Trial Outcomes & Findings for KIVEXA Vs TRUVADA, Both Administered With Efavirenz, In ART-Naive Subjects (NCT NCT00549198)

NCT ID: NCT00549198

Last Updated: 2011-04-12

Results Overview

Change from baseline was calculated as the Week 48 value minus the baseline value. GFR is a measure of the rate at which blood is filtered by the kidney. MDRD is an equation (calculation) used to estimate GFR in participants with impaired renal function based on serum creatinine, age, race, and gender. GFR (mL/min/1.73 m\^2) = 175 \* (Scr)\^-1.154 \* (Age)\^-0.203 \* (0.742 if female) \* (1.212 if African American) (conventional units). mL, milliliters; min, minute; m\^2, meters squared; Scr, serum creatinine; BMI, body mass index.

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 392 participants
• Primary outcome timeframe: Baseline, Week 48
• Results posted on: 2011-04-12

Participant Flow

Participant milestones

Measure	ABC/3TC FDC Abacavir (ABC) 600 mg/lamivudine (3TC) 300 mg fixed dose combination (FDC) once daily (QD) plus 600 mg efavirenz QD	TDF/FTC FDC Tenofovir (TDF) 300 mg/emtricitabine (FTC) 200 mg FDC once daily (QD) plus 600 mg efavirenz QD
Overall Study STARTED	195	197
Overall Study COMPLETED	115	134
Overall Study NOT COMPLETED	80	63

Reasons for withdrawal

Measure	ABC/3TC FDC Abacavir (ABC) 600 mg/lamivudine (3TC) 300 mg fixed dose combination (FDC) once daily (QD) plus 600 mg efavirenz QD	TDF/FTC FDC Tenofovir (TDF) 300 mg/emtricitabine (FTC) 200 mg FDC once daily (QD) plus 600 mg efavirenz QD
Overall Study Adverse Event	28	26
Overall Study Insufficient Viral Load Response	4	2
Overall Study Protocol-defined Virological Failure	7	0
Overall Study Non-compliance	2	4
Overall Study Lost to Follow-up	7	8
Overall Study Treatment Eligibility Criteria Not Met	3	0
Overall Study Protocol Violation	7	2
Overall Study Investigator Decision	4	3
Overall Study Withdrawal by Subject	7	7
Overall Study Disease Progression	1	0
Overall Study Participant Moved	2	0
Overall Study Participant not able to perform Week 96	1	0
Overall Study Participant moved.Week 96 visit, no scan	1	0
Overall Study Prohibited Medication	1	2
Overall Study Participant planning pregnancy	1	0
Overall Study Participant overweight, no scan possible	1	0
Overall Study No scan facilities	0	2
Overall Study Pregnancy	0	3
Overall Study Not Exposed to Study Drug	3	4

Baseline Characteristics

KIVEXA Vs TRUVADA, Both Administered With Efavirenz, In ART-Naive Subjects

Baseline characteristics by cohort

Measure	ABC/3TC FDC n=192 Participants Abacavir (ABC) 600 mg/lamivudine (3TC) 300 mg fixed dose combination (FDC) once daily (QD) plus 600 mg efavirenz QD	TDF/FTC FDC n=193 Participants Tenofovir (TDF) 300 mg/emtricitabine (FTC) 200 mg FDC once daily (QD) plus 600 mg efavirenz QD	Total n=385 Participants Total of all reporting groups
Age Continuous	38.0 Years n=5 Participants	36.0 Years n=7 Participants	37.0 Years n=5 Participants
Sex: Female, Male Female	33 Participants n=5 Participants	40 Participants n=7 Participants	73 Participants n=5 Participants
Sex: Female, Male Male	159 Participants n=5 Participants	153 Participants n=7 Participants	312 Participants n=5 Participants
Race/Ethnicity, Customized African American/African Heritage	26 participants n=5 Participants	30 participants n=7 Participants	56 participants n=5 Participants
Race/Ethnicity, Customized American Indian or Alaska Native	11 participants n=5 Participants	7 participants n=7 Participants	18 participants n=5 Participants
Race/Ethnicity, Customized Asian	2 participants n=5 Participants	5 participants n=7 Participants	7 participants n=5 Participants
Race/Ethnicity, Customized White	153 participants n=5 Participants	151 participants n=7 Participants	304 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline, Week 48

Population: Intent-to-Treat-Exposed (ITT-E) Population: all randomized participants who received at least one dose of study medication

Change from baseline was calculated as the Week 48 value minus the baseline value. GFR is a measure of the rate at which blood is filtered by the kidney. MDRD is an equation (calculation) used to estimate GFR in participants with impaired renal function based on serum creatinine, age, race, and gender. GFR (mL/min/1.73 m^2) = 175 * (Scr)^-1.154 * (Age)^-0.203 * (0.742 if female) * (1.212 if African American) (conventional units). mL, milliliters; min, minute; m^2, meters squared; Scr, serum creatinine; BMI, body mass index.

Outcome measures

Measure	ABC/3TC FDC n=192 Participants Abacavir (ABC) 600 mg/lamivudine (3TC) 300 mg fixed dose combination (FDC) once daily (QD) plus 600 mg efavirenz QD	TDF/FTC FDC n=193 Participants Tenofovir (TDF) 300 mg/emtricitabine (FTC) 200 mg FDC once daily (QD) plus 600 mg efavirenz QD
Mean Change From Baseline in Estimated Glomerular Filtration Rate (GFR), Calculated by Modification of Diet in Renal Disease (MDRD) Equation, at Week 48	0.22 milliliters per minute (mL/min)/1.73 m^2 Standard Error 0.890	1.18 milliliters per minute (mL/min)/1.73 m^2 Standard Error 0.828

SECONDARY outcome

Timeframe: Baseline, Week 24

Population: ITT-E Population

Change from baseline was calculated as the Week 24 value minus the baseline value. GFR is a measure of the rate at which blood is filtered by the kidney. MDRD is an equation (calculation) used to estimate GFR in participants with impaired renal function based on serum creatinine, age, race, and gender. GFR (mL/min/1.73 m^2) = 175 * (Scr)^-1.154 * (Age)^-0.203 * (0.742 if female) * (1.212 if African American) (conventional units). mL, milliliters; min, minute; m^2, meters squared; Scr, serum creatinine.

Outcome measures

Measure	ABC/3TC FDC n=192 Participants Abacavir (ABC) 600 mg/lamivudine (3TC) 300 mg fixed dose combination (FDC) once daily (QD) plus 600 mg efavirenz QD	TDF/FTC FDC n=193 Participants Tenofovir (TDF) 300 mg/emtricitabine (FTC) 200 mg FDC once daily (QD) plus 600 mg efavirenz QD
Mean Change From Baseline in Estimated Glomerular Filtration Rate (GFR), Calculated by Modification of Diet in Renal Disease (MDRD) Equation, at Week 24	2.78 mL/min/1.73m^2 Standard Error 0.884	0.43 mL/min/1.73m^2 Standard Error 0.842

SECONDARY outcome

Timeframe: Baseline, Week 96

Population: ITT-E Population

Change from baseline was calculated as the Week 96 value minus the baseline value. GFR is a measure of the rate at which blood is filtered by the kidney. MDRD is an equation (calculation) used to estimate GFR in participants with impaired renal function based on serum creatinine, age, race, and gender. GFR (mL/min/1.73 m^2) = 175 * (Scr)^-1.154 * (Age)^-0.203 * (0.742 if female) * (1.212 if African American) (conventional units). mL, milliliters; min, minute; m^s, meters squared; Scr, serum creatinine.

