Efficacy, Safety and Tolerability Study of Long-acting Cabotegravir Plus Long-acting Rilpivirine (CAB LA + RPV LA) in Human-immunodeficiency Virus-1 (HIV-1) Infected Adults

• ClinicalTrials.gov Identifier: NCT03299049
• Recruitment Status: Active, not recruiting
• First Posted: October 2, 2017
• Results First Posted: June 11, 2020
• Last Update Posted: June 11, 2020
• Sponsor: ViiV Healthcare
• Collaborator: Janssen Research and Development
• Information provided by (Responsible Party): ViiV Healthcare

• Study Type: Interventional
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: HIV Infections
• Interventions: Drug: Cabotegravir Tablets; Drug: Rilpivirine Tablets; Drug: Cabotegravir Injectable Suspension; Drug: Rilpivirine Injectable Suspension
• Enrollment: 1049

Participant Flow

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.
Pre-assignment 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.

Arm/Group Title	CAB LA + RPV LA Q8W	CAB LA + RPV LA Q4W
Arm/Group Description	Eligible participants transitioning from antiretroviral (ART) standard of care (SOC) therapy arm and CAB LA + RPV LA Q4W arm in the ATLAS (NCT02951052) study 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 received CAB LA 600 mg+RPV LA 900 mg intramuscular injections on Day 1, Week 8 and Q8W thereafter.	Eligible participants transitioning from ART SOC arm and CAB LA + RPV LA Q4W arm in the ATLAS (NCT02951052) study 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 continued to receive CAB LA 400 mg+RPV LA 600 mg intramuscular injections administered Q4W from Day 1.
Period Title: Overall Study
Started	522	523
Completed	0	0
Not Completed	522	523
Reason Not Completed
On-going	486	481
Withdrawal by Subject	6	21
Physician Decision	5	1
Lost to Follow-up	2	0
Pregnancy	1	3
Protocol Violation	1	1
Lack of Efficacy	9	3
Adverse Event	12	13

Baseline Characteristics

Arm/Group Title		CAB LA + RPV LA Q8W	CAB LA + RPV LA Q4W	Total
Arm/Group Description		Eligible participants transitioning from antiretroviral (ART) standard of care (SOC) therapy arm and CAB LA + RPV LA Q4W arm in the ATLAS (NCT02951052) study 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 received CAB LA 600 mg+RPV LA 900 mg intramuscular injections on Day 1, Week 8 and Q8W thereafter.	Eligible participants transitioning from ART SOC arm and CAB LA + RPV LA Q4W arm in the ATLAS (NCT02951052) study 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 continued to receive CAB LA 400 mg+RPV LA 600 mg intramuscular injections administered Q4W from Day 1.	Total of all reporting groups
Overall Number of Baseline Participants		522	523	1045
Baseline Analysis Population Description		[Not Specified]
Age, Continuous; Mean (Standard Deviation); Unit of measure: Years
	Number Analyzed	522 participants	523 participants	1045 participants
		42.7 (11.16)	42.3 (10.58)	42.5 (10.87)
Sex/Gender, Customized; Measure Type: Number; Unit of measure: Participants	Number Analyzed	522 participants	523 participants	1045 participants
Sex at birth=Female		137	143	280
Sex at birth=Male		385	380	765
Sex/Gender, Customized; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	522 participants	523 participants	1045 participants
	Reported gender=Female	142 27.2%	146 27.9%	288 27.6%
	Reported gender=Male	380 72.8%	377 72.1%	757 72.4%
Race/Ethnicity, Customized; Measure Type: Number; Unit of measure: Participants	Number Analyzed	522 participants	523 participants	1045 participants
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

Outcome Measures

1. Primary Outcome

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
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.
Time Frame	Week 48

Outcome Measure Data

Analysis Population Description

ITT-E Population.

Arm/Group Title	CAB LA + RPV LA Q8W	CAB LA + RPV LA Q4W
Arm/Group Description:	Eligible participants transitioning from antiretroviral (ART) standard of care (SOC) therapy arm and CAB LA + RPV LA Q4W arm in the ATLAS (NCT02951052) study 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 received CAB LA 600 mg+RPV LA 900 mg intramuscular injections on Day 1, Week 8 and Q8W thereafter.	Eligible participants transitioning from ART SOC arm and CAB LA + RPV LA Q4W arm in the ATLAS (NCT02951052) study 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 continued to receive CAB LA 400 mg+RPV LA 600 mg intramuscular injections administered Q4W from Day 1.
Overall Number of Participants Analyzed	522	523
Measure Type: Number; Unit of Measure: Percentage of participants
	1.7	1.0

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	CAB LA + RPV LA Q8W, CAB LA + RPV LA Q4W
	Comments	[Not Specified]
	Type of Statistical Test	Non-Inferiority
	Comments	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%.
Method of Estimation	Estimation Parameter	Adjusted difference
	Estimated Value	0.8
	Confidence Interval	(2-Sided) 95%; -0.6 to 2.2
	Estimation Comments	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.

2. Secondary Outcome

Title	Percentage of Participants With Plasma HIV-1 RNA <50 c/mL Using FDA Snapshot Algorithm at Week 48
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)
Time Frame	Week 48

Outcome Measure Data

Analysis Population Description

ITT-E Population.

Arm/Group Title	CAB LA + RPV LA Q8W	CAB LA + RPV LA Q4W
Arm/Group Description:	Eligible participants transitioning from antiretroviral (ART) standard of care (SOC) therapy arm and CAB LA + RPV LA Q4W arm in the ATLAS (NCT02951052) study 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 received CAB LA 600 mg+RPV LA 900 mg intramuscular injections on Day 1, Week 8 and Q8W thereafter.	Eligible participants transitioning from ART SOC arm and CAB LA + RPV LA Q4W arm in the ATLAS (NCT02951052) study 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 continued to receive CAB LA 400 mg+RPV LA 600 mg intramuscular injections administered Q4W from Day 1.
Overall Number of Participants Analyzed	522	523
Measure Type: Number; Unit of Measure: Percentage of participants
	94	93

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	CAB LA + RPV LA Q8W, CAB LA + RPV LA Q4W
	Comments	[Not Specified]
	Type of Statistical Test	Non-Inferiority
	Comments	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%
Method of Estimation	Estimation Parameter	Adjusted difference
	Estimated Value	0.8
	Confidence Interval	(2-Sided) 95%; -2.1 to 3.7
	Estimation Comments	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.

3. Secondary Outcome

Title	Percentage of Participants With Plasma HIV-1 RNA <50 c/mL Using FDA Snapshot Algorithm at Week 24
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)
Time Frame	Week 24

Outcome Measure Data

Analysis Population Description

ITT-E Population.

Arm/Group Title	CAB LA + RPV LA Q8W	CAB LA + RPV LA Q4W
Arm/Group Description:	Eligible participants transitioning from antiretroviral (ART) standard of care (SOC) therapy arm and CAB LA + RPV LA Q4W arm in the ATLAS (NCT02951052) study 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 received CAB LA 600 mg+RPV LA 900 mg intramuscular injections on Day 1, Week 8 and Q8W thereafter.	Eligible participants transitioning from ART SOC arm and CAB LA + RPV LA Q4W arm in the ATLAS (NCT02951052) study 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 continued to receive CAB LA 400 mg+RPV LA 600 mg intramuscular injections administered Q4W from Day 1.
Overall Number of Participants Analyzed	522	523
Measure Type: Number; Number (95% Confidence Interval); Unit of Measure: Percentage of participants
	95; (93 to 97)	95; (94 to 97)

4. Secondary Outcome

Title	Percentage of Participants With Protocol Defined Confirmed Virologic Failure (CVF) Through Weeks 24 and 48
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.
Time Frame	Weeks 24 and 48

Outcome Measure Data

Analysis Population Description

ITT-E Population.

Arm/Group Title	CAB LA + RPV LA Q8W	CAB LA + RPV LA Q4W
Arm/Group Description:	Eligible participants transitioning from antiretroviral (ART) standard of care (SOC) therapy arm and CAB LA + RPV LA Q4W arm in the ATLAS (NCT02951052) study 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 received CAB LA 600 mg+RPV LA 900 mg intramuscular injections on Day 1, Week 8 and Q8W thereafter.	Eligible participants transitioning from ART SOC arm and CAB LA + RPV LA Q4W arm in the ATLAS (NCT02951052) study 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 continued to receive CAB LA 400 mg+RPV LA 600 mg intramuscular injections administered Q4W from Day 1.
Overall Number of Participants Analyzed	522	523
Measure Type: Number; Unit of Measure: Percentage of participants
Week 24	1.3	0.2
Week 48	1.5	0.4

5. Secondary Outcome

Title	Percentage of Participants With HIV-RNA >=50 c/mL as Per FDA Snapshot Algorithm at Week 24
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).
Time Frame	Weeks 24

Outcome Measure Data

Analysis Population Description

ITT-E Population.

Arm/Group Title	CAB LA + RPV LA Q8W	CAB LA + RPV LA Q4W
Arm/Group Description:	Eligible participants transitioning from antiretroviral (ART) standard of care (SOC) therapy arm and CAB LA + RPV LA Q4W arm in the ATLAS (NCT02951052) study 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 received CAB LA 600 mg+RPV LA 900 mg intramuscular injections on Day 1, Week 8 and Q8W thereafter.	Eligible participants transitioning from ART SOC arm and CAB LA + RPV LA Q4W arm in the ATLAS (NCT02951052) study 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 continued to receive CAB LA 400 mg+RPV LA 600 mg intramuscular injections administered Q4W from Day 1.
Overall Number of Participants Analyzed	522	523
Measure Type: Number; Number (95% Confidence Interval); Unit of Measure: Percentage of participants
	2.1; (0.9 to 3.3)	1.5; (0.5 to 2.6)

6. Secondary Outcome

Title	Absolute Values for HIV-1 RNA at Week 48
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.
Time Frame	Weeks 48

Outcome Measure Data

Analysis Population Description

ITT-E Population. Only those participants with data available at the specified data points were analyzed.

Arm/Group Title	CAB LA + RPV LA Q8W	CAB LA + RPV LA Q4W
Arm/Group Description:	Eligible participants transitioning from antiretroviral (ART) standard of care (SOC) therapy arm and CAB LA + RPV LA Q4W arm in the ATLAS (NCT02951052) study 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 received CAB LA 600 mg+RPV LA 900 mg intramuscular injections on Day 1, Week 8 and Q8W thereafter.	Eligible participants transitioning from ART SOC arm and CAB LA + RPV LA Q4W arm in the ATLAS (NCT02951052) study 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 continued to receive CAB LA 400 mg+RPV LA 600 mg intramuscular injections administered Q4W from Day 1.
Overall Number of Participants Analyzed	493	487
Mean (Standard Deviation); Unit of Measure: Log 10 c/mL
	1.599 (0.0870)	1.593 (0.0302)

7. Secondary Outcome

Title	Change From Baseline Values for HIV-1 RNA at Week 48
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.
Time Frame	Baseline (Day 1) and Week 48

Outcome Measure Data

Analysis Population Description

ITT-E Population. Only those participants with data available at the specified data points were analyzed.

Arm/Group Title	CAB LA + RPV LA Q8W	CAB LA + RPV LA Q4W
Arm/Group Description:	Eligible participants transitioning from antiretroviral (ART) standard of care (SOC) therapy arm and CAB LA + RPV LA Q4W arm in the ATLAS (NCT02951052) study 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 received CAB LA 600 mg+RPV LA 900 mg intramuscular injections on Day 1, Week 8 and Q8W thereafter.	Eligible participants transitioning from ART SOC arm and CAB LA + RPV LA Q4W arm in the ATLAS (NCT02951052) study 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 continued to receive CAB LA 400 mg+RPV LA 600 mg intramuscular injections administered Q4W from Day 1.
Overall Number of Participants Analyzed	493	487
Mean (Standard Deviation); Unit of Measure: Log 10 c/mL
	0.007 (0.0888)	-0.015 (0.1673)

8. Secondary Outcome

Title	Absolute Values for Cluster of Differentiation 4 Plus (CD4+) at Week 48
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.
Time Frame	Week 48

Outcome Measure Data

Analysis Population Description

ITT-E Population. Only those participants with data available at the specified data points were analyzed.

Arm/Group Title	CAB LA + RPV LA Q8W	CAB LA + RPV LA Q4W
Arm/Group Description:	Eligible participants transitioning from antiretroviral (ART) standard of care (SOC) therapy arm and CAB LA + RPV LA Q4W arm in the ATLAS (NCT02951052) study 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 received CAB LA 600 mg+RPV LA 900 mg intramuscular injections on Day 1, Week 8 and Q8W thereafter.	Eligible participants transitioning from ART SOC arm and CAB LA + RPV LA Q4W arm in the ATLAS (NCT02951052) study 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 continued to receive CAB LA 400 mg+RPV LA 600 mg intramuscular injections administered Q4W from Day 1.
Overall Number of Participants Analyzed	493	486
Mean (Standard Deviation); Unit of Measure: Cells per cubic millimeter
	685.9 (261.70)	700.0 (278.18)

9. Secondary Outcome

Title	Change From Baseline Values for CD4+ at Week 48
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.
Time Frame	Baseline (Day 1) and Week 48

Outcome Measure Data

Analysis Population Description

ITT-E Population. Only those participants with data available at the specified data points were analyzed.

Arm/Group Title	CAB LA + RPV LA Q8W	CAB LA + RPV LA Q4W
Arm/Group Description:	Eligible participants transitioning from antiretroviral (ART) standard of care (SOC) therapy arm and CAB LA + RPV LA Q4W arm in the ATLAS (NCT02951052) study 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 received CAB LA 600 mg+RPV LA 900 mg intramuscular injections on Day 1, Week 8 and Q8W thereafter.	Eligible participants transitioning from ART SOC arm and CAB LA + RPV LA Q4W arm in the ATLAS (NCT02951052) study 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 continued to receive CAB LA 400 mg+RPV LA 600 mg intramuscular injections administered Q4W from Day 1.
Overall Number of Participants Analyzed	493	486
Mean (Standard Deviation); Unit of Measure: Cells per cubic millimeter
	5.3 (168.62)	-24.6 (199.02)

10. Secondary Outcome

Title	Number of Participants With Non-serious Adverse Events (Non-SAEs >=5% Incidence) and Serious Adverse Events (SAEs)-Maintenance Phase
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.
Time Frame	Up to Week 48

Outcome Measure Data

Analysis Population Description

Safety Population.

