Switch Study to Evaluate F/TAF in HIV-1 Infected Adults W... | NCT02469246

ID	Type	Description	Link
2015-000871-28	EudraCT Number

Label	Type	Description	Intervention Names
F/TAF (Double-Blind)	Experimental	F/TAF + ABC/3TC placebo + allowed 3rd antiretroviral (ARV) agent for 96 weeks After Week 96, participants will continue to take their blinded study drug and attend visits every 12 weeks until treatment assignments have been unblinded.	Drug: F/TAF Drug: ABC/3TC Placebo Drug: 3rd ARV agent
ABC/3TC (Double-Blind)	Active Comparator	ABC/3TC + F/TAF placebo + allowed 3rd ARV agent for 96 weeks After Week 96, participants will continue to take their blinded study drug and attend visits every 12 weeks until treatment assignments have been unblinded.	Drug: ABC/3TC Drug: F/TAF Placebo Drug: 3rd ARV agent
Open-Label F/TAF	Experimental	After the unblinding visit, in countries where F/TAF FDC is not commercially available, participants (except in certain countries such as the UK) will be given the option to receive open-label F/TAF (200/10 mg or 200/25 mg) FDC and attend study visits every 12 weeks until it becomes commercially available, or until Gilead terminates the study in that country.	Drug: F/TAF

Name	Type	Description	Arm Group Labels	Other Names
F/TAF	Drug	200/10 mg FDC tablet (with boosted 3rd ARV agents) or 200/25 mg FDC tablet (with unboosted 3rd ARV agents) administered orally once daily	F/TAF (Double-Blind)

Measure	Description	Time Frame
Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 48 as Determined by the FDA-Defined Snapshot Algorithm	The percentage of participants achieving HIV-1 RNA < 50 copies/mL at Week 48 was analyzed using the snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status.	Week 48

Measure	Description	Time Frame
Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 96 as Determined by the FDA-Defined Snapshot Algorithm	The percentage of participants achieving HIV-1 RNA < 50 copies/mL at Week 96 was analyzed using the snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status.

Eligibility Module

Eligibility Criteria

Key Inclusion Criteria:

The ability to understand and sign a written informed consent form
On antiretroviral regimen containing ABC/3TC FDC in combination with one 3rd agent for ≥ 6 consecutive months prior to screening
Plasma HIV-1 RNA levels < 50 copies/mL for ≥ 6 months preceding the screening visit (measured at least twice using the same assay) and without experiencing two consecutive HIV-1 RNA above detectable levels after achieving a confirmed (two consecutive) HIV-1 RNA below detectable levels on the current regimen in the past year
Plasma HIV-1 RNA should be < 50 copies/mL at the screening visit
Normal ECG
Estimated glomerular filtration rate (GFR) ≥ 50 mL/min according to the Cockcroft Gault formula for creatinine clearance
Hepatic transaminases (AST and ALT) ≤ 5 × upper limit of normal (ULN)
Total bilirubin ≤ 1.5 mg/dL, or normal direct bilirubin
Adequate hematologic function
Serum amylase ≤ 5 × ULN
Females of childbearing potential and males must agree to utilize highly effective contraception methods or be non-heterosexually active or practice sexual abstinence from screening throughout the duration of study treatment and for 30 days following the last dose of study drug

Key Exclusion Criteria:

A new AIDS-defining condition diagnosed within the 30 days prior to screening
Hepatitis B surface antigen (HBsAg) positive
Individuals experiencing decompensated cirrhosis
Individuals receiving ongoing treatment with bisphosphonate to treat bone disease (eg, osteoporosis)
Pregnant or lactating females
Have an implanted defibrillator or pacemaker
Current alcohol or substance use judged by the investigator to potentially interfere with study compliance
A history of malignancy within the past 5 years (prior to screening) or ongoing malignancy other than cutaneous Kaposi's sarcoma (KS), basal cell carcinoma, or resected, non-invasive cutaneous squamous carcinoma.
Active, serious infections (other than HIV-1 infection) requiring parenteral antibiotic or antifungal therapy within 30 days prior to Day 1 Visit
Any other clinical condition or prior therapy that, in the opinion of the investigator, would make the individual unsuitable for the study or unable to comply with dosing requirements
Participation in any other clinical trial (including observational trials) without prior approval
Medications excluded due to the potential for interaction with emtricitabine (FTC), TAF, ABC or 3TC

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Name	Affiliation	Role
Gilead Study Director	Gilead Sciences	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Spectrum Medical Group		Phoenix	Arizona		United States
Pacific Oaks Medical Group

PubMed Identifier	Type	Citation	Retractions
29475804	Result	Winston A, Post FA, DeJesus E, Podzamczer D, Di Perri G, Estrada V, Raffi F, Ruane P, Peyrani P, Crofoot G, Mallon PWG, Castelli F, Yan M, Cox S, Das M, Cheng A, Rhee MS. Tenofovir alafenamide plus emtricitabine versus abacavir plus lamivudine for treatment of virologically suppressed HIV-1-infected adults: a randomised, double-blind, active-controlled, non-inferiority phase 3 trial. Lancet HIV. 2018 Apr;5(4):e162-e171. doi: 10.1016/S2352-3018(18)30010-9. Epub 2018 Feb 20.
30932951

