL at Week 48, as Defined by the FDA Snapshot Analysis

96.3 percentage of participants Interval 81.0 to 99.9

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 based on missing = failure analyses.

Outcome measures

Measure

Cohort 1: Age 12 to < 18 Years and Weight ≥ 35 kg n=50 Participants Treatment naive adolescents (12 to \< 18 years of age) with human immunodeficiency virus (HIV) received elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) (150/150/200/10 mg) fixed-dose combination (FDC) tablets, once daily orally with food for 48 weeks. Participants who completed 48 weeks of study treatment had the option to receive E/C/F/TAF in an extension phase of the study until: a) the participant turned 18 years old and E/C/F/TAF was commercially available for adults in the country in which the participant was enrolled; b) age-appropriate E/C/F/TAF became commercially available in participant's country.

Cohort 1: Percentage of Participants With Plasma HIV-1 RNA < 50 Copies/mL at Week 24, Based on Missing = Failure Analyses

90.0 percentage of participants Interval 78.2 to 96.7

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 based on missing = failure analyses.

Outcome measures

Measure

Cohort 1: Age 12 to < 18 Years and Weight ≥ 35 kg n=50 Participants Treatment naive adolescents (12 to \< 18 years of age) with human immunodeficiency virus (HIV) received elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) (150/150/200/10 mg) fixed-dose combination (FDC) tablets, once daily orally with food for 48 weeks. Participants who completed 48 weeks of study treatment had the option to receive E/C/F/TAF in an extension phase of the study until: a) the participant turned 18 years old and E/C/F/TAF was commercially available for adults in the country in which the participant was enrolled; b) age-appropriate E/C/F/TAF became commercially available in participant's country.

Cohort 1: Percentage of Participants With Plasma HIV-1 RNA < 50 Copies/mL at Week 48, Based on Missing = Failure Analyses

92.0 percentage of participants Interval 80.8 to 97.8

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 based on missing = failure analyses.

Outcome measures

Measure

Cohort 1: Age 12 to < 18 Years and Weight ≥ 35 kg n=50 Participants Treatment naive adolescents (12 to \< 18 years of age) with human immunodeficiency virus (HIV) received elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) (150/150/200/10 mg) fixed-dose combination (FDC) tablets, once daily orally with food for 48 weeks. Participants who completed 48 weeks of study treatment had the option to receive E/C/F/TAF in an extension phase of the study until: a) the participant turned 18 years old and E/C/F/TAF was commercially available for adults in the country in which the participant was enrolled; b) age-appropriate E/C/F/TAF became commercially available in participant's country.

Cohort 1: Percentage of Participants With Plasma HIV-1 RNA < 400 Copies/mL at Week 24, Based on Missing = Failure Analyses

94.0 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 < 400 copies/mL at Week 48 was analyzed based on missing = failure analyses.

Outcome measures

Measure

Cohort 1: Age 12 to < 18 Years and Weight ≥ 35 kg n=50 Participants Treatment naive adolescents (12 to \< 18 years of age) with human immunodeficiency virus (HIV) received elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) (150/150/200/10 mg) fixed-dose combination (FDC) tablets, once daily orally with food for 48 weeks. Participants who completed 48 weeks of study treatment had the option to receive E/C/F/TAF in an extension phase of the study until: a) the participant turned 18 years old and E/C/F/TAF was commercially available for adults in the country in which the participant was enrolled; b) age-appropriate E/C/F/TAF became commercially available in participant's country.

Cohort 1: Percentage of Participants With Plasma HIV-1 RNA < 400 Copies/mL at Week 48, Based on Missing = Failure Analyses

94.0 percentage of participants

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 based on missing = failure analyses.

Outcome measures

Measure

Cohort 1: Age 12 to < 18 Years and Weight ≥ 35 kg n=52 Participants Treatment naive adolescents (12 to \< 18 years of age) with human immunodeficiency virus (HIV) received elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) (150/150/200/10 mg) fixed-dose combination (FDC) tablets, once daily orally with food for 48 weeks. Participants who completed 48 weeks of study treatment had the option to receive E/C/F/TAF in an extension phase of the study until: a) the participant turned 18 years old and E/C/F/TAF was commercially available for adults in the country in which the participant was enrolled; b) age-appropriate E/C/F/TAF became commercially available in participant's country.

Cohort 2: Percentage of Participants With Plasma HIV-1 RNA < 50 Copies/mL at Week 24, Based on Missing = Failure Analyses

100.0 percentage of participants Interval 93.2 to 100.0

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 based on missing = failure analyses.

Outcome measures

Measure

Cohort 1: Age 12 to < 18 Years and Weight ≥ 35 kg n=52 Participants Treatment naive adolescents (12 to \< 18 years of age) with human immunodeficiency virus (HIV) received elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) (150/150/200/10 mg) fixed-dose combination (FDC) tablets, once daily orally with food for 48 weeks. Participants who completed 48 weeks of study treatment had the option to receive E/C/F/TAF in an extension phase of the study until: a) the participant turned 18 years old and E/C/F/TAF was commercially available for adults in the country in which the participant was enrolled; b) age-appropriate E/C/F/TAF became commercially available in participant's country.

Cohort 2: Percentage of Participants With Plasma HIV-1 RNA < 50 Copies/mL at Week 48, Based on Missing = Failure Analyses

100.0 percentage of participants Interval 93.2 to 100.0

SECONDARY outcome

Timeframe: Week 24

Population: Participants in the Full Analysis Set were analyzed.

The percentage of participants with HIV-1 RNA < 400 copies/mL at Week 24 was analyzed based on missing = failure analyses.

Outcome measures

Measure

Cohort 1: Age 12 to < 18 Years and Weight ≥ 35 kg n=52 Participants Treatment naive adolescents (12 to \< 18 years of age) with human immunodeficiency virus (HIV) received elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) (150/150/200/10 mg) fixed-dose combination (FDC) tablets, once daily orally with food for 48 weeks. Participants who completed 48 weeks of study treatment had the option to receive E/C/F/TAF in an extension phase of the study until: a) the participant turned 18 years old and E/C/F/TAF was commercially available for adults in the country in which the participant was enrolled; b) age-appropriate E/C/F/TAF became commercially available in participant's country.

Cohort 2: Percentage of Participants With Plasma HIV-1 RNA < 400 Copies/mL at Week 24, Based on Missing = Failure Analyses

100.0 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 < 400 copies/mL at Week 48 was analyzed based on missing = failure analyses.

Outcome measures

Measure

Cohort 1: Age 12 to < 18 Years and Weight ≥ 35 kg n=52 Participants Treatment naive adolescents (12 to \< 18 years of age) with human immunodeficiency virus (HIV) received elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) (150/150/200/10 mg) fixed-dose combination (FDC) tablets, once daily orally with food for 48 weeks. Participants who completed 48 weeks of study treatment had the option to receive E/C/F/TAF in an extension phase of the study until: a) the participant turned 18 years old and E/C/F/TAF was commercially available for adults in the country in which the participant was enrolled; b) age-appropriate E/C/F/TAF became commercially available in participant's country.

Cohort 2: Percentage of Participants With Plasma HIV-1 RNA < 400 Copies/mL at Week 48, Based on Missing = Failure Analyses

100.0 percentage of participants

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 based on missing = failure analyses.

Outcome measures

Measure

Cohort 1: Age 12 to < 18 Years and Weight ≥ 35 kg n=27 Participants Treatment naive adolescents (12 to \< 18 years of age) with human immunodeficiency virus (HIV) received elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) (150/150/200/10 mg) fixed-dose combination (FDC) tablets, once daily orally with food for 48 weeks. Participants who completed 48 weeks of study treatment had the option to receive E/C/F/TAF in an extension phase of the study until: a) the participant turned 18 years old and E/C/F/TAF was commercially available for adults in the country in which the participant was enrolled; b) age-appropriate E/C/F/TAF became commercially available in participant's country.

Cohort 3: Percentage of Participants With Plasma HIV-1 RNA < 50 Copies/mL at Week 24, Based on Missing = Failure Analyses

96.3 percentage of participants Interval 81.0 to 99.9

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 based on missing = failure analyses.

