Trial Outcomes & Findings for Study To Evaluate Emtricitabine/Tenofovir Alafenamide (F/TAF) in Human Immunodeficiency Virus 1 (HIV-1) Infected Children and Adolescents Virologically Suppressed on a 2-Nucleoside/Nucleotide Reverse Transcriptase Inhibitor (2-NRTI)-Containing Regimen (NCT NCT02285114)
NCT ID: NCT02285114
Last Updated: 2025-06-27
Results Overview
AUCtau is defined as the area under the drug concentration versus time curve over the dosing interval.
Recruitment status
COMPLETED
Study phase
PHASE2/PHASE3
Target enrollment
41 participants
Primary outcome timeframe
Any time at Week 2 visit
Results posted on
2025-06-27
Participant Flow
49 participants were screened. Participants were enrolled at study sites in Panama, South Africa, and United States.
No participant was enrolled in Cohort 2 (Part B: Groups 1 and 2), and Cohorts 3 and 4 (Parts A and B). Data is reported only for Cohorts 1 and 2 (Part A: Groups 1 and 2). The study had a main treatment phase of 48 weeks and extension phase. It was prespecified to analyze Cohort 1 together as both treatments (F/TAF 200/10 mg with boosted 3rd ARV and F/TAF 200/25 mg with unboosted 3rd ARV) were expected to have a similar effect on efficacy and safety for target population.
Participant milestones
| Measure |
Main Phase: F/TAF+3rd ARV Agent (Cohort 1)
Participants between 12 to \< 18 years of age and ≥ 35 kg body weight received emtricitabine/tenofovir alafenamide (F/TAF) 200/10 mg fixed-dose combination (FDC) tablet (with boosted 3rd antiretroviral (ARV) agent) or F/TAF 200/25 mg FDC tablet (with unboosted 3rd ARV agent) orally once daily for 48 weeks. Allowed boosted 3rd ARV agents: lopinavir (LPV), atazanavir (ATV), darunavir (DRV); Allowed unboosted 3rd ARV agents: efavirenz (EFV), raltegravir (RAL), dolutegravir (DTG), or nevirapine (NVP).
|
Main Phase: F/TAF+3rd ARV Agent (Cohort 2, Part A - Group 1)
Participants between 6 to \< 12 years of age and ≥ 25 kg body weight received F/TAF 200/25 mg FDC tablet orally once daily while continuing on their boosted protease inhibitor (PI) for 48 weeks. Allowed boosted PIs: ATV, LPV or DRV.
|
Main Phase: F/TAF+3rd ARV Agent (Cohort 2, Part A - Group 2)
Participants between 2 to \< 12 years of age and 17 to \< 25 kg body weight received F/TAF 120/15 mg FDC orally once daily while continuing on their 3rd ARV agent for 48 weeks. Allowed boosted 3rd ARV agents: LPV, ATV, DRV; Allowed unboosted 3rd ARV agents: EFV, RAL, DTG, or NVP.
|
Extension Phase: F/TAF+3rd ARV Agent (Cohort 1)
After completion of 48 weeks, all participants were given the option to participate in an extension phase of the study to continue with F/TAF+3rd ARV Agent. Gilead provided F/TAF until a) the participant turned 18 and F/TAF was commercially available for use in adults in the country in which the participant was enrolled or, b) F/TAF became commercially available for pediatric use in the country in which the participant was enrolled or, c) Gilead Sciences elected to terminate development of F/TAF in the applicable country. The maximum exposure was 438.9 weeks. Allowed boosted 3rd ARV agents: LPV, ATV, DRV. Allowed unboosted 3rd ARV agents: EFV, RAL, DTG, or NVP.
|
Extension Phase: F/TAF+3rd ARV Agent (Cohort 2, Part A - Group 1)
After completion of 48 weeks, all participants were given the option to participate in an extension phase of the study to continue with F/TAF+3rd ARV agent. Gilead provided F/TAF until a) the participant turned 18 and F/TAF was commercially available for use in adults in the country in which the participant was enrolled or, b) F/TAF became commercially available for pediatric use in the country in which the participant is enrolled or, c) Gilead Sciences elected to terminate development of F/TAF in the applicable country. The maximum exposure was 315.0 weeks. Allowed boosted PIs: ATV, LPV or DRV
|
Extension Phase: F/TAF+3rd ARV Agent (Cohort 2, Part A -Group 2)
After completion of 48 weeks, all participants were given the option to participate in an extension phase of the study to continue with F/TAF+3rd ARV Agent. Gilead provided F/TAF until a) the participant turned 18 and F/TAF was commercially available for use in adults in the country in which the participant was enrolled or, b) F/TAF became commercially available for pediatric use in the country in which the participant was enrolled or, c) Gilead Sciences elected to terminate development of F/TAF in the applicable country. The maximum exposure was 103.1 weeks. Allowed boosted 3rd ARV agents: LPV, ATV, DRV; Allowed unboosted 3rd ARV agents: EFV, RAL, DTG, or NVP.
|
|---|---|---|---|---|---|---|
|
Main Phase
STARTED
|
29
|
9
|
3
|
0
|
0
|
0
|
|
Main Phase
COMPLETED
|
28
|
7
|
2
|
0
|
0
|
0
|
|
Main Phase
NOT COMPLETED
|
1
|
2
|
1
|
0
|
0
|
0
|
|
Extension Phase
STARTED
|
0
|
0
|
0
|
28
|
7
|
2
|
|
Extension Phase
COMPLETED
|
0
|
0
|
0
|
10
|
5
|
2
|
|
Extension Phase
NOT COMPLETED
|
0
|
0
|
0
|
18
|
2
|
0
|
Reasons for withdrawal
| Measure |
Main Phase: F/TAF+3rd ARV Agent (Cohort 1)
Participants between 12 to \< 18 years of age and ≥ 35 kg body weight received emtricitabine/tenofovir alafenamide (F/TAF) 200/10 mg fixed-dose combination (FDC) tablet (with boosted 3rd antiretroviral (ARV) agent) or F/TAF 200/25 mg FDC tablet (with unboosted 3rd ARV agent) orally once daily for 48 weeks. Allowed boosted 3rd ARV agents: lopinavir (LPV), atazanavir (ATV), darunavir (DRV); Allowed unboosted 3rd ARV agents: efavirenz (EFV), raltegravir (RAL), dolutegravir (DTG), or nevirapine (NVP).
|
Main Phase: F/TAF+3rd ARV Agent (Cohort 2, Part A - Group 1)
Participants between 6 to \< 12 years of age and ≥ 25 kg body weight received F/TAF 200/25 mg FDC tablet orally once daily while continuing on their boosted protease inhibitor (PI) for 48 weeks. Allowed boosted PIs: ATV, LPV or DRV.
|
Main Phase: F/TAF+3rd ARV Agent (Cohort 2, Part A - Group 2)
Participants between 2 to \< 12 years of age and 17 to \< 25 kg body weight received F/TAF 120/15 mg FDC orally once daily while continuing on their 3rd ARV agent for 48 weeks. Allowed boosted 3rd ARV agents: LPV, ATV, DRV; Allowed unboosted 3rd ARV agents: EFV, RAL, DTG, or NVP.
|
Extension Phase: F/TAF+3rd ARV Agent (Cohort 1)
After completion of 48 weeks, all participants were given the option to participate in an extension phase of the study to continue with F/TAF+3rd ARV Agent. Gilead provided F/TAF until a) the participant turned 18 and F/TAF was commercially available for use in adults in the country in which the participant was enrolled or, b) F/TAF became commercially available for pediatric use in the country in which the participant was enrolled or, c) Gilead Sciences elected to terminate development of F/TAF in the applicable country. The maximum exposure was 438.9 weeks. Allowed boosted 3rd ARV agents: LPV, ATV, DRV. Allowed unboosted 3rd ARV agents: EFV, RAL, DTG, or NVP.
|
Extension Phase: F/TAF+3rd ARV Agent (Cohort 2, Part A - Group 1)
After completion of 48 weeks, all participants were given the option to participate in an extension phase of the study to continue with F/TAF+3rd ARV agent. Gilead provided F/TAF until a) the participant turned 18 and F/TAF was commercially available for use in adults in the country in which the participant was enrolled or, b) F/TAF became commercially available for pediatric use in the country in which the participant is enrolled or, c) Gilead Sciences elected to terminate development of F/TAF in the applicable country. The maximum exposure was 315.0 weeks. Allowed boosted PIs: ATV, LPV or DRV
|
Extension Phase: F/TAF+3rd ARV Agent (Cohort 2, Part A -Group 2)
After completion of 48 weeks, all participants were given the option to participate in an extension phase of the study to continue with F/TAF+3rd ARV Agent. Gilead provided F/TAF until a) the participant turned 18 and F/TAF was commercially available for use in adults in the country in which the participant was enrolled or, b) F/TAF became commercially available for pediatric use in the country in which the participant was enrolled or, c) Gilead Sciences elected to terminate development of F/TAF in the applicable country. The maximum exposure was 103.1 weeks. Allowed boosted 3rd ARV agents: LPV, ATV, DRV; Allowed unboosted 3rd ARV agents: EFV, RAL, DTG, or NVP.
|
|---|---|---|---|---|---|---|
|
Main Phase
Investigator's Discretion
|
0
|
2
|
0
|
0
|
0
|
0
|
|
Main Phase
Enrolled but Never Treated
|
1
|
0
|
0
|
0
|
0
|
0
|
|
Main Phase
Withdrew Consent
|
0
|
0
|
1
|
0
|
0
|
0
|
|
Extension Phase
Investigator's Discretion
|
0
|
0
|
0
|
14
|
1
|
0
|
|
Extension Phase
Lost to Follow-up
|
0
|
0
|
0
|
1
|
1
|
0
|
|
Extension Phase
Non-compliance with Study Drug
|
0
|
0
|
0
|
2
|
0
|
0
|
|
Extension Phase
Pregnancy
|
0
|
0
|
0
|
1
|
0
|
0
|
Baseline Characteristics
Study To Evaluate Emtricitabine/Tenofovir Alafenamide (F/TAF) in Human Immunodeficiency Virus 1 (HIV-1) Infected Children and Adolescents Virologically Suppressed on a 2-Nucleoside/Nucleotide Reverse Transcriptase Inhibitor (2-NRTI)-Containing Regimen
Baseline characteristics by cohort
| Measure |
F/TAF+3rd ARV Agent (Cohort 1)
n=28 Participants
Participants between 12 to \< 18 years of age and ≥ 35 kg body weight received emtricitabine/tenofovir alafenamide (F/TAF) 200/10 mg fixed-dose combination (FDC) tablet (with boosted 3rd antiretroviral \[ARV\] agent) or F/TAF 200/25 mg FDC tablet (with unboosted 3rd ARV agent) orally once daily for 48 weeks. After completion of 48 weeks, all participants were given the option to participate in the extension phase of the study to continue with F/TAF+3rd ARV agent. Gilead provided F/TAF until a) the participant turned 18 and F/TAF was commercially available for use in adults in the country in which the participant was enrolled or, b) F/TAF became commercially available for pediatric use in the country in which the participant was enrolled or, c) Gilead Sciences elected to terminate development of F/TAF in the applicable country. (Allowed boosted 3rd ARV agents: lopinavir \[LPV\], atazanavir \[ATV\], darunavir \[DRV\]; Allowed unboosted 3rd ARV agents: efavirenz \[EFV\], raltegravir \[RAL\], dolutegravir \[DTG\], or nevirapine \[NVP\]). The participants received the study drug up to a maximum of 438.9 weeks.
|
F/TAF+3rd ARV Agent (Cohort 2, Part A - Group 1)
n=9 Participants
Participants between 6 to \< 12 years of age and ≥ 25 kg body weight received F/TAF 200/25 mg FDC tablet orally once daily while continuing on their boosted protease inhibitor (PI) for 48 weeks. After completion of 48 weeks, all participants were given the option to participate in the extension phase of the study to continue with F/TAF+3rd ARV agent. Gilead provided F/TAF until a) the participant turned 18 and F/TAF was commercially available for use in adults in the country in which the participant was enrolled or, b) F/TAF became commercially available for pediatric use in the country in which the participant was enrolled or, c) Gilead Sciences elected to terminate development of F/TAF in the applicable country. (Allowed boosted PIs: ATV, LPV or DRV). The participants received the study drug up to a maximum of 315.0 weeks.
|
F/TAF+3rd ARV Agent (Cohort 2, Part A - Group 2)
n=3 Participants
Participants between 2 to \< 12 years of age and 17 to \< 25 kg body weight received F/TAF 120/15 mg FDC orally once daily while continuing on their 3rd ARV agent for 48 weeks. After completion of 48 weeks, all participants were given the option to participate in the extension phase of the study to continue with F/TAF+3rd ARV agent. Gilead provided F/TAF until a) the participant turned 18 and F/TAF was commercially available for use in adults in the country in which the participant was enrolled or, b) F/TAF became commercially available for pediatric use in the country in which the participant was enrolled or, c) Gilead Sciences elected to terminate development of F/TAF in the applicable country. (Allowed boosted 3rd ARV agents: LPV, ATV, DRV; Allowed unboosted 3rd ARV agents: EFV, RAL, DTG, or NVP). The participants received the study drug up to a maximum of 103.1 weeks.
|
Total
n=40 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
14 years
STANDARD_DEVIATION 1.6 • n=5 Participants
|
10 years
STANDARD_DEVIATION 1.0 • n=7 Participants
|
7 years
STANDARD_DEVIATION 1.2 • n=5 Participants
|
13 years
STANDARD_DEVIATION 2.6 • n=4 Participants
|
|
Age, Customized
6 to < 12 years
|
0 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
|
Age, Customized
12 to < 15 years
|
19 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
19 Participants
n=4 Participants
|
|
Age, Customized
15 to < 18 years
|
9 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
19 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
16 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
21 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
14 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
20 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
14 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
20 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Race · Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Race · Black
|
12 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
18 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Race · White
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Race · Other
|
12 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
18 Participants
n=4 Participants
|
|
Region of Enrollment
Panama
|
12 participants
n=5 Participants
|
6 participants
n=7 Participants
|
1 participants
n=5 Participants
|
19 participants
n=4 Participants
|
|
Region of Enrollment
South Africa
|
10 participants
n=5 Participants
|
0 participants
n=7 Participants
|
2 participants
n=5 Participants
|
12 participants
n=4 Participants
|
|
Region of Enrollment
United States
|
6 participants
n=5 Participants
|
3 participants
n=7 Participants
|
0 participants
n=5 Participants
|
9 participants
n=4 Participants
|
|
Human Immunodeficiency Virus, Type 1 Ribonucleic Acid (HIV-1 RNA)
< 50 copies/mL
|
27 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
39 Participants
n=4 Participants
|
|
Human Immunodeficiency Virus, Type 1 Ribonucleic Acid (HIV-1 RNA)
≥ 50 copies/mL
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Cluster of Differentiation 4 (CD4) Cell Count
|
909 cells/µL
STANDARD_DEVIATION 242.7 • n=5 Participants
|
871 cells/µL
STANDARD_DEVIATION 364.8 • n=7 Participants
|
1209 cells/µL
STANDARD_DEVIATION 306.3 • n=5 Participants
|
923 cells/µL
STANDARD_DEVIATION 282.8 • n=4 Participants
|
|
CD4 Percentage (%)
|
36.1 percentage of lymphocytes
STANDARD_DEVIATION 6.40 • n=5 Participants
|
36.7 percentage of lymphocytes
STANDARD_DEVIATION 4.35 • n=7 Participants
|
36.1 percentage of lymphocytes
STANDARD_DEVIATION 3.35 • n=5 Participants
|
36.2 percentage of lymphocytes
STANDARD_DEVIATION 5.73 • n=4 Participants
|
PRIMARY outcome
Timeframe: Any time at Week 2 visitPopulation: Participants in the Intensive PK (IPK) Analysis Set (participants who were enrolled in Cohort 1 for IPK evaluation, had received at least one dose of study medication, and had at least 1 non-missing PK concentration data for any analyte of interest (e.g., emtricitabine (FTC), TAF, and tenofovir (TFV))) with available data were analyzed.
AUCtau is defined as the area under the drug concentration versus time curve over the dosing interval.
Outcome measures
| Measure |
F/TAF 200/10 mg+3rd ARV Agent (Cohort 1)
n=9 Participants
Participants between 12 to \< 18 years of age and ≥ 35 kg body weight received F/TAF 200/10 mg FDC tablet (with boosted 3rd ARV agent) orally once daily for 48 weeks. After completion of 48 weeks, all participants were given the option to participate in an extension phase of the study to continue with F/TAF+3rd ARV agent. Gilead provided F/TAF until a) the participant turned 18 and F/TAF was commercially available for use in adults in the country in which the participant was enrolled or, b) F/TAF became commercially available for pediatric use in the country in which the participant was enrolled or, c) Gilead Sciences elected to terminate development of F/TAF in the applicable country. (Allowed boosted 3rd ARV agents: LPV, ATV, DRV). The participants received the study drug up to a maximum of 438.9 weeks.
|
F/TAF 200/25 mg+3rd ARV Agent (Cohort 1)
n=9 Participants
Participants between 12 to \< 18 years of age and ≥ 35 kg body weight received F/TAF 200/25 mg FDC tablet (with unboosted 3rd ARV agent) orally once daily for 48 weeks. After completion of 48 weeks, all participants were given the option to participate in an extension phase of the study to continue with F/TAF+3rd ARV agent. Gilead provided F/TAF until a) the participant turned 18 and F/TAF was commercially available for use in adults in the country in which the participant was enrolled or, b) F/TAF became commercially available for pediatric use in the country in which the participant was enrolled or, c) Gilead Sciences elected to terminate development of F/TAF in the applicable country. (Allowed unboosted 3rd ARV agents: EFV, RAL, DTG, or NVP). The participants received the study drug up to a maximum of 438.9 weeks.
|
F/TAF+3rd ARV Agent (Cohort 2, Part A - Group 2)
Participants between 2 to \< 12 years of age and 17 to \< 25 kg body weight received F/TAF 120/15 mg FDC orally once daily while continuing on their 3rd ARV agent for 48 weeks. After completion of 48 weeks, all participants were given the option to participate in the extension phase of the study to continue with F/TAF+3rd ARV agent. Gilead provided F/TAF until a) the participant turned 18 and F/TAF was commercially available for use in adults in the country in which the participant was enrolled or, b) F/TAF became commercially available for pediatric use in the country in which the participant was enrolled or, c) Gilead Sciences elected to terminate development of F/TAF in the applicable country. (Allowed boosted 3rd ARV agents: LPV, ATV, DRV; Allowed unboosted 3rd ARV agents: EFV, RAL, DTG, or NVP). The participants received the study drug up to a maximum of 103.1 weeks.
|
|---|---|---|---|
|
Pharmacokinetic (PK) Parameter (Cohort 1): AUCtau of Tenofovir Alafenamide (TAF)
|
139.9 h*ng/mL
Standard Deviation 113.23
|
200.6 h*ng/mL
Standard Deviation 83.80
|
—
|
PRIMARY outcome
Timeframe: Any time at Week 2 or Week 4 visit, or within 7 days after the completion of Week 2 or Week 4 visitsPopulation: The IPK Analysis Set included all participants who were enrolled into the study, had received at least one dose of study medication, and had at least 1 non-missing PK concentration data for any analyte of interest (e.g., FTC, TAF, and TFV).
AUCtau is defined as the area under the drug concentration versus time curve over the dosing interval.
Outcome measures
| Measure |
F/TAF 200/10 mg+3rd ARV Agent (Cohort 1)
n=9 Participants
Participants between 12 to \< 18 years of age and ≥ 35 kg body weight received F/TAF 200/10 mg FDC tablet (with boosted 3rd ARV agent) orally once daily for 48 weeks. After completion of 48 weeks, all participants were given the option to participate in an extension phase of the study to continue with F/TAF+3rd ARV agent. Gilead provided F/TAF until a) the participant turned 18 and F/TAF was commercially available for use in adults in the country in which the participant was enrolled or, b) F/TAF became commercially available for pediatric use in the country in which the participant was enrolled or, c) Gilead Sciences elected to terminate development of F/TAF in the applicable country. (Allowed boosted 3rd ARV agents: LPV, ATV, DRV). The participants received the study drug up to a maximum of 438.9 weeks.
|
F/TAF 200/25 mg+3rd ARV Agent (Cohort 1)
n=3 Participants
Participants between 12 to \< 18 years of age and ≥ 35 kg body weight received F/TAF 200/25 mg FDC tablet (with unboosted 3rd ARV agent) orally once daily for 48 weeks. After completion of 48 weeks, all participants were given the option to participate in an extension phase of the study to continue with F/TAF+3rd ARV agent. Gilead provided F/TAF until a) the participant turned 18 and F/TAF was commercially available for use in adults in the country in which the participant was enrolled or, b) F/TAF became commercially available for pediatric use in the country in which the participant was enrolled or, c) Gilead Sciences elected to terminate development of F/TAF in the applicable country. (Allowed unboosted 3rd ARV agents: EFV, RAL, DTG, or NVP). The participants received the study drug up to a maximum of 438.9 weeks.
|
F/TAF+3rd ARV Agent (Cohort 2, Part A - Group 2)
Participants between 2 to \< 12 years of age and 17 to \< 25 kg body weight received F/TAF 120/15 mg FDC orally once daily while continuing on their 3rd ARV agent for 48 weeks. After completion of 48 weeks, all participants were given the option to participate in the extension phase of the study to continue with F/TAF+3rd ARV agent. Gilead provided F/TAF until a) the participant turned 18 and F/TAF was commercially available for use in adults in the country in which the participant was enrolled or, b) F/TAF became commercially available for pediatric use in the country in which the participant was enrolled or, c) Gilead Sciences elected to terminate development of F/TAF in the applicable country. (Allowed boosted 3rd ARV agents: LPV, ATV, DRV; Allowed unboosted 3rd ARV agents: EFV, RAL, DTG, or NVP). The participants received the study drug up to a maximum of 103.1 weeks.
|
|---|---|---|---|
|
PK Parameter (Cohort 2: Part A - Groups 1 and 2): AUCtau of TAF
|
210.8 h*ng/mL
Standard Deviation 97.35
|
220.2 h*ng/mL
Standard Deviation 187.96
|
—
|
PRIMARY outcome
Timeframe: Baseline through Week 24Population: The Safety Analysis Set included all participants who were enrolled in the study and had received at least one dose of study medication. It was prespecified to analyze data from Cohort 1 together because both treatments (F/TAF 200/10 mg with boosted 3rd ARV and F/TAF 200/25 mg with unboosted 3rd ARV) were expected to have a similar effect on the efficacy and safety for the target population.
An AE is any untoward medical occurrence in a clinical study participant which does not necessarily have a causal relationship with the treatment. An AE can therefore be any unfavorable and/or unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. The TEAEs were defined as any AEs with an onset date of on or after the study drug start date and no later than 30 days after permanent discontinuation of study drug or any AEs leading to premature discontinuation of study drug.
Outcome measures
| Measure |
F/TAF 200/10 mg+3rd ARV Agent (Cohort 1)
n=28 Participants
Participants between 12 to \< 18 years of age and ≥ 35 kg body weight received F/TAF 200/10 mg FDC tablet (with boosted 3rd ARV agent) orally once daily for 48 weeks. After completion of 48 weeks, all participants were given the option to participate in an extension phase of the study to continue with F/TAF+3rd ARV agent. Gilead provided F/TAF until a) the participant turned 18 and F/TAF was commercially available for use in adults in the country in which the participant was enrolled or, b) F/TAF became commercially available for pediatric use in the country in which the participant was enrolled or, c) Gilead Sciences elected to terminate development of F/TAF in the applicable country. (Allowed boosted 3rd ARV agents: LPV, ATV, DRV). The participants received the study drug up to a maximum of 438.9 weeks.
|
F/TAF 200/25 mg+3rd ARV Agent (Cohort 1)
n=9 Participants
Participants between 12 to \< 18 years of age and ≥ 35 kg body weight received F/TAF 200/25 mg FDC tablet (with unboosted 3rd ARV agent) orally once daily for 48 weeks. After completion of 48 weeks, all participants were given the option to participate in an extension phase of the study to continue with F/TAF+3rd ARV agent. Gilead provided F/TAF until a) the participant turned 18 and F/TAF was commercially available for use in adults in the country in which the participant was enrolled or, b) F/TAF became commercially available for pediatric use in the country in which the participant was enrolled or, c) Gilead Sciences elected to terminate development of F/TAF in the applicable country. (Allowed unboosted 3rd ARV agents: EFV, RAL, DTG, or NVP). The participants received the study drug up to a maximum of 438.9 weeks.
|
F/TAF+3rd ARV Agent (Cohort 2, Part A - Group 2)
n=3 Participants
Participants between 2 to \< 12 years of age and 17 to \< 25 kg body weight received F/TAF 120/15 mg FDC orally once daily while continuing on their 3rd ARV agent for 48 weeks. After completion of 48 weeks, all participants were given the option to participate in the extension phase of the study to continue with F/TAF+3rd ARV agent. Gilead provided F/TAF until a) the participant turned 18 and F/TAF was commercially available for use in adults in the country in which the participant was enrolled or, b) F/TAF became commercially available for pediatric use in the country in which the participant was enrolled or, c) Gilead Sciences elected to terminate development of F/TAF in the applicable country. (Allowed boosted 3rd ARV agents: LPV, ATV, DRV; Allowed unboosted 3rd ARV agents: EFV, RAL, DTG, or NVP). The participants received the study drug up to a maximum of 103.1 weeks.
|
|---|---|---|---|
|
Percentage of Participants Experiencing Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) Through Week 24
Any AEs
|
82.1 percentage of participants
|
66.7 percentage of participants
|
66.7 percentage of participants
|
|
Percentage of Participants Experiencing Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) Through Week 24
SAEs
|
7.1 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
SECONDARY outcome
Timeframe: Any time at Week 2 visitPopulation: Participants in the IPK Analysis Set with available data were analyzed.
Cmax is defined as the maximum concentration of drug.
Outcome measures
| Measure |
F/TAF 200/10 mg+3rd ARV Agent (Cohort 1)
n=13 Participants
Participants between 12 to \< 18 years of age and ≥ 35 kg body weight received F/TAF 200/10 mg FDC tablet (with boosted 3rd ARV agent) orally once daily for 48 weeks. After completion of 48 weeks, all participants were given the option to participate in an extension phase of the study to continue with F/TAF+3rd ARV agent. Gilead provided F/TAF until a) the participant turned 18 and F/TAF was commercially available for use in adults in the country in which the participant was enrolled or, b) F/TAF became commercially available for pediatric use in the country in which the participant was enrolled or, c) Gilead Sciences elected to terminate development of F/TAF in the applicable country. (Allowed boosted 3rd ARV agents: LPV, ATV, DRV). The participants received the study drug up to a maximum of 438.9 weeks.
|
F/TAF 200/25 mg+3rd ARV Agent (Cohort 1)
n=11 Participants
Participants between 12 to \< 18 years of age and ≥ 35 kg body weight received F/TAF 200/25 mg FDC tablet (with unboosted 3rd ARV agent) orally once daily for 48 weeks. After completion of 48 weeks, all participants were given the option to participate in an extension phase of the study to continue with F/TAF+3rd ARV agent. Gilead provided F/TAF until a) the participant turned 18 and F/TAF was commercially available for use in adults in the country in which the participant was enrolled or, b) F/TAF became commercially available for pediatric use in the country in which the participant was enrolled or, c) Gilead Sciences elected to terminate development of F/TAF in the applicable country. (Allowed unboosted 3rd ARV agents: EFV, RAL, DTG, or NVP). The participants received the study drug up to a maximum of 438.9 weeks.
|
F/TAF+3rd ARV Agent (Cohort 2, Part A - Group 2)
Participants between 2 to \< 12 years of age and 17 to \< 25 kg body weight received F/TAF 120/15 mg FDC orally once daily while continuing on their 3rd ARV agent for 48 weeks. After completion of 48 weeks, all participants were given the option to participate in the extension phase of the study to continue with F/TAF+3rd ARV agent. Gilead provided F/TAF until a) the participant turned 18 and F/TAF was commercially available for use in adults in the country in which the participant was enrolled or, b) F/TAF became commercially available for pediatric use in the country in which the participant was enrolled or, c) Gilead Sciences elected to terminate development of F/TAF in the applicable country. (Allowed boosted 3rd ARV agents: LPV, ATV, DRV; Allowed unboosted 3rd ARV agents: EFV, RAL, DTG, or NVP). The participants received the study drug up to a maximum of 103.1 weeks.
|
|---|---|---|---|
|
PK Parameter (Cohort 1): Cmax of TAF, FTC, and TFV
Cmax of TAF
|
89.1 ng/mL
Standard Deviation 77.63
|
139.3 ng/mL
Standard Deviation 76.17
|
—
|
|
PK Parameter (Cohort 1): Cmax of TAF, FTC, and TFV
Cmax of FTC
|
2259.2 ng/mL
Standard Deviation 470.75
|
2320.0 ng/mL
Standard Deviation 482.18
|
—
|
|
PK Parameter (Cohort 1): Cmax of TAF, FTC, and TFV
Cmax of TFV
|
21.2 ng/mL
Standard Deviation 4.89
|
11.6 ng/mL
Standard Deviation 2.74
|
—
|
SECONDARY outcome
Timeframe: Any time at Week 2 or Week 4 visit, or within 7 days after the completion of Week 2 or Week 4 visitsPopulation: Participants in the IPK Analysis Set were analyzed.
Cmax is defined as the maximum concentration of drug.
