Trial Outcomes & Findings for A Phase IIIb Study of the Safety, Efficacy, and Tolerability of Switching to a Fixed-dose Combination of Abacavir/Dolutegravir/ Lamivudine From Current Antiretroviral Regimen (NCT NCT02105987)

Results Overview

The Food and Drug Administration (FDA) snapshot (Missing, Switch or Discontinuation = Failure) algorithm is intended to be primarily a virologic assessment of the endpoint, and as such follows a "virology first" hierarchy. Virologic Success (e.g., \<50 c/mL) or virologic failure within an analysis window is typically determined by the last available HIV-1 RNA measurement in that window and in the treatment phase of interest (e.g., Week 24 snapshot outcomes of the early switch phase will not use HIV-1 RNA data from the late switch phase, even if such data is within the Week 24 analysis window). A virologic failure occurs when a participant changes to their ART regimen (e.g., addition of other ARTs to the study-specified regimens, or switches in components of the current ART regimen).

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

555 participants

Primary outcome timeframe

Week 24

Results posted on

2017-01-04

Participant Flow

841 participants (par.) were screened and 555 human immunodeficiency virus type 1 (HIV-1) infected par. who were on stable suppressive combination antiretroviral therapy (cART) with 2 nucleoside reverse transcriptase inhibitor (NRTIs) plus either a protease inhibitor (PI), an non-NRTI (NNRTI), or an integrase inhibitor (INI) were randomized.

Participant milestones

Participant milestones
Measure	ABC 600 mg / DTG 50 mg /3TC 300 mg FDC Participants received abacavir (ABC) 600 milligrams (mg)/ dolutegravir (DTG) 50 mg/ lamivudine (3TC) 300 mg fixed-dose combination (FDC) tablets with or without food once daily in the morning or the evening at approximately the same time each day for 24 weeks.	Current ART Participants continued on their current ART regimen for 24 weeks.	ABC 600 mg / DTG 50 mg /3TC 300 mg FDC Early Switch Participants who completed early switch phase continued to receive ABC 600 mg/DTG 50 mg/3TC 300 mg FDC tablets with or without food once daily in the morning or the evening at approximately the same time each day for an additional 24 weeks.	ABC 600 mg / DTG 50 mg /3TC 300 mg FDC Late Switch Participants who completed early switch phase and maintained viral suppression (\<50 Copies per milliliter \[c/mL\]) were switched to ABC 600 mg/DTG 50 mg/3TC 300 mg FDC tablets and were followed for an additional 24 weeks of treatment.	ABC 600 mg / DTG 50 mg /3TC 300 mg FDC Early Switch:Cont Phase If ABC/DTG/3TC was not locally approved and commercially available when a participant successfully completed the Week 48 visit, the participant had the opportunity to enter into the Continuation Phase. During the Continuation Phase, participants were supplied with ABC/DTG/3TC until it was locally approved and commercially available.	ABC 600 mg / DTG 50 mg /3TC 300 mg FDC Late Switch:Cont Phase If ABC/DTG/3TC was not locally approved and commercially available when a participant successfully completed the Week 48 visit, the participant had the opportunity to enter into the Continuation Phase. During the Continuation Phase, participants were supplied with ABC/DTG/3TC until it was locally approved and commercially available.
Early Switch Phase (24 Weeks) STARTED	275	278	0	0	0	0
Early Switch Phase (24 Weeks) COMPLETED	239	244	0	0	0	0
Early Switch Phase (24 Weeks) NOT COMPLETED	36	34	0	0	0	0
Late Switch Phase (24 Weeks) STARTED	0	0	275	244	0	0
Late Switch Phase (24 Weeks) COMPLETED	0	0	230	230	0	0
Late Switch Phase (24 Weeks) NOT COMPLETED	0	0	45	14	0	0
Continuation Phase STARTED	0	0	0	0	14	23
Continuation Phase COMPLETED	0	0	0	0	13	23
Continuation Phase NOT COMPLETED	0	0	0	0	1	0

Reasons for withdrawal

Reasons for withdrawal
Measure	ABC 600 mg / DTG 50 mg /3TC 300 mg FDC Participants received abacavir (ABC) 600 milligrams (mg)/ dolutegravir (DTG) 50 mg/ lamivudine (3TC) 300 mg fixed-dose combination (FDC) tablets with or without food once daily in the morning or the evening at approximately the same time each day for 24 weeks.	Current ART Participants continued on their current ART regimen for 24 weeks.	ABC 600 mg / DTG 50 mg /3TC 300 mg FDC Early Switch Participants who completed early switch phase continued to receive ABC 600 mg/DTG 50 mg/3TC 300 mg FDC tablets with or without food once daily in the morning or the evening at approximately the same time each day for an additional 24 weeks.	ABC 600 mg / DTG 50 mg /3TC 300 mg FDC Late Switch Participants who completed early switch phase and maintained viral suppression (\<50 Copies per milliliter \[c/mL\]) were switched to ABC 600 mg/DTG 50 mg/3TC 300 mg FDC tablets and were followed for an additional 24 weeks of treatment.	ABC 600 mg / DTG 50 mg /3TC 300 mg FDC Early Switch:Cont Phase If ABC/DTG/3TC was not locally approved and commercially available when a participant successfully completed the Week 48 visit, the participant had the opportunity to enter into the Continuation Phase. During the Continuation Phase, participants were supplied with ABC/DTG/3TC until it was locally approved and commercially available.
Early Switch Phase (24 Weeks) Adverse Event	10	0	0	0	0
Early Switch Phase (24 Weeks) Protocol Violation	15	17	0	0	0
Early Switch Phase (24 Weeks) Withdrawal by Subject	4	10	0	0	0
Early Switch Phase (24 Weeks) Lost to Follow-up	3	3	0	0	0
Early Switch Phase (24 Weeks) Physician Decision	4	3	0	0	0
Early Switch Phase (24 Weeks) Missing Disposition Data	0	1	0	0	0
Late Switch Phase (24 Weeks) Adverse Event	0	0	10	4	0
Late Switch Phase (24 Weeks) Protocol Violation	0	0	15	1	0
Late Switch Phase (24 Weeks) Withdrawal by Subject	0	0	6	5	0
Late Switch Phase (24 Weeks) Lost to Follow-up	0	0	8	3	0
Late Switch Phase (24 Weeks) Physician Decision	0	0	5	0	0
Late Switch Phase (24 Weeks) met protocol defined stopping criteria	0	0	0	1	0
Late Switch Phase (24 Weeks) Per sponsor request	0	0	1	0	0
Continuation Phase Protocol Violation	0	0	0	0	1

Baseline Characteristics

A Phase IIIb Study of the Safety, Efficacy, and Tolerability of Switching to a Fixed-dose Combination of Abacavir/Dolutegravir/ Lamivudine From Current Antiretroviral Regimen

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Early Switch ABC 600 mg / DTG 50 mg /3TC 300 mg FDC n=275 Participants Participants received ABC 600 mg/DTG 50 mg/3TC 300 mg FDC tablets with or without food once daily in the morning or the evening at approximately the same time each day for 24 weeks. At Week 24, participants will continue on this treatment for an additional 24 weeks.	Late Switch ABC 600 mg / DTG 50 mg /3TC 300 mg FDC n=244 Participants Participants continued on their current ART regimen for 24 weeks. At Week 24, participants originally randomly assigned to continue their current regimen switched to ABC 600 mg/DTG 50 mg/3TC 300 mg FDC tablets and were followed for an additional 24 weeks of treatment.	Total n=519 Participants Total of all reporting groups
Age, Continuous	44.1 Years STANDARD_DEVIATION 10.61 • n=5 Participants	45.5 Years STANDARD_DEVIATION 11.25 • n=7 Participants	44.8 Years STANDARD_DEVIATION 10.93 • n=5 Participants
Gender Female	38 Participants n=5 Participants	32 Participants n=7 Participants	70 Participants n=5 Participants
Gender Male	237 Participants n=5 Participants	212 Participants n=7 Participants	449 Participants n=5 Participants
Race/Ethnicity, Customized African American/African Heritage	81 Participants n=5 Participants	63 Participants n=7 Participants	144 Participants n=5 Participants
Race/Ethnicity, Customized American Indian or Alaska Native	3 Participants n=5 Participants	2 Participants n=7 Participants	5 Participants n=5 Participants
Race/Ethnicity, Customized Asian - Central/South Asian Heritage	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants
Race/Ethnicity, Customized Asian - East Asian Heritage	1 Participants n=5 Participants	3 Participants n=7 Participants	4 Participants n=5 Participants
Race/Ethnicity, Customized Asian - Japanese Heritage	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Race/Ethnicity, Customized Asian - South East Asian Heritage	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants
Race/Ethnicity, Customized Asian - Mixed Race	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race/Ethnicity, Customized Native Hawaiian or other Pacific Islander	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Race/Ethnicity, Customized White - Arabic/North African Heritage	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Race/Ethnicity, Customized White - White/Caucasian/European Heritage	176 Participants n=5 Participants	165 Participants n=7 Participants	341 Participants n=5 Participants
Race/Ethnicity, Customized White - Mixed Race	3 Participants n=5 Participants	3 Participants n=7 Participants	6 Participants n=5 Participants
Race/Ethnicity, Customized White - Asian	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Race/Ethnicity, Customized Mixed Race	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Race/Ethnicity, Customized Missing	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants

PRIMARY outcome

Timeframe: Week 24

Population: Intent-to-Treat Exposed (ITT-E) Population: all participants randomized to ABC/DTG/3TC and receive at least one dose of study drug or randomized to remain on current ART regimen and continue in the study past Day 1.