Outcome measures

Measure

Cohort 1: Age 12 to < 18 Years and Weight ≥ 35 kg n=27 Participants Treatment naive adolescents (12 to \< 18 years of age) with human immunodeficiency virus (HIV) received elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) (150/150/200/10 mg) fixed-dose combination (FDC) tablets, once daily orally with food for 48 weeks. Participants who completed 48 weeks of study treatment had the option to receive E/C/F/TAF in an extension phase of the study until: a) the participant turned 18 years old and E/C/F/TAF was commercially available for adults in the country in which the participant was enrolled; b) age-appropriate E/C/F/TAF became commercially available in participant's country.

Cohort 3: Percentage of Participants With Plasma HIV-1 RNA < 50 Copies/mL at Week 48, Based on Missing = Failure Analyses

96.3 percentage of participants Interval 81.0 to 99.9

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 based on missing = excluded analyses.

Outcome measures

Measure

Cohort 1: Age 12 to < 18 Years and Weight ≥ 35 kg n=48 Participants Treatment naive adolescents (12 to \< 18 years of age) with human immunodeficiency virus (HIV) received elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) (150/150/200/10 mg) fixed-dose combination (FDC) tablets, once daily orally with food for 48 weeks. Participants who completed 48 weeks of study treatment had the option to receive E/C/F/TAF in an extension phase of the study until: a) the participant turned 18 years old and E/C/F/TAF was commercially available for adults in the country in which the participant was enrolled; b) age-appropriate E/C/F/TAF became commercially available in participant's country.

Cohort 1: Percentage of Participants With Plasma HIV-1 RNA < 50 Copies/mL at Week 24, Based on Missing = Excluded Analyses

93.8 percentage of participants Interval 82.8 to 98.7

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 based on missing = excluded analyses.

Outcome measures

Measure

Cohort 1: Age 12 to < 18 Years and Weight ≥ 35 kg n=48 Participants Treatment naive adolescents (12 to \< 18 years of age) with human immunodeficiency virus (HIV) received elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) (150/150/200/10 mg) fixed-dose combination (FDC) tablets, once daily orally with food for 48 weeks. Participants who completed 48 weeks of study treatment had the option to receive E/C/F/TAF in an extension phase of the study until: a) the participant turned 18 years old and E/C/F/TAF was commercially available for adults in the country in which the participant was enrolled; b) age-appropriate E/C/F/TAF became commercially available in participant's country.

Cohort 1: Percentage of Participants With Plasma HIV-1 RNA < 50 Copies/mL at Week 48, Based on Missing = Excluded Analyses

95.8 percentage of participants Interval 85.7 to 99.5

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 < 400 copies/mL at Week 24 was analyzed based on missing = excluded analyses.

Outcome measures

Measure

Cohort 1: Age 12 to < 18 Years and Weight ≥ 35 kg n=48 Participants Treatment naive adolescents (12 to \< 18 years of age) with human immunodeficiency virus (HIV) received elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) (150/150/200/10 mg) fixed-dose combination (FDC) tablets, once daily orally with food for 48 weeks. Participants who completed 48 weeks of study treatment had the option to receive E/C/F/TAF in an extension phase of the study until: a) the participant turned 18 years old and E/C/F/TAF was commercially available for adults in the country in which the participant was enrolled; b) age-appropriate E/C/F/TAF became commercially available in participant's country.

Cohort 1: Percentage of Participants With Plasma HIV-1 RNA < 400 Copies/mL at Week 24, Based on Missing = Excluded Analyses

97.9 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 < 400 copies/mL at Week 48 was analyzed based on missing = excluded analyses.

Outcome measures

Measure

Cohort 1: Age 12 to < 18 Years and Weight ≥ 35 kg n=48 Participants Treatment naive adolescents (12 to \< 18 years of age) with human immunodeficiency virus (HIV) received elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) (150/150/200/10 mg) fixed-dose combination (FDC) tablets, once daily orally with food for 48 weeks. Participants who completed 48 weeks of study treatment had the option to receive E/C/F/TAF in an extension phase of the study until: a) the participant turned 18 years old and E/C/F/TAF was commercially available for adults in the country in which the participant was enrolled; b) age-appropriate E/C/F/TAF became commercially available in participant's country.

Cohort 1: Percentage of Participants With Plasma HIV-1 RNA < 400 Copies/mL at Week 48, Based on Missing = Excluded Analyses

97.9 percentage of participants

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 based on missing = excluded analyses.

Outcome measures

Measure

Cohort 1: Age 12 to < 18 Years and Weight ≥ 35 kg n=52 Participants Treatment naive adolescents (12 to \< 18 years of age) with human immunodeficiency virus (HIV) received elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) (150/150/200/10 mg) fixed-dose combination (FDC) tablets, once daily orally with food for 48 weeks. Participants who completed 48 weeks of study treatment had the option to receive E/C/F/TAF in an extension phase of the study until: a) the participant turned 18 years old and E/C/F/TAF was commercially available for adults in the country in which the participant was enrolled; b) age-appropriate E/C/F/TAF became commercially available in participant's country.

Cohort 2: Percentage of Participants With Plasma HIV-1 RNA < 50 Copies/mL at Week 24, Based on Missing = Excluded Analyses

100.0 percentage of participants Interval 93.2 to 100.0

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 based on missing = excluded analyses.

Outcome measures

Measure

Cohort 1: Age 12 to < 18 Years and Weight ≥ 35 kg n=52 Participants Treatment naive adolescents (12 to \< 18 years of age) with human immunodeficiency virus (HIV) received elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) (150/150/200/10 mg) fixed-dose combination (FDC) tablets, once daily orally with food for 48 weeks. Participants who completed 48 weeks of study treatment had the option to receive E/C/F/TAF in an extension phase of the study until: a) the participant turned 18 years old and E/C/F/TAF was commercially available for adults in the country in which the participant was enrolled; b) age-appropriate E/C/F/TAF became commercially available in participant's country.

Cohort 2: Percentage of Participants With Plasma HIV-1 RNA < 50 Copies/mL at Week 48, Based on Missing = Excluded Analyses

100.0 percentage of participants Interval 93.2 to 100.0

SECONDARY outcome

Timeframe: Week 24

Population: Participants in the Full Analysis Set were analyzed.

The percentage of participants with HIV-1 RNA < 400 copies/mL at Week 24 was analyzed based on missing = excluded analyses.

Outcome measures

Measure

Cohort 1: Age 12 to < 18 Years and Weight ≥ 35 kg n=52 Participants Treatment naive adolescents (12 to \< 18 years of age) with human immunodeficiency virus (HIV) received elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) (150/150/200/10 mg) fixed-dose combination (FDC) tablets, once daily orally with food for 48 weeks. Participants who completed 48 weeks of study treatment had the option to receive E/C/F/TAF in an extension phase of the study until: a) the participant turned 18 years old and E/C/F/TAF was commercially available for adults in the country in which the participant was enrolled; b) age-appropriate E/C/F/TAF became commercially available in participant's country.

Cohort 2: Percentage of Participants With Plasma HIV-1 RNA < 400 Copies/mL at Week 24, Based on Missing = Excluded Analyses

100.0 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 < 400 copies/mL at Week 48 was analyzed based on missing = excluded analyses.

Outcome measures

Measure

Cohort 1: Age 12 to < 18 Years and Weight ≥ 35 kg n=52 Participants Treatment naive adolescents (12 to \< 18 years of age) with human immunodeficiency virus (HIV) received elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) (150/150/200/10 mg) fixed-dose combination (FDC) tablets, once daily orally with food for 48 weeks. Participants who completed 48 weeks of study treatment had the option to receive E/C/F/TAF in an extension phase of the study until: a) the participant turned 18 years old and E/C/F/TAF was commercially available for adults in the country in which the participant was enrolled; b) age-appropriate E/C/F/TAF became commercially available in participant's country.

Cohort 2: Percentage of Participants With Plasma HIV-1 RNA < 400 Copies/mL at Week 48, Based on Missing = Excluded Analyses

100.0 percentage of participants

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 based on missing = excluded analyses.

Outcome measures

Measure

Cohort 1: Age 12 to < 18 Years and Weight ≥ 35 kg n=27 Participants Treatment naive adolescents (12 to \< 18 years of age) with human immunodeficiency virus (HIV) received elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) (150/150/200/10 mg) fixed-dose combination (FDC) tablets, once daily orally with food for 48 weeks. Participants who completed 48 weeks of study treatment had the option to receive E/C/F/TAF in an extension phase of the study until: a) the participant turned 18 years old and E/C/F/TAF was commercially available for adults in the country in which the participant was enrolled; b) age-appropriate E/C/F/TAF became commercially available in participant's country.

