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Clinical Trial Results:
A Phase III, Randomized, Multicenter, Parallel-group, Open- Label Study Evaluating the Efficacy, Safety, and Tolerability of Long-Acting Intramuscular Cabotegravir and Rilpivirine for Maintenance of Virologic Suppression Following Switch from an Integrase Inhibitor Single Tablet Regimen in HIV-1 Infected Antiretroviral Therapy Naive Adult Participants

Summary
EudraCT number	2016-001646-25
Trial protocol	ES GB DE NL IT
Global end of trial date

Results information
Results version number	v2(current)
This version publication date	25 Oct 2019
First version publication date	24 Aug 2019
Other versions	v1
Version creation reason

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

201584

ISRCTN number

US NCT number

WHO universal trial number (UTN)

Sponsor organisation name

ViiV Healthcare

Sponsor organisation address

980 Great West Road, Brentford, Middlesex, United Kingdom,

Public contact

GSK Response Center, ViiV Healthcare, 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

Interim

Date of interim/final analysis

27 Nov 2018

Is this the analysis of the primary completion data?

Yes

Primary completion date

30 Aug 2018

Global end of trial reached?

Main objective of the trial

To demonstrate the non-inferior antiviral activity of switching to intramuscular CAB LA + RPV LA every 4 weeks compared to continuation of ABC/DTG/3TC over 48 weeks in HIV-1 antiretroviral naïve participants.

Protection of trial subjects

Not applicable

Background therapy

Evidence for comparator

Actual start date of recruitment

27 Oct 2016

Long term follow-up planned

Yes

Long term follow-up rationale

Safety, Efficacy, Scientific research

Long term follow-up duration

12 Months

Independent data monitoring committee (IDMC) involvement?

Yes

Number of subjects enrolled per country

Country: Number of subjects enrolled

Canada: 23

Country: Number of subjects enrolled

France: 43

Country: Number of subjects enrolled

Germany: 44

Country: Number of subjects enrolled

Italy: 38

Country: Number of subjects enrolled

Japan: 20

Country: Number of subjects enrolled

Netherlands: 5

Country: Number of subjects enrolled

Russian Federation: 93

Country: Number of subjects enrolled

South Africa: 32

Country: Number of subjects enrolled

Spain: 157

Country: Number of subjects enrolled

United Kingdom: 25

Country: Number of subjects enrolled

United States: 86

Worldwide total number of subjects

566

EEA total number of subjects

312

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)

563

From 65 to 84 years

85 years and over

Subject disposition

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Recruitment details

This non-inferiority study evaluated antiviral activity of switching to intramuscular long acting carbotegravir (CAB) and rilpivirine (RPV) every 4 weeks compared to continuation of abacavir (ABC)/dolutegravir (DTG)/lamivudine (3TC) over 48 weeks in virologically suppressed participants with human immunodeficiency type 1 infection

Screening details

A total of 631 participants were enrolled into the Induction Phase of the study. 566 participants were subsequently randomized. Two randomized participants did not receive study treatment. This study was conducted in 11 countries. The results presented are based on Week 48 primary analysis

Period 1 title

Overall Study (overall period)

Is this the baseline period?

Yes

Allocation method

Randomised - controlled

Blinding used

Not blinded

Are arms mutually exclusive

Yes

CAB LA + RPV LA (Q4W)

Arm description

Participants who received ABC/DTG/3TC for 20 Weeks (Week [-20] to Day 1) in the Induction Phase and who have an HIV-1 ribonucleic acid (RNA) <50 copies per millilter (c/mL) at Week (-4) entered Maintenance Phase (Day 1 to Week 100) to begin oral therapy with CAB 30 milligram (mg) + RPV 25 mg once daily for 4 Weeks. At Week 4b visit, participants received last dose of oral CAB + RPV and first dose CAB LA 600 mg + RPV LA 900 mg injections. Participants received intramuscular (IM) injections of CAB LA 400 mg and RPV LA 600 mg at Week 8 and every four weeks (Q4W) through Week 100. After completion of Maintenance Phase, participants who chose to enter Extension Phase will continue to receive both CAB LA and RPV LA. Participants withdrawn from study treatment who received at least one CAB LA+RPV LA injection were required to enter a 52-week long term follow-up (LTFU) period.

Arm type

Experimental

Investigational medicinal product name

Cabotegravir oral

Investigational medicinal product code

Other name

Pharmaceutical forms

Film-coated tablet

Routes of administration

Oral use

Dosage and administration details

Participants received cabotegravir (CAB) 30 milligram (mg) tablet once daily from Day 1 to Week 4b approximately the same time each day with a meal

Investigational medicinal product name

Cabotegravir Injection

Investigational medicinal product code

Other name

Pharmaceutical forms

Suspension for injection

Routes of administration

Intramuscular use

Dosage and administration details

Participants received CAB 3 milliliter (mL; 600 mg) IM injection at Week 4b after the last dose of CAB oral regimen. Participants then received CAB 2 mL (400 mg) injections every 4 weeks from Week 8 to Week 100

Investigational medicinal product name

Rilpivirine Injection

Investigational medicinal product code

Other name

Pharmaceutical forms

Suspension for injection

Routes of administration

Intramuscular use

Dosage and administration details

Participants received RPV 3 mL (900 mg) IM injection at Week 4b after the last dose of RPV oral regimen. Participants then received RPV 2 mL (600 mg) injections every 4 weeks from Week 8 to Week 100

Investigational medicinal product name

Rilpivirine oral

Investigational medicinal product code

Other name

Pharmaceutical forms

Film-coated tablet

Routes of administration

Oral use

Dosage and administration details

Participants received rilpivirine (RPV) 25 mg tablet once daily from Day 1 to Week 4b approximately the same time each day with a meal

ABC/ DTG/ 3TC

Arm description

During Maintenance Phase (Day 1 to Week 100), participants continued to receive ABC/DTG/3TC. After completion of Maintenance Phase, participants who chose to enter the Extension Phase have the option to complete the study or switch to CAB LA+RPV LA

Arm type

Active comparator

Investigational medicinal product name

ABC/DTG/3TC Single Tablet Regimen (STR)

Investigational medicinal product code

Other name

Pharmaceutical forms

Film-coated tablet

Routes of administration

Oral use

Dosage and administration details

Participants received abacavir (ABC) 600 mg/ dolutegravir (DTG) 50 mg/ lamivudine (3TC) 300 mg film coated tablet once daily as single tablet regimen from Day 1 to Week 100

Number of subjects in period 1	CAB LA + RPV LA (Q4W)	ABC/ DTG/ 3TC
Started	283	283
Completed	0	0
Not completed	283	283
Physician decision	2	5
Consent withdrawn by subject	7	7
Adverse event, non-fatal	9	4
On-going at the time of analysis	258	261
Lost to follow-up	2	2
Lack of efficacy	5	3
Protocol deviation	-	1

Baseline characteristics

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Reporting group title

CAB LA + RPV LA (Q4W)

Reporting group description

Reporting group title

ABC/ DTG/ 3TC

Reporting group description

Reporting group values	CAB LA + RPV LA (Q4W)	ABC/ DTG/ 3TC	Total
Number of subjects	283	283	566
Age categorical
Units: Subjects
In utero	0	0	0
Preterm newborn infants (gestational age < 37 wks)	0	0	0
Newborns (0-27 days)	0	0	0
Infants and toddlers (28 days-23 months)	0	0	0
Children (2-11 years)	0	0	0
Adolescents (12-17 years)	0	0	0
Adults (18-64 years)	281	282	563
From 65-84 years	2	1	3
85 years and over	0	0	0
Age Continuous
Intent-to-Treat Exposed
Units: Years
arithmetic mean (standard deviation)	35.9 ± 10.17	36.0 ± 9.82	-
Sex: Female, Male
Intent-to-Treat Exposed
Units: Subjects
Female	63	64	127
Male	220	219	439
Race/Ethnicity, Customized
Units: Subjects
American Indian or Alaska Native	3	6	9
Asian-Central/South Asian Heritage	2	1	3
Asian-East Asian Heritage	1	2	3
Asian-South East Asian Heritage	1	0	1
Asian-Japanese Heritage	8	12	20
Black or African American	47	56	103
Native Hawaiian or other Pacific Islander	1	0	1
White-Arabic/North African Heritage	5	3	8
White-White /Caucasian/European Heritage	211	198	409
Multiple	4	3	7
Missing	0	2	2

End points

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Reporting group title

CAB LA + RPV LA (Q4W)

Reporting group description

Reporting group title

ABC/ DTG/ 3TC

Reporting group description

Subject analysis set title

CAB LA

Subject analysis set type

Sub-group analysis

Subject analysis set description

Participants in this arm received CAB 30 mg once daily for 4 Weeks during Maintenance Phase (Day 1 to Week 100). At Week 4b visit, participants received last dose of oral CAB and first dose CAB LA 600 mg injections. Participants received IM injections of CAB LA 400 mg at Week 8 and every four weeks through Week 100.

Subject analysis set title

RPV LA

Subject analysis set type

Sub-group analysis

Subject analysis set description

Participants in this arm received RPV 25 mg once daily for 4 Weeks during Maintenance Phase (Day 1 to Week 100). At Week 4b visit, participants received last dose of oral RPV and first dose CAB LA 900 mg injections. Participants received IM injections of RPV LA 600 mg at Week 8 and every four weeks through Week 100.

Primary: Percentage of participants with virologic failure (HIV-1 ribonucleic acid [RNA] >=50 copies per millilter [mL]) using snapshot algorithm at Week 48

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End point title

Percentage of participants with virologic failure (HIV-1 ribonucleic acid [RNA] >=50 copies per millilter [mL]) using snapshot algorithm at Week 48

End point description

Percentage of participants with virologic failure endpoint (HIV-1 RNA>=50 c/mL) as per Food and Drug Administration (FDA) snapshot algorithm at Week 48 was assessed to demonstrate the noninferior antiviral activity of switching to intramuscular (IM) CAB LA+RPV LA every 4 weeks compared to continuation of ABC/DTG/3TC regimen over 48 weeks in HIV-1 infected ARTexperienced participants. The HIV-1 RNA >=50 copies/mL per snapshot algorithm was determined by the last on-treatment HIV-1 RNA measurement within the Week 48 analysis visit window (+/- 6 weeks) or at time of discontinuation (if discontinuation occurred prior to Week 48 for reasons other than Adverse Event). Intent-to treat exposed (ITT-E) participants included all randomized participants who received at least one dose of Investigational Product (IP) during the Maintenance Phase. Participants were analyzed according to the randomized treatment regardless of what treatment actually received.

End point type

Primary

End point timeframe

Week 48

End point values	CAB LA + RPV LA (Q4W)	ABC/ DTG/ 3TC
Number of subjects analysed	283 ^[1]	283 ^[2]
Units: Percentage of Participants
number (not applicable)	2.1	2.5

Notes
[1] - ITT-E Population
[2] - ITT-E Population

Statistical Analysis 1

Statistical analysis description

Non-inferiority in the proportion of participants with virologic failure at Week 48 (per FDA’s snapshot algorithm for assessing HIV-1 RNA >=50 c/mL) can be concluded if the upper bound of a two-sided 95% confidence interval (CI) for the difference in failure rates between the two treatment arms (CAB – ABC/DTG/3TC) is less than 6%.

Comparison groups

CAB LA + RPV LA (Q4W) v ABC/ DTG/ 3TC

Number of subjects included in analysis

566

Analysis specification

Pre-specified

Analysis type

non-inferiority ^[3]

Method

Parameter type

Adjusted difference in proportion

Point estimate

-0.4

Confidence interval

level

95%

sides

2-sided

lower limit

-2.8

upper limit

2.1

Notes
[3] - Adjusted difference in proportion was based on Cochran-Mantel Haenszel stratified analysis adjusting for the following baseline stratification factors: sex at birth (Male, Female) and Induction Baseline (Week -20) HIV-1 RNA (<100,000 >=100,000 c/mL)

Secondary: Percentage of participants with HIV-1 RNA <50 copies/mL using snapshot algorithm at Week 48

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End point title

Percentage of participants with HIV-1 RNA <50 copies/mL using snapshot algorithm at Week 48

End point description

Percentage of participants with plasma HIV-1 RNA <50 copies/mL at Week 48 using FDA snapshot algorithm was assessed to demonstrate antiviral and immunologic activity of switching to IM CAB LA+RPV LA every 4 weeks compared to continuation of ABC/DTG/3TC. The HIV-1 RNA <50 copies/mL per snapshot algorithm was determined by last on-treatment HIV-1 RNA measurement within the Week 48 analysis visit window (+/- 6 weeks). Participants with no data in the analysis window were classificated as non-responders.

End point type

Secondary

End point timeframe

Week 48

End point values	CAB LA + RPV LA (Q4W)	ABC/ DTG/ 3TC
Number of subjects analysed	283 ^[4]	283 ^[5]
Units: Percentage of Participants	94	93

Notes
[4] - ITT-E Population
[5] - ITT-E Population

Statistical Analysis 1

Statistical analysis description

Non-inferiority in the proportion of participants with HIV-1 RNA<50 c/mL at Week 48 (per FDA’s snapshot algorithm) can be concluded if the lower bound of a two-sided 95% confidence interval for the difference in success rates between the two treatment arms (CAB – ABC/DTG/3TC) is more than -10%

Comparison groups

CAB LA + RPV LA (Q4W) v ABC/ DTG/ 3TC

Number of subjects included in analysis

566

Analysis specification

Pre-specified

Analysis type

non-inferiority ^[6]

Method

Parameter type

Adjusted difference in proportion

Point estimate

0.4

Confidence interval

level

95%

sides

2-sided

lower limit

-3.7

upper limit

4.5

Notes
[6] - Adjusted difference in proportion was based on Cochran-Mantel Haenszel stratified analysis adjusting for the following baseline stratification factors: sex at birth (Male, Female) and Induction Baseline (Week -20) HIV-1 RNA (<100,000 >=100,000 c/mL)

Secondary: Number of participants with HIV-1 RNA <200 copies/mL using snapshot algorithm at Week 48

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End point title

Number of participants with HIV-1 RNA <200 copies/mL using snapshot algorithm at Week 48

End point description

Percentage of participants with plasma HIV-1 RNA <200 copies/mL at Week 48 using the snapshot algorithm was assessed based on the antiviral and immunologic activity of switching to IM CAB LA+RPV LA every 4 weeks compared to continuation of ABC/DTG/3TC

End point type

Secondary

End point timeframe

Week 48

End point values	CAB LA + RPV LA (Q4W)	ABC/ DTG/ 3TC
Number of subjects analysed	283 ^[7]	283 ^[8]
Units: Percentage of Participants
number (confidence interval 95%)	94 (91 to 97)	94 (91 to 97)

Notes
[7] - ITT-E Population
[8] - ITT-E Population

No statistical analyses for this end point

Secondary: Number of participants with confirmed virologic failure (CVF) during the Maintenance Phase

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End point title

Number of participants with confirmed virologic failure (CVF) during the Maintenance Phase

End point description

The CVF is defined as rebound as indicated by two consecutive plasma HIV-1-RNA levels >=200 copies/mL after prior suppression to <200 copies/mL.

End point type

Secondary

End point timeframe

Week 48

End point values	CAB LA + RPV LA (Q4W)	ABC/ DTG/ 3TC
Number of subjects analysed	283 ^[9]	283 ^[10]
Units: Participants	4	3

Notes
[9] - ITT-E Population
[10] - ITT-E Population

No statistical analyses for this end point

Secondary: Absolute values for plasma HIV-1 RNA at Week 48

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End point title

Absolute values for plasma HIV-1 RNA at Week 48

End point description

Plasma for quantitative HIV-1 RNA were collected at indicated time points. Logarithm to base 10 (log10) values for plasma HIV-1 RNA has been presented. Only those participants with data available at the specified data points were analyzed

End point type

Secondary

End point timeframe

Week 48

End point values	CAB LA + RPV LA (Q4W)	ABC/ DTG/ 3TC
Number of subjects analysed	283 ^[11]	283 ^[12]
Units: log10 copies/mL
arithmetic mean (standard deviation)	1.513 ± 0.0954	1.518 ± 0.1152

Notes
[11] - ITT-E Population
[12] - ITT-E Population

No statistical analyses for this end point

Secondary: Change from Baseline values for plasma HIV-1 RNA at Week 48

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End point title

Change from Baseline values for plasma HIV-1 RNA at Week 48

End point description

Baseline value is defined as the last available recorded value up to and including the date of first Maintenance Phase dose of IP. Change from Baseline was defined as: HIV-1 RNA(log 10) at Week 48 minus HIV-1 RNA(log 10) at Baseline. Only those participants with data available at the specified data points were analyzed.

End point type

Secondary

End point timeframe

Baseline (Day 1) and at Week 48

End point values	CAB LA + RPV LA (Q4W)	ABC/ DTG/ 3TC
Number of subjects analysed	283 ^[13]	283 ^[14]
Units: log10 copies/mL
arithmetic mean (standard deviation)	-0.006 ± 0.1026	0.001 ± 0.1435

Notes
[13] - ITT-E Population
[14] - ITT-E Population

No statistical analyses for this end point

Secondary: Absolute values for CD4+ lymphocyte count at Week 48

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End point title

Absolute values for CD4+ lymphocyte count at Week 48

End point description

End point type

Secondary

End point timeframe

Week 48

End point values	CAB LA + RPV LA (Q4W)	ABC/ DTG/ 3TC
Number of subjects analysed	283 ^[15]	283 ^[16]
Units: Cells per cubic millimeter
arithmetic mean (standard deviation)	703.2 ± 285.75	731.2 ± 272.49

Notes
[15] - ITT-E Population
[16] - ITT-E Population

No statistical analyses for this end point

Secondary: Change from Baseline values for CD4+ lymphocyte count at Week 48

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End point title

Change from Baseline values for CD4+ lymphocyte count at Week 48

End point description

Blood samples were collected and CD4+ cell count assessment by flow cyclometry was carried out to evaluate the immunologic activity of switching to IM CAB LA+RPV LA every 4 weeks compared to ABC/DTG/3TC. Baseline value is defined as the last available recorded value up to and including the date of first Maintenance Phase dose of IP. Change from Baseline was defined as post-dose visit value at Week 48 minus Maintenance Baseline value. Only those participants with data available at the specified data points were analyzed.

End point type

Secondary

End point timeframe

Baseline (Day 1) and Week 48

End point values	CAB LA + RPV LA (Q4W)	ABC/ DTG/ 3TC
Number of subjects analysed	283 ^[17]	283 ^[18]
Units: Cells per cubic millimeter
arithmetic mean (standard deviation)	40.2 ± 195.17	79.9 ± 194.55

Notes
[17] - ITT-E Population
[18] - ITT-E Population

No statistical analyses for this end point

Secondary: Number of participants with disease progression

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End point title

Number of participants with disease progression

End point description

Data for participants who experienced disease progression to Centers for Disease Control and Prevention (CDC) Stage III or death has been presented. CDC stage is derived according to lowest post baseline CD4+ T-lympohocyte count and/or occurrence of AIDS-defining conditons (per 2014 CDC criteria).

End point type

Secondary

End point timeframe

Day 1 up to an average of 59 weeks

End point values	CAB LA + RPV LA (Q4W)	ABC/ DTG/ 3TC
Number of subjects analysed	283 ^[19]	283 ^[20]
Units: Participants	9	11

Notes
[19] - ITT-E Population
[20] - ITT-E Population

No statistical analyses for this end point

Secondary: Number of participants with non-serious adverse events (non-SAEs) and serious adverse events (SAEs)

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End point title

Number of participants with non-serious adverse events (non-SAEs) and serious adverse events (SAEs)

End point description

An AE is any untoward medical occurrence temporally associated with use of a study treatment, whether or not considered related to study treatment. A SAE is any untoward medical occurrence that, at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, is a congenital anomaly/birth defect, associated with liver injury and impaired liver function or any other situations as per medical or scientific judgment. Safety Population: all randomized participants who received at least 1 dose of IP during maintenance phase and assessed according to actual treatment received. All Maintenance Phase AEs was presented including AEs with start date occurring on/after date of 1st dose of randomized treatment, up to and including start date of LTFU antiretroviral therapy for participants who discontinued from Q4W arm. Non-SAE counts in >=5% of participants within any arm is reported

End point type

Secondary

End point timeframe

Day 1 up to an average of 59 Weeks

End point values	CAB LA + RPV LA (Q4W)	ABC/ DTG/ 3TC
Number of subjects analysed	283 ^[21]	283 ^[22]
Units: Participants
Any non-SAE	252	138
Any SAE	18	12

Notes
[21] - Safety Population
[22] - Safety Population

No statistical analyses for this end point

Secondary: Number of participants with severity of adverse events

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End point title

Number of participants with severity of adverse events

End point description

Severity of adverse events (AEs) were defined as per The Division of acquired immuno deficiency syndrome (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table) Version 2.0, November 2014. Severity grades for AEs were as Grade 1 (mild), Grade 2 (moderate), Grade 3 (severe), Grade 4 (Potentially life-threatening) and Grade 5 were all deaths related to an AE. All Maintenance Phase adverse events have been presented, which includes AEs with start date occuring on or after the date of first dose of randomized study treatment, up to and including the start date of LTFU antiretroviral therapy for participants who discontinued from the Q4W arm.

End point type

Secondary

End point timeframe

Up to Week 48

End point values	CAB LA + RPV LA (Q4W)	ABC/ DTG/ 3TC
Number of subjects analysed	283 ^[23]	283 ^[24]
Units: Participants
Grade 1	93	119
Grade 2	143	95
Grade 3	23	10
Grade 4	8	1
Grade 5	0	0

Notes
[23] - Safety Population
[24] - Safety Population

No statistical analyses for this end point

Secondary: Absolute values for hematology parameters over time including Week 48: basophils, eosinophils, leukocytes, lymphocytes, neutrophils, monocytes, and platelets

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End point title

Absolute values for hematology parameters over time including Week 48: basophils, eosinophils, leukocytes, lymphocytes, neutrophils, monocytes, and platelets

End point description

Blood samples were collected for the analysis of hematology parameters including basophil, eosinophils, leukocytes, lymphocytes, neutrophils, monocytes, and platelets at indicated time points. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).