Arm/Group Title	CAB LA + RPV LA Q8W	CAB LA + RPV LA Q4W
Arm/Group Description:	Eligible participants transitioning from antiretroviral (ART) standard of care (SOC) therapy arm and CAB LA + RPV LA Q4W arm in the ATLAS (NCT02951052) study 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 received CAB LA 600 mg+RPV LA 900 mg intramuscular injections on Day 1, Week 8 and Q8W thereafter.	Eligible participants transitioning from ART SOC arm and CAB LA + RPV LA Q4W arm in the ATLAS (NCT02951052) study 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 continued to receive CAB LA 400 mg+RPV LA 600 mg intramuscular injections administered Q4W from Day 1.
Overall Number of Participants Analyzed	522	523
Measure Type: Count of Participants; Unit of Measure: Participants
Any non-SAE (>=5%)	429 82.2%	427 81.6%
Any SAE	27 5.2%	19 3.6%

11. Secondary Outcome

Title	Number of Participants With Severity of Adverse Events-Maintenance Phase
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).
Time Frame	Up to Week 48

Outcome Measure Data

Analysis Population Description

Safety Population.

Arm/Group Title	CAB LA + RPV LA Q8W	CAB LA + RPV LA Q4W
Arm/Group Description:	Eligible participants transitioning from antiretroviral (ART) standard of care (SOC) therapy arm and CAB LA + RPV LA Q4W arm in the ATLAS (NCT02951052) study 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 received CAB LA 600 mg+RPV LA 900 mg intramuscular injections on Day 1, Week 8 and Q8W thereafter.	Eligible participants transitioning from ART SOC arm and CAB LA + RPV LA Q4W arm in the ATLAS (NCT02951052) study 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 continued to receive CAB LA 400 mg+RPV LA 600 mg intramuscular injections administered Q4W from Day 1.
Overall Number of Participants Analyzed	522	523
Measure Type: Count of Participants; Unit of Measure: Participants
Grade 1	201 38.5%	195 37.3%
Grade 2	231 44.3%	238 45.5%
Grade 3	38 7.3%	43 8.2%
Grade 4	2 0.4%	6 1.1%
Grade 5	1 0.2%	0 0.0%

12. Secondary Outcome

Title	Number of Participants With Maximum Post-Baseline Chemistry Toxicities-Maintenance Phase
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).
Time Frame	Up to Week 48

Outcome Measure Data

Analysis Population Description

Safety Population.

Arm/Group Title	CAB LA + RPV LA Q8W	CAB LA + RPV LA Q4W
Arm/Group Description:	Eligible participants transitioning from antiretroviral (ART) standard of care (SOC) therapy arm and CAB LA + RPV LA Q4W arm in the ATLAS (NCT02951052) study 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 received CAB LA 600 mg+RPV LA 900 mg intramuscular injections on Day 1, Week 8 and Q8W thereafter.	Eligible participants transitioning from ART SOC arm and CAB LA + RPV LA Q4W arm in the ATLAS (NCT02951052) study 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 continued to receive CAB LA 400 mg+RPV LA 600 mg intramuscular injections administered Q4W from Day 1.
Overall Number of Participants Analyzed	522	523
Measure Type: Count of Participants; Unit of Measure: Participants
ALT, Grade 1	45 8.6%	49 9.4%
ALT, Grade 2	10 1.9%	13 2.5%
ALT, Grade 3	1 0.2%	3 0.6%
ALT, Grade 4	1 0.2%	2 0.4%
Albumin, Grade 1	1 0.2%	0 0.0%
Albumin, Grade 2	1 0.2%	1 0.2%
Albumin, Grade 3	0 0.0%	0 0.0%
Albumin, Grade 4	0 0.0%	0 0.0%
ALP, Grade 1	1 0.2%	5 1.0%
ALP, Grade 2	0 0.0%	0 0.0%
ALP, Grade 3	0 0.0%	0 0.0%
ALP, Grade 4	0 0.0%	0 0.0%
AST, Grade 1	32 6.1%	44 8.4%
AST, Grade 2	10 1.9%	13 2.5%
AST, Grade 3	2 0.4%	4 0.8%
AST, Grade 4	1 0.2%	2 0.4%
Bilirubin, Grade 1	27 5.2%	25 4.8%
Bilirubin, Grade 2	7 1.3%	5 1.0%
Bilirubin, Grade 3	1 0.2%	1 0.2%
Bilirubin, Grade 4	1 0.2%	1 0.2%
CO2, Grade 1	98 18.8%	111 21.2%
CO2, Grade 2	2 0.4%	1 0.2%
CO2, Grade 3	0 0.0%	0 0.0%
CO2, Grade 4	0 0.0%	0 0.0%
Cholesterol, Grade 1	50 9.6%	52 9.9%
Cholesterol, Grade 2	31 5.9%	30 5.7%
Cholesterol, Grade 3	2 0.4%	3 0.6%
Cholesterol, Grade 4	0 0.0%	0 0.0%
Creatinine Kinase, Grade 1	41 7.9%	32 6.1%
Creatinine Kinase, Grade 2	22 4.2%	19 3.6%
Creatinine Kinase, Grade 3	7 1.3%	9 1.7%
Creatinine Kinase, Grade 4	9 1.7%	14 2.7%
Creatinine, Grade 1	5 1.0%	9 1.7%
Creatinine, Grade 2	2 0.4%	1 0.2%
Creatinine, Grade 3	0 0.0%	0 0.0%
Creatinine, Grade 4	0 0.0%	0 0.0%
GFR from creatinine adjusted for BSA, Grade 1	0 0.0%	0 0.0%
GFR from creatinine adjusted for BSA, Grade 2	110 21.1%	134 25.6%
GFR from creatinine adjusted for BSA, Grade 3	15 2.9%	19 3.6%
GFR from creatinine adjusted for BSA, Grade 4	0 0.0%	1 0.2%
Glucose, Grade 1	84 16.1%	87 16.6%
Glucose, Grade 2	34 6.5%	43 8.2%
Glucose, Grade 3	3 0.6%	5 1.0%
Glucose, Grade 4	1 0.2%	1 0.2%
Hyperglycemia, Grade 1	80 15.3%	77 14.7%
Hyperglycemia, Grade 2	32 6.1%	38 7.3%
Hyperglycemia, Grade 3	2 0.4%	5 1.0%
Hyperglycemia, Grade 4	0 0.0%	0 0.0%
Hyperkalemia, Grade 1	8 1.5%	2 0.4%
Hyperkalemia, Grade 2	0 0.0%	1 0.2%
Hyperkalemia, Grade 3	0 0.0%	0 0.0%
Hyperkalemia, Grade 4	0 0.0%	1 0.2%
Hypernatremia, Grade 1	6 1.1%	2 0.4%
Hypernatremia, Grade 2	0 0.0%	0 0.0%
Hypernatremia, Grade 3	0 0.0%	0 0.0%
Hypernatremia, Grade 4	0 0.0%	0 0.0%
Hypoglycemia, Grade 1	11 2.1%	13 2.5%
Hypoglycemia, Grade 2	2 0.4%	5 1.0%
Hypoglycemia, Grade 3	1 0.2%	0 0.0%
Hypoglycemia, Grade 4	1 0.2%	1 0.2%
Hypokalemia, Grade 1	10 1.9%	8 1.5%
Hypokalemia, Grade 2	0 0.0%	0 0.0%
Hypokalemia, Grade 3	0 0.0%	0 0.0%
Hypokalemia, Grade 4	0 0.0%	0 0.0%
Hyponatremia, Grade 1	23 4.4%	26 5.0%
Hyponatremia, Grade 2	0 0.0%	1 0.2%
Hyponatremia, Grade 3	0 0.0%	0 0.0%
Hyponatremia, Grade 4	0 0.0%	0 0.0%
LDL Cholesterol calculation, Grade 1	40 7.7%	41 7.8%
LDL Cholesterol calculation, Grade 2	20 3.8%	26 5.0%
LDL Cholesterol calculation, Grade 3	9 1.7%	4 0.8%
LDL Cholesterol calculation, Grade 4	0 0.0%	0 0.0%
Lipase, Grade 1	40 7.7%	44 8.4%
Lipase, Grade 2	31 5.9%	44 8.4%
Lipase, Grade 3	13 2.5%	4 0.8%
Lipase, Grade 4	3 0.6%	6 1.1%
Phosphate, Grade 1	75 14.4%	72 13.8%
Phosphate, Grade 2	20 3.8%	1 0.2%
Phosphate, Grade 3	0 0.0%	2 0.4%
Phosphate, Grade 4	0 0.0%	0 0.0%
Potassium, Grade 1	18 3.4%	10 1.9%
Potassium, Grade 2	0 0.0%	1 0.2%
Potassium, Grade 3	0 0.0%	0 0.0%
Potassium, Grade 4	0 0.0%	1 0.2%
Sodium, Grade 1	29 5.6%	28 5.4%
Sodium, Grade 2	0 0.0%	1 0.2%
Sodium, Grade 3	0 0.0%	0 0.0%
Sodium, Grade 4	0 0.0%	0 0.0%
Triglycerides, Grade 1	51 9.8%	42 8.0%
Triglycerides, Grade 2	11 2.1%	3 0.6%
Triglycerides, Grade 3	4 0.8%	2 0.4%
Triglycerides, Grade 4	0 0.0%	2 0.4%

13. Secondary Outcome

Title	Number of Participants With Maximum Post-Baseline Hematology Toxicities-Maintenance Phase
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).
Time Frame	Up to Week 48

Outcome Measure Data

Analysis Population Description

Safety Population.

Arm/Group Title	CAB LA + RPV LA Q8W	CAB LA + RPV LA Q4W
Arm/Group Description:	Eligible participants transitioning from antiretroviral (ART) standard of care (SOC) therapy arm and CAB LA + RPV LA Q4W arm in the ATLAS (NCT02951052) study 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 received CAB LA 600 mg+RPV LA 900 mg intramuscular injections on Day 1, Week 8 and Q8W thereafter.	Eligible participants transitioning from ART SOC arm and CAB LA + RPV LA Q4W arm in the ATLAS (NCT02951052) study 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 continued to receive CAB LA 400 mg+RPV LA 600 mg intramuscular injections administered Q4W from Day 1.
Overall Number of Participants Analyzed	522	523
Measure Type: Count of Participants; Unit of Measure: Participants
Hemoglobin, Grade 1	9 1.7%	4 0.8%
Hemoglobin, Grade 2	1 0.2%	3 0.6%
Hemoglobin, Grade 3	2 0.4%	4 0.8%
Hemoglobin, Grade 4	0 0.0%	0 0.0%
Leukocytes, Grade 1	12 2.3%	5 1.0%
Leukocytes, Grade 2	0 0.0%	0 0.0%
Leukocytes, Grade 3	1 0.2%	0 0.0%
Leukocytes, Grade 4	0 0.0%	0 0.0%
Neutrophils, Grade 1	7 1.3%	6 1.1%
Neutrophils, Grade 2	8 1.5%	5 1.0%
Neutrophils, Grade 3	1 0.2%	2 0.4%
Neutrophils, Grade 4	2 0.4%	1 0.2%
Platelets, Grade 1	8 1.5%	8 1.5%
Platelets, Grade 2	1 0.2%	1 0.2%
Platelets, Grade 3	1 0.2%	1 0.2%
Platelets, Grade 4	0 0.0%	0 0.0%

14. Secondary Outcome

Title	Percentage of Participants Who Discontinued Treatment Due to Adverse Events-Maintenance Phase
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. Percentage of participants with adverse events leading to withdrawal has been presented.
Time Frame	Up to Week 48

Outcome Measure Data

Analysis Population Description

Safety Population.

Arm/Group Title	CAB LA + RPV LA Q8W	CAB LA + RPV LA Q4W
Arm/Group Description:	Eligible participants transitioning from antiretroviral (ART) standard of care (SOC) therapy arm and CAB LA + RPV LA Q4W arm in the ATLAS (NCT02951052) study 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 received CAB LA 600 mg+RPV LA 900 mg intramuscular injections on Day 1, Week 8 and Q8W thereafter.	Eligible participants transitioning from ART SOC arm and CAB LA + RPV LA Q4W arm in the ATLAS (NCT02951052) study 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 continued to receive CAB LA 400 mg+RPV LA 600 mg intramuscular injections administered Q4W from Day 1.
Overall Number of Participants Analyzed	522	523
Measure Type: Number; Unit of Measure: Percentage of participants
	2	2

15. Secondary Outcome

Title	Change From Baseline in Clinical Chemistry Parameters: ALT, ALP, AST and Creatinine Kinase Over Time
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.
Time Frame	Baseline (Day 1) and Weeks 4, 8, 16, 24, 32, 40 and 48

Outcome Measure Data

Analysis Population Description

Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).