Cohort 3: Percentage of Participants With Plasma HIV-1 RNA < 50 Copies/mL at Week 24, Based on Missing = Excluded Analyses

96.3 percentage of participants Interval 81.0 to 99.9

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 based on missing = excluded analyses.

Outcome measures

Measure

Cohort 1: Age 12 to < 18 Years and Weight ≥ 35 kg n=27 Participants Treatment naive adolescents (12 to \< 18 years of age) with human immunodeficiency virus (HIV) received elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) (150/150/200/10 mg) fixed-dose combination (FDC) tablets, once daily orally with food for 48 weeks. Participants who completed 48 weeks of study treatment had the option to receive E/C/F/TAF in an extension phase of the study until: a) the participant turned 18 years old and E/C/F/TAF was commercially available for adults in the country in which the participant was enrolled; b) age-appropriate E/C/F/TAF became commercially available in participant's country.

Cohort 3: Percentage of Participants With Plasma HIV-1 RNA < 50 Copies/mL at Week 48, Based on Missing = Excluded Analyses

96.3 percentage of participants Interval 81.0 to 99.9

SECONDARY outcome

Timeframe: Baseline, Week 24

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

Outcome measures

Measure	Cohort 1: Age 12 to < 18 Years and Weight ≥ 35 kg n=50 Participants Treatment naive adolescents (12 to \< 18 years of age) with human immunodeficiency virus (HIV) received elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) (150/150/200/10 mg) fixed-dose combination (FDC) tablets, once daily orally with food for 48 weeks. Participants who completed 48 weeks of study treatment had the option to receive E/C/F/TAF in an extension phase of the study until: a) the participant turned 18 years old and E/C/F/TAF was commercially available for adults in the country in which the participant was enrolled; b) age-appropriate E/C/F/TAF became commercially available in participant's country.
Cohort 1: Change From Baseline in Plasma log10 HIV-1 RNA at Week 24 Baseline	4.62 copies/mL Standard Deviation 0.587
Cohort 1: Change From Baseline in Plasma log10 HIV-1 RNA at Week 24 Change at Week 24	-3.25 copies/mL Standard Deviation 0.645

SECONDARY outcome

Timeframe: Baseline, Week 48

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

Outcome measures

Measure	Cohort 1: Age 12 to < 18 Years and Weight ≥ 35 kg n=50 Participants Treatment naive adolescents (12 to \< 18 years of age) with human immunodeficiency virus (HIV) received elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) (150/150/200/10 mg) fixed-dose combination (FDC) tablets, once daily orally with food for 48 weeks. Participants who completed 48 weeks of study treatment had the option to receive E/C/F/TAF in an extension phase of the study until: a) the participant turned 18 years old and E/C/F/TAF was commercially available for adults in the country in which the participant was enrolled; b) age-appropriate E/C/F/TAF became commercially available in participant's country.
Cohort 1: Change From Baseline in Plasma log10 HIV-1 RNA at Week 48 Baseline	4.62 copies/mL Standard Deviation 0.587
Cohort 1: Change From Baseline in Plasma log10 HIV-1 RNA at Week 48 Change at Week 48	-3.26 copies/mL Standard Deviation 0.712

SECONDARY outcome

Timeframe: Baseline, Week 24

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

Outcome measures

Measure	Cohort 1: Age 12 to < 18 Years and Weight ≥ 35 kg n=50 Participants Treatment naive adolescents (12 to \< 18 years of age) with human immunodeficiency virus (HIV) received elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) (150/150/200/10 mg) fixed-dose combination (FDC) tablets, once daily orally with food for 48 weeks. Participants who completed 48 weeks of study treatment had the option to receive E/C/F/TAF in an extension phase of the study until: a) the participant turned 18 years old and E/C/F/TAF was commercially available for adults in the country in which the participant was enrolled; b) age-appropriate E/C/F/TAF became commercially available in participant's country.
Cohort 1: Change From Baseline in Cluster of Differentiation (CD4+) Cell Count at Week 24 Baseline	471 cells/μL Standard Deviation 212.2
Cohort 1: Change From Baseline in Cluster of Differentiation (CD4+) Cell Count at Week 24 Change at Week 24	191 cells/μL Standard Deviation 175.2

SECONDARY outcome

Timeframe: Baseline, Week 48

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

Outcome measures

Measure	Cohort 1: Age 12 to < 18 Years and Weight ≥ 35 kg n=50 Participants Treatment naive adolescents (12 to \< 18 years of age) with human immunodeficiency virus (HIV) received elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) (150/150/200/10 mg) fixed-dose combination (FDC) tablets, once daily orally with food for 48 weeks. Participants who completed 48 weeks of study treatment had the option to receive E/C/F/TAF in an extension phase of the study until: a) the participant turned 18 years old and E/C/F/TAF was commercially available for adults in the country in which the participant was enrolled; b) age-appropriate E/C/F/TAF became commercially available in participant's country.
Cohort 1: Change From Baseline in CD4+ Cell Count at Week 48 Baseline	471 cells/μL Standard Deviation 212.2
Cohort 1: Change From Baseline in CD4+ Cell Count at Week 48 Change at Week 48	224 cells/μL Standard Deviation 170.3

SECONDARY outcome

Timeframe: Baseline, Week 24

Population: Participants in the Full Analysis Set were analyzed.

Outcome measures

Measure	Cohort 1: Age 12 to < 18 Years and Weight ≥ 35 kg n=52 Participants Treatment naive adolescents (12 to \< 18 years of age) with human immunodeficiency virus (HIV) received elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) (150/150/200/10 mg) fixed-dose combination (FDC) tablets, once daily orally with food for 48 weeks. Participants who completed 48 weeks of study treatment had the option to receive E/C/F/TAF in an extension phase of the study until: a) the participant turned 18 years old and E/C/F/TAF was commercially available for adults in the country in which the participant was enrolled; b) age-appropriate E/C/F/TAF became commercially available in participant's country.
Cohort 2: Change From Baseline in CD4+ Cell Count at Week 24 Baseline	961 cells/μL Standard Deviation 275.5
Cohort 2: Change From Baseline in CD4+ Cell Count at Week 24 Change at Week 24	-118 cells/μL Standard Deviation 194.1

SECONDARY outcome

Timeframe: Baseline, Week 48

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

Outcome measures

Measure	Cohort 1: Age 12 to < 18 Years and Weight ≥ 35 kg n=52 Participants Treatment naive adolescents (12 to \< 18 years of age) with human immunodeficiency virus (HIV) received elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) (150/150/200/10 mg) fixed-dose combination (FDC) tablets, once daily orally with food for 48 weeks. Participants who completed 48 weeks of study treatment had the option to receive E/C/F/TAF in an extension phase of the study until: a) the participant turned 18 years old and E/C/F/TAF was commercially available for adults in the country in which the participant was enrolled; b) age-appropriate E/C/F/TAF became commercially available in participant's country.
Cohort 2: Change From Baseline in CD4+ Cell Count at Week 48 Baseline	961 cells/µL Standard Deviation 275.5
Cohort 2: Change From Baseline in CD4+ Cell Count at Week 48 Change at Week 48	-66 cells/µL Standard Deviation 203.6

SECONDARY outcome

Timeframe: Baseline, Week 24

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

Outcome measures

Measure	Cohort 1: Age 12 to < 18 Years and Weight ≥ 35 kg n=27 Participants Treatment naive adolescents (12 to \< 18 years of age) with human immunodeficiency virus (HIV) received elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) (150/150/200/10 mg) fixed-dose combination (FDC) tablets, once daily orally with food for 48 weeks. Participants who completed 48 weeks of study treatment had the option to receive E/C/F/TAF in an extension phase of the study until: a) the participant turned 18 years old and E/C/F/TAF was commercially available for adults in the country in which the participant was enrolled; b) age-appropriate E/C/F/TAF became commercially available in participant's country.
Cohort 3: Change From Baseline in CD4+ Cell Count at Week 24 Baseline	1153 cells/μL Standard Deviation 459.9
Cohort 3: Change From Baseline in CD4+ Cell Count at Week 24 Change at Week 24	-137 cells/μL Standard Deviation 278.3