Outcome measures
| Measure |
F/TAF 200/10 mg+3rd ARV Agent (Cohort 1)
n=9 Participants
Participants between 12 to \< 18 years of age and ≥ 35 kg body weight received F/TAF 200/10 mg FDC tablet (with boosted 3rd ARV agent) orally once daily for 48 weeks. After completion of 48 weeks, all participants were given the option to participate in an extension phase of the study to continue with F/TAF+3rd ARV agent. Gilead provided F/TAF until a) the participant turned 18 and F/TAF was commercially available for use in adults in the country in which the participant was enrolled or, b) F/TAF became commercially available for pediatric use in the country in which the participant was enrolled or, c) Gilead Sciences elected to terminate development of F/TAF in the applicable country. (Allowed boosted 3rd ARV agents: LPV, ATV, DRV). The participants received the study drug up to a maximum of 438.9 weeks.
|
F/TAF 200/25 mg+3rd ARV Agent (Cohort 1)
n=3 Participants
Participants between 12 to \< 18 years of age and ≥ 35 kg body weight received F/TAF 200/25 mg FDC tablet (with unboosted 3rd ARV agent) orally once daily for 48 weeks. After completion of 48 weeks, all participants were given the option to participate in an extension phase of the study to continue with F/TAF+3rd ARV agent. Gilead provided F/TAF until a) the participant turned 18 and F/TAF was commercially available for use in adults in the country in which the participant was enrolled or, b) F/TAF became commercially available for pediatric use in the country in which the participant was enrolled or, c) Gilead Sciences elected to terminate development of F/TAF in the applicable country. (Allowed unboosted 3rd ARV agents: EFV, RAL, DTG, or NVP). The participants received the study drug up to a maximum of 438.9 weeks.
|
F/TAF+3rd ARV Agent (Cohort 2, Part A - Group 2)
Participants between 2 to \< 12 years of age and 17 to \< 25 kg body weight received F/TAF 120/15 mg FDC orally once daily while continuing on their 3rd ARV agent for 48 weeks. After completion of 48 weeks, all participants were given the option to participate in the extension phase of the study to continue with F/TAF+3rd ARV agent. Gilead provided F/TAF until a) the participant turned 18 and F/TAF was commercially available for use in adults in the country in which the participant was enrolled or, b) F/TAF became commercially available for pediatric use in the country in which the participant was enrolled or, c) Gilead Sciences elected to terminate development of F/TAF in the applicable country. (Allowed boosted 3rd ARV agents: LPV, ATV, DRV; Allowed unboosted 3rd ARV agents: EFV, RAL, DTG, or NVP). The participants received the study drug up to a maximum of 103.1 weeks.
|
|---|---|---|---|
|
PK Parameter (Cohort 2: Part A - Groups 1 and 2): Cmax of TAF, FTC, and TFV
Cmax of TAF
|
230.4 ng/mL
Standard Deviation 264.70
|
232.0 ng/mL
Standard Deviation 253.59
|
—
|
|
PK Parameter (Cohort 2: Part A - Groups 1 and 2): Cmax of TAF, FTC, and TFV
Cmax of FTC
|
2074.4 ng/mL
Standard Deviation 565.91
|
2020.0 ng/mL
Standard Deviation 1151.91
|
—
|
|
PK Parameter (Cohort 2: Part A - Groups 1 and 2): Cmax of TAF, FTC, and TFV
Cmax of TFV
|
55.8 ng/mL
Standard Deviation 19.20
|
48.1 ng/mL
Standard Deviation 8.07
|
—
|
SECONDARY outcome
Timeframe: Any time at Week 2 visitPopulation: Participants in the IPK Analysis Set with available data were analyzed.
Clast is defined as the last observable concentration of drug.
Outcome measures
| Measure |
F/TAF 200/10 mg+3rd ARV Agent (Cohort 1)
n=13 Participants
Participants between 12 to \< 18 years of age and ≥ 35 kg body weight received F/TAF 200/10 mg FDC tablet (with boosted 3rd ARV agent) orally once daily for 48 weeks. After completion of 48 weeks, all participants were given the option to participate in an extension phase of the study to continue with F/TAF+3rd ARV agent. Gilead provided F/TAF until a) the participant turned 18 and F/TAF was commercially available for use in adults in the country in which the participant was enrolled or, b) F/TAF became commercially available for pediatric use in the country in which the participant was enrolled or, c) Gilead Sciences elected to terminate development of F/TAF in the applicable country. (Allowed boosted 3rd ARV agents: LPV, ATV, DRV). The participants received the study drug up to a maximum of 438.9 weeks.
|
F/TAF 200/25 mg+3rd ARV Agent (Cohort 1)
n=11 Participants
Participants between 12 to \< 18 years of age and ≥ 35 kg body weight received F/TAF 200/25 mg FDC tablet (with unboosted 3rd ARV agent) orally once daily for 48 weeks. After completion of 48 weeks, all participants were given the option to participate in an extension phase of the study to continue with F/TAF+3rd ARV agent. Gilead provided F/TAF until a) the participant turned 18 and F/TAF was commercially available for use in adults in the country in which the participant was enrolled or, b) F/TAF became commercially available for pediatric use in the country in which the participant was enrolled or, c) Gilead Sciences elected to terminate development of F/TAF in the applicable country. (Allowed unboosted 3rd ARV agents: EFV, RAL, DTG, or NVP). The participants received the study drug up to a maximum of 438.9 weeks.
|
F/TAF+3rd ARV Agent (Cohort 2, Part A - Group 2)
Participants between 2 to \< 12 years of age and 17 to \< 25 kg body weight received F/TAF 120/15 mg FDC orally once daily while continuing on their 3rd ARV agent for 48 weeks. After completion of 48 weeks, all participants were given the option to participate in the extension phase of the study to continue with F/TAF+3rd ARV agent. Gilead provided F/TAF until a) the participant turned 18 and F/TAF was commercially available for use in adults in the country in which the participant was enrolled or, b) F/TAF became commercially available for pediatric use in the country in which the participant was enrolled or, c) Gilead Sciences elected to terminate development of F/TAF in the applicable country. (Allowed boosted 3rd ARV agents: LPV, ATV, DRV; Allowed unboosted 3rd ARV agents: EFV, RAL, DTG, or NVP). The participants received the study drug up to a maximum of 103.1 weeks.
|
|---|---|---|---|
|
PK Parameter (Cohort 1): Clast of TAF
|
2.2 ng/mL
Standard Deviation 0.98
|
5.5 ng/mL
Standard Deviation 3.76
|
—
|
SECONDARY outcome
Timeframe: Any time at Week 2 or Week 4 visit, or within 7 days after the completion of Week 2 or Week 4 visitsPopulation: Participants in the IPK Analysis Set were analyzed.
Clast is defined as the last observable concentration of drug.
Outcome measures
| Measure |
F/TAF 200/10 mg+3rd ARV Agent (Cohort 1)
n=9 Participants
Participants between 12 to \< 18 years of age and ≥ 35 kg body weight received F/TAF 200/10 mg FDC tablet (with boosted 3rd ARV agent) orally once daily for 48 weeks. After completion of 48 weeks, all participants were given the option to participate in an extension phase of the study to continue with F/TAF+3rd ARV agent. Gilead provided F/TAF until a) the participant turned 18 and F/TAF was commercially available for use in adults in the country in which the participant was enrolled or, b) F/TAF became commercially available for pediatric use in the country in which the participant was enrolled or, c) Gilead Sciences elected to terminate development of F/TAF in the applicable country. (Allowed boosted 3rd ARV agents: LPV, ATV, DRV). The participants received the study drug up to a maximum of 438.9 weeks.
|
F/TAF 200/25 mg+3rd ARV Agent (Cohort 1)
n=3 Participants
Participants between 12 to \< 18 years of age and ≥ 35 kg body weight received F/TAF 200/25 mg FDC tablet (with unboosted 3rd ARV agent) orally once daily for 48 weeks. After completion of 48 weeks, all participants were given the option to participate in an extension phase of the study to continue with F/TAF+3rd ARV agent. Gilead provided F/TAF until a) the participant turned 18 and F/TAF was commercially available for use in adults in the country in which the participant was enrolled or, b) F/TAF became commercially available for pediatric use in the country in which the participant was enrolled or, c) Gilead Sciences elected to terminate development of F/TAF in the applicable country. (Allowed unboosted 3rd ARV agents: EFV, RAL, DTG, or NVP). The participants received the study drug up to a maximum of 438.9 weeks.
|
F/TAF+3rd ARV Agent (Cohort 2, Part A - Group 2)
Participants between 2 to \< 12 years of age and 17 to \< 25 kg body weight received F/TAF 120/15 mg FDC orally once daily while continuing on their 3rd ARV agent for 48 weeks. After completion of 48 weeks, all participants were given the option to participate in the extension phase of the study to continue with F/TAF+3rd ARV agent. Gilead provided F/TAF until a) the participant turned 18 and F/TAF was commercially available for use in adults in the country in which the participant was enrolled or, b) F/TAF became commercially available for pediatric use in the country in which the participant was enrolled or, c) Gilead Sciences elected to terminate development of F/TAF in the applicable country. (Allowed boosted 3rd ARV agents: LPV, ATV, DRV; Allowed unboosted 3rd ARV agents: EFV, RAL, DTG, or NVP). The participants received the study drug up to a maximum of 103.1 weeks.
|
|---|---|---|---|
|
PK Parameter (Cohort 2: Part A - Groups 1 and 2): Clast of TAF
|
2.9 ng/mL
Standard Deviation 2.32
|
2.1 ng/mL
Standard Deviation 0.86
|
—
|
SECONDARY outcome
Timeframe: Any time at Week 2 visitPopulation: Participants in the IPK Analysis Set with available data were analyzed.
CL/F is defined as the apparent clearance following oral administration of the drug.
Outcome measures
| Measure |
F/TAF 200/10 mg+3rd ARV Agent (Cohort 1)
n=9 Participants
Participants between 12 to \< 18 years of age and ≥ 35 kg body weight received F/TAF 200/10 mg FDC tablet (with boosted 3rd ARV agent) orally once daily for 48 weeks. After completion of 48 weeks, all participants were given the option to participate in an extension phase of the study to continue with F/TAF+3rd ARV agent. Gilead provided F/TAF until a) the participant turned 18 and F/TAF was commercially available for use in adults in the country in which the participant was enrolled or, b) F/TAF became commercially available for pediatric use in the country in which the participant was enrolled or, c) Gilead Sciences elected to terminate development of F/TAF in the applicable country. (Allowed boosted 3rd ARV agents: LPV, ATV, DRV). The participants received the study drug up to a maximum of 438.9 weeks.
|
F/TAF 200/25 mg+3rd ARV Agent (Cohort 1)
n=9 Participants
Participants between 12 to \< 18 years of age and ≥ 35 kg body weight received F/TAF 200/25 mg FDC tablet (with unboosted 3rd ARV agent) orally once daily for 48 weeks. After completion of 48 weeks, all participants were given the option to participate in an extension phase of the study to continue with F/TAF+3rd ARV agent. Gilead provided F/TAF until a) the participant turned 18 and F/TAF was commercially available for use in adults in the country in which the participant was enrolled or, b) F/TAF became commercially available for pediatric use in the country in which the participant was enrolled or, c) Gilead Sciences elected to terminate development of F/TAF in the applicable country. (Allowed unboosted 3rd ARV agents: EFV, RAL, DTG, or NVP). The participants received the study drug up to a maximum of 438.9 weeks.
|
F/TAF+3rd ARV Agent (Cohort 2, Part A - Group 2)
Participants between 2 to \< 12 years of age and 17 to \< 25 kg body weight received F/TAF 120/15 mg FDC orally once daily while continuing on their 3rd ARV agent for 48 weeks. After completion of 48 weeks, all participants were given the option to participate in the extension phase of the study to continue with F/TAF+3rd ARV agent. Gilead provided F/TAF until a) the participant turned 18 and F/TAF was commercially available for use in adults in the country in which the participant was enrolled or, b) F/TAF became commercially available for pediatric use in the country in which the participant was enrolled or, c) Gilead Sciences elected to terminate development of F/TAF in the applicable country. (Allowed boosted 3rd ARV agents: LPV, ATV, DRV; Allowed unboosted 3rd ARV agents: EFV, RAL, DTG, or NVP). The participants received the study drug up to a maximum of 103.1 weeks.
|
|---|---|---|---|
|
PK Parameter (Cohort 1): CL/F of TAF
|
129.8 L/hr
Standard Deviation 101.67
|
143.4 L/hr
Standard Deviation 53.55
|
—
|
SECONDARY outcome
Timeframe: Any time at Week 2 or Week 4 visit, or within 7 days after the completion of Week 2 or Week 4 visitsPopulation: Participants in the IPK Analysis Set were analyzed.
CL/F is defined as the apparent clearance following oral administration of the drug.
Outcome measures
| Measure |
F/TAF 200/10 mg+3rd ARV Agent (Cohort 1)
n=9 Participants
Participants between 12 to \< 18 years of age and ≥ 35 kg body weight received F/TAF 200/10 mg FDC tablet (with boosted 3rd ARV agent) orally once daily for 48 weeks. After completion of 48 weeks, all participants were given the option to participate in an extension phase of the study to continue with F/TAF+3rd ARV agent. Gilead provided F/TAF until a) the participant turned 18 and F/TAF was commercially available for use in adults in the country in which the participant was enrolled or, b) F/TAF became commercially available for pediatric use in the country in which the participant was enrolled or, c) Gilead Sciences elected to terminate development of F/TAF in the applicable country. (Allowed boosted 3rd ARV agents: LPV, ATV, DRV). The participants received the study drug up to a maximum of 438.9 weeks.
|
F/TAF 200/25 mg+3rd ARV Agent (Cohort 1)
n=3 Participants
Participants between 12 to \< 18 years of age and ≥ 35 kg body weight received F/TAF 200/25 mg FDC tablet (with unboosted 3rd ARV agent) orally once daily for 48 weeks. After completion of 48 weeks, all participants were given the option to participate in an extension phase of the study to continue with F/TAF+3rd ARV agent. Gilead provided F/TAF until a) the participant turned 18 and F/TAF was commercially available for use in adults in the country in which the participant was enrolled or, b) F/TAF became commercially available for pediatric use in the country in which the participant was enrolled or, c) Gilead Sciences elected to terminate development of F/TAF in the applicable country. (Allowed unboosted 3rd ARV agents: EFV, RAL, DTG, or NVP). The participants received the study drug up to a maximum of 438.9 weeks.
|
F/TAF+3rd ARV Agent (Cohort 2, Part A - Group 2)
Participants between 2 to \< 12 years of age and 17 to \< 25 kg body weight received F/TAF 120/15 mg FDC orally once daily while continuing on their 3rd ARV agent for 48 weeks. After completion of 48 weeks, all participants were given the option to participate in the extension phase of the study to continue with F/TAF+3rd ARV agent. Gilead provided F/TAF until a) the participant turned 18 and F/TAF was commercially available for use in adults in the country in which the participant was enrolled or, b) F/TAF became commercially available for pediatric use in the country in which the participant was enrolled or, c) Gilead Sciences elected to terminate development of F/TAF in the applicable country. (Allowed boosted 3rd ARV agents: LPV, ATV, DRV; Allowed unboosted 3rd ARV agents: EFV, RAL, DTG, or NVP). The participants received the study drug up to a maximum of 103.1 weeks.
|
|---|---|---|---|
|
PK Parameter (Cohort 2: Part A - Groups 1 and 2): CL/F of TAF
|
174.3 L/hr
Standard Deviation 156.75
|
102.1 L/hr
Standard Deviation 60.75
|
—
|
SECONDARY outcome
Timeframe: Any time at Week 2 visitPopulation: Participants in the IPK Analysis Set with available data were analyzed.
Vz/F is defined as the apparent volume of distribution of the drug following oral administration.
Outcome measures
| Measure |
F/TAF 200/10 mg+3rd ARV Agent (Cohort 1)
n=9 Participants
Participants between 12 to \< 18 years of age and ≥ 35 kg body weight received F/TAF 200/10 mg FDC tablet (with boosted 3rd ARV agent) orally once daily for 48 weeks. After completion of 48 weeks, all participants were given the option to participate in an extension phase of the study to continue with F/TAF+3rd ARV agent. Gilead provided F/TAF until a) the participant turned 18 and F/TAF was commercially available for use in adults in the country in which the participant was enrolled or, b) F/TAF became commercially available for pediatric use in the country in which the participant was enrolled or, c) Gilead Sciences elected to terminate development of F/TAF in the applicable country. (Allowed boosted 3rd ARV agents: LPV, ATV, DRV). The participants received the study drug up to a maximum of 438.9 weeks.
|
F/TAF 200/25 mg+3rd ARV Agent (Cohort 1)
n=9 Participants
Participants between 12 to \< 18 years of age and ≥ 35 kg body weight received F/TAF 200/25 mg FDC tablet (with unboosted 3rd ARV agent) orally once daily for 48 weeks. After completion of 48 weeks, all participants were given the option to participate in an extension phase of the study to continue with F/TAF+3rd ARV agent. Gilead provided F/TAF until a) the participant turned 18 and F/TAF was commercially available for use in adults in the country in which the participant was enrolled or, b) F/TAF became commercially available for pediatric use in the country in which the participant was enrolled or, c) Gilead Sciences elected to terminate development of F/TAF in the applicable country. (Allowed unboosted 3rd ARV agents: EFV, RAL, DTG, or NVP). The participants received the study drug up to a maximum of 438.9 weeks.
|
F/TAF+3rd ARV Agent (Cohort 2, Part A - Group 2)
Participants between 2 to \< 12 years of age and 17 to \< 25 kg body weight received F/TAF 120/15 mg FDC orally once daily while continuing on their 3rd ARV agent for 48 weeks. After completion of 48 weeks, all participants were given the option to participate in the extension phase of the study to continue with F/TAF+3rd ARV agent. Gilead provided F/TAF until a) the participant turned 18 and F/TAF was commercially available for use in adults in the country in which the participant was enrolled or, b) F/TAF became commercially available for pediatric use in the country in which the participant was enrolled or, c) Gilead Sciences elected to terminate development of F/TAF in the applicable country. (Allowed boosted 3rd ARV agents: LPV, ATV, DRV; Allowed unboosted 3rd ARV agents: EFV, RAL, DTG, or NVP). The participants received the study drug up to a maximum of 103.1 weeks.
|
|---|---|---|---|
|
PK Parameter (Cohort 1): Vz/F of TAF
|
87.3 liters
Standard Deviation 60.68
|
95.3 liters
Standard Deviation 43.47
|
—
|
SECONDARY outcome
Timeframe: Any time at Week 2 or Week 4 visit, or within 7 days after the completion of Week 2 or Week 4 visitsPopulation: Participants in the IPK Analysis Set were analyzed.
Vz/F is defined as the apparent volume of distribution of the drug following oral administration.
Outcome measures
| Measure |
F/TAF 200/10 mg+3rd ARV Agent (Cohort 1)
n=9 Participants
Participants between 12 to \< 18 years of age and ≥ 35 kg body weight received F/TAF 200/10 mg FDC tablet (with boosted 3rd ARV agent) orally once daily for 48 weeks. After completion of 48 weeks, all participants were given the option to participate in an extension phase of the study to continue with F/TAF+3rd ARV agent. Gilead provided F/TAF until a) the participant turned 18 and F/TAF was commercially available for use in adults in the country in which the participant was enrolled or, b) F/TAF became commercially available for pediatric use in the country in which the participant was enrolled or, c) Gilead Sciences elected to terminate development of F/TAF in the applicable country. (Allowed boosted 3rd ARV agents: LPV, ATV, DRV). The participants received the study drug up to a maximum of 438.9 weeks.
|
F/TAF 200/25 mg+3rd ARV Agent (Cohort 1)
n=3 Participants
Participants between 12 to \< 18 years of age and ≥ 35 kg body weight received F/TAF 200/25 mg FDC tablet (with unboosted 3rd ARV agent) orally once daily for 48 weeks. After completion of 48 weeks, all participants were given the option to participate in an extension phase of the study to continue with F/TAF+3rd ARV agent. Gilead provided F/TAF until a) the participant turned 18 and F/TAF was commercially available for use in adults in the country in which the participant was enrolled or, b) F/TAF became commercially available for pediatric use in the country in which the participant was enrolled or, c) Gilead Sciences elected to terminate development of F/TAF in the applicable country. (Allowed unboosted 3rd ARV agents: EFV, RAL, DTG, or NVP). The participants received the study drug up to a maximum of 438.9 weeks.
|
F/TAF+3rd ARV Agent (Cohort 2, Part A - Group 2)
Participants between 2 to \< 12 years of age and 17 to \< 25 kg body weight received F/TAF 120/15 mg FDC orally once daily while continuing on their 3rd ARV agent for 48 weeks. After completion of 48 weeks, all participants were given the option to participate in the extension phase of the study to continue with F/TAF+3rd ARV agent. Gilead provided F/TAF until a) the participant turned 18 and F/TAF was commercially available for use in adults in the country in which the participant was enrolled or, b) F/TAF became commercially available for pediatric use in the country in which the participant was enrolled or, c) Gilead Sciences elected to terminate development of F/TAF in the applicable country. (Allowed boosted 3rd ARV agents: LPV, ATV, DRV; Allowed unboosted 3rd ARV agents: EFV, RAL, DTG, or NVP). The participants received the study drug up to a maximum of 103.1 weeks.
|
|---|---|---|---|
|
PK Parameter (Cohort 2: Part A - Groups 1 and 2): Vz/F of TAF
|
160.8 liters
Standard Deviation 145.57
|
63.1 liters
Standard Deviation 63.39
|
—
|
SECONDARY outcome
Timeframe: Any time at Week 2 visitPopulation: Participants in the IPK Analysis Set with available data were analyzed.
AUCtau is defined as the area under the drug concentration versus time curve over the dosing interval.
Outcome measures
| Measure |
F/TAF 200/10 mg+3rd ARV Agent (Cohort 1)
n=13 Participants
Participants between 12 to \< 18 years of age and ≥ 35 kg body weight received F/TAF 200/10 mg FDC tablet (with boosted 3rd ARV agent) orally once daily for 48 weeks. After completion of 48 weeks, all participants were given the option to participate in an extension phase of the study to continue with F/TAF+3rd ARV agent. Gilead provided F/TAF until a) the participant turned 18 and F/TAF was commercially available for use in adults in the country in which the participant was enrolled or, b) F/TAF became commercially available for pediatric use in the country in which the participant was enrolled or, c) Gilead Sciences elected to terminate development of F/TAF in the applicable country. (Allowed boosted 3rd ARV agents: LPV, ATV, DRV). The participants received the study drug up to a maximum of 438.9 weeks.
|
F/TAF 200/25 mg+3rd ARV Agent (Cohort 1)
n=11 Participants
Participants between 12 to \< 18 years of age and ≥ 35 kg body weight received F/TAF 200/25 mg FDC tablet (with unboosted 3rd ARV agent) orally once daily for 48 weeks. After completion of 48 weeks, all participants were given the option to participate in an extension phase of the study to continue with F/TAF+3rd ARV agent. Gilead provided F/TAF until a) the participant turned 18 and F/TAF was commercially available for use in adults in the country in which the participant was enrolled or, b) F/TAF became commercially available for pediatric use in the country in which the participant was enrolled or, c) Gilead Sciences elected to terminate development of F/TAF in the applicable country. (Allowed unboosted 3rd ARV agents: EFV, RAL, DTG, or NVP). The participants received the study drug up to a maximum of 438.9 weeks.
|
F/TAF+3rd ARV Agent (Cohort 2, Part A - Group 2)
Participants between 2 to \< 12 years of age and 17 to \< 25 kg body weight received F/TAF 120/15 mg FDC orally once daily while continuing on their 3rd ARV agent for 48 weeks. After completion of 48 weeks, all participants were given the option to participate in the extension phase of the study to continue with F/TAF+3rd ARV agent. Gilead provided F/TAF until a) the participant turned 18 and F/TAF was commercially available for use in adults in the country in which the participant was enrolled or, b) F/TAF became commercially available for pediatric use in the country in which the participant was enrolled or, c) Gilead Sciences elected to terminate development of F/TAF in the applicable country. (Allowed boosted 3rd ARV agents: LPV, ATV, DRV; Allowed unboosted 3rd ARV agents: EFV, RAL, DTG, or NVP). The participants received the study drug up to a maximum of 103.1 weeks.
|
|---|---|---|---|
|
PK Parameter (Cohort 1): AUCtau of FTC and TFV
AUCtau of FTC
|
14769.9 h*ng/mL
Standard Deviation 4481.23
|
14339.8 h*ng/mL
Standard Deviation 6099.55
|
—
|
|
PK Parameter (Cohort 1): AUCtau of FTC and TFV
AUCtau of TFV
|
415.5 h*ng/mL
Standard Deviation 105.92
|
193.2 h*ng/mL
Standard Deviation 46.73
|
—
|
SECONDARY outcome
Timeframe: Any time at Week 2 or Week 4 visit, or within 7 days after the completion of Week 2 or Week 4 visitsPopulation: Participants in the IPK Analysis Set with available data were analyzed.
AUCtau is defined as the area under the drug concentration versus time curve over the dosing interval.
Outcome measures
| Measure |
F/TAF 200/10 mg+3rd ARV Agent (Cohort 1)
n=9 Participants
Participants between 12 to \< 18 years of age and ≥ 35 kg body weight received F/TAF 200/10 mg FDC tablet (with boosted 3rd ARV agent) orally once daily for 48 weeks. After completion of 48 weeks, all participants were given the option to participate in an extension phase of the study to continue with F/TAF+3rd ARV agent. Gilead provided F/TAF until a) the participant turned 18 and F/TAF was commercially available for use in adults in the country in which the participant was enrolled or, b) F/TAF became commercially available for pediatric use in the country in which the participant was enrolled or, c) Gilead Sciences elected to terminate development of F/TAF in the applicable country. (Allowed boosted 3rd ARV agents: LPV, ATV, DRV). The participants received the study drug up to a maximum of 438.9 weeks.
|
F/TAF 200/25 mg+3rd ARV Agent (Cohort 1)
n=3 Participants
Participants between 12 to \< 18 years of age and ≥ 35 kg body weight received F/TAF 200/25 mg FDC tablet (with unboosted 3rd ARV agent) orally once daily for 48 weeks. After completion of 48 weeks, all participants were given the option to participate in an extension phase of the study to continue with F/TAF+3rd ARV agent. Gilead provided F/TAF until a) the participant turned 18 and F/TAF was commercially available for use in adults in the country in which the participant was enrolled or, b) F/TAF became commercially available for pediatric use in the country in which the participant was enrolled or, c) Gilead Sciences elected to terminate development of F/TAF in the applicable country. (Allowed unboosted 3rd ARV agents: EFV, RAL, DTG, or NVP). The participants received the study drug up to a maximum of 438.9 weeks.
|
F/TAF+3rd ARV Agent (Cohort 2, Part A - Group 2)
Participants between 2 to \< 12 years of age and 17 to \< 25 kg body weight received F/TAF 120/15 mg FDC orally once daily while continuing on their 3rd ARV agent for 48 weeks. After completion of 48 weeks, all participants were given the option to participate in the extension phase of the study to continue with F/TAF+3rd ARV agent. Gilead provided F/TAF until a) the participant turned 18 and F/TAF was commercially available for use in adults in the country in which the participant was enrolled or, b) F/TAF became commercially available for pediatric use in the country in which the participant was enrolled or, c) Gilead Sciences elected to terminate development of F/TAF in the applicable country. (Allowed boosted 3rd ARV agents: LPV, ATV, DRV; Allowed unboosted 3rd ARV agents: EFV, RAL, DTG, or NVP). The participants received the study drug up to a maximum of 103.1 weeks.
|
|---|---|---|---|
|
PK Parameter (Cohort 2: Part A - Groups 1 and 2): AUCtau of FTC and TFV
AUCtau of FTC
|
12360.8 h*ng/mL
Standard Deviation 2928.36
|
11171.7 h*ng/mL
Standard Deviation 2921.64
|
—
|
|
PK Parameter (Cohort 2: Part A - Groups 1 and 2): AUCtau of FTC and TFV
AUCtau of TFV
|
999.4 h*ng/mL
Standard Deviation 409.33
|
908.2 h*ng/mL
Standard Deviation 90.62
|
—
|
SECONDARY outcome
Timeframe: Any time at Week 2 visitPopulation: Participants in the IPK 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 |
F/TAF 200/10 mg+3rd ARV Agent (Cohort 1)
n=13 Participants
Participants between 12 to \< 18 years of age and ≥ 35 kg body weight received F/TAF 200/10 mg FDC tablet (with boosted 3rd ARV agent) orally once daily for 48 weeks. After completion of 48 weeks, all participants were given the option to participate in an extension phase of the study to continue with F/TAF+3rd ARV agent. Gilead provided F/TAF until a) the participant turned 18 and F/TAF was commercially available for use in adults in the country in which the participant was enrolled or, b) F/TAF became commercially available for pediatric use in the country in which the participant was enrolled or, c) Gilead Sciences elected to terminate development of F/TAF in the applicable country. (Allowed boosted 3rd ARV agents: LPV, ATV, DRV). The participants received the study drug up to a maximum of 438.9 weeks.
|
F/TAF 200/25 mg+3rd ARV Agent (Cohort 1)
n=11 Participants
Participants between 12 to \< 18 years of age and ≥ 35 kg body weight received F/TAF 200/25 mg FDC tablet (with unboosted 3rd ARV agent) orally once daily for 48 weeks. After completion of 48 weeks, all participants were given the option to participate in an extension phase of the study to continue with F/TAF+3rd ARV agent. Gilead provided F/TAF until a) the participant turned 18 and F/TAF was commercially available for use in adults in the country in which the participant was enrolled or, b) F/TAF became commercially available for pediatric use in the country in which the participant was enrolled or, c) Gilead Sciences elected to terminate development of F/TAF in the applicable country. (Allowed unboosted 3rd ARV agents: EFV, RAL, DTG, or NVP). The participants received the study drug up to a maximum of 438.9 weeks.
|
F/TAF+3rd ARV Agent (Cohort 2, Part A - Group 2)
Participants between 2 to \< 12 years of age and 17 to \< 25 kg body weight received F/TAF 120/15 mg FDC orally once daily while continuing on their 3rd ARV agent for 48 weeks. After completion of 48 weeks, all participants were given the option to participate in the extension phase of the study to continue with F/TAF+3rd ARV agent. Gilead provided F/TAF until a) the participant turned 18 and F/TAF was commercially available for use in adults in the country in which the participant was enrolled or, b) F/TAF became commercially available for pediatric use in the country in which the participant was enrolled or, c) Gilead Sciences elected to terminate development of F/TAF in the applicable country. (Allowed boosted 3rd ARV agents: LPV, ATV, DRV; Allowed unboosted 3rd ARV agents: EFV, RAL, DTG, or NVP). The participants received the study drug up to a maximum of 103.1 weeks.
|
|---|---|---|---|
|
PK Parameter (Cohort 1): Ctau of FTC and TFV
Ctau of FTC
|
223.4 ng/mL
Standard Deviation 482.59
|
301.7 ng/mL
Standard Deviation 624.77
|
—
|
|
PK Parameter (Cohort 1): Ctau of FTC and TFV
Ctau of TFV
|
15.7 ng/mL
Standard Deviation 4.11
|
6.7 ng/mL
Standard Deviation 3.00
|
—
|
SECONDARY outcome
Timeframe: Any time at Week 2 or Week 4 visit, or within 7 days after the completion of Week 2 or Week 4 visitsPopulation: Participants in the IPK 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 |
F/TAF 200/10 mg+3rd ARV Agent (Cohort 1)
n=9 Participants
Participants between 12 to \< 18 years of age and ≥ 35 kg body weight received F/TAF 200/10 mg FDC tablet (with boosted 3rd ARV agent) orally once daily for 48 weeks. After completion of 48 weeks, all participants were given the option to participate in an extension phase of the study to continue with F/TAF+3rd ARV agent. Gilead provided F/TAF until a) the participant turned 18 and F/TAF was commercially available for use in adults in the country in which the participant was enrolled or, b) F/TAF became commercially available for pediatric use in the country in which the participant was enrolled or, c) Gilead Sciences elected to terminate development of F/TAF in the applicable country. (Allowed boosted 3rd ARV agents: LPV, ATV, DRV). The participants received the study drug up to a maximum of 438.9 weeks.
|
F/TAF 200/25 mg+3rd ARV Agent (Cohort 1)
n=3 Participants
Participants between 12 to \< 18 years of age and ≥ 35 kg body weight received F/TAF 200/25 mg FDC tablet (with unboosted 3rd ARV agent) orally once daily for 48 weeks. After completion of 48 weeks, all participants were given the option to participate in an extension phase of the study to continue with F/TAF+3rd ARV agent. Gilead provided F/TAF until a) the participant turned 18 and F/TAF was commercially available for use in adults in the country in which the participant was enrolled or, b) F/TAF became commercially available for pediatric use in the country in which the participant was enrolled or, c) Gilead Sciences elected to terminate development of F/TAF in the applicable country. (Allowed unboosted 3rd ARV agents: EFV, RAL, DTG, or NVP). The participants received the study drug up to a maximum of 438.9 weeks.
|
F/TAF+3rd ARV Agent (Cohort 2, Part A - Group 2)
Participants between 2 to \< 12 years of age and 17 to \< 25 kg body weight received F/TAF 120/15 mg FDC orally once daily while continuing on their 3rd ARV agent for 48 weeks. After completion of 48 weeks, all participants were given the option to participate in the extension phase of the study to continue with F/TAF+3rd ARV agent. Gilead provided F/TAF until a) the participant turned 18 and F/TAF was commercially available for use in adults in the country in which the participant was enrolled or, b) F/TAF became commercially available for pediatric use in the country in which the participant was enrolled or, c) Gilead Sciences elected to terminate development of F/TAF in the applicable country. (Allowed boosted 3rd ARV agents: LPV, ATV, DRV; Allowed unboosted 3rd ARV agents: EFV, RAL, DTG, or NVP). The participants received the study drug up to a maximum of 103.1 weeks.
|
|---|---|---|---|
|
PK Parameter (Cohort 2: Part A - Groups 1 and 2): Ctau of FTC and TFV
Ctau of FTC
|
75.4 ng/mL
Standard Deviation 22.71
|
75.4 ng/mL
Standard Deviation 27.63
|
—
|
|
PK Parameter (Cohort 2: Part A - Groups 1 and 2): Ctau of FTC and TFV
Ctau of TFV
|
34.8 ng/mL
Standard Deviation 16.39
|
30.9 ng/mL
Standard Deviation 3.53
|
—
|
SECONDARY outcome
Timeframe: Baseline through Week 48Population: Participants in the Safety Analysis Set were analyzed. It was prespecified to analyze data from Cohort 1 together because both treatments (F/TAF 200/10 mg with boosted 3rd ARV and F/TAF 200/25 mg with unboosted 3rd ARV) were expected to have a similar effect on the efficacy and safety for the target population.