Outcome measures

Measure	ABC/3TC FDC n=192 Participants Abacavir (ABC) 600 mg/lamivudine (3TC) 300 mg fixed dose combination (FDC) once daily (QD) plus 600 mg efavirenz QD	TDF/FTC FDC n=193 Participants Tenofovir (TDF) 300 mg/emtricitabine (FTC) 200 mg FDC once daily (QD) plus 600 mg efavirenz QD
Mean Change From Baseline in Estimated Glomerular Filtration Rate (GFR), Calculated by Modification of Diet in Renal Disease (MDRD) Equation, at Week 96	1.48 mL/min/1.73m^2 Standard Error 1.022	-1.15 mL/min/1.73m^2 Standard Error 0.944

SECONDARY outcome

Timeframe: Baseline, Week 24

Population: ITT-E Population

Change from baseline was calculated as the Week 24 value minus the baseline value. Cockcroft-Gault is an equation (calculation) used to estimate GFR based on serum creatinine, weight, and gender. GFR = (140 - age) * (mass in kg) * (0.85 if female) divided by 72 * serum creatinine in mg/dL. mg, milligram; dL, deciliter; kg, kilogram; CG, Cockcroft-Gault.

Outcome measures

Measure	ABC/3TC FDC n=192 Participants Abacavir (ABC) 600 mg/lamivudine (3TC) 300 mg fixed dose combination (FDC) once daily (QD) plus 600 mg efavirenz QD	TDF/FTC FDC n=193 Participants Tenofovir (TDF) 300 mg/emtricitabine (FTC) 200 mg FDC once daily (QD) plus 600 mg efavirenz QD
Mean Change From Baseline in Estimated GFR, Calculated by Cockcroft-Gault Equation, at Week 24	4.27 mL/min Standard Error 0.944	2.54 mL/min Standard Error 0.897

SECONDARY outcome

Timeframe: Baseline, Week 48

Population: ITT-E Population

Change from baseline was calculated as the Week 48 value minus the baseline value. Cockcroft-Gault is an equation (calculation) used to estimate GFR based on serum creatinine, weight, and gender. GFR = (140 - age) * (mass in kg) * (0.85 if female) divided by 72 * serum creatinine in mg/dL. mg, milligram; dL, deciliter; kg, kilogram.

Outcome measures

Measure	ABC/3TC FDC n=192 Participants Abacavir (ABC) 600 mg/lamivudine (3TC) 300 mg fixed dose combination (FDC) once daily (QD) plus 600 mg efavirenz QD	TDF/FTC FDC n=193 Participants Tenofovir (TDF) 300 mg/emtricitabine (FTC) 200 mg FDC once daily (QD) plus 600 mg efavirenz QD
Mean Change From Baseline in Estimated GFR, Calculated by Cockcroft-Gault Equation, at Week 48	2.66 mL/min Standard Error 1.005	3.80 mL/min Standard Error 0.933

SECONDARY outcome

Timeframe: Baseline, Week 96

Population: ITT-E Population

Change from baseline was calculated as the Week 96 value minus the baseline value. Cockcroft-Gault is an equation (calculation) used to estimate GFR based on serum creatinine, weight, and gender. GFR = (140 - age) * (mass in kg) * (0.85 if female) divided by 72 * serum creatinine in mg/dL. mg, milligram; dL, deciliter; kg, kilogram.

Outcome measures

Measure	ABC/3TC FDC n=192 Participants Abacavir (ABC) 600 mg/lamivudine (3TC) 300 mg fixed dose combination (FDC) once daily (QD) plus 600 mg efavirenz QD	TDF/FTC FDC n=193 Participants Tenofovir (TDF) 300 mg/emtricitabine (FTC) 200 mg FDC once daily (QD) plus 600 mg efavirenz QD
Mean Change From Baseline in Estimated GFR, Calculated by Cockcroft-Gault Equation, at Week 96	4.37 mL/min Standard Error 1.228	2.68 mL/min Standard Error 1.133

SECONDARY outcome

Timeframe: Baseline, Week 24

Population: ITT-E Population. Some participants had withdrawn from the study by Week 24.

mL, milliliter; min, minute; m^2, meters squared

Outcome measures

Measure	ABC/3TC FDC n=156 Participants Abacavir (ABC) 600 mg/lamivudine (3TC) 300 mg fixed dose combination (FDC) once daily (QD) plus 600 mg efavirenz QD	TDF/FTC FDC n=173 Participants Tenofovir (TDF) 300 mg/emtricitabine (FTC) 200 mg FDC once daily (QD) plus 600 mg efavirenz QD
Number of Participants With Decline From Baseline in Estimated GFR, Calculated by MDRD and Cockcroft-Gault Equations, of >=10 mL/Min/1.73 m^2 (mL/Min for Cockcroft-Gault), >=20 mL/Min/1.72 m^2, >=10%, and >=20% at Week 24 >=10%, MDRD	15 participants	24 participants
Number of Participants With Decline From Baseline in Estimated GFR, Calculated by MDRD and Cockcroft-Gault Equations, of >=10 mL/Min/1.73 m^2 (mL/Min for Cockcroft-Gault), >=20 mL/Min/1.72 m^2, >=10%, and >=20% at Week 24 >=10 mL/min, MDRD	16 participants	26 participants
Number of Participants With Decline From Baseline in Estimated GFR, Calculated by MDRD and Cockcroft-Gault Equations, of >=10 mL/Min/1.73 m^2 (mL/Min for Cockcroft-Gault), >=20 mL/Min/1.72 m^2, >=10%, and >=20% at Week 24 >=10 mL/min, Cockcroft-Gault	16 participants	20 participants
Number of Participants With Decline From Baseline in Estimated GFR, Calculated by MDRD and Cockcroft-Gault Equations, of >=10 mL/Min/1.73 m^2 (mL/Min for Cockcroft-Gault), >=20 mL/Min/1.72 m^2, >=10%, and >=20% at Week 24 >=20 mL/min, MDRD	4 participants	6 participants
Number of Participants With Decline From Baseline in Estimated GFR, Calculated by MDRD and Cockcroft-Gault Equations, of >=10 mL/Min/1.73 m^2 (mL/Min for Cockcroft-Gault), >=20 mL/Min/1.72 m^2, >=10%, and >=20% at Week 24 >=20 mL/min, Cockcroft-Gault	3 participants	4 participants
Number of Participants With Decline From Baseline in Estimated GFR, Calculated by MDRD and Cockcroft-Gault Equations, of >=10 mL/Min/1.73 m^2 (mL/Min for Cockcroft-Gault), >=20 mL/Min/1.72 m^2, >=10%, and >=20% at Week 24 >=10%, Cockcroft-Gault	10 participants	17 participants
Number of Participants With Decline From Baseline in Estimated GFR, Calculated by MDRD and Cockcroft-Gault Equations, of >=10 mL/Min/1.73 m^2 (mL/Min for Cockcroft-Gault), >=20 mL/Min/1.72 m^2, >=10%, and >=20% at Week 24 >=20%, MDRD	2 participants	3 participants
Number of Participants With Decline From Baseline in Estimated GFR, Calculated by MDRD and Cockcroft-Gault Equations, of >=10 mL/Min/1.73 m^2 (mL/Min for Cockcroft-Gault), >=20 mL/Min/1.72 m^2, >=10%, and >=20% at Week 24 >=20%, Cockcroft-Gault	2 participants	3 participants