SECONDARY outcome

Timeframe: Baseline, Week 48

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

Outcome measures

Measure	Cohort 1: Age 12 to < 18 Years and Weight ≥ 35 kg n=27 Participants Treatment naive adolescents (12 to \< 18 years of age) with human immunodeficiency virus (HIV) received elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) (150/150/200/10 mg) fixed-dose combination (FDC) tablets, once daily orally with food for 48 weeks. Participants who completed 48 weeks of study treatment had the option to receive E/C/F/TAF in an extension phase of the study until: a) the participant turned 18 years old and E/C/F/TAF was commercially available for adults in the country in which the participant was enrolled; b) age-appropriate E/C/F/TAF became commercially available in participant's country.
Cohort 3: Change From Baseline in CD4+ Cell Count at Week 48 Baseline	1153 cells/µL Standard Deviation 459.9
Cohort 3: Change From Baseline in CD4+ Cell Count at Week 48 Change at Week 48	-179 cells/µL Standard Deviation 319.2

SECONDARY outcome

Timeframe: Baseline, Week 24

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

Outcome measures

Measure	Cohort 1: Age 12 to < 18 Years and Weight ≥ 35 kg n=50 Participants Treatment naive adolescents (12 to \< 18 years of age) with human immunodeficiency virus (HIV) received elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) (150/150/200/10 mg) fixed-dose combination (FDC) tablets, once daily orally with food for 48 weeks. Participants who completed 48 weeks of study treatment had the option to receive E/C/F/TAF in an extension phase of the study until: a) the participant turned 18 years old and E/C/F/TAF was commercially available for adults in the country in which the participant was enrolled; b) age-appropriate E/C/F/TAF became commercially available in participant's country.
Cohort 1: Change From Baseline in CD4+ Cell Percentage at Week 24 Baseline	23.6 percentage of CD4+ cell Standard Deviation 8.80
Cohort 1: Change From Baseline in CD4+ Cell Percentage at Week 24 Change at Week 24	7.7 percentage of CD4+ cell Standard Deviation 4.77

SECONDARY outcome

Timeframe: Baseline, Week 48

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

Outcome measures

Measure	Cohort 1: Age 12 to < 18 Years and Weight ≥ 35 kg n=50 Participants Treatment naive adolescents (12 to \< 18 years of age) with human immunodeficiency virus (HIV) received elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) (150/150/200/10 mg) fixed-dose combination (FDC) tablets, once daily orally with food for 48 weeks. Participants who completed 48 weeks of study treatment had the option to receive E/C/F/TAF in an extension phase of the study until: a) the participant turned 18 years old and E/C/F/TAF was commercially available for adults in the country in which the participant was enrolled; b) age-appropriate E/C/F/TAF became commercially available in participant's country.
Cohort 1: Change From Baseline in CD4+ Cell Percentage at Week 48 Baseline	23.6 percentage of CD4+ cell Standard Deviation 8.80
Cohort 1: Change From Baseline in CD4+ Cell Percentage at Week 48 Change at Week 48	9.3 percentage of CD4+ cell Standard Deviation 5.19

SECONDARY outcome

Timeframe: Baseline, Week 24

Population: Participants in the Full Analysis Set were analyzed.

Outcome measures

Measure	Cohort 1: Age 12 to < 18 Years and Weight ≥ 35 kg n=52 Participants Treatment naive adolescents (12 to \< 18 years of age) with human immunodeficiency virus (HIV) received elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) (150/150/200/10 mg) fixed-dose combination (FDC) tablets, once daily orally with food for 48 weeks. Participants who completed 48 weeks of study treatment had the option to receive E/C/F/TAF in an extension phase of the study until: a) the participant turned 18 years old and E/C/F/TAF was commercially available for adults in the country in which the participant was enrolled; b) age-appropriate E/C/F/TAF became commercially available in participant's country.
Cohort 2: Change From Baseline in CD4+ Cell Percentage at Week 24 Baseline	38.2 percentage of CD4+ cell Standard Deviation 6.44
Cohort 2: Change From Baseline in CD4+ Cell Percentage at Week 24 Change at Week 24	-0.8 percentage of CD4+ cell Standard Deviation 3.97

SECONDARY outcome

Timeframe: Baseline, Week 48

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

Outcome measures

Measure	Cohort 1: Age 12 to < 18 Years and Weight ≥ 35 kg n=52 Participants Treatment naive adolescents (12 to \< 18 years of age) with human immunodeficiency virus (HIV) received elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) (150/150/200/10 mg) fixed-dose combination (FDC) tablets, once daily orally with food for 48 weeks. Participants who completed 48 weeks of study treatment had the option to receive E/C/F/TAF in an extension phase of the study until: a) the participant turned 18 years old and E/C/F/TAF was commercially available for adults in the country in which the participant was enrolled; b) age-appropriate E/C/F/TAF became commercially available in participant's country.
Cohort 2: Change From Baseline in CD4+ Cell Percentage at Week 48 Baseline	38.2 percentage of CD4+ cell Standard Deviation 6.44
Cohort 2: Change From Baseline in CD4+ Cell Percentage at Week 48 Change at Week 48	-0.6 percentage of CD4+ cell Standard Deviation 4.37

SECONDARY outcome

Timeframe: Baseline, Week 24

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

Outcome measures

Measure	Cohort 1: Age 12 to < 18 Years and Weight ≥ 35 kg n=27 Participants Treatment naive adolescents (12 to \< 18 years of age) with human immunodeficiency virus (HIV) received elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) (150/150/200/10 mg) fixed-dose combination (FDC) tablets, once daily orally with food for 48 weeks. Participants who completed 48 weeks of study treatment had the option to receive E/C/F/TAF in an extension phase of the study until: a) the participant turned 18 years old and E/C/F/TAF was commercially available for adults in the country in which the participant was enrolled; b) age-appropriate E/C/F/TAF became commercially available in participant's country.
Cohort 3: Change From Baseline in CD4+ Cell Percentage at Week 24 Baseline	35.9 percentage of CD4+ cell Standard Deviation 6.73
Cohort 3: Change From Baseline in CD4+ Cell Percentage at Week 24 Change at Week 24	0.0 percentage of CD4+ cell Standard Deviation 4.40

SECONDARY outcome

Timeframe: Baseline, Week 48

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

Outcome measures

Measure	Cohort 1: Age 12 to < 18 Years and Weight ≥ 35 kg n=27 Participants Treatment naive adolescents (12 to \< 18 years of age) with human immunodeficiency virus (HIV) received elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) (150/150/200/10 mg) fixed-dose combination (FDC) tablets, once daily orally with food for 48 weeks. Participants who completed 48 weeks of study treatment had the option to receive E/C/F/TAF in an extension phase of the study until: a) the participant turned 18 years old and E/C/F/TAF was commercially available for adults in the country in which the participant was enrolled; b) age-appropriate E/C/F/TAF became commercially available in participant's country.
Cohort 3: Change From Baseline in CD4+ Cell Percentage at Week 48 Baseline	35.9 percentage of CD4+ cell Standard Deviation 6.73
Cohort 3: Change From Baseline in CD4+ Cell Percentage at Week 48 Change at Week 48	0.2 percentage of CD4+ cell Standard Deviation 3.78

