Trial Outcomes & Findings for Phase 2b, Open-label, Multicenter, Rollover Study to Assess Antiviral Activity and Safety of Long-acting (LA) Cabotegravir (CAB) Plus LA Rilpivirine (RPV), Administered Every 2 Months (Q2M), in Human Immunodeficiency Virus (HIV)-Positive Participants From the LATTE Study (NCT NCT03639311)

Last Updated: 2024-06-11

Results Overview

Percentage of participants with HIV-1 RNA \>=50 c/mL as per FDA snapshot algorithm at Month 12 was assessed to demonstrate the antiviral activity of CAB LA+RPV LA Q2M and DTG + RPV regimen in HIV-1 infected antiretroviral therapy (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 12 months analysis visit window.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

97 participants

Primary outcome timeframe

At Month 12 [Maintenance Phase]

Results posted on

2024-06-11

Participant Flow

This was a multicenter, open-label, rollover study evaluating the efficacy, safety and tolerability of long acting (LA) cabotegravir (CAB) plus LA rilpivirine (RPV) administered every 2 months (Q2M) in human immunodeficiency virus-1 (HIV-1) adult participants who were virologically suppressed and participated in study LAI116482 (NCT01641809).

This study was conducted in 2 phases (Maintenance Phase and Long-term Follow-up \[LTFU\] Phase). Maintenance Phase was defined from Baseline (Day 1) up to Month 52. LTFU Phase was defined as approximately 12 months for participants who discontinued from the CAB LA+RPV LA treatment before Month 52 and complied with protocol-defined criteria for withdrawal. Participants in both the phases were mutually inclusive.

Participant milestones

Participant milestones
Measure	CAB LA + RPV LA Q2M Eligible participants from LAI116482 (NCT01641809 \[LATTE\]) study who were administered oral CAB 30 milligrams (mg) plus RPV 25 mg and who successfully completed Week 300 received their first dose CAB LA (600 mg) plus RPV LA (900 mg) injections within 2 hours of the final oral dose of LATTE given on the same day. The second loading injections were administered 1 month after initial loading dose, with subsequent injections (CAB LA 600 mg + RPV LA 900 mg) occurring Q2M thereafter. Participants continued to receive the treatment until the study intervention was locally approved and commercially available. Participants who received at least one dose of CAB LA and/or RPV LA and discontinued the CAB LA + RPV LA regimen for any reason entered a 52-week long-term follow-up (LTFU) Phase.	DTG + RPV Eligible participants from LAI116482 (NCT01641809 \[LATTE\]) study who were administered oral CAB 30 mg plus RPV 25 mg and who successfully completed Week 300 received their first dose of the Dolutegravir (DTG) 50 mg plus RPV 25 mg, once daily as oral regimen on Day 1 until Month 12 in the current study. These participants were not eligible for the LTFU phase.	LTFU: CAB LA+RPV LA Q2M Group This group included the participants who received at least one dose of CAB LA and/or RPV LA and discontinued the CAB LA + RPV LA regimen for any reason before end of Maintenance Period. The participants entered a 52-week LTFU period.
Maintenance Phase STARTED	90	7	0
Maintenance Phase COMPLETED	76	7	0
Maintenance Phase NOT COMPLETED	14	0	0
Long-term Follow-up Phase (LTFU Phase) STARTED	0	0	6
Long-term Follow-up Phase (LTFU Phase) COMPLETED	0	0	6
Long-term Follow-up Phase (LTFU Phase) NOT COMPLETED	0	0	0

Reasons for withdrawal

Reasons for withdrawal
Measure	CAB LA + RPV LA Q2M Eligible participants from LAI116482 (NCT01641809 \[LATTE\]) study who were administered oral CAB 30 milligrams (mg) plus RPV 25 mg and who successfully completed Week 300 received their first dose CAB LA (600 mg) plus RPV LA (900 mg) injections within 2 hours of the final oral dose of LATTE given on the same day. The second loading injections were administered 1 month after initial loading dose, with subsequent injections (CAB LA 600 mg + RPV LA 900 mg) occurring Q2M thereafter. Participants continued to receive the treatment until the study intervention was locally approved and commercially available. Participants who received at least one dose of CAB LA and/or RPV LA and discontinued the CAB LA + RPV LA regimen for any reason entered a 52-week long-term follow-up (LTFU) Phase.	DTG + RPV Eligible participants from LAI116482 (NCT01641809 \[LATTE\]) study who were administered oral CAB 30 mg plus RPV 25 mg and who successfully completed Week 300 received their first dose of the Dolutegravir (DTG) 50 mg plus RPV 25 mg, once daily as oral regimen on Day 1 until Month 12 in the current study. These participants were not eligible for the LTFU phase.	LTFU: CAB LA+RPV LA Q2M Group This group included the participants who received at least one dose of CAB LA and/or RPV LA and discontinued the CAB LA + RPV LA regimen for any reason before end of Maintenance Period. The participants entered a 52-week LTFU period.
Maintenance Phase Lost to Follow-up	1	0	0
Maintenance Phase Adverse Event	1	0	0
Maintenance Phase DECISION BY SUBJECT OR PROXY	7	0	0
Maintenance Phase STUDY SITE TERMINATED BY SPONSOR	3	0	0
Maintenance Phase SUBJECT REACHED PROTOCOL-DEFINED STOPPING CRITERIA	1	0	0
Maintenance Phase Lack of Efficacy	1	0	0

Baseline Characteristics

Phase 2b, Open-label, Multicenter, Rollover Study to Assess Antiviral Activity and Safety of Long-acting (LA) Cabotegravir (CAB) Plus LA Rilpivirine (RPV), Administered Every 2 Months (Q2M), in Human Immunodeficiency Virus (HIV)-Positive Participants From the LATTE Study

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	CAB LA + RPV LA Q2M n=90 Participants Eligible participants from LAI116482 (NCT01641809 \[LATTE\]) study who were administered oral CAB 30 milligrams (mg) plus RPV 25 mg and who successfully completed Week 300 received their first dose CAB LA (600 mg) plus RPV LA (900 mg) injections within 2 hours of the final oral dose of LATTE given on the same day. The second loading injections were administered 1 month after initial loading dose, with subsequent injections (CAB LA 600 mg + RPV LA 900 mg) occurring Q2M thereafter. Participants continued to receive the treatment until the study intervention was locally approved and commercially available. Participants who received at least one dose of CAB LA and/or RPV LA and discontinued the CAB LA + RPV LA regimen for any reason entered a 52-week long-term follow-up (LTFU) Phase.	DTG + RPV n=7 Participants Eligible participants from LAI116482 (NCT01641809 \[LATTE\]) study who were administered oral CAB 30 mg plus RPV 25 mg and who successfully completed Week 300 received their first dose of the Dolutegravir (DTG) 50 mg plus RPV 25 mg, once daily as oral regimen on Day 1 until Month 12 in the current study. These participants were not eligible for the LTFU phase.	Total n=97 Participants Total of all reporting groups
Age, Continuous Overall Study	41.2 Years STANDARD_DEVIATION 9.49 • n=5 Participants	49.1 Years STANDARD_DEVIATION 11.42 • n=7 Participants	41.7 Years STANDARD_DEVIATION 9.80 • n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Sex: Female, Male Male	88 Participants n=5 Participants	7 Participants n=7 Participants	95 Participants n=5 Participants
Race/Ethnicity, Customized American Indian or Alaska Native	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race/Ethnicity, Customized Asian-Japanese/East Asian/South East Asian Heritage	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race/Ethnicity, Customized Black or African American	21 Participants n=5 Participants	3 Participants n=7 Participants	24 Participants n=5 Participants
Race/Ethnicity, Customized White	63 Participants n=5 Participants	4 Participants n=7 Participants	67 Participants n=5 Participants
Race/Ethnicity, Customized Multiple	4 Participants n=5 Participants	0 Participants n=7 Participants	4 Participants n=5 Participants

PRIMARY outcome

Timeframe: At Month 12 [Maintenance Phase]

Population: Intent-to-treat-Exposed (ITT-E) population comprised of all participants who received at least one dose of investigational product (IP) during on or after Day 1 visit. Participants were analyzed according to the selected treatment regardless of what treatment was actually received.

Outcome measures

Outcome measures
Measure	CAB LA + RPV LA Q2M n=90 Participants Eligible participants from LAI116482 (NCT01641809 \[LATTE\]) study who were administered oral CAB 30 milligrams (mg) plus RPV 25 mg and who successfully completed Week 300 received their first dose CAB LA (600 mg) plus RPV LA (900 mg) injections within 2 hours of the final oral dose of LATTE given on the same day. The second loading injections were administered 1 month after initial loading dose, with subsequent injections (CAB LA 600 mg + RPV LA 900 mg) occurring Q2M thereafter. Participants continued to receive the treatment until the study intervention was locally approved and commercially available. Participants who received at least one dose of CAB LA and/or RPV LA and discontinued the CAB LA + RPV LA regimen for any reason entered a 52-week long-term follow-up (LTFU) Phase.	DTG + RPV n=7 Participants Eligible participants from LAI116482 (NCT01641809 \[LATTE\]) study who were administered oral CAB 30 mg plus RPV 25 mg and who successfully completed Week 300 received their first dose of the Dolutegravir (DTG) 50 mg plus RPV 25 mg, once daily as oral regimen on Day 1 until Month 12 in the current study. These participants were not eligible for the LTFU phase.
Percentage of Participants With HIV-ribonucleic Acid (RNA) >=50 Copies Per Milliliter (c/mL) as Per Food and Drug Administration (FDA) Snapshot Algorithm at Month 12 [Maintenance Phase]	0 Percentage of participants Interval 0.0 to 4.0	0 Percentage of participants Interval 0.0 to 41.0

SECONDARY outcome

Timeframe: At Month 12 [Maintenance Phase]

Population: ITT-E Population

Percentage of participants with HIV-1 RNA \<50 c/mL as per FDA snapshot algorithm at Month 12 was assessed to demonstrate the antiviral activity of CAB LA+RPV LA Q2M and oral DTG + RPV regimen. The HIV-1 RNA \<50 c/mL per Snapshot algorithm was determined by the last on-treatment HIV-1 RNA measurement within the 12 months analysis visit window.

Outcome measures

Outcome measures
Measure	CAB LA + RPV LA Q2M n=90 Participants Eligible participants from LAI116482 (NCT01641809 \[LATTE\]) study who were administered oral CAB 30 milligrams (mg) plus RPV 25 mg and who successfully completed Week 300 received their first dose CAB LA (600 mg) plus RPV LA (900 mg) injections within 2 hours of the final oral dose of LATTE given on the same day. The second loading injections were administered 1 month after initial loading dose, with subsequent injections (CAB LA 600 mg + RPV LA 900 mg) occurring Q2M thereafter. Participants continued to receive the treatment until the study intervention was locally approved and commercially available. Participants who received at least one dose of CAB LA and/or RPV LA and discontinued the CAB LA + RPV LA regimen for any reason entered a 52-week long-term follow-up (LTFU) Phase.	DTG + RPV n=7 Participants Eligible participants from LAI116482 (NCT01641809 \[LATTE\]) study who were administered oral CAB 30 mg plus RPV 25 mg and who successfully completed Week 300 received their first dose of the Dolutegravir (DTG) 50 mg plus RPV 25 mg, once daily as oral regimen on Day 1 until Month 12 in the current study. These participants were not eligible for the LTFU phase.
Percentage of Participants With HIV-RNA <50 c/mL as Per FDA Snapshot Algorithm at Month 12 [Maintenance Phase]	98 Percentage of participants Interval 95.0 to 100.0	100 Percentage of participants Interval 59.0 to 100.0

SECONDARY outcome

Timeframe: Up to End of Maintenance Phase (up to Month 52 for CAB LA+RPV LA Q2M group, up to Month 12 for DTG+RPV group)

Population: ITT-E Population

Confirmed virologic failure was defined as rebound as indicated by two consecutive plasma HIV-1-RNA levels \>=200 c/mL after prior suppression to \<200 c/mL.

Outcome measures

Outcome measures
Measure	CAB LA + RPV LA Q2M n=90 Participants Eligible participants from LAI116482 (NCT01641809 \[LATTE\]) study who were administered oral CAB 30 milligrams (mg) plus RPV 25 mg and who successfully completed Week 300 received their first dose CAB LA (600 mg) plus RPV LA (900 mg) injections within 2 hours of the final oral dose of LATTE given on the same day. The second loading injections were administered 1 month after initial loading dose, with subsequent injections (CAB LA 600 mg + RPV LA 900 mg) occurring Q2M thereafter. Participants continued to receive the treatment until the study intervention was locally approved and commercially available. Participants who received at least one dose of CAB LA and/or RPV LA and discontinued the CAB LA + RPV LA regimen for any reason entered a 52-week long-term follow-up (LTFU) Phase.	DTG + RPV n=7 Participants Eligible participants from LAI116482 (NCT01641809 \[LATTE\]) study who were administered oral CAB 30 mg plus RPV 25 mg and who successfully completed Week 300 received their first dose of the Dolutegravir (DTG) 50 mg plus RPV 25 mg, once daily as oral regimen on Day 1 until Month 12 in the current study. These participants were not eligible for the LTFU phase.
Number of Participants With Protocol-defined Confirmed Virologic Failure up to End of Maintenance Phase	1 Participants	0 Participants

SECONDARY outcome

Timeframe: At Baseline (Day 1) and at Months 2, 4, 6, 8, 10 and 12 [Maintenance Phase]

Population: ITT-E Population

Percentage of participants with HIV-1 RNA \>=50 c/mL as per FDA snapshot algorithm over time was assessed to demonstrate the antiviral activity of CAB LA+RPV LA Q2M regimen 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 12 months analysis visit window. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.

Outcome measures

Outcome measures
Measure	CAB LA + RPV LA Q2M n=90 Participants Eligible participants from LAI116482 (NCT01641809 \[LATTE\]) study who were administered oral CAB 30 milligrams (mg) plus RPV 25 mg and who successfully completed Week 300 received their first dose CAB LA (600 mg) plus RPV LA (900 mg) injections within 2 hours of the final oral dose of LATTE given on the same day. The second loading injections were administered 1 month after initial loading dose, with subsequent injections (CAB LA 600 mg + RPV LA 900 mg) occurring Q2M thereafter. Participants continued to receive the treatment until the study intervention was locally approved and commercially available. Participants who received at least one dose of CAB LA and/or RPV LA and discontinued the CAB LA + RPV LA regimen for any reason entered a 52-week long-term follow-up (LTFU) Phase.	DTG + RPV Eligible participants from LAI116482 (NCT01641809 \[LATTE\]) study who were administered oral CAB 30 mg plus RPV 25 mg and who successfully completed Week 300 received their first dose of the Dolutegravir (DTG) 50 mg plus RPV 25 mg, once daily as oral regimen on Day 1 until Month 12 in the current study. These participants were not eligible for the LTFU phase.
Percentage of Participants With HIV-RNA >=50 c/mL as Per FDA Snapshot Algorithm Over Time for CAB LA + RPV LA Q2M Arm up to Month 12 [Maintenance Phase] Baseline (Day 1)	0 Percentage of participants Interval 0.0 to 4.0	—
Percentage of Participants With HIV-RNA >=50 c/mL as Per FDA Snapshot Algorithm Over Time for CAB LA + RPV LA Q2M Arm up to Month 12 [Maintenance Phase] Month 2	0 Percentage of participants Interval 0.0 to 4.0	—
Percentage of Participants With HIV-RNA >=50 c/mL as Per FDA Snapshot Algorithm Over Time for CAB LA + RPV LA Q2M Arm up to Month 12 [Maintenance Phase] Month 4	1 Percentage of participants Interval 0.0 to 3.3	—
Percentage of Participants With HIV-RNA >=50 c/mL as Per FDA Snapshot Algorithm Over Time for CAB LA + RPV LA Q2M Arm up to Month 12 [Maintenance Phase] Month 6	0 Percentage of participants Interval 0.0 to 4.0	—
Percentage of Participants With HIV-RNA >=50 c/mL as Per FDA Snapshot Algorithm Over Time for CAB LA + RPV LA Q2M Arm up to Month 12 [Maintenance Phase] Month 8	0 Percentage of participants Interval 0.0 to 4.0	—
Percentage of Participants With HIV-RNA >=50 c/mL as Per FDA Snapshot Algorithm Over Time for CAB LA + RPV LA Q2M Arm up to Month 12 [Maintenance Phase] Month 10	0 Percentage of participants Interval 0.0 to 4.0	—
Percentage of Participants With HIV-RNA >=50 c/mL as Per FDA Snapshot Algorithm Over Time for CAB LA + RPV LA Q2M Arm up to Month 12 [Maintenance Phase] Month 12	0 Percentage of participants Interval 0.0 to 4.0	—

SECONDARY outcome

Timeframe: At Baseline (Day 1) and at Months 3, 6, 9 and 12 [Maintenance Phase]

Population: ITT-E Population

Percentage of participants with HIV-1 RNA \>=50 c/mL as per FDA snapshot algorithm over time was assessed to demonstrate the antiviral activity of DTG + RPV regimen 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 12 months analysis visit window. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.

Outcome measures

Outcome measures
Measure	CAB LA + RPV LA Q2M n=7 Participants Eligible participants from LAI116482 (NCT01641809 \[LATTE\]) study who were administered oral CAB 30 milligrams (mg) plus RPV 25 mg and who successfully completed Week 300 received their first dose CAB LA (600 mg) plus RPV LA (900 mg) injections within 2 hours of the final oral dose of LATTE given on the same day. The second loading injections were administered 1 month after initial loading dose, with subsequent injections (CAB LA 600 mg + RPV LA 900 mg) occurring Q2M thereafter. Participants continued to receive the treatment until the study intervention was locally approved and commercially available. Participants who received at least one dose of CAB LA and/or RPV LA and discontinued the CAB LA + RPV LA regimen for any reason entered a 52-week long-term follow-up (LTFU) Phase.	DTG + RPV Eligible participants from LAI116482 (NCT01641809 \[LATTE\]) study who were administered oral CAB 30 mg plus RPV 25 mg and who successfully completed Week 300 received their first dose of the Dolutegravir (DTG) 50 mg plus RPV 25 mg, once daily as oral regimen on Day 1 until Month 12 in the current study. These participants were not eligible for the LTFU phase.
Percentage of Participants With HIV-RNA >=50 c/mL as Per FDA Snapshot Algorithm Over Time for DTG + RPV up to Month 12 [Maintenance Phase] Baseline (Day 1)	0.0 Percentage of participants Interval 0.0 to 41.0	—
Percentage of Participants With HIV-RNA >=50 c/mL as Per FDA Snapshot Algorithm Over Time for DTG + RPV up to Month 12 [Maintenance Phase] Month 3	0.0 Percentage of participants Interval 0.0 to 41.0	—
Percentage of Participants With HIV-RNA >=50 c/mL as Per FDA Snapshot Algorithm Over Time for DTG + RPV up to Month 12 [Maintenance Phase] Month 6	0.0 Percentage of participants Interval 0.0 to 41.0	—
Percentage of Participants With HIV-RNA >=50 c/mL as Per FDA Snapshot Algorithm Over Time for DTG + RPV up to Month 12 [Maintenance Phase] Month 9	0.0 Percentage of participants Interval 0.0 to 41.0	—
Percentage of Participants With HIV-RNA >=50 c/mL as Per FDA Snapshot Algorithm Over Time for DTG + RPV up to Month 12 [Maintenance Phase] Month 12	0.0 Percentage of participants Interval 0.0 to 41.0	—

SECONDARY outcome

Timeframe: From Baseline (Day 1) up to End of LTFU Phase (approximately up to 12 months after exiting the Maintenance Phase)

Population: ITT-E Population. Only those participants with data available for specific analysis and specified time points analyzed.

Plasma samples were collected for quantitative analysis of HIV-1 RNA. Logarithm to base 10 (log10) values for plasma HIV-1 RNA have been presented. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Standard Deviation (SD)=0.0000 is defined as SD resulted below the detectable limit of the assay and approximate to 0.0000.

Outcome measures

Outcome measures
Measure	CAB LA + RPV LA Q2M n=90 Participants Eligible participants from LAI116482 (NCT01641809 \[LATTE\]) study who were administered oral CAB 30 milligrams (mg) plus RPV 25 mg and who successfully completed Week 300 received their first dose CAB LA (600 mg) plus RPV LA (900 mg) injections within 2 hours of the final oral dose of LATTE given on the same day. The second loading injections were administered 1 month after initial loading dose, with subsequent injections (CAB LA 600 mg + RPV LA 900 mg) occurring Q2M thereafter. Participants continued to receive the treatment until the study intervention was locally approved and commercially available. Participants who received at least one dose of CAB LA and/or RPV LA and discontinued the CAB LA + RPV LA regimen for any reason entered a 52-week long-term follow-up (LTFU) Phase.	DTG + RPV n=6 Participants Eligible participants from LAI116482 (NCT01641809 \[LATTE\]) study who were administered oral CAB 30 mg plus RPV 25 mg and who successfully completed Week 300 received their first dose of the Dolutegravir (DTG) 50 mg plus RPV 25 mg, once daily as oral regimen on Day 1 until Month 12 in the current study. These participants were not eligible for the LTFU phase.
Absolute Values for HIV-1 RNA of CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Baseline (Day 1)	1.591 Log 10 copies per milliliter Standard Deviation 0.0085	—
Absolute Values for HIV-1 RNA of CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Month 2	1.590 Log 10 copies per milliliter Standard Deviation 0.0000	—
Absolute Values for HIV-1 RNA of CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Month 4	1.594 Log 10 copies per milliliter Standard Deviation 0.0305	—
Absolute Values for HIV-1 RNA of CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Month 6	1.590 Log 10 copies per milliliter Standard Deviation 0.0042	—
Absolute Values for HIV-1 RNA of CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Month 8	1.590 Log 10 copies per milliliter Standard Deviation 0.0000	—
Absolute Values for HIV-1 RNA of CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Month 10	1.594 Log 10 copies per milliliter Standard Deviation 0.0384	—
Absolute Values for HIV-1 RNA of CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Month 12	1.590 Log 10 copies per milliliter Standard Deviation 0.0000	—
Absolute Values for HIV-1 RNA of CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Month 14	1.593 Log 10 copies per milliliter Standard Deviation 0.0216	—
Absolute Values for HIV-1 RNA of CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Month 16	1.598 Log 10 copies per milliliter Standard Deviation 0.0555	—
Absolute Values for HIV-1 RNA of CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Month 18	1.592 Log 10 copies per milliliter Standard Deviation 0.0217	—
Absolute Values for HIV-1 RNA of CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Month 20	1.592 Log 10 copies per milliliter Standard Deviation 0.0153	—
Absolute Values for HIV-1 RNA of CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Month 22	1.590 Log 10 copies per milliliter Standard Deviation 0.0000	—
Absolute Values for HIV-1 RNA of CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Month 24	1.602 Log 10 copies per milliliter Standard Deviation 0.0882	—
Absolute Values for HIV-1 RNA of CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Month 26	1.611 Log 10 copies per milliliter Standard Deviation 0.1246	—
Absolute Values for HIV-1 RNA of CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Month 28	1.594 Log 10 copies per milliliter Standard Deviation 0.0334	—
Absolute Values for HIV-1 RNA of CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Month 30	1.590 Log 10 copies per milliliter Standard Deviation 0.0000	—
Absolute Values for HIV-1 RNA of CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Month 32	1.590 Log 10 copies per milliliter Standard Deviation 0.0000	—
Absolute Values for HIV-1 RNA of CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Month 34	1.590 Log 10 copies per milliliter Standard Deviation 0.0000	—
Absolute Values for HIV-1 RNA of CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Month 36	1.590 Log 10 copies per milliliter Standard Deviation 0.0000	—
Absolute Values for HIV-1 RNA of CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Month 38	1.590 Log 10 copies per milliliter Standard Deviation 0.0000	—
Absolute Values for HIV-1 RNA of CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Month 40	1.590 Log 10 copies per milliliter Standard Deviation 0.0000	—
Absolute Values for HIV-1 RNA of CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Month 42	1.590 Log 10 copies per milliliter Standard Deviation 0.0000	—
Absolute Values for HIV-1 RNA of CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Month 44	1.591 Log 10 copies per milliliter Standard Deviation 0.0104	—
Absolute Values for HIV-1 RNA of CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Month 46	1.590 Log 10 copies per milliliter Standard Deviation 0.0000	—
Absolute Values for HIV-1 RNA of CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Month 48	1.590 Log 10 copies per milliliter Standard Deviation 0.0025	—
Absolute Values for HIV-1 RNA of CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Month 50	1.590 Log 10 copies per milliliter Standard Deviation 0.0000	—
Absolute Values for HIV-1 RNA of CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Month 52	1.590 Log 10 copies per milliliter Standard Deviation 0.0000	—
Absolute Values for HIV-1 RNA of CAB LA + RPV LA Q2M Arm up to End of LTFU Phase LTFU Month 1	—	1.852 Log 10 copies per milliliter Standard Deviation 0.4338
Absolute Values for HIV-1 RNA of CAB LA + RPV LA Q2M Arm up to End of LTFU Phase LTFU Month 3	—	1.590 Log 10 copies per milliliter Standard Deviation 0.0000
Absolute Values for HIV-1 RNA of CAB LA + RPV LA Q2M Arm up to End of LTFU Phase LTFU Month 6	—	1.590 Log 10 copies per milliliter Standard Deviation 0.0000
Absolute Values for HIV-1 RNA of CAB LA + RPV LA Q2M Arm up to End of LTFU Phase LTFU Month 9	—	2.027 Log 10 copies per milliliter Standard Deviation 1.0696
Absolute Values for HIV-1 RNA of CAB LA + RPV LA Q2M Arm up to End of LTFU Phase LTFU Month 12	—	1.616 Log 10 copies per milliliter Standard Deviation 0.0581

SECONDARY outcome

Timeframe: At Baseline (Day 1) and at Months 3, 6, 9 and 12 [Maintenance Phase]

Population: ITT-E Population

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. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. SD=0.0000 is defined as SD resulted below the detectable limit of the assay and approximate to 0.0000.

Outcome measures

Outcome measures
Measure	CAB LA + RPV LA Q2M n=7 Participants Eligible participants from LAI116482 (NCT01641809 \[LATTE\]) study who were administered oral CAB 30 milligrams (mg) plus RPV 25 mg and who successfully completed Week 300 received their first dose CAB LA (600 mg) plus RPV LA (900 mg) injections within 2 hours of the final oral dose of LATTE given on the same day. The second loading injections were administered 1 month after initial loading dose, with subsequent injections (CAB LA 600 mg + RPV LA 900 mg) occurring Q2M thereafter. Participants continued to receive the treatment until the study intervention was locally approved and commercially available. Participants who received at least one dose of CAB LA and/or RPV LA and discontinued the CAB LA + RPV LA regimen for any reason entered a 52-week long-term follow-up (LTFU) Phase.	DTG + RPV Eligible participants from LAI116482 (NCT01641809 \[LATTE\]) study who were administered oral CAB 30 mg plus RPV 25 mg and who successfully completed Week 300 received their first dose of the Dolutegravir (DTG) 50 mg plus RPV 25 mg, once daily as oral regimen on Day 1 until Month 12 in the current study. These participants were not eligible for the LTFU phase.
Absolute Values for HIV-1 RNA of DTG + RPV Arm up to Month 12 [Maintenance Phase] Baseline (Day 1)	1.590 Log 10 copies per milliliter Standard Deviation 0.0000	—
Absolute Values for HIV-1 RNA of DTG + RPV Arm up to Month 12 [Maintenance Phase] Month 3	1.590 Log 10 copies per milliliter Standard Deviation 0.0000	—
Absolute Values for HIV-1 RNA of DTG + RPV Arm up to Month 12 [Maintenance Phase] Month 6	1.590 Log 10 copies per milliliter Standard Deviation 0.0000	—
Absolute Values for HIV-1 RNA of DTG + RPV Arm up to Month 12 [Maintenance Phase] Month 9	1.590 Log 10 copies per milliliter Standard Deviation 0.0000	—
Absolute Values for HIV-1 RNA of DTG + RPV Arm up to Month 12 [Maintenance Phase] Month 12	1.590 Log 10 copies per milliliter Standard Deviation 0.0000	—

SECONDARY outcome

Timeframe: Up to End of LTFU Phase (compared with Baseline [Day1]), (approximately up to 12 months after exiting the Maintenance Phase)

Population: ITT-E Population. Only those participants with data available for specific analysis and specified time points analyzed.

Plasma samples were collected for quantitative analysis of HIV-1 RNA. Log 10 values for plasma HIV-1 RNA has been presented. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from baseline value is defined as post-dose value minus baseline value. SD=0.0000 is defined as SD resulted below the detectable limit of the assay and approximate to 0.0000.

Outcome measures

Outcome measures
Measure	CAB LA + RPV LA Q2M n=90 Participants Eligible participants from LAI116482 (NCT01641809 \[LATTE\]) study who were administered oral CAB 30 milligrams (mg) plus RPV 25 mg and who successfully completed Week 300 received their first dose CAB LA (600 mg) plus RPV LA (900 mg) injections within 2 hours of the final oral dose of LATTE given on the same day. The second loading injections were administered 1 month after initial loading dose, with subsequent injections (CAB LA 600 mg + RPV LA 900 mg) occurring Q2M thereafter. Participants continued to receive the treatment until the study intervention was locally approved and commercially available. Participants who received at least one dose of CAB LA and/or RPV LA and discontinued the CAB LA + RPV LA regimen for any reason entered a 52-week long-term follow-up (LTFU) Phase.	DTG + RPV n=6 Participants Eligible participants from LAI116482 (NCT01641809 \[LATTE\]) study who were administered oral CAB 30 mg plus RPV 25 mg and who successfully completed Week 300 received their first dose of the Dolutegravir (DTG) 50 mg plus RPV 25 mg, once daily as oral regimen on Day 1 until Month 12 in the current study. These participants were not eligible for the LTFU phase.
Change From Baseline in HIV-1 RNA for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Month 2	-0.001 Log 10 copies per milliliter Standard Deviation 0.0085	—
Change From Baseline in HIV-1 RNA for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Month 4	0.003 Log 10 copies per milliliter Standard Deviation 0.0299	—
Change From Baseline in HIV-1 RNA for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Month 6	-0.000 Log 10 copies per milliliter Standard Deviation 0.0096	—
Change From Baseline in HIV-1 RNA for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Month 8	-0.001 Log 10 copies per milliliter Standard Deviation 0.0085	—
Change From Baseline in HIV-1 RNA for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Month 10	0.003 Log 10 copies per milliliter Standard Deviation 0.0396	—
Change From Baseline in HIV-1 RNA for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Month 12	-0.001 Log 10 copies per milliliter Standard Deviation 0.0086	—
Change From Baseline in HIV-1 RNA for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Month 14	0.002 Log 10 copies per milliliter Standard Deviation 0.0234	—
Change From Baseline in HIV-1 RNA for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Month 16	0.007 Log 10 copies per milliliter Standard Deviation 0.0529	—
Change From Baseline in HIV-1 RNA for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Month 18	0.001 Log 10 copies per milliliter Standard Deviation 0.0235	—
Change From Baseline in HIV-1 RNA for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Month 20	0.001 Log 10 copies per milliliter Standard Deviation 0.0177	—
Change From Baseline in HIV-1 RNA for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Month 22	-0.001 Log 10 copies per milliliter Standard Deviation 0.0087	—
Change From Baseline in HIV-1 RNA for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Month 24	0.011 Log 10 copies per milliliter Standard Deviation 0.0888	—
Change From Baseline in HIV-1 RNA for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Month 26	0.020 Log 10 copies per milliliter Standard Deviation 0.1251	—
Change From Baseline in HIV-1 RNA for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Month 28	0.003 Log 10 copies per milliliter Standard Deviation 0.0346	—
Change From Baseline in HIV-1 RNA for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Month 30	-0.001 Log 10 copies per milliliter Standard Deviation 0.0088	—
Change From Baseline in HIV-1 RNA for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Month 32	-0.001 Log 10 copies per milliliter Standard Deviation 0.0087	—
Change From Baseline in HIV-1 RNA for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Month 34	-0.001 Log 10 copies per milliliter Standard Deviation 0.0087	—
Change From Baseline in HIV-1 RNA for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Month 36	-0.001 Log 10 copies per milliliter Standard Deviation 0.0088	—
Change From Baseline in HIV-1 RNA for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Month 38	0.000 Log 10 copies per milliliter Standard Deviation 0.0000	—
Change From Baseline in HIV-1 RNA for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Month 40	-0.001 Log 10 copies per milliliter Standard Deviation 0.0091	—
Change From Baseline in HIV-1 RNA for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Month 42	-0.001 Log 10 copies per milliliter Standard Deviation 0.0091	—
Change From Baseline in HIV-1 RNA for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Month 44	0.000 Log 10 copies per milliliter Standard Deviation 0.0140	—
Change From Baseline in HIV-1 RNA for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Month 46	-0.001 Log 10 copies per milliliter Standard Deviation 0.0096	—
Change From Baseline in HIV-1 RNA for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Month 48	-0.001 Log 10 copies per milliliter Standard Deviation 0.0102	—
Change From Baseline in HIV-1 RNA for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Month 50	0.000 Log 10 copies per milliliter Standard Deviation 0.0000	—
Change From Baseline in HIV-1 RNA for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Month 52	0.000 Log 10 copies per milliliter Standard Deviation 0.0000	—
Change From Baseline in HIV-1 RNA for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase LTFU Month 1	—	0.262 Log 10 copies per milliliter Standard Deviation 0.4338
Change From Baseline in HIV-1 RNA for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase LTFU Month 3	—	0.000 Log 10 copies per milliliter Standard Deviation 0.0000
Change From Baseline in HIV-1 RNA for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase LTFU Month 6	—	0.000 Log 10 copies per milliliter Standard Deviation 0.0000
Change From Baseline in HIV-1 RNA for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase LTFU Month 9	—	0.437 Log 10 copies per milliliter Standard Deviation 1.0696
Change From Baseline in HIV-1 RNA for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase LTFU Month 12	—	0.026 Log 10 copies per milliliter Standard Deviation 0.0581

SECONDARY outcome

Timeframe: At Months 3, 6, 9 and 12 (compared with Baseline [Day 1]) [Maintenance Phase]

Population: ITT-E Population

Outcome measures

Outcome measures
Measure	CAB LA + RPV LA Q2M n=7 Participants Eligible participants from LAI116482 (NCT01641809 \[LATTE\]) study who were administered oral CAB 30 milligrams (mg) plus RPV 25 mg and who successfully completed Week 300 received their first dose CAB LA (600 mg) plus RPV LA (900 mg) injections within 2 hours of the final oral dose of LATTE given on the same day. The second loading injections were administered 1 month after initial loading dose, with subsequent injections (CAB LA 600 mg + RPV LA 900 mg) occurring Q2M thereafter. Participants continued to receive the treatment until the study intervention was locally approved and commercially available. Participants who received at least one dose of CAB LA and/or RPV LA and discontinued the CAB LA + RPV LA regimen for any reason entered a 52-week long-term follow-up (LTFU) Phase.	DTG + RPV Eligible participants from LAI116482 (NCT01641809 \[LATTE\]) study who were administered oral CAB 30 mg plus RPV 25 mg and who successfully completed Week 300 received their first dose of the Dolutegravir (DTG) 50 mg plus RPV 25 mg, once daily as oral regimen on Day 1 until Month 12 in the current study. These participants were not eligible for the LTFU phase.
Change From Baseline in HIV-1 RNA for DTG + RPV Arm up to Month 12 [Maintenance Phase] Month 3	0.000 Log 10 copies per milliliter Standard Deviation 0.0000	—
Change From Baseline in HIV-1 RNA for DTG + RPV Arm up to Month 12 [Maintenance Phase] Month 6	0.000 Log 10 copies per milliliter Standard Deviation 0.0000	—
Change From Baseline in HIV-1 RNA for DTG + RPV Arm up to Month 12 [Maintenance Phase] Month 9	0.000 Log 10 copies per milliliter Standard Deviation 0.0000	—
Change From Baseline in HIV-1 RNA for DTG + RPV Arm up to Month 12 [Maintenance Phase] Month 12	0.000 Log 10 copies per milliliter Standard Deviation 0.0000	—

SECONDARY outcome

Timeframe: From Baseline (Day 1) up to End of LTFU Phase (approximately up to 12 months after exiting the Maintenance Phase)

Population: ITT-E Population. Only those participants with data available for specific analysis and specified time points analyzed.

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 Q2M. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.

Outcome measures

Outcome measures
Measure	CAB LA + RPV LA Q2M n=90 Participants Eligible participants from LAI116482 (NCT01641809 \[LATTE\]) study who were administered oral CAB 30 milligrams (mg) plus RPV 25 mg and who successfully completed Week 300 received their first dose CAB LA (600 mg) plus RPV LA (900 mg) injections within 2 hours of the final oral dose of LATTE given on the same day. The second loading injections were administered 1 month after initial loading dose, with subsequent injections (CAB LA 600 mg + RPV LA 900 mg) occurring Q2M thereafter. Participants continued to receive the treatment until the study intervention was locally approved and commercially available. Participants who received at least one dose of CAB LA and/or RPV LA and discontinued the CAB LA + RPV LA regimen for any reason entered a 52-week long-term follow-up (LTFU) Phase.	DTG + RPV n=6 Participants Eligible participants from LAI116482 (NCT01641809 \[LATTE\]) study who were administered oral CAB 30 mg plus RPV 25 mg and who successfully completed Week 300 received their first dose of the Dolutegravir (DTG) 50 mg plus RPV 25 mg, once daily as oral regimen on Day 1 until Month 12 in the current study. These participants were not eligible for the LTFU phase.
Absolute Values for Cluster of Differentiation 4 Plus (CD4+) for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Month 24	910.3 Cells per cubic millimeter Standard Deviation 286.21	—
Absolute Values for Cluster of Differentiation 4 Plus (CD4+) for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Baseline (Day 1)	873.0 Cells per cubic millimeter Standard Deviation 233.37	—
Absolute Values for Cluster of Differentiation 4 Plus (CD4+) for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Month 2	868.1 Cells per cubic millimeter Standard Deviation 261.49	—
Absolute Values for Cluster of Differentiation 4 Plus (CD4+) for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Month 4	879.8 Cells per cubic millimeter Standard Deviation 280.88	—
Absolute Values for Cluster of Differentiation 4 Plus (CD4+) for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Month 6	1046.8 Cells per cubic millimeter Standard Deviation 435.74	—
Absolute Values for Cluster of Differentiation 4 Plus (CD4+) for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Month 8	857 Cells per cubic millimeter Standard Deviation 277.46	—
Absolute Values for Cluster of Differentiation 4 Plus (CD4+) for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Month 12	859.2 Cells per cubic millimeter Standard Deviation 283.23	—
Absolute Values for Cluster of Differentiation 4 Plus (CD4+) for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Month 16	917.5 Cells per cubic millimeter Standard Deviation 295.27	—
Absolute Values for Cluster of Differentiation 4 Plus (CD4+) for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Month 20	912.8 Cells per cubic millimeter Standard Deviation 262.40	—
Absolute Values for Cluster of Differentiation 4 Plus (CD4+) for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Month 26	905.9 Cells per cubic millimeter Standard Deviation 274.22	—
Absolute Values for Cluster of Differentiation 4 Plus (CD4+) for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Month 28	867.3 Cells per cubic millimeter Standard Deviation 266.36	—
Absolute Values for Cluster of Differentiation 4 Plus (CD4+) for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Month 30	931.1 Cells per cubic millimeter Standard Deviation 220.94	—
Absolute Values for Cluster of Differentiation 4 Plus (CD4+) for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Month 32	853.7 Cells per cubic millimeter Standard Deviation 280.49	—
Absolute Values for Cluster of Differentiation 4 Plus (CD4+) for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Month 34	967.3 Cells per cubic millimeter Standard Deviation 300.72	—
Absolute Values for Cluster of Differentiation 4 Plus (CD4+) for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Month 36	865.4 Cells per cubic millimeter Standard Deviation 225.93	—
Absolute Values for Cluster of Differentiation 4 Plus (CD4+) for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Month 40	925.7 Cells per cubic millimeter Standard Deviation 271.70	—
Absolute Values for Cluster of Differentiation 4 Plus (CD4+) for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Month 42	1220.8 Cells per cubic millimeter Standard Deviation 536.73	—
Absolute Values for Cluster of Differentiation 4 Plus (CD4+) for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Month 44	905.7 Cells per cubic millimeter Standard Deviation 292.61	—
Absolute Values for Cluster of Differentiation 4 Plus (CD4+) for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Month 46	1011.0 Cells per cubic millimeter Standard Deviation 292.74	—
Absolute Values for Cluster of Differentiation 4 Plus (CD4+) for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Month 48	818.5 Cells per cubic millimeter Standard Deviation 291.82	—
Absolute Values for Cluster of Differentiation 4 Plus (CD4+) for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Month 50	755.0 Cells per cubic millimeter Standard Deviation 182.43	—
Absolute Values for Cluster of Differentiation 4 Plus (CD4+) for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Month 52	716.3 Cells per cubic millimeter Standard Deviation 143.21	—
Absolute Values for Cluster of Differentiation 4 Plus (CD4+) for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase LTFU Month 1	—	837.2 Cells per cubic millimeter Standard Deviation 224.49
Absolute Values for Cluster of Differentiation 4 Plus (CD4+) for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase LTFU Month 3	—	717.8 Cells per cubic millimeter Standard Deviation 188.88
Absolute Values for Cluster of Differentiation 4 Plus (CD4+) for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase LTFU Month 6	—	766.5 Cells per cubic millimeter Standard Deviation 184.84
Absolute Values for Cluster of Differentiation 4 Plus (CD4+) for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase LTFU Month 9	—	775.0 Cells per cubic millimeter Standard Deviation 293.45
Absolute Values for Cluster of Differentiation 4 Plus (CD4+) for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase LTFU Month 12	—	954.8 Cells per cubic millimeter Standard Deviation 259.47

SECONDARY outcome

Timeframe: At Baseline (Day 1) and at Months 3, 6, 9 and 12 [Maintenance Phase]

Population: ITT-E Population

Blood samples were collected and CD4+ cell count assessment by flow cytometry was carried out to evaluate the immunologic activity of DTG + RPV arm. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.