Arm/Group Title		CAB LA + RPV LA Q8W	CAB LA + RPV LA Q4W
Arm/Group Description:		Eligible participants transitioning from antiretroviral (ART) standard of care (SOC) therapy arm and CAB LA + RPV LA Q4W arm in the ATLAS (NCT02951052) study 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 received CAB LA 600 mg+RPV LA 900 mg intramuscular injections on Day 1, Week 8 and Q8W thereafter.	Eligible participants transitioning from ART SOC arm and CAB LA + RPV LA Q4W arm in the ATLAS (NCT02951052) study 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 continued to receive CAB LA 400 mg+RPV LA 600 mg intramuscular injections administered Q4W from Day 1.
Overall Number of Participants Analyzed		522	523
Mean (Standard Deviation); Unit of Measure: International units per liter
ALT, Week 4, n=326, 520	Number Analyzed	326 participants	520 participants
		-1.3 (11.11)	0.1 (14.01)
ALT, Week 8, n=510, 515	Number Analyzed	510 participants	515 participants
		0.8 (21.28)	0.3 (15.65)
ALT, Week 16, n=515, 513	Number Analyzed	515 participants	513 participants
		1.5 (47.60)	-0.7 (12.29)
ALT, Week 24, n=505, 503	Number Analyzed	505 participants	503 participants
		1.9 (63.03)	-0.3 (13.39)
ALT, Week 32, n=499, 498	Number Analyzed	499 participants	498 participants
		-0.4 (12.60)	2.4 (33.72)
ALT, Week 40, n=495, 490	Number Analyzed	495 participants	490 participants
		0.4 (13.50)	6.6 (112.13)
ALT, Week 48, n=493, 486	Number Analyzed	493 participants	486 participants
		1.1 (16.39)	1.6 (18.61)
ALP, Week 4, n=326, 520	Number Analyzed	326 participants	520 participants
		-5.5 (12.09)	-2.1 (10.25)
ALP, Week 8, n=510, 515	Number Analyzed	510 participants	515 participants
		-4.1 (13.07)	-3.3 (11.31)
ALP, Week 16, n=515, 513	Number Analyzed	515 participants	513 participants
		-4.8 (14.65)	-4.2 (13.07)
ALP, Week 24, n=505, 503	Number Analyzed	505 participants	503 participants
		-5.2 (16.04)	-4.0 (13.42)
ALP, Week 32, n=499, 498	Number Analyzed	499 participants	498 participants
		-5.7 (17.14)	-4.1 (14.95)
ALP, Week 40, n=495, 490	Number Analyzed	495 participants	490 participants
		-5.9 (17.61)	-3.9 (16.09)
ALP, Week 48, n=493, 486	Number Analyzed	493 participants	486 participants
		-6.6 (17.18)	-4.5 (15.02)
AST, Week 4, n=326, 520	Number Analyzed	326 participants	520 participants
		-0.6 (13.25)	-0.3 (18.47)
AST, Week 8, n=510, 515	Number Analyzed	510 participants	515 participants
		0.6 (11.71)	0.0 (14.46)
AST, Week 16, n=515, 513	Number Analyzed	515 participants	513 participants
		1.2 (24.79)	-0.3 (16.58)
AST, Week 24, n=505, 503	Number Analyzed	505 participants	503 participants
		1.6 (53.81)	-0.2 (21.65)
AST, Week 32, n=499, 498	Number Analyzed	499 participants	498 participants
		-1.6 (8.84)	0.8 (34.81)
AST, Week 40, n=495, 490	Number Analyzed	495 participants	490 participants
		-1.0 (10.14)	2.5 (66.54)
AST, Week 48, n=493, 486	Number Analyzed	493 participants	486 participants
		-0.2 (12.48)	-0.7 (16.12)
Creatinine kinase, Week 4, n=326, 520	Number Analyzed	326 participants	520 participants
		30.2 (689.41)	-29.3 (717.51)
Creatinine kinase, Week 8, n=510, 515	Number Analyzed	510 participants	515 participants
		24.1 (479.84)	-23.7 (682.90)
Creatinine kinase, Week 16, n=515, 513	Number Analyzed	515 participants	513 participants
		30.6 (692.65)	-4.7 (856.65)
Creatinine kinase, Week 24, n=505, 503	Number Analyzed	505 participants	503 participants
		-13.6 (265.16)	31.1 (1198.22)
Creatinine kinase, Week 32, n=499, 498	Number Analyzed	499 participants	498 participants
		-23.3 (314.46)	-5.8 (787.02)
Creatinine kinase, Week 40, n=495, 490	Number Analyzed	495 participants	490 participants
		-12.5 (336.08)	34.2 (1288.66)
Creatinine kinase, Week 48, n=493, 486	Number Analyzed	493 participants	486 participants
		17.9 (411.70)	-2.9 (810.46)

16. Secondary Outcome

Title	Change From Baseline in Clinical Chemistry Parameter: Albumin Over Time
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.
Time Frame	Baseline (Day 1) and Weeks 4, 8, 16, 24, 32, 40 and 48

Outcome Measure Data

Analysis Population Description

Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).

Arm/Group Title		CAB LA + RPV LA Q8W	CAB LA + RPV LA Q4W
Arm/Group Description:		Eligible participants transitioning from antiretroviral (ART) standard of care (SOC) therapy arm and CAB LA + RPV LA Q4W arm in the ATLAS (NCT02951052) study 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 received CAB LA 600 mg+RPV LA 900 mg intramuscular injections on Day 1, Week 8 and Q8W thereafter.	Eligible participants transitioning from ART SOC arm and CAB LA + RPV LA Q4W arm in the ATLAS (NCT02951052) study 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 continued to receive CAB LA 400 mg+RPV LA 600 mg intramuscular injections administered Q4W from Day 1.
Overall Number of Participants Analyzed		522	523
Mean (Standard Deviation); Unit of Measure: Grams per liter
Week 4, n=326, 520	Number Analyzed	326 participants	520 participants
		-0.5 (2.32)	-0.2 (2.45)
Week 8, n=510, 515	Number Analyzed	510 participants	515 participants
		-0.3 (2.48)	-0.1 (2.48)
Week 16, n=515, 513	Number Analyzed	515 participants	513 participants
		-0.3 (2.56)	-0.4 (2.51)
Week 24, n=505, 503	Number Analyzed	505 participants	503 participants
		-0.0 (2.49)	-0.2 (2.59)
Week 32, n=499, 498	Number Analyzed	499 participants	498 participants
		-0.2 (2.63)	-0.3 (2.68)
Week 40, n=495, 490	Number Analyzed	495 participants	490 participants
		0.1 (2.68)	-0.3 (2.54)
Week 48, n=493, 486	Number Analyzed	493 participants	486 participants
		-0.2 (2.59)	-0.2 (2.60)

17. Secondary Outcome

Title	Change From Baseline in Clinical Chemistry Parameters: Bilirubin and Creatinine Over Time
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.
Time Frame	Baseline (Day 1) and Weeks 4, 8, 16, 24, 32, 40 and 48

Outcome Measure Data

Analysis Population Description

Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).

Arm/Group Title		CAB LA + RPV LA Q8W	CAB LA + RPV LA Q4W
Arm/Group Description:		Eligible participants transitioning from antiretroviral (ART) standard of care (SOC) therapy arm and CAB LA + RPV LA Q4W arm in the ATLAS (NCT02951052) study 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 received CAB LA 600 mg+RPV LA 900 mg intramuscular injections on Day 1, Week 8 and Q8W thereafter.	Eligible participants transitioning from ART SOC arm and CAB LA + RPV LA Q4W arm in the ATLAS (NCT02951052) study 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 continued to receive CAB LA 400 mg+RPV LA 600 mg intramuscular injections administered Q4W from Day 1.
Overall Number of Participants Analyzed		522	523
Mean (Standard Deviation); Unit of Measure: Micromoles per liter
Bilirubin, Week 4, n=326, 520	Number Analyzed	326 participants	520 participants
		0.4 (6.44)	0.1 (5.70)
Bilirubin, Week 8, n=510, 515	Number Analyzed	510 participants	515 participants
		0.4 (5.68)	0.1 (5.39)
Bilirubin, Week 16, n=515, 513	Number Analyzed	515 participants	513 participants
		0.5 (5.78)	0.2 (5.69)
Bilirubin, Week 24, n=505, 503	Number Analyzed	505 participants	503 participants
		0.8 (9.42)	0.5 (5.23)
Bilirubin, Week 32, n=499, 498	Number Analyzed	499 participants	498 participants
		0.5 (5.54)	0.4 (5.46)
Bilirubin, Week 40, n=495, 490	Number Analyzed	495 participants	490 participants
		0.7 (6.00)	0.4 (5.77)
Bilirubin, Week 48, n=493, 486	Number Analyzed	493 participants	486 participants
		0.4 (5.77)	0.7 (4.93)
Creatinine, Week 4, n=326, 521	Number Analyzed	326 participants	521 participants
		0.89 (8.768)	-0.36 (7.215)
Creatinine, Week 8, n=510, 515	Number Analyzed	510 participants	515 participants
		-0.94 (8.638)	-0.39 (8.191)
Creatinine, Week 16, n=515, 513	Number Analyzed	515 participants	513 participants
		-0.24 (8.973)	-0.03 (8.516)
Creatinine, Week 24, n=505, 503	Number Analyzed	505 participants	503 participants
		0.22 (9.085)	0.94 (9.591)
Creatinine, Week 32, n=499, 498	Number Analyzed	499 participants	498 participants
		1.01 (9.490)	2.09 (9.313)
Creatinine, Week 40, n=495, 490	Number Analyzed	495 participants	490 participants
		1.02 (9.604)	2.05 (9.414)
Creatinine, Week 48, n=493, 486	Number Analyzed	493 participants	486 participants
		1.30 (9.813)	2.30 (8.678)

18. Secondary Outcome

Title	Change From Baseline in Clinical Chemistry Parameters: CO2, Chloride, Phosphate, Potassium, Sodium and Urea Over Time
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.
Time Frame	Baseline (Day 1) and Weeks 4, 8, 16, 24, 32, 40 and 48

Outcome Measure Data

Analysis Population Description

Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).

Arm/Group Title		CAB LA + RPV LA Q8W	CAB LA + RPV LA Q4W
Arm/Group Description:		Eligible participants transitioning from antiretroviral (ART) standard of care (SOC) therapy arm and CAB LA + RPV LA Q4W arm in the ATLAS (NCT02951052) study 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 received CAB LA 600 mg+RPV LA 900 mg intramuscular injections on Day 1, Week 8 and Q8W thereafter.	Eligible participants transitioning from ART SOC arm and CAB LA + RPV LA Q4W arm in the ATLAS (NCT02951052) study 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 continued to receive CAB LA 400 mg+RPV LA 600 mg intramuscular injections administered Q4W from Day 1.
Overall Number of Participants Analyzed		522	523
Mean (Standard Deviation); Unit of Measure: Millimoles per liter
CO2, Week 4, n=326, 520	Number Analyzed	326 participants	520 participants
		-0.5 (2.29)	-0.7 (2.32)
CO2, Week 8, n=510, 515	Number Analyzed	510 participants	515 participants
		-0.8 (2.12)	-0.8 (2.23)
CO2, Week 16, n=515, 513	Number Analyzed	515 participants	513 participants
		-1.0 (2.31)	-0.9 (2.33)
CO2, Week 24, n=505, 503	Number Analyzed	505 participants	503 participants
		-0.7 (2.38)	-0.7 (2.28)
CO2, Week 32, n=499, 498	Number Analyzed	499 participants	498 participants
		-0.9 (2.31)	-0.8 (2.43)
CO2, Week 40, n=495, 490	Number Analyzed	495 participants	490 participants
		-0.6 (2.33)	-0.7 (2.44)
CO2, Week 48, n=493, 485	Number Analyzed	493 participants	485 participants
		-0.4 (2.32)	-0.4 (2.41)
Chloride, Week 4, n=326, 520	Number Analyzed	326 participants	520 participants
		0.6 (2.19)	0.2 (2.35)
Chloride, Week 8, n=510, 515	Number Analyzed	510 participants	515 participants
		0.3 (2.24)	0.2 (2.34)
Chloride, Week 16, n=515, 513	Number Analyzed	515 participants	513 participants
		0.4 (2.30)	0.2 (2.40)
Chloride, Week 24, n=505, 503	Number Analyzed	505 participants	503 participants
		0.1 (2.36)	-0.1 (2.59)
Chloride, Week 32, n=499, 498	Number Analyzed	499 participants	498 participants
		0.2 (2.34)	0.1 (2.64)
Chloride, Week 40, n=495, 490	Number Analyzed	495 participants	490 participants
		-0.1 (2.46)	0.0 (2.36)
Chloride, Week 48, n=493, 486	Number Analyzed	493 participants	486 participants
		-0.0 (2.25)	-0.1 (2.46)
Phosphate, Week 4, n=326, 520	Number Analyzed	326 participants	520 participants
		0.054 (0.182)	0.018 (0.167)
Phosphate, Week 8, n=510, 515	Number Analyzed	510 participants	515 participants
		0.025 (0.177)	0.029 (0.160)
Phosphate, Week 16, n=515, 513	Number Analyzed	515 participants	513 participants
		0.017 (0.181)	0.007 (0.172)
Phosphate, Week 24, n=505, 502	Number Analyzed	505 participants	502 participants
		0.016 (0.170)	-0.004 (0.168)
Phosphate, Week 32, n=499, 498	Number Analyzed	499 participants	498 participants
		-0.001 (0.183)	0.001 (0.172)
Phosphate, Week 40, n=495, 490	Number Analyzed	495 participants	490 participants
		0.014 (0.180)	0.001 (0.170)
Phosphate, Week 48, n=493, 486	Number Analyzed	493 participants	486 participants
		0.007 (0.169)	0.010 (0.157)
Potassium, Week 4, n=326, 520	Number Analyzed	326 participants	520 participants
		0.03 (0.337)	0.03 (0.303)
Potassium, Week 8, n=510, 515	Number Analyzed	510 participants	515 participants
		0.04 (0.317)	0.04 (0.331)
Potassium, Week 16, n=515, 513	Number Analyzed	515 participants	513 participants
		0.03 (0.328)	0.03 (0.341)
Potassium, Week 24, n=505, 503	Number Analyzed	505 participants	503 participants
		0.04 (0.338)	0.03 (0.321)
Potassium, Week 32, n=499, 498	Number Analyzed	499 participants	498 participants
		0.04 (0.364)	0.00 (0.340)
Potassium, Week 40, n=495, 490	Number Analyzed	495 participants	490 participants
		0.04 (0.351)	0.02 (0.334)
Potassium, Week 48, n=493, 486	Number Analyzed	493 participants	486 participants
		0.04 (0.315)	0.03 (0.327)
Sodium, Week 4, n=326, 520	Number Analyzed	326 participants	520 participants
		0.4 (2.02)	0.1 (2.11)
Sodium, Week 8, n=510, 515	Number Analyzed	510 participants	515 participants
		0.1 (2.14)	0.2 (2.02)
Sodium, Week 16, n=515, 513	Number Analyzed	515 participants	513 participants
		0.0 (2.00)	-0.1 (2.01)
Sodium, Week 24, n=505, 503	Number Analyzed	505 participants	503 participants
		-0.2 (2.07)	-0.3 (2.20)
Sodium, Week 32, n=499, 498	Number Analyzed	499 participants	498 participants
		-0.1 (2.10)	-0.1 (2.21)
Sodium, Week 40, n=495, 490	Number Analyzed	495 participants	490 participants
		-0.3 (2.09)	-0.2 (2.13)
Sodium, Week 48, n=493, 486	Number Analyzed	493 participants	486 participants
		-0.4 (2.02)	-0.3 (2.21)
Urea, Week 4, n=326, 520	Number Analyzed	326 participants	520 participants
		0.24 (1.251)	0.19 (1.227)
Urea, Week 8, n=510, 515	Number Analyzed	510 participants	515 participants
		0.07 (1.306)	0.19 (1.336)
Urea, Week 16, n=515, 513	Number Analyzed	515 participants	513 participants
		0.07 (1.372)	0.15 (1.320)
Urea, Week 24, n=505, 503	Number Analyzed	505 participants	503 participants
		0.06 (1.298)	0.15 (1.270)
Urea, Week 32, n=499, 498	Number Analyzed	499 participants	498 participants
		0.11 (1.297)	0.16 (1.356)
Urea, Week 40, n=495, 490	Number Analyzed	495 participants	490 participants
		0.18 (1.345)	0.21 (1.412)
Urea, Week 48, n=493, 486	Number Analyzed	493 participants	486 participants
		0.13 (1.350)	0.14 (1.457)

19. Secondary Outcome

Title	Change From Baseline in Clinical Chemistry Parameters: Cholesterol, Glucose, Direct High Density Lipoprotein (HDL) Cholesterol, LDL Cholesterol Calculation and Triglycerides at Week 48
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.
Time Frame	Baseline (Day 1) and Week 48

Outcome Measure Data

Analysis Population Description

Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).

