Switching to a Fixed Dose Combination of Bictegravir/Emtr... | NCT03110380

NCT03110380

ID	Type	Description	Link
2017-000308-17	EudraCT Number

Status Module

Oversight Module

Description Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
B/F/TAF	Experimental	Bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) fixed-dose combination (FDC) tablet + dolutegravir (DTG) placebo tablet + emtricitabine/tenofovir alafenamide (F/TAF) placebo tablet administered without regard to food for at least 48 weeks.	Drug: B/F/TAF Drug: DTG Placebo Drug: F/TAF Placebo
DTG + F/TAF	Active Comparator	DTG 50 mg tablet + F/TAF FDC tablet + B/F/TAF placebo tablet administered without regard to food for at least 48 weeks.	Drug: F/TAF Drug: DTG Drug: B/F/TAF Placebo
Open-label Phase B/F/TAF from B/F/TAF	Experimental	Participants who received B/F/TAF in double-blind phase and from a country where B/F/TAF was not available were given the option to receive B/F/TAF orally once daily for up to 96 weeks in the open-label extension phase.	Drug: B/F/TAF
Open-label Phase B/F/TAF from DTG + F/TAF	Experimental	Participants who received DTG + F/TAF in double-blind phase and from a country where B/F/TAF was not available were given the option to receive B/F/TAF orally once daily for up to 96 weeks in the open-label extension phase.	Drug: B/F/TAF

Interventions

Name	Type	Description	Arm Group Labels	Other Names
B/F/TAF	Drug	50/200/25 mg FDC tablet(s) administered orally once daily	B/F/TAF Open-label Phase B/F/TAF from B/F/TAF Open-label Phase B/F/TAF from DTG + F/TAF

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Percentage of Participants With HIV-1 RNA ≥ 50 Copies/mL at Week 48 as Defined by the US 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.	Week 48

Secondary Outcomes

Measure	Description	Time Frame
Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 48 as Defined by the US 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.

Eligibility Module

Name	Affiliation	Role
Gilead Study Director	Gilead Sciences	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Spectrum Medical Group		Phoenix	Arizona	85012	United States
Ruane Clinical Research Group Inc.

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
32668455	Result	Sax PE, Rockstroh JK, Luetkemeyer AF, Yazdanpanah Y, Ward D, Trottier B, Rieger A, Liu H, Acosta R, Collins SE, Brainard DM, Martin H; GS-US-380-4030 Investigators. Switching to Bictegravir, Emtricitabine, and Tenofovir Alafenamide in Virologically Suppressed Adults With Human Immunodeficiency Virus. Clin Infect Dis. 2021 Jul 15;73(2):e485-e493. doi: 10.1093/cid/ciaa988.
32701823

IPD Sharing Statement Module

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	B/F/TAF	Bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) (50/200/25 mg) fixed-dose combination (FDC) tablet + dolutegravir (DTG) placebo tablet + emtricitabine/tenofovir alafenamide (F/TAF) placebo tablet administered orally once daily without regard to food for at least 48 weeks.
FG001

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Jun 28, 2018	Oct 3, 2019

Arm/Group Information

ID	Title	Description
BG000	B/F/TAF	B/F/TAF (50/200/25 mg) FDC tablet + DTG placebo tablet + F/TAF placebo tablet administered orally once daily without regard to food for at least 48 weeks.
BG001	DTG + F/TAF	DTG 50 mg tablet + F/TAF (200/25 mg) FDC tablet + B/F/TAF placebo tablet administered orally once daily without regard to food for at least 48 weeks.
BG002	Total	Total of all reporting groups

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Mean

Standard Deviation

years

Title

Denominators

Categories

Title	Measurements
	BG00050± 11.3 BG00149± 11.3 BG00250± 11.3

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG00039 BG00141 BG002

Race/Ethnicity, Customized

Count of Participants

Participants

Title

Denominators

Categories

Race

Title	Measurements
American Indian or Alaska Native	BG0000 BG0011 BG002

Race/Ethnicity, Customized

Count of Participants

Participants

Title

Denominators

Categories

Ethnicity

Title	Measurements
Hispanic or Latino	BG00061 BG00149 BG002

Region of Enrollment

Count of Participants

Participants

Title

Denominators

Categories

Canada

Title	Measurements
	BG00024 BG00125 BG002

HIV-1 RNA Category

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
< 50 copies/mL	BG000276 BG001275 BG002

