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Clinical Trial Results:
A Phase IIIb, Randomized, Multicenter, Active-controlled, Parallel-group, Non-inferiority, Open-label Study Evaluating the Efficacy, Safety, and Tolerability of Switching to Long-acting Cabotegravir Plus Long-acting Rilpivirine administered every two months from a Bictegravir/emtricitabine/tenofovir alafenamide Single Tablet Regimen in HIV-1 Infected Adults who are Virologically Suppressed

Summary
EudraCT number	2020-002623-11
Trial protocol	FR NL GB IE DE AT IT BE
Global end of trial date	17 Apr 2023

Results information
Results version number	v4(current)
This version publication date	12 Jul 2024
First version publication date	28 Jul 2023
Other versions	v1 , v2 , v3
Version creation reason	Correction of full data set Data set corrected based on latest feedback.

Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information

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Trial information

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Sponsor protocol code

213500

ISRCTN number

US NCT number

NCT04542070

WHO universal trial number (UTN)

Sponsor organisation name

ViiV Healthcare

Sponsor organisation address

980 GreatWest Road, Brentford,Middlesex, United Kingdom, TW8 9GS

Public contact

ViiV Healthcare, GSK Response Center, 1 8664357343, GSKClinicalSupportHD@gsk.com

Scientific contact

GSK Response Center, ViiV Healthcare, 1 8664357343, GSKClinicalSupportHD@gsk.com

Is trial part of an agreed paediatric investigation plan (PIP)

Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?

Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?

Analysis stage

Final

Date of interim/final analysis

26 May 2023

Is this the analysis of the primary completion data?

Global end of trial reached?

Yes

Global end of trial date

17 Apr 2023

Was the trial ended prematurely?

Main objective of the trial

To demonstrate the non-inferior antiviral activity of CAB LA + RPV LA every two months compared to a BIK single tablet regimen administered once daily over 12 months in suppressed HIV-1 infected antiretroviral therapy (ART)-experienced participants.

Protection of trial subjects

Not applicable

Background therapy

Evidence for comparator

Actual start date of recruitment

09 Nov 2020

Long term follow-up planned

Yes

Long term follow-up rationale

Safety, Efficacy

Long term follow-up duration

12 Months

Independent data monitoring committee (IDMC) involvement?

Number of subjects enrolled per country

Country: Number of subjects enrolled

Belgium: 15

Country: Number of subjects enrolled

Canada: 52

Country: Number of subjects enrolled

France: 33

Country: Number of subjects enrolled

Germany: 39

Country: Number of subjects enrolled

Ireland: 5

Country: Number of subjects enrolled

Japan: 20

Country: Number of subjects enrolled

Australia: 22

Country: Number of subjects enrolled

Netherlands: 9

Country: Number of subjects enrolled

Spain: 78

Country: Number of subjects enrolled

Switzerland: 16

Country: Number of subjects enrolled

United Kingdom: 17

Country: Number of subjects enrolled

United States: 286

Country: Number of subjects enrolled

Austria: 9

Country: Number of subjects enrolled

Italy: 86

Worldwide total number of subjects

687

EEA total number of subjects

274

Number of subjects enrolled per age group

In utero

Preterm newborn - gestational age < 37 wk

Newborns (0-27 days)

Infants and toddlers (28 days-23 months)

Children (2-11 years)

Adolescents (12-17 years)

Adults (18-64 years)

676

From 65 to 84 years

85 years and over

Subject disposition

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Recruitment details

The study consists in 2 periods: Maintenance Period and Extension Period. Any participants who successfully completed 12 months of CAB+RPV treatment in the Maintenance Phase had the option to enter the Extension Phase and continued to have access to CAB + RPV.

Screening details

687 participants were enrolled in this study, out of which 681 were included in intent-to-treat exposed population (ITT-E).The Modified ITT-E (excluded participants due to eligibility criteria violations and GCP non-compliance) was used to primarily present the participant flow, baseline characteristics and efficacy analysis. Safety analyses were

Period 1 title

Maintenance Period (Day 1 - Month 12)

Is this the baseline period?

Yes

Allocation method

Randomised - controlled

Blinding used

Not blinded

Are arms mutually exclusive

Yes

Oral lead-in phase (OLI)

Arm description

Participants with human immunodeficiency viruses (HIV)-1 who chose oral lead in (OLI) received oral 30 milligram (mg) Cabotegravir (CAB) tablet + 25 mg Rilpivirine (RPV) tablet once daily (QD) for one month. At the month 1 visit, the last dose of oral CAB + RPV was given, followed by the first 600 mg CAB long-acting (LA) + 900 mg RPV LA intramuscular injection (IM), and second injection of CAB LA 600 mg + RPV LA 900 mg at month 2, and then subsequent injections once every 2 months (Q2M) until Month 12 (Maintenance Phase). The participants had the option to continue the regimen in the Extension Phase.

Arm type

Experimental

Investigational medicinal product name

Cabotegravir (CAB) + Rilpivirine (RPV)

Investigational medicinal product code

Other name

Pharmaceutical forms

Injection, Tablet

Routes of administration

Intramuscular use, Oral use

Dosage and administration details

Participants with human immunodeficiency viruses (HIV)-1 who chose oral lead in (OLI) received oral 30 milligram (mg) Cabotegravir (CAB) tablet + 25 mg Rilpivirine (RPV) tablet once daily (QD) for one month. At the month 1 visit, the last dose of oral CAB + RPV was given, followed by the first 600 mg CAB long-acting (LA) + 900 mg RPV LA intramuscular injection (IM) and then once every 2 months (Q2M) until end of Extension Phase.

Direct to injections (D2I)

Arm description

Participants with HIV-1 who chose direct to injections (D2I) received the first injections of 600 mg CAB LA + 900 mg RPV LA, IM as initial loading doses at Day 1 one month, followed by second and third subsequent injections (CAB LA 600 mg + RPV LA 900 mg) at month 1 and month 3 followed by Q2M until Month 11. The participants had the option to continue the regimen in the Extension Phase.

Arm type

Experimental

Investigational medicinal product name

Cabotegravir (CAB) + Rilpivirine (RPV)

Investigational medicinal product code

Other name

Pharmaceutical forms

Injection

Routes of administration

Intramuscular use

Dosage and administration details

Biktarvy (BIK)

Arm description

Participants with HIV-1 received BIK tablet orally until month 12. BIK was a fixed dose combination of 50 mg Bictegravir (BIC) + 200 mg Emtricitabine (FTC) + 25 mg Tenofovir alafenamide (TAF).

Arm type

Active comparator

Investigational medicinal product name

Bictegravir (BIC) + Emtricitabine (FTC) + Tenofovir alafenamide (TAF)

Investigational medicinal product code

Other name

Pharmaceutical forms

Tablet

Routes of administration

Oral use

Dosage and administration details

Participants with HIV-1 received BIK tablet orally until month 12. BIK was a fixed dose combination of 50 mg Bictegravir (BIC) + 200 mg Emtricitabine (FTC) + 25 mg Tenofovir alafenamide (TAF) up to Month 12.

Number of subjects in period 1 ^[1]	Oral lead-in phase (OLI)	Direct to injections (D2I)	Biktarvy (BIK)
Started	175	279	227
Completed	152	255	213
Not completed	23	24	14
Physician decision	1	-	1
Consent withdrawn by subject	5	8	9
Adverse event, non-fatal	10	3	1
Protocol Deviation	2	6	1
Protocol-Specified Withdrawal Criterion Met	1	1	-
Lost to follow-up	3	4	2
Lack of efficacy	1	2	-

Notes
[1] - The number of subjects reported to be in the baseline period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
Justification: Worldwide 687 participants were enrolled, whereof 681 participants were actually included in the study.

Period 2 title

Maintenance + Extension Period

Is this the baseline period?

Allocation method

Randomised - controlled

Blinding used

Not blinded

Are arms mutually exclusive

Yes

Oral lead-in phase (OLI)

Arm description

Arm type

Experimental

Investigational medicinal product name

Cabotegravir (CAB) + Rilpivirine (RPV)

Investigational medicinal product code

Other name

Pharmaceutical forms

Injection, Tablet

Routes of administration

Intramuscular use, Oral use

Dosage and administration details

Participants with human immunodeficiency viruses (HIV)-1 who chose oral lead in (OLI) received oral 30 milligram (mg) Cabotegravir (CAB) tablet + 25 mg Rilpivirine (RPV) tablet once daily (QD) for one month. At the month 1 visit, the last dose of oral CAB + RPV was given, followed by the first 600 mg CAB long-acting (LA) + 900 mg RPV LA intramuscular injection (IM) and then once every 2 months (Q2M) until end of Extension Phase.

Direct to injections (D2I)

Arm description

Arm type

Experimental

Investigational medicinal product name

Cabotegravir (CAB) + Rilpivirine (RPV)

Investigational medicinal product code

Other name

Pharmaceutical forms

Injection

Routes of administration

Intramuscular use

Dosage and administration details

Number of subjects in period 2 ^[2]	Oral lead-in phase (OLI)	Direct to injections (D2I)
Started	173	274
Completed	150	247
Not completed	23	27
Physician decision	1	1
Consent withdrawn by subject	4	12
Adverse event, non-fatal	10	2
Protocol-Specified Withdrawal Criterion Met	1	1
Lost to follow-up	3	4
Lack of efficacy	2	2
Protocol deviation	2	5

Notes
[2] - The number of subjects starting the period is not consistent with the number completing the preceding period. It is expected the number of subjects starting the subsequent period will be the same as the number completing the preceding period.
Justification: The participants in Oral lead-in phase (OLI) group and Direct to injections (D2I) group received same treatment regimen in both Maintenance and Extension Periods, hence data was summarized by Maintenance Period and by Maintenance+Extension Period. The Biktarvy (BIK) group was followed only in Maintenance Period, since it was dissolved at the start of Extension Phase, when participants transitioned to Switch Q2M Group or commercial available treatments, based on protocol criteria.

Period 3 title

Extension Period (Month 13 - Month 27)

Is this the baseline period?

Allocation method

Randomised - controlled

Blinding used

Not blinded

Switch Q2M Group

Arm description

Eligible participants with HIV-1 who received BIK tablet orally switched treatment after month 12 (Extension Phase) to CAB LA 600 mg + RPV LA 900 mg regimen, administered once every 2 months.

Arm type

Active comparator

Investigational medicinal product name

Cabotegravir (CAB) + Rilpivirine (RPV)

Investigational medicinal product code

Other name

Pharmaceutical forms

Injection

Routes of administration

Intramuscular use

Dosage and administration details

Participants received 600 mg CAB long-acting (LA) + 900 mg RPV LA intramuscular injection (IM) and then once every 2 months (Q2M) until end of Extension Phase.

Number of subjects in period 3 ^[3]	Switch Q2M Group
Started	143
Completed	130
Not completed	13
Physician decision	2
Consent withdrawn by subject	5
Adverse event, non-fatal	4
Lost to follow-up	1
Lack of efficacy	1

Notes
[3] - The number of subjects starting the period is not consistent with the number completing the preceding period. It is expected the number of subjects starting the subsequent period will be the same as the number completing the preceding period.
Justification: Extension Period followed the participants from Oral lead-in phase (OLI), Direct to injections (D2I) and the Switch Q2M groups. The data for Oral lead-in phase (OLI) and Direct to injections (D2I) groups was summarized and presented by Maintenance Period and by Maintenance+Extension Period, hence were not added in this period. The data for Switch Q2M group was summarized and presented only for Extension Period, as this group was formed at the start of Extension Period.

Baseline characteristics

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Reporting group title

Oral lead-in phase (OLI)

Reporting group description

Reporting group title

Direct to injections (D2I)

Reporting group description

Reporting group title

Biktarvy (BIK)

Reporting group description

Participants with HIV-1 received BIK tablet orally until month 12. BIK was a fixed dose combination of 50 mg Bictegravir (BIC) + 200 mg Emtricitabine (FTC) + 25 mg Tenofovir alafenamide (TAF).

Reporting group values	Oral lead-in phase (OLI)	Direct to injections (D2I)	Biktarvy (BIK)	Total
Number of subjects	175	279	227	681
Age categorical
Units: Subjects
Over (>=) 18 years of age	175	279	227	681
Sex: Female, Male
Units: Participants
FEMALE	27	52	41	120
MALE	148	227	186	561
Race/Ethnicity, Customized
Units: Subjects
American Indian or Alaska Native	10	4	2	16
Asian - Central/South Asian Heritage	0	3	0	3
Asian - East Asian Heritage	1	0	2	3
Asian - Japanese Heritage	4	10	6	20
Asian - South East Asian Heritage	2	3	3	8
Black or African American	40	56	49	145
Native Hawaiian or Other Pacific Islander	0	0	1	1
White - Arabic/North African Heritage	10	5	10	25
White - White/Caucasian/European Heritage	104	194	149	447
Mixed White Race	0	0	1	1
Multiple	4	4	4	12
Age, Continuous
Units: YEARS
arithmetic mean (standard deviation)	38.5 ( 11.38 )	39.0 ( 11.09 )	38.6 ( 11.41 )	-

Subject analysis set title

Q2M (OLI + D2I)

Subject analysis set type

Sub-group analysis

Subject analysis set description

Participants with HIV-1 who started OLI were administered with Cabotegravir and Rilpivirine (CAB + RPV) tablets orally for one month. At the month 1 visit, the last dose of oral 30 mg CAB + 25 mg RPV tablets were given, followed by the first 600 mg CAB LA + 900 mg RPV LA intramuscular injection, and second injection of CAB LA 600 mg + RPV LA 900 mg at month 2, and then subsequent injections every 2 months (Q2M) until Month 12. Participants with HIV-1 who started with D2I, received the first injection of 600 mg CAB LA + 900 mg RPV LA, IM as initial loading dose at Day 1 followed by second and third subsequent injections (CAB LA 600 mg + RPV LA 900 mg) at month 1 and 3 followed by Q2M until Month 11.