ID	Title	Description
FG000	F/TAF	Double-Blind Phase: 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) + abacavir/lamivudine (ABC/3TC) placebo tablet once daily for 96 weeks, and continued blinded treatment until unblinding. [Allowed boosted 3rd ARV agents: ritonavir boosted lopinavir (LPV/r), atazanavir (ATV) + ritonavir (RTV), ATV + cobicistat (COBI) or ATV/COBI FDC, darunavir (DRV) + RTV, DRV+COBI or DRV/COBI FDC; Allowed unboosted 3rd ARV agents: efavirenz (EFV), rilpivirine (RPV), raltegravir (RAL), dolutegravir (DTG), maraviroc (MVC), or nevirapine (NVP)]. Open-Label Extension: After the unblinding visit, in countries where F/TAF FDC was not commercially available, participants (except in certain countries) were given the option to receive the open-label F/TAF FDC until it became commercially available, or until Gilead terminated the study in that country.

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Mar 11, 2015	Mar 1, 2018

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 48 as Determined by the FDA-Defined Snapshot Algorithm

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

The Full Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. Participants were grouped according to the treatment to which they were randomized.

Posted

Number

percentage of participants

Week 48

ID	Title	Description
OG000	F/TAF	F/TAF (200/10 mg) FDC tablet (with boosted 3rd ARV agent) or F/TAF (200/25 mg) FDC tablet (with unboosted 3rd ARV agent) + ABC/3TC placebo tablet once daily for 96 weeks
OG001	ABC/3TC	ABC/3TC (600/300 mg) FDC tablet + F/TAF placebo tablet once daily + allowed 3rd ARV agent for 96 weeks

Units	Counts
Participants	OG000280 OG001276

Title

Denominators

Categories

Title	Measurements
	OG00088.6 OG00192.4

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001	The analysis purpose of the primary efficacy endpoint was to assess the noninferiority of switching to F/TAF+3rd Agent relative to maintaining treatment with ABC/3TC+3rd Agent.	Fisher Exact		0.15		Difference in Percentages	-3.8			2-Sided	95.002	-8.9	1.1			The difference in percentages and its 95.002% CI were calculated based on an unconditional exact method using 2 inverted 1-sided tests.		Non-Inferiority	Non-inferiority was assessed using a 2-sided exact 95% confidence interval (CI) approach, with a non-inferiority margin of 10%.

Secondary

Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 96 as Determined by the FDA-Defined Snapshot Algorithm

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

Participants in the Full Analysis Set were analyzed.

Posted

Number

percentage of participants

Week 96

ID	Title	Description
OG000	F/TAF	F/TAF (200/10 mg) FDC tablet (with boosted 3rd ARV agent) or F/TAF (200/25 mg) FDC tablet (with unboosted 3rd ARV agent) + ABC/3TC placebo tablet once daily for 96 weeks
OG001	ABC/3TC	ABC/3TC (600/300 mg) FDC tablet + F/TAF placebo tablet once daily + allowed 3rd ARV agent for 96 weeks

Units	Counts
Participants	OG000

Secondary

Percentage of Participants With HIV-1 RNA ≥ 50 Copies/mL at Week 48 as Determined by the FDA-Defined Snapshot Algorithm

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

Participants in the Full Analysis Set were analyzed.

Posted

Number

percentage of participants

Week 48

ID	Title	Description
OG000	F/TAF	F/TAF (200/10 mg) FDC tablet (with boosted 3rd ARV agent) or F/TAF (200/25 mg) FDC tablet (with unboosted 3rd ARV agent) + ABC/3TC placebo tablet once daily for 96 weeks
OG001	ABC/3TC	ABC/3TC (600/300 mg) FDC tablet + F/TAF placebo tablet once daily + allowed 3rd ARV agent for 96 weeks

Units	Counts
Participants	OG000

Secondary

Percentage of Participants With HIV-1 RNA ≥ 50 Copies/mL at Week 96 as Determined by the FDA-Defined Snapshot Algorithm

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

Participants in the Full Analysis Set were analyzed.

Posted

Number

percentage of participants

Week 96

ID	Title	Description
OG000	F/TAF	F/TAF (200/10 mg) FDC tablet (with boosted 3rd ARV agent) or F/TAF (200/25 mg) FDC tablet (with unboosted 3rd ARV agent) + ABC/3TC placebo tablet once daily for 96 weeks
OG001	ABC/3TC	ABC/3TC (600/300 mg) FDC tablet + F/TAF placebo tablet once daily + allowed 3rd ARV agent for 96 weeks

Units	Counts
Participants	OG000

Secondary

Percentage of Participants With HIV-1 RNA < 20 Copies/mL at Week 48 as Determined by the FDA-Defined Snapshot Algorithm

The percentage of participants achieving HIV-1 RNA < 20 copies/mL at Week 48 was analyzed using the snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status.

Participants in the Full Analysis Set were analyzed.

Posted

Number

percentage of participants

Week 48

ID	Title	Description
OG000	F/TAF	F/TAF (200/10 mg) FDC tablet (with boosted 3rd ARV agent) or F/TAF (200/25 mg) FDC tablet (with unboosted 3rd ARV agent) + ABC/3TC placebo tablet once daily for 96 weeks
OG001	ABC/3TC	ABC/3TC (600/300 mg) FDC tablet + F/TAF placebo tablet once daily + allowed 3rd ARV agent for 96 weeks

Units	Counts
Participants	OG000

Secondary

Percentage of Participants With HIV-1 RNA < 20 Copies/mL at Week 96 as Determined by the FDA-Defined Snapshot Algorithm

The percentage of participants achieving HIV-1 RNA < 20 copies/mL at Week 96 was analyzed using the snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status.