CD4 Cell Count

Mean

Standard Deviation

Cells/μL

Title

Denominators

Categories

Title	Measurements
	BG000714± 309.1 BG001658± 294.7 BG002

CD4 Cell Count Category

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
< 50 Cells/ μL	BG0000 BG0011 BG002

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 Defined by the US 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.

The Full Analysis Set included participants who were randomized and received at least 1 dose of study drug.

Posted

Number

percentage of participants

Week 48

ID	Title	Description
OG000	B/F/TAF	B/F/TAF (50/200/25 mg) FDC tablet + DTG placebo tablet + F/TAF placebo tablet administered orally once daily without regard to food for at least 48 weeks.
OG001	DTG + F/TAF	DTG 50 mg tablet + F/TAF (200/25 mg) FDC tablet + B/F/TAF placebo tablet administered orally once daily without regard to food for at least 48 weeks.

Units	Counts
Participants	OG000284 OG001281

Title

Denominators

Categories

Title	Measurements
	OG0000.4 OG0011.1

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 null hypothesis was that the B/F/TAF group is at least 4% higher than the DTG + F/TAF group with respect to the percentage of participants with HIV-1 RNA ≥ 50 copies/mL as determined by the US FDA-defined snapshot algorithm at Week 48; the alternative hypothesis was that the B/F/TAF group is less than 4% higher than the DTG + F/TAF group with respect to the percentage of participants with HIV-1 RNA ≥ 50 copies/mL at Week 48.					Difference in Percentages	-0.7			2-Sided	95.001	-2.8	1.0			The differences in percentages of participants between treatment groups and their 95.001% confidence intervals (CI) were calculated based on an unconditional exact method using 2 inverted 1-sided tests.

Secondary

Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 48 as Defined by the US 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.

Participants in the Full Analysis Set were analyzed.

Posted

Number

percentage of participants

Week 48

ID	Title	Description
OG000	B/F/TAF	B/F/TAF (50/200/25 mg) FDC tablet + DTG placebo tablet + F/TAF placebo tablet administered orally once daily without regard to food for at least 48 weeks.
OG001	DTG + F/TAF	DTG 50 mg tablet + F/TAF (200/25 mg) FDC tablet + B/F/TAF placebo tablet administered orally once daily without regard to food for at least 48 weeks.

Units	Counts
Participants

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	B/F/TAF	B/F/TAF (50/200/25 mg) FDC tablet + DTG placebo tablet + F/TAF placebo tablet administered orally once daily without regard to food for at least 48 weeks.
OG001	DTG + F/TAF	DTG 50 mg tablet + F/TAF (200/25 mg) FDC tablet + B/F/TAF placebo tablet administered orally once daily without regard to food for at least 48 weeks.

Units	Counts
Participants	OG000

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Double-Blind Treatment Phase B/F/TAF	B/F/TAF (50/200/25 mg) FDC tablet + DTG placebo tablet + F/TAF placebo tablet administered orally once daily without regard to food for atleast 48 weeks.	3	284	36	284	181	284
EG001	Double-Blind Treatment Phase DTG + F/TAF	DTG 50 mg tablet + F/TAF (200/25 mg) FDC tablet + B/F/TAF placebo tablet administered orally once daily without regard to food for atleast 48 weeks.	2	283	27	281	170	281
EG002	Open-label Extension Phase B/F/TAF From B/F/TAF	Participants who received B/F/TAF in double-blind phase and from a country where B/F/TAF was not available were given the option to receive B/F/TAF orally once daily for up to 96 weeks in the open-label extension phase.	0	125	12	125	30	125
EG003	Open-label Extension Phase B/F/TAF From DTG + F/TAF	Participants who received DTG + F/TAF in double-blind phase and from a country where B/F/TAF was not available were given the option to receive B/F/TAF orally once daily for up to 96 weeks in the open-label extension phase.	0	117	11	116	33	116