Adverse Events

Cohort 1: Age 12 to < 18 Years and Weight ≥ 35 kg

Serious events: 10 serious events

Other events: 47 other events

Deaths: 1 deaths

Cohort 2: Age 6 to < 12 Years and Weight ≥ 25 kg

Serious events: 7 serious events

Other events: 45 other events

Deaths: 0 deaths

Cohort 3: Age ≥ 2 Years and Weight ≥ 14 to < 25 kg

Serious events: 1 serious events

Other events: 25 other events

Deaths: 0 deaths

Serious adverse events

Measure	Cohort 1: Age 12 to < 18 Years and Weight ≥ 35 kg n=50 participants at risk Treatment naive adolescents (12 to \< 18 years of age) with human immunodeficiency virus (HIV) received elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) (150/150/200/10 mg) fixed-dose combination (FDC) tablets, once daily orally with food for 48 weeks. Participants who completed 48 weeks of study treatment had the option to receive E/C/F/TAF in an extension phase of the study until: a) the participant turned 18 years old and E/C/F/TAF was commercially available for adults in the country in which the participant was enrolled; b) age-appropriate E/C/F/TAF became commercially available in participant's country.	Cohort 2: Age 6 to < 12 Years and Weight ≥ 25 kg n=52 participants at risk Children (6 to \< 12 years of age weighing ≥ 25 kg) with HIV who were virologically suppressed received E/C/F/TAF (150/150/200/10 mg) FDC tablets, once daily orally with food for 48 weeks. Participants who completed 48 weeks of study treatment had the option to receive E/C/F/TAF in an extension phase of the study until: a) the participant turned 18 years old and E/C/F/TAF was commercially available for adults in the country in which the participant was enrolled; b) age-appropriate E/C/F/TAF became commercially available in participant's country.	Cohort 3: Age ≥ 2 Years and Weight ≥ 14 to < 25 kg n=27 participants at risk Children (≥ 2 years of age weighing ≥ 14 to \< 25 kg) with HIV who were virologically suppressed received E/C/F/TAF (90/90/120/6 mg) FDC tablets, once daily orally with food for 48 weeks. Participants who attained a weight of ≥ 25 kg during the course of the study were switched to adult E/C/F/TAF (150/150/200/10 mg) tablets administered orally, once daily with food. Participants who completed 48 weeks of study treatment had the option to receive E/C/F/TAF in an extension phase of the study until: a) the participant turned 18 years old and E/C/F/TAF was commercially available for adults in the country in which the participant was enrolled; b) age-appropriate E/C/F/TAF became commercially available in participant's country.
Eye disorders Uveitis	2.0% 1/50 • Up to 583 Weeks The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/52 • Up to 583 Weeks The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/27 • Up to 583 Weeks The Safety Analysis Set included all participants who received at least 1 dose of study drug.
Eye disorders Visual impairment	2.0% 1/50 • Up to 583 Weeks The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/52 • Up to 583 Weeks The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/27 • Up to 583 Weeks The Safety Analysis Set included all participants who received at least 1 dose of study drug.
Gastrointestinal disorders Abdominal pain	0.00% 0/50 • Up to 583 Weeks The Safety Analysis Set included all participants who received at least 1 dose of study drug.	1.9% 1/52 • Up to 583 Weeks The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/27 • Up to 583 Weeks The Safety Analysis Set included all participants who received at least 1 dose of study drug.
Gastrointestinal disorders Constipation	2.0% 1/50 • Up to 583 Weeks The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/52 • Up to 583 Weeks The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/27 • Up to 583 Weeks The Safety Analysis Set included all participants who received at least 1 dose of study drug.
Gastrointestinal disorders Gastritis	0.00% 0/50 • Up to 583 Weeks The Safety Analysis Set included all participants who received at least 1 dose of study drug.	1.9% 1/52 • Up to 583 Weeks The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/27 • Up to 583 Weeks The Safety Analysis Set included all participants who received at least 1 dose of study drug.
Infections and infestations Abortion infected	0.00% 0/50 • Up to 583 Weeks The Safety Analysis Set included all participants who received at least 1 dose of study drug.	1.9% 1/52 • Up to 583 Weeks The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/27 • Up to 583 Weeks The Safety Analysis Set included all participants who received at least 1 dose of study drug.
Infections and infestations Abscess limb	2.0% 1/50 • Up to 583 Weeks The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/52 • Up to 583 Weeks The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/27 • Up to 583 Weeks The Safety Analysis Set included all participants who received at least 1 dose of study drug.
Infections and infestations Appendicitis	0.00% 0/50 • Up to 583 Weeks The Safety Analysis Set included all participants who received at least 1 dose of study drug.	1.9% 1/52 • Up to 583 Weeks The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/27 • Up to 583 Weeks The Safety Analysis Set included all participants who received at least 1 dose of study drug.
Infections and infestations Gastroenteritis	2.0% 1/50 • Up to 583 Weeks The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/52 • Up to 583 Weeks The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/27 • Up to 583 Weeks The Safety Analysis Set included all participants who received at least 1 dose of study drug.
Infections and infestations Periorbital cellulitis	0.00% 0/50 • Up to 583 Weeks The Safety Analysis Set included all participants who received at least 1 dose of study drug.	1.9% 1/52 • Up to 583 Weeks The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/27 • Up to 583 Weeks The Safety Analysis Set included all participants who received at least 1 dose of study drug.
Infections and infestations Pneumonia	0.00% 0/50 • Up to 583 Weeks The Safety Analysis Set included all participants who received at least 1 dose of study drug.	1.9% 1/52 • Up to 583 Weeks The Safety Analysis Set included all participants who received at least 1 dose of study drug.	3.7% 1/27 • Up to 583 Weeks The Safety Analysis Set included all participants who received at least 1 dose of study drug.
Infections and infestations Sinusitis bacterial	0.00% 0/50 • Up to 583 Weeks The Safety Analysis Set included all participants who received at least 1 dose of study drug.	1.9% 1/52 • Up to 583 Weeks The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/27 • Up to 583 Weeks The Safety Analysis Set included all participants who received at least 1 dose of study drug.
Injury, poisoning and procedural complications Radius fracture	2.0% 1/50 • Up to 583 Weeks The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/52 • Up to 583 Weeks The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/27 • Up to 583 Weeks The Safety Analysis Set included all participants who received at least 1 dose of study drug.
Injury, poisoning and procedural complications Road traffic accident	2.0% 1/50 • Up to 583 Weeks The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/52 • Up to 583 Weeks The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/27 • Up to 583 Weeks The Safety Analysis Set included all participants who received at least 1 dose of study drug.
Injury, poisoning and procedural complications Skin abrasion	0.00% 0/50 • Up to 583 Weeks The Safety Analysis Set included all participants who received at least 1 dose of study drug.	1.9% 1/52 • Up to 583 Weeks The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/27 • Up to 583 Weeks The Safety Analysis Set included all participants who received at least 1 dose of study drug.
Injury, poisoning and procedural complications Ulna fracture	2.0% 1/50 • Up to 583 Weeks The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/52 • Up to 583 Weeks The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/27 • Up to 583 Weeks The Safety Analysis Set included all participants who received at least 1 dose of study drug.
Nervous system disorders Epilepsy	2.0% 1/50 • Up to 583 Weeks The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/52 • Up to 583 Weeks The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/27 • Up to 583 Weeks The Safety Analysis Set included all participants who received at least 1 dose of study drug.
Nervous system disorders Neuralgia	2.0% 1/50 • Up to 583 Weeks The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/52 • Up to 583 Weeks The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/27 • Up to 583 Weeks The Safety Analysis Set included all participants who received at least 1 dose of study drug.
Pregnancy, puerperium and perinatal conditions Abortion missed	0.00% 0/50 • Up to 583 Weeks The Safety Analysis Set included all participants who received at least 1 dose of study drug.	1.9% 1/52 • Up to 583 Weeks The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/27 • Up to 583 Weeks The Safety Analysis Set included all participants who received at least 1 dose of study drug.
Pregnancy, puerperium and perinatal conditions Abortion spontaneous	2.0% 1/50 • Up to 583 Weeks The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/52 • Up to 583 Weeks The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/27 • Up to 583 Weeks The Safety Analysis Set included all participants who received at least 1 dose of study drug.
Psychiatric disorders Acute psychosis	2.0% 1/50 • Up to 583 Weeks The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/52 • Up to 583 Weeks The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/27 • Up to 583 Weeks The Safety Analysis Set included all participants who received at least 1 dose of study drug.
Psychiatric disorders Agitation	2.0% 1/50 • Up to 583 Weeks The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/52 • Up to 583 Weeks The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/27 • Up to 583 Weeks The Safety Analysis Set included all participants who received at least 1 dose of study drug.
Psychiatric disorders Behaviour disorder	2.0% 1/50 • Up to 583 Weeks The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/52 • Up to 583 Weeks The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/27 • Up to 583 Weeks The Safety Analysis Set included all participants who received at least 1 dose of study drug.
Psychiatric disorders Bipolar I disorder	2.0% 1/50 • Up to 583 Weeks The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/52 • Up to 583 Weeks The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/27 • Up to 583 Weeks The Safety Analysis Set included all participants who received at least 1 dose of study drug.
Psychiatric disorders Drug abuse	2.0% 1/50 • Up to 583 Weeks The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/52 • Up to 583 Weeks The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/27 • Up to 583 Weeks The Safety Analysis Set included all participants who received at least 1 dose of study drug.
Psychiatric disorders Substance abuse	2.0% 1/50 • Up to 583 Weeks The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/52 • Up to 583 Weeks The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/27 • Up to 583 Weeks The Safety Analysis Set included all participants who received at least 1 dose of study drug.
Psychiatric disorders Suicidal ideation	2.0% 1/50 • Up to 583 Weeks The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/52 • Up to 583 Weeks The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/27 • Up to 583 Weeks The Safety Analysis Set included all participants who received at least 1 dose of study drug.
Psychiatric disorders Suicide attempt	4.0% 2/50 • Up to 583 Weeks The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/52 • Up to 583 Weeks The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/27 • Up to 583 Weeks The Safety Analysis Set included all participants who received at least 1 dose of study drug.
Renal and urinary disorders Glomerulonephritis acute	0.00% 0/50 • Up to 583 Weeks The Safety Analysis Set included all participants who received at least 1 dose of study drug.	1.9% 1/52 • Up to 583 Weeks The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/27 • Up to 583 Weeks The Safety Analysis Set included all participants who received at least 1 dose of study drug.
Renal and urinary disorders Urinary retention	2.0% 1/50 • Up to 583 Weeks The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/52 • Up to 583 Weeks The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/27 • Up to 583 Weeks The Safety Analysis Set included all participants who received at least 1 dose of study drug.
Respiratory, thoracic and mediastinal disorders Tonsillar hypertrophy	0.00% 0/50 • Up to 583 Weeks The Safety Analysis Set included all participants who received at least 1 dose of study drug.	1.9% 1/52 • Up to 583 Weeks The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/27 • Up to 583 Weeks The Safety Analysis Set included all participants who received at least 1 dose of study drug.
Vascular disorders Hypertension	0.00% 0/50 • Up to 583 Weeks The Safety Analysis Set included all participants who received at least 1 dose of study drug.	1.9% 1/52 • Up to 583 Weeks The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/27 • Up to 583 Weeks The Safety Analysis Set included all participants who received at least 1 dose of study drug.