The Food and Drug Administration (FDA) snapshot (Missing, Switch or Discontinuation = Failure) algorithm is intended to be primarily a virologic assessment of the endpoint, and as such follows a "virology first" hierarchy. Virologic Success (e.g., \<50 c/mL) or virologic failure within an analysis window is typically determined by the last available HIV-1 RNA measurement in that window and in the treatment phase of interest (e.g., Week 24 snapshot outcomes of the early switch phase will not use HIV-1 RNA data from the late switch phase, even if such data is within the Week 24 analysis window). A virologic failure occurs when a participant changes to their ART regimen (e.g., addition of other ARTs to the study-specified regimens, or switches in components of the current ART regimen).

Outcome measures

Outcome measures
Measure	ABC 600 mg / DTG 50 mg /3TC 300 mg FDC n=275 Participants Participants received ABC 600 mg/DTG 50 mg/3TC 300 mg FDC tablets with or without food once daily in the morning or the evening at approximately the same time each day for 24 weeks. At Week 24, participants will continue on this treatment for an additional 24 weeks.	Current ART n=278 Participants Participants continued on their current ART regimen for 24 weeks. At Week 24, participants originally randomly assigned to continue their current regimen switched to ABC 600 mg/DTG 50 mg/3TC 300 mg FDC tablets and were followed for an additional 24 weeks of treatment.
Number of Participants With Plasma HIV-1 Ribonucleic Acid (RNA) <50 Copies Per Milliliter (c/mL) at Week 24 Using the Snapshot Algorithm	233 Participants	245 Participants

SECONDARY outcome

Timeframe: Baseline and Week 24

Population: ITT-E Population. Only participants with non-missing CD4 data at Week 24 are included.

Change from Baseline in CD4+ cell counts were assessed at Baseline, Weeks 4, 8, 16 and 24. No imputation for missing data or premature discontinuation was performed and the observed values were used. Baseline value is defined as the last pre-treatment value observed. Change from Baseline was calculated as the observed value minus the Baseline value. The Week 24 data were summarized.

Outcome measures

Outcome measures
Measure	ABC 600 mg / DTG 50 mg /3TC 300 mg FDC n=238 Participants Participants received ABC 600 mg/DTG 50 mg/3TC 300 mg FDC tablets with or without food once daily in the morning or the evening at approximately the same time each day for 24 weeks. At Week 24, participants will continue on this treatment for an additional 24 weeks.	Current ART n=248 Participants Participants continued on their current ART regimen for 24 weeks. At Week 24, participants originally randomly assigned to continue their current regimen switched to ABC 600 mg/DTG 50 mg/3TC 300 mg FDC tablets and were followed for an additional 24 weeks of treatment.
Change From Baseline in Cluster of Differentiation 4+ (CD4+) Cell Counts at Week 24	50.0 Cells per cubic millimeter (cells/mm^3) Interval -48.0 to 130.0	11.0 Cells per cubic millimeter (cells/mm^3) Interval -60.0 to 103.5

SECONDARY outcome

Timeframe: Week 24

Population: ITT-E Population

Virologic non-responders were defined as the participants with a viral load \>=50 c/mL in the Week 24 analysis window. Virologic non-response includes participants who had HIV-1 RNA \>=50 c/mL, who discontinued for lack of efficacy, who discontinued for other reasons while not suppressed, data in window but not \<50 c/mL, and who changed ART regimen at Week 24. Difference is calculated as the proportion on ABC/DTG/3TC - proportion on current ART regimen.

Outcome measures

Outcome measures
Measure	ABC 600 mg / DTG 50 mg /3TC 300 mg FDC n=275 Participants Participants received ABC 600 mg/DTG 50 mg/3TC 300 mg FDC tablets with or without food once daily in the morning or the evening at approximately the same time each day for 24 weeks. At Week 24, participants will continue on this treatment for an additional 24 weeks.	Current ART n=278 Participants Participants continued on their current ART regimen for 24 weeks. At Week 24, participants originally randomly assigned to continue their current regimen switched to ABC 600 mg/DTG 50 mg/3TC 300 mg FDC tablets and were followed for an additional 24 weeks of treatment.
Number of Participants in the Virologic Non-response Category From the Snapshot Analysis at Week 24	3 Participants	4 Participants

SECONDARY outcome

Timeframe: Baseline and up to 24 weeks

Population: Safety Population: all participants who received at least one dose of study drug.

An AE is defined as any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is any untoward medical occurrence that, at any dose results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, based on medical or scientific judgment and all events of possible drug-induced liver injury with hyperbilirubinemia. The DAIDS table for grading the severity of adult and pediatric AEs was utilized for AE reporting. The DAIDS estimates the severity grade as Grade 1 (mild), Grade 2 (moderate), Grade 3 (severe) and Grade 4 (potentially life threatening) for each parameter.

Outcome measures

Outcome measures
Measure	ABC 600 mg / DTG 50 mg /3TC 300 mg FDC n=276 Participants Participants received ABC 600 mg/DTG 50 mg/3TC 300 mg FDC tablets with or without food once daily in the morning or the evening at approximately the same time each day for 24 weeks. At Week 24, participants will continue on this treatment for an additional 24 weeks.	Current ART n=277 Participants Participants continued on their current ART regimen for 24 weeks. At Week 24, participants originally randomly assigned to continue their current regimen switched to ABC 600 mg/DTG 50 mg/3TC 300 mg FDC tablets and were followed for an additional 24 weeks of treatment.
Number of Participants With Incidence and Severity of Adverse Events (AEs) and Serious Adverse Events (SAEs) up to 24 Weeks Any AEs	183 Participants	129 Participants
Number of Participants With Incidence and Severity of Adverse Events (AEs) and Serious Adverse Events (SAEs) up to 24 Weeks Any SAEs	6 Participants	5 Participants

SECONDARY outcome

Timeframe: Baseline and up to 24 weeks

Population: Safety Population

The number of participants with maximum post-Baseline emergent chemistry toxicities for each grade were summarized by parameter. A toxicity is considered emergent if it develops or increases in intensity from Baseline. For participants who were originally randomized to current ART regimen on Day 1 and then switched to ABC/DTG/3TC on Week 24, Baseline is defined as the last non-missing value from the early switch phase and maximum post-Baseline emergent during the late switch phase was determined relative to this Baseline. The DAIDS table for grading the severity of adult and pediatric AEs was utilized for AE reporting. The DAIDS defined the severity grade as Grade 1 (mild), Grade 2 (moderate), Grade 3 (severe) and Grade 4 (potentially life threatening) for each parameter.

Outcome measures

Outcome measures
Measure	ABC 600 mg / DTG 50 mg /3TC 300 mg FDC n=276 Participants Participants received ABC 600 mg/DTG 50 mg/3TC 300 mg FDC tablets with or without food once daily in the morning or the evening at approximately the same time each day for 24 weeks. At Week 24, participants will continue on this treatment for an additional 24 weeks.	Current ART n=277 Participants Participants continued on their current ART regimen for 24 weeks. At Week 24, participants originally randomly assigned to continue their current regimen switched to ABC 600 mg/DTG 50 mg/3TC 300 mg FDC tablets and were followed for an additional 24 weeks of treatment.
Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to 24 Weeks Grade 1	98 Participants	108 Participants
Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to 24 Weeks Grade 2	73 Participants	71 Participants
Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to 24 Weeks Grade 3	21 Participants	25 Participants
Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to 24 Weeks Grade 4	10 Participants	10 Participants

SECONDARY outcome

Timeframe: Baseline and up to 24 weeks

Population: Safety Population

The number of participants with maximum post-Baseline emergent hematology toxicities for each grade were summarized by parameter. A toxicity is considered emergent if it develops or increases in intensity from Baseline. For participants who were originally randomized to current ART regimen on Day 1 and then switched to ABC/DTG/3TC on Week 24, Baseline is defined as the last non-missing value from the early switch phase and maximum post-Baseline emergent during the late switch phase was determined relative to this Baseline. The DAIDS table for grading the severity of adult and pediatric AEs was utilized for AE reporting. The DAIDS defined the severity grade as Grade 1 (mild), Grade 2 (moderate), Grade 3 (severe) and Grade 4 (potentially life threatening) for each parameter.