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Lymphocytic infiltration	Blood and lymphatic system disorders	MedDRA 23.1	Systematic Assessment	EG0000 affected284 at risk EG0010 affected281 at risk EG0020 affected125 at risk EG0031 affected116 at risk
Acute myocardial infarction	Cardiac disorders	MedDRA 23.1	Systematic Assessment	EG0000 affected284 at risk EG0010 affected281 at risk EG0022 affected125 at risk EG003
Angina pectoris	Cardiac disorders	MedDRA 23.1	Systematic Assessment	EG0000 affected284 at risk EG0011 affected281 at risk EG0020 affected125 at risk EG003
Cardiac failure congestive	Cardiac disorders	MedDRA 23.1	Systematic Assessment	EG0001 affected284 at risk EG0010 affected281 at risk EG0020 affected125 at risk EG003
Cardio-respiratory arrest	Cardiac disorders	MedDRA 23.1	Systematic Assessment	EG0001 affected284 at risk EG0010 affected281 at risk EG0020 affected125 at risk EG003
Coronary artery disease	Cardiac disorders	MedDRA 23.1	Systematic Assessment	EG0002 affected284 at risk EG0010 affected281 at risk EG0020 affected125 at risk EG003
Myocardial infarction	Cardiac disorders	MedDRA 23.1	Systematic Assessment	EG0000 affected284 at risk EG0011 affected281 at risk EG0020 affected125 at risk EG003
Sinus tachycardia	Cardiac disorders	MedDRA 23.1	Systematic Assessment	EG0001 affected284 at risk EG0010 affected281 at risk EG0020 affected125 at risk EG003
Ventricular tachycardia	Cardiac disorders	MedDRA 23.1	Systematic Assessment	EG0001 affected284 at risk EG0010 affected281 at risk EG0020 affected125 at risk EG003
Abdominal pain	Gastrointestinal disorders	MedDRA 23.1	Systematic Assessment	EG0000 affected284 at risk EG0011 affected281 at risk EG0020 affected125 at risk EG003
Colitis	Gastrointestinal disorders	MedDRA 23.1	Systematic Assessment	EG0000 affected284 at risk EG0011 affected281 at risk EG0020 affected125 at risk EG003
Inguinal hernia	Gastrointestinal disorders	MedDRA 23.1	Systematic Assessment	EG0000 affected284 at risk EG0011 affected281 at risk EG0020 affected125 at risk EG003
Large intestine perforation	Gastrointestinal disorders	MedDRA 23.1	Systematic Assessment	EG0001 affected284 at risk EG0010 affected281 at risk EG0020 affected125 at risk EG003
Obstructive pancreatitis	Gastrointestinal disorders	MedDRA 23.1	Systematic Assessment	EG0000 affected284 at risk EG0010 affected281 at risk EG0021 affected125 at risk EG003
Vomiting	Gastrointestinal disorders	MedDRA 23.1	Systematic Assessment	EG0000 affected284 at risk EG0011 affected281 at risk EG0021 affected125 at risk EG003
Chest pain	General disorders	MedDRA 23.1	Systematic Assessment	EG0001 affected284 at risk EG0010 affected281 at risk EG0021 affected125 at risk EG003
Death	General disorders	MedDRA 23.1	Systematic Assessment	EG0000 affected284 at risk EG0011 affected281 at risk EG0020 affected125 at risk EG003
Non-cardiac chest pain	General disorders	MedDRA 23.1	Systematic Assessment	EG0000 affected284 at risk EG0010 affected281 at risk EG0020 affected125 at risk EG003
Biliary dyskinesia	Hepatobiliary disorders	MedDRA 23.1	Systematic Assessment	EG0001 affected284 at risk EG0010 affected281 at risk EG0020 affected125 at risk EG003
Cholangitis acute	Hepatobiliary disorders	MedDRA 23.1	Systematic Assessment	EG0000 affected284 at risk EG0010 affected281 at risk EG0020 affected125 at risk EG003
Cholecystitis	Hepatobiliary disorders	MedDRA 23.1	Systematic Assessment	EG0001 affected284 at risk EG0011 affected281 at risk EG0020 affected125 at risk EG003
Cholecystitis acute	Hepatobiliary disorders	MedDRA 23.1	Systematic Assessment	EG0000 affected284 at risk EG0011 affected281 at risk EG0020 affected125 at risk EG003
Anti-neutrophil cytoplasmic antibody positive vasculitis	Immune system disorders	MedDRA 23.1	Systematic Assessment	EG0000 affected284 at risk EG0010 affected281 at risk EG0020 affected125 at risk EG003
