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Clinical Trial Results:
A Phase IIIb, Randomized, Multicenter, Parallel-group, Non-inferiority, Open-label Study Evaluating the Efficacy, Safety, and Tolerability of Long-acting Cabotegravir Plus Long-acting Rilpivirine Administered Every 8 Weeks or Every 4 Weeks in HIV-1-infected Adults who are Virologically Suppressed

Summary
EudraCT number	2017-002946-62
Trial protocol	ES SE DE IT
Global end of trial date

Results information
Results version number	v1(current)
This version publication date	11 Jun 2020
First version publication date	11 Jun 2020
Other versions

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

207966

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, TW8 9GS

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

17 Sep 2019

Is this the analysis of the primary completion data?

Yes

Primary completion date

06 Jun 2019

Global end of trial reached?

Main objective of the trial

To demonstrate the non-inferior antiviral activity of CAB LA + RPV LA every 8 weeks (every two months) compared to CAB LA + RPV LA every 4 weeks (monthly) over 48 weeks in suppressed HIV-1 infected antiretroviral therapy (ART)-experienced participants

Protection of trial subjects

Participants entering the study from oral standard of care (SOC) received oral cabotegravir (CAB) 30 milligram (mg) + rilpivirine (RPV) 25 mg once daily during the 4-week oral lead-in phase to confirm tolerability prior to receiving CAB long acting (LA) + RPV LA injectable treatment. In exceptional circumstances, to address pre-planned missed CAB LA + RPV LA dosing visits, in consultation with the medical monitor, Investigators may provide daily oral CAB 30 mg and RPV 25 mg as a short-term “bridging” strategy for participants who have begun CAB LA + RPV LA. In certain circumstances (e.g., prior to steady state dosing and following a >4 week oral bridge) repeating the loading doses of CAB intramuscular (IM) and RPV IM may be required. Should a participant require “oral bridging”, sites must contact the study Medical Monitor for guidance with treatment and dosing strategies prior to a missed CAB LA + RPV LA dose. All injections must be given intramuscularly in the gluteus medius. Sites may use their discretion as to where in the gluteus muscle each injection is given according to individual participant circumstance. If possible, injections should be spaced approximately 2 centimeter (cm) from one another, from the site of any previous injection or any injection site reaction.

Background therapy

Evidence for comparator

Actual start date of recruitment

27 Oct 2017

Long term follow-up planned

Yes

Long term follow-up rationale

Safety

Long term follow-up duration

1 Years

Independent data monitoring committee (IDMC) involvement?

Yes

Number of subjects enrolled per country

Country: Number of subjects enrolled

Argentina: 29

Country: Number of subjects enrolled

Australia: 23

Country: Number of subjects enrolled

Canada: 76

Country: Number of subjects enrolled

France: 55

Country: Number of subjects enrolled

Germany: 84

Country: Number of subjects enrolled

Italy: 49

Country: Number of subjects enrolled

Korea, Republic of: 27

Country: Number of subjects enrolled

Mexico: 16

Country: Number of subjects enrolled

Russian Federation: 138

Country: Number of subjects enrolled

South Africa: 82

Country: Number of subjects enrolled

Spain: 159

Country: Number of subjects enrolled

Sweden: 21

Country: Number of subjects enrolled

United States: 290

Worldwide total number of subjects

1049

EEA total number of subjects

368

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)

1021

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 cabotegravir(CAB) long acting(LA) 600 milligrams(mg) + rilpivirine(RPV) LA 900 mg administered every 8 weeks(Q8W) compared with CAB LA 400 mg+RPV LA 600 mg administered every 4 weeks(Q4W) over a 48-week period in virologically suppressed human immunodeficiency type 1 infection participants.

Screening details

A total of 1049 eligible participants were randomized in a ratio of 1:1 to 1 of the 2 treatment arms in Maintenance Phase, of which 4 participants did not receive study treatment and 1045 participants were included in Intent to treat-Exposed Population. 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 Q8W

Arm description

Eligible participants transitioning from antiretroviral (ART) standard of care (SOC) therapy arm in the ATLAS study (2016-001647-39) and randomized to receive CAB LA+RPV LA Q8W in the current study were administered oral therapy with CAB 30 mg + RPV 25 mg once daily at Day 1 for 4 weeks. Participants then received intramuscular (IM) injections of CAB LA 600 mg and RPV LA 900 mg at Week 4b and Week 8 followed by injections Q8W thereafter. Participants transitioned from the CAB LA+RPV LA Q4W arm of ATLAS study (2016-001647-39) received CAB LA 600 mg+RPV LA 900 mg intramuscular injections on Day 1, Week 8 and Q8W thereafter.

Arm type

Experimental

Investigational medicinal product name

CAB 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) IM injection at Week 4b after the last dose of CAB oral regimen. Participants then received CAB 2 mL injections Q8W from Week 8 to Week 48.

Investigational medicinal product name

RPV 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 IM injection at Week 4b after the last dose of RPV oral regimen. Participants then received RPV 2 mL injections Q8W from Week 8 to Week 48

Investigational medicinal product name

CAB Oral

Investigational medicinal product code

Other name

Pharmaceutical forms

Film-coated tablet

Routes of administration

Oral use

Dosage and administration details

Participants received both CAB 30 mg tablets once daily from Day 1 to Week 4b approximately the same time each day with a meal

Investigational medicinal product name

RPV Oral

Investigational medicinal product code

Other name

Pharmaceutical forms

Film-coated tablet

Routes of administration

Oral use

Dosage and administration details

Participants received both RPV 25 mg tablets once daily from Day 1 to Week 4b approximately the same time each day with a meal

CAB LA + RPV LA Q4W

Arm description

Eligible participants transitioning from ART SOC arm in the ATLAS study (2016-001647-39) and randomized to receive CAB LA+RPV LA Q4W in the current study were administered oral therapy with CAB 30 mg + RPV 25 mg once daily at Day 1 for 4 weeks. Participants then received a loading dose of CAB LA 600 mg and RPV LA 900 mg IM injections at Week 4b followed maintenance injections of CAB LA 400 mg +RPV LA 600 mg Q4W thereafter. Participants transitioned from the Q4W arm of ATLAS study (2016-001647-39) continued to receive CAB LA 400 mg+RPV LA 600 mg intramuscular injections administered Q4W from Day 1.

Arm type

Experimental

Investigational medicinal product name

CAB 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 mL IM injection at Week 4b after the last dose of CAB oral regimen. Participants then received CAB 2 mL injections Q4W from Week 8 to Week 48

Investigational medicinal product name

RPV 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 IM injection at Week 4b after the last dose of RPV oral regimen. Participants then received RPV 2 mL injections Q4W from Week 8 to Week 48

Number of subjects in period 1 ^[1]	CAB LA + RPV LA Q8W	CAB LA + RPV LA Q4W
Started	522	523
Completed	0	0
Not completed	522	523
Consent withdrawn by subject	6	21
Physician decision	5	1
On-going	486	481
Adverse event, non-fatal	12	13
Pregnancy	1	3
Lost to follow-up	2	-
Protocol deviation	1	1
Lack of efficacy	9	3

Notes
[1] - The number of subjects reported to be in the baseline period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
Justification: A total 1049 participants were enrolled in the study out of which 4 participants did not receive the study treatment.

Baseline characteristics

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Reporting group title

CAB LA + RPV LA Q8W

Reporting group description

Reporting group title

CAB LA + RPV LA Q4W

Reporting group description

Reporting group values	CAB LA + RPV LA Q8W	CAB LA + RPV LA Q4W	Total
Number of subjects	522	523	1045
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)	502	515	1017
From 65-84 years	20	8	28
85 years and over	0	0	0
Age Continuous
Units: Years
arithmetic mean (standard deviation)	42.7 ( 11.16 )	42.3 ( 10.58 )	-
Sex/Gender, Customized
Units: Participants
Reported gender=Female	142	146	288
Reported gender=Male	380	377	757
Race/Ethnicity, Customized
Units: Subjects
American Indian (AI) or Alaska Native (AN)	17	11	28
Asian-Central/South Asian Heritage (H)	1	1	2
Asian-East Asian H	20	12	32
Asian-Japanese H	0	2	2
Asian-South East Asian (SEA) H	8	7	15
Black or African American (AA)	101	90	191
Native Hawaiian (NH) or other Pacific Islander	3	1	4
White-Arabic/North African H	2	4	6
White-White/Caucasian/European (EU) H	368	388	756
White-Mixed White Race	0	1	1
Multiple-AI/AN and Black/AA/White/Caucasian/EU H	1	1	2
Multiple-AI/AN and NH/Other Pacific Islander	1	0	1
Multiple-SEA H and White/Caucasian/ EU H	0	1	1
Multiple-Black/AA and White-Arabic/North African H	0	1	1
Multiple-Black/AA and White/Caucasian/EU H	0	3	3
Sex/Gender, Customized
Units: Subjects
Sex at Birth, Female	137	143	280
Sex at Birth, Male	385	380	765

End points

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Reporting group title

CAB LA + RPV LA Q8W

Reporting group description

Reporting group title

CAB LA + RPV LA Q4W

Reporting group description

Subject analysis set title

CAB LA Q8W

Subject analysis set type

Sub-group analysis

Subject analysis set description

Participants in this arm received 2 x 3ml CAB LA injections at week 4b and 2 x 3 ml CAB LA injections Q8W thereafter

Subject analysis set title

CAB LA Q4W

Subject analysis set type

Sub-group analysis

Subject analysis set description

Participants in this arm received 2 x 3ml CAB LA injections at week 4b and 2 x 2 ml CAB LA injections Q4W thereafter

Subject analysis set title

RPV LA Q8W

Subject analysis set type

Sub-group analysis

Subject analysis set description

Participants in this arm received 2 x 3ml RPV LA injections at week 4b and 2 x 3 ml RPV LA injections Q8W thereafter

Subject analysis set title

RPV LA Q4W

Subject analysis set type

Sub-group analysis

Subject analysis set description

Participants in this arm received 2 x 3ml RPV LA injections at week 4b and 2 x 2 ml RPV LA injections Q4W thereafter

Subject analysis set title

CAB LA

Subject analysis set type

Sub-group analysis

Subject analysis set description

Participants in this arm received CAB LA 600 mg Q8W and 400 mg Q4W at week 4b, week 8 and then 8 weekly thereafter

Subject analysis set title

RPV LA

Subject analysis set type

Sub-group analysis

Subject analysis set description

Participants in this arm received RPV LA 900 mg Q8W and 600 mg Q4W at week 4b, week 8 and then 8 weekly thereafter

Subject analysis set title

CAB LA Q8W

Subject analysis set type

Sub-group analysis

Subject analysis set description

Participants in this arm received 2 x 3 ml CAB LA injections at week 4b and 2 x 3 ml CAB La injections Q8W therafter

Subject analysis set title

CAB LA Q4W

Subject analysis set type

Sub-group analysis

Subject analysis set description

Participants in this arm received 2 x 3 ml CAB LA injections at week 4b and 2 x 2 ml CAB LA injections Q4W thereafter

Subject analysis set title

RPV LA Q8W

Subject analysis set type

Sub-group analysis

Subject analysis set description

Participants in this arm received 2 x 3 ml RPV LA injections at week 4b and 2 x 3 ml RPV LA injections Q8W thereafter

Subject analysis set title

RPV LA Q4W

Subject analysis set type

Sub-group analysis

Subject analysis set description

Participants in this arm received 2 x 3ml RPV LA injections at week 4b and 2 x 2 ml RPV LA injections Q4W thereafter

Primary: Percentage of participants with plasma human immunodeficiency virus-ribonucleic acid (HIV-RNA) >=50 copies per milliliter (c/mL) as per Food and Drug Administration (FDA) Snapshot algorithm at Week 48

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End point title

Percentage of participants with plasma human immunodeficiency virus-ribonucleic acid (HIV-RNA) >=50 copies per milliliter (c/mL) as per Food and Drug Administration (FDA) Snapshot algorithm at Week 48

End point description

Percentage of participants with HIV-1 RNA >=50 c/mL as per FDA snapshot algorithm at Week 48 was assessed to demonstrate the non-inferior antiviral activity of CAB LA+RPV LA Q8W compared to CAB LA + RPV LA Q4W regimen over 48 weeks in HIV-1 infected ART experienced participants. The HIV-1 RNA >=50 c/mL per Snapshot algorithm was determined by the last on-treatment HIV-1 RNA measurement within the Week 48 analysis visit window. Intent-to-treat-Exposed (ITT-E) Population comprised of all randomized participants who received at least one dose of study treatment. Participants were assessed according to their randomized treatment, regardless of the treatment they received.

End point type

Primary

End point timeframe

Week 48

End point values	CAB LA + RPV LA Q8W	CAB LA + RPV LA Q4W
Number of subjects analysed	522 ^[1]	523 ^[2]
Units: Percentage of participants
number (not applicable)	1.7	1.0

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

Statistical Analysis 1

Statistical analysis description

Adjusted CMH estimate of the difference in the percentage of participants with Plasma HIV-1 >=50 c/mL between each treatment group (Q8W minus Q4W) and corresponding 95% confidence interval is presented.

Comparison groups

CAB LA + RPV LA Q8W v CAB LA + RPV LA Q4W

Number of subjects included in analysis

1045

Analysis specification

Pre-specified

Analysis type

non-inferiority ^[3]

Method

Parameter type

Adjusted difference

Point estimate

0.8

Confidence interval

level

95%

sides

2-sided

lower limit

-0.6

upper limit

2.2

Notes
[3] - Non-inferiority was concluded if the upper bound of the two-sided 95% confidence interval (CI) for the Cochran-Mantel Haenzel (CMH) adjusted treatment difference (Q8W minus Q4W) is less than 4%.

Secondary: Percentage of participants with plasma HIV-1 RNA <50 c/mL using FDA Snapshot algorithm at Week 48

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End point title

Percentage of participants with plasma HIV-1 RNA <50 c/mL using FDA Snapshot algorithm at Week 48

End point description

Percentage of participants with plasma HIV-1 RNA <50 c/mL at Week 48 using FDA Snapshot algorithm was assessed to demonstrate antiviral activity of CAB LA+RPV LA Q8W compared to CAB LA+ RPV LA Q4W. The HIV-1 RNA <50 c/mL per Snapshot algorithm was determined by last on-treatment HIV-1 RNA measurement within the analysis visit window. The 95% CIs were derived using normal approximation (Wald CI)

End point type

Secondary

End point timeframe

Week 48

End point values	CAB LA + RPV LA Q8W	CAB LA + RPV LA Q4W
Number of subjects analysed	522 ^[4]	523 ^[5]
Units: Percentage of participants	94	93

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

Statistical Analysis 1

Statistical analysis description

Adjusted CMH estimate of the difference in the percentage of participants with Plasma HIV-1 <50 c/mL between each treatment group (Q8W-Q4W) and corresponding 95% CI is presented.