Subject analysis set title

Q2M (OLI + D2I)

Subject analysis set type

Sub-group analysis

Subject analysis set description

Subject analysis set title

Q2M (OLI + D2I)

Subject analysis set type

Sub-group analysis

Subject analysis set description

Subject analysis set title

Q2M (OLI + D2I)

Subject analysis set type

Sub-group analysis

Subject analysis set description

Subject analysis set title

Q2M (OLI + D2I)

Subject analysis set type

Sub-group analysis

Subject analysis set description

Subject analysis set title

Q2M (OLI + D2I)

Subject analysis set type

Sub-group analysis

Subject analysis set description

Subject analysis set title

Q2M (OLI + D2I)

Subject analysis set type

Sub-group analysis

Subject analysis set description

Subject analysis set title

Q2M (OLI + D2I)

Subject analysis set type

Sub-group analysis

Subject analysis set description

Subject analysis set title

Q2M (OLI + D2I)

Subject analysis set type

Sub-group analysis

Subject analysis set description

Subject analysis set title

Q2M (OLI + D2I)

Subject analysis set type

Sub-group analysis

Subject analysis set description

Subject analysis set title

Q2M (OLI + D2I)

Subject analysis set type

Sub-group analysis

Subject analysis set description

Subject analysis set title

Q2M (OLI + D2I)

Subject analysis set type

Sub-group analysis

Subject analysis set description

Subject analysis set title

Q2M (OLI + D2I)

Subject analysis set type

Sub-group analysis

Subject analysis set description

Subject analysis sets values	Q2M (OLI + D2I)	Q2M (OLI + D2I)	Q2M (OLI + D2I)	Q2M (OLI + D2I)	Q2M (OLI + D2I)	Q2M (OLI + D2I)	Q2M (OLI + D2I)	Q2M (OLI + D2I)	Q2M (OLI + D2I)	Q2M (OLI + D2I)	Q2M (OLI + D2I)	Q2M (OLI + D2I)	Q2M (OLI + D2I)
Number of subjects	454	447	2	1	449	440	448	216	182	409	446	426	427
Age categorical
Units: Subjects
Over (>=) 18 years of age	454	447	2	1	449	440	448	216	182	409	446	426	427
Age continuous
Units:
	( )	( )	( )	( )	( )	( )	( )	( )	( )	( )	( )	( )	( )
Sex: Female, Male
Units: Participants
FEMALE
MALE
Race/Ethnicity, Customized
Units: Subjects
American Indian or Alaska Native
Asian - Central/South Asian Heritage
Asian - East Asian Heritage
Asian - Japanese Heritage
Asian - South East Asian Heritage
Black or African American
Native Hawaiian or Other Pacific Islander
White - Arabic/North African Heritage
White - White/Caucasian/European Heritage
Mixed White Race
Multiple
Age, Continuous
Units: YEARS
arithmetic mean (standard deviation)	1.3 ( )	1.1 ( )	( )	( )	( )	( )	( )	( )	( )	( )	( )	26.97 ( 10.135 )	( )

End points

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Reporting group title

Oral lead-in phase (OLI)

Reporting group description

Reporting group title

Direct to injections (D2I)

Reporting group description

Reporting group title

Biktarvy (BIK)

Reporting group description

Participants with HIV-1 received BIK tablet orally until month 12. BIK was a fixed dose combination of 50 mg Bictegravir (BIC) + 200 mg Emtricitabine (FTC) + 25 mg Tenofovir alafenamide (TAF).

Reporting group title

Oral lead-in phase (OLI)

Reporting group description

Reporting group title

Direct to injections (D2I)

Reporting group description

Reporting group title

Switch Q2M Group

Reporting group description

Eligible participants with HIV-1 who received BIK tablet orally switched treatment after month 12 (Extension Phase) to CAB LA 600 mg + RPV LA 900 mg regimen, administered once every 2 months.

Subject analysis set title

Q2M (OLI + D2I)

Subject analysis set type

Sub-group analysis

Subject analysis set description

Subject analysis set title

Q2M (OLI + D2I)

Subject analysis set type

Sub-group analysis

Subject analysis set description

Subject analysis set title

Q2M (OLI + D2I)

Subject analysis set type

Sub-group analysis

Subject analysis set description

Subject analysis set title

Q2M (OLI + D2I)

Subject analysis set type

Sub-group analysis

Subject analysis set description

Subject analysis set title

Q2M (OLI + D2I)

Subject analysis set type

Sub-group analysis

Subject analysis set description

Subject analysis set title

Q2M (OLI + D2I)

Subject analysis set type

Sub-group analysis

Subject analysis set description

Subject analysis set title

Q2M (OLI + D2I)

Subject analysis set type

Sub-group analysis

Subject analysis set description

Subject analysis set title

Q2M (OLI + D2I)

Subject analysis set type

Sub-group analysis

Subject analysis set description

Subject analysis set title

Q2M (OLI + D2I)

Subject analysis set type

Sub-group analysis

Subject analysis set description

Subject analysis set title

Q2M (OLI + D2I)

Subject analysis set type

Sub-group analysis

Subject analysis set description

Subject analysis set title

Q2M (OLI + D2I)

Subject analysis set type

Sub-group analysis

Subject analysis set description

Subject analysis set title

Q2M (OLI + D2I)

Subject analysis set type

Sub-group analysis

Subject analysis set description

Subject analysis set title

Q2M (OLI + D2I)

Subject analysis set type

Sub-group analysis

Subject analysis set description

Primary: Percentage of participants with plasma human immunodeficiency viruses (HIV)-1 ribonucleic acid (RNA) greater than or equal to (>=) 50 copies per milliliter (c/mL) at Month 12/11 - ITT-E Population

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End point title

Percentage of participants with plasma human immunodeficiency viruses (HIV)-1 ribonucleic acid (RNA) greater than or equal to (>=) 50 copies per milliliter (c/mL) at Month 12/11 - ITT-E Population ^[1]

End point description

Percentage of participants with plasma HIV 1 RNA >= 50 c/mL at month 12 was assessed using the food and drug administration (FDA) snapshot algorithm. For the Q2M arm, data from the Q2M OLI participants at Month 12 visit and Q2M D2I participants at Month 11 visit were combined as the study objective was to demonstrate the non-inferior antiviral activity of (Q2M) (OLI+ D2I combined) compared to BIK. For BIK arm, data was collected at month 12 visit. Month 12/11 refers to the Month 12 (OLI and BIK) visit/Month 11 (DTI) visit. The FDA snapshot algorithm defines a participant's virologic response status using only the viral load at the predefined time point within a window of time (HIV-RNA equal to or above 50 copies/mL and HIV-RNA below 50 copies/mL), along with study drug discontinuation status. The third category of the FDA snapshot ("No virologic data") is not pre-defined as an endpoint and therefore not reported separately.

End point type

Primary

End point timeframe

At month 12/11

Notes
[1] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: As per study design, the endpoints were presented for OLI + D2I arms combined as Q2M. Whereas, the baseline period was separated as OLI and D2I.

End point values	Biktarvy (BIK)	Q2M (OLI + D2I)
Number of subjects analysed	227	454
Units: Percentage of participants
number (confidence interval 95%)	0.4 (0.0 to 2.4)	1.3 (0.5 to 2.9)

Statistical Analysis 2

Comparison groups

Biktarvy (BIK) v Q2M (OLI + D2I)

Number of subjects included in analysis

681

Analysis specification

Pre-specified

Analysis type

^[2]

Method

Parameter type

Adjusted difference in percentage

Point estimate

0.9

Confidence interval

level

95%

sides

2-sided

lower limit

-0.5

upper limit

2.2

Notes
[2] - Non-inferiority concluded if the upper limit of a two-sided 95% confidence interval for the difference in percentage of participants with HIV-1 RNA ≥ 50 c/mL at Month 12 (OLI and BIK)/Month 11 (D2I) between the two treatment arms (Q2M - BIK) is less than 4%.

Statistical Analysis 1

Comparison groups

Biktarvy (BIK) v Q2M (OLI + D2I)

Number of subjects included in analysis

681

Analysis specification

Pre-specified

Analysis type

^[3]

Method

Parameter type

Difference in percentage

Point estimate

0.9

Confidence interval

level

95%

sides

2-sided

lower limit

-0.5

upper limit

2.2

Notes
[3] - Non-inferiority concluded if the upper limit of a two-sided 95% confidence interval for the difference in percentage of participants with HIV-1 RNA ≥ 50 c/mL at Month 12 (OLI and BIK)/Month 11 (D2I) between the two treatment arms (Q2M - BIK) is less than 4%.

Primary: Percentage of participants with plasma HIV-1 RNA greater >=50 copies per milliliter (c/mL) at Month 12/11 - mITT-E Population

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End point title

Percentage of participants with plasma HIV-1 RNA greater >=50 copies per milliliter (c/mL) at Month 12/11 - mITT-E Population ^[4]

End point description

End point type

Primary

End point timeframe

At month 12/11

Notes
[4] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: As per study design, the endpoints were presented for OLI + D2I arms combined as Q2M. Whereas, the baseline period was separated as OLI and D2I.

End point values	Biktarvy (BIK)	Q2M (OLI + D2I)
Number of subjects analysed	223	447
Units: Percentage of participants
number (confidence interval 95%)	0.4 (0.0 to 2.5)	1.1 (0.4 to 2.6)

Statistical Analysis 4

Comparison groups

Biktarvy (BIK) v Q2M (OLI + D2I)

Number of subjects included in analysis

670

Analysis specification

Pre-specified

Analysis type

^[5]

Method

Parameter type

Adjusted difference in percentage

Point estimate

0.7

Confidence interval

level

95%

sides

2-sided

lower limit

-0.7

upper limit

Notes
[5] - Non-inferiority concluded if the upper limit of a two-sided 95% confidence interval for the difference in percentage of participants with HIV-1 RNA ≥ 50 c/mL at Month 12 (OLI and BIK)/Month 11 (D2I) between the two treatment arms (Q2M - BIK) is less than 4%.

Statistical Analysis 3

Comparison groups

Biktarvy (BIK) v Q2M (OLI + D2I)

Number of subjects included in analysis

670

Analysis specification

Pre-specified

Analysis type

^[6]

Method

Parameter type

Difference in percentage

Point estimate

0.7

Confidence interval

level

95%

sides

2-sided

lower limit

-0.6

upper limit

Notes
[6] - Non-inferiority concluded if the upper limit of a two-sided 95% confidence interval for the difference in percentage of participants with HIV-1 RNA ≥ 50 c/mL at Month 12 (OLI and BIK)/Month 11 (D2I) between the two treatment arms (Q2M - BIK) is less than 4%.

Secondary: Percentage of participants with plasma HIV-1 RNA less than (<)50 c/mL at Month 12/11 - ITT-E Population

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End point title

Percentage of participants with plasma HIV-1 RNA less than (<)50 c/mL at Month 12/11 - ITT-E Population ^[7]

End point description

Percentage of participants with plasma HIV 1 RNA < 50 c/mL was assessed using the FDA snapshot algorithm. For the Q2M arm, data from the Q2M OLI participants at Month 12 visit and Q2M D2I participants at Month 11 visit were combined as the study objective was to demonstrate the non-inferior antiviral activity of (Q2M) (OLI+ D2I combined) compared to BIK. For BIK arm, data was collected at month 12 visit. Month 12/11 refers to the Month 12 (OLI and BIK) visit/Month 11 (DTI) visit. The FDA snapshot algorithm defines a participant's virologic response status using only the viral load at the predefined time point within a window of time (HIV-RNA equal to or above 50 copies/mL and HIV-RNA below 50 copies/mL), along with study drug discontinuation status. The third category of the FDA snapshot ("No virologic data") is not pre-defined as an endpoint and therefore not reported separately.

End point type

Secondary

End point timeframe

At month 12/11

Notes
[7] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: As per study design, the endpoints were presented for OLI + D2I arms combined as Q2M. Whereas, the baseline period was separated as OLI and D2I.