Participants in the Full Analysis Set were analyzed.

Posted

Number

percentage of participants

Week 96

ID	Title	Description
OG000	F/TAF	F/TAF (200/10 mg) FDC tablet (with boosted 3rd ARV agent) or F/TAF (200/25 mg) FDC tablet (with unboosted 3rd ARV agent) + ABC/3TC placebo tablet once daily for 96 weeks
OG001	ABC/3TC	ABC/3TC (600/300 mg) FDC tablet + F/TAF placebo tablet once daily + allowed 3rd ARV agent for 96 weeks

Units	Counts
Participants	OG000

Secondary

Change From Baseline in CD4 Cell Count at Week 48

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

Posted

Mean

Standard Deviation

cells/µL

Baseline; Week 48

ID	Title	Description
OG000	F/TAF	F/TAF (200/10 mg) FDC tablet (with boosted 3rd ARV agent) or F/TAF (200/25 mg) FDC tablet (with unboosted 3rd ARV agent) + ABC/3TC placebo tablet once daily for 96 weeks
OG001	ABC/3TC	ABC/3TC (600/300 mg) FDC tablet + F/TAF placebo tablet once daily + allowed 3rd ARV agent for 96 weeks

Units	Counts
Participants	OG000

Secondary

Change From Baseline in CD4 Cell Count at Week 96

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

Posted

Mean

Standard Deviation

cells/μL

Baseline; Week 96

ID	Title	Description
OG000	F/TAF	F/TAF (200/10 mg) FDC tablet (with boosted 3rd ARV agent) or F/TAF (200/25 mg) FDC tablet (with unboosted 3rd ARV agent) + ABC/3TC placebo tablet once daily for 96 weeks
OG001	ABC/3TC	ABC/3TC (600/300 mg) FDC tablet + F/TAF placebo tablet once daily + allowed 3rd ARV agent for 96 weeks

Units	Counts
Participants	OG000

Secondary

Percent Change From Baseline in Hip Bone Mineral Density (BMD) at Week 48

Participants in the Hip Dual-Energy X-Ray Absorptiometry (DXA) Analysis Set (all participants who are randomized and have received at least one dose of study drug, and have nonmissing baseline hip BMD values) with available data were analyzed.

Posted

Mean

Standard Deviation

percent change

Baseline; Week 48

ID	Title	Description
OG000	F/TAF	F/TAF (200/10 mg) FDC tablet (with boosted 3rd ARV agent) or F/TAF (200/25 mg) FDC tablet (with unboosted 3rd ARV agent) + ABC/3TC placebo tablet once daily for 96 weeks
OG001	ABC/3TC	ABC/3TC (600/300 mg) FDC tablet + F/TAF placebo tablet once daily + allowed 3rd ARV agent for 96 weeks

Units	Counts
Participants	OG000

Secondary

Percent Change From Baseline in Hip BMD at Week 96

Participants in the Hip DXA Analysis Set with available data were analyzed.

Posted

Mean

Standard Deviation

percent change

Baseline; Week 96

ID	Title	Description
OG000	F/TAF	F/TAF (200/10 mg) FDC tablet (with boosted 3rd ARV agent) or F/TAF (200/25 mg) FDC tablet (with unboosted 3rd ARV agent) + ABC/3TC placebo tablet once daily for 96 weeks
OG001	ABC/3TC	ABC/3TC (600/300 mg) FDC tablet + F/TAF placebo tablet once daily + allowed 3rd ARV agent for 96 weeks

Units	Counts
Participants	OG000

Secondary

Percent Change From Baseline in Spine BMD at Week 48

Participants in the Spine DXA Analysis Set (all participants who are randomized and have received at least one dose of study drug, and have nonmissing baseline spine BMD values) with available data were analyzed.

Posted

Mean

Standard Deviation

percent change

Baseline; Week 48

ID	Title	Description
OG000	F/TAF	F/TAF (200/10 mg) FDC tablet (with boosted 3rd ARV agent) or F/TAF (200/25 mg) FDC tablet (with unboosted 3rd ARV agent) + ABC/3TC placebo tablet once daily for 96 weeks
OG001	ABC/3TC	ABC/3TC (600/300 mg) FDC tablet + F/TAF placebo tablet once daily + allowed 3rd ARV agent for 96 weeks

Units	Counts
Participants	OG000

Secondary

Percent Change From Baseline in Spine BMD at Week 96

Participants in the Spine DXA Analysis Set with available data were analyzed.