Comparison groups

CAB LA + RPV LA Q8W v CAB LA + RPV LA Q4W

Number of subjects included in analysis

1045

Analysis specification

Pre-specified

Analysis type

non-inferiority ^[6]

Method

Parameter type

Adjusted difference

Point estimate

0.8

Confidence interval

level

95%

sides

2-sided

lower limit

-2.1

upper limit

3.7

Notes
[6] - Non-inferiority was concluded if the upper bound of the two-sided 95% CI for the CMH adjusted treatment difference (Q8W minus Q4W) is greater than -10%

Secondary: Percentage of participants with plasma HIV-1 RNA <50 c/mL using FDA Snapshot algorithm at Week 24

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End point title

Percentage of participants with plasma HIV-1 RNA <50 c/mL using FDA Snapshot algorithm at Week 24

End point description

End point type

Secondary

End point timeframe

Week 24

End point values	CAB LA + RPV LA Q8W	CAB LA + RPV LA Q4W
Number of subjects analysed	522 ^[7]	523 ^[8]
Units: Percentage of participants
number (confidence interval 95%)	95 (93 to 97)	95 (94 to 97)

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

No statistical analyses for this end point

Secondary: Percentage of participants with protocol defined confirmed virologic failure (CVF) through Weeks 24 and 48

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End point title

Percentage of participants with protocol defined confirmed virologic failure (CVF) through Weeks 24 and 48

End point description

CVF was defined as rebound as indicated by two consecutive plasma HIV-1-RNA levels >=200 c/mL after prior suppression to <200 c/mL. Cumulative percentage of participants with protocol defined CVF up to Weeks 24 and 48 has been presented.

End point type

Secondary

End point timeframe

Weeks 24 and 48

End point values	CAB LA + RPV LA Q8W	CAB LA + RPV LA Q4W
Number of subjects analysed	522 ^[9]	523 ^[10]
Units: Percentage of participants
number (not applicable)
Week 24	1.3	0.2
Week 48	1.5	0.4

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

No statistical analyses for this end point

Secondary: Percentage of participants with HIV-RNA >=50 c/mL as per FDA Snapshot algorithm at Week 24

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End point title

Percentage of participants with HIV-RNA >=50 c/mL as per FDA Snapshot algorithm at Week 24

End point description

Percentage of participants with plasma HIV-1 RNA >=50 c/mL at Week 24 using FDA Snapshot algorithm was assessed to demonstrate antiviral activity of CAB LA+RPV LA Q8W compared to CAB LA+ RPV LA Q4W. The HIV-1 RNA >=50 c/mL per Snapshot algorithm was determined by the last on-treatment HIV-1 RNA measurement within the analysis visit window. The 95% CIs were derived using normal approximation (Wald CI).

End point type

Secondary

End point timeframe

Weeks 24

End point values	CAB LA + RPV LA Q8W	CAB LA + RPV LA Q4W
Number of subjects analysed	522 ^[11]	523 ^[12]
Units: Percentage of participants
number (confidence interval 95%)	2.1 (0.9 to 3.3)	1.5 (0.5 to 2.6)

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

No statistical analyses for this end point

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

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End point title

Absolute values for HIV-1 RNA at Week 48

End point description

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

End point type

Secondary

End point timeframe

Weeks 48

End point values	CAB LA + RPV LA Q8W	CAB LA + RPV LA Q4W
Number of subjects analysed	493 ^[13]	487 ^[14]
Units: Log 10 c/mL
arithmetic mean (standard deviation)	1.599 ( 0.0870 )	1.593 ( 0.0302 )

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

No statistical analyses for this end point

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

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End point title

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

End point description

Plasma samples were collected for quantitative analysis of HIV-1 RNA. Baseline value is defined as latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from Baseline is defined as post-dose visit value minus Baseline value. Logarithm to base 10 values for plasma HIV-1 RNA has been presented. 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 Q8W	CAB LA + RPV LA Q4W
Number of subjects analysed	493 ^[15]	487 ^[16]
Units: Log 10 c/mL
arithmetic mean (standard deviation)	0.007 ( 0.0888 )	-0.015 ( 0.1673 )

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

No statistical analyses for this end point

Secondary: Absolute values for cluster of differentiation 4 plus (CD4+) at Week 48

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End point title

Absolute values for cluster of differentiation 4 plus (CD4+) at Week 48

End point description

Blood samples were collected and CD4+ cell count assessment by flow cytometry was carried out to evaluate the immunologic activity of CAB LA+RPV LA Q8W compared to CAB LA+RPV LA Q8W. 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 Q8W	CAB LA + RPV LA Q4W
Number of subjects analysed	493 ^[17]	486 ^[18]
Units: Cells per cubic millimeter
arithmetic mean (standard deviation)	685.9 ( 261.70 )	700.0 ( 278.18 )

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

No statistical analyses for this end point

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

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End point title

Change from Baseline values for CD4+ at Week 48

End point description

Blood samples were collected and CD4+ cell count assessment by flow cytometry was carried out to evaluate the immunologic activity of CAB LA+RPV LA Q8W compared to CAB LA+RPV LA Q4W. Baseline value is defined as latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from Baseline is defined as post-dose visit value minus Baseline value. 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 Q8W	CAB LA + RPV LA Q4W
Number of subjects analysed	493 ^[19]	486 ^[20]
Units: Cells per cubic millimeter
arithmetic mean (standard deviation)	5.3 ( 168.62 )	-24.6 ( 199.02 )

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 >=5% incidence) and serious adverse events (SAEs)-Maintenance phase

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End point title

Number of participants with non-serious adverse events (non-SAEs >=5% incidence) and serious adverse events (SAEs)-Maintenance phase

End point description

An adverse event 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. A SAE is defined as 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 judgement. Safety Population comprised of all randomized participants who received at least one dose of study treatment. Participants were assessed according to actual treatment received.

End point type

Secondary

End point timeframe

Up to Week 48

End point values	CAB LA + RPV LA Q8W	CAB LA + RPV LA Q4W
Number of subjects analysed	522 ^[21]	523 ^[22]
Units: Participants
Any non-SAE (>=5%)	429	427
Any SAE	27	19

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

No statistical analyses for this end point

Secondary: Number of participants with severity of adverse events-Maintenance phase

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End point title

Number of participants with severity of adverse events-Maintenance phase

End point description

Severity of adverse events were defined as per The Division of Acquired Immunodeficiency Syndrome (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS adverse events Grading Table). Severity grades for adverse events were as Grade 1 (mild), Grade 2 (moderate), Grade 3 (severe), Grade 4 (Potentially life-threatening) and Grade 5 (all deaths related to an AE).

End point type

Secondary

End point timeframe

Up to Week 48

End point values	CAB LA + RPV LA Q8W	CAB LA + RPV LA Q4W
Number of subjects analysed	522 ^[23]	523 ^[24]
Units: Participants
Grade 1	201	195
Grade 2	231	238
Grade 3	38	43
Grade 4	2	6
Grade 5	1	0

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

No statistical analyses for this end point

Secondary: Number of participants with maximum Post-Baseline chemistry toxicities-Maintenance phase

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End point title

Number of participants with maximum Post-Baseline chemistry toxicities-Maintenance phase

End point description

Clinical chemistry toxicities were graded as per the DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)Blood samples were collected for the analysis of following clinical chemistry parameters: alanine aminotransferase (ALT), albumin, alkaline phosphate (ALP), aspartate aminotranferase (AST), bilirubin, carbon dioxide (CO2), cholesterol, creatinine kinase, creatinine, glomerular filtration rate (GFR) from creatinine adjusted for bovine serum albumin (BSA), glucose, hyperglycemia, hyperkalemia, hypernatremia, hypoglycemia, hypokalemia, hyponatremia, low density lipoprotein (LDL) calculation, lipase, phosphate, potassium, sodium and triglycerides. Severity grades were: Grade 1 (mild), Grade 2 (moderate), Grade 3 (severe) and Grade 4 (Potentially life-threatening).

End point type

Secondary

End point timeframe

Up to Week 48

End point values	CAB LA + RPV LA Q8W	CAB LA + RPV LA Q4W
Number of subjects analysed	522 ^[25]	523 ^[26]
Units: Participants
ALT, Grade 1	45	49
ALT, Grade 2	10	13
ALT, Grade 3	1	3
ALT, Grade 4	1	2
Albumin, Grade 1	1	0
Albumin, Grade 2	1	1
Albumin, Grade 3	0	0
Albumin, Grade 4	0	0
ALP, Grade 1	1	5
ALP, Grade 2	0	0
ALP, Grade 3	0	0
ALP, Grade 4	0	0
AST, Grade 1	32	44
AST, Grade 2	10	13
AST, Grade 3	2	4
AST, Grade 4	1	2
Bilirubin, Grade 1	27	25
Bilirubin, Grade 2	7	5
Bilirubin, Grade 3	1	1
Bilirubin, Grade 4	1	1
CO2, Grade 1	98	111
CO2, Grade 2	2	1
CO2, Grade 3	0	0
CO2, Grade 4	0	0
Cholesterol, Grade 1	50	52
Cholesterol, Grade 2	31	30
Cholesterol, Grade 3	2	3
Cholesterol, Grade 4	0	0
Creatinine Kinase, Grade 1	41	32
Creatinine Kinase, Grade 2	22	19
Creatinine Kinase, Grade 3	7	9
Creatinine Kinase, Grade 4	9	14
Creatinine, Grade 1	5	9
Creatinine, Grade 2	2	1
Creatinine, Grade 3	0	0
Creatinine, Grade 4	0	0
GFR from creatinine adjusted for BSA, Grade 1	0	0
GFR from creatinine adjusted for BSA, Grade 2	110	134
GFR from creatinine adjusted for BSA, Grade 3	15	19
GFR from creatinine adjusted for BSA, Grade 4	0	1
Glucose, Grade 1	84	87
Glucose, Grade 2	34	43
Glucose, Grade 3	3	5
Glucose, Grade 4	1	1
Hyperglycemia, Grade 1	80	77
Hyperglycemia, Grade 2	32	38
Hyperglycemia, Grade 3	2	5
Hyperglycemia, Grade 4	0	0
Hyperkalemia, Grade 1	8	2
Hyperkalemia, Grade 2	0	1
Hyperkalemia, Grade 3	0	0
Hyperkalemia, Grade 4	0	1
Hypernatremia, Grade 1	6	2
Hypernatremia, Grade 2	0	0
Hypernatremia, Grade 3	0	0
Hypernatremia, Grade 4	0	0
Hypoglycemia, Grade 1	11	13
Hypoglycemia, Grade 2	2	5
Hypoglycemia, Grade 3	1	0
Hypoglycemia, Grade 4	1	1
Hypokalemia, Grade 1	10	8
Hypokalemia, Grade 2	0	0
Hypokalemia, Grade 3	0	0
Hypokalemia, Grade 4	0	0
Hyponatremia, Grade 1	23	26
Hyponatremia, Grade 2	0	1
Hyponatremia, Grade 3	0	0
Hyponatremia, Grade 4	0	0
LDL Cholesterol calculation, Grade 1	40	41
LDL Cholesterol calculation, Grade 2	20	26
LDL Cholesterol calculation, Grade 3	9	4
LDL Cholesterol calculation, Grade 4	0	0
Lipase, Grade 1	40	44
Lipase, Grade 2	31	44
Lipase, Grade 3	13	4
Lipase, Grade 4	3	6
Phosphate, Grade 1	75	75
Phosphate, Grade 2	20	17
Phosphate, Grade 3	0	2
Phosphate, Grade 4	0	0
Potassium, Grade 1	18	10
Potassium, Grade 2	0	1
Potassium, Grade 3	0	0
Potassium, Grade 4	0	1
Sodium, Grade 1	29	28
Sodium, Grade 2	0	1
Sodium, Grade 3	0	0
Sodium, Grade 4	0	0
Triglycerides, Grade 1	51	42
Triglycerides, Grade 2	11	3
Triglycerides, Grade 3	4	2
Triglycerides, Grade 4	0	2

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

No statistical analyses for this end point

Secondary: Number of participants with maximum Post-Baseline hematology toxicities-Maintenance phase

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End point title

Number of participants with maximum Post-Baseline hematology toxicities-Maintenance phase

End point description

The hematology toxicities were graded as per the DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table). Blood samples were collected for the analysis of following hematology parameters: hemoglobin, leukocytes, neutrophils and platelets. Severity grades were as Grade 1 (mild), Grade 2 (moderate), Grade 3 (severe) and Grade 4 (Potentially life-threatening).

End point type

Secondary

End point timeframe

Up to Week 48

End point values	CAB LA + RPV LA Q8W	CAB LA + RPV LA Q4W
Number of subjects analysed	522 ^[27]	523 ^[28]
Units: Participants
Hemoglobin, Grade 1	9	4
Hemoglobin, Grade 2	1	3
Hemoglobin, Grade 3	2	4
Hemoglobin, Grade 4	0	0
Leukocytes, Grade 1	12	5
Leukocytes, Grade 2	0	0
Leukocytes, Grade 3	1	0
Leukocytes, Grade 4	0	0
Neutrophils, Grade 1	7	6
Neutrophils, Grade 2	8	5
Neutrophils, Grade 3	1	2
Neutrophils, Grade 4	2	1
Platelets, Grade 1	8	8
Platelets, Grade 2	1	1
Platelets, Grade 3	1	1
Platelets, Grade 4	0	0

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

No statistical analyses for this end point

Secondary: Percentage of participants who discontinued treatment due to adverse events-Maintenance phase

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End point title

Percentage of participants who discontinued treatment due to adverse events-Maintenance phase

End point description

End point type

Secondary

End point timeframe

Up to Week 48

End point values	CAB LA + RPV LA Q8W	CAB LA + RPV LA Q4W
Number of subjects analysed	522 ^[29]	523 ^[30]
Units: Percentage of participants	2	2

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

No statistical analyses for this end point

Secondary: Change from Baseline in clinical chemistry parameters: ALT, ALP, AST and creatinine kinase over time

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End point title

Change from Baseline in clinical chemistry parameters: ALT, ALP, AST and creatinine kinase over time

End point description

Blood samples were collected for the analysis of clinical chemical parameters including ALT, ALP, AST and creatinine kinase. Baseline value is defined as latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. 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 Weeks 4, 8, 16, 24, 32, 40 and 48

End point values	CAB LA + RPV LA Q8W	CAB LA + RPV LA Q4W
Number of subjects analysed	522 ^[31]	523 ^[32]
Units: International units per liter
arithmetic mean (standard deviation)
ALT, Week 4, n=326, 520	-1.3 ( 11.11 )	0.1 ( 14.01 )
ALT, Week 8, n=510, 515	0.8 ( 21.28 )	0.3 ( 15.65 )
ALT, Week 16, n=515, 513	1.5 ( 47.60 )	-0.7 ( 12.29 )
ALT, Week 24, n=505, 503	1.9 ( 63.03 )	-0.3 ( 13.39 )
ALT, Week 32, n=499, 498	-0.4 ( 12.60 )	2.4 ( 33.72 )
ALT, Week 40, n=495, 490	0.4 ( 13.50 )	6.6 ( 112.13 )
ALT, Week 48, n=493, 486	1.1 ( 16.39 )	1.6 ( 18.61 )
ALP, Week 4, n=326, 520	-5.5 ( 12.09 )	-2.1 ( 10.25 )
ALP, Week 8, n=510, 515	-4.1 ( 13.07 )	-3.3 ( 11.31 )
ALP, Week 16, n=515, 513	-4.8 ( 14.65 )	-4.2 ( 13.07 )
ALP, Week 24, n=505, 503	-5.2 ( 16.04 )	-4.0 ( 13.42 )
ALP, Week 32, n=499, 498	-5.7 ( 17.14 )	-4.1 ( 14.95 )
ALP, Week 40, n=495, 490	-5.9 ( 17.61 )	-3.9 ( 16.09 )
ALP, Week 48, n=493, 486	-6.6 ( 17.18 )	-4.5 ( 15.02 )
AST, Week 4, n=326, 520	-0.6 ( 13.25 )	-0.3 ( 18.47 )
AST, Week 8, n=510, 515	0.6 ( 11.71 )	0.0 ( 14.46 )
AST, Week 16, n=515, 513	1.2 ( 24.79 )	-0.3 ( 16.58 )
AST, Week 24, n=505, 503	1.6 ( 53.81 )	-0.2 ( 21.65 )
AST, Week 32, n=499, 498	-1.6 ( 8.84 )	0.8 ( 34.81 )
AST, Week 40, n=495, 490	-1.0 ( 10.14 )	2.5 ( 66.54 )
AST, Week 48, n=493, 486	-0.2 ( 12.48 )	-0.7 ( 16.12 )
Creatinine kinase, Week 4, n=326, 520	30.2 ( 689.41 )	-29.3 ( 717.51 )
Creatinine kinase, Week 8, n=510, 515	24.1 ( 479.84 )	-23.7 ( 682.90 )
Creatinine kinase, Week 16, n=515, 513	30.6 ( 692.65 )	-4.7 ( 856.65 )
Creatinine kinase, Week 24, n=505, 503	-13.6 ( 265.16 )	31.1 ( 1198.22 )
Creatinine kinase, Week 32, n=499, 498	-23.3 ( 314.46 )	-5.8 ( 787.02 )
Creatinine kinase, Week 40, n=495, 490	-12.5 ( 336.08 )	34.2 ( 1288.66 )
Creatinine kinase, Week 48, n=493, 486	17.9 ( 411.70 )	-2.9 ( 810.46 )