Outcome measures

Outcome measures
Measure	CAB LA + RPV LA Q2M n=7 Participants Eligible participants from LAI116482 (NCT01641809 \[LATTE\]) study who were administered oral CAB 30 milligrams (mg) plus RPV 25 mg and who successfully completed Week 300 received their first dose CAB LA (600 mg) plus RPV LA (900 mg) injections within 2 hours of the final oral dose of LATTE given on the same day. The second loading injections were administered 1 month after initial loading dose, with subsequent injections (CAB LA 600 mg + RPV LA 900 mg) occurring Q2M thereafter. Participants continued to receive the treatment until the study intervention was locally approved and commercially available. Participants who received at least one dose of CAB LA and/or RPV LA and discontinued the CAB LA + RPV LA regimen for any reason entered a 52-week long-term follow-up (LTFU) Phase.	DTG + RPV Eligible participants from LAI116482 (NCT01641809 \[LATTE\]) study who were administered oral CAB 30 mg plus RPV 25 mg and who successfully completed Week 300 received their first dose of the Dolutegravir (DTG) 50 mg plus RPV 25 mg, once daily as oral regimen on Day 1 until Month 12 in the current study. These participants were not eligible for the LTFU phase.
Absolute Values for CD4+ for DTG + RPV Arm up to Month 12 [Maintenance Phase] Month 12	790.4 Cells per cubic millimeter Standard Deviation 141.80	—
Absolute Values for CD4+ for DTG + RPV Arm up to Month 12 [Maintenance Phase] Baseline (Day 1)	804.3 Cells per cubic millimeter Standard Deviation 167.73	—
Absolute Values for CD4+ for DTG + RPV Arm up to Month 12 [Maintenance Phase] Month 3	780.3 Cells per cubic millimeter Standard Deviation 145.22	—
Absolute Values for CD4+ for DTG + RPV Arm up to Month 12 [Maintenance Phase] Month 6	728.9 Cells per cubic millimeter Standard Deviation 147.06	—
Absolute Values for CD4+ for DTG + RPV Arm up to Month 12 [Maintenance Phase] Month 9	777.0 Cells per cubic millimeter Standard Deviation 251.37	—

SECONDARY outcome

Timeframe: Up to End of LTFU Phase (compared with Baseline [Day1]), (approximately up to 12 months after exiting the Maintenance Phase)

Population: ITT-E Population. Only those participants with data available for specific analysis and specified time points analyzed.

Outcome measures

Outcome measures
Measure	CAB LA + RPV LA Q2M n=90 Participants Eligible participants from LAI116482 (NCT01641809 \[LATTE\]) study who were administered oral CAB 30 milligrams (mg) plus RPV 25 mg and who successfully completed Week 300 received their first dose CAB LA (600 mg) plus RPV LA (900 mg) injections within 2 hours of the final oral dose of LATTE given on the same day. The second loading injections were administered 1 month after initial loading dose, with subsequent injections (CAB LA 600 mg + RPV LA 900 mg) occurring Q2M thereafter. Participants continued to receive the treatment until the study intervention was locally approved and commercially available. Participants who received at least one dose of CAB LA and/or RPV LA and discontinued the CAB LA + RPV LA regimen for any reason entered a 52-week long-term follow-up (LTFU) Phase.	DTG + RPV n=6 Participants Eligible participants from LAI116482 (NCT01641809 \[LATTE\]) study who were administered oral CAB 30 mg plus RPV 25 mg and who successfully completed Week 300 received their first dose of the Dolutegravir (DTG) 50 mg plus RPV 25 mg, once daily as oral regimen on Day 1 until Month 12 in the current study. These participants were not eligible for the LTFU phase.
Change From Baseline Values for CD4+ for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Month 2	-4.9 Cells per cubic millimeter Standard Deviation 196.47	—
Change From Baseline Values for CD4+ for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Month 4	5.3 Cells per cubic millimeter Standard Deviation 221.68	—
Change From Baseline Values for CD4+ for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Month 6	100.2 Cells per cubic millimeter Standard Deviation 343.66	—
Change From Baseline Values for CD4+ for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Month 8	-20.7 Cells per cubic millimeter Standard Deviation 218.39	—
Change From Baseline Values for CD4+ for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Month 12	-19.4 Cells per cubic millimeter Standard Deviation 189.19	—
Change From Baseline Values for CD4+ for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Month 16	45.6 Cells per cubic millimeter Standard Deviation 227.11	—
Change From Baseline Values for CD4+ for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Month 20	43.8 Cells per cubic millimeter Standard Deviation 193.72	—
Change From Baseline Values for CD4+ for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Month 24	41.6 Cells per cubic millimeter Standard Deviation 224.99	—
Change From Baseline Values for CD4+ for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Month 26	4.2 Cells per cubic millimeter Standard Deviation 160.08	—
Change From Baseline Values for CD4+ for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Month 28	-6.2 Cells per cubic millimeter Standard Deviation 196.62	—
Change From Baseline Values for CD4+ for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Month 30	18.1 Cells per cubic millimeter Standard Deviation 192.09	—
Change From Baseline Values for CD4+ for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Month 32	-13.5 Cells per cubic millimeter Standard Deviation 215.60	—
Change From Baseline Values for CD4+ for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Month 34	15.8 Cells per cubic millimeter Standard Deviation 239.28	—
Change From Baseline Values for CD4+ for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Month 36	0.0 Cells per cubic millimeter Standard Deviation 195.92	—
Change From Baseline Values for CD4+ for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Month 40	67.1 Cells per cubic millimeter Standard Deviation 205.26	—
Change From Baseline Values for CD4+ for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Month 42	390.8 Cells per cubic millimeter Standard Deviation 406.79	—
Change From Baseline Values for CD4+ for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Month 44	31.6 Cells per cubic millimeter Standard Deviation 244.33	—
Change From Baseline Values for CD4+ for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Month 46	-98.5 Cells per cubic millimeter Standard Deviation 424.97	—
Change From Baseline Values for CD4+ for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Month 48	-44.2 Cells per cubic millimeter Standard Deviation 236.71	—
Change From Baseline Values for CD4+ for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Month 50	-451.0 Cells per cubic millimeter Standard Deviation 485.08	—
Change From Baseline Values for CD4+ for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Month 52	-23.0 Cells per cubic millimeter Standard Deviation 78.28	—
Change From Baseline Values for CD4+ for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase LTFU Month 1	—	-88.8 Cells per cubic millimeter Standard Deviation 156.64
Change From Baseline Values for CD4+ for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase LTFU Month 3	—	-97.8 Cells per cubic millimeter Standard Deviation 188.52
Change From Baseline Values for CD4+ for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase LTFU Month 6	—	-111.8 Cells per cubic millimeter Standard Deviation 236.26
Change From Baseline Values for CD4+ for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase LTFU Month 9	—	-103.3 Cells per cubic millimeter Standard Deviation 87.22
Change From Baseline Values for CD4+ for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase LTFU Month 12	—	28.8 Cells per cubic millimeter Standard Deviation 209.33

SECONDARY outcome

Timeframe: At Months 3, 6, 9 and 12 (compared with Baseline [Day 1]) [Maintenance Phase]

Population: ITT-E Population

Outcome measures

Outcome measures
Measure	CAB LA + RPV LA Q2M n=7 Participants Eligible participants from LAI116482 (NCT01641809 \[LATTE\]) study who were administered oral CAB 30 milligrams (mg) plus RPV 25 mg and who successfully completed Week 300 received their first dose CAB LA (600 mg) plus RPV LA (900 mg) injections within 2 hours of the final oral dose of LATTE given on the same day. The second loading injections were administered 1 month after initial loading dose, with subsequent injections (CAB LA 600 mg + RPV LA 900 mg) occurring Q2M thereafter. Participants continued to receive the treatment until the study intervention was locally approved and commercially available. Participants who received at least one dose of CAB LA and/or RPV LA and discontinued the CAB LA + RPV LA regimen for any reason entered a 52-week long-term follow-up (LTFU) Phase.	DTG + RPV Eligible participants from LAI116482 (NCT01641809 \[LATTE\]) study who were administered oral CAB 30 mg plus RPV 25 mg and who successfully completed Week 300 received their first dose of the Dolutegravir (DTG) 50 mg plus RPV 25 mg, once daily as oral regimen on Day 1 until Month 12 in the current study. These participants were not eligible for the LTFU phase.
Change From Baseline Values for CD4+ for DTG + RPV Arm up to Month 12 [Maintenance Phase] Month 3	-24.0 Cells per cubic millimeter Standard Deviation 118.40	—
Change From Baseline Values for CD4+ for DTG + RPV Arm up to Month 12 [Maintenance Phase] Month 6	-75.4 Cells per cubic millimeter Standard Deviation 123.71	—
Change From Baseline Values for CD4+ for DTG + RPV Arm up to Month 12 [Maintenance Phase] Month 9	-27.3 Cells per cubic millimeter Standard Deviation 150.96	—
Change From Baseline Values for CD4+ for DTG + RPV Arm up to Month 12 [Maintenance Phase] Month 12	-13.9 Cells per cubic millimeter Standard Deviation 145.76	—

SECONDARY outcome

Timeframe: Up to End of LTFU Phase (approximately up to 12 months after exiting the Maintenance Phase)

Population: Safety Population comprised of all participants who received at least one dose of study treatment on or after Day 1 visit. Participants were assessed according to actual treatment received.

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.

Outcome measures

Outcome measures
Measure	CAB LA + RPV LA Q2M n=90 Participants Eligible participants from LAI116482 (NCT01641809 \[LATTE\]) study who were administered oral CAB 30 milligrams (mg) plus RPV 25 mg and who successfully completed Week 300 received their first dose CAB LA (600 mg) plus RPV LA (900 mg) injections within 2 hours of the final oral dose of LATTE given on the same day. The second loading injections were administered 1 month after initial loading dose, with subsequent injections (CAB LA 600 mg + RPV LA 900 mg) occurring Q2M thereafter. Participants continued to receive the treatment until the study intervention was locally approved and commercially available. Participants who received at least one dose of CAB LA and/or RPV LA and discontinued the CAB LA + RPV LA regimen for any reason entered a 52-week long-term follow-up (LTFU) Phase.	DTG + RPV Eligible participants from LAI116482 (NCT01641809 \[LATTE\]) study who were administered oral CAB 30 mg plus RPV 25 mg and who successfully completed Week 300 received their first dose of the Dolutegravir (DTG) 50 mg plus RPV 25 mg, once daily as oral regimen on Day 1 until Month 12 in the current study. These participants were not eligible for the LTFU phase.
Number of Participants With Non-serious Adverse Events (Non-SAEs >=5 Percent [%] Incidence) and Serious Adverse Events (SAEs) for CAB LA + RPV LA Q2M Arm Non-SAE (>=5%)	86 Participants	—
Number of Participants With Non-serious Adverse Events (Non-SAEs >=5 Percent [%] Incidence) and Serious Adverse Events (SAEs) for CAB LA + RPV LA Q2M Arm SAE	10 Participants	—

SECONDARY outcome

Timeframe: Up to Month 12 [Maintenance Phase]

Outcome measures

Outcome measures
Measure	CAB LA + RPV LA Q2M n=7 Participants Eligible participants from LAI116482 (NCT01641809 \[LATTE\]) study who were administered oral CAB 30 milligrams (mg) plus RPV 25 mg and who successfully completed Week 300 received their first dose CAB LA (600 mg) plus RPV LA (900 mg) injections within 2 hours of the final oral dose of LATTE given on the same day. The second loading injections were administered 1 month after initial loading dose, with subsequent injections (CAB LA 600 mg + RPV LA 900 mg) occurring Q2M thereafter. Participants continued to receive the treatment until the study intervention was locally approved and commercially available. Participants who received at least one dose of CAB LA and/or RPV LA and discontinued the CAB LA + RPV LA regimen for any reason entered a 52-week long-term follow-up (LTFU) Phase.	DTG + RPV Eligible participants from LAI116482 (NCT01641809 \[LATTE\]) study who were administered oral CAB 30 mg plus RPV 25 mg and who successfully completed Week 300 received their first dose of the Dolutegravir (DTG) 50 mg plus RPV 25 mg, once daily as oral regimen on Day 1 until Month 12 in the current study. These participants were not eligible for the LTFU phase.
Number of Participants With Non-serious Adverse Events (Non-SAEs >=5 Percent [%] Incidence) and Serious Adverse Events (SAEs) for DTG + RPV Arm Non-SAE (>=5%)	3 Participants	—
Number of Participants With Non-serious Adverse Events (Non-SAEs >=5 Percent [%] Incidence) and Serious Adverse Events (SAEs) for DTG + RPV Arm SAE	0 Participants	—

SECONDARY outcome

Timeframe: Up to End of LTFU Phase (approximately up to 12 months after exiting the Maintenance Phase)

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 Grade 1 (mild), Grade 2 (moderate), Grade 3 (severe), Grade 4 (Potentially life-threatening) and Grade 5 (all deaths related to an AE).

Outcome measures

Outcome measures
Measure	CAB LA + RPV LA Q2M n=90 Participants Eligible participants from LAI116482 (NCT01641809 \[LATTE\]) study who were administered oral CAB 30 milligrams (mg) plus RPV 25 mg and who successfully completed Week 300 received their first dose CAB LA (600 mg) plus RPV LA (900 mg) injections within 2 hours of the final oral dose of LATTE given on the same day. The second loading injections were administered 1 month after initial loading dose, with subsequent injections (CAB LA 600 mg + RPV LA 900 mg) occurring Q2M thereafter. Participants continued to receive the treatment until the study intervention was locally approved and commercially available. Participants who received at least one dose of CAB LA and/or RPV LA and discontinued the CAB LA + RPV LA regimen for any reason entered a 52-week long-term follow-up (LTFU) Phase.	DTG + RPV Eligible participants from LAI116482 (NCT01641809 \[LATTE\]) study who were administered oral CAB 30 mg plus RPV 25 mg and who successfully completed Week 300 received their first dose of the Dolutegravir (DTG) 50 mg plus RPV 25 mg, once daily as oral regimen on Day 1 until Month 12 in the current study. These participants were not eligible for the LTFU phase.
Number of Participants With Severity of Adverse Events for CAB LA + RPV LA Q2M Arm Grade 4	4 Participants	—
Number of Participants With Severity of Adverse Events for CAB LA + RPV LA Q2M Arm Grade 1	22 Participants	—
Number of Participants With Severity of Adverse Events for CAB LA + RPV LA Q2M Arm Grade 2	53 Participants	—
Number of Participants With Severity of Adverse Events for CAB LA + RPV LA Q2M Arm Grade 3	10 Participants	—
Number of Participants With Severity of Adverse Events for CAB LA + RPV LA Q2M Arm Grade 5	0 Participants	—

SECONDARY outcome

Timeframe: Up to Month 12 [Maintenance Phase]

Outcome measures

Outcome measures
Measure	CAB LA + RPV LA Q2M n=7 Participants Eligible participants from LAI116482 (NCT01641809 \[LATTE\]) study who were administered oral CAB 30 milligrams (mg) plus RPV 25 mg and who successfully completed Week 300 received their first dose CAB LA (600 mg) plus RPV LA (900 mg) injections within 2 hours of the final oral dose of LATTE given on the same day. The second loading injections were administered 1 month after initial loading dose, with subsequent injections (CAB LA 600 mg + RPV LA 900 mg) occurring Q2M thereafter. Participants continued to receive the treatment until the study intervention was locally approved and commercially available. Participants who received at least one dose of CAB LA and/or RPV LA and discontinued the CAB LA + RPV LA regimen for any reason entered a 52-week long-term follow-up (LTFU) Phase.	DTG + RPV Eligible participants from LAI116482 (NCT01641809 \[LATTE\]) study who were administered oral CAB 30 mg plus RPV 25 mg and who successfully completed Week 300 received their first dose of the Dolutegravir (DTG) 50 mg plus RPV 25 mg, once daily as oral regimen on Day 1 until Month 12 in the current study. These participants were not eligible for the LTFU phase.
Number of Participants With Severity of Adverse Events for DTG + RPV Arm Grade 1	0 Participants	—
Number of Participants With Severity of Adverse Events for DTG + RPV Arm Grade 2	3 Participants	—
Number of Participants With Severity of Adverse Events for DTG + RPV Arm Grade 3	0 Participants	—
Number of Participants With Severity of Adverse Events for DTG + RPV Arm Grade 4	0 Participants	—
Number of Participants With Severity of Adverse Events for DTG + RPV Arm Grade 5	0 Participants	—

SECONDARY outcome

Timeframe: Up to End of Maintenance Phase (up to Month 52)

Population: Safety Population

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, aspartate aminotransferase (AST), bilirubin, carbon dioxide (CO2), cholesterol, creatinine kinase, creatinine, direct bilirubin, glomerular filtration rate (GFR) from creatinine adjusted using chronic kidney disease epidemiology collaboration (CKD-EPI), GFR from creatinine adjusted for bovine serum albumin (BSA), glucose, low density lipoprotein (LDL) cholesterol calculation, lipase, phosphate, sodium and triglycerides. Severity grades were: Grade 1 (mild), Grade 2 (moderate), Grade 3 (severe) and Grade 4 (Potentially life-threatening).

Outcome measures

Outcome measures
Measure	CAB LA + RPV LA Q2M n=90 Participants Eligible participants from LAI116482 (NCT01641809 \[LATTE\]) study who were administered oral CAB 30 milligrams (mg) plus RPV 25 mg and who successfully completed Week 300 received their first dose CAB LA (600 mg) plus RPV LA (900 mg) injections within 2 hours of the final oral dose of LATTE given on the same day. The second loading injections were administered 1 month after initial loading dose, with subsequent injections (CAB LA 600 mg + RPV LA 900 mg) occurring Q2M thereafter. Participants continued to receive the treatment until the study intervention was locally approved and commercially available. Participants who received at least one dose of CAB LA and/or RPV LA and discontinued the CAB LA + RPV LA regimen for any reason entered a 52-week long-term follow-up (LTFU) Phase.	DTG + RPV Eligible participants from LAI116482 (NCT01641809 \[LATTE\]) study who were administered oral CAB 30 mg plus RPV 25 mg and who successfully completed Week 300 received their first dose of the Dolutegravir (DTG) 50 mg plus RPV 25 mg, once daily as oral regimen on Day 1 until Month 12 in the current study. These participants were not eligible for the LTFU phase.
Number of Participants With Maximum Post-Baseline Chemistry Toxicities for CAB LA + RPV LA Q2M Arm up to End of Maintenance Phase Cholesterol, Grade 2	5 Participants	—
Number of Participants With Maximum Post-Baseline Chemistry Toxicities for CAB LA + RPV LA Q2M Arm up to End of Maintenance Phase Cholesterol, Grade 3	0 Participants	—
Number of Participants With Maximum Post-Baseline Chemistry Toxicities for CAB LA + RPV LA Q2M Arm up to End of Maintenance Phase Cholesterol, Grade 4	0 Participants	—
Number of Participants With Maximum Post-Baseline Chemistry Toxicities for CAB LA + RPV LA Q2M Arm up to End of Maintenance Phase Creatine kinase, Grade 1	8 Participants	—
Number of Participants With Maximum Post-Baseline Chemistry Toxicities for CAB LA + RPV LA Q2M Arm up to End of Maintenance Phase Creatine kinase, Grade 2	7 Participants	—
Number of Participants With Maximum Post-Baseline Chemistry Toxicities for CAB LA + RPV LA Q2M Arm up to End of Maintenance Phase Creatine kinase, Grade 3	6 Participants	—
Number of Participants With Maximum Post-Baseline Chemistry Toxicities for CAB LA + RPV LA Q2M Arm up to End of Maintenance Phase Creatine kinase, Grade 4	2 Participants	—
Number of Participants With Maximum Post-Baseline Chemistry Toxicities for CAB LA + RPV LA Q2M Arm up to End of Maintenance Phase Creatinine, Grade 1	3 Participants	—
Number of Participants With Maximum Post-Baseline Chemistry Toxicities for CAB LA + RPV LA Q2M Arm up to End of Maintenance Phase Creatinine, Grade 2	0 Participants	—
Number of Participants With Maximum Post-Baseline Chemistry Toxicities for CAB LA + RPV LA Q2M Arm up to End of Maintenance Phase Creatinine, Grade 3	0 Participants	—
Number of Participants With Maximum Post-Baseline Chemistry Toxicities for CAB LA + RPV LA Q2M Arm up to End of Maintenance Phase Creatinine, Grade 4	0 Participants	—
Number of Participants With Maximum Post-Baseline Chemistry Toxicities for CAB LA + RPV LA Q2M Arm up to End of Maintenance Phase Direct bilirubin, Grade 1	0 Participants	—
Number of Participants With Maximum Post-Baseline Chemistry Toxicities for CAB LA + RPV LA Q2M Arm up to End of Maintenance Phase Direct bilirubin, Grade 2	0 Participants	—
Number of Participants With Maximum Post-Baseline Chemistry Toxicities for CAB LA + RPV LA Q2M Arm up to End of Maintenance Phase Direct bilirubin, Grade 3	1 Participants	—
Number of Participants With Maximum Post-Baseline Chemistry Toxicities for CAB LA + RPV LA Q2M Arm up to End of Maintenance Phase Direct bilirubin, Grade 4	0 Participants	—
Number of Participants With Maximum Post-Baseline Chemistry Toxicities for CAB LA + RPV LA Q2M Arm up to End of Maintenance Phase GFR from creatinine adjusted using CKD-EPI, Grade 1	0 Participants	—
Number of Participants With Maximum Post-Baseline Chemistry Toxicities for CAB LA + RPV LA Q2M Arm up to End of Maintenance Phase GFR from creatinine adjusted using CKD-EPI, Grade 2	23 Participants	—
Number of Participants With Maximum Post-Baseline Chemistry Toxicities for CAB LA + RPV LA Q2M Arm up to End of Maintenance Phase GFR from creatinine adjusted using CKD-EPI, Grade 3	3 Participants	—
Number of Participants With Maximum Post-Baseline Chemistry Toxicities for CAB LA + RPV LA Q2M Arm up to End of Maintenance Phase GFR from creatinine adjusted using CKD-EPI, Grade 4	0 Participants	—
Number of Participants With Maximum Post-Baseline Chemistry Toxicities for CAB LA + RPV LA Q2M Arm up to End of Maintenance Phase GFR from creatinine adjusted for BSA, Grade 1	0 Participants	—
Number of Participants With Maximum Post-Baseline Chemistry Toxicities for CAB LA + RPV LA Q2M Arm up to End of Maintenance Phase GFR from creatinine adjusted for BSA, Grade 2	23 Participants	—
Number of Participants With Maximum Post-Baseline Chemistry Toxicities for CAB LA + RPV LA Q2M Arm up to End of Maintenance Phase GFR from creatinine adjusted for BSA, Grade 3	3 Participants	—
Number of Participants With Maximum Post-Baseline Chemistry Toxicities for CAB LA + RPV LA Q2M Arm up to End of Maintenance Phase GFR from creatinine adjusted for BSA, Grade 4	0 Participants	—
Number of Participants With Maximum Post-Baseline Chemistry Toxicities for CAB LA + RPV LA Q2M Arm up to End of Maintenance Phase Glucose, Grade 1	21 Participants	—
Number of Participants With Maximum Post-Baseline Chemistry Toxicities for CAB LA + RPV LA Q2M Arm up to End of Maintenance Phase Glucose, Grade 2	20 Participants	—
Number of Participants With Maximum Post-Baseline Chemistry Toxicities for CAB LA + RPV LA Q2M Arm up to End of Maintenance Phase Glucose, Grade 3	0 Participants	—
Number of Participants With Maximum Post-Baseline Chemistry Toxicities for CAB LA + RPV LA Q2M Arm up to End of Maintenance Phase Glucose, Grade 4	0 Participants	—
Number of Participants With Maximum Post-Baseline Chemistry Toxicities for CAB LA + RPV LA Q2M Arm up to End of Maintenance Phase LDL cholesterol calculation, Grade 1	7 Participants	—
Number of Participants With Maximum Post-Baseline Chemistry Toxicities for CAB LA + RPV LA Q2M Arm up to End of Maintenance Phase LDL cholesterol calculation, Grade 2	4 Participants	—
Number of Participants With Maximum Post-Baseline Chemistry Toxicities for CAB LA + RPV LA Q2M Arm up to End of Maintenance Phase LDL cholesterol calculation, Grade 3	1 Participants	—
Number of Participants With Maximum Post-Baseline Chemistry Toxicities for CAB LA + RPV LA Q2M Arm up to End of Maintenance Phase LDL cholesterol calculation, Grade 4	0 Participants	—
Number of Participants With Maximum Post-Baseline Chemistry Toxicities for CAB LA + RPV LA Q2M Arm up to End of Maintenance Phase Lipase, Grade 1	10 Participants	—
Number of Participants With Maximum Post-Baseline Chemistry Toxicities for CAB LA + RPV LA Q2M Arm up to End of Maintenance Phase Lipase, Grade 2	15 Participants	—
Number of Participants With Maximum Post-Baseline Chemistry Toxicities for CAB LA + RPV LA Q2M Arm up to End of Maintenance Phase Lipase, Grade 3	3 Participants	—
Number of Participants With Maximum Post-Baseline Chemistry Toxicities for CAB LA + RPV LA Q2M Arm up to End of Maintenance Phase Lipase, Grade 4	4 Participants	—
Number of Participants With Maximum Post-Baseline Chemistry Toxicities for CAB LA + RPV LA Q2M Arm up to End of Maintenance Phase Phosphate, Grade 1	14 Participants	—
Number of Participants With Maximum Post-Baseline Chemistry Toxicities for CAB LA + RPV LA Q2M Arm up to End of Maintenance Phase Phosphate, Grade 2	2 Participants	—
Number of Participants With Maximum Post-Baseline Chemistry Toxicities for CAB LA + RPV LA Q2M Arm up to End of Maintenance Phase Phosphate, Grade 3	0 Participants	—
Number of Participants With Maximum Post-Baseline Chemistry Toxicities for CAB LA + RPV LA Q2M Arm up to End of Maintenance Phase Phosphate, Grade 4	0 Participants	—
Number of Participants With Maximum Post-Baseline Chemistry Toxicities for CAB LA + RPV LA Q2M Arm up to End of Maintenance Phase Sodium, Grade 1	9 Participants	—
Number of Participants With Maximum Post-Baseline Chemistry Toxicities for CAB LA + RPV LA Q2M Arm up to End of Maintenance Phase Sodium, Grade 2	1 Participants	—
Number of Participants With Maximum Post-Baseline Chemistry Toxicities for CAB LA + RPV LA Q2M Arm up to End of Maintenance Phase Sodium, Grade 3	0 Participants	—
Number of Participants With Maximum Post-Baseline Chemistry Toxicities for CAB LA + RPV LA Q2M Arm up to End of Maintenance Phase Sodium, Grade 4	0 Participants	—
Number of Participants With Maximum Post-Baseline Chemistry Toxicities for CAB LA + RPV LA Q2M Arm up to End of Maintenance Phase Triglycerides, Grade 1	11 Participants	—
Number of Participants With Maximum Post-Baseline Chemistry Toxicities for CAB LA + RPV LA Q2M Arm up to End of Maintenance Phase Triglycerides, Grade 2	8 Participants	—
Number of Participants With Maximum Post-Baseline Chemistry Toxicities for CAB LA + RPV LA Q2M Arm up to End of Maintenance Phase Triglycerides, Grade 3	2 Participants	—
Number of Participants With Maximum Post-Baseline Chemistry Toxicities for CAB LA + RPV LA Q2M Arm up to End of Maintenance Phase Triglycerides, Grade 4	1 Participants	—
Number of Participants With Maximum Post-Baseline Chemistry Toxicities for CAB LA + RPV LA Q2M Arm up to End of Maintenance Phase ALT, Grade 1	15 Participants	—
Number of Participants With Maximum Post-Baseline Chemistry Toxicities for CAB LA + RPV LA Q2M Arm up to End of Maintenance Phase ALT, Grade 2	3 Participants	—
Number of Participants With Maximum Post-Baseline Chemistry Toxicities for CAB LA + RPV LA Q2M Arm up to End of Maintenance Phase ALT, Grade 3	3 Participants	—
Number of Participants With Maximum Post-Baseline Chemistry Toxicities for CAB LA + RPV LA Q2M Arm up to End of Maintenance Phase ALT, Grade 4	0 Participants	—
Number of Participants With Maximum Post-Baseline Chemistry Toxicities for CAB LA + RPV LA Q2M Arm up to End of Maintenance Phase AST, Grade 1	12 Participants	—
Number of Participants With Maximum Post-Baseline Chemistry Toxicities for CAB LA + RPV LA Q2M Arm up to End of Maintenance Phase AST, Grade 2	6 Participants	—
Number of Participants With Maximum Post-Baseline Chemistry Toxicities for CAB LA + RPV LA Q2M Arm up to End of Maintenance Phase AST, Grade 3	0 Participants	—
Number of Participants With Maximum Post-Baseline Chemistry Toxicities for CAB LA + RPV LA Q2M Arm up to End of Maintenance Phase AST, Grade 4	0 Participants	—
Number of Participants With Maximum Post-Baseline Chemistry Toxicities for CAB LA + RPV LA Q2M Arm up to End of Maintenance Phase Bilirubin, Grade 1	4 Participants	—
Number of Participants With Maximum Post-Baseline Chemistry Toxicities for CAB LA + RPV LA Q2M Arm up to End of Maintenance Phase Bilirubin, Grade 2	1 Participants	—
Number of Participants With Maximum Post-Baseline Chemistry Toxicities for CAB LA + RPV LA Q2M Arm up to End of Maintenance Phase Bilirubin, Grade 3	0 Participants	—
Number of Participants With Maximum Post-Baseline Chemistry Toxicities for CAB LA + RPV LA Q2M Arm up to End of Maintenance Phase Bilirubin, Grade 4	0 Participants	—
Number of Participants With Maximum Post-Baseline Chemistry Toxicities for CAB LA + RPV LA Q2M Arm up to End of Maintenance Phase CO2, Grade 1	13 Participants	—
Number of Participants With Maximum Post-Baseline Chemistry Toxicities for CAB LA + RPV LA Q2M Arm up to End of Maintenance Phase CO2, Grade 2	0 Participants	—
Number of Participants With Maximum Post-Baseline Chemistry Toxicities for CAB LA + RPV LA Q2M Arm up to End of Maintenance Phase CO2, Grade 3	0 Participants	—
Number of Participants With Maximum Post-Baseline Chemistry Toxicities for CAB LA + RPV LA Q2M Arm up to End of Maintenance Phase CO2, Grade 4	0 Participants	—
Number of Participants With Maximum Post-Baseline Chemistry Toxicities for CAB LA + RPV LA Q2M Arm up to End of Maintenance Phase Cholesterol, Grade 1	8 Participants	—

SECONDARY outcome

Timeframe: Up to Month 12 [Maintenance Phase]

Population: Safety Population

Outcome measures

Outcome measures
Measure	CAB LA + RPV LA Q2M n=7 Participants Eligible participants from LAI116482 (NCT01641809 \[LATTE\]) study who were administered oral CAB 30 milligrams (mg) plus RPV 25 mg and who successfully completed Week 300 received their first dose CAB LA (600 mg) plus RPV LA (900 mg) injections within 2 hours of the final oral dose of LATTE given on the same day. The second loading injections were administered 1 month after initial loading dose, with subsequent injections (CAB LA 600 mg + RPV LA 900 mg) occurring Q2M thereafter. Participants continued to receive the treatment until the study intervention was locally approved and commercially available. Participants who received at least one dose of CAB LA and/or RPV LA and discontinued the CAB LA + RPV LA regimen for any reason entered a 52-week long-term follow-up (LTFU) Phase.	DTG + RPV Eligible participants from LAI116482 (NCT01641809 \[LATTE\]) study who were administered oral CAB 30 mg plus RPV 25 mg and who successfully completed Week 300 received their first dose of the Dolutegravir (DTG) 50 mg plus RPV 25 mg, once daily as oral regimen on Day 1 until Month 12 in the current study. These participants were not eligible for the LTFU phase.
Number of Participants With Maximum Post-Baseline Chemistry Toxicities for DTG + RPV Arm up to Month 12 [Maintenance Phase] ALT, Grade 1	1 Participants	—
Number of Participants With Maximum Post-Baseline Chemistry Toxicities for DTG + RPV Arm up to Month 12 [Maintenance Phase] ALT, Grade 2	0 Participants	—
Number of Participants With Maximum Post-Baseline Chemistry Toxicities for DTG + RPV Arm up to Month 12 [Maintenance Phase] ALT, Grade 3	0 Participants	—
Number of Participants With Maximum Post-Baseline Chemistry Toxicities for DTG + RPV Arm up to Month 12 [Maintenance Phase] ALT, Grade 4	0 Participants	—
Number of Participants With Maximum Post-Baseline Chemistry Toxicities for DTG + RPV Arm up to Month 12 [Maintenance Phase] AST, Grade 1	0 Participants	—
Number of Participants With Maximum Post-Baseline Chemistry Toxicities for DTG + RPV Arm up to Month 12 [Maintenance Phase] AST, Grade 2	0 Participants	—
Number of Participants With Maximum Post-Baseline Chemistry Toxicities for DTG + RPV Arm up to Month 12 [Maintenance Phase] AST, Grade 3	0 Participants	—
Number of Participants With Maximum Post-Baseline Chemistry Toxicities for DTG + RPV Arm up to Month 12 [Maintenance Phase] AST, Grade 4	0 Participants	—
Number of Participants With Maximum Post-Baseline Chemistry Toxicities for DTG + RPV Arm up to Month 12 [Maintenance Phase] Bilirubin, Grade 1	0 Participants	—
Number of Participants With Maximum Post-Baseline Chemistry Toxicities for DTG + RPV Arm up to Month 12 [Maintenance Phase] Bilirubin, Grade 2	0 Participants	—
Number of Participants With Maximum Post-Baseline Chemistry Toxicities for DTG + RPV Arm up to Month 12 [Maintenance Phase] Bilirubin, Grade 3	0 Participants	—
Number of Participants With Maximum Post-Baseline Chemistry Toxicities for DTG + RPV Arm up to Month 12 [Maintenance Phase] Bilirubin, Grade 4	0 Participants	—
Number of Participants With Maximum Post-Baseline Chemistry Toxicities for DTG + RPV Arm up to Month 12 [Maintenance Phase] CO2, Grade 1	1 Participants	—
Number of Participants With Maximum Post-Baseline Chemistry Toxicities for DTG + RPV Arm up to Month 12 [Maintenance Phase] CO2, Grade 2	0 Participants	—
Number of Participants With Maximum Post-Baseline Chemistry Toxicities for DTG + RPV Arm up to Month 12 [Maintenance Phase] CO2, Grade 3	0 Participants	—
Number of Participants With Maximum Post-Baseline Chemistry Toxicities for DTG + RPV Arm up to Month 12 [Maintenance Phase] CO2, Grade 4	0 Participants	—
Number of Participants With Maximum Post-Baseline Chemistry Toxicities for DTG + RPV Arm up to Month 12 [Maintenance Phase] Cholesterol, Grade 1	0 Participants	—
Number of Participants With Maximum Post-Baseline Chemistry Toxicities for DTG + RPV Arm up to Month 12 [Maintenance Phase] Cholesterol, Grade 2	0 Participants	—
Number of Participants With Maximum Post-Baseline Chemistry Toxicities for DTG + RPV Arm up to Month 12 [Maintenance Phase] Cholesterol, Grade 3	0 Participants	—
Number of Participants With Maximum Post-Baseline Chemistry Toxicities for DTG + RPV Arm up to Month 12 [Maintenance Phase] Cholesterol, Grade 4	0 Participants	—
Number of Participants With Maximum Post-Baseline Chemistry Toxicities for DTG + RPV Arm up to Month 12 [Maintenance Phase] Creatine kinase, Grade 1	0 Participants	—
Number of Participants With Maximum Post-Baseline Chemistry Toxicities for DTG + RPV Arm up to Month 12 [Maintenance Phase] Creatine kinase, Grade 2	0 Participants	—
Number of Participants With Maximum Post-Baseline Chemistry Toxicities for DTG + RPV Arm up to Month 12 [Maintenance Phase] Creatine kinase, Grade 3	0 Participants	—
Number of Participants With Maximum Post-Baseline Chemistry Toxicities for DTG + RPV Arm up to Month 12 [Maintenance Phase] Creatine kinase, Grade 4	0 Participants	—
Number of Participants With Maximum Post-Baseline Chemistry Toxicities for DTG + RPV Arm up to Month 12 [Maintenance Phase] Creatinine, Grade 1	0 Participants	—
Number of Participants With Maximum Post-Baseline Chemistry Toxicities for DTG + RPV Arm up to Month 12 [Maintenance Phase] Creatinine, Grade 2	0 Participants	—
Number of Participants With Maximum Post-Baseline Chemistry Toxicities for DTG + RPV Arm up to Month 12 [Maintenance Phase] Creatinine, Grade 3	0 Participants	—
Number of Participants With Maximum Post-Baseline Chemistry Toxicities for DTG + RPV Arm up to Month 12 [Maintenance Phase] Creatinine, Grade 4	0 Participants	—
Number of Participants With Maximum Post-Baseline Chemistry Toxicities for DTG + RPV Arm up to Month 12 [Maintenance Phase] Direct bilirubin, Grade 1	0 Participants	—
Number of Participants With Maximum Post-Baseline Chemistry Toxicities for DTG + RPV Arm up to Month 12 [Maintenance Phase] Direct bilirubin, Grade 2	0 Participants	—
Number of Participants With Maximum Post-Baseline Chemistry Toxicities for DTG + RPV Arm up to Month 12 [Maintenance Phase] Direct bilirubin, Grade 3	0 Participants	—
Number of Participants With Maximum Post-Baseline Chemistry Toxicities for DTG + RPV Arm up to Month 12 [Maintenance Phase] Direct bilirubin, Grade 4	0 Participants	—
Number of Participants With Maximum Post-Baseline Chemistry Toxicities for DTG + RPV Arm up to Month 12 [Maintenance Phase] GFR from creatinine adjusted using CKD-EPI, Grade 1	0 Participants	—
Number of Participants With Maximum Post-Baseline Chemistry Toxicities for DTG + RPV Arm up to Month 12 [Maintenance Phase] GFR from creatinine adjusted using CKD-EPI, Grade 2	5 Participants	—
Number of Participants With Maximum Post-Baseline Chemistry Toxicities for DTG + RPV Arm up to Month 12 [Maintenance Phase] GFR from creatinine adjusted using CKD-EPI, Grade 3	1 Participants	—
Number of Participants With Maximum Post-Baseline Chemistry Toxicities for DTG + RPV Arm up to Month 12 [Maintenance Phase] GFR from creatinine adjusted using CKD-EPI, Grade 4	0 Participants	—
Number of Participants With Maximum Post-Baseline Chemistry Toxicities for DTG + RPV Arm up to Month 12 [Maintenance Phase] GFR from creatinine adjusted for BSA, Grade 1	0 Participants	—
Number of Participants With Maximum Post-Baseline Chemistry Toxicities for DTG + RPV Arm up to Month 12 [Maintenance Phase] GFR from creatinine adjusted for BSA, Grade 2	5 Participants	—
Number of Participants With Maximum Post-Baseline Chemistry Toxicities for DTG + RPV Arm up to Month 12 [Maintenance Phase] GFR from creatinine adjusted for BSA, Grade 3	1 Participants	—
Number of Participants With Maximum Post-Baseline Chemistry Toxicities for DTG + RPV Arm up to Month 12 [Maintenance Phase] GFR from creatinine adjusted for BSA, Grade 4	0 Participants	—
Number of Participants With Maximum Post-Baseline Chemistry Toxicities for DTG + RPV Arm up to Month 12 [Maintenance Phase] Glucose, Grade 1	1 Participants	—
Number of Participants With Maximum Post-Baseline Chemistry Toxicities for DTG + RPV Arm up to Month 12 [Maintenance Phase] Glucose, Grade 2	0 Participants	—
Number of Participants With Maximum Post-Baseline Chemistry Toxicities for DTG + RPV Arm up to Month 12 [Maintenance Phase] Glucose, Grade 3	0 Participants	—
Number of Participants With Maximum Post-Baseline Chemistry Toxicities for DTG + RPV Arm up to Month 12 [Maintenance Phase] Glucose, Grade 4	0 Participants	—
Number of Participants With Maximum Post-Baseline Chemistry Toxicities for DTG + RPV Arm up to Month 12 [Maintenance Phase] LDL cholesterol calculation, Grade 1	0 Participants	—
Number of Participants With Maximum Post-Baseline Chemistry Toxicities for DTG + RPV Arm up to Month 12 [Maintenance Phase] LDL cholesterol calculation, Grade 2	0 Participants	—
Number of Participants With Maximum Post-Baseline Chemistry Toxicities for DTG + RPV Arm up to Month 12 [Maintenance Phase] LDL cholesterol calculation, Grade 3	0 Participants	—
Number of Participants With Maximum Post-Baseline Chemistry Toxicities for DTG + RPV Arm up to Month 12 [Maintenance Phase] LDL cholesterol calculation, Grade 4	0 Participants	—
Number of Participants With Maximum Post-Baseline Chemistry Toxicities for DTG + RPV Arm up to Month 12 [Maintenance Phase] Lipase, Grade 1	0 Participants	—
Number of Participants With Maximum Post-Baseline Chemistry Toxicities for DTG + RPV Arm up to Month 12 [Maintenance Phase] Lipase, Grade 2	2 Participants	—
Number of Participants With Maximum Post-Baseline Chemistry Toxicities for DTG + RPV Arm up to Month 12 [Maintenance Phase] Lipase, Grade 3	0 Participants	—
Number of Participants With Maximum Post-Baseline Chemistry Toxicities for DTG + RPV Arm up to Month 12 [Maintenance Phase] Lipase, Grade 4	0 Participants	—
Number of Participants With Maximum Post-Baseline Chemistry Toxicities for DTG + RPV Arm up to Month 12 [Maintenance Phase] Phosphate, Grade 1	0 Participants	—
Number of Participants With Maximum Post-Baseline Chemistry Toxicities for DTG + RPV Arm up to Month 12 [Maintenance Phase] Phosphate, Grade 2	0 Participants	—
Number of Participants With Maximum Post-Baseline Chemistry Toxicities for DTG + RPV Arm up to Month 12 [Maintenance Phase] Phosphate, Grade 3	0 Participants	—
Number of Participants With Maximum Post-Baseline Chemistry Toxicities for DTG + RPV Arm up to Month 12 [Maintenance Phase] Phosphate, Grade 4	0 Participants	—
Number of Participants With Maximum Post-Baseline Chemistry Toxicities for DTG + RPV Arm up to Month 12 [Maintenance Phase] Sodium, Grade 1	0 Participants	—
Number of Participants With Maximum Post-Baseline Chemistry Toxicities for DTG + RPV Arm up to Month 12 [Maintenance Phase] Sodium, Grade 2	0 Participants	—
Number of Participants With Maximum Post-Baseline Chemistry Toxicities for DTG + RPV Arm up to Month 12 [Maintenance Phase] Sodium, Grade 3	0 Participants	—
Number of Participants With Maximum Post-Baseline Chemistry Toxicities for DTG + RPV Arm up to Month 12 [Maintenance Phase] Sodium, Grade 4	0 Participants	—
Number of Participants With Maximum Post-Baseline Chemistry Toxicities for DTG + RPV Arm up to Month 12 [Maintenance Phase] Triglycerides, Grade 1	0 Participants	—
Number of Participants With Maximum Post-Baseline Chemistry Toxicities for DTG + RPV Arm up to Month 12 [Maintenance Phase] Triglycerides, Grade 2	0 Participants	—
Number of Participants With Maximum Post-Baseline Chemistry Toxicities for DTG + RPV Arm up to Month 12 [Maintenance Phase] Triglycerides, Grade 3	0 Participants	—
Number of Participants With Maximum Post-Baseline Chemistry Toxicities for DTG + RPV Arm up to Month 12 [Maintenance Phase] Triglycerides, Grade 4	0 Participants	—

SECONDARY outcome

Timeframe: Up to End of Maintenance Phase (up to Month 52)

Population: Safety Population

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 the hematology parameter: platelets. Severity grades were: Grade 1 (mild), Grade 2 (moderate), Grade 3 (severe) and Grade 4 (Potentially life-threatening).