Posted

Mean

Standard Deviation

percent change

Baseline; Week 96

ID	Title	Description
OG000	F/TAF	F/TAF (200/10 mg) FDC tablet (with boosted 3rd ARV agent) or F/TAF (200/25 mg) FDC tablet (with unboosted 3rd ARV agent) + ABC/3TC placebo tablet once daily for 96 weeks
OG001	ABC/3TC	ABC/3TC (600/300 mg) FDC tablet + F/TAF placebo tablet once daily + allowed 3rd ARV agent for 96 weeks

Units	Counts
Participants	OG000

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Iron deficiency anaemia	Blood and lymphatic system disorders	MedDRA 21.1	Systematic Assessment	EG0001 affected280 at risk EG0010 affected276 at risk EG0020 affected6 at risk EG0030 affected5 at risk
Leukocytosis	Blood and lymphatic system disorders	MedDRA 21.1	Systematic Assessment	EG0000 affected280 at risk EG0011 affected276 at risk EG0020 affected6 at risk EG003
Neutropenia	Blood and lymphatic system disorders	MedDRA 21.1	Systematic Assessment	EG0001 affected280 at risk EG0010 affected276 at risk EG0020 affected6 at risk EG003
Atrial fibrillation	Cardiac disorders	MedDRA 21.1	Systematic Assessment	EG0000 affected280 at risk EG0011 affected276 at risk EG0020 affected6 at risk EG003
Cardiac failure congestive	Cardiac disorders	MedDRA 21.1	Systematic Assessment	EG0001 affected280 at risk EG0010 affected276 at risk EG0020 affected6 at risk EG003
Cardio-respiratory arrest	Cardiac disorders	MedDRA 21.1	Systematic Assessment	EG0001 affected280 at risk EG0010 affected276 at risk EG0020 affected6 at risk EG003
Coronary artery disease	Cardiac disorders	MedDRA 21.1	Systematic Assessment	EG0001 affected280 at risk EG0011 affected276 at risk EG0020 affected6 at risk EG003
Coronary artery stenosis	Cardiac disorders	MedDRA 21.1	Systematic Assessment	EG0001 affected280 at risk EG0010 affected276 at risk EG0020 affected6 at risk EG003
Myocardial infarction	Cardiac disorders	MedDRA 21.1	Systematic Assessment	EG0001 affected280 at risk EG0011 affected276 at risk EG0020 affected6 at risk EG003
Pericarditis	Cardiac disorders	MedDRA 21.1	Systematic Assessment	EG0000 affected280 at risk EG0011 affected276 at risk EG0020 affected6 at risk EG003
Abdominal pain	Gastrointestinal disorders	MedDRA 21.1	Systematic Assessment	EG0001 affected280 at risk EG0011 affected276 at risk EG0020 affected6 at risk EG003
Diarrhoea	Gastrointestinal disorders	MedDRA 21.1	Systematic Assessment	EG0001 affected280 at risk EG0010 affected276 at risk EG0020 affected6 at risk EG003
Faecaloma	Gastrointestinal disorders	MedDRA 21.1	Systematic Assessment	EG0000 affected280 at risk EG0011 affected276 at risk EG0020 affected6 at risk EG003
Gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA 21.1	Systematic Assessment	EG0000 affected280 at risk EG0011 affected276 at risk EG0020 affected6 at risk EG003
Haematemesis	Gastrointestinal disorders	MedDRA 21.1	Systematic Assessment	EG0000 affected280 at risk EG0011 affected276 at risk EG0020 affected6 at risk EG003
Ileus paralytic	Gastrointestinal disorders	MedDRA 21.1	Systematic Assessment	EG0001 affected280 at risk EG0010 affected276 at risk EG0020 affected6 at risk EG003
Intestinal ischaemia	Gastrointestinal disorders	MedDRA 21.1	Systematic Assessment	EG0000 affected280 at risk EG0011 affected276 at risk EG0020 affected6 at risk EG003
Large intestine perforation	Gastrointestinal disorders	MedDRA 21.1	Systematic Assessment	EG0001 affected280 at risk EG0010 affected276 at risk EG0020 affected6 at risk EG003
Oesophageal ulcer	Gastrointestinal disorders	MedDRA 21.1	Systematic Assessment	EG0001 affected280 at risk EG0010 affected276 at risk EG0020 affected6 at risk EG003
Pancreatitis	Gastrointestinal disorders	MedDRA 21.1	Systematic Assessment	EG0001 affected280 at risk EG0010 affected276 at risk EG0020 affected6 at risk EG003
Pancreatitis acute	Gastrointestinal disorders	MedDRA 21.1	Systematic Assessment	EG0001 affected280 at risk EG0010 affected276 at risk EG0020 affected6 at risk EG003
Rectal haemorrhage	Gastrointestinal disorders	MedDRA 21.1	Systematic Assessment	EG0001 affected280 at risk EG0010 affected276 at risk EG0020 affected6 at risk EG003
Small intestinal obstruction	Gastrointestinal disorders	MedDRA 21.1	Systematic Assessment	EG0000 affected280 at risk EG0011 affected276 at risk EG0020 affected6 at risk EG003
Umbilical hernia	Gastrointestinal disorders	MedDRA 21.1	Systematic Assessment	EG0000 affected280 at risk EG0011 affected276 at risk EG0020 affected6 at risk EG003
Asthenia	General disorders	MedDRA 21.1	Systematic Assessment	EG0001 affected280 at risk EG0010 affected276 at risk EG0020 affected6 at risk EG003
Chest pain	General disorders	MedDRA 21.1	Systematic Assessment	EG0002 affected280 at risk EG0010 affected276 at risk EG0020 affected6 at risk EG003
Death	General disorders	MedDRA 21.1	Systematic Assessment	EG0001 affected280 at risk EG0010 affected276 at risk EG0020 affected6 at risk EG003
Sudden cardiac death	General disorders	MedDRA 21.1	Systematic Assessment	EG0001 affected280 at risk EG0010 affected276 at risk EG0020 affected6 at risk EG003
Abdominal wall abscess	Infections and infestations	MedDRA 21.1	Systematic Assessment	EG0000 affected280 at risk EG0011 affected276 at risk EG0020 affected6 at risk EG003
Abscess neck	Infections and infestations	MedDRA 21.1	Systematic Assessment	EG0001 affected280 at risk EG0010 affected276 at risk EG0020 affected6 at risk EG003
Acute hepatitis C	Infections and infestations	MedDRA 21.1	Systematic Assessment	EG0000 affected280 at risk EG0011 affected276 at risk EG0020 affected6 at risk EG003
Appendicitis	Infections and infestations	MedDRA 21.1	Systematic Assessment	EG0001 affected280 at risk EG0011 affected276 at risk EG0020 affected6 at risk EG003
Clostridium difficile infection	Infections and infestations	MedDRA 21.1	Systematic Assessment	EG0001 affected280 at risk EG0010 affected276 at risk EG0020 affected6 at risk EG003
Dengue fever	Infections and infestations	MedDRA 21.1	Systematic Assessment	EG0001 affected280 at risk EG0010 affected276 at risk EG0020 affected6 at risk EG003
Diarrhoea infectious	Infections and infestations	MedDRA 21.1	Systematic Assessment	EG0001 affected280 at risk EG0010 affected276 at risk EG0020 affected6 at risk EG003
Diverticulitis	Infections and infestations	MedDRA 21.1	Systematic Assessment	EG0001 affected280 at risk EG0010 affected276 at risk EG0020 affected6 at risk EG003