End point type

Secondary

End point timeframe

Baseline (Day 1) and at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44 and 48

End point values	CAB LA + RPV LA (Q4W)	ABC/ DTG/ 3TC
Number of subjects analysed	283 ^[25]	283 ^[26]
Units: 10^9 cells per Liter
arithmetic mean (standard deviation)
Basophils, Baseline (Day 1), n=283, 283	0.022 ± 0.0124	0.022 ± 0.0138
Basophils, Week 4, n=277, 270	0.024 ± 0.0136	0.024 ± 0.0142
Basophils, Week 8, n=210, 272	0.023 ± 0.0135	0.023 ± 0.0122
Basophils, Week 12, n=267, 272	0.025 ± 0.0166	0.023 ± 0.0144
Basophils, Week 16, n=247, 259	0.030 ± 0.0212	0.028 ± 0.0209
Basophils, Week 20, n=247, 259	0.035 ± 0.0254	0.032 ± 0.0256
Basophils, Week 24, n=256, 260	0.037 ± 0.0245	0.036 ± 0.0256
Basophils, Week 28, n=239, 258	0.039 ± 0.0249	0.038 ± 0.0247
Basophils, Week 32, n=246, 263	0.044 ± 0.0254	0.038 ± 0.0246
Basophils, Week 36, n=250, 259	0.042 ± 0.0237	0.040 ± 0.0250
Basophils, Week 40, n=244, 245	0.041 ± 0.0248	0.041 ± 0.0252
Basophils, Week 44, n=249, 260	0.040 ± 0.0246	0.040 ± 0.0257
Basophils, Week 48, n=239, 258	0.038 ± 0.0214	0.038 ± 0.0246
Eosinophils, Baseline (Day 1), n=283, 283	0.142 ± 0.1238	0.141 ± 0.1449
Eosinophils, Week 4, n=277, 270	0.164 ± 0.1470	0.154 ± 0.1535
Eosinophils, Week 8, n=210, 272	0.169 ± 0.1401	0.150 ± 0.1393
Eosinophils, Week 12, n=267, 272	0.165 ± 0.1375	0.157 ± 0.1481
Eosinophils, Week 16, n=247, 259	0.177 ± 0.1538	0.162 ± 0.1434
Eosinophils, Week 20, n=247, 259	0.185 ± 0.1617	0.166 ± 0.1675
Eosinophils, Week 24, n=256, 260	0.193 ± 0.1591	0.172 ± 0.1518
Eosinophils, Week 28, n=239, 258	0.206 ± 0.1634	0.179 ± 0.1659
Eosinophils, Week 32, n=246, 263	0.206 ± 0.1779	0.169 ± 0.1466
Eosinophils, Week 36, n=250, 259	0.209 ± 0.2043	0.172 ± 0.1540
Eosinophils, Week 40, n=244, 245	0.203 ± 0.1837	0.174 ± 0.1495
Eosinophils, Week 44, n=249, 260	0.198 ± 0.1867	0.180 ± 0.1723
Eosinophils, Week 48, n=239, 258	0.182 ± 0.1508	0.172 ± 0.1533
Leukocytes, Baseline (Day 1), n=283, 283	5.82 ± 1.792	5.68 ± 1.684
Leukocytes, Week 4, n=279, 272	6.41 ± 1.989	6.11 ± 1.770
Leukocytes, Week 8, n=211, 275	6.04 ± 1.806	6.00 ± 1.714
Leukocytes, Week 12, n=270, 275	5.88 ± 1.590	6.08 ± 1.836
Leukocytes, Week 16, n=252, 265	6.08 ± 2.045	6.11 ± 1.887
Leukocytes, Week 20, n=254, 265	6.08 ± 1.788	6.15 ± 1.926
Leukocytes, Week 24, n=258, 264	6.11 ± 1.841	6.16 ± 2.046
Leukocytes, Week 28, n=244, 263	6.17 ± 1.929	6.17 ± 1.939
Leukocytes, Week 32, n=253, 266	6.07 ± 1.925	6.12 ± 1.918
Leukocytes, Week 36, n=252, 259	6.11 ± 1.992	6.23 ± 2.104
Leukocytes, Week 40, n=246, 253	5.96 ± 1.773	6.12 ± 2.076
Leukocytes, Week 44, n=256, 262	6.03 ± 2.000	6.19 ± 1.970
Leukocytes, Week 48, n=243, 260	5.85 ± 1.884	5.99 ± 1.986
Lymphocytes, Baseline (Day 1), n=283, 283	2.022 ± 0.6893	1.957 ± 0.6408
Lymphocytes, Week 4, n=277, 270	2.227 ± 0.7321	2.197 ± 0.7198
Lymphocytes, Week 8, n=210, 272	2.102 ± 0.6980	2.110 ± 0.7015
Lymphocytes, Week 12, n=267, 272	2.032 ± 0.6095	2.117 ± 0.7162
Lymphocytes, Week 16, n=247, 259	2.028 ± 0.6931	2.130 ± 0.7245
Lymphocytes, Week 20, n=247, 259	2.028 ± 0.6284	2.121 ± 0.6995
Lymphocytes, Week 24, n=256, 260	2.014 ± 0.6456	2.111 ± 0.7092
Lymphocytes, Week 28, n=239, 258	2.051 ± 0.6592	2.106 ± 0.6679
Lymphocytes, Week 32, n=246, 263	2.037 ± 0.6543	2.112 ± 0.6950
Lymphocytes, Week 36, n=250, 259	2.023 ± 0.6878	2.098 ± 0.6921
Lymphocytes, Week 40, n=244, 245	2.021 ± 0.6646	2.030 ± 0.6357
Lymphocytes, Week 44, n=249, 260	1.997 ± 0.6748	2.068 ± 0.6754
Lymphocytes, Week 48, n=239, 258	1.926 ± 0.6126	2.003 ± 0.7651
Monocytes, Baseline (Day 1), n=283, 283	0.382 ± 0.1666	0.366 ± 0.1705
Monocytes, Week 4, n=277, 270	0.422 ± 0.1778	0.398 ± 0.1778
Monocytes, Week 8, n=210, 272	0.415 ± 0.1824	0.380 ± 0.1771
Monocytes, Week 12, n=267, 272	0.395 ± 0.1662	0.383 ± 0.1570
Monocytes, Week 16, n=247, 259	0.438 ± 0.1859	0.409 ± 0.1810
Monocytes, Week 20, n=247, 259	0.455 ± 0.1927	0.423 ± 0.1904
Monocytes, Week 24, n=256, 260	0.438 ± 0.1859	0.438 ± 0.1897
Monocytes, Week 28, n=239, 258	0.471 ± 0.1916	0.447 ± 0.2003
Monocytes, Week 32, n=246, 263	0.462 ± 0.1898	0.459 ± 0.2107
Monocytes, Week 36, n=250, 259	0.458 ± 0.2116	0.456 ± 0.2021
Monocytes, Week 40, n=244, 245	0.438 ± 0.1740	0.442 ± 0.2038
Monocytes, Week 44, n=249, 260	0.440 ± 0.1907	0.428 ± 0.1965
Monocytes, Week 48, n=239, 258	0.402 ± 0.1911	0.396 ± 0.1857
Neutrophils, Baseline (Day 1), n=283, 283	3.246 ± 1.3715	3.205 ± 1.2803
Neutrophils, Week 4, n=277, 270	3.573 ± 1.5681	3.342 ± 1.3344
Neutrophils, Week 8, n=210, 272	3.334 ± 1.3166	3.316 ± 1.3588
Neutrophils, Week 12, n=267, 272	3.271 ± 1.2151	3.379 ± 1.4884
Neutrophils, Week 16, n=247, 259	3.410 ± 1.7208	3.432 ± 1.5052
Neutrophils, Week 20, n=247, 259	3.406 ± 1.4209	3.433 ± 1.5620
Neutrophils, Week 24, n=256, 260	3.428 ± 1.4938	3.424 ± 1.6766
Neutrophils, Week 28, n=239, 258	3.439 ± 1.5379	3.423 ± 1.5514
Neutrophils, Week 32, n=246, 263	3.367 ± 1.5670	3.392 ± 1.4892
Neutrophils, Week 36, n=250, 259	3.388 ± 1.5215	3.468 ± 1.6269
Neutrophils, Week 40, n=244, 245	3.274 ± 1.3654	3.477 ± 1.7021
Neutrophils, Week 44, n=249, 260	3.398 ± 1.5679	3.503 ± 1.5486
Neutrophils, Week 48, n=239, 258	3.309 ± 1.4923	3.419 ± 1.5186
Platelets, Baseline (Day 1), n=283, 282	226.7 ± 55.39	230.6 ± 58.33
Platelets, Week 4, n=278, 269	233.1 ± 56.85	233.4 ± 56.56
Platelets, Week 8, n=207, 273	226.9 ± 53.23	232.0 ± 56.31
Platelets, Week 12, n=269, 271	226.6 ± 55.07	235.5 ± 57.26
Platelets, Week 16, n=251, 263	225.5 ± 55.49	239.9 ± 70.40
Platelets, Week 20, n=255, 264	233.8 ± 60.98	243.4 ± 62.06
Platelets, Week 24, n=256, 261	233.9 ± 58.12	244.2 ± 59.95
Platelets, Week 28, n=245, 258	233.7 ± 61.56	247.2 ± 63.18
Platelets, Week 32, n=249, 262	235.0 ± 62.74	245.3 ± 60.25
Platelets, Week 36, n=248, 259	237.3 ± 58.56	248.1 ± 59.57
Platelets, Week 40, n=244, 254	233.9 ± 56.93	247.4 ± 63.85
Platelets, Week 44, n=254, 261	236.7 ± 58.18	249.5 ± 71.56
Platelets, Week 48, n=240, 255	232.8 ± 57.07	246.0 ± 70.35

Notes
[25] - Safety Population
[26] - Safety Population

No statistical analyses for this end point

Secondary: Absolute values for hematology parameters over time including Week 48: erythrocyte mean corpuscular volume

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End point title

Absolute values for hematology parameters over time including Week 48: erythrocyte mean corpuscular volume

End point description

Blood samples were collected for the analysis of hematology parameter including erythrocyte mean corpuscular volume at indicated timepoints. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).

End point type

Secondary

End point timeframe

Baseline (Day 1) and at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44 and 48

End point values	CAB LA + RPV LA (Q4W)	ABC/ DTG/ 3TC
Number of subjects analysed	283 ^[27]	283 ^[28]
Units: Femtoliters
arithmetic mean (standard deviation)
Baseline (Day 1), n=283, 283	94.8 ± 4.94	94.3 ± 5.69
Week 4, n=279, 273	94.1 ± 4.77	94.6 ± 5.85
Week 8, n=211, 275	92.3 ± 4.86	94.6 ± 5.78
Week 12, n=270, 275	91.0 ± 4.64	94.0 ± 5.81
Week 16, n=254, 265	89.9 ± 4.43	94.1 ± 5.78
Week 20, n=255, 267	89.3 ± 4.46	93.9 ± 5.64
Week 24, n=259, 264	89.4 ± 4.33	93.8 ± 5.69
Week 28, n=246, 265	89.3 ± 4.64	93.5 ± 5.78
Week 32, n=254, 267	89.6 ± 4.69	93.6 ± 5.90
Week 36, n=252, 261	89.5 ± 4.65	94.1 ± 5.65
Week 40, n=246, 255	90.3 ± 4.62	94.4 ± 6.09
Week 44, n=256, 262	90.7 ± 5.05	94.6 ± 6.32
Week 48, n=243, 260	91.2 ± 5.21	95.4 ± 6.60

Notes
[27] - Safety Population
[28] - Safety Population

No statistical analyses for this end point

Secondary: Absolute values for hematology parameters over time including Week 48: erythrocytes

Top of page

End point title

Absolute values for hematology parameters over time including Week 48: erythrocytes

End point description

Blood samples were collected for the analysis of hematology parameters including erythrocytes at indicated timepoints. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).

End point type

Secondary

End point timeframe

Baseline (Day 1) and at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44 and 48

End point values	CAB LA + RPV LA (Q4W)	ABC/ DTG/ 3TC
Number of subjects analysed	283 ^[29]	283 ^[30]
Units: 10^12 cells per Liter
arithmetic mean (standard deviation)
Baseline (Day 1), n=283, 283	4.59 ± 0.434	4.65 ± 0.412
Week 4, n=279, 273	4.67 ± 0.423	4.62 ± 0.406
Week 8, n=211, 275	4.76 ± 0.435	4.67 ± 0.410
Week 12, n=270, 275	4.82 ± 0.435	4.66 ± 0.419
Week 16, n=254, 265	4.87 ± 0.430	4.66 ± 0.407
Week 20, n=255, 267	4.89 ± 0.418	4.64 ± 0.410
Week 24, n=259, 264	4.87 ± 0.418	4.67 ± 0.425
Week 28, n=246, 265	4.87 ± 0.416	4.69 ± 0.395
Week 32, n=254, 267	4.83 ± 0.435	4.66 ± 0.418
Week 36, n=252, 261	4.82 ± 0.403	4.64 ± 0.395
Week 40, n=246, 255	4.81 ± 0.407	4.63 ± 0.409
Week 44, n=256, 262	4.79 ± 0.425	4.59 ± 0.403
Week 48, n=243, 260	4.74 ± 0.443	4.59 ± 0.437

Notes
[29] - Safety Population
[30] - Safety Population

No statistical analyses for this end point

Secondary: Absolute values for hematology parameters over time including Week 48: hemoglobin

Top of page

End point title

Absolute values for hematology parameters over time including Week 48: hemoglobin

End point description

Blood samples were collected for the analysis of hematology parameter including hemoglobin at indicated timepoints. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).

End point type

Secondary

End point timeframe

Baseline (Day 1) and at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44 and 48

End point values	CAB LA + RPV LA (Q4W)	ABC/ DTG/ 3TC
Number of subjects analysed	283 ^[31]	283 ^[32]
Units: Grams per liter
arithmetic mean (standard deviation)
Baseline (Day 1), n=283, 283	142.5 ± 13.59	143.1 ± 13.51
Week 4, n=279, 273	144.3 ± 13.34	143.4 ± 13.47
Week 8, n=211, 275	143.9 ± 13.84	144.7 ± 13.59
Week 12, n=270, 275	144.5 ± 13.89	144.7 ± 14.66
Week 16, n=254, 265	145.3 ± 13.52	144.6 ± 13.88
Week 20, n=255, 267	145.4 ± 12.69	144.8 ± 13.87
Week 24, n=259, 264	145.0 ± 13.14	145.3 ± 14.07
Week 28, n=246, 265	145.3 ± 12.80	146.5 ± 14.17
Week 32, n=254, 267	145.1 ± 13.37	146.2 ± 14.80
Week 36, n=252, 261	144.6 ± 12.27	146.2 ± 13.85
Week 40, n=246, 255	145.9 ± 12.32	146.2 ± 13.85
Week 44, n=256, 262	145.1 ± 12.79	145.0 ± 14.13
Week 48, n=243, 260	143.8 ± 13.56	145.4 ± 14.56

Notes
[31] - Safety Population
[32] - Safety Population

No statistical analyses for this end point

Secondary: Absolute values for hematology parameters over time including Week 48: hematocrit

Top of page

End point title

Absolute values for hematology parameters over time including Week 48: hematocrit

End point description

Blood samples were collected for the analysis of hematology parameters including hematocrit at indicated timepoints. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).

End point type

Secondary

End point timeframe

Baseline (Day 1) and at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44 and 48

End point values	CAB LA + RPV LA (Q4W)	ABC/ DTG/ 3TC
Number of subjects analysed	283 ^[33]	283 ^[34]
Units: Proportion of red blood cells in blood
arithmetic mean (standard deviation)
Baseline (Day 1), n=283, 283	0.4341 ± 0.03889	0.4370 ± 0.03887
Week 4, n=279, 273	0.4387 ± 0.03809	0.4363 ± 0.03832
Week 8, n=211, 275	0.4382 ± 0.04056	0.4403 ± 0.03978
Week 12, n=270, 275	0.4377 ± 0.04020	0.4373 ± 0.04144
Week 16, n=254, 265	0.4366 ± 0.03769	0.4371 ± 0.03890
Week 20, n=255, 267	0.4363 ± 0.03574	0.4349 ± 0.03839
Week 24, n=259, 264	0.4351 ± 0.03580	0.4366 ± 0.03901
Week 28, n=246, 265	0.4342 ± 0.03519	0.4374 ± 0.03867
Week 32, n=254, 267	0.4318 ± 0.03623	0.4347 ± 0.04025
Week 36, n=252, 261	0.4301 ± 0.03392	0.4349 ± 0.03774
Week 40, n=246, 255	0.4328 ± 0.03433	0.4358 ± 0.03845
Week 44, n=256, 262	0.4332 ± 0.03570	0.4328 ± 0.03847
Week 48, n=243, 260	0.4310 ± 0.03875	0.4361 ± 0.04156

Notes
[33] - Safety Population
[34] - Safety Population

No statistical analyses for this end point

Secondary: Absolute values for clinical chemistry parameters over time including Week 48: Alanine aminotransferase (ALT), alkaline phosphatase (ALP), aspartate aminotransferase (AST) and creatinine kinase (CK)

Top of page

End point title

Absolute values for clinical chemistry parameters over time including Week 48: Alanine aminotransferase (ALT), alkaline phosphatase (ALP), aspartate aminotransferase (AST) and creatinine kinase (CK)

End point description

Blood samples were collected for the analysis of clinical chemistry parameters including ALT, ALP, AST and CK at indicated timepoints. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).

End point type

Secondary

End point timeframe

Baseline (Day 1) and at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44 and 48

End point values	CAB LA + RPV LA (Q4W)	ABC/ DTG/ 3TC
Number of subjects analysed	283 ^[35]	283 ^[36]
Units: International units per liter
arithmetic mean (standard deviation)
ALT, Baseline (Day 1), n=283, 283	28.7 ± 125.27	19.5 ± 14.76
ALT, Week 4, n=281, 277	25.1 ± 64.74	17.9 ± 11.10
ALT, Week 8, n=212, 278	20.8 ± 17.43	18.4 ± 11.34
ALT, Week 12, n=270, 276	21.4 ± 16.94	19.2 ± 11.29
ALT, Week 16, n=255, 269	21.6 ± 17.61	20.3 ± 13.34
ALT, Week 20, n=260, 272	25.8 ± 72.51	19.6 ± 15.78
ALT, Week 24, n=261, 268	23.9 ± 31.14	19.1 ± 11.91
ALT, Week 28, n=253, 268	22.5 ± 19.78	19.6 ± 10.73
ALT, Week 32, n=256, 268	38.5 ± 293.55	19.0 ± 11.56
ALT, Week 36, n=255, 261	20.3 ± 13.92	21.2 ± 31.68
ALT, Week 40, n=250, 266	20.9 ± 17.32	19.5 ± 12.35
ALT, Week 44, n=258, 263	22.2 ± 27.14	19.8 ± 17.43
ALT, Week 48, n=247, 262	20.1 ± 21.78	19.7 ± 16.58
ALP, Baseline (Day 1), n=283, 283	66.5 ± 22.06	67.1 ± 22.98
ALP, Week 4, n=281, 277	66.2 ± 19.56	65.5 ± 17.07
ALP, Week 8, n=212, 278	66.8 ± 18.82	66.3 ± 17.49
ALP, Week 12, n=270, 276	66.8 ± 19.80	66.1 ± 17.23
ALP, Week 16, n=255, 269	66.7 ± 19.96	66.1 ± 17.89
ALP, Week 20, n=260, 272	67.6 ± 19.11	65.6 ± 16.71
ALP, Week 24, n=261, 268	67.1 ± 19.68	66.1 ± 17.96
ALP, Week 28, n=253, 268	67.4 ± 20.05	67.5 ± 18.07
ALP, Week 32, n=256, 268	68.0 ± 22.17	66.6 ± 17.65
ALP, Week 36, n=255, 261	69.5 ± 26.86	68.3 ± 20.19
ALP, Week 40, n=250, 266	67.4 ± 18.94	67.7 ± 18.30
ALP, Week 44, n=258, 263	67.7 ± 18.59	68.2 ± 18.62
ALP, Week 48, n=247, 262	66.4 ± 17.95	67.7 ± 18.15
AST, Baseline (Day 1), n=283, 283	28.8 ± 90.66	22.5 ± 14.80
AST, Week 4, n=281, 277	25.1 ± 32.67	20.9 ± 8.47
AST, Week 8, n=212, 278	23.6 ± 20.85	20.5 ± 6.26
AST, Week 12, n=270, 276	22.8 ± 10.38	21.0 ± 8.14
AST, Week 16, n=255, 269	23.0 ± 10.71	22.8 ± 14.03
AST, Week 20, n=260, 272	25.3 ± 32.64	22.7 ± 23.48
AST, Week 24, n=261, 268	25.9 ± 25.16	21.2 ± 9.73
AST, Week 28, n=253, 268	24.8 ± 16.50	21.7 ± 10.61
AST, Week 32, n=256, 268	37.1 ± 233.23	20.7 ± 6.42
AST, Week 36, n=255, 261	23.0 ± 12.44	22.4 ± 17.37
AST, Week 40, n=250, 266	23.1 ± 12.22	21.0 ± 6.51
AST, Week 44, n=258, 263	24.4 ± 15.66	21.9 ± 13.25
AST Week 48, n=247, 262	22.3 ± 10.98	23.5 ± 42.49
CK, Baseline (Day 1), n=283, 283	197.8 ± 291.21	199.8 ± 482.84
CK, Week 4, n=280, 277	230.2 ± 447.94	173.0 ± 220.54
CK, Week 8, n=212, 278	258.0 ± 928.82	152.9 ± 146.05
CK, Week 12, n=270, 276	201.8 ± 348.13	182.6 ± 387.61
CK, Week 16, n=255, 269	179.7 ± 248.71	234.0 ± 576.62
CK, Week 20, n=260, 272	215.7 ± 539.34	258.9 ± 1109.04
CK, Week 24, n=261, 268	248.6 ± 628.44	183.1 ± 368.02
CK, Week 28, n=253, 268	252.7 ± 673.98	194.5 ± 506.24
CK, Week 32, n=256, 268	175.8 ± 223.16	160.0 ± 176.09
CK, Week 36, n=254, 261	219.0 ± 507.30	215.2 ± 460.38
CK, Week 40, n=250, 266	220.5 ± 507.68	149.5 ± 115.14
CK, Week 44, n=258, 263	254.0 ± 477.19	181.9 ± 428.28
CK, Week 48, n=247, 262	185.5 ± 227.54	323.6 ± 2637.27

Notes
[35] - Safety Population
[36] - Safety Population

No statistical analyses for this end point

Secondary: Absolute values for clinical chemistry parameter over time including Week 48: Albumin

Top of page

End point title

Absolute values for clinical chemistry parameter over time including Week 48: Albumin

End point description

Blood samples were collected for the analysis of clinical chemistry parameter-albumin at indicated timepoints. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).

End point type

Secondary

End point timeframe

Baseline (Day 1) and at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44 and 48

End point values	CAB LA + RPV LA (Q4W)	ABC/ DTG/ 3TC
Number of subjects analysed	283 ^[37]	283 ^[38]
Units: Grams per liter
arithmetic mean (standard deviation)
Baseline (Day 1), n=283, 283	43.8 ± 3.04	44.1 ± 2.80
Week 4, n=280, 277	43.7 ± 3.03	43.8 ± 2.70
Week 8, n=212, 278	43.5 ± 2.85	43.9 ± 2.76
Week 12, n=270, 276	43.7 ± 3.06	44.1 ± 2.87
Week 16, n=255, 269	44.1 ± 2.99	44.0 ± 2.78
Week 20, n=260, 272	44.1 ± 3.11	43.9 ± 2.72
Week 24, n=261, 268	44.3 ± 3.08	44.2 ± 2.60
Week 28, n=253, 268	44.4 ± 3.09	44.5 ± 2.66
Week 32, n=255, 268	44.6 ± 3.17	44.4 ± 2.76
Week 36, n=254, 261	44.1 ± 3.05	44.3 ± 2.63
Week 40, n=250, 266	44.8 ± 3.02	44.5 ± 2.76
Week 44, n=258, 263	44.7 ± 2.98	44.4 ± 2.71
Week 48, n=247, 262	44.6 ± 2.98	44.6 ± 2.86

Notes
[37] - Safety Population
[38] - Safety Population

No statistical analyses for this end point

Secondary: Absolute values for clinical chemistry parameters over time including Week 48: bilirubin, direct bilirubin and creatinine

Top of page

End point title

Absolute values for clinical chemistry parameters over time including Week 48: bilirubin, direct bilirubin and creatinine

End point description

Blood samples were collected for the analysis of clinical chemistry parameters including bilirubin, creatinine and direct bilirubin at indicated timepoints. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).