Other adverse events

Measure	Cohort 1: Age 12 to < 18 Years and Weight ≥ 35 kg n=50 participants at risk Treatment naive adolescents (12 to \< 18 years of age) with human immunodeficiency virus (HIV) received elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) (150/150/200/10 mg) fixed-dose combination (FDC) tablets, once daily orally with food for 48 weeks. Participants who completed 48 weeks of study treatment had the option to receive E/C/F/TAF in an extension phase of the study until: a) the participant turned 18 years old and E/C/F/TAF was commercially available for adults in the country in which the participant was enrolled; b) age-appropriate E/C/F/TAF became commercially available in participant's country.	Cohort 2: Age 6 to < 12 Years and Weight ≥ 25 kg n=52 participants at risk Children (6 to \< 12 years of age weighing ≥ 25 kg) with HIV who were virologically suppressed received E/C/F/TAF (150/150/200/10 mg) FDC tablets, once daily orally with food for 48 weeks. Participants who completed 48 weeks of study treatment had the option to receive E/C/F/TAF in an extension phase of the study until: a) the participant turned 18 years old and E/C/F/TAF was commercially available for adults in the country in which the participant was enrolled; b) age-appropriate E/C/F/TAF became commercially available in participant's country.	Cohort 3: Age ≥ 2 Years and Weight ≥ 14 to < 25 kg n=27 participants at risk Children (≥ 2 years of age weighing ≥ 14 to \< 25 kg) with HIV who were virologically suppressed received E/C/F/TAF (90/90/120/6 mg) FDC tablets, once daily orally with food for 48 weeks. Participants who attained a weight of ≥ 25 kg during the course of the study were switched to adult E/C/F/TAF (150/150/200/10 mg) tablets administered orally, once daily with food. Participants who completed 48 weeks of study treatment had the option to receive E/C/F/TAF in an extension phase of the study until: a) the participant turned 18 years old and E/C/F/TAF was commercially available for adults in the country in which the participant was enrolled; b) age-appropriate E/C/F/TAF became commercially available in participant's country.
Gastrointestinal disorders Nausea	30.0% 15/50 • Up to 583 Weeks The Safety Analysis Set included all participants who received at least 1 dose of study drug.	3.8% 2/52 • Up to 583 Weeks The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/27 • Up to 583 Weeks The Safety Analysis Set included all participants who received at least 1 dose of study drug.
Product Issues Product size issue	10.0% 5/50 • Up to 583 Weeks The Safety Analysis Set included all participants who received at least 1 dose of study drug.	1.9% 1/52 • Up to 583 Weeks The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/27 • Up to 583 Weeks The Safety Analysis Set included all participants who received at least 1 dose of study drug.
Gastrointestinal disorders Vomiting	24.0% 12/50 • Up to 583 Weeks The Safety Analysis Set included all participants who received at least 1 dose of study drug.	25.0% 13/52 • Up to 583 Weeks The Safety Analysis Set included all participants who received at least 1 dose of study drug.	14.8% 4/27 • Up to 583 Weeks The Safety Analysis Set included all participants who received at least 1 dose of study drug.
Investigations Weight decreased	8.0% 4/50 • Up to 583 Weeks The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/52 • Up to 583 Weeks The Safety Analysis Set included all participants who received at least 1 dose of study drug.	3.7% 1/27 • Up to 583 Weeks The Safety Analysis Set included all participants who received at least 1 dose of study drug.
Gastrointestinal disorders Constipation	6.0% 3/50 • Up to 583 Weeks The Safety Analysis Set included all participants who received at least 1 dose of study drug.	7.7% 4/52 • Up to 583 Weeks The Safety Analysis Set included all participants who received at least 1 dose of study drug.	11.1% 3/27 • Up to 583 Weeks The Safety Analysis Set included all participants who received at least 1 dose of study drug.
Gastrointestinal disorders Dental caries	14.0% 7/50 • Up to 583 Weeks The Safety Analysis Set included all participants who received at least 1 dose of study drug.	5.8% 3/52 • Up to 583 Weeks The Safety Analysis Set included all participants who received at least 1 dose of study drug.	14.8% 4/27 • Up to 583 Weeks The Safety Analysis Set included all participants who received at least 1 dose of study drug.
Gastrointestinal disorders Diarrhoea	28.0% 14/50 • Up to 583 Weeks The Safety Analysis Set included all participants who received at least 1 dose of study drug.	13.5% 7/52 • Up to 583 Weeks The Safety Analysis Set included all participants who received at least 1 dose of study drug.	7.4% 2/27 • Up to 583 Weeks The Safety Analysis Set included all participants who received at least 1 dose of study drug.
Gastrointestinal disorders Gastritis	14.0% 7/50 • Up to 583 Weeks The Safety Analysis Set included all participants who received at least 1 dose of study drug.	3.8% 2/52 • Up to 583 Weeks The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/27 • Up to 583 Weeks The Safety Analysis Set included all participants who received at least 1 dose of study drug.
Blood and lymphatic system disorders Iron deficiency anaemia	10.0% 5/50 • Up to 583 Weeks The Safety Analysis Set included all participants who received at least 1 dose of study drug.	5.8% 3/52 • Up to 583 Weeks The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/27 • Up to 583 Weeks The Safety Analysis Set included all participants who received at least 1 dose of study drug.
Blood and lymphatic system disorders Lymphadenopathy	6.0% 3/50 • Up to 583 Weeks The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/52 • Up to 583 Weeks The Safety Analysis Set included all participants who received at least 1 dose of study drug.	3.7% 1/27 • Up to 583 Weeks The Safety Analysis Set included all participants who received at least 1 dose of study drug.
Eye disorders Visual impairment	6.0% 3/50 • Up to 583 Weeks The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/52 • Up to 583 Weeks The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/27 • Up to 583 Weeks The Safety Analysis Set included all participants who received at least 1 dose of study drug.
Gastrointestinal disorders Abdominal pain	22.0% 11/50 • Up to 583 Weeks The Safety Analysis Set included all participants who received at least 1 dose of study drug.	19.2% 10/52 • Up to 583 Weeks The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/27 • Up to 583 Weeks The Safety Analysis Set included all participants who received at least 1 dose of study drug.
Gastrointestinal disorders Abdominal pain upper	10.0% 5/50 • Up to 583 Weeks The Safety Analysis Set included all participants who received at least 1 dose of study drug.	1.9% 1/52 • Up to 583 Weeks The Safety Analysis Set included all participants who received at least 1 dose of study drug.	3.7% 1/27 • Up to 583 Weeks The Safety Analysis Set included all participants who received at least 1 dose of study drug.
General disorders Pyrexia	6.0% 3/50 • Up to 583 Weeks The Safety Analysis Set included all participants who received at least 1 dose of study drug.	5.8% 3/52 • Up to 583 Weeks The Safety Analysis Set included all participants who received at least 1 dose of study drug.	7.4% 2/27 • Up to 583 Weeks The Safety Analysis Set included all participants who received at least 1 dose of study drug.
Infections and infestations Anal gonococcal infection	6.0% 3/50 • Up to 583 Weeks The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/52 • Up to 583 Weeks The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/27 • Up to 583 Weeks The Safety Analysis Set included all participants who received at least 1 dose of study drug.
Infections and infestations Body tinea	14.0% 7/50 • Up to 583 Weeks The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/52 • Up to 583 Weeks The Safety Analysis Set included all participants who received at least 1 dose of study drug.	7.4% 2/27 • Up to 583 Weeks The Safety Analysis Set included all participants who received at least 1 dose of study drug.
Infections and infestations Bronchitis	4.0% 2/50 • Up to 583 Weeks The Safety Analysis Set included all participants who received at least 1 dose of study drug.	3.8% 2/52 • Up to 583 Weeks The Safety Analysis Set included all participants who received at least 1 dose of study drug.	7.4% 2/27 • Up to 583 Weeks The Safety Analysis Set included all participants who received at least 1 dose of study drug.