Arm/Group Title		CAB LA + RPV LA Q8W	CAB LA + RPV LA Q4W
Arm/Group Description:		Eligible participants transitioning from antiretroviral (ART) standard of care (SOC) therapy arm and CAB LA + RPV LA Q4W arm in the ATLAS (NCT02951052) study 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 received CAB LA 600 mg+RPV LA 900 mg intramuscular injections on Day 1, Week 8 and Q8W thereafter.	Eligible participants transitioning from ART SOC arm and CAB LA + RPV LA Q4W arm in the ATLAS (NCT02951052) study 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 continued to receive CAB LA 400 mg+RPV LA 600 mg intramuscular injections administered Q4W from Day 1.
Overall Number of Participants Analyzed		522	523
Mean (Standard Deviation); Unit of Measure: Millimoles per liter
Cholesterol, Week 48, n=423, 408	Number Analyzed	423 participants	408 participants
		0.023 (0.742)	0.075 (0.748)
Glucose, Week 48, n=478, 470	Number Analyzed	478 participants	470 participants
		0.16 (0.907)	0.12 (1.208)
Direct HDL cholesterol, Week 48, n=423, 408	Number Analyzed	423 participants	408 participants
		0.011 (0.292)	-0.000 (0.288)
LDL cholesterol calculation, Week 48, n=415, 398	Number Analyzed	415 participants	398 participants
		0.026 (0.629)	0.098 (0.585)
Triglycerides, Week 48, n=423, 408	Number Analyzed	423 participants	408 participants
		-0.039 (0.790)	-0.017 (0.880)

20. Secondary Outcome

Title	Change From Baseline in Clinical Chemistry Parameter: GFR From Creatinine Adjusted Using Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) Over Time
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.
Time Frame	Baseline (Day 1) and Weeks 4, 8, 16, 24, 32, 40 and 48

Outcome Measure Data

Analysis Population Description

Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).

Arm/Group Title		CAB LA + RPV LA Q8W	CAB LA + RPV LA Q4W
Arm/Group Description:		Eligible participants transitioning from antiretroviral (ART) standard of care (SOC) therapy arm and CAB LA + RPV LA Q4W arm in the ATLAS (NCT02951052) study 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 received CAB LA 600 mg+RPV LA 900 mg intramuscular injections on Day 1, Week 8 and Q8W thereafter.	Eligible participants transitioning from ART SOC arm and CAB LA + RPV LA Q4W arm in the ATLAS (NCT02951052) study 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 continued to receive CAB LA 400 mg+RPV LA 600 mg intramuscular injections administered Q4W from Day 1.
Overall Number of Participants Analyzed		522	523
Mean (Standard Deviation); Unit of Measure: milliliters/minute/1.73 square meter
Week 4, n=326, 521	Number Analyzed	326 participants	521 participants
		-0.8 (9.05)	0.4 (7.91)
Week 8, n=508, 514	Number Analyzed	508 participants	514 participants
		1.0 (9.07)	0.4 (8.62)
Week 16, n=515, 513	Number Analyzed	515 participants	513 participants
		-0.2 (9.08)	-0.4 (9.01)
Week 24, n=503, 503	Number Analyzed	503 participants	503 participants
		-0.7 (9.67)	-1.7 (10.65)
Week 32, n=499, 498	Number Analyzed	499 participants	498 participants
		-1.7 (10.12)	-3.0 (10.19)
Week 40, n=494, 489	Number Analyzed	494 participants	489 participants
		-1.7 (9.92)	-2.9 (9.95)
Week 48, n=493, 486	Number Analyzed	493 participants	486 participants
		-1.9 (9.96)	-3.3 (9.79)

21. Secondary Outcome

Title	Change From Baseline in Clinical Chemistry Parameter: Lipase Over Time
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.
Time Frame	Baseline (Day 1) and Weeks 4, 8, 16, 24, 32, 40 and 48

Outcome Measure Data

Analysis Population Description

Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).

Arm/Group Title		CAB LA + RPV LA Q8W	CAB LA + RPV LA Q4W
Arm/Group Description:		Eligible participants transitioning from antiretroviral (ART) standard of care (SOC) therapy arm and CAB LA + RPV LA Q4W arm in the ATLAS (NCT02951052) study 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 received CAB LA 600 mg+RPV LA 900 mg intramuscular injections on Day 1, Week 8 and Q8W thereafter.	Eligible participants transitioning from ART SOC arm and CAB LA + RPV LA Q4W arm in the ATLAS (NCT02951052) study 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 continued to receive CAB LA 400 mg+RPV LA 600 mg intramuscular injections administered Q4W from Day 1.
Overall Number of Participants Analyzed		522	523
Mean (Standard Deviation); Unit of Measure: Units per liter
Week 4, n=326, 521	Number Analyzed	326 participants	521 participants
		1.7 (28.76)	1.1 (22.67)
Week 8, n=510, 514	Number Analyzed	510 participants	514 participants
		1.5 (23.82)	1.4 (24.74)
Week 16, n=515, 513	Number Analyzed	515 participants	513 participants
		2.7 (33.41)	0.7 (18.82)
Week 24, n=503, 503	Number Analyzed	503 participants	503 participants
		0.7 (19.71)	2.6 (34.49)
Week 32, n=499, 498	Number Analyzed	499 participants	498 participants
		3.1 (35.20)	-0.5 (21.91)
Week 40, n=494, 486	Number Analyzed	494 participants	486 participants
		1.3 (23.35)	2.7 (30.95)
Week 48, n=493, 486	Number Analyzed	493 participants	486 participants
		3.2 (53.46)	2.9 (42.61)

22. Secondary Outcome

Title	Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets Over Time
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.
Time Frame	Baseline (Day 1) and Weeks 4, 8, 16, 24, 32, 40 and 48

Outcome Measure Data

Analysis Population Description

Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).

Arm/Group Title		CAB LA + RPV LA Q8W	CAB LA + RPV LA Q4W
Arm/Group Description:		Eligible participants transitioning from antiretroviral (ART) standard of care (SOC) therapy arm and CAB LA + RPV LA Q4W arm in the ATLAS (NCT02951052) study 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 received CAB LA 600 mg+RPV LA 900 mg intramuscular injections on Day 1, Week 8 and Q8W thereafter.	Eligible participants transitioning from ART SOC arm and CAB LA + RPV LA Q4W arm in the ATLAS (NCT02951052) study 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 continued to receive CAB LA 400 mg+RPV LA 600 mg intramuscular injections administered Q4W from Day 1.
Overall Number of Participants Analyzed		522	523
Mean (Standard Deviation); Unit of Measure: 10^9 cells per liter
Basophils, Week 4, n=330, 516	Number Analyzed	330 participants	516 participants
		0.006 (0.02751)	0.003 (0.02811)
Basophils, Week 8, n=506, 505	Number Analyzed	506 participants	505 participants
		0.000 (0.02682)	0.002 (0.02699)
Basophils, Week 16, n=508, 507	Number Analyzed	508 participants	507 participants
		-0.000 (0.02651)	0.001 (0.02929)
Basophils, Week 24, n=497, 495	Number Analyzed	497 participants	495 participants
		0.002 (0.02809)	0.002 (0.02803)
Basophils, Week 32, n=489, 486	Number Analyzed	489 participants	486 participants
		0.005 (0.02708)	0.003 (0.02988)
Basophils, Week 40, n=479, 472	Number Analyzed	479 participants	472 participants
		0.004 (0.02716)	0.004 (0.02772)
Basophils, Week 48, n=486, 478	Number Analyzed	486 participants	478 participants
		0.005 (0.02730)	0.003 (0.02926)
Eosinophils, Week 4, n=330, 516	Number Analyzed	330 participants	516 participants
		0.031 (0.13775)	0.015 (0.15112)
Eosinophils, Week 8, n=506, 505	Number Analyzed	506 participants	505 participants
		0.015 (0.14391)	0.012 (0.13314)
Eosinophils, Week 16, n=508, 507	Number Analyzed	508 participants	507 participants
		0.001 (0.13474)	0.010 (0.13012)
Eosinophils, Week 24, n=497, 495	Number Analyzed	497 participants	495 participants
		0.001 (0.13607)	0.009 (0.12836)
Eosinophils, Week 32, n=489, 486	Number Analyzed	489 participants	486 participants
		0.005 (0.12762)	0.011 (0.13810)
Eosinophils, Week 40, n=479, 472	Number Analyzed	479 participants	472 participants
		0.006 (0.13578)	0.009 (0.12297)
Eosinophils, Week 48, n=486, 478	Number Analyzed	486 participants	478 participants
		0.001 (0.12444)	0.002 (0.12646)
Leukocytes, Week 4, n=331, 520	Number Analyzed	331 participants	520 participants
		0.437 (1.5653)	0.335 (1.6343)
Leukocytes, Week 8, n=508, 507	Number Analyzed	508 participants	507 participants
		0.110 (1.5863)	0.214 (1.6109)
Leukocytes, Week 16, n=509, 507	Number Analyzed	509 participants	507 participants
		0.050 (1.4281)	0.139 (1.6384)
Leukocytes, Week 24, n=499, 497	Number Analyzed	499 participants	497 participants
		0.148 (1.5229)	0.139 (1.6301)
Leukocytes, Week 32, n=491, 489	Number Analyzed	491 participants	489 participants
		0.185 (1.5455)	0.111 (1.6454)
Leukocytes, Week 40, n=480, 476	Number Analyzed	480 participants	476 participants
		0.177 (1.6601)	0.100 (1.8042)
Leukocytes, Week 48, n=488, 478	Number Analyzed	488 participants	478 participants
		-0.007 (1.5561)	-0.012 (1.6035)
Lymphocytes, Week 4, n=330, 516	Number Analyzed	330 participants	516 participants
		0.187 (0.44013)	0.063 (0.42683)
Lymphocytes, Week 8, n=506, 505	Number Analyzed	506 participants	505 participants
		0.040 (0.39452)	0.039 (0.44987)
Lymphocytes, Week 16, n=508, 507	Number Analyzed	508 participants	507 participants
		0.060 (0.43470)	0.033 (0.44030)
Lymphocytes, Week 24, n=497, 495	Number Analyzed	497 participants	495 participants
		0.081 (0.41863)	0.061 (0.46240)
Lymphocytes, Week 32, n=489, 486	Number Analyzed	489 participants	486 participants
		0.119 (0.46387)	0.096 (0.45178)
Lymphocytes, Week 40, n=479, 472	Number Analyzed	479 participants	472 participants
		0.126 (0.44614)	0.107 (0.50590)
Lymphocytes, Week 48, n=486, 478	Number Analyzed	486 participants	478 participants
		0.063 (0.43255)	0.049 (0.48991)
Monocytes, Week 4, n=330, 516	Number Analyzed	330 participants	516 participants
		0.051 (0.14208)	0.021 (0.13359)
Monocytes, Week 8, n=506, 505	Number Analyzed	506 participants	505 participants
		0.003 (0.12080)	0.003 (0.14270)
Monocytes, Week 16, n=508, 507	Number Analyzed	508 participants	507 participants
		-0.002 (0.12804)	-0.007 (0.14361)
Monocytes, Week 24, n=497, 495	Number Analyzed	497 participants	495 participants
		0.019 (0.13460)	0.020 (0.14458)
Monocytes, Week 32, n=489, 486	Number Analyzed	489 participants	486 participants
		0.048 (0.13969)	0.039 (0.14531)
Monocytes, Week 40, n=479, 472	Number Analyzed	479 participants	472 participants
		0.060 (0.13570)	0.060 (0.15692)
Monocytes, Week 48, n=486, 478	Number Analyzed	486 participants	478 participants
		0.030 (0.13329)	0.033 (0.13116)
Neutrophils, Week 4, n=330, 516	Number Analyzed	330 participants	516 participants
		0.152 (1.44916)	0.228 (1.48979)
Neutrophils, Week 8, n=506, 505	Number Analyzed	506 participants	505 participants
		0.035 (1.49397)	0.141 (1.48054)
Neutrophils, Week 16, n=508, 507	Number Analyzed	508 participants	507 participants
		-0.018 (1.34384)	0.082 (1.52187)
Neutrophils, Week 24, n=497, 495	Number Analyzed	497 participants	495 participants
		0.047 (1.36697)	0.027 (1.46192)
Neutrophils, Week 32, n=489, 486	Number Analyzed	489 participants	486 participants
		0.001 (1.43051)	-0.054 (1.53192)
Neutrophils, Week 40, n=479, 472	Number Analyzed	479 participants	472 participants
		-0.021 (1.53092)	-0.090 (1.58850)
Neutrophils, Week 48, n=486, 478	Number Analyzed	486 participants	478 participants
		-0.108 (1.39875)	-0.118 (1.37189)
Platelets, Week 4, n=329, 518	Number Analyzed	329 participants	518 participants
		2.09 (32.330)	5.91 (39.613)
Platelets, Week 8, n=506, 507	Number Analyzed	506 participants	507 participants
		-0.62 (35.873)	0.27 (34.345)
Platelets, Week 16, n=498, 505	Number Analyzed	498 participants	505 participants
		0.01 (35.207)	-1.70 (34.072)
Platelets, Week 24, n=496, 496	Number Analyzed	496 participants	496 participants
		0.26 (36.085)	-2.53 (35.214)
Platelets, Week 32, n=487, 486	Number Analyzed	487 participants	486 participants
		1.67 (40.601)	-1.76 (37.490)
Platelets, Week 40, n=478, 472	Number Analyzed	478 participants	472 participants
		0.38 (38.636)	0.32 (38.028)
Platelets, Week 48, n=489, 474	Number Analyzed	489 participants	474 participants
		0.06 (39.549)	-1.51 (35.440)

23. Secondary Outcome

Title	Change From Baseline in Hematology Parameter: Erythrocyte Mean Corpuscular Volume (MCV) Over Time
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.
Time Frame	Baseline (Day 1) and Weeks 4, 8, 16, 24, 32, 40 and 48

Outcome Measure Data

Analysis Population Description

Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).