Erysipelas	Infections and infestations	MedDRA 21.1	Systematic Assessment	EG0001 affected280 at risk EG0010 affected276 at risk EG0020 affected6 at risk EG003
Escherichia pyelonephritis	Infections and infestations	MedDRA 21.1	Systematic Assessment	EG0001 affected280 at risk EG0010 affected276 at risk EG0020 affected6 at risk EG003
Gastroenteritis	Infections and infestations	MedDRA 21.1	Systematic Assessment	EG0000 affected280 at risk EG0012 affected276 at risk EG0020 affected6 at risk EG003
Groin abscess	Infections and infestations	MedDRA 21.1	Systematic Assessment	EG0001 affected280 at risk EG0010 affected276 at risk EG0020 affected6 at risk EG003
Herpes zoster oticus	Infections and infestations	MedDRA 21.1	Systematic Assessment	EG0001 affected280 at risk EG0010 affected276 at risk EG0020 affected6 at risk EG003
Oesophageal candidiasis	Infections and infestations	MedDRA 21.1	Systematic Assessment	EG0001 affected280 at risk EG0010 affected276 at risk EG0020 affected6 at risk EG003
Peritonitis	Infections and infestations	MedDRA 21.1	Systematic Assessment	EG0001 affected280 at risk EG0010 affected276 at risk EG0020 affected6 at risk EG003
Pneumonia	Infections and infestations	MedDRA 21.1	Systematic Assessment	EG0005 affected280 at risk EG0012 affected276 at risk EG0020 affected6 at risk EG003
Pneumonia legionella	Infections and infestations	MedDRA 21.1	Systematic Assessment	EG0000 affected280 at risk EG0011 affected276 at risk EG0020 affected6 at risk EG003
Postoperative wound infection	Infections and infestations	MedDRA 21.1	Systematic Assessment	EG0000 affected280 at risk EG0011 affected276 at risk EG0020 affected6 at risk EG003
Pyelonephritis	Infections and infestations	MedDRA 21.1	Systematic Assessment	EG0001 affected280 at risk EG0010 affected276 at risk EG0020 affected6 at risk EG003
Respiratory tract infection	Infections and infestations	MedDRA 21.1	Systematic Assessment	EG0001 affected280 at risk EG0010 affected276 at risk EG0020 affected6 at risk EG003
Staphylococcal abscess	Infections and infestations	MedDRA 21.1	Systematic Assessment	EG0000 affected280 at risk EG0011 affected276 at risk EG0020 affected6 at risk EG003
Staphylococcal infection	Infections and infestations	MedDRA 21.1	Systematic Assessment	EG0001 affected280 at risk EG0010 affected276 at risk EG0020 affected6 at risk EG003
Urosepsis	Infections and infestations	MedDRA 21.1	Systematic Assessment	EG0001 affected280 at risk EG0012 affected276 at risk EG0020 affected6 at risk EG003
Viral myocarditis	Infections and infestations	MedDRA 21.1	Systematic Assessment	EG0000 affected280 at risk EG0011 affected276 at risk EG0020 affected6 at risk EG003
Fall	Injury, poisoning and procedural complications	MedDRA 21.1	Systematic Assessment	EG0001 affected280 at risk EG0010 affected276 at risk EG0020 affected6 at risk EG003
Femoral neck fracture	Injury, poisoning and procedural complications	MedDRA 21.1	Systematic Assessment	EG0000 affected280 at risk EG0011 affected276 at risk EG0020 affected6 at risk EG003
Femur fracture	Injury, poisoning and procedural complications	MedDRA 21.1	Systematic Assessment	EG0000 affected280 at risk EG0011 affected276 at risk EG0020 affected6 at risk EG003
Fibula fracture	Injury, poisoning and procedural complications	MedDRA 21.1	Systematic Assessment	EG0001 affected280 at risk EG0010 affected276 at risk EG0020 affected6 at risk EG003
Meniscus injury	Injury, poisoning and procedural complications	MedDRA 21.1	Systematic Assessment	EG0001 affected280 at risk EG0010 affected276 at risk EG0020 affected6 at risk EG003
Poisoning	Injury, poisoning and procedural complications	MedDRA 21.1	Systematic Assessment	EG0001 affected280 at risk EG0010 affected276 at risk EG0020 affected6 at risk EG003
Road traffic accident	Injury, poisoning and procedural complications	MedDRA 21.1	Systematic Assessment	EG0001 affected280 at risk EG0010 affected276 at risk EG0020 affected6 at risk EG003
Seroma	Injury, poisoning and procedural complications	MedDRA 21.1	Systematic Assessment	EG0001 affected280 at risk EG0010 affected276 at risk EG0020 affected6 at risk EG003
Uterine perforation	Injury, poisoning and procedural complications	MedDRA 21.1	Systematic Assessment	EG0000 affected280 at risk EG0011 affected276 at risk EG0020 affected6 at risk EG003
Blood creatine phosphokinase increased	Investigations	MedDRA 21.1	Systematic Assessment	EG0001 affected280 at risk EG0010 affected276 at risk EG0020 affected6 at risk EG003
Transaminases increased	Investigations	MedDRA 21.1	Systematic Assessment	EG0000 affected280 at risk EG0011 affected276 at risk EG0020 affected6 at risk EG003
Viral load increased	Investigations	MedDRA 21.1	Systematic Assessment	EG0001 affected280 at risk EG0010 affected276 at risk EG0020 affected6 at risk EG003
Dehydration	Metabolism and nutrition disorders	MedDRA 21.1	Systematic Assessment	EG0000 affected280 at risk EG0011 affected276 at risk EG0020 affected6 at risk EG003
Diabetic ketoacidosis	Metabolism and nutrition disorders	MedDRA 21.1	Systematic Assessment	EG0001 affected280 at risk EG0010 affected276 at risk EG0020 affected6 at risk EG003
Hyponatraemia	Metabolism and nutrition disorders	MedDRA 21.1	Systematic Assessment	EG0000 affected280 at risk EG0011 affected276 at risk EG0020 affected6 at risk EG003
Type 2 diabetes mellitus	Metabolism and nutrition disorders	MedDRA 21.1	Systematic Assessment	EG0002 affected280 at risk EG0010 affected276 at risk EG0020 affected6 at risk EG003
Intervertebral disc protrusion	Musculoskeletal and connective tissue disorders	MedDRA 21.1	Systematic Assessment	EG0001 affected280 at risk EG0011 affected276 at risk EG0020 affected6 at risk EG003
Osteonecrosis	Musculoskeletal and connective tissue disorders	MedDRA 21.1	Systematic Assessment	EG0001 affected280 at risk EG0010 affected276 at risk EG0020 affected6 at risk EG003
Pathological fracture	Musculoskeletal and connective tissue disorders	MedDRA 21.1	Systematic Assessment	EG0001 affected280 at risk EG0010 affected276 at risk EG0020 affected6 at risk EG003
Rhabdomyolysis	Musculoskeletal and connective tissue disorders	MedDRA 21.1	Systematic Assessment	EG0000 affected280 at risk EG0011 affected276 at risk EG0020 affected6 at risk EG003
Rotator cuff syndrome	Musculoskeletal and connective tissue disorders	MedDRA 21.1	Systematic Assessment	EG0000 affected280 at risk EG0011 affected276 at risk EG0020 affected6 at risk EG003