End point type

Secondary

End point timeframe

Baseline (Day 1) and at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44 and 48

End point values	CAB LA + RPV LA (Q4W)	ABC/ DTG/ 3TC
Number of subjects analysed	283 ^[39]	283 ^[40]
Units: Micromoles per liter
arithmetic mean (standard deviation)
Bilirubin, Baseline (Day 1), n=283, 283	9.3 ± 5.12	9.4 ± 4.68
Bilirubin, Week 4, n=281, 277	10.7 ± 6.37	8.9 ± 4.40
Bilirubin, Week 8, n=212, 278	10.1 ± 4.62	8.8 ± 3.85
Bilirubin, Week 12, n=270, 276	10.5 ± 5.45	8.6 ± 3.53
Bilirubin, Week 16, n=255, 269	10.6 ± 5.49	8.7 ± 3.74
Bilirubin, Week 20, n=260, 272	10.3 ± 5.29	8.5 ± 3.40
Bilirubin, Week 24, n=261, 268	10.0 ± 5.09	8.9 ± 3.86
Bilirubin, Week 28, n=253, 268	10.4 ± 5.67	8.6 ± 3.90
Bilirubin, Week 32, n=256, 268	10.5 ± 7.86	8.7 ± 3.95
Bilirubin, Week 36, n=255, 260	9.9 ± 6.35	8.5 ± 3.42
Bilirubin, Week 40, n=250, 266	10.2 ± 5.26	8.5 ± 3.52
Bilirubin, Week 44, n=258, 263	10.3 ± 5.15	8.8 ± 3.78
Bilirubin, Week 48, n=247, 262	10.3 ± 5.23	8.9 ± 3.71
Direct bilirubin, Baseline (Day 1), n=283, 283	2.3 ± 1.32	2.2 ± 1.09
Direct bilirubin, Week 4, n=277, 277	2.4 ± 1.47	2.1 ± 1.08
Direct bilirubin, Week 8, n=212, 278	2.4 ± 1.17	2.1 ± 0.93
Direct bilirubin, Week 12, n=269, 273	2.5 ± 1.26	2.1 ± 0.91
Direct bilirubin, Week 16, n=254, 268	2.4 ± 1.46	2.1 ± 0.95
Direct bilirubin, Week 20, n=260, 272	2.4 ± 1.54	2.1 ± 0.90
Direct bilirubin, Week 24, n=260, 266	2.3 ± 1.20	2.1 ± 0.96
Direct bilirubin, Week 28, n=253, 268	2.5 ± 1.29	2.1 ± 0.94
Direct bilirubin, Week 32, n=256, 268	2.5 ± 3.48	2.1 ± 0.94
Direct bilirubin, Week 36, n=255, 260	2.4 ± 2.24	2.0 ± 0.89
Direct bilirubin, Week 40, n=249, 266	2.3 ± 1.29	2.1 ± 0.98
Direct bilirubin, Week 44, n=258, 263	2.4 ± 1.34	2.1 ± 0.95
Direct bilirubin, Week 48, n=247, 262	2.3 ± 1.26	2.2 ± 1.00
Creatinine, Baseline (Day 1), n=283, 283	89.00 ± 16.061	85.80 ± 15.660
Creatinine, Week 4, n=280, 277	82.99 ± 15.599	86.43 ± 14.655
Creatinine, Week 8, n=212, 278	79.50 ± 14.103	85.50 ± 15.925
Creatinine, Week 12, n=270, 276	79.25 ± 14.433	84.63 ± 15.155
Creatinine, Week 16, n=255, 269	79.58 ± 14.509	85.18 ± 14.997
Creatinine, Week 20, n=261, 272	78.50 ± 13.966	85.02 ± 15.488
Creatinine, Week 24, n=262, 268	79.10 ± 15.340	85.05 ± 14.690
Creatinine, Week 28, n=253, 268	78.79 ± 14.741	84.38 ± 15.023
Creatinine, Week 32, n=255, 268	78.89 ± 14.558	84.50 ± 15.047
Creatinine, Week 36, n=254, 262	79.58 ± 14.973	84.75 ± 14.352
Creatinine, Week 40, n=250, 266	79.50 ± 15.615	84.70 ± 14.808
Creatinine, Week 44, n=258, 263	80.04 ± 15.401	83.90 ± 14.604
Creatinine, Week 48, n=247, 262	79.95 ± 15.613	90.88 ± 87.655

Notes
[39] - Safety Population
[40] - Safety Population

No statistical analyses for this end point

Secondary: Absolute values for clinical chemistry parameters: total carbon-dioxide (CO2), chloride, glucose, phosphate, potassium, sodium and urea over time including Week 48

Top of page

End point title

Absolute values for clinical chemistry parameters: total carbon-dioxide (CO2), chloride, glucose, phosphate, potassium, sodium and urea over time including Week 48

End point description

Blood samples were collected for the analysis of clinical chemistry parameters which includes total CO2, chloride, glucose, phosphate, potassium, sodium and urea at indicated timepoints. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).

End point type

Secondary

End point timeframe

Baseline (Day 1) and at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44 and 48

End point values	CAB LA + RPV LA (Q4W)	ABC/ DTG/ 3TC
Number of subjects analysed	283 ^[41]	283 ^[42]
Units: Millimoles per liter
arithmetic mean (standard deviation)
CO2, Baseline (Day 1), n=283, 283	22.4 ± 2.24	22.4 ± 2.10
CO2, Week 4, n=280, 276	23.0 ± 2.29	22.6 ± 2.28
CO2, Week 8, n=212, 278	22.8 ± 2.07	22.3 ± 2.27
CO2, Week 12, n=270, 276	22.6 ± 2.50	22.2 ± 2.34
CO2, Week 16, n=255, 269	22.9 ± 2.40	22.3 ± 2.50
CO2, Week 20, n=260, 272	22.8 ± 2.30	22.4 ± 2.32
CO2, Week 24, n=261, 268	23.0 ± 2.71	22.8 ± 2.19
CO2, Week 28, n=253, 268	23.0 ± 2.31	22.8 ± 2.47
CO2, Week 32, n=255, 268	23.0 ± 2.31	22.7 ± 2.35
CO2, Week 36, n=253, 261	23.1 ± 2.37	22.5 ± 2.26
CO2, Week 40, n=249, 265	22.8 ± 2.34	22.6 ± 2.39
CO2, Week 44, n=257, 263	22.9 ± 2.34	22.4 ± 2.12
CO2, Week 48, n=247, 262	22.5 ± 2.18	22.3 ± 2.04
Chloride, Baseline (Day 1), n=283, 283	104.6 ± 2.32	104.3 ± 2.32
Chloride, Week 4, n=280, 277	104.6 ± 2.22	104.7 ± 2.13
Chloride, Week 8, n=212, 278	104.7 ± 1.96	104.6 ± 2.32
Chloride, Week 12, n=270, 276	104.6 ± 2.16	104.7 ± 2.35
Chloride, Week 16, n=255, 269	104.4 ± 2.31	104.7 ± 2.24
Chloride, Week 20, n=260, 272	104.3 ± 2.28	104.7 ± 2.06
Chloride, Week 24, n=261, 268	104.4 ± 2.33	104.5 ± 2.42
Chloride, Week 28, n=253, 268	104.5 ± 2.20	104.5 ± 2.28
Chloride, Week 32, n=255, 268	104.4 ± 2.46	104.5 ± 2.33
Chloride, Week 36, n=254, 261	104.4 ± 2.42	104.7 ± 2.20
Chloride, Week 40, n=250, 266	104.8 ± 2.55	104.7 ± 2.25
Chloride, Week 44, n=258, 263	104.7 ± 2.19	105.0 ± 2.22
Chloride, Week 48, n=247, 262	104.7 ± 2.21	104.7 ± 2.28
Glucose, Baseline (Day 1), n=283, 283	5.21 ± 1.632	5.17 ± 0.932
Glucose, Week 4, n=236, 230	5.27 ± 1.322	5.23 ± 0.734
Glucose, Week 8, n=172, 227	5.31 ± 1.347	5.19 ± 0.644
Glucose, Week 12, n=229, 216	5.26 ± 0.911	5.27 ± 0.616
Glucose, Week 16, n=204, 213	5.36 ± 1.804	5.28 ± 0.801
Glucose, Week 20, n=209, 218	5.32 ± 0.735	5.26 ± 0.634
Glucose, Week 24, n=221, 214	5.35 ± 1.219	5.21 ± 0.634
Glucose, Week 28, n=207, 211	5.35 ± 1.633	5.23 ± 0.614
Glucose, Week 32, n=201, 213	5.44 ± 1.355	5.27 ± 0.600
Glucose, Week 36, n=199, 204	5.35 ± 0.797	5.31 ± 0.960
Glucose, Week 40, n=203, 202	5.44 ± 1.319	5.35 ± 0.753
Glucose, Week 44, n=208, 202	5.34 ± 0.991	5.35 ± 0.709
Glucose, Week 48, n=248, 251	5.22 ± 0.895	5.22 ± 0.690
Phosphate, Baseline (Day 1), n=283, 283	1.103 ± 0.1747	1.097 ± 0.1765
Phosphate, Week 4, n=279, 277	1.137 ± 0.1774	1.112 ± 0.1850
Phosphate, Week 8, n=212, 278	1.096 ± 0.1742	1.114 ± 0.1858
Phosphate, Week 12, n=270, 276	1.097 ± 0.1802	1.106 ± 0.1876
Phosphate, Week 16, n=255, 269	1.104 ± 0.1806	1.119 ± 0.1823
Phosphate, Week 20, n=260, 272	1.078 ± 0.1843	1.114 ± 0.1812
Phosphate, Week 24, n=261, 268	1.106 ± 0.1797	1.109 ± 0.1791
Phosphate, Week 28, n=253, 268	1.094 ± 0.1814	1.119 ± 0.1893
Phosphate, Week 32, n=255, 268	1.105 ± 0.1769	1.104 ± 0.1945
Phosphate, Week 36, n=254, 261	1.102 ± 0.1862	1.122 ± 0.1872
Phosphate, Week 40, n=250, 266	1.093 ± 0.1699	1.114 ± 0.1837
Phosphate, Week 44, n=258, 263	1.096 ± 0.1851	1.120 ± 0.1903
Phosphate, Week 48, n=247, 262	1.096 ± 0.1888	1.120 ± 0.2341
Potassium, Baseline (Day 1), n=283, 283	4.12 ± 0.301	4.14 ± 0.288
Potassium, Week 4, n=280, 277	4.27 ± 0.308	4.20 ± 0.327
Potassium, Week 8, n=212, 278	4.22 ± 0.302	4.22 ± 0.343
Potassium, Week 12, n=270, 276	4.21 ± 0.305	4.19 ± 0.282
Potassium, Week 16, n=255, 269	4.21 ± 0.283	4.18 ± 0.303
Potassium, Week 20, n=260, 272	4.21 ± 0.320	4.19 ± 0.313
Potassium, Week 24, n=261, 268	4.24 ± 0.322	4.21 ± 0.312
Potassium, Week 28, n=253, 268	4.20 ± 0.298	4.23 ± 0.294
Potassium, Week 32, n=255, 268	4.21 ± 0.295	4.21 ± 0.315
Potassium, Week 36, n=254, 261	4.21 ± 0.314	4.22 ± 0.314
Potassium, Week 40, n=250, 266	4.19 ± 0.301	4.20 ± 0.305
Potassium, Week 44, n=258, 263	4.21 ± 0.302	4.21 ± 0.324
Potassium, Week 48, n=247, 262	4.13 ± 0.288	4.17 ± 0.449
Sodium, Baseline (Day 1), n=283, 283	139.2 ± 1.89	139.2 ± 1.76
Sodium, Week 4, n=280, 277	139.5 ± 1.98	139.4 ± 1.83
Sodium, Week 8, n=212, 278	139.4 ± 1.78	139.3 ± 1.86
Sodium, Week 12, n=270, 276	139.5 ± 1.80	139.3 ± 1.84
Sodium, Week 16, n=255, 269	139.4 ± 1.76	139.4 ± 1.94
Sodium, Week 20, n=260, 272	139.4 ± 1.75	139.5 ± 1.77
Sodium, Week 24, n=261, 268	139.3 ± 1.82	139.4 ± 1.95
Sodium, Week 28, n=253, 268	139.4 ± 1.80	139.5 ± 1.83
Sodium, Week 32, n=255, 268	139.4 ± 1.83	139.4 ± 1.72
Sodium, Week 36, n=254, 261	139.3 ± 1.87	139.5 ± 1.70
Sodium, Week 40, n=250, 266	139.3 ± 2.04	139.5 ± 1.84
Sodium, Week 44, n=258, 263	139.5 ± 1.95	139.6 ± 1.79
Sodium, Week 48, n=247, 262	139.4 ± 1.68	139.5 ± 1.75
Urea, Baseline (Day 1), n=283, 283	5.30 ± 1.468	5.17 ± 1.458
Urea, Week 4, n=280, 277	5.33 ± 1.424	5.14 ± 1.508
Urea, Week 8, n=212, 278	5.32 ± 1.485	5.12 ± 1.480
Urea, Week 12, n=270, 276	5.28 ± 1.424	5.20 ± 1.574
Urea, Week 16, n=255, 269	5.26 ± 1.385	5.20 ± 1.561
Urea, Week 20, n=260, 272	5.18 ± 1.349	5.22 ± 1.483
Urea, Week 24, n=261, 268	5.38 ± 1.489	5.11 ± 1.449
Urea, Week 28, n=253, 268	5.32 ± 1.422	5.21 ± 1.406
Urea, Week 32, n=255, 268	5.43 ± 1.440	5.17 ± 1.491
Urea, Week 36, n=254, 261	5.31 ± 1.396	5.23 ± 1.556
Urea, Week 40, n=250, 266	5.40 ± 1.523	5.26 ± 1.566
Urea, Week 44, n=258, 263	5.38 ± 1.543	5.24 ± 1.512
Urea, Week 48, n=247, 262	5.37 ± 1.402	5.27 ± 2.305

Notes
[41] - Safety Population
[42] - Safety Population

No statistical analyses for this end point

Secondary: Absolute values for clinical chemistry parameter over time including Week 48: Lipase

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End point title

Absolute values for clinical chemistry parameter over time including Week 48: Lipase

End point description

Blood samples were collected for the analysis of clinical chemistry parameter-lipase at indicated timepoints. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).

End point type

Secondary

End point timeframe

Baseline (Day 1) and at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44 and 48

End point values	CAB LA + RPV LA (Q4W)	ABC/ DTG/ 3TC
Number of subjects analysed	283 ^[43]	283 ^[44]
Units: Units per liter
arithmetic mean (standard deviation)
Baseline (Day 1), n=283, 283	31.0 ± 21.04	30.9 ± 28.89
Week 4, n=278, 276	31.7 ± 27.17	32.6 ± 24.73
Week 8, n=211, 278	31.5 ± 21.15	31.3 ± 19.96
Week 12, n=270, 276	31.4 ± 23.94	33.6 ± 23.37
Week 16, n=254, 269	30.8 ± 22.39	32.1 ± 18.99
Week 20, n=260, 270	31.3 ± 23.46	31.9 ± 19.13
Week 24, n=260, 268	31.3 ± 22.60	32.2 ± 21.08
Week 28, n=253, 268	30.3 ± 18.71	33.0 ± 22.56
Week 32, n=254, 268	33.5 ± 35.38	33.2 ± 32.95
Week 36, n=254, 261	31.5 ± 20.49	31.2 ± 20.03
Week 40, n=250, 266	32.6 ± 27.07	32.1 ± 22.19
Week 44, n=258, 263	36.3 ± 45.04	33.0 ± 24.09
Week 48, n=247, 261	30.1 ± 20.31	32.6 ± 28.96

Notes
[43] - Safety Population
[44] - Safety Population

No statistical analyses for this end point

Secondary: Absolute values for clinical chemistry parameter over time including Week 48: Creatinine clearance.

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End point title

Absolute values for clinical chemistry parameter over time including Week 48: Creatinine clearance.

End point description

Blood samples were collected for the analysis of clinical chemistry parameter-creatinine clearance at indicated timepoints. Glomerular filtration rate (GFR) will be estimated by the central laboratory using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI). Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).

End point type

Secondary

End point timeframe

Baseline (Day 1) and at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44 and 48

End point values	CAB LA + RPV LA (Q4W)	ABC/ DTG/ 3TC
Number of subjects analysed	283 ^[45]	283 ^[46]
Units: mL/min/1.73/m^2
arithmetic mean (standard deviation)
Baseline (Day 1), n=283, 283	94.3 ± 17.61	97.9 ± 17.70
Week 4, n=278, 277	101.2 ± 16.56	96.5 ± 17.14
Week 8, n=211, 278	104.9 ± 15.64	98.1 ± 17.46
Week 12, n=270, 276	104.8 ± 16.08	98.6 ± 17.77
Week 16, n=254, 269	104.2 ± 15.03	97.6 ± 16.84
Week 20, n=261, 271	105.5 ± 15.19	98.0 ± 17.67
Week 24, n=261, 268	105.1 ± 16.05	97.9 ± 17.33
Week 28, n=253, 268	105.3 ± 16.18	98.8 ± 17.40
Week 32, n=254, 268	105.1 ± 16.10	98.8 ± 17.39
Week 36, n=254, 262	104.7 ± 15.88	98.0 ± 16.60
Week 40, n=250, 266	104.3 ± 16.47	98.3 ± 17.25
Week 44, n=258, 263	104.4 ± 16.73	98.9 ± 16.67
Week 48, n=247, 261	103.6 ± 16.34	96.9 ± 18.21

Notes
[45] - Safety Population
[46] - Safety Population

No statistical analyses for this end point

Secondary: Absolute values for fasting lipid panel overtime including Week 48

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End point title

Absolute values for fasting lipid panel overtime including Week 48

End point description

Blood samples were collected at Baseline and at Week 48 to assess fasting lipids which included total cholesterol, high density lipoprotein (HDL)cholesterol, low density lipoprotein (LDL) cholesterol and triglycerides. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).

End point type

Secondary

End point timeframe

Baseline (Day 1) and at Week 48

End point values	CAB LA + RPV LA (Q4W)	ABC/ DTG/ 3TC
Number of subjects analysed	283 ^[47]	283 ^[48]
Units: Millimoles per liter
arithmetic mean (standard deviation)
Total Cholesterol, Baseline (Day 1), n=268, 275	4.44 ± 0.928	4.42 ± 0.986
Total Cholesterol, Week 48, n=240, 239	4.65 ± 1.021	4.46 ± 0.944
HDL cholesterol, Baseline (Day 1), n=268, 275	1.249 ± 0.3761	1.302 ± 0.3851
HDL cholesterol, Week 48, n=240, 239	1.359 ± 0.4096	1.376 ± 0.4335
LDL cholesterol, Baseline (Day 1), n=267, 275	2.557 ± 0.7991	2.529 ± 0.7870
LDL cholesterol, Week 48, n=238, 237	2.697 ± 0.9158	2.472 ± 0.7693
Triglycerides, Baseline (Day 1), n=268, 275	1.387 ± 0.9142	1.294 ± 0.7392
Triglycerides, Week 48, n=240, 239	1.323 ± 0.9333	1.341 ± 0.9059

Notes
[47] - Safety Population
[48] - Safety Population

No statistical analyses for this end point

Secondary: Number of participants with abnormal urinalysis parameter over time including Week 48

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End point title

Number of participants with abnormal urinalysis parameter over time including Week 48

End point description

The dipstick test gives results in a semi-quantitative manner and results for urinalysis parameters (ketones, glucose, bilirubin, occult blood, nitrite and blood protein) can be read as positive, trace, 1+, 2+, 3+ and 4+ indicating proportional concentrations in the urine sample. The urine parameters were graded according to DAIDS scale where Grade 1 indicates mild (trace to 1+), Grade 2 indicates moderate (2+) and Grade 3 indicates severe (3+ or higher). Only participants with abnormal findings for urinalysis at any visit has been presented. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).

End point type

Secondary

End point timeframe

Baseline (Day 1) and at Weeks 4, 24 and 48

End point values	CAB LA + RPV LA (Q4W)	ABC/ DTG/ 3TC
Number of subjects analysed	283 ^[49]	283 ^[50]
Units: Participants
number (not applicable)
Urine bilirubin,Baseline (Day 1),Trace, n=276, 276	0	0
Urine bilirubin, Baseline (Day 1), 1+, n=276, 276	15	22
Urine bilirubin, Baseline (Day 1), 2+, n=276, 276	0	1
Urine bilirubin, Baseline (Day 1), 3+, n=276, 276	0	0
Urine glucose, Baseline (Day 1), Trace, n=282, 282	0	1
Urine glucose, Baseline (Day 1), 1+, n=282, 282	2	0
Urine glucose, Baseline (Day 1), 2+, n=282, 282	0	0
Urine glucose, Baseline (Day 1), 3+, n=282, 282	1	1
Urine ketones, Baseline (Day 1), Trace, n=276, 276	30	29
Urine ketones, Baseline (Day 1), 1+, n=276, 276	4	2
Urine ketones, Baseline (Day 1), 2+, n=276, 276	0	1
Urine ketones, Baseline (Day 1), 3+, n=276, 276	0	0
Urine leukocyte esterase,Baseline,Trace,n=276, 276	22	21
Urine leukocyte esterase, Baseline, 1+, n=276, 276	12	14
Urine leukocyte esterase, Baseline, 2+, n=276, 276	9	9
Urine leukocyte esterase, Baseline, 3+, n=276, 276	3	3
Urine nitrite, Baseline, positive, n=276, 276	6	9
Urine occult blood, Baseline, Trace, n=276, 276	13	9
Urine occult blood, Baseline, 1+, n=276, 276	5	6
Urine occult blood, Baseline, 2+, n=276, 276	6	3
Urine occult blood, Baseline, 3+, n=276, 276	3	2
Urine protein, Baseline, Trace, n=276, 276	25	20
Urine protein, Baseline, 1+, n=276, 276	4	10
Urine protein, Baseline, 2+, n=276, 276	3	7
Urine protein, Baseline, 3+, n=276, 276	0	0
Urine bilirubin, Week 4, Trace, n=278, 272	0	0
Urine bilirubin, Week 4, 1+, n=278, 272	14	28
Urine bilirubin, Week 4, 2+, n=278, 272	0	0
Urine bilirubin, Week 4, 3+, n=278, 272	0	0
Urine glucose, Week 4, Trace, n=278, 272	0	0
Urine glucose, Week 4, 1+, n=278, 272	0	2
Urine glucose, Week 4, 2+, n=278, 272	0	0
Urine glucose, Week 4, 3+, n=278, 272	1	0
Urine ketones, Week 4, Trace, n=278, 272	20	21
Urine ketones, Week 4, 1+, n=278, 272	1	5
Urine ketones, Week 4, 2+, n=278, 272	0	0
Urine ketones, Week 4, 3+, n=278, 272	1	0
Urine leukocyte esterase, Week 4, Trace,n=278, 272	19	23
Urine leukocyte esterase, Week 4, 1+, n=278, 272	9	17
Urine leukocyte esterase, Week 4, 2+, n=278, 272	6	6
Urine leukocyte esterase, Week 4, 3+, n=278, 272	2	4
Urine nitrite, Week 4, positive, n=278, 272	2	10
Urine occult blood, Week 4, Trace, n=278, 272	11	13
Urine occult blood, Week 4, 1+, n=278, 272	8	3
Urine occult blood, Week 4, 2+, n=278, 272	5	1
Urine occult blood, Week 4, 3+, n=278, 272	0	6
Urine protein, Week 4, Trace, n=278, 272	12	24
Urine protein, Week 4, 1+, n=278, 272	4	11
Urine protein, Week 4, 2+, n=278, 272	1	3
Urine protein, Week 4, 3+, n=278, 272	1	1
Urine bilirubin, Week 24, Trace, n=195, 258	0	0
Urine bilirubin, Week 24, 1+, n=195, 258	7	14
, Urine bilirubin, Week 24, 2+, n=195, 258	0	0
Urine bilirubin, Week 24, 3+, n=195, 258	0	0
Urine glucose, Week 24, Trace, n=195, 258	0	0
Urine glucose, Week 24, 1+, n=195, 258	0	0
Urine glucose, Week 24, 2+, n=195, 258	1	0
Urine glucose, Week 24, 3+, n=195, 258	1	1
Urine ketones, Week 24, Trace, n=195, 258	13	9
Urine ketones, Week 24, 1+, n=195, 258	0	2
Urine ketones, Week 24, 2+, n=195, 258	0	0
Urine ketones, Week 24, 3+, n=195, 258	0	0
Urine leukocyte esterase,Week 24, Trace,n=195, 258	15	28
Urine leukocyte esterase, Week 24, 1+, n=195, 258	8	12
Urine leukocyte esterase, Week 24, 2+, n=195, 258	3	10
Urine leukocyte esterase, Week 24, 3+, n=195, 258	1	3
Urine nitrite, Week 24, positive, n=195, 258	4	5
Urine occult blood, Week 24, Trace, n=195, 258	9	9
Urine occult blood, Week 24, 1+, n=195, 258	3	8
Urine occult blood, Week 24, 2+, n=195, 258	3	2
Urine occult blood, Week 24, 3+, n=195, 258	1	3
Urine protein, Week 24, Trace, n=195, 258	11	21
Urine protein, Week 24, 1+, n=195, 258	4	7
Urine protein, Week 24, 2+, n=195, 258	2	4
Urine protein, Week 24, 3+, n=195, 258	0	1
Urine bilirubin, Week 48, Trace, n=261, 259	0	0
Urine bilirubin, Week 48, 1+, n=261, 259	9	12
Urine bilirubin, Week 48, 2+, n=261, 259	0	0
Urine bilirubin, Week 48, 3+, n=261, 259	0	1
Urine glucose, Week 48, Trace, n=261, 259	0	0
Urine glucose, Week 48, 1+, n=261, 259	1	0
Urine glucose, Week 48, 2+, n=261, 259	0	0
Urine glucose, Week 48, 3+, n=261, 259	2	0
Urine ketones, Week 48, Trace, n=261, 259	12	13
Urine ketones, Week 48, 1+, n=261, 259	0	4
Urine ketones, Week 48, 2+, n=261, 259	0	0
Urine ketones, Week 48, 3+, n=261, 259	0	0
Urine leukocyte esterase, Week 48,Trace,n=261, 259	12	15
Urine leukocyte esterase, Week 48, 1+, n=261, 259	5	10
Urine leukocyte esterase, Week 48, 2+, n=261, 259	4	7
Urine leukocyte esterase, Week 48, 3+, n=261, 259	2	2
Urine nitrite, Week 48, positive, n=261, 259	2	6
Urine occult blood, Week 48, Trace, n=261, 259	9	8
Urine occult blood, Week 48, 1+, n=261, 259	4	6
Urine occult blood, Week 48, 2+, n=261, 259	8	3
Urine occult blood, Week 48, 3+, n=261, 259	1	0
Urine protein, Week 48, Trace, n=261, 259	14	23
Urine protein, Week 48, 1+, n=261, 259	5	8
Urine protein, Week 48, 2+, n=261, 259	6	6
Urine protein, Week 48, 3+, n=261, 259	0	0