Arm/Group Title		CAB LA + RPV LA Q8W	CAB LA + RPV LA Q4W
Arm/Group Description:		Eligible participants transitioning from antiretroviral (ART) standard of care (SOC) therapy arm and CAB LA + RPV LA Q4W arm in the ATLAS (NCT02951052) study 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 received CAB LA 600 mg+RPV LA 900 mg intramuscular injections on Day 1, Week 8 and Q8W thereafter.	Eligible participants transitioning from ART SOC arm and CAB LA + RPV LA Q4W arm in the ATLAS (NCT02951052) study 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 continued to receive CAB LA 400 mg+RPV LA 600 mg intramuscular injections administered Q4W from Day 1.
Overall Number of Participants Analyzed		522	523
Mean (Standard Deviation); Unit of Measure: Femtoliters
Week 4, n=331, 520	Number Analyzed	331 participants	520 participants
		-0.32 (2.136)	-0.13 (2.322)
Week 8, n=509, 510	Number Analyzed	509 participants	510 participants
		-1.16 (3.270)	-0.84 (3.132)
Week 16, n=509, 507	Number Analyzed	509 participants	507 participants
		-1.99 (4.583)	-1.84 (4.370)
Week 24, n=500, 498	Number Analyzed	500 participants	498 participants
		-2.46 (5.085)	-2.41 (4.777)
Week 32, n=491, 491	Number Analyzed	491 participants	491 participants
		-3.17 (5.005)	-2.75 (4.682)
Week 40, n=481, 476	Number Analyzed	481 participants	476 participants
		-3.35 (4.740)	-3.15 (4.578)
Week 48, n=489, 478	Number Analyzed	489 participants	478 participants
		-3.28 (5.000)	-3.08 (4.797)

24. Secondary Outcome

Title	Change From Baseline in Hematology Parameter: Erythrocytes Over Time
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.
Time Frame	Baseline (Day 1) and Weeks 4, 8, 16, 24, 32, 40 and 48

Outcome Measure Data

Analysis Population Description

Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).

Arm/Group Title		CAB LA + RPV LA Q8W	CAB LA + RPV LA Q4W
Arm/Group Description:		Eligible participants transitioning from antiretroviral (ART) standard of care (SOC) therapy arm and CAB LA + RPV LA Q4W arm in the ATLAS (NCT02951052) study 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 received CAB LA 600 mg+RPV LA 900 mg intramuscular injections on Day 1, Week 8 and Q8W thereafter.	Eligible participants transitioning from ART SOC arm and CAB LA + RPV LA Q4W arm in the ATLAS (NCT02951052) study 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 continued to receive CAB LA 400 mg+RPV LA 600 mg intramuscular injections administered Q4W from Day 1.
Overall Number of Participants Analyzed		522	523
Mean (Standard Deviation); Unit of Measure: 10^12 cells per liter
Week 4, n=331, 520	Number Analyzed	331 participants	520 participants
		0.033 (0.2206)	0.024 (0.2211)
Week 8, n=509, 510	Number Analyzed	509 participants	510 participants
		0.092 (0.2669)	0.083 (0.2651)
Week 16, n=509, 507	Number Analyzed	509 participants	507 participants
		0.182 (0.3050)	0.162 (0.3222)
Week 24, n=500, 498	Number Analyzed	500 participants	498 participants
		0.209 (0.3071)	0.170 (0.3225)
Week 32, n=491, 491	Number Analyzed	491 participants	491 participants
		0.189 (0.3145)	0.150 (0.3337)
Week 40, n=481, 476	Number Analyzed	481 participants	476 participants
		0.229 (0.3217)	0.157 (0.3184)
Week 48, n=489, 478	Number Analyzed	489 participants	478 participants
		0.188 (0.3288)	0.170 (0.3329)

25. Secondary Outcome

Title	Change From Baseline in Hematology Parameter: Hematocrit Over Time
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.
Time Frame	Baseline (Day 1) and Weeks 4, 8, 16, 24, 32, 40 and 48

Outcome Measure Data

Analysis Population Description

Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).

Arm/Group Title		CAB LA + RPV LA Q8W	CAB LA + RPV LA Q4W
Arm/Group Description:		Eligible participants transitioning from antiretroviral (ART) standard of care (SOC) therapy arm and CAB LA + RPV LA Q4W arm in the ATLAS (NCT02951052) study 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 received CAB LA 600 mg+RPV LA 900 mg intramuscular injections on Day 1, Week 8 and Q8W thereafter.	Eligible participants transitioning from ART SOC arm and CAB LA + RPV LA Q4W arm in the ATLAS (NCT02951052) study 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 continued to receive CAB LA 400 mg+RPV LA 600 mg intramuscular injections administered Q4W from Day 1.
Overall Number of Participants Analyzed		522	523
Mean (Standard Deviation); Unit of Measure: Proportion of red blood cells in blood
Week 4, n=331, 520	Number Analyzed	331 participants	520 participants
		0.002 (0.02088)	0.002 (0.02202)
Week 8, n=509, 510	Number Analyzed	509 participants	510 participants
		0.004 (0.02274)	0.004 (0.02362)
Week 16, n=509, 507	Number Analyzed	509 participants	507 participants
		0.008 (0.02290)	0.007 (0.02485)
Week 24, n=500, 498	Number Analyzed	500 participants	498 participants
		0.008 (0.02219)	0.004 (0.02413)
Week 32, n=491, 491	Number Analyzed	491 participants	491 participants
		0.003 (0.02352)	0.001 (0.02469)
Week 40, n=481, 476	Number Analyzed	481 participants	476 participants
		0.006 (0.02323)	0.000 (0.02378)
Week 48, n=489, 478	Number Analyzed	489 participants	478 participants
		0.003 (0.02414)	0.001 (0.02565)

26. Secondary Outcome

Title	Change From Baseline in Hematology Parameter: Hemoglobin Over Time
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.
Time Frame	Baseline (Day 1) and Weeks 4, 8, 16, 24, 32, 40 and 48

Outcome Measure Data

Analysis Population Description

Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).

Arm/Group Title		CAB LA + RPV LA Q8W	CAB LA + RPV LA Q4W
Arm/Group Description:		Eligible participants transitioning from antiretroviral (ART) standard of care (SOC) therapy arm and CAB LA + RPV LA Q4W arm in the ATLAS (NCT02951052) study 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 received CAB LA 600 mg+RPV LA 900 mg intramuscular injections on Day 1, Week 8 and Q8W thereafter.	Eligible participants transitioning from ART SOC arm and CAB LA + RPV LA Q4W arm in the ATLAS (NCT02951052) study 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 continued to receive CAB LA 400 mg+RPV LA 600 mg intramuscular injections administered Q4W from Day 1.
Overall Number of Participants Analyzed		522	523
Mean (Standard Deviation); Unit of Measure: Grams per liter
Week 4, n=331, 520	Number Analyzed	331 participants	520 participants
		0.08 (6.425)	-0.16 (6.797)
Week 8, n=509, 510	Number Analyzed	509 participants	510 participants
		0.28 (7.028)	-0.05 (7.419)
Week 16, n=509, 507	Number Analyzed	509 participants	507 participants
		0.44 (6.979)	0.05 (7.531)
Week 24, n=501, 498	Number Analyzed	501 participants	498 participants
		1.48 (7.013)	0.45 (7.488)
Week 32, n=491, 491	Number Analyzed	491 participants	491 participants
		1.11 (7.633)	0.05 (8.041)
Week 40, n=481, 476	Number Analyzed	481 participants	476 participants
		1.36 (7.503)	-0.47 (7.788)
Week 48, n=489, 478	Number Analyzed	489 participants	478 participants
		-0.13 (7.631)	-0.80 (8.462)

27. Secondary Outcome

Title	Number of Participants With Phenotypic Resistance- Maintenance Phase
Description	Phenotypic resistance (PR) was analyzed in participants who met CVF criteria. PR 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; nucleoside reverse transcriptase inhibitor (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 the 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)
Time Frame	Up to Week 48 analysis

Outcome Measure Data

Analysis Population Description

The CVF Population comprised of all participants in ITT-E population who met CVF criteria. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).

Arm/Group Title		CAB LA + RPV LA Q8W	CAB LA + RPV LA Q4W
Arm/Group Description:		Eligible participants transitioning from antiretroviral (ART) standard of care (SOC) therapy arm and CAB LA + RPV LA Q4W arm in the ATLAS (NCT02951052) study 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 received CAB LA 600 mg+RPV LA 900 mg intramuscular injections on Day 1, Week 8 and Q8W thereafter.	Eligible participants transitioning from ART SOC arm and CAB LA + RPV LA Q4W arm in the ATLAS (NCT02951052) study 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 continued to receive CAB LA 400 mg+RPV LA 600 mg intramuscular injections administered Q4W from Day 1.
Overall Number of Participants Analyzed		8	2
Measure Type: Count of Participants; Unit of Measure: Participants
INI, BIC, resistant, n=6, 2	Number Analyzed	6 participants	2 participants
		0 0.0%	0 0.0%
INI, BIC, sensitive, n=6, 2	Number Analyzed	6 participants	2 participants
		6 100.0%	2 100.0%
INI, CAB, resistant, n=6, 2	Number Analyzed	6 participants	2 participants
		3 50.0%	1 50.0%
INI, CAB, sensitive, n=6, 2	Number Analyzed	6 participants	2 participants
		3 50.0%	1 50.0%
INI, DTG, resistant, n=6, 2	Number Analyzed	6 participants	2 participants
		0 0.0%	0 0.0%
INI, DTG, partially sensitive, n=6, 2	Number Analyzed	6 participants	2 participants
		0 0.0%	0 0.0%
INI, DTG, sensitive, n=6, 2	Number Analyzed	6 participants	2 participants
		6 100.0%	2 100.0%
INI, EVG, resistant, n=6, 2	Number Analyzed	6 participants	2 participants
		4 66.7%	2 100.0%
INI, EVG, sensitive, n=6, 2	Number Analyzed	6 participants	2 participants
		2 33.3%	0 0.0%
INI, RAL, resistant, n=6, 2	Number Analyzed	6 participants	2 participants
		4 66.7%	2 100.0%
INI, RAL, sensitive, n=6, 2	Number Analyzed	6 participants	2 participants
		2 33.3%	0 0.0%
NNRTI, DLV, resistant, n=7, 2	Number Analyzed	7 participants	2 participants
		6 85.7%	2 100.0%
NNRTI, DLV, sensitive, n=7, 2	Number Analyzed	7 participants	2 participants
		1 14.3%	0 0.0%
NNRTI, EFV, resistant, n=7, 2	Number Analyzed	7 participants	2 participants
		5 71.4%	2 100.0%
NNRTI, EFV, sensitive, n=7, 2	Number Analyzed	7 participants	2 participants
		2 28.6%	0 0.0%
NNRTI, ETR, resistant, n=7, 2	Number Analyzed	7 participants	2 participants
		0 0.0%	2 100.0%
NNRTI, ETR, partially sensitive, n=7, 2	Number Analyzed	7 participants	2 participants
		4 57.1%	0 0.0%
NNRTI, ETR, sensitive, n=7, 2	Number Analyzed	7 participants	2 participants
		3 42.9%	0 0.0%
NNRTI, NVP, resistant, n=7, 2	Number Analyzed	7 participants	2 participants
		6 85.7%	2 100.0%
NNRTI, NVP, sensitive, n=7, 2	Number Analyzed	7 participants	2 participants
		1 14.3%	0 0.0%
NNRTI, RPV, resistant, n=7, 2	Number Analyzed	7 participants	2 participants
		6 85.7%	2 100.0%
NNRTI, RPV, sensitive, n=7, 2	Number Analyzed	7 participants	2 participants
		1 14.3%	0 0.0%
NRTI, 3TC, resistant, n=7, 2	Number Analyzed	7 participants	2 participants
		1 14.3%	1 50.0%
NRTI, 3TC, sensitive, n=7, 2	Number Analyzed	7 participants	2 participants
		6 85.7%	1 50.0%
NRTI, ABC, resistant, n=7, 2	Number Analyzed	7 participants	2 participants
		0 0.0%	0 0.0%
NRTI, ABC, partially sensitive, n=7, 2	Number Analyzed	7 participants	2 participants
		0 0.0%	0 0.0%
NRTI, ABC, sensitive, n=7, 2	Number Analyzed	7 participants	2 participants
		7 100.0%	2 100.0%
NRTI, FTC, resistant, n=7, 2	Number Analyzed	7 participants	2 participants
		1 14.3%	1 50.0%
NRTI, FTC, sensitive, n=7, 2	Number Analyzed	7 participants	2 participants
		6 85.7%	1 50.0%
NRTI, TDF, resistant, n=7, 2	Number Analyzed	7 participants	2 participants
		0 0.0%	0 0.0%
NRTI, TDF, partially sensitive, n=7, 2	Number Analyzed	7 participants	2 participants
		0 0.0%	1 50.0%
NRTI, TDF, sensitive, n=7, 2	Number Analyzed	7 participants	2 participants
		7 100.0%	1 50.0%
NRTI, ZDV, resistant, n=7, 2	Number Analyzed	7 participants	2 participants
		0 0.0%	2 100.0%
NRTI, ZDV, sensitive, n=7, 2	Number Analyzed	7 participants	2 participants
		7 100.0%	0 0.0%
NRTI, d4T, resistant, n=7, 2	Number Analyzed	7 participants	2 participants
		0 0.0%	0 0.0%
NRTI, d4T, sensitive, n=7, 2	Number Analyzed	7 participants	2 participants
		7 100.0%	2 100.0%
NRTI, ddI, resistant, n=7, 2	Number Analyzed	7 participants	2 participants
		0 0.0%	0 0.0%
NRTI, ddI, partially sensitive, n=7, 2	Number Analyzed	7 participants	2 participants
		0 0.0%	0 0.0%
NRTI, ddI, sensitive, n=7, 2	Number Analyzed	7 participants	2 participants
		7 100.0%	2 100.0%
PI, ATV, resistant, n=7, 2	Number Analyzed	7 participants	2 participants
		0 0.0%	0 0.0%
PI, ATV, sensitive, n=7, 2	Number Analyzed	7 participants	2 participants
		7 100.0%	2 100.0%
PI, DRV, resistant, n=7, 2	Number Analyzed	7 participants	2 participants
		0 0.0%	0 0.0%
PI, DRV, partially sensitive, n=7, 2	Number Analyzed	7 participants	2 participants
		0 0.0%	0 0.0%
PI, DRV, sensitive, n=7, 2	Number Analyzed	7 participants	2 participants
		7 100.0%	2 100.0%
PI, FPV, resistant, n=7, 2	Number Analyzed	7 participants	2 participants
		0 0.0%	0 0.0%
PI, FPV, partially sensitive, n=7, 2	Number Analyzed	7 participants	2 participants
		0 0.0%	0 0.0%
PI, FPV, sensitive, n=7, 2	Number Analyzed	7 participants	2 participants
		7 100.0%	2 100.0%
PI, IDV, resistant, n=7, 2	Number Analyzed	7 participants	2 participants
		0 0.0%	0 0.0%
PI, IDV, sensitive, n=7, 2	Number Analyzed	7 participants	2 participants
		7 100.0%	2 100.0%
PI, LPV, resistant, n=7, 2	Number Analyzed	7 participants	2 participants
		0 0.0%	0 0.0%
PI, LPV, partially sensitive, n=7, 2	Number Analyzed	7 participants	2 participants
		0 0.0%	0 0.0%
PI, LPV, sensitive, n=7, 2	Number Analyzed	7 participants	2 participants
		7 100.0%	2 100.0%
PI, NFV, resistant, n=7, 2	Number Analyzed	7 participants	2 participants
		0 0.0%	1 50.0%
PI, NFV, sensitive, n=7, 2	Number Analyzed	7 participants	2 participants
		7 100.0%	1 50.0%
PI, RTV, resistant, n=7, 2	Number Analyzed	7 participants	2 participants
		0 0.0%	1 50.0%
PI, RTV, sensitive, n=7, 2	Number Analyzed	7 participants	2 participants
		7 100.0%	1 50.0%
PI, SQV, resistant, n=7, 2	Number Analyzed	7 participants	2 participants
		0 0.0%	0 0.0%
PI, SQV, partially sensitive, n=7, 2	Number Analyzed	7 participants	2 participants
		0 0.0%	0 0.0%
PI, SQV, sensitive, n=7, 2	Number Analyzed	7 participants	2 participants
		7 100.0%	2 100.0%
PI, TPV, resistant, n=7, 2	Number Analyzed	7 participants	2 participants
		0 0.0%	0 0.0%
PI, TPV, partially sensitive, n=7, 2	Number Analyzed	7 participants	2 participants
		0 0.0%	0 0.0%
PI, TPV, sensitive, n=7, 2	Number Analyzed	7 participants	2 participants
		7 100.0%	2 100.0%