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

No statistical analyses for this end point

Secondary: Change from Baseline in clinical chemistry parameter: albumin over time

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End point title

Change from Baseline in clinical chemistry parameter: albumin over time

End point description

Blood samples were collected for the analysis of clinical chemistry parameter: albumin. Baseline value is defined as latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. 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 Weeks 4, 8, 16, 24, 32, 40 and 48

End point values	CAB LA + RPV LA Q8W	CAB LA + RPV LA Q4W
Number of subjects analysed	522 ^[33]	523 ^[34]
Units: Grams per liter
arithmetic mean (standard deviation)
Week 4, n=326, 520	-0.5 ( 2.32 )	-0.2 ( 2.45 )
Week 8, n=510, 515	-0.3 ( 2.48 )	-0.1 ( 2.48 )
Week 16, n=515, 513	-0.3 ( 2.56 )	-0.4 ( 2.51 )
Week 24, n=505, 503	-0.0 ( 2.49 )	-0.2 ( 2.59 )
Week 32, n=499, 498	-0.2 ( 2.63 )	-0.3 ( 2.68 )
Week 40, n=495, 490	0.1 ( 2.68 )	-0.3 ( 2.54 )
Week 48, n=493, 486	-0.2 ( 2.59 )	-0.2 ( 2.60 )

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

No statistical analyses for this end point

Secondary: Change from Baseline in clinical chemistry parameters: bilirubin and creatinine over time

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End point title

Change from Baseline in clinical chemistry parameters: bilirubin and creatinine over time

End point description

Blood samples were collected for the analysis of clinical chemistry parameters: bilirubin and creatinine. Baseline value is defined as latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. 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 Weeks 4, 8, 16, 24, 32, 40 and 48

End point values	CAB LA + RPV LA Q8W	CAB LA + RPV LA Q4W
Number of subjects analysed	522 ^[35]	523 ^[36]
Units: Micromoles per liter
arithmetic mean (standard deviation)
Bilirubin, Week 4, n=326, 520	0.4 ( 6.44 )	0.1 ( 5.70 )
Bilirubin, Week 8, n=510, 515	0.4 ( 5.68 )	0.1 ( 5.39 )
Bilirubin, Week 16, n=515, 513	0.5 ( 5.78 )	0.2 ( 5.69 )
Bilirubin, Week 24, n=505, 503	0.8 ( 9.42 )	0.5 ( 5.23 )
Bilirubin, Week 32, n=499, 498	0.5 ( 5.54 )	0.4 ( 5.46 )
Bilirubin, Week 40, n=495, 490	0.7 ( 6.00 )	0.4 ( 5.77 )
Bilirubin, Week 48, n=493, 486	0.4 ( 5.77 )	0.7 ( 4.93 )
Creatinine, Week 4, n=326, 521	0.89 ( 8.768 )	-0.36 ( 7.215 )
Creatinine, Week 8, n=510, 515	-0.94 ( 8.638 )	-0.39 ( 8.191 )
Creatinine, Week 16, n=515, 513	-0.24 ( 8.973 )	-0.03 ( 8.516 )
Creatinine, Week 24, n=505, 503	0.22 ( 9.085 )	0.94 ( 9.591 )
Creatinine, Week 32, n=499, 498	1.01 ( 9.490 )	2.09 ( 9.313 )
Creatinine, Week 40, n=495, 490	1.02 ( 9.604 )	2.05 ( 9.414 )
Creatinine, Week 48, n=493, 486	1.30 ( 9.813 )	2.30 ( 8.678 )

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

No statistical analyses for this end point

Secondary: Change from Baseline in clinical chemistry parameters: CO2, chloride, phosphate, potassium, sodium and urea over time

Top of page

End point title

Change from Baseline in clinical chemistry parameters: CO2, chloride, phosphate, potassium, sodium and urea over time

End point description

Blood samples were collected for the analysis of clinical chemistry parameters: CO2, chloride, phosphate, potassium, sodium and urea. Baseline value is defined as latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. 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 Weeks 4, 8, 16, 24, 32, 40 and 48

End point values	CAB LA + RPV LA Q8W	CAB LA + RPV LA Q4W
Number of subjects analysed	522 ^[37]	523 ^[38]
Units: Millimoles per liter
arithmetic mean (standard deviation)
CO2, Week 4, n=326, 520	-0.5 ( 2.29 )	-0.7 ( 2.32 )
CO2, Week 8, n=510, 515	-0.8 ( 2.12 )	-0.8 ( 2.23 )
CO2, Week 16, n=515, 513	-1.0 ( 2.31 )	-0.9 ( 2.33 )
CO2, Week 24, n=505, 503	-0.7 ( 2.38 )	-0.7 ( 2.28 )
CO2, Week 32, n=499, 498	-0.9 ( 2.31 )	-0.8 ( 2.43 )
CO2, Week 40, n=495, 490	-0.6 ( 2.33 )	-0.7 ( 2.44 )
CO2, Week 48, n=493, 485	-0.4 ( 2.32 )	-0.4 ( 2.41 )
Chloride, Week 4, n=326, 520	0.6 ( 2.19 )	0.2 ( 2.35 )
Chloride, Week 8, n=510, 515	0.3 ( 2.24 )	0.2 ( 2.34 )
Chloride, Week 16, n=515, 513	0.4 ( 2.30 )	0.2 ( 2.40 )
Chloride, Week 24, n=505, 503	0.1 ( 2.36 )	-0.1 ( 2.59 )
Chloride, Week 32, n=499, 498	0.2 ( 2.34 )	0.1 ( 2.64 )
Chloride, Week 40, n=495, 490	-0.1 ( 2.46 )	0.0 ( 2.36 )
Chloride, Week 48, n=493, 486	-0.0 ( 2.25 )	-0.1 ( 2.46 )
Phosphate, Week 4, n=326, 520	0.054 ( 0.182 )	0.018 ( 0.167 )
Phosphate, Week 8, n=510, 515	0.025 ( 0.177 )	0.029 ( 0.160 )
Phosphate, Week 16, n=515, 513	0.017 ( 0.181 )	0.007 ( 0.172 )
Phosphate, Week 24, n=505, 502	0.016 ( 0.170 )	-0.004 ( 0.168 )
Phosphate, Week 32, n=499, 498	-0.001 ( 0.183 )	0.001 ( 0.172 )
Phosphate, Week 40, n=495, 490	0.014 ( 0.180 )	0.001 ( 0.170 )
Phosphate, Week 48, n=493, 486	0.007 ( 0.169 )	0.010 ( 0.157 )
Potassium, Week 4, n=326, 520	0.03 ( 0.337 )	0.03 ( 0.303 )
Potassium, Week 8, n=510, 515	0.04 ( 0.317 )	0.04 ( 0.331 )
Potassium, Week 16, n=515, 513	0.03 ( 0.328 )	0.03 ( 0.341 )
Potassium, Week 24, n=505, 503	0.04 ( 0.338 )	0.03 ( 0.321 )
Potassium, Week 32, n=499, 498	0.04 ( 0.364 )	0.00 ( 0.340 )
Potassium, Week 40, n=495, 490	0.04 ( 0.351 )	0.02 ( 0.334 )
Potassium, Week 48, n=493, 486	0.04 ( 0.315 )	0.03 ( 0.327 )
Sodium, Week 4, n=326, 520	0.4 ( 2.02 )	0.1 ( 2.11 )
Sodium, Week 8, n=510, 515	0.1 ( 2.14 )	0.2 ( 2.02 )
Sodium, Week 16, n=515, 513	0.0 ( 2.00 )	-0.1 ( 2.01 )
Sodium, Week 24, n=505, 503	-0.2 ( 2.07 )	-0.3 ( 2.20 )
Sodium, Week 32, n=499, 498	-0.1 ( 2.10 )	-0.1 ( 2.21 )
Sodium, Week 40, n=495, 490	-0.3 ( 2.09 )	-0.2 ( 2.13 )
Sodium, Week 48, n=493, 486	-0.4 ( 2.02 )	-0.3 ( 2.21 )
Urea, Week 4, n=326, 520	0.24 ( 1.251 )	0.19 ( 1.227 )
Urea, Week 8, n=510, 515	0.07 ( 1.306 )	0.19 ( 1.336 )
Urea, Week 16, n=515, 513	0.07 ( 1.372 )	0.15 ( 1.320 )
Urea, Week 24, n=505, 503	0.06 ( 1.298 )	0.15 ( 1.270 )
Urea, Week 32, n=499, 498	0.11 ( 1.297 )	0.16 ( 1.356 )
Urea, Week 40, n=495, 490	0.18 ( 1.345 )	0.21 ( 1.412 )
Urea, Week 48, n=493, 486	0.13 ( 1.350 )	0.14 ( 1.457 )

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

No statistical analyses for this end point

Secondary: Change from Baseline in clinical chemistry parameters: cholesterol, glucose, direct high density lipoprotein (HDL) cholesterol, LDL cholesterol calculation and triglycerides at Week 48

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End point title

Change from Baseline in clinical chemistry parameters: cholesterol, glucose, direct high density lipoprotein (HDL) cholesterol, LDL cholesterol calculation and triglycerides at Week 48

End point description

Blood samples were collected for the analysis of clinical chemistry parameters: cholesterol, glucose, direct HDL cholesterol, LDL cholesterol calculation and triglycerides. Baseline value is defined as latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. 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 Week 48

End point values	CAB LA + RPV LA Q8W	CAB LA + RPV LA Q4W
Number of subjects analysed	522 ^[39]	523 ^[40]
Units: Millimoles per liter
arithmetic mean (standard deviation)
Cholesterol, Week 48, n=423, 408	0.023 ( 0.742 )	0.075 ( 0.748 )
Glucose, Week 48, n=478, 470	0.16 ( 0.907 )	0.12 ( 1.208 )
Direct HDL cholesterol, Week 48, n=423, 408	0.011 ( 0.292 )	-0.000 ( 0.288 )
LDL cholesterol calculation, Week 48, n=415, 398	0.026 ( 0.629 )	0.098 ( 0.585 )
Triglycerides, Week 48, n=423, 408	-0.039 ( 0.790 )	-0.017 ( 0.880 )

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

No statistical analyses for this end point

Secondary: Change from Baseline in clinical chemistry parameter: GFR from creatinine adjusted using Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) over time

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End point title

Change from Baseline in clinical chemistry parameter: GFR from creatinine adjusted using Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) over time

End point description

Blood samples were collected for the analysis of clinical chemistry parameter: GFR from creatinine adjusted using CKD-EPI. Baseline value is defined as latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. 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 Weeks 4, 8, 16, 24, 32, 40 and 48

End point values	CAB LA + RPV LA Q8W	CAB LA + RPV LA Q4W
Number of subjects analysed	522 ^[41]	523 ^[42]
Units: milliliters/minute/1.73 square meter
arithmetic mean (standard deviation)
Week 4, n=326, 521	-0.8 ( 9.05 )	0.4 ( 7.91 )
Week 8, n=508, 514	1.0 ( 9.07 )	0.4 ( 8.62 )
Week 16, n=515, 513	-0.2 ( 9.08 )	-0.4 ( 9.01 )
Week 24, n=503, 503	-0.7 ( 9.67 )	-1.7 ( 10.65 )
Week 32, n=499, 498	-1.7 ( 10.12 )	-3.0 ( 10.19 )
Week 40, n=494, 489	-1.7 ( 9.92 )	-2.9 ( 9.95 )
Week 48, n=493, 486	-1.9 ( 9.96 )	-3.3 ( 9.79 )

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

No statistical analyses for this end point

Secondary: Change from Baseline in clinical chemistry parameter: Lipase over time

Top of page

End point title

Change from Baseline in clinical chemistry parameter: Lipase over time

End point description

Blood samples were collected for the analysis of clinical chemistry parameter: Lipase. Baseline value is defined as latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. 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 Weeks 4, 8, 16, 24, 32, 40 and 48

End point values	CAB LA + RPV LA Q8W	CAB LA + RPV LA Q4W
Number of subjects analysed	522 ^[43]	523 ^[44]
Units: Units per liter
arithmetic mean (standard deviation)
Week 4, n=326, 521	1.7 ( 28.76 )	1.1 ( 22.67 )
Week 8, n=510, 514	1.5 ( 23.82 )	1.4 ( 24.74 )
Week 16, n=515, 513	2.7 ( 33.41 )	0.7 ( 18.82 )
Week 24, n=503, 503	0.7 ( 19.71 )	2.6 ( 34.49 )
Week 32, n=499, 498	3.1 ( 35.20 )	-0.5 ( 21.91 )
Week 40, n=494, 486	1.3 ( 23.35 )	2.7 ( 30.95 )
Week 48, n=493, 486	3.2 ( 53.46 )	2.9 ( 42.61 )

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

No statistical analyses for this end point

Secondary: Change from Baseline in hematology parameters: basophils, eosinophils, leukocytes, lymphocytes, monocytes, neutrophils and platelets over time

Top of page

End point title

Change from Baseline in hematology parameters: basophils, eosinophils, leukocytes, lymphocytes, monocytes, neutrophils and platelets over time

End point description

Blood samples were collected for the analysis of hematology parameters: basophils, eosinophils, leukocytes, lymphocytes, monocytes, neutrophils and platelets. Baseline value is defined as latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. 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 Weeks 4, 8, 16, 24, 32, 40 and 48