Acute myeloid leukaemia	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.1	Systematic Assessment	EG0001 affected280 at risk EG0010 affected276 at risk EG0020 affected6 at risk EG003
Anal cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.1	Systematic Assessment	EG0001 affected280 at risk EG0010 affected276 at risk EG0020 affected6 at risk EG003
Anogenital warts	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.1	Systematic Assessment	EG0001 affected280 at risk EG0010 affected276 at risk EG0020 affected6 at risk EG003
Bladder transitional cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.1	Systematic Assessment	EG0001 affected280 at risk EG0010 affected276 at risk EG0020 affected6 at risk EG003
Choroid melanoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.1	Systematic Assessment	EG0001 affected280 at risk EG0010 affected276 at risk EG0020 affected6 at risk EG003
Colon cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.1	Systematic Assessment	EG0001 affected280 at risk EG0010 affected276 at risk EG0020 affected6 at risk EG003
Ganglioneuroma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.1	Systematic Assessment	EG0001 affected280 at risk EG0010 affected276 at risk EG0020 affected6 at risk EG003
Hodgkin's disease	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.1	Systematic Assessment	EG0002 affected280 at risk EG0010 affected276 at risk EG0020 affected6 at risk EG003
Lung cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.1	Systematic Assessment	EG0001 affected280 at risk EG0011 affected276 at risk EG0020 affected6 at risk EG003
Ovarian cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.1	Systematic Assessment	EG0001 affected280 at risk EG0010 affected276 at risk EG0020 affected6 at risk EG003
Prostate cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.1	Systematic Assessment	EG0001 affected280 at risk EG0010 affected276 at risk EG0020 affected6 at risk EG003
Rectal cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.1	Systematic Assessment	EG0001 affected280 at risk EG0010 affected276 at risk EG0020 affected6 at risk EG003
Cerebral haemorrhage	Nervous system disorders	MedDRA 21.1	Systematic Assessment	EG0001 affected280 at risk EG0010 affected276 at risk EG0020 affected6 at risk EG003
Cerebral infarction	Nervous system disorders	MedDRA 21.1	Systematic Assessment	EG0001 affected280 at risk EG0010 affected276 at risk EG0020 affected6 at risk EG003
Epilepsy	Nervous system disorders	MedDRA 21.1	Systematic Assessment	EG0001 affected280 at risk EG0010 affected276 at risk EG0020 affected6 at risk EG003
Hydrocephalus	Nervous system disorders	MedDRA 21.1	Systematic Assessment	EG0001 affected280 at risk EG0010 affected276 at risk EG0020 affected6 at risk EG003
Loss of consciousness	Nervous system disorders	MedDRA 21.1	Systematic Assessment	EG0001 affected280 at risk EG0010 affected276 at risk EG0020 affected6 at risk EG003
Metabolic encephalopathy	Nervous system disorders	MedDRA 21.1	Systematic Assessment	EG0001 affected280 at risk EG0010 affected276 at risk EG0020 affected6 at risk EG003
Presyncope	Nervous system disorders	MedDRA 21.1	Systematic Assessment	EG0001 affected280 at risk EG0010 affected276 at risk EG0020 affected6 at risk EG003
Seizure	Nervous system disorders	MedDRA 21.1	Systematic Assessment	EG0001 affected280 at risk EG0010 affected276 at risk EG0020 affected6 at risk EG003
Transient ischaemic attack	Nervous system disorders	MedDRA 21.1	Systematic Assessment	EG0001 affected280 at risk EG0010 affected276 at risk EG0020 affected6 at risk EG003
Alcohol abuse	Psychiatric disorders	MedDRA 21.1	Systematic Assessment	EG0000 affected280 at risk EG0011 affected276 at risk EG0020 affected6 at risk EG003
Bipolar disorder	Psychiatric disorders	MedDRA 21.1	Systematic Assessment	EG0001 affected280 at risk EG0010 affected276 at risk EG0020 affected6 at risk EG003
Depression	Psychiatric disorders	MedDRA 21.1	Systematic Assessment	EG0000 affected280 at risk EG0011 affected276 at risk EG0020 affected6 at risk EG003
Drug abuse	Psychiatric disorders	MedDRA 21.1	Systematic Assessment	EG0001 affected280 at risk EG0010 affected276 at risk EG0020 affected6 at risk EG003
Intentional self-injury	Psychiatric disorders	MedDRA 21.1	Systematic Assessment	EG0000 affected280 at risk EG0011 affected276 at risk EG0020 affected6 at risk EG003
Psychotic disorder	Psychiatric disorders	MedDRA 21.1	Systematic Assessment	EG0001 affected280 at risk EG0011 affected276 at risk EG0020 affected6 at risk EG003
Schizophrenia	Psychiatric disorders	MedDRA 21.1	Systematic Assessment	EG0000 affected280 at risk EG0011 affected276 at risk EG0020 affected6 at risk EG003
Substance abuse	Psychiatric disorders	MedDRA 21.1	Systematic Assessment	EG0001 affected280 at risk EG0010 affected276 at risk EG0020 affected6 at risk EG003
Suicide attempt	Psychiatric disorders	MedDRA 21.1	Systematic Assessment	EG0002 affected280 at risk EG0011 affected276 at risk EG0020 affected6 at risk EG003
Acute kidney injury	Renal and urinary disorders	MedDRA 21.1	Systematic Assessment	EG0003 affected280 at risk EG0010 affected276 at risk EG0020 affected6 at risk EG003
Nephrolithiasis	Renal and urinary disorders	MedDRA 21.1	Systematic Assessment	EG0001 affected280 at risk EG0010 affected276 at risk EG0020 affected6 at risk EG003
Renal colic	Renal and urinary disorders	MedDRA 21.1	Systematic Assessment	EG0001 affected280 at risk EG0010 affected276 at risk EG0020 affected6 at risk EG003
Benign prostatic hyperplasia	Reproductive system and breast disorders	MedDRA 21.1	Systematic Assessment	EG0000 affected280 at risk EG0011 affected276 at risk EG0020 affected6 at risk EG003
Pneumonia aspiration	Respiratory, thoracic and mediastinal disorders	MedDRA 21.1	Systematic Assessment	EG0001 affected280 at risk EG0010 affected276 at risk EG0020 affected6 at risk EG003
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA 21.1	Systematic Assessment	EG0000 affected280 at risk EG0013 affected276 at risk EG0020 affected6 at risk EG003
Substance use	Social circumstances	MedDRA 21.1	Systematic Assessment	EG0001 affected280 at risk EG0010 affected276 at risk EG0020 affected6 at risk EG003
Deep vein thrombosis	Vascular disorders	MedDRA 21.1	Systematic Assessment	EG0002 affected280 at risk EG0013 affected276 at risk EG0020 affected6 at risk EG003
Hypertension	Vascular disorders	MedDRA 21.1	Systematic Assessment	EG0001 affected280 at risk EG0010 affected276 at risk EG0020 affected6 at risk EG003