Outcome measures

Outcome measures
Measure	ABC 600 mg / DTG 50 mg /3TC 300 mg FDC n=276 Participants Participants received ABC 600 mg/DTG 50 mg/3TC 300 mg FDC tablets with or without food once daily in the morning or the evening at approximately the same time each day for 24 weeks. At Week 24, participants will continue on this treatment for an additional 24 weeks.	Current ART n=277 Participants Participants continued on their current ART regimen for 24 weeks. At Week 24, participants originally randomly assigned to continue their current regimen switched to ABC 600 mg/DTG 50 mg/3TC 300 mg FDC tablets and were followed for an additional 24 weeks of treatment.
Number of Participants With Maximum Post-Baseline Emergent Hematology Toxicities up to 24 Weeks Grade 1	19 Participants	15 Participants
Number of Participants With Maximum Post-Baseline Emergent Hematology Toxicities up to 24 Weeks Grade 2	3 Participants	6 Participants
Number of Participants With Maximum Post-Baseline Emergent Hematology Toxicities up to 24 Weeks Grade 3	0 Participants	2 Participants
Number of Participants With Maximum Post-Baseline Emergent Hematology Toxicities up to 24 Weeks Grade 4	1 Participants	0 Participants

SECONDARY outcome

Timeframe: Baseline and up to 24 weeks

Population: Safety Population

An AE is defined as any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is any untoward medical occurrence that, at any dose results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, based on medical or scientific judgment and all events of possible drug-induced liver injury with hyperbilirubinemia.

Outcome measures

Outcome measures
Measure	ABC 600 mg / DTG 50 mg /3TC 300 mg FDC n=276 Participants Participants received ABC 600 mg/DTG 50 mg/3TC 300 mg FDC tablets with or without food once daily in the morning or the evening at approximately the same time each day for 24 weeks. At Week 24, participants will continue on this treatment for an additional 24 weeks.	Current ART n=277 Participants Participants continued on their current ART regimen for 24 weeks. At Week 24, participants originally randomly assigned to continue their current regimen switched to ABC 600 mg/DTG 50 mg/3TC 300 mg FDC tablets and were followed for an additional 24 weeks of treatment.
Number of Participants With AEs Leading to Withdrawal Over 24 Weeks	11 Participants	0 Participants

SECONDARY outcome

Timeframe: Baseline and Week 24

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

Change from Baseline for each fasting lipid parameters included cholesterol, LDL cholesterol, HDL cholesterol, and triglycerides. Adjusted mean is the estimated mean change from Baseline in each parameter at Week 24 in each arm calculated from an analysis of covariance (ANCOVA) model which includes the following covariates: treatment, original ART third agent class, interaction of treatment and original ART 3rd agent, use of lipid modifying agent and Baseline lipid level. Difference is calculated as ABC/DTG/3TC - Current ART regimen. For fasting lipid assessments, an overnight fast is preferred; however, a minimum of a 6-hour fast was acceptable for participants with afternoon appointments.

Outcome measures

Outcome measures
Measure	ABC 600 mg / DTG 50 mg /3TC 300 mg FDC n=276 Participants Participants received ABC 600 mg/DTG 50 mg/3TC 300 mg FDC tablets with or without food once daily in the morning or the evening at approximately the same time each day for 24 weeks. At Week 24, participants will continue on this treatment for an additional 24 weeks.	Current ART n=277 Participants Participants continued on their current ART regimen for 24 weeks. At Week 24, participants originally randomly assigned to continue their current regimen switched to ABC 600 mg/DTG 50 mg/3TC 300 mg FDC tablets and were followed for an additional 24 weeks of treatment.
Change From Baseline in Fasting Lipids (Cholesterol, LDL Cholesterol, HDL Cholesterol, and Triglycerides) at Week 24 HDL Cholesterol, n=226, 231	0.00 Millimoles per liter (mmol/L) Interval -0.04 to 0.03	-0.03 Millimoles per liter (mmol/L) Interval -0.06 to 0.01
Change From Baseline in Fasting Lipids (Cholesterol, LDL Cholesterol, HDL Cholesterol, and Triglycerides) at Week 24 Cholesterol,n=226, 231	0.10 Millimoles per liter (mmol/L) Interval 0.0 to 0.21	-0.01 Millimoles per liter (mmol/L) Interval -0.11 to 0.1
Change From Baseline in Fasting Lipids (Cholesterol, LDL Cholesterol, HDL Cholesterol, and Triglycerides) at Week 24 LDL Cholesterol, n=221, 226	0.10 Millimoles per liter (mmol/L) Interval 0.01 to 0.18	0.02 Millimoles per liter (mmol/L) Interval -0.06 to 0.11
Change From Baseline in Fasting Lipids (Cholesterol, LDL Cholesterol, HDL Cholesterol, and Triglycerides) at Week 24 Triglycerides, n=226, 231	0.07 Millimoles per liter (mmol/L) Interval -0.07 to 0.21	-0.04 Millimoles per liter (mmol/L) Interval -0.17 to 0.1

SECONDARY outcome

Timeframe: Baseline and Week 24

Population: Safety Population. Only those participants available at the specified time points.

Change from Baseline for fasting lipid parameter total cholesterol/HDL cholesterol ratio. Adjusted mean is the estimated mean change from Baseline at Week 24 in each arm calculated from an analysis of covariance (ANCOVA) model which includes the following covariates: treatment, original ART third agent class, interaction of treatment and original ART 3rd agent, use of lipid modifying agent and Baseline lipid level. Difference is calculated as ABC/DTG/3TC - Current ART regimen. For fasting lipid assessments, an overnight fast is preferred; however, a minimum of a 6-hour fast was acceptable for participants with afternoon appointments.

Outcome measures

Outcome measures
Measure	ABC 600 mg / DTG 50 mg /3TC 300 mg FDC n=226 Participants Participants received ABC 600 mg/DTG 50 mg/3TC 300 mg FDC tablets with or without food once daily in the morning or the evening at approximately the same time each day for 24 weeks. At Week 24, participants will continue on this treatment for an additional 24 weeks.	Current ART n=231 Participants Participants continued on their current ART regimen for 24 weeks. At Week 24, participants originally randomly assigned to continue their current regimen switched to ABC 600 mg/DTG 50 mg/3TC 300 mg FDC tablets and were followed for an additional 24 weeks of treatment.
Change From Baseline in Fasting Lipids (Total Cholesterol/HDL Cholesterol Ratio) at Week 24	0.10 Ratio Interval -0.02 to 0.22	0.00 Ratio Interval -0.12 to 0.12

SECONDARY outcome

Timeframe: Baseline, Week 4 and Week 24

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

The HIV treatment satisfaction questionnaire (TSQ) is a 10 item self-reported scale. Individual item scores range from 6 (very satisfied) to 0 (very dissatisfied). The treatment satisfaction total score (range 0-60) is the sum of all the 10 individual items. The general satisfaction/Clinical subscale (range 0-30) is the sum of the 5 clinical items and the lifestyle/ease subscale (range 0-30) is the sum of the remaining 5 lifestyle items. Last observation carried forward (LOCF) were used for the analysis. If a participant had a missing value at Week 24, his previous non-missing available value while on the same treatment was carried forward (ie the Week 4 or withdrawal value is used in the Week 24 summary for participants in the ABC/DTG3TC with missing Week 24 value). Data were analyzed using an ANCOVA model with factors including treatment, Baseline score and stratification factor. Treatment group difference (ABC/DTG/3TC-cART) estimate and 95% CI were presented.

Outcome measures

Outcome measures
Measure	ABC 600 mg / DTG 50 mg /3TC 300 mg FDC n=275 Participants Participants received ABC 600 mg/DTG 50 mg/3TC 300 mg FDC tablets with or without food once daily in the morning or the evening at approximately the same time each day for 24 weeks. At Week 24, participants will continue on this treatment for an additional 24 weeks.	Current ART n=278 Participants Participants continued on their current ART regimen for 24 weeks. At Week 24, participants originally randomly assigned to continue their current regimen switched to ABC 600 mg/DTG 50 mg/3TC 300 mg FDC tablets and were followed for an additional 24 weeks of treatment.
Change From Baseline in Treatment Satisfaction at Week 4 and Week 24 Total score, n=270,276	3.2 Units on a scale Standard Error 0.40	0.8 Units on a scale Standard Error 0.39
Change From Baseline in Treatment Satisfaction at Week 4 and Week 24 General Satisfaction/Clinical Subscale, n=269, 276	1.3 Units on a scale Standard Error 0.24	0.2 Units on a scale Standard Error 0.23
Change From Baseline in Treatment Satisfaction at Week 4 and Week 24 Lifestyle/Ease Subscale Score, n=269, 276	1.8 Units on a scale Standard Error 0.19	0.6 Units on a scale Standard Error 0.19

SECONDARY outcome

Timeframe: Baseline and Week 24

Population: Safety Population. Only participants with a non-missing value at Week 24 are included.

Renal markers included creatinine and summarized based on an observed case (OC) data set at Week 24. Adjusted mean is the estimated mean change from Baseline in each biomarker at Week 24 in each arm calculated from an ANCOVA analysis of covariance model including the following covariates: treatment, original ART third agent class, interaction of treatment and original ART third agent class, and Baseline biomarker level. Differences are calculated as ABC/DTG/3TC - Current ART regimen.