Notes
[49] - Safety Population
[50] - Safety Population

No statistical analyses for this end point

Secondary: Number of participants with urine potential of hydrogen (pH) over time including Week 48

Top of page

End point title

Number of participants with urine potential of hydrogen (pH) over time including Week 48

End point description

End point type

Secondary

End point timeframe

Baseline (Day 1) and at Weeks 4, 24 and 48

End point values	CAB LA + RPV LA (Q4W)	ABC/ DTG/ 3TC
Number of subjects analysed	283 ^[51]	283 ^[52]
Units: Participants
number (not applicable)
Baseline (Day 1), pH=5, n=276, 276	36	32
Baseline (Day 1), pH=5.5, n=276, 276	104	101
Baseline (Day 1), pH=6, n=276, 276	66	62
Baseline (Day 1), pH=6.5, n=276, 276	29	35
Baseline (Day 1), pH=7, n=276, 276	27	27
Baseline (Day 1), pH=7.5, n=276, 276	7	12
Baseline (Day 1), pH=8, n=276, 276	4	4
Baseline (Day 1), pH=8.5, n=276, 276	2	1
Baseline (Day 1), pH>9.0, n=276, 276	1	2
Week 4, pH=5, n=278, 272	33	41
Week 4, pH=5.5, n=278, 272	83	81
Week 4, pH=6, n=278, 272	68	71
Week 4, pH=6.5, n=278, 272	48	36
Week 4, pH=7, n=278, 272	25	22
Week 4, pH=7.5, n=278, 272	10	12
Week 4, pH=8, n=278, 272	5	5
Week 4, pH=8.5, n=278, 272	6	1
Week 4, pH>9.0, n=278, 272	0	3
Week 24, pH=5, n=195, 258	42	50
Week 24, pH=5.5, n=195, 258	55	78
Week 24, pH=6, n=195, 258	47	51
Week 24, pH=6.5, n=195, 258	19	46
Week 24, pH=7, n=195, 258	22	16
Week 24, pH=7.5, n=195, 258	4	13
Week 24, pH=8, n=195, 258	3	2
Week 24, pH=8.5, n=195, 258	3	1
Week 24, pH>9.0, n=195, 258	0	1
Week 48, pH=5, n=261, 259	54	57
Week 48, pH=5.5, n=261, 259	81	77
Week 48, pH=6, n=261, 259	50	61
Week 48, pH=6.5, n=261, 259	30	27
Week 48, pH=7, n=261, 259	24	18
Week 48, pH=7.5, n=261, 259	14	10
Week 48, pH=8, n=261, 259	5	4
Week 48, pH=8.5, n=261, 259	2	3
Week 48, pH>9.0, n=261, 259	1	2

Notes
[51] - Safety Population
[52] - Safety Population

No statistical analyses for this end point

Secondary: Change from Baseline for hematology parameters: basophil, eosinophils, leukocytes, lymphocytes, neutrophils, monocytes, and platelets

Top of page

End point title

Change from Baseline for hematology parameters: basophil, eosinophils, leukocytes, lymphocytes, neutrophils, monocytes, and platelets

End point description

Blood samples were collected for the analysis of hematology parameters including basophil, eosinophils, leukocytes, lymphocytes, neutrophils, monocytes, and platelets at indicated timepoints. Baseline value is defined as the last available recorded value up to and including the date of first Maintenance Phase dose of IP. Change from Baseline was defined as post-dose visit value minus Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).

End point type

Secondary

End point timeframe

Baseline (Day 1) and at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44 and 48

End point values	CAB LA + RPV LA (Q4W)	ABC/ DTG/ 3TC
Number of subjects analysed	283 ^[53]	283 ^[54]
Units: 10^9 cells per Liter
arithmetic mean (standard deviation)
Basophils, Week 4, n=277, 270	0.002 ± 0.0155	0.002 ± 0.0155
Basophils, Week 8, n=210, 272	0.002 ± 0.0161	0.001 ± 0.0153
Basophils, Week 12, n=267, 272	0.003 ± 0.0181	0.001 ± 0.0157
Basophils, Week 16, n=247, 259	0.008 ± 0.0215	0.006 ± 0.0227
Basophils, Week 20, n=247, 259	0.013 ± 0.0250	0.010 ± 0.0271
Basophils, Week 24, n=256, 260	0.015 ± 0.0247	0.014 ± 0.0269
Basophils, Week 28, n=239, 258	0.017 ± 0.0265	0.016 ± 0.0251
Basophils, Week 32, n=246, 263	0.022 ± 0.0266	0.017 ± 0.0227
Basophils, Week 36, n=250, 259	0.021 ± 0.0235	0.018 ± 0.0249
Basophils, Week 40, n=244, 245	0.020 ± 0.0252	0.019 ± 0.0243
Basophils, Week 44, n=249, 260	0.018 ± 0.0246	0.018 ± 0.0265
Basophils, Week 48, n=239, 258	0.016 ± 0.0218	0.016 ± 0.0243
Eosinophils, Week 4, n=277, 270	0.024 ± 0.1099	0.013 ± 0.1220
Eosinophils, Week 8, n=210, 272	0.023 ± 0.1101	0.009 ± 0.1075
Eosinophils, Week 12, n=267, 272	0.023 ± 0.1305	0.018 ± 0.1082
Eosinophils, Week 16, n=247, 259	0.037 ± 0.1425	0.022 ± 0.1262
Eosinophils, Week 20, n=247, 259	0.044 ± 0.1478	0.027 ± 0.1288
Eosinophils, Week 24, n=256, 260	0.051 ± 0.1307	0.030 ± 0.1124
Eosinophils, Week 28, n=239, 258	0.061 ± 0.1367	0.037 ± 0.1393
Eosinophils, Week 32, n=246, 263	0.061 ± 0.1556	0.029 ± 0.1158
Eosinophils, Week 36, n=250, 259	0.070 ± 0.1797	0.030 ± 0.1303
Eosinophils, Week 40, n=244, 245	0.062 ± 0.1623	0.035 ± 0.1155
Eosinophils, Week 44, n=249, 260	0.057 ± 0.1598	0.038 ± 0.1410
Eosinophils, Week 48, n=239, 258	0.039 ± 0.1416	0.030 ± 0.1183
Leukocytes, Week 4, n=279, 272	0.57 ± 1.404	0.42 ± 1.383
Leukocytes, Week 8, n=211, 275	0.18 ± 1.278	0.32 ± 1.374
Leukocytes, Week 12, n=270, 275	0.07 ± 1.402	0.40 ± 1.465
Leukocytes, Week 16, n=252, 265	0.32 ± 1.641	0.41 ± 1.621
Leukocytes, Week 20, n=254, 265	0.27 ± 1.505	0.44 ± 1.480
Leukocytes, Week 24, n=258, 264	0.34 ± 1.581	0.45 ± 1.725
Leukocytes, Week 28, n=244, 263	0.34 ± 1.713	0.48 ± 1.551
Leukocytes, Week 32, n=253, 266	0.28 ± 1.726	0.42 ± 1.748
Leukocytes, Week 36, n=252, 259	0.34 ± 1.549	0.52 ± 1.789
Leukocytes, Week 40, n=246, 253	0.16 ± 1.497	0.42 ± 1.614
Leukocytes, Week 44, n=256, 262	0.22 ± 1.732	0.49 ± 1.626
Leukocytes, Week 48, n=243, 260	0.09 ± 1.455	0.29 ± 1.520
Lymphocytes, Week 4, n=277, 270	0.198 ± 0.5156	0.231 ± 0.5066
Lymphocytes, Week 8, n=210, 272	0.054 ± 0.4812	0.155 ± 0.5088
Lymphocytes, Week 12, n=267, 272	0.012 ± 0.4632	0.164 ± 0.5560
Lymphocytes, Week 16, n=247, 259	0.020 ± 0.4971	0.158 ± 0.5246
Lymphocytes, Week 20, n=247, 259	0.030 ± 0.4889	0.146 ± 0.5292
Lymphocytes, Week 24, n=256, 260	0.014 ± 0.5195	0.148 ± 0.5716
Lymphocytes, Week 28, n=239, 258	0.021 ± 0.5389	0.145 ± 0.5469
Lymphocytes, Week 32, n=246, 263	0.021 ± 0.5195	0.129 ± 0.5812
Lymphocytes, Week 36, n=250, 259	0.028 ± 0.5261	0.132 ± 0.5258
Lymphocytes, Week 40, n=244, 245	0.006 ± 0.5303	0.054 ± 0.5106
Lymphocytes, Week 44, n=249, 260	-0.021 ± 0.6176	0.098 ± 0.5139
Lymphocytes, Week 48, n=239, 258	-0.074 ± 0.5191	0.039 ± 0.5936
Monocytes, Week 4, n=277, 270	0.038 ± 0.1269	0.031 ± 0.1528
Monocytes, Week 8, n=210, 272	0.022 ± 0.1464	0.013 ± 0.1600
Monocytes, Week 12, n=267, 272	0.016 ± 0.1234	0.018 ± 0.1613
Monocytes, Week 16, n=247, 259	0.059 ± 0.1548	0.035 ± 0.1618
Monocytes, Week 20, n=247, 259	0.070 ± 0.1583	0.053 ± 0.1790
Monocytes, Week 24, n=256, 260	0.059 ± 0.1442	0.070 ± 0.1599
Monocytes, Week 28, n=239, 258	0.086 ± 0.1584	0.077 ± 0.1806
Monocytes, Week 32, n=246, 263	0.081 ± 0.1530	0.088 ± 0.1841
Monocytes, Week 36, n=250, 259	0.084 ± 0.1685	0.086 ± 0.1772
Monocytes, Week 40, n=244, 245	0.056 ± 0.1378	0.076 ± 0.1651
Monocytes, Week 44, n=249, 260	0.062 ± 0.1522	0.057 ± 0.1558
Monocytes, Week 48, n=239, 258	0.024 ± 0.1395	0.031 ± 0.1389
Neutrophils, Week 4, n=277, 270	0.313 ± 1.3508	0.130 ± 1.1869
Neutrophils, Week 8, n=210, 272	0.084 ± 1.1310	0.125 ± 1.2775
Neutrophils, Week 12, n=267, 272	0.032 ± 1.3016	0.185 ± 1.3016
Neutrophils, Week 16, n=247, 259	0.215 ± 1.5752	0.211 ± 1.4233
Neutrophils, Week 20, n=247, 259	0.132 ± 1.4116	0.217 ± 1.3130
Neutrophils, Week 24, n=256, 260	0.218 ± 1.4890	0.217 ± 1.4694
Neutrophils, Week 28, n=239, 258	0.193 ± 1.5833	0.221 ± 1.3274
Neutrophils, Week 32, n=246, 263	0.144 ± 1.5739	0.175 ± 1.5009
Neutrophils, Week 36, n=250, 259	0.170 ± 1.3865	0.243 ± 1.4938
Neutrophils, Week 40, n=244, 245	0.055 ± 1.4372	0.259 ± 1.4739
Neutrophils, Week 44, n=249, 260	0.156 ± 1.5382	0.273 ± 1.4445
Neutrophils, Week 48, n=239, 258	0.110 ± 1.3697	0.201 ± 1.3169
Platelets, Week 4, n=278, 269	5.7 ± 29.10	4.3 ± 31.11
Platelets, Week 8, n=207, 273	-0.9 ± 29.09	2.2 ± 35.14
Platelets, Week 12, n=269, 271	0.8 ± 32.49	6.2 ± 36.23
Platelets, Week 16, n=251, 263	1.6 ± 33.34	9.3 ± 51.53
Platelets, Week 20, n=255, 264	7.6 ± 38.18	13.4 ± 39.24
Platelets, Week 24, n=256, 261	6.5 ± 36.11	14.4 ± 35.15
Platelets, Week 28, n=245, 258	8.6 ± 38.23	18.4 ± 38.56
Platelets, Week 32, n=249, 262	7.9 ± 40.22	14.6 ± 34.28
Platelets, Week 36, n=248, 259	12.1 ± 38.48	18.6 ± 35.81
Platelets, Week 40, n=244, 254	8.2 ± 36.08	17.7 ± 43.30
Platelets, Week 44, n=254, 261	9.4 ± 38.42	19.3 ± 47.64
Platelets, Week 48, n=240, 255	7.7 ± 39.61	16.4 ± 47.45

Notes
[53] - Safety Population
[54] - Safety Population

No statistical analyses for this end point

Secondary: Change from Baseline for hematology parameters: erythrocyte mean corpuscular volume

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End point title

Change from Baseline for hematology parameters: erythrocyte mean corpuscular volume

End point description

Blood samples were collected for the analysis of hematology parameter including erythrocyte mean corpuscular volume at indicated timepoints. Baseline value is defined as the last available recorded value up to and including the date of first Maintenance phase dose of IP. Change from Baseline was defined as post-dose visit value minus Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).

End point type

Secondary

End point timeframe

Baseline (Day 1) and at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44 and 48

End point values	CAB LA + RPV LA (Q4W)	ABC/ DTG/ 3TC
Number of subjects analysed	283 ^[55]	283 ^[56]
Units: Femtoliters
arithmetic mean (standard deviation)
Week 4, n=279, 273	-0.7 ± 1.66	0.2 ± 1.56
Week 8, n=211, 275	-2.5 ± 2.33	0.2 ± 2.06
Week 12, n=270, 275	-3.8 ± 2.49	-0.3 ± 2.48
Week 16, n=254, 265	-5.1 ± 2.63	-0.2 ± 2.65
Week 20, n=255, 267	-5.6 ± 2.72	-0.5 ± 2.55
Week 24, n=259, 264	-5.6 ± 2.85	-0.5 ± 2.58
Week 28, n=246, 265	-5.6 ± 2.97	-0.9 ± 2.52
Week 32, n=254, 267	-5.3 ± 3.02	-0.9 ± 2.55
Week 36, n=252, 261	-5.3 ± 3.00	-0.6 ± 2.45
Week 40, n=246, 255	-4.8 ± 3.02	-0.1 ± 2.64
Week 44, n=256, 262	-4.2 ± 3.12	0.2 ± 2.81
Week 48, n=243, 260	-3.7 ± 3.12	1.0 ± 2.93

Notes
[55] - Safety Population
[56] - Safety Population

No statistical analyses for this end point

Secondary: Change from Baseline for hematology parameters: erythrocytes

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End point title

Change from Baseline for hematology parameters: erythrocytes

End point description

Blood samples were collected for the analysis of hematology parameters including erythrocytes at indicated timepoints. Baseline value is defined as the last available recorded value up to and including the date of first Maintenance phase dose of IP. Change from Baseline was defined as post-dose visit value minus Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).

End point type

Secondary

End point timeframe

Baseline (Day 1) and at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44 and 48

End point values	CAB LA + RPV LA (Q4W)	ABC/ DTG/ 3TC
Number of subjects analysed	283 ^[57]	283 ^[58]
Units: 10^12 cells per Liter
arithmetic mean (standard deviation)
Week 4, n=279, 273	0.08 ± 0.226	-0.03 ± 0.228
Week 8, n=211, 275	0.18 ± 0.249	0.02 ± 0.239
Week 12, n=270, 275	0.23 ± 0.269	0.01 ± 0.273
Week 16, n=254, 265	0.30 ± 0.263	0.01 ± 0.255
Week 20, n=255, 267	0.31 ± 0.272	-0.01 ± 0.242
Week 24, n=259, 264	0.31 ± 0.254	0.02 ± 0.242
Week 28, n=246, 265	0.29 ± 0.248	0.04 ± 0.259
Week 32, n=254, 267	0.25 ± 0.283	0.01 ± 0.259
Week 36, n=252, 261	0.23 ± 0.263	-0.01 ± 0.250
Week 40, n=246, 255	0.23 ± 0.246	-0.01 ± 0.239
Week 44, n=256, 262	0.21 ± 0.234	-0.06 ± 0.243
Week 48, n=243, 260	0.16 ± 0.264	-0.06 ± 0.257

Notes
[57] - Safety Population
[58] - Safety Population

No statistical analyses for this end point

Secondary: Change from Baseline for hematology parameters: hematocrit

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End point title

Change from Baseline for hematology parameters: hematocrit

End point description

Blood samples were collected for the analysis of hematology parameters including hematocrit at indicated timepoints. Baseline value is defined as the last available recorded value up to and including the date of first Maintenance phase dose of IP. Change from Baseline was defined as post-dose visit value minus Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).

End point type

Secondary

End point timeframe

Baseline (Day 1) and at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44 and 48

End point values	CAB LA + RPV LA (Q4W)	ABC/ DTG/ 3TC
Number of subjects analysed	283 ^[59]	283 ^[60]
Units: Proportion of red blood cells in blood
arithmetic mean (standard deviation)
Week 4, n=279, 273	0.0046 ± 0.02082	-0.0013 ± 0.02213
Week 8, n=211, 275	0.0053 ± 0.02344	0.0026 ± 0.02314
Week 12, n=270, 275	0.0040 ± 0.02383	-0.0000 ± 0.02618
Week 16, n=254, 265	0.0035 ± 0.02338	-0.0003 ± 0.02489
Week 20, n=255, 267	0.0024 ± 0.02335	-0.0033 ± 0.02323
Week 24, n=259, 264	0.0021 ± 0.02299	-0.0012 ± 0.02337
Week 28, n=246, 265	-0.0003 ± 0.02262	-0.0001 ± 0.02460
Week 32, n=254, 267	-0.0017 ± 0.02607	-0.0032 ± 0.02503
Week 36, n=252, 261	-0.0041 ± 0.02515	-0.0032 ± 0.02407
Week 40, n=246, 255	-0.0014 ± 0.02461	-0.0017 ± 0.02388
Week 44, n=256, 262	-0.0011 ± 0.02230	-0.0045 ± 0.02328
Week 48, n=243, 260	-0.0027 ± 0.02571	-0.0019 ± 0.02572

Notes
[59] - Safety Population
[60] - Safety Population

No statistical analyses for this end point

Secondary: Change from Baseline for hematology parameters: hemoglobin

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End point title

Change from Baseline for hematology parameters: hemoglobin

End point description

Blood samples were collected for the analysis of hematology parameter including hemoglobin at indicated timepoints. Baseline value is defined as the last available recorded value up to and including the date of first Maintenance Phase dose of IP. Baseline value is defined as the latest pre-treatment assessment with a non-missing value. Change from Baseline was defined as post-dose visit value minus Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).

End point type

Secondary

End point timeframe

Baseline (Day 1) and at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44 and 48

End point values	CAB LA + RPV LA (Q4W)	ABC/ DTG/ 3TC
Number of subjects analysed	283 ^[61]	283 ^[62]
Units: Grams per liter
arithmetic mean (standard deviation)
Week 4, n=279, 273	1.8 ± 6.59	0.1 ± 6.47
Week 8, n=211, 275	1.9 ± 7.29	1.3 ± 7.26
Week 12, n=270, 275	2.1 ± 7.47	1.5 ± 8.28
Week 16, n=254, 265	2.9 ± 6.98	1.4 ± 7.88
Week 20, n=255, 267	2.9 ± 7.43	1.4 ± 7.18
Week 24, n=259, 264	2.7 ± 7.32	2.0 ± 7.11
Week 28, n=246, 265	2.7 ± 6.80	3.3 ± 7.75
Week 32, n=254, 267	2.7 ± 8.08	2.9 ± 7.73
Week 36, n=252, 261	2.0 ± 7.93	2.8 ± 7.73
Week 40, n=246, 255	3.2 ± 7.91	3.1 ± 7.85
Week 44, n=256, 262	2.5 ± 7.66	1.8 ± 7.62
Week 48, n=243, 260	1.4 ± 7.98	2.1 ± 8.33

Notes
[61] - Safety Population
[62] - Safety Population

No statistical analyses for this end point

Secondary: Change from Baseline in clinical chemistry parameters over time including Week 48: ALT, ALP, AST and CK

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End point title

Change from Baseline in clinical chemistry parameters over time including Week 48: ALT, ALP, AST and CK

End point description

Blood samples were collected for the analysis of clinical chemistry parameters including ALT, ALP, AST and CK. Baseline values is defined as the latest pre-treatment assessment with a non-missing value. Baseline value is defined as the last available recorded value up to and including the date of first Maintenance Phase dose of IP. Change from Baseline value is calculated as the value at the post-dose visit minus the Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).

End point type

Secondary

End point timeframe

Baseline (Day 1) and at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44 and 48

End point values	CAB LA + RPV LA (Q4W)	ABC/ DTG/ 3TC
Number of subjects analysed	283 ^[63]	283 ^[64]
Units: International units per liter
arithmetic mean (standard deviation)
ALT, Week 4, n=281, 277	3.7 ± 49.90	-1.4 ± 11.14
ALT, Week 8, n=212, 278	1.0 ± 14.28	-0.9 ± 11.86
ALT, Week 12, n=270, 276	1.0 ± 15.80	-0.1 ± 13.27
ALT, Week 16, n=255, 269	1.2 ± 16.61	1.5 ± 13.99
ALT, Week 20, n=260, 272	5.3 ± 72.80	0.2 ± 17.04
ALT, Week 24, n=261, 268	3.3 ± 30.00	-0.4 ± 12.75
ALT, Week 28, n=253, 268	1.9 ± 18.82	0.2 ± 12.72
ALT, Week 32, n=256, 268	18.1 ± 293.85	-0.4 ± 13.08
ALT, Week 36, n=255, 261	-0.1 ± 14.10	1.7 ± 32.63
ALT, Week 40, n=250, 266	0.6 ± 17.42	0.0 ± 14.84
ALT, Week 44, n=258, 263	1.7 ± 27.55	0.8 ± 16.75
ALT, Week 48, n=247, 262	-0.2 ± 22.91	0.1 ± 18.81
ALP, Week 4, n=281, 277	0.3 ± 11.04	-1.3 ± 15.74
ALP, Week 8, n=212, 278	0.6 ± 10.41	-0.5 ± 17.00
ALP, Week 12, n=270, 276	1.4 ± 12.71	-0.7 ± 17.40
ALP, Week 16, n=255, 269	0.8 ± 10.34	-0.3 ± 17.99
ALP, Week 20, n=260, 272	1.5 ± 10.20	-1.1 ± 17.35
ALP, Week 24, n=261, 268	1.2 ± 9.57	-0.7 ± 17.03
ALP, Week 28, n=253, 268	1.4 ± 10.57	0.6 ± 17.28
ALP, Week 32, n=256, 268	1.9 ± 15.42	-0.3 ± 18.11
ALP, Week 36, n=255, 261	3.3 ± 20.31	1.3 ± 20.90
ALP, Week 40, n=250, 266	1.8 ± 9.84	0.7 ± 18.50
ALP, Week 44, n=258, 263	1.4 ± 11.00	1.2 ± 17.62
ALP, Week 48, n=247, 262	1.1 ± 12.75	0.7 ± 17.54
AST, Week 4, n=281, 277	1.5 ± 24.47	-1.6 ± 14.58
AST, Week 8, n=212, 278	0.7 ± 19.90	-2.0 ± 14.13
AST, Week 12, n=270, 276	-0.3 ± 10.74	-1.5 ± 15.34
AST, Week 16, n=255, 269	-0.1 ± 11.31	1.0 ± 16.68
AST, Week 20, n=260, 272	2.3 ± 32.28	0.2 ± 26.46
AST, Week 24, n=261, 268	2.8 ± 24.22	-1.5 ± 16.00
AST, Week 28, n=253, 268	1.7 ± 15.85	-0.9 ± 16.99
AST, Week 32, n=256, 268	14.0 ± 233.48	-1.9 ± 14.68
AST, Week 36, n=255, 261	-0.1 ± 12.22	-0.2 ± 22.03
AST, Week 40, n=250, 266	0.2 ± 13.31	-1.5 ± 15.24
AST, Week 44, n=258, 263	1.3 ± 16.49	-0.5 ± 18.31
AST Week 48, n=247, 262	-0.8 ± 11.88	0.8 ± 44.70
CK, Week 4, n=280, 277	31.1 ± 456.63	-27.0 ± 523.89
CK, Week 8, n=212, 278	53.5 ± 907.83	-46.6 ± 499.91
CK, Week 12, n=270, 276	1.2 ± 420.32	-17.2 ± 605.92
CK, Week 16, n=255, 269	-18.0 ± 316.74	40.2 ± 746.32
CK, Week 20, n=260, 272	19.2 ± 536.70	57.3 ± 1208.73
CK, Week 24, n=261, 268	47.3 ± 635.42	-19.6 ± 605.13
CK, Week 28, n=253, 268	49.9 ± 669.37	-8.5 ± 705.35
CK, Week 32, n=256, 268	-24.5 ± 298.70	-42.5 ± 509.77
CK, Week 36, n=254, 261	14.7 ± 515.62	12.2 ± 674.76
CK, Week 40, n=250, 266	24.8 ± 544.72	-51.7 ± 497.70
CK, Week 44, n=258, 263	54.8 ± 526.28	-20.1 ± 652.24
CK, Week 48, n=247, 262	-17.8 ± 309.33	121.1 ± 2682.33

Notes
[63] - Safety Population
[64] - Safety Population

No statistical analyses for this end point

Secondary: Change from Baseline values for clinical chemistry parameter over time including Week 48: Albumin

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End point title

Change from Baseline values for clinical chemistry parameter over time including Week 48: Albumin

End point description

Blood samples were collected for the analysis of clinical chemistry parameter-albumin. Baseline value is defined as the last available recorded value up to and including the date of first Maintenance Phase dose of IP. Change from Baseline value is calculated as the value at the post-dose visit minus the Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).