End point values	CAB LA + RPV LA Q8W	CAB LA + RPV LA Q4W
Number of subjects analysed	522 ^[45]	523 ^[46]
Units: 10^9 cells per liter
arithmetic mean (standard deviation)
Basophils, Week 4, n=330, 516	0.006 ( 0.02751 )	0.003 ( 0.02811 )
Basophils, Week 8, n=506, 505	0.000 ( 0.02682 )	0.002 ( 0.02699 )
Basophils, Week 16, n=508, 507	-0.000 ( 0.02651 )	0.001 ( 0.02929 )
Basophils, Week 24, n=497, 495	0.002 ( 0.02809 )	0.002 ( 0.02803 )
Basophils, Week 32, n=489, 486	0.005 ( 0.02708 )	0.003 ( 0.02988 )
Basophils, Week 40, n=479, 472	0.004 ( 0.02716 )	0.004 ( 0.02772 )
Basophils, Week 48, n=486, 478	0.005 ( 0.02730 )	0.003 ( 0.02926 )
Eosinophils, Week 4, n=330, 516	0.031 ( 0.13775 )	0.015 ( 0.15112 )
Eosinophils, Week 8, n=506, 505	0.015 ( 0.14391 )	0.012 ( 0.13314 )
Eosinophils, Week 16, n=508, 507	0.001 ( 0.13474 )	0.010 ( 0.13012 )
Eosinophils, Week 24, n=497, 495	0.001 ( 0.13607 )	0.009 ( 0.12836 )
Eosinophils, Week 32, n=489, 486	0.005 ( 0.12762 )	0.011 ( 0.13810 )
Eosinophils, Week 40, n=479, 472	0.006 ( 0.13578 )	0.009 ( 0.12297 )
Eosinophils, Week 48, n=486, 478	0.001 ( 0.12444 )	0.002 ( 0.12646 )
Leukocytes, Week 4, n=331, 520	0.437 ( 1.5653 )	0.335 ( 1.6343 )
Leukocytes, Week 8, n=508, 507	0.110 ( 1.5863 )	0.214 ( 1.6109 )
Leukocytes, Week 16, n=509, 507	0.050 ( 1.4281 )	0.139 ( 1.6384 )
Leukocytes, Week 24, n=499, 497	0.148 ( 1.5229 )	0.139 ( 1.6301 )
Leukocytes, Week 32, n=491, 489	0.185 ( 1.5455 )	0.111 ( 1.6454 )
Leukocytes, Week 40, n=480, 476	0.177 ( 1.6601 )	0.100 ( 1.8042 )
Leukocytes, Week 48, n=488, 478	-0.007 ( 1.5561 )	-0.012 ( 1.6035 )
Lymphocytes, Week 4, n=330, 516	0.187 ( 0.44013 )	0.063 ( 0.42683 )
Lymphocytes, Week 8, n=506, 505	0.040 ( 0.39452 )	0.039 ( 0.44987 )
Lymphocytes, Week 16, n=508, 507	0.060 ( 0.43470 )	0.033 ( 0.44030 )
Lymphocytes, Week 24, n=497, 495	0.081 ( 0.41863 )	0.061 ( 0.46240 )
Lymphocytes, Week 32, n=489, 486	0.119 ( 0.46387 )	0.096 ( 0.45178 )
Lymphocytes, Week 40, n=479, 472	0.126 ( 0.44614 )	0.107 ( 0.50590 )
Lymphocytes, Week 48, n=486, 478	0.063 ( 0.43255 )	0.049 ( 0.48991 )
Monocytes, Week 4, n=330, 516	0.051 ( 0.14208 )	0.021 ( 0.13359 )
Monocytes, Week 8, n=506, 505	0.003 ( 0.12080 )	0.003 ( 0.14270 )
Monocytes, Week 16, n=508, 507	-0.002 ( 0.12804 )	-0.007 ( 0.14361 )
Monocytes, Week 24, n=497, 495	0.019 ( 0.13460 )	0.020 ( 0.14458 )
Monocytes, Week 32, n=489, 486	0.048 ( 0.13969 )	0.039 ( 0.14531 )
Monocytes, Week 40, n=479, 472	0.060 ( 0.13570 )	0.060 ( 0.15692 )
Monocytes, Week 48, n=486, 478	0.030 ( 0.13329 )	0.033 ( 0.13116 )
Neutrophils, Week 4, n=330, 516	0.152 ( 1.44916 )	0.228 ( 1.48979 )
Neutrophils, Week 8, n=506, 505	0.035 ( 1.49397 )	0.141 ( 1.48054 )
Neutrophils, Week 16, n=508, 507	-0.018 ( 1.34384 )	0.082 ( 1.52187 )
Neutrophils, Week 24, n=497, 495	0.047 ( 1.36697 )	0.027 ( 1.46192 )
Neutrophils, Week 32, n=489, 486	0.001 ( 1.43051 )	-0.054 ( 1.53192 )
Neutrophils, Week 40, n=479, 472	-0.021 ( 1.53092 )	-0.090 ( 1.58850 )
Neutrophils, Week 48, n=486, 478	-0.108 ( 1.39875 )	-0.118 ( 1.37189 )
Platelets, Week 4, n=329, 518	2.09 ( 32.330 )	5.91 ( 39.613 )
Platelets, Week 8, n=506, 507	-0.62 ( 35.873 )	0.27 ( 34.345 )
Platelets, Week 16, n=498, 505	0.01 ( 35.207 )	-1.70 ( 34.072 )
Platelets, Week 24, n=496, 496	0.26 ( 36.085 )	-2.53 ( 35.214 )
Platelets, Week 32, n=487, 486	1.67 ( 40.601 )	-1.76 ( 37.490 )
Platelets, Week 40, n=478, 472	0.38 ( 38.636 )	0.32 ( 38.028 )
Platelets, Week 48, n=489, 474	0.06 ( 39.549 )	-1.51 ( 35.440 )

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

No statistical analyses for this end point

Secondary: Change from Baseline in hematology parameter: erythrocyte mean corpuscular volume (MCV) over time

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End point title

Change from Baseline in hematology parameter: erythrocyte mean corpuscular volume (MCV) over time

End point description

Blood samples were collected for the analysis of hematology parameter: erythrocyte MCV. Baseline value is defined as latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. 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 Weeks 4, 8, 16, 24, 32, 40 and 48

End point values	CAB LA + RPV LA Q8W	CAB LA + RPV LA Q4W
Number of subjects analysed	522 ^[47]	523 ^[48]
Units: Femtoliters
arithmetic mean (standard deviation)
Week 4, n=331, 520	-0.32 ( 2.136 )	-0.13 ( 2.322 )
Week 8, n=509, 510	-1.16 ( 3.270 )	-0.84 ( 3.132 )
Week 16, n=509, 507	-1.99 ( 4.583 )	-1.84 ( 4.370 )
Week 24, n=500, 498	-2.46 ( 5.085 )	-2.41 ( 4.777 )
Week 32, n=491, 491	-3.17 ( 5.005 )	-2.75 ( 4.682 )
Week 40, n=481, 476	-3.35 ( 4.740 )	-3.15 ( 4.578 )
Week 48, n=489, 478	-3.28 ( 5.000 )	-3.08 ( 4.797 )

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

No statistical analyses for this end point

Secondary: Change from Baseline in hematology parameter: erythrocytes over time

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End point title

Change from Baseline in hematology parameter: erythrocytes over time

End point description

Blood samples were collected for the analysis of hematology parameter: erythrocytes. Baseline value is defined as latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. 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 Weeks 4, 8, 16, 24, 32, 40 and 48

End point values	CAB LA + RPV LA Q8W	CAB LA + RPV LA Q4W
Number of subjects analysed	522 ^[49]	523 ^[50]
Units: 10^12 cells per liter
arithmetic mean (standard deviation)
Week 4, n=331, 520	0.033 ( 0.2206 )	0.024 ( 0.2211 )
Week 8, n=509, 510	0.092 ( 0.2669 )	0.083 ( 0.2651 )
Week 16, n=509, 507	0.182 ( 0.3050 )	0.162 ( 0.3222 )
Week 24, n=500, 498	0.209 ( 0.3071 )	0.170 ( 0.3225 )
Week 32, n=491, 491	0.189 ( 0.3145 )	0.150 ( 0.3337 )
Week 40, n=481, 476	0.229 ( 0.3217 )	0.157 ( 0.3184 )
Week 48, n=489, 478	0.188 ( 0.3288 )	0.170 ( 0.3329 )

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

No statistical analyses for this end point

Secondary: Change from Baseline in hematology parameter: hematocrit over time

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End point title

Change from Baseline in hematology parameter: hematocrit over time

End point description

Blood samples were collected for the analysis of hematology parameter: hematocrit. Baseline value is defined as latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. 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 Weeks 4, 8, 16, 24, 32, 40 and 48

End point values	CAB LA + RPV LA Q8W	CAB LA + RPV LA Q4W
Number of subjects analysed	522 ^[51]	523 ^[52]
Units: Proportion of red blood cells in blood
arithmetic mean (standard deviation)
Week 4, n=331, 520	0.002 ( 0.02088 )	0.002 ( 0.02202 )
Week 8, n=509, 510	0.004 ( 0.02274 )	0.004 ( 0.02362 )
Week 16, n=509, 507	0.008 ( 0.02290 )	0.007 ( 0.02485 )
Week 24, n=500, 498	0.008 ( 0.02219 )	0.004 ( 0.02413 )
Week 32, n=491, 491	0.003 ( 0.02352 )	0.001 ( 0.02469 )
Week 40, n=481, 476	0.006 ( 0.02323 )	0.000 ( 0.02378 )
Week 48, n=489, 478	0.003 ( 0.02414 )	0.001 ( 0.02565 )

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

No statistical analyses for this end point

Secondary: Change from Baseline in hematology parameter: hemoglobin over time

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End point title

Change from Baseline in hematology parameter: hemoglobin over time

End point description

Blood samples were collected for the analysis of hematology parameter: hemoglobin. Baseline value is defined as latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. 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 Weeks 4, 8, 16, 24, 32, 40 and 48

End point values	CAB LA + RPV LA Q8W	CAB LA + RPV LA Q4W
Number of subjects analysed	522 ^[53]	523 ^[54]
Units: Grams per liter
arithmetic mean (standard deviation)
Week 4, n=331, 520	0.08 ( 6.425 )	-0.16 ( 6.797 )
Week 8, n=509, 510	0.28 ( 7.028 )	-0.05 ( 7.419 )
Week 16, n=509, 507	0.44 ( 6.979 )	0.05 ( 7.531 )
Week 24, n=501, 498	1.48 ( 7.013 )	0.45 ( 7.488 )
Week 32, n=491, 491	1.11 ( 7.633 )	0.05 ( 8.041 )
Week 40, n=481, 476	1.36 ( 7.503 )	-0.47 ( 7.788 )
Week 48, n=489, 478	-0.13 ( 7.631 )	-0.80 ( 8.462 )

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

No statistical analyses for this end point

Secondary: Number of participants with phenotypic resistance- Maintenance phase

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End point title

Number of participants with phenotypic resistance- Maintenance phase

End point description

Phenotypic resistance for following Baseline third agent drugs: Integrase inhibitors(INI):bictegravir(BIC), CAB,dolutegravir(DTG),elvitegravir(EVG),raltegravir(RAL);non-nucleoside reverse transcriptase inhibitors(NNRTI):delavirdine(DLV),efavirenz(EFV),etravirine(ETR),nevirapine(NVP),RPV; NRTI: lamivudine(3TC), abacavir(ABC), emtricitabine(FTC), tenofovir(TDF), zidovudine(ZDV), stavudine(d4T), didanosine(ddI) and protease inhibitors(PI): atazanavir(ATV), darunavir(DRV), fosamprenavir(FPV), indinavir(IDV), lopinavir(LPV), nelfinavir(NFV), ritonavir(RTV), saquinavir(SQV) and tipranavir (TPV) is presented. Phenotypic susceptibility was defined based on fold change (FC) value: resistant (FC>clinical higher cutoff or biological cutoff), partially sensitive (FC<=clinical higher cutoff and > clinical lower cutoff), sensitive(FC<=clinical lower cutoff or biological cutoff). Participants with data available at specified data points were analyzed (n= X in category titles).

End point type

Secondary

End point timeframe

Up to Week 48 analysis

End point values	CAB LA + RPV LA Q8W	CAB LA + RPV LA Q4W
Number of subjects analysed	8 ^[55]	2 ^[56]
Units: Participants
INI, BIC, resistant, n=6, 2	0	0
INI, BIC, sensitive, n=6, 2	6	2
INI, CAB, resistant, n=6, 2	3	1
INI, CAB, sensitive, n=6, 2	3	1
INI, DTG, resistant, n=6, 2	0	0
INI, DTG, partially sensitive, n=6, 2	0	0
INI, DTG, sensitive, n=6, 2	6	2
INI, EVG, resistant, n=6, 2	4	2
INI, EVG, sensitive, n=6, 2	2	0
INI, RAL, resistant, n=6, 2	4	2
INI, RAL, sensitive, n=6, 2	2	0
NNRTI, DLV, resistant, n=7, 2	6	2
NNRTI, DLV, sensitive, n=7, 2	1	0
NNRTI, EFV, resistant, n=7, 2	5	2
NNRTI, EFV, sensitive, n=7, 2	2	0
NNRTI, ETR, resistant, n=7, 2	0	2
NNRTI, ETR, partially sensitive, n=7, 2	4	0
NNRTI, ETR, sensitive, n=7, 2	3	0
NNRTI, NVP, resistant, n=7, 2	6	2
NNRTI, NVP, sensitive, n=7, 2	1	0
NNRTI, RPV, resistant, n=7, 2	6	2
NNRTI, RPV, sensitive, n=7, 2	1	0
NRTI, 3TC, resistant, n=7, 2	1	1
NRTI, 3TC, sensitive, n=7, 2	6	1
NRTI, ABC, resistant, n=7, 2	0	0
NRTI, ABC, partially sensitive, n=7, 2	0	0
NRTI, ABC, sensitive, n=7, 2	7	2
NRTI, FTC, resistant, n=7, 2	1	1
NRTI, FTC, sensitive, n=7, 2	6	1
NRTI, TDF, resistant, n=7, 2	0	0
NRTI, TDF, partially sensitive, n=7, 2	0	1
NRTI, TDF, sensitive, n=7, 2	7	1
NRTI, ZDV, resistant, n=7, 2	0	2
NRTI, ZDV, sensitive, n=7, 2	7	0
NRTI, d4T, resistant, n=7, 2	0	0
NRTI, d4T, sensitive, n=7, 2	7	2
NRTI, ddI, resistant, n=7, 2	0	0
NRTI, ddI, partially sensitive, n=7, 2	0	0
NRTI, ddI, sensitive, n=7, 2	7	2
PI, ATV, resistant, n=7, 2	0	0
PI, ATV, sensitive, n=7, 2	7	2
PI, DRV, resistant, n=7, 2	0	0
PI, DRV, partially sensitive, n=7, 2	0	0
PI, DRV, sensitive, n=7, 2	7	2
PI, FPV, resistant, n=7, 2	0	0
PI, FPV, partially sensitive, n=7, 2	0	0
PI, FPV, sensitive, n=7, 2	7	2
PI, IDV, resistant, n=7, 2	0	0
PI, IDV, sensitive, n=7, 2	7	2
PI, LPV, resistant, n=7, 2	0	0
PI, LPV, partially sensitive, n=7, 2	0	0
PI, LPV, sensitive, n=7, 2	7	2
PI, NFV, resistant, n=7, 2	0	1
PI, NFV, sensitive, n=7, 2	7	1
PI, RTV, resistant, n=7, 2	0	1
PI, RTV, sensitive, n=7, 2	7	1
PI, SQV, resistant, n=7, 2	0	0
PI, SQV, partially sensitive, n=7, 2	0	0
PI, SQV, sensitive, n=7, 2	7	2
PI, TPV, resistant, n=7, 2	0	0
PI, TPV, partially sensitive, n=7, 2	0	0
PI, TPV, sensitive, n=7, 2	7	2

Notes
[55] - CVF Population comprised of all participants who met CVF criteria.
[56] - CVF Population comprised of all participants who met CVF criteria.