SECONDARY outcome

Timeframe: Baseline, Week 48

Population: ITT-E Population. Some participants had withdrawn by Week 48.

mL, milliliter; min, minute; m^2, meters squared

Outcome measures

Measure	ABC/3TC FDC n=136 Participants Abacavir (ABC) 600 mg/lamivudine (3TC) 300 mg fixed dose combination (FDC) once daily (QD) plus 600 mg efavirenz QD	TDF/FTC FDC n=159 Participants Tenofovir (TDF) 300 mg/emtricitabine (FTC) 200 mg FDC once daily (QD) plus 600 mg efavirenz QD
Number of Participants With Decline From Baseline in Estimated GFR, Calculated by MDRD and Cockcroft-Gault Equations, of >=10 mL/Min/1.73m^2 (mL/Min for Cockcroft-Gault), >=20 mL/Min/1.72m^2, >=10%, and >=20% at Week 48 >=10 mL/min, MDRD	23 participants	21 participants
Number of Participants With Decline From Baseline in Estimated GFR, Calculated by MDRD and Cockcroft-Gault Equations, of >=10 mL/Min/1.73m^2 (mL/Min for Cockcroft-Gault), >=20 mL/Min/1.72m^2, >=10%, and >=20% at Week 48 >=10 mL/min, Cockcroft-Gault	15 participants	14 participants
Number of Participants With Decline From Baseline in Estimated GFR, Calculated by MDRD and Cockcroft-Gault Equations, of >=10 mL/Min/1.73m^2 (mL/Min for Cockcroft-Gault), >=20 mL/Min/1.72m^2, >=10%, and >=20% at Week 48 >=20 mL/min, MDRD	4 participants	3 participants
Number of Participants With Decline From Baseline in Estimated GFR, Calculated by MDRD and Cockcroft-Gault Equations, of >=10 mL/Min/1.73m^2 (mL/Min for Cockcroft-Gault), >=20 mL/Min/1.72m^2, >=10%, and >=20% at Week 48 >=20 mL/min, Cockcroft-Gault	4 participants	2 participants
Number of Participants With Decline From Baseline in Estimated GFR, Calculated by MDRD and Cockcroft-Gault Equations, of >=10 mL/Min/1.73m^2 (mL/Min for Cockcroft-Gault), >=20 mL/Min/1.72m^2, >=10%, and >=20% at Week 48 >=10%, MDRD	21 participants	21 participants
Number of Participants With Decline From Baseline in Estimated GFR, Calculated by MDRD and Cockcroft-Gault Equations, of >=10 mL/Min/1.73m^2 (mL/Min for Cockcroft-Gault), >=20 mL/Min/1.72m^2, >=10%, and >=20% at Week 48 >=10%, Cockcroft-Gault	11 participants	9 participants
Number of Participants With Decline From Baseline in Estimated GFR, Calculated by MDRD and Cockcroft-Gault Equations, of >=10 mL/Min/1.73m^2 (mL/Min for Cockcroft-Gault), >=20 mL/Min/1.72m^2, >=10%, and >=20% at Week 48 >=20%, MDRD	4 participants	2 participants
Number of Participants With Decline From Baseline in Estimated GFR, Calculated by MDRD and Cockcroft-Gault Equations, of >=10 mL/Min/1.73m^2 (mL/Min for Cockcroft-Gault), >=20 mL/Min/1.72m^2, >=10%, and >=20% at Week 48 >=20%, Cockcroft-Gault	3 participants	0 participants

SECONDARY outcome

Timeframe: Baseline, Week 96

Population: ITT-E Population. Some participants had withdrawn by Week 96.

mL, milliliter; min, minute; m^2, meters squared

Outcome measures

Measure	ABC/3TC FDC n=111 Participants Abacavir (ABC) 600 mg/lamivudine (3TC) 300 mg fixed dose combination (FDC) once daily (QD) plus 600 mg efavirenz QD	TDF/FTC FDC n=131 Participants Tenofovir (TDF) 300 mg/emtricitabine (FTC) 200 mg FDC once daily (QD) plus 600 mg efavirenz QD
Number of Participants With Decline From Baseline in Estimated GFR, Calculated by MDRD and Cockcroft-Gault Equations, of >=10 mL/Min/1.73m^2 (mL/Min for Cockcroft-Gault), >=20 mL/Min/1.72m^2, >=10%, and >=20% at Week 96 >=20%, Cockcroft-Gault	3 participants	4 participants
Number of Participants With Decline From Baseline in Estimated GFR, Calculated by MDRD and Cockcroft-Gault Equations, of >=10 mL/Min/1.73m^2 (mL/Min for Cockcroft-Gault), >=20 mL/Min/1.72m^2, >=10%, and >=20% at Week 96 >=10 mL/min, MDRD	15 participants	38 participants
Number of Participants With Decline From Baseline in Estimated GFR, Calculated by MDRD and Cockcroft-Gault Equations, of >=10 mL/Min/1.73m^2 (mL/Min for Cockcroft-Gault), >=20 mL/Min/1.72m^2, >=10%, and >=20% at Week 96 >=10 mL/min, Cockcroft-Gault	11 participants	19 participants
Number of Participants With Decline From Baseline in Estimated GFR, Calculated by MDRD and Cockcroft-Gault Equations, of >=10 mL/Min/1.73m^2 (mL/Min for Cockcroft-Gault), >=20 mL/Min/1.72m^2, >=10%, and >=20% at Week 96 >=20 mL/min, MDRD	4 participants	7 participants
Number of Participants With Decline From Baseline in Estimated GFR, Calculated by MDRD and Cockcroft-Gault Equations, of >=10 mL/Min/1.73m^2 (mL/Min for Cockcroft-Gault), >=20 mL/Min/1.72m^2, >=10%, and >=20% at Week 96 >=20 mL/min, Cockcroft-Gault	4 participants	5 participants
Number of Participants With Decline From Baseline in Estimated GFR, Calculated by MDRD and Cockcroft-Gault Equations, of >=10 mL/Min/1.73m^2 (mL/Min for Cockcroft-Gault), >=20 mL/Min/1.72m^2, >=10%, and >=20% at Week 96 >=10%, MDRD	15 participants	27 participants
Number of Participants With Decline From Baseline in Estimated GFR, Calculated by MDRD and Cockcroft-Gault Equations, of >=10 mL/Min/1.73m^2 (mL/Min for Cockcroft-Gault), >=20 mL/Min/1.72m^2, >=10%, and >=20% at Week 96 >=10%, Cockcroft-Gault	12 participants	16 participants
Number of Participants With Decline From Baseline in Estimated GFR, Calculated by MDRD and Cockcroft-Gault Equations, of >=10 mL/Min/1.73m^2 (mL/Min for Cockcroft-Gault), >=20 mL/Min/1.72m^2, >=10%, and >=20% at Week 96 >=20%, MDRD	3 participants	6 participants

SECONDARY outcome

Timeframe: Baseline, Week 24

Population: ITT-E Population. Some participants had withdrawn by Week 24.