End point type

Secondary

End point timeframe

Baseline (Day 1) and at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44 and 48

End point values	CAB LA + RPV LA (Q4W)	ABC/ DTG/ 3TC
Number of subjects analysed	283 ^[65]	283 ^[66]
Units: Grams per liter
arithmetic mean (standard deviation)
Week 4, n=280, 277	-0.1 ± 2.15	-0.3 ± 2.14
Week 8, n=212, 278	-0.1 ± 2.32	-0.3 ± 2.25
Week 12, n=270, 276	-0.1 ± 2.38	0.0 ± 2.58
Week 16, n=255, 269	0.2 ± 2.23	-0.1 ± 2.48
Week 20, n=260, 272	0.2 ± 2.51	-0.2 ± 2.47
Week 24, n=261, 268	0.5 ± 2.28	0.2 ± 2.37
Week 28, n=253, 268	0.5 ± 2.42	0.4 ± 2.32
Week 32, n=255, 268	0.7 ± 2.47	0.4 ± 2.60
Week 36, n=254, 261	0.3 ± 2.44	0.3 ± 2.52
Week 40, n=250, 266	0.9 ± 2.42	0.5 ± 2.46
Week 44, n=258, 263	0.9 ± 2.44	0.4 ± 2.49
Week 48, n=247, 262	0.7 ± 2.40	0.5 ± 2.63

Notes
[65] - Safety Population
[66] - Safety Population

No statistical analyses for this end point

Secondary: Change from Baseline values for clinical chemistry parameters over time including Week 48: Bilirubin, direct bilirubin and creatinine

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End point title

Change from Baseline values for clinical chemistry parameters over time including Week 48: Bilirubin, direct bilirubin and creatinine

End point description

Blood samples were collected for the analysis of clinical chemistry parameters including bilirubin, creatinine and direct bilirubin. Baseline value is defined as the last available recorded value up to and including the date of first Maintenance Phase dose of IP. Baseline value is defined as the latest pre-treatment assessment with a non-missing value. Change from Baseline value is calculated as the value at the post-dose visit minus the Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).

End point type

Secondary

End point timeframe

Baseline (Day 1) and at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44 and 48

End point values	CAB LA + RPV LA (Q4W)	ABC/ DTG/ 3TC
Number of subjects analysed	283 ^[67]	283 ^[68]
Units: Micromoles per liter
arithmetic mean (standard deviation)
Bilirubin, Week 4, n=281, 277	1.4 ± 4.74	-0.3 ± 3.77
Bilirubin, Week 8, n=212, 278	0.9 ± 4.04	-0.5 ± 4.17
Bilirubin, Week 12, n=270, 276	1.2 ± 4.15	-0.7 ± 4.51
Bilirubin, Week 16, n=255, 269	1.2 ± 4.30	-0.3 ± 3.61
Bilirubin, Week 20, n=260, 272	1.1 ± 4.14	-0.7 ± 4.02
Bilirubin, Week 24, n=261, 268	0.8 ± 4.12	-0.4 ± 3.85
Bilirubin, Week 28, n=253, 268	1.2 ± 4.41	-0.7 ± 3.75
Bilirubin, Week 32, n=256, 268	1.3 ± 6.44	-0.6 ± 4.05
Bilirubin, Week 36, n=255, 260	0.6 ± 5.36	-0.7 ± 4.28
Bilirubin, Week 40, n=250, 266	0.9 ± 4.31	-0.8 ± 4.32
Bilirubin, Week 44, n=258, 263	1.2 ± 4.34	-0.4 ± 4.28
Bilirubin, Week 48, n=247, 262	1.1 ± 4.18	-0.3 ± 4.17
Direct bilirubin, Week 4, n=277, 277	0.2 ± 1.40	-0.1 ± 1.33
Direct bilirubin, Week 8, n=212, 278	0.2 ± 1.30	-0.1 ± 1.19
Direct bilirubin, Week 12, n=269, 273	0.2 ± 1.22	0.0 ± 1.22
Direct bilirubin, Week 16, n=254, 268	0.2 ± 1.44	-0.1 ± 1.14
Direct bilirubin, Week 20, n=260, 272	0.2 ± 1.57	-0.1 ± 1.14
Direct bilirubin, Week 24, n=260, 266	0.1 ± 1.46	-0.1 ± 1.10
Direct bilirubin, Week 28, n=253, 268	0.2 ± 1.26	-0.1 ± 1.22
Direct bilirubin, Week 32, n=256, 268	0.3 ± 3.39	-0.1 ± 1.08
Direct bilirubin, Week 36, n=255, 260	0.1 ± 2.18	-0.1 ± 1.16
Direct bilirubin, Week 40, n=249, 266	0.1 ± 1.42	-0.1 ± 1.26
Direct bilirubin, Week 44, n=258, 263	0.2 ± 1.41	-0.1 ± 1.19
Direct bilirubin, Week 48, n=247, 262	0.0 ± 1.41	0.0 ± 1.19
Creatinine, Week 4, n=280, 277	-6.07 ± 9.696	0.61 ± 7.635
Creatinine, Week 8, n=212, 278	-9.25 ± 9.936	-0.24 ± 8.838
Creatinine, Week 12, n=270, 276	-9.89 ± 9.703	-1.20 ± 8.710
Creatinine, Week 16, n=255, 269	-9.75 ± 9.572	-0.33 ± 8.964
Creatinine, Week 20, n=261, 272	-10.10 ± 9.839	-0.68 ± 8.700
Creatinine, Week 24, n=262, 268	-9.73 ± 9.499	-0.75 ± 8.327
Creatinine, Week 28, n=253, 268	-10.34 ± 9.731	-1.33 ± 8.892
Creatinine, Week 32, n=255, 268	-9.77 ± 9.166	-1.26 ± 9.243
Creatinine, Week 36, n=254, 262	-9.57 ± 9.712	-0.74 ± 8.565
Creatinine, Week 40, n=250, 266	-9.60 ± 10.656	-1.10 ± 7.875
Creatinine, Week 44, n=258, 263	-9.02 ± 9.562	-1.91 ± 8.306
Creatinine, Week 48, n=247, 262	-8.97 ± 9.742	5.00 ± 85.535

Notes
[67] - Safety Population
[68] - Safety Population

No statistical analyses for this end point

Secondary: Change from Baseline values for clinical chemistry parameters over time including Week 48

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End point title

Change from Baseline values for clinical chemistry parameters over time including Week 48

End point description

Blood samples were collected for the analysis of clinical chemistry parameters which includes total CO2, chloride, glucose, phosphate, potassium, sodium and urea. Baseline value is defined as the last available recorded value up to and including the date of first Maintenance Phase dose of IP. Change from Baseline value is calculated as the value at the post-dose visit minus the Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).

End point type

Secondary

End point timeframe

Baseline (Day 1) and at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44 and 48

End point values	CAB LA + RPV LA (Q4W)	ABC/ DTG/ 3TC
Number of subjects analysed	283 ^[69]	283 ^[70]
Units: Millimoles per liter
arithmetic mean (standard deviation)
CO2, Week 4, n=280, 276	0.6 ± 2.67	0.2 ± 2.32
CO2, Week 8, n=212, 278	0.2 ± 2.51	-0.1 ± 2.24
CO2, Week 12, n=270, 276	0.2 ± 2.56	-0.1 ± 2.26
CO2, Week 16, n=255, 269	0.4 ± 2.55	-0.1 ± 2.72
CO2, Week 20, n=260, 272	0.3 ± 2.52	0.1 ± 2.38
CO2, Week 24, n=261, 268	0.6 ± 2.84	0.4 ± 2.56
CO2, Week 28, n=253, 268	0.5 ± 2.51	0.4 ± 2.39
CO2, Week 32, n=255, 268	0.5 ± 2.72	0.3 ± 2.37
CO2, Week 36, n=253, 261	0.7 ± 2.54	0.2 ± 2.35
CO2, Week 40, n=249, 265	0.4 ± 2.53	0.2 ± 2.61
CO2, Week 44, n=257, 263	0.4 ± 2.71	0.1 ± 2.37
CO2, Week 48, n=247, 262	0.0 ± 2.70	0.0 ± 2.27
Chloride, Week 4, n=280, 277	0.0 ± 2.13	0.5 ± 2.17
Chloride, Week 8, n=212, 278	0.0 ± 2.05	0.3 ± 2.14
Chloride, Week 12, n=270, 276	0.0 ± 2.10	0.4 ± 2.16
Chloride, Week 16, n=255, 269	-0.2 ± 2.32	0.3 ± 2.39
Chloride, Week 20, n=260, 272	-0.3 ± 2.49	0.4 ± 2.15
Chloride, Week 24, n=261, 268	-0.2 ± 2.40	0.2 ± 2.47
Chloride, Week 28, n=253, 268	-0.2 ± 2.21	0.1 ± 2.18
Chloride, Week 32, n=255, 268	-0.2 ± 2.37	0.3 ± 2.34
Chloride, Week 36, n=254, 261	-0.1 ± 2.46	0.4 ± 2.37
Chloride, Week 40, n=250, 266	0.1 ± 2.35	0.4 ± 2.20
Chloride, Week 44, n=258, 263	0.1 ± 2.40	0.7 ± 2.23
Chloride, Week 48, n=247, 262	0.0 ± 2.23	0.3 ± 2.09
Phosphate, Week 4, n=279, 277	0.032 ± 0.1865	0.014 ± 0.1771
Phosphate, Week 8, n=212, 278	-0.016 ± 0.1834	0.017 ± 0.1855
Phosphate, Week 12, n=270, 276	-0.010 ± 0.1825	0.009 ± 0.1772
Phosphate, Week 16, n=255, 269	0.000 ± 0.1789	0.017 ± 0.1892
Phosphate, Week 20, n=260, 272	-0.029 ± 0.1932	0.016 ± 0.1764
Phosphate, Week 24, n=261, 268	-0.001 ± 0.1907	0.011 ± 0.1852
Phosphate, Week 28, n=253, 268	-0.007 ± 0.1894	0.019 ± 0.1882
Phosphate, Week 32, n=255, 268	-0.004 ± 0.1806	0.005 ± 0.2092
Phosphate, Week 36, n=254, 261	-0.006 ± 0.1798	0.021 ± 0.1965
Phosphate, Week 40, n=250, 266	-0.011 ± 0.1851	0.015 ± 0.1753
Phosphate, Week 44, n=258, 263	-0.004 ± 0.1824	0.020 ± 0.1801
Phosphate, Week 48, n=247, 262	-0.007 ± 0.1784	0.020 ± 0.2333
Potassium, Week 4, n=280, 277	0.15 ± 0.334	0.06 ± 0.368
Potassium, Week 8, n=212, 278	0.10 ± 0.348	0.08 ± 0.346
Potassium, Week 12, n=270, 276	0.09 ± 0.352	0.05 ± 0.305
Potassium, Week 16, n=255, 269	0.10 ± 0.321	0.04 ± 0.314
Potassium, Week 20, n=260, 272	0.09 ± 0.374	0.04 ± 0.364
Potassium, Week 24, n=261, 268	0.12 ± 0.353	0.07 ± 0.309
Potassium, Week 28, n=253, 268	0.08 ± 0.341	0.08 ± 0.350
Potassium, Week 32, n=255, 268	0.09 ± 0.334	0.06 ± 0.345
Potassium, Week 36, n=254, 261	0.10 ± 0.353	0.08 ± 0.347
Potassium, Week 40, n=250, 266	0.07 ± 0.347	0.06 ± 0.345
Potassium, Week 44, n=258, 263	0.08 ± 0.353	0.06 ± 0.338
Potassium, Week 48, n=247, 262	0.01 ± 0.343	0.03 ± 0.496
Sodium, Week 4, n=280, 277	0.3 ± 2.25	0.2 ± 1.95
Sodium, Week 8, n=212, 278	0.1 ± 1.98	0.1 ± 1.92
Sodium, Week 12, n=270, 276	0.3 ± 1.84	0.1 ± 1.89
Sodium, Week 16, n=255, 269	0.2 ± 2.10	0.3 ± 2.21
Sodium, Week 20, n=260, 272	0.2 ± 2.08	0.4 ± 1.79
Sodium, Week 24, n=261, 268	0.2 ± 2.02	0.2 ± 2.12
Sodium, Week 28, n=253, 268	0.2 ± 1.88	0.4 ± 1.82
Sodium, Week 32, n=255, 268	0.3 ± 2.13	0.3 ± 2.02
Sodium, Week 36, n=254, 261	0.2 ± 2.16	0.4 ± 1.94
Sodium, Week 40, n=250, 266	0.1 ± 2.08	0.4 ± 2.13
Sodium, Week 44, n=258, 263	0.3 ± 2.30	0.4 ± 2.01
Sodium, Week 48, n=247, 262	0.2 ± 2.11	0.3 ± 1.72
Urea, Week 4, n=280, 277	0.04 ± 1.292	-0.05 ± 1.240
Urea, Week 8, n=212, 278	0.04 ± 1.315	-0.05 ± 1.278
Urea, Week 12, n=270, 276	-0.01 ± 1.287	0.04 ± 1.340
Urea, Week 16, n=255, 269	0.02 ± 1.394	0.01 ± 1.171
Urea, Week 20, n=260, 272	-0.07 ± 1.359	0.04 ± 1.190
Urea, Week 24, n=261, 268	0.09 ± 1.459	-0.08 ± 1.154
Urea, Week 28, n=253, 268	0.02 ± 1.412	0.02 ± 1.230
Urea, Week 32, n=255, 268	0.16 ± 1.364	-0.03 ± 1.330
Urea, Week 36, n=254, 261	0.05 ± 1.451	0.04 ± 1.265
Urea, Week 40, n=250, 266	0.07 ± 1.466	0.05 ± 1.312
Urea, Week 44, n=258, 263	0.12 ± 1.361	0.03 ± 1.290
Urea, Week 48, n=247, 262	0.09 ± 1.362	0.06 ± 2.189

Notes
[69] - Safety Population
[70] - Safety Population

No statistical analyses for this end point

Secondary: Change from Baseline values for clinical chemistry parameter over time including Week 48: Lipase

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End point title

Change from Baseline values for clinical chemistry parameter over time including Week 48: Lipase

End point description

Blood samples were collected for the analysis of clinical chemistry parameter-lipase. Baseline value is defined as the last available recorded value up to and including the date of first Maintenance Phase dose of IP. Change from Baseline value is calculated as the value at the post-dose visit minus the Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).

End point type

Secondary

End point timeframe

Baseline (Day 1) and at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44 and 48

End point values	CAB LA + RPV LA (Q4W)	ABC/ DTG/ 3TC
Number of subjects analysed	283 ^[71]	283 ^[72]
Units: Units per liter
arithmetic mean (standard deviation)
Week 4, n=278, 276	1.6 ± 23.51	1.8 ± 30.92
Week 8, n=211, 278	0.8 ± 19.07	0.4 ± 27.41
Week 12, n=270, 276	1.3 ± 18.55	2.5 ± 29.44
Week 16, n=254, 269	0.8 ± 20.27	1.2 ± 27.24
Week 20, n=260, 270	1.6 ± 16.26	0.8 ± 27.96
Week 24, n=260, 268	0.9 ± 18.74	0.9 ± 27.58
Week 28, n=253, 268	-0.4 ± 16.73	1.8 ± 29.09
Week 32, n=254, 268	2.9 ± 29.88	2.0 ± 34.42
Week 36, n=254, 261	1.0 ± 17.45	-0.1 ± 28.89
Week 40, n=250, 266	2.3 ± 22.71	0.6 ± 27.95
Week 44, n=258, 263	5.7 ± 41.87	1.6 ± 29.05
Week 48, n=247, 261	0.7 ± 16.14	1.1 ± 32.35

Notes
[71] - Safety Population
[72] - Safety Population

No statistical analyses for this end point

Secondary: Change from Baseline values for clinical chemistry parameter over time including Week 48: Creatinine clearance

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End point title

Change from Baseline values for clinical chemistry parameter over time including Week 48: Creatinine clearance

End point description

Blood samples were collected for the analysis of clinical chemistry parameter-creatinine clearance. GFR will be estimated by the central laboratory using the CKD-EPI. Baseline value is defined as the last available recorded value up to and including the date of first Maintenance Phase dose of IP. Change from Baseline value is calculated as the value at the post-dose visit minus the Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).

End point type

Secondary

End point timeframe

Baseline (Day 1) and at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44 and 48

End point values	CAB LA + RPV LA (Q4W)	ABC/ DTG/ 3TC
Number of subjects analysed	283 ^[73]	283 ^[74]
Units: mL/min/1.73/m^2
arithmetic mean (standard deviation)
Week 4, n=278, 277	6.9 ± 10.16	-1.2 ± 8.72
Week 8, n=211, 278	10.0 ± 11.83	0.2 ± 9.13
Week 12, n=270, 276	10.7 ± 11.49	0.9 ± 9.83
Week 16, n=254, 269	10.4 ± 11.28	-0.3 ± 10.23
Week 20, n=261, 271	10.9 ± 11.45	0.3 ± 9.90
Week 24, n=261, 268	10.5 ± 11.38	0.2 ± 9.63
Week 28, n=253, 268	10.9 ± 11.90	1.0 ± 9.90
Week 32, n=254, 268	10.6 ± 11.45	1.1 ± 10.05
Week 36, n=254, 262	10.3 ± 11.94	0.2 ± 10.08
Week 40, n=250, 266	10.2 ± 12.57	0.7 ± 9.19
Week 44, n=258, 263	9.8 ± 11.61	1.4 ± 9.88
Week 48, n=247, 261	9.5 ± 11.35	-0.7 ± 10.86

Notes
[73] - Safety Population
[74] - Safety Population

No statistical analyses for this end point

Secondary: Change from Baseline values for fasting lipid panel and glucose overtime including Week 48

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End point title

Change from Baseline values for fasting lipid panel and glucose overtime including Week 48

End point description

Blood samples were collected at Baseline and at Week 48 to assess glucose and fasting lipids which included total cholesterol, high density lipoprotein (HDL)cholesterol, low density lipoprotein (LDL) cholesterol and triglycerides. Only fasting data is presented for glucose and lipids. Baseline value is defined as the last available fasting recorded value up to and including the date of first Maintenance Phase dose of IP. Change from Baseline value is calculated as the value at Week 48 visit (if collected while fasting) minus the Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).

End point type

Secondary

End point timeframe

Baseline (Day 1) and at Week 48

End point values	CAB LA + RPV LA (Q4W)	ABC/ DTG/ 3TC
Number of subjects analysed	283 ^[75]	283 ^[76]
Units: Millimoles per liter
arithmetic mean (standard deviation)
Glucose, Week 48, n=248, 251	0.02 ± 1.220	0.04 ± 0.923
Total Cholesterol, Week 48, n=240, 239	0.09 ± 0.658	0.05 ± 0.607
HDL cholesterol, Week 48, n=240, 239	0.109 ± 0.2587	0.076 ± 0.2478
LDL cholesterol, Week 48, n=238, 237	0.122 ± 0.5807	-0.045 ± 0.5384
Triglycerides, Week 48, n=240, 239	-0.085 ± 0.7167	0.073 ± 0.8361

Notes
[75] - Safety Population
[76] - Safety Population

No statistical analyses for this end point

Secondary: Change from Baseline values in urine albumin/creatinine ratio and urine protein/creatinine ratio over time including Week 48

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End point title

Change from Baseline values in urine albumin/creatinine ratio and urine protein/creatinine ratio over time including Week 48

End point description

Urine biomarker samples were collected for the analysis of urine albumin/creatinine ratio and urine protein/creatinine ratio. Baseline value is defined as the last available recorded value up to and including the date of first Maintenance Phase dose of IP. Change from Baseline value is calculated as the value at the post-dose visit minus the Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).

End point type

Secondary

End point timeframe

Baseline (Day 1) and at Weeks 4, 24 and 48

End point values	CAB LA + RPV LA (Q4W)	ABC/ DTG/ 3TC
Number of subjects analysed	283 ^[77]	283 ^[78]
Units: Grams per mole
arithmetic mean (standard deviation)
Urine albumin/creatinine ratio, Week 4,n=199, 194	0.36 ± 6.714	0.23 ± 4.062
Urine albumin/creatinine ratio, Week 24,n=137, 184	0.30 ± 4.941	1.06 ± 7.186
Urine albumin/creatinine ratio, Week 48,n=181, 184	-0.53 ± 17.469	0.19 ± 3.944
Urine protein/creatinine, Week 4, n=211, 215	-0.16 ± 18.641	0.19 ± 6.439
Urine protein/creatinine, Week 24, n=151, 204	2.23 ± 35.187	1.32 ± 12.171
Urine protein/creatinine, Week 48, n=194, 197	-1.86 ± 21.898	0.26 ± 8.180

Notes
[77] - Safety Population
[78] - Safety Population

No statistical analyses for this end point

Secondary: Change from Baseline values in urine creatinine over time including Week 48

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End point title

Change from Baseline values in urine creatinine over time including Week 48

End point description

Urine biomarker samples were collected for the analysis of urine creatinine. Baseline value is defined as the last available recorded value up to and including the date of first Maintenance Phase dose of IP. Change from Baseline value is calculated as the value at the post-dose visit minus the Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).

End point type

Secondary

End point timeframe

Baseline (Day 1) and at Weeks 4, 24 and 48

End point values	CAB LA + RPV LA (Q4W)	ABC/ DTG/ 3TC
Number of subjects analysed	283 ^[79]	283 ^[80]
Units: Micromoles per liter
arithmetic mean (standard deviation)
Week 4, n=277, 272	-519.5 ± 9558.55	-429.0 ± 9540.31
Week 24, n=193, 258	-597.4 ± 9405.95	-17.1 ± 9575.04
Week 48, n=260, 258	-1359.2 ± 9059.43	-505.4 ± 8873.05

Notes
[79] - Safety Population
[80] - Safety Population

No statistical analyses for this end point

Secondary: Change from Baseline values in urine phosphate over time including Week 48

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End point title

Change from Baseline values in urine phosphate over time including Week 48

End point description

Urine biomarker samples were collected for the analysis of urine phosphate. Baseline value is defined as the last available recorded value up to and including the date of first Maintenance Phase dose of IP. Change from Baseline value is calculated as the value at the post-dose visit minus the Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).