An AE is any untoward medical occurrence in a clinical study participant which does not necessarily have a causal relationship with the treatment. An AE can therefore be any unfavorable and/or unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. The TEAEs were defined as any AEs with an onset date of on or after the study drug start date and no later than 30 days after permanent discontinuation of study drug or any AEs leading to premature discontinuation of study drug.
Outcome measures
| Measure |
F/TAF 200/10 mg+3rd ARV Agent (Cohort 1)
n=28 Participants
Participants between 12 to \< 18 years of age and ≥ 35 kg body weight received F/TAF 200/10 mg FDC tablet (with boosted 3rd ARV agent) orally once daily for 48 weeks. After completion of 48 weeks, all participants were given the option to participate in an extension phase of the study to continue with F/TAF+3rd ARV agent. Gilead provided F/TAF until a) the participant turned 18 and F/TAF was commercially available for use in adults in the country in which the participant was enrolled or, b) F/TAF became commercially available for pediatric use in the country in which the participant was enrolled or, c) Gilead Sciences elected to terminate development of F/TAF in the applicable country. (Allowed boosted 3rd ARV agents: LPV, ATV, DRV). The participants received the study drug up to a maximum of 438.9 weeks.
|
F/TAF 200/25 mg+3rd ARV Agent (Cohort 1)
n=9 Participants
Participants between 12 to \< 18 years of age and ≥ 35 kg body weight received F/TAF 200/25 mg FDC tablet (with unboosted 3rd ARV agent) orally once daily for 48 weeks. After completion of 48 weeks, all participants were given the option to participate in an extension phase of the study to continue with F/TAF+3rd ARV agent. Gilead provided F/TAF until a) the participant turned 18 and F/TAF was commercially available for use in adults in the country in which the participant was enrolled or, b) F/TAF became commercially available for pediatric use in the country in which the participant was enrolled or, c) Gilead Sciences elected to terminate development of F/TAF in the applicable country. (Allowed unboosted 3rd ARV agents: EFV, RAL, DTG, or NVP). The participants received the study drug up to a maximum of 438.9 weeks.
|
F/TAF+3rd ARV Agent (Cohort 2, Part A - Group 2)
n=3 Participants
Participants between 2 to \< 12 years of age and 17 to \< 25 kg body weight received F/TAF 120/15 mg FDC orally once daily while continuing on their 3rd ARV agent for 48 weeks. After completion of 48 weeks, all participants were given the option to participate in the extension phase of the study to continue with F/TAF+3rd ARV agent. Gilead provided F/TAF until a) the participant turned 18 and F/TAF was commercially available for use in adults in the country in which the participant was enrolled or, b) F/TAF became commercially available for pediatric use in the country in which the participant was enrolled or, c) Gilead Sciences elected to terminate development of F/TAF in the applicable country. (Allowed boosted 3rd ARV agents: LPV, ATV, DRV; Allowed unboosted 3rd ARV agents: EFV, RAL, DTG, or NVP). The participants received the study drug up to a maximum of 103.1 weeks.
|
|---|---|---|---|
|
Percentage of Participants Experiencing TEAEs and SAEs Through Week 48
Any AEs
|
89.3 percentage of participants
|
77.8 percentage of participants
|
66.7 percentage of participants
|
|
Percentage of Participants Experiencing TEAEs and SAEs Through Week 48
SAEs
|
7.1 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
SECONDARY outcome
Timeframe: Week 24Population: The Full Analysis Set included all participants who were enrolled in the study and had received at least one dose of study medication. It was prespecified to analyze data from Cohort 1 together because both treatments (F/TAF 200/10 mg with boosted 3rd ARV and F/TAF 200/25 mg with unboosted 3rd ARV) were expected to have a similar effect on the efficacy and safety for the target population.
The percentage of participants with HIV-1 RNA \< 50 copies/mL at Week 24 was analyzed using the snapshot algorithm, which defined a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status.
Outcome measures
| Measure |
F/TAF 200/10 mg+3rd ARV Agent (Cohort 1)
n=28 Participants
Participants between 12 to \< 18 years of age and ≥ 35 kg body weight received F/TAF 200/10 mg FDC tablet (with boosted 3rd ARV agent) orally once daily for 48 weeks. After completion of 48 weeks, all participants were given the option to participate in an extension phase of the study to continue with F/TAF+3rd ARV agent. Gilead provided F/TAF until a) the participant turned 18 and F/TAF was commercially available for use in adults in the country in which the participant was enrolled or, b) F/TAF became commercially available for pediatric use in the country in which the participant was enrolled or, c) Gilead Sciences elected to terminate development of F/TAF in the applicable country. (Allowed boosted 3rd ARV agents: LPV, ATV, DRV). The participants received the study drug up to a maximum of 438.9 weeks.
|
F/TAF 200/25 mg+3rd ARV Agent (Cohort 1)
n=9 Participants
Participants between 12 to \< 18 years of age and ≥ 35 kg body weight received F/TAF 200/25 mg FDC tablet (with unboosted 3rd ARV agent) orally once daily for 48 weeks. After completion of 48 weeks, all participants were given the option to participate in an extension phase of the study to continue with F/TAF+3rd ARV agent. Gilead provided F/TAF until a) the participant turned 18 and F/TAF was commercially available for use in adults in the country in which the participant was enrolled or, b) F/TAF became commercially available for pediatric use in the country in which the participant was enrolled or, c) Gilead Sciences elected to terminate development of F/TAF in the applicable country. (Allowed unboosted 3rd ARV agents: EFV, RAL, DTG, or NVP). The participants received the study drug up to a maximum of 438.9 weeks.
|
F/TAF+3rd ARV Agent (Cohort 2, Part A - Group 2)
n=3 Participants
Participants between 2 to \< 12 years of age and 17 to \< 25 kg body weight received F/TAF 120/15 mg FDC orally once daily while continuing on their 3rd ARV agent for 48 weeks. After completion of 48 weeks, all participants were given the option to participate in the extension phase of the study to continue with F/TAF+3rd ARV agent. Gilead provided F/TAF until a) the participant turned 18 and F/TAF was commercially available for use in adults in the country in which the participant was enrolled or, b) F/TAF became commercially available for pediatric use in the country in which the participant was enrolled or, c) Gilead Sciences elected to terminate development of F/TAF in the applicable country. (Allowed boosted 3rd ARV agents: LPV, ATV, DRV; Allowed unboosted 3rd ARV agents: EFV, RAL, DTG, or NVP). The participants received the study drug up to a maximum of 103.1 weeks.
|
|---|---|---|---|
|
Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 24, as Defined by the United States Food and Drug Administration (US FDA)-Defined Snapshot Algorithm
|
92.9 percentage of participants
|
100.0 percentage of participants
|
66.7 percentage of participants
|
SECONDARY outcome
Timeframe: Week 48Population: Participants in the Full Analysis Set were analyzed. It was prespecified to analyze data from Cohort 1 together because both treatments (F/TAF 200/10 mg with boosted 3rd ARV and F/TAF 200/25 mg with unboosted 3rd ARV) were expected to have a similar effect on the efficacy and safety for the target population.
The percentage of participants with HIV-1 RNA \< 50 copies/mL at Week 48 was analyzed using the snapshot algorithm, which defined a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status.
Outcome measures
| Measure |
F/TAF 200/10 mg+3rd ARV Agent (Cohort 1)
n=28 Participants
Participants between 12 to \< 18 years of age and ≥ 35 kg body weight received F/TAF 200/10 mg FDC tablet (with boosted 3rd ARV agent) orally once daily for 48 weeks. After completion of 48 weeks, all participants were given the option to participate in an extension phase of the study to continue with F/TAF+3rd ARV agent. Gilead provided F/TAF until a) the participant turned 18 and F/TAF was commercially available for use in adults in the country in which the participant was enrolled or, b) F/TAF became commercially available for pediatric use in the country in which the participant was enrolled or, c) Gilead Sciences elected to terminate development of F/TAF in the applicable country. (Allowed boosted 3rd ARV agents: LPV, ATV, DRV). The participants received the study drug up to a maximum of 438.9 weeks.
|
F/TAF 200/25 mg+3rd ARV Agent (Cohort 1)
n=9 Participants
Participants between 12 to \< 18 years of age and ≥ 35 kg body weight received F/TAF 200/25 mg FDC tablet (with unboosted 3rd ARV agent) orally once daily for 48 weeks. After completion of 48 weeks, all participants were given the option to participate in an extension phase of the study to continue with F/TAF+3rd ARV agent. Gilead provided F/TAF until a) the participant turned 18 and F/TAF was commercially available for use in adults in the country in which the participant was enrolled or, b) F/TAF became commercially available for pediatric use in the country in which the participant was enrolled or, c) Gilead Sciences elected to terminate development of F/TAF in the applicable country. (Allowed unboosted 3rd ARV agents: EFV, RAL, DTG, or NVP). The participants received the study drug up to a maximum of 438.9 weeks.
|
F/TAF+3rd ARV Agent (Cohort 2, Part A - Group 2)
n=3 Participants
Participants between 2 to \< 12 years of age and 17 to \< 25 kg body weight received F/TAF 120/15 mg FDC orally once daily while continuing on their 3rd ARV agent for 48 weeks. After completion of 48 weeks, all participants were given the option to participate in the extension phase of the study to continue with F/TAF+3rd ARV agent. Gilead provided F/TAF until a) the participant turned 18 and F/TAF was commercially available for use in adults in the country in which the participant was enrolled or, b) F/TAF became commercially available for pediatric use in the country in which the participant was enrolled or, c) Gilead Sciences elected to terminate development of F/TAF in the applicable country. (Allowed boosted 3rd ARV agents: LPV, ATV, DRV; Allowed unboosted 3rd ARV agents: EFV, RAL, DTG, or NVP). The participants received the study drug up to a maximum of 103.1 weeks.
|
|---|---|---|---|
|
Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 48, as Defined by the US FDA-Defined Snapshot Algorithm
|
89.3 percentage of participants
|
77.8 percentage of participants
|
66.7 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, Week 24Population: Participants in the Full Analysis Set with available data were analyzed. It was prespecified to analyze data from Cohort 1 together because both treatments (F/TAF 200/10 mg with boosted 3rd ARV and F/TAF 200/25 mg with unboosted 3rd ARV) were expected to have a similar effect on the efficacy and safety for the target population.
Outcome measures
| Measure |
F/TAF 200/10 mg+3rd ARV Agent (Cohort 1)
n=28 Participants
Participants between 12 to \< 18 years of age and ≥ 35 kg body weight received F/TAF 200/10 mg FDC tablet (with boosted 3rd ARV agent) orally once daily for 48 weeks. After completion of 48 weeks, all participants were given the option to participate in an extension phase of the study to continue with F/TAF+3rd ARV agent. Gilead provided F/TAF until a) the participant turned 18 and F/TAF was commercially available for use in adults in the country in which the participant was enrolled or, b) F/TAF became commercially available for pediatric use in the country in which the participant was enrolled or, c) Gilead Sciences elected to terminate development of F/TAF in the applicable country. (Allowed boosted 3rd ARV agents: LPV, ATV, DRV). The participants received the study drug up to a maximum of 438.9 weeks.
|
F/TAF 200/25 mg+3rd ARV Agent (Cohort 1)
n=8 Participants
Participants between 12 to \< 18 years of age and ≥ 35 kg body weight received F/TAF 200/25 mg FDC tablet (with unboosted 3rd ARV agent) orally once daily for 48 weeks. After completion of 48 weeks, all participants were given the option to participate in an extension phase of the study to continue with F/TAF+3rd ARV agent. Gilead provided F/TAF until a) the participant turned 18 and F/TAF was commercially available for use in adults in the country in which the participant was enrolled or, b) F/TAF became commercially available for pediatric use in the country in which the participant was enrolled or, c) Gilead Sciences elected to terminate development of F/TAF in the applicable country. (Allowed unboosted 3rd ARV agents: EFV, RAL, DTG, or NVP). The participants received the study drug up to a maximum of 438.9 weeks.
|
F/TAF+3rd ARV Agent (Cohort 2, Part A - Group 2)
n=2 Participants
Participants between 2 to \< 12 years of age and 17 to \< 25 kg body weight received F/TAF 120/15 mg FDC orally once daily while continuing on their 3rd ARV agent for 48 weeks. After completion of 48 weeks, all participants were given the option to participate in the extension phase of the study to continue with F/TAF+3rd ARV agent. Gilead provided F/TAF until a) the participant turned 18 and F/TAF was commercially available for use in adults in the country in which the participant was enrolled or, b) F/TAF became commercially available for pediatric use in the country in which the participant was enrolled or, c) Gilead Sciences elected to terminate development of F/TAF in the applicable country. (Allowed boosted 3rd ARV agents: LPV, ATV, DRV; Allowed unboosted 3rd ARV agents: EFV, RAL, DTG, or NVP). The participants received the study drug up to a maximum of 103.1 weeks.
|
|---|---|---|---|
|
Change From Baseline in CD4+ Cell Count at Week 24
|
-130 cells/µL
Standard Deviation 272.6
|
68 cells/µL
Standard Deviation 352.5
|
-299 cells/µL
Standard Deviation 48.8
|
SECONDARY outcome
Timeframe: Baseline, Week 48Population: Participants in the Full Analysis Set with available data were analyzed. It was prespecified to analyze data from Cohort 1 together because both treatments (F/TAF 200/10 mg with boosted 3rd ARV and F/TAF 200/25 mg with unboosted 3rd ARV) were expected to have a similar effect on the efficacy and safety for the target population.
Outcome measures
| Measure |
F/TAF 200/10 mg+3rd ARV Agent (Cohort 1)
n=28 Participants
Participants between 12 to \< 18 years of age and ≥ 35 kg body weight received F/TAF 200/10 mg FDC tablet (with boosted 3rd ARV agent) orally once daily for 48 weeks. After completion of 48 weeks, all participants were given the option to participate in an extension phase of the study to continue with F/TAF+3rd ARV agent. Gilead provided F/TAF until a) the participant turned 18 and F/TAF was commercially available for use in adults in the country in which the participant was enrolled or, b) F/TAF became commercially available for pediatric use in the country in which the participant was enrolled or, c) Gilead Sciences elected to terminate development of F/TAF in the applicable country. (Allowed boosted 3rd ARV agents: LPV, ATV, DRV). The participants received the study drug up to a maximum of 438.9 weeks.
|
F/TAF 200/25 mg+3rd ARV Agent (Cohort 1)
n=7 Participants
Participants between 12 to \< 18 years of age and ≥ 35 kg body weight received F/TAF 200/25 mg FDC tablet (with unboosted 3rd ARV agent) orally once daily for 48 weeks. After completion of 48 weeks, all participants were given the option to participate in an extension phase of the study to continue with F/TAF+3rd ARV agent. Gilead provided F/TAF until a) the participant turned 18 and F/TAF was commercially available for use in adults in the country in which the participant was enrolled or, b) F/TAF became commercially available for pediatric use in the country in which the participant was enrolled or, c) Gilead Sciences elected to terminate development of F/TAF in the applicable country. (Allowed unboosted 3rd ARV agents: EFV, RAL, DTG, or NVP). The participants received the study drug up to a maximum of 438.9 weeks.
|
F/TAF+3rd ARV Agent (Cohort 2, Part A - Group 2)
n=2 Participants
Participants between 2 to \< 12 years of age and 17 to \< 25 kg body weight received F/TAF 120/15 mg FDC orally once daily while continuing on their 3rd ARV agent for 48 weeks. After completion of 48 weeks, all participants were given the option to participate in the extension phase of the study to continue with F/TAF+3rd ARV agent. Gilead provided F/TAF until a) the participant turned 18 and F/TAF was commercially available for use in adults in the country in which the participant was enrolled or, b) F/TAF became commercially available for pediatric use in the country in which the participant was enrolled or, c) Gilead Sciences elected to terminate development of F/TAF in the applicable country. (Allowed boosted 3rd ARV agents: LPV, ATV, DRV; Allowed unboosted 3rd ARV agents: EFV, RAL, DTG, or NVP). The participants received the study drug up to a maximum of 103.1 weeks.
|
|---|---|---|---|
|
Change From Baseline in CD4+ Cell Count at Week 48
|
-105 cells/µL
Standard Deviation 162.9
|
210 cells/µL
Standard Deviation 406.5
|
-124 cells/µL
Standard Deviation 37.5
|
SECONDARY outcome
Timeframe: Baseline, Week 24Population: Participants in the Full Analysis Set with available data were analyzed. It was prespecified to analyze data from Cohort 1 together because both treatments (F/TAF 200/10 mg with boosted 3rd ARV and F/TAF 200/25 mg with unboosted 3rd ARV) were expected to have a similar effect on the efficacy and safety for the target population.
Outcome measures
| Measure |
F/TAF 200/10 mg+3rd ARV Agent (Cohort 1)
n=28 Participants
Participants between 12 to \< 18 years of age and ≥ 35 kg body weight received F/TAF 200/10 mg FDC tablet (with boosted 3rd ARV agent) orally once daily for 48 weeks. After completion of 48 weeks, all participants were given the option to participate in an extension phase of the study to continue with F/TAF+3rd ARV agent. Gilead provided F/TAF until a) the participant turned 18 and F/TAF was commercially available for use in adults in the country in which the participant was enrolled or, b) F/TAF became commercially available for pediatric use in the country in which the participant was enrolled or, c) Gilead Sciences elected to terminate development of F/TAF in the applicable country. (Allowed boosted 3rd ARV agents: LPV, ATV, DRV). The participants received the study drug up to a maximum of 438.9 weeks.
|
F/TAF 200/25 mg+3rd ARV Agent (Cohort 1)
n=8 Participants
Participants between 12 to \< 18 years of age and ≥ 35 kg body weight received F/TAF 200/25 mg FDC tablet (with unboosted 3rd ARV agent) orally once daily for 48 weeks. After completion of 48 weeks, all participants were given the option to participate in an extension phase of the study to continue with F/TAF+3rd ARV agent. Gilead provided F/TAF until a) the participant turned 18 and F/TAF was commercially available for use in adults in the country in which the participant was enrolled or, b) F/TAF became commercially available for pediatric use in the country in which the participant was enrolled or, c) Gilead Sciences elected to terminate development of F/TAF in the applicable country. (Allowed unboosted 3rd ARV agents: EFV, RAL, DTG, or NVP). The participants received the study drug up to a maximum of 438.9 weeks.
|
F/TAF+3rd ARV Agent (Cohort 2, Part A - Group 2)
n=2 Participants
Participants between 2 to \< 12 years of age and 17 to \< 25 kg body weight received F/TAF 120/15 mg FDC orally once daily while continuing on their 3rd ARV agent for 48 weeks. After completion of 48 weeks, all participants were given the option to participate in the extension phase of the study to continue with F/TAF+3rd ARV agent. Gilead provided F/TAF until a) the participant turned 18 and F/TAF was commercially available for use in adults in the country in which the participant was enrolled or, b) F/TAF became commercially available for pediatric use in the country in which the participant was enrolled or, c) Gilead Sciences elected to terminate development of F/TAF in the applicable country. (Allowed boosted 3rd ARV agents: LPV, ATV, DRV; Allowed unboosted 3rd ARV agents: EFV, RAL, DTG, or NVP). The participants received the study drug up to a maximum of 103.1 weeks.
|
|---|---|---|---|
|
Change From Baseline in CD4 Percentage at Week 24
|
-0.21 percentage of lymphocytes
Standard Deviation 3.840
|
1.29 percentage of lymphocytes
Standard Deviation 2.395
|
0.60 percentage of lymphocytes
Standard Deviation 5.798
|
SECONDARY outcome
Timeframe: Baseline, Week 48Population: Participants in the Full Analysis Set with available data were analyzed. It was prespecified to analyze data from Cohort 1 together because both treatments (F/TAF 200/10 mg with boosted 3rd ARV and F/TAF 200/25 mg with unboosted 3rd ARV) were expected to have a similar effect on the efficacy and safety for the target population.
Outcome measures
| Measure |
F/TAF 200/10 mg+3rd ARV Agent (Cohort 1)
n=28 Participants
Participants between 12 to \< 18 years of age and ≥ 35 kg body weight received F/TAF 200/10 mg FDC tablet (with boosted 3rd ARV agent) orally once daily for 48 weeks. After completion of 48 weeks, all participants were given the option to participate in an extension phase of the study to continue with F/TAF+3rd ARV agent. Gilead provided F/TAF until a) the participant turned 18 and F/TAF was commercially available for use in adults in the country in which the participant was enrolled or, b) F/TAF became commercially available for pediatric use in the country in which the participant was enrolled or, c) Gilead Sciences elected to terminate development of F/TAF in the applicable country. (Allowed boosted 3rd ARV agents: LPV, ATV, DRV). The participants received the study drug up to a maximum of 438.9 weeks.
|
F/TAF 200/25 mg+3rd ARV Agent (Cohort 1)
n=7 Participants
Participants between 12 to \< 18 years of age and ≥ 35 kg body weight received F/TAF 200/25 mg FDC tablet (with unboosted 3rd ARV agent) orally once daily for 48 weeks. After completion of 48 weeks, all participants were given the option to participate in an extension phase of the study to continue with F/TAF+3rd ARV agent. Gilead provided F/TAF until a) the participant turned 18 and F/TAF was commercially available for use in adults in the country in which the participant was enrolled or, b) F/TAF became commercially available for pediatric use in the country in which the participant was enrolled or, c) Gilead Sciences elected to terminate development of F/TAF in the applicable country. (Allowed unboosted 3rd ARV agents: EFV, RAL, DTG, or NVP). The participants received the study drug up to a maximum of 438.9 weeks.
|
F/TAF+3rd ARV Agent (Cohort 2, Part A - Group 2)
n=2 Participants
Participants between 2 to \< 12 years of age and 17 to \< 25 kg body weight received F/TAF 120/15 mg FDC orally once daily while continuing on their 3rd ARV agent for 48 weeks. After completion of 48 weeks, all participants were given the option to participate in the extension phase of the study to continue with F/TAF+3rd ARV agent. Gilead provided F/TAF until a) the participant turned 18 and F/TAF was commercially available for use in adults in the country in which the participant was enrolled or, b) F/TAF became commercially available for pediatric use in the country in which the participant was enrolled or, c) Gilead Sciences elected to terminate development of F/TAF in the applicable country. (Allowed boosted 3rd ARV agents: LPV, ATV, DRV; Allowed unboosted 3rd ARV agents: EFV, RAL, DTG, or NVP). The participants received the study drug up to a maximum of 103.1 weeks.
|
|---|---|---|---|
|
Change From Baseline in CD4 Percentage at Week 48
|
-0.20 percentage of lymphocytes
Standard Deviation 3.407
|
0.70 percentage of lymphocytes
Standard Deviation 3.520
|
3.65 percentage of lymphocytes
Standard Deviation 7.283
|
SECONDARY outcome
Timeframe: Week 2 (for Cohort 1), Week 2 and Week 4 (for Cohort 2)Population: Participants in the Safety Analysis Set were analyzed. It was prespecified to analyze data from Cohort 1 together because both treatments (F/TAF 200/10 mg with boosted 3rd ARV and F/TAF 200/25 mg with unboosted 3rd ARV) were expected to have a similar effect on the efficacy and safety for the target population.
Palatability was reported based on the pleasant product taste as 'Yes' or 'No'. Data has been reported for Participant Response (PR) and Guardian Response (GR). Participants with missing data were reported as N/A.
Outcome measures
| Measure |
F/TAF 200/10 mg+3rd ARV Agent (Cohort 1)
n=28 Participants
Participants between 12 to \< 18 years of age and ≥ 35 kg body weight received F/TAF 200/10 mg FDC tablet (with boosted 3rd ARV agent) orally once daily for 48 weeks. After completion of 48 weeks, all participants were given the option to participate in an extension phase of the study to continue with F/TAF+3rd ARV agent. Gilead provided F/TAF until a) the participant turned 18 and F/TAF was commercially available for use in adults in the country in which the participant was enrolled or, b) F/TAF became commercially available for pediatric use in the country in which the participant was enrolled or, c) Gilead Sciences elected to terminate development of F/TAF in the applicable country. (Allowed boosted 3rd ARV agents: LPV, ATV, DRV). The participants received the study drug up to a maximum of 438.9 weeks.
|
F/TAF 200/25 mg+3rd ARV Agent (Cohort 1)
n=9 Participants
Participants between 12 to \< 18 years of age and ≥ 35 kg body weight received F/TAF 200/25 mg FDC tablet (with unboosted 3rd ARV agent) orally once daily for 48 weeks. After completion of 48 weeks, all participants were given the option to participate in an extension phase of the study to continue with F/TAF+3rd ARV agent. Gilead provided F/TAF until a) the participant turned 18 and F/TAF was commercially available for use in adults in the country in which the participant was enrolled or, b) F/TAF became commercially available for pediatric use in the country in which the participant was enrolled or, c) Gilead Sciences elected to terminate development of F/TAF in the applicable country. (Allowed unboosted 3rd ARV agents: EFV, RAL, DTG, or NVP). The participants received the study drug up to a maximum of 438.9 weeks.
|
F/TAF+3rd ARV Agent (Cohort 2, Part A - Group 2)
n=3 Participants
Participants between 2 to \< 12 years of age and 17 to \< 25 kg body weight received F/TAF 120/15 mg FDC orally once daily while continuing on their 3rd ARV agent for 48 weeks. After completion of 48 weeks, all participants were given the option to participate in the extension phase of the study to continue with F/TAF+3rd ARV agent. Gilead provided F/TAF until a) the participant turned 18 and F/TAF was commercially available for use in adults in the country in which the participant was enrolled or, b) F/TAF became commercially available for pediatric use in the country in which the participant was enrolled or, c) Gilead Sciences elected to terminate development of F/TAF in the applicable country. (Allowed boosted 3rd ARV agents: LPV, ATV, DRV; Allowed unboosted 3rd ARV agents: EFV, RAL, DTG, or NVP). The participants received the study drug up to a maximum of 103.1 weeks.
|
|---|---|---|---|
|
Number of Participants With Palatability of F/TAF Formulation
Week 2: Participant Response: Was the Study Drug Palatable? · Yes
|
25 Participants
|
9 Participants
|
2 Participants
|
|
Number of Participants With Palatability of F/TAF Formulation
Week 2: Participant Response: Was the Study Drug Palatable? · No
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Palatability of F/TAF Formulation
Week 2: Participant Response: Was the Study Drug Palatable? · NA
|
3 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Palatability of F/TAF Formulation
Week 4: Participant Response: Was the Study Drug Palatable? · Yes
|
—
|
9 Participants
|
3 Participants
|
|
Number of Participants With Palatability of F/TAF Formulation
Week 4: Participant Response: Was the Study Drug Palatable? · No
|
—
|
0 Participants
|
0 Participants
|
|
Number of Participants With Palatability of F/TAF Formulation
Week 4: Participant Response: Was the Study Drug Palatable? · NA
|
—
|
0 Participants
|
0 Participants
|
|
Number of Participants With Palatability of F/TAF Formulation
Week 2: Guardian Response: Was the Study Drug Palatable to the Participant? · Yes
|
11 Participants
|
9 Participants
|
1 Participants
|
|
Number of Participants With Palatability of F/TAF Formulation
Week 2: Guardian Response: Was the Study Drug Palatable to the Participant? · No
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Palatability of F/TAF Formulation
Week 2: Guardian Response: Was the Study Drug Palatable to the Participant? · NA
|
17 Participants
|
0 Participants
|
2 Participants
|
|
Number of Participants With Palatability of F/TAF Formulation
Week 4: Guardian Response: Was the Study Drug Palatable to the Participant? · Yes
|
—
|
9 Participants
|
1 Participants
|
|
Number of Participants With Palatability of F/TAF Formulation
Week 4: Guardian Response: Was the Study Drug Palatable to the Participant? · No
|
—
|
0 Participants
|
0 Participants
|
|
Number of Participants With Palatability of F/TAF Formulation
Week 4: Guardian Response: Was the Study Drug Palatable to the Participant? · NA
|
—
|
0 Participants
|
2 Participants
|
|
Number of Participants With Palatability of F/TAF Formulation
Week 2: Guardian Response: Did the Participant Complain of the Taste of the Tablet? · Yes
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Palatability of F/TAF Formulation
Week 2: Guardian Response: Did the Participant Complain of the Taste of the Tablet? · No
|
12 Participants
|
9 Participants
|
1 Participants
|
|
Number of Participants With Palatability of F/TAF Formulation
Week 2: Guardian Response: Did the Participant Complain of the Taste of the Tablet? · NA
|
16 Participants
|
0 Participants
|
2 Participants
|
|
Number of Participants With Palatability of F/TAF Formulation
Week 4: Guardian Response: Did the Participant Complain of the Taste of the Tablet? · Yes
|
—
|
0 Participants
|
0 Participants
|
|
Number of Participants With Palatability of F/TAF Formulation
Week 4: Guardian Response: Did the Participant Complain of the Taste of the Tablet? · No
|
—
|
9 Participants
|
1 Participants
|
|
Number of Participants With Palatability of F/TAF Formulation
Week 4: Guardian Response: Did the Participant Complain of the Taste of the Tablet? · NA
|
—
|
0 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Baseline up to Week 4Population: Participants in the Safety Analysis Set with available data were analyzed. It was prespecified to analyze data from Cohort 1 together because both treatments (F/TAF 200/10 mg with boosted 3rd ARV and F/TAF 200/25 mg with unboosted 3rd ARV) were expected to have a similar effect on the efficacy and safety for the target population.