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Diarrhoea	Gastrointestinal disorders	MedDRA 21.1	Systematic Assessment	EG00030 affected280 at risk EG00137 affected276 at risk EG0020 affected6 at risk EG0030 affected5 at risk
Nausea	Gastrointestinal disorders	MedDRA 21.1	Systematic Assessment	EG00014 affected280 at risk EG00111 affected276 at risk EG0020 affected6 at risk EG003
Vomiting	Gastrointestinal disorders	MedDRA 21.1	Systematic Assessment	EG00014 affected280 at risk EG00110 affected276 at risk EG0020 affected6 at risk EG003
Fatigue	General disorders	MedDRA 21.1	Systematic Assessment	EG00021 affected280 at risk EG00115 affected276 at risk EG0020 affected6 at risk EG003
Bronchitis	Infections and infestations	MedDRA 21.1	Systematic Assessment	EG00019 affected280 at risk EG00114 affected276 at risk EG0020 affected6 at risk EG003
Gastroenteritis	Infections and infestations	MedDRA 21.1	Systematic Assessment	EG00011 affected280 at risk EG00115 affected276 at risk EG0020 affected6 at risk EG003
Influenza	Infections and infestations	MedDRA 21.1	Systematic Assessment	EG00012 affected280 at risk EG00115 affected276 at risk EG0020 affected6 at risk EG003
Nasopharyngitis	Infections and infestations	MedDRA 21.1	Systematic Assessment	EG00057 affected280 at risk EG00149 affected276 at risk EG0020 affected6 at risk EG003
Rhinitis	Infections and infestations	MedDRA 21.1	Systematic Assessment	EG0007 affected280 at risk EG0016 affected276 at risk EG0020 affected6 at risk EG003
Syphilis	Infections and infestations	MedDRA 21.1	Systematic Assessment	EG00015 affected280 at risk EG0015 affected276 at risk EG0020 affected6 at risk EG003
Upper respiratory tract infection	Infections and infestations	MedDRA 21.1	Systematic Assessment	EG00036 affected280 at risk EG00146 affected276 at risk EG0020 affected6 at risk EG003
Urinary tract infection	Infections and infestations	MedDRA 21.1	Systematic Assessment	EG00013 affected280 at risk EG00118 affected276 at risk EG0020 affected6 at risk EG003
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 21.1	Systematic Assessment	EG00028 affected280 at risk EG00129 affected276 at risk EG0020 affected6 at risk EG003
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 21.1	Systematic Assessment	EG00024 affected280 at risk EG00131 affected276 at risk EG0020 affected6 at risk EG003
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	MedDRA 21.1	Systematic Assessment	EG00011 affected280 at risk EG00114 affected276 at risk EG0020 affected6 at risk EG003
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA 21.1	Systematic Assessment	EG00022 affected280 at risk EG00115 affected276 at risk EG0020 affected6 at risk EG003
Spinal pain	Musculoskeletal and connective tissue disorders	MedDRA 21.1	Systematic Assessment	EG0000 affected280 at risk EG0011 affected276 at risk EG0021 affected6 at risk EG003
Headache	Nervous system disorders	MedDRA 21.1	Systematic Assessment	EG00031 affected280 at risk EG00125 affected276 at risk EG0020 affected6 at risk EG003
Renal colic	Renal and urinary disorders	MedDRA 21.1	Systematic Assessment	EG0001 affected280 at risk EG0010 affected276 at risk EG0020 affected6 at risk EG003
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 21.1	Systematic Assessment	EG00034 affected280 at risk EG00130 affected276 at risk EG0020 affected6 at risk EG003
Rash	Skin and subcutaneous tissue disorders	MedDRA 21.1	Systematic Assessment	EG00014 affected280 at risk EG00117 affected276 at risk EG0020 affected6 at risk EG003
Hypertension	Vascular disorders	MedDRA 21.1	Systematic Assessment	EG00015 affected280 at risk EG00115 affected276 at risk EG0020 affected6 at risk EG003