End point values	Biktarvy (BIK)	Q2M (OLI + D2I)
Number of subjects analysed	227	454
Units: Percentage of participants
number (confidence interval 95%)	93.0 (89.6 to 96.3)	89.4 (86.6 to 92.3)

No statistical analyses for this end point

Secondary: Percentage of participants with plasma HIV-1 RNA <50 c/mL at Month 12/11 -mITT-E Population

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End point title

Percentage of participants with plasma HIV-1 RNA <50 c/mL at Month 12/11 -mITT-E Population ^[8]

End point description

End point type

Secondary

End point timeframe

At month 12/11

Notes
[8] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: As per study design, the endpoints were presented for OLI + D2I arms combined as Q2M. Whereas, the baseline period was separated as OLI and D2I.

End point values	Biktarvy (BIK)	Q2M (OLI + D2I)
Number of subjects analysed	223	447
Units: Percentage of participants
number (confidence interval 95%)	92.8 (89.4 to 96.2)	90.2 (87.4 to 92.9)

No statistical analyses for this end point

Secondary: Percentage of participants with plasma HIV-1 RNA <50 c/mL at Month 6/5 - ITT-E Population

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End point title

Percentage of participants with plasma HIV-1 RNA <50 c/mL at Month 6/5 - ITT-E Population ^[9]

End point description

Percentage of participants with plasma HIV 1 RNA < 50 c/mL was assessed using the FDA snapshot algorithm. For the Q2M arm, data from the Q2M OLI participants at Month 6 visit and Q2M D2I participants at Month 5 visit were combined as the study objective was to demonstrate the non-inferior antiviral activity of (Q2M) (OLI+ D2I combined) compared to BIK. For BIK arm, data was collected at month 6 visit. Month 6/5 refers to the Month 6 (OLI and BIK) visit/Month 5 (DTI) visit. The FDA snapshot algorithm defines a participant's virologic response status using only the viral load at the predefined time point within a window of time (HIV-RNA equal to or above 50 copies/mL and HIV-RNA below 50 copies/mL), along with study drug discontinuation status. The third category of the FDA snapshot ("No virologic data") is not pre-defined as an endpoint and therefore not reported separately.

End point type

Secondary

End point timeframe

At month 6/5

Notes
[9] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: As per study design, the endpoints were presented for OLI + D2I arms combined as Q2M. Whereas, the baseline period was separated as OLI and D2I.

End point values	Biktarvy (BIK)	Q2M (OLI + D2I)
Number of subjects analysed	227	454
Units: Percentage of participants
number (confidence interval 95%)	97.8 (95.9 to 99.7)	92.7 (90.3 to 95.1)

No statistical analyses for this end point

Secondary: Percentage of participants with plasma HIV-1 RNA <50 c/mL at Month 6/5 - mITT-E Population

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End point title

Percentage of participants with plasma HIV-1 RNA <50 c/mL at Month 6/5 - mITT-E Population ^[10]

End point description

End point type

Secondary

End point timeframe

At month 6/5

Notes
[10] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: As per study design, the endpoints were presented for OLI + D2I arms combined as Q2M. Whereas, the baseline period was separated as OLI and D2I.

End point values	Biktarvy (BIK)	Q2M (OLI + D2I)
Number of subjects analysed	223	447
Units: Percentage of participants
number (confidence interval 95%)	97.8 (95.8 to 99.7)	93.5 (91.2 to 95.8)

No statistical analyses for this end point

Secondary: Number of participants with protocol-defined confirmed virologic failure (CVF) through Month 6/5 and 12/11

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End point title

Number of participants with protocol-defined confirmed virologic failure (CVF) through Month 6/5 and 12/11 ^[11]

End point description

Protocol-defined confirmed virologic failure was defined as rebound as indicated by two consecutive plasma HIV-1 RNA levels >= 200 c/mL (Day 1 values are not applicable) after prior suppression to <200 c/mL. For the Q2M arm, data from the Q2M OLI participants at Month 6 and 12 visit and Q2M D2I participants at Month 5 and 11 visit were combined as the study objective was to demonstrate the non-inferior antiviral activity of (Q2M) (OLI+ D2I combined) compared to BIK. For BIK arm, data was collected at Month 6 and 12 visit. Month 6/5 refers to the Month 6 (OLI and BIK) visit/Month 5 (DTI) visit. Month 12/11 refers to the Month 12 (OLI and BIK) visit/Month 11 (DTI) visit. Cumulative number of participants with protocol defined CVF through Month 6/5 and 12/11 has been presented.

End point type

Secondary

End point timeframe

Up to month 12

Notes
[11] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: As per study design, the endpoints were presented for OLI + D2I arms combined as Q2M. Whereas, the baseline period was separated as OLI and D2I.

End point values	Biktarvy (BIK)	Q2M (OLI + D2I)
Number of subjects analysed	223	447
Units: Participants
Month 6/5	0	1
Month 12/11	0	2

No statistical analyses for this end point

Secondary: Percentage of participants with plasma HIV-1 RNA greater than or equal to (>=) 50 c/mL at Month 6/5

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End point title

Percentage of participants with plasma HIV-1 RNA greater than or equal to (>=) 50 c/mL at Month 6/5 ^[12]

End point description

Percentage of participants with plasma HIV 1 RNA >= 50 c/mL at month 6 was assessed using the food and drug administration (FDA) snapshot algorithm. For the Q2M arm, data from the Q2M OLI participants at Month 6 visit and Q2M D2I participants at Month 5 visit were combined as the study objective was to demonstrate the non-inferior antiviral activity of (Q2M) (OLI+ D2I combined) compared to BIK. For BIK arm, data was collected at month 6 visit. Month 6/5 refers to the Month 6 (OLI and BIK) visit/Month 5 (DTI) visit. The FDA snapshot algorithm defines a participant's virologic response status using only the viral load at the predefined time point within a window of time (HIV-RNA equal to or above 50 copies/mL and HIV-RNA below 50 copies/mL), along with study drug discontinuation status. The third category of the FDA snapshot ("No virologic data") is not pre-defined as an endpoint and therefore not reported separately.

End point type

Secondary

End point timeframe

At month 6/5

Notes
[12] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: As per study design, the endpoints were presented for OLI + D2I arms combined as Q2M. Whereas, the baseline period was separated as OLI and D2I.

End point values	Biktarvy (BIK)	Q2M (OLI + D2I)
Number of subjects analysed	223	447
Units: Percentage of participants
number (confidence interval 95%)	0 (0.0 to 1.6)	0.4 (0.1 to 1.6)

No statistical analyses for this end point

Secondary: Change from baseline in HIV viral load

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End point title

Change from baseline in HIV viral load ^[13]

End point description

Plasma samples were collected for quantitative analysis of HIV-1 RNA. Baseline value is defined as latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from Baseline is defined as post-dose visit value minus Baseline value. Logarithm to base 10 values for plasma HIV-1 RNA has been presented. For the Q2M arm, data from the Q2M OLI participants at Month 6 and 12 visit and Q2M D2I participants at Month 5 and 11 visit were combined as the study objective was to demonstrate the non-inferior antiviral activity of (Q2M) (OLI+ D2I combined) compared to BIK. For BIK arm, data was collected at month 6 and 12 visit. Month 6/5 refers to the Month 6 (OLI and BIK) visit/Month 5 (DTI) visit. Month 12/11 refers to the Month 12 (OLI and BIK) visit/Month 11 (DTI) visit.

End point type

Secondary

End point timeframe

Baseline (Day 1) and up to Month 12

Notes
[13] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: As per study design, the endpoints were presented for OLI + D2I arms combined as Q2M. Whereas, the baseline period was separated as OLI and D2I.

End point values	Biktarvy (BIK)	Q2M (OLI + D2I)
Number of subjects analysed	223	447
Units: log10 c/mL
arithmetic mean (standard deviation)
Baseline (Day 1)	1.5947 ( 0.06640 )	1.5993 ( 0.10559 )
Month 6/5	-0.0039 ( 0.06826 )	0.0015 ( 0.13997 )
Month 12/11	-0.0041 ( 0.07172 )	0.0029 ( 0.17038 )

No statistical analyses for this end point

Secondary: Absolute values of HIV viral load

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End point title

Absolute values of HIV viral load ^[14]

End point description

Plasma samples were collected for quantitative analysis of HIV-1 RNA. Logarithm to base 10 (log10) values for plasma HIV-1 RNA has been presented. For the Q2M arm, data from the Q2M OLI participants at Month 6 and 12 visit and Q2M D2I participants at Month 5 and 11 visit were combined as the study objective was to demonstrate the non-inferior antiviral activity of (Q2M) (OLI+ D2I combined) compared to BIK. For BIK arm, data was collected at month 6 and 12 visit. Month 6/5 refers to the Month 6 (OLI and BIK) visit/Month 5 (DTI) visit. Month 12/11 refers to the Month 12 (OLI and BIK) visit/Month 11 (DTI) visit.

End point type

Secondary

End point timeframe

Baseline (Day 1) and up to Month 12

Notes
[14] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: As per study design, the endpoints were presented for OLI + D2I arms combined as Q2M. Whereas, the baseline period was separated as OLI and D2I.

End point values	Biktarvy (BIK)	Q2M (OLI + D2I)
Number of subjects analysed	223	447
Units: log10 copies per milliliter(c/mL)
arithmetic mean (standard deviation)
Baseline (Day 1)	1.5947 ( 0.06640 )	1.5993 ( 0.10559 )
Month 6/5	1.5910 ( 0.01182 )	1.6002 ( 0.09268 )
Month 12/11	1.5911 ( 0.01552 )	1.6019 ( 0.13064 )

No statistical analyses for this end point

Secondary: Absolute values of cluster of differentiation 4 plus (CD4+) cell count

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End point title

Absolute values of cluster of differentiation 4 plus (CD4+) cell count ^[15]

End point description

Blood samples were collected and CD4+ cell count was assessed using flow cytometry. For the Q2M arm, data from the Q2M OLI participants at Month 6 and 12 visit and Q2M D2I participants at Month 5 and 11 visit were combined as the study objective was to demonstrate the non-inferior antiviral activity of (Q2M) (OLI+ D2I combined) compared to BIK. For BIK arm, data was collected at month 6 and 12 visit. Month 6/5 refers to the Month 6 (OLI and BIK) visit/Month 5 (DTI) visit. Month 12/11 refers to the Month 12 (OLI and BIK) visit/Month 11 (DTI) visit.

End point type

Secondary

End point timeframe

Baseline (Day 1) and up to Month 12

Notes
[15] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: As per study design, the endpoints were presented for OLI + D2I arms combined as Q2M. Whereas, the baseline period was separated as OLI and D2I.

End point values	Biktarvy (BIK)	Q2M (OLI + D2I)
Number of subjects analysed	222	447
Units: cells per cubic millimeter(cells/mm^3)
arithmetic mean (standard deviation)
Baseline (Day 1)	679.4 ( 306.89 )	670.9 ( 282.11 )
Month 6/5	673.7 ( 290.46 )	689.1 ( 284.89 )
Month 12/11	717.3 ( 317.82 )	711.9 ( 297.13 )

No statistical analyses for this end point

Secondary: Change from Baseline in CD4+ cell count

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End point title

Change from Baseline in CD4+ cell count ^[16]

End point description

Blood samples were collected and CD4+ cell count was assessed using flow cytometry. Baseline value is defined as latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from baseline is defined as post-dose visit value minus baseline value. For the Q2M arm, data from the Q2M OLI participants at Month 6 and 12 visit and Q2M D2I participants at Month 5 and 11 visit were combined as the study objective was to demonstrate the non-inferior antiviral activity of (Q2M) (OLI+ D2I combined) compared to BIK. For BIK arm, data was collected at month 6 and 12 visit. Month 6/5 refers to the Month 6 (OLI and BIK) visit/Month 5 (DTI) visit. Month 12/11 refers to the Month 12 (OLI and BIK) visit/Month 11 (DTI) visit.

End point type

Secondary

End point timeframe

Baseline (Day 1) and up to Month 12

Notes
[16] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: As per study design, the endpoints were presented for OLI + D2I arms combined as Q2M. Whereas, the baseline period was separated as OLI and D2I.

End point values	Biktarvy (BIK)	Q2M (OLI + D2I)
Number of subjects analysed	223	447
Units: cells/mm^3
arithmetic mean (standard deviation)
Baseline (Day 1)	679.4 ( 306.89 )	670.9 ( 282.11 )
Month 6/5	-3.1 ( 197.62 )	20.4 ( 202.38 )
Month 12/11	32.2 ( 208.29 )	35.2 ( 219.79 )

No statistical analyses for this end point

Secondary: Number of participants with treatment-emergent phenotypic resistance through Month 6/5

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End point title

Number of participants with treatment-emergent phenotypic resistance through Month 6/5

End point description

Blood samples were collected to evaluate the phenotypic resistance to CAB, RPV, BIC, FTC, and TAF. For each participant, prevalence of phenotype, fold changes to CAB, RPV, and BIC, replication capacity of Integrase, protease, and reverse transcriptase enzymes at the time of CVF was assessed. For the Q2M arm, data from the Q2M OLI participants at Month 6 visit and Q2M D2I participants at Month 5 visit were combined as the study objective was to demonstrate the non-inferior antiviral activity of (Q2M) (OLI+ D2I combined) compared to BIK. For BIK arm, data was collected at month 6 visit. Month 6/5 refers to the Month 6 (OLI and BIK) visit/Month 5 (DTI) visit. No participants in the BIK arm met CVF.