Acceptability has been reported for categories medication size, shape and difficulty swallowing as 'Yes' or 'No' for Participant Response (PR) and Guardian Response (GR). Participants with missing data were reported as N/A.
Outcome measures
| Measure |
F/TAF 200/10 mg+3rd ARV Agent (Cohort 1)
n=25 Participants
Participants between 12 to \< 18 years of age and ≥ 35 kg body weight received F/TAF 200/10 mg FDC tablet (with boosted 3rd ARV agent) orally once daily for 48 weeks. After completion of 48 weeks, all participants were given the option to participate in an extension phase of the study to continue with F/TAF+3rd ARV agent. Gilead provided F/TAF until a) the participant turned 18 and F/TAF was commercially available for use in adults in the country in which the participant was enrolled or, b) F/TAF became commercially available for pediatric use in the country in which the participant was enrolled or, c) Gilead Sciences elected to terminate development of F/TAF in the applicable country. (Allowed boosted 3rd ARV agents: LPV, ATV, DRV). The participants received the study drug up to a maximum of 438.9 weeks.
|
F/TAF 200/25 mg+3rd ARV Agent (Cohort 1)
n=9 Participants
Participants between 12 to \< 18 years of age and ≥ 35 kg body weight received F/TAF 200/25 mg FDC tablet (with unboosted 3rd ARV agent) orally once daily for 48 weeks. After completion of 48 weeks, all participants were given the option to participate in an extension phase of the study to continue with F/TAF+3rd ARV agent. Gilead provided F/TAF until a) the participant turned 18 and F/TAF was commercially available for use in adults in the country in which the participant was enrolled or, b) F/TAF became commercially available for pediatric use in the country in which the participant was enrolled or, c) Gilead Sciences elected to terminate development of F/TAF in the applicable country. (Allowed unboosted 3rd ARV agents: EFV, RAL, DTG, or NVP). The participants received the study drug up to a maximum of 438.9 weeks.
|
F/TAF+3rd ARV Agent (Cohort 2, Part A - Group 2)
n=3 Participants
Participants between 2 to \< 12 years of age and 17 to \< 25 kg body weight received F/TAF 120/15 mg FDC orally once daily while continuing on their 3rd ARV agent for 48 weeks. After completion of 48 weeks, all participants were given the option to participate in the extension phase of the study to continue with F/TAF+3rd ARV agent. Gilead provided F/TAF until a) the participant turned 18 and F/TAF was commercially available for use in adults in the country in which the participant was enrolled or, b) F/TAF became commercially available for pediatric use in the country in which the participant was enrolled or, c) Gilead Sciences elected to terminate development of F/TAF in the applicable country. (Allowed boosted 3rd ARV agents: LPV, ATV, DRV; Allowed unboosted 3rd ARV agents: EFV, RAL, DTG, or NVP). The participants received the study drug up to a maximum of 103.1 weeks.
|
|---|---|---|---|
|
Number of Participants With Acceptability of F/TAF Formulation
Participant Response: Was the Study Medication Shape Acceptable? · No
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Acceptability of F/TAF Formulation
Participant Response: Was the Study Medication Size Acceptable? · Yes
|
25 Participants
|
9 Participants
|
3 Participants
|
|
Number of Participants With Acceptability of F/TAF Formulation
Participant Response: Was the Study Medication Size Acceptable? · No
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Acceptability of F/TAF Formulation
Participant Response: Was the Study Medication Size Acceptable? · N/A
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Acceptability of F/TAF Formulation
Participant Response: Was the Study Medication Shape Acceptable? · Yes
|
25 Participants
|
9 Participants
|
3 Participants
|
|
Number of Participants With Acceptability of F/TAF Formulation
Participant Response: Was the Study Medication Shape Acceptable? · N/A
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Acceptability of F/TAF Formulation
Guardian Response: Did the Participant Have Difficulty Swallowing the Tablet? · Yes
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Acceptability of F/TAF Formulation
Guardian Response: Did the Participant Have Difficulty Swallowing the Tablet? · No
|
21 Participants
|
9 Participants
|
2 Participants
|
|
Number of Participants With Acceptability of F/TAF Formulation
Guardian Response: Did the Participant Have Difficulty Swallowing the Tablet? · N/A
|
4 Participants
|
0 Participants
|
1 Participants
|
Adverse Events
F/TAF+3rd ARV Agent (Cohort 1)
Serious events: 4 serious events
Other events: 27 other events
Deaths: 0 deaths
F/TAF+3rd ARV Agent (Cohort 2, Part A - Group 1)
Serious events: 1 serious events
Other events: 8 other events
Deaths: 0 deaths
F/TAF+3rd ARV Agent (Cohort 2, Part A - Group 2)
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
F/TAF+3rd ARV Agent (Cohort 1)
n=28 participants at risk
Participants between 12 to \< 18 years of age and ≥ 35 kg body weight received emtricitabine/tenofovir alafenamide (F/TAF) 200/10 mg fixed-dose combination (FDC) tablet (with boosted 3rd antiretroviral (ARV) agent) or F/TAF 200/25 mg FDC tablet (with unboosted 3rd ARV agent) orally once daily for 48 weeks. After completion of 48 weeks, all participants were given the option to participate in the extension phase of the study to continue with F/TAF+3rd ARV agent. Gilead provided F/TAF until a) the participant turned 18 and F/TAF was commercially available for use in adults in the country in which the participant was enrolled or, b) F/TAF became commercially available for pediatric use in the country in which the participant was enrolled or, c) Gilead Sciences elected to terminate development of F/TAF in the applicable country. (Allowed boosted 3rd ARV agents: lopinavir (LPV), atazanavir (ATV), darunavir (DRV); Allowed unboosted 3rd ARV agents: efavirenz (EFV), raltegravir (RAL), dolutegravir (DTG), or nevirapine (NVP)). The participants received the study drug up to a maximum of 438.9 weeks.
|
F/TAF+3rd ARV Agent (Cohort 2, Part A - Group 1)
n=9 participants at risk
Participants between 6 to \< 12 years of age and ≥ 25 kg body weight received F/TAF 200/25 mg FDC tablet orally once daily while continuing on their boosted protease inhibitor (PI) for 48 weeks. After completion of 48 weeks, all participants were given the option to participate in the extension phase of the study to continue with F/TAF+3rd ARV agent. Gilead provided F/TAF until a) the participant turned 18 and F/TAF was commercially available for use in adults in the country in which the participant was enrolled or, b) F/TAF became commercially available for pediatric use in the country in which the participant was enrolled or, c) Gilead Sciences elected to terminate development of F/TAF in the applicable country. (Allowed boosted PIs: ATV, LPV or DRV). The participants received the study drug up to a maximum of 315.0 weeks.
|
F/TAF+3rd ARV Agent (Cohort 2, Part A - Group 2)
n=3 participants at risk
Participants between 2 to \< 12 years of age and 17 to \< 25 kg body weight received F/TAF 120/15 mg FDC orally once daily while continuing on their 3rd ARV agent for 48 weeks. After completion of 48 weeks, all participants were given the option to participate in the extension phase of the study to continue with F/TAF+3rd ARV agent. Gilead provided F/TAF until a) the participant turned 18 and F/TAF was commercially available for use in adults in the country in which the participant was enrolled or, b) F/TAF became commercially available for pediatric use in the country in which the participant was enrolled or, c) Gilead Sciences elected to terminate development of F/TAF in the applicable country. (Allowed boosted 3rd ARV agents: LPV, ATV, DRV; Allowed unboosted 3rd ARV agents: EFV, RAL, DTG, or NVP). The participants received the study drug up to a maximum of 103.1 weeks.
|
|---|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
3.6%
1/28 • All-cause mortality: Up to 439 weeks; Adverse events (AEs): Up to 410.4 weeks
All-cause mortality: All Enrolled Analysis Set. AEs: Safety Analysis Set: all participants who had received at least 1 dose of study medication. It was prespecified to analyze data from Cohort 1 together because both treatments (F/TAF 200/10 mg+boosted 3rd ARV and F/TAF 200/25 mg+unboosted 3rd ARV) were expected to have a similar effect on efficacy and safety for target population. AEs are reported together for both phases as participants continued same medication from main to extension phase.
|
0.00%
0/9 • All-cause mortality: Up to 439 weeks; Adverse events (AEs): Up to 410.4 weeks
All-cause mortality: All Enrolled Analysis Set. AEs: Safety Analysis Set: all participants who had received at least 1 dose of study medication. It was prespecified to analyze data from Cohort 1 together because both treatments (F/TAF 200/10 mg+boosted 3rd ARV and F/TAF 200/25 mg+unboosted 3rd ARV) were expected to have a similar effect on efficacy and safety for target population. AEs are reported together for both phases as participants continued same medication from main to extension phase.
|
0.00%
0/3 • All-cause mortality: Up to 439 weeks; Adverse events (AEs): Up to 410.4 weeks
All-cause mortality: All Enrolled Analysis Set. AEs: Safety Analysis Set: all participants who had received at least 1 dose of study medication. It was prespecified to analyze data from Cohort 1 together because both treatments (F/TAF 200/10 mg+boosted 3rd ARV and F/TAF 200/25 mg+unboosted 3rd ARV) were expected to have a similar effect on efficacy and safety for target population. AEs are reported together for both phases as participants continued same medication from main to extension phase.
|
|
Infections and infestations
Appendicitis
|
0.00%
0/28 • All-cause mortality: Up to 439 weeks; Adverse events (AEs): Up to 410.4 weeks
All-cause mortality: All Enrolled Analysis Set. AEs: Safety Analysis Set: all participants who had received at least 1 dose of study medication. It was prespecified to analyze data from Cohort 1 together because both treatments (F/TAF 200/10 mg+boosted 3rd ARV and F/TAF 200/25 mg+unboosted 3rd ARV) were expected to have a similar effect on efficacy and safety for target population. AEs are reported together for both phases as participants continued same medication from main to extension phase.
|
11.1%
1/9 • All-cause mortality: Up to 439 weeks; Adverse events (AEs): Up to 410.4 weeks
All-cause mortality: All Enrolled Analysis Set. AEs: Safety Analysis Set: all participants who had received at least 1 dose of study medication. It was prespecified to analyze data from Cohort 1 together because both treatments (F/TAF 200/10 mg+boosted 3rd ARV and F/TAF 200/25 mg+unboosted 3rd ARV) were expected to have a similar effect on efficacy and safety for target population. AEs are reported together for both phases as participants continued same medication from main to extension phase.
|
0.00%
0/3 • All-cause mortality: Up to 439 weeks; Adverse events (AEs): Up to 410.4 weeks
All-cause mortality: All Enrolled Analysis Set. AEs: Safety Analysis Set: all participants who had received at least 1 dose of study medication. It was prespecified to analyze data from Cohort 1 together because both treatments (F/TAF 200/10 mg+boosted 3rd ARV and F/TAF 200/25 mg+unboosted 3rd ARV) were expected to have a similar effect on efficacy and safety for target population. AEs are reported together for both phases as participants continued same medication from main to extension phase.
|
|
Injury, poisoning and procedural complications
Forearm fracture
|
3.6%
1/28 • All-cause mortality: Up to 439 weeks; Adverse events (AEs): Up to 410.4 weeks
All-cause mortality: All Enrolled Analysis Set. AEs: Safety Analysis Set: all participants who had received at least 1 dose of study medication. It was prespecified to analyze data from Cohort 1 together because both treatments (F/TAF 200/10 mg+boosted 3rd ARV and F/TAF 200/25 mg+unboosted 3rd ARV) were expected to have a similar effect on efficacy and safety for target population. AEs are reported together for both phases as participants continued same medication from main to extension phase.
|
0.00%
0/9 • All-cause mortality: Up to 439 weeks; Adverse events (AEs): Up to 410.4 weeks
All-cause mortality: All Enrolled Analysis Set. AEs: Safety Analysis Set: all participants who had received at least 1 dose of study medication. It was prespecified to analyze data from Cohort 1 together because both treatments (F/TAF 200/10 mg+boosted 3rd ARV and F/TAF 200/25 mg+unboosted 3rd ARV) were expected to have a similar effect on efficacy and safety for target population. AEs are reported together for both phases as participants continued same medication from main to extension phase.
|
0.00%
0/3 • All-cause mortality: Up to 439 weeks; Adverse events (AEs): Up to 410.4 weeks
All-cause mortality: All Enrolled Analysis Set. AEs: Safety Analysis Set: all participants who had received at least 1 dose of study medication. It was prespecified to analyze data from Cohort 1 together because both treatments (F/TAF 200/10 mg+boosted 3rd ARV and F/TAF 200/25 mg+unboosted 3rd ARV) were expected to have a similar effect on efficacy and safety for target population. AEs are reported together for both phases as participants continued same medication from main to extension phase.
|
|
Injury, poisoning and procedural complications
Joint dislocation
|
3.6%
1/28 • All-cause mortality: Up to 439 weeks; Adverse events (AEs): Up to 410.4 weeks
All-cause mortality: All Enrolled Analysis Set. AEs: Safety Analysis Set: all participants who had received at least 1 dose of study medication. It was prespecified to analyze data from Cohort 1 together because both treatments (F/TAF 200/10 mg+boosted 3rd ARV and F/TAF 200/25 mg+unboosted 3rd ARV) were expected to have a similar effect on efficacy and safety for target population. AEs are reported together for both phases as participants continued same medication from main to extension phase.
|
0.00%
0/9 • All-cause mortality: Up to 439 weeks; Adverse events (AEs): Up to 410.4 weeks
All-cause mortality: All Enrolled Analysis Set. AEs: Safety Analysis Set: all participants who had received at least 1 dose of study medication. It was prespecified to analyze data from Cohort 1 together because both treatments (F/TAF 200/10 mg+boosted 3rd ARV and F/TAF 200/25 mg+unboosted 3rd ARV) were expected to have a similar effect on efficacy and safety for target population. AEs are reported together for both phases as participants continued same medication from main to extension phase.
|
0.00%
0/3 • All-cause mortality: Up to 439 weeks; Adverse events (AEs): Up to 410.4 weeks
All-cause mortality: All Enrolled Analysis Set. AEs: Safety Analysis Set: all participants who had received at least 1 dose of study medication. It was prespecified to analyze data from Cohort 1 together because both treatments (F/TAF 200/10 mg+boosted 3rd ARV and F/TAF 200/25 mg+unboosted 3rd ARV) were expected to have a similar effect on efficacy and safety for target population. AEs are reported together for both phases as participants continued same medication from main to extension phase.
|
|
Injury, poisoning and procedural complications
Stab wound
|
3.6%
1/28 • All-cause mortality: Up to 439 weeks; Adverse events (AEs): Up to 410.4 weeks
All-cause mortality: All Enrolled Analysis Set. AEs: Safety Analysis Set: all participants who had received at least 1 dose of study medication. It was prespecified to analyze data from Cohort 1 together because both treatments (F/TAF 200/10 mg+boosted 3rd ARV and F/TAF 200/25 mg+unboosted 3rd ARV) were expected to have a similar effect on efficacy and safety for target population. AEs are reported together for both phases as participants continued same medication from main to extension phase.
|
0.00%
0/9 • All-cause mortality: Up to 439 weeks; Adverse events (AEs): Up to 410.4 weeks
All-cause mortality: All Enrolled Analysis Set. AEs: Safety Analysis Set: all participants who had received at least 1 dose of study medication. It was prespecified to analyze data from Cohort 1 together because both treatments (F/TAF 200/10 mg+boosted 3rd ARV and F/TAF 200/25 mg+unboosted 3rd ARV) were expected to have a similar effect on efficacy and safety for target population. AEs are reported together for both phases as participants continued same medication from main to extension phase.
|
0.00%
0/3 • All-cause mortality: Up to 439 weeks; Adverse events (AEs): Up to 410.4 weeks
All-cause mortality: All Enrolled Analysis Set. AEs: Safety Analysis Set: all participants who had received at least 1 dose of study medication. It was prespecified to analyze data from Cohort 1 together because both treatments (F/TAF 200/10 mg+boosted 3rd ARV and F/TAF 200/25 mg+unboosted 3rd ARV) were expected to have a similar effect on efficacy and safety for target population. AEs are reported together for both phases as participants continued same medication from main to extension phase.
|
|
Metabolism and nutrition disorders
Electrolyte imbalance
|
3.6%
1/28 • All-cause mortality: Up to 439 weeks; Adverse events (AEs): Up to 410.4 weeks
All-cause mortality: All Enrolled Analysis Set. AEs: Safety Analysis Set: all participants who had received at least 1 dose of study medication. It was prespecified to analyze data from Cohort 1 together because both treatments (F/TAF 200/10 mg+boosted 3rd ARV and F/TAF 200/25 mg+unboosted 3rd ARV) were expected to have a similar effect on efficacy and safety for target population. AEs are reported together for both phases as participants continued same medication from main to extension phase.
|
0.00%
0/9 • All-cause mortality: Up to 439 weeks; Adverse events (AEs): Up to 410.4 weeks
All-cause mortality: All Enrolled Analysis Set. AEs: Safety Analysis Set: all participants who had received at least 1 dose of study medication. It was prespecified to analyze data from Cohort 1 together because both treatments (F/TAF 200/10 mg+boosted 3rd ARV and F/TAF 200/25 mg+unboosted 3rd ARV) were expected to have a similar effect on efficacy and safety for target population. AEs are reported together for both phases as participants continued same medication from main to extension phase.
|
0.00%
0/3 • All-cause mortality: Up to 439 weeks; Adverse events (AEs): Up to 410.4 weeks
All-cause mortality: All Enrolled Analysis Set. AEs: Safety Analysis Set: all participants who had received at least 1 dose of study medication. It was prespecified to analyze data from Cohort 1 together because both treatments (F/TAF 200/10 mg+boosted 3rd ARV and F/TAF 200/25 mg+unboosted 3rd ARV) were expected to have a similar effect on efficacy and safety for target population. AEs are reported together for both phases as participants continued same medication from main to extension phase.
|
|
Nervous system disorders
Syncope
|
3.6%
1/28 • All-cause mortality: Up to 439 weeks; Adverse events (AEs): Up to 410.4 weeks
All-cause mortality: All Enrolled Analysis Set. AEs: Safety Analysis Set: all participants who had received at least 1 dose of study medication. It was prespecified to analyze data from Cohort 1 together because both treatments (F/TAF 200/10 mg+boosted 3rd ARV and F/TAF 200/25 mg+unboosted 3rd ARV) were expected to have a similar effect on efficacy and safety for target population. AEs are reported together for both phases as participants continued same medication from main to extension phase.
|
0.00%
0/9 • All-cause mortality: Up to 439 weeks; Adverse events (AEs): Up to 410.4 weeks
All-cause mortality: All Enrolled Analysis Set. AEs: Safety Analysis Set: all participants who had received at least 1 dose of study medication. It was prespecified to analyze data from Cohort 1 together because both treatments (F/TAF 200/10 mg+boosted 3rd ARV and F/TAF 200/25 mg+unboosted 3rd ARV) were expected to have a similar effect on efficacy and safety for target population. AEs are reported together for both phases as participants continued same medication from main to extension phase.
|
0.00%
0/3 • All-cause mortality: Up to 439 weeks; Adverse events (AEs): Up to 410.4 weeks
All-cause mortality: All Enrolled Analysis Set. AEs: Safety Analysis Set: all participants who had received at least 1 dose of study medication. It was prespecified to analyze data from Cohort 1 together because both treatments (F/TAF 200/10 mg+boosted 3rd ARV and F/TAF 200/25 mg+unboosted 3rd ARV) were expected to have a similar effect on efficacy and safety for target population. AEs are reported together for both phases as participants continued same medication from main to extension phase.
|
Other adverse events
| Measure |
F/TAF+3rd ARV Agent (Cohort 1)
n=28 participants at risk
Participants between 12 to \< 18 years of age and ≥ 35 kg body weight received emtricitabine/tenofovir alafenamide (F/TAF) 200/10 mg fixed-dose combination (FDC) tablet (with boosted 3rd antiretroviral (ARV) agent) or F/TAF 200/25 mg FDC tablet (with unboosted 3rd ARV agent) orally once daily for 48 weeks. After completion of 48 weeks, all participants were given the option to participate in the extension phase of the study to continue with F/TAF+3rd ARV agent. Gilead provided F/TAF until a) the participant turned 18 and F/TAF was commercially available for use in adults in the country in which the participant was enrolled or, b) F/TAF became commercially available for pediatric use in the country in which the participant was enrolled or, c) Gilead Sciences elected to terminate development of F/TAF in the applicable country. (Allowed boosted 3rd ARV agents: lopinavir (LPV), atazanavir (ATV), darunavir (DRV); Allowed unboosted 3rd ARV agents: efavirenz (EFV), raltegravir (RAL), dolutegravir (DTG), or nevirapine (NVP)). The participants received the study drug up to a maximum of 438.9 weeks.
|
F/TAF+3rd ARV Agent (Cohort 2, Part A - Group 1)
n=9 participants at risk
Participants between 6 to \< 12 years of age and ≥ 25 kg body weight received F/TAF 200/25 mg FDC tablet orally once daily while continuing on their boosted protease inhibitor (PI) for 48 weeks. After completion of 48 weeks, all participants were given the option to participate in the extension phase of the study to continue with F/TAF+3rd ARV agent. Gilead provided F/TAF until a) the participant turned 18 and F/TAF was commercially available for use in adults in the country in which the participant was enrolled or, b) F/TAF became commercially available for pediatric use in the country in which the participant was enrolled or, c) Gilead Sciences elected to terminate development of F/TAF in the applicable country. (Allowed boosted PIs: ATV, LPV or DRV). The participants received the study drug up to a maximum of 315.0 weeks.
|
F/TAF+3rd ARV Agent (Cohort 2, Part A - Group 2)
n=3 participants at risk
Participants between 2 to \< 12 years of age and 17 to \< 25 kg body weight received F/TAF 120/15 mg FDC orally once daily while continuing on their 3rd ARV agent for 48 weeks. After completion of 48 weeks, all participants were given the option to participate in the extension phase of the study to continue with F/TAF+3rd ARV agent. Gilead provided F/TAF until a) the participant turned 18 and F/TAF was commercially available for use in adults in the country in which the participant was enrolled or, b) F/TAF became commercially available for pediatric use in the country in which the participant was enrolled or, c) Gilead Sciences elected to terminate development of F/TAF in the applicable country. (Allowed boosted 3rd ARV agents: LPV, ATV, DRV; Allowed unboosted 3rd ARV agents: EFV, RAL, DTG, or NVP). The participants received the study drug up to a maximum of 103.1 weeks.
|
|---|---|---|---|
|
Infections and infestations
Covid-19
|
7.1%
2/28 • All-cause mortality: Up to 439 weeks; Adverse events (AEs): Up to 410.4 weeks
All-cause mortality: All Enrolled Analysis Set. AEs: Safety Analysis Set: all participants who had received at least 1 dose of study medication. It was prespecified to analyze data from Cohort 1 together because both treatments (F/TAF 200/10 mg+boosted 3rd ARV and F/TAF 200/25 mg+unboosted 3rd ARV) were expected to have a similar effect on efficacy and safety for target population. AEs are reported together for both phases as participants continued same medication from main to extension phase.
|
22.2%
2/9 • All-cause mortality: Up to 439 weeks; Adverse events (AEs): Up to 410.4 weeks
All-cause mortality: All Enrolled Analysis Set. AEs: Safety Analysis Set: all participants who had received at least 1 dose of study medication. It was prespecified to analyze data from Cohort 1 together because both treatments (F/TAF 200/10 mg+boosted 3rd ARV and F/TAF 200/25 mg+unboosted 3rd ARV) were expected to have a similar effect on efficacy and safety for target population. AEs are reported together for both phases as participants continued same medication from main to extension phase.
|
0.00%
0/3 • All-cause mortality: Up to 439 weeks; Adverse events (AEs): Up to 410.4 weeks
All-cause mortality: All Enrolled Analysis Set. AEs: Safety Analysis Set: all participants who had received at least 1 dose of study medication. It was prespecified to analyze data from Cohort 1 together because both treatments (F/TAF 200/10 mg+boosted 3rd ARV and F/TAF 200/25 mg+unboosted 3rd ARV) were expected to have a similar effect on efficacy and safety for target population. AEs are reported together for both phases as participants continued same medication from main to extension phase.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/28 • All-cause mortality: Up to 439 weeks; Adverse events (AEs): Up to 410.4 weeks
All-cause mortality: All Enrolled Analysis Set. AEs: Safety Analysis Set: all participants who had received at least 1 dose of study medication. It was prespecified to analyze data from Cohort 1 together because both treatments (F/TAF 200/10 mg+boosted 3rd ARV and F/TAF 200/25 mg+unboosted 3rd ARV) were expected to have a similar effect on efficacy and safety for target population. AEs are reported together for both phases as participants continued same medication from main to extension phase.
|
0.00%
0/9 • All-cause mortality: Up to 439 weeks; Adverse events (AEs): Up to 410.4 weeks
All-cause mortality: All Enrolled Analysis Set. AEs: Safety Analysis Set: all participants who had received at least 1 dose of study medication. It was prespecified to analyze data from Cohort 1 together because both treatments (F/TAF 200/10 mg+boosted 3rd ARV and F/TAF 200/25 mg+unboosted 3rd ARV) were expected to have a similar effect on efficacy and safety for target population. AEs are reported together for both phases as participants continued same medication from main to extension phase.
|
33.3%
1/3 • All-cause mortality: Up to 439 weeks; Adverse events (AEs): Up to 410.4 weeks
All-cause mortality: All Enrolled Analysis Set. AEs: Safety Analysis Set: all participants who had received at least 1 dose of study medication. It was prespecified to analyze data from Cohort 1 together because both treatments (F/TAF 200/10 mg+boosted 3rd ARV and F/TAF 200/25 mg+unboosted 3rd ARV) were expected to have a similar effect on efficacy and safety for target population. AEs are reported together for both phases as participants continued same medication from main to extension phase.
|
|
Cardiac disorders
Sinus bradycardia
|
14.3%
4/28 • All-cause mortality: Up to 439 weeks; Adverse events (AEs): Up to 410.4 weeks
All-cause mortality: All Enrolled Analysis Set. AEs: Safety Analysis Set: all participants who had received at least 1 dose of study medication. It was prespecified to analyze data from Cohort 1 together because both treatments (F/TAF 200/10 mg+boosted 3rd ARV and F/TAF 200/25 mg+unboosted 3rd ARV) were expected to have a similar effect on efficacy and safety for target population. AEs are reported together for both phases as participants continued same medication from main to extension phase.
|
22.2%
2/9 • All-cause mortality: Up to 439 weeks; Adverse events (AEs): Up to 410.4 weeks
All-cause mortality: All Enrolled Analysis Set. AEs: Safety Analysis Set: all participants who had received at least 1 dose of study medication. It was prespecified to analyze data from Cohort 1 together because both treatments (F/TAF 200/10 mg+boosted 3rd ARV and F/TAF 200/25 mg+unboosted 3rd ARV) were expected to have a similar effect on efficacy and safety for target population. AEs are reported together for both phases as participants continued same medication from main to extension phase.
|
0.00%
0/3 • All-cause mortality: Up to 439 weeks; Adverse events (AEs): Up to 410.4 weeks
All-cause mortality: All Enrolled Analysis Set. AEs: Safety Analysis Set: all participants who had received at least 1 dose of study medication. It was prespecified to analyze data from Cohort 1 together because both treatments (F/TAF 200/10 mg+boosted 3rd ARV and F/TAF 200/25 mg+unboosted 3rd ARV) were expected to have a similar effect on efficacy and safety for target population. AEs are reported together for both phases as participants continued same medication from main to extension phase.
|
|
Ear and labyrinth disorders
Ear pain
|
0.00%
0/28 • All-cause mortality: Up to 439 weeks; Adverse events (AEs): Up to 410.4 weeks
All-cause mortality: All Enrolled Analysis Set. AEs: Safety Analysis Set: all participants who had received at least 1 dose of study medication. It was prespecified to analyze data from Cohort 1 together because both treatments (F/TAF 200/10 mg+boosted 3rd ARV and F/TAF 200/25 mg+unboosted 3rd ARV) were expected to have a similar effect on efficacy and safety for target population. AEs are reported together for both phases as participants continued same medication from main to extension phase.
|
0.00%
0/9 • All-cause mortality: Up to 439 weeks; Adverse events (AEs): Up to 410.4 weeks
All-cause mortality: All Enrolled Analysis Set. AEs: Safety Analysis Set: all participants who had received at least 1 dose of study medication. It was prespecified to analyze data from Cohort 1 together because both treatments (F/TAF 200/10 mg+boosted 3rd ARV and F/TAF 200/25 mg+unboosted 3rd ARV) were expected to have a similar effect on efficacy and safety for target population. AEs are reported together for both phases as participants continued same medication from main to extension phase.
|
33.3%
1/3 • All-cause mortality: Up to 439 weeks; Adverse events (AEs): Up to 410.4 weeks
All-cause mortality: All Enrolled Analysis Set. AEs: Safety Analysis Set: all participants who had received at least 1 dose of study medication. It was prespecified to analyze data from Cohort 1 together because both treatments (F/TAF 200/10 mg+boosted 3rd ARV and F/TAF 200/25 mg+unboosted 3rd ARV) were expected to have a similar effect on efficacy and safety for target population. AEs are reported together for both phases as participants continued same medication from main to extension phase.
|
|
Eye disorders
Eczema eyelids
|
0.00%
0/28 • All-cause mortality: Up to 439 weeks; Adverse events (AEs): Up to 410.4 weeks
All-cause mortality: All Enrolled Analysis Set. AEs: Safety Analysis Set: all participants who had received at least 1 dose of study medication. It was prespecified to analyze data from Cohort 1 together because both treatments (F/TAF 200/10 mg+boosted 3rd ARV and F/TAF 200/25 mg+unboosted 3rd ARV) were expected to have a similar effect on efficacy and safety for target population. AEs are reported together for both phases as participants continued same medication from main to extension phase.