Outcome measures

Outcome measures
Measure	ABC 600 mg / DTG 50 mg /3TC 300 mg FDC n=240 Participants Participants received ABC 600 mg/DTG 50 mg/3TC 300 mg FDC tablets with or without food once daily in the morning or the evening at approximately the same time each day for 24 weeks. At Week 24, participants will continue on this treatment for an additional 24 weeks.	Current ART n=249 Participants Participants continued on their current ART regimen for 24 weeks. At Week 24, participants originally randomly assigned to continue their current regimen switched to ABC 600 mg/DTG 50 mg/3TC 300 mg FDC tablets and were followed for an additional 24 weeks of treatment.
Change From Baseline in Creatinine at Week 24	7.63 Micromoles per liter (umol/L) Interval 6.46 to 8.8	1.12 Micromoles per liter (umol/L) Interval -0.03 to 2.27

SECONDARY outcome

Timeframe: Baseline and Week 24

Population: Safety Population. Only participants with a non-missing value at Week 24 are included.

Renal markers included GFR from creatinine adjusted using chronic kidney disease epidemiology collaboration (CKD-EPI) equation and summarized based on an OC data set at Week 24. Adjusted mean is the estimated mean change from Baseline in each biomarker at Week 24 in each arm calculated from an ANCOVA analysis of covariance model including the following covariates: treatment, original ART third agent class, interaction of treatment and original ART third agent class, and Baseline biomarker level. Differences are calculated as ABC/DTG/3TC - Current ART regimen.

Outcome measures

Outcome measures
Measure	ABC 600 mg / DTG 50 mg /3TC 300 mg FDC n=240 Participants Participants received ABC 600 mg/DTG 50 mg/3TC 300 mg FDC tablets with or without food once daily in the morning or the evening at approximately the same time each day for 24 weeks. At Week 24, participants will continue on this treatment for an additional 24 weeks.	Current ART n=249 Participants Participants continued on their current ART regimen for 24 weeks. At Week 24, participants originally randomly assigned to continue their current regimen switched to ABC 600 mg/DTG 50 mg/3TC 300 mg FDC tablets and were followed for an additional 24 weeks of treatment.
Change From Baseline in Glomerular Filtration Rate (GFR) From Creatinine Adjusted Using CKD-EPI Equation at Week 24	-8.05 mL/second Interval -9.3 to -6.8	-1.18 mL/second Interval -2.41 to 0.06

SECONDARY outcome

Timeframe: Baseline and Week 24

Population: Safety Population. Only participants with a non-missing value at Week 24 are included.

Renal markers included GFR from creatinine adjusted using modification of diet in renal disease (MDRD) enzymatic equation and summarized based on an OC data set at Week 24. Adjusted mean is the estimated mean change from Baseline in each biomarker at Week 24 in each arm calculated from an ANCOVA analysis of covariance model including the following covariates: treatment, original ART third agent class, interaction of treatment and original ART third agent class, and Baseline biomarker level. Differences are calculated as ABC/DTG/3TC - Current ART regimen.

Outcome measures

Outcome measures
Measure	ABC 600 mg / DTG 50 mg /3TC 300 mg FDC n=239 Participants Participants received ABC 600 mg/DTG 50 mg/3TC 300 mg FDC tablets with or without food once daily in the morning or the evening at approximately the same time each day for 24 weeks. At Week 24, participants will continue on this treatment for an additional 24 weeks.	Current ART n=249 Participants Participants continued on their current ART regimen for 24 weeks. At Week 24, participants originally randomly assigned to continue their current regimen switched to ABC 600 mg/DTG 50 mg/3TC 300 mg FDC tablets and were followed for an additional 24 weeks of treatment.
Change From Baseline in GFR From Creatinine Adjusted Using MDRD Enzymatic Equation at Week 24	-0.16 mL/second/1.73 meter square Interval -0.18 to -0.13	-0.02 mL/second/1.73 meter square Interval -0.04 to 0.0

SECONDARY outcome

Timeframe: Baseline and Week 24

Population: Safety Population. Only participants with a non-missing value at Week 24 are included.

Renal markers included urea and summarized based on an OC data set at Week 24. Adjusted mean is the estimated mean change from Baseline in each biomarker at Week 24 in each arm calculated from an ANCOVA analysis of covariance model including the following covariates: treatment, original ART third agent class, interaction of treatment and original ART third agent class, and Baseline biomarker level. Differences are calculated as ABC/DTG/3TC - Current ART regimen.

Outcome measures

Outcome measures
Measure	ABC 600 mg / DTG 50 mg /3TC 300 mg FDC n=240 Participants Participants received ABC 600 mg/DTG 50 mg/3TC 300 mg FDC tablets with or without food once daily in the morning or the evening at approximately the same time each day for 24 weeks. At Week 24, participants will continue on this treatment for an additional 24 weeks.	Current ART n=249 Participants Participants continued on their current ART regimen for 24 weeks. At Week 24, participants originally randomly assigned to continue their current regimen switched to ABC 600 mg/DTG 50 mg/3TC 300 mg FDC tablets and were followed for an additional 24 weeks of treatment.
Change From Baseline in Urea at Week 24	-0.03 Millimoles per liter (mmol/L) Interval -0.18 to 0.12	0.07 Millimoles per liter (mmol/L) Interval -0.08 to 0.22

SECONDARY outcome

Timeframe: Baseline and Week 24

Population: Safety Population. Only participants with a non-missing value at Week 24 are included.

Renal markers included urine albumin/creatinine ratioand summarized based on an OC data set at Week 24. Adjusted mean is the estimated mean change from Baseline in each biomarker at Week 24 in each arm calculated from an ANCOVA analysis of covariance model including the following covariates: treatment, original ART third agent class, interaction of treatment and original ART third agent class, and Baseline biomarker level. Differences are calculated as ABC/DTG/3TC - Current ART regimen.

Outcome measures

Outcome measures
Measure	ABC 600 mg / DTG 50 mg /3TC 300 mg FDC n=197 Participants Participants received ABC 600 mg/DTG 50 mg/3TC 300 mg FDC tablets with or without food once daily in the morning or the evening at approximately the same time each day for 24 weeks. At Week 24, participants will continue on this treatment for an additional 24 weeks.	Current ART n=222 Participants Participants continued on their current ART regimen for 24 weeks. At Week 24, participants originally randomly assigned to continue their current regimen switched to ABC 600 mg/DTG 50 mg/3TC 300 mg FDC tablets and were followed for an additional 24 weeks of treatment.
Change From Baseline in Urine Albumin/Creatinine Ratio at Week 24	0.11 Gram per mole (G/mol) creatinine Interval -0.7 to 0.92	-0.07 Gram per mole (G/mol) creatinine Interval -0.84 to 0.69

SECONDARY outcome

Timeframe: Baseline and Week 24

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

Outcome Measure Description: Bone biomarkers analytes include bone specific alkaline phosphatase, osteocalcin, procollagen 1 n-terminal propeptide, type I collagen c-telopeptides and were analyzed based on log transformed data. Estimates were from an ANCOVA model adjusting for ART third agent class, interaction of treatment and original ART third agent class, age, sex (male or female), body mass index (BMI) (\<25 kilogram per meter \[kg/m\] or \>=25 kg/m), smoking status (never smoked or former smoker or current smoker), Baseline vitamin D (no vitamin D use at Baseline or vitamin D use at Baseline), and Baseline biomarker level.

Outcome measures

Outcome measures
Measure	ABC 600 mg / DTG 50 mg /3TC 300 mg FDC n=276 Participants Participants received ABC 600 mg/DTG 50 mg/3TC 300 mg FDC tablets with or without food once daily in the morning or the evening at approximately the same time each day for 24 weeks. At Week 24, participants will continue on this treatment for an additional 24 weeks.	Current ART n=277 Participants Participants continued on their current ART regimen for 24 weeks. At Week 24, participants originally randomly assigned to continue their current regimen switched to ABC 600 mg/DTG 50 mg/3TC 300 mg FDC tablets and were followed for an additional 24 weeks of treatment.
Percent Change From Baseline in Bone Marker Analytes at Week 24 Bone specific alkaline phosphatase, n= 214, 224	0.84 Percent Interval 0.79 to 0.88	0.98 Percent Interval 0.93 to 1.03
Percent Change From Baseline in Bone Marker Analytes at Week 24 Osteocalcin, n=211, 221	0.87 Percent Interval 0.82 to 0.93	0.96 Percent Interval 0.9 to 1.03
Percent Change From Baseline in Bone Marker Analytes at Week 24 Procollagen 1 n-terminal propeptide, n=212, 222	0.88 Percent Interval 0.83 to 0.94	0.96 Percent Interval 0.91 to 1.03
Percent Change From Baseline in Bone Marker Analytes at Week 24 Type I collagen c-telopeptides, n=212, 223	0.87 Percent Interval 0.79 to 0.95	1.03 Percent Interval 0.94 to 1.14

SECONDARY outcome

Timeframe: Baseline and Week 24

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

Cardiovascular biomarkers were analyzed based on log transformed data. Estimates were from an ANCOVA model adjusting for ART third agent class, interaction of treatment and original ART third agent class, sex, race (white, black or African American, Other), and Baseline biomarker level.