End point type

Secondary

End point timeframe

Baseline (Day 1) and at Weeks 4, 24 and 48

End point values	CAB LA + RPV LA (Q4W)	ABC/ DTG/ 3TC
Number of subjects analysed	283 ^[81]	283 ^[82]
Units: Micromoles per liter
arithmetic mean (standard deviation)
Week 4, n=275, 273	1.842 ± 18.4414	-0.693 ± 18.4830
Week 24, n=192, 260	0.585 ± 19.2777	-0.689 ± 16.9500
Week 48, n=259, 258	0.043 ± 17.3741	0.304 ± 16.7073

Notes
[81] - Safety Population
[82] - Safety Population

No statistical analyses for this end point

Secondary: Change from Baseline values in urine retinol binding protein over time including Week 48

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End point title

Change from Baseline values in urine retinol binding protein over time including Week 48

End point description

Urine biomarker samples were collected for the analysis of urine retinol binding protein. Baseline value is defined as the last available recorded value up to and including the date of first Maintenance Phase dose of IP. Change from Baseline value is calculated as the value at the post-dose visit minus the Baseline value. Only those participants with data available at the specified data points were analyzed.

End point type

Secondary

End point timeframe

Baseline (Day 1) and at Week 48

End point values	CAB LA + RPV LA (Q4W)	ABC/ DTG/ 3TC
Number of subjects analysed	283 ^[83]	283 ^[84]
Units: Nanomoles per liter
arithmetic mean (standard deviation)	-0.33 ± 0.938	-0.24 ± 0.932

Notes
[83] - Safety Population
[84] - Safety Population

No statistical analyses for this end point

Secondary: Change from Baseline values in urine specific gravity over time including Week 48

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End point title

Change from Baseline values in urine specific gravity over time including Week 48

End point description

Urine biomarker samples were collected for the analysis of urine specific gravity. Urine specific gravity is a measure of the concentration of solutes in the urine and provides information on the kidney’s ability to concentrate urine. Baseline value is defined as the last available recorded value up to and including the date of first Maintenance Phase dose of IP. Change from Baseline value is calculated as the value at the post-dose visit minus the Baseline value. The urine specific gravity was measured as the ratio of urine density compared with water density.

End point type

Secondary

End point timeframe

Baseline (Day 1) and at Weeks 4, 24 and 48

End point values	CAB LA + RPV LA (Q4W)	ABC/ DTG/ 3TC
Number of subjects analysed	283	283
Units: Ratio of urine density to water density
arithmetic mean (standard deviation)
Week 4, n=271, 266	-0.0004 ± 0.00837	-0.0005 ± 0.00798
Week 24, n=191, 252	-0.0001 ± 0.00805	-0.0002 ± 0.00825
Week 48, n=255, 252	-0.0009 ± 0.00784	-0.0007 ± 0.00783

No statistical analyses for this end point

Secondary: Change from Baseline values in urine pH over time including Week 48

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End point title

Change from Baseline values in urine pH over time including Week 48

End point description

Urine samples were collected for analysis of urine pH. pH is calculated on a scale of 0 to 14, values on the scale refer to the degree of alkalinity or acidity. A pH of 7 is neutral. A pH of less than 7 is acidic and a pH of greater than 7 is basic. Normal urine has a slightly acidic pH (5.0-6.0). Baseline value is defined as the last available recorded value up to and including the date of first Maintenance Phase dose of IP. Change from Baseline value is calculated as the value at the post-dose visit minus the Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).

End point type

Secondary

End point timeframe

Baseline (Day 1) and at Weeks 4, 24 and 48

End point values	CAB LA + RPV LA (Q4W)	ABC/ DTG/ 3TC
Number of subjects analysed	283 ^[85]	283 ^[86]
Units: pH
arithmetic mean (standard deviation)
Week 4, n=271, 266	0.12 ± 0.833	0.01 ± 0.884
Week 24, n=191, 252	-0.01 ± 0.889	-0.07 ± 0.910
Week 48, n=255, 252	0.01 ± 0.926	-0.10 ± 0.988

Notes
[85] - Safety Population
[86] - Safety Population

No statistical analyses for this end point

Secondary: Number of participants who discontinued or withdrawn due to AEs over time including Week 48

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End point title

Number of participants who discontinued or withdrawn due to AEs over time including Week 48

End point description

An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. All Maintenance Phase adverse events (start date occurring on or after the date of first dose of randomized study treatment) leading to withdrawal have been presented.

End point type

Secondary

End point timeframe

Up to Week 48

End point values	CAB LA + RPV LA (Q4W)	ABC/ DTG/ 3TC
Number of subjects analysed	283 ^[87]	283 ^[88]
Units: Participants	9	4

Notes
[87] - Safety Population
[88] - Safety Population

No statistical analyses for this end point

Secondary: Percentage change from Baseline in fasting lipids overtime including Week 48

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End point title

Percentage change from Baseline in fasting lipids overtime including Week 48

End point description

Blood samples were collected at Baseline and at Week 48 to assess fasting lipids which included total cholesterol, HDL cholesterol, LDL cholesterol and triglycerides. Baseline value is defined as the last available recorded fasting value up to and including the date of first Maintenance Phase dose of IP. Percentage change from baseline is calculated as: value at Week 48 (if collected while fasting) minus Baseline value divided by Baseline value multiplied by 100. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).

End point type

Secondary

End point timeframe

Baseline (Day 1) and at Week 48

End point values	CAB LA + RPV LA (Q4W)	ABC/ DTG/ 3TC
Number of subjects analysed	283 ^[89]	283 ^[90]
Units: Millimoles per liter
arithmetic mean (standard deviation)
Cholesterol, Week 48, Overall, n=240, 239	5.09 ± 15.695	2.32 ± 14.456
HDL cholesterol, Week 48, Overall, n=240, 239	15.448 ± 78.5208	7.361 ± 20.3088
LDL cholesterol, Week 48, Overall, n=238, 237	7.048 ± 29.2139	0.462 ± 23.9648
Triglycerides, Week 48, Overall, n=240, 239	2.633 ± 44.1663	14.252 ± 62.2823

Notes
[89] - Safety Population
[90] - Safety Population

No statistical analyses for this end point

Secondary: Number of participants with phenotypic resistance through Week 48

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End point title

Number of participants with phenotypic resistance through Week 48

End point description

Plasma samples were collected from participants who met confirmed virologic withdrawal criteria.Phenotypic Resistance data for drugs:CAB, DTG,elvitegravir (EVG), raltegravir(RAL),delavirdine(DLV),efavirenz(EFV),etravirine(ETR),nevirapine(NVP),RPV,3TC, ABC,emtricitabine(FTC),tenofovir(TDF),zidovudine(ZDV),stavudine(d4T),didanosine(ddI),atazanavir(ATV),darunavir(DRV),fosamprenavir(FPV),indinavir(IDV),lopinavir(LPV),nelfinavir(NFV),ritonavir(RTV), saquinavir(SQV) and tipranavir (TPV) is presented.Phenotypic resistance, partially sensitive, and Sensitive are based on fold change(FC) value from Monogram as:resistance(FC>clinical higher cutoff/biologic cutoff),partially sensitive (FC=clinical higher cutoff and > clinical lower cutoff),sensitive(FC<=clinical lower cutoff/biologic cutoff). CVF population comprised of participants in ITT-E population who met CVF criteria. Only participants with data available at specified data points were analyzed.

End point type

Secondary

End point timeframe

Week 48

End point values	CAB LA + RPV LA (Q4W)	ABC/ DTG/ 3TC
Number of subjects analysed	3 ^[91]	3 ^[92]
Units: Participants
number (not applicable)
INI, CAB, sensitive	0	3
INI, CAB, partially sensitive	0	0
INI, CAB, resistant	3	0
INI, DTG, sensitive	3	3
INI, DTG, partially sensitive	0	0
INI, DTG, resistant	0	0
INI, EVG, sensitive	0	3
INI, EVG, partially sensitive	0	0
INI, EVG, resistant	3	0
INI, RAL, sensitive	0	3
INI, RAL, partially sensitive	0	0
INI, RAL, resistant	3	0
NNRTI, DLV, sensitive	1	3
NNRTI, DLV, partially sensitive	0	0
NNRTI, DLV, resistant	2	0
NNRTI, EFV, sensitive	1	3
NNRTI, EFV, partially sensitive	0	0
NNRTI, EFV, resistant	2	0
NNRTI, ETR, sensitive	2	3
NNRTI, ETR, partially sensitive	1	0
NNRTI, ETR, resistant	0	0
NNRTI, NVP, sensitive	1	3
NNRTI, NVP, partially sensitive	0	0
NNRTI, NVP, resistant	2	0
NNRTI, RPV, sensitive	1	3
NNRTI, RPV, partially sensitive	0	0
NNRTI, RPV, resistant	2	0
NRTI, 3TC, sensitive	3	3
NRTI, 3TC, partially sensitive	0	0
NRTI, 3TC, resistant	0	0
NRTI, ABC, sensitive	3	3
NRTI, ABC, partially sensitive	0	0
NRTI, ABC, resistant	0	0
NRTI, FTC, sensitive	3	0
NRTI, FTC, partially sensitive	0	0
NRTI, FTC, resistant	0	0
NRTI, TDF, sensitive	1	3
NRTI, TDF, partially sensitive	2	0
NRTI, TDF, resistant	0	0
NRTI, ZDV, sensitive	2	3
NRTI, ZDV, partially sensitive	0	0
NRTI, ZDV, resistant	1	0
NRTI, d4T, sensitive	3	3
NRTI, d4T, partially sensitive	0	0
NRTI, d4T, resistant	0	0
NRTI, ddI, sensitive	3	3
NRTI, ddI, partially sensitive	0	0
NRTI, ddI, resistant	0	0
PI, ATV, sensitive	3	3
PI, ATV, partially sensitive	0	0
PI, ATV, resistant	0	0
PI, DRV, sensitive	3	3
PI, DRV, partially sensitive	0	0
PI, DRV, resistant	0	0
PI, FPV, sensitive	3	3
PI, FPV, partially sensitive	0	0
PI, FPV, resistant	0	0
PI, IDV, sensitive	3	3
PI, IDV, partially sensitive	0	0
PI, IDV, resistant	0	0
PI, LPV, sensitive	3	3
PI, LPV, partially sensitive	0	0
PI, LPV, resistant	0	0
PI, NFV, sensitive	3	3
PI, NFV, partially sensitive	0	0
PI, NFV, resistant	0	0
PI, RTV, sensitive	3	3
PI, RTV, partially sensitive	0	0
PI, RTV, resistant	0	0
PI, SQV, sensitive	3	3
PI, SQV, partially sensitive	0	0
PI, SQV, resistant	0	0
PI, TPV, sensitive	3	3
PI, TPV, partially sensitive	0	0
PI, TPV, resistant	0	0

Notes
[91] - CVF Population
[92] - CVF Population

No statistical analyses for this end point

Secondary: Number of participants with genotypic resistance through Week 48

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End point title

Number of participants with genotypic resistance through Week 48

End point description

Plasma samples were collected and analyzed from participants who met confirmed virologic withdrawal criteria. Genotypic Resistance data for the following drugs: DTG, EVG, RAL, DLV, EFV, ETR, NVP, RPV, 3TC, ABC, FTC, TDF, ZDV, d4T, ddI, ATV, DRV, FPV, IDV, LPV, NFV, RTV, SQV and TPV in participants meeting CVF criteria has been presented. Only those participants with data available at the specified data points were analyzed.

End point type

Secondary

End point timeframe

Week 48

End point values	CAB LA + RPV LA (Q4W)	ABC/ DTG/ 3TC
Number of subjects analysed	3 ^[93]	3 ^[94]
Units: Participants
number (not applicable)
INI, DTG, resistant	0	0
INI, DTG, resistance possible	2	0
INI, DTG, sensitive	1	3
INI, EVG, resistant	2	0
INI, EVG, resistance possible	0	0
INI, EVG, sensitive	1	3
INI, RAL, resistant	2	0
INI, RAL, resistance possible	0	0
INI, RAL, sensitive	1	3
NNRTI, DLV, resistant	0	0
NNRTI, DLV, resistance possible	0	0
NNRTI, DLV, sensitive	3	3
NNRTI, EFV, resistant	0	0
INI, EFV, resistance possible	1	0
NNRTI, EFV, sensitive	2	3
NNRTI, ETR, resistant	0	0
NNRTI, ETR, resistance possible	0	0
NNRTI, ETR, sensitive	3	3
NNRTI, NVP, resistant	0	0
NNRTI, NVP, resistance possible	1	0
NNRTI, NVP, sensitive	2	3
NNRTI, RPV, resistant	3	0
NNRTI, RPV, resistance possible	0	0
NNRTI, RPV, sensitive	0	3
NRTI, 3TC, resistant	0	0
NNRTI, 3TC, resistance possible	0	0
NRTI, 3TC, sensitive	3	3
NRTI, ABC, resistant	0	0
NRTI, ABC, resistance possible	0	0
NRTI, ABC, sensitive	3	3
NRTI, FTC, resistant	0	0
NRTI, FTC, resistance possible	0	0
NRTI, FTC, sensitive	3	3
NRTI, TDF, resistant	0	0
NRTI, TDF, resistance possible	0	0
NRTI, TDF, sensitive	3	3
NRTI, ZDV, resistant	0	0
NRTI, ZDV, resistance possible	0	0
NRTI, ZDV, sensitive	3	3
NRTI, d4T, resistant	0	0
NRTI, d4T, resistance possible	0	0
NRTI, d4T, sensitive	3	3
NRTI, ddI, resistant	0	0
NRTI, ddI, resistance possible	0	0
NRTI, ddI, sensitive	3	3
PI, ATV, resistant	0	0
PI, ATV, resistance possible	0	0
PI, ATV, sensitive	3	3
PI, ATV/r, resistant	0	0
PI, ATV/r, resistance possible	0	0
PI, ATV/r, sensitive	3	3
PI, DRV/r, resistant	0	0
PI, DRV/r, resistance possible	0	0
PI, DRV/r, sensitive	3	3
PI, FPV/r, resistant	0	0
PI, FPV/r, resistance possible	0	0
PI, FPV/r, sensitive	3	3
PI, IDV/r, resistant	0	0
PI, IDV/r, resistance possible	0	0
PI, IDV/r, sensitive	3	3
PI, LPV/r, resistant	0	0
PI, LPV/r, resistance possible	0	0
PI, LPV/r, sensitive	3	3
PI, NFV, resistant	0	0
PI, NFV, resistance possible	0	0
PI, NFV, sensitive	3	3
PI, RTV, resistant	0	0
PI, RTV, resistance possible	0	0
PI, RTV, sensitive	3	3
PI, SQV/r, resistant	0	0
PI, SQV/r, resistance possible	0	0
PI, SQV/r, sensitive	3	3
PI, TPV/r, resistant	0	0
PI, TPV/r, resistance possible	1	0
PI, TPV/r, sensitive	2	3

Notes
[93] - CVF Population
[94] - CVF Population

No statistical analyses for this end point

Secondary: Area under the curve (AUC) for CAB LA

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End point title

Area under the curve (AUC) for CAB LA

End point description

AUC values are Bayesian pharmacokinetic (PK) parameter estimates obtained from a population PK meta-analysis of the data collected from studies 201584 and 201585# NCT02951052. Blood samples from the current study 201584 were collected at indicated time points to analyse concentration in plasma for CAB LA. The PK Population includes all participants who received CAB and / or RPV and undergo PK sampling during the study, and provide CAB and /or RPV plasma concentration data.

End point type

Secondary

End point timeframe

Pre-dose at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48; 1 Week post-dose at Weeks 5, 41, 2 hours post-dose at Weeks 4 and 48

End point values	CAB LA
Number of subjects analysed	278 ^[95]
Units: Hours*micrograms per milliliter
geometric mean (confidence interval 95%)	2517.40 (2439.876 to 2597.394)

Notes
[95] - PK Population

No statistical analyses for this end point

Secondary: Plasma trough concentration (Ctrough) for CAB LA evaluable

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End point title

Plasma trough concentration (Ctrough) for CAB LA evaluable

End point description

Blood samples were collected at indicated time points for PK analysis of CAB LA. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).

End point type

Secondary

End point timeframe

Pre-dose at Weeks 8, 12, 16, 20, 24, 28, 32, 36, 40, 44 and 48

End point values	CAB LA
Number of subjects analysed	278
Units: Microgram per milliliter
geometric mean (confidence interval 95%)
Pre-dose, Week 8, n=250	1.5616 (1.4508 to 1.6808)
Pre-dose, Week 12, n=237	2.0141 (1.8990 to 2.1362)
Pre-dose, Week 16, n=215	2.0960 (1.9740 to 2.2255)
Pre-dose, Week 20, n=233	2.1739 (2.0580 to 2.2963)
Pre-dose, Week 24, n=227	2.3827 (2.2731 to 2.4976)
Pre-dose, Week 28, n=220	2.4683 (2.3421 to 2.6013)
Pre-dose, Week 32, n=219	2.6729 (2.5339 to 2.8196)
Pre-dose, Week 36, n=215	2.8590 (2.7096 to 3.0165)
Pre-dose, Week 40, n=210	2.9378 (2.7872 to 3.0966)
Pre-dose, Week 44, n=217	3.0133 (2.8739 to 3.1595)
Pre-dose, Week 48, n=197	3.1325 (2.9454 to 3.3315)

No statistical analyses for this end point

Secondary: AUC for RPV LA

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End point title

AUC for RPV LA

End point description

AUC values are Bayesian PK parameter estimates obtained from a population PK meta-analysis of the data collected from studies 201584 and 201585# NCT02951052. Blood samples from the current study 201584 were collected at indicated time points to analyse concentration in plasma for RPV LA.

End point type

Secondary

End point timeframe

Pre-dose at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48; 1 Week post-dose at Weeks 5, 41, 2 hours post-dose at Weeks 4 and 48

End point values	RPV LA
Number of subjects analysed	278
Units: Hours*nanograms per milliliter
geometric mean (confidence interval 95%)	63989.13 (61489.692 to 66590.156)

No statistical analyses for this end point

Secondary: Ctrough for RPV LA evaluable

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End point title

Ctrough for RPV LA evaluable

End point description

Blood samples were collected at indicated time points for PK analysis of RPV LA. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).

End point type

Secondary

End point timeframe

Pre-dose at Weeks 8, 12, 16, 20, 24, 28, 32, 36, 40, 44 and 48

End point values	RPV LA
Number of subjects analysed	278
Units: Nanograms per milliliter
geometric mean (confidence interval 95%)
Pre-dose, Week 8, n=251	41.23 (38.74 to 43.88)
Pre-dose, Week 12, n=236	46.86 (43.82 to 50.12)
Pre-dose, Week 16, n=217	50.01 (47.06 to 53.15)
Pre-dose, Week 20, n=233	52.76 (49.79 to 55.91)
Pre-dose, Week 24, n=228	55.56 (52.48 to 58.82)
Pre-dose, Week 28, n=220	59.46 (55.43 to 63.79)
Pre-dose, Week 32, n=220	66.88 (62.95 to 71.05)
Pre-dose, Week 36, n=215	69.09 (64.90 to 73.55)
Pre-dose, Week 40, n=210	75.71 (71.38 to 80.29)
Pre-dose, Week 44, n=216	77.96 (73.87 to 82.28)
Pre-dose, Week 48, n=197	82.38 (77.82 to 87.22)

No statistical analyses for this end point

Secondary: Maximum concentration (Cmax) in plasma for CAB LA evaluable at Week 41

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End point title

Maximum concentration (Cmax) in plasma for CAB LA evaluable at Week 41

End point description

Blood samples will be collected at indicated time points for PK analysis of CAB LA. Only those participants with data available at the specified data points were analyzed.

End point type

Secondary

End point timeframe

Week 41- 1 Week post dose

End point values	CAB LA
Number of subjects analysed	236
Units: Micrograms per milliliter
geometric mean (confidence interval 95%)	4.0334 (3.8488 to 4.2269)

No statistical analyses for this end point

Secondary: Cmax in plasma for RPV LA evaluable at Week 41

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End point title

Cmax in plasma for RPV LA evaluable at Week 41

End point description

Blood samples will be collected at indicated time points for PK analysis of RPV LA. Only those participants with data available at the specified data points were analyzed.

End point type

Secondary

End point timeframe

Week 41- 1 Week post dose

End point values	RPV LA
Number of subjects analysed	236
Units: Nanograms per milliliter
geometric mean (confidence interval 95%)	106.3 (101.03 to 111.28)

No statistical analyses for this end point

Secondary: Number of participants with different demographic parameters for inter-subject variability

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End point title

Number of participants with different demographic parameters for inter-subject variability

End point description

Blood samples were planned to be collected at indicated time points for PK analysis of CAB LA and RPV LA. Demographic parameters including, but not limited to, age, sex, race, body weight, body mass index, and relevant laboratory parameters were planned to be evaluated as potential predictors of inter subject variability for pharmacokinetic parameters. This was an exploratory Outcome Measure. Data will not be analyzed and reported.

End point type

Secondary

End point timeframe

Up to Week 48

End point values	CAB LA	RPV LA
Number of subjects analysed	0 ^[96]	0 ^[97]
Units: Participants
number (not applicable)

Notes
[96] - PK Population
[97] - PK Population

No statistical analyses for this end point

Secondary: Change from Week 5 in dimension scores using perception of injection questionnaire (PIN)-Last Observation Carried Forward (LOCF)

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End point title

Change from Week 5 in dimension scores using perception of injection questionnaire (PIN)-Last Observation Carried Forward (LOCF) ^[98]

End point description

PIN questionnaire explores bother of pain at injection site and injection site reactions (ISR),anxiety before and after injection, willingness to receive HIV injectable treatment and satisfaction with mode of treatment administration of individuals receiving injection and perceptions associated with receiving injections.This measure contains 21 items:pain at injection site, local site reactions, impact on functioning and willingness to pursue injectable treatment outside clinical trial. Scores range from 1 to 5; questions are phrased to ensure that 1:most favorable perception of vaccination, and 5:most unfavorable.Dimension scores include bother from ISR, leg movement, sleep and acceptability.Score of a domain is calculated as mean of all items with domain.Higher scores represent worse perception of injection.LOCF was primary method of analysis.Only those participants with data available at specified data points were analysed. p-value was derived only for acceptance: <0.001.

End point type

Secondary

End point timeframe

Weeks 5 and at Weeks 41 and 48

Notes
[98] - 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: This endpoint is specific to CAB LA + RPV LA (Q4W) arm

End point values	CAB LA + RPV LA (Q4W)
Number of subjects analysed	270 ^[99]
Units: Scores on a scale
arithmetic mean (standard deviation)
Bother of ISRs, Week 41	-0.14 ± 0.551
Bother of ISRs, Week 48	-0.14 ± 0.639
Leg movement, Week 41	-0.58 ± 0.880
Leg movement, Week 48	-0.63 ± 0.964
Sleep, Week 41	-0.57 ± 0.925
Sleep, Week 48	-0.58 ± 1.033
Acceptance, Week 41	-0.36 ± 0.959
Acceptance, Week 48	-0.40 ± 0.943

Notes
[99] - ITT-E Population

No statistical analyses for this end point

Secondary: Percentage of participants with extremely or very acceptable pain and local reaction: acceptability score on PIN questionnaire

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End point title

Percentage of participants with extremely or very acceptable pain and local reaction: acceptability score on PIN questionnaire ^[100]

End point description

PIN questionnaire explores bother of pain at injection site and injection site reactions (ISR),anxiety before and after injection, willingness to receive HIV injectable treatment, following visit and satisfaction with mode of treatment administration of individuals receiving injection and perceptions associated with receiving injections.This measure contains 21 items:pain at injection site, local site reactions, impact on functioning and willingness to pursue injectable treatment outside clinical trial. Scores range from 1 to 5; questions are phrased to ensure that 1:most favorable perception of vaccination, and 5:most unfavorable.Dimension scores include bother from ISR, leg movement, sleep and acceptability.Score of a domain is calculated as mean of all items with domain.Higher scores represent worse perception of injection.LOCF was primary method of analysis.Only those participants with data available at specified data points were analyzed (represented by n= X in category titles).