28. Secondary Outcome

Title	Number of Participants With Genotypic Resistance-Maintenance Phase
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.
Time Frame	Up to Week 48 analysis

Outcome Measure Data

Analysis Population Description

CVF Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).

Arm/Group Title		CAB LA + RPV LA Q8W	CAB LA + RPV LA Q4W
Arm/Group Description:		Eligible participants transitioning from antiretroviral (ART) standard of care (SOC) therapy arm and CAB LA + RPV LA Q4W arm in the ATLAS (NCT02951052) study 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 received CAB LA 600 mg+RPV LA 900 mg intramuscular injections on Day 1, Week 8 and Q8W thereafter.	Eligible participants transitioning from ART SOC arm and CAB LA + RPV LA Q4W arm in the ATLAS (NCT02951052) study 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 continued to receive CAB LA 400 mg+RPV LA 600 mg intramuscular injections administered Q4W from Day 1.
Overall Number of Participants Analyzed		8	2
Measure Type: Count of Participants; Unit of Measure: Participants
INI, BIC, resistant, n=6, 2	Number Analyzed	6 participants	2 participants
		1 16.7%	0 0.0%
INI, BIC, resistance possible, n=6, 2	Number Analyzed	6 participants	2 participants
		2 33.3%	1 50.0%
INI, BIC, sensitive, n=6, 2	Number Analyzed	6 participants	2 participants
		3 50.0%	1 50.0%
INI, DTG, resistant, n=6, 2	Number Analyzed	6 participants	2 participants
		1 16.7%	0 0.0%
INI, DTG, resistance possible, n=6, 2	Number Analyzed	6 participants	2 participants
		2 33.3%	1 50.0%
INI, DTG, sensitive, n=6, 2	Number Analyzed	6 participants	2 participants
		3 50.0%	1 50.0%
INI, EVG, resistant, n=6, 2	Number Analyzed	6 participants	2 participants
		4 66.7%	2 100.0%
INI, EVG, resistance possible, n=6, 2	Number Analyzed	6 participants	2 participants
		0 0.0%	0 0.0%
INI, EVG, sensitive, n=6, 2	Number Analyzed	6 participants	2 participants
		2 33.3%	0 0.0%
INI, RAL, resistant, n=6, 2	Number Analyzed	6 participants	2 participants
		4 66.7%	2 100.0%
INI, RAL, resistance possible, n=6, 2	Number Analyzed	6 participants	2 participants
		0 0.0%	0 0.0%
INI, RAL, sensitive, n=6, 2	Number Analyzed	6 participants	2 participants
		2 33.3%	0 0.0%
NNRTI, DLV, resistant, n=8, 2	Number Analyzed	8 participants	2 participants
		2 25.0%	1 50.0%
NNRTI, DLV, resistance possible, n=8, 2	Number Analyzed	8 participants	2 participants
		2 25.0%	1 50.0%
NNRTI, DLV, sensitive, n=8, 2	Number Analyzed	8 participants	2 participants
		4 50.0%	0 0.0%
NNRTI, EFV, resistant, n=8, 2	Number Analyzed	8 participants	2 participants
		4 50.0%	2 100.0%
NNRTI, EFV, resistance possible, n=8, 2	Number Analyzed	8 participants	2 participants
		2 25.0%	0 0.0%
NNRTI, EFV, sensitive, n=8, 2	Number Analyzed	8 participants	2 participants
		2 25.0%	0 0.0%
NNRTI, ETR, resistant, n=8, 2	Number Analyzed	8 participants	2 participants
		0 0.0%	1 50.0%
NNRTI, ETR, resistance possible, n=8, 2	Number Analyzed	8 participants	2 participants
		2 25.0%	1 50.0%
NNRTI, ETR, sensitive, n=8, 2	Number Analyzed	8 participants	2 participants
		6 75.0%	0 0.0%
NNRTI, NVP, resistant, n=8, 2	Number Analyzed	8 participants	2 participants
		4 50.0%	2 100.0%
NNRTI, NVP, resistance possible, n=8, 2	Number Analyzed	8 participants	2 participants
		2 25.0%	0 0.0%
NNRTI, NVP, sensitive, n=8, 2	Number Analyzed	8 participants	2 participants
		2 25.0%	0 0.0%
NNRTI, RPV, resistant, n=8, 2	Number Analyzed	8 participants	2 participants
		6 75.0%	1 50.0%
NNRTI, RPV, resistance possible, n=8, 2	Number Analyzed	8 participants	2 participants
		0 0.0%	0 0.0%
NNRTI, RPV, sensitive, n=8, 2	Number Analyzed	8 participants	2 participants
		2 25.0%	1 50.0%
NRTI, 3TC, resistant, n=8, 2	Number Analyzed	8 participants	2 participants
		1 12.5%	1 50.0%
NRTI, 3TC, resistance possible, n=8, 2	Number Analyzed	8 participants	2 participants
		0 0.0%	0 0.0%
NRTI, 3TC, sensitive, n=8, 2	Number Analyzed	8 participants	2 participants
		7 87.5%	1 50.0%
NRTI, ABC, resistant, n=8, 2	Number Analyzed	8 participants	2 participants
		0 0.0%	0 0.0%
NRTI, ABC, resistance possible, n=8, 2	Number Analyzed	8 participants	2 participants
		0 0.0%	1 50.0%
NRTI, ABC, sensitive, n=8, 2	Number Analyzed	8 participants	2 participants
		8 100.0%	1 50.0%
NRTI, FTC, resistant, n=8, 2	Number Analyzed	8 participants	2 participants
		1 12.5%	1 50.0%
NRTI, FTC, resistance possible, n=8, 2	Number Analyzed	8 participants	2 participants
		0 0.0%	0 0.0%
NRTI, FTC, sensitive, n=8, 2	Number Analyzed	8 participants	2 participants
		7 87.5%	1 50.0%
NRTI, TDF, resistant, n=8, 2	Number Analyzed	8 participants	2 participants
		0 0.0%	1 50.0%
NRTI, TDF, resistance possible, n=8, 2	Number Analyzed	8 participants	2 participants
		0 0.0%	0 0.0%
NRTI, TDF, sensitive, n=8, 2	Number Analyzed	8 participants	2 participants
		8 100.0%	1 50.0%
NRTI, ZDV, resistant, n=8, 2	Number Analyzed	8 participants	2 participants
		0 0.0%	1 50.0%
NRTI, ZDV, resistance possible, n=8, 2	Number Analyzed	8 participants	2 participants
		0 0.0%	0 0.0%
NRTI, ZDV, sensitive, n=8, 2	Number Analyzed	8 participants	2 participants
		8 100.0%	1 50.0%
NRTI, d4T, resistant, n=8, 2	Number Analyzed	8 participants	2 participants
		0 0.0%	1 50.0%
NRTI, d4T, resistance possible, n=8, 2	Number Analyzed	8 participants	2 participants
		0 0.0%	0 0.0%
NRTI, d4T, sensitive, n=8, 2	Number Analyzed	8 participants	2 participants
		8 100.0%	1 50.0%
NRTI, ddI, resistant, n=8, 2	Number Analyzed	8 participants	2 participants
		0 0.0%	1 50.0%
NRTI, ddI, resistance possible, n=8, 2	Number Analyzed	8 participants	2 participants
		1 12.5%	0 0.0%
NRTI, ddI, sensitive, n=8, 2	Number Analyzed	8 participants	2 participants
		7 87.5%	1 50.0%
PI, ATV, resistant, n=8, 2	Number Analyzed	8 participants	2 participants
		0 0.0%	1 50.0%
PI, ATV, resistance possible, n=8, 2	Number Analyzed	8 participants	2 participants
		0 0.0%	0 0.0%
PI, ATV, sensitive, n=8, 2	Number Analyzed	8 participants	2 participants
		8 100.0%	1 50.0%
PI, ATV/r, resistant, n=8, 2	Number Analyzed	8 participants	2 participants
		0 0.0%	0 0.0%
PI, ATV/r, resistance possible, n=8, 2	Number Analyzed	8 participants	2 participants
		0 0.0%	1 50.0%
PI, ATV/r, sensitive, n=8, 2	Number Analyzed	8 participants	2 participants
		8 100.0%	1 50.0%
PI, DRV/r, resistant, n=8, 2	Number Analyzed	8 participants	2 participants
		0 0.0%	0 0.0%
PI, DRV/r, resistance possible, n=8, 2	Number Analyzed	8 participants	2 participants
		0 0.0%	0 0.0%
PI, DRV/r, sensitive, n=8, 2	Number Analyzed	8 participants	2 participants
		8 100.0%	2 100.0%
PI, FPV/r, resistant, n=8, 2	Number Analyzed	8 participants	2 participants
		0 0.0%	0 0.0%
PI, FPV/r, resistance possible, n=8, 2	Number Analyzed	8 participants	2 participants
		0 0.0%	0 0.0%
PI, FPV/r, sensitive, n=8, 2	Number Analyzed	8 participants	2 participants
		8 100.0%	2 100.0%
PI, IDV/r, resistant, n=8, 2	Number Analyzed	8 participants	2 participants
		0 0.0%	0 0.0%
PI, IDV/r, resistance possible, n=8, 2	Number Analyzed	8 participants	2 participants
		0 0.0%	1 50.0%
PI, IDV/r, sensitive, n=8, 2	Number Analyzed	8 participants	2 participants
		8 100.0%	1 50.0%
PI, LPV/r, resistant, n=8, 2	Number Analyzed	8 participants	2 participants
		0 0.0%	0 0.0%
PI, LPV/r, resistance possible, n=8, 2	Number Analyzed	8 participants	2 participants
		0 0.0%	0 0.0%
PI, LPV/r, sensitive, n=8, 2	Number Analyzed	8 participants	2 participants
		8 100.0%	2 100.0%
PI, NFV, resistant, n=8, 2	Number Analyzed	8 participants	2 participants
		0 0.0%	1 50.0%
PI, NFV, resistance possible, n=8, 2	Number Analyzed	8 participants	2 participants
		0 0.0%	0 0.0%
PI, NFV, sensitive, n=8, 2	Number Analyzed	8 participants	2 participants
		8 100.0%	1 50.0%
PI, RTV, resistant, n=8, 2	Number Analyzed	8 participants	2 participants
		0 0.0%	1 50.0%
PI, RTV, resistance possible, n=8, 2	Number Analyzed	8 participants	2 participants
		0 0.0%	0 0.0%
PI, RTV, sensitive, n=8, 2	Number Analyzed	8 participants	2 participants
		8 100.0%	1 50.0%
PI, SQV/r, resistant, n=8, 2	Number Analyzed	8 participants	2 participants
		0 0.0%	0 0.0%
PI, SQV/r, resistance possible, n=8, 2	Number Analyzed	8 participants	2 participants
		0 0.0%	0 0.0%
PI, SQV/r, sensitive, n=8, 2	Number Analyzed	8 participants	2 participants
		8 100.0%	2 100.0%
PI, TPV/r, resistant, n=8, 2	Number Analyzed	8 participants	2 participants
		0 0.0%	1 50.0%
PI, TPV/r, resistance possible, n=8, 2	Number Analyzed	8 participants	2 participants
		0 0.0%	0 0.0%
PI, TPV/r, sensitive, n=8, 2	Number Analyzed	8 participants	2 participants
		8 100.0%	1 50.0%

29. Secondary Outcome

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
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.
Time Frame	Week 48

Outcome Measure Data

Analysis Population Description

ITT-E Population. Only those participants with data available at indicated time point is analyzed.