End point type

Secondary

End point timeframe

Up to Month 6/5

End point values	Q2M (OLI + D2I)
Number of subjects analysed	1
Units: Participants
NNRTI	1
IN	1

No statistical analyses for this end point

Secondary: Number of participants with treatment-emergent phenotypic resistance through Month 12/11

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End point title

Number of participants with treatment-emergent phenotypic resistance through Month 12/11

End point description

Blood samples were collected to evaluate the phenotypic resistance to CAB, RPV, BIC, FTC, and TAF. For each participant, prevalence of phenotype, fold changes to CAB, RPV, and BIC, replication capacity of Integrase, protease, and reverse transcriptase enzymes at the time of CVF was assessed. For the Q2M arm, data from the Q2M OLI participants at Month 12 visit and Q2M D2I participants at Month 11 visit were combined as the study objective was to demonstrate the non-inferior antiviral activity of (Q2M) (OLI+ D2I combined) compared to BIK. For BIK arm, data was collected at month 12 visit. Month 12/11 refers to the Month 12 (OLI and BIK) visit/Month 11 (DTI) visit. No participants in the BIK arm met CVF.

End point type

Secondary

End point timeframe

Up to Month 12/11

End point values	Q2M (OLI + D2I)
Number of subjects analysed	2
Units: Participants
NNRTI	2
IN	2

No statistical analyses for this end point

Secondary: Number of participants with treatment-emergent genotypic resistance through Month 12/11

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End point title

Number of participants with treatment-emergent genotypic resistance through Month 12/11

End point description

Blood samples were collected to evaluate the genotypic resistance to CAB, RPV, BIC, FTC, and TAF. For each participant, prevalence of resistance mutations and genotypic susceptibility at the time of CVF was assessed. For the Q2M arm, data from the Q2M OLI participants at Month 12 visit and Q2M D2I participants at Month 11 visit were combined as the study objective was to demonstrate the non-inferior antiviral activity of (Q2M) (OLI+ D2I combined) compared to BIK. For BIK arm, data was collected at month 12 visit. Month 12/11 refers to the Month 12 (OLI and BIK) visit/Month 11 (DTI) visit. No participants in the BIK arm met CVF.

End point type

Secondary

End point timeframe

Up to Month 12/11

End point values	Q2M (OLI + D2I)
Number of subjects analysed	2
Units: Participants
M230L	1
Q148R	1
K101E	1
G118R	1

No statistical analyses for this end point

Secondary: Number of participants with treatment-emergent genotypic resistance through Month 6/5

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End point title

Number of participants with treatment-emergent genotypic resistance through Month 6/5

End point description

Blood samples were collected to evaluate the genotypic resistance to CAB, RPV, BIC, FTC, and TAF. For each participant, prevalence of resistance mutations and genotypic susceptibility at the time of CVF was assessed. For the Q2M arm, data from the Q2M OLI participants at Month 6 visit and Q2M D2I participants at Month 5 visit were combined as the study objective was to demonstrate the non-inferior antiviral activity of (Q2M) (OLI+ D2I combined) compared to BIK. For BIK arm, data was collected at month 6 visit. Month 6/5 refers to the Month 6 (OLI and BIK) visit/Month 5 (DTI) visit. No participants in the BIK arm met CVF.

End point type

Secondary

End point timeframe

Up to Month 6/5

End point values	Q2M (OLI + D2I)
Number of subjects analysed	1
Units: Participants
M230L	1
Q148R	1

No statistical analyses for this end point

Secondary: Change from baseline in bone biomarkers: specific alkaline phosphatase, procollagen type 1 N-Terminal propeptide, type 1 collagen cross-linked C-telopeptide, osteocalcin (micrograms per liter (ug/L))

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End point title

Change from baseline in bone biomarkers: specific alkaline phosphatase, procollagen type 1 N-Terminal propeptide, type 1 collagen cross-linked C-telopeptide, osteocalcin (micrograms per liter (ug/L)) ^[17]

End point description

Serum samples were collected to evaluate bone specific biomarkers: specific alkaline phosphatase, procollagen type 1 N-propeptide, type 1 collagen cross-linked C-telopeptide, osteocalcin. Baseline value is defined as latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from baseline is defined as post-dose visit value minus baseline value. For the Q2M arm, data from the Q2M OLI participants at Month 6 and 12 visit and Q2M D2I participants at Month 5 and 11 visit were combined as the study objective was to demonstrate the non-inferior antiviral activity of (Q2M) (OLI+ D2I combined) compared to BIK. For BIK arm, data was collected at month 6 and 12 visit. Month 6/5 refers to the Month 6 (OLI and BIK) visit/Month 5 (DTI) visit. Month 12/11 refers to the Month 12 (OLI and BIK) visit/Month 11 (DTI) visit.

End point type

Secondary

End point timeframe

Baseline (Day 1) and up to Month 12

Notes
[17] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: As per study design, the endpoints were presented for OLI + D2I arms combined as Q2M. Whereas, the baseline period was separated as OLI and D2I.

End point values	Biktarvy (BIK)	Q2M (OLI + D2I)
Number of subjects analysed	227	449
Units: micrograms per liter (ug/L)
arithmetic mean (standard deviation)
Serum Bone Specific Alkaline Phosphatase, Day 1	12.9 ( 4.60 )	12.7 ( 4.27 )
Serum Bone Specific Alkaline Phosphatase, M6/5	0.2 ( 2.60 )	0.3 ( 9.89 )
Serum Bone Specific Alkaline Phosphatase, M12/11	0.5 ( 3.55 )	0.1 ( 5.03 )
Serum Osteocalcin, Day 1	20.4 ( 7.48 )	21.0 ( 7.35 )
Serum Osteocalcin, Month 6/5	-0.4 ( 5.11 )	0.4 ( 5.53 )
Serum Osteocalcin, M12/11	-0.6 ( 5.51 )	0.9 ( 6.11 )
Serum Procollagen 1 N-Terminal Propeptide, Day 1	59.2 ( 23.88 )	59.1 ( 23.06 )
Serum Procollagen 1 N-Terminal Propeptide, M6/5	0.1 ( 18.53 )	-1.5 ( 15.70 )
Serum Procollagen 1 N-Terminal Propeptide, M12/11	0.6 ( 19.63 )	-0.7 ( 19.73 )
Serum Type I Collagen C-Telopeptides, Day 1	0.5 ( 0.25 )	0.4 ( 0.25 )
Serum Type I Collagen C-Telopeptides, M6/5	-0.1 ( 0.21 )	-0.1 ( 0.23 )
Serum Type I Collagen C-Telopeptides, M12/11	0.0 ( 0.22 )	0.0 ( 0.25 )

No statistical analyses for this end point

Secondary: Change from baseline in bone biomarkers: serum 25-hydroxyvitamin D (nanomoles per liter (nmol/L))

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End point title

Change from baseline in bone biomarkers: serum 25-hydroxyvitamin D (nanomoles per liter (nmol/L)) ^[18]

End point description

Serum samples were collected to evaluate bone specific biomarkers: serum 25-hydroxyvitamin D. Baseline value is defined as latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from baseline is defined as post-dose visit value minus baseline value. For the Q2M arm, data from the Q2M OLI participants at Month 6 and 12 visit and Q2M D2I participants at Month 5 and 11 visit were combined as the study objective was to demonstrate the non-inferior antiviral activity of (Q2M) (OLI+ D2I combined) compared to BIK. For BIK arm, data was collected at month 6 and 12 visit. Month 6/5 refers to the Month 6 (OLI and BIK) visit/Month 5 (DTI) visit. Month 12/11 refers to the Month 12 (OLI and BIK) visit/Month 11 (DTI) visit.

End point type

Secondary

End point timeframe

Baseline (Day 1) and up to Month 12

Notes
[18] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: As per study design, the endpoints were presented for OLI + D2I arms combined as Q2M. Whereas, the baseline period was separated as OLI and D2I.

End point values	Biktarvy (BIK)	Q2M (OLI + D2I)
Number of subjects analysed	219	440
Units: nanomoles per liter (nmol/L)
arithmetic mean (standard deviation)
Baseline (Day 1)	59.9 ( 33.30 )	61.0 ( 34.69 )
Month 6/5	6.0 ( 34.16 )	2.8 ( 29.24 )
Month 12/11	-3.1 ( 26.38 )	-2.3 ( 29.00 )

No statistical analyses for this end point

Secondary: Change from baseline in renal biomarkers: specific serum beta-2 microglobulin, cystatin c, retinol binding protein, urine beta-2 microglobulin (milligrams per liter [mg/L])

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End point title

Change from baseline in renal biomarkers: specific serum beta-2 microglobulin, cystatin c, retinol binding protein, urine beta-2 microglobulin (milligrams per liter [mg/L]) ^[19]

End point description

Serum samples were collected to evaluate renal specific biomarkers: specific serum beta-2 microglobulin, cystatin c, retinol binding protein, urine beta-2 microglobulin. Baseline value is defined as latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from baseline is defined as post-dose visit value minus baseline value. For the Q2M arm, data from the Q2M OLI participants at Month 6 and 12 visit and Q2M D2I participants at Month 5 and 11 visit were combined as the study objective was to demonstrate the non-inferior antiviral activity of (Q2M) (OLI+ D2I combined) compared to BIK. For BIK arm, data was collected at month 6 and 12 visit. Month 6/5 refers to the Month 6 (OLI and BIK) visit/Month 5 (DTI) visit. Month 12/11 refers to the Month 12 (OLI and BIK) visit/Month 11 (DTI) visit.

End point type

Secondary

End point timeframe

Baseline (Day 1) and up to Month 12

Notes
[19] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: As per study design, the endpoints were presented for OLI + D2I arms combined as Q2M. Whereas, the baseline period was separated as OLI and D2I.

End point values	Biktarvy (BIK)	Q2M (OLI + D2I)
Number of subjects analysed	227	448
Units: milligrams per liter (mg/L)
arithmetic mean (standard deviation)
Serum beta-2 microglobulin, Baseline (Day 1)	1.8 ( 0.38 )	1.8 ( 0.40 )
Serum beta-2 microglobulin, Month 6/5	0.0 ( 0.28 )	0.0 ( 0.28 )
Serum beta-2 microglobulin, Month 12/11	0.0 ( 0.32 )	0.0 ( 0.33 )
Serum cystatin C, Baseline (Day 1)	0.9 ( 0.14 )	0.9 ( 0.13 )
Serum cystatin C, Month 6/5	0.0 ( 0.08 )	0.0 ( 0.08 )
Serum cystatin C, Month 12/11	0.0 ( 0.08 )	0.0 ( 0.08 )
Serum retinol binding protein, Baseline (Day 1)	52.2 ( 12.61 )	51.3 ( 13.01 )
Serum retinol binding protein, Month 6/5	-0.3 ( 8.75 )	-1.0 ( 9.00 )
Serum retinol binding protein, Month 12/11	0.2 ( 9.06 )	-1.2 ( 9.24 )
Urine beta-2 microglobulin, Baseline (Day 1)	0.2 ( 0.40 )	0.2 ( 0.34 )
Urine beta-2 microglobulin, Month 6/5	0.1 ( 0.65 )	0.0 ( 0.40 )
Urine beta-2 microglobulin, Month 12/11	0.1 ( 0.52 )	0.0 ( 0.24 )

No statistical analyses for this end point

Secondary: Change from baseline in renal biomarkers: urine phosphate (millimoles per liter (mmol/L))

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End point title

Change from baseline in renal biomarkers: urine phosphate (millimoles per liter (mmol/L)) ^[20]

End point description

Serum samples were collected to evaluate renal specific biomarkers: urine phosphate. Baseline value is defined as latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from baseline is defined as post-dose visit value minus baseline value. For the Q2M arm, data from the Q2M OLI participants at Month 6 and 12 visit and Q2M D2I participants at Month 5 and 11 visit were combined as the study objective was to demonstrate the non-inferior antiviral activity of (Q2M) (OLI+ D2I combined) compared to BIK. For BIK arm, data was collected at month 6 and 12 visit. Month 6/5 refers to the Month 6 (OLI and BIK) visit/Month 5 (DTI) visit. Month 12/11 refers to the Month 12 (OLI and BIK) visit/Month 11 (DTI) visit.

End point type

Secondary

End point timeframe

Baseline (Day 1) and up to Month 12

Notes
[20] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: As per study design, the endpoints were presented for OLI + D2I arms combined as Q2M. Whereas, the baseline period was separated as OLI and D2I.