No statistical analyses for this end point

Secondary: Number of participants with genotypic resistance-Maintenance phase

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End point title

Number of participants with genotypic resistance-Maintenance phase

End point description

Genotypic resistance was analyzed in participants who met confirmed virologic withdrawal criteria. Genotypic Resistance data for the following Baseline third agent drugs, INI: BIC, DTG, EVG, RAL; NNRTI: DLV, EFV, ETR, NVP, RPV; NRTI: 3TC, ABC, FTC, TDF, ZDV, d4T, ddI and PI: ATV, ATV/ritonavir (r), DRV/r, FPV/r, IDV/r, LPV/r, NFV, RTV, SQV/r and TPV/r in participants meeting CVF criteria 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

Up to Week 48 analysis

End point values	CAB LA + RPV LA Q8W	CAB LA + RPV LA Q4W
Number of subjects analysed	8 ^[57]	2 ^[58]
Units: Participants
INI, BIC, resistant, n=6, 2	1	0
INI, BIC, resistance possible, n=6, 2	2	1
INI, BIC, sensitive, n=6, 2	3	1
INI, DTG, resistant, n=6, 2	1	0
INI, DTG, resistance possible, n=6, 2	2	1
INI, DTG, sensitive, n=6, 2	3	1
INI, EVG, resistant, n=6, 2	4	2
INI, EVG, resistance possible, n=6, 2	0	0
INI, EVG, sensitive, n=6, 2	2	0
INI, RAL, resistant, n=6, 2	4	2
INI, RAL, resistance possible, n=6, 2	0	0
INI, RAL, sensitive, n=6, 2	2	0
NNRTI, DLV, resistant, n=8, 2	2	1
NNRTI, DLV, resistance possible, n=8, 2	2	1
NNRTI, DLV, sensitive, n=8, 2	4	0
NNRTI, EFV, resistant, n=8, 2	4	2
NNRTI, EFV, resistance possible, n=8, 2	2	0
NNRTI, EFV, sensitive, n=8, 2	2	0
NNRTI, ETR, resistant, n=8, 2	0	1
NNRTI, ETR, resistance possible, n=8, 2	2	1
NNRTI, ETR, sensitive, n=8, 2	6	0
NNRTI, NVP, resistant, n=8, 2	4	2
NNRTI, NVP, resistance possible, n=8, 2	2	0
NNRTI, NVP, sensitive, n=8, 2	2	0
NNRTI, RPV, resistant, n=8, 2	6	1
NNRTI, RPV, resistance possible, n=8, 2	0	0
NNRTI, RPV, sensitive, n=8, 2	2	1
NRTI, 3TC, resistant, n=8, 2	1	1
NRTI, 3TC, resistance possible, n=8, 2	0	0
NRTI, 3TC, sensitive, n=8, 2	7	1
NRTI, ABC, resistant, n=8, 2	0	0
NRTI, ABC, resistance possible, n=8, 2	0	1
NRTI, ABC, sensitive, n=8, 2	8	1
NRTI, FTC, resistant, n=8, 2	1	1
NRTI, FTC, resistance possible, n=8, 2	0	0
NRTI, FTC, sensitive, n=8, 2	7	1
NRTI, TDF, resistant, n=8, 2	0	1
NRTI, TDF, resistance possible, n=8, 2	0	0
NRTI, TDF, sensitive, n=8, 2	8	1
NRTI, ZDV, resistant, n=8, 2	0	1
NRTI, ZDV, resistance possible, n=8, 2	0	0
NRTI, ZDV, sensitive, n=8, 2	8	1
NRTI, d4T, resistant, n=8, 2	0	1
NRTI, d4T, resistance possible, n=8, 2	0	0
NRTI, d4T, sensitive, n=8, 2	8	1
NRTI, ddI, resistant, n=8, 2	0	1
NRTI, ddI, resistance possible, n=8, 2	1	0
NRTI, ddI, sensitive, n=8, 2	7	1
PI, ATV, resistant, n=8, 2	0	1
PI, ATV, resistance possible, n=8, 2	0	0
PI, ATV, sensitive, n=8, 2	8	1
PI, ATV/r, resistant, n=8, 2	0	0
PI, ATV/r, resistance possible, n=8, 2	0	1
PI, ATV/r, sensitive, n=8, 2	8	1
PI, DRV/r, resistant, n=8, 2	0	0
PI, DRV/r, resistance possible, n=8, 2	0	0
PI, DRV/r, sensitive, n=8, 2	8	2
PI, FPV/r, resistant, n=8, 2	0	0
PI, FPV/r, resistance possible, n=8, 2	0	0
PI, FPV/r, sensitive, n=8, 2	8	2
PI, IDV/r, resistant, n=8, 2	0	0
PI, IDV/r, resistance possible, n=8, 2	0	1
PI, IDV/r, sensitive, n=8, 2	8	1
PI, LPV/r, resistant, n=8, 2	0	0
PI, LPV/r, resistance possible, n=8, 2	0	0
PI, LPV/r, sensitive, n=8, 2	8	2
PI, NFV, resistant, n=8, 2	0	1
PI, NFV, resistance possible, n=8, 2	0	0
PI, NFV, sensitive, n=8, 2	8	1
PI, RTV, resistant, n=8, 2	0	1
PI, RTV, resistance possible, n=8, 2	0	0
PI, RTV, sensitive, n=8, 2	8	1
PI, SQV/r, resistant, n=8, 2	0	0
PI, SQV/r, resistance possible, n=8, 2	0	0
PI, SQV/r, sensitive, n=8, 2	8	2
PI, TPV/r, resistant, n=8, 2	0	1
PI, TPV/r, resistance possible, n=8, 2	0	0
PI, TPV/r, sensitive, n=8, 2	8	1

Notes
[57] - CVF Population.
[58] - CVF Population.

No statistical analyses for this end point

Secondary: Number of participants with their treatment preference as assessed using preference questionnaire at Week 48 without (w/o) prior exposure to CAB+RPV-CAB 600 mg LA +RPV 900 mg LA Q8W arm only

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End point title

Number of participants with their treatment preference as assessed using preference questionnaire at Week 48 without (w/o) prior exposure to CAB+RPV-CAB 600 mg LA +RPV 900 mg LA Q8W arm only ^[59]

End point description

Participants were administered the preference questionnaire which had 3 questions. For treatment preference, participants were required to provide their response to Question 1, which stated "Based on your experience which HIV treatment do you prefer". The responses included 1) Injectable LA HIV treatment Q4W, 2) Injectable LA HIV Treatment Q8W (only select this answer if you received the 8-week injectable regimen of CAB LA + RPV LA during study), 3) Oral daily HIV treatment and 4) No preference. Oral daily HIV Treatment refers to the oral medication of CAB + RPV subjects received during the oral lead-in period. Number of participants without prior exposure to CAB+RPV who selected each of the responses based on their treatment preference is presented. Only those participants with data available at indicated time point is analyzed.

End point type

Secondary

End point timeframe

Week 48

Notes
[59] - 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: The endpoint is only with respect to Q8W arm where treatment preference was assessed using preference questionnaire at Week 48 without prior exposure to CABLA+RPV LA.

End point values	CAB LA + RPV LA Q8W
Number of subjects analysed	306 ^[60]
Units: Participants
Injectable LA HIV treatment every 4 weeks	0
Injectable LA HIV treatment every 8 weeks	300
Oral daily HIV treatment	4
No preference	2

Notes
[60] - ITT-E Population.

No statistical analyses for this end point

Secondary: Number of participants with their treatment preference as assessed using preference questionnaire at Week 48 with >=1 weeks of prior exposure to CAB+RPV-CAB 600 mg LA +RPV 900 mg LA Q8W arm only

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End point title

Number of participants with their treatment preference as assessed using preference questionnaire at Week 48 with >=1 weeks of prior exposure to CAB+RPV-CAB 600 mg LA +RPV 900 mg LA Q8W arm only ^[61]

End point description

Participants were administered the preference questionnaire which had 3 questions. For treatment preference, participants were required to provide their response to Question 1, which stated "Based on your experience which HIV treatment do you prefer". The responses included 1) Injectable LA HIV treatment Q4W, 2) Injectable LA HIV Treatment Q8W (only select this answer if you received the 8-week injectable regimen of CAB LA + RPV LA during study), 3) Oral daily HIV treatment and 4) No preference. Oral daily HIV Treatment refers to the oral medication of CAB + RPV subjects received during the oral lead-in period. Number of participants with >=1 weeks of prior exposure to CAB+RPV who selected each of the responses based on their treatment preference is presented. Only those participants with data available at indicated time point is analyzed.

End point type

Secondary

End point timeframe

Week 48

Notes
[61] - 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: The endpoint is only with respect to Q8W arm where treatment preference was assessed using preference questionnaire at Week 48 without prior exposure to CABLA+RPV LA.

End point values	CAB LA + RPV LA Q8W
Number of subjects analysed	191 ^[62]
Units: Participants
Injectable LA HIV treatment every 4 weeks	6
Injectable LA HIV treatment every 8 weeks	179
Oral daily HIV treatment	4
No preference	2

Notes
[62] - ITT-E Population

No statistical analyses for this end point

Secondary: Number of participants with their treatment preference as assessed using preference questionnaire at Week 48-CAB 400 mg LA +RPV 600 mg LA Q4W arm only

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End point title

Number of participants with their treatment preference as assessed using preference questionnaire at Week 48-CAB 400 mg LA +RPV 600 mg LA Q4W arm only ^[63]

End point description

Participants were administered the preference questionnaire which had 3 questions. For treatment preference, participants were required to provide their response to Question 1, which stated "Based on your experience which HIV treatment do you prefer". The responses included 1) Injectable LA HIV treatment Q4W, 2) Injectable LA HIV Treatment Q8W (only select this answer if you received the 8-week injectable regimen of CAB LA + RPV LA during study), 3) Oral daily HIV treatment and 4) No preference. Oral daily HIV Treatment refers to the oral medication of CAB + RPV subjects received during the oral lead-in period. Number of participants who selected each of the responses based on their treatment preference is presented. Only those participants with data available at indicated time point is analyzed.

End point type

Secondary

End point timeframe

Week 48

Notes
[63] - 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: The endpoint is only with respect to Q8W arm where treatment preference was assessed using preference questionnaire at Week 48 without prior exposure to CABLA+RPV LA.

End point values	CAB LA + RPV LA Q4W
Number of subjects analysed	497 ^[64]
Units: Participants
Injectable LA HIV treatment every 4 weeks	468
Injectable LA HIV treatment every 8 weeks	0
Oral daily HIV treatment	16
No preference	13

Notes
[64] - 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 in participants with or without prior exposure to CAB+RPV

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End point title

Change from Baseline in Life Satisfaction (LISAT) Using HIV/AIDs-targeted Quality of Life (HATQoL) Questionnaire in participants with or without prior exposure to CAB+RPV

End point description

HATQoL questionnaire, used to assess health related QoL(HRQoL). It comprises of 3 dimensions:LISAT, medication worries(MEDWO) and disclosure worries(DISWO). Total imputed value score for LISAT is calculated on a 0-100 scale using formula:LISAT 100=[100 divided by (20 minus 4)]*(LISAT minus 4). Response of 5 shows satisfaction all of time and 1 as none of time. Higher the score, greater satisfaction to life and less worry. Transformed dimension score for each domain was summarized and analyzed. Last Observation Carried Forward(LOCF) was primary method of analysis. Data for participants w/o/with prior exposure to CAB+RPV(0 Weeks[w/o exposure] and >=1 Weeks[with exposure]) has been presented. Baseline value is defined as last available recorded value up to and including the Maintenance treatment start. Change from Baseline value is calculated as value at post-dose visit minus Baseline value. Participants with data available at specified data points were analyzed(n= X in category titles)

End point type

Secondary

End point timeframe

Baseline (Day 1) and Weeks 24 and 48

End point values	CAB LA + RPV LA Q8W	CAB LA + RPV LA Q4W
Number of subjects analysed	522 ^[65]	523 ^[66]
Units: Scores on a scale
arithmetic mean (standard deviation)
Without exposure, Week 24, n=318, 324	1.5 ( 14.87 )	-0.5 ( 18.00 )
Without exposure, Week 48, n=319, 324	-0.8 ( 15.24 )	0.6 ( 17.51 )
With exposure, Week 24, n=192, 194	-0.8 ( 14.31 )	0.8 ( 13.73 )
With exposure, Week 48, n=192, 194	0.3 ( 14.03 )	-1.3 ( 14.50 )

Notes
[65] - ITT-E Population.
[66] - ITT-E Population.

No statistical analyses for this end point

Secondary: Change from Baseline in HIV medication, MEDWO using HATQoL Questionnaire in participants with or without prior exposure to CAB+RPV

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End point title

Change from Baseline in HIV medication, MEDWO using HATQoL Questionnaire in participants with or without prior exposure to CAB+RPV

End point description

Total imputed value score for MEDWO is calculated on a 0-100 scale using formula: MEDWO 100=[100 divided by (25 minus 5)]*(MEDWO minus 5). A response of 1 in MEDWO score shows medication worries all of the time and 5 as none of the time. The higher the score, the greater satisfaction to life and the less worry. The transformed dimension score for each domain was summarized and analyzed. LOCF was used as primary method of analysis. Participants without/with prior exposure to CAB+RPV (0 Weeks [without exposure] and >=1 Weeks [with exposure]) has been presented. Baseline value is defined as last available recorded value up to and including the Maintenance treatment start. 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 Weeks 24 and 48

End point values	CAB LA + RPV LA Q8W	CAB LA + RPV LA Q4W
Number of subjects analysed	522 ^[67]	523 ^[68]
Units: Scores on a scale
arithmetic mean (standard deviation)
Without exposure, Week 24, n=318, 324	2.7 ( 16.53 )	2.6 ( 15.61 )
Without exposure, Week 48, n=319, 324	3.0 ( 15.87 )	1.9 ( 15.97 )
With exposure, Week 24, n=192, 194	0.7 ( 10.57 )	1.7 ( 14.86 )
With exposure, Week 48, n=192, 194	1.3 ( 8.82 )	1.3 ( 17.95 )

Notes
[67] - ITT-E Population
[68] - ITT-E Population

No statistical analyses for this end point

Secondary: Change from Baseline in DISWO using HATQoL Questionnaire in participants with or without prior exposure to CAB+RPV

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End point title

Change from Baseline in DISWO using HATQoL Questionnaire in participants with or without prior exposure to CAB+RPV

End point description

The total imputed value score for DISWO is calculated on a 0-100 scale using the formula: DISWO 100=[100 divided by (25 minus 5)]*(DISWO minus 5). A response of 1 in DISWO score shows disclosure worries all of the time and 5 as none of the time. The higher the score, the greater satisfaction to life and the less worry. The transformed dimension score for each domain was summarized and analyzed. LOCF was used as primary method of analysis. Participants without/with prior exposure to CAB+RPV (0 Weeks [without exposure] and >=1 Weeks [with exposure]) has been presented. Baseline value is defined as last available recorded value up to and including the Maintenance treatment start. 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 Weeks 24 and 48

End point values	CAB LA + RPV LA Q8W	CAB LA + RPV LA Q4W
Number of subjects analysed	522 ^[69]	523 ^[70]
Units: Scores on a scale
arithmetic mean (standard deviation)
Without exposure, Week 24, n=317, 324	1.4 ( 25.58 )	1.2 ( 23.18 )
Without exposure, Week 48, n=318, 324	-0.5 ( 28.14 )	-0.5 ( 23.86 )
With exposure, Week 24, n=192, 194	0.9 ( 21.13 )	1.8 ( 24.20 )
With exposure, Week 48, n=192, 194	-0.6 ( 24.11 )	1.5 ( 26.84 )

Notes
[69] - ITT-E Population
[70] - ITT-E Population

No statistical analyses for this end point

Secondary: Change from Baseline in total treatment satisfaction score using HIV treatment satisfaction status questionnaire (HIVTSQs) at Weeks 24 and 48

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End point title

Change from Baseline in total treatment satisfaction score using HIV treatment satisfaction status questionnaire (HIVTSQs) at Weeks 24 and 48