Infections and infestations Conjunctivitis	8.0% 4/50 • Up to 583 Weeks The Safety Analysis Set included all participants who received at least 1 dose of study drug.	1.9% 1/52 • Up to 583 Weeks The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/27 • Up to 583 Weeks The Safety Analysis Set included all participants who received at least 1 dose of study drug.
Infections and infestations Covid-19	4.0% 2/50 • Up to 583 Weeks The Safety Analysis Set included all participants who received at least 1 dose of study drug.	5.8% 3/52 • Up to 583 Weeks The Safety Analysis Set included all participants who received at least 1 dose of study drug.	3.7% 1/27 • Up to 583 Weeks The Safety Analysis Set included all participants who received at least 1 dose of study drug.
Infections and infestations Folliculitis	6.0% 3/50 • Up to 583 Weeks The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/52 • Up to 583 Weeks The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/27 • Up to 583 Weeks The Safety Analysis Set included all participants who received at least 1 dose of study drug.
Infections and infestations Gastroenteritis	10.0% 5/50 • Up to 583 Weeks The Safety Analysis Set included all participants who received at least 1 dose of study drug.	5.8% 3/52 • Up to 583 Weeks The Safety Analysis Set included all participants who received at least 1 dose of study drug.	3.7% 1/27 • Up to 583 Weeks The Safety Analysis Set included all participants who received at least 1 dose of study drug.
Infections and infestations Hordeolum	6.0% 3/50 • Up to 583 Weeks The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/52 • Up to 583 Weeks The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/27 • Up to 583 Weeks The Safety Analysis Set included all participants who received at least 1 dose of study drug.
Infections and infestations Lower respiratory tract infection	0.00% 0/50 • Up to 583 Weeks The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/52 • Up to 583 Weeks The Safety Analysis Set included all participants who received at least 1 dose of study drug.	11.1% 3/27 • Up to 583 Weeks The Safety Analysis Set included all participants who received at least 1 dose of study drug.
Infections and infestations Malaria	28.0% 14/50 • Up to 583 Weeks The Safety Analysis Set included all participants who received at least 1 dose of study drug.	7.7% 4/52 • Up to 583 Weeks The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/27 • Up to 583 Weeks The Safety Analysis Set included all participants who received at least 1 dose of study drug.
Infections and infestations Nasal herpes	6.0% 3/50 • Up to 583 Weeks The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/52 • Up to 583 Weeks The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/27 • Up to 583 Weeks The Safety Analysis Set included all participants who received at least 1 dose of study drug.
Infections and infestations Nasopharyngitis	6.0% 3/50 • Up to 583 Weeks The Safety Analysis Set included all participants who received at least 1 dose of study drug.	3.8% 2/52 • Up to 583 Weeks The Safety Analysis Set included all participants who received at least 1 dose of study drug.	18.5% 5/27 • Up to 583 Weeks The Safety Analysis Set included all participants who received at least 1 dose of study drug.
Infections and infestations Oral herpes	6.0% 3/50 • Up to 583 Weeks The Safety Analysis Set included all participants who received at least 1 dose of study drug.	1.9% 1/52 • Up to 583 Weeks The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/27 • Up to 583 Weeks The Safety Analysis Set included all participants who received at least 1 dose of study drug.
Infections and infestations Otitis media	0.00% 0/50 • Up to 583 Weeks The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/52 • Up to 583 Weeks The Safety Analysis Set included all participants who received at least 1 dose of study drug.	7.4% 2/27 • Up to 583 Weeks The Safety Analysis Set included all participants who received at least 1 dose of study drug.
Infections and infestations Otitis media acute	4.0% 2/50 • Up to 583 Weeks The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/52 • Up to 583 Weeks The Safety Analysis Set included all participants who received at least 1 dose of study drug.	7.4% 2/27 • Up to 583 Weeks The Safety Analysis Set included all participants who received at least 1 dose of study drug.
Infections and infestations Pharyngitis	8.0% 4/50 • Up to 583 Weeks The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/52 • Up to 583 Weeks The Safety Analysis Set included all participants who received at least 1 dose of study drug.	11.1% 3/27 • Up to 583 Weeks The Safety Analysis Set included all participants who received at least 1 dose of study drug.
Infections and infestations Pneumonia	12.0% 6/50 • Up to 583 Weeks The Safety Analysis Set included all participants who received at least 1 dose of study drug.	1.9% 1/52 • Up to 583 Weeks The Safety Analysis Set included all participants who received at least 1 dose of study drug.	3.7% 1/27 • Up to 583 Weeks The Safety Analysis Set included all participants who received at least 1 dose of study drug.
Infections and infestations Respiratory tract infection	38.0% 19/50 • Up to 583 Weeks The Safety Analysis Set included all participants who received at least 1 dose of study drug.	21.2% 11/52 • Up to 583 Weeks The Safety Analysis Set included all participants who received at least 1 dose of study drug.	14.8% 4/27 • Up to 583 Weeks The Safety Analysis Set included all participants who received at least 1 dose of study drug.
Infections and infestations Rhinitis	6.0% 3/50 • Up to 583 Weeks The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/52 • Up to 583 Weeks The Safety Analysis Set included all participants who received at least 1 dose of study drug.	3.7% 1/27 • Up to 583 Weeks The Safety Analysis Set included all participants who received at least 1 dose of study drug.
Infections and infestations Tinea capitis	4.0% 2/50 • Up to 583 Weeks The Safety Analysis Set included all participants who received at least 1 dose of study drug.	7.7% 4/52 • Up to 583 Weeks The Safety Analysis Set included all participants who received at least 1 dose of study drug.	7.4% 2/27 • Up to 583 Weeks The Safety Analysis Set included all participants who received at least 1 dose of study drug.
Infections and infestations Tonsillitis	12.0% 6/50 • Up to 583 Weeks The Safety Analysis Set included all participants who received at least 1 dose of study drug.	5.8% 3/52 • Up to 583 Weeks The Safety Analysis Set included all participants who received at least 1 dose of study drug.	18.5% 5/27 • Up to 583 Weeks The Safety Analysis Set included all participants who received at least 1 dose of study drug.
Infections and infestations Upper respiratory tract infection	40.0% 20/50 • Up to 583 Weeks The Safety Analysis Set included all participants who received at least 1 dose of study drug.	26.9% 14/52 • Up to 583 Weeks The Safety Analysis Set included all participants who received at least 1 dose of study drug.	51.9% 14/27 • Up to 583 Weeks The Safety Analysis Set included all participants who received at least 1 dose of study drug.
Infections and infestations Urinary tract infection	18.0% 9/50 • Up to 583 Weeks The Safety Analysis Set included all participants who received at least 1 dose of study drug.	9.6% 5/52 • Up to 583 Weeks The Safety Analysis Set included all participants who received at least 1 dose of study drug.	11.1% 3/27 • Up to 583 Weeks The Safety Analysis Set included all participants who received at least 1 dose of study drug.
Infections and infestations Vulvovaginal candidiasis	10.0% 5/50 • Up to 583 Weeks The Safety Analysis Set included all participants who received at least 1 dose of study drug.	1.9% 1/52 • Up to 583 Weeks The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/27 • Up to 583 Weeks The Safety Analysis Set included all participants who received at least 1 dose of study drug.
Infections and infestations Vulvovaginal mycotic infection	0.00% 0/50 • Up to 583 Weeks The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/52 • Up to 583 Weeks The Safety Analysis Set included all participants who received at least 1 dose of study drug.	7.4% 2/27 • Up to 583 Weeks The Safety Analysis Set included all participants who received at least 1 dose of study drug.
Injury, poisoning and procedural complications Contusion	0.00% 0/50 • Up to 583 Weeks The Safety Analysis Set included all participants who received at least 1 dose of study drug.	5.8% 3/52 • Up to 583 Weeks The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/27 • Up to 583 Weeks The Safety Analysis Set included all participants who received at least 1 dose of study drug.