End point values	Biktarvy (BIK)	Q2M (OLI + D2I)
Number of subjects analysed	223	449
Units: millimoles per liter (mmol/L)
arithmetic mean (standard deviation)
Baseline (Day 1)	18.4 ( 13.10 )	20.0 ( 14.03 )
Month 6/5	0.4 ( 15.60 )	-1.0 ( 16.29 )
Month 12/11	-0.6 ( 15.16 )	0.1 ( 16.17 )

No statistical analyses for this end point

Secondary: Change from baseline in renal biomarker: urine retinol binding protein 4 (microgram per liter (ug/L))

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End point title

Change from baseline in renal biomarker: urine retinol binding protein 4 (microgram per liter (ug/L)) ^[21]

End point description

Serum samples were collected to evaluate renal specific biomarkers: urine retinol binding protein 4. Baseline value is defined as latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from baseline is defined as post-dose visit value minus baseline value. For the Q2M arm, data from the Q2M OLI participants at Month 6 and 12 visit and Q2M D2I participants at Month 5 and 11 visit were combined as the study objective was to demonstrate the non-inferior antiviral activity of (Q2M) (OLI+ D2I combined) compared to BIK. For BIK arm, data was collected at month 6 and 12 visit. Month 6/5 refers to the Month 6 (OLI and BIK) visit/Month 5 (DTI) visit. Month 12/11 refers to the Month 12 (OLI and BIK) visit/Month 11 (DTI) visit.

End point type

Secondary

End point timeframe

Baseline (Day 1) and up to Month 12

Notes
[21] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: As per study design, the endpoints were presented for OLI + D2I arms combined as Q2M. Whereas, the baseline period was separated as OLI and D2I.

End point values	Biktarvy (BIK)	Q2M (OLI + D2I)
Number of subjects analysed	222	447
Units: microgram per liter (ug/L)
arithmetic mean (standard deviation)
Baseline (Day 1)	100.0 ( 82.00 )	114.2 ( 111.45 )
Month 6/5	5.7 ( 105.08 )	0.8 ( 139.88 )
Month 12/11	-1.2 ( 105.26 )	-0.6 ( 123.52 )

No statistical analyses for this end point

Secondary: Change from baseline in renal biomarker: urine retinol binding protein/creatinine (milligram per mole (mg/mol))

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End point title

Change from baseline in renal biomarker: urine retinol binding protein/creatinine (milligram per mole (mg/mol)) ^[22]

End point description

Serum samples were collected to evaluate renal specific biomarkers: urine retinol binding protein/creatinine. Baseline value is defined as latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from baseline is defined as post-dose visit value minus baseline value. For the Q2M arm, data from the Q2M OLI participants at Month 6 and 12 visit and Q2M D2I participants at Month 5 and 11 visit were combined as the study objective was to demonstrate the non-inferior antiviral activity of (Q2M) (OLI+ D2I combined) compared to BIK. For BIK arm, data was collected at month 6 and 12 visit. Month 6/5 refers to the Month 6 (OLI and BIK) visit/Month 5 (DTI) visit. Month 12/11 refers to the Month 12 (OLI and BIK) visit/Month 11 (DTI) visit.

End point type

Secondary

End point timeframe

Baseline (Day 1) and up to Month 12

Notes
[22] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: As per study design, the endpoints were presented for OLI + D2I arms combined as Q2M. Whereas, the baseline period was separated as OLI and D2I.

End point values	Biktarvy (BIK)	Q2M (OLI + D2I)
Number of subjects analysed	107	216
Units: milligram per mole (mg/mol)
arithmetic mean (standard deviation)
Baseline (Day 1)	8.0 ( 5.75 )	8.6 ( 6.32 )
Month 6/5	-0.8 ( 7.23 )	0.8 ( 6.00 )
Month 12/11	0.0 ( 4.15 )	-0.5 ( 6.41 )

No statistical analyses for this end point

Secondary: Change from baseline in renal biomarker: urine beta-2 microglobulin/ creatinine (grams per mole (g/mol))

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End point title

Change from baseline in renal biomarker: urine beta-2 microglobulin/ creatinine (grams per mole (g/mol)) ^[23]

End point description

Serum samples were collected to evaluate renal specific biomarkers: urine beta-2 microglobulin/ creatinine. Baseline value is defined as latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from baseline is defined as post-dose visit value minus baseline value. For the Q2M arm, data from the Q2M OLI participants at Month 6 and 12 visit and Q2M D2I participants at Month 5 and 11 visit were combined as the study objective was to demonstrate the non-inferior antiviral activity of (Q2M) (OLI+ D2I combined) compared to BIK. For BIK arm, data was collected at month 6 and 12 visit. Month 6/5 refers to the Month 6 (OLI and BIK) visit/Month 5 (DTI) visit. Month 12/11 refers to the Month 12 (OLI and BIK) visit/Month 11 (DTI) visit.

End point type

Secondary

End point timeframe

Baseline (Day 1) and up to Month 12

Notes
[23] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: As per study design, the endpoints were presented for OLI + D2I arms combined as Q2M. Whereas, the baseline period was separated as OLI and D2I.

End point values	Biktarvy (BIK)	Q2M (OLI + D2I)
Number of subjects analysed	88	182
Units: grams per mole (g/mol)
arithmetic mean (standard deviation)
Baseline (Day 1)	0.0 ( 0.04 )	0.0 ( 0.03 )
Month 6/5	0.0 ( 0.19 )	0.0 ( 0.03 )
Month 12/11	0.0 ( 0.04 )	0.0 ( 0.02 )

No statistical analyses for this end point

Secondary: Change From Baseline in percentage of participants with metabolic syndrome at month 12/11

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End point title

Change From Baseline in percentage of participants with metabolic syndrome at month 12/11 ^[24]

End point description

Metabolic syndrome defined as cluster of conditions that occurred together increasing one's risk of heart disease, stroke and type 2 diabetes mellitus (DM). These conditions included increased blood pressure (BP), elevated blood glucose levels, excess body fat around the waist and abnormal fasting cholesterol and triglyceride (TG) levels. Baseline value is defined as latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from baseline is defined as post-dose visit value minus baseline value. For the Q2M arm, data from the Q2M OLI participants at Month 12 visit and Q2M D2I participants at Month 11 visit were combined as the study objective was to demonstrate the non-inferior antiviral activity of (Q2M) (OLI+ D2I combined) compared to BIK. For BIK arm, data was collected at month 12 visit. Month 12/11 refers to the Month 12 (OLI and BIK) visit/Month 11 (DTI) visit.

End point type

Secondary

End point timeframe

Baseline (Day 1) and at Month 12/11

Notes
[24] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: As per study design, the endpoints were presented for OLI + D2I arms combined as Q2M. Whereas, the baseline period was separated as OLI and D2I.

End point values	Biktarvy (BIK)	Q2M (OLI + D2I)
Number of subjects analysed	227	454
Units: Percentage of participants
Yes (Baseline) to Yes (Month 12/11)	9	9
Yes (Baseline) to No (Month 12/11)	7	5
Yes (Baseline) to Missing (Month 12/11)	1	2
No (Baseline) to Yes (Month 12/11)	8	6
No (Baseline) to No (Month 12/11)	70	69
No (Baseline) to Missing ((Month 12/11))	6	8

No statistical analyses for this end point

Secondary: Change From Baseline in percentage of participants with metabolic syndrome at month 6/5

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End point title

Change From Baseline in percentage of participants with metabolic syndrome at month 6/5 ^[25]

End point description

Metabolic syndrome defined as cluster of conditions that occurred together increasing one's risk of heart disease, stroke and type 2 diabetes mellitus (DM). These conditions included increased blood pressure (BP), elevated blood glucose levels, excess body fat around the waist and abnormal fasting cholesterol and triglyceride (TG) levels. Baseline value is defined as latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from baseline is defined as post-dose visit value minus baseline value. For the Q2M arm, data from the Q2M OLI participants at Month 6 visit and Q2M D2I participants at Month 5 visit were combined as the study objective was to demonstrate the non-inferior antiviral activity of (Q2M) (OLI+ D2I combined) compared to BIK. For BIK arm, data was collected at month 6 visit. Month 6/5 refers to the Month 6 (OLI and BIK) visit/Month 5 (DTI) visit.

End point type

Secondary

End point timeframe

Baseline (Day 1) and at month 6/5

Notes
[25] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: As per study design, the endpoints were presented for OLI + D2I arms combined as Q2M. Whereas, the baseline period was separated as OLI and D2I.

End point values	Biktarvy (BIK)	Q2M (OLI + D2I)
Number of subjects analysed	227	454
Units: Percentage of participants
Yes (Baseline) to Yes (Month 6/5)	11	9
Yes (Baseline) to No (Month 6/5)	6	7
Yes (Baseline) to Missing (Month 6/5)	0	1
No (Baseline) to Yes (Month 6/5)	10	5
No (Baseline) to No (Month 6/5)	71	74
No (Baseline) to Missing (Month 6/5)	2	5

No statistical analyses for this end point

Secondary: Change from baseline in homeostasis model of assessment-insulin resistance (HOMA-IR)

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End point title

Change from baseline in homeostasis model of assessment-insulin resistance (HOMA-IR) ^[26]

End point description

The homeostatic model assessment (HOMA) is a method used to quantify insulin resistance. HOMA-IR is calculated as fasting insulin microunits per liter (microU/L) multiplied by fasting glucose (nmol/L) divided by 22.5. Higher HOMA-IR values indicate increased insulin resistance; values <2 is generally regarded as normal. Baseline value is defined as latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from baseline is defined as post-dose visit value minus baseline value. For the Q2M arm, data from the Q2M OLI participants at Month 6 and 12 visit and Q2M D2I participants at Month 5 and 11 visit were combined as the study objective was to demonstrate the non-inferior antiviral activity of (Q2M) (OLI+ D2I combined) compared to BIK. For BIK arm, data was collected at month 6 and 12 visit. Month 6/5 refers to the Month 6 (OLI and BIK) visit/Month 5 (DTI) visit. Month 12/11 refers to the Month 12 (OLI and BIK) visit/Month 11 (DTI) visit.

End point type

Secondary

End point timeframe

Baseline (Day 1) and up to Month 12

Notes
[26] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: As per study design, the endpoints were presented for OLI + D2I arms combined as Q2M. Whereas, the baseline period was separated as OLI and D2I.

End point values	Biktarvy (BIK)	Q2M (OLI + D2I)
Number of subjects analysed	210	409
Units: HOMA-IR score
arithmetic mean (standard deviation)
Baseline (Day 1)	3.1 ( 5.06 )	2.8 ( 4.05 )
Month 6/5	-0.1 ( 5.09 )	0.3 ( 4.11 )
Month 12/11	-0.4 ( 3.76 )	0.2 ( 3.99 )

No statistical analyses for this end point

Secondary: Percentage of participants with treatment preference as assessed using preference questionnaire at month 12/11 - Q2M

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End point title

Percentage of participants with treatment preference as assessed using preference questionnaire at month 12/11 - Q2M ^[27]

End point description

Participants who had switched from the daily oral BIK regimen to CAB + RPV, were assessed as per the preference questionnaire every two months. There were 3 preference questions included to assess the preferred treatment 1) Long-acting injectable HIV medication, 2) Daily oral HIV medication, 3) No Preference. This endpoint was only planned to be analyzed for Q2M arm only. Month 12/11 refers to the Month 12 (OLI and BIK) visit/Month 11 (DTI) visit. Data represented included maintenance withdrawal or Month 12/11.

End point type

Secondary

End point timeframe

Up to month 12/11

Notes
[27] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: As per study design, the endpoints were presented for OLI + D2I arms combined as Q2M. Whereas, the baseline period was separated as OLI and D2I.

End point values	Oral lead-in phase (OLI)	Direct to injections (D2I)
Number of subjects analysed	163	262
Units: Percentage of participants
Long-acting injectable HIV medication	87	92
Daily oral HIV medication	7	4
No Preference	6	5

No statistical analyses for this end point

Secondary: Change from baseline in total treatment satisfaction score using HIV treatment satisfaction status questionnaire (HIVTSQs)

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End point title

Change from baseline in total treatment satisfaction score using HIV treatment satisfaction status questionnaire (HIVTSQs) ^[28]

End point description

The HIVTSQs total treatment satisfaction score comprised of 11 items based on HIVTSQ questionnaire each graded on a scale of 0 (very dissatisfied) to 6 (very satisfied) which were summed to produce a total score range of 0-66. Higher scores represent greater treatment satisfaction. Baseline value is defined as latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from baseline is defined as post-dose visit value minus baseline value. For the Q2M arm, data from the Q2M OLI participants at Month 6 and 12 visit and Q2M D2I participants at Month 5 and 11 visit were combined as the study objective was to demonstrate the non-inferior antiviral activity of (Q2M) (OLI+ D2I combined) compared to BIK. For BIK arm, data was collected at month 6 and 12 visit. Month 6/5 refers to the Month 6 (OLI and BIK) visit/Month 5 (DTI) visit. Month 12/11 refers to the Month 12 (OLI and BIK) visit/Month 11 (DTI) visit.

End point type

Secondary

End point timeframe

Baseline (Day 1) and up to Month 12

Notes
[28] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: As per study design, the endpoints were presented for OLI + D2I arms combined as Q2M. Whereas, the baseline period was separated as OLI and D2I.