Outcome measures

Outcome measures
Measure	ABC 600 mg / DTG 50 mg /3TC 300 mg FDC n=276 Participants Participants received ABC 600 mg/DTG 50 mg/3TC 300 mg FDC tablets with or without food once daily in the morning or the evening at approximately the same time each day for 24 weeks. At Week 24, participants will continue on this treatment for an additional 24 weeks.	Current ART n=277 Participants Participants continued on their current ART regimen for 24 weeks. At Week 24, participants originally randomly assigned to continue their current regimen switched to ABC 600 mg/DTG 50 mg/3TC 300 mg FDC tablets and were followed for an additional 24 weeks of treatment.
Percent Change From Baseline in Cardiovascular Marker Analytes at Week 24 Fatty acid binding protein 2 [ng/L], n=212,222	0.67 Percent Interval 0.59 to 0.75	1.04 Percent Interval 0.92 to 1.17
Percent Change From Baseline in Cardiovascular Marker Analytes at Week 24 Interleukin 6 [ng/L], n=213,222	0.86 Percent Interval 0.74 to 0.99	0.80 Percent Interval 0.69 to 0.92
Percent Change From Baseline in Cardiovascular Marker Analytes at Week 24 Soluble cd14 [ng/L], n=214,223	0.76 Percent Interval 0.73 to 0.79	0.82 Percent Interval 0.79 to 0.85
Percent Change From Baseline in Cardiovascular Marker Analytes at Week 24 Soluble vasc cell adhesion mol 1[ng/L], n=213,222	0.86 Percent Interval 0.8 to 0.92	0.85 Percent Interval 0.8 to 0.91

SECONDARY outcome

Timeframe: Baseline and Week 24

Population: Safety Population. Only participants with a non-missing value at Week 24 are included.

Cardiovascular biomarkers were analyzed based on log transformed data. Estimates were from an ANCOVA model adjusting for ART third agent class, interaction of treatment and original ART third agent class, sex, race (white, black or African American, Other), and Baseline biomarker level.

Outcome measures

Outcome measures
Measure	ABC 600 mg / DTG 50 mg /3TC 300 mg FDC n=226 Participants Participants received ABC 600 mg/DTG 50 mg/3TC 300 mg FDC tablets with or without food once daily in the morning or the evening at approximately the same time each day for 24 weeks. At Week 24, participants will continue on this treatment for an additional 24 weeks.	Current ART n=231 Participants Participants continued on their current ART regimen for 24 weeks. At Week 24, participants originally randomly assigned to continue their current regimen switched to ABC 600 mg/DTG 50 mg/3TC 300 mg FDC tablets and were followed for an additional 24 weeks of treatment.
Percent Change From Baseline in Cardiovascular Marker Analyte, C-reactive Protein at Week 24	1.25 Percent Interval 1.04 to 1.5	1.25 Percent Interval 1.04 to 1.49

SECONDARY outcome

Timeframe: Baseline and Week 24

Population: Safety Population. Only participants with a non-missing value at Week 24 are included.

Cardiovascular biomarkers were analyzed based on log transformed data. Estimates were from an ANCOVA model adjusting for ART third agent class, interaction of treatment and original ART third agent class, sex, race (white, black or African American, Other), and Baseline biomarker level.

Outcome measures

Outcome measures
Measure	ABC 600 mg / DTG 50 mg /3TC 300 mg FDC n=212 Participants Participants received ABC 600 mg/DTG 50 mg/3TC 300 mg FDC tablets with or without food once daily in the morning or the evening at approximately the same time each day for 24 weeks. At Week 24, participants will continue on this treatment for an additional 24 weeks.	Current ART n=221 Participants Participants continued on their current ART regimen for 24 weeks. At Week 24, participants originally randomly assigned to continue their current regimen switched to ABC 600 mg/DTG 50 mg/3TC 300 mg FDC tablets and were followed for an additional 24 weeks of treatment.
Percent Change From Baseline in Cardiovascular Marker Analyte, D-Dimer at Week 24	1.00 Percent Interval 0.91 to 1.1	1.00 Percent Interval 0.91 to 1.1

SECONDARY outcome

Timeframe: Baseline and Week 24

Population: Safety Population. Only participants with a non-missing value at Week 24 are included.

Cardiovascular biomarkers were analyzed based on log transformed data. Estimates were from an ANCOVA model adjusting for ART third agent class, interaction of treatment and original ART third agent class, sex, race (white, black or african american, other), and Baseline biomarker level.

Outcome measures

Outcome measures
Measure	ABC 600 mg / DTG 50 mg /3TC 300 mg FDC n=210 Participants Participants received ABC 600 mg/DTG 50 mg/3TC 300 mg FDC tablets with or without food once daily in the morning or the evening at approximately the same time each day for 24 weeks. At Week 24, participants will continue on this treatment for an additional 24 weeks.	Current ART n=219 Participants Participants continued on their current ART regimen for 24 weeks. At Week 24, participants originally randomly assigned to continue their current regimen switched to ABC 600 mg/DTG 50 mg/3TC 300 mg FDC tablets and were followed for an additional 24 weeks of treatment.
Percent Change From Baseline in Cardiovascular Marker Analyte, Homostat Model Assess of Insulin Resistance at Week 24	0.97 Percent Interval 0.84 to 1.11	1.00 Percent Interval 0.87 to 1.14

SECONDARY outcome

Timeframe: Baseline and Week 24

Population: Safety Population. Only participants with a non-missing value at Week 24 are included.

Cardiovascular biomarkers were analyzed based on log transformed data. Estimates were from an ANCOVA model adjusting for ART third agent class, interaction of treatment and original ART third agent class, sex, race (white, black or african american, other), and Baseline biomarker level.

Outcome measures

Outcome measures
Measure	ABC 600 mg / DTG 50 mg /3TC 300 mg FDC n=213 Participants Participants received ABC 600 mg/DTG 50 mg/3TC 300 mg FDC tablets with or without food once daily in the morning or the evening at approximately the same time each day for 24 weeks. At Week 24, participants will continue on this treatment for an additional 24 weeks.	Current ART n=222 Participants Participants continued on their current ART regimen for 24 weeks. At Week 24, participants originally randomly assigned to continue their current regimen switched to ABC 600 mg/DTG 50 mg/3TC 300 mg FDC tablets and were followed for an additional 24 weeks of treatment.
Percent Change From Baseline in Cardiovascular Marker Analyte, Insulin at Week 24	0.97 Percent Interval 0.86 to 1.09	0.99 Percent Interval 0.88 to 1.12

SECONDARY outcome

Timeframe: Baseline and Week 24

Population: Safety Population. Only participants with a non-missing value at Week 24 are included.

Cardiovascular biomarkers were analyzed based on log transformed data. Estimates were from an ANCOVA model adjusting for ART third agent class, interaction of treatment and original ART third agent class, sex, race (white, black or african american, other), and Baseline biomarker level.

Outcome measures

Outcome measures
Measure	ABC 600 mg / DTG 50 mg /3TC 300 mg FDC n=213 Participants Participants received ABC 600 mg/DTG 50 mg/3TC 300 mg FDC tablets with or without food once daily in the morning or the evening at approximately the same time each day for 24 weeks. At Week 24, participants will continue on this treatment for an additional 24 weeks.	Current ART n=222 Participants Participants continued on their current ART regimen for 24 weeks. At Week 24, participants originally randomly assigned to continue their current regimen switched to ABC 600 mg/DTG 50 mg/3TC 300 mg FDC tablets and were followed for an additional 24 weeks of treatment.
Percent Change From Baseline in Cardiovascular Marker Analyte, Soluble CD163 at Week 24	1.09 Percent Interval 1.04 to 1.15	1.08 Percent Interval 1.02 to 1.13

SECONDARY outcome

Timeframe: Baseline and Week 24

Population: Safety Population. Only participants with a non-missing value at Week 24 are included.

Cardiovascular biomarkers were analyzed based on log transformed data. Estimates were from an ANCOVA model adjusting for ART third agent class, interaction of treatment and original ART third agent class, sex, race (white, black or african american, other), and Baseline biomarker level.

Outcome measures

Outcome measures
Measure	ABC 600 mg / DTG 50 mg /3TC 300 mg FDC n=240 Participants Participants received ABC 600 mg/DTG 50 mg/3TC 300 mg FDC tablets with or without food once daily in the morning or the evening at approximately the same time each day for 24 weeks. At Week 24, participants will continue on this treatment for an additional 24 weeks.	Current ART n=249 Participants Participants continued on their current ART regimen for 24 weeks. At Week 24, participants originally randomly assigned to continue their current regimen switched to ABC 600 mg/DTG 50 mg/3TC 300 mg FDC tablets and were followed for an additional 24 weeks of treatment.
Percent Change From Baseline in Cardiovascular Marker Analyte, Glucose at Week 24	1.02 Percent Interval 0.99 to 1.05	1.01 Percent Interval 0.99 to 1.04

SECONDARY outcome

Timeframe: Baseline and up to 24 weeks

Population: Viral Genotypic and Phenotypic Populations: Comprised of all participants in the ITT-E Population with available on-treatment genotypic and phenotypic resistance data, respectively, at the time confirmed virologic withdrawal criterion was met.

Genotypic and phenotypic testing was conducted for participants who met the confirmed virologic withdrawal criteria, i.e., confirmed HIV-1 RNA \>=400 c/mL any time after Day 1. The sample from the "suspected virologic withdrawal criterion" visit was tested for HIV-1 PRO and RT genotype and phenotype and HIV-1 integrase genotype and phenotype (i.e., the first of the two consecutive results \>=400 c/mL). At the time of the data cut-off for this Week 24 analysis, no participants met the confirmed virologic withdrawal criteria over 24 weeks; therefore, the virologic analyses were not assessed.