Outcome measures

Outcome measures
Measure	CAB LA + RPV LA Q2M n=90 Participants Eligible participants from LAI116482 (NCT01641809 \[LATTE\]) study who were administered oral CAB 30 milligrams (mg) plus RPV 25 mg and who successfully completed Week 300 received their first dose CAB LA (600 mg) plus RPV LA (900 mg) injections within 2 hours of the final oral dose of LATTE given on the same day. The second loading injections were administered 1 month after initial loading dose, with subsequent injections (CAB LA 600 mg + RPV LA 900 mg) occurring Q2M thereafter. Participants continued to receive the treatment until the study intervention was locally approved and commercially available. Participants who received at least one dose of CAB LA and/or RPV LA and discontinued the CAB LA + RPV LA regimen for any reason entered a 52-week long-term follow-up (LTFU) Phase.	DTG + RPV Eligible participants from LAI116482 (NCT01641809 \[LATTE\]) study who were administered oral CAB 30 mg plus RPV 25 mg and who successfully completed Week 300 received their first dose of the Dolutegravir (DTG) 50 mg plus RPV 25 mg, once daily as oral regimen on Day 1 until Month 12 in the current study. These participants were not eligible for the LTFU phase.
Number of Participants With Maximum Post-Baseline Hematology Toxicities for CAB LA + RPV LA Q2M Arm up to End of Maintenance Phase Platelets, Grade 1	2 Participants	—
Number of Participants With Maximum Post-Baseline Hematology Toxicities for CAB LA + RPV LA Q2M Arm up to End of Maintenance Phase Platelets, Grade 2	0 Participants	—
Number of Participants With Maximum Post-Baseline Hematology Toxicities for CAB LA + RPV LA Q2M Arm up to End of Maintenance Phase Platelets, Grade 3	0 Participants	—
Number of Participants With Maximum Post-Baseline Hematology Toxicities for CAB LA + RPV LA Q2M Arm up to End of Maintenance Phase Platelets, Grade 4	0 Participants	—

SECONDARY outcome

Timeframe: Up to Month 12 [Maintenance Phase]

Population: Safety Population

Outcome measures

Outcome measures
Measure	CAB LA + RPV LA Q2M n=7 Participants Eligible participants from LAI116482 (NCT01641809 \[LATTE\]) study who were administered oral CAB 30 milligrams (mg) plus RPV 25 mg and who successfully completed Week 300 received their first dose CAB LA (600 mg) plus RPV LA (900 mg) injections within 2 hours of the final oral dose of LATTE given on the same day. The second loading injections were administered 1 month after initial loading dose, with subsequent injections (CAB LA 600 mg + RPV LA 900 mg) occurring Q2M thereafter. Participants continued to receive the treatment until the study intervention was locally approved and commercially available. Participants who received at least one dose of CAB LA and/or RPV LA and discontinued the CAB LA + RPV LA regimen for any reason entered a 52-week long-term follow-up (LTFU) Phase.	DTG + RPV Eligible participants from LAI116482 (NCT01641809 \[LATTE\]) study who were administered oral CAB 30 mg plus RPV 25 mg and who successfully completed Week 300 received their first dose of the Dolutegravir (DTG) 50 mg plus RPV 25 mg, once daily as oral regimen on Day 1 until Month 12 in the current study. These participants were not eligible for the LTFU phase.
Number of Participants With Maximum Post-Baseline Hematology Toxicities for DTG + RPV Arm up to Month 12 [Maintenance Phase] Platelets, Grade 1	0 Participants	—
Number of Participants With Maximum Post-Baseline Hematology Toxicities for DTG + RPV Arm up to Month 12 [Maintenance Phase] Platelets, Grade 2	0 Participants	—
Number of Participants With Maximum Post-Baseline Hematology Toxicities for DTG + RPV Arm up to Month 12 [Maintenance Phase] Platelets, Grade 3	0 Participants	—
Number of Participants With Maximum Post-Baseline Hematology Toxicities for DTG + RPV Arm up to Month 12 [Maintenance Phase] Platelets, Grade 4	0 Participants	—

SECONDARY outcome

Timeframe: Up to End of Maintenance Phase (up to Month 52)

Population: Safety Population

Outcome measures

Outcome measures
Measure	CAB LA + RPV LA Q2M n=90 Participants Eligible participants from LAI116482 (NCT01641809 \[LATTE\]) study who were administered oral CAB 30 milligrams (mg) plus RPV 25 mg and who successfully completed Week 300 received their first dose CAB LA (600 mg) plus RPV LA (900 mg) injections within 2 hours of the final oral dose of LATTE given on the same day. The second loading injections were administered 1 month after initial loading dose, with subsequent injections (CAB LA 600 mg + RPV LA 900 mg) occurring Q2M thereafter. Participants continued to receive the treatment until the study intervention was locally approved and commercially available. Participants who received at least one dose of CAB LA and/or RPV LA and discontinued the CAB LA + RPV LA regimen for any reason entered a 52-week long-term follow-up (LTFU) Phase.	DTG + RPV Eligible participants from LAI116482 (NCT01641809 \[LATTE\]) study who were administered oral CAB 30 mg plus RPV 25 mg and who successfully completed Week 300 received their first dose of the Dolutegravir (DTG) 50 mg plus RPV 25 mg, once daily as oral regimen on Day 1 until Month 12 in the current study. These participants were not eligible for the LTFU phase.
Number of Participants Who Permanently Discontinued Treatment Due to Adverse Events for CAB LA + RPV LA Q2M Arm up to End of Maintenance Phase	1 Participants	—

SECONDARY outcome

Timeframe: Up to Month 12 [Maintenance Phase]

Population: Safety Population

Outcome measures

Outcome measures
Measure	CAB LA + RPV LA Q2M n=7 Participants Eligible participants from LAI116482 (NCT01641809 \[LATTE\]) study who were administered oral CAB 30 milligrams (mg) plus RPV 25 mg and who successfully completed Week 300 received their first dose CAB LA (600 mg) plus RPV LA (900 mg) injections within 2 hours of the final oral dose of LATTE given on the same day. The second loading injections were administered 1 month after initial loading dose, with subsequent injections (CAB LA 600 mg + RPV LA 900 mg) occurring Q2M thereafter. Participants continued to receive the treatment until the study intervention was locally approved and commercially available. Participants who received at least one dose of CAB LA and/or RPV LA and discontinued the CAB LA + RPV LA regimen for any reason entered a 52-week long-term follow-up (LTFU) Phase.	DTG + RPV Eligible participants from LAI116482 (NCT01641809 \[LATTE\]) study who were administered oral CAB 30 mg plus RPV 25 mg and who successfully completed Week 300 received their first dose of the Dolutegravir (DTG) 50 mg plus RPV 25 mg, once daily as oral regimen on Day 1 until Month 12 in the current study. These participants were not eligible for the LTFU phase.
Number of Participants Who Permanently Discontinued Treatment Due to Adverse Events for DTG + RPV Arm up to Month 12 [Maintenance Phase]	0 Participants	—

SECONDARY outcome

Timeframe: Up to End of LTFU Phase (compared with Baseline [Day1]), (approximately up to 12 months after exiting the Maintenance Phase)

Population: Safety Population. Only those participants with data available at the specified data points were analyzed.

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.

Outcome measures

Outcome measures
Measure	CAB LA + RPV LA Q2M n=90 Participants Eligible participants from LAI116482 (NCT01641809 \[LATTE\]) study who were administered oral CAB 30 milligrams (mg) plus RPV 25 mg and who successfully completed Week 300 received their first dose CAB LA (600 mg) plus RPV LA (900 mg) injections within 2 hours of the final oral dose of LATTE given on the same day. The second loading injections were administered 1 month after initial loading dose, with subsequent injections (CAB LA 600 mg + RPV LA 900 mg) occurring Q2M thereafter. Participants continued to receive the treatment until the study intervention was locally approved and commercially available. Participants who received at least one dose of CAB LA and/or RPV LA and discontinued the CAB LA + RPV LA regimen for any reason entered a 52-week long-term follow-up (LTFU) Phase.	DTG + RPV n=6 Participants Eligible participants from LAI116482 (NCT01641809 \[LATTE\]) study who were administered oral CAB 30 mg plus RPV 25 mg and who successfully completed Week 300 received their first dose of the Dolutegravir (DTG) 50 mg plus RPV 25 mg, once daily as oral regimen on Day 1 until Month 12 in the current study. These participants were not eligible for the LTFU phase.
Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Creatinine Kinase for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase ALT, Month 2	-1.1 International units per liter Standard Deviation 16.99	—
Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Creatinine Kinase for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase ALT, Month 4	-1.0 International units per liter Standard Deviation 26.15	—
Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Creatinine Kinase for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase ALT, Month 8	0.0 International units per liter Standard Deviation 29.86	—
Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Creatinine Kinase for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase ALT, Month 12	4.0 International units per liter Standard Deviation 44.62	—
Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Creatinine Kinase for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase ALT, Month 14	-7.5 International units per liter Standard Deviation 61.52	—
Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Creatinine Kinase for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase ALT, Month 16	-2.5 International units per liter Standard Deviation 24.07	—
Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Creatinine Kinase for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase ALT, Month 20	-3.4 International units per liter Standard Deviation 18.61	—
Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Creatinine Kinase for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase ALT, Month 24	-3.0 International units per liter Standard Deviation 17.53	—
Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Creatinine Kinase for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase ALT, Month 26	-21.7 International units per liter Standard Deviation 49.26	—
Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Creatinine Kinase for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase ALT, Month 28	1.0 International units per liter Standard Deviation 31.18	—
Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Creatinine Kinase for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase ALT, Month 30	11.2 International units per liter Standard Deviation 49.09	—
Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Creatinine Kinase for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase ALT, Month 32	-0.9 International units per liter Standard Deviation 18.02	—
Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Creatinine Kinase for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase ALT, Month 34	-7.0 International units per liter Standard Deviation 30.17	—
Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Creatinine Kinase for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase ALT, Month 36	0.2 International units per liter Standard Deviation 18.90	—
Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Creatinine Kinase for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase ALT, Month 38	2.5 International units per liter Standard Deviation 4.95	—
Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Creatinine Kinase for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase ALT, Month 40	-1.7 International units per liter Standard Deviation 19.97	—
Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Creatinine Kinase for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase ALT, Month 42	-1.5 International units per liter Standard Deviation 6.36	—
Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Creatinine Kinase for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase ALT, Month 44	-0.5 International units per liter Standard Deviation 14.51	—
Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Creatinine Kinase for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase ALT, Month 46	0.5 International units per liter Standard Deviation 3.79	—
Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Creatinine Kinase for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase ALT, Month 48	-2.6 International units per liter Standard Deviation 11.38	—
Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Creatinine Kinase for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase ALT, Month 50	-4.5 International units per liter Standard Deviation 7.78	—
Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Creatinine Kinase for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase ALT, Month 52	-3.5 International units per liter Standard Deviation 13.62	—
Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Creatinine Kinase for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase ALT, LTFU Month 1	—	-5.0 International units per liter Standard Deviation 7.07
Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Creatinine Kinase for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase ALT, LTFU Month 3	—	2.8 International units per liter Standard Deviation 29.93
Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Creatinine Kinase for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase ALT, LTFU Month 6	—	-7.7 International units per liter Standard Deviation 48.87
Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Creatinine Kinase for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase ALT, LTFU Month 9	—	-6.0 International units per liter Standard Deviation 15.17
Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Creatinine Kinase for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase ALT, LTFU Month 12	—	0.2 International units per liter Standard Deviation 54.36
Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Creatinine Kinase for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase ALP, Month 2	0.2 International units per liter Standard Deviation 8.29	—
Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Creatinine Kinase for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase ALP, Month 4	0.2 International units per liter Standard Deviation 14.20	—
Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Creatinine Kinase for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase ALP, Month 8	2.0 International units per liter Standard Deviation 11.58	—
Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Creatinine Kinase for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase ALP, Month 12	2.1 International units per liter Standard Deviation 12.39	—
Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Creatinine Kinase for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase ALP, Month 14	-15.5 International units per liter Standard Deviation 33.23	—
Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Creatinine Kinase for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase ALP, Month 16	1.7 International units per liter Standard Deviation 10.83	—
Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Creatinine Kinase for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase ALP, Month 20	5.5 International units per liter Standard Deviation 11.50	—
Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Creatinine Kinase for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase ALP, Month 24	2.3 International units per liter Standard Deviation 12.64	—
Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Creatinine Kinase for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase ALP, Month 26	-2.2 International units per liter Standard Deviation 23.09	—
Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Creatinine Kinase for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase ALP, Month 28	1.0 International units per liter Standard Deviation 12.89	—
Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Creatinine Kinase for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase ALP, Month 30	2.3 International units per liter Standard Deviation 19.06	—
Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Creatinine Kinase for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase ALP, Month 32	2.4 International units per liter Standard Deviation 11.79	—
Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Creatinine Kinase for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase ALP, Month 34	0.4 International units per liter Standard Deviation 10.26	—
Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Creatinine Kinase for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase ALP, Month 36	3.3 International units per liter Standard Deviation 9.81	—
Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Creatinine Kinase for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase ALP, Month 38	-10.0 International units per liter Standard Deviation 14.14	—
Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Creatinine Kinase for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase ALP, Month 40	5.7 International units per liter Standard Deviation 14.32	—
Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Creatinine Kinase for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase ALP, Month 42	7.0 International units per liter Standard Deviation 2.83	—
Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Creatinine Kinase for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase ALP, Month 44	5.3 International units per liter Standard Deviation 16.34	—
Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Creatinine Kinase for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase ALP, Month 46	1.8 International units per liter Standard Deviation 7.89	—
Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Creatinine Kinase for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase ALP, Month 48	3.3 International units per liter Standard Deviation 12.21	—
Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Creatinine Kinase for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase ALP, Month 50	10.5 International units per liter Standard Deviation 2.12	—
Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Creatinine Kinase for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase ALP, Month 52	-2.5 International units per liter Standard Deviation 7.12	—
Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Creatinine Kinase for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase ALP, LTFU Month 1	—	-3.6 International units per liter Standard Deviation 19.24
Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Creatinine Kinase for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase ALP, LTFU Month 3	—	-10.3 International units per liter Standard Deviation 23.91
Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Creatinine Kinase for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase ALP, LTFU Month 6	—	-5.0 International units per liter Standard Deviation 24.71
Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Creatinine Kinase for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase ALP, LTFU Month 9	—	-5.7 International units per liter Standard Deviation 18.28
Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Creatinine Kinase for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase ALP, LTFU Month 12	—	0.0 International units per liter Standard Deviation 26.31
Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Creatinine Kinase for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase AST, Month 2	-5.6 International units per liter Standard Deviation 47.9	—
Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Creatinine Kinase for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase AST, Month 4	-5.0 International units per liter Standard Deviation 50.5	—
Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Creatinine Kinase for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase AST, Month 8	-5.3 International units per liter Standard Deviation 49.56	—
Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Creatinine Kinase for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase AST, Month 12	-2.7 International units per liter Standard Deviation 54.93	—
Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Creatinine Kinase for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase AST, Month 14	0.0 International units per liter Standard Deviation 16.97	—
Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Creatinine Kinase for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase AST, Month 16	-5.1 International units per liter Standard Deviation 51.27	—
Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Creatinine Kinase for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase AST, Month 20	-7.5 International units per liter Standard Deviation 49.83	—
Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Creatinine Kinase for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase AST, Month 24	-7.2 International units per liter Standard Deviation 50.49	—
Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Creatinine Kinase for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase AST, Month 26	-11.5 International units per liter Standard Deviation 15.35	—
Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Creatinine Kinase for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase AST, Month 28	-7.3 International units per liter Standard Deviation 57.53	—
Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Creatinine Kinase for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase AST, Month 30	3.3 International units per liter Standard Deviation 29.38	—
Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Creatinine Kinase for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase AST, Month 32	-6.7 International units per liter Standard Deviation 51.96	—
Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Creatinine Kinase for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase AST, Month 34	-6.4 International units per liter Standard Deviation 16.56	—
Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Creatinine Kinase for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase AST, Month 36	-5.0 International units per liter Standard Deviation 54.45	—
Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Creatinine Kinase for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase AST, Month 38	-2.0 International units per liter Standard Deviation 7.07	—
Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Creatinine Kinase for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase AST, Month 40	-8.4 International units per liter Standard Deviation 52.46	—
Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Creatinine Kinase for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase AST, Month 42	-0.5 International units per liter Standard Deviation 3.54	—
Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Creatinine Kinase for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase AST, Month 44	-2.0 International units per liter Standard Deviation 9.01	—
Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Creatinine Kinase for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase AST, Month 46	-4.3 International units per liter Standard Deviation 3.59	—
Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Creatinine Kinase for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase AST, Month 48	-3.0 International units per liter Standard Deviation 8.02	—
Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Creatinine Kinase for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase AST, Month 50	-4.5 International units per liter Standard Deviation 3.54	—
Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Creatinine Kinase for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase AST, Month 52	-6.0 International units per liter Standard Deviation 7.90	—
Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Creatinine Kinase for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase AST, LTFU Month 1	—	3.6 International units per liter Standard Deviation 18.68
Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Creatinine Kinase for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase AST, LTFU Month 3	—	8.5 International units per liter Standard Deviation 4.51
Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Creatinine Kinase for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase AST, LTFU Month 9	—	1.5 International units per liter Standard Deviation 6.86
Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Creatinine Kinase for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase AST, LTFU Month 12	—	14.6 International units per liter Standard Deviation 41.38
Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Creatinine Kinase for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Creatine kinase, Month 2	-255.2 International units per liter Standard Deviation 2327.32	—
Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Creatinine Kinase for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Creatine kinase, Month 4	-204.0 International units per liter Standard Deviation 2483.41	—
Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Creatinine Kinase for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Creatine kinase, Month 8	-237.0 International units per liter Standard Deviation 2362.99	—
Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Creatinine Kinase for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Creatine kinase, Month 12	-252.0 International units per liter Standard Deviation 2429.86	—
Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Creatinine Kinase for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Creatine kinase, Month 14	120.0 International units per liter Standard Deviation NA Standard Deviation (SD) could not be calculated for a single participant.	—
Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Creatinine Kinase for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Creatine kinase, Month 16	-245.1 International units per liter Standard Deviation 2421.43	—
Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Creatinine Kinase for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Creatine kinase, Month 20	-292.8 International units per liter Standard Deviation 2390.38	—
Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Creatinine Kinase for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Creatine kinase, Month 24	-290.0 International units per liter Standard Deviation 2435.94	—
Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Creatinine Kinase for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Creatine kinase, Month 26	-44.0 International units per liter Standard Deviation 115.53	—
Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Creatinine Kinase for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Creatine kinase, Month 28	-393.7 International units per liter Standard Deviation 2738.54	—
Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Creatinine Kinase for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Creatine kinase, Month 30	-33.2 International units per liter Standard Deviation 238.35	—
Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Creatinine Kinase for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Creatine kinase, Month 32	-276.7 International units per liter Standard Deviation 2518.73	—
Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Creatinine Kinase for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Creatine kinase, Month 34	-17.0 International units per liter Standard Deviation 173.27	—
Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Creatinine Kinase for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Creatine kinase, Month 36	-318.6 International units per liter Standard Deviation 2488.91	—
Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Creatinine Kinase for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Creatine kinase, Month 38	-21.0 International units per liter Standard Deviation 32.53	—
Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Creatinine Kinase for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Creatine kinase, Month 40	-341.7 International units per liter Standard Deviation 2552.60	—
Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Creatinine Kinase for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Creatine kinase, Month 42	30.5 International units per liter Standard Deviation 31.82	—
Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Creatinine Kinase for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Creatine kinase, Month 44	-15.9 International units per liter Standard Deviation 463.41	—
Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Creatinine Kinase for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Creatine kinase, Month 46	6.0 International units per liter Standard Deviation 50.28	—
Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Creatinine Kinase for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Creatine kinase, Month 48	1.0 International units per liter Standard Deviation 140.26	—
Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Creatinine Kinase for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Creatine kinase, Month 50	-136.5 International units per liter Standard Deviation 178.90	—
Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Creatinine Kinase for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Creatine kinase, Month 52	-67.7 International units per liter Standard Deviation 84.29	—
Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Creatinine Kinase for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Creatine kinase, LTFU Month 1	—	-18.0 International units per liter Standard Deviation 21.76
Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Creatinine Kinase for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Creatine kinase, LTFU Month 3	—	81.3 International units per liter Standard Deviation 245.69
Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Creatinine Kinase for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Creatine kinase, LTFU Month 6	—	50.8 International units per liter Standard Deviation 157.89
Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Creatinine Kinase for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Creatine kinase, LTFU Month 9	—	-8.8 International units per liter Standard Deviation 88.04
Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Creatinine Kinase for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Creatine kinase, LTFU Month 12	—	844.2 International units per liter Standard Deviation 1731.52
Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Creatinine Kinase for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase AST, LTFU Month 6	—	1.5 International units per liter Standard Deviation 12.82

SECONDARY outcome

Timeframe: At Months 3, 6, 9 and 12 (compared with Baseline [Day 1]) [Maintenance Phase]

Population: Safety Population

Outcome measures

Outcome measures
Measure	CAB LA + RPV LA Q2M n=7 Participants Eligible participants from LAI116482 (NCT01641809 \[LATTE\]) study who were administered oral CAB 30 milligrams (mg) plus RPV 25 mg and who successfully completed Week 300 received their first dose CAB LA (600 mg) plus RPV LA (900 mg) injections within 2 hours of the final oral dose of LATTE given on the same day. The second loading injections were administered 1 month after initial loading dose, with subsequent injections (CAB LA 600 mg + RPV LA 900 mg) occurring Q2M thereafter. Participants continued to receive the treatment until the study intervention was locally approved and commercially available. Participants who received at least one dose of CAB LA and/or RPV LA and discontinued the CAB LA + RPV LA regimen for any reason entered a 52-week long-term follow-up (LTFU) Phase.	DTG + RPV Eligible participants from LAI116482 (NCT01641809 \[LATTE\]) study who were administered oral CAB 30 mg plus RPV 25 mg and who successfully completed Week 300 received their first dose of the Dolutegravir (DTG) 50 mg plus RPV 25 mg, once daily as oral regimen on Day 1 until Month 12 in the current study. These participants were not eligible for the LTFU phase.
Change From Baseline in Clinical Chemistry Parameters: ALT, ALP, AST and Creatinine Kinase for DTG + RPV Arm up to Month 12 [Maintenance Phase] ALT, Month 3	-0.7 International units per liter Standard Deviation 22.37	—
Change From Baseline in Clinical Chemistry Parameters: ALT, ALP, AST and Creatinine Kinase for DTG + RPV Arm up to Month 12 [Maintenance Phase] ALT, Month 6	-4.3 International units per liter Standard Deviation 19.99	—
Change From Baseline in Clinical Chemistry Parameters: ALT, ALP, AST and Creatinine Kinase for DTG + RPV Arm up to Month 12 [Maintenance Phase] ALT, Month 9	1.7 International units per liter Standard Deviation 8.16	—
Change From Baseline in Clinical Chemistry Parameters: ALT, ALP, AST and Creatinine Kinase for DTG + RPV Arm up to Month 12 [Maintenance Phase] ALT, Month 12	-0.3 International units per liter Standard Deviation 32.32	—
Change From Baseline in Clinical Chemistry Parameters: ALT, ALP, AST and Creatinine Kinase for DTG + RPV Arm up to Month 12 [Maintenance Phase] ALP, Month 3	1.4 International units per liter Standard Deviation 10.11	—
Change From Baseline in Clinical Chemistry Parameters: ALT, ALP, AST and Creatinine Kinase for DTG + RPV Arm up to Month 12 [Maintenance Phase] ALP, Month 6	1.6 International units per liter Standard Deviation 8.04	—
Change From Baseline in Clinical Chemistry Parameters: ALT, ALP, AST and Creatinine Kinase for DTG + RPV Arm up to Month 12 [Maintenance Phase] ALP, Month 9	-1.1 International units per liter Standard Deviation 11.74	—
Change From Baseline in Clinical Chemistry Parameters: ALT, ALP, AST and Creatinine Kinase for DTG + RPV Arm up to Month 12 [Maintenance Phase] ALP, Month 12	10.0 International units per liter Standard Deviation 33.16	—
Change From Baseline in Clinical Chemistry Parameters: ALT, ALP, AST and Creatinine Kinase for DTG + RPV Arm up to Month 12 [Maintenance Phase] AST, Month 3	-0.6 International units per liter Standard Deviation 10.61	—
Change From Baseline in Clinical Chemistry Parameters: ALT, ALP, AST and Creatinine Kinase for DTG + RPV Arm up to Month 12 [Maintenance Phase] AST, Month 6	-3.3 International units per liter Standard Deviation 7.30	—
Change From Baseline in Clinical Chemistry Parameters: ALT, ALP, AST and Creatinine Kinase for DTG + RPV Arm up to Month 12 [Maintenance Phase] AST, Month 9	-1.4 International units per liter Standard Deviation 6.68	—
Change From Baseline in Clinical Chemistry Parameters: ALT, ALP, AST and Creatinine Kinase for DTG + RPV Arm up to Month 12 [Maintenance Phase] AST, Month 12	-0.6 International units per liter Standard Deviation 14.68	—
Change From Baseline in Clinical Chemistry Parameters: ALT, ALP, AST and Creatinine Kinase for DTG + RPV Arm up to Month 12 [Maintenance Phase] Creatine kinase, Month 3	-66.6 International units per liter Standard Deviation 287.66	—
Change From Baseline in Clinical Chemistry Parameters: ALT, ALP, AST and Creatinine Kinase for DTG + RPV Arm up to Month 12 [Maintenance Phase] Creatine kinase, Month 6	-107.9 International units per liter Standard Deviation 112.18	—
Change From Baseline in Clinical Chemistry Parameters: ALT, ALP, AST and Creatinine Kinase for DTG + RPV Arm up to Month 12 [Maintenance Phase] Creatine kinase, Month 9	-90.6 International units per liter Standard Deviation 163.40	—
Change From Baseline in Clinical Chemistry Parameters: ALT, ALP, AST and Creatinine Kinase for DTG + RPV Arm up to Month 12 [Maintenance Phase] Creatine kinase, Month 12	-134.0 International units per liter Standard Deviation 149.59	—

SECONDARY outcome

Timeframe: Up to End of LTFU Phase (compared with Baseline [Day1]), (approximately up to 12 months after exiting the Maintenance Phase)

Population: Safety Population. Only those participants with data available at the specified data points were analyzed.

Blood samples were collected for the analysis of clinical chemical 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. SD=0.00 is defined as SD resulted below the detectable limit of the assay and approximate to 0.00.

Outcome measures

Outcome measures
Measure	CAB LA + RPV LA Q2M n=90 Participants Eligible participants from LAI116482 (NCT01641809 \[LATTE\]) study who were administered oral CAB 30 milligrams (mg) plus RPV 25 mg and who successfully completed Week 300 received their first dose CAB LA (600 mg) plus RPV LA (900 mg) injections within 2 hours of the final oral dose of LATTE given on the same day. The second loading injections were administered 1 month after initial loading dose, with subsequent injections (CAB LA 600 mg + RPV LA 900 mg) occurring Q2M thereafter. Participants continued to receive the treatment until the study intervention was locally approved and commercially available. Participants who received at least one dose of CAB LA and/or RPV LA and discontinued the CAB LA + RPV LA regimen for any reason entered a 52-week long-term follow-up (LTFU) Phase.	DTG + RPV n=6 Participants Eligible participants from LAI116482 (NCT01641809 \[LATTE\]) study who were administered oral CAB 30 mg plus RPV 25 mg and who successfully completed Week 300 received their first dose of the Dolutegravir (DTG) 50 mg plus RPV 25 mg, once daily as oral regimen on Day 1 until Month 12 in the current study. These participants were not eligible for the LTFU phase.
Change From Baseline in Clinical Chemistry Parameter: Albumin for CAB LA + RPV LA Q2M Arm up to LTFU Phase Month 2	-0.8 Grams per liter Standard Deviation 2.31	—
Change From Baseline in Clinical Chemistry Parameter: Albumin for CAB LA + RPV LA Q2M Arm up to LTFU Phase Month 4	-0.9 Grams per liter Standard Deviation 2.46	—
Change From Baseline in Clinical Chemistry Parameter: Albumin for CAB LA + RPV LA Q2M Arm up to LTFU Phase Month 8	-0.8 Grams per liter Standard Deviation 2.63	—
Change From Baseline in Clinical Chemistry Parameter: Albumin for CAB LA + RPV LA Q2M Arm up to LTFU Phase Month 12	-0.9 Grams per liter Standard Deviation 2.67	—
Change From Baseline in Clinical Chemistry Parameter: Albumin for CAB LA + RPV LA Q2M Arm up to LTFU Phase Month 14	2.0 Grams per liter Standard Deviation NA Standard deviation (SD) could not be calculated for a single participant.	—
Change From Baseline in Clinical Chemistry Parameter: Albumin for CAB LA + RPV LA Q2M Arm up to LTFU Phase Month 16	-0.7 Grams per liter Standard Deviation 2.81	—
Change From Baseline in Clinical Chemistry Parameter: Albumin for CAB LA + RPV LA Q2M Arm up to LTFU Phase Month 20	-0.3 Grams per liter Standard Deviation 2.47	—
Change From Baseline in Clinical Chemistry Parameter: Albumin for CAB LA + RPV LA Q2M Arm up to LTFU Phase Month 24	-0.8 Grams per liter Standard Deviation 2.98	—
Change From Baseline in Clinical Chemistry Parameter: Albumin for CAB LA + RPV LA Q2M Arm up to LTFU Phase Month 26	0.8 Grams per liter Standard Deviation 2.56	—
Change From Baseline in Clinical Chemistry Parameter: Albumin for CAB LA + RPV LA Q2M Arm up to LTFU Phase Month 28	-1.1 Grams per liter Standard Deviation 2.68	—
Change From Baseline in Clinical Chemistry Parameter: Albumin for CAB LA + RPV LA Q2M Arm up to LTFU Phase Month 30	-0.3 Grams per liter Standard Deviation 1.51	—
Change From Baseline in Clinical Chemistry Parameter: Albumin for CAB LA + RPV LA Q2M Arm up to LTFU Phase Month 32	-1.2 Grams per liter Standard Deviation 2.69	—
Change From Baseline in Clinical Chemistry Parameter: Albumin for CAB LA + RPV LA Q2M Arm up to LTFU Phase Month 34	-0.8 Grams per liter Standard Deviation 2.68	—
Change From Baseline in Clinical Chemistry Parameter: Albumin for CAB LA + RPV LA Q2M Arm up to LTFU Phase Month 36	-1.1 Grams per liter Standard Deviation 2.80	—
Change From Baseline in Clinical Chemistry Parameter: Albumin for CAB LA + RPV LA Q2M Arm up to LTFU Phase Month 38	-1.0 Grams per liter Standard Deviation 1.41	—
Change From Baseline in Clinical Chemistry Parameter: Albumin for CAB LA + RPV LA Q2M Arm up to LTFU Phase Month 40	-0.9 Grams per liter Standard Deviation 3.00	—
Change From Baseline in Clinical Chemistry Parameter: Albumin for CAB LA + RPV LA Q2M Arm up to LTFU Phase Month 42	-3.0 Grams per liter Standard Deviation 0.00	—
Change From Baseline in Clinical Chemistry Parameter: Albumin for CAB LA + RPV LA Q2M Arm up to LTFU Phase Month 44	-0.9 Grams per liter Standard Deviation 2.50	—
Change From Baseline in Clinical Chemistry Parameter: Albumin for CAB LA + RPV LA Q2M Arm up to LTFU Phase Month 46	-3.3 Grams per liter Standard Deviation 3.50	—
Change From Baseline in Clinical Chemistry Parameter: Albumin for CAB LA + RPV LA Q2M Arm up to LTFU Phase Month 48	-1.4 Grams per liter Standard Deviation 2.56	—
Change From Baseline in Clinical Chemistry Parameter: Albumin for CAB LA + RPV LA Q2M Arm up to LTFU Phase Month 50	-2.5 Grams per liter Standard Deviation 2.12	—
Change From Baseline in Clinical Chemistry Parameter: Albumin for CAB LA + RPV LA Q2M Arm up to LTFU Phase Month 52	-1.0 Grams per liter Standard Deviation 2.00	—
Change From Baseline in Clinical Chemistry Parameter: Albumin for CAB LA + RPV LA Q2M Arm up to LTFU Phase LTFU Month 1	—	-3.4 Grams per liter Standard Deviation 2.88
Change From Baseline in Clinical Chemistry Parameter: Albumin for CAB LA + RPV LA Q2M Arm up to LTFU Phase LTFU Month 3	—	-1.5 Grams per liter Standard Deviation 1.29
Change From Baseline in Clinical Chemistry Parameter: Albumin for CAB LA + RPV LA Q2M Arm up to LTFU Phase LTFU Month 6	—	-3.0 Grams per liter Standard Deviation 3.22
Change From Baseline in Clinical Chemistry Parameter: Albumin for CAB LA + RPV LA Q2M Arm up to LTFU Phase LTFU Month 9	—	-2.8 Grams per liter Standard Deviation 3.06
Change From Baseline in Clinical Chemistry Parameter: Albumin for CAB LA + RPV LA Q2M Arm up to LTFU Phase LTFU Month 12	—	-3.2 Grams per liter Standard Deviation 2.05

SECONDARY outcome

Timeframe: At Months 3, 6, 9 and 12 (compared with Baseline [Day 1]) [Maintenance Phase]

Population: Safety Population

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.

Outcome measures

Outcome measures
Measure	CAB LA + RPV LA Q2M n=7 Participants Eligible participants from LAI116482 (NCT01641809 \[LATTE\]) study who were administered oral CAB 30 milligrams (mg) plus RPV 25 mg and who successfully completed Week 300 received their first dose CAB LA (600 mg) plus RPV LA (900 mg) injections within 2 hours of the final oral dose of LATTE given on the same day. The second loading injections were administered 1 month after initial loading dose, with subsequent injections (CAB LA 600 mg + RPV LA 900 mg) occurring Q2M thereafter. Participants continued to receive the treatment until the study intervention was locally approved and commercially available. Participants who received at least one dose of CAB LA and/or RPV LA and discontinued the CAB LA + RPV LA regimen for any reason entered a 52-week long-term follow-up (LTFU) Phase.	DTG + RPV Eligible participants from LAI116482 (NCT01641809 \[LATTE\]) study who were administered oral CAB 30 mg plus RPV 25 mg and who successfully completed Week 300 received their first dose of the Dolutegravir (DTG) 50 mg plus RPV 25 mg, once daily as oral regimen on Day 1 until Month 12 in the current study. These participants were not eligible for the LTFU phase.
Change From Baseline in Clinical Chemistry Parameter: Albumin for DTG+ RPV Arm up to Month 12 [Maintenance Phase] Month 3	-1.6 Grams per liter Standard Deviation 3.87	—
Change From Baseline in Clinical Chemistry Parameter: Albumin for DTG+ RPV Arm up to Month 12 [Maintenance Phase] Month 6	-1.4 Grams per liter Standard Deviation 2.30	—
Change From Baseline in Clinical Chemistry Parameter: Albumin for DTG+ RPV Arm up to Month 12 [Maintenance Phase] Month 9	-1.3 Grams per liter Standard Deviation 2.63	—
Change From Baseline in Clinical Chemistry Parameter: Albumin for DTG+ RPV Arm up to Month 12 [Maintenance Phase] Month 12	-2.6 Grams per liter Standard Deviation 2.37	—

SECONDARY outcome

Timeframe: Up to End of LTFU Phase (compared with Baseline [Day1]), (approximately up to 12 months after exiting the Maintenance Phase)

Population: Safety Population. Only those participants with data available at the specified data points were analyzed.

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.

Outcome measures

Outcome measures
Measure	CAB LA + RPV LA Q2M n=90 Participants Eligible participants from LAI116482 (NCT01641809 \[LATTE\]) study who were administered oral CAB 30 milligrams (mg) plus RPV 25 mg and who successfully completed Week 300 received their first dose CAB LA (600 mg) plus RPV LA (900 mg) injections within 2 hours of the final oral dose of LATTE given on the same day. The second loading injections were administered 1 month after initial loading dose, with subsequent injections (CAB LA 600 mg + RPV LA 900 mg) occurring Q2M thereafter. Participants continued to receive the treatment until the study intervention was locally approved and commercially available. Participants who received at least one dose of CAB LA and/or RPV LA and discontinued the CAB LA + RPV LA regimen for any reason entered a 52-week long-term follow-up (LTFU) Phase.	DTG + RPV n=6 Participants Eligible participants from LAI116482 (NCT01641809 \[LATTE\]) study who were administered oral CAB 30 mg plus RPV 25 mg and who successfully completed Week 300 received their first dose of the Dolutegravir (DTG) 50 mg plus RPV 25 mg, once daily as oral regimen on Day 1 until Month 12 in the current study. These participants were not eligible for the LTFU phase.
Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Bilirubin, Month 2	-1.0 Micromoles per liter Standard Deviation 4.33	—
Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Bilirubin, Month 4	-1.0 Micromoles per liter Standard Deviation 5.14	—
Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Bilirubin, Month 8	-1.0 Micromoles per liter Standard Deviation 4.83	—
Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Bilirubin, Month 12	-0.5 Micromoles per liter Standard Deviation 4.35	—
Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Bilirubin, Month 14	2.0 Micromoles per liter Standard Deviation 8.49	—
Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Bilirubin, Month 16	-1.0 Micromoles per liter Standard Deviation 4.99	—
Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Bilirubin, Month 20	-1.4 Micromoles per liter Standard Deviation 3.76	—
Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Bilirubin, Month 24	-0.8 Micromoles per liter Standard Deviation 5.16	—
Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Bilirubin, Month 26	0.0 Micromoles per liter Standard Deviation 4.56	—
Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Bilirubin, Month 28	-0.9 Micromoles per liter Standard Deviation 3.36	—
Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Bilirubin, Month 30	2.0 Micromoles per liter Standard Deviation 3.58	—
Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Bilirubin, Month 32	-1.0 Micromoles per liter Standard Deviation 5.40	—
Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Bilirubin, Month 34	0.0 Micromoles per liter Standard Deviation 7.07	—
Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Bilirubin, Month 36	-0.4 Micromoles per liter Standard Deviation 4.02	—
Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Bilirubin, Month 38	-2.0 Micromoles per liter Standard Deviation 2.83	—
Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Bilirubin, Month 40	-1.6 Micromoles per liter Standard Deviation 4.87	—
Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Bilirubin, Month 42	-1.0 Micromoles per liter Standard Deviation 4.24	—
Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Bilirubin, Month 44	-0.9 Micromoles per liter Standard Deviation 4.36	—
Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Bilirubin, Month 46	-3.5 Micromoles per liter Standard Deviation 2.52	—
Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Bilirubin, Month 48	-1.7 Micromoles per liter Standard Deviation 3.92	—
Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Bilirubin, Month 50	1.0 Micromoles per liter Standard Deviation 1.41	—
Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Bilirubin, Month 52	-1.3 Micromoles per liter Standard Deviation 4.68	—
Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Bilirubin, LTFU Month 1	—	-3.2 Micromoles per liter Standard Deviation 5.76
Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Bilirubin, LTFU Month 3	—	1.5 Micromoles per liter Standard Deviation 7.72
Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Bilirubin, LTFU Month 6	—	1.3 Micromoles per liter Standard Deviation 9.27
Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Bilirubin, LTFU Month 9	—	1.0 Micromoles per liter Standard Deviation 9.10
Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Bilirubin, LTFU Month 12	—	-0.8 Micromoles per liter Standard Deviation 6.10
Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Creatinine, Month 2	-1.84 Micromoles per liter Standard Deviation 7.121	—
Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Creatinine, Month 4	-1.70 Micromoles per liter Standard Deviation 9.393	—
Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Creatinine, Month 8	-0.98 Micromoles per liter Standard Deviation 7.977	—
Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Creatinine, Month 10	-1.14 Micromoles per liter Standard Deviation 9.204	—
Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Creatinine, Month 14	-1.80 Micromoles per liter Standard Deviation NA Standard deviation (SD) could not be calculated for a single participant.	—
Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Creatinine, Month 16	1.15 Micromoles per liter Standard Deviation 9.508	—
Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Creatinine, Month 20	-0.50 Micromoles per liter Standard Deviation 9.569	—
Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Creatinine, Month 24	3.57 Micromoles per liter Standard Deviation 10.039	—
Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Creatinine, Month 26	1.03 Micromoles per liter Standard Deviation 9.423	—
Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Creatinine, Month 28	4.64 Micromoles per liter Standard Deviation 10.159	—
Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Creatinine, Month 30	9.87 Micromoles per liter Standard Deviation 8.190	—
Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Creatinine, Month 32	1.07 Micromoles per liter Standard Deviation 9.648	—
Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Creatinine, Month 34	1.06 Micromoles per liter Standard Deviation 8.331	—
Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Creatinine, Month 36	0.76 Micromoles per liter Standard Deviation 9.661	—
Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Creatinine, Month 38	0.27 Micromoles per liter Standard Deviation 4.007	—
Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Creatinine, Month 40	-2.71 Micromoles per liter Standard Deviation 8.065	—
Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Creatinine, Month 42	4.73 Micromoles per liter Standard Deviation 7.524	—
Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Creatinine, Month 44	0.11 Micromoles per liter Standard Deviation 11.223	—
Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Creatinine, Month 46	8.63 Micromoles per liter Standard Deviation 13.822	—
Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Creatinine, Month 48	0.01 Micromoles per liter Standard Deviation 9.828	—
Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Creatinine, Month 50	-3.50 Micromoles per liter Standard Deviation 4.950	—
Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Creatinine, Month 52	-2.50 Micromoles per liter Standard Deviation 16.393	—
Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Creatinine, LTFU Month 1	—	3.00 Micromoles per liter Standard Deviation 12.761
Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Creatinine, LTFU Month 3	—	13.48 Micromoles per liter Standard Deviation 9.469
Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Creatinine, LTFU Month 6	—	8.42 Micromoles per liter Standard Deviation 12.726
Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Creatinine, LTFU Month 9	—	6.65 Micromoles per liter Standard Deviation 7.731
Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Creatinine, LTFU Month 12	—	9.74 Micromoles per liter Standard Deviation 7.416

SECONDARY outcome

Timeframe: At Months 3, 6, 9 and 12 (compared with Baseline [Day 1]) [Maintenance Phase]

Population: Safety Population. Only those participants with data available at the specified data points were analyzed.