Arm/Group Title	CAB LA + RPV LA Q8W
Arm/Group Description:	Eligible participants transitioning from antiretroviral (ART) standard of care (SOC) therapy arm and CAB LA + RPV LA Q4W arm in the ATLAS (NCT02951052) study 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 received CAB LA 600 mg+RPV LA 900 mg intramuscular injections on Day 1, Week 8 and Q8W thereafter.
Overall Number of Participants Analyzed	306
Measure Type: Count of Participants; Unit of Measure: Participants
Injectable LA HIV treatment Q4W	0 0.0%
Injectable LA HIV treatment Q8W	300 98.0%
Oral daily HIV treatment	4 1.3%
No preference	2 0.7%

30. Secondary Outcome

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
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.
Time Frame	Week 48

Outcome Measure Data

Analysis Population Description

ITT-E Population. Only those participants with data available at indicated time point is analyzed.

Arm/Group Title	CAB LA + RPV LA Q8W
Arm/Group Description:	Eligible participants transitioning from antiretroviral (ART) standard of care (SOC) therapy arm and CAB LA + RPV LA Q4W arm in the ATLAS (NCT02951052) study 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 received CAB LA 600 mg+RPV LA 900 mg intramuscular injections on Day 1, Week 8 and Q8W thereafter.
Overall Number of Participants Analyzed	191
Measure Type: Count of Participants; Unit of Measure: Participants
Injectable LA HIV treatment Q4W	6 3.1%
Injectable LA HIV treatment Q8W	179 93.7%
Oral daily HIV treatment	4 2.1%
No preference	2 1.0%

31. Secondary Outcome

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
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 participants received during the oral lead-in period. Number of participants who selected each of the responses based on their treatment preference is presented.
Time Frame	Week 48

Outcome Measure Data

Analysis Population Description

ITT-E Population. Only those participants with data available at indicated time point is analyzed.

Arm/Group Title	CAB LA + RPV LA Q4W
Arm/Group Description:	Eligible participants transitioning from ART SOC arm and CAB LA + RPV LA Q4W arm in the ATLAS (NCT02951052) study 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 continued to receive CAB LA 400 mg+RPV LA 600 mg intramuscular injections administered Q4W from Day 1.
Overall Number of Participants Analyzed	497
Measure Type: Count of Participants; Unit of Measure: Participants
Injectable LA HIV treatment Q4W	468 94.2%
Injectable LA HIV treatment Q8W	0 0.0%
Oral daily HIV treatment	16 3.2%
No preference	13 2.6%

32. Secondary Outcome

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
Description	The HATQoL questionnaire was used to assess the health related QoL (HRQoL). It comprises of three dimensions:LISAT, medication worries (MEDWO) and disclosure worries (DISWO). Total imputed value score for LISAT is calculated on a 0-100 scale using the formula: LISAT 100=[100 divided by (20 minus 4)]*(LISAT minus 4). A response of 5 in LISAT score shows satisfaction all of the time and 1 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. Last Observation Carried Forward (LOCF) was used as primary method of analysis. Data for 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.
Time Frame	Baseline (Day 1) and Weeks 24 and 48

Outcome Measure Data

Analysis Population Description

ITT-E Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).

Arm/Group Title		CAB LA + RPV LA Q8W	CAB LA + RPV LA Q4W
Arm/Group Description:		Eligible participants transitioning from antiretroviral (ART) standard of care (SOC) therapy arm and CAB LA + RPV LA Q4W arm in the ATLAS (NCT02951052) study 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 received CAB LA 600 mg+RPV LA 900 mg intramuscular injections on Day 1, Week 8 and Q8W thereafter.	Eligible participants transitioning from ART SOC arm and CAB LA + RPV LA Q4W arm in the ATLAS (NCT02951052) study 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 continued to receive CAB LA 400 mg+RPV LA 600 mg intramuscular injections administered Q4W from Day 1.
Overall Number of Participants Analyzed		522	523
Mean (Standard Deviation); Unit of Measure: Scores on a scale
Without exposure, Week 24, n=318, 324	Number Analyzed	318 participants	324 participants
		1.5 (14.87)	-0.5 (18.00)
Without exposure, Week 48, n=319, 324	Number Analyzed	319 participants	324 participants
		-0.8 (15.24)	0.6 (17.51)
With exposure, Week 24, n=192, 194	Number Analyzed	192 participants	194 participants
		-0.8 (14.31)	0.8 (13.73)
With exposure, Week 48, n=192, 194	Number Analyzed	192 participants	194 participants
		0.3 (14.03)	-1.3 (14.50)

33. Secondary Outcome

Title	Change From Baseline in HIV Medication, MEDWO Using HATQoL Questionnaire in Participants With or Without Prior Exposure to CAB+RPV
Description	The HATQoL questionnaire was used to assess the HRQoL. It comprises of three dimensions:LISAT, MEDWO and DISWO. The total imputed value score for MEDWO is calculated on a 0-100 scale using the 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.
Time Frame	Baseline (Day 1) and Weeks 24 and 48

Outcome Measure Data

Analysis Population Description

ITT-E Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).

Arm/Group Title		CAB LA + RPV LA Q8W	CAB LA + RPV LA Q4W
Arm/Group Description:		Eligible participants transitioning from antiretroviral (ART) standard of care (SOC) therapy arm and CAB LA + RPV LA Q4W arm in the ATLAS (NCT02951052) study 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 received CAB LA 600 mg+RPV LA 900 mg intramuscular injections on Day 1, Week 8 and Q8W thereafter.	Eligible participants transitioning from ART SOC arm and CAB LA + RPV LA Q4W arm in the ATLAS (NCT02951052) study 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 continued to receive CAB LA 400 mg+RPV LA 600 mg intramuscular injections administered Q4W from Day 1.
Overall Number of Participants Analyzed		522	523
Mean (Standard Deviation); Unit of Measure: Scores on a scale
Without exposure, Week 24, n=318, 324	Number Analyzed	318 participants	324 participants
		2.7 (16.53)	2.6 (15.61)
Without exposure, Week 48, n=319, 324	Number Analyzed	319 participants	324 participants
		3.0 (15.87)	1.9 (15.97)
With exposure, Week 24, n=192, 194	Number Analyzed	192 participants	194 participants
		0.7 (10.57)	1.7 (14.86)
With exposure, Week 48, n=192, 194	Number Analyzed	192 participants	194 participants
		1.3 (8.82)	1.3 (17.95)

34. Secondary Outcome

Title	Change From Baseline in DISWO Using HATQoL Questionnaire in Participants With or Without Prior Exposure to CAB+RPV
Description	The HATQoL questionnaire was used to assess the HRQoL. It comprises of three dimensions:LISAT, MEDWO and DISWO. 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.
Time Frame	Baseline (Day 1) and Weeks 24 and 48

Outcome Measure Data

Analysis Population Description

ITT-E Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).

Arm/Group Title		CAB LA + RPV LA Q8W	CAB LA + RPV LA Q4W
Arm/Group Description:		Eligible participants transitioning from antiretroviral (ART) standard of care (SOC) therapy arm and CAB LA + RPV LA Q4W arm in the ATLAS (NCT02951052) study 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 received CAB LA 600 mg+RPV LA 900 mg intramuscular injections on Day 1, Week 8 and Q8W thereafter.	Eligible participants transitioning from ART SOC arm and CAB LA + RPV LA Q4W arm in the ATLAS (NCT02951052) study 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 continued to receive CAB LA 400 mg+RPV LA 600 mg intramuscular injections administered Q4W from Day 1.
Overall Number of Participants Analyzed		522	523
Mean (Standard Deviation); Unit of Measure: Scores on a scale
Without exposure, Week 24, n=317, 324	Number Analyzed	317 participants	324 participants
		1.4 (25.58)	1.2 (23.18)
Without exposure, Week 48, n=318, 324	Number Analyzed	318 participants	324 participants
		-0.5 (28.14)	-0.5 (23.86)
With exposure, Week 24, n=192, 194	Number Analyzed	192 participants	194 participants
		0.9 (21.13)	1.8 (24.20)
With exposure, Week 48, n=192, 194	Number Analyzed	192 participants	194 participants
		-0.6 (24.11)	1.5 (26.84)

35. Secondary Outcome

Title	Change From Baseline in Total Treatment Satisfaction Score Using HIV Treatment Satisfaction Status Questionnaire (HIVTSQs) at Weeks 24 and 48
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.
Time Frame	Baseline (Day 1) and Weeks 24 and 48

Outcome Measure Data

Analysis Population Description

ITT-E Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).

Arm/Group Title		CAB LA + RPV LA Q8W	CAB LA + RPV LA Q4W
Arm/Group Description:		Eligible participants transitioning from antiretroviral (ART) standard of care (SOC) therapy arm and CAB LA + RPV LA Q4W arm in the ATLAS (NCT02951052) study 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 received CAB LA 600 mg+RPV LA 900 mg intramuscular injections on Day 1, Week 8 and Q8W thereafter.	Eligible participants transitioning from ART SOC arm and CAB LA + RPV LA Q4W arm in the ATLAS (NCT02951052) study 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 continued to receive CAB LA 400 mg+RPV LA 600 mg intramuscular injections administered Q4W from Day 1.
Overall Number of Participants Analyzed		522	523
Mean (Standard Deviation); Unit of Measure: Scores on a scale
Without exposure, Week 24, n=319, 323	Number Analyzed	319 participants	323 participants
		4.63 (9.818)	4.44 (9.709)
Without exposure, Week 48, n=319, 323	Number Analyzed	319 participants	323 participants
		4.42 (10.351)	3.55 (10.224)
With exposure, Week 24, n=191, 193	Number Analyzed	191 participants	193 participants
		0.55 (5.050)	0.55 (5.347)
With exposure, Week 48, n=191, 194	Number Analyzed	191 participants	194 participants
		0.40 (5.242)	-0.01 (6.521)

36. Secondary Outcome

Title	Change From Baseline in Individual Item Scores Using HIVTSQs at Weeks 24 and 48
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.
Time Frame	Baseline (Day 1) and Weeks 24 and 48

Outcome Measure Data

Analysis Population Description

ITT-E Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).