Outcome measures

Outcome data not reported

Adverse Events

Early Switch ABC 600 mg / DTG 50 mg /3TC 300 mg FDC

Serious events: 9 serious events

Other events: 101 other events

Deaths: 0 deaths

Late Switch ABC 600 mg / DTG 50 mg /3TC 300 mg FDC

Serious events: 6 serious events

Other events: 61 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	Early Switch ABC 600 mg / DTG 50 mg /3TC 300 mg FDC n=275 participants at risk Participants received ABC 600 mg/DTG 50 mg/3TC 300 mg FDC tablets with or without food once daily in the morning or the evening at approximately the same time each day for 24 weeks. At Week 24, participants will continue on this treatment for an additional 24 weeks.	Late Switch ABC 600 mg / DTG 50 mg /3TC 300 mg FDC n=244 participants at risk Participants continued on their current ART regimen for 24 weeks. At Week 24, participants originally randomly assigned to continue their current regimen switched to ABC 600 mg/DTG 50 mg/3TC 300 mg FDC tablets and were followed for an additional 24 weeks of treatment.
Gastrointestinal disorders Diarrhoea	7.3% 20/275 • Early Switch group AEs/SAEs are included from time of switch to ABC 600mg/DTG 50mg/3TC 300mg at baseline up to Week 48. Late Switch group AEs/SAEs are included from the time of switch to ABC 600mg/DTG 50mg/3TC 300mg at week 24 up to Week 48. Adverse events (AEs) and serious adverse events (SAEs) are presented for the early Switch and Late Switch group. AEs and SAEs were collected from participants of the safety population, comprised of all participants who received atleast one dose of the study drug.	3.7% 9/244 • Early Switch group AEs/SAEs are included from time of switch to ABC 600mg/DTG 50mg/3TC 300mg at baseline up to Week 48. Late Switch group AEs/SAEs are included from the time of switch to ABC 600mg/DTG 50mg/3TC 300mg at week 24 up to Week 48. Adverse events (AEs) and serious adverse events (SAEs) are presented for the early Switch and Late Switch group. AEs and SAEs were collected from participants of the safety population, comprised of all participants who received atleast one dose of the study drug.
Infections and infestations Upper respiratory tract infection	12.7% 35/275 • Early Switch group AEs/SAEs are included from time of switch to ABC 600mg/DTG 50mg/3TC 300mg at baseline up to Week 48. Late Switch group AEs/SAEs are included from the time of switch to ABC 600mg/DTG 50mg/3TC 300mg at week 24 up to Week 48. Adverse events (AEs) and serious adverse events (SAEs) are presented for the early Switch and Late Switch group. AEs and SAEs were collected from participants of the safety population, comprised of all participants who received atleast one dose of the study drug.	9.0% 22/244 • Early Switch group AEs/SAEs are included from time of switch to ABC 600mg/DTG 50mg/3TC 300mg at baseline up to Week 48. Late Switch group AEs/SAEs are included from the time of switch to ABC 600mg/DTG 50mg/3TC 300mg at week 24 up to Week 48. Adverse events (AEs) and serious adverse events (SAEs) are presented for the early Switch and Late Switch group. AEs and SAEs were collected from participants of the safety population, comprised of all participants who received atleast one dose of the study drug.
Gastrointestinal disorders Nausea	10.2% 28/275 • Early Switch group AEs/SAEs are included from time of switch to ABC 600mg/DTG 50mg/3TC 300mg at baseline up to Week 48. Late Switch group AEs/SAEs are included from the time of switch to ABC 600mg/DTG 50mg/3TC 300mg at week 24 up to Week 48. Adverse events (AEs) and serious adverse events (SAEs) are presented for the early Switch and Late Switch group. AEs and SAEs were collected from participants of the safety population, comprised of all participants who received atleast one dose of the study drug.	6.1% 15/244 • Early Switch group AEs/SAEs are included from time of switch to ABC 600mg/DTG 50mg/3TC 300mg at baseline up to Week 48. Late Switch group AEs/SAEs are included from the time of switch to ABC 600mg/DTG 50mg/3TC 300mg at week 24 up to Week 48. Adverse events (AEs) and serious adverse events (SAEs) are presented for the early Switch and Late Switch group. AEs and SAEs were collected from participants of the safety population, comprised of all participants who received atleast one dose of the study drug.
General disorders Fatigue	8.0% 22/275 • Early Switch group AEs/SAEs are included from time of switch to ABC 600mg/DTG 50mg/3TC 300mg at baseline up to Week 48. Late Switch group AEs/SAEs are included from the time of switch to ABC 600mg/DTG 50mg/3TC 300mg at week 24 up to Week 48. Adverse events (AEs) and serious adverse events (SAEs) are presented for the early Switch and Late Switch group. AEs and SAEs were collected from participants of the safety population, comprised of all participants who received atleast one dose of the study drug.	2.5% 6/244 • Early Switch group AEs/SAEs are included from time of switch to ABC 600mg/DTG 50mg/3TC 300mg at baseline up to Week 48. Late Switch group AEs/SAEs are included from the time of switch to ABC 600mg/DTG 50mg/3TC 300mg at week 24 up to Week 48. Adverse events (AEs) and serious adverse events (SAEs) are presented for the early Switch and Late Switch group. AEs and SAEs were collected from participants of the safety population, comprised of all participants who received atleast one dose of the study drug.
Nervous system disorders Headache	6.2% 17/275 • Early Switch group AEs/SAEs are included from time of switch to ABC 600mg/DTG 50mg/3TC 300mg at baseline up to Week 48. Late Switch group AEs/SAEs are included from the time of switch to ABC 600mg/DTG 50mg/3TC 300mg at week 24 up to Week 48. Adverse events (AEs) and serious adverse events (SAEs) are presented for the early Switch and Late Switch group. AEs and SAEs were collected from participants of the safety population, comprised of all participants who received atleast one dose of the study drug.	4.1% 10/244 • Early Switch group AEs/SAEs are included from time of switch to ABC 600mg/DTG 50mg/3TC 300mg at baseline up to Week 48. Late Switch group AEs/SAEs are included from the time of switch to ABC 600mg/DTG 50mg/3TC 300mg at week 24 up to Week 48. Adverse events (AEs) and serious adverse events (SAEs) are presented for the early Switch and Late Switch group. AEs and SAEs were collected from participants of the safety population, comprised of all participants who received atleast one dose of the study drug.
Respiratory, thoracic and mediastinal disorders Cough	6.2% 17/275 • Early Switch group AEs/SAEs are included from time of switch to ABC 600mg/DTG 50mg/3TC 300mg at baseline up to Week 48. Late Switch group AEs/SAEs are included from the time of switch to ABC 600mg/DTG 50mg/3TC 300mg at week 24 up to Week 48. Adverse events (AEs) and serious adverse events (SAEs) are presented for the early Switch and Late Switch group. AEs and SAEs were collected from participants of the safety population, comprised of all participants who received atleast one dose of the study drug.	2.5% 6/244 • Early Switch group AEs/SAEs are included from time of switch to ABC 600mg/DTG 50mg/3TC 300mg at baseline up to Week 48. Late Switch group AEs/SAEs are included from the time of switch to ABC 600mg/DTG 50mg/3TC 300mg at week 24 up to Week 48. Adverse events (AEs) and serious adverse events (SAEs) are presented for the early Switch and Late Switch group. AEs and SAEs were collected from participants of the safety population, comprised of all participants who received atleast one dose of the study drug.
Psychiatric disorders Insomnia	5.1% 14/275 • Early Switch group AEs/SAEs are included from time of switch to ABC 600mg/DTG 50mg/3TC 300mg at baseline up to Week 48. Late Switch group AEs/SAEs are included from the time of switch to ABC 600mg/DTG 50mg/3TC 300mg at week 24 up to Week 48. Adverse events (AEs) and serious adverse events (SAEs) are presented for the early Switch and Late Switch group. AEs and SAEs were collected from participants of the safety population, comprised of all participants who received atleast one dose of the study drug.	3.7% 9/244 • Early Switch group AEs/SAEs are included from time of switch to ABC 600mg/DTG 50mg/3TC 300mg at baseline up to Week 48. Late Switch group AEs/SAEs are included from the time of switch to ABC 600mg/DTG 50mg/3TC 300mg at week 24 up to Week 48. Adverse events (AEs) and serious adverse events (SAEs) are presented for the early Switch and Late Switch group. AEs and SAEs were collected from participants of the safety population, comprised of all participants who received atleast one dose of the study drug.