End point type

Secondary

End point timeframe

Weeks 5, 41 and 48

Notes
[100] - 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: This endpoint is specific to CAB LA + RPV LA (Q4W) arm

End point values	CAB LA + RPV LA (Q4W)
Number of subjects analysed	283 ^[101]
Units: Percentage of participants
number (not applicable)
Local reactions, Week 5, totally acceptable, n=270	47
Local reactions,Week 5, very acceptable, n=270	29
Local reactions, Week 5, moderate, n=270	16
Local reactions, Week 5, little acceptable, n=270	6
Local reactions, Week 5, not at all, n=270	3
Pain, Week 5, totally acceptable, n=270	33
Pain, Week 5, very acceptable, n=270	28
Pain, Week 5, moderate acceptable, n=270	24
Pain, Week 5, little acceptable, n=270	11
Pain, Week 5, not at all acceptable, n=270	5
Local reactions, week 41, totally, n=276	57
Local reactions, Week 41, very acceptable, n=276	29
Local reactions, Week 41, moderate, n=276	11
Local reactions, Week 41, little acceptable, n=276	3
Local reactions, Week 41, not at all, n=276	0.7
Pain, Week 41, totally acceptable, n=276	45
Pain, Week 41, very acceptable, n=276	35
Pain, Week 41, moderate acceptable, n=276	14
Pain, Week 41, little acceptable, n=276	4
Pain, Week 41, not at all acceptable, n=276	1
Local reactions, week 48, totally, n=278	55
Local reactions, Week 48, very acceptable, n=278	31
Local reactions, Week 48, moderate, n=278	11
Local reactions, Week 48, little acceptable, n=278	2
Local reactions, Week 48, not at all, n=278	0.7
Pain, Week 48, totally acceptable, n=278	49
Pain, Week 48, very acceptable, n=278	35
Pain, Week 48, moderate acceptable, n=278	12
Pain, Week 48 little acceptable, n=278	3
Pain, Week 48, not at all acceptable, n=278	0.7

Notes
[101] - ITT-E Population

No statistical analyses for this end point

Secondary: Change from Baseline in life satisfaction (LISAT) using HIV/AIDs-targeted quality of life (HATQoL) questionnaire

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End point title

Change from Baseline in life satisfaction (LISAT) using HIV/AIDs-targeted quality of life (HATQoL) questionnaire

End point description

HATQoL comprises of three dimensions LISAT, medication worries (MEDWO) and disclosure worries (DISWO). For LISAT domain, each question is scored as 1-5, where 5 corresponds to satisfaction ‘all of time’ and 1 as ‘none of time’. Total score for LISAT domain (sum of item scores for questions 1a to 1d) is transformed to a 0-100 scale using formula:[100/(20 minus 4)]*(raw total score for LISAT minus 4). Higher LISAT score, greater satisfaction to life. Transformed dimension score for each domain was summarized and analyzed. LOCF was primary method of analysis. Measure type was mean for adjusted mean and dispersion measure as 95% CI. Baseline value is defined as last available value up to and including date of first Maintenance phase dose of IP. Change from Baseline value is calculated as value at post-dose visit minus Baseline value. Only participants with data available at specified data points were analyzed (represented by n= X in category titles).

End point type

Secondary

End point timeframe

Baseline (Day 1) and at Weeks 24 and 48

End point values	CAB LA + RPV LA (Q4W)	ABC/ DTG/ 3TC
Number of subjects analysed	283 ^[102]	283 ^[103]
Units: Scores on a scale
arithmetic mean (confidence interval 95%)
Week 24, n=252, 253	0.4 (-1.3 to 2.1)	-0.8 (-2.5 to 0.9)
Week 48, n=253, 258	0.9 (-0.8 to 2.6)	0.0 (-1.6 to 1.7)

Notes
[102] - ITT-E Population
[103] - ITT-E Population

Statistical Analysis 1

Comparison groups

CAB LA + RPV LA (Q4W) v ABC/ DTG/ 3TC

Number of subjects included in analysis

566

Analysis specification

Pre-specified

Analysis type

other ^[104]

P-value

= 0.307

Method

ANCOVA

Parameter type

Adjusted difference

Point estimate

1.2

Confidence interval

level

95%

sides

2-sided

lower limit

-1.1

upper limit

3.6

Notes
[104] - Treatment comparison at Week 24 is presented, adjusted for Maintenance Baseline (Day 1) Score, Induction Baseline (Week -20) HIV-1 RNA (<100,000, >=100,000 c/mL), gender at birth, age (<50, >= 50 Years) and race (white, non-white).

Statistical Analysis 2

Comparison groups

CAB LA + RPV LA (Q4W) v ABC/ DTG/ 3TC

Number of subjects included in analysis

566

Analysis specification

Pre-specified

Analysis type

other ^[105]

P-value

= 0.472

Method

ANCOVA

Parameter type

Adjusted difference

Point estimate

0.9

Confidence interval

level

95%

sides

2-sided

lower limit

-1.5

upper limit

3.2

Notes
[105] - Treatment comparison at Week 48 is presented, adjusted for Maintenance Baseline (Day 1) Score, Induction Baseline (Week -20) HIV-1 RNA (<100,000, >=100,000 c/mL), gender at birth, age (<50, >= 50 Years) and race (white, non-white).

Secondary: Change from Baseline in HIV medication, MEDWO using HATQoL

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End point title

Change from Baseline in HIV medication, MEDWO using HATQoL

End point description

HATQoL comprises of three dimensions: LISAT, MEDWO and DISWO. For the MEDWO domain, each question is scored as 1-5, where 5 is associated with medication worry ‘none of the time’ and 1 as ‘all of the time’. Total score for MEDWO domain (sum of item scores for questions 2a to 3e) is transformed to a 0-100 scale using formula: [100/(25 minus 5)]* (raw total score for MEDWO minus 5). Higher MEDWO scores correspond to lower medication worries. Transformed dimension score for each domain was summarized and analyzed. LOCF was used as primary method of analysis. Measure type was considered as mean for adjusted mean and dispersion measure as 95% CI. Baseline value is defined as the last available value up to and including the date of first Maintenance phase dose of IP. Change from Baseline value is calculated as value at post-dose visit minus Baseline value.Only those participants with data available at specified data points were analyzed (represented by n= X in category titles).

End point type

Secondary

End point timeframe

Baseline and at Weeks 24 and 48

End point values	CAB LA + RPV LA (Q4W)	ABC/ DTG/ 3TC
Number of subjects analysed	283 ^[106]	283 ^[107]
Units: Scores on a scale
arithmetic mean (confidence interval 95%)
Week 24, n=252, 253	3.2 (1.6 to 4.7)	1.4 (-0.1 to 3.0)
Week 48, n=253, 258	1.4 (-0.3 to 3.1)	1.3 (-0.4 to 3.0)

Notes
[106] - ITT-E Population
[107] - ITT-E Population

Statistical Analysis 1

Comparison groups

CAB LA + RPV LA (Q4W) v ABC/ DTG/ 3TC

Number of subjects included in analysis

566

Analysis specification

Pre-specified

Analysis type

other ^[108]

P-value

= 0.116

Method

ANCOVA

Parameter type

Adjusted difference

Point estimate

1.8

Confidence interval

level

95%

sides

2-sided

lower limit

-0.4

upper limit

3.9

Notes
[108] - Treatment comparison at Week 24 is presented, adjusted for Maintenance Baseline (Day 1) Score, Induction Baseline (Week -20) HIV-1 RNA (<100,000, >=100,000 c/mL), gender at birth, age (<50, >= 50 Years) and race (white, non-white).

Statistical Analysis 2

Comparison groups

CAB LA + RPV LA (Q4W) v ABC/ DTG/ 3TC

Number of subjects included in analysis

566

Analysis specification

Pre-specified

Analysis type

other ^[109]

P-value

= 0.944

Method

ANCOVA

Parameter type

Adjusted difference

Point estimate

0.1

Confidence interval

level

95%

sides

2-sided

lower limit

-2.3

upper limit

2.5

Notes
[109] - Treatment comparison at Week 48 is presented, adjusted for Maintenance Baseline (Day 1) Score, Induction Baseline (Week -20) HIV-1 RNA (<100,000, >=100,000 c/mL), gender at birth, age (<50, >= 50 Years) and race (white, non-white).

Secondary: Change from Baseline in DISWO using HATQoL

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End point title

Change from Baseline in DISWO using HATQoL

End point description

HATQoL comprises of three dimensions: LISAT, MEDWO and DISWO. For the DISWO domain, each question is scored as 1-5, where 5 is associated with disclosure worry ‘none of the time’ and 1 as ‘all of the time’. Total score for DISWO domain (sum of item scores for questions 3a to 3e) is transformed to a 0-100 scale using formula: [100/(25 minus 5)]* (raw total score for DISWO minus 5). Higher DISWO total scores correspond to lower disclosure worries. Transformed dimension score for each domain was summarized and analyzed. LOCF was used as primary method of analysis. Measure type was considered as mean for adjusted mean and dispersion measure as 95% CI. Baseline value is defined as last available value up to and including date of first Maintenance phase dose of IP. Change from Baseline value is calculated as value at post-dose visit minus Baseline value.Only those participants with data available at specified data points were analyzed (represented by n= X in category titles).

End point type

Secondary

End point timeframe

Baseline and at Weeks 24 and 48

End point values	CAB LA + RPV LA (Q4W)	ABC/ DTG/ 3TC
Number of subjects analysed	283 ^[110]	283 ^[111]
Units: Scores on a scale
arithmetic mean (confidence interval 95%)
Week 24, n=252, 253	-0.8 (-3.9 to 2.3)	0.5 (-2.6 to 3.6)
Week 48, n=253, 258	-3.6 (-6.6 to -0.6)	1.1 (-1.9 to 4.0)

Notes
[110] - ITT-E Population
[111] - ITT-E Population

Statistical Analysis 1

Comparison groups

CAB LA + RPV LA (Q4W) v ABC/ DTG/ 3TC

Number of subjects included in analysis

566

Analysis specification

Pre-specified

Analysis type

other ^[112]

P-value

= 0.552

Method

ANCOVA

Parameter type

Adjusted difference

Point estimate

-1.3

Confidence interval

level

95%

sides

2-sided

lower limit

-5.7

upper limit

Notes
[112] - Treatment comparison at Week 24 is presented, adjusted for Maintenance Baseline (Day 1) Score, Induction Baseline (Week -20) HIV-1 RNA (<100,000, >=100,000 c/mL), gender at birth, age (<50, >= 50 Years) and race (white, non-white).

Statistical Analysis 2

Comparison groups

CAB LA + RPV LA (Q4W) v ABC/ DTG/ 3TC

Number of subjects included in analysis

566

Analysis specification

Pre-specified

Analysis type

other ^[113]

P-value

= 0.033

Method

ANCOVA

Parameter type

Adjusted difference

Point estimate

-4.6

Confidence interval

level

95%

sides

2-sided

lower limit

-8.9

upper limit

-0.4

Notes
[113] - Treatment comparison at Week 48 is presented, adjusted for Maintenance Baseline (Day 1) Score, Induction Baseline (Week -20) HIV-1 RNA (<100,000, >=100,000 c/mL), gender at birth, age (<50, >= 50 Years) and race (white, non-white).

Secondary: Change from Baseline in health status using 12-item short form survey (SF-12)

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End point title

Change from Baseline in health status using 12-item short form survey (SF-12)

End point description

The SF-12 questionnaire consists of 7 questions which measures degree of general health status and mental health distress. Each question is scored 0-5, except for question 2 scored 0-3. HRQoL using SF-12 for physical component summary (PCS) and mental component summary (MCS) were assessed for two treatment groups.Missing component scores was imputed using LOCF.PCS/MCS are calculated using computer software purchased from QualityMetric (http://www.qualitymetric.com).The higher the score, the better will be the health status.Measure type was considered as mean for adjusted mean and dispersion measure as 95% CI. Baseline value is defined as the last available recorded value up to and including the date of first Maintenance phase dose of IP. Change from Baseline value is calculated as value at post-dose visit minus Baseline value.Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).

End point type

Secondary

End point timeframe

Baseline and at Weeks 24 and 48

End point values	CAB LA + RPV LA (Q4W)	ABC/ DTG/ 3TC
Number of subjects analysed	283 ^[114]	283 ^[115]
Units: Scores on a scale
arithmetic mean (confidence interval 95%)
MCS, Week 24, n=251, 253	-0.045 (-0.963 to 0.874)	-1.066 (-1.980 to -0.151)
MCS, Week 48, n=252, 258	-0.013 (-0.973 to 0.947)	-1.116 (-2.065 to -0.167)
PCS, Week 24, n=251, 253	-0.019 (-0.568 to 0.531)	-0.201 (-0.748 to 0.347)
PCS, Week 48, n=252, 258	-0.294 (-0.881 to 0.293)	-0.126 (-0.706 to 0.455)

Notes
[114] - ITT-E Population
[115] - ITT-E Population

Statistical Analysis 1

Comparison groups

CAB LA + RPV LA (Q4W) v ABC/ DTG/ 3TC

Number of subjects included in analysis

566

Analysis specification

Pre-specified

Analysis type

other ^[116]

P-value

= 0.122

Method

ANCOVA

Parameter type

Adjusted difference

Point estimate

1.021

Confidence interval

level

95%

sides

2-sided

lower limit

-0.275

upper limit

2.318

Notes
[116] - Treatment comparison of SF-12 MCS at Week 24 is presented, adjusted for Maintenance Baseline (Day 1) Score, Induction Baseline (Week -20) HIV-1 RNA (<100,000, >=100,000 c/mL), gender at birth, age (<50, >= 50 Years) and race (white, non-white).

Statistical Analysis 2

Comparison groups

CAB LA + RPV LA (Q4W) v ABC/ DTG/ 3TC

Number of subjects included in analysis

566

Analysis specification

Pre-specified

Analysis type

other ^[117]

P-value

= 0.109

Method

ANCOVA

Parameter type

Adjusted difference

Point estimate

1.103

Confidence interval

level

95%

sides

2-sided

lower limit

-0.248

upper limit

2.453

Notes
[117] - Treatment comparison of SF-12 MCS at Week 48 is presented, adjusted for Maintenance Baseline (Day 1) Score, Induction Baseline (Week -20) HIV-1 RNA (<100,000, >=100,000 c/mL), gender at birth, age (<50, >= 50 Years) and race (white, non-white).

Statistical Analysis 3

Comparison groups

CAB LA + RPV LA (Q4W) v ABC/ DTG/ 3TC

Number of subjects included in analysis

566

Analysis specification

Pre-specified

Analysis type

other ^[118]

P-value

= 0.645

Method

ANCOVA

Parameter type

Adjusted difference

Point estimate

0.182

Confidence interval

level

95%

sides

2-sided

lower limit

-0.594

upper limit

0.958

Notes
[118] - Treatment comparison of SF-12 PCS at Week 24 is presented, adjusted for Maintenance Baseline (Day 1) Score, Induction Baseline (Week -20) HIV-1 RNA (<100,000, >=100,000 c/mL), gender at birth, age (<50, >= 50 Years) and race (white, non-white).

Statistical Analysis 4

Comparison groups

CAB LA + RPV LA (Q4W) v ABC/ DTG/ 3TC

Number of subjects included in analysis

566

Analysis specification

Pre-specified

Analysis type

other ^[119]

P-value

= 0.689

Method

ANCOVA

Parameter type

Adjusted difference

Point estimate

-0.169

Confidence interval

level

95%

sides

2-sided

lower limit

-0.994

upper limit

0.657

Notes
[119] - Treatment comparison of SF-12 PCS at Week 48 is presented, adjusted for Maintenance Baseline (Day 1) Score, Induction Baseline (Week -20) HIV-1 RNA (<100,000, >=100,000 c/mL), gender at birth, age (<50, >= 50 Years) and race (white, non-white).

Secondary: Change from Baseline in total treatment satisfaction using HIV treatment satisfaction questionnaire (HIVTSQs) at Weeks 4b, 24 and 44

Top of page

End point title

Change from Baseline in total treatment satisfaction using HIV treatment satisfaction questionnaire (HIVTSQs) at Weeks 4b, 24 and 44

End point description

HIVTSQs (status version) total treatment satisfaction score is computed with 1-11 items. Items 1-11 are summed to produce score with possible range of 0 to 66. Higher the score, greater improvement in satisfaction with treatment; lower score, greater the deterioration in satisfaction with treatment. A score of 0 represents no change. LOCF was primary method of analysis. Baseline value is defined as the last available value up to and including the date of first Maintenance phase dose of IP. Change from Baseline value is calculated as value at post-dose visit minus Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). Adjusted mean and 95% CI of adjusted mean values has been presented.

End point type

Secondary

End point timeframe

Baseline and at Weeks 4b, 24 and 44

End point values	CAB LA + RPV LA (Q4W)	ABC/ DTG/ 3TC
Number of subjects analysed	283 ^[120]	283 ^[121]
Units: Scores on a scale
arithmetic mean (confidence interval 95%)
Week 4b, n=257, 0	0.2 (-0.5 to 1.0)	99999 (99999 to 99999)
Week 24, n=257, 253	1.6 (0.5 to 2.5)	-0.5 (-1.4 to 0.3)
Week 44, n=257, 256	1.3 (0.5 to 2.1)	0.5 (-0.3 to 1.4)

Notes
[120] - ITT-E Population. 99999 indicates data not available due to insufficient participants
[121] - ITT-E Population. 99999 indicates data not available due to insufficient participants

Statistical Analysis 1

Comparison groups

CAB LA + RPV LA (Q4W) v ABC/ DTG/ 3TC

Number of subjects included in analysis

566

Analysis specification

Pre-specified

Analysis type

other ^[122]

P-value

< 0.001

Method

ANCOVA

Parameter type

Adjusted difference

Point estimate

2.2

Confidence interval

level

95%

sides

2-sided

lower limit

upper limit

3.4

Notes
[122] - Treatment comparison at Week 24 is presented, adjusted for Maintenance Baseline (Day 1) Score, Induction Baseline (Week -20) HIV-1 RNA (<100,000, >=100,000 c/mL), gender at birth, age (<50, >= 50 Years) and race (white, non-white).

Statistical Analysis 2

Comparison groups

CAB LA + RPV LA (Q4W) v ABC/ DTG/ 3TC

Number of subjects included in analysis

566

Analysis specification

Pre-specified

Analysis type

other ^[123]

P-value

= 0.217

Method

ANCOVA

Parameter type

Adjusted difference

Point estimate

0.7

Confidence interval

level

95%

sides

2-sided

lower limit

-0.4

upper limit

1.9

Notes
[123] - Treatment comparison at Week 44 is presented, adjusted for Maintenance Baseline (Day 1) Score, Induction Baseline (Week -20) HIV-1 RNA (<100,000, >=100,000 c/mL), gender at birth, age (<50, >= 50 Years) and race (white, non-white).

Secondary: Change in treatment satisfaction over time using HIVTSQc at Week 48

Top of page

End point title

Change in treatment satisfaction over time using HIVTSQc at Week 48

End point description

HIVTSQc (change version) total treatment satisfaction score is computed with 1-11 items. Items 1-11 are summed to produce score with possible range:-33 to 33. Higher scores represent greater improvement in treatment satisfaction compared to satisfaction with treatment received during the induction phase; lower scores representedeterioration in satisfaction with treatment. A score of 0 represents no change. LOCF was primary method of analysis. Baseline value is defined as the last available value up to and including the date of first Maintenance phase dose of IP. Change from Baseline value is calculated as value at post-dose visit minus Baseline value. Only those participants with data available at the specified data points were analyzed.

End point type

Secondary

End point timeframe

Week 48

End point values	CAB LA + RPV LA (Q4W)	ABC/ DTG/ 3TC
Number of subjects analysed	263 ^[124]	266 ^[125]
Units: Scores on a scale
arithmetic mean (standard error)	29.6 ± 0.49	25.5 ± 0.48

Notes
[124] - ITT-E Population.
[125] - ITT-E Population.

Statistical Analysis 1

Comparison groups

CAB LA + RPV LA (Q4W) v ABC/ DTG/ 3TC

Number of subjects included in analysis

529

Analysis specification

Pre-specified

Analysis type

other ^[126]

P-value

< 0.001

Method

ANOVA

Parameter type

Difference

Point estimate

4.1

Confidence interval

level

95%

sides

2-sided

lower limit

2.8

upper limit

5.5

Notes
[126] - Treatment comparison of HIVTSQc-total treatment satisfaction score at Week 48 is presented, adjusted for Induction Baseline (Week -20) HIV-1 RNA (<100,000, >=100,000 c/mL), gender at birth, age (<50, >= 50 Years) and race (white, non-white).

Secondary: Change from Baseline in individual item scores of HIVTSQs at Weeks 4b, 24 and 44

Top of page

End point title

Change from Baseline in individual item scores of HIVTSQs at Weeks 4b, 24 and 44

End point description

HIVTSQs (status version) is a 12 item questionnaire. The individual item scores are ratedas 6 (very satisfied, convenient, flexible, etc.) to 0 (very dissatisfied, inconvenient, inflexible, etc.). Higher scores represent greater treatment satisfaction as compared to the past few weeks. LOCF was used as primary method of analysis. Baseline value is defined as the last available value up to and including the date of first Maintenance phase dose of IP. Change from Baseline value is calculated as the value at the post-dose visit minus the Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).

End point type

Secondary

End point timeframe

Baseline and at Weeks 4b, 24 and 44

End point values	CAB LA + RPV LA (Q4W)	ABC/ DTG/ 3TC
Number of subjects analysed	283 ^[127]	283 ^[128]
Units: Scores on a scale
arithmetic mean (standard deviation)
Item 1; Week 4b, n=257, 0	-0.0 ± 0.91	99999 ± 99999
Item 1; Week 24, n=257, 255	0.1 ± 0.96	-0.0 ± 0.95
Item 1; Week 44, n=257, 258	0.0 ± 1.02	0.0 ± 0.93
Item 2; Week 4b, n=257, 0	0.0 ± 0.61	99999 ± 99999
Item 2; Week 24, n=257, 255	-0.0 ± 0.62	-0.0 ± 0.87
Item 2; Week 44, n=257, 258	-0.1 ± 0.61	0.1 ± 0.62
Item 3; Week 4b, n=257, 0	0.2 ± 1.02	99999 ± 99999
Item 3; Week 24, n=257, 255	-0.1 ± 1.21	-0.0 ± 1.16
Item 3; Week 44, n=257, 258	-0.0 ± 1.35	0.1 ± 1.22
Item 4; Week 4b, n=257, 0	0.1 ± 1.02	99999 ± 99999
Item 4; Week 24, n=257, 255	0.1 ± 1.03	-0.0 ± 1.14
Item 4; Week 44, n=257, 258	0.0 ± 1.08	0.1 ± 1.10
Item 5; Week 4b, n=257, 0	0.1 ± 0.98	99999 ± 99999
Item 5; Week 24, n=257, 255	0.4 ± 1.22	-0.1 ± 1.05
Item 5; Week 44, n=257, 258	0.3 ± 1.28	0.0 ± 1.06
Item 6; Week 4b, n=257, 0	0.1 ± 1.40	99999 ± 99999
Item 6; Week 24, n=257, 255	0.3 ± 1.47	-0.1 ± 1.63
Item 6; Week 44, n=257, 258	0.3 ± 1.70	0.2 ± 1.48
Item 7; Week 4b, n=257, 0	0.0 ± 0.83	99999 ± 99999
Item 7; Week 24, n=257, 255	0.0 ± 0.79	0.0 ± 1.02
Item 7; Week 44, n=257, 258	0.1 ± 0.85	0.1 ± 0.95
Item 8; Week 4b, n=257, 0	-0.0 ± 1.06	99999 ± 99999
Item 8; Week 24, n=257, 255	0.2 ± 1.22	-0.0 ± 1.11
Item 8; Week 44, n=257, 258	0.2 ± 1.27	0.1 ± 1.16
Item 9; Week 4b, n=257, 0	-0.1 ± 0.85	99999 ± 99999
Item 9; Week 24, n=257, 255	0.0 ± 0.78	-0.1 ± 1.11
Item 9; Week 44, n=257, 258	0.0 ± 0.85	0.0 ± 1.01
Item 10; Week 4b, n=257, 0	-0.1 ± 1.16	99999 ± 99999
Item 10; Week 24, n=257, 256	0.4 ± 1.28	-0.1 ± 1.35
Item 10; Week 44, n=257, 259	0.4 ± 1.33	-0.0 ± 1.20
Item 11; Week 4b, n=257, 0	-0.0 ± 1.02	99999 ± 99999
Item 11; Week 24, n=257, 255	0.2 ± 1.18	-0.1 ± 0.99
Item 11; Week 44, n=257, 258	0.1 ± 1.18	0.0 ± 0.97
Item 12; Week 4b, n=257, 0	-0.0 ± 0.99	99999 ± 99999
Item 12; Week 24, n=257, 255	-0.4 ± 1.26	0.1 ± 1.19
Item 12; Week 44, n=257, 258	-0.5 ± 1.20	0.1 ± 1.29

Notes
[127] - ITT-E Population. 99999 indicates data not available due to insufficient participants
[128] - ITT-E Population. 99999 indicates data not available due to insufficient participants

No statistical analyses for this end point

Secondary: Change from Baseline in treatment acceptance at Weeks 8, 24 and 48 using “General acceptance” dimension of the Chronic Treatment Acceptance (ACCEPT) questionnaire

Top of page

End point title

Change from Baseline in treatment acceptance at Weeks 8, 24 and 48 using “General acceptance” dimension of the Chronic Treatment Acceptance (ACCEPT) questionnaire

End point description

ACCEPT questionnaire is generic medication acceptance measure assessing how participants weigh advantages and disadvantages of long-term medication. It consists 25 items, capturing six dimensions. 3 questions focusing on general acceptance of study medication were analyzed. Items scores are rated as 1-5 :1-totally disagree,2-somewhat disagree,3-somewhat agree,4-totally agree and 5-I don’t know. Acceptance domain score (ranging from 0 to 100) is calculated using following formula:100*(mean of recoded items in dimension minus 1) divided by 2.LOCF was primary method of analysis. Measure type is mean for adjusted mean and dispersion measure: 95% CI. Baseline value is defined as the last available value up to and including the date of first Maintenance phase dose of IP. Change from Baseline value is calculated as value at post-dose visit minus Baseline value. Only those participants with data available at specified data points were analyzed (represented by n= X in category titles).