|
11.1%
1/9 • All-cause mortality: Up to 439 weeks; Adverse events (AEs): Up to 410.4 weeks
All-cause mortality: All Enrolled Analysis Set. AEs: Safety Analysis Set: all participants who had received at least 1 dose of study medication. It was prespecified to analyze data from Cohort 1 together because both treatments (F/TAF 200/10 mg+boosted 3rd ARV and F/TAF 200/25 mg+unboosted 3rd ARV) were expected to have a similar effect on efficacy and safety for target population. AEs are reported together for both phases as participants continued same medication from main to extension phase.
|
0.00%
0/3 • All-cause mortality: Up to 439 weeks; Adverse events (AEs): Up to 410.4 weeks
All-cause mortality: All Enrolled Analysis Set. AEs: Safety Analysis Set: all participants who had received at least 1 dose of study medication. It was prespecified to analyze data from Cohort 1 together because both treatments (F/TAF 200/10 mg+boosted 3rd ARV and F/TAF 200/25 mg+unboosted 3rd ARV) were expected to have a similar effect on efficacy and safety for target population. AEs are reported together for both phases as participants continued same medication from main to extension phase.
|
|
Eye disorders
Vernal keratoconjunctivitis
|
0.00%
0/28 • All-cause mortality: Up to 439 weeks; Adverse events (AEs): Up to 410.4 weeks
All-cause mortality: All Enrolled Analysis Set. AEs: Safety Analysis Set: all participants who had received at least 1 dose of study medication. It was prespecified to analyze data from Cohort 1 together because both treatments (F/TAF 200/10 mg+boosted 3rd ARV and F/TAF 200/25 mg+unboosted 3rd ARV) were expected to have a similar effect on efficacy and safety for target population. AEs are reported together for both phases as participants continued same medication from main to extension phase.
|
11.1%
1/9 • All-cause mortality: Up to 439 weeks; Adverse events (AEs): Up to 410.4 weeks
All-cause mortality: All Enrolled Analysis Set. AEs: Safety Analysis Set: all participants who had received at least 1 dose of study medication. It was prespecified to analyze data from Cohort 1 together because both treatments (F/TAF 200/10 mg+boosted 3rd ARV and F/TAF 200/25 mg+unboosted 3rd ARV) were expected to have a similar effect on efficacy and safety for target population. AEs are reported together for both phases as participants continued same medication from main to extension phase.
|
0.00%
0/3 • All-cause mortality: Up to 439 weeks; Adverse events (AEs): Up to 410.4 weeks
All-cause mortality: All Enrolled Analysis Set. AEs: Safety Analysis Set: all participants who had received at least 1 dose of study medication. It was prespecified to analyze data from Cohort 1 together because both treatments (F/TAF 200/10 mg+boosted 3rd ARV and F/TAF 200/25 mg+unboosted 3rd ARV) were expected to have a similar effect on efficacy and safety for target population. AEs are reported together for both phases as participants continued same medication from main to extension phase.
|
|
Gastrointestinal disorders
Abdominal pain
|
7.1%
2/28 • All-cause mortality: Up to 439 weeks; Adverse events (AEs): Up to 410.4 weeks
All-cause mortality: All Enrolled Analysis Set. AEs: Safety Analysis Set: all participants who had received at least 1 dose of study medication. It was prespecified to analyze data from Cohort 1 together because both treatments (F/TAF 200/10 mg+boosted 3rd ARV and F/TAF 200/25 mg+unboosted 3rd ARV) were expected to have a similar effect on efficacy and safety for target population. AEs are reported together for both phases as participants continued same medication from main to extension phase.
|
0.00%
0/9 • All-cause mortality: Up to 439 weeks; Adverse events (AEs): Up to 410.4 weeks
All-cause mortality: All Enrolled Analysis Set. AEs: Safety Analysis Set: all participants who had received at least 1 dose of study medication. It was prespecified to analyze data from Cohort 1 together because both treatments (F/TAF 200/10 mg+boosted 3rd ARV and F/TAF 200/25 mg+unboosted 3rd ARV) were expected to have a similar effect on efficacy and safety for target population. AEs are reported together for both phases as participants continued same medication from main to extension phase.
|
0.00%
0/3 • All-cause mortality: Up to 439 weeks; Adverse events (AEs): Up to 410.4 weeks
All-cause mortality: All Enrolled Analysis Set. AEs: Safety Analysis Set: all participants who had received at least 1 dose of study medication. It was prespecified to analyze data from Cohort 1 together because both treatments (F/TAF 200/10 mg+boosted 3rd ARV and F/TAF 200/25 mg+unboosted 3rd ARV) were expected to have a similar effect on efficacy and safety for target population. AEs are reported together for both phases as participants continued same medication from main to extension phase.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
10.7%
3/28 • All-cause mortality: Up to 439 weeks; Adverse events (AEs): Up to 410.4 weeks
All-cause mortality: All Enrolled Analysis Set. AEs: Safety Analysis Set: all participants who had received at least 1 dose of study medication. It was prespecified to analyze data from Cohort 1 together because both treatments (F/TAF 200/10 mg+boosted 3rd ARV and F/TAF 200/25 mg+unboosted 3rd ARV) were expected to have a similar effect on efficacy and safety for target population. AEs are reported together for both phases as participants continued same medication from main to extension phase.
|
0.00%
0/9 • All-cause mortality: Up to 439 weeks; Adverse events (AEs): Up to 410.4 weeks
All-cause mortality: All Enrolled Analysis Set. AEs: Safety Analysis Set: all participants who had received at least 1 dose of study medication. It was prespecified to analyze data from Cohort 1 together because both treatments (F/TAF 200/10 mg+boosted 3rd ARV and F/TAF 200/25 mg+unboosted 3rd ARV) were expected to have a similar effect on efficacy and safety for target population. AEs are reported together for both phases as participants continued same medication from main to extension phase.
|
0.00%
0/3 • All-cause mortality: Up to 439 weeks; Adverse events (AEs): Up to 410.4 weeks
All-cause mortality: All Enrolled Analysis Set. AEs: Safety Analysis Set: all participants who had received at least 1 dose of study medication. It was prespecified to analyze data from Cohort 1 together because both treatments (F/TAF 200/10 mg+boosted 3rd ARV and F/TAF 200/25 mg+unboosted 3rd ARV) were expected to have a similar effect on efficacy and safety for target population. AEs are reported together for both phases as participants continued same medication from main to extension phase.
|
|
Gastrointestinal disorders
Dental caries
|
14.3%
4/28 • All-cause mortality: Up to 439 weeks; Adverse events (AEs): Up to 410.4 weeks
All-cause mortality: All Enrolled Analysis Set. AEs: Safety Analysis Set: all participants who had received at least 1 dose of study medication. It was prespecified to analyze data from Cohort 1 together because both treatments (F/TAF 200/10 mg+boosted 3rd ARV and F/TAF 200/25 mg+unboosted 3rd ARV) were expected to have a similar effect on efficacy and safety for target population. AEs are reported together for both phases as participants continued same medication from main to extension phase.
|
22.2%
2/9 • All-cause mortality: Up to 439 weeks; Adverse events (AEs): Up to 410.4 weeks
All-cause mortality: All Enrolled Analysis Set. AEs: Safety Analysis Set: all participants who had received at least 1 dose of study medication. It was prespecified to analyze data from Cohort 1 together because both treatments (F/TAF 200/10 mg+boosted 3rd ARV and F/TAF 200/25 mg+unboosted 3rd ARV) were expected to have a similar effect on efficacy and safety for target population. AEs are reported together for both phases as participants continued same medication from main to extension phase.
|
0.00%
0/3 • All-cause mortality: Up to 439 weeks; Adverse events (AEs): Up to 410.4 weeks
All-cause mortality: All Enrolled Analysis Set. AEs: Safety Analysis Set: all participants who had received at least 1 dose of study medication. It was prespecified to analyze data from Cohort 1 together because both treatments (F/TAF 200/10 mg+boosted 3rd ARV and F/TAF 200/25 mg+unboosted 3rd ARV) were expected to have a similar effect on efficacy and safety for target population. AEs are reported together for both phases as participants continued same medication from main to extension phase.
|
|
Gastrointestinal disorders
Diarrhoea
|
21.4%
6/28 • All-cause mortality: Up to 439 weeks; Adverse events (AEs): Up to 410.4 weeks
All-cause mortality: All Enrolled Analysis Set. AEs: Safety Analysis Set: all participants who had received at least 1 dose of study medication. It was prespecified to analyze data from Cohort 1 together because both treatments (F/TAF 200/10 mg+boosted 3rd ARV and F/TAF 200/25 mg+unboosted 3rd ARV) were expected to have a similar effect on efficacy and safety for target population. AEs are reported together for both phases as participants continued same medication from main to extension phase.
|
0.00%
0/9 • All-cause mortality: Up to 439 weeks; Adverse events (AEs): Up to 410.4 weeks
All-cause mortality: All Enrolled Analysis Set. AEs: Safety Analysis Set: all participants who had received at least 1 dose of study medication. It was prespecified to analyze data from Cohort 1 together because both treatments (F/TAF 200/10 mg+boosted 3rd ARV and F/TAF 200/25 mg+unboosted 3rd ARV) were expected to have a similar effect on efficacy and safety for target population. AEs are reported together for both phases as participants continued same medication from main to extension phase.
|
0.00%
0/3 • All-cause mortality: Up to 439 weeks; Adverse events (AEs): Up to 410.4 weeks
All-cause mortality: All Enrolled Analysis Set. AEs: Safety Analysis Set: all participants who had received at least 1 dose of study medication. It was prespecified to analyze data from Cohort 1 together because both treatments (F/TAF 200/10 mg+boosted 3rd ARV and F/TAF 200/25 mg+unboosted 3rd ARV) were expected to have a similar effect on efficacy and safety for target population. AEs are reported together for both phases as participants continued same medication from main to extension phase.
|
|
Gastrointestinal disorders
Dyspepsia
|
3.6%
1/28 • All-cause mortality: Up to 439 weeks; Adverse events (AEs): Up to 410.4 weeks
All-cause mortality: All Enrolled Analysis Set. AEs: Safety Analysis Set: all participants who had received at least 1 dose of study medication. It was prespecified to analyze data from Cohort 1 together because both treatments (F/TAF 200/10 mg+boosted 3rd ARV and F/TAF 200/25 mg+unboosted 3rd ARV) were expected to have a similar effect on efficacy and safety for target population. AEs are reported together for both phases as participants continued same medication from main to extension phase.
|
11.1%
1/9 • All-cause mortality: Up to 439 weeks; Adverse events (AEs): Up to 410.4 weeks
All-cause mortality: All Enrolled Analysis Set. AEs: Safety Analysis Set: all participants who had received at least 1 dose of study medication. It was prespecified to analyze data from Cohort 1 together because both treatments (F/TAF 200/10 mg+boosted 3rd ARV and F/TAF 200/25 mg+unboosted 3rd ARV) were expected to have a similar effect on efficacy and safety for target population. AEs are reported together for both phases as participants continued same medication from main to extension phase.
|
0.00%
0/3 • All-cause mortality: Up to 439 weeks; Adverse events (AEs): Up to 410.4 weeks
All-cause mortality: All Enrolled Analysis Set. AEs: Safety Analysis Set: all participants who had received at least 1 dose of study medication. It was prespecified to analyze data from Cohort 1 together because both treatments (F/TAF 200/10 mg+boosted 3rd ARV and F/TAF 200/25 mg+unboosted 3rd ARV) were expected to have a similar effect on efficacy and safety for target population. AEs are reported together for both phases as participants continued same medication from main to extension phase.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/28 • All-cause mortality: Up to 439 weeks; Adverse events (AEs): Up to 410.4 weeks
All-cause mortality: All Enrolled Analysis Set. AEs: Safety Analysis Set: all participants who had received at least 1 dose of study medication. It was prespecified to analyze data from Cohort 1 together because both treatments (F/TAF 200/10 mg+boosted 3rd ARV and F/TAF 200/25 mg+unboosted 3rd ARV) were expected to have a similar effect on efficacy and safety for target population. AEs are reported together for both phases as participants continued same medication from main to extension phase.
|
11.1%
1/9 • All-cause mortality: Up to 439 weeks; Adverse events (AEs): Up to 410.4 weeks
All-cause mortality: All Enrolled Analysis Set. AEs: Safety Analysis Set: all participants who had received at least 1 dose of study medication. It was prespecified to analyze data from Cohort 1 together because both treatments (F/TAF 200/10 mg+boosted 3rd ARV and F/TAF 200/25 mg+unboosted 3rd ARV) were expected to have a similar effect on efficacy and safety for target population. AEs are reported together for both phases as participants continued same medication from main to extension phase.
|
0.00%
0/3 • All-cause mortality: Up to 439 weeks; Adverse events (AEs): Up to 410.4 weeks
All-cause mortality: All Enrolled Analysis Set. AEs: Safety Analysis Set: all participants who had received at least 1 dose of study medication. It was prespecified to analyze data from Cohort 1 together because both treatments (F/TAF 200/10 mg+boosted 3rd ARV and F/TAF 200/25 mg+unboosted 3rd ARV) were expected to have a similar effect on efficacy and safety for target population. AEs are reported together for both phases as participants continued same medication from main to extension phase.
|
|
Gastrointestinal disorders
Haemorrhoids
|
10.7%
3/28 • All-cause mortality: Up to 439 weeks; Adverse events (AEs): Up to 410.4 weeks
All-cause mortality: All Enrolled Analysis Set. AEs: Safety Analysis Set: all participants who had received at least 1 dose of study medication. It was prespecified to analyze data from Cohort 1 together because both treatments (F/TAF 200/10 mg+boosted 3rd ARV and F/TAF 200/25 mg+unboosted 3rd ARV) were expected to have a similar effect on efficacy and safety for target population. AEs are reported together for both phases as participants continued same medication from main to extension phase.
|
0.00%
0/9 • All-cause mortality: Up to 439 weeks; Adverse events (AEs): Up to 410.4 weeks
All-cause mortality: All Enrolled Analysis Set. AEs: Safety Analysis Set: all participants who had received at least 1 dose of study medication. It was prespecified to analyze data from Cohort 1 together because both treatments (F/TAF 200/10 mg+boosted 3rd ARV and F/TAF 200/25 mg+unboosted 3rd ARV) were expected to have a similar effect on efficacy and safety for target population. AEs are reported together for both phases as participants continued same medication from main to extension phase.
|
0.00%
0/3 • All-cause mortality: Up to 439 weeks; Adverse events (AEs): Up to 410.4 weeks
All-cause mortality: All Enrolled Analysis Set. AEs: Safety Analysis Set: all participants who had received at least 1 dose of study medication. It was prespecified to analyze data from Cohort 1 together because both treatments (F/TAF 200/10 mg+boosted 3rd ARV and F/TAF 200/25 mg+unboosted 3rd ARV) were expected to have a similar effect on efficacy and safety for target population. AEs are reported together for both phases as participants continued same medication from main to extension phase.
|
|
Gastrointestinal disorders
Nausea
|
21.4%
6/28 • All-cause mortality: Up to 439 weeks; Adverse events (AEs): Up to 410.4 weeks
All-cause mortality: All Enrolled Analysis Set. AEs: Safety Analysis Set: all participants who had received at least 1 dose of study medication. It was prespecified to analyze data from Cohort 1 together because both treatments (F/TAF 200/10 mg+boosted 3rd ARV and F/TAF 200/25 mg+unboosted 3rd ARV) were expected to have a similar effect on efficacy and safety for target population. AEs are reported together for both phases as participants continued same medication from main to extension phase.
|
0.00%
0/9 • All-cause mortality: Up to 439 weeks; Adverse events (AEs): Up to 410.4 weeks
All-cause mortality: All Enrolled Analysis Set. AEs: Safety Analysis Set: all participants who had received at least 1 dose of study medication. It was prespecified to analyze data from Cohort 1 together because both treatments (F/TAF 200/10 mg+boosted 3rd ARV and F/TAF 200/25 mg+unboosted 3rd ARV) were expected to have a similar effect on efficacy and safety for target population. AEs are reported together for both phases as participants continued same medication from main to extension phase.
|
0.00%
0/3 • All-cause mortality: Up to 439 weeks; Adverse events (AEs): Up to 410.4 weeks
All-cause mortality: All Enrolled Analysis Set. AEs: Safety Analysis Set: all participants who had received at least 1 dose of study medication. It was prespecified to analyze data from Cohort 1 together because both treatments (F/TAF 200/10 mg+boosted 3rd ARV and F/TAF 200/25 mg+unboosted 3rd ARV) were expected to have a similar effect on efficacy and safety for target population. AEs are reported together for both phases as participants continued same medication from main to extension phase.
|
|
Gastrointestinal disorders
Vomiting
|
25.0%
7/28 • All-cause mortality: Up to 439 weeks; Adverse events (AEs): Up to 410.4 weeks
All-cause mortality: All Enrolled Analysis Set. AEs: Safety Analysis Set: all participants who had received at least 1 dose of study medication. It was prespecified to analyze data from Cohort 1 together because both treatments (F/TAF 200/10 mg+boosted 3rd ARV and F/TAF 200/25 mg+unboosted 3rd ARV) were expected to have a similar effect on efficacy and safety for target population. AEs are reported together for both phases as participants continued same medication from main to extension phase.
|
11.1%
1/9 • All-cause mortality: Up to 439 weeks; Adverse events (AEs): Up to 410.4 weeks
All-cause mortality: All Enrolled Analysis Set. AEs: Safety Analysis Set: all participants who had received at least 1 dose of study medication. It was prespecified to analyze data from Cohort 1 together because both treatments (F/TAF 200/10 mg+boosted 3rd ARV and F/TAF 200/25 mg+unboosted 3rd ARV) were expected to have a similar effect on efficacy and safety for target population. AEs are reported together for both phases as participants continued same medication from main to extension phase.
|
0.00%
0/3 • All-cause mortality: Up to 439 weeks; Adverse events (AEs): Up to 410.4 weeks
All-cause mortality: All Enrolled Analysis Set. AEs: Safety Analysis Set: all participants who had received at least 1 dose of study medication. It was prespecified to analyze data from Cohort 1 together because both treatments (F/TAF 200/10 mg+boosted 3rd ARV and F/TAF 200/25 mg+unboosted 3rd ARV) were expected to have a similar effect on efficacy and safety for target population. AEs are reported together for both phases as participants continued same medication from main to extension phase.
|
|
General disorders
Pyrexia
|
7.1%
2/28 • All-cause mortality: Up to 439 weeks; Adverse events (AEs): Up to 410.4 weeks
All-cause mortality: All Enrolled Analysis Set. AEs: Safety Analysis Set: all participants who had received at least 1 dose of study medication. It was prespecified to analyze data from Cohort 1 together because both treatments (F/TAF 200/10 mg+boosted 3rd ARV and F/TAF 200/25 mg+unboosted 3rd ARV) were expected to have a similar effect on efficacy and safety for target population. AEs are reported together for both phases as participants continued same medication from main to extension phase.
|
0.00%
0/9 • All-cause mortality: Up to 439 weeks; Adverse events (AEs): Up to 410.4 weeks
All-cause mortality: All Enrolled Analysis Set. AEs: Safety Analysis Set: all participants who had received at least 1 dose of study medication. It was prespecified to analyze data from Cohort 1 together because both treatments (F/TAF 200/10 mg+boosted 3rd ARV and F/TAF 200/25 mg+unboosted 3rd ARV) were expected to have a similar effect on efficacy and safety for target population. AEs are reported together for both phases as participants continued same medication from main to extension phase.
|
0.00%
0/3 • All-cause mortality: Up to 439 weeks; Adverse events (AEs): Up to 410.4 weeks
All-cause mortality: All Enrolled Analysis Set. AEs: Safety Analysis Set: all participants who had received at least 1 dose of study medication. It was prespecified to analyze data from Cohort 1 together because both treatments (F/TAF 200/10 mg+boosted 3rd ARV and F/TAF 200/25 mg+unboosted 3rd ARV) were expected to have a similar effect on efficacy and safety for target population. AEs are reported together for both phases as participants continued same medication from main to extension phase.
|
|
Infections and infestations
Acarodermatitis
|
7.1%
2/28 • All-cause mortality: Up to 439 weeks; Adverse events (AEs): Up to 410.4 weeks
All-cause mortality: All Enrolled Analysis Set. AEs: Safety Analysis Set: all participants who had received at least 1 dose of study medication. It was prespecified to analyze data from Cohort 1 together because both treatments (F/TAF 200/10 mg+boosted 3rd ARV and F/TAF 200/25 mg+unboosted 3rd ARV) were expected to have a similar effect on efficacy and safety for target population. AEs are reported together for both phases as participants continued same medication from main to extension phase.
|
0.00%
0/9 • All-cause mortality: Up to 439 weeks; Adverse events (AEs): Up to 410.4 weeks
All-cause mortality: All Enrolled Analysis Set. AEs: Safety Analysis Set: all participants who had received at least 1 dose of study medication. It was prespecified to analyze data from Cohort 1 together because both treatments (F/TAF 200/10 mg+boosted 3rd ARV and F/TAF 200/25 mg+unboosted 3rd ARV) were expected to have a similar effect on efficacy and safety for target population. AEs are reported together for both phases as participants continued same medication from main to extension phase.
|
0.00%
0/3 • All-cause mortality: Up to 439 weeks; Adverse events (AEs): Up to 410.4 weeks
All-cause mortality: All Enrolled Analysis Set. AEs: Safety Analysis Set: all participants who had received at least 1 dose of study medication. It was prespecified to analyze data from Cohort 1 together because both treatments (F/TAF 200/10 mg+boosted 3rd ARV and F/TAF 200/25 mg+unboosted 3rd ARV) were expected to have a similar effect on efficacy and safety for target population. AEs are reported together for both phases as participants continued same medication from main to extension phase.
|
|
Infections and infestations
Bacterial vaginosis
|
7.1%
2/28 • All-cause mortality: Up to 439 weeks; Adverse events (AEs): Up to 410.4 weeks
All-cause mortality: All Enrolled Analysis Set. AEs: Safety Analysis Set: all participants who had received at least 1 dose of study medication. It was prespecified to analyze data from Cohort 1 together because both treatments (F/TAF 200/10 mg+boosted 3rd ARV and F/TAF 200/25 mg+unboosted 3rd ARV) were expected to have a similar effect on efficacy and safety for target population. AEs are reported together for both phases as participants continued same medication from main to extension phase.
|
0.00%
0/9 • All-cause mortality: Up to 439 weeks; Adverse events (AEs): Up to 410.4 weeks
All-cause mortality: All Enrolled Analysis Set. AEs: Safety Analysis Set: all participants who had received at least 1 dose of study medication. It was prespecified to analyze data from Cohort 1 together because both treatments (F/TAF 200/10 mg+boosted 3rd ARV and F/TAF 200/25 mg+unboosted 3rd ARV) were expected to have a similar effect on efficacy and safety for target population. AEs are reported together for both phases as participants continued same medication from main to extension phase.
|
0.00%
0/3 • All-cause mortality: Up to 439 weeks; Adverse events (AEs): Up to 410.4 weeks
All-cause mortality: All Enrolled Analysis Set. AEs: Safety Analysis Set: all participants who had received at least 1 dose of study medication. It was prespecified to analyze data from Cohort 1 together because both treatments (F/TAF 200/10 mg+boosted 3rd ARV and F/TAF 200/25 mg+unboosted 3rd ARV) were expected to have a similar effect on efficacy and safety for target population. AEs are reported together for both phases as participants continued same medication from main to extension phase.
|
|
Infections and infestations
Body tinea
|
14.3%
4/28 • All-cause mortality: Up to 439 weeks; Adverse events (AEs): Up to 410.4 weeks
All-cause mortality: All Enrolled Analysis Set. AEs: Safety Analysis Set: all participants who had received at least 1 dose of study medication. It was prespecified to analyze data from Cohort 1 together because both treatments (F/TAF 200/10 mg+boosted 3rd ARV and F/TAF 200/25 mg+unboosted 3rd ARV) were expected to have a similar effect on efficacy and safety for target population. AEs are reported together for both phases as participants continued same medication from main to extension phase.
|
0.00%
0/9 • All-cause mortality: Up to 439 weeks; Adverse events (AEs): Up to 410.4 weeks
All-cause mortality: All Enrolled Analysis Set. AEs: Safety Analysis Set: all participants who had received at least 1 dose of study medication. It was prespecified to analyze data from Cohort 1 together because both treatments (F/TAF 200/10 mg+boosted 3rd ARV and F/TAF 200/25 mg+unboosted 3rd ARV) were expected to have a similar effect on efficacy and safety for target population. AEs are reported together for both phases as participants continued same medication from main to extension phase.
|
0.00%
0/3 • All-cause mortality: Up to 439 weeks; Adverse events (AEs): Up to 410.4 weeks
All-cause mortality: All Enrolled Analysis Set. AEs: Safety Analysis Set: all participants who had received at least 1 dose of study medication. It was prespecified to analyze data from Cohort 1 together because both treatments (F/TAF 200/10 mg+boosted 3rd ARV and F/TAF 200/25 mg+unboosted 3rd ARV) were expected to have a similar effect on efficacy and safety for target population. AEs are reported together for both phases as participants continued same medication from main to extension phase.
|
|
Infections and infestations
Conjunctivitis
|
10.7%
3/28 • All-cause mortality: Up to 439 weeks; Adverse events (AEs): Up to 410.4 weeks
All-cause mortality: All Enrolled Analysis Set. AEs: Safety Analysis Set: all participants who had received at least 1 dose of study medication. It was prespecified to analyze data from Cohort 1 together because both treatments (F/TAF 200/10 mg+boosted 3rd ARV and F/TAF 200/25 mg+unboosted 3rd ARV) were expected to have a similar effect on efficacy and safety for target population. AEs are reported together for both phases as participants continued same medication from main to extension phase.
|
0.00%
0/9 • All-cause mortality: Up to 439 weeks; Adverse events (AEs): Up to 410.4 weeks
All-cause mortality: All Enrolled Analysis Set. AEs: Safety Analysis Set: all participants who had received at least 1 dose of study medication. It was prespecified to analyze data from Cohort 1 together because both treatments (F/TAF 200/10 mg+boosted 3rd ARV and F/TAF 200/25 mg+unboosted 3rd ARV) were expected to have a similar effect on efficacy and safety for target population. AEs are reported together for both phases as participants continued same medication from main to extension phase.
|
0.00%
0/3 • All-cause mortality: Up to 439 weeks; Adverse events (AEs): Up to 410.4 weeks
All-cause mortality: All Enrolled Analysis Set. AEs: Safety Analysis Set: all participants who had received at least 1 dose of study medication. It was prespecified to analyze data from Cohort 1 together because both treatments (F/TAF 200/10 mg+boosted 3rd ARV and F/TAF 200/25 mg+unboosted 3rd ARV) were expected to have a similar effect on efficacy and safety for target population. AEs are reported together for both phases as participants continued same medication from main to extension phase.
|
|
Infections and infestations
Folliculitis
|
7.1%
2/28 • All-cause mortality: Up to 439 weeks; Adverse events (AEs): Up to 410.4 weeks
All-cause mortality: All Enrolled Analysis Set. AEs: Safety Analysis Set: all participants who had received at least 1 dose of study medication. It was prespecified to analyze data from Cohort 1 together because both treatments (F/TAF 200/10 mg+boosted 3rd ARV and F/TAF 200/25 mg+unboosted 3rd ARV) were expected to have a similar effect on efficacy and safety for target population. AEs are reported together for both phases as participants continued same medication from main to extension phase.
|
0.00%
0/9 • All-cause mortality: Up to 439 weeks; Adverse events (AEs): Up to 410.4 weeks
All-cause mortality: All Enrolled Analysis Set. AEs: Safety Analysis Set: all participants who had received at least 1 dose of study medication. It was prespecified to analyze data from Cohort 1 together because both treatments (F/TAF 200/10 mg+boosted 3rd ARV and F/TAF 200/25 mg+unboosted 3rd ARV) were expected to have a similar effect on efficacy and safety for target population. AEs are reported together for both phases as participants continued same medication from main to extension phase.
|
0.00%
0/3 • All-cause mortality: Up to 439 weeks; Adverse events (AEs): Up to 410.4 weeks
All-cause mortality: All Enrolled Analysis Set. AEs: Safety Analysis Set: all participants who had received at least 1 dose of study medication. It was prespecified to analyze data from Cohort 1 together because both treatments (F/TAF 200/10 mg+boosted 3rd ARV and F/TAF 200/25 mg+unboosted 3rd ARV) were expected to have a similar effect on efficacy and safety for target population. AEs are reported together for both phases as participants continued same medication from main to extension phase.
|
|
Infections and infestations
Gastroenteritis
|
14.3%
4/28 • All-cause mortality: Up to 439 weeks; Adverse events (AEs): Up to 410.4 weeks
All-cause mortality: All Enrolled Analysis Set. AEs: Safety Analysis Set: all participants who had received at least 1 dose of study medication. It was prespecified to analyze data from Cohort 1 together because both treatments (F/TAF 200/10 mg+boosted 3rd ARV and F/TAF 200/25 mg+unboosted 3rd ARV) were expected to have a similar effect on efficacy and safety for target population. AEs are reported together for both phases as participants continued same medication from main to extension phase.
|
22.2%
2/9 • All-cause mortality: Up to 439 weeks; Adverse events (AEs): Up to 410.4 weeks
All-cause mortality: All Enrolled Analysis Set. AEs: Safety Analysis Set: all participants who had received at least 1 dose of study medication. It was prespecified to analyze data from Cohort 1 together because both treatments (F/TAF 200/10 mg+boosted 3rd ARV and F/TAF 200/25 mg+unboosted 3rd ARV) were expected to have a similar effect on efficacy and safety for target population. AEs are reported together for both phases as participants continued same medication from main to extension phase.
|
0.00%
0/3 • All-cause mortality: Up to 439 weeks; Adverse events (AEs): Up to 410.4 weeks
All-cause mortality: All Enrolled Analysis Set. AEs: Safety Analysis Set: all participants who had received at least 1 dose of study medication. It was prespecified to analyze data from Cohort 1 together because both treatments (F/TAF 200/10 mg+boosted 3rd ARV and F/TAF 200/25 mg+unboosted 3rd ARV) were expected to have a similar effect on efficacy and safety for target population. AEs are reported together for both phases as participants continued same medication from main to extension phase.
|
|
Infections and infestations
Gastroenteritis viral
|
7.1%
2/28 • All-cause mortality: Up to 439 weeks; Adverse events (AEs): Up to 410.4 weeks
All-cause mortality: All Enrolled Analysis Set. AEs: Safety Analysis Set: all participants who had received at least 1 dose of study medication. It was prespecified to analyze data from Cohort 1 together because both treatments (F/TAF 200/10 mg+boosted 3rd ARV and F/TAF 200/25 mg+unboosted 3rd ARV) were expected to have a similar effect on efficacy and safety for target population. AEs are reported together for both phases as participants continued same medication from main to extension phase.