Appendicitis	Infections and infestations	MedDRA 23.1	Systematic Assessment	EG0000 affected284 at risk EG0011 affected281 at risk EG0020 affected125 at risk EG003
Bronchitis	Infections and infestations	MedDRA 23.1	Systematic Assessment	EG0000 affected284 at risk EG0011 affected281 at risk EG0020 affected125 at risk EG003
Cellulitis	Infections and infestations	MedDRA 23.1	Systematic Assessment	EG0001 affected284 at risk EG0010 affected281 at risk EG0020 affected125 at risk EG003
Cellulitis orbital	Infections and infestations	MedDRA 23.1	Systematic Assessment	EG0001 affected284 at risk EG0010 affected281 at risk EG0020 affected125 at risk EG003
Colonic abscess	Infections and infestations	MedDRA 23.1	Systematic Assessment	EG0000 affected284 at risk EG0010 affected281 at risk EG0020 affected125 at risk EG003
Covid-19 pneumonia	Infections and infestations	MedDRA 23.1	Systematic Assessment	EG0000 affected284 at risk EG0010 affected281 at risk EG0021 affected125 at risk EG003
Device related infection	Infections and infestations	MedDRA 23.1	Systematic Assessment	EG0001 affected284 at risk EG0010 affected281 at risk EG0020 affected125 at risk EG003
Diarrhoea infectious	Infections and infestations	MedDRA 23.1	Systematic Assessment	EG0001 affected284 at risk EG0010 affected281 at risk EG0020 affected125 at risk EG003
Diverticulitis	Infections and infestations	MedDRA 23.1	Systematic Assessment	EG0002 affected284 at risk EG0011 affected281 at risk EG0020 affected125 at risk EG003
Epididymitis	Infections and infestations	MedDRA 23.1	Systematic Assessment	EG0000 affected284 at risk EG0010 affected281 at risk EG0020 affected125 at risk EG003
Gastroenteritis	Infections and infestations	MedDRA 23.1	Systematic Assessment	EG0001 affected284 at risk EG0010 affected281 at risk EG0020 affected125 at risk EG003
Meningitis	Infections and infestations	MedDRA 23.1	Systematic Assessment	EG0001 affected284 at risk EG0010 affected281 at risk EG0020 affected125 at risk EG003
Perirectal abscess	Infections and infestations	MedDRA 23.1	Systematic Assessment	EG0001 affected284 at risk EG0010 affected281 at risk EG0020 affected125 at risk EG003
Pneumonia	Infections and infestations	MedDRA 23.1	Systematic Assessment	EG0001 affected284 at risk EG0012 affected281 at risk EG0020 affected125 at risk EG003
Post procedural infection	Infections and infestations	MedDRA 23.1	Systematic Assessment	EG0001 affected284 at risk EG0010 affected281 at risk EG0020 affected125 at risk EG003
Pyelonephritis	Infections and infestations	MedDRA 23.1	Systematic Assessment	EG0001 affected284 at risk EG0011 affected281 at risk EG0020 affected125 at risk EG003
Sepsis	Infections and infestations	MedDRA 23.1	Systematic Assessment	EG0000 affected284 at risk EG0010 affected281 at risk EG0020 affected125 at risk EG003
Viral upper respiratory tract infection	Infections and infestations	MedDRA 23.1	Systematic Assessment	EG0000 affected284 at risk EG0011 affected281 at risk EG0020 affected125 at risk EG003
Wound infection	Infections and infestations	MedDRA 23.1	Systematic Assessment	EG0000 affected284 at risk EG0010 affected281 at risk EG0021 affected125 at risk EG003
Ankle fracture	Injury, poisoning and procedural complications	MedDRA 23.1	Systematic Assessment	EG0000 affected284 at risk EG0011 affected281 at risk EG0020 affected125 at risk EG003
Clavicle fracture	Injury, poisoning and procedural complications	MedDRA 23.1	Systematic Assessment	EG0001 affected284 at risk EG0010 affected281 at risk EG0020 affected125 at risk EG003
Concussion	Injury, poisoning and procedural complications	MedDRA 23.1	Systematic Assessment	EG0001 affected284 at risk EG0010 affected281 at risk EG0020 affected125 at risk EG003
Facial bones fracture	Injury, poisoning and procedural complications	MedDRA 23.1	Systematic Assessment	EG0000 affected284 at risk EG0010 affected281 at risk EG0021 affected125 at risk EG003