End point description

The HIVTSQs treatment satisfaction questionnaire comprises of 1-12 questions and the total treatment satisfaction score is computed with items 1-11 and summed to produce a score with a possible range of 0 to 66. Higher scores represent greater treatment satisfaction as compared to the past few weeks. LOCF was used as primary method of analysis. Participants without/with prior exposure to CAB+RPV (0 Weeks [without exposure] and >=1 Weeks [with exposure]) has been presented. Baseline value is defined as last available recorded value up to and including the Maintenance treatment start. 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 Weeks 24 and 48

End point values	CAB LA + RPV LA Q8W	CAB LA + RPV LA Q4W
Number of subjects analysed	522 ^[71]	523 ^[72]
Units: Scores on a scale
arithmetic mean (standard deviation)
Without exposure, Week 24, n=319, 323	4.63 ( 9.818 )	4.44 ( 9.709 )
Without exposure, Week 48, n=319, 323	4.42 ( 10.351 )	3.55 ( 10.224 )
With exposure, Week 24, n=191, 193	0.55 ( 5.050 )	0.55 ( 5.347 )
With exposure, Week 48, n=191, 194	0.40 ( 5.242 )	-0.01 ( 6.521 )

Notes
[71] - ITT-E Population
[72] - ITT-E Population

No statistical analyses for this end point

Secondary: Change from Baseline in individual item scores using HIVTSQs at Weeks 24 and 48

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End point title

Change from Baseline in individual item scores using HIVTSQs at Weeks 24 and 48

End point description

HIVTSQs is a 12 item questionnaire. The individual item scores on HIVTSQs scale are rated as 6 (very satisfied, convenient, flexible, etc.) to 0 (very dissatisfied, inconvenient, inflexible, etc.). Higher scores represent greater satisfaction with each aspect of treatment. LOCF was used as primary method of analysis. Participants without/with prior exposure to CAB+RPV (0 Weeks [without exposure] and >=1 Weeks [with exposure]) has been presented. Baseline value is defined as last available recorded value up to and including the Maintenance treatment start. 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 Weeks 24 and 48

End point values	CAB LA + RPV LA Q8W	CAB LA + RPV LA Q4W
Number of subjects analysed	522 ^[73]	523 ^[74]
Units: Scores on a scale
arithmetic mean (standard deviation)
Item 1, Without exposure, Week 24, n=319, 323	0.3 ( 1.19 )	0.3 ( 1.18 )
Item 1, Without exposure, Week 48, n=319, 323	0.3 ( 1.23 )	0.2 ( 1.27 )
Item 1, With exposure, Week 24, n=191, 193	0.1 ( 0.77 )	0.0 ( 0.78 )
Item 1, With exposure, Week 48, n=191, 194	0.1 ( 0.81 )	0.0 ( 0.90 )
Item 2, Without exposure, Week 24, n=319, 323	0.0 ( 0.73 )	0.1 ( 0.67 )
Item 2, Without exposure, Week 48, n=319, 323	0.0 ( 0.78 )	0.0 ( 0.65 )
Item 2, With exposure, Week 24, n=191, 193	0.0 ( 0.42 )	0.1 ( 0.61 )
Item 2, With exposure, Week 48, n=191, 194	0.0 ( 0.49 )	0.1 ( 0.63 )
Item 3, Without exposure, Week 24, n=319, 323	0.0 ( 1.42 )	0.0 ( 1.49 )
Item 3, Without exposure, Week 48, n=319, 323	0.0 ( 1.45 )	0.0 ( 1.48 )
Item 3, With exposure, Week 24, n=191, 193	0.0 ( 0.82 )	0.1 ( 1.03 )
Item 3, With exposure, Week 48, n=191, 194	0.0 ( 1.05 )	0.0 ( 1.20 )
Item 4, Without exposure, Week 24, n=319, 323	0.3 ( 1.05 )	0.3 ( 1.28 )
Item 4, Without exposure, Week 48, n=319, 323	0.2 ( 1.20 )	0.2 ( 1.28 )
Item 4, With exposure, Week 24, n=191, 193	0.1 ( 0.73 )	0.0 ( 0.80 )
Item 4, With exposure, Week 48, n=191, 194	0.1 ( 0.73 )	0.0 ( 0.98 )
Item 5, Without exposure, Week 24, n=319, 323	0.7 ( 1.41 )	0.6 ( 1.37 )
Item 5, Without exposure, Week 48, n=319, 323	0.7 ( 1.36 )	0.5 ( 1.42 )
Item 5, With exposure, Week 24, n=191, 193	0.0 ( 0.58 )	0.1 ( 0.72 )
Item 5, With exposure, Week 48, n=191, 194	0.0 ( 0.69 )	0.0 ( 0.88 )
Item 6, Without exposure, Week 24, n=319, 323	0.9 ( 1.72 )	0.8 ( 1.71 )
Item 6, Without exposure, Week 48, n=319, 323	0.8 ( 1.71 )	0.8 ( 1.80 )
Item 6, With exposure, Week 24, n=191, 193	0.2 ( 0.96 )	0.1 ( 0.90 )
Item 6, With exposure, Week 48, n=191, 194	0.1 ( 1.13 )	-0.1 ( 1.12 )
Item 7, Without exposure, Week 24, n=319, 323	0.3 ( 0.78 )	0.2 ( 0.98 )
Item 7, Without exposure, Week 48, n=319, 323	0.2 ( 0.94 )	0.2 ( 0.92 )
Item 7, With exposure, Week 24, n=191, 193	0.0 ( 0.55 )	0.0 ( 0.70 )
Item 7, With exposure, Week 48, n=191, 194	0.1 ( 0.73 )	0.1 ( 0.69 )
Item 8, Without exposure, Week 24, n=318, 322	0.5 ( 1.31 )	0.6 ( 1.30 )
Item 8, Without exposure, Week 48, n=319, 323	0.5 ( 1.31 )	0.5 ( 1.41 )
Item 8, With exposure, Week 24, n=191, 194	0.1 ( 0.61 )	0.1 ( 0.58 )
Item 8, With exposure, Week 48, n=191, 194	0.0 ( 0.64 )	0.0 ( 0.80 )
Item 9, Without exposure, Week 24, n=319, 322	0.4 ( 1.16 )	0.4 ( 1.30 )
Item 9, Without exposure, Week 48, n=319, 323	0.4 ( 1.23 )	0.3 ( 1.36 )
Item 9, With exposure, Week 24, n=191, 194	0.0 ( 0.52 )	0.0 ( 0.72 )
Item 9, With exposure, Week 48, n=191, 194	0.1 ( 0.55 )	0.0 ( 0.85 )
Item 10, Without exposure, Week 24, n=319, 322	0.8 ( 1.44 )	0.9 ( 1.50 )
Item 10, Without exposure, Week 48, n=319, 323	0.8 ( 1.52 )	0.7 ( 1.63 )
Item 10, With exposure, Week 24, n=191, 194	0.0 ( 0.78 )	0.0 ( 0.67 )
Item 10, With exposure, Week 48, n=191, 194	0.0 ( 0.79 )	0.0 ( 0.77 )
Item 11, Without exposure, Week 24, n=319, 322	0.4 ( 1.22 )	0.4 ( 1.25 )
Item 11, Without exposure, Week 48, n=319, 323	0.4 ( 1.26 )	0.3 ( 1.31 )
Item 11, With exposure, Week 24, n=191, 194	0.0 ( 0.73 )	0.1 ( 0.65 )
Item 11, With exposure, Week 48, n=191, 194	0.0 ( 0.62 )	-0.1 ( 0.84 )
Item 12, Without exposure, Week 24, n=319, 322	-0.4 ( 1.46 )	-0.4 ( 1.48 )
Item 12, Without exposure, Week 48, n=319, 323	-0.3 ( 1.46 )	-0.5 ( 1.57 )
Item 12, With exposure, Week 24, n=191, 194	-0.1 ( 0.92 )	0.0 ( 0.92 )
Item 12, With exposure, Week 48, n=191, 194	-0.1 ( 1.08 )	0.0 ( 1.02 )

Notes
[73] - ITT-E Population
[74] - ITT-E Population

No statistical analyses for this end point

Secondary: Total treatment satisfaction change score using HIV treatment satisfaction change questionnaire (HIVTSQc) at Week 48

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End point title

Total treatment satisfaction change score using HIV treatment satisfaction change questionnaire (HIVTSQc) at Week 48

End point description

The HIVTSQc is a 1-12 items questionnaire. Each item is scored -3 to 3. Total treatment satisfaction change score is computed using items 1 to 11 and are summed to produce a score with a possible range of -33 to 33. Higher the score, greater the improvement in satisfaction with treatment; the lower the score, the greater the deterioration in satisfaction with treatment. A score of 0 represented no change. LOCF was used as primary method of analysis. Total treatment satisfaction change score for participants who entered the current study from Q4W arm of ATLAS (NCT number: NCT02951052) and from either standard of care (SOC) arms of ATLAS or the new SOC participants) 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

Week 48

End point values	CAB LA + RPV LA Q8W	CAB LA + RPV LA Q4W
Number of subjects analysed	522 ^[75]	523 ^[76]
Units: Scores on a scale
arithmetic mean (standard deviation)
Q4W ATLAS, n=124, 125	29.1 ( 6.72 )	24.7 ( 12.33 )
SOC, n=380, 382	28.9 ( 7.68 )	27.3 ( 9.50 )

Notes
[75] - ITT-E Population
[76] - ITT-E Population

No statistical analyses for this end point

Secondary: Change from Week 8 in dimension scores using perception of injection (PIN) questionnaire.

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End point title

Change from Week 8 in dimension scores using perception of injection (PIN) questionnaire.

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 an HIV injectable treatment following visit and satisfaction with mode of treatment administration of individuals receiving injection and perceptions of individuals associated with receiving injections. This measure contains 21 items that measure pain at injection site, local site reactions, impact on functioning and willingness to pursue injectable treatment outside of a clinical trial. Scores range from 1 to 5 and 1 always = most favourable perception of vaccination, and 5=most unfavourable. Dimension scores include bother from ISR, leg movement, sleep and acceptability. Domain scores is calculated as mean of all items within domain. Higher the scores, worse perception of injection. LOCF was primary method of analysis. Participants with data available at specified data points were analyzed (represented by n= X in category titles)

End point type

Secondary

End point timeframe

Week 8 and Weeks 24 and 48

End point values	CAB LA + RPV LA Q8W	CAB LA + RPV LA Q4W
Number of subjects analysed	522 ^[77]	523 ^[78]
Units: Scores on a scale
arithmetic mean (standard deviation)
Bother of ISRs, Week 24, n=515, 515	-0.00 ( 0.459 )	-0.01 ( 0.509 )
Bother of ISRs, Week 48, n=515, 515	-0.00 ( 0.531 )	0.01 ( 0.543 )
Leg Movement, Week 24, n=515, 514	-0.11 ( 0.804 )	-0.23 ( 0.809 )
Leg Movement, Week 48, n=515, 514	-0.12 ( 0.818 )	-0.24 ( 0.789 )
Sleep, Week 24, n=515, 514	-0.00 ( 0.772 )	-0.20 ( 0.793 )
Sleep, Week 48, n=515, 514	-0.03 ( 0.814 )	-0.18 ( 0.804 )
Acceptance, Week 24, n=514, 515	-0.13 ( 0.813 )	-0.13 ( 0.837 )
Acceptance, Week 48, n=514, 515	-0.18 ( 0.829 )	-0.13 ( 0.880 )

Notes
[77] - ITT-E Population
[78] - ITT-E Population

No statistical analyses for this end point

Secondary: Change from Week 8 in individual item scores (Anxiety before, Pain, Satisfaction, Anxiety after and Willingness) using perception of injection (PIN) questionnaire.

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End point title

Change from Week 8 in individual item scores (Anxiety before, Pain, Satisfaction, Anxiety after and Willingness) using perception of injection (PIN) questionnaire.

End point description

The PIN questionnaire explores the bother of pain at the injection site and ISRs, anxiety before and after injection, willingness to receive an HIV injectable treatment the following visit and satisfaction with the mode of treatment administration of individuals receiving injection and perceptions of individuals associated with receiving injections. This measure contains 21 items that measure pain at injection site, local site reactions, impact on functioning and willingness to pursue injectable treatment outside of a clinical trial. The items in the scale are rated on a 5-point scale ranging from 1(very dissatisfied, extremely, etc.) to 5 (very satisfied, not at all, etc.). Lower scores represent worse perception of injection. LOCF was used as primary method of analysis. 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

Week 8 and Weeks 24 and 48

End point values	CAB LA + RPV LA Q8W	CAB LA + RPV LA Q4W
Number of subjects analysed	522 ^[79]	523 ^[80]
Units: Scores on a scale
arithmetic mean (standard deviation)
Anxiety before, Week 24, n=515, 515	0.0 ( 0.83 )	-0.1 ( 0.85 )
Anxiety before, Week 48, n=515, 515	-0.1 ( 0.82 )	-0.1 ( 0.85 )
Pain, Week 24, n=515, 515	0.1 ( 0.83 )	0.1 ( 0.84 )
Pain, Week 48, n=515, 515	0.0 ( 0.85 )	0.0 ( 0.84 )
Satisfaction, Week 24, n=514, 515	0.1 ( 0.77 )	-0.0 ( 0.77 )
Satisfaction, Week 48, n=514, 515	-0.0 ( 0.77 )	-0.0 ( 0.84 )
Anxiety after, Week 24, n=514, 515	-0.0 ( 0.76 )	0.0 ( 0.83 )
Anxiety after, Week 48, n=514, 515	-0.1 ( 0.79 )	-0.1 ( 0.89 )
Willingness, Week 24, n=514, 514	-0.1 ( 0.55 )	-0.1 ( 0.65 )
Willingness, Week 48, n=514, 514	-0.0 ( 0.66 )	-0.1 ( 0.72 )

Notes
[79] - ITT-E Population
[80] - ITT-E Population

No statistical analyses for this end point

Secondary: Change from Baseline in Treatment Acceptance a Using "General Acceptance" Dimension of the Chronic Treatment Acceptance (ACCEPT) Questionnaire in participants with or without prior exposure to CAB+RPV

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End point title

Change from Baseline in Treatment Acceptance a Using "General Acceptance" Dimension of the Chronic Treatment Acceptance (ACCEPT) Questionnaire in participants with or without prior exposure to CAB+RPV

End point description

ACCEPT questionnaire is a generic medication acceptance measure assessing how participants weigh advantages and disadvantages of long-term medication. It consists of 25 items that capture 6 dimensions. 3 questions that focus on general acceptance of study medication were analyzed.Items on scale are rated as 1-5 scores:1:not at all acceptable,2:not very acceptable,3:somewhat acceptable, 4:totally acceptable and 5:I don't know.Total score of dimension is mean of recoded items of dimension and then linearly transformed on a scale from 0 to 100:Total Score=(mean of recoded items in dimension minus1)divided by2*100. LOCF was primary method of analysis. Data for participants w/o or with prior exposure has been presented.Baseline value is last available value up to and including Maintenance treatment. Change from Baseline value is value at post-dose visit minus Baseline value. 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 Weeks 24 and 48

End point values	CAB LA + RPV LA Q8W	CAB LA + RPV LA Q4W
Number of subjects analysed	522 ^[81]	523 ^[82]
Units: Scores on a scale
arithmetic mean (standard deviation)
Without exposure, Week 24, n=319, 323	6.0 ( 27.96 )	4.0 ( 33.53 )
Without exposure, Week 48, n=319, 324	6.9 ( 30.96 )	5.6 ( 31.77 )
With exposure, Week 24, n=192, 194	0.3 ( 21.37 )	-1.7 ( 21.79 )
With exposure, Week 48, n=192, 194	-0.1 ( 24.92 )	-2.7 ( 24.25 )

Notes
[81] - ITT-E Population
[82] - ITT-E 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 pharmacokinetic (PK) analysis of CAB LA. PK Population comprises of all participants who received CAB and / or RPV and underwent PK sampling during the study and provide at least 1 non-missing CAB and / or RPV plasma concentration value (Non-quantifiable [NQ] values will be considered as non-missing values). 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 4, 8, 16, 24, 32, 40 and 48

End point values	CAB LA Q8W	CAB LA Q4W
Number of subjects analysed	521 ^[83]	521 ^[84]
Units: Micrograms per milliliter
geometric mean (confidence interval 95%)
Pre-dose, Week 4, n=314, 513	5.1543 (4.8702 to 5.4550)	4.0285 (3.8303 to 4.2369)
Pre-dose, Week 8, n=516, 513	1.7938 (1.7007 to 1.8920)	1.9011 (1.7965 to 2.0119)
Pre-dose, Week 16, n=512, 514	1.5983 (1.5223 to 1.6781)	2.3358 (2.2436 to 2.4317)
Pre-dose, Week 24, n=506, 510	1.5955 (1.5203 to 1.6744)	2.5795 (2.4826 to 2.6802)
Pre-dose, Week 32, n=499, 498	1.7414 (1.6612 to 1.8254)	2.8529 (2.7408 to 2.9696)
Pre-dose, Week 40, n=496, 497	1.7873 (1.7058 to 1.8727)	2.9739 (2.8713 to 3.0801)
Pre-dose, Week 48, n=494, 486	1.6747 (1.6033 to 1.7493)	2.7449 (2.6492 to 2.8441)

Notes
[83] - PK Population.
[84] - PK Population.