Additional Information

GSK Response Center

GlaxoSmithKline

Phone: 866-435-7343

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	Early Switch ABC 600 mg / DTG 50 mg /3TC 300 mg FDC n=275 participants at risk Participants received ABC 600 mg/DTG 50 mg/3TC 300 mg FDC tablets with or without food once daily in the morning or the evening at approximately the same time each day for 24 weeks. At Week 24, participants will continue on this treatment for an additional 24 weeks.	Late Switch ABC 600 mg / DTG 50 mg /3TC 300 mg FDC n=244 participants at risk Participants continued on their current ART regimen for 24 weeks. At Week 24, participants originally randomly assigned to continue their current regimen switched to ABC 600 mg/DTG 50 mg/3TC 300 mg FDC tablets and were followed for an additional 24 weeks of treatment.
Cardiac disorders Cardiac failure congestive	0.36% 1/275 • Early Switch group AEs/SAEs are included from time of switch to ABC 600mg/DTG 50mg/3TC 300mg at baseline up to Week 48. Late Switch group AEs/SAEs are included from the time of switch to ABC 600mg/DTG 50mg/3TC 300mg at week 24 up to Week 48. Adverse events (AEs) and serious adverse events (SAEs) are presented for the early Switch and Late Switch group. AEs and SAEs were collected from participants of the safety population, comprised of all participants who received atleast one dose of the study drug.	0.00% 0/244 • Early Switch group AEs/SAEs are included from time of switch to ABC 600mg/DTG 50mg/3TC 300mg at baseline up to Week 48. Late Switch group AEs/SAEs are included from the time of switch to ABC 600mg/DTG 50mg/3TC 300mg at week 24 up to Week 48. Adverse events (AEs) and serious adverse events (SAEs) are presented for the early Switch and Late Switch group. AEs and SAEs were collected from participants of the safety population, comprised of all participants who received atleast one dose of the study drug.
Cardiac disorders Myocardial infarction	0.00% 0/275 • Early Switch group AEs/SAEs are included from time of switch to ABC 600mg/DTG 50mg/3TC 300mg at baseline up to Week 48. Late Switch group AEs/SAEs are included from the time of switch to ABC 600mg/DTG 50mg/3TC 300mg at week 24 up to Week 48. Adverse events (AEs) and serious adverse events (SAEs) are presented for the early Switch and Late Switch group. AEs and SAEs were collected from participants of the safety population, comprised of all participants who received atleast one dose of the study drug.	0.41% 1/244 • Early Switch group AEs/SAEs are included from time of switch to ABC 600mg/DTG 50mg/3TC 300mg at baseline up to Week 48. Late Switch group AEs/SAEs are included from the time of switch to ABC 600mg/DTG 50mg/3TC 300mg at week 24 up to Week 48. Adverse events (AEs) and serious adverse events (SAEs) are presented for the early Switch and Late Switch group. AEs and SAEs were collected from participants of the safety population, comprised of all participants who received atleast one dose of the study drug.
Infections and infestations Cellulitis	0.36% 1/275 • Early Switch group AEs/SAEs are included from time of switch to ABC 600mg/DTG 50mg/3TC 300mg at baseline up to Week 48. Late Switch group AEs/SAEs are included from the time of switch to ABC 600mg/DTG 50mg/3TC 300mg at week 24 up to Week 48. Adverse events (AEs) and serious adverse events (SAEs) are presented for the early Switch and Late Switch group. AEs and SAEs were collected from participants of the safety population, comprised of all participants who received atleast one dose of the study drug.	0.00% 0/244 • Early Switch group AEs/SAEs are included from time of switch to ABC 600mg/DTG 50mg/3TC 300mg at baseline up to Week 48. Late Switch group AEs/SAEs are included from the time of switch to ABC 600mg/DTG 50mg/3TC 300mg at week 24 up to Week 48. Adverse events (AEs) and serious adverse events (SAEs) are presented for the early Switch and Late Switch group. AEs and SAEs were collected from participants of the safety population, comprised of all participants who received atleast one dose of the study drug.
Infections and infestations Diverticulitis	0.00% 0/275 • Early Switch group AEs/SAEs are included from time of switch to ABC 600mg/DTG 50mg/3TC 300mg at baseline up to Week 48. Late Switch group AEs/SAEs are included from the time of switch to ABC 600mg/DTG 50mg/3TC 300mg at week 24 up to Week 48. Adverse events (AEs) and serious adverse events (SAEs) are presented for the early Switch and Late Switch group. AEs and SAEs were collected from participants of the safety population, comprised of all participants who received atleast one dose of the study drug.	0.41% 1/244 • Early Switch group AEs/SAEs are included from time of switch to ABC 600mg/DTG 50mg/3TC 300mg at baseline up to Week 48. Late Switch group AEs/SAEs are included from the time of switch to ABC 600mg/DTG 50mg/3TC 300mg at week 24 up to Week 48. Adverse events (AEs) and serious adverse events (SAEs) are presented for the early Switch and Late Switch group. AEs and SAEs were collected from participants of the safety population, comprised of all participants who received atleast one dose of the study drug.
Infections and infestations Gastroenteritis	0.36% 1/275 • Early Switch group AEs/SAEs are included from time of switch to ABC 600mg/DTG 50mg/3TC 300mg at baseline up to Week 48. Late Switch group AEs/SAEs are included from the time of switch to ABC 600mg/DTG 50mg/3TC 300mg at week 24 up to Week 48. Adverse events (AEs) and serious adverse events (SAEs) are presented for the early Switch and Late Switch group. AEs and SAEs were collected from participants of the safety population, comprised of all participants who received atleast one dose of the study drug.	0.00% 0/244 • Early Switch group AEs/SAEs are included from time of switch to ABC 600mg/DTG 50mg/3TC 300mg at baseline up to Week 48. Late Switch group AEs/SAEs are included from the time of switch to ABC 600mg/DTG 50mg/3TC 300mg at week 24 up to Week 48. Adverse events (AEs) and serious adverse events (SAEs) are presented for the early Switch and Late Switch group. AEs and SAEs were collected from participants of the safety population, comprised of all participants who received atleast one dose of the study drug.
Infections and infestations Pneumonia bacterial	0.36% 1/275 • Early Switch group AEs/SAEs are included from time of switch to ABC 600mg/DTG 50mg/3TC 300mg at baseline up to Week 48. Late Switch group AEs/SAEs are included from the time of switch to ABC 600mg/DTG 50mg/3TC 300mg at week 24 up to Week 48. Adverse events (AEs) and serious adverse events (SAEs) are presented for the early Switch and Late Switch group. AEs and SAEs were collected from participants of the safety population, comprised of all participants who received atleast one dose of the study drug.	0.00% 0/244 • Early Switch group AEs/SAEs are included from time of switch to ABC 600mg/DTG 50mg/3TC 300mg at baseline up to Week 48. Late Switch group AEs/SAEs are included from the time of switch to ABC 600mg/DTG 50mg/3TC 300mg at week 24 up to Week 48. Adverse events (AEs) and serious adverse events (SAEs) are presented for the early Switch and Late Switch group. AEs and SAEs were collected from participants of the safety population, comprised of all participants who received atleast one dose of the study drug.
Infections and infestations Pyelonephritis	0.36% 1/275 • Early Switch group AEs/SAEs are included from time of switch to ABC 600mg/DTG 50mg/3TC 300mg at baseline up to Week 48. Late Switch group AEs/SAEs are included from the time of switch to ABC 600mg/DTG 50mg/3TC 300mg at week 24 up to Week 48. Adverse events (AEs) and serious adverse events (SAEs) are presented for the early Switch and Late Switch group. AEs and SAEs were collected from participants of the safety population, comprised of all participants who received atleast one dose of the study drug.	0.00% 0/244 • Early Switch group AEs/SAEs are included from time of switch to ABC 600mg/DTG 50mg/3TC 300mg at baseline up to Week 48. Late Switch group AEs/SAEs are included from the time of switch to ABC 600mg/DTG 50mg/3TC 300mg at week 24 up to Week 48. Adverse events (AEs) and serious adverse events (SAEs) are presented for the early Switch and Late Switch group. AEs and SAEs were collected from participants of the safety population, comprised of all participants who received atleast one dose of the study drug.
Infections and infestations Subcutaneous abscess	0.00% 0/275 • Early Switch group AEs/SAEs are included from time of switch to ABC 600mg/DTG 50mg/3TC 300mg at baseline up to Week 48. Late Switch group AEs/SAEs are included from the time of switch to ABC 600mg/DTG 50mg/3TC 300mg at week 24 up to Week 48. Adverse events (AEs) and serious adverse events (SAEs) are presented for the early Switch and Late Switch group. AEs and SAEs were collected from participants of the safety population, comprised of all participants who received atleast one dose of the study drug.	0.41% 1/244 • Early Switch group AEs/SAEs are included from time of switch to ABC 600mg/DTG 50mg/3TC 300mg at baseline up to Week 48. Late Switch group AEs/SAEs are included from the time of switch to ABC 600mg/DTG 50mg/3TC 300mg at week 24 up to Week 48. Adverse events (AEs) and serious adverse events (SAEs) are presented for the early Switch and Late Switch group. AEs and SAEs were collected from participants of the safety population, comprised of all participants who received atleast one dose of the study drug.