|
0.00%
0/9 • All-cause mortality: Up to 439 weeks; Adverse events (AEs): Up to 410.4 weeks
All-cause mortality: All Enrolled Analysis Set. AEs: Safety Analysis Set: all participants who had received at least 1 dose of study medication. It was prespecified to analyze data from Cohort 1 together because both treatments (F/TAF 200/10 mg+boosted 3rd ARV and F/TAF 200/25 mg+unboosted 3rd ARV) were expected to have a similar effect on efficacy and safety for target population. AEs are reported together for both phases as participants continued same medication from main to extension phase.
|
0.00%
0/3 • All-cause mortality: Up to 439 weeks; Adverse events (AEs): Up to 410.4 weeks
All-cause mortality: All Enrolled Analysis Set. AEs: Safety Analysis Set: all participants who had received at least 1 dose of study medication. It was prespecified to analyze data from Cohort 1 together because both treatments (F/TAF 200/10 mg+boosted 3rd ARV and F/TAF 200/25 mg+unboosted 3rd ARV) were expected to have a similar effect on efficacy and safety for target population. AEs are reported together for both phases as participants continued same medication from main to extension phase.
|
|
Infections and infestations
Helminthic infection
|
0.00%
0/28 • All-cause mortality: Up to 439 weeks; Adverse events (AEs): Up to 410.4 weeks
All-cause mortality: All Enrolled Analysis Set. AEs: Safety Analysis Set: all participants who had received at least 1 dose of study medication. It was prespecified to analyze data from Cohort 1 together because both treatments (F/TAF 200/10 mg+boosted 3rd ARV and F/TAF 200/25 mg+unboosted 3rd ARV) were expected to have a similar effect on efficacy and safety for target population. AEs are reported together for both phases as participants continued same medication from main to extension phase.
|
0.00%
0/9 • All-cause mortality: Up to 439 weeks; Adverse events (AEs): Up to 410.4 weeks
All-cause mortality: All Enrolled Analysis Set. AEs: Safety Analysis Set: all participants who had received at least 1 dose of study medication. It was prespecified to analyze data from Cohort 1 together because both treatments (F/TAF 200/10 mg+boosted 3rd ARV and F/TAF 200/25 mg+unboosted 3rd ARV) were expected to have a similar effect on efficacy and safety for target population. AEs are reported together for both phases as participants continued same medication from main to extension phase.
|
33.3%
1/3 • All-cause mortality: Up to 439 weeks; Adverse events (AEs): Up to 410.4 weeks
All-cause mortality: All Enrolled Analysis Set. AEs: Safety Analysis Set: all participants who had received at least 1 dose of study medication. It was prespecified to analyze data from Cohort 1 together because both treatments (F/TAF 200/10 mg+boosted 3rd ARV and F/TAF 200/25 mg+unboosted 3rd ARV) were expected to have a similar effect on efficacy and safety for target population. AEs are reported together for both phases as participants continued same medication from main to extension phase.
|
|
Infections and infestations
Hordeolum
|
10.7%
3/28 • All-cause mortality: Up to 439 weeks; Adverse events (AEs): Up to 410.4 weeks
All-cause mortality: All Enrolled Analysis Set. AEs: Safety Analysis Set: all participants who had received at least 1 dose of study medication. It was prespecified to analyze data from Cohort 1 together because both treatments (F/TAF 200/10 mg+boosted 3rd ARV and F/TAF 200/25 mg+unboosted 3rd ARV) were expected to have a similar effect on efficacy and safety for target population. AEs are reported together for both phases as participants continued same medication from main to extension phase.
|
11.1%
1/9 • All-cause mortality: Up to 439 weeks; Adverse events (AEs): Up to 410.4 weeks
All-cause mortality: All Enrolled Analysis Set. AEs: Safety Analysis Set: all participants who had received at least 1 dose of study medication. It was prespecified to analyze data from Cohort 1 together because both treatments (F/TAF 200/10 mg+boosted 3rd ARV and F/TAF 200/25 mg+unboosted 3rd ARV) were expected to have a similar effect on efficacy and safety for target population. AEs are reported together for both phases as participants continued same medication from main to extension phase.
|
0.00%
0/3 • All-cause mortality: Up to 439 weeks; Adverse events (AEs): Up to 410.4 weeks
All-cause mortality: All Enrolled Analysis Set. AEs: Safety Analysis Set: all participants who had received at least 1 dose of study medication. It was prespecified to analyze data from Cohort 1 together because both treatments (F/TAF 200/10 mg+boosted 3rd ARV and F/TAF 200/25 mg+unboosted 3rd ARV) were expected to have a similar effect on efficacy and safety for target population. AEs are reported together for both phases as participants continued same medication from main to extension phase.
|
|
Infections and infestations
Influenza
|
28.6%
8/28 • All-cause mortality: Up to 439 weeks; Adverse events (AEs): Up to 410.4 weeks
All-cause mortality: All Enrolled Analysis Set. AEs: Safety Analysis Set: all participants who had received at least 1 dose of study medication. It was prespecified to analyze data from Cohort 1 together because both treatments (F/TAF 200/10 mg+boosted 3rd ARV and F/TAF 200/25 mg+unboosted 3rd ARV) were expected to have a similar effect on efficacy and safety for target population. AEs are reported together for both phases as participants continued same medication from main to extension phase.
|
11.1%
1/9 • All-cause mortality: Up to 439 weeks; Adverse events (AEs): Up to 410.4 weeks
All-cause mortality: All Enrolled Analysis Set. AEs: Safety Analysis Set: all participants who had received at least 1 dose of study medication. It was prespecified to analyze data from Cohort 1 together because both treatments (F/TAF 200/10 mg+boosted 3rd ARV and F/TAF 200/25 mg+unboosted 3rd ARV) were expected to have a similar effect on efficacy and safety for target population. AEs are reported together for both phases as participants continued same medication from main to extension phase.
|
0.00%
0/3 • All-cause mortality: Up to 439 weeks; Adverse events (AEs): Up to 410.4 weeks
All-cause mortality: All Enrolled Analysis Set. AEs: Safety Analysis Set: all participants who had received at least 1 dose of study medication. It was prespecified to analyze data from Cohort 1 together because both treatments (F/TAF 200/10 mg+boosted 3rd ARV and F/TAF 200/25 mg+unboosted 3rd ARV) were expected to have a similar effect on efficacy and safety for target population. AEs are reported together for both phases as participants continued same medication from main to extension phase.
|
|
Infections and infestations
Nasopharyngitis
|
46.4%
13/28 • All-cause mortality: Up to 439 weeks; Adverse events (AEs): Up to 410.4 weeks
All-cause mortality: All Enrolled Analysis Set. AEs: Safety Analysis Set: all participants who had received at least 1 dose of study medication. It was prespecified to analyze data from Cohort 1 together because both treatments (F/TAF 200/10 mg+boosted 3rd ARV and F/TAF 200/25 mg+unboosted 3rd ARV) were expected to have a similar effect on efficacy and safety for target population. AEs are reported together for both phases as participants continued same medication from main to extension phase.
|
55.6%
5/9 • All-cause mortality: Up to 439 weeks; Adverse events (AEs): Up to 410.4 weeks
All-cause mortality: All Enrolled Analysis Set. AEs: Safety Analysis Set: all participants who had received at least 1 dose of study medication. It was prespecified to analyze data from Cohort 1 together because both treatments (F/TAF 200/10 mg+boosted 3rd ARV and F/TAF 200/25 mg+unboosted 3rd ARV) were expected to have a similar effect on efficacy and safety for target population. AEs are reported together for both phases as participants continued same medication from main to extension phase.
|
0.00%
0/3 • All-cause mortality: Up to 439 weeks; Adverse events (AEs): Up to 410.4 weeks
All-cause mortality: All Enrolled Analysis Set. AEs: Safety Analysis Set: all participants who had received at least 1 dose of study medication. It was prespecified to analyze data from Cohort 1 together because both treatments (F/TAF 200/10 mg+boosted 3rd ARV and F/TAF 200/25 mg+unboosted 3rd ARV) were expected to have a similar effect on efficacy and safety for target population. AEs are reported together for both phases as participants continued same medication from main to extension phase.
|
|
Infections and infestations
Otitis externa
|
3.6%
1/28 • All-cause mortality: Up to 439 weeks; Adverse events (AEs): Up to 410.4 weeks
All-cause mortality: All Enrolled Analysis Set. AEs: Safety Analysis Set: all participants who had received at least 1 dose of study medication. It was prespecified to analyze data from Cohort 1 together because both treatments (F/TAF 200/10 mg+boosted 3rd ARV and F/TAF 200/25 mg+unboosted 3rd ARV) were expected to have a similar effect on efficacy and safety for target population. AEs are reported together for both phases as participants continued same medication from main to extension phase.
|
11.1%
1/9 • All-cause mortality: Up to 439 weeks; Adverse events (AEs): Up to 410.4 weeks
All-cause mortality: All Enrolled Analysis Set. AEs: Safety Analysis Set: all participants who had received at least 1 dose of study medication. It was prespecified to analyze data from Cohort 1 together because both treatments (F/TAF 200/10 mg+boosted 3rd ARV and F/TAF 200/25 mg+unboosted 3rd ARV) were expected to have a similar effect on efficacy and safety for target population. AEs are reported together for both phases as participants continued same medication from main to extension phase.
|
0.00%
0/3 • All-cause mortality: Up to 439 weeks; Adverse events (AEs): Up to 410.4 weeks
All-cause mortality: All Enrolled Analysis Set. AEs: Safety Analysis Set: all participants who had received at least 1 dose of study medication. It was prespecified to analyze data from Cohort 1 together because both treatments (F/TAF 200/10 mg+boosted 3rd ARV and F/TAF 200/25 mg+unboosted 3rd ARV) were expected to have a similar effect on efficacy and safety for target population. AEs are reported together for both phases as participants continued same medication from main to extension phase.
|
|
Infections and infestations
Otitis media acute
|
7.1%
2/28 • All-cause mortality: Up to 439 weeks; Adverse events (AEs): Up to 410.4 weeks
All-cause mortality: All Enrolled Analysis Set. AEs: Safety Analysis Set: all participants who had received at least 1 dose of study medication. It was prespecified to analyze data from Cohort 1 together because both treatments (F/TAF 200/10 mg+boosted 3rd ARV and F/TAF 200/25 mg+unboosted 3rd ARV) were expected to have a similar effect on efficacy and safety for target population. AEs are reported together for both phases as participants continued same medication from main to extension phase.
|
0.00%
0/9 • All-cause mortality: Up to 439 weeks; Adverse events (AEs): Up to 410.4 weeks
All-cause mortality: All Enrolled Analysis Set. AEs: Safety Analysis Set: all participants who had received at least 1 dose of study medication. It was prespecified to analyze data from Cohort 1 together because both treatments (F/TAF 200/10 mg+boosted 3rd ARV and F/TAF 200/25 mg+unboosted 3rd ARV) were expected to have a similar effect on efficacy and safety for target population. AEs are reported together for both phases as participants continued same medication from main to extension phase.
|
0.00%
0/3 • All-cause mortality: Up to 439 weeks; Adverse events (AEs): Up to 410.4 weeks
All-cause mortality: All Enrolled Analysis Set. AEs: Safety Analysis Set: all participants who had received at least 1 dose of study medication. It was prespecified to analyze data from Cohort 1 together because both treatments (F/TAF 200/10 mg+boosted 3rd ARV and F/TAF 200/25 mg+unboosted 3rd ARV) were expected to have a similar effect on efficacy and safety for target population. AEs are reported together for both phases as participants continued same medication from main to extension phase.
|
|
Infections and infestations
Pharyngitis
|
17.9%
5/28 • All-cause mortality: Up to 439 weeks; Adverse events (AEs): Up to 410.4 weeks
All-cause mortality: All Enrolled Analysis Set. AEs: Safety Analysis Set: all participants who had received at least 1 dose of study medication. It was prespecified to analyze data from Cohort 1 together because both treatments (F/TAF 200/10 mg+boosted 3rd ARV and F/TAF 200/25 mg+unboosted 3rd ARV) were expected to have a similar effect on efficacy and safety for target population. AEs are reported together for both phases as participants continued same medication from main to extension phase.
|
11.1%
1/9 • All-cause mortality: Up to 439 weeks; Adverse events (AEs): Up to 410.4 weeks
All-cause mortality: All Enrolled Analysis Set. AEs: Safety Analysis Set: all participants who had received at least 1 dose of study medication. It was prespecified to analyze data from Cohort 1 together because both treatments (F/TAF 200/10 mg+boosted 3rd ARV and F/TAF 200/25 mg+unboosted 3rd ARV) were expected to have a similar effect on efficacy and safety for target population. AEs are reported together for both phases as participants continued same medication from main to extension phase.
|
33.3%
1/3 • All-cause mortality: Up to 439 weeks; Adverse events (AEs): Up to 410.4 weeks
All-cause mortality: All Enrolled Analysis Set. AEs: Safety Analysis Set: all participants who had received at least 1 dose of study medication. It was prespecified to analyze data from Cohort 1 together because both treatments (F/TAF 200/10 mg+boosted 3rd ARV and F/TAF 200/25 mg+unboosted 3rd ARV) were expected to have a similar effect on efficacy and safety for target population. AEs are reported together for both phases as participants continued same medication from main to extension phase.
|
|
Infections and infestations
Pharyngotonsillitis
|
0.00%
0/28 • All-cause mortality: Up to 439 weeks; Adverse events (AEs): Up to 410.4 weeks
All-cause mortality: All Enrolled Analysis Set. AEs: Safety Analysis Set: all participants who had received at least 1 dose of study medication. It was prespecified to analyze data from Cohort 1 together because both treatments (F/TAF 200/10 mg+boosted 3rd ARV and F/TAF 200/25 mg+unboosted 3rd ARV) were expected to have a similar effect on efficacy and safety for target population. AEs are reported together for both phases as participants continued same medication from main to extension phase.
|
22.2%
2/9 • All-cause mortality: Up to 439 weeks; Adverse events (AEs): Up to 410.4 weeks
All-cause mortality: All Enrolled Analysis Set. AEs: Safety Analysis Set: all participants who had received at least 1 dose of study medication. It was prespecified to analyze data from Cohort 1 together because both treatments (F/TAF 200/10 mg+boosted 3rd ARV and F/TAF 200/25 mg+unboosted 3rd ARV) were expected to have a similar effect on efficacy and safety for target population. AEs are reported together for both phases as participants continued same medication from main to extension phase.
|
0.00%
0/3 • All-cause mortality: Up to 439 weeks; Adverse events (AEs): Up to 410.4 weeks
All-cause mortality: All Enrolled Analysis Set. AEs: Safety Analysis Set: all participants who had received at least 1 dose of study medication. It was prespecified to analyze data from Cohort 1 together because both treatments (F/TAF 200/10 mg+boosted 3rd ARV and F/TAF 200/25 mg+unboosted 3rd ARV) were expected to have a similar effect on efficacy and safety for target population. AEs are reported together for both phases as participants continued same medication from main to extension phase.
|
|
Infections and infestations
Pneumonia
|
7.1%
2/28 • All-cause mortality: Up to 439 weeks; Adverse events (AEs): Up to 410.4 weeks
All-cause mortality: All Enrolled Analysis Set. AEs: Safety Analysis Set: all participants who had received at least 1 dose of study medication. It was prespecified to analyze data from Cohort 1 together because both treatments (F/TAF 200/10 mg+boosted 3rd ARV and F/TAF 200/25 mg+unboosted 3rd ARV) were expected to have a similar effect on efficacy and safety for target population. AEs are reported together for both phases as participants continued same medication from main to extension phase.
|
0.00%
0/9 • All-cause mortality: Up to 439 weeks; Adverse events (AEs): Up to 410.4 weeks
All-cause mortality: All Enrolled Analysis Set. AEs: Safety Analysis Set: all participants who had received at least 1 dose of study medication. It was prespecified to analyze data from Cohort 1 together because both treatments (F/TAF 200/10 mg+boosted 3rd ARV and F/TAF 200/25 mg+unboosted 3rd ARV) were expected to have a similar effect on efficacy and safety for target population. AEs are reported together for both phases as participants continued same medication from main to extension phase.
|
0.00%
0/3 • All-cause mortality: Up to 439 weeks; Adverse events (AEs): Up to 410.4 weeks
All-cause mortality: All Enrolled Analysis Set. AEs: Safety Analysis Set: all participants who had received at least 1 dose of study medication. It was prespecified to analyze data from Cohort 1 together because both treatments (F/TAF 200/10 mg+boosted 3rd ARV and F/TAF 200/25 mg+unboosted 3rd ARV) were expected to have a similar effect on efficacy and safety for target population. AEs are reported together for both phases as participants continued same medication from main to extension phase.
|
|
Infections and infestations
Respiratory tract infection
|
10.7%
3/28 • All-cause mortality: Up to 439 weeks; Adverse events (AEs): Up to 410.4 weeks
All-cause mortality: All Enrolled Analysis Set. AEs: Safety Analysis Set: all participants who had received at least 1 dose of study medication. It was prespecified to analyze data from Cohort 1 together because both treatments (F/TAF 200/10 mg+boosted 3rd ARV and F/TAF 200/25 mg+unboosted 3rd ARV) were expected to have a similar effect on efficacy and safety for target population. AEs are reported together for both phases as participants continued same medication from main to extension phase.
|
0.00%
0/9 • All-cause mortality: Up to 439 weeks; Adverse events (AEs): Up to 410.4 weeks
All-cause mortality: All Enrolled Analysis Set. AEs: Safety Analysis Set: all participants who had received at least 1 dose of study medication. It was prespecified to analyze data from Cohort 1 together because both treatments (F/TAF 200/10 mg+boosted 3rd ARV and F/TAF 200/25 mg+unboosted 3rd ARV) were expected to have a similar effect on efficacy and safety for target population. AEs are reported together for both phases as participants continued same medication from main to extension phase.
|
0.00%
0/3 • All-cause mortality: Up to 439 weeks; Adverse events (AEs): Up to 410.4 weeks
All-cause mortality: All Enrolled Analysis Set. AEs: Safety Analysis Set: all participants who had received at least 1 dose of study medication. It was prespecified to analyze data from Cohort 1 together because both treatments (F/TAF 200/10 mg+boosted 3rd ARV and F/TAF 200/25 mg+unboosted 3rd ARV) were expected to have a similar effect on efficacy and safety for target population. AEs are reported together for both phases as participants continued same medication from main to extension phase.
|
|
Infections and infestations
Sinusitis
|
7.1%
2/28 • All-cause mortality: Up to 439 weeks; Adverse events (AEs): Up to 410.4 weeks
All-cause mortality: All Enrolled Analysis Set. AEs: Safety Analysis Set: all participants who had received at least 1 dose of study medication. It was prespecified to analyze data from Cohort 1 together because both treatments (F/TAF 200/10 mg+boosted 3rd ARV and F/TAF 200/25 mg+unboosted 3rd ARV) were expected to have a similar effect on efficacy and safety for target population. AEs are reported together for both phases as participants continued same medication from main to extension phase.
|
0.00%
0/9 • All-cause mortality: Up to 439 weeks; Adverse events (AEs): Up to 410.4 weeks
All-cause mortality: All Enrolled Analysis Set. AEs: Safety Analysis Set: all participants who had received at least 1 dose of study medication. It was prespecified to analyze data from Cohort 1 together because both treatments (F/TAF 200/10 mg+boosted 3rd ARV and F/TAF 200/25 mg+unboosted 3rd ARV) were expected to have a similar effect on efficacy and safety for target population. AEs are reported together for both phases as participants continued same medication from main to extension phase.
|
0.00%
0/3 • All-cause mortality: Up to 439 weeks; Adverse events (AEs): Up to 410.4 weeks
All-cause mortality: All Enrolled Analysis Set. AEs: Safety Analysis Set: all participants who had received at least 1 dose of study medication. It was prespecified to analyze data from Cohort 1 together because both treatments (F/TAF 200/10 mg+boosted 3rd ARV and F/TAF 200/25 mg+unboosted 3rd ARV) were expected to have a similar effect on efficacy and safety for target population. AEs are reported together for both phases as participants continued same medication from main to extension phase.
|
|
Infections and infestations
Tonsillitis
|
7.1%
2/28 • All-cause mortality: Up to 439 weeks; Adverse events (AEs): Up to 410.4 weeks
All-cause mortality: All Enrolled Analysis Set. AEs: Safety Analysis Set: all participants who had received at least 1 dose of study medication. It was prespecified to analyze data from Cohort 1 together because both treatments (F/TAF 200/10 mg+boosted 3rd ARV and F/TAF 200/25 mg+unboosted 3rd ARV) were expected to have a similar effect on efficacy and safety for target population. AEs are reported together for both phases as participants continued same medication from main to extension phase.
|
0.00%
0/9 • All-cause mortality: Up to 439 weeks; Adverse events (AEs): Up to 410.4 weeks
All-cause mortality: All Enrolled Analysis Set. AEs: Safety Analysis Set: all participants who had received at least 1 dose of study medication. It was prespecified to analyze data from Cohort 1 together because both treatments (F/TAF 200/10 mg+boosted 3rd ARV and F/TAF 200/25 mg+unboosted 3rd ARV) were expected to have a similar effect on efficacy and safety for target population. AEs are reported together for both phases as participants continued same medication from main to extension phase.
|
0.00%
0/3 • All-cause mortality: Up to 439 weeks; Adverse events (AEs): Up to 410.4 weeks
All-cause mortality: All Enrolled Analysis Set. AEs: Safety Analysis Set: all participants who had received at least 1 dose of study medication. It was prespecified to analyze data from Cohort 1 together because both treatments (F/TAF 200/10 mg+boosted 3rd ARV and F/TAF 200/25 mg+unboosted 3rd ARV) were expected to have a similar effect on efficacy and safety for target population. AEs are reported together for both phases as participants continued same medication from main to extension phase.
|
|
Infections and infestations
Tooth abscess
|
10.7%
3/28 • All-cause mortality: Up to 439 weeks; Adverse events (AEs): Up to 410.4 weeks
All-cause mortality: All Enrolled Analysis Set. AEs: Safety Analysis Set: all participants who had received at least 1 dose of study medication. It was prespecified to analyze data from Cohort 1 together because both treatments (F/TAF 200/10 mg+boosted 3rd ARV and F/TAF 200/25 mg+unboosted 3rd ARV) were expected to have a similar effect on efficacy and safety for target population. AEs are reported together for both phases as participants continued same medication from main to extension phase.
|
0.00%
0/9 • All-cause mortality: Up to 439 weeks; Adverse events (AEs): Up to 410.4 weeks
All-cause mortality: All Enrolled Analysis Set. AEs: Safety Analysis Set: all participants who had received at least 1 dose of study medication. It was prespecified to analyze data from Cohort 1 together because both treatments (F/TAF 200/10 mg+boosted 3rd ARV and F/TAF 200/25 mg+unboosted 3rd ARV) were expected to have a similar effect on efficacy and safety for target population. AEs are reported together for both phases as participants continued same medication from main to extension phase.
|
0.00%
0/3 • All-cause mortality: Up to 439 weeks; Adverse events (AEs): Up to 410.4 weeks
All-cause mortality: All Enrolled Analysis Set. AEs: Safety Analysis Set: all participants who had received at least 1 dose of study medication. It was prespecified to analyze data from Cohort 1 together because both treatments (F/TAF 200/10 mg+boosted 3rd ARV and F/TAF 200/25 mg+unboosted 3rd ARV) were expected to have a similar effect on efficacy and safety for target population. AEs are reported together for both phases as participants continued same medication from main to extension phase.
|
|
Infections and infestations
Upper respiratory tract infection
|
25.0%
7/28 • All-cause mortality: Up to 439 weeks; Adverse events (AEs): Up to 410.4 weeks
All-cause mortality: All Enrolled Analysis Set. AEs: Safety Analysis Set: all participants who had received at least 1 dose of study medication. It was prespecified to analyze data from Cohort 1 together because both treatments (F/TAF 200/10 mg+boosted 3rd ARV and F/TAF 200/25 mg+unboosted 3rd ARV) were expected to have a similar effect on efficacy and safety for target population. AEs are reported together for both phases as participants continued same medication from main to extension phase.
|
0.00%
0/9 • All-cause mortality: Up to 439 weeks; Adverse events (AEs): Up to 410.4 weeks
All-cause mortality: All Enrolled Analysis Set. AEs: Safety Analysis Set: all participants who had received at least 1 dose of study medication. It was prespecified to analyze data from Cohort 1 together because both treatments (F/TAF 200/10 mg+boosted 3rd ARV and F/TAF 200/25 mg+unboosted 3rd ARV) were expected to have a similar effect on efficacy and safety for target population. AEs are reported together for both phases as participants continued same medication from main to extension phase.
|
0.00%
0/3 • All-cause mortality: Up to 439 weeks; Adverse events (AEs): Up to 410.4 weeks
All-cause mortality: All Enrolled Analysis Set. AEs: Safety Analysis Set: all participants who had received at least 1 dose of study medication. It was prespecified to analyze data from Cohort 1 together because both treatments (F/TAF 200/10 mg+boosted 3rd ARV and F/TAF 200/25 mg+unboosted 3rd ARV) were expected to have a similar effect on efficacy and safety for target population. AEs are reported together for both phases as participants continued same medication from main to extension phase.
|
|
Infections and infestations
Urinary tract infection
|
7.1%
2/28 • All-cause mortality: Up to 439 weeks; Adverse events (AEs): Up to 410.4 weeks
All-cause mortality: All Enrolled Analysis Set. AEs: Safety Analysis Set: all participants who had received at least 1 dose of study medication. It was prespecified to analyze data from Cohort 1 together because both treatments (F/TAF 200/10 mg+boosted 3rd ARV and F/TAF 200/25 mg+unboosted 3rd ARV) were expected to have a similar effect on efficacy and safety for target population. AEs are reported together for both phases as participants continued same medication from main to extension phase.
|
0.00%
0/9 • All-cause mortality: Up to 439 weeks; Adverse events (AEs): Up to 410.4 weeks
All-cause mortality: All Enrolled Analysis Set. AEs: Safety Analysis Set: all participants who had received at least 1 dose of study medication. It was prespecified to analyze data from Cohort 1 together because both treatments (F/TAF 200/10 mg+boosted 3rd ARV and F/TAF 200/25 mg+unboosted 3rd ARV) were expected to have a similar effect on efficacy and safety for target population. AEs are reported together for both phases as participants continued same medication from main to extension phase.
|
0.00%
0/3 • All-cause mortality: Up to 439 weeks; Adverse events (AEs): Up to 410.4 weeks
All-cause mortality: All Enrolled Analysis Set. AEs: Safety Analysis Set: all participants who had received at least 1 dose of study medication. It was prespecified to analyze data from Cohort 1 together because both treatments (F/TAF 200/10 mg+boosted 3rd ARV and F/TAF 200/25 mg+unboosted 3rd ARV) were expected to have a similar effect on efficacy and safety for target population. AEs are reported together for both phases as participants continued same medication from main to extension phase.
|
|
Infections and infestations
Viral upper respiratory tract infection
|
7.1%
2/28 • All-cause mortality: Up to 439 weeks; Adverse events (AEs): Up to 410.4 weeks
All-cause mortality: All Enrolled Analysis Set. AEs: Safety Analysis Set: all participants who had received at least 1 dose of study medication. It was prespecified to analyze data from Cohort 1 together because both treatments (F/TAF 200/10 mg+boosted 3rd ARV and F/TAF 200/25 mg+unboosted 3rd ARV) were expected to have a similar effect on efficacy and safety for target population. AEs are reported together for both phases as participants continued same medication from main to extension phase.
|
0.00%
0/9 • All-cause mortality: Up to 439 weeks; Adverse events (AEs): Up to 410.4 weeks
All-cause mortality: All Enrolled Analysis Set. AEs: Safety Analysis Set: all participants who had received at least 1 dose of study medication. It was prespecified to analyze data from Cohort 1 together because both treatments (F/TAF 200/10 mg+boosted 3rd ARV and F/TAF 200/25 mg+unboosted 3rd ARV) were expected to have a similar effect on efficacy and safety for target population. AEs are reported together for both phases as participants continued same medication from main to extension phase.
|
66.7%
2/3 • All-cause mortality: Up to 439 weeks; Adverse events (AEs): Up to 410.4 weeks
All-cause mortality: All Enrolled Analysis Set. AEs: Safety Analysis Set: all participants who had received at least 1 dose of study medication. It was prespecified to analyze data from Cohort 1 together because both treatments (F/TAF 200/10 mg+boosted 3rd ARV and F/TAF 200/25 mg+unboosted 3rd ARV) were expected to have a similar effect on efficacy and safety for target population. AEs are reported together for both phases as participants continued same medication from main to extension phase.
|
|
Infections and infestations
Vulvovaginal mycotic infection
|
7.1%
2/28 • All-cause mortality: Up to 439 weeks; Adverse events (AEs): Up to 410.4 weeks
All-cause mortality: All Enrolled Analysis Set. AEs: Safety Analysis Set: all participants who had received at least 1 dose of study medication. It was prespecified to analyze data from Cohort 1 together because both treatments (F/TAF 200/10 mg+boosted 3rd ARV and F/TAF 200/25 mg+unboosted 3rd ARV) were expected to have a similar effect on efficacy and safety for target population. AEs are reported together for both phases as participants continued same medication from main to extension phase.
|
0.00%
0/9 • All-cause mortality: Up to 439 weeks; Adverse events (AEs): Up to 410.4 weeks
All-cause mortality: All Enrolled Analysis Set. AEs: Safety Analysis Set: all participants who had received at least 1 dose of study medication. It was prespecified to analyze data from Cohort 1 together because both treatments (F/TAF 200/10 mg+boosted 3rd ARV and F/TAF 200/25 mg+unboosted 3rd ARV) were expected to have a similar effect on efficacy and safety for target population. AEs are reported together for both phases as participants continued same medication from main to extension phase.
|
0.00%
0/3 • All-cause mortality: Up to 439 weeks; Adverse events (AEs): Up to 410.4 weeks
All-cause mortality: All Enrolled Analysis Set. AEs: Safety Analysis Set: all participants who had received at least 1 dose of study medication. It was prespecified to analyze data from Cohort 1 together because both treatments (F/TAF 200/10 mg+boosted 3rd ARV and F/TAF 200/25 mg+unboosted 3rd ARV) were expected to have a similar effect on efficacy and safety for target population. AEs are reported together for both phases as participants continued same medication from main to extension phase.
|
|
Injury, poisoning and procedural complications
Animal bite
|
7.1%
2/28 • All-cause mortality: Up to 439 weeks; Adverse events (AEs): Up to 410.4 weeks
All-cause mortality: All Enrolled Analysis Set. AEs: Safety Analysis Set: all participants who had received at least 1 dose of study medication. It was prespecified to analyze data from Cohort 1 together because both treatments (F/TAF 200/10 mg+boosted 3rd ARV and F/TAF 200/25 mg+unboosted 3rd ARV) were expected to have a similar effect on efficacy and safety for target population. AEs are reported together for both phases as participants continued same medication from main to extension phase.