Foreign body in gastrointestinal tract	Injury, poisoning and procedural complications	MedDRA 23.1	Systematic Assessment	EG0001 affected284 at risk EG0010 affected281 at risk EG0020 affected125 at risk EG003
Hip fracture	Injury, poisoning and procedural complications	MedDRA 23.1	Systematic Assessment	EG0000 affected284 at risk EG0010 affected281 at risk EG0020 affected125 at risk EG003
Ligament rupture	Injury, poisoning and procedural complications	MedDRA 23.1	Systematic Assessment	EG0001 affected284 at risk EG0010 affected281 at risk EG0020 affected125 at risk EG003
Lisfranc fracture	Injury, poisoning and procedural complications	MedDRA 23.1	Systematic Assessment	EG0000 affected284 at risk EG0011 affected281 at risk EG0020 affected125 at risk EG003
Overdose	Injury, poisoning and procedural complications	MedDRA 23.1	Systematic Assessment	EG0001 affected284 at risk EG0010 affected281 at risk EG0020 affected125 at risk EG003
Rib fracture	Injury, poisoning and procedural complications	MedDRA 23.1	Systematic Assessment	EG0000 affected284 at risk EG0010 affected281 at risk EG0021 affected125 at risk EG003
Subdural haematoma	Injury, poisoning and procedural complications	MedDRA 23.1	Systematic Assessment	EG0000 affected284 at risk EG0010 affected281 at risk EG0021 affected125 at risk EG003
Subdural haemorrhage	Injury, poisoning and procedural complications	MedDRA 23.1	Systematic Assessment	EG0000 affected284 at risk EG0011 affected281 at risk EG0020 affected125 at risk EG003
Tendon rupture	Injury, poisoning and procedural complications	MedDRA 23.1	Systematic Assessment	EG0001 affected284 at risk EG0010 affected281 at risk EG0020 affected125 at risk EG003
Blood glucose increased	Investigations	MedDRA 23.1	Systematic Assessment	EG0000 affected284 at risk EG0011 affected281 at risk EG0020 affected125 at risk EG003
Lipase increased	Investigations	MedDRA 23.1	Systematic Assessment	EG0000 affected284 at risk EG0011 affected281 at risk EG0020 affected125 at risk EG003
Liver function test increased	Investigations	MedDRA 23.1	Systematic Assessment	EG0000 affected284 at risk EG0010 affected281 at risk EG0020 affected125 at risk EG003
Transaminases increased	Investigations	MedDRA 23.1	Systematic Assessment	EG0000 affected284 at risk EG0010 affected281 at risk EG0021 affected125 at risk EG003
Dehydration	Metabolism and nutrition disorders	MedDRA 23.1	Systematic Assessment	EG0001 affected284 at risk EG0010 affected281 at risk EG0020 affected125 at risk EG003
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA 23.1	Systematic Assessment	EG0000 affected284 at risk EG0011 affected281 at risk EG0020 affected125 at risk EG003
Hypokalaemia	Metabolism and nutrition disorders	MedDRA 23.1	Systematic Assessment	EG0000 affected284 at risk EG0010 affected281 at risk EG0021 affected125 at risk EG003
Lumbar spinal stenosis	Musculoskeletal and connective tissue disorders	MedDRA 23.1	Systematic Assessment	EG0001 affected284 at risk EG0010 affected281 at risk EG0020 affected125 at risk EG003
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA 23.1	Systematic Assessment	EG0001 affected284 at risk EG0010 affected281 at risk EG0020 affected125 at risk EG003
Osteonecrosis	Musculoskeletal and connective tissue disorders	MedDRA 23.1	Systematic Assessment	EG0000 affected284 at risk EG0011 affected281 at risk EG0020 affected125 at risk EG003
Osteoporosis	Musculoskeletal and connective tissue disorders	MedDRA 23.1	Systematic Assessment	EG0000 affected284 at risk EG0011 affected281 at risk EG0020 affected125 at risk EG003
Rhabdomyolysis	Musculoskeletal and connective tissue disorders	MedDRA 23.1	Systematic Assessment	EG0001 affected284 at risk EG0010 affected281 at risk EG0020 affected125 at risk EG003