End point type

Secondary

End point timeframe

Baseline and at Weeks 8, 24 and 48

End point values	CAB LA + RPV LA (Q4W)	ABC/ DTG/ 3TC
Number of subjects analysed	283 ^[129]	283 ^[130]
Units: Scores on a scale
arithmetic mean (confidence interval 95%)
Week 8, n=253, 256	3.3 (0.8 to 5.8)	1.2 (-1.3 to 3.6)
Week 24, 255, 261	3.7 (1.1 to 6.4)	1.1 (-1.5 to 3.7)
Week 48, n=255, 262	3.0 (0.4 to 5.6)	0.8 (-1.7 to 3.4)

Notes
[129] - ITT-E Population
[130] - ITT-E Population

Statistical Analysis 1

Comparison groups

CAB LA + RPV LA (Q4W) v ABC/ DTG/ 3TC

Number of subjects included in analysis

566

Analysis specification

Pre-specified

Analysis type

other ^[131]

P-value

= 0.232

Method

ANCOVA

Parameter type

Adjusted difference

Point estimate

2.2

Confidence interval

level

95%

sides

2-sided

lower limit

-1.4

upper limit

5.7

Notes
[131] - Treatment comparison at Week 8 is presented, adjusted for Maintenance Baseline (Day 1) Score, Induction Baseline (Week -20) HIV-1 RNA (<100,000, >=100,000 c/mL), gender at birth, age (<50, >= 50 Years) and race (white, non-white).

Statistical Analysis 2

Comparison groups

CAB LA + RPV LA (Q4W) v ABC/ DTG/ 3TC

Number of subjects included in analysis

566

Analysis specification

Pre-specified

Analysis type

other ^[132]

P-value

= 0.154

Method

ANCOVA

Parameter type

Adjusted difference

Point estimate

2.7

Confidence interval

level

95%

sides

2-sided

lower limit

-1

upper limit

6.4

Notes
[132] - Treatment comparison Week 24 is presented, adjusted for Maintenance Baseline (Day 1) Score, Induction Baseline (Week -20) HIV-1 RNA (<100,000, >=100,000 c/mL), gender at birth, age (<50, >= 50 Years) and race (white, non-white).

Statistical Analysis 3

Comparison groups

CAB LA + RPV LA (Q4W) v ABC/ DTG/ 3TC

Number of subjects included in analysis

566

Analysis specification

Pre-specified

Analysis type

other ^[133]

P-value

= 0.236

Method

ANCOVA

Parameter type

Adjusted difference

Point estimate

2.2

Confidence interval

level

95%

sides

2-sided

lower limit

-1.4

upper limit

5.8

Notes
[133] - Treatment comparison at Week 48 is presented, adjusted for Maintenance Baseline (Day 1) Score, Induction Baseline (Week -20) HIV-1 RNA (<100,000, >=100,000 c/mL), gender at birth, age (<50, >= 50 Years) and race (white, non-white).

Secondary: Change from 4b in tolerability of injection at Weeks 5, 40 and 41 using numeric rating scale (NRS) within CAB LA+RPV LA arm

Top of page

End point title

Change from 4b in tolerability of injection at Weeks 5, 40 and 41 using numeric rating scale (NRS) within CAB LA+RPV LA arm ^[134]

End point description

The NRS questionnaire is used to assess the tolerability of injections in CAB LA+RPV LA arm only. The questionnaire consists of one single question and will assess maximum level of pain experienced with the most recent injections ranking from no pain (0) to extreme pain (10). Missing scores was imputed using LOCF. Only those participants with data available at the specified data points were analyzed.

End point type

Secondary

End point timeframe

Weeks 4b, 5, 40 and 41

Notes
[134] - 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: This endpoint is specific to CAB LA + RPV LA (Q4W) arm

End point values	CAB LA + RPV LA (Q4W)
Number of subjects analysed	263 ^[135]
Units: Scores on a scale
arithmetic mean (standard deviation)
Week 5	1.8 ± 2.78
Week 40	0.8 ± 2.72
Week 41	0.4 ± 2.69

Notes
[135] - ITT-E Population

No statistical analyses for this end point

Adverse events

Top of page

Timeframe for reporting adverse events

Non-serious AEs and SAEs were collected up to an average of 59 weeks

Adverse event reporting additional description

AEs and SAEs were collected in Safety population.

Assessment type

Systematic

Dictionary name

MedDRA

Dictionary version

21.0

Reporting group title

ABC/ DTG/ 3TC

Reporting group description

Reporting group title

CAB LA+RPV LA (Q4W)

Reporting group description

Serious adverse events	ABC/ DTG/ 3TC	CAB LA+RPV LA (Q4W)
Total subjects affected by serious adverse events
subjects affected / exposed	12 / 283 (4.24%)	18 / 283 (6.36%)
number of deaths (all causes)	0	0
number of deaths resulting from adverse events
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Anogenital warts
subjects affected / exposed	1 / 283 (0.35%)	1 / 283 (0.35%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Adenocarcinoma of colon
subjects affected / exposed	0 / 283 (0.00%)	1 / 283 (0.35%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Breast cancer
subjects affected / exposed	1 / 283 (0.35%)	0 / 283 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Kaposi's sarcoma
subjects affected / exposed	1 / 283 (0.35%)	0 / 283 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Investigations
Weight decreased
subjects affected / exposed	0 / 283 (0.00%)	1 / 283 (0.35%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Injury, poisoning and procedural complications
Laceration
subjects affected / exposed	0 / 283 (0.00%)	1 / 283 (0.35%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Road traffic accident
subjects affected / exposed	1 / 283 (0.35%)	0 / 283 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Tibia fracture
subjects affected / exposed	1 / 283 (0.35%)	0 / 283 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Vascular disorders
Peripheral artery thrombosis
subjects affected / exposed	0 / 283 (0.00%)	1 / 283 (0.35%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Peripheral ischaemia
subjects affected / exposed	0 / 283 (0.00%)	1 / 283 (0.35%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
General disorders and administration site conditions
Pyrexia
subjects affected / exposed	0 / 283 (0.00%)	1 / 283 (0.35%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Systemic inflammatory response syndrome
subjects affected / exposed	1 / 283 (0.35%)	0 / 283 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Gastrointestinal disorders
Anal fistula
subjects affected / exposed	0 / 283 (0.00%)	1 / 283 (0.35%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Colitis
subjects affected / exposed	0 / 283 (0.00%)	1 / 283 (0.35%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Enterocolitis
subjects affected / exposed	0 / 283 (0.00%)	1 / 283 (0.35%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Large intestine perforation
subjects affected / exposed	1 / 283 (0.35%)	0 / 283 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Rectal fissure
subjects affected / exposed	1 / 283 (0.35%)	0 / 283 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Umbilical hernia
subjects affected / exposed	0 / 283 (0.00%)	1 / 283 (0.35%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Reproductive system and breast disorders
Priapism
subjects affected / exposed	0 / 283 (0.00%)	1 / 283 (0.35%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Hepatobiliary disorders
Bile duct stone
subjects affected / exposed	0 / 283 (0.00%)	1 / 283 (0.35%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Cholecystitis
subjects affected / exposed	0 / 283 (0.00%)	1 / 283 (0.35%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Hydrocholecystis
subjects affected / exposed	0 / 283 (0.00%)	1 / 283 (0.35%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Psychiatric disorders
Drug abuse
subjects affected / exposed	1 / 283 (0.35%)	0 / 283 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Suicide attempt
subjects affected / exposed	1 / 283 (0.35%)	0 / 283 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Musculoskeletal and connective tissue disorders
Arthritis
subjects affected / exposed	0 / 283 (0.00%)	1 / 283 (0.35%)
occurrences causally related to treatment / all	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Infections and infestations
Hepatitis A
subjects affected / exposed	1 / 283 (0.35%)	3 / 283 (1.06%)
occurrences causally related to treatment / all	0 / 1	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Anal abscess
subjects affected / exposed	1 / 283 (0.35%)	0 / 283 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Bronchitis pneumococcal
subjects affected / exposed	1 / 283 (0.35%)	0 / 283 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Gastroenteritis
subjects affected / exposed	1 / 283 (0.35%)	0 / 283 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Pyelonephritis
subjects affected / exposed	0 / 283 (0.00%)	1 / 283 (0.35%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Viral infection
subjects affected / exposed	1 / 283 (0.35%)	0 / 283 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Metabolism and nutrition disorders
Diabetic ketoacidosis
subjects affected / exposed	0 / 283 (0.00%)	1 / 283 (0.35%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0

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

Non-serious adverse events	ABC/ DTG/ 3TC	CAB LA+RPV LA (Q4W)
Total subjects affected by non serious adverse events
subjects affected / exposed	138 / 283 (48.76%)	252 / 283 (89.05%)
Nervous system disorders
Headache
subjects affected / exposed	21 / 283 (7.42%)	39 / 283 (13.78%)
occurrences all number	24	48
Dizziness
subjects affected / exposed	3 / 283 (1.06%)	15 / 283 (5.30%)
occurrences all number	3	17
General disorders and administration site conditions
Injection site pain
subjects affected / exposed	0 / 283 (0.00%)	227 / 283 (80.21%)
occurrences all number	0	1879
Injection site nodule
subjects affected / exposed	0 / 283 (0.00%)	44 / 283 (15.55%)
occurrences all number	0	86
Injection site induration
subjects affected / exposed	0 / 283 (0.00%)	38 / 283 (13.43%)
occurrences all number	0	82
Pyrexia
subjects affected / exposed	4 / 283 (1.41%)	21 / 283 (7.42%)
occurrences all number	4	33
Injection site swelling
subjects affected / exposed	0 / 283 (0.00%)	23 / 283 (8.13%)
occurrences all number	0	38
Injection site pruritus
subjects affected / exposed	0 / 283 (0.00%)	16 / 283 (5.65%)
occurrences all number	0	25
Gastrointestinal disorders
Diarrhoea
subjects affected / exposed	25 / 283 (8.83%)	32 / 283 (11.31%)
occurrences all number	30	40
Nausea
subjects affected / exposed	11 / 283 (3.89%)	16 / 283 (5.65%)
occurrences all number	12	17
Haemorrhoids
subjects affected / exposed	3 / 283 (1.06%)	16 / 283 (5.65%)
occurrences all number	4	18
Musculoskeletal and connective tissue disorders
Back pain
subjects affected / exposed	13 / 283 (4.59%)	22 / 283 (7.77%)
occurrences all number	14	26
Infections and infestations
Nasopharyngitis
subjects affected / exposed	48 / 283 (16.96%)	56 / 283 (19.79%)
occurrences all number	70	92
Upper respiratory tract infection
subjects affected / exposed	28 / 283 (9.89%)	38 / 283 (13.43%)
occurrences all number	35	50
Influenza
subjects affected / exposed	20 / 283 (7.07%)	25 / 283 (8.83%)
occurrences all number	22	27
Gastroenteritis
subjects affected / exposed	10 / 283 (3.53%)	15 / 283 (5.30%)
occurrences all number	10	18
Pharyngitis
subjects affected / exposed	9 / 283 (3.18%)	15 / 283 (5.30%)
occurrences all number	9	16
Metabolism and nutrition disorders
Vitamin D deficiency
subjects affected / exposed	13 / 283 (4.59%)	23 / 283 (8.13%)
occurrences all number	13	23

More information

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Were there any global substantial amendments to the protocol? Yes

13 Dec 2016

Amendment No.1: New Medical Monitor contact information; added lipid objective and endpoint to table in Synopsis; PRO assessments and timing clarification; provision of CAB+RPV LA until available in public/private sectors; allowed use of local labs for eligibility in exceptional circumstances; updated Time & Events Table; timing of ABC/DTG/3TC on the Day 1; continued use of contraception for at least 52 weeks after the last injection; revised text regarding provision of ‘bridging’ supply; CAB+RPV exposure may persist for more than 1 year after injections; edits to prohibited medication information; indicated drugs that cause TdP should be used with caution with RPV; background NRTI is not IP and accountability not required; film coat color for DTG changed from white to yellow; removed “protect from light” (for Triumeq and Tivicay); collection of device details for IM dosing in eCRF; additional information added regarding randomization schedule; added text stating investigator must discuss long-term study commitment with potential participants; added statement regarding serofast Screening RPR results; allowed serum pregnancy testing where required locally (e.g. when urine testing is not available); added option for PRO assessments to be collected on paper instrument if needed; removed information requiring collection of pregnancy information for female partners of male study participants; other minor corrections (e.g., typos, links, etc).

19 Jul 2017

Amendment No.2: Modified text to allow dose reduction for participants who have a decline in creatinine clearance to <50 mL/min during the Induction Phase; clarify that for participants not eligible to continue into the Maintenance Phase, only samples with HIV-1 RNA > 400 c/mL will be sent for resistance testing; add mitigation for electrocardiogram (ECG) pad removal; clarify +- 3 day window is for all oral dosing (both Induction and Maintenance Phase); add "LA Arm" back to columns for Week 68, 76, 84, 92 on Time and Events Schedule (hidden when column was narrowed); clarify Week 104b visit is specific to those participants transitioning from oral IP to CAB LA + RPV LA; clarification added to footnote ‘p’ that genetics sample can be collected at any visit after signing informed consent, but Week [-20] preferred; correct footnote on Week 5 visit to reflect footnote 't'; add footnote 'y' back to Time and Events column for Withdrawal Visit (for Induction Phase); add clarification to Time and Events column that Injection Site Reaction (ISR) assessments are only conducted for subjects receiving injections. Administrative typographical errors corrected (e.g. clarification provided regarding genetics sample taken after participants are enrolled into the study [vs when participants are randomized]), and investigator brochure (IB) references updated, references added.

25 Jun 2018

Amendment No.3: Changes for Amendment 3 were primarily made to the protocol to manage and mitigate risks following identification of a potential safety issue related to neural tube defect in infants born to women with exposure to DTG at the time of conception. - A Risk Assessment table was added to include language regarding risk and mitigation of neural tube defects seen with DTG. - The withdrawal criteria were updated to include a reminder that females of reproductive potential who change their minds and desire to be pregnant should also be withdrawn from the study. - The Time and Events table was updated to include a reminder for investigators to check at every visit that females of reproductive potential are avoiding pregnancy. Additionally, clarifications were provided for the following: - the DTG IB should be referenced for additional risks, safety information, drug interactions, etc.; - ‘suspected’ was added to the text prior to the bulleted definition of suspected virologic failure; - specific storage conditions were removed from the protocol for IP, and a statement added to store according to product label; - insulin was removed from the section regarding clinical assessments performed during the study; - timeframe for pregnancy reporting and follow-up were updated to 24 hours to align with current reporting process; - prescribing information and IB references were updated.

24 Sep 2018

Amendment No.4: The primary reason for protocol amendment 04 was to allow an optional (vs mandatory) oral lead-in for participants randomized to the ABC/DTG/3TC arm who choose to continue into the Extension Phase of the study and receive CAB LA + RPV LA. The Appendix for contraceptive guidance and collection of pregnancy information was updated to be consistent with current protocol template text. Other minor clarifications were made as needed, e.g., the Columbia Suicide Severity Rating Scale (eCSSRs) timing in the footnote for the Time and Events Table, updated abbreviations, etc.

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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Clinical trials

Trial information

Trial information

Subject disposition

Subject disposition

Baseline characteristics

Baseline characteristics

End points

End points

Primary: Percentage of participants with virologic failure (HIV-1 ribonucleic acid [RNA] >=50 copies per millilter [mL]) using snapshot algorithm at Week 48

Primary: Percentage of participants with virologic failure (HIV-1 ribonucleic acid [RNA] >=50 copies per millilter [mL]) using snapshot algorithm at Week 48

Secondary: Percentage of participants with HIV-1 RNA <50 copies/mL using snapshot algorithm at Week 48

Secondary: Percentage of participants with HIV-1 RNA <50 copies/mL using snapshot algorithm at Week 48

Secondary: Number of participants with HIV-1 RNA <200 copies/mL using snapshot algorithm at Week 48

Secondary: Number of participants with HIV-1 RNA <200 copies/mL using snapshot algorithm at Week 48

Secondary: Number of participants with confirmed virologic failure (CVF) during the Maintenance Phase

Secondary: Number of participants with confirmed virologic failure (CVF) during the Maintenance Phase

Secondary: Absolute values for plasma HIV-1 RNA at Week 48

Secondary: Absolute values for plasma HIV-1 RNA at Week 48

Secondary: Change from Baseline values for plasma HIV-1 RNA at Week 48

Secondary: Change from Baseline values for plasma HIV-1 RNA at Week 48

Secondary: Absolute values for CD4+ lymphocyte count at Week 48

Secondary: Absolute values for CD4+ lymphocyte count at Week 48

Secondary: Change from Baseline values for CD4+ lymphocyte count at Week 48

Secondary: Change from Baseline values for CD4+ lymphocyte count at Week 48

Secondary: Number of participants with disease progression

Secondary: Number of participants with disease progression

Secondary: Number of participants with non-serious adverse events (non-SAEs) and serious adverse events (SAEs)

Secondary: Number of participants with non-serious adverse events (non-SAEs) and serious adverse events (SAEs)

Secondary: Number of participants with severity of adverse events

Secondary: Number of participants with severity of adverse events

Secondary: Absolute values for hematology parameters over time including Week 48: basophils, eosinophils, leukocytes, lymphocytes, neutrophils, monocytes, and platelets

Secondary: Absolute values for hematology parameters over time including Week 48: basophils, eosinophils, leukocytes, lymphocytes, neutrophils, monocytes, and platelets

Secondary: Absolute values for hematology parameters over time including Week 48: erythrocyte mean corpuscular volume

Secondary: Absolute values for hematology parameters over time including Week 48: erythrocyte mean corpuscular volume

Secondary: Absolute values for hematology parameters over time including Week 48: erythrocytes

Secondary: Absolute values for hematology parameters over time including Week 48: erythrocytes

Secondary: Absolute values for hematology parameters over time including Week 48: hemoglobin

Secondary: Absolute values for hematology parameters over time including Week 48: hemoglobin

Secondary: Absolute values for hematology parameters over time including Week 48: hematocrit

Secondary: Absolute values for hematology parameters over time including Week 48: hematocrit

Secondary: Absolute values for clinical chemistry parameters over time including Week 48: Alanine aminotransferase (ALT), alkaline phosphatase (ALP), aspartate aminotransferase (AST) and creatinine kinase (CK)

Secondary: Absolute values for clinical chemistry parameters over time including Week 48: Alanine aminotransferase (ALT), alkaline phosphatase (ALP), aspartate aminotransferase (AST) and creatinine kinase (CK)

Secondary: Absolute values for clinical chemistry parameter over time including Week 48: Albumin

Secondary: Absolute values for clinical chemistry parameter over time including Week 48: Albumin

Secondary: Absolute values for clinical chemistry parameters over time including Week 48: bilirubin, direct bilirubin and creatinine

Secondary: Absolute values for clinical chemistry parameters over time including Week 48: bilirubin, direct bilirubin and creatinine

Secondary: Absolute values for clinical chemistry parameters: total carbon-dioxide (CO2), chloride, glucose, phosphate, potassium, sodium and urea over time including Week 48

Secondary: Absolute values for clinical chemistry parameters: total carbon-dioxide (CO2), chloride, glucose, phosphate, potassium, sodium and urea over time including Week 48

Secondary: Absolute values for clinical chemistry parameter over time including Week 48: Lipase

Secondary: Absolute values for clinical chemistry parameter over time including Week 48: Lipase

Secondary: Absolute values for clinical chemistry parameter over time including Week 48: Creatinine clearance.

Secondary: Absolute values for clinical chemistry parameter over time including Week 48: Creatinine clearance.

Secondary: Absolute values for fasting lipid panel overtime including Week 48

Secondary: Absolute values for fasting lipid panel overtime including Week 48

Secondary: Number of participants with abnormal urinalysis parameter over time including Week 48

Secondary: Number of participants with abnormal urinalysis parameter over time including Week 48

Secondary: Number of participants with urine potential of hydrogen (pH) over time including Week 48

Secondary: Number of participants with urine potential of hydrogen (pH) over time including Week 48

Secondary: Change from Baseline for hematology parameters: basophil, eosinophils, leukocytes, lymphocytes, neutrophils, monocytes, and platelets

Secondary: Change from Baseline for hematology parameters: basophil, eosinophils, leukocytes, lymphocytes, neutrophils, monocytes, and platelets

Secondary: Change from Baseline for hematology parameters: erythrocyte mean corpuscular volume

Secondary: Change from Baseline for hematology parameters: erythrocyte mean corpuscular volume

Secondary: Change from Baseline for hematology parameters: erythrocytes

Secondary: Change from Baseline for hematology parameters: erythrocytes

Secondary: Change from Baseline for hematology parameters: hematocrit

Secondary: Change from Baseline for hematology parameters: hematocrit

Secondary: Change from Baseline for hematology parameters: hemoglobin

Secondary: Change from Baseline for hematology parameters: hemoglobin

Secondary: Change from Baseline in clinical chemistry parameters over time including Week 48: ALT, ALP, AST and CK

Secondary: Change from Baseline in clinical chemistry parameters over time including Week 48: ALT, ALP, AST and CK

Secondary: Change from Baseline values for clinical chemistry parameter over time including Week 48: Albumin

Secondary: Change from Baseline values for clinical chemistry parameter over time including Week 48: Albumin

Secondary: Change from Baseline values for clinical chemistry parameters over time including Week 48: Bilirubin, direct bilirubin and creatinine

Secondary: Change from Baseline values for clinical chemistry parameters over time including Week 48: Bilirubin, direct bilirubin and creatinine

Secondary: Change from Baseline values for clinical chemistry parameters over time including Week 48

Secondary: Change from Baseline values for clinical chemistry parameters over time including Week 48

Secondary: Change from Baseline values for clinical chemistry parameter over time including Week 48: Lipase

Secondary: Change from Baseline values for clinical chemistry parameter over time including Week 48: Lipase

Secondary: Change from Baseline values for clinical chemistry parameter over time including Week 48: Creatinine clearance