|
0.00%
0/9 • All-cause mortality: Up to 439 weeks; Adverse events (AEs): Up to 410.4 weeks
All-cause mortality: All Enrolled Analysis Set. AEs: Safety Analysis Set: all participants who had received at least 1 dose of study medication. It was prespecified to analyze data from Cohort 1 together because both treatments (F/TAF 200/10 mg+boosted 3rd ARV and F/TAF 200/25 mg+unboosted 3rd ARV) were expected to have a similar effect on efficacy and safety for target population. AEs are reported together for both phases as participants continued same medication from main to extension phase.
|
0.00%
0/3 • All-cause mortality: Up to 439 weeks; Adverse events (AEs): Up to 410.4 weeks
All-cause mortality: All Enrolled Analysis Set. AEs: Safety Analysis Set: all participants who had received at least 1 dose of study medication. It was prespecified to analyze data from Cohort 1 together because both treatments (F/TAF 200/10 mg+boosted 3rd ARV and F/TAF 200/25 mg+unboosted 3rd ARV) were expected to have a similar effect on efficacy and safety for target population. AEs are reported together for both phases as participants continued same medication from main to extension phase.
|
|
Injury, poisoning and procedural complications
Contusion
|
10.7%
3/28 • All-cause mortality: Up to 439 weeks; Adverse events (AEs): Up to 410.4 weeks
All-cause mortality: All Enrolled Analysis Set. AEs: Safety Analysis Set: all participants who had received at least 1 dose of study medication. It was prespecified to analyze data from Cohort 1 together because both treatments (F/TAF 200/10 mg+boosted 3rd ARV and F/TAF 200/25 mg+unboosted 3rd ARV) were expected to have a similar effect on efficacy and safety for target population. AEs are reported together for both phases as participants continued same medication from main to extension phase.
|
0.00%
0/9 • All-cause mortality: Up to 439 weeks; Adverse events (AEs): Up to 410.4 weeks
All-cause mortality: All Enrolled Analysis Set. AEs: Safety Analysis Set: all participants who had received at least 1 dose of study medication. It was prespecified to analyze data from Cohort 1 together because both treatments (F/TAF 200/10 mg+boosted 3rd ARV and F/TAF 200/25 mg+unboosted 3rd ARV) were expected to have a similar effect on efficacy and safety for target population. AEs are reported together for both phases as participants continued same medication from main to extension phase.
|
0.00%
0/3 • All-cause mortality: Up to 439 weeks; Adverse events (AEs): Up to 410.4 weeks
All-cause mortality: All Enrolled Analysis Set. AEs: Safety Analysis Set: all participants who had received at least 1 dose of study medication. It was prespecified to analyze data from Cohort 1 together because both treatments (F/TAF 200/10 mg+boosted 3rd ARV and F/TAF 200/25 mg+unboosted 3rd ARV) were expected to have a similar effect on efficacy and safety for target population. AEs are reported together for both phases as participants continued same medication from main to extension phase.
|
|
Injury, poisoning and procedural complications
Heat stroke
|
0.00%
0/28 • All-cause mortality: Up to 439 weeks; Adverse events (AEs): Up to 410.4 weeks
All-cause mortality: All Enrolled Analysis Set. AEs: Safety Analysis Set: all participants who had received at least 1 dose of study medication. It was prespecified to analyze data from Cohort 1 together because both treatments (F/TAF 200/10 mg+boosted 3rd ARV and F/TAF 200/25 mg+unboosted 3rd ARV) were expected to have a similar effect on efficacy and safety for target population. AEs are reported together for both phases as participants continued same medication from main to extension phase.
|
11.1%
1/9 • All-cause mortality: Up to 439 weeks; Adverse events (AEs): Up to 410.4 weeks
All-cause mortality: All Enrolled Analysis Set. AEs: Safety Analysis Set: all participants who had received at least 1 dose of study medication. It was prespecified to analyze data from Cohort 1 together because both treatments (F/TAF 200/10 mg+boosted 3rd ARV and F/TAF 200/25 mg+unboosted 3rd ARV) were expected to have a similar effect on efficacy and safety for target population. AEs are reported together for both phases as participants continued same medication from main to extension phase.
|
0.00%
0/3 • All-cause mortality: Up to 439 weeks; Adverse events (AEs): Up to 410.4 weeks
All-cause mortality: All Enrolled Analysis Set. AEs: Safety Analysis Set: all participants who had received at least 1 dose of study medication. It was prespecified to analyze data from Cohort 1 together because both treatments (F/TAF 200/10 mg+boosted 3rd ARV and F/TAF 200/25 mg+unboosted 3rd ARV) were expected to have a similar effect on efficacy and safety for target population. AEs are reported together for both phases as participants continued same medication from main to extension phase.
|
|
Injury, poisoning and procedural complications
Muscle strain
|
3.6%
1/28 • All-cause mortality: Up to 439 weeks; Adverse events (AEs): Up to 410.4 weeks
All-cause mortality: All Enrolled Analysis Set. AEs: Safety Analysis Set: all participants who had received at least 1 dose of study medication. It was prespecified to analyze data from Cohort 1 together because both treatments (F/TAF 200/10 mg+boosted 3rd ARV and F/TAF 200/25 mg+unboosted 3rd ARV) were expected to have a similar effect on efficacy and safety for target population. AEs are reported together for both phases as participants continued same medication from main to extension phase.
|
11.1%
1/9 • All-cause mortality: Up to 439 weeks; Adverse events (AEs): Up to 410.4 weeks
All-cause mortality: All Enrolled Analysis Set. AEs: Safety Analysis Set: all participants who had received at least 1 dose of study medication. It was prespecified to analyze data from Cohort 1 together because both treatments (F/TAF 200/10 mg+boosted 3rd ARV and F/TAF 200/25 mg+unboosted 3rd ARV) were expected to have a similar effect on efficacy and safety for target population. AEs are reported together for both phases as participants continued same medication from main to extension phase.
|
0.00%
0/3 • All-cause mortality: Up to 439 weeks; Adverse events (AEs): Up to 410.4 weeks
All-cause mortality: All Enrolled Analysis Set. AEs: Safety Analysis Set: all participants who had received at least 1 dose of study medication. It was prespecified to analyze data from Cohort 1 together because both treatments (F/TAF 200/10 mg+boosted 3rd ARV and F/TAF 200/25 mg+unboosted 3rd ARV) were expected to have a similar effect on efficacy and safety for target population. AEs are reported together for both phases as participants continued same medication from main to extension phase.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
7.1%
2/28 • All-cause mortality: Up to 439 weeks; Adverse events (AEs): Up to 410.4 weeks
All-cause mortality: All Enrolled Analysis Set. AEs: Safety Analysis Set: all participants who had received at least 1 dose of study medication. It was prespecified to analyze data from Cohort 1 together because both treatments (F/TAF 200/10 mg+boosted 3rd ARV and F/TAF 200/25 mg+unboosted 3rd ARV) were expected to have a similar effect on efficacy and safety for target population. AEs are reported together for both phases as participants continued same medication from main to extension phase.
|
0.00%
0/9 • All-cause mortality: Up to 439 weeks; Adverse events (AEs): Up to 410.4 weeks
All-cause mortality: All Enrolled Analysis Set. AEs: Safety Analysis Set: all participants who had received at least 1 dose of study medication. It was prespecified to analyze data from Cohort 1 together because both treatments (F/TAF 200/10 mg+boosted 3rd ARV and F/TAF 200/25 mg+unboosted 3rd ARV) were expected to have a similar effect on efficacy and safety for target population. AEs are reported together for both phases as participants continued same medication from main to extension phase.
|
0.00%
0/3 • All-cause mortality: Up to 439 weeks; Adverse events (AEs): Up to 410.4 weeks
All-cause mortality: All Enrolled Analysis Set. AEs: Safety Analysis Set: all participants who had received at least 1 dose of study medication. It was prespecified to analyze data from Cohort 1 together because both treatments (F/TAF 200/10 mg+boosted 3rd ARV and F/TAF 200/25 mg+unboosted 3rd ARV) were expected to have a similar effect on efficacy and safety for target population. AEs are reported together for both phases as participants continued same medication from main to extension phase.
|
|
Injury, poisoning and procedural complications
Seroma
|
0.00%
0/28 • All-cause mortality: Up to 439 weeks; Adverse events (AEs): Up to 410.4 weeks
All-cause mortality: All Enrolled Analysis Set. AEs: Safety Analysis Set: all participants who had received at least 1 dose of study medication. It was prespecified to analyze data from Cohort 1 together because both treatments (F/TAF 200/10 mg+boosted 3rd ARV and F/TAF 200/25 mg+unboosted 3rd ARV) were expected to have a similar effect on efficacy and safety for target population. AEs are reported together for both phases as participants continued same medication from main to extension phase.
|
11.1%
1/9 • All-cause mortality: Up to 439 weeks; Adverse events (AEs): Up to 410.4 weeks
All-cause mortality: All Enrolled Analysis Set. AEs: Safety Analysis Set: all participants who had received at least 1 dose of study medication. It was prespecified to analyze data from Cohort 1 together because both treatments (F/TAF 200/10 mg+boosted 3rd ARV and F/TAF 200/25 mg+unboosted 3rd ARV) were expected to have a similar effect on efficacy and safety for target population. AEs are reported together for both phases as participants continued same medication from main to extension phase.
|
0.00%
0/3 • All-cause mortality: Up to 439 weeks; Adverse events (AEs): Up to 410.4 weeks
All-cause mortality: All Enrolled Analysis Set. AEs: Safety Analysis Set: all participants who had received at least 1 dose of study medication. It was prespecified to analyze data from Cohort 1 together because both treatments (F/TAF 200/10 mg+boosted 3rd ARV and F/TAF 200/25 mg+unboosted 3rd ARV) were expected to have a similar effect on efficacy and safety for target population. AEs are reported together for both phases as participants continued same medication from main to extension phase.
|
|
Injury, poisoning and procedural complications
Skin laceration
|
3.6%
1/28 • All-cause mortality: Up to 439 weeks; Adverse events (AEs): Up to 410.4 weeks
All-cause mortality: All Enrolled Analysis Set. AEs: Safety Analysis Set: all participants who had received at least 1 dose of study medication. It was prespecified to analyze data from Cohort 1 together because both treatments (F/TAF 200/10 mg+boosted 3rd ARV and F/TAF 200/25 mg+unboosted 3rd ARV) were expected to have a similar effect on efficacy and safety for target population. AEs are reported together for both phases as participants continued same medication from main to extension phase.
|
0.00%
0/9 • All-cause mortality: Up to 439 weeks; Adverse events (AEs): Up to 410.4 weeks
All-cause mortality: All Enrolled Analysis Set. AEs: Safety Analysis Set: all participants who had received at least 1 dose of study medication. It was prespecified to analyze data from Cohort 1 together because both treatments (F/TAF 200/10 mg+boosted 3rd ARV and F/TAF 200/25 mg+unboosted 3rd ARV) were expected to have a similar effect on efficacy and safety for target population. AEs are reported together for both phases as participants continued same medication from main to extension phase.
|
33.3%
1/3 • All-cause mortality: Up to 439 weeks; Adverse events (AEs): Up to 410.4 weeks
All-cause mortality: All Enrolled Analysis Set. AEs: Safety Analysis Set: all participants who had received at least 1 dose of study medication. It was prespecified to analyze data from Cohort 1 together because both treatments (F/TAF 200/10 mg+boosted 3rd ARV and F/TAF 200/25 mg+unboosted 3rd ARV) were expected to have a similar effect on efficacy and safety for target population. AEs are reported together for both phases as participants continued same medication from main to extension phase.
|
|
Investigations
Blood creatine phosphokinase increased
|
3.6%
1/28 • All-cause mortality: Up to 439 weeks; Adverse events (AEs): Up to 410.4 weeks
All-cause mortality: All Enrolled Analysis Set. AEs: Safety Analysis Set: all participants who had received at least 1 dose of study medication. It was prespecified to analyze data from Cohort 1 together because both treatments (F/TAF 200/10 mg+boosted 3rd ARV and F/TAF 200/25 mg+unboosted 3rd ARV) were expected to have a similar effect on efficacy and safety for target population. AEs are reported together for both phases as participants continued same medication from main to extension phase.
|
11.1%
1/9 • All-cause mortality: Up to 439 weeks; Adverse events (AEs): Up to 410.4 weeks
All-cause mortality: All Enrolled Analysis Set. AEs: Safety Analysis Set: all participants who had received at least 1 dose of study medication. It was prespecified to analyze data from Cohort 1 together because both treatments (F/TAF 200/10 mg+boosted 3rd ARV and F/TAF 200/25 mg+unboosted 3rd ARV) were expected to have a similar effect on efficacy and safety for target population. AEs are reported together for both phases as participants continued same medication from main to extension phase.
|
0.00%
0/3 • All-cause mortality: Up to 439 weeks; Adverse events (AEs): Up to 410.4 weeks
All-cause mortality: All Enrolled Analysis Set. AEs: Safety Analysis Set: all participants who had received at least 1 dose of study medication. It was prespecified to analyze data from Cohort 1 together because both treatments (F/TAF 200/10 mg+boosted 3rd ARV and F/TAF 200/25 mg+unboosted 3rd ARV) were expected to have a similar effect on efficacy and safety for target population. AEs are reported together for both phases as participants continued same medication from main to extension phase.
|
|
Investigations
Vitamin D decreased
|
0.00%
0/28 • All-cause mortality: Up to 439 weeks; Adverse events (AEs): Up to 410.4 weeks
All-cause mortality: All Enrolled Analysis Set. AEs: Safety Analysis Set: all participants who had received at least 1 dose of study medication. It was prespecified to analyze data from Cohort 1 together because both treatments (F/TAF 200/10 mg+boosted 3rd ARV and F/TAF 200/25 mg+unboosted 3rd ARV) were expected to have a similar effect on efficacy and safety for target population. AEs are reported together for both phases as participants continued same medication from main to extension phase.
|
11.1%
1/9 • All-cause mortality: Up to 439 weeks; Adverse events (AEs): Up to 410.4 weeks
All-cause mortality: All Enrolled Analysis Set. AEs: Safety Analysis Set: all participants who had received at least 1 dose of study medication. It was prespecified to analyze data from Cohort 1 together because both treatments (F/TAF 200/10 mg+boosted 3rd ARV and F/TAF 200/25 mg+unboosted 3rd ARV) were expected to have a similar effect on efficacy and safety for target population. AEs are reported together for both phases as participants continued same medication from main to extension phase.
|
0.00%
0/3 • All-cause mortality: Up to 439 weeks; Adverse events (AEs): Up to 410.4 weeks
All-cause mortality: All Enrolled Analysis Set. AEs: Safety Analysis Set: all participants who had received at least 1 dose of study medication. It was prespecified to analyze data from Cohort 1 together because both treatments (F/TAF 200/10 mg+boosted 3rd ARV and F/TAF 200/25 mg+unboosted 3rd ARV) were expected to have a similar effect on efficacy and safety for target population. AEs are reported together for both phases as participants continued same medication from main to extension phase.
|
|
Investigations
Weight decreased
|
17.9%
5/28 • All-cause mortality: Up to 439 weeks; Adverse events (AEs): Up to 410.4 weeks
All-cause mortality: All Enrolled Analysis Set. AEs: Safety Analysis Set: all participants who had received at least 1 dose of study medication. It was prespecified to analyze data from Cohort 1 together because both treatments (F/TAF 200/10 mg+boosted 3rd ARV and F/TAF 200/25 mg+unboosted 3rd ARV) were expected to have a similar effect on efficacy and safety for target population. AEs are reported together for both phases as participants continued same medication from main to extension phase.
|
0.00%
0/9 • All-cause mortality: Up to 439 weeks; Adverse events (AEs): Up to 410.4 weeks
All-cause mortality: All Enrolled Analysis Set. AEs: Safety Analysis Set: all participants who had received at least 1 dose of study medication. It was prespecified to analyze data from Cohort 1 together because both treatments (F/TAF 200/10 mg+boosted 3rd ARV and F/TAF 200/25 mg+unboosted 3rd ARV) were expected to have a similar effect on efficacy and safety for target population. AEs are reported together for both phases as participants continued same medication from main to extension phase.
|
0.00%
0/3 • All-cause mortality: Up to 439 weeks; Adverse events (AEs): Up to 410.4 weeks
All-cause mortality: All Enrolled Analysis Set. AEs: Safety Analysis Set: all participants who had received at least 1 dose of study medication. It was prespecified to analyze data from Cohort 1 together because both treatments (F/TAF 200/10 mg+boosted 3rd ARV and F/TAF 200/25 mg+unboosted 3rd ARV) were expected to have a similar effect on efficacy and safety for target population. AEs are reported together for both phases as participants continued same medication from main to extension phase.
|
|
Metabolism and nutrition disorders
Vitamin D deficiency
|
25.0%
7/28 • All-cause mortality: Up to 439 weeks; Adverse events (AEs): Up to 410.4 weeks
All-cause mortality: All Enrolled Analysis Set. AEs: Safety Analysis Set: all participants who had received at least 1 dose of study medication. It was prespecified to analyze data from Cohort 1 together because both treatments (F/TAF 200/10 mg+boosted 3rd ARV and F/TAF 200/25 mg+unboosted 3rd ARV) were expected to have a similar effect on efficacy and safety for target population. AEs are reported together for both phases as participants continued same medication from main to extension phase.
|
0.00%
0/9 • All-cause mortality: Up to 439 weeks; Adverse events (AEs): Up to 410.4 weeks
All-cause mortality: All Enrolled Analysis Set. AEs: Safety Analysis Set: all participants who had received at least 1 dose of study medication. It was prespecified to analyze data from Cohort 1 together because both treatments (F/TAF 200/10 mg+boosted 3rd ARV and F/TAF 200/25 mg+unboosted 3rd ARV) were expected to have a similar effect on efficacy and safety for target population. AEs are reported together for both phases as participants continued same medication from main to extension phase.
|
0.00%
0/3 • All-cause mortality: Up to 439 weeks; Adverse events (AEs): Up to 410.4 weeks
All-cause mortality: All Enrolled Analysis Set. AEs: Safety Analysis Set: all participants who had received at least 1 dose of study medication. It was prespecified to analyze data from Cohort 1 together because both treatments (F/TAF 200/10 mg+boosted 3rd ARV and F/TAF 200/25 mg+unboosted 3rd ARV) were expected to have a similar effect on efficacy and safety for target population. AEs are reported together for both phases as participants continued same medication from main to extension phase.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
7.1%
2/28 • All-cause mortality: Up to 439 weeks; Adverse events (AEs): Up to 410.4 weeks
All-cause mortality: All Enrolled Analysis Set. AEs: Safety Analysis Set: all participants who had received at least 1 dose of study medication. It was prespecified to analyze data from Cohort 1 together because both treatments (F/TAF 200/10 mg+boosted 3rd ARV and F/TAF 200/25 mg+unboosted 3rd ARV) were expected to have a similar effect on efficacy and safety for target population. AEs are reported together for both phases as participants continued same medication from main to extension phase.
|
0.00%
0/9 • All-cause mortality: Up to 439 weeks; Adverse events (AEs): Up to 410.4 weeks
All-cause mortality: All Enrolled Analysis Set. AEs: Safety Analysis Set: all participants who had received at least 1 dose of study medication. It was prespecified to analyze data from Cohort 1 together because both treatments (F/TAF 200/10 mg+boosted 3rd ARV and F/TAF 200/25 mg+unboosted 3rd ARV) were expected to have a similar effect on efficacy and safety for target population. AEs are reported together for both phases as participants continued same medication from main to extension phase.
|
0.00%
0/3 • All-cause mortality: Up to 439 weeks; Adverse events (AEs): Up to 410.4 weeks
All-cause mortality: All Enrolled Analysis Set. AEs: Safety Analysis Set: all participants who had received at least 1 dose of study medication. It was prespecified to analyze data from Cohort 1 together because both treatments (F/TAF 200/10 mg+boosted 3rd ARV and F/TAF 200/25 mg+unboosted 3rd ARV) were expected to have a similar effect on efficacy and safety for target population. AEs are reported together for both phases as participants continued same medication from main to extension phase.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
7.1%
2/28 • All-cause mortality: Up to 439 weeks; Adverse events (AEs): Up to 410.4 weeks
All-cause mortality: All Enrolled Analysis Set. AEs: Safety Analysis Set: all participants who had received at least 1 dose of study medication. It was prespecified to analyze data from Cohort 1 together because both treatments (F/TAF 200/10 mg+boosted 3rd ARV and F/TAF 200/25 mg+unboosted 3rd ARV) were expected to have a similar effect on efficacy and safety for target population. AEs are reported together for both phases as participants continued same medication from main to extension phase.
|
0.00%
0/9 • All-cause mortality: Up to 439 weeks; Adverse events (AEs): Up to 410.4 weeks
All-cause mortality: All Enrolled Analysis Set. AEs: Safety Analysis Set: all participants who had received at least 1 dose of study medication. It was prespecified to analyze data from Cohort 1 together because both treatments (F/TAF 200/10 mg+boosted 3rd ARV and F/TAF 200/25 mg+unboosted 3rd ARV) were expected to have a similar effect on efficacy and safety for target population. AEs are reported together for both phases as participants continued same medication from main to extension phase.
|
0.00%
0/3 • All-cause mortality: Up to 439 weeks; Adverse events (AEs): Up to 410.4 weeks
All-cause mortality: All Enrolled Analysis Set. AEs: Safety Analysis Set: all participants who had received at least 1 dose of study medication. It was prespecified to analyze data from Cohort 1 together because both treatments (F/TAF 200/10 mg+boosted 3rd ARV and F/TAF 200/25 mg+unboosted 3rd ARV) were expected to have a similar effect on efficacy and safety for target population. AEs are reported together for both phases as participants continued same medication from main to extension phase.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
7.1%
2/28 • All-cause mortality: Up to 439 weeks; Adverse events (AEs): Up to 410.4 weeks
All-cause mortality: All Enrolled Analysis Set. AEs: Safety Analysis Set: all participants who had received at least 1 dose of study medication. It was prespecified to analyze data from Cohort 1 together because both treatments (F/TAF 200/10 mg+boosted 3rd ARV and F/TAF 200/25 mg+unboosted 3rd ARV) were expected to have a similar effect on efficacy and safety for target population. AEs are reported together for both phases as participants continued same medication from main to extension phase.
|
11.1%
1/9 • All-cause mortality: Up to 439 weeks; Adverse events (AEs): Up to 410.4 weeks
All-cause mortality: All Enrolled Analysis Set. AEs: Safety Analysis Set: all participants who had received at least 1 dose of study medication. It was prespecified to analyze data from Cohort 1 together because both treatments (F/TAF 200/10 mg+boosted 3rd ARV and F/TAF 200/25 mg+unboosted 3rd ARV) were expected to have a similar effect on efficacy and safety for target population. AEs are reported together for both phases as participants continued same medication from main to extension phase.
|
0.00%
0/3 • All-cause mortality: Up to 439 weeks; Adverse events (AEs): Up to 410.4 weeks
All-cause mortality: All Enrolled Analysis Set. AEs: Safety Analysis Set: all participants who had received at least 1 dose of study medication. It was prespecified to analyze data from Cohort 1 together because both treatments (F/TAF 200/10 mg+boosted 3rd ARV and F/TAF 200/25 mg+unboosted 3rd ARV) were expected to have a similar effect on efficacy and safety for target population. AEs are reported together for both phases as participants continued same medication from main to extension phase.
|
|
Nervous system disorders
Dizziness
|
21.4%
6/28 • All-cause mortality: Up to 439 weeks; Adverse events (AEs): Up to 410.4 weeks
All-cause mortality: All Enrolled Analysis Set. AEs: Safety Analysis Set: all participants who had received at least 1 dose of study medication. It was prespecified to analyze data from Cohort 1 together because both treatments (F/TAF 200/10 mg+boosted 3rd ARV and F/TAF 200/25 mg+unboosted 3rd ARV) were expected to have a similar effect on efficacy and safety for target population. AEs are reported together for both phases as participants continued same medication from main to extension phase.
|
0.00%
0/9 • All-cause mortality: Up to 439 weeks; Adverse events (AEs): Up to 410.4 weeks
All-cause mortality: All Enrolled Analysis Set. AEs: Safety Analysis Set: all participants who had received at least 1 dose of study medication. It was prespecified to analyze data from Cohort 1 together because both treatments (F/TAF 200/10 mg+boosted 3rd ARV and F/TAF 200/25 mg+unboosted 3rd ARV) were expected to have a similar effect on efficacy and safety for target population. AEs are reported together for both phases as participants continued same medication from main to extension phase.
|
0.00%
0/3 • All-cause mortality: Up to 439 weeks; Adverse events (AEs): Up to 410.4 weeks
All-cause mortality: All Enrolled Analysis Set. AEs: Safety Analysis Set: all participants who had received at least 1 dose of study medication. It was prespecified to analyze data from Cohort 1 together because both treatments (F/TAF 200/10 mg+boosted 3rd ARV and F/TAF 200/25 mg+unboosted 3rd ARV) were expected to have a similar effect on efficacy and safety for target population. AEs are reported together for both phases as participants continued same medication from main to extension phase.
|
|
Nervous system disorders
Headache
|
46.4%
13/28 • All-cause mortality: Up to 439 weeks; Adverse events (AEs): Up to 410.4 weeks
All-cause mortality: All Enrolled Analysis Set. AEs: Safety Analysis Set: all participants who had received at least 1 dose of study medication. It was prespecified to analyze data from Cohort 1 together because both treatments (F/TAF 200/10 mg+boosted 3rd ARV and F/TAF 200/25 mg+unboosted 3rd ARV) were expected to have a similar effect on efficacy and safety for target population. AEs are reported together for both phases as participants continued same medication from main to extension phase.
|
0.00%
0/9 • All-cause mortality: Up to 439 weeks; Adverse events (AEs): Up to 410.4 weeks
All-cause mortality: All Enrolled Analysis Set. AEs: Safety Analysis Set: all participants who had received at least 1 dose of study medication. It was prespecified to analyze data from Cohort 1 together because both treatments (F/TAF 200/10 mg+boosted 3rd ARV and F/TAF 200/25 mg+unboosted 3rd ARV) were expected to have a similar effect on efficacy and safety for target population. AEs are reported together for both phases as participants continued same medication from main to extension phase.
|
0.00%
0/3 • All-cause mortality: Up to 439 weeks; Adverse events (AEs): Up to 410.4 weeks
All-cause mortality: All Enrolled Analysis Set. AEs: Safety Analysis Set: all participants who had received at least 1 dose of study medication. It was prespecified to analyze data from Cohort 1 together because both treatments (F/TAF 200/10 mg+boosted 3rd ARV and F/TAF 200/25 mg+unboosted 3rd ARV) were expected to have a similar effect on efficacy and safety for target population. AEs are reported together for both phases as participants continued same medication from main to extension phase.
|
|
Nervous system disorders
Syncope
|
3.6%
1/28 • All-cause mortality: Up to 439 weeks; Adverse events (AEs): Up to 410.4 weeks
All-cause mortality: All Enrolled Analysis Set. AEs: Safety Analysis Set: all participants who had received at least 1 dose of study medication. It was prespecified to analyze data from Cohort 1 together because both treatments (F/TAF 200/10 mg+boosted 3rd ARV and F/TAF 200/25 mg+unboosted 3rd ARV) were expected to have a similar effect on efficacy and safety for target population. AEs are reported together for both phases as participants continued same medication from main to extension phase.
|
0.00%
0/9 • All-cause mortality: Up to 439 weeks; Adverse events (AEs): Up to 410.4 weeks
All-cause mortality: All Enrolled Analysis Set. AEs: Safety Analysis Set: all participants who had received at least 1 dose of study medication. It was prespecified to analyze data from Cohort 1 together because both treatments (F/TAF 200/10 mg+boosted 3rd ARV and F/TAF 200/25 mg+unboosted 3rd ARV) were expected to have a similar effect on efficacy and safety for target population. AEs are reported together for both phases as participants continued same medication from main to extension phase.
|
33.3%
1/3 • All-cause mortality: Up to 439 weeks; Adverse events (AEs): Up to 410.4 weeks
All-cause mortality: All Enrolled Analysis Set. AEs: Safety Analysis Set: all participants who had received at least 1 dose of study medication. It was prespecified to analyze data from Cohort 1 together because both treatments (F/TAF 200/10 mg+boosted 3rd ARV and F/TAF 200/25 mg+unboosted 3rd ARV) were expected to have a similar effect on efficacy and safety for target population. AEs are reported together for both phases as participants continued same medication from main to extension phase.
|
|
Psychiatric disorders
Adjustment disorder
|
7.1%
2/28 • All-cause mortality: Up to 439 weeks; Adverse events (AEs): Up to 410.4 weeks
All-cause mortality: All Enrolled Analysis Set. AEs: Safety Analysis Set: all participants who had received at least 1 dose of study medication. It was prespecified to analyze data from Cohort 1 together because both treatments (F/TAF 200/10 mg+boosted 3rd ARV and F/TAF 200/25 mg+unboosted 3rd ARV) were expected to have a similar effect on efficacy and safety for target population. AEs are reported together for both phases as participants continued same medication from main to extension phase.
|
0.00%
0/9 • All-cause mortality: Up to 439 weeks; Adverse events (AEs): Up to 410.4 weeks
All-cause mortality: All Enrolled Analysis Set. AEs: Safety Analysis Set: all participants who had received at least 1 dose of study medication. It was prespecified to analyze data from Cohort 1 together because both treatments (F/TAF 200/10 mg+boosted 3rd ARV and F/TAF 200/25 mg+unboosted 3rd ARV) were expected to have a similar effect on efficacy and safety for target population. AEs are reported together for both phases as participants continued same medication from main to extension phase.
|
0.00%
0/3 • All-cause mortality: Up to 439 weeks; Adverse events (AEs): Up to 410.4 weeks
All-cause mortality: All Enrolled Analysis Set. AEs: Safety Analysis Set: all participants who had received at least 1 dose of study medication. It was prespecified to analyze data from Cohort 1 together because both treatments (F/TAF 200/10 mg+boosted 3rd ARV and F/TAF 200/25 mg+unboosted 3rd ARV) were expected to have a similar effect on efficacy and safety for target population. AEs are reported together for both phases as participants continued same medication from main to extension phase.
|
|
Psychiatric disorders
Depression
|
17.9%
5/28 • All-cause mortality: Up to 439 weeks; Adverse events (AEs): Up to 410.4 weeks
All-cause mortality: All Enrolled Analysis Set. AEs: Safety Analysis Set: all participants who had received at least 1 dose of study medication. It was prespecified to analyze data from Cohort 1 together because both treatments (F/TAF 200/10 mg+boosted 3rd ARV and F/TAF 200/25 mg+unboosted 3rd ARV) were expected to have a similar effect on efficacy and safety for target population. AEs are reported together for both phases as participants continued same medication from main to extension phase.