Spondylolisthesis	Musculoskeletal and connective tissue disorders	MedDRA 23.1	Systematic Assessment	EG0000 affected284 at risk EG0011 affected281 at risk EG0020 affected125 at risk EG003
Lung neoplasm malignant	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 23.1	Systematic Assessment	EG0001 affected284 at risk EG0010 affected281 at risk EG0020 affected125 at risk EG003
Metastases to spine	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 23.1	Systematic Assessment	EG0001 affected284 at risk EG0010 affected281 at risk EG0020 affected125 at risk EG003
Yolk sac tumour site unspecified	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 23.1	Systematic Assessment	EG0000 affected284 at risk EG0011 affected281 at risk EG0020 affected125 at risk EG003
Cerebrovascular accident	Nervous system disorders	MedDRA 23.1	Systematic Assessment	EG0000 affected284 at risk EG0010 affected281 at risk EG0021 affected125 at risk EG003
Sciatica	Nervous system disorders	MedDRA 23.1	Systematic Assessment	EG0001 affected284 at risk EG0010 affected281 at risk EG0020 affected125 at risk EG003
Seizure	Nervous system disorders	MedDRA 23.1	Systematic Assessment	EG0001 affected284 at risk EG0010 affected281 at risk EG0020 affected125 at risk EG003
Vertebral artery dissection	Nervous system disorders	MedDRA 23.1	Systematic Assessment	EG0000 affected284 at risk EG0011 affected281 at risk EG0020 affected125 at risk EG003
Alcohol withdrawal syndrome	Psychiatric disorders	MedDRA 23.1	Systematic Assessment	EG0000 affected284 at risk EG0011 affected281 at risk EG0020 affected125 at risk EG003
Drug abuse	Psychiatric disorders	MedDRA 23.1	Systematic Assessment	EG0002 affected284 at risk EG0010 affected281 at risk EG0020 affected125 at risk EG003
Psychotic disorder	Psychiatric disorders	MedDRA 23.1	Systematic Assessment	EG0001 affected284 at risk EG0010 affected281 at risk EG0020 affected125 at risk EG003
Rebound psychosis	Psychiatric disorders	MedDRA 23.1	Systematic Assessment	EG0001 affected284 at risk EG0010 affected281 at risk EG0020 affected125 at risk EG003
Acute kidney injury	Renal and urinary disorders	MedDRA 23.1	Systematic Assessment	EG0000 affected284 at risk EG0010 affected281 at risk EG0020 affected125 at risk EG003
Nephrolithiasis	Renal and urinary disorders	MedDRA 23.1	Systematic Assessment	EG0000 affected284 at risk EG0010 affected281 at risk EG0021 affected125 at risk EG003
Urinary tract obstruction	Renal and urinary disorders	MedDRA 23.1	Systematic Assessment	EG0000 affected284 at risk EG0010 affected281 at risk EG0021 affected125 at risk EG003
Bronchospasm	Respiratory, thoracic and mediastinal disorders	MedDRA 23.1	Systematic Assessment	EG0001 affected284 at risk EG0010 affected281 at risk EG0020 affected125 at risk EG003
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	MedDRA 23.1	Systematic Assessment	EG0001 affected284 at risk EG0010 affected281 at risk EG0020 affected125 at risk EG003
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 23.1	Systematic Assessment	EG0002 affected284 at risk EG0011 affected281 at risk EG0020 affected125 at risk EG003
Pneumonia aspiration	Respiratory, thoracic and mediastinal disorders	MedDRA 23.1	Systematic Assessment	EG0000 affected284 at risk EG0010 affected281 at risk EG0020 affected125 at risk EG003
Pneumonitis	Respiratory, thoracic and mediastinal disorders	MedDRA 23.1	Systematic Assessment	EG0001 affected284 at risk EG0010 affected281 at risk EG0020 affected125 at risk EG003
Pneumothorax	Respiratory, thoracic and mediastinal disorders	MedDRA 23.1	Systematic Assessment	EG0001 affected284 at risk EG0010 affected281 at risk EG0020 affected125 at risk EG003
Purpura	Skin and subcutaneous tissue disorders	MedDRA 23.1	Systematic Assessment	EG0000 affected284 at risk EG0010 affected281 at risk EG0020 affected125 at risk EG003