End point values	Biktarvy (BIK)	Q2M (OLI + D2I)
Number of subjects analysed	222	446
Units: Scores on scale
arithmetic mean (standard deviation)
Baseline (Day 1)	58.38 ( 8.229 )	57.88 ( 7.906 )
Month 6/5	-0.66 ( 7.417 )	3.99 ( 9.670 )
Month 12/11	-1.93 ( 8.045 )	4.21 ( 9.273 )

No statistical analyses for this end point

Secondary: Change from baseline in individual item scores using HIVTSQs

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End point title

Change from baseline in individual item scores using HIVTSQs ^[29]

End point description

The individual item scores on HIVTSQs scale were rated on a scale of 6 (very satisfied, convenient, flexible, etc.) to -6 (very dissatisfied, inconvenient, inflexible, etc.). Higher scores represent greater satisfaction with each aspect of treatment. Baseline value is defined as latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from baseline is defined as post-dose visit value minus baseline value. For the Q2M arm, data from the Q2M OLI participants at Month 6 and 12 visit and Q2M D2I participants at Month 5 and 11 visit were combined as the study objective was to demonstrate the non-inferior antiviral activity of (Q2M) (OLI+ D2I combined) compared to BIK. For BIK arm, data was collected at month 6 and 12 visit. Month 6/5 refers to the Month 6 (OLI and BIK) visit/Month 5 (DTI) visit. Month 12/11 refers to the Month 12 (OLI and BIK) visit/Month 11 (DTI) visit.

End point type

Secondary

End point timeframe

Baseline (Day 1) and up to Month 12

Notes
[29] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: As per study design, the endpoints were presented for OLI + D2I arms combined as Q2M. Whereas, the baseline period was separated as OLI and D2I.

End point values	Biktarvy (BIK)	Q2M (OLI + D2I)
Number of subjects analysed	222	446
Units: Scores on scale
arithmetic mean (standard deviation)
I1=Satisfaction with current treatment,Day 1	5.6 ( 0.75 )	5.5 ( 0.86 )
I1=Satisfaction with current treatment,M6/5	-0.2 ( 0.91 )	0.1 ( 1.10 )
I1=Satisfaction with current treatment,M12/11	-0.3 ( 1.00 )	0.2 ( 1.07 )
I2=Controlled HIV, Day 1	5.8 ( 0.45 )	5.8 ( 0.54 )
I2=Controlled HIV, M6/5	-0.1 ( 0.55 )	0.0 ( 0.80 )
I2=Controlled HIV, M12/11	-0.1 ( 0.69 )	0.0 ( 0.70 )
I3=Satisfaction with side effects, Day 1	5.5 ( 1.02 )	5.5 ( 0.91 )
I3=Satisfaction with side effects,M6/5	0.0 ( 1.21 )	-0.3 ( 1.42 )
I3=Satisfaction with side effects,M12/11	0.0 ( 1.16 )	-0.1 ( 1.38 )
I4=Satisfaction with treatment demands, Day 1	5.2 ( 1.21 )	5.2 ( 1.16 )
I4=Satisfaction with treatment demands,M6/5	-0.1 ( 1.28 )	0.4 ( 1.32 )
I4=Satisfaction with treatment demands,M12/11	-0.2 ( 1.35 )	0.3 ( 1.33 )
I5=Treatment convenience, Day 1	5.2 ( 1.16 )	5.0 ( 1.24 )
I5=Treatment convenience, M6/5	-0.1 ( 1.30 )	0.6 ( 1.42 )
I5=Treatment convenience, M12/11	-0.2 ( 1.33 )	0.7 ( 1.43 )
I6=Treatment flexibility, Day 1	4.9 ( 1.55 )	4.7 ( 1.70 )
I6=Treatment flexibility,M6/5	0.0 ( 1.58 )	0.9 ( 1.77 )
I6=Treatment flexibility, M12/11	-0.1 ( 1.58 )	0.9 ( 1.74 )
I7=Satisfaction with understanding of HIV, Day 1	5.5 ( 0.92 )	5.5 ( 0.80 )
I7=Satisfaction with understanding of HIV,M6/5	0.1 ( 0.75 )	0.2 ( 0.81 )
I7=Satisfaction with understanding of HIV,M12/11	0.1 ( 0.78 )	0.1 ( 0.86 )
I8=Treatment fitting in with lifestyle, Day 1	5.1 ( 1.11 )	5.0 ( 1.20 )
I8=Treatment fitting in with lifestyle, M6/5	-0.1 ( 1.26 )	0.7 ( 1.36 )
I8=Treatment fitting in with lifestyle, M12/11	-0.2 ( 1.38 )	0.7 ( 1.31 )
I9=Recommendation of treatment for HIV,Day 1	5.5 ( 1.02 )	5.5 ( 0.86 )
I9=Recommendation of treatment for HIV,M6/5	0.0 ( 1.09 )	0.2 ( 1.10 )
I9=Recommendation of treatment for HIV,M12/11	-0.1 ( 1.04 )	0.2 ( 1.04 )
I10=Satisfaction with treatment continuation,Day 1	4.9 ( 1.28 )	4.9 ( 1.23 )
I10=Satisfaction with treatment continuation,M6/5	0.0 ( 1.38 )	0.8 ( 1.54 )
I10=Satisfaction with treatm. continuation,M12/11	-0.2 ( 1.45 )	0.9 ( 1.49 )
I11=Ease/difficulty with current treatment,Day 1	5.3 ( 1.06 )	5.2 ( 1.10 )
I11=Ease/difficulty with current treatment,M 6/5	-0.2 ( 1.20 )	0.5 ( 1.34 )
I11=Ease/difficulty with current treatment,M12/11	-0.3 ( 1.13 )	0.5 ( 1.34 )
I12=Satisfaction with treatm. discomfort,Day 1	5.6 ( 0.94 )	5.5 ( 1.02 )
I12=Satisfaction with treatm. discomfort,M6/5	-0.1 ( 0.93 )	-0.6 ( 1.64 )
I12=Satisfaction with treatm. discomfort,M12/11	-0.2 ( 1.09 )	-0.5 ( 1.54 )

No statistical analyses for this end point

Secondary: HIV treatment satisfaction change questionnaire (HIVTSQc) total score at Month 12/11

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End point title

HIV treatment satisfaction change questionnaire (HIVTSQc) total score at Month 12/11 ^[30]

End point description

HIV treatment satisfaction change questionnaire (HIVTSQc) total Score is computed with items 1-11 which were summed to produce a total score range of -33 to 33. Higher score indicated greater improvement in the satisfaction with the treatment and lower score indicated greater deterioration in treatment satisfaction. A score of 0 represents no change. For the Q2M arm, data from the Q2M OLI participants at Month 12 visit and Q2M D2I participants at Month 11 visit were combined as the study objective was to demonstrate the non-inferior antiviral activity of (Q2M) (OLI+ D2I combined) compared to BIK. For BIK arm, data was collected at month 12 visit. Month 12/11 refers to the Month 12 (OLI and BIK) visit/Month 11 (DTI) visit.

End point type

Secondary

End point timeframe

At Month 12/11

Notes
[30] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: As per study design, the endpoints were presented for OLI + D2I arms combined as Q2M. Whereas, the baseline period was separated as OLI and D2I.

End point values	Biktarvy (BIK)	Q2M (OLI + D2I)
Number of subjects analysed	214	426
Units: Scores on scale
arithmetic mean (standard deviation)	16.89 ( 14.299 )	26.97 ( 10.135 )

No statistical analyses for this end point

Secondary: Individual item scores of HIVTSQc at Month 12/11

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End point title

Individual item scores of HIVTSQc at Month 12/11 ^[31]

End point description

Individual item scores were rated on a scale of +3 (much more satisfied’, ‘much more convenient’, ‘much more flexible’) to -3 (much less satisfied’, ‘much less convenient’, ‘much less flexible’). Higher score indicates greater improvement, and lower score indicates greater deterioration in satisfaction with each aspect of treatment. A score of 0 represents no change. For the Q2M arm, data from the Q2M OLI participants at Month 12 visit and Q2M D2I participants at Month 11 visit were combined as the study objective was to demonstrate the non-inferior antiviral activity of (Q2M) (OLI+ D2I combined) compared to BIK. For BIK arm, data was collected at month 12 visit. Month 12/11 refers to the Month 12 (OLI and BIK) visit/Month 11 (DTI) visit.

End point type

Secondary

End point timeframe

At Month 12/11

Notes
[31] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: As per study design, the endpoints were presented for OLI + D2I arms combined as Q2M. Whereas, the baseline period was separated as OLI and D2I.

End point values	Biktarvy (BIK)	Q2M (OLI + D2I)
Number of subjects analysed	214	427
Units: Scores on scale
arithmetic mean (standard deviation)
I1=Satisfaction with current treatment	1.60 ( 1.417 )	2.56 ( 1.043 )
I 2=Controlled HIV	1.88 ( 1.375 )	2.47 ( 1.086 )
I3=Satisfaction with side effects	1.63 ( 1.463 )	2.10 ( 1.388 )
I4=Satisfaction with treatment demands	1.42 ( 1.560 )	2.41 ( 1.109 )
I5=Treatment convenience	1.38 ( 1.520 )	2.50 ( 1.070 )
I6=Treatment flexibility	1.24 ( 1.591 )	2.41 ( 1.138 )
I7=Satisfaction with understanding of HIV	1.94 ( 1.297 )	2.35 ( 1.065 )
I8=Treatment fitting in with lifestyle	1.43 ( 1.489 )	2.56 ( 0.994 )
I9=Recommendation of current treatment for HIV	1.73 ( 1.467 )	2.61 ( 1.065 )
I10=Satisfaction with treatment continuation	1.22 ( 1.602 )	2.58 ( 1.093 )
I11=Ease/difficulty with treatment	1.43 ( 1.542 )	2.46 ( 1.107 )
I12=Satisfaction with discomfort of treatment	1.64 ( 1.465 )	1.85 ( 1.530 )

No statistical analyses for this end point

Secondary: Change from month 2/1 in dimension scores using perception of injection (PIN) questionnaire - Q2M

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End point title

Change from month 2/1 in dimension scores using perception of injection (PIN) questionnaire - Q2M ^[32]

End point description

The PIN questionnaire was used to explore the dimension scores based on 4 dimensions including acceptance of injection site reactions (ISRs), Bother from ISRs, Leg movement and Sleep categories. Domain scores were calculated as a mean of all items with the domain. The PIN response options range from 1 (totally acceptable) to 5 (not at all acceptable). This endpoint was only planned to be analyzed for Q2M arm. Month 2/1 refers to the Month 2 (OLI and BIK) visit/Month 1 (DTI) visit. Month 6/5 refers to the Month 6 (OLI and BIK) visit/Month 5 (DTI) visit. Month 12/11 refers to the Month 12 (OLI and BIK) visit/Month 11 (DTI) visit.

End point type

Secondary

End point timeframe

From Month 2/1 up to Month 12

Notes
[32] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: As per study design, the endpoints were presented for OLI + D2I arms combined as Q2M. Whereas, the baseline period was separated as OLI and D2I.

End point values	Oral lead-in phase (OLI)	Direct to injections (D2I)
Number of subjects analysed	163	271
Units: Scores on scale
arithmetic mean (standard deviation)
Bother of ISRs, Month 2/1	1.58 ( 0.568 )	1.60 ( 0.583 )
Bother of ISRs, Month 6/5	0.01 ( 0.528 )	-0.03 ( 0.590 )
Bother of ISRs, Month 12/11	0.08 ( 0.594 )	-0.04 ( 0.583 )
Leg Movement, Month 2/1	1.93 ( 1.013 )	1.83 ( 0.913 )
Leg Movement, Month 6/5	-0.14 ( 0.779 )	-0.22 ( 0.868 )
Leg Movement, Month 12/11	-0.18 ( 0.859 )	-0.24 ( 0.817 )
Sleep, Month 2/1	1.83 ( 0.936 )	1.87 ( 0.965 )
Sleep, Month 6/5	-0.01 ( 0.915 )	-0.16 ( 0.869 )
Sleep, Month 12/11	-0.07 ( 0.948 )	-0.17 ( 0.870 )
Acceptance, Month 2/1	2.02 ( 1.017 )	2.05 ( 0.949 )
Acceptance, Month 6/5	-0.14 ( 0.906 )	-0.13 ( 0.879 )
Acceptance, Month 12/11	-0.20 ( 0.873 )	-0.26 ( 0.856 )

No statistical analyses for this end point

Secondary: Change from month 2/1 in individual item scores using PIN questionnaire- Q2M

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End point title

Change from month 2/1 in individual item scores using PIN questionnaire- Q2M ^[33]

End point description

The PIN questionnaire was used to explore the individual item scores based on anxiety before, pain, satisfaction, anxiety after and willingness categories. The items in the scale are rated on a 5-point scale and questions are phrased in such a way as to ensure that 1 is very dissatisfied and 5 was very satisfied. This endpoint was only planned to be analyzed for Q2M arm. Month 2/1 refers to the Month 2 (OLI and BIK) visit/Month 1 (DTI) visit. Month 6/5 refers to the Month 6 (OLI and BIK) visit/Month 5 (DTI) visit. Month 12/11 refers to the Month 12 (OLI and BIK) visit/Month 11 (DTI) visit.