Outcome measures

Outcome measures
Measure	CAB LA + RPV LA Q2M n=7 Participants Eligible participants from LAI116482 (NCT01641809 \[LATTE\]) study who were administered oral CAB 30 milligrams (mg) plus RPV 25 mg and who successfully completed Week 300 received their first dose CAB LA (600 mg) plus RPV LA (900 mg) injections within 2 hours of the final oral dose of LATTE given on the same day. The second loading injections were administered 1 month after initial loading dose, with subsequent injections (CAB LA 600 mg + RPV LA 900 mg) occurring Q2M thereafter. Participants continued to receive the treatment until the study intervention was locally approved and commercially available. Participants who received at least one dose of CAB LA and/or RPV LA and discontinued the CAB LA + RPV LA regimen for any reason entered a 52-week long-term follow-up (LTFU) Phase.	DTG + RPV Eligible participants from LAI116482 (NCT01641809 \[LATTE\]) study who were administered oral CAB 30 mg plus RPV 25 mg and who successfully completed Week 300 received their first dose of the Dolutegravir (DTG) 50 mg plus RPV 25 mg, once daily as oral regimen on Day 1 until Month 12 in the current study. These participants were not eligible for the LTFU phase.
Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine for DTG+ RPV Arm up to Month 12 [Maintenance Phase] Bilirubin, Month 3	-1.7 Micromoles per liter Standard Deviation 4.23	—
Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine for DTG+ RPV Arm up to Month 12 [Maintenance Phase] Bilirubin, Month 6	-1.4 Micromoles per liter Standard Deviation 3.21	—
Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine for DTG+ RPV Arm up to Month 12 [Maintenance Phase] Bilirubin, Month 9	-0.9 Micromoles per liter Standard Deviation 2.54	—
Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine for DTG+ RPV Arm up to Month 12 [Maintenance Phase] Bilirubin, Month 12	-1.4 Micromoles per liter Standard Deviation 3.78	—
Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine for DTG+ RPV Arm up to Month 12 [Maintenance Phase] Creatinine, Month 3	11.89 Micromoles per liter Standard Deviation 8.89	—
Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine for DTG+ RPV Arm up to Month 12 [Maintenance Phase] Creatinine, Month 6	8.36 Micromoles per liter Standard Deviation 4.419	—
Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine for DTG+ RPV Arm up to Month 12 [Maintenance Phase] Creatinine, Month 9	16.56 Micromoles per liter Standard Deviation 10.131	—
Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine for DTG+ RPV Arm up to Month 12 [Maintenance Phase] Creatinine, Month 12	7.47 Micromoles per liter Standard Deviation 7.328	—

SECONDARY outcome

Timeframe: Up to End of LTFU Phase (compared with Baseline [Day1]), (approximately up to 12 months after exiting the Maintenance Phase)

Population: Safety Population. Only those participants with data available at the specified data points were analyzed.

Blood samples were collected for the analysis of clinical chemistry parameters: carbon dioxide, chloride, glucose, 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. SD=0.00(0) is defined as SD resulted below the detectable limit of the assay and approximate to 0.00(0).

Outcome measures

Outcome measures
Measure	CAB LA + RPV LA Q2M n=90 Participants Eligible participants from LAI116482 (NCT01641809 \[LATTE\]) study who were administered oral CAB 30 milligrams (mg) plus RPV 25 mg and who successfully completed Week 300 received their first dose CAB LA (600 mg) plus RPV LA (900 mg) injections within 2 hours of the final oral dose of LATTE given on the same day. The second loading injections were administered 1 month after initial loading dose, with subsequent injections (CAB LA 600 mg + RPV LA 900 mg) occurring Q2M thereafter. Participants continued to receive the treatment until the study intervention was locally approved and commercially available. Participants who received at least one dose of CAB LA and/or RPV LA and discontinued the CAB LA + RPV LA regimen for any reason entered a 52-week long-term follow-up (LTFU) Phase.	DTG + RPV n=6 Participants Eligible participants from LAI116482 (NCT01641809 \[LATTE\]) study who were administered oral CAB 30 mg plus RPV 25 mg and who successfully completed Week 300 received their first dose of the Dolutegravir (DTG) 50 mg plus RPV 25 mg, once daily as oral regimen on Day 1 until Month 12 in the current study. These participants were not eligible for the LTFU phase.
Change From Baseline in Clinical Chemistry Parameters: Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Urea, Month 32	0.14 Millimoles per liter Standard Deviation 1.419	—
Change From Baseline in Clinical Chemistry Parameters: Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Urea, Month 34	0.50 Millimoles per liter Standard Deviation 2.000	—
Change From Baseline in Clinical Chemistry Parameters: Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Urea, Month 36	0.22 Millimoles per liter Standard Deviation 1.393	—
Change From Baseline in Clinical Chemistry Parameters: Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Urea, Month 38	1.00 Millimoles per liter Standard Deviation 0.707	—
Change From Baseline in Clinical Chemistry Parameters: Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Urea, Month 40	0.27 Millimoles per liter Standard Deviation 1.390	—
Change From Baseline in Clinical Chemistry Parameters: Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Urea, Month 42	0.25 Millimoles per liter Standard Deviation 1.061	—
Change From Baseline in Clinical Chemistry Parameters: Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Urea, Month 44	0.34 Millimoles per liter Standard Deviation 1.475	—
Change From Baseline in Clinical Chemistry Parameters: Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Urea, Month 46	0.63 Millimoles per liter Standard Deviation 2.056	—
Change From Baseline in Clinical Chemistry Parameters: Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Carbon dioxide, Month 2	-0.4 Millimoles per liter Standard Deviation 1.86	—
Change From Baseline in Clinical Chemistry Parameters: Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Urea, Month 48	0.26 Millimoles per liter Standard Deviation 1.266	—
Change From Baseline in Clinical Chemistry Parameters: Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Carbon dioxide, Month 4	-0.1 Millimoles per liter Standard Deviation 2.00	—
Change From Baseline in Clinical Chemistry Parameters: Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Carbon dioxide, Month 8	-0.2 Millimoles per liter Standard Deviation 2.22	—
Change From Baseline in Clinical Chemistry Parameters: Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Carbon dioxide, Month 12	-0.7 Millimoles per liter Standard Deviation 2.18	—
Change From Baseline in Clinical Chemistry Parameters: Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Carbon dioxide, Month 14	2.0 Millimoles per liter Standard Deviation NA Standard deviation (SD) could not be calculated for a single participant.	—
Change From Baseline in Clinical Chemistry Parameters: Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Carbon dioxide, Month 16	0.3 Millimoles per liter Standard Deviation 2.25	—
Change From Baseline in Clinical Chemistry Parameters: Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Carbon dioxide, Month 20	-0.2 Millimoles per liter Standard Deviation 2.17	—
Change From Baseline in Clinical Chemistry Parameters: Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Carbon dioxide, Month 24	-0.6 Millimoles per liter Standard Deviation 2.12	—
Change From Baseline in Clinical Chemistry Parameters: Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Carbon dioxide, Month 26	1.7 Millimoles per liter Standard Deviation 3.27	—
Change From Baseline in Clinical Chemistry Parameters: Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Carbon dioxide, Month 28	0.3 Millimoles per liter Standard Deviation 2.61	—
Change From Baseline in Clinical Chemistry Parameters: Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Carbon dioxide, Month 30	1.7 Millimoles per liter Standard Deviation 2.73	—
Change From Baseline in Clinical Chemistry Parameters: Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Carbon dioxide, Month 32	0.4 Millimoles per liter Standard Deviation 2.43	—
Change From Baseline in Clinical Chemistry Parameters: Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Carbon dioxide, Month 34	0.4 Millimoles per liter Standard Deviation 3.13	—
Change From Baseline in Clinical Chemistry Parameters: Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Carbon dioxide, Month 36	0.5 Millimoles per liter Standard Deviation 2.46	—
Change From Baseline in Clinical Chemistry Parameters: Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Carbon dioxide, Month 38	1.0 Millimoles per liter Standard Deviation 1.41	—
Change From Baseline in Clinical Chemistry Parameters: Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Carbon dioxide, Month 40	1.1 Millimoles per liter Standard Deviation 2.63	—
Change From Baseline in Clinical Chemistry Parameters: Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Carbon dioxide, Month 42	0.5 Millimoles per liter Standard Deviation 0.71	—
Change From Baseline in Clinical Chemistry Parameters: Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Carbon dioxide, Month 44	0.7 Millimoles per liter Standard Deviation 2.61	—
Change From Baseline in Clinical Chemistry Parameters: Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Carbon dioxide, Month 46	0.0 Millimoles per liter Standard Deviation 3.74	—
Change From Baseline in Clinical Chemistry Parameters: Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Urea, Month 50	0.50 Millimoles per liter Standard Deviation 1.414	—
Change From Baseline in Clinical Chemistry Parameters: Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Carbon dioxide, Month 48	0.4 Millimoles per liter Standard Deviation 2.25	—
Change From Baseline in Clinical Chemistry Parameters: Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Carbon dioxide, Month 50	1.0 Millimoles per liter Standard Deviation 2.83	—
Change From Baseline in Clinical Chemistry Parameters: Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Carbon dioxide, Month 52	1.3 Millimoles per liter Standard Deviation 4.32	—
Change From Baseline in Clinical Chemistry Parameters: Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Urea, Month 52	-0.83 Millimoles per liter Standard Deviation 1.211	—
Change From Baseline in Clinical Chemistry Parameters: Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Carbon dioxide, LTFU Month 1	—	1.0 Millimoles per liter Standard Deviation 3.39
Change From Baseline in Clinical Chemistry Parameters: Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Carbon dioxide, LTFU Month 3	—	1.5 Millimoles per liter Standard Deviation 2.52
Change From Baseline in Clinical Chemistry Parameters: Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Carbon dioxide, LTFU Month 6	—	0.7 Millimoles per liter Standard Deviation 2.58
Change From Baseline in Clinical Chemistry Parameters: Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Carbon dioxide, LTFU Month 9	—	1.0 Millimoles per liter Standard Deviation 2.97
Change From Baseline in Clinical Chemistry Parameters: Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Carbon dioxide, LTFU Month 12	—	0.2 Millimoles per liter Standard Deviation 2.28
Change From Baseline in Clinical Chemistry Parameters: Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Chloride, Month 2	1.0 Millimoles per liter Standard Deviation 2.06	—
Change From Baseline in Clinical Chemistry Parameters: Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Chloride, Month 4	1.1 Millimoles per liter Standard Deviation 2.20	—
Change From Baseline in Clinical Chemistry Parameters: Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Chloride, Month 8	1.2 Millimoles per liter Standard Deviation 2.07	—
Change From Baseline in Clinical Chemistry Parameters: Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Chloride, Month 12	1.0 Millimoles per liter Standard Deviation 2.24	—
Change From Baseline in Clinical Chemistry Parameters: Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Chloride, Month 14	-5.0 Millimoles per liter Standard Deviation NA Standard deviation (SD) could not be calculated for a single participant.	—
Change From Baseline in Clinical Chemistry Parameters: Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Chloride, Month 16	0.3 Millimoles per liter Standard Deviation 2.27	—
Change From Baseline in Clinical Chemistry Parameters: Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Chloride, Month 20	0.5 Millimoles per liter Standard Deviation 2.52	—
Change From Baseline in Clinical Chemistry Parameters: Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Chloride, Month 24	0.3 Millimoles per liter Standard Deviation 2.56	—
Change From Baseline in Clinical Chemistry Parameters: Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Chloride, Month 26	-2.5 Millimoles per liter Standard Deviation 1.97	—
Change From Baseline in Clinical Chemistry Parameters: Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Chloride, Month 28	-0.3 Millimoles per liter Standard Deviation 2.42	—
Change From Baseline in Clinical Chemistry Parameters: Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Chloride, Month 30	-1.7 Millimoles per liter Standard Deviation 2.42	—
Change From Baseline in Clinical Chemistry Parameters: Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Chloride, Month 32	-0.4 Millimoles per liter Standard Deviation 2.31	—
Change From Baseline in Clinical Chemistry Parameters: Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Chloride, Month 34	-1.8 Millimoles per liter Standard Deviation 2.28	—
Change From Baseline in Clinical Chemistry Parameters: Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Chloride, Month 36	-0.5 Millimoles per liter Standard Deviation 2.24	—
Change From Baseline in Clinical Chemistry Parameters: Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Chloride, Month 38	1.0 Millimoles per liter Standard Deviation 0.00	—
Change From Baseline in Clinical Chemistry Parameters: Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Chloride, Month 40	-0.1 Millimoles per liter Standard Deviation 2.40	—
Change From Baseline in Clinical Chemistry Parameters: Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Chloride, Month 42	-2.0 Millimoles per liter Standard Deviation 4.24	—
Change From Baseline in Clinical Chemistry Parameters: Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Chloride, Month 44	0.1 Millimoles per liter Standard Deviation 2.18	—
Change From Baseline in Clinical Chemistry Parameters: Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Chloride, Month 46	0.5 Millimoles per liter Standard Deviation 2.65	—
Change From Baseline in Clinical Chemistry Parameters: Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Chloride, Month 48	-0.3 Millimoles per liter Standard Deviation 2.31	—
Change From Baseline in Clinical Chemistry Parameters: Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Chloride, Month 50	0.0 Millimoles per liter Standard Deviation 1.41	—
Change From Baseline in Clinical Chemistry Parameters: Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Chloride, Month 52	-0.2 Millimoles per liter Standard Deviation 2.32	—
Change From Baseline in Clinical Chemistry Parameters: Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Chloride, LTFU Month 1	—	0.6 Millimoles per liter Standard Deviation 3.91
Change From Baseline in Clinical Chemistry Parameters: Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Chloride, LTFU Month 3	—	-1.8 Millimoles per liter Standard Deviation 3.30
Change From Baseline in Clinical Chemistry Parameters: Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Chloride, LTFU Month 6	—	0.2 Millimoles per liter Standard Deviation 2.32
Change From Baseline in Clinical Chemistry Parameters: Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Chloride, LTFU Month 9	—	0.8 Millimoles per liter Standard Deviation 2.14
Change From Baseline in Clinical Chemistry Parameters: Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Chloride, LTFU Month 12	—	-0.2 Millimoles per liter Standard Deviation 2.28
Change From Baseline in Clinical Chemistry Parameters: Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Glucose, Month 2	0.32 Millimoles per liter Standard Deviation 0.568	—
Change From Baseline in Clinical Chemistry Parameters: Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Glucose, Month 4	0.42 Millimoles per liter Standard Deviation 0.684	—
Change From Baseline in Clinical Chemistry Parameters: Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Glucose, Month 8	0.47 Millimoles per liter Standard Deviation 0.842	—
Change From Baseline in Clinical Chemistry Parameters: Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Glucose, Month 12	0.32 Millimoles per liter Standard Deviation 0.662	—
Change From Baseline in Clinical Chemistry Parameters: Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Glucose, Month 14	-1.60 Millimoles per liter Standard Deviation NA Standard deviation (SD) could not be calculated for a single participant.	—
Change From Baseline in Clinical Chemistry Parameters: Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Glucose, Month 16	0.36 Millimoles per liter Standard Deviation 0.754	—
Change From Baseline in Clinical Chemistry Parameters: Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Glucose, Month 20	0.33 Millimoles per liter Standard Deviation 0.838	—
Change From Baseline in Clinical Chemistry Parameters: Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Glucose, Month 24	0.19 Millimoles per liter Standard Deviation 0.654	—
Change From Baseline in Clinical Chemistry Parameters: Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Glucose, Month 26	-0.17 Millimoles per liter Standard Deviation 1.457	—
Change From Baseline in Clinical Chemistry Parameters: Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Glucose, Month 28	0.30 Millimoles per liter Standard Deviation 0.694	—
Change From Baseline in Clinical Chemistry Parameters: Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Glucose, Month 30	-0.36 Millimoles per liter Standard Deviation 0.709	—
Change From Baseline in Clinical Chemistry Parameters: Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Glucose, Month 32	0.34 Millimoles per liter Standard Deviation 0.792	—
Change From Baseline in Clinical Chemistry Parameters: Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Glucose, Month 34	0.95 Millimoles per liter Standard Deviation 2.475	—
Change From Baseline in Clinical Chemistry Parameters: Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Glucose, Month 36	0.26 Millimoles per liter Standard Deviation 0.770	—
Change From Baseline in Clinical Chemistry Parameters: Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Glucose, Month 38	0.20 Millimoles per liter Standard Deviation 0.566	—
Change From Baseline in Clinical Chemistry Parameters: Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Glucose, Month 40	0.25 Millimoles per liter Standard Deviation 0.929	—
Change From Baseline in Clinical Chemistry Parameters: Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Glucose, Month 42	0.20 Millimoles per liter Standard Deviation NA Standard deviation (SD) could not be calculated for a single participant.	—
Change From Baseline in Clinical Chemistry Parameters: Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Glucose, Month 44	0.54 Millimoles per liter Standard Deviation 1.044	—
Change From Baseline in Clinical Chemistry Parameters: Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Glucose, Month 46	0.40 Millimoles per liter Standard Deviation 0.265	—
Change From Baseline in Clinical Chemistry Parameters: Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Glucose, Month 48	0.12 Millimoles per liter Standard Deviation 0.593	—
Change From Baseline in Clinical Chemistry Parameters: Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Glucose, Month 50	0.40 Millimoles per liter Standard Deviation 0.283	—
Change From Baseline in Clinical Chemistry Parameters: Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Glucose, Month 52	2.10 Millimoles per liter Standard Deviation NA Standard deviation (SD) could not be calculated for a single participant.	—
Change From Baseline in Clinical Chemistry Parameters: Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Glucose, LTFU Month 1	—	-0.37 Millimoles per liter Standard Deviation 0.058
Change From Baseline in Clinical Chemistry Parameters: Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Glucose, LTFU Month 3	—	-0.45 Millimoles per liter Standard Deviation 0.354
Change From Baseline in Clinical Chemistry Parameters: Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Glucose, LTFU Month 6	—	-0.40 Millimoles per liter Standard Deviation 0.627
Change From Baseline in Clinical Chemistry Parameters: Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Glucose, LTFU Month 9	—	0.02 Millimoles per liter Standard Deviation 0.259
Change From Baseline in Clinical Chemistry Parameters: Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Glucose, LTFU Month 12	—	-0.12 Millimoles per liter Standard Deviation 0.084
Change From Baseline in Clinical Chemistry Parameters: Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Phosphate, Month 2	-0.00 Millimoles per liter Standard Deviation 0.176	—
Change From Baseline in Clinical Chemistry Parameters: Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Phosphate, Month 4	-0.00 Millimoles per liter Standard Deviation 0.191	—
Change From Baseline in Clinical Chemistry Parameters: Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Phosphate, Month 8	-0.02 Millimoles per liter Standard Deviation 0.206	—
Change From Baseline in Clinical Chemistry Parameters: Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Phosphate, Month 12	-0.02 Millimoles per liter Standard Deviation 0.199	—
Change From Baseline in Clinical Chemistry Parameters: Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Phosphate, Month 14	0.25 Millimoles per liter Standard Deviation NA Standard deviation (SD) could not be calculated for a single participant.	—
Change From Baseline in Clinical Chemistry Parameters: Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Phosphate, Month 16	-0.02 Millimoles per liter Standard Deviation 0.199	—
Change From Baseline in Clinical Chemistry Parameters: Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Phosphate, Month 20	-0.00 Millimoles per liter Standard Deviation 0.227	—
Change From Baseline in Clinical Chemistry Parameters: Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Phosphate, Month 24	-0.01 Millimoles per liter Standard Deviation 0.198	—
Change From Baseline in Clinical Chemistry Parameters: Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Phosphate, Month 26	-0.14 Millimoles per liter Standard Deviation 0.206	—
Change From Baseline in Clinical Chemistry Parameters: Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Phosphate, Month 28	-0.05 Millimoles per liter Standard Deviation 0.216	—
Change From Baseline in Clinical Chemistry Parameters: Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Phosphate, Month 30	0.05 Millimoles per liter Standard Deviation 0.268	—
Change From Baseline in Clinical Chemistry Parameters: Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Phosphate, Month 32	-0.02 Millimoles per liter Standard Deviation 0.186	—
Change From Baseline in Clinical Chemistry Parameters: Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Phosphate, Month 34	-0.02 Millimoles per liter Standard Deviation 0.270	—
Change From Baseline in Clinical Chemistry Parameters: Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Phosphate, Month 36	-0.01 Millimoles per liter Standard Deviation 0.192	—
Change From Baseline in Clinical Chemistry Parameters: Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Phosphate, Month 38	-0.30 Millimoles per liter Standard Deviation 0.212	—
Change From Baseline in Clinical Chemistry Parameters: Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Phosphate, Month 40	0.00 Millimoles per liter Standard Deviation 0.214	—
Change From Baseline in Clinical Chemistry Parameters: Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Phosphate, Month 42	0.10 Millimoles per liter Standard Deviation 0.070	—
Change From Baseline in Clinical Chemistry Parameters: Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Phosphate, Month 44	0.00 Millimoles per liter Standard Deviation 0.201	—
Change From Baseline in Clinical Chemistry Parameters: Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Phosphate, Month 46	0.02 Millimoles per liter Standard Deviation 0.125	—
Change From Baseline in Clinical Chemistry Parameters: Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Phosphate, Month 48	0.01 Millimoles per liter Standard Deviation 0.192	—
Change From Baseline in Clinical Chemistry Parameters: Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Phosphate, Month 50	-0.20 Millimoles per liter Standard Deviation 0.141	—
Change From Baseline in Clinical Chemistry Parameters: Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Phosphate, Month 52	-0.22 Millimoles per liter Standard Deviation 0.216	—
Change From Baseline in Clinical Chemistry Parameters: Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Phosphate, LTFU Month 1	—	-0.03 Millimoles per liter Standard Deviation 0.222
Change From Baseline in Clinical Chemistry Parameters: Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Phosphate, LTFU Month 3	—	0.11 Millimoles per liter Standard Deviation 0.225
Change From Baseline in Clinical Chemistry Parameters: Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Phosphate, LTFU Month 6	—	-0.02 Millimoles per liter Standard Deviation 0.175
Change From Baseline in Clinical Chemistry Parameters: Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Phosphate, LTFU Month 9	—	-0.05 Millimoles per liter Standard Deviation 0.165
Change From Baseline in Clinical Chemistry Parameters: Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Phosphate, LTFU Month 12	—	0.11 Millimoles per liter Standard Deviation 0.143
Change From Baseline in Clinical Chemistry Parameters: Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Potassium, Month 2	0.06 Millimoles per liter Standard Deviation 0.392	—
Change From Baseline in Clinical Chemistry Parameters: Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Potassium, Month 4	-0.02 Millimoles per liter Standard Deviation 0.450	—
Change From Baseline in Clinical Chemistry Parameters: Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Potassium, Month 8	0.05 Millimoles per liter Standard Deviation 0.408	—
Change From Baseline in Clinical Chemistry Parameters: Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Potassium, Month 12	0.06 Millimoles per liter Standard Deviation 0.375	—
Change From Baseline in Clinical Chemistry Parameters: Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Potassium, Month 14	0.00 Millimoles per liter Standard Deviation NA Standard deviation (SD) could not be calculated for a single participant.	—
Change From Baseline in Clinical Chemistry Parameters: Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Potassium, Month 16	0.00 Millimoles per liter Standard Deviation 0.339	—
Change From Baseline in Clinical Chemistry Parameters: Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Potassium, Month 20	0.01 Millimoles per liter Standard Deviation 0.374	—
Change From Baseline in Clinical Chemistry Parameters: Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Potassium, Month 24	-0.04 Millimoles per liter Standard Deviation 0.384	—
Change From Baseline in Clinical Chemistry Parameters: Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Potassium, Month 26	0.10 Millimoles per liter Standard Deviation 0.228	—
Change From Baseline in Clinical Chemistry Parameters: Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Potassium, Month 28	-0.09 Millimoles per liter Standard Deviation 0.388	—
Change From Baseline in Clinical Chemistry Parameters: Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Potassium, Month 30	0.08 Millimoles per liter Standard Deviation 0.293	—
Change From Baseline in Clinical Chemistry Parameters: Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Potassium, Month 32	0.00 Millimoles per liter Standard Deviation 0.432	—
Change From Baseline in Clinical Chemistry Parameters: Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Potassium, Month 34	0.18 Millimoles per liter Standard Deviation 0.370	—
Change From Baseline in Clinical Chemistry Parameters: Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Potassium, Month 36	-0.06 Millimoles per liter Standard Deviation 0.411	—
Change From Baseline in Clinical Chemistry Parameters: Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Potassium, Month 38	0.35 Millimoles per liter Standard Deviation 0.354	—
Change From Baseline in Clinical Chemistry Parameters: Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Potassium, Month 40	-0.06 Millimoles per liter Standard Deviation 0.420	—
Change From Baseline in Clinical Chemistry Parameters: Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Potassium, Month 42	-0.10 Millimoles per liter Standard Deviation 0.424	—
Change From Baseline in Clinical Chemistry Parameters: Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Potassium, Month 44	-0.04 Millimoles per liter Standard Deviation 0.406	—
Change From Baseline in Clinical Chemistry Parameters: Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Potassium, Month 46	-0.20 Millimoles per liter Standard Deviation 0.455	—
Change From Baseline in Clinical Chemistry Parameters: Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Potassium, Month 48	-0.01 Millimoles per liter Standard Deviation 0.374	—
Change From Baseline in Clinical Chemistry Parameters: Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Potassium, Month 50	0.00 Millimoles per liter Standard Deviation 0.000	—
Change From Baseline in Clinical Chemistry Parameters: Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Potassium, Month 52	0.17 Millimoles per liter Standard Deviation 0.589	—
Change From Baseline in Clinical Chemistry Parameters: Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Potassium, LTFU Month 1	—	0.04 Millimoles per liter Standard Deviation 0.313
Change From Baseline in Clinical Chemistry Parameters: Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Potassium, LTFU Month 3	—	0.10 Millimoles per liter Standard Deviation 0.606
Change From Baseline in Clinical Chemistry Parameters: Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Potassium, LTFU Month 6	—	0.13 Millimoles per liter Standard Deviation 0.501
Change From Baseline in Clinical Chemistry Parameters: Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Potassium, LTFU Month 9	—	0.17 Millimoles per liter Standard Deviation 0.873
Change From Baseline in Clinical Chemistry Parameters: Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Potassium, LTFU Month 12	—	0.10 Millimoles per liter Standard Deviation 0.212
Change From Baseline in Clinical Chemistry Parameters: Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Sodium, Month 2	0.2 Millimoles per liter Standard Deviation 1.84	—
Change From Baseline in Clinical Chemistry Parameters: Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Sodium, Month 4	0.6 Millimoles per liter Standard Deviation 2.10	—
Change From Baseline in Clinical Chemistry Parameters: Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Sodium, Month 8	0.6 Millimoles per liter Standard Deviation 1.96	—
Change From Baseline in Clinical Chemistry Parameters: Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Sodium, Month 12	0.2 Millimoles per liter Standard Deviation 1.88	—
Change From Baseline in Clinical Chemistry Parameters: Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Sodium, Month 14	-3.0 Millimoles per liter Standard Deviation NA Standard deviation (SD) could not be calculated for a single participant.	—
Change From Baseline in Clinical Chemistry Parameters: Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Sodium, Month 16	0.5 Millimoles per liter Standard Deviation 2.02	—
Change From Baseline in Clinical Chemistry Parameters: Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Sodium, Month 20	0.4 Millimoles per liter Standard Deviation 1.96	—
Change From Baseline in Clinical Chemistry Parameters: Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Sodium, Month 24	0.5 Millimoles per liter Standard Deviation 1.84	—
Change From Baseline in Clinical Chemistry Parameters: Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Sodium, Month 26	0.2 Millimoles per liter Standard Deviation 2.32	—
Change From Baseline in Clinical Chemistry Parameters: Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Sodium, Month 28	0.3 Millimoles per liter Standard Deviation 2.12	—
Change From Baseline in Clinical Chemistry Parameters: Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Sodium, Month 30	-0.8 Millimoles per liter Standard Deviation 2.14	—
Change From Baseline in Clinical Chemistry Parameters: Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Sodium, Month 32	0.4 Millimoles per liter Standard Deviation 2.09	—
Change From Baseline in Clinical Chemistry Parameters: Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Sodium, Month 34	-0.6 Millimoles per liter Standard Deviation 4.72	—
Change From Baseline in Clinical Chemistry Parameters: Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Sodium, Month 36	-0.1 Millimoles per liter Standard Deviation 2.26	—
Change From Baseline in Clinical Chemistry Parameters: Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Sodium, Month 38	1.0 Millimoles per liter Standard Deviation 0.00	—
Change From Baseline in Clinical Chemistry Parameters: Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Sodium, Month 40	-0.1 Millimoles per liter Standard Deviation 2.11	—
Change From Baseline in Clinical Chemistry Parameters: Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Sodium, Month 42	-1.0 Millimoles per liter Standard Deviation 1.41	—
Change From Baseline in Clinical Chemistry Parameters: Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Sodium, Month 44	0.2 Millimoles per liter Standard Deviation 2.35	—
Change From Baseline in Clinical Chemistry Parameters: Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Sodium, Month 46	0.0 Millimoles per liter Standard Deviation 2.94	—
Change From Baseline in Clinical Chemistry Parameters: Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Sodium, Month 48	0.1 Millimoles per liter Standard Deviation 1.86	—
Change From Baseline in Clinical Chemistry Parameters: Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Sodium, Month 50	1.0 Millimoles per liter Standard Deviation 1.41	—
Change From Baseline in Clinical Chemistry Parameters: Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Sodium, Month 52	2.5 Millimoles per liter Standard Deviation 3.15	—
Change From Baseline in Clinical Chemistry Parameters: Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Sodium, LTFU Month 1	—	1.0 Millimoles per liter Standard Deviation 1.22
Change From Baseline in Clinical Chemistry Parameters: Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Sodium, LTFU Month 3	—	-0.5 Millimoles per liter Standard Deviation 1.91
Change From Baseline in Clinical Chemistry Parameters: Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Sodium, LTFU Month 6	—	0.2 Millimoles per liter Standard Deviation 0.75
Change From Baseline in Clinical Chemistry Parameters: Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Sodium, LTFU Month 9	—	0.2 Millimoles per liter Standard Deviation 0.75
Change From Baseline in Clinical Chemistry Parameters: Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Sodium, LTFU Month 12	—	-0.4 Millimoles per liter Standard Deviation 0.89
Change From Baseline in Clinical Chemistry Parameters: Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Urea, Month 2	0.13 Millimoles per liter Standard Deviation 1.253	—
Change From Baseline in Clinical Chemistry Parameters: Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Urea, Month 4	-0.06 Millimoles per liter Standard Deviation 1.346	—
Change From Baseline in Clinical Chemistry Parameters: Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Urea, Month 8	0.28 Millimoles per liter Standard Deviation 1.131	—
Change From Baseline in Clinical Chemistry Parameters: Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Urea, Month 12	-0.11 Millimoles per liter Standard Deviation 1.318	—
Change From Baseline in Clinical Chemistry Parameters: Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Urea, Month 14	-0.50 Millimoles per liter Standard Deviation NA Standard deviation (SD) could not be calculated for a single participant.	—
Change From Baseline in Clinical Chemistry Parameters: Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Urea, Month 16	0.13 Millimoles per liter Standard Deviation 1.444	—
Change From Baseline in Clinical Chemistry Parameters: Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Urea, Month 20	0.17 Millimoles per liter Standard Deviation 1.332	—
Change From Baseline in Clinical Chemistry Parameters: Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Urea, Month 24	0.15 Millimoles per liter Standard Deviation 1.474	—
Change From Baseline in Clinical Chemistry Parameters: Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Urea, Month 26	-0.92 Millimoles per liter Standard Deviation 0.736	—
Change From Baseline in Clinical Chemistry Parameters: Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Urea, Month 28	-0.01 Millimoles per liter Standard Deviation 1.628	—
Change From Baseline in Clinical Chemistry Parameters: Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Urea, Month 30	0.17 Millimoles per liter Standard Deviation 1.941	—
Change From Baseline in Clinical Chemistry Parameters: Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Urea, LTFU Month 1	—	-0.80 Millimoles per liter Standard Deviation 0.758
Change From Baseline in Clinical Chemistry Parameters: Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Urea, LTFU Month 3	—	0.25 Millimoles per liter Standard Deviation 0.866
Change From Baseline in Clinical Chemistry Parameters: Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Urea, LTFU Month 6	—	-1.08 Millimoles per liter Standard Deviation 0.861
Change From Baseline in Clinical Chemistry Parameters: Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Urea, LTFU Month 9	—	-0.17 Millimoles per liter Standard Deviation 1.291
Change From Baseline in Clinical Chemistry Parameters: Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Urea, LTFU Month 12	—	-0.30 Millimoles per liter Standard Deviation 0.671

SECONDARY outcome

Timeframe: At Months 3, 6, 9 and 12 (compared with Baseline [Day 1]) [Maintenance Phase]

Population: Safety Population. Only those participants with data available at the specified data points were analyzed.

Outcome measures

Outcome measures
Measure	CAB LA + RPV LA Q2M n=7 Participants Eligible participants from LAI116482 (NCT01641809 \[LATTE\]) study who were administered oral CAB 30 milligrams (mg) plus RPV 25 mg and who successfully completed Week 300 received their first dose CAB LA (600 mg) plus RPV LA (900 mg) injections within 2 hours of the final oral dose of LATTE given on the same day. The second loading injections were administered 1 month after initial loading dose, with subsequent injections (CAB LA 600 mg + RPV LA 900 mg) occurring Q2M thereafter. Participants continued to receive the treatment until the study intervention was locally approved and commercially available. Participants who received at least one dose of CAB LA and/or RPV LA and discontinued the CAB LA + RPV LA regimen for any reason entered a 52-week long-term follow-up (LTFU) Phase.	DTG + RPV Eligible participants from LAI116482 (NCT01641809 \[LATTE\]) study who were administered oral CAB 30 mg plus RPV 25 mg and who successfully completed Week 300 received their first dose of the Dolutegravir (DTG) 50 mg plus RPV 25 mg, once daily as oral regimen on Day 1 until Month 12 in the current study. These participants were not eligible for the LTFU phase.
Change From Baseline in Clinical Chemistry Parameters: Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for DTG + RPV Arm up to Month 12 [Maintenance Phase] Carbon dioxide, Month 3	-1.0 Millimoles per liter Standard Deviation 1.53	—
Change From Baseline in Clinical Chemistry Parameters: Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for DTG + RPV Arm up to Month 12 [Maintenance Phase] Carbon dioxide, Month 6	-1.7 Millimoles per liter Standard Deviation 1.50	—
Change From Baseline in Clinical Chemistry Parameters: Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for DTG + RPV Arm up to Month 12 [Maintenance Phase] Carbon dioxide, Month 9	-1.9 Millimoles per liter Standard Deviation 2.85	—
Change From Baseline in Clinical Chemistry Parameters: Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for DTG + RPV Arm up to Month 12 [Maintenance Phase] Carbon dioxide, Month 12	-1.9 Millimoles per liter Standard Deviation 2.48	—
Change From Baseline in Clinical Chemistry Parameters: Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for DTG + RPV Arm up to Month 12 [Maintenance Phase] Chloride, Month 3	1.0 Millimoles per liter Standard Deviation 1.83	—
Change From Baseline in Clinical Chemistry Parameters: Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for DTG + RPV Arm up to Month 12 [Maintenance Phase] Chloride, Month 6	1.7 Millimoles per liter Standard Deviation 2.14	—
Change From Baseline in Clinical Chemistry Parameters: Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for DTG + RPV Arm up to Month 12 [Maintenance Phase] Chloride, Month 9	1.0 Millimoles per liter Standard Deviation 0.82	—
Change From Baseline in Clinical Chemistry Parameters: Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for DTG + RPV Arm up to Month 12 [Maintenance Phase] Chloride, Month 12	1.0 Millimoles per liter Standard Deviation 2.08	—
Change From Baseline in Clinical Chemistry Parameters: Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for DTG + RPV Arm up to Month 12 [Maintenance Phase] Glucose, Month 3	0.08 Millimoles per liter Standard Deviation 0.259	—
Change From Baseline in Clinical Chemistry Parameters: Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for DTG + RPV Arm up to Month 12 [Maintenance Phase] Glucose, Month 6	0.16 Millimoles per liter Standard Deviation 0.483	—
Change From Baseline in Clinical Chemistry Parameters: Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for DTG + RPV Arm up to Month 12 [Maintenance Phase] Glucose, Month 9	0.15 Millimoles per liter Standard Deviation 0.700	—
Change From Baseline in Clinical Chemistry Parameters: Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for DTG + RPV Arm up to Month 12 [Maintenance Phase] Glucose, Month 12	0.07 Millimoles per liter Standard Deviation 0.55	—
Change From Baseline in Clinical Chemistry Parameters: Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for DTG + RPV Arm up to Month 12 [Maintenance Phase] Phosphate, Month 3	0.02 Millimoles per liter Standard Deviation 0.131	—
Change From Baseline in Clinical Chemistry Parameters: Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for DTG + RPV Arm up to Month 12 [Maintenance Phase] Phosphate, Month 6	0.08 Millimoles per liter Standard Deviation 0.177	—
Change From Baseline in Clinical Chemistry Parameters: Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for DTG + RPV Arm up to Month 12 [Maintenance Phase] Phosphate, Month 9	0.05 Millimoles per liter Standard Deviation 0.178	—
Change From Baseline in Clinical Chemistry Parameters: Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for DTG + RPV Arm up to Month 12 [Maintenance Phase] Phosphate, Month 12	-0.05 Millimoles per liter Standard Deviation 0.101	—
Change From Baseline in Clinical Chemistry Parameters: Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for DTG + RPV Arm up to Month 12 [Maintenance Phase] Potassium, Month 3	-0.26 Millimoles per liter Standard Deviation 0.378	—
Change From Baseline in Clinical Chemistry Parameters: Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for DTG + RPV Arm up to Month 12 [Maintenance Phase] Potassium, Month 6	-0.03 Millimoles per liter Standard Deviation 0.250	—
Change From Baseline in Clinical Chemistry Parameters: Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for DTG + RPV Arm up to Month 12 [Maintenance Phase] Potassium, Month 9	0.01 Millimoles per liter Standard Deviation 0.135	—
Change From Baseline in Clinical Chemistry Parameters: Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for DTG + RPV Arm up to Month 12 [Maintenance Phase] Potassium, Month 12	-0.06 Millimoles per liter Standard Deviation 0.257	—
Change From Baseline in Clinical Chemistry Parameters: Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for DTG + RPV Arm up to Month 12 [Maintenance Phase] Sodium, Month 3	0.1 Millimoles per liter Standard Deviation 1.68	—
Change From Baseline in Clinical Chemistry Parameters: Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for DTG + RPV Arm up to Month 12 [Maintenance Phase] Sodium, Month 6	-0.9 Millimoles per liter Standard Deviation 0.90	—
Change From Baseline in Clinical Chemistry Parameters: Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for DTG + RPV Arm up to Month 12 [Maintenance Phase] Sodium, Month 9	-1.0 Millimoles per liter Standard Deviation 2.58	—
Change From Baseline in Clinical Chemistry Parameters: Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for DTG + RPV Arm up to Month 12 [Maintenance Phase] Sodium, Month 12	-1.1 Millimoles per liter Standard Deviation 1.07	—
Change From Baseline in Clinical Chemistry Parameters: Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for DTG + RPV Arm up to Month 12 [Maintenance Phase] Urea, Month 3	1.43 Millimoles per liter Standard Deviation 0.732	—
Change From Baseline in Clinical Chemistry Parameters: Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for DTG + RPV Arm up to Month 12 [Maintenance Phase] Urea, Month 6	1.14 Millimoles per liter Standard Deviation 1.144	—
Change From Baseline in Clinical Chemistry Parameters: Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for DTG + RPV Arm up to Month 12 [Maintenance Phase] Urea, Month 9	1.86 Millimoles per liter Standard Deviation 1.994	—
Change From Baseline in Clinical Chemistry Parameters: Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for DTG + RPV Arm up to Month 12 [Maintenance Phase] Urea, Month 12	0.71 Millimoles per liter Standard Deviation 0.756	—

SECONDARY outcome

Timeframe: Up to End of LTFU Phase (compared with Baseline [Day1]), (approximately up to 12 months after exiting the Maintenance Phase)

Population: Safety Population. Only those participants with data available at the specified data points were analyzed.

Blood samples were collected for the analysis of clinical chemistry parameters: cholesterol, direct high density lipoprotein cholesterol, LDL cholesterol calculation, direct low density lipoprotein cholesterol 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.