Normal: GFR >=60 mL/min/1.73 m^2 and creatinine ratio <=200 mg/g GFR; Stage 1: GFR >=90 mL/min/1.73 m^2 and creatinine ratio >200 mg/g; Stage 2: GFR >=60-<90 mL/min/1.73 m^2 and creatinine ratio >200 mg/g; Stage 3: GFR >=30-<60 mL/min/1.73 m^2; Stage 4: GFR >=15-<30 mL/min/1.73 m^2; Stage 5: GFR <15 mL/min/1.73 m^2. mL, milliliter; min, minute; m^2, meters squared; mg, milligram; g, gram.

Outcome measures

Measure	ABC/3TC FDC n=114 Participants Abacavir (ABC) 600 mg/lamivudine (3TC) 300 mg fixed dose combination (FDC) once daily (QD) plus 600 mg efavirenz QD	TDF/FTC FDC n=135 Participants Tenofovir (TDF) 300 mg/emtricitabine (FTC) 200 mg FDC once daily (QD) plus 600 mg efavirenz QD
Number of Participants With National Kidney Foundation Chronic Kidney Disease Stage 1, 2, 3, 4, or 5 Categories of Renal Function at Week 24 Stage 5	0 participants	0 participants
Number of Participants With National Kidney Foundation Chronic Kidney Disease Stage 1, 2, 3, 4, or 5 Categories of Renal Function at Week 24 Normal	97 participants	114 participants
Number of Participants With National Kidney Foundation Chronic Kidney Disease Stage 1, 2, 3, 4, or 5 Categories of Renal Function at Week 24 Stage 1	11 participants	15 participants
Number of Participants With National Kidney Foundation Chronic Kidney Disease Stage 1, 2, 3, 4, or 5 Categories of Renal Function at Week 24 Stage 2	5 participants	5 participants
Number of Participants With National Kidney Foundation Chronic Kidney Disease Stage 1, 2, 3, 4, or 5 Categories of Renal Function at Week 24 Stage 3	1 participants	1 participants
Number of Participants With National Kidney Foundation Chronic Kidney Disease Stage 1, 2, 3, 4, or 5 Categories of Renal Function at Week 24 Stage 4	0 participants	0 participants

SECONDARY outcome

Timeframe: Baseline, Week 48

Population: ITT-E Population. Some participants had withdrawn by Week 48.

Normal: GFR >=60 mL/min/1.73 m^2 and creatinine ratio <=200 mg/g GFR; Stage 1: GFR >=90 mL/min/1.73 m^2 and creatinine ratio >200 mg/g; Stage 2: GFR >=60-<90 mL/min/1.73 m^2 and creatinine ratio >200 mg/g; Stage 3: GFR >=30-<60 mL/min/1.73 m^2; Stage 4: GFR >=15-<30 mL/min/1.73 m^2; Stage 5: GFR <15 mL/min/1.73 m^2. mL, milliliter; min, minute; m^2, meters squared; mg, milligram; g, gram.

Outcome measures

Measure	ABC/3TC FDC n=112 Participants Abacavir (ABC) 600 mg/lamivudine (3TC) 300 mg fixed dose combination (FDC) once daily (QD) plus 600 mg efavirenz QD	TDF/FTC FDC n=133 Participants Tenofovir (TDF) 300 mg/emtricitabine (FTC) 200 mg FDC once daily (QD) plus 600 mg efavirenz QD
Number of Participants With National Kidney Foundation Chronic Kidney Disease Stage 1, 2, 3, 4, or 5 Categories of Renal Function at Week 48 Missing	12 participants	19 participants
Number of Participants With National Kidney Foundation Chronic Kidney Disease Stage 1, 2, 3, 4, or 5 Categories of Renal Function at Week 48 Normal	90 participants	106 participants
Number of Participants With National Kidney Foundation Chronic Kidney Disease Stage 1, 2, 3, 4, or 5 Categories of Renal Function at Week 48 Stage 1	7 participants	5 participants
Number of Participants With National Kidney Foundation Chronic Kidney Disease Stage 1, 2, 3, 4, or 5 Categories of Renal Function at Week 48 Stage 2	3 participants	3 participants
Number of Participants With National Kidney Foundation Chronic Kidney Disease Stage 1, 2, 3, 4, or 5 Categories of Renal Function at Week 48 Stage 3	0 participants	0 participants
Number of Participants With National Kidney Foundation Chronic Kidney Disease Stage 1, 2, 3, 4, or 5 Categories of Renal Function at Week 48 Stage 4	0 participants	0 participants
Number of Participants With National Kidney Foundation Chronic Kidney Disease Stage 1, 2, 3, 4, or 5 Categories of Renal Function at Week 48 Stage 5	0 participants	0 participants

SECONDARY outcome

Timeframe: Baseline, Week 96

Population: ITT-E Population. Some participants had withdrawn by Week 96.

Normal: GFR >=60 mL/min/1.73 m^2 and creatinine ratio <=200 mg/g GFR; Stage 1: GFR >=90 mL/min/1.73 m^2 and creatinine ratio >200 mg/g; Stage 2: GFR >=60-<90 mL/min/1.73 m^2 and creatinine ratio >200 mg/g; Stage 3: GFR >=30-<60 mL/min/1.73 m^2; Stage 4: GFR >=15-<30 mL/min/1.73 m^2; Stage 5: GFR <15 mL/min/1.73 m^2. mL, milliliter; min, minute; m^2, meters squared; mg, milligram; g, gram.

Outcome measures

Measure	ABC/3TC FDC n=93 Participants Abacavir (ABC) 600 mg/lamivudine (3TC) 300 mg fixed dose combination (FDC) once daily (QD) plus 600 mg efavirenz QD	TDF/FTC FDC n=109 Participants Tenofovir (TDF) 300 mg/emtricitabine (FTC) 200 mg FDC once daily (QD) plus 600 mg efavirenz QD
Number of Participants With National Kidney Foundation Chronic Kidney Disease Stage 1, 2, 3, 4, or 5 Categories of Renal Function at Week 96 Missing	11 participants	18 participants
Number of Participants With National Kidney Foundation Chronic Kidney Disease Stage 1, 2, 3, 4, or 5 Categories of Renal Function at Week 96 Normal	75 participants	83 participants
Number of Participants With National Kidney Foundation Chronic Kidney Disease Stage 1, 2, 3, 4, or 5 Categories of Renal Function at Week 96 Stage 1	3 participants	4 participants
Number of Participants With National Kidney Foundation Chronic Kidney Disease Stage 1, 2, 3, 4, or 5 Categories of Renal Function at Week 96 Stage 2	4 participants	4 participants
Number of Participants With National Kidney Foundation Chronic Kidney Disease Stage 1, 2, 3, 4, or 5 Categories of Renal Function at Week 96 Stage 3	0 participants	0 participants
Number of Participants With National Kidney Foundation Chronic Kidney Disease Stage 1, 2, 3, 4, or 5 Categories of Renal Function at Week 96 Stage 4	0 participants	0 participants
Number of Participants With National Kidney Foundation Chronic Kidney Disease Stage 1, 2, 3, 4, or 5 Categories of Renal Function at Week 96 Stage 5	0 participants	0 participants

SECONDARY outcome

Timeframe: Baseline, Week 24

Population: ITT-E Population

BMD is a measure (grams [g] per centimeters cubed [cm^3]) of the mineral content of bone in a particular skeletal area. DXA scans use low energy x-rays to measure the density of bones. The standard error (SE) of both treatment groups was based on the model on the log scale.