Injury, poisoning and procedural complications Skin abrasion	0.00% 0/50 • Up to 583 Weeks The Safety Analysis Set included all participants who received at least 1 dose of study drug.	5.8% 3/52 • Up to 583 Weeks The Safety Analysis Set included all participants who received at least 1 dose of study drug.	3.7% 1/27 • Up to 583 Weeks The Safety Analysis Set included all participants who received at least 1 dose of study drug.
Injury, poisoning and procedural complications Tooth fracture	6.0% 3/50 • Up to 583 Weeks The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/52 • Up to 583 Weeks The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/27 • Up to 583 Weeks The Safety Analysis Set included all participants who received at least 1 dose of study drug.
Metabolism and nutrition disorders Decreased appetite	4.0% 2/50 • Up to 583 Weeks The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/52 • Up to 583 Weeks The Safety Analysis Set included all participants who received at least 1 dose of study drug.	14.8% 4/27 • Up to 583 Weeks The Safety Analysis Set included all participants who received at least 1 dose of study drug.
Metabolism and nutrition disorders Vitamin D deficiency	16.0% 8/50 • Up to 583 Weeks The Safety Analysis Set included all participants who received at least 1 dose of study drug.	5.8% 3/52 • Up to 583 Weeks The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/27 • Up to 583 Weeks The Safety Analysis Set included all participants who received at least 1 dose of study drug.
Musculoskeletal and connective tissue disorders Arthralgia	6.0% 3/50 • Up to 583 Weeks The Safety Analysis Set included all participants who received at least 1 dose of study drug.	3.8% 2/52 • Up to 583 Weeks The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/27 • Up to 583 Weeks The Safety Analysis Set included all participants who received at least 1 dose of study drug.
Musculoskeletal and connective tissue disorders Pain in extremity	6.0% 3/50 • Up to 583 Weeks The Safety Analysis Set included all participants who received at least 1 dose of study drug.	1.9% 1/52 • Up to 583 Weeks The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/27 • Up to 583 Weeks The Safety Analysis Set included all participants who received at least 1 dose of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Anogenital warts	6.0% 3/50 • Up to 583 Weeks The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/52 • Up to 583 Weeks The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/27 • Up to 583 Weeks The Safety Analysis Set included all participants who received at least 1 dose of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Skin papilloma	8.0% 4/50 • Up to 583 Weeks The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/52 • Up to 583 Weeks The Safety Analysis Set included all participants who received at least 1 dose of study drug.	3.7% 1/27 • Up to 583 Weeks The Safety Analysis Set included all participants who received at least 1 dose of study drug.
Nervous system disorders Dizziness	12.0% 6/50 • Up to 583 Weeks The Safety Analysis Set included all participants who received at least 1 dose of study drug.	3.8% 2/52 • Up to 583 Weeks The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/27 • Up to 583 Weeks The Safety Analysis Set included all participants who received at least 1 dose of study drug.
Nervous system disorders Headache	28.0% 14/50 • Up to 583 Weeks The Safety Analysis Set included all participants who received at least 1 dose of study drug.	15.4% 8/52 • Up to 583 Weeks The Safety Analysis Set included all participants who received at least 1 dose of study drug.	3.7% 1/27 • Up to 583 Weeks The Safety Analysis Set included all participants who received at least 1 dose of study drug.
Nervous system disorders Somnolence	6.0% 3/50 • Up to 583 Weeks The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/52 • Up to 583 Weeks The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/27 • Up to 583 Weeks The Safety Analysis Set included all participants who received at least 1 dose of study drug.
Renal and urinary disorders Leukocyturia	0.00% 0/50 • Up to 583 Weeks The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/52 • Up to 583 Weeks The Safety Analysis Set included all participants who received at least 1 dose of study drug.	7.4% 2/27 • Up to 583 Weeks The Safety Analysis Set included all participants who received at least 1 dose of study drug.
Reproductive system and breast disorders Heavy menstrual bleeding	6.0% 3/50 • Up to 583 Weeks The Safety Analysis Set included all participants who received at least 1 dose of study drug.	1.9% 1/52 • Up to 583 Weeks The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/27 • Up to 583 Weeks The Safety Analysis Set included all participants who received at least 1 dose of study drug.
Respiratory, thoracic and mediastinal disorders Cough	16.0% 8/50 • Up to 583 Weeks The Safety Analysis Set included all participants who received at least 1 dose of study drug.	13.5% 7/52 • Up to 583 Weeks The Safety Analysis Set included all participants who received at least 1 dose of study drug.	33.3% 9/27 • Up to 583 Weeks The Safety Analysis Set included all participants who received at least 1 dose of study drug.
Respiratory, thoracic and mediastinal disorders Epistaxis	0.00% 0/50 • Up to 583 Weeks The Safety Analysis Set included all participants who received at least 1 dose of study drug.	1.9% 1/52 • Up to 583 Weeks The Safety Analysis Set included all participants who received at least 1 dose of study drug.	7.4% 2/27 • Up to 583 Weeks The Safety Analysis Set included all participants who received at least 1 dose of study drug.
Respiratory, thoracic and mediastinal disorders Nasal congestion	4.0% 2/50 • Up to 583 Weeks The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/52 • Up to 583 Weeks The Safety Analysis Set included all participants who received at least 1 dose of study drug.	7.4% 2/27 • Up to 583 Weeks The Safety Analysis Set included all participants who received at least 1 dose of study drug.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	6.0% 3/50 • Up to 583 Weeks The Safety Analysis Set included all participants who received at least 1 dose of study drug.	3.8% 2/52 • Up to 583 Weeks The Safety Analysis Set included all participants who received at least 1 dose of study drug.	3.7% 1/27 • Up to 583 Weeks The Safety Analysis Set included all participants who received at least 1 dose of study drug.
Respiratory, thoracic and mediastinal disorders Rhinitis allergic	0.00% 0/50 • Up to 583 Weeks The Safety Analysis Set included all participants who received at least 1 dose of study drug.	9.6% 5/52 • Up to 583 Weeks The Safety Analysis Set included all participants who received at least 1 dose of study drug.	14.8% 4/27 • Up to 583 Weeks The Safety Analysis Set included all participants who received at least 1 dose of study drug.
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	6.0% 3/50 • Up to 583 Weeks The Safety Analysis Set included all participants who received at least 1 dose of study drug.	11.5% 6/52 • Up to 583 Weeks The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/27 • Up to 583 Weeks The Safety Analysis Set included all participants who received at least 1 dose of study drug.
Skin and subcutaneous tissue disorders Acne	10.0% 5/50 • Up to 583 Weeks The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/52 • Up to 583 Weeks The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/27 • Up to 583 Weeks The Safety Analysis Set included all participants who received at least 1 dose of study drug.
Skin and subcutaneous tissue disorders Rash	6.0% 3/50 • Up to 583 Weeks The Safety Analysis Set included all participants who received at least 1 dose of study drug.	3.8% 2/52 • Up to 583 Weeks The Safety Analysis Set included all participants who received at least 1 dose of study drug.	3.7% 1/27 • Up to 583 Weeks The Safety Analysis Set included all participants who received at least 1 dose of study drug.
Skin and subcutaneous tissue disorders Rash papular	8.0% 4/50 • Up to 583 Weeks The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/52 • Up to 583 Weeks The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/27 • Up to 583 Weeks The Safety Analysis Set included all participants who received at least 1 dose of study drug.
Skin and subcutaneous tissue disorders Seborrhoeic dermatitis	14.0% 7/50 • Up to 583 Weeks The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/52 • Up to 583 Weeks The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/27 • Up to 583 Weeks The Safety Analysis Set included all participants who 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