Arm/Group Title		CAB LA + RPV LA Q8W	CAB LA + RPV LA Q4W
Arm/Group Description:		Eligible participants transitioning from antiretroviral (ART) standard of care (SOC) therapy arm and CAB LA + RPV LA Q4W arm in the ATLAS (NCT02951052) study 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 received CAB LA 600 mg+RPV LA 900 mg intramuscular injections on Day 1, Week 8 and Q8W thereafter.	Eligible participants transitioning from ART SOC arm and CAB LA + RPV LA Q4W arm in the ATLAS (NCT02951052) study 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 continued to receive CAB LA 400 mg+RPV LA 600 mg intramuscular injections administered Q4W from Day 1.
Overall Number of Participants Analyzed		522	523
Mean (Standard Deviation); Unit of Measure: Scores on a scale
Item 1, Without exposure, Week 24, n=319, 323	Number Analyzed	319 participants	323 participants
		0.3 (1.19)	0.3 (1.18)
Item 1, Without exposure, Week 48, n=319, 323	Number Analyzed	319 participants	323 participants
		0.3 (1.23)	0.2 (1.27)
Item 1, With exposure, Week 24, n=191, 193	Number Analyzed	191 participants	193 participants
		0.1 (0.77)	0.0 (0.78)
Item 1, With exposure, Week 48, n=191, 194	Number Analyzed	191 participants	194 participants
		0.1 (0.81)	0.0 (0.90)
Item 2, Without exposure, Week 24, n=319, 323	Number Analyzed	319 participants	323 participants
		0.0 (0.73)	0.1 (0.67)
Item 2, Without exposure, Week 48, n=319, 323	Number Analyzed	319 participants	323 participants
		0.0 (0.78)	0.0 (0.65)
Item 2, With exposure, Week 24, n=191, 193	Number Analyzed	191 participants	193 participants
		0.0 (0.42)	0.1 (0.61)
Item 2, With exposure, Week 48, n=191, 194	Number Analyzed	191 participants	194 participants
		0.0 (0.49)	0.1 (0.63)
Item 3, Without exposure, Week 24, n=319, 323	Number Analyzed	319 participants	323 participants
		0.0 (1.42)	0.0 (1.49)
Item 3, Without exposure, Week 48, n=319, 323	Number Analyzed	319 participants	323 participants
		0.0 (1.45)	0.0 (1.48)
Item 3, With exposure, Week 24, n=191, 193	Number Analyzed	191 participants	193 participants
		0.0 (0.82)	0.1 (1.03)
Item 3, With exposure, Week 48, n=191, 194	Number Analyzed	191 participants	194 participants
		0.0 (1.05)	0.0 (1.20)
Item 4, Without exposure, Week 24, n=319, 323	Number Analyzed	319 participants	323 participants
		0.3 (1.05)	0.3 (1.28)
Item 4, Without exposure, Week 48, n=319, 323	Number Analyzed	319 participants	323 participants
		0.2 (1.20)	0.2 (1.28)
Item 4, With exposure, Week 24, n=191, 193	Number Analyzed	191 participants	193 participants
		0.1 (0.73)	0.0 (0.80)
Item 4, With exposure, Week 48, n=191, 194	Number Analyzed	191 participants	194 participants
		0.1 (0.73)	0.0 (0.98)
Item 5, Without exposure, Week 24, n=319, 323	Number Analyzed	319 participants	323 participants
		0.7 (1.41)	0.6 (1.37)
Item 5, Without exposure, Week 48, n=319, 323	Number Analyzed	319 participants	323 participants
		0.7 (1.36)	0.5 (1.42)
Item 5, With exposure, Week 24, n=191, 193	Number Analyzed	191 participants	193 participants
		0.0 (0.58)	0.1 (0.72)
Item 5, With exposure, Week 48, n=191, 194	Number Analyzed	191 participants	194 participants
		0.0 (0.69)	0.0 (0.88)
Item 6, Without exposure, Week 24, n=319, 323	Number Analyzed	319 participants	323 participants
		0.9 (1.72)	0.8 (1.71)
Item 6, Without exposure, Week 48, n=319, 323	Number Analyzed	319 participants	323 participants
		0.8 (1.71)	0.8 (1.80)
Item 6, With exposure, Week 24, n=191, 193	Number Analyzed	191 participants	193 participants
		0.2 (0.96)	0.1 (0.90)
Item 6, With exposure, Week 48, n=191, 194	Number Analyzed	191 participants	194 participants
		0.1 (1.13)	-0.1 (1.12)
Item 7, Without exposure, Week 24, n=319, 323	Number Analyzed	319 participants	323 participants
		0.3 (0.78)	0.2 (0.98)
Item 7, Without exposure, Week 48, n=319, 323	Number Analyzed	319 participants	323 participants
		0.2 (0.94)	0.2 (0.92)
Item 7, With exposure, Week 24, n=191, 193	Number Analyzed	191 participants	193 participants
		0.0 (0.55)	0.0 (0.70)
Item 7, With exposure, Week 48, n=191, 194	Number Analyzed	191 participants	194 participants
		0.1 (0.73)	0.1 (0.69)
Item 8, Without exposure, Week 24, n=318, 322	Number Analyzed	318 participants	322 participants
		0.5 (1.31)	0.6 (1.30)
Item 8, Without exposure, Week 48, n=319, 323	Number Analyzed	319 participants	323 participants
		0.5 (1.31)	0.5 (1.41)
Item 8, With exposure, Week 24, n=191, 194	Number Analyzed	191 participants	194 participants
		0.1 (0.61)	0.1 (0.58)
Item 8, With exposure, Week 48, n=191, 194	Number Analyzed	191 participants	194 participants
		0.0 (0.64)	0.0 (0.80)
Item 9, Without exposure, Week 24, n=319, 322	Number Analyzed	319 participants	322 participants
		0.4 (1.16)	0.4 (1.30)
Item 9, Without exposure, Week 48, n=319, 323	Number Analyzed	319 participants	323 participants
		0.4 (1.23)	0.3 (1.36)
Item 9, With exposure, Week 24, n=191, 194	Number Analyzed	191 participants	194 participants
		0.0 (0.52)	0.0 (0.72)
Item 9, With exposure, Week 48, n=191, 194	Number Analyzed	191 participants	194 participants
		0.1 (0.55)	0.0 (0.85)
Item 10, Without exposure, Week 24, n=319, 322	Number Analyzed	319 participants	322 participants
		0.8 (1.44)	0.9 (1.50)
Item 10, Without exposure, Week 48, n=319, 323	Number Analyzed	319 participants	323 participants
		0.8 (1.52)	0.7 (1.63)
Item 10, With exposure, Week 24, n=191, 194	Number Analyzed	191 participants	194 participants
		0.0 (0.78)	0.0 (0.67)
Item 10, With exposure, Week 48, n=191, 194	Number Analyzed	191 participants	194 participants
		0.0 (0.79)	0.0 (0.77)
Item 11, Without exposure, Week 24, n=319, 322	Number Analyzed	319 participants	322 participants
		0.4 (1.22)	0.4 (1.25)
Item 11, Without exposure, Week 48, n=319, 323	Number Analyzed	319 participants	323 participants
		0.4 (1.26)	0.3 (1.31)
Item 11, With exposure, Week 24, n=191, 194	Number Analyzed	191 participants	194 participants
		0.0 (0.73)	0.1 (0.65)
Item 11, With exposure, Week 48, n=191, 194	Number Analyzed	191 participants	194 participants
		0.0 (0.62)	-0.1 (0.84)
Item 12, Without exposure, Week 24, n=319, 322	Number Analyzed	319 participants	322 participants
		-0.4 (1.46)	-0.4 (1.48)
Item 12, Without exposure, Week 48, n=319, 323	Number Analyzed	319 participants	323 participants
		-0.3 (1.46)	-0.5 (1.57)
Item 12, With exposure, Week 24, n=191, 194	Number Analyzed	191 participants	194 participants
		-0.1 (0.92)	0.0 (0.92)
Item 12, With exposure, Week 48, n=191, 194	Number Analyzed	191 participants	194 participants
		-0.1 (1.08)	0.0 (1.02)

37. Secondary Outcome

Title	Total Treatment Satisfaction Change Score Using HIV Treatment Satisfaction Change Questionnaire (HIVTSQc) at Week 48
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.
Time Frame	Week 48

Outcome Measure Data

Analysis Population Description

ITT-E Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).

Arm/Group Title		CAB LA + RPV LA Q8W	CAB LA + RPV LA Q4W
Arm/Group Description:		Eligible participants transitioning from antiretroviral (ART) standard of care (SOC) therapy arm and CAB LA + RPV LA Q4W arm in the ATLAS (NCT02951052) study 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 received CAB LA 600 mg+RPV LA 900 mg intramuscular injections on Day 1, Week 8 and Q8W thereafter.	Eligible participants transitioning from ART SOC arm and CAB LA + RPV LA Q4W arm in the ATLAS (NCT02951052) study 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 continued to receive CAB LA 400 mg+RPV LA 600 mg intramuscular injections administered Q4W from Day 1.
Overall Number of Participants Analyzed		522	523
Mean (Standard Deviation); Unit of Measure: Scores on a scale
Q4W ATLAS, n=124, 125	Number Analyzed	124 participants	125 participants
		29.1 (6.72)	24.7 (12.33)
SOC, n=380, 382	Number Analyzed	380 participants	382 participants
		28.9 (7.68)	27.3 (9.50)

38. Secondary Outcome

Title	Change From Week 8 in Dimension Scores Using Perception of Injection (PIN) Questionnaire.
Description	The 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 the 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 questions are phrased in such a way as to ensure that 1 always equated with the most favourable perception of vaccination, and 5 most unfavourable. Dimension scores include bother from ISR, leg movement, sleep and acceptability. Score of a domain is calculated as mean of all items within the domain. Higher scores represent worse perception of injection. LOCF was used as primary method of analysis.
Time Frame	Week 8 and Weeks 24 and 48

Outcome Measure Data

Analysis Population Description

ITT-E Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).

Arm/Group Title		CAB LA + RPV LA Q8W	CAB LA + RPV LA Q4W
Arm/Group Description:		Eligible participants transitioning from antiretroviral (ART) standard of care (SOC) therapy arm and CAB LA + RPV LA Q4W arm in the ATLAS (NCT02951052) study 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 received CAB LA 600 mg+RPV LA 900 mg intramuscular injections on Day 1, Week 8 and Q8W thereafter.	Eligible participants transitioning from ART SOC arm and CAB LA + RPV LA Q4W arm in the ATLAS (NCT02951052) study 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 continued to receive CAB LA 400 mg+RPV LA 600 mg intramuscular injections administered Q4W from Day 1.
Overall Number of Participants Analyzed		522	523
Mean (Standard Deviation); Unit of Measure: Scores on a scale
Bother of ISRs, Week 24, n=515, 515	Number Analyzed	515 participants	515 participants
		-0.00 (0.459)	-0.01 (0.509)
Bother of ISRs, Week 48, n=515, 515	Number Analyzed	515 participants	515 participants
		-0.00 (0.531)	0.01 (0.543)
Leg Movement, Week 24, n=515, 514	Number Analyzed	515 participants	514 participants
		-0.11 (0.804)	-0.23 (0.809)
Leg Movement, Week 48, n=515, 514	Number Analyzed	515 participants	514 participants
		-0.12 (0.818)	-0.24 (0.789)
Sleep, Week 24, n=515, 514	Number Analyzed	515 participants	514 participants
		-0.00 (0.772)	-0.20 (0.793)
Sleep, Week 48, n=515, 514	Number Analyzed	515 participants	514 participants
		-0.03 (0.814)	-0.18 (0.804)
Acceptance, Week 24, n=514, 515	Number Analyzed	514 participants	515 participants
		-0.13 (0.813)	-0.13 (0.837)
Acceptance, Week 48, n=514, 515	Number Analyzed	514 participants	515 participants
		-0.18 (0.829)	-0.13 (0.880)

39. Secondary Outcome

Title	Change From Week 8 in Individual Item Scores (Anxiety Before, Pain, Satisfaction, Anxiety After and Willingness) Using Perception of Injection (PIN) Questionnaire.
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.
Time Frame	Week 8 and Weeks 24 and 48

Outcome Measure Data

Analysis Population Description

ITT-E Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).

Arm/Group Title		CAB LA + RPV LA Q8W	CAB LA + RPV LA Q4W
Arm/Group Description:		Eligible participants transitioning from antiretroviral (ART) standard of care (SOC) therapy arm and CAB LA + RPV LA Q4W arm in the ATLAS (NCT02951052) study 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 received CAB LA 600 mg+RPV LA 900 mg intramuscular injections on Day 1, Week 8 and Q8W thereafter.	Eligible participants transitioning from ART SOC arm and CAB LA + RPV LA Q4W arm in the ATLAS (NCT02951052) study 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 continued to receive CAB LA 400 mg+RPV LA 600 mg intramuscular injections administered Q4W from Day 1.
Overall Number of Participants Analyzed		522	523
Mean (Standard Deviation); Unit of Measure: Scores on a scale
Anxiety before, Week 24, n=515, 515	Number Analyzed	515 participants	515 participants
		0.0 (0.83)	-0.1 (0.85)
Anxiety before, Week 48, n=515, 515	Number Analyzed	515 participants	515 participants
		-0.1 (0.82)	-0.1 (0.85)
Pain, Week 24, n=515, 515	Number Analyzed	515 participants	515 participants
		0.1 (0.83)	0.1 (0.84)
Pain, Week 48, n=515, 515	Number Analyzed	515 participants	515 participants
		0.0 (0.85)	0.0 (0.84)
Satisfaction, Week 24, n=514, 515	Number Analyzed	514 participants	515 participants
		0.1 (0.77)	-0.0 (0.77)
Satisfaction, Week 48, n=514, 515	Number Analyzed	514 participants	515 participants
		-0.0 (0.77)	-0.0 (0.84)
Anxiety after, Week 24, n=514, 515	Number Analyzed	514 participants	515 participants
		-0.0 (0.76)	0.0 (0.83)
Anxiety after, Week 48, n=514, 515	Number Analyzed	514 participants	515 participants
		-0.1 (0.79)	-0.1 (0.89)
Willingness, Week 24, n=514, 514	Number Analyzed	514 participants	514 participants
		-0.1 (0.55)	-0.1 (0.65)
Willingness, Week 48, n=514, 514	Number Analyzed	514 participants	514 participants
		-0.0 (0.66)	-0.1 (0.72)

40. Secondary Outcome

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
Description	The ACCEPT questionnaire is a generic medication acceptance measure assessing how participants weigh advantages and disadvantages of long-term medication.The questionnaire consists of 25 items that capture six dimensions.3 questions that focus on general acceptance of study medication were analyzed.Items on the 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 the dimension is calculated as the mean of recoded items of the dimension and then linearly transformed to be on a scale from 0 to 100:Total Score=(mean of the recoded items in the dimension minus1)divided by2*100. LOCF was used as primary method of analysis. Data for participants without or with prior exposure has been presented. Baseline value is defined as last available value up to and including the Maintenance treatment. Change from Baseline value is calculated as the value at the post-dose visit minus the Baseline value.
Time Frame	Baseline (Day 1) and Weeks 24 and 48

Outcome Measure Data

Analysis Population Description

ITT-E Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).

Arm/Group Title		CAB LA + RPV LA Q8W	CAB LA + RPV LA Q4W
Arm/Group Description:		Eligible participants transitioning from antiretroviral (ART) standard of care (SOC) therapy arm and CAB LA + RPV LA Q4W arm in the ATLAS (NCT02951052) study 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 received CAB LA 600 mg+RPV LA 900 mg intramuscular injections on Day 1, Week 8 and Q8W thereafter.	Eligible participants transitioning from ART SOC arm and CAB LA + RPV LA Q4W arm in the ATLAS (NCT02951052) study 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 continued to receive CAB LA 400 mg+RPV LA 600 mg intramuscular injections administered Q4W from Day 1.
Overall Number of Participants Analyzed		522	523
Mean (Standard Deviation); Unit of Measure: Scores on a scale
Without exposure, Week 24, n=319, 323	Number Analyzed	319 participants	323 participants
		6.0 (27.96)	4.0 (33.53)
Without exposure, Week 48, n=319, 324	Number Analyzed	319 participants	324 participants
		6.9 (30.96)	5.6 (31.77)
With exposure, Week 24, n=192, 194	Number Analyzed	192 participants	194 participants
		0.3 (21.37)	-1.7 (21.79)
With exposure, Week 48, n=192, 194	Number Analyzed	192 participants	194 participants
		-0.1 (24.92)	-2.7 (24.25)

41. Secondary Outcome

Title	Plasma Trough Concentration (Ctrough) for CAB LA Evaluable
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