End point type

Secondary

End point timeframe

From Month 2/1 up to Month 12

Notes
[33] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: As per study design, the endpoints were presented for OLI + D2I arms combined as Q2M. Whereas, the baseline period was separated as OLI and D2I.

End point values	Oral lead-in phase (OLI)	Direct to injections (D2I)
Number of subjects analysed	163	271
Units: Scores on scale
arithmetic mean (standard deviation)
Anxiety Before, Month 2/1	1.9 ( 1.02 )	1.9 ( 1.02 )
Anxiety Before, Month 6/5	-0.14 ( 1.021 )	-0.22 ( 1.000 )
Anxiety Before, Month 12/11	-0.28 ( 0.973 )	-0.22 ( 0.914 )
Pain, Month 2/1	1.8 ( 0.88 )	2.0 ( 0.93 )
Pain, Month 6/5	0.09 ( 0.907 )	-0.03 ( 0.935 )
Pain, Month 12/11	0.13 ( 0.995 )	0.02 ( 0.943 )
Satisfaction, Month 2/1	1.7 ( 0.90 )	1.6 ( 0.81 )
Satisfaction, Month 6/5	-0.06 ( 0.837 )	0.00 ( 0.867 )
Satisfaction, Month 12/11	-0.12 ( 0.861 )	-0.11 ( 0.830 )
Anxiety After, Month 2/1	1.8 ( 1.12 )	1.7 ( 0.96 )
Anxiety After, Month 6/5	-0.14 ( 0.994 )	-0.04 ( 0.916 )
Anxiety After, Month 12/11	-0.24 ( 0.947 )	-0.16 ( 0.850 )
Willingness, Month 2/1	1.4 ( 0.76 )	1.4 ( 0.78 )
Willingness, Month 6/5	0.01 ( 0.716 )	-0.08 ( 0.794 )
Willingness, Month 12/11	-0.01 ( 0.744 )	-0.10 ( 0.742 )

No statistical analyses for this end point

Adverse events

Top of page

Timeframe for reporting adverse events

All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to end of Extension Phase (approximately Month 27).

Adverse event reporting additional description

AEs are reported based on Safety set population, which included all randomized participants who received at least one dose of study drug, based on the study phase they were included in. The Safety set included all participants irrespective of eligibility criteria violation and GCP non-compliance, since they received at least a study intervention d

Assessment type

Systematic

Dictionary name

MedDRA

Dictionary version

24.1

Reporting group title

Oral lead-in phase (OLI)

Reporting group description

Reporting group title

Switch Q2M Group

Reporting group description

Eligible participants with HIV-1 who received BIK tablet orally switched treatment after month 12 (Extension Phase) to CAB LA 600 mg + RPV LA 900 mg regimen, administered once every 2 months.

Reporting group title

Biktarvy (BIK)

Reporting group description

Participants with HIV-1 received BIK tablet orally until month 12. BIK was a fixed dose combination of 50 mg Bictegravir (BIC) + 200 mg Emtricitabine (FTC) + 25 mg Tenofovir alafenamide (TAF).

Reporting group title

Direct to injections (D2I)

Reporting group description

Serious adverse events	Oral lead-in phase (OLI)	Switch Q2M Group	Biktarvy (BIK)	Direct to injections (D2I)
Total subjects affected by serious adverse events
subjects affected / exposed	11 / 175 (6.29%)	5 / 145 (3.45%)	15 / 227 (6.61%)	10 / 279 (3.58%)
number of deaths (all causes)	0	1	1	0
number of deaths resulting from adverse events	0	0	0	0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Glioblastoma multiforme
alternative dictionary used: v24.1 24.1
subjects affected / exposed	0 / 175 (0.00%)	0 / 145 (0.00%)	0 / 227 (0.00%)	1 / 279 (0.36%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Bladder transitional cell carcinoma
alternative dictionary used: v24.1 24.1
subjects affected / exposed	1 / 175 (0.57%)	0 / 145 (0.00%)	0 / 227 (0.00%)	0 / 279 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Surgical and medical procedures
Abortion induced
alternative dictionary used: v24.1 24.1
subjects affected / exposed	0 / 175 (0.00%)	0 / 145 (0.00%)	0 / 227 (0.00%)	1 / 279 (0.36%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
General disorders and administration site conditions
Pyrexia
alternative dictionary used: v24.1 24.1
subjects affected / exposed	0 / 175 (0.00%)	0 / 145 (0.00%)	1 / 227 (0.44%)	0 / 279 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Injection site pain
alternative dictionary used: v24.1 24.1
subjects affected / exposed	1 / 175 (0.57%)	0 / 145 (0.00%)	0 / 227 (0.00%)	0 / 279 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Sudden death
subjects affected / exposed	0 / 175 (0.00%)	1 / 145 (0.69%)	0 / 227 (0.00%)	0 / 279 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
alternative dictionary used: v24.1 24.1
subjects affected / exposed	0 / 175 (0.00%)	0 / 145 (0.00%)	0 / 227 (0.00%)	1 / 279 (0.36%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Psychiatric disorders
Drug abuse
alternative dictionary used: v24.1 24.1
subjects affected / exposed	0 / 175 (0.00%)	0 / 145 (0.00%)	1 / 227 (0.44%)	0 / 279 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Substance abuse
alternative dictionary used: v24.1 24.1
subjects affected / exposed	1 / 175 (0.57%)	0 / 145 (0.00%)	0 / 227 (0.00%)	0 / 279 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Product issues
Device breakage
alternative dictionary used: v24.1 24.1
subjects affected / exposed	0 / 175 (0.00%)	0 / 145 (0.00%)	1 / 227 (0.44%)	0 / 279 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Investigations
Alanine aminotransferase increased
alternative dictionary used: v24.1 24.1
subjects affected / exposed	2 / 175 (1.14%)	0 / 145 (0.00%)	0 / 227 (0.00%)	1 / 279 (0.36%)
occurrences causally related to treatment / all	0 / 2	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Blood creatine phosphokinase increased
alternative dictionary used: v24.1 24.1
subjects affected / exposed	0 / 175 (0.00%)	0 / 145 (0.00%)	1 / 227 (0.44%)	0 / 279 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Injury, poisoning and procedural complications
Abdominal injury
alternative dictionary used: v24.1 24.1
subjects affected / exposed	0 / 175 (0.00%)	0 / 145 (0.00%)	1 / 227 (0.44%)	0 / 279 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Overdose
alternative dictionary used: v24.1 24.1
subjects affected / exposed	1 / 175 (0.57%)	0 / 145 (0.00%)	1 / 227 (0.44%)	0 / 279 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Skin laceration
alternative dictionary used: v24.1 24.1
subjects affected / exposed	0 / 175 (0.00%)	0 / 145 (0.00%)	0 / 227 (0.00%)	1 / 279 (0.36%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Ulna fracture
alternative dictionary used: v24.1 24.1
subjects affected / exposed	0 / 175 (0.00%)	0 / 145 (0.00%)	1 / 227 (0.44%)	0 / 279 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Radius fracture
alternative dictionary used: v24.1 24.1
subjects affected / exposed	0 / 175 (0.00%)	0 / 145 (0.00%)	1 / 227 (0.44%)	0 / 279 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Joint dislocation
alternative dictionary used: v24.1 24.1
subjects affected / exposed	0 / 175 (0.00%)	0 / 145 (0.00%)	0 / 227 (0.00%)	1 / 279 (0.36%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Contusion
alternative dictionary used: v24.1 24.1
subjects affected / exposed	0 / 175 (0.00%)	0 / 145 (0.00%)	1 / 227 (0.44%)	0 / 279 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Road traffic accident
alternative dictionary used: v24.1 24.1
subjects affected / exposed	0 / 175 (0.00%)	0 / 145 (0.00%)	2 / 227 (0.88%)	1 / 279 (0.36%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Skin abrasion
alternative dictionary used: v24.1 24.1
subjects affected / exposed	0 / 175 (0.00%)	0 / 145 (0.00%)	0 / 227 (0.00%)	1 / 279 (0.36%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Cardiac disorders
Atrial fibrillation
alternative dictionary used: v24.1 24.1
subjects affected / exposed	1 / 175 (0.57%)	0 / 145 (0.00%)	0 / 227 (0.00%)	0 / 279 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Acute myocardial infarction
alternative dictionary used: v24.1 24.1
subjects affected / exposed	1 / 175 (0.57%)	0 / 145 (0.00%)	0 / 227 (0.00%)	0 / 279 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
Nervous system disorders
Haemorrhagic transformation stroke
alternative dictionary used: v24.1 24.1
subjects affected / exposed	0 / 175 (0.00%)	0 / 145 (0.00%)	0 / 227 (0.00%)	1 / 279 (0.36%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Encephalopathy
alternative dictionary used: v24.1 24.1
subjects affected / exposed	0 / 175 (0.00%)	0 / 145 (0.00%)	1 / 227 (0.44%)	0 / 279 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
Brain injury
alternative dictionary used: v24.1 24.1
subjects affected / exposed	0 / 175 (0.00%)	0 / 145 (0.00%)	1 / 227 (0.44%)	0 / 279 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Syncope
alternative dictionary used: v24.1 24.1
subjects affected / exposed	0 / 175 (0.00%)	0 / 145 (0.00%)	1 / 227 (0.44%)	0 / 279 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Gastrointestinal disorders
Anorectal disorder
alternative dictionary used: v24.1 24.1
subjects affected / exposed	0 / 175 (0.00%)	0 / 145 (0.00%)	1 / 227 (0.44%)	0 / 279 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Hepatobiliary disorders
Cholecystitis
alternative dictionary used: v24.1 24.1
subjects affected / exposed	1 / 175 (0.57%)	0 / 145 (0.00%)	0 / 227 (0.00%)	0 / 279 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Hepatitis acute
subjects affected / exposed	0 / 175 (0.00%)	1 / 145 (0.69%)	0 / 227 (0.00%)	0 / 279 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Skin and subcutaneous tissue disorders
Angioedema
alternative dictionary used: v24.1 24.1
subjects affected / exposed	1 / 175 (0.57%)	0 / 145 (0.00%)	0 / 227 (0.00%)	0 / 279 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Renal and urinary disorders
Urinary retention
alternative dictionary used: v24.1 24.1
subjects affected / exposed	1 / 175 (0.57%)	0 / 145 (0.00%)	0 / 227 (0.00%)	0 / 279 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Acute kidney injury
alternative dictionary used: v24.1 24.1
subjects affected / exposed	0 / 175 (0.00%)	0 / 145 (0.00%)	1 / 227 (0.44%)	0 / 279 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Musculoskeletal and connective tissue disorders
Bursitis
alternative dictionary used: v24.1 24.1
subjects affected / exposed	0 / 175 (0.00%)	0 / 145 (0.00%)	1 / 227 (0.44%)	0 / 279 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Back pain
alternative dictionary used: v24.1 24.1
subjects affected / exposed	1 / 175 (0.57%)	0 / 145 (0.00%)	0 / 227 (0.00%)	0 / 279 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Intervertebral disc protrusion
alternative dictionary used: v24.1 24.1
subjects affected / exposed	0 / 175 (0.00%)	0 / 145 (0.00%)	1 / 227 (0.44%)	0 / 279 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Infections and infestations
COVID-19
alternative dictionary used: v24.1 24.1
subjects affected / exposed	0 / 175 (0.00%)	0 / 145 (0.00%)	1 / 227 (0.44%)	1 / 279 (0.36%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Cellulitis
alternative dictionary used: v24.1 24.1
subjects affected / exposed	0 / 175 (0.00%)	0 / 145 (0.00%)	1 / 227 (0.44%)	0 / 279 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Anal abscess
alternative dictionary used: v24.1 24.1
subjects affected / exposed	0 / 175 (0.00%)	0 / 145 (0.00%)	0 / 227 (0.00%)	1 / 279 (0.36%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Respiratory tract infection
alternative dictionary used: v24.1 24.1
subjects affected / exposed	0 / 175 (0.00%)	0 / 145 (0.00%)	1 / 227 (0.44%)	0 / 279 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Tonsillitis
alternative dictionary used: v24.1 24.1
subjects affected / exposed	0 / 175 (0.00%)	0 / 145 (0.00%)	1 / 227 (0.44%)	0 / 279 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Pyelonephritis
alternative dictionary used: v24.1 24.1
subjects affected / exposed	0 / 175 (0.00%)	1 / 145 (0.69%)	0 / 227 (0.00%)	1 / 279 (0.36%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Herpes simplex meningoencephalitis
alternative dictionary used: v24.1 24.1
subjects affected / exposed	1 / 175 (0.57%)	0 / 145 (0.00%)	0 / 227 (0.00%)	0 / 279 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Herpes simplex meningitis
alternative dictionary used: v24.1 24.1
subjects affected / exposed	1 / 175 (0.57%)	0 / 145 (0.00%)	0 / 227 (0.00%)	0 / 279 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
COVID-19 pneumonia
alternative dictionary used: v24.1 24.1
subjects affected / exposed	0 / 175 (0.00%)	0 / 145 (0.00%)	0 / 227 (0.00%)	1 / 279 (0.36%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Appendicitis
alternative dictionary used: v24.1 24.1
subjects affected / exposed	0 / 175 (0.00%)	1 / 145 (0.69%)	1 / 227 (0.44%)	0 / 279 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Tuberculosis
alternative dictionary used: v24.1 24.1
subjects affected / exposed	0 / 175 (0.00%)	0 / 145 (0.00%)	1 / 227 (0.44%)	0 / 279 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Cytomegalovirus infection
subjects affected / exposed	0 / 175 (0.00%)	1 / 145 (0.69%)	0 / 227 (0.00%)	0 / 279 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Hepatitis C
subjects affected / exposed	0 / 175 (0.00%)	1 / 145 (0.69%)	0 / 227 (0.00%)	0 / 279 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Metabolism and nutrition disorders
Obesity
alternative dictionary used: v24.1 24.1
subjects affected / exposed	0 / 175 (0.00%)	0 / 145 (0.00%)	1 / 227 (0.44%)	0 / 279 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0