Injury, poisoning and procedural complications Femur fracture	0.00% 0/275 • Early Switch group AEs/SAEs are included from time of switch to ABC 600mg/DTG 50mg/3TC 300mg at baseline up to Week 48. Late Switch group AEs/SAEs are included from the time of switch to ABC 600mg/DTG 50mg/3TC 300mg at week 24 up to Week 48. Adverse events (AEs) and serious adverse events (SAEs) are presented for the early Switch and Late Switch group. AEs and SAEs were collected from participants of the safety population, comprised of all participants who received atleast one dose of the study drug.	0.41% 1/244 • Early Switch group AEs/SAEs are included from time of switch to ABC 600mg/DTG 50mg/3TC 300mg at baseline up to Week 48. Late Switch group AEs/SAEs are included from the time of switch to ABC 600mg/DTG 50mg/3TC 300mg at week 24 up to Week 48. Adverse events (AEs) and serious adverse events (SAEs) are presented for the early Switch and Late Switch group. AEs and SAEs were collected from participants of the safety population, comprised of all participants who received atleast one dose of the study drug.
Investigations Alanine aminotransferase increased	0.00% 0/275 • Early Switch group AEs/SAEs are included from time of switch to ABC 600mg/DTG 50mg/3TC 300mg at baseline up to Week 48. Late Switch group AEs/SAEs are included from the time of switch to ABC 600mg/DTG 50mg/3TC 300mg at week 24 up to Week 48. Adverse events (AEs) and serious adverse events (SAEs) are presented for the early Switch and Late Switch group. AEs and SAEs were collected from participants of the safety population, comprised of all participants who received atleast one dose of the study drug.	0.41% 1/244 • Early Switch group AEs/SAEs are included from time of switch to ABC 600mg/DTG 50mg/3TC 300mg at baseline up to Week 48. Late Switch group AEs/SAEs are included from the time of switch to ABC 600mg/DTG 50mg/3TC 300mg at week 24 up to Week 48. Adverse events (AEs) and serious adverse events (SAEs) are presented for the early Switch and Late Switch group. AEs and SAEs were collected from participants of the safety population, comprised of all participants who received atleast one dose of the study drug.
Nervous system disorders Cerebrovascular accident	0.36% 1/275 • Early Switch group AEs/SAEs are included from time of switch to ABC 600mg/DTG 50mg/3TC 300mg at baseline up to Week 48. Late Switch group AEs/SAEs are included from the time of switch to ABC 600mg/DTG 50mg/3TC 300mg at week 24 up to Week 48. Adverse events (AEs) and serious adverse events (SAEs) are presented for the early Switch and Late Switch group. AEs and SAEs were collected from participants of the safety population, comprised of all participants who received atleast one dose of the study drug.	0.00% 0/244 • Early Switch group AEs/SAEs are included from time of switch to ABC 600mg/DTG 50mg/3TC 300mg at baseline up to Week 48. Late Switch group AEs/SAEs are included from the time of switch to ABC 600mg/DTG 50mg/3TC 300mg at week 24 up to Week 48. Adverse events (AEs) and serious adverse events (SAEs) are presented for the early Switch and Late Switch group. AEs and SAEs were collected from participants of the safety population, comprised of all participants who received atleast one dose of the study drug.
Nervous system disorders Speech disorder	0.36% 1/275 • Early Switch group AEs/SAEs are included from time of switch to ABC 600mg/DTG 50mg/3TC 300mg at baseline up to Week 48. Late Switch group AEs/SAEs are included from the time of switch to ABC 600mg/DTG 50mg/3TC 300mg at week 24 up to Week 48. Adverse events (AEs) and serious adverse events (SAEs) are presented for the early Switch and Late Switch group. AEs and SAEs were collected from participants of the safety population, comprised of all participants who received atleast one dose of the study drug.	0.00% 0/244 • Early Switch group AEs/SAEs are included from time of switch to ABC 600mg/DTG 50mg/3TC 300mg at baseline up to Week 48. Late Switch group AEs/SAEs are included from the time of switch to ABC 600mg/DTG 50mg/3TC 300mg at week 24 up to Week 48. Adverse events (AEs) and serious adverse events (SAEs) are presented for the early Switch and Late Switch group. AEs and SAEs were collected from participants of the safety population, comprised of all participants who received atleast one dose of the study drug.
Psychiatric disorders Suicide attempt	0.36% 1/275 • Early Switch group AEs/SAEs are included from time of switch to ABC 600mg/DTG 50mg/3TC 300mg at baseline up to Week 48. Late Switch group AEs/SAEs are included from the time of switch to ABC 600mg/DTG 50mg/3TC 300mg at week 24 up to Week 48. Adverse events (AEs) and serious adverse events (SAEs) are presented for the early Switch and Late Switch group. AEs and SAEs were collected from participants of the safety population, comprised of all participants who received atleast one dose of the study drug.	0.00% 0/244 • Early Switch group AEs/SAEs are included from time of switch to ABC 600mg/DTG 50mg/3TC 300mg at baseline up to Week 48. Late Switch group AEs/SAEs are included from the time of switch to ABC 600mg/DTG 50mg/3TC 300mg at week 24 up to Week 48. Adverse events (AEs) and serious adverse events (SAEs) are presented for the early Switch and Late Switch group. AEs and SAEs were collected from participants of the safety population, comprised of all participants who received atleast one dose of the study drug.
Respiratory, thoracic and mediastinal disorders Asthma	0.36% 1/275 • Early Switch group AEs/SAEs are included from time of switch to ABC 600mg/DTG 50mg/3TC 300mg at baseline up to Week 48. Late Switch group AEs/SAEs are included from the time of switch to ABC 600mg/DTG 50mg/3TC 300mg at week 24 up to Week 48. Adverse events (AEs) and serious adverse events (SAEs) are presented for the early Switch and Late Switch group. AEs and SAEs were collected from participants of the safety population, comprised of all participants who received atleast one dose of the study drug.	0.00% 0/244 • Early Switch group AEs/SAEs are included from time of switch to ABC 600mg/DTG 50mg/3TC 300mg at baseline up to Week 48. Late Switch group AEs/SAEs are included from the time of switch to ABC 600mg/DTG 50mg/3TC 300mg at week 24 up to Week 48. Adverse events (AEs) and serious adverse events (SAEs) are presented for the early Switch and Late Switch group. AEs and SAEs were collected from participants of the safety population, comprised of all participants who received atleast one dose of the study drug.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.00% 0/275 • Early Switch group AEs/SAEs are included from time of switch to ABC 600mg/DTG 50mg/3TC 300mg at baseline up to Week 48. Late Switch group AEs/SAEs are included from the time of switch to ABC 600mg/DTG 50mg/3TC 300mg at week 24 up to Week 48. Adverse events (AEs) and serious adverse events (SAEs) are presented for the early Switch and Late Switch group. AEs and SAEs were collected from participants of the safety population, comprised of all participants who received atleast one dose of the study drug.	0.41% 1/244 • Early Switch group AEs/SAEs are included from time of switch to ABC 600mg/DTG 50mg/3TC 300mg at baseline up to Week 48. Late Switch group AEs/SAEs are included from the time of switch to ABC 600mg/DTG 50mg/3TC 300mg at week 24 up to Week 48. Adverse events (AEs) and serious adverse events (SAEs) are presented for the early Switch and Late Switch group. AEs and SAEs were collected from participants of the safety population, comprised of all participants who received atleast one dose of the study drug.
Social circumstances Homicide	0.36% 1/275 • Early Switch group AEs/SAEs are included from time of switch to ABC 600mg/DTG 50mg/3TC 300mg at baseline up to Week 48. Late Switch group AEs/SAEs are included from the time of switch to ABC 600mg/DTG 50mg/3TC 300mg at week 24 up to Week 48. Adverse events (AEs) and serious adverse events (SAEs) are presented for the early Switch and Late Switch group. AEs and SAEs were collected from participants of the safety population, comprised of all participants who received atleast one dose of the study drug.	0.00% 0/244 • Early Switch group AEs/SAEs are included from time of switch to ABC 600mg/DTG 50mg/3TC 300mg at baseline up to Week 48. Late Switch group AEs/SAEs are included from the time of switch to ABC 600mg/DTG 50mg/3TC 300mg at week 24 up to Week 48. Adverse events (AEs) and serious adverse events (SAEs) are presented for the early Switch and Late Switch group. AEs and SAEs were collected from participants of the safety population, comprised of all participants who received atleast one dose of the study drug.
Vascular disorders Hypertension	0.36% 1/275 • Early Switch group AEs/SAEs are included from time of switch to ABC 600mg/DTG 50mg/3TC 300mg at baseline up to Week 48. Late Switch group AEs/SAEs are included from the time of switch to ABC 600mg/DTG 50mg/3TC 300mg at week 24 up to Week 48. Adverse events (AEs) and serious adverse events (SAEs) are presented for the early Switch and Late Switch group. AEs and SAEs were collected from participants of the safety population, comprised of all participants who received atleast one dose of the study drug.	0.00% 0/244 • Early Switch group AEs/SAEs are included from time of switch to ABC 600mg/DTG 50mg/3TC 300mg at baseline up to Week 48. Late Switch group AEs/SAEs are included from the time of switch to ABC 600mg/DTG 50mg/3TC 300mg at week 24 up to Week 48. Adverse events (AEs) and serious adverse events (SAEs) are presented for the early Switch and Late Switch group. AEs and SAEs were collected from participants of the safety population, comprised of all participants who received atleast one dose of the study drug.