Outcome measures

Measure	ABC/3TC FDC n=192 Participants Abacavir (ABC) 600 mg/lamivudine (3TC) 300 mg fixed dose combination (FDC) once daily (QD) plus 600 mg efavirenz QD	TDF/FTC FDC n=193 Participants Tenofovir (TDF) 300 mg/emtricitabine (FTC) 200 mg FDC once daily (QD) plus 600 mg efavirenz QD
Percent Change From Baseline in Lumbar Spine Bone Mineral Density (BMD), Measured by Dual-energy X-ray Absorptiometry (DXA), at Week 24	-2.12 percent change Standard Error 0.0011	-3.30 percent change Standard Error 0.0011

SECONDARY outcome

Timeframe: Baseline, Week 24

Population: ITT-E Population

BMD is a measure (grams per cm^3) of the mineral content of bone in a particular skeletal area. DXA scans use low energy x-rays to measure the density of bones. The standard error (SE) of both treatment groups was based on the model on the log scale.

Outcome measures

Measure	ABC/3TC FDC n=192 Participants Abacavir (ABC) 600 mg/lamivudine (3TC) 300 mg fixed dose combination (FDC) once daily (QD) plus 600 mg efavirenz QD	TDF/FTC FDC n=193 Participants Tenofovir (TDF) 300 mg/emtricitabine (FTC) 200 mg FDC once daily (QD) plus 600 mg efavirenz QD
Percent Change From Baseline in Hip Bone Mineral Density (BMD), Measured by Dual-energy X-ray Absorptiometry (DXA), at Week 24	-1.19 percent change Standard Error 0.0007	-2.73 percent change Standard Error 0.0007

SECONDARY outcome

Timeframe: Baseline, Week 48

Population: ITT-E Population

BMD is a measure (grams per cm^3) of the mineral content of bone in a particular skeletal area. DXA scans use low energy x-rays to measure the density of bones. The standard error (SE) of both treatment groups was based on the model on the log scale.

Outcome measures

Measure	ABC/3TC FDC n=192 Participants Abacavir (ABC) 600 mg/lamivudine (3TC) 300 mg fixed dose combination (FDC) once daily (QD) plus 600 mg efavirenz QD	TDF/FTC FDC n=193 Participants Tenofovir (TDF) 300 mg/emtricitabine (FTC) 200 mg FDC once daily (QD) plus 600 mg efavirenz QD
Percent Change From Baseline in Lumbar Spine Bone Mineral Density (BMD), Measured by Dual-energy X-ray Absorptiometry (DXA), at Week 48	-1.59 percent change Standard Error 0.0013	-2.41 percent change Standard Error 0.0012

SECONDARY outcome

Timeframe: Baseline, Week 48

Population: ITT-E Population

BMD is a measure (grams per cm^3) of the mineral content of bone in a particular skeletal area. DXA scans use low energy x-rays to measure the density of bones. The standard error (SE) of both treatment groups was based on the model on the log scale.

Outcome measures

Measure	ABC/3TC FDC n=192 Participants Abacavir (ABC) 600 mg/lamivudine (3TC) 300 mg fixed dose combination (FDC) once daily (QD) plus 600 mg efavirenz QD	TDF/FTC FDC n=193 Participants Tenofovir (TDF) 300 mg/emtricitabine (FTC) 200 mg FDC once daily (QD) plus 600 mg efavirenz QD
Percent Change From Baseline in Hip Bone Mineral Density (BMD), Measured by Dual-energy X-ray Absorptiometry (DXA), at Week 48	-1.90 percent change Standard Error 0.0010	-3.56 percent change Standard Error 0.0009

SECONDARY outcome

Timeframe: Baseline, Week 96

Population: ITT-E Population

BMD is a measure (grams per cm^3) of the mineral content of bone in a particular skeletal area. DXA scans use low energy x-rays to measure the density of bones. The standard error (SE) of both treatment groups was based on the model on the log scale.

Outcome measures

Measure	ABC/3TC FDC n=192 Participants Abacavir (ABC) 600 mg/lamivudine (3TC) 300 mg fixed dose combination (FDC) once daily (QD) plus 600 mg efavirenz QD	TDF/FTC FDC n=193 Participants Tenofovir (TDF) 300 mg/emtricitabine (FTC) 200 mg FDC once daily (QD) plus 600 mg efavirenz QD
Percent Change From Baseline in Lumbar Spine Bone Mineral Density (BMD), Measured by Dual-energy X-ray Absorptiometry (DXA), at Week 96	-0.87 percent change Standard Error 0.0017	-1.70 percent change Standard Error 0.0015

SECONDARY outcome

Timeframe: Baseline, Week 96

Population: ITT-E Population

BMD is a measure (grams per cm^3) of the mineral content of bone in a particular skeletal area. DXA scans use low energy x-rays to measure the density of bones. The standard error (SE) of both treatment groups was based on the model on the log scale.

Outcome measures

Measure	ABC/3TC FDC n=192 Participants Abacavir (ABC) 600 mg/lamivudine (3TC) 300 mg fixed dose combination (FDC) once daily (QD) plus 600 mg efavirenz QD	TDF/FTC FDC n=193 Participants Tenofovir (TDF) 300 mg/emtricitabine (FTC) 200 mg FDC once daily (QD) plus 600 mg efavirenz QD
Percent Change From Baseline in Hip Bone Mineral Density (BMD), Measured by Dual-energy X-ray Absorptiometry (DXA), at Week 96	-2.17 percent change Standard Error 0.0013	-3.55 percent change Standard Error 0.0012

SECONDARY outcome

Timeframe: Baseline, Week 24

Population: ITT-E Population. Some participants had withdrawn by Week 24/did not have a DXA scan performed. DXA, dual energy x-ray absorptiometry.

BMD is a measure of the mineral content of bone in a particular skeletal area. DXA scans use low energy x-rays to measure the density of bones.