Outcome measures

Outcome measures
Measure	CAB LA + RPV LA Q2M n=90 Participants Eligible participants from LAI116482 (NCT01641809 \[LATTE\]) study who were administered oral CAB 30 milligrams (mg) plus RPV 25 mg and who successfully completed Week 300 received their first dose CAB LA (600 mg) plus RPV LA (900 mg) injections within 2 hours of the final oral dose of LATTE given on the same day. The second loading injections were administered 1 month after initial loading dose, with subsequent injections (CAB LA 600 mg + RPV LA 900 mg) occurring Q2M thereafter. Participants continued to receive the treatment until the study intervention was locally approved and commercially available. Participants who received at least one dose of CAB LA and/or RPV LA and discontinued the CAB LA + RPV LA regimen for any reason entered a 52-week long-term follow-up (LTFU) Phase.	DTG + RPV n=6 Participants Eligible participants from LAI116482 (NCT01641809 \[LATTE\]) study who were administered oral CAB 30 mg plus RPV 25 mg and who successfully completed Week 300 received their first dose of the Dolutegravir (DTG) 50 mg plus RPV 25 mg, once daily as oral regimen on Day 1 until Month 12 in the current study. These participants were not eligible for the LTFU phase.
Change From Baseline in Clinical Chemistry Parameters: Cholesterol, High Density Lipoprotein, Cholesterol Direct, Low Density Lipoprotein Cholesterol Calculation, and Cholesterol Direct, Triglycerides for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Cholesterol, Month 12	0.12 Millimoles per liter Standard Deviation 0.760	—
Change From Baseline in Clinical Chemistry Parameters: Cholesterol, High Density Lipoprotein, Cholesterol Direct, Low Density Lipoprotein Cholesterol Calculation, and Cholesterol Direct, Triglycerides for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Cholesterol, Month 24	0.13 Millimoles per liter Standard Deviation 0.849	—
Change From Baseline in Clinical Chemistry Parameters: Cholesterol, High Density Lipoprotein, Cholesterol Direct, Low Density Lipoprotein Cholesterol Calculation, and Cholesterol Direct, Triglycerides for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Cholesterol, Month 26	0.48 Millimoles per liter Standard Deviation 0.569	—
Change From Baseline in Clinical Chemistry Parameters: Cholesterol, High Density Lipoprotein, Cholesterol Direct, Low Density Lipoprotein Cholesterol Calculation, and Cholesterol Direct, Triglycerides for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Cholesterol, Month 28	0.00 Millimoles per liter Standard Deviation 0.906	—
Change From Baseline in Clinical Chemistry Parameters: Cholesterol, High Density Lipoprotein, Cholesterol Direct, Low Density Lipoprotein Cholesterol Calculation, and Cholesterol Direct, Triglycerides for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Cholesterol, Month 30	0.07 Millimoles per liter Standard Deviation 1.378	—
Change From Baseline in Clinical Chemistry Parameters: Cholesterol, High Density Lipoprotein, Cholesterol Direct, Low Density Lipoprotein Cholesterol Calculation, and Cholesterol Direct, Triglycerides for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Cholesterol, Month 32	-0.87 Millimoles per liter Standard Deviation 0.601	—
Change From Baseline in Clinical Chemistry Parameters: Cholesterol, High Density Lipoprotein, Cholesterol Direct, Low Density Lipoprotein Cholesterol Calculation, and Cholesterol Direct, Triglycerides for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Cholesterol, Month 34	0.67 Millimoles per liter Standard Deviation 1.378	—
Change From Baseline in Clinical Chemistry Parameters: Cholesterol, High Density Lipoprotein, Cholesterol Direct, Low Density Lipoprotein Cholesterol Calculation, and Cholesterol Direct, Triglycerides for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Cholesterol, Month 40	-0.85 Millimoles per liter Standard Deviation 0.804	—
Change From Baseline in Clinical Chemistry Parameters: Cholesterol, High Density Lipoprotein, Cholesterol Direct, Low Density Lipoprotein Cholesterol Calculation, and Cholesterol Direct, Triglycerides for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Cholesterol, Month 44	0.27 Millimoles per liter Standard Deviation 0.106	—
Change From Baseline in Clinical Chemistry Parameters: Cholesterol, High Density Lipoprotein, Cholesterol Direct, Low Density Lipoprotein Cholesterol Calculation, and Cholesterol Direct, Triglycerides for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Cholesterol, Month 46	-0.10 Millimoles per liter Standard Deviation NA Standard deviation (SD) could not be calculated for a single participant.	—
Change From Baseline in Clinical Chemistry Parameters: Cholesterol, High Density Lipoprotein, Cholesterol Direct, Low Density Lipoprotein Cholesterol Calculation, and Cholesterol Direct, Triglycerides for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Cholesterol, Month 48	-0.15 Millimoles per liter Standard Deviation 0.070	—
Change From Baseline in Clinical Chemistry Parameters: Cholesterol, High Density Lipoprotein, Cholesterol Direct, Low Density Lipoprotein Cholesterol Calculation, and Cholesterol Direct, Triglycerides for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Cholesterol, LTFU Month 1	—	-0.87 Millimoles per liter Standard Deviation 1.097
Change From Baseline in Clinical Chemistry Parameters: Cholesterol, High Density Lipoprotein, Cholesterol Direct, Low Density Lipoprotein Cholesterol Calculation, and Cholesterol Direct, Triglycerides for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Cholesterol, LTFU Month 12	—	-0.68 Millimoles per liter Standard Deviation 1.362
Change From Baseline in Clinical Chemistry Parameters: Cholesterol, High Density Lipoprotein, Cholesterol Direct, Low Density Lipoprotein Cholesterol Calculation, and Cholesterol Direct, Triglycerides for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Direct HDL cholesterol, Month 12	-0.05 Millimoles per liter Standard Deviation 0.224	—
Change From Baseline in Clinical Chemistry Parameters: Cholesterol, High Density Lipoprotein, Cholesterol Direct, Low Density Lipoprotein Cholesterol Calculation, and Cholesterol Direct, Triglycerides for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Direct HDL cholesterol, Month 24	-0.02 Millimoles per liter Standard Deviation 0.230	—
Change From Baseline in Clinical Chemistry Parameters: Cholesterol, High Density Lipoprotein, Cholesterol Direct, Low Density Lipoprotein Cholesterol Calculation, and Cholesterol Direct, Triglycerides for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Direct HDL cholesterol, Month 26	-0.05 Millimoles per liter Standard Deviation 0.154	—
Change From Baseline in Clinical Chemistry Parameters: Cholesterol, High Density Lipoprotein, Cholesterol Direct, Low Density Lipoprotein Cholesterol Calculation, and Cholesterol Direct, Triglycerides for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Direct HDL cholesterol, Month 28	-0.05 Millimoles per liter Standard Deviation 0.241	—
Change From Baseline in Clinical Chemistry Parameters: Cholesterol, High Density Lipoprotein, Cholesterol Direct, Low Density Lipoprotein Cholesterol Calculation, and Cholesterol Direct, Triglycerides for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Direct HDL cholesterol, Month 30	0.25 Millimoles per liter Standard Deviation 0.141	—
Change From Baseline in Clinical Chemistry Parameters: Cholesterol, High Density Lipoprotein, Cholesterol Direct, Low Density Lipoprotein Cholesterol Calculation, and Cholesterol Direct, Triglycerides for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Direct HDL cholesterol, Month 32	-0.20 Millimoles per liter Standard Deviation 0.353	—
Change From Baseline in Clinical Chemistry Parameters: Cholesterol, High Density Lipoprotein, Cholesterol Direct, Low Density Lipoprotein Cholesterol Calculation, and Cholesterol Direct, Triglycerides for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Direct HDL cholesterol, Month 34	-0.07 Millimoles per liter Standard Deviation 0.247	—
Change From Baseline in Clinical Chemistry Parameters: Cholesterol, High Density Lipoprotein, Cholesterol Direct, Low Density Lipoprotein Cholesterol Calculation, and Cholesterol Direct, Triglycerides for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Direct HDL cholesterol, Month 40	0.08 Millimoles per liter Standard Deviation 0.368	—
Change From Baseline in Clinical Chemistry Parameters: Cholesterol, High Density Lipoprotein, Cholesterol Direct, Low Density Lipoprotein Cholesterol Calculation, and Cholesterol Direct, Triglycerides for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Direct HDL cholesterol, Month 44	-0.27 Millimoles per liter Standard Deviation 0.247	—
Change From Baseline in Clinical Chemistry Parameters: Cholesterol, High Density Lipoprotein, Cholesterol Direct, Low Density Lipoprotein Cholesterol Calculation, and Cholesterol Direct, Triglycerides for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Direct HDL cholesterol, Month 46	-0.35 Millimoles per liter Standard Deviation NA Standard deviation (SD) could not be calculated for a single participant.	—
Change From Baseline in Clinical Chemistry Parameters: Cholesterol, High Density Lipoprotein, Cholesterol Direct, Low Density Lipoprotein Cholesterol Calculation, and Cholesterol Direct, Triglycerides for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Direct HDL cholesterol, Month 48	-0.20 Millimoles per liter Standard Deviation 0.212	—
Change From Baseline in Clinical Chemistry Parameters: Cholesterol, High Density Lipoprotein, Cholesterol Direct, Low Density Lipoprotein Cholesterol Calculation, and Cholesterol Direct, Triglycerides for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Direct HDL cholesterol, LTFU Month 1	—	-0.18 Millimoles per liter Standard Deviation 0.213
Change From Baseline in Clinical Chemistry Parameters: Cholesterol, High Density Lipoprotein, Cholesterol Direct, Low Density Lipoprotein Cholesterol Calculation, and Cholesterol Direct, Triglycerides for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Direct HDL cholesterol, LTFU Month 12	—	-0.04 Millimoles per liter Standard Deviation 0.290
Change From Baseline in Clinical Chemistry Parameters: Cholesterol, High Density Lipoprotein, Cholesterol Direct, Low Density Lipoprotein Cholesterol Calculation, and Cholesterol Direct, Triglycerides for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase LDL cholesterol calculation, Month 12	0.10 Millimoles per liter Standard Deviation 0.718	—
Change From Baseline in Clinical Chemistry Parameters: Cholesterol, High Density Lipoprotein, Cholesterol Direct, Low Density Lipoprotein Cholesterol Calculation, and Cholesterol Direct, Triglycerides for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase LDL cholesterol calculation, Month 24	0.14 Millimoles per liter Standard Deviation 0.823	—
Change From Baseline in Clinical Chemistry Parameters: Cholesterol, High Density Lipoprotein, Cholesterol Direct, Low Density Lipoprotein Cholesterol Calculation, and Cholesterol Direct, Triglycerides for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase LDL cholesterol calculation, Month 26	0.73 Millimoles per liter Standard Deviation 0.613	—
Change From Baseline in Clinical Chemistry Parameters: Cholesterol, High Density Lipoprotein, Cholesterol Direct, Low Density Lipoprotein Cholesterol Calculation, and Cholesterol Direct, Triglycerides for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase LDL cholesterol calculation, Month 28	0.06 Millimoles per liter Standard Deviation 0.913	—
Change From Baseline in Clinical Chemistry Parameters: Cholesterol, High Density Lipoprotein, Cholesterol Direct, Low Density Lipoprotein Cholesterol Calculation, and Cholesterol Direct, Triglycerides for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase LDL cholesterol calculation, Month 30	0.31 Millimoles per liter Standard Deviation 2.128	—
Change From Baseline in Clinical Chemistry Parameters: Cholesterol, High Density Lipoprotein, Cholesterol Direct, Low Density Lipoprotein Cholesterol Calculation, and Cholesterol Direct, Triglycerides for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase LDL cholesterol calculation, Month 32	-0.30 Millimoles per liter Standard Deviation 0.502	—
Change From Baseline in Clinical Chemistry Parameters: Cholesterol, High Density Lipoprotein, Cholesterol Direct, Low Density Lipoprotein Cholesterol Calculation, and Cholesterol Direct, Triglycerides for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase LDL cholesterol calculation, Month 34	0.95 Millimoles per liter Standard Deviation 1.286	—
Change From Baseline in Clinical Chemistry Parameters: Cholesterol, High Density Lipoprotein, Cholesterol Direct, Low Density Lipoprotein Cholesterol Calculation, and Cholesterol Direct, Triglycerides for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase LDL cholesterol calculation, Month 40	-0.91 Millimoles per liter Standard Deviation 0.202	—
Change From Baseline in Clinical Chemistry Parameters: Cholesterol, High Density Lipoprotein, Cholesterol Direct, Low Density Lipoprotein Cholesterol Calculation, and Cholesterol Direct, Triglycerides for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase LDL cholesterol calculation, Month 44	-0.18 Millimoles per liter Standard Deviation 0.530	—
Change From Baseline in Clinical Chemistry Parameters: Cholesterol, High Density Lipoprotein, Cholesterol Direct, Low Density Lipoprotein Cholesterol Calculation, and Cholesterol Direct, Triglycerides for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase LDL cholesterol calculation, Month 46	0.05 Millimoles per liter Standard Deviation NA Standard deviation (SD) could not be calculated for a single participant.	—
Change From Baseline in Clinical Chemistry Parameters: Cholesterol, High Density Lipoprotein, Cholesterol Direct, Low Density Lipoprotein Cholesterol Calculation, and Cholesterol Direct, Triglycerides for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase LDL cholesterol calculation, Month 48	-0.03 Millimoles per liter Standard Deviation 0.311	—
Change From Baseline in Clinical Chemistry Parameters: Cholesterol, High Density Lipoprotein, Cholesterol Direct, Low Density Lipoprotein Cholesterol Calculation, and Cholesterol Direct, Triglycerides for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase LDL cholesterol calculation, LTFU Month 1	—	-0.55 Millimoles per liter Standard Deviation 0.989
Change From Baseline in Clinical Chemistry Parameters: Cholesterol, High Density Lipoprotein, Cholesterol Direct, Low Density Lipoprotein Cholesterol Calculation, and Cholesterol Direct, Triglycerides for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase LDL cholesterol calculation, LTFU Month 12	—	-0.34 Millimoles per liter Standard Deviation 1.510
Change From Baseline in Clinical Chemistry Parameters: Cholesterol, High Density Lipoprotein, Cholesterol Direct, Low Density Lipoprotein Cholesterol Calculation, and Cholesterol Direct, Triglycerides for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Direct LDL cholesterol, Month 12	0.21 Millimoles per liter Standard Deviation 0.367	—
Change From Baseline in Clinical Chemistry Parameters: Cholesterol, High Density Lipoprotein, Cholesterol Direct, Low Density Lipoprotein Cholesterol Calculation, and Cholesterol Direct, Triglycerides for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Direct LDL cholesterol, Month 24	-0.23 Millimoles per liter Standard Deviation NA Standard deviation (SD) could not be calculated for a single participant.	—
Change From Baseline in Clinical Chemistry Parameters: Cholesterol, High Density Lipoprotein, Cholesterol Direct, Low Density Lipoprotein Cholesterol Calculation, and Cholesterol Direct, Triglycerides for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Triglycerides, Month 12	0.28 Millimoles per liter Standard Deviation 1.965	—
Change From Baseline in Clinical Chemistry Parameters: Cholesterol, High Density Lipoprotein, Cholesterol Direct, Low Density Lipoprotein Cholesterol Calculation, and Cholesterol Direct, Triglycerides for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Triglycerides, Month 24	0.20 Millimoles per liter Standard Deviation 1.071	—
Change From Baseline in Clinical Chemistry Parameters: Cholesterol, High Density Lipoprotein, Cholesterol Direct, Low Density Lipoprotein Cholesterol Calculation, and Cholesterol Direct, Triglycerides for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Triglycerides, Month 26	-0.20 Millimoles per liter Standard Deviation 0.888	—
Change From Baseline in Clinical Chemistry Parameters: Cholesterol, High Density Lipoprotein, Cholesterol Direct, Low Density Lipoprotein Cholesterol Calculation, and Cholesterol Direct, Triglycerides for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Triglycerides, Month 28	-0.02 Millimoles per liter Standard Deviation 0.705	—
Change From Baseline in Clinical Chemistry Parameters: Cholesterol, High Density Lipoprotein, Cholesterol Direct, Low Density Lipoprotein Cholesterol Calculation, and Cholesterol Direct, Triglycerides for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Triglycerides, Month 30	-1.06 Millimoles per liter Standard Deviation 1.329	—
Change From Baseline in Clinical Chemistry Parameters: Cholesterol, High Density Lipoprotein, Cholesterol Direct, Low Density Lipoprotein Cholesterol Calculation, and Cholesterol Direct, Triglycerides for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Triglycerides, Month 32	-0.80 Millimoles per liter Standard Deviation 0.989	—
Change From Baseline in Clinical Chemistry Parameters: Cholesterol, High Density Lipoprotein, Cholesterol Direct, Low Density Lipoprotein Cholesterol Calculation, and Cholesterol Direct, Triglycerides for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Triglycerides, Month 34	-0.43 Millimoles per liter Standard Deviation 0.353	—
Change From Baseline in Clinical Chemistry Parameters: Cholesterol, High Density Lipoprotein, Cholesterol Direct, Low Density Lipoprotein Cholesterol Calculation, and Cholesterol Direct, Triglycerides for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Triglycerides, Month 40	-0.04 Millimoles per liter Standard Deviation 1.724	—
Change From Baseline in Clinical Chemistry Parameters: Cholesterol, High Density Lipoprotein, Cholesterol Direct, Low Density Lipoprotein Cholesterol Calculation, and Cholesterol Direct, Triglycerides for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Triglycerides, Month 44	1.61 Millimoles per liter Standard Deviation 0.834	—
Change From Baseline in Clinical Chemistry Parameters: Cholesterol, High Density Lipoprotein, Cholesterol Direct, Low Density Lipoprotein Cholesterol Calculation, and Cholesterol Direct, Triglycerides for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Triglycerides, Month 46	0.44 Millimoles per liter Standard Deviation NA Standard deviation (SD) could not be calculated for a single participant.	—
Change From Baseline in Clinical Chemistry Parameters: Cholesterol, High Density Lipoprotein, Cholesterol Direct, Low Density Lipoprotein Cholesterol Calculation, and Cholesterol Direct, Triglycerides for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Triglycerides, Month 48	0.18 Millimoles per liter Standard Deviation 0.056	—
Change From Baseline in Clinical Chemistry Parameters: Cholesterol, High Density Lipoprotein, Cholesterol Direct, Low Density Lipoprotein Cholesterol Calculation, and Cholesterol Direct, Triglycerides for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Triglycerides, LTFU Month 1	—	-0.29 Millimoles per liter Standard Deviation 0.834
Change From Baseline in Clinical Chemistry Parameters: Cholesterol, High Density Lipoprotein, Cholesterol Direct, Low Density Lipoprotein Cholesterol Calculation, and Cholesterol Direct, Triglycerides for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Triglycerides, LTFU Month 12	—	-0.64 Millimoles per liter Standard Deviation 1.088

SECONDARY outcome

Timeframe: At Baseline (Day 1)

Population: Safety Population. Only those participants with data available at the specified data points were analyzed.

Blood samples were collected for the analysis of clinical chemistry parameters: cholesterol, HDL cholesterol direct, LDL cholesterol calculation, LDL cholesterol direct and triglycerides.

Outcome measures

Outcome measures
Measure	CAB LA + RPV LA Q2M n=7 Participants Eligible participants from LAI116482 (NCT01641809 \[LATTE\]) study who were administered oral CAB 30 milligrams (mg) plus RPV 25 mg and who successfully completed Week 300 received their first dose CAB LA (600 mg) plus RPV LA (900 mg) injections within 2 hours of the final oral dose of LATTE given on the same day. The second loading injections were administered 1 month after initial loading dose, with subsequent injections (CAB LA 600 mg + RPV LA 900 mg) occurring Q2M thereafter. Participants continued to receive the treatment until the study intervention was locally approved and commercially available. Participants who received at least one dose of CAB LA and/or RPV LA and discontinued the CAB LA + RPV LA regimen for any reason entered a 52-week long-term follow-up (LTFU) Phase.	DTG + RPV Eligible participants from LAI116482 (NCT01641809 \[LATTE\]) study who were administered oral CAB 30 mg plus RPV 25 mg and who successfully completed Week 300 received their first dose of the Dolutegravir (DTG) 50 mg plus RPV 25 mg, once daily as oral regimen on Day 1 until Month 12 in the current study. These participants were not eligible for the LTFU phase.
Absolute Values of Clinical Chemistry Parameters: Cholesterol, Direct HDL Cholesterol, LDL Calculation, Direct LDL Cholesterol and Triglycerides for DTG + RPV Arm at Baseline Cholesterol	4.88 Millimoles per liter Standard Deviation 1.352	—
Absolute Values of Clinical Chemistry Parameters: Cholesterol, Direct HDL Cholesterol, LDL Calculation, Direct LDL Cholesterol and Triglycerides for DTG + RPV Arm at Baseline Direct HDL cholesterol	1.59 Millimoles per liter Standard Deviation 0.258	—
Absolute Values of Clinical Chemistry Parameters: Cholesterol, Direct HDL Cholesterol, LDL Calculation, Direct LDL Cholesterol and Triglycerides for DTG + RPV Arm at Baseline LDL cholesterol calculation	2.29 Millimoles per liter Standard Deviation 0.52	—
Absolute Values of Clinical Chemistry Parameters: Cholesterol, Direct HDL Cholesterol, LDL Calculation, Direct LDL Cholesterol and Triglycerides for DTG + RPV Arm at Baseline Direct LDL cholesterol	4.45 Millimoles per liter Standard Deviation NA Standard deviation could not be calculated for single participant.	—
Absolute Values of Clinical Chemistry Parameters: Cholesterol, Direct HDL Cholesterol, LDL Calculation, Direct LDL Cholesterol and Triglycerides for DTG + RPV Arm at Baseline Triglycerides	1.52 Millimoles per liter Standard Deviation 1.493	—

SECONDARY outcome

Timeframe: Up to End of LTFU Phase (compared with Baseline [Day1]), (approximately up to 12 months after exiting the Maintenance Phase)

Population: Safety Population. Only those participants with data available at the specified data points were analyzed.

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.

Outcome measures

Outcome measures
Measure	CAB LA + RPV LA Q2M n=90 Participants Eligible participants from LAI116482 (NCT01641809 \[LATTE\]) study who were administered oral CAB 30 milligrams (mg) plus RPV 25 mg and who successfully completed Week 300 received their first dose CAB LA (600 mg) plus RPV LA (900 mg) injections within 2 hours of the final oral dose of LATTE given on the same day. The second loading injections were administered 1 month after initial loading dose, with subsequent injections (CAB LA 600 mg + RPV LA 900 mg) occurring Q2M thereafter. Participants continued to receive the treatment until the study intervention was locally approved and commercially available. Participants who received at least one dose of CAB LA and/or RPV LA and discontinued the CAB LA + RPV LA regimen for any reason entered a 52-week long-term follow-up (LTFU) Phase.	DTG + RPV n=6 Participants Eligible participants from LAI116482 (NCT01641809 \[LATTE\]) study who were administered oral CAB 30 mg plus RPV 25 mg and who successfully completed Week 300 received their first dose of the Dolutegravir (DTG) 50 mg plus RPV 25 mg, once daily as oral regimen on Day 1 until Month 12 in the current study. These participants were not eligible for the LTFU phase.
Change From Baseline in Clinical Chemistry Parameter: GFR From Creatinine Adjusted Using CKD-EPI for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Month 2	1.9 Milliliter per minute per 1.73 meter^2 Standard Deviation 7.70	—
Change From Baseline in Clinical Chemistry Parameter: GFR From Creatinine Adjusted Using CKD-EPI for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Month 4	1.7 Milliliter per minute per 1.73 meter^2 Standard Deviation 10.09	—
Change From Baseline in Clinical Chemistry Parameter: GFR From Creatinine Adjusted Using CKD-EPI for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Month 6	1.4 Milliliter per minute per 1.73 meter^2 Standard Deviation 7.86	—
Change From Baseline in Clinical Chemistry Parameter: GFR From Creatinine Adjusted Using CKD-EPI for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Month 8	0.8 Milliliter per minute per 1.73 meter^2 Standard Deviation 8.63	—
Change From Baseline in Clinical Chemistry Parameter: GFR From Creatinine Adjusted Using CKD-EPI for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Month 12	0.4 Milliliter per minute per 1.73 meter^2 Standard Deviation 9.93	—
Change From Baseline in Clinical Chemistry Parameter: GFR From Creatinine Adjusted Using CKD-EPI for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Month 16	-1.7 Milliliter per minute per 1.73 meter^2 Standard Deviation 10.06	—
Change From Baseline in Clinical Chemistry Parameter: GFR From Creatinine Adjusted Using CKD-EPI for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Month 20	-0.2 Milliliter per minute per 1.73 meter^2 Standard Deviation 10.69	—
Change From Baseline in Clinical Chemistry Parameter: GFR From Creatinine Adjusted Using CKD-EPI for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Month 24	-5.0 Milliliter per minute per 1.73 meter^2 Standard Deviation 11.01	—
Change From Baseline in Clinical Chemistry Parameter: GFR From Creatinine Adjusted Using CKD-EPI for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Month 26	1.8 Milliliter per minute per 1.73 meter^2 Standard Deviation 5.68	—
Change From Baseline in Clinical Chemistry Parameter: GFR From Creatinine Adjusted Using CKD-EPI for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Month 28	-6.5 Milliliter per minute per 1.73 meter^2 Standard Deviation 9.44	—
Change From Baseline in Clinical Chemistry Parameter: GFR From Creatinine Adjusted Using CKD-EPI for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Month 30	-12.3 Milliliter per minute per 1.73 meter^2 Standard Deviation 14.47	—
Change From Baseline in Clinical Chemistry Parameter: GFR From Creatinine Adjusted Using CKD-EPI for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Month 32	-2.1 Milliliter per minute per 1.73 meter^2 Standard Deviation 9.71	—
Change From Baseline in Clinical Chemistry Parameter: GFR From Creatinine Adjusted Using CKD-EPI for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Month 34	-0.5 Milliliter per minute per 1.73 meter^2 Standard Deviation 5.07	—
Change From Baseline in Clinical Chemistry Parameter: GFR From Creatinine Adjusted Using CKD-EPI for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Month 36	-2.7 Milliliter per minute per 1.73 meter^2 Standard Deviation 10.12	—
Change From Baseline in Clinical Chemistry Parameter: GFR From Creatinine Adjusted Using CKD-EPI for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Month 38	-8.0 Milliliter per minute per 1.73 meter^2 Standard Deviation NA Standard deviation (SD) could not be calculated for a single participant.	—
Change From Baseline in Clinical Chemistry Parameter: GFR From Creatinine Adjusted Using CKD-EPI for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Month 40	0.8 Milliliter per minute per 1.73 meter^2 Standard Deviation 8.56	—
Change From Baseline in Clinical Chemistry Parameter: GFR From Creatinine Adjusted Using CKD-EPI for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Month 42	-6.0 Milliliter per minute per 1.73 meter^2 Standard Deviation 7.94	—
Change From Baseline in Clinical Chemistry Parameter: GFR From Creatinine Adjusted Using CKD-EPI for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Month 44	-1.9 Milliliter per minute per 1.73 meter^2 Standard Deviation 11.07	—
Change From Baseline in Clinical Chemistry Parameter: GFR From Creatinine Adjusted Using CKD-EPI for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Month 46	-8.5 Milliliter per minute per 1.73 meter^2 Standard Deviation 7.78	—
Change From Baseline in Clinical Chemistry Parameter: GFR From Creatinine Adjusted Using CKD-EPI for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Month 48	-2.8 Milliliter per minute per 1.73 meter^2 Standard Deviation 9.92	—
Change From Baseline in Clinical Chemistry Parameter: GFR From Creatinine Adjusted Using CKD-EPI for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Month 50	2.0 Milliliter per minute per 1.73 meter^2 Standard Deviation 7.07	—
Change From Baseline in Clinical Chemistry Parameter: GFR From Creatinine Adjusted Using CKD-EPI for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Month 52	-0.5 Milliliter per minute per 1.73 meter^2 Standard Deviation 12.85	—
Change From Baseline in Clinical Chemistry Parameter: GFR From Creatinine Adjusted Using CKD-EPI for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase LTFU Month 1	—	-1.2 Milliliter per minute per 1.73 meter^2 Standard Deviation 9.26
Change From Baseline in Clinical Chemistry Parameter: GFR From Creatinine Adjusted Using CKD-EPI for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase LTFU Month 3	—	-14.3 Milliliter per minute per 1.73 meter^2 Standard Deviation 10.63
Change From Baseline in Clinical Chemistry Parameter: GFR From Creatinine Adjusted Using CKD-EPI for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase LTFU Month 6	—	-10.0 Milliliter per minute per 1.73 meter^2 Standard Deviation 14.62
Change From Baseline in Clinical Chemistry Parameter: GFR From Creatinine Adjusted Using CKD-EPI for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase LTFU Month 9	—	-8.8 Milliliter per minute per 1.73 meter^2 Standard Deviation 9.87
Change From Baseline in Clinical Chemistry Parameter: GFR From Creatinine Adjusted Using CKD-EPI for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase LTFU Month 12	—	-11.0 Milliliter per minute per 1.73 meter^2 Standard Deviation 7.11

SECONDARY outcome

Timeframe: At Months 3, 6, 9 and 12 (compared with Baseline [Day 1]) [Maintenance Phase]

Population: Safety Population

Outcome measures

Outcome measures
Measure	CAB LA + RPV LA Q2M n=7 Participants Eligible participants from LAI116482 (NCT01641809 \[LATTE\]) study who were administered oral CAB 30 milligrams (mg) plus RPV 25 mg and who successfully completed Week 300 received their first dose CAB LA (600 mg) plus RPV LA (900 mg) injections within 2 hours of the final oral dose of LATTE given on the same day. The second loading injections were administered 1 month after initial loading dose, with subsequent injections (CAB LA 600 mg + RPV LA 900 mg) occurring Q2M thereafter. Participants continued to receive the treatment until the study intervention was locally approved and commercially available. Participants who received at least one dose of CAB LA and/or RPV LA and discontinued the CAB LA + RPV LA regimen for any reason entered a 52-week long-term follow-up (LTFU) Phase.	DTG + RPV Eligible participants from LAI116482 (NCT01641809 \[LATTE\]) study who were administered oral CAB 30 mg plus RPV 25 mg and who successfully completed Week 300 received their first dose of the Dolutegravir (DTG) 50 mg plus RPV 25 mg, once daily as oral regimen on Day 1 until Month 12 in the current study. These participants were not eligible for the LTFU phase.
Change From Baseline in Clinical Chemistry Parameter: GFR From Creatinine Adjusted Using CKD-EPI for DTG + RPV Arm up to Month 12 [Maintenance Phase] Month 3	-11.7 Milliliter per minute per 1.73 meter^2 Standard Deviation 10.83	—
Change From Baseline in Clinical Chemistry Parameter: GFR From Creatinine Adjusted Using CKD-EPI for DTG + RPV Arm up to Month 12 [Maintenance Phase] Month 6	-7.4 Milliliter per minute per 1.73 meter^2 Standard Deviation 4.28	—
Change From Baseline in Clinical Chemistry Parameter: GFR From Creatinine Adjusted Using CKD-EPI for DTG + RPV Arm up to Month 12 [Maintenance Phase] Month 9	-16.6 Milliliter per minute per 1.73 meter^2 Standard Deviation 12.27	—
Change From Baseline in Clinical Chemistry Parameter: GFR From Creatinine Adjusted Using CKD-EPI for DTG + RPV Arm up to Month 12 [Maintenance Phase] Month 12	-7.3 Milliliter per minute per 1.73 meter^2 Standard Deviation 8.71	—

SECONDARY outcome

Timeframe: Up to End of LTFU Phase (compared with Baseline [Day1]), (approximately up to 12 months after exiting the Maintenance Phase)

Population: Safety Population. Only those participants with data available at the specified data points were analyzed.

Blood samples were collected for the analysis of clinical chemistry parameter: GFR from creatinine adjusted for BSA. 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.

Outcome measures

Outcome measures
Measure	CAB LA + RPV LA Q2M n=90 Participants Eligible participants from LAI116482 (NCT01641809 \[LATTE\]) study who were administered oral CAB 30 milligrams (mg) plus RPV 25 mg and who successfully completed Week 300 received their first dose CAB LA (600 mg) plus RPV LA (900 mg) injections within 2 hours of the final oral dose of LATTE given on the same day. The second loading injections were administered 1 month after initial loading dose, with subsequent injections (CAB LA 600 mg + RPV LA 900 mg) occurring Q2M thereafter. Participants continued to receive the treatment until the study intervention was locally approved and commercially available. Participants who received at least one dose of CAB LA and/or RPV LA and discontinued the CAB LA + RPV LA regimen for any reason entered a 52-week long-term follow-up (LTFU) Phase.	DTG + RPV n=6 Participants Eligible participants from LAI116482 (NCT01641809 \[LATTE\]) study who were administered oral CAB 30 mg plus RPV 25 mg and who successfully completed Week 300 received their first dose of the Dolutegravir (DTG) 50 mg plus RPV 25 mg, once daily as oral regimen on Day 1 until Month 12 in the current study. These participants were not eligible for the LTFU phase.
Change From Baseline in Clinical Chemistry Parameter: GFR From Creatinine Adjusted BSA for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Month 2	0.03 Milliliter per second per 1.73 meter^2 Standard Deviation 0.128	—
Change From Baseline in Clinical Chemistry Parameter: GFR From Creatinine Adjusted BSA for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Month 4	0.02 Milliliter per second per 1.73 meter^2 Standard Deviation 0.168	—
Change From Baseline in Clinical Chemistry Parameter: GFR From Creatinine Adjusted BSA for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Month 8	0.01 Milliliter per second per 1.73 meter^2 Standard Deviation 0.143	—
Change From Baseline in Clinical Chemistry Parameter: GFR From Creatinine Adjusted BSA for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Month 12	0.00 Milliliter per second per 1.73 meter^2 Standard Deviation 0.165	—
Change From Baseline in Clinical Chemistry Parameter: GFR From Creatinine Adjusted BSA for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Month 16	-0.02 Milliliter per second per 1.73 meter^2 Standard Deviation 0.167	—
Change From Baseline in Clinical Chemistry Parameter: GFR From Creatinine Adjusted BSA for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Month 20	0.00 Milliliter per second per 1.73 meter^2 Standard Deviation 0.178	—
Change From Baseline in Clinical Chemistry Parameter: GFR From Creatinine Adjusted BSA for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Month 24	-0.08 Milliliter per second per 1.73 meter^2 Standard Deviation 0.183	—
Change From Baseline in Clinical Chemistry Parameter: GFR From Creatinine Adjusted BSA for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Month 26	0.02 Milliliter per second per 1.73 meter^2 Standard Deviation 0.094	—
Change From Baseline in Clinical Chemistry Parameter: GFR From Creatinine Adjusted BSA for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Month 28	-0.10 Milliliter per second per 1.73 meter^2 Standard Deviation 0.157	—
Change From Baseline in Clinical Chemistry Parameter: GFR From Creatinine Adjusted BSA for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Month 30	-0.20 Milliliter per second per 1.73 meter^2 Standard Deviation 0.241	—
Change From Baseline in Clinical Chemistry Parameter: GFR From Creatinine Adjusted BSA for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Month 32	-0.03 Milliliter per second per 1.73 meter^2 Standard Deviation 0.161	—
Change From Baseline in Clinical Chemistry Parameter: GFR From Creatinine Adjusted BSA for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Month 34	0.00 Milliliter per second per 1.73 meter^2 Standard Deviation 0.084	—
Change From Baseline in Clinical Chemistry Parameter: GFR From Creatinine Adjusted BSA for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Month 36	-0.04 Milliliter per second per 1.73 meter^2 Standard Deviation 0.168	—
Change From Baseline in Clinical Chemistry Parameter: GFR From Creatinine Adjusted BSA for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Month 38	-0.13 Milliliter per second per 1.73 meter^2 Standard Deviation NA Standard deviation (SD) could not be calculated for a single participant.	—
Change From Baseline in Clinical Chemistry Parameter: GFR From Creatinine Adjusted BSA for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Month 40	0.01 Milliliter per second per 1.73 meter^2 Standard Deviation 0.142	—
Change From Baseline in Clinical Chemistry Parameter: GFR From Creatinine Adjusted BSA for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Month 42	-0.10 Milliliter per second per 1.73 meter^2 Standard Deviation 0.132	—
Change From Baseline in Clinical Chemistry Parameter: GFR From Creatinine Adjusted BSA for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Month 44	-0.03 Milliliter per second per 1.73 meter^2 Standard Deviation 0.184	—
Change From Baseline in Clinical Chemistry Parameter: GFR From Creatinine Adjusted BSA for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Month 46	-0.14 Milliliter per second per 1.73 meter^2 Standard Deviation 0.129	—
Change From Baseline in Clinical Chemistry Parameter: GFR From Creatinine Adjusted BSA for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Month 48	-0.04 Milliliter per second per 1.73 meter^2 Standard Deviation 0.165	—
Change From Baseline in Clinical Chemistry Parameter: GFR From Creatinine Adjusted BSA for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Month 50	0.03 Milliliter per second per 1.73 meter^2 Standard Deviation 0.117	—
Change From Baseline in Clinical Chemistry Parameter: GFR From Creatinine Adjusted BSA for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Month 52	0.00 Milliliter per second per 1.73 meter^2 Standard Deviation 0.214	—
Change From Baseline in Clinical Chemistry Parameter: GFR From Creatinine Adjusted BSA for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase LTFU Month 1	—	-0.02 Milliliter per second per 1.73 meter^2 Standard Deviation 0.154
Change From Baseline in Clinical Chemistry Parameter: GFR From Creatinine Adjusted BSA for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase LTFU Month 3	—	-0.23 Milliliter per second per 1.73 meter^2 Standard Deviation 0.177
Change From Baseline in Clinical Chemistry Parameter: GFR From Creatinine Adjusted BSA for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase LTFU Month 6	—	-0.16 Milliliter per second per 1.73 meter^2 Standard Deviation 0.243
Change From Baseline in Clinical Chemistry Parameter: GFR From Creatinine Adjusted BSA for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase LTFU Month 9	—	-0.14 Milliliter per second per 1.73 meter^2 Standard Deviation 0.164
Change From Baseline in Clinical Chemistry Parameter: GFR From Creatinine Adjusted BSA for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase LTFU Month 12	—	-0.18 Milliliter per second per 1.73 meter^2 Standard Deviation 0.118

SECONDARY outcome

Timeframe: At Months 3, 6, 9 and 12 (compared with Baseline [Day 1]) [Maintenance Phase]

Population: Safety Population

Outcome measures

Outcome measures
Measure	CAB LA + RPV LA Q2M n=7 Participants Eligible participants from LAI116482 (NCT01641809 \[LATTE\]) study who were administered oral CAB 30 milligrams (mg) plus RPV 25 mg and who successfully completed Week 300 received their first dose CAB LA (600 mg) plus RPV LA (900 mg) injections within 2 hours of the final oral dose of LATTE given on the same day. The second loading injections were administered 1 month after initial loading dose, with subsequent injections (CAB LA 600 mg + RPV LA 900 mg) occurring Q2M thereafter. Participants continued to receive the treatment until the study intervention was locally approved and commercially available. Participants who received at least one dose of CAB LA and/or RPV LA and discontinued the CAB LA + RPV LA regimen for any reason entered a 52-week long-term follow-up (LTFU) Phase.	DTG + RPV Eligible participants from LAI116482 (NCT01641809 \[LATTE\]) study who were administered oral CAB 30 mg plus RPV 25 mg and who successfully completed Week 300 received their first dose of the Dolutegravir (DTG) 50 mg plus RPV 25 mg, once daily as oral regimen on Day 1 until Month 12 in the current study. These participants were not eligible for the LTFU phase.
Change From Baseline in Clinical Chemistry Parameter: GFR From Creatinine Adjusted BSA for DTG + RPV Arm up to Month 12 [Maintenance Phase] Month 3	-0.19 Milliliter per second per 1.73 meter^2 Standard Deviation 0.180	—
Change From Baseline in Clinical Chemistry Parameter: GFR From Creatinine Adjusted BSA for DTG + RPV Arm up to Month 12 [Maintenance Phase] Month 6	-0.12 Milliliter per second per 1.73 meter^2 Standard Deviation 0.071	—
Change From Baseline in Clinical Chemistry Parameter: GFR From Creatinine Adjusted BSA for DTG + RPV Arm up to Month 12 [Maintenance Phase] Month 9	-0.27 Milliliter per second per 1.73 meter^2 Standard Deviation 0.204	—
Change From Baseline in Clinical Chemistry Parameter: GFR From Creatinine Adjusted BSA for DTG + RPV Arm up to Month 12 [Maintenance Phase] Month 12	-0.12 Milliliter per second per 1.73 meter^2 Standard Deviation 0.145	—

SECONDARY outcome

Timeframe: Up to End of LTFU Phase (compared with Baseline [Day1]), (approximately up to 12 months after exiting the Maintenance Phase)

Population: Safety Population. Only those participants with data available at the specified data points were analyzed.

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.