No statistical analyses for this end point

Secondary: Plasma Ctrough for RPV LA Evaluable

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End point title

Plasma 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 4, 8, 16, 24, 32, 40 and 48

End point values	RPV LA Q8W	RPV LA Q4W
Number of subjects analysed	521 ^[85]	521 ^[86]
Units: Nanograms per milliliters
geometric mean (confidence interval 95%)
Pre-dose, Week 4, n=315, 514	78.05 (73.32 to 83.09)	78.60 (75.03 to 82.35)
Pre-dose, Week 8, n=515, 512	56.35 (53.73 to 59.09)	57.95 (55.09 to 60.96)
Pre-dose, Week 16, n=512, 513	54.84 (52.55 to 57.22)	68.12 (65.15 to 71.23)
Pre-dose, Week 24, n=506, 509	57.16 (54.77 to 59.66)	75.76 (72.64 to 79.02)
Pre-dose, Week 32, n=498, 498	62.07 (59.54 to 64.71)	85.76 (82.35 to 89.30)
Pre-dose, Week 40, n=497, 497	67.22 (64.58 to 69.97)	89.49 (86.22 to 92.88)
Pre-dose, Week 48, n=495, 488	72.29 (69.50 to 75.19)	97.22 (93.49 to 101.09)

Notes
[85] - PK Population.
[86] - PK 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

Blood samples were collected at indicated time points to analyze concentration in plasma for CAB LA. Participants who transitioned from ATLAS (201585 - NCT02951052) into this ATLAS-2M (207966) study had been treated with CAB + RPV for at least one year, were approaching steady state exposures, and were therefore excluded in order to focus the population analysis on those without prior exposure. Only those participants with data available at specified time points has been analyzed.

End point type

Secondary

End point timeframe

Predose at Weeks 4, 8, 13, 24, 32, 40, 48; 1 Week post-dose at Week 9 and 41

End point values	CAB LA Q8W	CAB LA Q4W
Number of subjects analysed	321 ^[87]	321 ^[88]
Units: Micrograms*hours per milliliter
geometric mean (confidence interval 95%)	3756.03 (3648.02 to 3867.25)	2449.75 (2378.56 to 2523.07)

Notes
[87] - PK Population.
[88] - PK Population.

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

Blood samples were collected at indicated time points to analyze concentration in plasma for RPV LA. Participants who transitioned from ATLAS (201585 - NCT02951052) into this ATLAS-2M (207966) study had been treated with CAB + RPV for at least one year, were approaching steady state exposures, and were therefore excluded in order to focus the population analysis on those without prior exposure. Only those participants with data available at specified time points has been analyzed.

End point type

Secondary

End point timeframe

Predose at Weeks 4, 8, 13, 24, 32, 40, 48; 1 Week post-dose at Week 9 and 41

End point values	RPV LA Q8W	RPV LA Q4W
Number of subjects analysed	321 ^[89]	320 ^[90]
Units: Nanograms*hours per milliliter
geometric mean (confidence interval 95%)	126467.59 (122284.26 to 130794.04)	70306.62 (67814.64 to 72890.17)

Notes
[89] - PK Population.
[90] - PK Population.

No statistical analyses for this end point

Secondary: Maximum Concentration (Cmax) in Plasma for CAB LA Evaluable

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End point title

Maximum Concentration (Cmax) in Plasma for CAB LA Evaluable

End point description

Blood samples were collected at indicated time points to analyze Cmax in plasma for CAB LA. Participants who transitioned from ATLAS (201585 - NCT02951052) into this ATLAS-2M (207966) study had been treated with CAB + RPV for at least one year, were approaching steady state exposures, and were therefore excluded in order to focus the population analysis on those without prior exposure. Only those participants with data available at specified time points has been analyzed.

End point type

Secondary

End point timeframe

Predose at Weeks 4, 8, 13, 24, 32, 40, 48; 1 Week post-dose at Week 9 and 41

End point values	CAB LA Q8W	CAB LA Q4W
Number of subjects analysed	321 ^[91]	321 ^[92]
Units: Micrograms per milliliter
geometric mean (confidence interval 95%)	3.976 (3.839 to 4.117)	4.277 (4.140 to 4.418)

Notes
[91] - PK Population.
[92] - PK Population.

No statistical analyses for this end point

Secondary: Cmax in Plasma for RPV LA Evaluable

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End point title

Cmax in Plasma for RPV LA Evaluable

End point description

Blood samples were collected at indicated time points to analyze Cmax in plasma for RPV LA. Participants who transitioned from ATLAS (201585 - NCT02951052) into this ATLAS-2M (207966) study had been treated with CAB + RPV for at least one year, were approaching steady state exposures, and were therefore excluded in order to focus the population analysis on those without prior exposure. Only those participants with data available at specified time points has been analyzed.

End point type

Secondary

End point timeframe

Predose at Weeks 4, 8, 13, 24, 32, 40, 48; 1 Week post-dose at Week 9 and 41

End point values	RPV LA Q8W	RPV LA Q4W
Number of subjects analysed	321 ^[93]	320 ^[94]
Units: Nanograms per milliliter
geometric mean (confidence interval 95%)	133.062 (128.452 to 137.837)	124.279 (119.825 to 128.899)

Notes
[93] - PK Population.
[94] - PK Population.

No statistical analyses for this end point

Other pre-specified: Number of Participants With Different Demographic Parameters for Inter-participant Variability

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End point title

Number of Participants With Different Demographic Parameters for Inter-participant 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 participant variability for pharmacokinetic parameters.

End point type

Other pre-specified

End point timeframe

Up to Week 48

End point values	CAB LA	RPV LA
Number of subjects analysed	0 ^[95]	0 ^[96]
Units: Participants

Notes
[95] - PK Population. This was an exploratory Outcome Measure. Data will not be analyzed and reported.
[96] - PK Population. This was an exploratory Outcome Measure. Data will not be analyzed and reported.

No statistical analyses for this end point

Other pre-specified: Number of Participants With Different Demographic Parameters for Intra-participant Variability

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End point title

Number of Participants With Different Demographic Parameters for Intra-participant 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 intra participant variability for pharmacokinetic parameters.

End point type

Other pre-specified

End point timeframe

Up to Week 48

End point values	CAB LA	RPV LA
Number of subjects analysed	0 ^[97]	0 ^[98]
Units: Participants

Notes
[97] - PK Population. This was an exploratory Outcome Measure. Data will not be analyzed and reported.
[98] - PK Population. This was an exploratory Outcome Measure. Data will not be analyzed and reported.

No statistical analyses for this end point

Adverse events

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Timeframe for reporting adverse events

Non-SAEs and SAEs were collected from the start of the treatment and up to Week 48 analysis

Adverse event reporting additional description

Non-SAEs and SAEs were collected in Safety Population.

Assessment type

Non-systematic

Dictionary name

MedDRA

Dictionary version

22.0

Reporting group title

CAB LA + RPV LA Q8W

Reporting group description

Eligible participants transitioning from antiretroviral (ART) standard of care (SOC) therapy arm in the ATLAS study and randomized to receive CAB LA+RPV LA every 8 weeks in the current study were administered oral therapy with CAB 30 mg + RPV 25 mg once daily at Day 1 for 4 weeks. Participants then received intramuscular (IM) injections of CAB LA 600 mg and RPV LA 900 mg at Week 4b and Week 8 followed by injections every 8 weeks thereafter. Participants transitioned from the CAB LA+RPV LA every 4 week (Q4W) arm of ATLAS study received CAB LA 600 mg+RPV LA 900 mg intramuscular injections on Day 1, Week 8 and every 8 weeks thereafter.

Reporting group title

CAB LA + RPV LA Q4W

Reporting group description

Eligible participants transitioning from ART SOC arm in the ATLAS study and randomized to receive CAB LA+RPV LA every 4 weeks in the current study were administered oral therapy with CAB 30 mg + RPV 25 mg once daily at Day 1 for 4 weeks. Participants then received a loading dose of CAB LA 600 mg and RPV LA 900 mg IM injections at Week 4b followed maintenance injections of CAB LA 400 mg +RPV LA 600 mg every 4 weeks thereafter. Participants transitioned from the Q4W arm of ATLAS study continued to receive CAB LA 400 mg+RPV LA 600 mg intramuscular injections administered every 4 weeks from Day 1.

Serious adverse events	CAB LA + RPV LA Q8W	CAB LA + RPV LA Q4W
Total subjects affected by serious adverse events
subjects affected / exposed	27 / 522 (5.17%)	19 / 523 (3.63%)
number of deaths (all causes)	1	0
number of deaths resulting from adverse events
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
alternative assessment type: Systematic
subjects affected / exposed	0 / 522 (0.00%)	1 / 523 (0.19%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Diffuse large B-cell lymphoma
alternative assessment type: Systematic
subjects affected / exposed	1 / 522 (0.19%)	0 / 523 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Glioblastoma
alternative assessment type: Systematic
subjects affected / exposed	0 / 522 (0.00%)	1 / 523 (0.19%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Vascular disorders
Deep vein thrombosis
alternative assessment type: Systematic
subjects affected / exposed	1 / 522 (0.19%)	0 / 523 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Pregnancy, puerperium and perinatal conditions
Abortion spontaneous
alternative assessment type: Systematic
subjects affected / exposed	0 / 522 (0.00%)	1 / 523 (0.19%)
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
Chest pain
alternative assessment type: Systematic
subjects affected / exposed	1 / 522 (0.19%)	0 / 523 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Immune system disorders
Hypersensitivity
alternative assessment type: Systematic
subjects affected / exposed	0 / 522 (0.00%)	1 / 523 (0.19%)
occurrences causally related to treatment / all	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Reproductive system and breast disorders
Priapism
alternative assessment type: Systematic
subjects affected / exposed	0 / 522 (0.00%)	1 / 523 (0.19%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
subjects affected / exposed	1 / 522 (0.19%)	0 / 523 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Sleep apnoea syndrome
alternative assessment type: Systematic
subjects affected / exposed	0 / 522 (0.00%)	1 / 523 (0.19%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Psychiatric disorders
Bipolar disorder
alternative assessment type: Systematic
subjects affected / exposed	1 / 522 (0.19%)	0 / 523 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Drug dependence
alternative assessment type: Systematic
subjects affected / exposed	0 / 522 (0.00%)	1 / 523 (0.19%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Major depression
alternative assessment type: Systematic
subjects affected / exposed	1 / 522 (0.19%)	0 / 523 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Substance-induced psychotic disorder
alternative assessment type: Systematic
subjects affected / exposed	1 / 522 (0.19%)	0 / 523 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Injury, poisoning and procedural complications
Ankle fracture
alternative assessment type: Systematic
subjects affected / exposed	0 / 522 (0.00%)	1 / 523 (0.19%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Head injury
alternative assessment type: Systematic
subjects affected / exposed	1 / 522 (0.19%)	0 / 523 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Overdose
alternative assessment type: Systematic
subjects affected / exposed	1 / 522 (0.19%)	0 / 523 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Cardiac disorders
Acute myocardial infarction
alternative assessment type: Systematic
subjects affected / exposed	1 / 522 (0.19%)	1 / 523 (0.19%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Cardio-respiratory arrest
alternative assessment type: Systematic
subjects affected / exposed	1 / 522 (0.19%)	0 / 523 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Coronary artery stenosis
alternative assessment type: Systematic
subjects affected / exposed	0 / 522 (0.00%)	1 / 523 (0.19%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Nervous system disorders
Cerebral infarction
alternative assessment type: Systematic
subjects affected / exposed	1 / 522 (0.19%)	0 / 523 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Cerebrovascular accident
alternative assessment type: Systematic
subjects affected / exposed	0 / 522 (0.00%)	1 / 523 (0.19%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Epilepsy
subjects affected / exposed	1 / 522 (0.19%)	0 / 523 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Presyncope
alternative assessment type: Systematic
subjects affected / exposed	1 / 522 (0.19%)	0 / 523 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Blood and lymphatic system disorders
Disseminated intravascular coagulation
alternative assessment type: Systematic
subjects affected / exposed	1 / 522 (0.19%)	0 / 523 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Microcytic anaemia
alternative assessment type: Systematic
subjects affected / exposed	1 / 522 (0.19%)	0 / 523 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Ear and labyrinth disorders
Vertigo positional
alternative assessment type: Systematic
subjects affected / exposed	1 / 522 (0.19%)	0 / 523 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Gastrointestinal disorders
Haemorrhoids
alternative assessment type: Systematic
subjects affected / exposed	2 / 522 (0.38%)	0 / 523 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Anal fistula
alternative assessment type: Systematic
subjects affected / exposed	1 / 522 (0.19%)	0 / 523 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Colitis
alternative assessment type: Systematic
subjects affected / exposed	0 / 522 (0.00%)	1 / 523 (0.19%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Haematemesis
subjects affected / exposed	1 / 522 (0.19%)	0 / 523 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Oroantral fistula
alternative assessment type: Systematic
subjects affected / exposed	1 / 522 (0.19%)	0 / 523 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Pancreatic pseudocyst
alternative assessment type: Systematic
subjects affected / exposed	1 / 522 (0.19%)	0 / 523 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Pancreatitis acute
alternative assessment type: Systematic
subjects affected / exposed	1 / 522 (0.19%)	0 / 523 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Hepatobiliary disorders
Cholecystitis
alternative assessment type: Systematic
subjects affected / exposed	0 / 522 (0.00%)	1 / 523 (0.19%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Cholecystitis acute
alternative assessment type: Systematic
subjects affected / exposed	1 / 522 (0.19%)	0 / 523 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Renal and urinary disorders
Acute kidney injury
alternative assessment type: Systematic
subjects affected / exposed	1 / 522 (0.19%)	0 / 523 (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
Intervertebral disc protrusion
alternative assessment type: Systematic
subjects affected / exposed	1 / 522 (0.19%)	0 / 523 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Rotator cuff syndrome
alternative assessment type: Systematic
subjects affected / exposed	1 / 522 (0.19%)	0 / 523 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Infections and infestations
Pneumonia
alternative assessment type: Systematic
subjects affected / exposed	2 / 522 (0.38%)	2 / 523 (0.38%)
occurrences causally related to treatment / all	0 / 2	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Acute hepatitis B
alternative assessment type: Systematic
subjects affected / exposed	1 / 522 (0.19%)	1 / 523 (0.19%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Appendicitis
alternative assessment type: Systematic
subjects affected / exposed	2 / 522 (0.38%)	0 / 523 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Abdominal abscess
alternative assessment type: Systematic
subjects affected / exposed	1 / 522 (0.19%)	0 / 523 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Acute hepatitis C
alternative assessment type: Systematic
subjects affected / exposed	0 / 522 (0.00%)	1 / 523 (0.19%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Anal abscess
alternative assessment type: Systematic
subjects affected / exposed	1 / 522 (0.19%)	0 / 523 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Diverticulitis
alternative assessment type: Systematic
subjects affected / exposed	0 / 522 (0.00%)	1 / 523 (0.19%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Epiglottitis obstructive
alternative assessment type: Systematic
subjects affected / exposed	1 / 522 (0.19%)	0 / 523 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Erysipelas
alternative assessment type: Systematic
subjects affected / exposed	1 / 522 (0.19%)	0 / 523 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Gastritis viral
alternative assessment type: Systematic
subjects affected / exposed	0 / 522 (0.00%)	1 / 523 (0.19%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Gastroenteritis Escherichia coli
alternative assessment type: Systematic
subjects affected / exposed	1 / 522 (0.19%)	0 / 523 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Infectious pleural effusion
alternative assessment type: Systematic
subjects affected / exposed	1 / 522 (0.19%)	0 / 523 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Injection site abscess
alternative assessment type: Systematic
subjects affected / exposed	1 / 522 (0.19%)	0 / 523 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Peritonsillar abscess
subjects affected / exposed	1 / 522 (0.19%)	0 / 523 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Sepsis
alternative assessment type: Systematic
subjects affected / exposed	1 / 522 (0.19%)	0 / 523 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0
Septic shock
alternative assessment type: Systematic
subjects affected / exposed	1 / 522 (0.19%)	0 / 523 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Sialoadenitis
alternative assessment type: Systematic
subjects affected / exposed	0 / 522 (0.00%)	1 / 523 (0.19%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Sinusitis
alternative assessment type: Systematic
subjects affected / exposed	0 / 522 (0.00%)	1 / 523 (0.19%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Urinary tract infection
subjects affected / exposed	1 / 522 (0.19%)	0 / 523 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Wound infection
subjects affected / exposed	0 / 522 (0.00%)	1 / 523 (0.19%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0