Outcome measures

Measure	ABC/3TC FDC n=142 Participants Abacavir (ABC) 600 mg/lamivudine (3TC) 300 mg fixed dose combination (FDC) once daily (QD) plus 600 mg efavirenz QD	TDF/FTC FDC n=165 Participants Tenofovir (TDF) 300 mg/emtricitabine (FTC) 200 mg FDC once daily (QD) plus 600 mg efavirenz QD
Number of Participants With a Decline From Baseline in Lumbar Spine and Hip Bone Mineral Density (BMD) >=2.0% and >=6.0% at Week 24 >=2%, spine, n=142, 165	73 participants	115 participants
Number of Participants With a Decline From Baseline in Lumbar Spine and Hip Bone Mineral Density (BMD) >=2.0% and >=6.0% at Week 24 >=6%, spine, n=142, 165	10 participants	17 participants
Number of Participants With a Decline From Baseline in Lumbar Spine and Hip Bone Mineral Density (BMD) >=2.0% and >=6.0% at Week 24 >=2%, hip, n=137, 160	38 participants	93 participants
Number of Participants With a Decline From Baseline in Lumbar Spine and Hip Bone Mineral Density (BMD) >=2.0% and >=6.0% at Week 24 >=6%, hip, n=137, 160	1 participants	6 participants

SECONDARY outcome

Timeframe: Baseline, Week 48

Population: ITT-E Population. Some participants had withdrawn by Week 48/did not have a DXA scan performed. DXA, dual energy x-ray absorptiometry.

BMD is a measure of the mineral content of bone in a particular skeletal area. DXA scans use low energy x-rays to measure the density of bones.

Outcome measures

Measure	ABC/3TC FDC n=125 Participants Abacavir (ABC) 600 mg/lamivudine (3TC) 300 mg fixed dose combination (FDC) once daily (QD) plus 600 mg efavirenz QD	TDF/FTC FDC n=141 Participants Tenofovir (TDF) 300 mg/emtricitabine (FTC) 200 mg FDC once daily (QD) plus 600 mg efavirenz QD
Number of Participants With a Decline From Baseline in Lumbar Spine and Hip Bone Mineral Density (BMD) >=2.0% and >=6.0% at Week 48 >=2%, hip, n=119, 140	54 participants	111 participants
Number of Participants With a Decline From Baseline in Lumbar Spine and Hip Bone Mineral Density (BMD) >=2.0% and >=6.0% at Week 48 >=2%, spine, n=125, 141	51 participants	84 participants
Number of Participants With a Decline From Baseline in Lumbar Spine and Hip Bone Mineral Density (BMD) >=2.0% and >=6.0% at Week 48 >=6%, spine, n=125, 141	5 participants	13 participants
Number of Participants With a Decline From Baseline in Lumbar Spine and Hip Bone Mineral Density (BMD) >=2.0% and >=6.0% at Week 48 >=6%, hip, n=119, 140	3 participants	17 participants

SECONDARY outcome

Timeframe: Baseline, Week 96

Population: ITT-E Population. Some participants had withdrawn by Week 96/did not have a DXA scan performed. DXA, dual energy x-ray absorptiometry.

BMD is a measure of the mineral content of bone in a particular skeletal area. DXA scans use low energy x-rays to measure the density of bones.

Outcome measures

Measure	ABC/3TC FDC n=59 Participants Abacavir (ABC) 600 mg/lamivudine (3TC) 300 mg fixed dose combination (FDC) once daily (QD) plus 600 mg efavirenz QD	TDF/FTC FDC n=79 Participants Tenofovir (TDF) 300 mg/emtricitabine (FTC) 200 mg FDC once daily (QD) plus 600 mg efavirenz QD
Number of Participants With a Decline From Baseline in Lumbar Spine and Hip Bone Mineral Density (BMD) >=2.0% and >=6.0% at Week 96 >=2%, spine, n=59, 79	21 participants	39 participants
Number of Participants With a Decline From Baseline in Lumbar Spine and Hip Bone Mineral Density (BMD) >=2.0% and >=6.0% at Week 96 >=6%, spine, n=59, 79	3 participants	8 participants
Number of Participants With a Decline From Baseline in Lumbar Spine and Hip Bone Mineral Density (BMD) >=2.0% and >=6.0% at Week 96 >=2%, hip, n=58, 76	33 participants	52 participants
Number of Participants With a Decline From Baseline in Lumbar Spine and Hip Bone Mineral Density (BMD) >=2.0% and >=6.0% at Week 96 >=6%, hip, n=58, 76	1 participants	13 participants

SECONDARY outcome

Timeframe: Week 24

Population: ITT-E Population. Some participants had withdrawn by Week 24.

The T-score is a radiographic diagnosis that compares bone mineral density (BMD) to that of a "normal, healthy, 30-year-old female". The lower the T-score, the lower the BMD. A T-score of +1 to -1 is normal. A T-score decrease of -1 indicates a 10%-15% decrease in BMD.

Outcome measures

Measure	ABC/3TC FDC n=149 Participants Abacavir (ABC) 600 mg/lamivudine (3TC) 300 mg fixed dose combination (FDC) once daily (QD) plus 600 mg efavirenz QD	TDF/FTC FDC n=173 Participants Tenofovir (TDF) 300 mg/emtricitabine (FTC) 200 mg FDC once daily (QD) plus 600 mg efavirenz QD
Number of Participants Meeting World Health Organization (WHO) Criteria for Osteopenia (T-score of -2.5 to -1.0) and Osteoporosis (T-score of <-2.5) at Week 24 Osteopenia, spine, n=147, 173	41 participants	68 participants
Number of Participants Meeting World Health Organization (WHO) Criteria for Osteopenia (T-score of -2.5 to -1.0) and Osteoporosis (T-score of <-2.5) at Week 24 Osteporosis, spine, n=147, 173	16 participants	9 participants
Number of Participants Meeting World Health Organization (WHO) Criteria for Osteopenia (T-score of -2.5 to -1.0) and Osteoporosis (T-score of <-2.5) at Week 24 Osteopenia, hip, n=149, 170	38 participants	54 participants
Number of Participants Meeting World Health Organization (WHO) Criteria for Osteopenia (T-score of -2.5 to -1.0) and Osteoporosis (T-score of <-2.5) at Week 24 Osteoporosis, hip, n=149, 170	4 participants	1 participants

SECONDARY outcome

Timeframe: Week 48

Population: ITT-E Population. Some participants had withdrawn by Week 48.

The T-score is a radiographic diagnosis that compares bone mineral density (BMD) to that of a "normal, healthy, 30-year-old female". The lower the T-score, the lower the BMD. A T-score of +1 to -1 is normal. A T-score decrease of -1 indicates a 10%-15% decrease in BMD.

Outcome measures

Measure	ABC/3TC FDC n=132 Participants Abacavir (ABC) 600 mg/lamivudine (3TC) 300 mg fixed dose combination (FDC) once daily (QD) plus 600 mg efavirenz QD	TDF/FTC FDC n=147 Participants Tenofovir (TDF) 300 mg/emtricitabine (FTC) 200 mg FDC once daily (QD) plus 600 mg efavirenz QD
Number of Participants Meeting World Health Organization (WHO) Criteria for Osteopenia (T-score of -2.5 to -1.0) and Osteoporosis (T-score of <-2.5) at Week 48 Osteopenia, hip, n=130, 147	37 participants	50 participants
Number of Participants Meeting World Health Organization (WHO) Criteria for Osteopenia (T-score of -2.5 to -1.0) and Osteoporosis (T-score of <-2.5) at Week 48 Osteoporosis, hip, n=130, 147	4 participants	0 participants
Number of Participants Meeting World Health Organization (WHO) Criteria for Osteopenia (T-score of -2.5 to -1.0) and Osteoporosis (T-score of <-2.5) at Week 48 Osteopenia, spine, n=132, 147	41 participants	57 participants
Number of Participants Meeting World Health Organization (WHO) Criteria for Osteopenia (T-score of -2.5 to -1.0) and Osteoporosis (T-score of <-2.5) at Week 48 Osteporosis, spine, n=132, 147	15 participants	5 participants

SECONDARY outcome

Timeframe: Week 96

Population: ITT-E Population. Some participants had withdrawn by Week 96.