Outcome measures

Outcome measures
Measure	CAB LA + RPV LA Q2M n=90 Participants Eligible participants from LAI116482 (NCT01641809 \[LATTE\]) study who were administered oral CAB 30 milligrams (mg) plus RPV 25 mg and who successfully completed Week 300 received their first dose CAB LA (600 mg) plus RPV LA (900 mg) injections within 2 hours of the final oral dose of LATTE given on the same day. The second loading injections were administered 1 month after initial loading dose, with subsequent injections (CAB LA 600 mg + RPV LA 900 mg) occurring Q2M thereafter. Participants continued to receive the treatment until the study intervention was locally approved and commercially available. Participants who received at least one dose of CAB LA and/or RPV LA and discontinued the CAB LA + RPV LA regimen for any reason entered a 52-week long-term follow-up (LTFU) Phase.	DTG + RPV n=6 Participants Eligible participants from LAI116482 (NCT01641809 \[LATTE\]) study who were administered oral CAB 30 mg plus RPV 25 mg and who successfully completed Week 300 received their first dose of the Dolutegravir (DTG) 50 mg plus RPV 25 mg, once daily as oral regimen on Day 1 until Month 12 in the current study. These participants were not eligible for the LTFU phase.
Change From Baseline in Clinical Chemistry Parameter: Lipase for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Month 2	-0.1 Units per liter Standard Deviation 29.11	—
Change From Baseline in Clinical Chemistry Parameter: Lipase for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Month 4	3.7 Units per liter Standard Deviation 47.68	—
Change From Baseline in Clinical Chemistry Parameter: Lipase for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Month 6	24.5 Units per liter Standard Deviation 64.27	—
Change From Baseline in Clinical Chemistry Parameter: Lipase for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Month 8	-1.3 Units per liter Standard Deviation 29.43	—
Change From Baseline in Clinical Chemistry Parameter: Lipase for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Month 12	-2.9 Units per liter Standard Deviation 36.83	—
Change From Baseline in Clinical Chemistry Parameter: Lipase for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Month 16	-6.4 Units per liter Standard Deviation 31.83	—
Change From Baseline in Clinical Chemistry Parameter: Lipase for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Month 20	-4.0 Units per liter Standard Deviation 32.29	—
Change From Baseline in Clinical Chemistry Parameter: Lipase for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Month 24	-2.0 Units per liter Standard Deviation 34.89	—
Change From Baseline in Clinical Chemistry Parameter: Lipase for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Month 26	11.0 Units per liter Standard Deviation 4.55	—
Change From Baseline in Clinical Chemistry Parameter: Lipase for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Month 28	-1.9 Units per liter Standard Deviation 26.19	—
Change From Baseline in Clinical Chemistry Parameter: Lipase for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Month 30	-1.0 Units per liter Standard Deviation 14.14	—
Change From Baseline in Clinical Chemistry Parameter: Lipase for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Month 32	5.5 Units per liter Standard Deviation 56.93	—
Change From Baseline in Clinical Chemistry Parameter: Lipase for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Month 34	-12.8 Units per liter Standard Deviation 45.17	—
Change From Baseline in Clinical Chemistry Parameter: Lipase for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Month 36	4.9 Units per liter Standard Deviation 51.90	—
Change From Baseline in Clinical Chemistry Parameter: Lipase for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Month 38	20.0 Units per liter Standard Deviation NA Standard deviation (SD) could not be calculated for a single participant.	—
Change From Baseline in Clinical Chemistry Parameter: Lipase for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Month 40	0.7 Units per liter Standard Deviation 41.09	—
Change From Baseline in Clinical Chemistry Parameter: Lipase for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Month 42	-12.7 Units per liter Standard Deviation 27.39	—
Change From Baseline in Clinical Chemistry Parameter: Lipase for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Month 44	5.6 Units per liter Standard Deviation 40.12	—
Change From Baseline in Clinical Chemistry Parameter: Lipase for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Month 46	-33.3 Units per liter Standard Deviation 118.26	—
Change From Baseline in Clinical Chemistry Parameter: Lipase for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Month 48	3.7 Units per liter Standard Deviation 31.55	—
Change From Baseline in Clinical Chemistry Parameter: Lipase for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Month 50	-3.0 Units per liter Standard Deviation 28.28	—
Change From Baseline in Clinical Chemistry Parameter: Lipase for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Month 52	3.2 Units per liter Standard Deviation 12.24	—
Change From Baseline in Clinical Chemistry Parameter: Lipase for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase LTFU Month 1	—	27.4 Units per liter Standard Deviation 48.97
Change From Baseline in Clinical Chemistry Parameter: Lipase for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase LTFU Month 3	—	1.5 Units per liter Standard Deviation 10.60
Change From Baseline in Clinical Chemistry Parameter: Lipase for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase LTFU Month 6	—	10.8 Units per liter Standard Deviation 30.53
Change From Baseline in Clinical Chemistry Parameter: Lipase for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase LTFU Month 9	—	3.7 Units per liter Standard Deviation 9.40
Change From Baseline in Clinical Chemistry Parameter: Lipase for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase LTFU Month 12	—	5.2 Units per liter Standard Deviation 6.38

SECONDARY outcome

Timeframe: At Months 3, 6, 9 and 12 (compared with Baseline [Day 1]) [Maintenance Phase]

Population: Safety Population

Outcome measures

Outcome measures
Measure	CAB LA + RPV LA Q2M n=7 Participants Eligible participants from LAI116482 (NCT01641809 \[LATTE\]) study who were administered oral CAB 30 milligrams (mg) plus RPV 25 mg and who successfully completed Week 300 received their first dose CAB LA (600 mg) plus RPV LA (900 mg) injections within 2 hours of the final oral dose of LATTE given on the same day. The second loading injections were administered 1 month after initial loading dose, with subsequent injections (CAB LA 600 mg + RPV LA 900 mg) occurring Q2M thereafter. Participants continued to receive the treatment until the study intervention was locally approved and commercially available. Participants who received at least one dose of CAB LA and/or RPV LA and discontinued the CAB LA + RPV LA regimen for any reason entered a 52-week long-term follow-up (LTFU) Phase.	DTG + RPV Eligible participants from LAI116482 (NCT01641809 \[LATTE\]) study who were administered oral CAB 30 mg plus RPV 25 mg and who successfully completed Week 300 received their first dose of the Dolutegravir (DTG) 50 mg plus RPV 25 mg, once daily as oral regimen on Day 1 until Month 12 in the current study. These participants were not eligible for the LTFU phase.
Change From Baseline in Clinical Chemistry Parameter: Lipase for DTG + RPV Arm up to Month 12 [Maintenance Phase] Month 3	2.6 Units per liter Standard Deviation 6.90	—
Change From Baseline in Clinical Chemistry Parameter: Lipase for DTG + RPV Arm up to Month 12 [Maintenance Phase] Month 6	4.4 Units per liter Standard Deviation 4.35	—
Change From Baseline in Clinical Chemistry Parameter: Lipase for DTG + RPV Arm up to Month 12 [Maintenance Phase] Month 9	1.3 Units per liter Standard Deviation 6.85	—
Change From Baseline in Clinical Chemistry Parameter: Lipase for DTG + RPV Arm up to Month 12 [Maintenance Phase] Month 12	26.0 Units per liter Standard Deviation 49.76	—

SECONDARY outcome

Timeframe: Up to End of LTFU Phase (compared with Baseline [Day1]), (approximately up to 12 months after exiting the Maintenance Phase)

Population: Safety Population. Only those participants with data available at the specified data points were analyzed.

Blood samples were collected for the analysis of clinical chemistry parameter: total cholesterol/ HDL cholesterol ratio. 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.

Outcome measures

Outcome measures
Measure	CAB LA + RPV LA Q2M n=88 Participants Eligible participants from LAI116482 (NCT01641809 \[LATTE\]) study who were administered oral CAB 30 milligrams (mg) plus RPV 25 mg and who successfully completed Week 300 received their first dose CAB LA (600 mg) plus RPV LA (900 mg) injections within 2 hours of the final oral dose of LATTE given on the same day. The second loading injections were administered 1 month after initial loading dose, with subsequent injections (CAB LA 600 mg + RPV LA 900 mg) occurring Q2M thereafter. Participants continued to receive the treatment until the study intervention was locally approved and commercially available. Participants who received at least one dose of CAB LA and/or RPV LA and discontinued the CAB LA + RPV LA regimen for any reason entered a 52-week long-term follow-up (LTFU) Phase.	DTG + RPV n=6 Participants Eligible participants from LAI116482 (NCT01641809 \[LATTE\]) study who were administered oral CAB 30 mg plus RPV 25 mg and who successfully completed Week 300 received their first dose of the Dolutegravir (DTG) 50 mg plus RPV 25 mg, once daily as oral regimen on Day 1 until Month 12 in the current study. These participants were not eligible for the LTFU phase.
Change From Baseline in Clinical Chemistry Parameter: Total Cholesterol/ HDL Cholesterol Ratio for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Month 12	0.20 Total Cholesterol/HDL Cholesterol Ratio Standard Deviation 1.698	—
Change From Baseline in Clinical Chemistry Parameter: Total Cholesterol/ HDL Cholesterol Ratio for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Month 24	0.05 Total Cholesterol/HDL Cholesterol Ratio Standard Deviation 1.279	—
Change From Baseline in Clinical Chemistry Parameter: Total Cholesterol/ HDL Cholesterol Ratio for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Month 26	0.55 Total Cholesterol/HDL Cholesterol Ratio Standard Deviation 0.861	—
Change From Baseline in Clinical Chemistry Parameter: Total Cholesterol/ HDL Cholesterol Ratio for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Month 28	0.11 Total Cholesterol/HDL Cholesterol Ratio Standard Deviation 1.153	—
Change From Baseline in Clinical Chemistry Parameter: Total Cholesterol/ HDL Cholesterol Ratio for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Month 30	-1.01 Total Cholesterol/HDL Cholesterol Ratio Standard Deviation 1.630	—
Change From Baseline in Clinical Chemistry Parameter: Total Cholesterol/ HDL Cholesterol Ratio for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Month 32	-0.48 Total Cholesterol/HDL Cholesterol Ratio Standard Deviation 1.191	—
Change From Baseline in Clinical Chemistry Parameter: Total Cholesterol/ HDL Cholesterol Ratio for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Month 34	0.43 Total Cholesterol/HDL Cholesterol Ratio Standard Deviation 0.425	—
Change From Baseline in Clinical Chemistry Parameter: Total Cholesterol/ HDL Cholesterol Ratio for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Month 40	-1.09 Total Cholesterol/HDL Cholesterol Ratio Standard Deviation 1.390	—
Change From Baseline in Clinical Chemistry Parameter: Total Cholesterol/ HDL Cholesterol Ratio for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Month 44	1.65 Total Cholesterol/HDL Cholesterol Ratio Standard Deviation 0.640	—
Change From Baseline in Clinical Chemistry Parameter: Total Cholesterol/ HDL Cholesterol Ratio for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Month 46	1.37 Total Cholesterol/HDL Cholesterol Ratio Standard Deviation NA Standard deviation (SD) could not be calculated for a single participant.	—
Change From Baseline in Clinical Chemistry Parameter: Total Cholesterol/ HDL Cholesterol Ratio for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Month 48	0.30 Total Cholesterol/HDL Cholesterol Ratio Standard Deviation 0.434	—
Change From Baseline in Clinical Chemistry Parameter: Total Cholesterol/ HDL Cholesterol Ratio for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase LTFU Month 1	—	-0.28 Total Cholesterol/HDL Cholesterol Ratio Standard Deviation 0.916
Change From Baseline in Clinical Chemistry Parameter: Total Cholesterol/ HDL Cholesterol Ratio for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase LTFU Month 12	—	-0.51 Total Cholesterol/HDL Cholesterol Ratio Standard Deviation 1.078

SECONDARY outcome

Timeframe: At Month 6 (compared with Baseline [Day 1]) [Maintenance Phase]

Population: Safety Population. Only those participants with data available at the specified data points were analyzed.

Outcome measures

Outcome measures
Measure	CAB LA + RPV LA Q2M n=2 Participants Eligible participants from LAI116482 (NCT01641809 \[LATTE\]) study who were administered oral CAB 30 milligrams (mg) plus RPV 25 mg and who successfully completed Week 300 received their first dose CAB LA (600 mg) plus RPV LA (900 mg) injections within 2 hours of the final oral dose of LATTE given on the same day. The second loading injections were administered 1 month after initial loading dose, with subsequent injections (CAB LA 600 mg + RPV LA 900 mg) occurring Q2M thereafter. Participants continued to receive the treatment until the study intervention was locally approved and commercially available. Participants who received at least one dose of CAB LA and/or RPV LA and discontinued the CAB LA + RPV LA regimen for any reason entered a 52-week long-term follow-up (LTFU) Phase.	DTG + RPV Eligible participants from LAI116482 (NCT01641809 \[LATTE\]) study who were administered oral CAB 30 mg plus RPV 25 mg and who successfully completed Week 300 received their first dose of the Dolutegravir (DTG) 50 mg plus RPV 25 mg, once daily as oral regimen on Day 1 until Month 12 in the current study. These participants were not eligible for the LTFU phase.
Change From Baseline in Clinical Chemistry Parameter: Total Cholesterol/ HDL Cholesterol Ratio for DTG + RPV Arm at Month 6 [Maintenance Phase]	0.55 Total Cholesterol/HDL Cholesterol Ratio Standard Deviation 0.679	—

SECONDARY outcome

Timeframe: Up to End of LTFU Phase (compared with Baseline [Day1]), (approximately up to 12 months after exiting the Maintenance Phase)

Population: Safety Population. Only those participants with data available at the specified data points were analyzed.

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.

Outcome measures

Outcome measures
Measure	CAB LA + RPV LA Q2M n=90 Participants Eligible participants from LAI116482 (NCT01641809 \[LATTE\]) study who were administered oral CAB 30 milligrams (mg) plus RPV 25 mg and who successfully completed Week 300 received their first dose CAB LA (600 mg) plus RPV LA (900 mg) injections within 2 hours of the final oral dose of LATTE given on the same day. The second loading injections were administered 1 month after initial loading dose, with subsequent injections (CAB LA 600 mg + RPV LA 900 mg) occurring Q2M thereafter. Participants continued to receive the treatment until the study intervention was locally approved and commercially available. Participants who received at least one dose of CAB LA and/or RPV LA and discontinued the CAB LA + RPV LA regimen for any reason entered a 52-week long-term follow-up (LTFU) Phase.	DTG + RPV n=6 Participants Eligible participants from LAI116482 (NCT01641809 \[LATTE\]) study who were administered oral CAB 30 mg plus RPV 25 mg and who successfully completed Week 300 received their first dose of the Dolutegravir (DTG) 50 mg plus RPV 25 mg, once daily as oral regimen on Day 1 until Month 12 in the current study. These participants were not eligible for the LTFU phase.
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Basophils, Month 2	-0.000 10^9 cells per liter Standard Deviation 0.02200	—
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Basophils, Month 4	0.009 10^9 cells per liter Standard Deviation 0.02913	—
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Basophils, Month 8	0.003 10^9 cells per liter Standard Deviation 0.02524	—
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Basophils, Month 12	-0.003 10^9 cells per liter Standard Deviation 0.02501	—
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Basophils, Month 16	0.003 10^9 cells per liter Standard Deviation 0.02629	—
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Basophils, Month 20	0.003 10^9 cells per liter Standard Deviation 0.02751	—
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Basophils, Month 22	-0.020 10^9 cells per liter Standard Deviation 0.04243	—
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Basophils, Month 24	0.001 10^9 cells per liter Standard Deviation 0.02306	—
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Basophils, Month 26	-0.004 10^9 cells per liter Standard Deviation 0.01673	—
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Basophils, Month 28	0.008 10^9 cells per liter Standard Deviation 0.02919	—
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Basophils, Month 30	0.007 10^9 cells per liter Standard Deviation 0.03862	—
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Basophils, Month 32	0.003 10^9 cells per liter Standard Deviation 0.02567	—
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Basophils, Month 34	-0.010 10^9 cells per liter Standard Deviation 0.01000	—
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Basophils, Month 36	-0.001 10^9 cells per liter Standard Deviation 0.03325	—
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Basophils, Month 38	0.000 10^9 cells per liter Standard Deviation 0.01414	—
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Basophils, Month 40	0.004 10^9 cells per liter Standard Deviation 0.02461	—
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Basophils, Month 42	0.000 10^9 cells per liter Standard Deviation 0.03606	—
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Basophils, Month 44	-0.001 10^9 cells per liter Standard Deviation 0.02271	—
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Basophils, Month 46	0.005 10^9 cells per liter Standard Deviation 0.02121	—
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Basophils, Month 48	-0.002 10^9 cells per liter Standard Deviation 0.02682	—
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Basophils, Month 50	-0.045 10^9 cells per liter Standard Deviation 0.04950	—
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Basophils, Month 52	0.021 10^9 cells per liter Standard Deviation 0.02858	—
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Basophils, LTFU Month 1	—	0.004 10^9 cells per liter Standard Deviation 0.02702
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Basophils, LTFU Month 3	—	0.000 10^9 cells per liter Standard Deviation 0.02944
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Basophils, LTFU Month 6	—	-0.001 10^9 cells per liter Standard Deviation 0.03764
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Basophils, LTFU Month 9	—	0.000 10^9 cells per liter Standard Deviation 0.02000
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Basophils, LTFU Month 12	—	0.010 10^9 cells per liter Standard Deviation 0.03240
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Eosinophils, Month 2	0.017 10^9 cells per liter Standard Deviation 0.11886	—
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Eosinophils, Month 4	0.004 10^9 cells per liter Standard Deviation 0.12341	—
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Eosinophils, Month 8	0.003 10^9 cells per liter Standard Deviation 0.14555	—
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Eosinophils, Month 12	-0.000 10^9 cells per liter Standard Deviation 0.13671	—
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Eosinophils, Month 16	-0.002 10^9 cells per liter Standard Deviation 0.12115	—
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Eosinophils, Month 20	-0.004 10^9 cells per liter Standard Deviation 0.11308	—
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Eosinophils, Month 22	0.005 10^9 cells per liter Standard Deviation 0.00707	—
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Eosinophils, Month 24	-0.021 10^9 cells per liter Standard Deviation 0.10959	—
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Eosinophils, Month 26	0.014 10^9 cells per liter Standard Deviation 0.04393	—
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Eosinophils, Month 28	-0.021 10^9 cells per liter Standard Deviation 0.12165	—
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Eosinophils, Month 30	0.072 10^9 cells per liter Standard Deviation 0.09878	—
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Eosinophils, Month 32	-0.009 10^9 cells per liter Standard Deviation 0.15093	—
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Eosinophils, Month 34	0.083 10^9 cells per liter Standard Deviation 0.11846	—
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Eosinophils, Month 36	-0.020 10^9 cells per liter Standard Deviation 0.13447	—
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Eosinophils, Month 38	0.070 10^9 cells per liter Standard Deviation 0.21213	—
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Eosinophils, Month 40	-0.014 10^9 cells per liter Standard Deviation 0.14536	—
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Eosinophils, Month 42	0.146 10^9 cells per liter Standard Deviation 0.04933	—
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Eosinophils, Month 44	-0.023 10^9 cells per liter Standard Deviation 0.12973	—
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Eosinophils, Month 46	0.065 10^9 cells per liter Standard Deviation 0.02121	—
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Eosinophils, Month 48	-0.016 10^9 cells per liter Standard Deviation 0.13128	—
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Eosinophils, Month 50	-0.085 10^9 cells per liter Standard Deviation 0.19092	—
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Eosinophils, Month 52	-0.020 10^9 cells per liter Standard Deviation 0.09675	—
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Eosinophils, LTFU Month 1	—	-0.006 10^9 cells per liter Standard Deviation 0.03847
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Eosinophils, LTFU Month 3	—	-0.042 10^9 cells per liter Standard Deviation 0.02062
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Eosinophils, LTFU Month 6	—	0.015 10^9 cells per liter Standard Deviation 0.05925
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Eosinophils, LTFU Month 9	—	-0.041 10^9 cells per liter Standard Deviation 0.04535
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Eosinophils, LTFU Month 12	—	0.036 10^9 cells per liter Standard Deviation 0.04930
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Leukocytes, Month 2	-0.054 10^9 cells per liter Standard Deviation 1.1875	—
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Leukocytes, Month 4	0.276 10^9 cells per liter Standard Deviation 1.4416	—
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Leukocytes, Month 8	0.257 10^9 cells per liter Standard Deviation 1.4252	—
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Leukocytes, Month 12	-0.153 10^9 cells per liter Standard Deviation 1.1961	—
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Leukocytes, Month 16	0.333 10^9 cells per liter Standard Deviation 1.4322	—
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Leukocytes, Month 20	0.069 10^9 cells per liter Standard Deviation 1.2588	—
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Leukocytes, Month 22	-0.050 10^9 cells per liter Standard Deviation 0.4950	—
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Leukocytes, Month 24	0.247 10^9 cells per liter Standard Deviation 1.3444	—
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Leukocytes, Month 26	-0.700 10^9 cells per liter Standard Deviation 0.9220	—
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Leukocytes, Month 28	0.369 10^9 cells per liter Standard Deviation 1.2534	—
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Leukocytes, Month 30	0.775 10^9 cells per liter Standard Deviation 1.1147	—
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Leukocytes, Month 32	0.582 10^9 cells per liter Standard Deviation 1.5079	—
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Leukocytes, Month 34	-0.033 10^9 cells per liter Standard Deviation 0.6351	—
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Leukocytes, Month 36	0.197 10^9 cells per liter Standard Deviation 1.3119	—
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Leukocytes, Month 38	0.450 10^9 cells per liter Standard Deviation 2.3335	—
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Leukocytes, Month 40	0.111 10^9 cells per liter Standard Deviation 1.4863	—
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Leukocytes, Month 42	0.750 10^9 cells per liter Standard Deviation 1.6299	—
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Leukocytes, Month 44	0.016 10^9 cells per liter Standard Deviation 1.4332	—
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Leukocytes, Month 46	0.700 10^9 cells per liter Standard Deviation 0.2828	—
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Leukocytes, Month 48	0.237 10^9 cells per liter Standard Deviation 1.3630	—
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Leukocytes, Month 50	-2.650 10^9 cells per liter Standard Deviation 1.2021	—
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Leukocytes, Month 52	0.950 10^9 cells per liter Standard Deviation 0.6804	—
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Leukocytes, LTFU Month 1	—	0.740 10^9 cells per liter Standard Deviation 1.1327
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Leukocytes, LTFU Month 3	—	1.100 10^9 cells per liter Standard Deviation 1.4720
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Leukocytes, LTFU Month 6	—	-0.067 10^9 cells per liter Standard Deviation 1.0820
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Leukocytes, LTFU Month 9	—	-0.317 10^9 cells per liter Standard Deviation 0.5529
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Leukocytes, LTFU Month 12	—	-0.240 10^9 cells per liter Standard Deviation 0.7369
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Lymphocytes, Month 2	0.116 10^9 cells per liter Standard Deviation 0.44032	—
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Lymphocytes, Month 4	0.150 10^9 cells per liter Standard Deviation 0.42751	—
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Lymphocytes, Month 8	0.100 10^9 cells per liter Standard Deviation 0.49306	—
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Lymphocytes, Month 12	0.022 10^9 cells per liter Standard Deviation 0.61142	—
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Lymphocytes, Month 16	0.144 10^9 cells per liter Standard Deviation 0.50914	—
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Lymphocytes, Month 20	0.197 10^9 cells per liter Standard Deviation 0.49264	—
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Lymphocytes, Month 22	0.815 10^9 cells per liter Standard Deviation 0.82731	—
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Lymphocytes, Month 24	0.184 10^9 cells per liter Standard Deviation 0.53796	—
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Lymphocytes, Month 26	0.064 10^9 cells per liter Standard Deviation 0.30262	—
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Lymphocytes, Month 28	0.269 10^9 cells per liter Standard Deviation 0.50159	—
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Lymphocytes, Month 30	0.657 10^9 cells per liter Standard Deviation 0.34219	—
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Lymphocytes, Month 32	0.294 10^9 cells per liter Standard Deviation 0.54583	—
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Lymphocytes, Month 34	0.260 10^9 cells per liter Standard Deviation 0.58813	—
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Lymphocytes, Month 36	0.176 10^9 cells per liter Standard Deviation 0.53181	—
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Lymphocytes, Month 38	0.185 10^9 cells per liter Standard Deviation 0.71418	—
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Lymphocytes, Month 40	0.193 10^9 cells per liter Standard Deviation 0.51843	—
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Lymphocytes, Month 42	0.990 10^9 cells per liter Standard Deviation 0.23388	—
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Lymphocytes, Month 44	0.090 10^9 cells per liter Standard Deviation 0.55940	—
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Lymphocytes, Month 46	-0.375 10^9 cells per liter Standard Deviation 0.86974	—
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Lymphocytes, Month 48	0.225 10^9 cells per liter Standard Deviation 0.55785	—
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Lymphocytes, Month 50	-0.765 10^9 cells per liter Standard Deviation 0.54447	—
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Lymphocytes, Month 52	0.580 10^9 cells per liter Standard Deviation 0.26967	—
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Lymphocytes, LTFU Month 1	—	0.316 10^9 cells per liter Standard Deviation 0.68995
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Lymphocytes, LTFU Month 3	—	0.215 10^9 cells per liter Standard Deviation 0.31268
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Lymphocytes, LTFU Month 6	—	0.018 10^9 cells per liter Standard Deviation 0.40276
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Lymphocytes, LTFU Month 9	—	-0.013 10^9 cells per liter Standard Deviation 0.33339
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Lymphocytes, LTFU Month 12	—	0.182 10^9 cells per liter Standard Deviation 0.43906
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Monocytes, Month 2	0.022 10^9 cells per liter Standard Deviation 0.11715	—
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Monocytes, Month 4	0.048 10^9 cells per liter Standard Deviation 0.14689	—
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Monocytes, Month 8	0.026 10^9 cells per liter Standard Deviation 0.16979	—
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Monocytes, Month 12	-0.021 10^9 cells per liter Standard Deviation 0.15241	—
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Monocytes, Month 16	0.060 10^9 cells per liter Standard Deviation 0.14219	—
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Monocytes, Month 20	0.032 10^9 cells per liter Standard Deviation 0.15386	—
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Monocytes, Month 22	0.060 10^9 cells per liter Standard Deviation 0.11314	—
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Monocytes, Month 24	0.039 10^9 cells per liter Standard Deviation 0.15115	—
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Monocytes, Month 26	-0.012 10^9 cells per liter Standard Deviation 0.08585	—
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Monocytes, Month 28	0.093 10^9 cells per liter Standard Deviation 0.15913	—
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Monocytes, Month 30	0.105 10^9 cells per liter Standard Deviation 0.11328	—
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Monocytes, Month 32	0.030 10^9 cells per liter Standard Deviation 0.13926	—
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Monocytes, Month 34	-0.060 10^9 cells per liter Standard Deviation 0.06557	—
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Monocytes, Month 36	0.016 10^9 cells per liter Standard Deviation 0.16850	—
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Monocytes, Month 38	0.195 10^9 cells per liter Standard Deviation 0.12021	—
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Monocytes, Month 40	0.037 10^9 cells per liter Standard Deviation 0.17293	—
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Monocytes, Month 42	0.230 10^9 cells per liter Standard Deviation 0.11358	—
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Monocytes, Month 44	0.003 10^9 cells per liter Standard Deviation 0.14568	—
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Monocytes, Month 46	0.020 10^9 cells per liter Standard Deviation 0.08485	—
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Monocytes, Month 48	0.026 10^9 cells per liter Standard Deviation 0.13077	—
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Monocytes, Month 50	-0.085 10^9 cells per liter Standard Deviation 0.23335	—
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Monocytes, Month 52	0.198 10^9 cells per liter Standard Deviation 0.13556	—
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Monocytes, LTFU Month 1	—	-0.020 10^9 cells per liter Standard Deviation 0.06245
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Monocytes, LTFU Month 3	—	-0.007 10^9 cells per liter Standard Deviation 0.13451
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Monocytes, LTFU Month 6	—	0.038 10^9 cells per liter Standard Deviation 0.09621
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Monocytes, LTFU Month 9	—	-0.031 10^9 cells per liter Standard Deviation 0.09283
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Monocytes, LTFU Month 12	—	0.008 10^9 cells per liter Standard Deviation 0.05541
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Neutrophils, Month 2	-0.197 10^9 cells per liter Standard Deviation 0.99349	—
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Neutrophils, Month 4	0.056 10^9 cells per liter Standard Deviation 1.19574	—
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Neutrophils, Month 8	0.120 10^9 cells per liter Standard Deviation 1.18605	—
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Neutrophils, Month 12	-0.134 10^9 cells per liter Standard Deviation 1.03311	—
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Neutrophils, Month 16	0.129 10^9 cells per liter Standard Deviation 1.23997	—
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Neutrophils, Month 20	-0.158 10^9 cells per liter Standard Deviation 1.09672	—
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Neutrophils, Month 22	-0.890 10^9 cells per liter Standard Deviation 1.14551	—
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Neutrophils, Month 24	0.019 10^9 cells per liter Standard Deviation 1.06166	—
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Neutrophils, Month 26	-0.788 10^9 cells per liter Standard Deviation 0.92394	—
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Neutrophils, Month 28	0.025 10^9 cells per liter Standard Deviation 1.10870	—
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Neutrophils, Month 30	-0.065 10^9 cells per liter Standard Deviation 0.70174	—
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Neutrophils, Month 32	0.265 10^9 cells per liter Standard Deviation 1.45710	—
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Neutrophils, Month 34	-0.310 10^9 cells per liter Standard Deviation 0.32187	—
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Neutrophils, Month 36	0.027 10^9 cells per liter Standard Deviation 1.15025	—
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Neutrophils, Month 38	-0.005 10^9 cells per liter Standard Deviation 1.70413	—
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Neutrophils, Month 40	-0.100 10^9 cells per liter Standard Deviation 1.23231	—
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Neutrophils, Month 42	0.000 10^9 cells per liter Standard Deviation 1.35532	—
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Neutrophils, Month 44	-0.049 10^9 cells per liter Standard Deviation 1.19998	—
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Neutrophils, Month 46	1.015 10^9 cells per liter Standard Deviation 1.30815	—
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Neutrophils, Month 48	0.005 10^9 cells per liter Standard Deviation 1.16199	—
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Neutrophils, Month 50	-1.665 10^9 cells per liter Standard Deviation 1.26572	—
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Neutrophils, Month 52	0.151 10^9 cells per liter Standard Deviation 0.58952	—
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Neutrophils, LTFU Month 1	—	0.448 10^9 cells per liter Standard Deviation 0.47694
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Neutrophils, LTFU Month 3	—	0.932 10^9 cells per liter Standard Deviation 1.35866
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Neutrophils, LTFU Month 6	—	-0.148 10^9 cells per liter Standard Deviation 0.90442
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Neutrophils, LTFU Month 9	—	-0.238 10^9 cells per liter Standard Deviation 0.37408
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Neutrophils, LTFU Month 12	—	-0.462 10^9 cells per liter Standard Deviation 0.51611
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Platelets, Month 2	3.77 10^9 cells per liter Standard Deviation 23.389	—
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Platelets, Month 4	5.40 10^9 cells per liter Standard Deviation 30.889	—
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Platelets, Month 8	3.74 10^9 cells per liter Standard Deviation 24.695	—
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Platelets, Month 12	1.14 10^9 cells per liter Standard Deviation 32.005	—
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Platelets, Month 16	8.37 10^9 cells per liter Standard Deviation 34.613	—
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Platelets, Month 20	4.19 10^9 cells per liter Standard Deviation 33.235	—
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Platelets, Month 22	-10.50 10^9 cells per liter Standard Deviation 24.749	—
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Platelets, Month 24	5.36 10^9 cells per liter Standard Deviation 29.747	—
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Platelets, Month 26	31.00 10^9 cells per liter Standard Deviation 34.728	—
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Platelets, Month 28	7.05 10^9 cells per liter Standard Deviation 36.502	—
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Platelets, Month 30	10.00 10^9 cells per liter Standard Deviation 41.873	—
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Platelets, Month 32	16.29 10^9 cells per liter Standard Deviation 43.183	—
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Platelets, Month 34	24.67 10^9 cells per liter Standard Deviation 28.024	—
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Platelets, Month 36	18.09 10^9 cells per liter Standard Deviation 40.388	—
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Platelets, Month 38	9.50 10^9 cells per liter Standard Deviation 38.891	—
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Platelets, Month 40	12.52 10^9 cells per liter Standard Deviation 33.756	—
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Platelets, Month 42	18.50 10^9 cells per liter Standard Deviation 9.434	—
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Platelets, Month 44	21.07 10^9 cells per liter Standard Deviation 40.846	—
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Platelets, Month 46	28.50 10^9 cells per liter Standard Deviation 14.849	—
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Platelets, Month 48	16.70 10^9 cells per liter Standard Deviation 38.627	—
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Platelets, Month 50	-2.50 10^9 cells per liter Standard Deviation 7.778	—
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Platelets, Month 52	22.50 10^9 cells per liter Standard Deviation 54.357	—
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Platelets, LTFU Month 1	—	10.80 10^9 cells per liter Standard Deviation 25.762
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Platelets, LTFU Month 3	—	7.25 10^9 cells per liter Standard Deviation 19.973
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Platelets, LTFU Month 6	—	-8.00 10^9 cells per liter Standard Deviation 24.503
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Platelets, LTFU Month 9	—	-13.50 10^9 cells per liter Standard Deviation 37.877
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Platelets, LTFU Month 12	—	0.80 10^9 cells per liter Standard Deviation 22.709

SECONDARY outcome

Timeframe: At Months 3, 6, 9 and 12 (compared with Baseline [Day 1]) [Maintenance Phase]

Population: Safety Population

Outcome measures

Outcome measures
Measure	CAB LA + RPV LA Q2M n=7 Participants Eligible participants from LAI116482 (NCT01641809 \[LATTE\]) study who were administered oral CAB 30 milligrams (mg) plus RPV 25 mg and who successfully completed Week 300 received their first dose CAB LA (600 mg) plus RPV LA (900 mg) injections within 2 hours of the final oral dose of LATTE given on the same day. The second loading injections were administered 1 month after initial loading dose, with subsequent injections (CAB LA 600 mg + RPV LA 900 mg) occurring Q2M thereafter. Participants continued to receive the treatment until the study intervention was locally approved and commercially available. Participants who received at least one dose of CAB LA and/or RPV LA and discontinued the CAB LA + RPV LA regimen for any reason entered a 52-week long-term follow-up (LTFU) Phase.	DTG + RPV Eligible participants from LAI116482 (NCT01641809 \[LATTE\]) study who were administered oral CAB 30 mg plus RPV 25 mg and who successfully completed Week 300 received their first dose of the Dolutegravir (DTG) 50 mg plus RPV 25 mg, once daily as oral regimen on Day 1 until Month 12 in the current study. These participants were not eligible for the LTFU phase.
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets for DTG + RPV Arm up to Month 12 [Maintenance Phase] Lymphocytes, Month 3	0.053 10^9 cells per liter Standard Deviation 0.43811	—
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets for DTG + RPV Arm up to Month 12 [Maintenance Phase] Lymphocytes, Month 6	-0.019 10^9 cells per liter Standard Deviation 0.35435	—
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets for DTG + RPV Arm up to Month 12 [Maintenance Phase] Lymphocytes, Month 9	0.085 10^9 cells per liter Standard Deviation 0.59379	—
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets for DTG + RPV Arm up to Month 12 [Maintenance Phase] Lymphocytes, Month 12	-0.001 10^9 cells per liter Standard Deviation 0.39121	—
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets for DTG + RPV Arm up to Month 12 [Maintenance Phase] Monocytes, Month 3	0.098 10^9 cells per liter Standard Deviation 0.08877	—
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets for DTG + RPV Arm up to Month 12 [Maintenance Phase] Monocytes, Month 6	0.020 10^9 cells per liter Standard Deviation 0.07211	—
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets for DTG + RPV Arm up to Month 12 [Maintenance Phase] Monocytes, Month 9	-0.021 10^9 cells per liter Standard Deviation 0.06644	—
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets for DTG + RPV Arm up to Month 12 [Maintenance Phase] Monocytes, Month 12	0.004 10^9 cells per liter Standard Deviation 0.07435	—
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets for DTG + RPV Arm up to Month 12 [Maintenance Phase] Neutrophils, Month 3	0.097 10^9 cells per liter Standard Deviation 0.47612	—
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets for DTG + RPV Arm up to Month 12 [Maintenance Phase] Neutrophils, Month 6	-0.295 10^9 cells per liter Standard Deviation 0.64143	—
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets for DTG + RPV Arm up to Month 12 [Maintenance Phase] Neutrophils, Month 9	0.115 10^9 cells per liter Standard Deviation 1.20803	—
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets for DTG + RPV Arm up to Month 12 [Maintenance Phase] Neutrophils, Month 12	-0.034 10^9 cells per liter Standard Deviation 0.80715	—
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets for DTG + RPV Arm up to Month 12 [Maintenance Phase] Platelets, Month 3	-1.00 10^9 cells per liter Standard Deviation 18.841	—
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets for DTG + RPV Arm up to Month 12 [Maintenance Phase] Platelets, Month 6	-12.57 10^9 cells per liter Standard Deviation 35.298	—
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets for DTG + RPV Arm up to Month 12 [Maintenance Phase] Platelets, Month 9	-21.29 10^9 cells per liter Standard Deviation 61.372	—
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets for DTG + RPV Arm up to Month 12 [Maintenance Phase] Platelets, Month 12	-2.86 10^9 cells per liter Standard Deviation 47.544	—
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets for DTG + RPV Arm up to Month 12 [Maintenance Phase] Basophils, Month 3	-0.008 10^9 cells per liter Standard Deviation 0.01464	—
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets for DTG + RPV Arm up to Month 12 [Maintenance Phase] Basophils, Month 6	-0.010 10^9 cells per liter Standard Deviation 0.02309	—
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets for DTG + RPV Arm up to Month 12 [Maintenance Phase] Basophils, Month 9	-0.005 10^9 cells per liter Standard Deviation 0.01512	—
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets for DTG + RPV Arm up to Month 12 [Maintenance Phase] Basophils, Month 12	-0.010 10^9 cells per liter Standard Deviation 0.01732	—
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets for DTG + RPV Arm up to Month 12 [Maintenance Phase] Eosinophils, Month 3	-0.072 10^9 cells per liter Standard Deviation 0.16307	—
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets for DTG + RPV Arm up to Month 12 [Maintenance Phase] Eosinophils, Month 6	-0.057 10^9 cells per liter Standard Deviation 0.11236	—
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets for DTG + RPV Arm up to Month 12 [Maintenance Phase] Eosinophils, Month 9	-0.051 10^9 cells per liter Standard Deviation 0.10040	—
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets for DTG + RPV Arm up to Month 12 [Maintenance Phase] Eosinophils, Month 12	-0.030 10^9 cells per liter Standard Deviation 0.17127	—
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets for DTG + RPV Arm up to Month 12 [Maintenance Phase] Leukocytes, Month 3	0.014 10^9 cells per liter Standard Deviation 0.7669	—
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets for DTG + RPV Arm up to Month 12 [Maintenance Phase] Leukocytes, Month 6	-0.386 10^9 cells per liter Standard Deviation 0.8355	—
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets for DTG + RPV Arm up to Month 12 [Maintenance Phase] Leukocytes, Month 9	0.014 10^9 cells per liter Standard Deviation 1.3508	—
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets for DTG + RPV Arm up to Month 12 [Maintenance Phase] Leukocytes, Month 12	-0.057 10^9 cells per liter Standard Deviation 0.9343	—

SECONDARY outcome

Timeframe: Up to End of LTFU Phase (compared with Baseline [Day1]), (approximately up to 12 months after exiting the Maintenance Phase)

Population: Safety Population. Only those participants with data available at the specified data points were analyzed.

Blood samples were collected for the analysis of hematology parameter: erythrocytes mean corpuscular volume. 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.

Outcome measures

Outcome measures
Measure	CAB LA + RPV LA Q2M n=90 Participants Eligible participants from LAI116482 (NCT01641809 \[LATTE\]) study who were administered oral CAB 30 milligrams (mg) plus RPV 25 mg and who successfully completed Week 300 received their first dose CAB LA (600 mg) plus RPV LA (900 mg) injections within 2 hours of the final oral dose of LATTE given on the same day. The second loading injections were administered 1 month after initial loading dose, with subsequent injections (CAB LA 600 mg + RPV LA 900 mg) occurring Q2M thereafter. Participants continued to receive the treatment until the study intervention was locally approved and commercially available. Participants who received at least one dose of CAB LA and/or RPV LA and discontinued the CAB LA + RPV LA regimen for any reason entered a 52-week long-term follow-up (LTFU) Phase.	DTG + RPV n=6 Participants Eligible participants from LAI116482 (NCT01641809 \[LATTE\]) study who were administered oral CAB 30 mg plus RPV 25 mg and who successfully completed Week 300 received their first dose of the Dolutegravir (DTG) 50 mg plus RPV 25 mg, once daily as oral regimen on Day 1 until Month 12 in the current study. These participants were not eligible for the LTFU phase.
Change From Baseline in Hematology Parameter: Erythrocyte Mean Corpuscular Volume for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Month 36	-1.78 Femtoliters Standard Deviation 2.592	—
Change From Baseline in Hematology Parameter: Erythrocyte Mean Corpuscular Volume for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Month 38	-1.50 Femtoliters Standard Deviation 0.707	—
Change From Baseline in Hematology Parameter: Erythrocyte Mean Corpuscular Volume for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Month 40	-3.71 Femtoliters Standard Deviation 3.217	—
Change From Baseline in Hematology Parameter: Erythrocyte Mean Corpuscular Volume for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Month 42	-6.75 Femtoliters Standard Deviation 2.630	—
Change From Baseline in Hematology Parameter: Erythrocyte Mean Corpuscular Volume for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Month 44	-2.84 Femtoliters Standard Deviation 3.167	—
Change From Baseline in Hematology Parameter: Erythrocyte Mean Corpuscular Volume for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Month 46	0.50 Femtoliters Standard Deviation 2.121	—
Change From Baseline in Hematology Parameter: Erythrocyte Mean Corpuscular Volume for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Month 48	-2.30 Femtoliters Standard Deviation 3.339	—
Change From Baseline in Hematology Parameter: Erythrocyte Mean Corpuscular Volume for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Month 50	-1.00 Femtoliters Standard Deviation 2.828	—
Change From Baseline in Hematology Parameter: Erythrocyte Mean Corpuscular Volume for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Month 52	-4.00 Femtoliters Standard Deviation 3.847	—
Change From Baseline in Hematology Parameter: Erythrocyte Mean Corpuscular Volume for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase LTFU Month 1	—	-3.20 Femtoliters Standard Deviation 3.962
Change From Baseline in Hematology Parameter: Erythrocyte Mean Corpuscular Volume for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase LTFU Month 3	—	-4.00 Femtoliters Standard Deviation 3.742
Change From Baseline in Hematology Parameter: Erythrocyte Mean Corpuscular Volume for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase LTFU Month 6	—	-0.83 Femtoliters Standard Deviation 4.167
Change From Baseline in Hematology Parameter: Erythrocyte Mean Corpuscular Volume for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase LTFU Month 9	—	-1.33 Femtoliters Standard Deviation 4.457
Change From Baseline in Hematology Parameter: Erythrocyte Mean Corpuscular Volume for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase LTFU Month 12	—	-1.60 Femtoliters Standard Deviation 6.504
Change From Baseline in Hematology Parameter: Erythrocyte Mean Corpuscular Volume for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Month 2	-1.07 Femtoliters Standard Deviation 1.731	—
Change From Baseline in Hematology Parameter: Erythrocyte Mean Corpuscular Volume for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Month 4	-2.04 Femtoliters Standard Deviation 2.186	—
Change From Baseline in Hematology Parameter: Erythrocyte Mean Corpuscular Volume for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Month 8	-1.42 Femtoliters Standard Deviation 2.527	—
Change From Baseline in Hematology Parameter: Erythrocyte Mean Corpuscular Volume for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Month 12	-1.28 Femtoliters Standard Deviation 2.528	—
Change From Baseline in Hematology Parameter: Erythrocyte Mean Corpuscular Volume for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Month 16	-2.91 Femtoliters Standard Deviation 2.379	—
Change From Baseline in Hematology Parameter: Erythrocyte Mean Corpuscular Volume for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Month 20	-1.93 Femtoliters Standard Deviation 2.544	—
Change From Baseline in Hematology Parameter: Erythrocyte Mean Corpuscular Volume for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Month 22	2.00 Femtoliters Standard Deviation 4.243	—
Change From Baseline in Hematology Parameter: Erythrocyte Mean Corpuscular Volume for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Month 24	-1.35 Femtoliters Standard Deviation 2.985	—
Change From Baseline in Hematology Parameter: Erythrocyte Mean Corpuscular Volume for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Month 26	-2.60 Femtoliters Standard Deviation 0.894	—
Change From Baseline in Hematology Parameter: Erythrocyte Mean Corpuscular Volume for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Month 28	-3.18 Femtoliters Standard Deviation 2.918	—
Change From Baseline in Hematology Parameter: Erythrocyte Mean Corpuscular Volume for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Month 30	-6.75 Femtoliters Standard Deviation 2.500	—
Change From Baseline in Hematology Parameter: Erythrocyte Mean Corpuscular Volume for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Month 32	-2.77 Femtoliters Standard Deviation 3.355	—
Change From Baseline in Hematology Parameter: Erythrocyte Mean Corpuscular Volume for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Month 34	-3.67 Femtoliters Standard Deviation 3.512	—

SECONDARY outcome

Timeframe: At Months 3, 6, 9 and 12 (compared with Baseline [Day 1]) [Maintenance Phase]

Population: Safety Population

Outcome measures

Outcome measures
Measure	CAB LA + RPV LA Q2M n=7 Participants Eligible participants from LAI116482 (NCT01641809 \[LATTE\]) study who were administered oral CAB 30 milligrams (mg) plus RPV 25 mg and who successfully completed Week 300 received their first dose CAB LA (600 mg) plus RPV LA (900 mg) injections within 2 hours of the final oral dose of LATTE given on the same day. The second loading injections were administered 1 month after initial loading dose, with subsequent injections (CAB LA 600 mg + RPV LA 900 mg) occurring Q2M thereafter. Participants continued to receive the treatment until the study intervention was locally approved and commercially available. Participants who received at least one dose of CAB LA and/or RPV LA and discontinued the CAB LA + RPV LA regimen for any reason entered a 52-week long-term follow-up (LTFU) Phase.	DTG + RPV Eligible participants from LAI116482 (NCT01641809 \[LATTE\]) study who were administered oral CAB 30 mg plus RPV 25 mg and who successfully completed Week 300 received their first dose of the Dolutegravir (DTG) 50 mg plus RPV 25 mg, once daily as oral regimen on Day 1 until Month 12 in the current study. These participants were not eligible for the LTFU phase.
Change From Baseline in Hematology Parameter: Erythrocyte Mean Corpuscular Volume for DTG + RPV Arm up to Month 12 [Maintenance Phase] Month 3	-1.00 Femtoliters Standard Deviation 1.000	—
Change From Baseline in Hematology Parameter: Erythrocyte Mean Corpuscular Volume for DTG + RPV Arm up to Month 12 [Maintenance Phase] Month 9	0.29 Femtoliters Standard Deviation 1.704	—
Change From Baseline in Hematology Parameter: Erythrocyte Mean Corpuscular Volume for DTG + RPV Arm up to Month 12 [Maintenance Phase] Month 12	-0.14 Femtoliters Standard Deviation 1.952	—
Change From Baseline in Hematology Parameter: Erythrocyte Mean Corpuscular Volume for DTG + RPV Arm up to Month 12 [Maintenance Phase] Month 6	0.14 Femtoliters Standard Deviation 1.574	—

SECONDARY outcome

Timeframe: Up to End of LTFU Phase (compared with Baseline [Day1]), (approximately up to 12 months after exiting the Maintenance Phase)

Population: Safety Population. Only those participants with data available at the specified data points were analyzed.