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

Non-serious adverse events	CAB LA + RPV LA Q8W	CAB LA + RPV LA Q4W
Total subjects affected by non serious adverse events
subjects affected / exposed	429 / 522 (82.18%)	427 / 523 (81.64%)
Nervous system disorders
Headache
alternative assessment type: Systematic
subjects affected / exposed	35 / 522 (6.70%)	36 / 523 (6.88%)
occurrences all number	45	53
General disorders and administration site conditions
Injection site pain
alternative assessment type: Systematic
subjects affected / exposed	371 / 522 (71.07%)	363 / 523 (69.41%)
occurrences all number	2014	2568
Injection site nodule
alternative assessment type: Systematic
subjects affected / exposed	54 / 522 (10.34%)	89 / 523 (17.02%)
occurrences all number	113	204
Injection site induration
alternative assessment type: Systematic
subjects affected / exposed	41 / 522 (7.85%)	39 / 523 (7.46%)
occurrences all number	86	96
Injection site discomfort
subjects affected / exposed	36 / 522 (6.90%)	41 / 523 (7.84%)
occurrences all number	92	110
Pyrexia
alternative assessment type: Systematic
subjects affected / exposed	28 / 522 (5.36%)	44 / 523 (8.41%)
occurrences all number	46	70
Injection site swelling
alternative assessment type: Systematic
subjects affected / exposed	32 / 522 (6.13%)	27 / 523 (5.16%)
occurrences all number	70	45
Injection site pruritus
alternative assessment type: Systematic
subjects affected / exposed	27 / 522 (5.17%)	25 / 523 (4.78%)
occurrences all number	63	55
Fatigue
alternative assessment type: Systematic
subjects affected / exposed	13 / 522 (2.49%)	33 / 523 (6.31%)
occurrences all number	18	41
Gastrointestinal disorders
Diarrhoea
alternative assessment type: Systematic
subjects affected / exposed	33 / 522 (6.32%)	37 / 523 (7.07%)
occurrences all number	35	39
Respiratory, thoracic and mediastinal disorders
Cough
alternative assessment type: Systematic
subjects affected / exposed	17 / 522 (3.26%)	29 / 523 (5.54%)
occurrences all number	17	30
Musculoskeletal and connective tissue disorders
Back pain
alternative assessment type: Systematic
subjects affected / exposed	28 / 522 (5.36%)	29 / 523 (5.54%)
occurrences all number	32	39
Infections and infestations
Nasopharyngitis
alternative assessment type: Systematic
subjects affected / exposed	71 / 522 (13.60%)	74 / 523 (14.15%)
occurrences all number	86	101
Upper respiratory tract infection
alternative assessment type: Systematic
subjects affected / exposed	50 / 522 (9.58%)	71 / 523 (13.58%)
occurrences all number	65	99
Gastroenteritis
alternative assessment type: Systematic
subjects affected / exposed	16 / 522 (3.07%)	28 / 523 (5.35%)
occurrences all number	17	28
Pharyngitis
alternative assessment type: Systematic
subjects affected / exposed	16 / 522 (3.07%)	28 / 523 (5.35%)
occurrences all number	16	31

More information

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Were there any global substantial amendments to the protocol? Yes

14 Sep 2017

Amendment 01: The primary purpose of protocol amendment 1 is to revise the study sample size to randomize approximately 1020 participants including 510 participants per arm based on a non-inferiority margin of 4% between the CAB LA + RPV LA every 8 weeks and every 4 weeks arms. Assuming the true proportion with human immunodeficiency virus-ribonucleic acid (HIV-RNA) >=50 copies per milliliter (c/mL) is 3% for the Q8W arm and 2% for the Q4W arm, the revised sample size will provide at least 85% power to show non-inferiority at Week 48. Additional minor clarifications and corrections have been added to the protocol text.

03 Jul 2018

Amendment 02: Add additional interim analysis of data when all participants have completed Week 24 visit, with intent of expediting submission of study results to Health Authorities;Change objective for assessing preference for CAB LA + RPV LA every 8 weeks or CAB LA + RPV LA every 4 weeks LA compared to oral antiretroviral (ARV) and the preference for CAB LA+ RPV LA every 8 weeks compared to CAB LA + RPV LA every 4 weeks from an exploratory objective to a secondary objective. A change to supporting version of Preference questionnaire administered to participants at Week 48 (or withdrawal) is also acknowledged;Add revisions and clarifications for administration of health outcomes questionnaires;Extend exclusion criterion 28 to also exclude hereditary coagulation and platelet disorders such as hemophilia or Von Willebrand Disease;Update exclusion criterion 11 to indicate that cluster of differentiation 4 plus (CD4+) counts ˂200 cells per microliter(cells/µL) are not exclusionary;Offer clarification that withdrawal assessments will be performed for any participant who withdraws prematurely from Maintenance or Extension Phase. Additional guidance for participants withdrawing at Week 52 or 100 has been added;Offer guidance to monitor medications that are dependent on Organic Anion Transporters 1(OAT1) and OAT3 transport upon concomitant exposure with CAB;Specify that 2-hour post-dose electrocardiogram(ECG) should be performed at Day 1 and Week 48 only for participants receiving CAB LA+RPV LA as it is not required for those receiving oral CAB+RPV at Day1;Exclude language that previously indicated hormonal contraception may be susceptible to interaction with study drugs. Lack of a demonstrated interaction with a representative contraceptive supports use of CAB and RPV across a broad range of estrogen and progestin or progestin only hormonal contraceptives;Add minor clarifications and corrections to typographical errors/formatting to protocol text.

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 plasma human immunodeficiency virus-ribonucleic acid (HIV-RNA) >=50 copies per milliliter (c/mL) as per Food and Drug Administration (FDA) Snapshot algorithm at Week 48

Primary: Percentage of participants with plasma human immunodeficiency virus-ribonucleic acid (HIV-RNA) >=50 copies per milliliter (c/mL) as per Food and Drug Administration (FDA) Snapshot algorithm at Week 48

Secondary: Percentage of participants with plasma HIV-1 RNA <50 c/mL using FDA Snapshot algorithm at Week 48

Secondary: Percentage of participants with plasma HIV-1 RNA <50 c/mL using FDA Snapshot algorithm at Week 48

Secondary: Percentage of participants with plasma HIV-1 RNA <50 c/mL using FDA Snapshot algorithm at Week 24

Secondary: Percentage of participants with plasma HIV-1 RNA <50 c/mL using FDA Snapshot algorithm at Week 24

Secondary: Percentage of participants with protocol defined confirmed virologic failure (CVF) through Weeks 24 and 48

Secondary: Percentage of participants with protocol defined confirmed virologic failure (CVF) through Weeks 24 and 48

Secondary: Percentage of participants with HIV-RNA >=50 c/mL as per FDA Snapshot algorithm at Week 24

Secondary: Percentage of participants with HIV-RNA >=50 c/mL as per FDA Snapshot algorithm at Week 24

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

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

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

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

Secondary: Absolute values for cluster of differentiation 4 plus (CD4+) at Week 48

Secondary: Absolute values for cluster of differentiation 4 plus (CD4+) at Week 48

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

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

Secondary: Number of participants with non-serious adverse events (non-SAEs >=5% incidence) and serious adverse events (SAEs)-Maintenance phase

Secondary: Number of participants with non-serious adverse events (non-SAEs >=5% incidence) and serious adverse events (SAEs)-Maintenance phase

Secondary: Number of participants with severity of adverse events-Maintenance phase

Secondary: Number of participants with severity of adverse events-Maintenance phase

Secondary: Number of participants with maximum Post-Baseline chemistry toxicities-Maintenance phase

Secondary: Number of participants with maximum Post-Baseline chemistry toxicities-Maintenance phase

Secondary: Number of participants with maximum Post-Baseline hematology toxicities-Maintenance phase

Secondary: Number of participants with maximum Post-Baseline hematology toxicities-Maintenance phase

Secondary: Percentage of participants who discontinued treatment due to adverse events-Maintenance phase

Secondary: Percentage of participants who discontinued treatment due to adverse events-Maintenance phase

Secondary: Change from Baseline in clinical chemistry parameters: ALT, ALP, AST and creatinine kinase over time

Secondary: Change from Baseline in clinical chemistry parameters: ALT, ALP, AST and creatinine kinase over time

Secondary: Change from Baseline in clinical chemistry parameter: albumin over time

Secondary: Change from Baseline in clinical chemistry parameter: albumin over time

Secondary: Change from Baseline in clinical chemistry parameters: bilirubin and creatinine over time

Secondary: Change from Baseline in clinical chemistry parameters: bilirubin and creatinine over time

Secondary: Change from Baseline in clinical chemistry parameters: CO2, chloride, phosphate, potassium, sodium and urea over time

Secondary: Change from Baseline in clinical chemistry parameters: CO2, chloride, phosphate, potassium, sodium and urea over time

Secondary: Change from Baseline in clinical chemistry parameters: cholesterol, glucose, direct high density lipoprotein (HDL) cholesterol, LDL cholesterol calculation and triglycerides at Week 48

Secondary: Change from Baseline in clinical chemistry parameters: cholesterol, glucose, direct high density lipoprotein (HDL) cholesterol, LDL cholesterol calculation and triglycerides at Week 48

Secondary: Change from Baseline in clinical chemistry parameter: GFR from creatinine adjusted using Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) over time

Secondary: Change from Baseline in clinical chemistry parameter: GFR from creatinine adjusted using Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) over time

Secondary: Change from Baseline in clinical chemistry parameter: Lipase over time

Secondary: Change from Baseline in clinical chemistry parameter: Lipase over time

Secondary: Change from Baseline in hematology parameters: basophils, eosinophils, leukocytes, lymphocytes, monocytes, neutrophils and platelets over time

Secondary: Change from Baseline in hematology parameters: basophils, eosinophils, leukocytes, lymphocytes, monocytes, neutrophils and platelets over time

Secondary: Change from Baseline in hematology parameter: erythrocyte mean corpuscular volume (MCV) over time

Secondary: Change from Baseline in hematology parameter: erythrocyte mean corpuscular volume (MCV) over time

Secondary: Change from Baseline in hematology parameter: erythrocytes over time

Secondary: Change from Baseline in hematology parameter: erythrocytes over time

Secondary: Change from Baseline in hematology parameter: hematocrit over time

Secondary: Change from Baseline in hematology parameter: hematocrit over time

Secondary: Change from Baseline in hematology parameter: hemoglobin over time

Secondary: Change from Baseline in hematology parameter: hemoglobin over time

Secondary: Number of participants with phenotypic resistance- Maintenance phase

Secondary: Number of participants with phenotypic resistance- Maintenance phase

Secondary: Number of participants with genotypic resistance-Maintenance phase

Secondary: Number of participants with genotypic resistance-Maintenance phase

Secondary: Number of participants with their treatment preference as assessed using preference questionnaire at Week 48 without (w/o) prior exposure to CAB+RPV-CAB 600 mg LA +RPV 900 mg LA Q8W arm only

Secondary: Number of participants with their treatment preference as assessed using preference questionnaire at Week 48 without (w/o) prior exposure to CAB+RPV-CAB 600 mg LA +RPV 900 mg LA Q8W arm only

Secondary: Number of participants with their treatment preference as assessed using preference questionnaire at Week 48 with >=1 weeks of prior exposure to CAB+RPV-CAB 600 mg LA +RPV 900 mg LA Q8W arm only

Secondary: Number of participants with their treatment preference as assessed using preference questionnaire at Week 48 with >=1 weeks of prior exposure to CAB+RPV-CAB 600 mg LA +RPV 900 mg LA Q8W arm only

Secondary: Number of participants with their treatment preference as assessed using preference questionnaire at Week 48-CAB 400 mg LA +RPV 600 mg LA Q4W arm only

Secondary: Number of participants with their treatment preference as assessed using preference questionnaire at Week 48-CAB 400 mg LA +RPV 600 mg LA Q4W arm only

Secondary: Change from Baseline in Life Satisfaction (LISAT) Using HIV/AIDs-targeted Quality of Life (HATQoL) Questionnaire in participants with or without prior exposure to CAB+RPV

Secondary: Change from Baseline in Life Satisfaction (LISAT) Using HIV/AIDs-targeted Quality of Life (HATQoL) Questionnaire in participants with or without prior exposure to CAB+RPV

Secondary: Change from Baseline in HIV medication, MEDWO using HATQoL Questionnaire in participants with or without prior exposure to CAB+RPV

Secondary: Change from Baseline in HIV medication, MEDWO using HATQoL Questionnaire in participants with or without prior exposure to CAB+RPV

Secondary: Change from Baseline in DISWO using HATQoL Questionnaire in participants with or without prior exposure to CAB+RPV

Secondary: Change from Baseline in DISWO using HATQoL Questionnaire in participants with or without prior exposure to CAB+RPV

Secondary: Change from Baseline in total treatment satisfaction score using HIV treatment satisfaction status questionnaire (HIVTSQs) at Weeks 24 and 48

Secondary: Change from Baseline in total treatment satisfaction score using HIV treatment satisfaction status questionnaire (HIVTSQs) at Weeks 24 and 48

Secondary: Change from Baseline in individual item scores using HIVTSQs at Weeks 24 and 48