The T-score is a radiographic diagnosis that compares bone mineral density (BMD) to that of a "normal, healthy, 30-year-old female". The lower the T-score, the lower the BMD. A T-score of +1 to -1 is normal. A T-score decrease of -1 indicates a 10%-15% decrease in BMD.

Outcome measures

Measure	ABC/3TC FDC n=65 Participants Abacavir (ABC) 600 mg/lamivudine (3TC) 300 mg fixed dose combination (FDC) once daily (QD) plus 600 mg efavirenz QD	TDF/FTC FDC n=82 Participants Tenofovir (TDF) 300 mg/emtricitabine (FTC) 200 mg FDC once daily (QD) plus 600 mg efavirenz QD
Number of Participants Meeting World Health Organization (WHO) Criteria for Osteopenia (T-score of -2.5 to -1.0) and Osteoporosis (T-score of <-2.5) at Week 96 Osteopenia, spine, n=64, 82	21 participants	34 participants
Number of Participants Meeting World Health Organization (WHO) Criteria for Osteopenia (T-score of -2.5 to -1.0) and Osteoporosis (T-score of <-2.5) at Week 96 Osteporosis, spine, n=64, 82	5 participants	3 participants
Number of Participants Meeting World Health Organization (WHO) Criteria for Osteopenia (T-score of -2.5 to -1.0) and Osteoporosis (T-score of <-2.5) at Week 96 Osteopenia, hip, n=65, 80	20 participants	31 participants
Number of Participants Meeting World Health Organization (WHO) Criteria for Osteopenia (T-score of -2.5 to -1.0) and Osteoporosis (T-score of <-2.5) at Week 96 Osteoporosis, hip, n=65, 80	0 participants	0 participants

SECONDARY outcome

Timeframe: Baseline to Week 24

Population: Safety Population: all randomized participants who received at least one dose of study medication

An adverse event was 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. Adverse events occurring in two or more participants are presented.

Outcome measures

Measure	ABC/3TC FDC n=192 Participants Abacavir (ABC) 600 mg/lamivudine (3TC) 300 mg fixed dose combination (FDC) once daily (QD) plus 600 mg efavirenz QD	TDF/FTC FDC n=193 Participants Tenofovir (TDF) 300 mg/emtricitabine (FTC) 200 mg FDC once daily (QD) plus 600 mg efavirenz QD
Number of Participants Experiencing an Adverse Event (AE) Leading to Discontinuation by Week 24 Any event	26 participants	14 participants
Number of Participants Experiencing an Adverse Event (AE) Leading to Discontinuation by Week 24 Drug hypersensitivity	11 participants	1 participants
Number of Participants Experiencing an Adverse Event (AE) Leading to Discontinuation by Week 24 Rash	2 participants	3 participants
Number of Participants Experiencing an Adverse Event (AE) Leading to Discontinuation by Week 24 Dizziness	0 participants	2 participants
Number of Participants Experiencing an Adverse Event (AE) Leading to Discontinuation by Week 24 Hypersensitivity	3 participants	0 participants
Number of Participants Experiencing an Adverse Event (AE) Leading to Discontinuation by Week 24 Drug eruption	1 participants	1 participants

SECONDARY outcome

Timeframe: Baseline to Week 48

Population: Safety Population: all randomized participants who received at least one dose of study medication

An adverse event was 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. Adverse events occurring in two or more participants are presented.

Outcome measures

Measure	ABC/3TC FDC n=192 Participants Abacavir (ABC) 600 mg/lamivudine (3TC) 300 mg fixed dose combination (FDC) once daily (QD) plus 600 mg efavirenz QD	TDF/FTC FDC n=193 Participants Tenofovir (TDF) 300 mg/emtricitabine (FTC) 200 mg FDC once daily (QD) plus 600 mg efavirenz QD
Number of Participants Experiencing an Adverse Event (AE) Leading to Discontinuation by Week 48 Any event	29 participants	21 participants
Number of Participants Experiencing an Adverse Event (AE) Leading to Discontinuation by Week 48 Drug hypersensitivity	11 participants	1 participants
Number of Participants Experiencing an Adverse Event (AE) Leading to Discontinuation by Week 48 Bone density decreased	0 participants	2 participants
Number of Participants Experiencing an Adverse Event (AE) Leading to Discontinuation by Week 48 Rash	2 participants	3 participants
Number of Participants Experiencing an Adverse Event (AE) Leading to Discontinuation by Week 48 Dizziness	1 participants	3 participants
Number of Participants Experiencing an Adverse Event (AE) Leading to Discontinuation by Week 48 Hypersensitivity	3 participants	0 participants
Number of Participants Experiencing an Adverse Event (AE) Leading to Discontinuation by Week 48 Drug eruption	1 participants	1 participants

SECONDARY outcome

Timeframe: Baseline to Week 96

Population: Safety Population: all randomized participants who received at least one dose of study medication

An adverse event was 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. Adverse events occurring in two or more participants are presented.

Outcome measures

Measure	ABC/3TC FDC n=192 Participants Abacavir (ABC) 600 mg/lamivudine (3TC) 300 mg fixed dose combination (FDC) once daily (QD) plus 600 mg efavirenz QD	TDF/FTC FDC n=193 Participants Tenofovir (TDF) 300 mg/emtricitabine (FTC) 200 mg FDC once daily (QD) plus 600 mg efavirenz QD
Number of Participants Experiencing an Adverse Event (AE) Leading to Discontinuation by Week 96 Any event	33 participants	28 participants
Number of Participants Experiencing an Adverse Event (AE) Leading to Discontinuation by Week 96 Drug hypersensitivity	11 participants	1 participants
Number of Participants Experiencing an Adverse Event (AE) Leading to Discontinuation by Week 96 Bone density decreased	0 participants	8 participants
Number of Participants Experiencing an Adverse Event (AE) Leading to Discontinuation by Week 96 Rash	2 participants	3 participants
Number of Participants Experiencing an Adverse Event (AE) Leading to Discontinuation by Week 96 Dizziness	1 participants	3 participants
Number of Participants Experiencing an Adverse Event (AE) Leading to Discontinuation by Week 96 Hypersensitivity	3 participants	0 participants
Number of Participants Experiencing an Adverse Event (AE) Leading to Discontinuation by Week 96 Abnormal dreams	3 participants	0 participants
Number of Participants Experiencing an Adverse Event (AE) Leading to Discontinuation by Week 96 Drug eruption	1 participants	1 participants
Number of Participants Experiencing an Adverse Event (AE) Leading to Discontinuation by Week 96 Depression	0 participants	2 participants

SECONDARY outcome

Timeframe: Baseline, Week 24

Population: Safety Population

Blood samples were collected from participants for analysis of their lipid profile. Data are categorized by the maximum post-baseline threshold reached. <200 mg/dL, desirable; 200-<240 mg/dL, borderline high; >=240 mg/dL, high. mg, milligram; dL, deciliter.