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. SD=0.0000 is defined as SD resulted below the detectable limit of the assay and approximate to 0.0000.

Outcome measures

Outcome measures
Measure	CAB LA + RPV LA Q2M n=90 Participants Eligible participants from LAI116482 (NCT01641809 \[LATTE\]) study who were administered oral CAB 30 milligrams (mg) plus RPV 25 mg and who successfully completed Week 300 received their first dose CAB LA (600 mg) plus RPV LA (900 mg) injections within 2 hours of the final oral dose of LATTE given on the same day. The second loading injections were administered 1 month after initial loading dose, with subsequent injections (CAB LA 600 mg + RPV LA 900 mg) occurring Q2M thereafter. Participants continued to receive the treatment until the study intervention was locally approved and commercially available. Participants who received at least one dose of CAB LA and/or RPV LA and discontinued the CAB LA + RPV LA regimen for any reason entered a 52-week long-term follow-up (LTFU) Phase.	DTG + RPV n=6 Participants Eligible participants from LAI116482 (NCT01641809 \[LATTE\]) study who were administered oral CAB 30 mg plus RPV 25 mg and who successfully completed Week 300 received their first dose of the Dolutegravir (DTG) 50 mg plus RPV 25 mg, once daily as oral regimen on Day 1 until Month 12 in the current study. These participants were not eligible for the LTFU phase.
Change From Baseline in Hematology Parameter: Erythrocytes for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Month 20	-0.020 10^12 cells per liter Standard Deviation 0.2754	—
Change From Baseline in Hematology Parameter: Erythrocytes for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Month 22	-0.450 10^12 cells per liter Standard Deviation 0.0707	—
Change From Baseline in Hematology Parameter: Erythrocytes for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Month 24	-0.061 10^12 cells per liter Standard Deviation 0.3181	—
Change From Baseline in Hematology Parameter: Erythrocytes for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Month 26	0.020 10^12 cells per liter Standard Deviation 0.1924	—
Change From Baseline in Hematology Parameter: Erythrocytes for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Month 28	-0.113 10^12 cells per liter Standard Deviation 0.2949	—
Change From Baseline in Hematology Parameter: Erythrocytes for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Month 30	-0.075 10^12 cells per liter Standard Deviation 0.0500	—
Change From Baseline in Hematology Parameter: Erythrocytes for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Month 32	-0.087 10^12 cells per liter Standard Deviation 0.3801	—
Change From Baseline in Hematology Parameter: Erythrocytes for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Month 34	-0.233 10^12 cells per liter Standard Deviation 0.1155	—
Change From Baseline in Hematology Parameter: Erythrocytes for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Month 36	-0.090 10^12 cells per liter Standard Deviation 0.3591	—
Change From Baseline in Hematology Parameter: Erythrocytes for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Month 38	-0.350 10^12 cells per liter Standard Deviation 0.3536	—
Change From Baseline in Hematology Parameter: Erythrocytes for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Month 40	-0.056 10^12 cells per liter Standard Deviation 0.3528	—
Change From Baseline in Hematology Parameter: Erythrocytes for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Month 42	0.025 10^12 cells per liter Standard Deviation 0.4272	—
Change From Baseline in Hematology Parameter: Erythrocytes for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Month 44	-0.072 10^12 cells per liter Standard Deviation 0.4086	—
Change From Baseline in Hematology Parameter: Erythrocytes for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Month 46	-0.100 10^12 cells per liter Standard Deviation 0.1414	—
Change From Baseline in Hematology Parameter: Erythrocytes for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Month 48	-0.090 10^12 cells per liter Standard Deviation 0.3196	—
Change From Baseline in Hematology Parameter: Erythrocytes for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Month 50	-0.300 10^12 cells per liter Standard Deviation 0.0000	—
Change From Baseline in Hematology Parameter: Erythrocytes for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Month 52	-0.200 10^12 cells per liter Standard Deviation 0.5177	—
Change From Baseline in Hematology Parameter: Erythrocytes for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase LTFU Month 1	—	-0.160 10^12 cells per liter Standard Deviation 0.2408
Change From Baseline in Hematology Parameter: Erythrocytes for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Month 2	-0.064 10^12 cells per liter Standard Deviation 0.2773	—
Change From Baseline in Hematology Parameter: Erythrocytes for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Month 4	-0.021 10^12 cells per liter Standard Deviation 0.3185	—
Change From Baseline in Hematology Parameter: Erythrocytes for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Month 8	-0.085 10^12 cells per liter Standard Deviation 0.3164	—
Change From Baseline in Hematology Parameter: Erythrocytes for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Month 12	-0.063 10^12 cells per liter Standard Deviation 0.3279	—
Change From Baseline in Hematology Parameter: Erythrocytes for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Month 16	-0.034 10^12 cells per liter Standard Deviation 0.3014	—
Change From Baseline in Hematology Parameter: Erythrocytes for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase LTFU Month 3	—	0.075 10^12 cells per liter Standard Deviation 0.2217
Change From Baseline in Hematology Parameter: Erythrocytes for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase LTFU Month 6	—	-0.250 10^12 cells per liter Standard Deviation 0.2811
Change From Baseline in Hematology Parameter: Erythrocytes for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase LTFU Month 9	—	-0.433 10^12 cells per liter Standard Deviation 0.2944
Change From Baseline in Hematology Parameter: Erythrocytes for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase LTFU Month 12	—	-0.160 10^12 cells per liter Standard Deviation 0.4722

SECONDARY outcome

Timeframe: At Months 3, 6, 9 and 12 (compared with Baseline [Day 1]) [Maintenance Phase]

Population: Safety Population

Outcome measures

Outcome measures
Measure	CAB LA + RPV LA Q2M n=7 Participants Eligible participants from LAI116482 (NCT01641809 \[LATTE\]) study who were administered oral CAB 30 milligrams (mg) plus RPV 25 mg and who successfully completed Week 300 received their first dose CAB LA (600 mg) plus RPV LA (900 mg) injections within 2 hours of the final oral dose of LATTE given on the same day. The second loading injections were administered 1 month after initial loading dose, with subsequent injections (CAB LA 600 mg + RPV LA 900 mg) occurring Q2M thereafter. Participants continued to receive the treatment until the study intervention was locally approved and commercially available. Participants who received at least one dose of CAB LA and/or RPV LA and discontinued the CAB LA + RPV LA regimen for any reason entered a 52-week long-term follow-up (LTFU) Phase.	DTG + RPV Eligible participants from LAI116482 (NCT01641809 \[LATTE\]) study who were administered oral CAB 30 mg plus RPV 25 mg and who successfully completed Week 300 received their first dose of the Dolutegravir (DTG) 50 mg plus RPV 25 mg, once daily as oral regimen on Day 1 until Month 12 in the current study. These participants were not eligible for the LTFU phase.
Change From Baseline in Hematology Parameter: Erythrocytes for DTG + RPV Arm up to Month 12 [Maintenance Phase] Month 3	-0.114 10^12 cells per liter Standard Deviation 0.1464	—
Change From Baseline in Hematology Parameter: Erythrocytes for DTG + RPV Arm up to Month 12 [Maintenance Phase] Month 6	-0.171 10^12 cells per liter Standard Deviation 0.1113	—
Change From Baseline in Hematology Parameter: Erythrocytes for DTG + RPV Arm up to Month 12 [Maintenance Phase] Month 9	-0.171 10^12 cells per liter Standard Deviation 0.1704	—
Change From Baseline in Hematology Parameter: Erythrocytes for DTG + RPV Arm up to Month 12 [Maintenance Phase] Month 12	-0.143 10^12 cells per liter Standard Deviation 0.0976	—

SECONDARY outcome

Timeframe: Up to End of LTFU Phase (compared with Baseline [Day1]), (approximately up to 12 months after exiting the Maintenance Phase)

Population: Safety Population. Only those participants with data available at the specified data points were analyzed.

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.

Outcome measures

Outcome measures
Measure	CAB LA + RPV LA Q2M n=90 Participants Eligible participants from LAI116482 (NCT01641809 \[LATTE\]) study who were administered oral CAB 30 milligrams (mg) plus RPV 25 mg and who successfully completed Week 300 received their first dose CAB LA (600 mg) plus RPV LA (900 mg) injections within 2 hours of the final oral dose of LATTE given on the same day. The second loading injections were administered 1 month after initial loading dose, with subsequent injections (CAB LA 600 mg + RPV LA 900 mg) occurring Q2M thereafter. Participants continued to receive the treatment until the study intervention was locally approved and commercially available. Participants who received at least one dose of CAB LA and/or RPV LA and discontinued the CAB LA + RPV LA regimen for any reason entered a 52-week long-term follow-up (LTFU) Phase.	DTG + RPV n=6 Participants Eligible participants from LAI116482 (NCT01641809 \[LATTE\]) study who were administered oral CAB 30 mg plus RPV 25 mg and who successfully completed Week 300 received their first dose of the Dolutegravir (DTG) 50 mg plus RPV 25 mg, once daily as oral regimen on Day 1 until Month 12 in the current study. These participants were not eligible for the LTFU phase.
Change From Baseline in Hematology Parameter: Hematocrit for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Month 2	-0.011 Proportion of red blood cells in blood Standard Deviation 0.02762	—
Change From Baseline in Hematology Parameter: Hematocrit for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Month 4	-0.012 Proportion of red blood cells in blood Standard Deviation 0.02935	—
Change From Baseline in Hematology Parameter: Hematocrit for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Month 8	-0.015 Proportion of red blood cells in blood Standard Deviation 0.02809	—
Change From Baseline in Hematology Parameter: Hematocrit for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Month 12	-0.011 Proportion of red blood cells in blood Standard Deviation 0.02760	—
Change From Baseline in Hematology Parameter: Hematocrit for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Month 16	-0.017 Proportion of red blood cells in blood Standard Deviation 0.02824	—
Change From Baseline in Hematology Parameter: Hematocrit for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Month 20	-0.011 Proportion of red blood cells in blood Standard Deviation 0.02731	—
Change From Baseline in Hematology Parameter: Hematocrit for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Month 22	-0.032 Proportion of red blood cells in blood Standard Deviation 0.00707	—
Change From Baseline in Hematology Parameter: Hematocrit for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Month 24	-0.012 Proportion of red blood cells in blood Standard Deviation 0.02668	—
Change From Baseline in Hematology Parameter: Hematocrit for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Month 26	-0.010 Proportion of red blood cells in blood Standard Deviation 0.01723	—
Change From Baseline in Hematology Parameter: Hematocrit for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Month 28	-0.026 Proportion of red blood cells in blood Standard Deviation 0.02663	—
Change From Baseline in Hematology Parameter: Hematocrit for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Month 30	-0.040 Proportion of red blood cells in blood Standard Deviation 0.00822	—
Change From Baseline in Hematology Parameter: Hematocrit for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Month 32	-0.022 Proportion of red blood cells in blood Standard Deviation 0.03499	—
Change From Baseline in Hematology Parameter: Hematocrit for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Month 34	-0.037 Proportion of red blood cells in blood Standard Deviation 0.01442	—
Change From Baseline in Hematology Parameter: Hematocrit for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Month 36	-0.017 Proportion of red blood cells in blood Standard Deviation 0.03340	—
Change From Baseline in Hematology Parameter: Hematocrit for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Month 38	-0.034 Proportion of red blood cells in blood Standard Deviation 0.02192	—
Change From Baseline in Hematology Parameter: Hematocrit for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Month 40	-0.023 Proportion of red blood cells in blood Standard Deviation 0.03088	—
Change From Baseline in Hematology Parameter: Hematocrit for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Month 42	-0.025 Proportion of red blood cells in blood Standard Deviation 0.03938	—
Change From Baseline in Hematology Parameter: Hematocrit for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Month 44	-0.021 Proportion of red blood cells in blood Standard Deviation 0.03702	—
Change From Baseline in Hematology Parameter: Hematocrit for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Month 46	-0.006 Proportion of red blood cells in blood Standard Deviation 0.00353	—
Change From Baseline in Hematology Parameter: Hematocrit for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Month 48	-0.019 Proportion of red blood cells in blood Standard Deviation 0.03114	—
Change From Baseline in Hematology Parameter: Hematocrit for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Month 50	-0.033 Proportion of red blood cells in blood Standard Deviation 0.01697	—
Change From Baseline in Hematology Parameter: Hematocrit for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Month 52	-0.041 Proportion of red blood cells in blood Standard Deviation 0.04229	—
Change From Baseline in Hematology Parameter: Hematocrit for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase LTFU Month 1	—	-0.028 Proportion of red blood cells in blood Standard Deviation 0.01864
Change From Baseline in Hematology Parameter: Hematocrit for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase LTFU Month 3	—	-0.012 Proportion of red blood cells in blood Standard Deviation 0.02102
Change From Baseline in Hematology Parameter: Hematocrit for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase LTFU Month 6	—	-0.027 Proportion of red blood cells in blood Standard Deviation 0.03065
Change From Baseline in Hematology Parameter: Hematocrit for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase LTFU Month 9	—	-0.044 Proportion of red blood cells in blood Standard Deviation 0.02265
Change From Baseline in Hematology Parameter: Hematocrit for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase LTFU Month 12	—	-0.022 Proportion of red blood cells in blood Standard Deviation 0.03928

SECONDARY outcome

Timeframe: At Months 3, 6, 9 and 12 (compared with Baseline [Day 1]) [Maintenance Phase]

Population: Safety Population

Outcome measures

Outcome measures
Measure	CAB LA + RPV LA Q2M n=7 Participants Eligible participants from LAI116482 (NCT01641809 \[LATTE\]) study who were administered oral CAB 30 milligrams (mg) plus RPV 25 mg and who successfully completed Week 300 received their first dose CAB LA (600 mg) plus RPV LA (900 mg) injections within 2 hours of the final oral dose of LATTE given on the same day. The second loading injections were administered 1 month after initial loading dose, with subsequent injections (CAB LA 600 mg + RPV LA 900 mg) occurring Q2M thereafter. Participants continued to receive the treatment until the study intervention was locally approved and commercially available. Participants who received at least one dose of CAB LA and/or RPV LA and discontinued the CAB LA + RPV LA regimen for any reason entered a 52-week long-term follow-up (LTFU) Phase.	DTG + RPV Eligible participants from LAI116482 (NCT01641809 \[LATTE\]) study who were administered oral CAB 30 mg plus RPV 25 mg and who successfully completed Week 300 received their first dose of the Dolutegravir (DTG) 50 mg plus RPV 25 mg, once daily as oral regimen on Day 1 until Month 12 in the current study. These participants were not eligible for the LTFU phase.
Change From Baseline in Hematology Parameter: Hematocrit for DTG + RPV Arm up to Month 12 [Maintenance Phase] Month 3	-0.015 Proportion of red blood cells in blood Standard Deviation 0.01516	—
Change From Baseline in Hematology Parameter: Hematocrit for DTG + RPV Arm up to Month 12 [Maintenance Phase] Month 6	-0.013 Proportion of red blood cells in blood Standard Deviation 0.01287	—
Change From Baseline in Hematology Parameter: Hematocrit for DTG + RPV Arm up to Month 12 [Maintenance Phase] Month 9	-0.013 Proportion of red blood cells in blood Standard Deviation 0.01332	—
Change From Baseline in Hematology Parameter: Hematocrit for DTG + RPV Arm up to Month 12 [Maintenance Phase] Month 12	-0.013 Proportion of red blood cells in blood Standard Deviation 0.01491	—

SECONDARY outcome

Timeframe: Up to End of LTFU Phase (compared with Baseline [Day1]), (approximately up to 12 months after exiting the Maintenance Phase)

Population: Safety Population. Only those participants with data available at the specified data points were analyzed.

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.

Outcome measures

Outcome measures
Measure	CAB LA + RPV LA Q2M n=90 Participants Eligible participants from LAI116482 (NCT01641809 \[LATTE\]) study who were administered oral CAB 30 milligrams (mg) plus RPV 25 mg and who successfully completed Week 300 received their first dose CAB LA (600 mg) plus RPV LA (900 mg) injections within 2 hours of the final oral dose of LATTE given on the same day. The second loading injections were administered 1 month after initial loading dose, with subsequent injections (CAB LA 600 mg + RPV LA 900 mg) occurring Q2M thereafter. Participants continued to receive the treatment until the study intervention was locally approved and commercially available. Participants who received at least one dose of CAB LA and/or RPV LA and discontinued the CAB LA + RPV LA regimen for any reason entered a 52-week long-term follow-up (LTFU) Phase.	DTG + RPV n=6 Participants Eligible participants from LAI116482 (NCT01641809 \[LATTE\]) study who were administered oral CAB 30 mg plus RPV 25 mg and who successfully completed Week 300 received their first dose of the Dolutegravir (DTG) 50 mg plus RPV 25 mg, once daily as oral regimen on Day 1 until Month 12 in the current study. These participants were not eligible for the LTFU phase.
Change From Baseline in Hematology Parameter: Hemoglobin for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Month 2	-2.11 Grams per liter Standard Deviation 8.801	—
Change From Baseline in Hematology Parameter: Hemoglobin for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Month 4	-1.57 Grams per liter Standard Deviation 9.433	—
Change From Baseline in Hematology Parameter: Hemoglobin for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Month 8	-3.29 Grams per liter Standard Deviation 8.542	—
Change From Baseline in Hematology Parameter: Hemoglobin for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Month 12	-3.19 Grams per liter Standard Deviation 8.814	—
Change From Baseline in Hematology Parameter: Hemoglobin for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Month 16	-3.44 Grams per liter Standard Deviation 8.293	—
Change From Baseline in Hematology Parameter: Hemoglobin for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Month 20	-2.30 Grams per liter Standard Deviation 8.054	—
Change From Baseline in Hematology Parameter: Hemoglobin for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Month 22	-13.00 Grams per liter Standard Deviation 1.414	—
Change From Baseline in Hematology Parameter: Hemoglobin for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Month 24	-3.35 Grams per liter Standard Deviation 8.671	—
Change From Baseline in Hematology Parameter: Hemoglobin for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Month 26	0.60 Grams per liter Standard Deviation 6.804	—
Change From Baseline in Hematology Parameter: Hemoglobin for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Month 28	-4.06 Grams per liter Standard Deviation 8.281	—
Change From Baseline in Hematology Parameter: Hemoglobin for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Month 30	-4.00 Grams per liter Standard Deviation 4.243	—
Change From Baseline in Hematology Parameter: Hemoglobin for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Month 32	-4.13 Grams per liter Standard Deviation 11.183	—
Change From Baseline in Hematology Parameter: Hemoglobin for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Month 34	-8.33 Grams per liter Standard Deviation 3.215	—
Change From Baseline in Hematology Parameter: Hemoglobin for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Month 36	-4.86 Grams per liter Standard Deviation 10.749	—
Change From Baseline in Hematology Parameter: Hemoglobin for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Month 38	-8.50 Grams per liter Standard Deviation 6.364	—
Change From Baseline in Hematology Parameter: Hemoglobin for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Month 40	-4.51 Grams per liter Standard Deviation 9.701	—
Change From Baseline in Hematology Parameter: Hemoglobin for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Month 42	-3.50 Grams per liter Standard Deviation 11.358	—
Change From Baseline in Hematology Parameter: Hemoglobin for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Month 44	-6.27 Grams per liter Standard Deviation 11.766	—
Change From Baseline in Hematology Parameter: Hemoglobin for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Month 46	-6.50 Grams per liter Standard Deviation 2.121	—
Change From Baseline in Hematology Parameter: Hemoglobin for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Month 48	-7.41 Grams per liter Standard Deviation 9.341	—
Change From Baseline in Hematology Parameter: Hemoglobin for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Month 50	-9.00 Grams per liter Standard Deviation 9.899	—
Change From Baseline in Hematology Parameter: Hemoglobin for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase Month 52	-6.67 Grams per liter Standard Deviation 11.605	—
Change From Baseline in Hematology Parameter: Hemoglobin for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase LTFU Month 1	—	-3.40 Grams per liter Standard Deviation 7.956
Change From Baseline in Hematology Parameter: Hemoglobin for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase LTFU Month 3	—	1.50 Grams per liter Standard Deviation 3.697
Change From Baseline in Hematology Parameter: Hemoglobin for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase LTFU Month 6	—	-4.67 Grams per liter Standard Deviation 9.993
Change From Baseline in Hematology Parameter: Hemoglobin for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase LTFU Month 9	—	-10.00 Grams per liter Standard Deviation 6.000
Change From Baseline in Hematology Parameter: Hemoglobin for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase LTFU Month 12	—	-1.20 Grams per liter Standard Deviation 14.464

SECONDARY outcome

Timeframe: At Months 3, 6, 9 and 12 (compared with Baseline [Day 1]) [Maintenance Phase]

Population: Safety Population

Outcome measures

Outcome measures
Measure	CAB LA + RPV LA Q2M n=7 Participants Eligible participants from LAI116482 (NCT01641809 \[LATTE\]) study who were administered oral CAB 30 milligrams (mg) plus RPV 25 mg and who successfully completed Week 300 received their first dose CAB LA (600 mg) plus RPV LA (900 mg) injections within 2 hours of the final oral dose of LATTE given on the same day. The second loading injections were administered 1 month after initial loading dose, with subsequent injections (CAB LA 600 mg + RPV LA 900 mg) occurring Q2M thereafter. Participants continued to receive the treatment until the study intervention was locally approved and commercially available. Participants who received at least one dose of CAB LA and/or RPV LA and discontinued the CAB LA + RPV LA regimen for any reason entered a 52-week long-term follow-up (LTFU) Phase.	DTG + RPV Eligible participants from LAI116482 (NCT01641809 \[LATTE\]) study who were administered oral CAB 30 mg plus RPV 25 mg and who successfully completed Week 300 received their first dose of the Dolutegravir (DTG) 50 mg plus RPV 25 mg, once daily as oral regimen on Day 1 until Month 12 in the current study. These participants were not eligible for the LTFU phase.
Change From Baseline in Hematology Parameter: Hemoglobin for DTG + RPV Arm up to Month 12 [Maintenance Phase] Month 6	-4.29 Grams per liter Standard Deviation 2.928	—
Change From Baseline in Hematology Parameter: Hemoglobin for DTG + RPV Arm up to Month 12 [Maintenance Phase] Month 9	-4.86 Grams per liter Standard Deviation 3.891	—
Change From Baseline in Hematology Parameter: Hemoglobin for DTG + RPV Arm up to Month 12 [Maintenance Phase] Month 12	-4.57 Grams per liter Standard Deviation 5.062	—
Change From Baseline in Hematology Parameter: Hemoglobin for DTG + RPV Arm up to Month 12 [Maintenance Phase] Month 3	-3.57 Grams per liter Standard Deviation 6.554	—

SECONDARY outcome

Timeframe: At Baseline (Day 1)

Population: Safety Population. Only those participants with data available at the specified data points were analyzed.

Urine samples were collected for the analysis of urine albumin/creatinine ratio and urine protein/creatinine ratio.

Outcome measures

Outcome measures
Measure	CAB LA + RPV LA Q2M n=90 Participants Eligible participants from LAI116482 (NCT01641809 \[LATTE\]) study who were administered oral CAB 30 milligrams (mg) plus RPV 25 mg and who successfully completed Week 300 received their first dose CAB LA (600 mg) plus RPV LA (900 mg) injections within 2 hours of the final oral dose of LATTE given on the same day. The second loading injections were administered 1 month after initial loading dose, with subsequent injections (CAB LA 600 mg + RPV LA 900 mg) occurring Q2M thereafter. Participants continued to receive the treatment until the study intervention was locally approved and commercially available. Participants who received at least one dose of CAB LA and/or RPV LA and discontinued the CAB LA + RPV LA regimen for any reason entered a 52-week long-term follow-up (LTFU) Phase.	DTG + RPV n=7 Participants Eligible participants from LAI116482 (NCT01641809 \[LATTE\]) study who were administered oral CAB 30 mg plus RPV 25 mg and who successfully completed Week 300 received their first dose of the Dolutegravir (DTG) 50 mg plus RPV 25 mg, once daily as oral regimen on Day 1 until Month 12 in the current study. These participants were not eligible for the LTFU phase.
Urine Albumin/Creatinine Ratio and Urine Protein/Creatinine Ratio Urine albumin/creatinine ratio	0.7 Ratio Standard Deviation 0.980	0.4 Ratio Standard Deviation 0.122
Urine Albumin/Creatinine Ratio and Urine Protein/Creatinine Ratio Urine protein/creatinine ratio	7.6 Ratio Standard Deviation 4.528	9.1 Ratio Standard Deviation 7.237

SECONDARY outcome

Timeframe: At Baseline (Day 1)

Population: Safety Population.

Urine samples were collected for the analysis of urine creatinine.

Outcome measures

Outcome measures
Measure	CAB LA + RPV LA Q2M n=90 Participants Eligible participants from LAI116482 (NCT01641809 \[LATTE\]) study who were administered oral CAB 30 milligrams (mg) plus RPV 25 mg and who successfully completed Week 300 received their first dose CAB LA (600 mg) plus RPV LA (900 mg) injections within 2 hours of the final oral dose of LATTE given on the same day. The second loading injections were administered 1 month after initial loading dose, with subsequent injections (CAB LA 600 mg + RPV LA 900 mg) occurring Q2M thereafter. Participants continued to receive the treatment until the study intervention was locally approved and commercially available. Participants who received at least one dose of CAB LA and/or RPV LA and discontinued the CAB LA + RPV LA regimen for any reason entered a 52-week long-term follow-up (LTFU) Phase.	DTG + RPV n=7 Participants Eligible participants from LAI116482 (NCT01641809 \[LATTE\]) study who were administered oral CAB 30 mg plus RPV 25 mg and who successfully completed Week 300 received their first dose of the Dolutegravir (DTG) 50 mg plus RPV 25 mg, once daily as oral regimen on Day 1 until Month 12 in the current study. These participants were not eligible for the LTFU phase.
Absolute Values of Urine Creatinine	14875.6 Micromoles per liter Standard Deviation 9267.95	12112.9 Micromoles per liter Standard Deviation 7186.16

SECONDARY outcome

Timeframe: At Baseline (Day 1)

Population: Safety Population

Urine samples were collected for the analysis of urine phosphate.

Outcome measures

Outcome measures
Measure	CAB LA + RPV LA Q2M n=90 Participants Eligible participants from LAI116482 (NCT01641809 \[LATTE\]) study who were administered oral CAB 30 milligrams (mg) plus RPV 25 mg and who successfully completed Week 300 received their first dose CAB LA (600 mg) plus RPV LA (900 mg) injections within 2 hours of the final oral dose of LATTE given on the same day. The second loading injections were administered 1 month after initial loading dose, with subsequent injections (CAB LA 600 mg + RPV LA 900 mg) occurring Q2M thereafter. Participants continued to receive the treatment until the study intervention was locally approved and commercially available. Participants who received at least one dose of CAB LA and/or RPV LA and discontinued the CAB LA + RPV LA regimen for any reason entered a 52-week long-term follow-up (LTFU) Phase.	DTG + RPV n=7 Participants Eligible participants from LAI116482 (NCT01641809 \[LATTE\]) study who were administered oral CAB 30 mg plus RPV 25 mg and who successfully completed Week 300 received their first dose of the Dolutegravir (DTG) 50 mg plus RPV 25 mg, once daily as oral regimen on Day 1 until Month 12 in the current study. These participants were not eligible for the LTFU phase.
Absolute Values of Urine Phosphate	18.2 Millimoles per liter Standard Deviation 15.306	14.7 Millimoles per liter Standard Deviation 6.917

SECONDARY outcome

Timeframe: At Baseline (Day 1)

Population: Safety Population. Only those participants with data available at specified time points has been presented.

Urine samples were collected for the analysis of urine specific gravity. Urine specific gravity is a measure of the concentration of solutes in the urine and provides information on the kidney's ability to concentrate urine.

Outcome measures

Outcome measures
Measure	CAB LA + RPV LA Q2M n=89 Participants Eligible participants from LAI116482 (NCT01641809 \[LATTE\]) study who were administered oral CAB 30 milligrams (mg) plus RPV 25 mg and who successfully completed Week 300 received their first dose CAB LA (600 mg) plus RPV LA (900 mg) injections within 2 hours of the final oral dose of LATTE given on the same day. The second loading injections were administered 1 month after initial loading dose, with subsequent injections (CAB LA 600 mg + RPV LA 900 mg) occurring Q2M thereafter. Participants continued to receive the treatment until the study intervention was locally approved and commercially available. Participants who received at least one dose of CAB LA and/or RPV LA and discontinued the CAB LA + RPV LA regimen for any reason entered a 52-week long-term follow-up (LTFU) Phase.	DTG + RPV n=7 Participants Eligible participants from LAI116482 (NCT01641809 \[LATTE\]) study who were administered oral CAB 30 mg plus RPV 25 mg and who successfully completed Week 300 received their first dose of the Dolutegravir (DTG) 50 mg plus RPV 25 mg, once daily as oral regimen on Day 1 until Month 12 in the current study. These participants were not eligible for the LTFU phase.
Absolute Values of Urine Specific Gravity	1.0 Ratio Standard Deviation 0.007	1.0 Ratio Standard Deviation 0.007

SECONDARY outcome

Timeframe: At Baseline (Day 1)

Population: Safety Population. Only those participants with data available at specified time points has been presented.

Urine samples were collected for analysis of urine pH. pH is calculated on a scale of 0 to 14, values on the scale refer to the degree of alkalinity or acidity. A pH of 7 is neutral. A pH of less than 7 is acidic and a pH of greater than 7 is basic. Normal urine has a slightly acidic pH (5.0-6.0).

Outcome measures

Outcome measures
Measure	CAB LA + RPV LA Q2M n=89 Participants Eligible participants from LAI116482 (NCT01641809 \[LATTE\]) study who were administered oral CAB 30 milligrams (mg) plus RPV 25 mg and who successfully completed Week 300 received their first dose CAB LA (600 mg) plus RPV LA (900 mg) injections within 2 hours of the final oral dose of LATTE given on the same day. The second loading injections were administered 1 month after initial loading dose, with subsequent injections (CAB LA 600 mg + RPV LA 900 mg) occurring Q2M thereafter. Participants continued to receive the treatment until the study intervention was locally approved and commercially available. Participants who received at least one dose of CAB LA and/or RPV LA and discontinued the CAB LA + RPV LA regimen for any reason entered a 52-week long-term follow-up (LTFU) Phase.	DTG + RPV n=7 Participants Eligible participants from LAI116482 (NCT01641809 \[LATTE\]) study who were administered oral CAB 30 mg plus RPV 25 mg and who successfully completed Week 300 received their first dose of the Dolutegravir (DTG) 50 mg plus RPV 25 mg, once daily as oral regimen on Day 1 until Month 12 in the current study. These participants were not eligible for the LTFU phase.
Absolute Values of Urine Potential of Hydrogen (pH)	6.1 pH Standard Deviation 0.739	6.5 pH Standard Deviation 0.345

SECONDARY outcome

Timeframe: Up to End of LTFU Phase (approximately up to 12 months after exiting the Maintenance Phase)

Population: Safety Population. Only those participants reporting confirmed virologic failure were analyzed.

Plasma samples were collected and analyzed for genotypic resistance from participants who met confirmed virologic withdrawal criteria.

Outcome measures

Outcome measures
Measure	CAB LA + RPV LA Q2M n=1 Participants Eligible participants from LAI116482 (NCT01641809 \[LATTE\]) study who were administered oral CAB 30 milligrams (mg) plus RPV 25 mg and who successfully completed Week 300 received their first dose CAB LA (600 mg) plus RPV LA (900 mg) injections within 2 hours of the final oral dose of LATTE given on the same day. The second loading injections were administered 1 month after initial loading dose, with subsequent injections (CAB LA 600 mg + RPV LA 900 mg) occurring Q2M thereafter. Participants continued to receive the treatment until the study intervention was locally approved and commercially available. Participants who received at least one dose of CAB LA and/or RPV LA and discontinued the CAB LA + RPV LA regimen for any reason entered a 52-week long-term follow-up (LTFU) Phase.	DTG + RPV Eligible participants from LAI116482 (NCT01641809 \[LATTE\]) study who were administered oral CAB 30 mg plus RPV 25 mg and who successfully completed Week 300 received their first dose of the Dolutegravir (DTG) 50 mg plus RPV 25 mg, once daily as oral regimen on Day 1 until Month 12 in the current study. These participants were not eligible for the LTFU phase.
Number of Participants With Treatment Emergent Genotypic Resistance	0 Participants	—

SECONDARY outcome

Timeframe: Up to End of LTFU Phase (approximately up to 12 months after exiting the Maintenance Phase)

Population: Safety Population. Only those participants reporting confirmed virologic failure were analyzed.

Plasma samples were collected and analyzed from participants who met confirmed virologic withdrawal criteria.

Outcome measures

Outcome measures
Measure	CAB LA + RPV LA Q2M n=1 Participants Eligible participants from LAI116482 (NCT01641809 \[LATTE\]) study who were administered oral CAB 30 milligrams (mg) plus RPV 25 mg and who successfully completed Week 300 received their first dose CAB LA (600 mg) plus RPV LA (900 mg) injections within 2 hours of the final oral dose of LATTE given on the same day. The second loading injections were administered 1 month after initial loading dose, with subsequent injections (CAB LA 600 mg + RPV LA 900 mg) occurring Q2M thereafter. Participants continued to receive the treatment until the study intervention was locally approved and commercially available. Participants who received at least one dose of CAB LA and/or RPV LA and discontinued the CAB LA + RPV LA regimen for any reason entered a 52-week long-term follow-up (LTFU) Phase.	DTG + RPV Eligible participants from LAI116482 (NCT01641809 \[LATTE\]) study who were administered oral CAB 30 mg plus RPV 25 mg and who successfully completed Week 300 received their first dose of the Dolutegravir (DTG) 50 mg plus RPV 25 mg, once daily as oral regimen on Day 1 until Month 12 in the current study. These participants were not eligible for the LTFU phase.
Number of Participants With Treatment Emergent Phenotypic Resistance	0 Participants	—

SECONDARY outcome

Timeframe: At Months 6 and 12 (compared with Baseline [Day 1]) [Maintenance Phase]

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

HIVDQoL includes 2 overview items and 26 domain items. The 2 overview items: Item 1: 3(excellent) to -3(extremely bad); Higher score indicates better quality of life. Item 2: -3(very much better) to 1(worse); Lower score indicates better quality of life. The Weighted Impact Score (WIS) was calculated for the 26 domain items by multiplying impact score(IS) (-3\[maximum {max.} negative impact\] to +1\[max. positive impact\] by the corresponding importance score (3 \[very important\] to 0\[not all important\]). Average Weighted Impact (AWI) score was calculated by summing individual weighted IS and dividing by the number of domain items. The ranges of WIS and average IS were from -9(max. negative) to +3(max. positive);higher score indicates positive impact. Change from Baseline was defined as post-dose visit value minus Baseline value (latest pre-treatment assessment with a non-missing value). SD=0.00 is defined as SD resulted below the detectable limit of the assay and approximate to 0.00.