|
0.00%
0/9 • All-cause mortality: Up to 439 weeks; Adverse events (AEs): Up to 410.4 weeks
All-cause mortality: All Enrolled Analysis Set. AEs: Safety Analysis Set: all participants who had received at least 1 dose of study medication. It was prespecified to analyze data from Cohort 1 together because both treatments (F/TAF 200/10 mg+boosted 3rd ARV and F/TAF 200/25 mg+unboosted 3rd ARV) were expected to have a similar effect on efficacy and safety for target population. AEs are reported together for both phases as participants continued same medication from main to extension phase.
|
0.00%
0/3 • All-cause mortality: Up to 439 weeks; Adverse events (AEs): Up to 410.4 weeks
All-cause mortality: All Enrolled Analysis Set. AEs: Safety Analysis Set: all participants who had received at least 1 dose of study medication. It was prespecified to analyze data from Cohort 1 together because both treatments (F/TAF 200/10 mg+boosted 3rd ARV and F/TAF 200/25 mg+unboosted 3rd ARV) were expected to have a similar effect on efficacy and safety for target population. AEs are reported together for both phases as participants continued same medication from main to extension phase.
|
|
Psychiatric disorders
Insomnia
|
10.7%
3/28 • All-cause mortality: Up to 439 weeks; Adverse events (AEs): Up to 410.4 weeks
All-cause mortality: All Enrolled Analysis Set. AEs: Safety Analysis Set: all participants who had received at least 1 dose of study medication. It was prespecified to analyze data from Cohort 1 together because both treatments (F/TAF 200/10 mg+boosted 3rd ARV and F/TAF 200/25 mg+unboosted 3rd ARV) were expected to have a similar effect on efficacy and safety for target population. AEs are reported together for both phases as participants continued same medication from main to extension phase.
|
0.00%
0/9 • All-cause mortality: Up to 439 weeks; Adverse events (AEs): Up to 410.4 weeks
All-cause mortality: All Enrolled Analysis Set. AEs: Safety Analysis Set: all participants who had received at least 1 dose of study medication. It was prespecified to analyze data from Cohort 1 together because both treatments (F/TAF 200/10 mg+boosted 3rd ARV and F/TAF 200/25 mg+unboosted 3rd ARV) were expected to have a similar effect on efficacy and safety for target population. AEs are reported together for both phases as participants continued same medication from main to extension phase.
|
0.00%
0/3 • All-cause mortality: Up to 439 weeks; Adverse events (AEs): Up to 410.4 weeks
All-cause mortality: All Enrolled Analysis Set. AEs: Safety Analysis Set: all participants who had received at least 1 dose of study medication. It was prespecified to analyze data from Cohort 1 together because both treatments (F/TAF 200/10 mg+boosted 3rd ARV and F/TAF 200/25 mg+unboosted 3rd ARV) were expected to have a similar effect on efficacy and safety for target population. AEs are reported together for both phases as participants continued same medication from main to extension phase.
|
|
Renal and urinary disorders
Haematuria
|
7.1%
2/28 • All-cause mortality: Up to 439 weeks; Adverse events (AEs): Up to 410.4 weeks
All-cause mortality: All Enrolled Analysis Set. AEs: Safety Analysis Set: all participants who had received at least 1 dose of study medication. It was prespecified to analyze data from Cohort 1 together because both treatments (F/TAF 200/10 mg+boosted 3rd ARV and F/TAF 200/25 mg+unboosted 3rd ARV) were expected to have a similar effect on efficacy and safety for target population. AEs are reported together for both phases as participants continued same medication from main to extension phase.
|
0.00%
0/9 • All-cause mortality: Up to 439 weeks; Adverse events (AEs): Up to 410.4 weeks
All-cause mortality: All Enrolled Analysis Set. AEs: Safety Analysis Set: all participants who had received at least 1 dose of study medication. It was prespecified to analyze data from Cohort 1 together because both treatments (F/TAF 200/10 mg+boosted 3rd ARV and F/TAF 200/25 mg+unboosted 3rd ARV) were expected to have a similar effect on efficacy and safety for target population. AEs are reported together for both phases as participants continued same medication from main to extension phase.
|
0.00%
0/3 • All-cause mortality: Up to 439 weeks; Adverse events (AEs): Up to 410.4 weeks
All-cause mortality: All Enrolled Analysis Set. AEs: Safety Analysis Set: all participants who had received at least 1 dose of study medication. It was prespecified to analyze data from Cohort 1 together because both treatments (F/TAF 200/10 mg+boosted 3rd ARV and F/TAF 200/25 mg+unboosted 3rd ARV) were expected to have a similar effect on efficacy and safety for target population. AEs are reported together for both phases as participants continued same medication from main to extension phase.
|
|
Reproductive system and breast disorders
Balanoposthitis
|
3.6%
1/28 • All-cause mortality: Up to 439 weeks; Adverse events (AEs): Up to 410.4 weeks
All-cause mortality: All Enrolled Analysis Set. AEs: Safety Analysis Set: all participants who had received at least 1 dose of study medication. It was prespecified to analyze data from Cohort 1 together because both treatments (F/TAF 200/10 mg+boosted 3rd ARV and F/TAF 200/25 mg+unboosted 3rd ARV) were expected to have a similar effect on efficacy and safety for target population. AEs are reported together for both phases as participants continued same medication from main to extension phase.
|
11.1%
1/9 • All-cause mortality: Up to 439 weeks; Adverse events (AEs): Up to 410.4 weeks
All-cause mortality: All Enrolled Analysis Set. AEs: Safety Analysis Set: all participants who had received at least 1 dose of study medication. It was prespecified to analyze data from Cohort 1 together because both treatments (F/TAF 200/10 mg+boosted 3rd ARV and F/TAF 200/25 mg+unboosted 3rd ARV) were expected to have a similar effect on efficacy and safety for target population. AEs are reported together for both phases as participants continued same medication from main to extension phase.
|
0.00%
0/3 • All-cause mortality: Up to 439 weeks; Adverse events (AEs): Up to 410.4 weeks
All-cause mortality: All Enrolled Analysis Set. AEs: Safety Analysis Set: all participants who had received at least 1 dose of study medication. It was prespecified to analyze data from Cohort 1 together because both treatments (F/TAF 200/10 mg+boosted 3rd ARV and F/TAF 200/25 mg+unboosted 3rd ARV) were expected to have a similar effect on efficacy and safety for target population. AEs are reported together for both phases as participants continued same medication from main to extension phase.
|
|
Reproductive system and breast disorders
Dysmenorrhoea
|
7.1%
2/28 • All-cause mortality: Up to 439 weeks; Adverse events (AEs): Up to 410.4 weeks
All-cause mortality: All Enrolled Analysis Set. AEs: Safety Analysis Set: all participants who had received at least 1 dose of study medication. It was prespecified to analyze data from Cohort 1 together because both treatments (F/TAF 200/10 mg+boosted 3rd ARV and F/TAF 200/25 mg+unboosted 3rd ARV) were expected to have a similar effect on efficacy and safety for target population. AEs are reported together for both phases as participants continued same medication from main to extension phase.
|
0.00%
0/9 • All-cause mortality: Up to 439 weeks; Adverse events (AEs): Up to 410.4 weeks
All-cause mortality: All Enrolled Analysis Set. AEs: Safety Analysis Set: all participants who had received at least 1 dose of study medication. It was prespecified to analyze data from Cohort 1 together because both treatments (F/TAF 200/10 mg+boosted 3rd ARV and F/TAF 200/25 mg+unboosted 3rd ARV) were expected to have a similar effect on efficacy and safety for target population. AEs are reported together for both phases as participants continued same medication from main to extension phase.
|
0.00%
0/3 • All-cause mortality: Up to 439 weeks; Adverse events (AEs): Up to 410.4 weeks
All-cause mortality: All Enrolled Analysis Set. AEs: Safety Analysis Set: all participants who had received at least 1 dose of study medication. It was prespecified to analyze data from Cohort 1 together because both treatments (F/TAF 200/10 mg+boosted 3rd ARV and F/TAF 200/25 mg+unboosted 3rd ARV) were expected to have a similar effect on efficacy and safety for target population. AEs are reported together for both phases as participants continued same medication from main to extension phase.
|
|
Reproductive system and breast disorders
Vaginal discharge
|
7.1%
2/28 • All-cause mortality: Up to 439 weeks; Adverse events (AEs): Up to 410.4 weeks
All-cause mortality: All Enrolled Analysis Set. AEs: Safety Analysis Set: all participants who had received at least 1 dose of study medication. It was prespecified to analyze data from Cohort 1 together because both treatments (F/TAF 200/10 mg+boosted 3rd ARV and F/TAF 200/25 mg+unboosted 3rd ARV) were expected to have a similar effect on efficacy and safety for target population. AEs are reported together for both phases as participants continued same medication from main to extension phase.
|
0.00%
0/9 • All-cause mortality: Up to 439 weeks; Adverse events (AEs): Up to 410.4 weeks
All-cause mortality: All Enrolled Analysis Set. AEs: Safety Analysis Set: all participants who had received at least 1 dose of study medication. It was prespecified to analyze data from Cohort 1 together because both treatments (F/TAF 200/10 mg+boosted 3rd ARV and F/TAF 200/25 mg+unboosted 3rd ARV) were expected to have a similar effect on efficacy and safety for target population. AEs are reported together for both phases as participants continued same medication from main to extension phase.
|
0.00%
0/3 • All-cause mortality: Up to 439 weeks; Adverse events (AEs): Up to 410.4 weeks
All-cause mortality: All Enrolled Analysis Set. AEs: Safety Analysis Set: all participants who had received at least 1 dose of study medication. It was prespecified to analyze data from Cohort 1 together because both treatments (F/TAF 200/10 mg+boosted 3rd ARV and F/TAF 200/25 mg+unboosted 3rd ARV) were expected to have a similar effect on efficacy and safety for target population. AEs are reported together for both phases as participants continued same medication from main to extension phase.
|
|
Respiratory, thoracic and mediastinal disorders
Asthmatic crisis
|
7.1%
2/28 • All-cause mortality: Up to 439 weeks; Adverse events (AEs): Up to 410.4 weeks
All-cause mortality: All Enrolled Analysis Set. AEs: Safety Analysis Set: all participants who had received at least 1 dose of study medication. It was prespecified to analyze data from Cohort 1 together because both treatments (F/TAF 200/10 mg+boosted 3rd ARV and F/TAF 200/25 mg+unboosted 3rd ARV) were expected to have a similar effect on efficacy and safety for target population. AEs are reported together for both phases as participants continued same medication from main to extension phase.
|
0.00%
0/9 • All-cause mortality: Up to 439 weeks; Adverse events (AEs): Up to 410.4 weeks
All-cause mortality: All Enrolled Analysis Set. AEs: Safety Analysis Set: all participants who had received at least 1 dose of study medication. It was prespecified to analyze data from Cohort 1 together because both treatments (F/TAF 200/10 mg+boosted 3rd ARV and F/TAF 200/25 mg+unboosted 3rd ARV) were expected to have a similar effect on efficacy and safety for target population. AEs are reported together for both phases as participants continued same medication from main to extension phase.
|
0.00%
0/3 • All-cause mortality: Up to 439 weeks; Adverse events (AEs): Up to 410.4 weeks
All-cause mortality: All Enrolled Analysis Set. AEs: Safety Analysis Set: all participants who had received at least 1 dose of study medication. It was prespecified to analyze data from Cohort 1 together because both treatments (F/TAF 200/10 mg+boosted 3rd ARV and F/TAF 200/25 mg+unboosted 3rd ARV) were expected to have a similar effect on efficacy and safety for target population. AEs are reported together for both phases as participants continued same medication from main to extension phase.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
10.7%
3/28 • All-cause mortality: Up to 439 weeks; Adverse events (AEs): Up to 410.4 weeks
All-cause mortality: All Enrolled Analysis Set. AEs: Safety Analysis Set: all participants who had received at least 1 dose of study medication. It was prespecified to analyze data from Cohort 1 together because both treatments (F/TAF 200/10 mg+boosted 3rd ARV and F/TAF 200/25 mg+unboosted 3rd ARV) were expected to have a similar effect on efficacy and safety for target population. AEs are reported together for both phases as participants continued same medication from main to extension phase.
|
0.00%
0/9 • All-cause mortality: Up to 439 weeks; Adverse events (AEs): Up to 410.4 weeks
All-cause mortality: All Enrolled Analysis Set. AEs: Safety Analysis Set: all participants who had received at least 1 dose of study medication. It was prespecified to analyze data from Cohort 1 together because both treatments (F/TAF 200/10 mg+boosted 3rd ARV and F/TAF 200/25 mg+unboosted 3rd ARV) were expected to have a similar effect on efficacy and safety for target population. AEs are reported together for both phases as participants continued same medication from main to extension phase.
|
0.00%
0/3 • All-cause mortality: Up to 439 weeks; Adverse events (AEs): Up to 410.4 weeks
All-cause mortality: All Enrolled Analysis Set. AEs: Safety Analysis Set: all participants who had received at least 1 dose of study medication. It was prespecified to analyze data from Cohort 1 together because both treatments (F/TAF 200/10 mg+boosted 3rd ARV and F/TAF 200/25 mg+unboosted 3rd ARV) were expected to have a similar effect on efficacy and safety for target population. AEs are reported together for both phases as participants continued same medication from main to extension phase.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
10.7%
3/28 • All-cause mortality: Up to 439 weeks; Adverse events (AEs): Up to 410.4 weeks
All-cause mortality: All Enrolled Analysis Set. AEs: Safety Analysis Set: all participants who had received at least 1 dose of study medication. It was prespecified to analyze data from Cohort 1 together because both treatments (F/TAF 200/10 mg+boosted 3rd ARV and F/TAF 200/25 mg+unboosted 3rd ARV) were expected to have a similar effect on efficacy and safety for target population. AEs are reported together for both phases as participants continued same medication from main to extension phase.
|
0.00%
0/9 • All-cause mortality: Up to 439 weeks; Adverse events (AEs): Up to 410.4 weeks
All-cause mortality: All Enrolled Analysis Set. AEs: Safety Analysis Set: all participants who had received at least 1 dose of study medication. It was prespecified to analyze data from Cohort 1 together because both treatments (F/TAF 200/10 mg+boosted 3rd ARV and F/TAF 200/25 mg+unboosted 3rd ARV) were expected to have a similar effect on efficacy and safety for target population. AEs are reported together for both phases as participants continued same medication from main to extension phase.
|
0.00%
0/3 • All-cause mortality: Up to 439 weeks; Adverse events (AEs): Up to 410.4 weeks
All-cause mortality: All Enrolled Analysis Set. AEs: Safety Analysis Set: all participants who had received at least 1 dose of study medication. It was prespecified to analyze data from Cohort 1 together because both treatments (F/TAF 200/10 mg+boosted 3rd ARV and F/TAF 200/25 mg+unboosted 3rd ARV) were expected to have a similar effect on efficacy and safety for target population. AEs are reported together for both phases as participants continued same medication from main to extension phase.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
10.7%
3/28 • All-cause mortality: Up to 439 weeks; Adverse events (AEs): Up to 410.4 weeks
All-cause mortality: All Enrolled Analysis Set. AEs: Safety Analysis Set: all participants who had received at least 1 dose of study medication. It was prespecified to analyze data from Cohort 1 together because both treatments (F/TAF 200/10 mg+boosted 3rd ARV and F/TAF 200/25 mg+unboosted 3rd ARV) were expected to have a similar effect on efficacy and safety for target population. AEs are reported together for both phases as participants continued same medication from main to extension phase.
|
0.00%
0/9 • All-cause mortality: Up to 439 weeks; Adverse events (AEs): Up to 410.4 weeks
All-cause mortality: All Enrolled Analysis Set. AEs: Safety Analysis Set: all participants who had received at least 1 dose of study medication. It was prespecified to analyze data from Cohort 1 together because both treatments (F/TAF 200/10 mg+boosted 3rd ARV and F/TAF 200/25 mg+unboosted 3rd ARV) were expected to have a similar effect on efficacy and safety for target population. AEs are reported together for both phases as participants continued same medication from main to extension phase.
|
0.00%
0/3 • All-cause mortality: Up to 439 weeks; Adverse events (AEs): Up to 410.4 weeks
All-cause mortality: All Enrolled Analysis Set. AEs: Safety Analysis Set: all participants who had received at least 1 dose of study medication. It was prespecified to analyze data from Cohort 1 together because both treatments (F/TAF 200/10 mg+boosted 3rd ARV and F/TAF 200/25 mg+unboosted 3rd ARV) were expected to have a similar effect on efficacy and safety for target population. AEs are reported together for both phases as participants continued same medication from main to extension phase.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory symptom
|
7.1%
2/28 • All-cause mortality: Up to 439 weeks; Adverse events (AEs): Up to 410.4 weeks
All-cause mortality: All Enrolled Analysis Set. AEs: Safety Analysis Set: all participants who had received at least 1 dose of study medication. It was prespecified to analyze data from Cohort 1 together because both treatments (F/TAF 200/10 mg+boosted 3rd ARV and F/TAF 200/25 mg+unboosted 3rd ARV) were expected to have a similar effect on efficacy and safety for target population. AEs are reported together for both phases as participants continued same medication from main to extension phase.
|
0.00%
0/9 • All-cause mortality: Up to 439 weeks; Adverse events (AEs): Up to 410.4 weeks
All-cause mortality: All Enrolled Analysis Set. AEs: Safety Analysis Set: all participants who had received at least 1 dose of study medication. It was prespecified to analyze data from Cohort 1 together because both treatments (F/TAF 200/10 mg+boosted 3rd ARV and F/TAF 200/25 mg+unboosted 3rd ARV) were expected to have a similar effect on efficacy and safety for target population. AEs are reported together for both phases as participants continued same medication from main to extension phase.
|
0.00%
0/3 • All-cause mortality: Up to 439 weeks; Adverse events (AEs): Up to 410.4 weeks
All-cause mortality: All Enrolled Analysis Set. AEs: Safety Analysis Set: all participants who had received at least 1 dose of study medication. It was prespecified to analyze data from Cohort 1 together because both treatments (F/TAF 200/10 mg+boosted 3rd ARV and F/TAF 200/25 mg+unboosted 3rd ARV) were expected to have a similar effect on efficacy and safety for target population. AEs are reported together for both phases as participants continued same medication from main to extension phase.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
14.3%
4/28 • All-cause mortality: Up to 439 weeks; Adverse events (AEs): Up to 410.4 weeks
All-cause mortality: All Enrolled Analysis Set. AEs: Safety Analysis Set: all participants who had received at least 1 dose of study medication. It was prespecified to analyze data from Cohort 1 together because both treatments (F/TAF 200/10 mg+boosted 3rd ARV and F/TAF 200/25 mg+unboosted 3rd ARV) were expected to have a similar effect on efficacy and safety for target population. AEs are reported together for both phases as participants continued same medication from main to extension phase.
|
22.2%
2/9 • All-cause mortality: Up to 439 weeks; Adverse events (AEs): Up to 410.4 weeks
All-cause mortality: All Enrolled Analysis Set. AEs: Safety Analysis Set: all participants who had received at least 1 dose of study medication. It was prespecified to analyze data from Cohort 1 together because both treatments (F/TAF 200/10 mg+boosted 3rd ARV and F/TAF 200/25 mg+unboosted 3rd ARV) were expected to have a similar effect on efficacy and safety for target population. AEs are reported together for both phases as participants continued same medication from main to extension phase.
|
0.00%
0/3 • All-cause mortality: Up to 439 weeks; Adverse events (AEs): Up to 410.4 weeks
All-cause mortality: All Enrolled Analysis Set. AEs: Safety Analysis Set: all participants who had received at least 1 dose of study medication. It was prespecified to analyze data from Cohort 1 together because both treatments (F/TAF 200/10 mg+boosted 3rd ARV and F/TAF 200/25 mg+unboosted 3rd ARV) were expected to have a similar effect on efficacy and safety for target population. AEs are reported together for both phases as participants continued same medication from main to extension phase.
|
|
Skin and subcutaneous tissue disorders
Acne
|
28.6%
8/28 • All-cause mortality: Up to 439 weeks; Adverse events (AEs): Up to 410.4 weeks
All-cause mortality: All Enrolled Analysis Set. AEs: Safety Analysis Set: all participants who had received at least 1 dose of study medication. It was prespecified to analyze data from Cohort 1 together because both treatments (F/TAF 200/10 mg+boosted 3rd ARV and F/TAF 200/25 mg+unboosted 3rd ARV) were expected to have a similar effect on efficacy and safety for target population. AEs are reported together for both phases as participants continued same medication from main to extension phase.
|
11.1%
1/9 • All-cause mortality: Up to 439 weeks; Adverse events (AEs): Up to 410.4 weeks
All-cause mortality: All Enrolled Analysis Set. AEs: Safety Analysis Set: all participants who had received at least 1 dose of study medication. It was prespecified to analyze data from Cohort 1 together because both treatments (F/TAF 200/10 mg+boosted 3rd ARV and F/TAF 200/25 mg+unboosted 3rd ARV) were expected to have a similar effect on efficacy and safety for target population. AEs are reported together for both phases as participants continued same medication from main to extension phase.
|
0.00%
0/3 • All-cause mortality: Up to 439 weeks; Adverse events (AEs): Up to 410.4 weeks
All-cause mortality: All Enrolled Analysis Set. AEs: Safety Analysis Set: all participants who had received at least 1 dose of study medication. It was prespecified to analyze data from Cohort 1 together because both treatments (F/TAF 200/10 mg+boosted 3rd ARV and F/TAF 200/25 mg+unboosted 3rd ARV) were expected to have a similar effect on efficacy and safety for target population. AEs are reported together for both phases as participants continued same medication from main to extension phase.
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
3.6%
1/28 • All-cause mortality: Up to 439 weeks; Adverse events (AEs): Up to 410.4 weeks
All-cause mortality: All Enrolled Analysis Set. AEs: Safety Analysis Set: all participants who had received at least 1 dose of study medication. It was prespecified to analyze data from Cohort 1 together because both treatments (F/TAF 200/10 mg+boosted 3rd ARV and F/TAF 200/25 mg+unboosted 3rd ARV) were expected to have a similar effect on efficacy and safety for target population. AEs are reported together for both phases as participants continued same medication from main to extension phase.
|
0.00%
0/9 • All-cause mortality: Up to 439 weeks; Adverse events (AEs): Up to 410.4 weeks
All-cause mortality: All Enrolled Analysis Set. AEs: Safety Analysis Set: all participants who had received at least 1 dose of study medication. It was prespecified to analyze data from Cohort 1 together because both treatments (F/TAF 200/10 mg+boosted 3rd ARV and F/TAF 200/25 mg+unboosted 3rd ARV) were expected to have a similar effect on efficacy and safety for target population. AEs are reported together for both phases as participants continued same medication from main to extension phase.
|
33.3%
1/3 • All-cause mortality: Up to 439 weeks; Adverse events (AEs): Up to 410.4 weeks
All-cause mortality: All Enrolled Analysis Set. AEs: Safety Analysis Set: all participants who had received at least 1 dose of study medication. It was prespecified to analyze data from Cohort 1 together because both treatments (F/TAF 200/10 mg+boosted 3rd ARV and F/TAF 200/25 mg+unboosted 3rd ARV) were expected to have a similar effect on efficacy and safety for target population. AEs are reported together for both phases as participants continued same medication from main to extension phase.
|
|
Skin and subcutaneous tissue disorders
Dermatitis allergic
|
0.00%
0/28 • All-cause mortality: Up to 439 weeks; Adverse events (AEs): Up to 410.4 weeks
All-cause mortality: All Enrolled Analysis Set. AEs: Safety Analysis Set: all participants who had received at least 1 dose of study medication. It was prespecified to analyze data from Cohort 1 together because both treatments (F/TAF 200/10 mg+boosted 3rd ARV and F/TAF 200/25 mg+unboosted 3rd ARV) were expected to have a similar effect on efficacy and safety for target population. AEs are reported together for both phases as participants continued same medication from main to extension phase.
|
22.2%
2/9 • All-cause mortality: Up to 439 weeks; Adverse events (AEs): Up to 410.4 weeks
All-cause mortality: All Enrolled Analysis Set. AEs: Safety Analysis Set: all participants who had received at least 1 dose of study medication. It was prespecified to analyze data from Cohort 1 together because both treatments (F/TAF 200/10 mg+boosted 3rd ARV and F/TAF 200/25 mg+unboosted 3rd ARV) were expected to have a similar effect on efficacy and safety for target population. AEs are reported together for both phases as participants continued same medication from main to extension phase.
|
0.00%
0/3 • All-cause mortality: Up to 439 weeks; Adverse events (AEs): Up to 410.4 weeks
All-cause mortality: All Enrolled Analysis Set. AEs: Safety Analysis Set: all participants who had received at least 1 dose of study medication. It was prespecified to analyze data from Cohort 1 together because both treatments (F/TAF 200/10 mg+boosted 3rd ARV and F/TAF 200/25 mg+unboosted 3rd ARV) were expected to have a similar effect on efficacy and safety for target population. AEs are reported together for both phases as participants continued same medication from main to extension phase.
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
7.1%
2/28 • All-cause mortality: Up to 439 weeks; Adverse events (AEs): Up to 410.4 weeks
All-cause mortality: All Enrolled Analysis Set. AEs: Safety Analysis Set: all participants who had received at least 1 dose of study medication. It was prespecified to analyze data from Cohort 1 together because both treatments (F/TAF 200/10 mg+boosted 3rd ARV and F/TAF 200/25 mg+unboosted 3rd ARV) were expected to have a similar effect on efficacy and safety for target population. AEs are reported together for both phases as participants continued same medication from main to extension phase.
|
0.00%
0/9 • All-cause mortality: Up to 439 weeks; Adverse events (AEs): Up to 410.4 weeks
All-cause mortality: All Enrolled Analysis Set. AEs: Safety Analysis Set: all participants who had received at least 1 dose of study medication. It was prespecified to analyze data from Cohort 1 together because both treatments (F/TAF 200/10 mg+boosted 3rd ARV and F/TAF 200/25 mg+unboosted 3rd ARV) were expected to have a similar effect on efficacy and safety for target population. AEs are reported together for both phases as participants continued same medication from main to extension phase.
|
0.00%
0/3 • All-cause mortality: Up to 439 weeks; Adverse events (AEs): Up to 410.4 weeks
All-cause mortality: All Enrolled Analysis Set. AEs: Safety Analysis Set: all participants who had received at least 1 dose of study medication. It was prespecified to analyze data from Cohort 1 together because both treatments (F/TAF 200/10 mg+boosted 3rd ARV and F/TAF 200/25 mg+unboosted 3rd ARV) were expected to have a similar effect on efficacy and safety for target population. AEs are reported together for both phases as participants continued same medication from main to extension phase.
|
|
Skin and subcutaneous tissue disorders
Rash papular
|
7.1%
2/28 • All-cause mortality: Up to 439 weeks; Adverse events (AEs): Up to 410.4 weeks
All-cause mortality: All Enrolled Analysis Set. AEs: Safety Analysis Set: all participants who had received at least 1 dose of study medication. It was prespecified to analyze data from Cohort 1 together because both treatments (F/TAF 200/10 mg+boosted 3rd ARV and F/TAF 200/25 mg+unboosted 3rd ARV) were expected to have a similar effect on efficacy and safety for target population. AEs are reported together for both phases as participants continued same medication from main to extension phase.
|
0.00%
0/9 • All-cause mortality: Up to 439 weeks; Adverse events (AEs): Up to 410.4 weeks
All-cause mortality: All Enrolled Analysis Set. AEs: Safety Analysis Set: all participants who had received at least 1 dose of study medication. It was prespecified to analyze data from Cohort 1 together because both treatments (F/TAF 200/10 mg+boosted 3rd ARV and F/TAF 200/25 mg+unboosted 3rd ARV) were expected to have a similar effect on efficacy and safety for target population. AEs are reported together for both phases as participants continued same medication from main to extension phase.
|
0.00%
0/3 • All-cause mortality: Up to 439 weeks; Adverse events (AEs): Up to 410.4 weeks
All-cause mortality: All Enrolled Analysis Set. AEs: Safety Analysis Set: all participants who had received at least 1 dose of study medication. It was prespecified to analyze data from Cohort 1 together because both treatments (F/TAF 200/10 mg+boosted 3rd ARV and F/TAF 200/25 mg+unboosted 3rd ARV) were expected to have a similar effect on efficacy and safety for target population. AEs are reported together for both phases as participants continued same medication from main to extension phase.
|
|
Surgical and medical procedures
Circumcision
|
7.1%
2/28 • All-cause mortality: Up to 439 weeks; Adverse events (AEs): Up to 410.4 weeks
All-cause mortality: All Enrolled Analysis Set. AEs: Safety Analysis Set: all participants who had received at least 1 dose of study medication. It was prespecified to analyze data from Cohort 1 together because both treatments (F/TAF 200/10 mg+boosted 3rd ARV and F/TAF 200/25 mg+unboosted 3rd ARV) were expected to have a similar effect on efficacy and safety for target population. AEs are reported together for both phases as participants continued same medication from main to extension phase.
|
0.00%
0/9 • All-cause mortality: Up to 439 weeks; Adverse events (AEs): Up to 410.4 weeks
All-cause mortality: All Enrolled Analysis Set. AEs: Safety Analysis Set: all participants who had received at least 1 dose of study medication. It was prespecified to analyze data from Cohort 1 together because both treatments (F/TAF 200/10 mg+boosted 3rd ARV and F/TAF 200/25 mg+unboosted 3rd ARV) were expected to have a similar effect on efficacy and safety for target population. AEs are reported together for both phases as participants continued same medication from main to extension phase.
|
0.00%
0/3 • All-cause mortality: Up to 439 weeks; Adverse events (AEs): Up to 410.4 weeks
All-cause mortality: All Enrolled Analysis Set. AEs: Safety Analysis Set: all participants who had received at least 1 dose of study medication. It was prespecified to analyze data from Cohort 1 together because both treatments (F/TAF 200/10 mg+boosted 3rd ARV and F/TAF 200/25 mg+unboosted 3rd ARV) were expected to have a similar effect on efficacy and safety for target population. AEs are reported together for both phases as participants continued same medication from main to extension phase.
|
Additional Information
Gilead Clinical Study Information Center
Gilead Sciences
Phone: 1-833-445-3230 (GILEAD-0)
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee After conclusion of the study and without prior written approval from Gilead, investigators in this study may communicate, orally present, or publish in scientific journals or other media only after the following conditions have been met: * The results of the study in their entirety have been publicly disclosed by or with the consent of Gilead in an abstract, manuscript, or presentation form; or * The study has been completed at all study sites for at least 2 years
- Publication restrictions are in place
Restriction type: OTHER