Frequency threshold for reporting non-serious adverse events: 5%

Non-serious adverse events	Oral lead-in phase (OLI)	Switch Q2M Group	Biktarvy (BIK)	Direct to injections (D2I)
Total subjects affected by non serious adverse events
subjects affected / exposed	156 / 175 (89.14%)	76 / 145 (52.41%)	77 / 227 (33.92%)	257 / 279 (92.11%)
Nervous system disorders
Headache
alternative dictionary used: v24.1 24.1
subjects affected / exposed	17 / 175 (9.71%)	0 / 145 (0.00%)	12 / 227 (5.29%)	35 / 279 (12.54%)
occurrences all number	17	0	12	35
General disorders and administration site conditions
Injection site pain
alternative dictionary used: v24.1 24.1
subjects affected / exposed	106 / 175 (60.57%)	55 / 145 (37.93%)	1 / 227 (0.44%)	182 / 279 (65.23%)
occurrences all number	106	55	2	182
Injection site swelling
alternative dictionary used: v24.1 24.1
subjects affected / exposed	15 / 175 (8.57%)	0 / 145 (0.00%)	0 / 227 (0.00%)	27 / 279 (9.68%)
occurrences all number	15	0	0	27
Injection site nodule
alternative dictionary used: v24.1 24.1
subjects affected / exposed	17 / 175 (9.71%)	0 / 145 (0.00%)	0 / 227 (0.00%)	26 / 279 (9.32%)
occurrences all number	17	0	0	26
Fatigue
alternative dictionary used: v24.1 24.1
subjects affected / exposed	17 / 175 (9.71%)	0 / 145 (0.00%)	6 / 227 (2.64%)	14 / 279 (5.02%)
occurrences all number	17	0	7	14
Injection site discomfort
alternative dictionary used: v24.1 24.1
subjects affected / exposed	17 / 175 (9.71%)	0 / 145 (0.00%)	0 / 227 (0.00%)	26 / 279 (9.32%)
occurrences all number	17	0	0	26
Pyrexia
alternative dictionary used: v24.1 24.1
subjects affected / exposed	10 / 175 (5.71%)	0 / 145 (0.00%)	8 / 227 (3.52%)	26 / 279 (9.32%)
occurrences all number	10	0	8	26
Injection site induration
alternative dictionary used: v24.1 24.1
subjects affected / exposed	20 / 175 (11.43%)	0 / 145 (0.00%)	0 / 227 (0.00%)	17 / 279 (6.09%)
occurrences all number	20	0	0	17
Gastrointestinal disorders
Diarrhoea
alternative dictionary used: v24.1 24.1
subjects affected / exposed	8 / 175 (4.57%)	0 / 145 (0.00%)	9 / 227 (3.96%)	21 / 279 (7.53%)
occurrences all number	8	0	9	21
Musculoskeletal and connective tissue disorders
Arthralgia
subjects affected / exposed	8 / 175 (4.57%)	0 / 145 (0.00%)	0 / 227 (0.00%)	16 / 279 (5.73%)
occurrences all number	8	0	0	16
Back pain
subjects affected / exposed	10 / 175 (5.71%)	0 / 145 (0.00%)	0 / 227 (0.00%)	17 / 279 (6.09%)
occurrences all number	10	0	0	17
Infections and infestations
COVID-19
alternative dictionary used: v24.1 24.1
subjects affected / exposed	34 / 175 (19.43%)	21 / 145 (14.48%)	38 / 227 (16.74%)	50 / 279 (17.92%)
occurrences all number	34	21	38	50
Nasopharyngitis
alternative dictionary used: v24.1 24.1
subjects affected / exposed	8 / 175 (4.57%)	0 / 145 (0.00%)	10 / 227 (4.41%)	25 / 279 (8.96%)
occurrences all number	8	0	13	25
Syphilis
alternative dictionary used: v24.1 24.1
subjects affected / exposed	8 / 175 (4.57%)	0 / 145 (0.00%)	9 / 227 (3.96%)	23 / 279 (8.24%)
occurrences all number	8	0	10	23

More information

Top of page

Were there any global substantial amendments to the protocol? Yes

30 Jun 2020

The primary reason for protocol amendment 01 is to add minor clarifications to address study completion, PK collection, and endpoint timings. Country-specific details were added to Appendix 10 to address UK MHRA requirements. The protocol short title was updated. Corrections to typographical errors in protocol text and title were made throughout.

08 Sep 2021

The primary reason for protocol amendment 02 is to address and clarify comments raised during the course of the study and to implement country specific changes following regulatory review.

10 Feb 2022

The primary reason for protocol amendment 03 is to address and clarify comments raised during the course of the study.

Were there any global interruptions to the trial? No

Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.

None reported

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Outside EU/EEA

Clinical trials

Trial information

Trial information

Subject disposition

Subject disposition

Baseline characteristics

Baseline characteristics

End points

End points

Primary: Percentage of participants with plasma human immunodeficiency viruses (HIV)-1 ribonucleic acid (RNA) greater than or equal to (>=) 50 copies per milliliter (c/mL) at Month 12/11 - ITT-E Population

Primary: Percentage of participants with plasma human immunodeficiency viruses (HIV)-1 ribonucleic acid (RNA) greater than or equal to (>=) 50 copies per milliliter (c/mL) at Month 12/11 - ITT-E Population

Primary: Percentage of participants with plasma HIV-1 RNA greater >=50 copies per milliliter (c/mL) at Month 12/11 - mITT-E Population

Primary: Percentage of participants with plasma HIV-1 RNA greater >=50 copies per milliliter (c/mL) at Month 12/11 - mITT-E Population

Secondary: Percentage of participants with plasma HIV-1 RNA less than (<)50 c/mL at Month 12/11 - ITT-E Population

Secondary: Percentage of participants with plasma HIV-1 RNA less than (<)50 c/mL at Month 12/11 - ITT-E Population

Secondary: Percentage of participants with plasma HIV-1 RNA <50 c/mL at Month 12/11 -mITT-E Population

Secondary: Percentage of participants with plasma HIV-1 RNA <50 c/mL at Month 12/11 -mITT-E Population

Secondary: Percentage of participants with plasma HIV-1 RNA <50 c/mL at Month 6/5 - ITT-E Population

Secondary: Percentage of participants with plasma HIV-1 RNA <50 c/mL at Month 6/5 - ITT-E Population

Secondary: Percentage of participants with plasma HIV-1 RNA <50 c/mL at Month 6/5 - mITT-E Population

Secondary: Percentage of participants with plasma HIV-1 RNA <50 c/mL at Month 6/5 - mITT-E Population

Secondary: Number of participants with protocol-defined confirmed virologic failure (CVF) through Month 6/5 and 12/11

Secondary: Number of participants with protocol-defined confirmed virologic failure (CVF) through Month 6/5 and 12/11

Secondary: Percentage of participants with plasma HIV-1 RNA greater than or equal to (>=) 50 c/mL at Month 6/5

Secondary: Percentage of participants with plasma HIV-1 RNA greater than or equal to (>=) 50 c/mL at Month 6/5

Secondary: Change from baseline in HIV viral load

Secondary: Change from baseline in HIV viral load

Secondary: Absolute values of HIV viral load

Secondary: Absolute values of HIV viral load

Secondary: Absolute values of cluster of differentiation 4 plus (CD4+) cell count

Secondary: Absolute values of cluster of differentiation 4 plus (CD4+) cell count

Secondary: Change from Baseline in CD4+ cell count

Secondary: Change from Baseline in CD4+ cell count

Secondary: Number of participants with treatment-emergent phenotypic resistance through Month 6/5

Secondary: Number of participants with treatment-emergent phenotypic resistance through Month 6/5

Secondary: Number of participants with treatment-emergent phenotypic resistance through Month 12/11

Secondary: Number of participants with treatment-emergent phenotypic resistance through Month 12/11

Secondary: Number of participants with treatment-emergent genotypic resistance through Month 12/11

Secondary: Number of participants with treatment-emergent genotypic resistance through Month 12/11

Secondary: Number of participants with treatment-emergent genotypic resistance through Month 6/5

Secondary: Number of participants with treatment-emergent genotypic resistance through Month 6/5

Secondary: Change from baseline in bone biomarkers: specific alkaline phosphatase, procollagen type 1 N-Terminal propeptide, type 1 collagen cross-linked C-telopeptide, osteocalcin (micrograms per liter (ug/L))

Secondary: Change from baseline in bone biomarkers: specific alkaline phosphatase, procollagen type 1 N-Terminal propeptide, type 1 collagen cross-linked C-telopeptide, osteocalcin (micrograms per liter (ug/L))

Secondary: Change from baseline in bone biomarkers: serum 25-hydroxyvitamin D (nanomoles per liter (nmol/L))

Secondary: Change from baseline in bone biomarkers: serum 25-hydroxyvitamin D (nanomoles per liter (nmol/L))

Secondary: Change from baseline in renal biomarkers: specific serum beta-2 microglobulin, cystatin c, retinol binding protein, urine beta-2 microglobulin (milligrams per liter [mg/L])

Secondary: Change from baseline in renal biomarkers: specific serum beta-2 microglobulin, cystatin c, retinol binding protein, urine beta-2 microglobulin (milligrams per liter [mg/L])

Secondary: Change from baseline in renal biomarkers: urine phosphate (millimoles per liter (mmol/L))

Secondary: Change from baseline in renal biomarkers: urine phosphate (millimoles per liter (mmol/L))

Secondary: Change from baseline in renal biomarker: urine retinol binding protein 4 (microgram per liter (ug/L))

Secondary: Change from baseline in renal biomarker: urine retinol binding protein 4 (microgram per liter (ug/L))

Secondary: Change from baseline in renal biomarker: urine retinol binding protein/creatinine (milligram per mole (mg/mol))

Secondary: Change from baseline in renal biomarker: urine retinol binding protein/creatinine (milligram per mole (mg/mol))

Secondary: Change from baseline in renal biomarker: urine beta-2 microglobulin/ creatinine (grams per mole (g/mol))

Secondary: Change from baseline in renal biomarker: urine beta-2 microglobulin/ creatinine (grams per mole (g/mol))

Secondary: Change From Baseline in percentage of participants with metabolic syndrome at month 12/11

Secondary: Change From Baseline in percentage of participants with metabolic syndrome at month 12/11

Secondary: Change From Baseline in percentage of participants with metabolic syndrome at month 6/5

Secondary: Change From Baseline in percentage of participants with metabolic syndrome at month 6/5

Secondary: Change from baseline in homeostasis model of assessment-insulin resistance (HOMA-IR)

Secondary: Change from baseline in homeostasis model of assessment-insulin resistance (HOMA-IR)

Secondary: Percentage of participants with treatment preference as assessed using preference questionnaire at month 12/11 - Q2M

Secondary: Percentage of participants with treatment preference as assessed using preference questionnaire at month 12/11 - Q2M

Secondary: Change from baseline in total treatment satisfaction score using HIV treatment satisfaction status questionnaire (HIVTSQs)

Secondary: Change from baseline in total treatment satisfaction score using HIV treatment satisfaction status questionnaire (HIVTSQs)

Secondary: Change from baseline in individual item scores using HIVTSQs

Secondary: Change from baseline in individual item scores using HIVTSQs

Secondary: HIV treatment satisfaction change questionnaire (HIVTSQc) total score at Month 12/11

Secondary: HIV treatment satisfaction change questionnaire (HIVTSQc) total score at Month 12/11

Secondary: Individual item scores of HIVTSQc at Month 12/11

Secondary: Individual item scores of HIVTSQc at Month 12/11

Secondary: Change from month 2/1 in dimension scores using perception of injection (PIN) questionnaire - Q2M

Secondary: Change from month 2/1 in dimension scores using perception of injection (PIN) questionnaire - Q2M

Secondary: Change from month 2/1 in individual item scores using PIN questionnaire- Q2M

Secondary: Change from month 2/1 in individual item scores using PIN questionnaire- Q2M

Adverse events

Adverse events

More information

Substantial protocol amendments (globally)

Interruptions (globally)