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Diarrhoea	Gastrointestinal disorders	MedDRA 23.1	Systematic Assessment	EG00026 affected284 at risk EG00135 affected281 at risk EG0024 affected125 at risk EG0037 affected116 at risk
Fatigue	General disorders	MedDRA 23.1	Systematic Assessment	EG00022 affected284 at risk EG0019 affected281 at risk EG0021 affected125 at risk EG003
Bronchitis	Infections and infestations	MedDRA 23.1	Systematic Assessment	EG00018 affected284 at risk EG00114 affected281 at risk EG0024 affected125 at risk EG003
Influenza	Infections and infestations	MedDRA 23.1	Systematic Assessment	EG00019 affected284 at risk EG00117 affected281 at risk EG0022 affected125 at risk EG003
Nasopharyngitis	Infections and infestations	MedDRA 23.1	Systematic Assessment	EG00044 affected284 at risk EG00132 affected281 at risk EG0023 affected125 at risk EG003
Sinusitis	Infections and infestations	MedDRA 23.1	Systematic Assessment	EG00016 affected284 at risk EG00111 affected281 at risk EG0021 affected125 at risk EG003
Upper respiratory tract infection	Infections and infestations	MedDRA 23.1	Systematic Assessment	EG00033 affected284 at risk EG00140 affected281 at risk EG0029 affected125 at risk EG003
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 23.1	Systematic Assessment	EG00024 affected284 at risk EG00121 affected281 at risk EG0024 affected125 at risk EG003
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 23.1	Systematic Assessment	EG00020 affected284 at risk EG00115 affected281 at risk EG0022 affected125 at risk EG003
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA 23.1	Systematic Assessment	EG00015 affected284 at risk EG00115 affected281 at risk EG0021 affected125 at risk EG003
Headache	Nervous system disorders	MedDRA 23.1	Systematic Assessment	EG00016 affected284 at risk EG00123 affected281 at risk EG0021 affected125 at risk EG003
Insomnia	Psychiatric disorders	MedDRA 23.1	Systematic Assessment	EG00019 affected284 at risk EG00114 affected281 at risk EG0021 affected125 at risk EG003
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 23.1	Systematic Assessment	EG00011 affected284 at risk EG00116 affected281 at risk EG0024 affected125 at risk EG003
Rash	Skin and subcutaneous tissue disorders	MedDRA 23.1	Systematic Assessment	EG0009 affected284 at risk EG00115 affected281 at risk EG0020 affected125 at risk EG003
Hypertension	Vascular disorders	MedDRA 23.1	Systematic Assessment	EG00015 affected284 at risk EG00111 affected281 at risk EG0023 affected125 at risk EG003

ID	Term
C000654125	bictegravir, emtricitabine, tenofovir alafenamide, drug combination
C000613801	emtricitabine tenofovir alafenamide
C562325	dolutegravir