Outcome measures

Outcome measures
Measure	CAB LA + RPV LA Q2M n=90 Participants Eligible participants from LAI116482 (NCT01641809 \[LATTE\]) study who were administered oral CAB 30 milligrams (mg) plus RPV 25 mg and who successfully completed Week 300 received their first dose CAB LA (600 mg) plus RPV LA (900 mg) injections within 2 hours of the final oral dose of LATTE given on the same day. The second loading injections were administered 1 month after initial loading dose, with subsequent injections (CAB LA 600 mg + RPV LA 900 mg) occurring Q2M thereafter. Participants continued to receive the treatment until the study intervention was locally approved and commercially available. Participants who received at least one dose of CAB LA and/or RPV LA and discontinued the CAB LA + RPV LA regimen for any reason entered a 52-week long-term follow-up (LTFU) Phase.	DTG + RPV n=7 Participants Eligible participants from LAI116482 (NCT01641809 \[LATTE\]) study who were administered oral CAB 30 mg plus RPV 25 mg and who successfully completed Week 300 received their first dose of the Dolutegravir (DTG) 50 mg plus RPV 25 mg, once daily as oral regimen on Day 1 until Month 12 in the current study. These participants were not eligible for the LTFU phase.
Change From Baseline in HIV Dependent Quality of Life (HIVDQoL - Self-completion Questionnaire Designed to Measure QoL in People Living With HIV) Overview Item 1, Month 6	0.1 Scores on a scale Standard Deviation 0.65	0.4 Scores on a scale Standard Deviation 0.53
Change From Baseline in HIV Dependent Quality of Life (HIVDQoL - Self-completion Questionnaire Designed to Measure QoL in People Living With HIV) Overview Item 1, Month 12	0.0 Scores on a scale Standard Deviation 0.75	-0.1 Scores on a scale Standard Deviation 0.38
Change From Baseline in HIV Dependent Quality of Life (HIVDQoL - Self-completion Questionnaire Designed to Measure QoL in People Living With HIV) Overview Item 2, Month 6	0.0 Scores on a scale Standard Deviation 1.11	0.3 Scores on a scale Standard Deviation 1.25
Change From Baseline in HIV Dependent Quality of Life (HIVDQoL - Self-completion Questionnaire Designed to Measure QoL in People Living With HIV) Overview Item 2, Month 12	0.2 Scores on a scale Standard Deviation 1.05	-0.6 Scores on a scale Standard Deviation 1.13
Change From Baseline in HIV Dependent Quality of Life (HIVDQoL - Self-completion Questionnaire Designed to Measure QoL in People Living With HIV) Leisure, Month 6	0.1 Scores on a scale Standard Deviation 2.20	0.9 Scores on a scale Standard Deviation 1.46
Change From Baseline in HIV Dependent Quality of Life (HIVDQoL - Self-completion Questionnaire Designed to Measure QoL in People Living With HIV) Leisure, Month 12	0.2 Scores on a scale Standard Deviation 2.02	-1.6 Scores on a scale Standard Deviation 3.74
Change From Baseline in HIV Dependent Quality of Life (HIVDQoL - Self-completion Questionnaire Designed to Measure QoL in People Living With HIV) Work, Month 6	-0.3 Scores on a scale Standard Deviation 2.07	-0.9 Scores on a scale Standard Deviation 4.14
Change From Baseline in HIV Dependent Quality of Life (HIVDQoL - Self-completion Questionnaire Designed to Measure QoL in People Living With HIV) Work, Month 12	-0.1 Scores on a scale Standard Deviation 2.48	-0.7 Scores on a scale Standard Deviation 2.75
Change From Baseline in HIV Dependent Quality of Life (HIVDQoL - Self-completion Questionnaire Designed to Measure QoL in People Living With HIV) Holiday, Month 6	-0.5 Scores on a scale Standard Deviation 2.24	-0.3 Scores on a scale Standard Deviation 3.55
Change From Baseline in HIV Dependent Quality of Life (HIVDQoL - Self-completion Questionnaire Designed to Measure QoL in People Living With HIV) Holiday, Month 12	-0.1 Scores on a scale Standard Deviation 2.76	-2.0 Scores on a scale Standard Deviation 2.83
Change From Baseline in HIV Dependent Quality of Life (HIVDQoL - Self-completion Questionnaire Designed to Measure QoL in People Living With HIV) Getting out and about, Month 6	0.0 Scores on a scale Standard Deviation 1.83	-1.1 Scores on a scale Standard Deviation 3.76
Change From Baseline in HIV Dependent Quality of Life (HIVDQoL - Self-completion Questionnaire Designed to Measure QoL in People Living With HIV) Getting out and about, Month 12	-0.2 Scores on a scale Standard Deviation 2.01	-1.9 Scores on a scale Standard Deviation 2.48
Change From Baseline in HIV Dependent Quality of Life (HIVDQoL - Self-completion Questionnaire Designed to Measure QoL in People Living With HIV) Long journey, Month 6	0.3 Scores on a scale Standard Deviation 2.24	-0.4 Scores on a scale Standard Deviation 2.70
Change From Baseline in HIV Dependent Quality of Life (HIVDQoL - Self-completion Questionnaire Designed to Measure QoL in People Living With HIV) Long journey, Month 12	0.4 Scores on a scale Standard Deviation 2.45	-2.3 Scores on a scale Standard Deviation 2.93
Change From Baseline in HIV Dependent Quality of Life (HIVDQoL - Self-completion Questionnaire Designed to Measure QoL in People Living With HIV) Do Physically, Month 6	-0.2 Scores on a scale Standard Deviation 2.09	-0.7 Scores on a scale Standard Deviation 2.36
Change From Baseline in HIV Dependent Quality of Life (HIVDQoL - Self-completion Questionnaire Designed to Measure QoL in People Living With HIV) Do Physically, Month 12	-0.3 Scores on a scale Standard Deviation 2.39	-1.7 Scores on a scale Standard Deviation 2.63
Change From Baseline in HIV Dependent Quality of Life (HIVDQoL - Self-completion Questionnaire Designed to Measure QoL in People Living With HIV) Family, Month 6	-0.1 Scores on a scale Standard Deviation 1.38	-0.9 Scores on a scale Standard Deviation 2.27
Change From Baseline in HIV Dependent Quality of Life (HIVDQoL - Self-completion Questionnaire Designed to Measure QoL in People Living With HIV) Family, Month 12	-0.3 Scores on a scale Standard Deviation 2.30	-1.5 Scores on a scale Standard Deviation 2.51
Change From Baseline in HIV Dependent Quality of Life (HIVDQoL - Self-completion Questionnaire Designed to Measure QoL in People Living With HIV) Friends, Month 6	-0.7 Scores on a scale Standard Deviation 1.93	-1.1 Scores on a scale Standard Deviation 2.85
Change From Baseline in HIV Dependent Quality of Life (HIVDQoL - Self-completion Questionnaire Designed to Measure QoL in People Living With HIV) Friends, Month 12	-0.3 Scores on a scale Standard Deviation 2.57	-2.0 Scores on a scale Standard Deviation 2.38
Change From Baseline in HIV Dependent Quality of Life (HIVDQoL - Self-completion Questionnaire Designed to Measure QoL in People Living With HIV) Go on dates, Month 6	-0.4 Scores on a scale Standard Deviation 2.04	-3.5 Scores on a scale Standard Deviation 3.54
Change From Baseline in HIV Dependent Quality of Life (HIVDQoL - Self-completion Questionnaire Designed to Measure QoL in People Living With HIV) Go on dates, Month 12	-0.2 Scores on a scale Standard Deviation 3.11	-3.5 Scores on a scale Standard Deviation 3.54
Change From Baseline in HIV Dependent Quality of Life (HIVDQoL - Self-completion Questionnaire Designed to Measure QoL in People Living With HIV) Close relationships, Month 6	0.4 Scores on a scale Standard Deviation 3.10	-0.5 Scores on a scale Standard Deviation 2.95
Change From Baseline in HIV Dependent Quality of Life (HIVDQoL - Self-completion Questionnaire Designed to Measure QoL in People Living With HIV) Close relationships, Month 12	0.2 Scores on a scale Standard Deviation 3.13	-0.5 Scores on a scale Standard Deviation 2.95
Change From Baseline in HIV Dependent Quality of Life (HIVDQoL - Self-completion Questionnaire Designed to Measure QoL in People Living With HIV) Sex life, Month 6	0.2 Scores on a scale Standard Deviation 2.74	-1.3 Scores on a scale Standard Deviation 2.80
Change From Baseline in HIV Dependent Quality of Life (HIVDQoL - Self-completion Questionnaire Designed to Measure QoL in People Living With HIV) Sex life, Month 12	-0.2 Scores on a scale Standard Deviation 2.62	-1.0 Scores on a scale Standard Deviation 3.00
Change From Baseline in HIV Dependent Quality of Life (HIVDQoL - Self-completion Questionnaire Designed to Measure QoL in People Living With HIV) Physical appearance, Month 6	-0.3 Scores on a scale Standard Deviation 1.78	-1.1 Scores on a scale Standard Deviation 2.85
Change From Baseline in HIV Dependent Quality of Life (HIVDQoL - Self-completion Questionnaire Designed to Measure QoL in People Living With HIV) Physical appearance, Month 12	-0.2 Scores on a scale Standard Deviation 2.28	-1.4 Scores on a scale Standard Deviation 2.23
Change From Baseline in HIV Dependent Quality of Life (HIVDQoL - Self-completion Questionnaire Designed to Measure QoL in People Living With HIV) Self-confidence, Month 6	0.0 Scores on a scale Standard Deviation 2.35	-1.7 Scores on a scale Standard Deviation 2.43
Change From Baseline in HIV Dependent Quality of Life (HIVDQoL - Self-completion Questionnaire Designed to Measure QoL in People Living With HIV) Self-confidence, Month 12	0.2 Scores on a scale Standard Deviation 2.83	-2.9 Scores on a scale Standard Deviation 3.48
Change From Baseline in HIV Dependent Quality of Life (HIVDQoL - Self-completion Questionnaire Designed to Measure QoL in People Living With HIV) Motivation, Month 6	-0.3 Scores on a scale Standard Deviation 2.04	-0.6 Scores on a scale Standard Deviation 2.51
Change From Baseline in HIV Dependent Quality of Life (HIVDQoL - Self-completion Questionnaire Designed to Measure QoL in People Living With HIV) Motivation, Month 12	-0.3 Scores on a scale Standard Deviation 2.85	-2.1 Scores on a scale Standard Deviation 2.85
Change From Baseline in HIV Dependent Quality of Life (HIVDQoL - Self-completion Questionnaire Designed to Measure QoL in People Living With HIV) Stigma, Month 6	-1.1 Scores on a scale Standard Deviation 2.38	—
Change From Baseline in HIV Dependent Quality of Life (HIVDQoL - Self-completion Questionnaire Designed to Measure QoL in People Living With HIV) Stigma, Month 12	0.0 Scores on a scale Standard Deviation 3.03	-2.0 Scores on a scale Standard Deviation NA Standard deviation could not be calculated for single participant.
Change From Baseline in HIV Dependent Quality of Life (HIVDQoL - Self-completion Questionnaire Designed to Measure QoL in People Living With HIV) Conceal, Month 6	-0.6 Scores on a scale Standard Deviation 2.91	-1.6 Scores on a scale Standard Deviation 3.51
Change From Baseline in HIV Dependent Quality of Life (HIVDQoL - Self-completion Questionnaire Designed to Measure QoL in People Living With HIV) Conceal, Month 12	0.3 Scores on a scale Standard Deviation 3.04	-0.4 Scores on a scale Standard Deviation 4.10
Change From Baseline in HIV Dependent Quality of Life (HIVDQoL - Self-completion Questionnaire Designed to Measure QoL in People Living With HIV) Feelings About the Future, Month 6	0.0 Scores on a scale Standard Deviation 2.89	1.0 Scores on a scale Standard Deviation 2.24
Change From Baseline in HIV Dependent Quality of Life (HIVDQoL - Self-completion Questionnaire Designed to Measure QoL in People Living With HIV) Feelings About the Future, Month 12	0.3 Scores on a scale Standard Deviation 3.02	-0.9 Scores on a scale Standard Deviation 2.85
Change From Baseline in HIV Dependent Quality of Life (HIVDQoL - Self-completion Questionnaire Designed to Measure QoL in People Living With HIV) Financial Situation, Month 6	-0.1 Scores on a scale Standard Deviation 2.76	1.1 Scores on a scale Standard Deviation 1.46
Change From Baseline in HIV Dependent Quality of Life (HIVDQoL - Self-completion Questionnaire Designed to Measure QoL in People Living With HIV) Financial Situation, Month 12	-0.1 Scores on a scale Standard Deviation 2.59	-0.6 Scores on a scale Standard Deviation 4.61
Change From Baseline in HIV Dependent Quality of Life (HIVDQoL - Self-completion Questionnaire Designed to Measure QoL in People Living With HIV) Depend on Others, Month 6	-0.4 Scores on a scale Standard Deviation 3.11	0.0 Scores on a scale Standard Deviation 0.00
Change From Baseline in HIV Dependent Quality of Life (HIVDQoL - Self-completion Questionnaire Designed to Measure QoL in People Living With HIV) Depend on Others, Month 12	-0.2 Scores on a scale Standard Deviation 2.73	-1.2 Scores on a scale Standard Deviation 3.25
Change From Baseline in HIV Dependent Quality of Life (HIVDQoL - Self-completion Questionnaire Designed to Measure QoL in People Living With HIV) Others Fuss or Worry, Month 6	0.0 Scores on a scale Standard Deviation 3.00	-1.6 Scores on a scale Standard Deviation 3.36
Change From Baseline in HIV Dependent Quality of Life (HIVDQoL - Self-completion Questionnaire Designed to Measure QoL in People Living With HIV) Others Fuss or Worry, Month 12	0.1 Scores on a scale Standard Deviation 3.21	-0.3 Scores on a scale Standard Deviation 3.50
Change From Baseline in HIV Dependent Quality of Life (HIVDQoL - Self-completion Questionnaire Designed to Measure QoL in People Living With HIV) Freedom to Eat, Month 6	0.0 Scores on a scale Standard Deviation 1.98	-1.3 Scores on a scale Standard Deviation 3.40
Change From Baseline in HIV Dependent Quality of Life (HIVDQoL - Self-completion Questionnaire Designed to Measure QoL in People Living With HIV) Freedom to Eat, Month 12	0.1 Scores on a scale Standard Deviation 2.62	-1.1 Scores on a scale Standard Deviation 2.48
Change From Baseline in HIV Dependent Quality of Life (HIVDQoL - Self-completion Questionnaire Designed to Measure QoL in People Living With HIV) Freedom to Drink, Month 6	-0.2 Scores on a scale Standard Deviation 1.81	-0.7 Scores on a scale Standard Deviation 4.42
Change From Baseline in HIV Dependent Quality of Life (HIVDQoL - Self-completion Questionnaire Designed to Measure QoL in People Living With HIV) Freedom to Drink, Month 12	-0.1 Scores on a scale Standard Deviation 2.47	-1.7 Scores on a scale Standard Deviation 3.40
Change From Baseline in HIV Dependent Quality of Life (HIVDQoL - Self-completion Questionnaire Designed to Measure QoL in People Living With HIV) Spiritual/Religious Life, Month 6	-0.1 Scores on a scale Standard Deviation 2.46	-0.5 Scores on a scale Standard Deviation 1.22
Change From Baseline in HIV Dependent Quality of Life (HIVDQoL - Self-completion Questionnaire Designed to Measure QoL in People Living With HIV) Spiritual/Religious Life, Month 12	-0.1 Scores on a scale Standard Deviation 1.14	-1.0 Scores on a scale Standard Deviation 2.45
Change From Baseline in HIV Dependent Quality of Life (HIVDQoL - Self-completion Questionnaire Designed to Measure QoL in People Living With HIV) Feelings About the Past, Month 6	-0.3 Scores on a scale Standard Deviation 2.69	0.7 Scores on a scale Standard Deviation 2.21
Change From Baseline in HIV Dependent Quality of Life (HIVDQoL - Self-completion Questionnaire Designed to Measure QoL in People Living With HIV) Feelings About the Past, Month 12	0.0 Scores on a scale Standard Deviation 2.74	-1.3 Scores on a scale Standard Deviation 2.21
Change From Baseline in HIV Dependent Quality of Life (HIVDQoL - Self-completion Questionnaire Designed to Measure QoL in People Living With HIV) Having Children or More Children, Month 6	0.3 Scores on a scale Standard Deviation 1.86	1.3 Scores on a scale Standard Deviation 4.27
Change From Baseline in HIV Dependent Quality of Life (HIVDQoL - Self-completion Questionnaire Designed to Measure QoL in People Living With HIV) Having Children or More Children, Month 12	-0.3 Scores on a scale Standard Deviation 2.82	-1.5 Scores on a scale Standard Deviation 3.00
Change From Baseline in HIV Dependent Quality of Life (HIVDQoL - Self-completion Questionnaire Designed to Measure QoL in People Living With HIV) Sleep, Month 6	-0.2 Scores on a scale Standard Deviation 2.32	0.7 Scores on a scale Standard Deviation 1.25
Change From Baseline in HIV Dependent Quality of Life (HIVDQoL - Self-completion Questionnaire Designed to Measure QoL in People Living With HIV) Sleep, Month 12	0.0 Scores on a scale Standard Deviation 2.56	-0.4 Scores on a scale Standard Deviation 2.70
Change From Baseline in HIV Dependent Quality of Life (HIVDQoL - Self-completion Questionnaire Designed to Measure QoL in People Living With HIV) Average Weighted Impact, Month 6	-0.17 Scores on a scale Standard Deviation 1.084	-0.43 Scores on a scale Standard Deviation 1.792
Change From Baseline in HIV Dependent Quality of Life (HIVDQoL - Self-completion Questionnaire Designed to Measure QoL in People Living With HIV) Average Weighted Impact, Month 12	-0.07 Scores on a scale Standard Deviation 1.690	-1.27 Scores on a scale Standard Deviation 1.695

SECONDARY outcome

Timeframe: At Months 6 and 12 (compared with Baseline [Day 1]) [Maintenance Phase]

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

HIVTSQs total treatment satisfaction score is computed with 1-11 items. Items 1-11 are summed to produce score with possible range of 0 to 66. Higher the score, greater improvement in satisfaction with treatment as compared to the past few weeks; lower score, greater the deterioration in satisfaction with treatment. A score of 0 represents no change. 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.

Outcome measures

Outcome measures
Measure	CAB LA + RPV LA Q2M n=90 Participants Eligible participants from LAI116482 (NCT01641809 \[LATTE\]) study who were administered oral CAB 30 milligrams (mg) plus RPV 25 mg and who successfully completed Week 300 received their first dose CAB LA (600 mg) plus RPV LA (900 mg) injections within 2 hours of the final oral dose of LATTE given on the same day. The second loading injections were administered 1 month after initial loading dose, with subsequent injections (CAB LA 600 mg + RPV LA 900 mg) occurring Q2M thereafter. Participants continued to receive the treatment until the study intervention was locally approved and commercially available. Participants who received at least one dose of CAB LA and/or RPV LA and discontinued the CAB LA + RPV LA regimen for any reason entered a 52-week long-term follow-up (LTFU) Phase.	DTG + RPV n=7 Participants Eligible participants from LAI116482 (NCT01641809 \[LATTE\]) study who were administered oral CAB 30 mg plus RPV 25 mg and who successfully completed Week 300 received their first dose of the Dolutegravir (DTG) 50 mg plus RPV 25 mg, once daily as oral regimen on Day 1 until Month 12 in the current study. These participants were not eligible for the LTFU phase.
Change From Baseline in Total Treatment Satisfaction Score of HIV Treatment Satisfaction Status Questionnaire (HIVTSQs) Month 6	-0.19 Scores on a scale Standard Deviation 6.419	0.71 Scores on a scale Standard Deviation 3.773
Change From Baseline in Total Treatment Satisfaction Score of HIV Treatment Satisfaction Status Questionnaire (HIVTSQs) Month 12	-0.42 Scores on a scale Standard Deviation 6.659	0.14 Scores on a scale Standard Deviation 6.256

SECONDARY outcome

Timeframe: At Months 6 and 12 (compared with Baseline [Day 1]) [Maintenance Phase]

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

HIVTSQs is a 12 item questionnaire. The individual item scores are rated as 6 (very satisfied, convenient, flexible, etc.) to 0 (very dissatisfied, inconvenient, inflexible, etc.). Higher scores represent greater treatment satisfaction as compared to the past few weeks. Change from Baseline is defined as post-dose value minus Baseline value. Baseline value is defined as latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. SD=0.00 is defined as SD resulted below the detectable limit of the assay and approximate to 0.00.

Outcome measures

SECONDARY outcome

Timeframe: At Month 12 (compared with Baseline [Day 1]) [Maintenance Phase]

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

HIVTSQc (change version) total treatment satisfaction score is computed with 1-11 items. Items 1-11 are summed to produce score with possible range:-33 to 33. Higher scores represent greater improvement in treatment satisfaction compared to satisfaction with treatment received during the induction phase; lower scores represented deterioration in satisfaction with treatment. A score of 0 represents no change. A maximum of 5 items can be missing, the missing scores were imputed with the mean of the completed item scores. If 6 or more items are missing, then the overall treatment satisfaction scale score was not computed and remained missing.

Outcome measures

Outcome measures
Measure	CAB LA + RPV LA Q2M n=88 Participants Eligible participants from LAI116482 (NCT01641809 \[LATTE\]) study who were administered oral CAB 30 milligrams (mg) plus RPV 25 mg and who successfully completed Week 300 received their first dose CAB LA (600 mg) plus RPV LA (900 mg) injections within 2 hours of the final oral dose of LATTE given on the same day. The second loading injections were administered 1 month after initial loading dose, with subsequent injections (CAB LA 600 mg + RPV LA 900 mg) occurring Q2M thereafter. Participants continued to receive the treatment until the study intervention was locally approved and commercially available. Participants who received at least one dose of CAB LA and/or RPV LA and discontinued the CAB LA + RPV LA regimen for any reason entered a 52-week long-term follow-up (LTFU) Phase.	DTG + RPV n=7 Participants Eligible participants from LAI116482 (NCT01641809 \[LATTE\]) study who were administered oral CAB 30 mg plus RPV 25 mg and who successfully completed Week 300 received their first dose of the Dolutegravir (DTG) 50 mg plus RPV 25 mg, once daily as oral regimen on Day 1 until Month 12 in the current study. These participants were not eligible for the LTFU phase.
Change in Treatment Satisfaction Over Time Using the HIV Treatment Satisfaction Change Questionnaire (HIVTSQc)	28.0 Scores on a scale Standard Deviation 6.78	27.7 Scores on a scale Standard Deviation 6.97

OTHER_PRE_SPECIFIED outcome

Timeframe: Pre-dose (Day 1) and Month 12 [Maintenance Phase]

Population: Pharmacokinetic Population

Blood samples were collected at indicated time points for pharmacokinetic analysis of CAB LA. This was a conditional secondary endpoint for which results are not available because the trough concentrations for this product are well characterized and therefore, secondary population pharmacokinetic (Pop PK) analyses were not conducted.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Pre-dose (Day 1) and Month 12 [Maintenance Phase]

Population: Pharmacokinetic Population

Blood samples were collected at indicated time points for pharmacokinetic analysis of RPV LA. This was a conditional secondary endpoint for which results are not available because the trough concentrations for this product are well characterized and therefore, secondary Pop PK analyses were not conducted.

Outcome measures

Outcome data not reported

Adverse Events

CAB LA + RPV LA Q2M

Serious events: 10 serious events

Other events: 86 other events

Deaths: 0 deaths

DTG + RPV

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

LTFU: CAB LA+RPV LA Q2M Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	CAB LA + RPV LA Q2M n=90 participants at risk Eligible participants from LAI116482 (NCT01641809 \[LATTE\]) study who were administered oral CAB 30 milligrams (mg) plus RPV 25 mg and who successfully completed Week 300 received their first dose CAB LA (600 mg) plus RPV LA (900 mg) injections within 2 hours of the final oral dose of LATTE given on the same day. The second loading injections were administered 1 month after initial loading dose, with subsequent injections (CAB LA 600 mg + RPV LA 900 mg) occurring Q2M thereafter. Participants continued to receive the treatment until the study intervention was locally approved and commercially available. Participants who received at least one dose of CAB LA and/or RPV LA and discontinued the CAB LA + RPV LA regimen for any reason entered a 52-week long-term follow-up (LTFU) Phase.	DTG + RPV n=7 participants at risk Eligible participants from LAI116482 (NCT01641809 \[LATTE\]) study who were administered oral CAB 30 mg plus RPV 25 mg and who successfully completed Week 300 received their first dose of the Dolutegravir (DTG) 50 mg plus RPV 25 mg, once daily as oral regimen on Day 1 until Month 12 in the current study. These participants were not eligible for the LTFU phase.	LTFU: CAB LA+RPV LA Q2M Group n=6 participants at risk This group included the participants who received at least one dose of CAB LA and/or RPV LA and discontinued the CAB LA + RPV LA regimen for any reason before end of Maintenance Period. The participants entered a 52-week LTFU period.
Hepatobiliary disorders Cholecystitis acute	1.1% 1/90 • Number of events 1 • Non-Serious adverse events (Other Adverse events (AEs)) and Serious adverse events (SAE) were collected from Day 1 and up to End of LTFU Phase (approximately up to 12 months after exiting the Maintenance Phase, up to a maximum of 52 months). As specified in protocol, Non-SAEs (Other AEs) and SAEs were only collected on participants who received at least one dose of study treatment on or after Day 1 visit.	0.00% 0/7 • Non-Serious adverse events (Other Adverse events (AEs)) and Serious adverse events (SAE) were collected from Day 1 and up to End of LTFU Phase (approximately up to 12 months after exiting the Maintenance Phase, up to a maximum of 52 months). As specified in protocol, Non-SAEs (Other AEs) and SAEs were only collected on participants who received at least one dose of study treatment on or after Day 1 visit.	0.00% 0/6 • Non-Serious adverse events (Other Adverse events (AEs)) and Serious adverse events (SAE) were collected from Day 1 and up to End of LTFU Phase (approximately up to 12 months after exiting the Maintenance Phase, up to a maximum of 52 months). As specified in protocol, Non-SAEs (Other AEs) and SAEs were only collected on participants who received at least one dose of study treatment on or after Day 1 visit.
Hepatobiliary disorders Cholelithiasis	1.1% 1/90 • Number of events 1 • Non-Serious adverse events (Other Adverse events (AEs)) and Serious adverse events (SAE) were collected from Day 1 and up to End of LTFU Phase (approximately up to 12 months after exiting the Maintenance Phase, up to a maximum of 52 months). As specified in protocol, Non-SAEs (Other AEs) and SAEs were only collected on participants who received at least one dose of study treatment on or after Day 1 visit.	0.00% 0/7 • Non-Serious adverse events (Other Adverse events (AEs)) and Serious adverse events (SAE) were collected from Day 1 and up to End of LTFU Phase (approximately up to 12 months after exiting the Maintenance Phase, up to a maximum of 52 months). As specified in protocol, Non-SAEs (Other AEs) and SAEs were only collected on participants who received at least one dose of study treatment on or after Day 1 visit.	0.00% 0/6 • Non-Serious adverse events (Other Adverse events (AEs)) and Serious adverse events (SAE) were collected from Day 1 and up to End of LTFU Phase (approximately up to 12 months after exiting the Maintenance Phase, up to a maximum of 52 months). As specified in protocol, Non-SAEs (Other AEs) and SAEs were only collected on participants who received at least one dose of study treatment on or after Day 1 visit.
Infections and infestations Anal abscess	1.1% 1/90 • Number of events 1 • Non-Serious adverse events (Other Adverse events (AEs)) and Serious adverse events (SAE) were collected from Day 1 and up to End of LTFU Phase (approximately up to 12 months after exiting the Maintenance Phase, up to a maximum of 52 months). As specified in protocol, Non-SAEs (Other AEs) and SAEs were only collected on participants who received at least one dose of study treatment on or after Day 1 visit.	0.00% 0/7 • Non-Serious adverse events (Other Adverse events (AEs)) and Serious adverse events (SAE) were collected from Day 1 and up to End of LTFU Phase (approximately up to 12 months after exiting the Maintenance Phase, up to a maximum of 52 months). As specified in protocol, Non-SAEs (Other AEs) and SAEs were only collected on participants who received at least one dose of study treatment on or after Day 1 visit.	0.00% 0/6 • Non-Serious adverse events (Other Adverse events (AEs)) and Serious adverse events (SAE) were collected from Day 1 and up to End of LTFU Phase (approximately up to 12 months after exiting the Maintenance Phase, up to a maximum of 52 months). As specified in protocol, Non-SAEs (Other AEs) and SAEs were only collected on participants who received at least one dose of study treatment on or after Day 1 visit.
Infections and infestations Orchitis	1.1% 1/90 • Number of events 1 • Non-Serious adverse events (Other Adverse events (AEs)) and Serious adverse events (SAE) were collected from Day 1 and up to End of LTFU Phase (approximately up to 12 months after exiting the Maintenance Phase, up to a maximum of 52 months). As specified in protocol, Non-SAEs (Other AEs) and SAEs were only collected on participants who received at least one dose of study treatment on or after Day 1 visit.	0.00% 0/7 • Non-Serious adverse events (Other Adverse events (AEs)) and Serious adverse events (SAE) were collected from Day 1 and up to End of LTFU Phase (approximately up to 12 months after exiting the Maintenance Phase, up to a maximum of 52 months). As specified in protocol, Non-SAEs (Other AEs) and SAEs were only collected on participants who received at least one dose of study treatment on or after Day 1 visit.	0.00% 0/6 • Non-Serious adverse events (Other Adverse events (AEs)) and Serious adverse events (SAE) were collected from Day 1 and up to End of LTFU Phase (approximately up to 12 months after exiting the Maintenance Phase, up to a maximum of 52 months). As specified in protocol, Non-SAEs (Other AEs) and SAEs were only collected on participants who received at least one dose of study treatment on or after Day 1 visit.
Infections and infestations Urinary tract infection bacterial	1.1% 1/90 • Number of events 1 • Non-Serious adverse events (Other Adverse events (AEs)) and Serious adverse events (SAE) were collected from Day 1 and up to End of LTFU Phase (approximately up to 12 months after exiting the Maintenance Phase, up to a maximum of 52 months). As specified in protocol, Non-SAEs (Other AEs) and SAEs were only collected on participants who received at least one dose of study treatment on or after Day 1 visit.	0.00% 0/7 • Non-Serious adverse events (Other Adverse events (AEs)) and Serious adverse events (SAE) were collected from Day 1 and up to End of LTFU Phase (approximately up to 12 months after exiting the Maintenance Phase, up to a maximum of 52 months). As specified in protocol, Non-SAEs (Other AEs) and SAEs were only collected on participants who received at least one dose of study treatment on or after Day 1 visit.	0.00% 0/6 • Non-Serious adverse events (Other Adverse events (AEs)) and Serious adverse events (SAE) were collected from Day 1 and up to End of LTFU Phase (approximately up to 12 months after exiting the Maintenance Phase, up to a maximum of 52 months). As specified in protocol, Non-SAEs (Other AEs) and SAEs were only collected on participants who received at least one dose of study treatment on or after Day 1 visit.
Gastrointestinal disorders Proctitis	1.1% 1/90 • Number of events 1 • Non-Serious adverse events (Other Adverse events (AEs)) and Serious adverse events (SAE) were collected from Day 1 and up to End of LTFU Phase (approximately up to 12 months after exiting the Maintenance Phase, up to a maximum of 52 months). As specified in protocol, Non-SAEs (Other AEs) and SAEs were only collected on participants who received at least one dose of study treatment on or after Day 1 visit.	0.00% 0/7 • Non-Serious adverse events (Other Adverse events (AEs)) and Serious adverse events (SAE) were collected from Day 1 and up to End of LTFU Phase (approximately up to 12 months after exiting the Maintenance Phase, up to a maximum of 52 months). As specified in protocol, Non-SAEs (Other AEs) and SAEs were only collected on participants who received at least one dose of study treatment on or after Day 1 visit.	0.00% 0/6 • Non-Serious adverse events (Other Adverse events (AEs)) and Serious adverse events (SAE) were collected from Day 1 and up to End of LTFU Phase (approximately up to 12 months after exiting the Maintenance Phase, up to a maximum of 52 months). As specified in protocol, Non-SAEs (Other AEs) and SAEs were only collected on participants who received at least one dose of study treatment on or after Day 1 visit.
General disorders Injection site extravasation	1.1% 1/90 • Number of events 1 • Non-Serious adverse events (Other Adverse events (AEs)) and Serious adverse events (SAE) were collected from Day 1 and up to End of LTFU Phase (approximately up to 12 months after exiting the Maintenance Phase, up to a maximum of 52 months). As specified in protocol, Non-SAEs (Other AEs) and SAEs were only collected on participants who received at least one dose of study treatment on or after Day 1 visit.	0.00% 0/7 • Non-Serious adverse events (Other Adverse events (AEs)) and Serious adverse events (SAE) were collected from Day 1 and up to End of LTFU Phase (approximately up to 12 months after exiting the Maintenance Phase, up to a maximum of 52 months). As specified in protocol, Non-SAEs (Other AEs) and SAEs were only collected on participants who received at least one dose of study treatment on or after Day 1 visit.	0.00% 0/6 • Non-Serious adverse events (Other Adverse events (AEs)) and Serious adverse events (SAE) were collected from Day 1 and up to End of LTFU Phase (approximately up to 12 months after exiting the Maintenance Phase, up to a maximum of 52 months). As specified in protocol, Non-SAEs (Other AEs) and SAEs were only collected on participants who received at least one dose of study treatment on or after Day 1 visit.
Infections and infestations COVID-19 pneumonia	1.1% 1/90 • Number of events 1 • Non-Serious adverse events (Other Adverse events (AEs)) and Serious adverse events (SAE) were collected from Day 1 and up to End of LTFU Phase (approximately up to 12 months after exiting the Maintenance Phase, up to a maximum of 52 months). As specified in protocol, Non-SAEs (Other AEs) and SAEs were only collected on participants who received at least one dose of study treatment on or after Day 1 visit.	0.00% 0/7 • Non-Serious adverse events (Other Adverse events (AEs)) and Serious adverse events (SAE) were collected from Day 1 and up to End of LTFU Phase (approximately up to 12 months after exiting the Maintenance Phase, up to a maximum of 52 months). As specified in protocol, Non-SAEs (Other AEs) and SAEs were only collected on participants who received at least one dose of study treatment on or after Day 1 visit.	0.00% 0/6 • Non-Serious adverse events (Other Adverse events (AEs)) and Serious adverse events (SAE) were collected from Day 1 and up to End of LTFU Phase (approximately up to 12 months after exiting the Maintenance Phase, up to a maximum of 52 months). As specified in protocol, Non-SAEs (Other AEs) and SAEs were only collected on participants who received at least one dose of study treatment on or after Day 1 visit.
Infections and infestations Cellulitis	1.1% 1/90 • Number of events 1 • Non-Serious adverse events (Other Adverse events (AEs)) and Serious adverse events (SAE) were collected from Day 1 and up to End of LTFU Phase (approximately up to 12 months after exiting the Maintenance Phase, up to a maximum of 52 months). As specified in protocol, Non-SAEs (Other AEs) and SAEs were only collected on participants who received at least one dose of study treatment on or after Day 1 visit.	0.00% 0/7 • Non-Serious adverse events (Other Adverse events (AEs)) and Serious adverse events (SAE) were collected from Day 1 and up to End of LTFU Phase (approximately up to 12 months after exiting the Maintenance Phase, up to a maximum of 52 months). As specified in protocol, Non-SAEs (Other AEs) and SAEs were only collected on participants who received at least one dose of study treatment on or after Day 1 visit.	0.00% 0/6 • Non-Serious adverse events (Other Adverse events (AEs)) and Serious adverse events (SAE) were collected from Day 1 and up to End of LTFU Phase (approximately up to 12 months after exiting the Maintenance Phase, up to a maximum of 52 months). As specified in protocol, Non-SAEs (Other AEs) and SAEs were only collected on participants who received at least one dose of study treatment on or after Day 1 visit.
Infections and infestations Staphylococcal infection	1.1% 1/90 • Number of events 1 • Non-Serious adverse events (Other Adverse events (AEs)) and Serious adverse events (SAE) were collected from Day 1 and up to End of LTFU Phase (approximately up to 12 months after exiting the Maintenance Phase, up to a maximum of 52 months). As specified in protocol, Non-SAEs (Other AEs) and SAEs were only collected on participants who received at least one dose of study treatment on or after Day 1 visit.	0.00% 0/7 • Non-Serious adverse events (Other Adverse events (AEs)) and Serious adverse events (SAE) were collected from Day 1 and up to End of LTFU Phase (approximately up to 12 months after exiting the Maintenance Phase, up to a maximum of 52 months). As specified in protocol, Non-SAEs (Other AEs) and SAEs were only collected on participants who received at least one dose of study treatment on or after Day 1 visit.	0.00% 0/6 • Non-Serious adverse events (Other Adverse events (AEs)) and Serious adverse events (SAE) were collected from Day 1 and up to End of LTFU Phase (approximately up to 12 months after exiting the Maintenance Phase, up to a maximum of 52 months). As specified in protocol, Non-SAEs (Other AEs) and SAEs were only collected on participants who received at least one dose of study treatment on or after Day 1 visit.
Musculoskeletal and connective tissue disorders Rhabdomyolysis	1.1% 1/90 • Number of events 1 • Non-Serious adverse events (Other Adverse events (AEs)) and Serious adverse events (SAE) were collected from Day 1 and up to End of LTFU Phase (approximately up to 12 months after exiting the Maintenance Phase, up to a maximum of 52 months). As specified in protocol, Non-SAEs (Other AEs) and SAEs were only collected on participants who received at least one dose of study treatment on or after Day 1 visit.	0.00% 0/7 • Non-Serious adverse events (Other Adverse events (AEs)) and Serious adverse events (SAE) were collected from Day 1 and up to End of LTFU Phase (approximately up to 12 months after exiting the Maintenance Phase, up to a maximum of 52 months). As specified in protocol, Non-SAEs (Other AEs) and SAEs were only collected on participants who received at least one dose of study treatment on or after Day 1 visit.	0.00% 0/6 • Non-Serious adverse events (Other Adverse events (AEs)) and Serious adverse events (SAE) were collected from Day 1 and up to End of LTFU Phase (approximately up to 12 months after exiting the Maintenance Phase, up to a maximum of 52 months). As specified in protocol, Non-SAEs (Other AEs) and SAEs were only collected on participants who received at least one dose of study treatment on or after Day 1 visit.
Nervous system disorders Alcoholic seizure	1.1% 1/90 • Number of events 1 • Non-Serious adverse events (Other Adverse events (AEs)) and Serious adverse events (SAE) were collected from Day 1 and up to End of LTFU Phase (approximately up to 12 months after exiting the Maintenance Phase, up to a maximum of 52 months). As specified in protocol, Non-SAEs (Other AEs) and SAEs were only collected on participants who received at least one dose of study treatment on or after Day 1 visit.	0.00% 0/7 • Non-Serious adverse events (Other Adverse events (AEs)) and Serious adverse events (SAE) were collected from Day 1 and up to End of LTFU Phase (approximately up to 12 months after exiting the Maintenance Phase, up to a maximum of 52 months). As specified in protocol, Non-SAEs (Other AEs) and SAEs were only collected on participants who received at least one dose of study treatment on or after Day 1 visit.	0.00% 0/6 • Non-Serious adverse events (Other Adverse events (AEs)) and Serious adverse events (SAE) were collected from Day 1 and up to End of LTFU Phase (approximately up to 12 months after exiting the Maintenance Phase, up to a maximum of 52 months). As specified in protocol, Non-SAEs (Other AEs) and SAEs were only collected on participants who received at least one dose of study treatment on or after Day 1 visit.

Other adverse events

Additional Information

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Results disclosure agreements

Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
Publication restrictions are in place

Restriction type: OTHER

Measure	CAB LA + RPV LA Q2M n=90 Participants Eligible participants from LAI116482 (NCT01641809 \[LATTE\]) study who were administered oral CAB 30 milligrams (mg) plus RPV 25 mg and who successfully completed Week 300 received their first dose CAB LA (600 mg) plus RPV LA (900 mg) injections within 2 hours of the final oral dose of LATTE given on the same day. The second loading injections were administered 1 month after initial loading dose, with subsequent injections (CAB LA 600 mg + RPV LA 900 mg) occurring Q2M thereafter. Participants continued to receive the treatment until the study intervention was locally approved and commercially available. Participants who received at least one dose of CAB LA and/or RPV LA and discontinued the CAB LA + RPV LA regimen for any reason entered a 52-week long-term follow-up (LTFU) Phase.	DTG + RPV n=7 Participants Eligible participants from LAI116482 (NCT01641809 \[LATTE\]) study who were administered oral CAB 30 mg plus RPV 25 mg and who successfully completed Week 300 received their first dose of the Dolutegravir (DTG) 50 mg plus RPV 25 mg, once daily as oral regimen on Day 1 until Month 12 in the current study. These participants were not eligible for the LTFU phase.
Change From Baseline in Individual Item Score of HIVTSQs Item 1, Month 6	-0.1 Scores on a scale Standard Deviation 0.82	0.0 Scores on a scale Standard Deviation 0.00
Change From Baseline in Individual Item Score of HIVTSQs Item 1, Month 12	-0.1 Scores on a scale Standard Deviation 0.75	-0.1 Scores on a scale Standard Deviation 0.38
Change From Baseline in Individual Item Score of HIVTSQs Item 2, Month 6	-0.1 Scores on a scale Standard Deviation 0.46	-0.3 Scores on a scale Standard Deviation 0.49
Change From Baseline in Individual Item Score of HIVTSQs Item 2, Month 12	0.0 Scores on a scale Standard Deviation 0.34	-0.1 Scores on a scale Standard Deviation 0.38
Change From Baseline in Individual Item Score of HIVTSQs Item 3, Month 6	-0.5 Scores on a scale Standard Deviation 1.41	0.1 Scores on a scale Standard Deviation 0.38
Change From Baseline in Individual Item Score of HIVTSQs Item 3, Month 12	-0.5 Scores on a scale Standard Deviation 1.21	-0.1 Scores on a scale Standard Deviation 0.38
Change From Baseline in Individual Item Score of HIVTSQs Item 4, Month 6	0.0 Scores on a scale Standard Deviation 0.95	0.0 Scores on a scale Standard Deviation 0.00
Change From Baseline in Individual Item Score of HIVTSQs Item 4, Month 12	0.1 Scores on a scale Standard Deviation 0.93	0.1 Scores on a scale Standard Deviation 0.69
Change From Baseline in Individual Item Score of HIVTSQs Item 5, Month 6	0.1 Scores on a scale Standard Deviation 1.00	0.3 Scores on a scale Standard Deviation 0.49
Change From Baseline in Individual Item Score of HIVTSQs Item 5, Month 12	0.1 Scores on a scale Standard Deviation 1.14	0.1 Scores on a scale Standard Deviation 0.38
Change From Baseline in Individual Item Score of HIVTSQs Item 6, Month 6	0.1 Scores on a scale Standard Deviation 1.13	0.4 Scores on a scale Standard Deviation 1.62
Change From Baseline in Individual Item Score of HIVTSQs Item 6, Month 12	0.0 Scores on a scale Standard Deviation 1.31	0.3 Scores on a scale Standard Deviation 1.80
Change From Baseline in Individual Item Score of HIVTSQs Item 7, Month 6	0.1 Scores on a scale Standard Deviation 0.74	0.0 Scores on a scale Standard Deviation 0.58
Change From Baseline in Individual Item Score of HIVTSQs Item 7, Month 12	0.0 Scores on a scale Standard Deviation 1.06	0.1 Scores on a scale Standard Deviation 0.69
Change From Baseline in Individual Item Score of HIVTSQs Item 8, Month 6	0.2 Scores on a scale Standard Deviation 0.93	0.0 Scores on a scale Standard Deviation 0.58
Change From Baseline in Individual Item Score of HIVTSQs Item 8, Month 12	0.1 Scores on a scale Standard Deviation 0.95	0.0 Scores on a scale Standard Deviation 0.58
Change From Baseline in Individual Item Score of HIVTSQs Item 9, Month 6	-0.1 Scores on a scale Standard Deviation 0.61	0.0 Scores on a scale Standard Deviation 0.00
Change From Baseline in Individual Item Score of HIVTSQs Item 9, Month 12	-0.2 Scores on a scale Standard Deviation 0.80	-0.1 Scores on a scale Standard Deviation 0.38
Change From Baseline in Individual Item Score of HIVTSQs Item 10, Month 6	0.1 Scores on a scale Standard Deviation 0.91	0.3 Scores on a scale Standard Deviation 0.76
Change From Baseline in Individual Item Score of HIVTSQs Item 10, Month 12	0.1 Scores on a scale Standard Deviation 1.03	0.1 Scores on a scale Standard Deviation 0.90
Change From Baseline in Individual Item Score of HIVTSQs Item 11, Month 6	0.0 Scores on a scale Standard Deviation 1.09	-0.1 Scores on a scale Standard Deviation 0.38
Change From Baseline in Individual Item Score of HIVTSQs Item 11, Month 12	0.1 Scores on a scale Standard Deviation 0.79	-0.1 Scores on a scale Standard Deviation 0.90
Change From Baseline in Individual Item Score of HIVTSQs Item 12, Month 6	-1.3 Scores on a scale Standard Deviation 1.59	-0.6 Scores on a scale Standard Deviation 1.13
Change From Baseline in Individual Item Score of HIVTSQs Item 12, Month 12	-1.1 Scores on a scale Standard Deviation 1.58	-0.1 Scores on a scale Standard Deviation 0.38