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	F/TAF (Double-Blind Phase)	Adverse events reported occurred during the Double-Blind Phase in participants from the F/TAF group, who received F/TAF (200/10 mg) FDC tablet (with boosted 3rd ARV agent) or F/TAF (200/25 mg) FDC tablet (with unboosted 3rd ARV agent) + ABC/3TC placebo tablet once daily.	5	280	55	280	190	280
EG001	ABC/3TC (Double-Blind Phase)	Adverse events reported occurred during the Double-Blind Phase in participants from the ABC/3TC group, who received ABC/3TC (600/300 mg) FDC tablet + F/TAF placebo tablet once daily + allowed 3rd ARV agent.	0	276	32	276	199	276
EG002	Open-Label F/TAF From F/TAF	Adverse events reported occurred during the Open-Label Extension Phase in participants who enrolled into the Open-Label Extension Phase from the F/TAF group and received F/TAF (200/10 mg or 200/25 mg) FDC tablet once daily.	0	6	0	6	1	6
EG003	Open-Label F/TAF From ABC/3TC	Adverse events reported occurred during the Open-Label Extension Phase in participants who enrolled into the Open-Label Extension Phase from the ABC/3TC group and received F/TAF (200/10 mg or 200/25 mg) FDC tablet once daily.	0	5	0	5	2	5

ID	Title	Description
BG000	F/TAF	F/TAF (200/10 mg) FDC tablet (with boosted 3rd ARV agent) or F/TAF (200/25 mg) FDC tablet (with unboosted 3rd ARV agent) + ABC/3TC placebo tablet once daily for 96 weeks
BG001	ABC/3TC	ABC/3TC (600/300 mg) FDC tablet + F/TAF placebo tablet once daily + allowed 3rd ARV agent for 96 weeks
BG002	Total	Total of all reporting groups