Outcome measures

Measure	ABC/3TC FDC n=192 Participants Abacavir (ABC) 600 mg/lamivudine (3TC) 300 mg fixed dose combination (FDC) once daily (QD) plus 600 mg efavirenz QD	TDF/FTC FDC n=193 Participants Tenofovir (TDF) 300 mg/emtricitabine (FTC) 200 mg FDC once daily (QD) plus 600 mg efavirenz QD
Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting Total Cholesterol at Week 24 Desirable to desirable	54 participants	104 participants
Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting Total Cholesterol at Week 24 Desirable to borderline high	47 participants	29 participants
Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting Total Cholesterol at Week 24 Desirable to high	32 participants	9 participants
Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting Total Cholesterol at Week 24 Borderline high to desirable	1 participants	3 participants
Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting Total Cholesterol at Week 24 Borderline high to borderline high	2 participants	9 participants
Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting Total Cholesterol at Week 24 Borderline high to high	10 participants	6 participants
Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting Total Cholesterol at Week 24 High to desirable	0 participants	0 participants
Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting Total Cholesterol at Week 24 High to borderline high	0 participants	0 participants
Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting Total Cholesterol at Week 24 High to high	3 participants	2 participants

SECONDARY outcome

Timeframe: Baseline, Week 48

Population: Safety Population

Blood samples were collected from participants for analysis of their lipid profile. Data are categorized by the maximum post-baseline threshold reached. <200 mg/dL, desirable; 200-<240 mg/dL, borderline high; >=240 mg/dL, high. mg, milligram; dL, deciliter.

Outcome measures

Measure	ABC/3TC FDC n=192 Participants Abacavir (ABC) 600 mg/lamivudine (3TC) 300 mg fixed dose combination (FDC) once daily (QD) plus 600 mg efavirenz QD	TDF/FTC FDC n=193 Participants Tenofovir (TDF) 300 mg/emtricitabine (FTC) 200 mg FDC once daily (QD) plus 600 mg efavirenz QD
Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting Total Cholesterol at Week 48 Desirable to desirable	46 participants	96 participants
Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting Total Cholesterol at Week 48 Desirable to borderline high	52 participants	37 participants
Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting Total Cholesterol at Week 48 Desirable to high	36 participants	9 participants
Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting Total Cholesterol at Week 48 Borderline high to desirable	1 participants	1 participants
Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting Total Cholesterol at Week 48 Borderline high to borderline high	2 participants	9 participants
Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting Total Cholesterol at Week 48 Borderline high to high	10 participants	8 participants
Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting Total Cholesterol at Week 48 High to desirable	0 participants	0 participants
Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting Total Cholesterol at Week 48 High to borderline high	0 participants	0 participants
Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting Total Cholesterol at Week 48 High to high	3 participants	2 participants

SECONDARY outcome

Timeframe: Baseline, Week 96

Population: Safety Population

Blood samples were collected from participants for analysis of their lipid profile. Data are categorized by the maximum post-baseline threshold reached. <200 mg/dL, desirable; 200-<240 mg/dL, borderline high; >=240 mg/dL, high. mg, milligram; dL, deciliter.

Outcome measures

Measure	ABC/3TC FDC n=192 Participants Abacavir (ABC) 600 mg/lamivudine (3TC) 300 mg fixed dose combination (FDC) once daily (QD) plus 600 mg efavirenz QD	TDF/FTC FDC n=193 Participants Tenofovir (TDF) 300 mg/emtricitabine (FTC) 200 mg FDC once daily (QD) plus 600 mg efavirenz QD
Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting Total Cholesterol at Week 96 Desirable to desirable	39 participants	86 participants
Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting Total Cholesterol at Week 96 Desirable to borderline high	49 participants	47 participants
Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting Total Cholesterol at Week 96 Desirable to high	46 participants	10 participants
Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting Total Cholesterol at Week 96 Borderline high to desirable	1 participants	1 participants
Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting Total Cholesterol at Week 96 Borderline high to borderline high	2 participants	9 participants
Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting Total Cholesterol at Week 96 Borderline high to high	10 participants	8 participants
Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting Total Cholesterol at Week 96 High to desirable	0 participants	0 participants
Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting Total Cholesterol at Week 96 High to borderline high	0 participants	0 participants
Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting Total Cholesterol at Week 96 High to high	3 participants	2 participants

SECONDARY outcome

Timeframe: Baseline, Week 24

Population: Safety Population

Blood samples were collected from participants for analysis of their lipid profile. Data are categorized by the maximum post-baseline threshold reached. <100 mg/dL, optimal; 100-<130 mg/dL, near/above optimal; 130-<160 mg/dL, borderline high; 160-<190 mg/dL, high; >=190 mg/dL, very high.

Outcome measures

Measure	ABC/3TC FDC n=192 Participants Abacavir (ABC) 600 mg/lamivudine (3TC) 300 mg fixed dose combination (FDC) once daily (QD) plus 600 mg efavirenz QD	TDF/FTC FDC n=193 Participants Tenofovir (TDF) 300 mg/emtricitabine (FTC) 200 mg FDC once daily (QD) plus 600 mg efavirenz QD
Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Low-density Lipoprotein (LDL) at Week 24 High to high	1 participants	1 participants
Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Low-density Lipoprotein (LDL) at Week 24 High to very high	0 participants	0 participants
Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Low-density Lipoprotein (LDL) at Week 24 Very high to optimal	0 participants	0 participants
Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Low-density Lipoprotein (LDL) at Week 24 Very high to near or above optimal	0 participants	0 participants
Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Low-density Lipoprotein (LDL) at Week 24 Very high to borderline high	1 participants	0 participants
Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Low-density Lipoprotein (LDL) at Week 24 Very high to high	0 participants	0 participants
Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Low-density Lipoprotein (LDL) at Week 24 Very high to very high	1 participants	1 participants
Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Low-density Lipoprotein (LDL) at Week 24 Optimal to optimal	22 participants	46 participants
Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Low-density Lipoprotein (LDL) at Week 24 Optimal to near or above optimal	41 participants	43 participants
Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Low-density Lipoprotein (LDL) at Week 24 Optimal to borderline high	22 participants	11 participants
Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Low-density Lipoprotein (LDL) at Week 24 Optimal to high	6 participants	1 participants
Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Low-density Lipoprotein (LDL) at Week 24 Optimal to very high	1 participants	0 participants
Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Low-density Lipoprotein (LDL) at Week 24 Near or above optimal to optimal	0 participants	5 participants
Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Low-density Lipoprotein (LDL) at Week 24 Near or above optimal to near or above optimal	6 participants	22 participants
Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Low-density Lipoprotein (LDL) at Week 24 Near or above optimal to borderline high	17 participants	11 participants
Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Low-density Lipoprotein (LDL) at Week 24 Near or above optimal to high	12 participants	5 participants
Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Low-density Lipoprotein (LDL) at Week 24 Near or above optimal to very high	4 participants	1 participants
Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Low-density Lipoprotein (LDL) at Week 24 Borderline high to optimal	0 participants	0 participants
Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Low-density Lipoprotein (LDL) at Week 24 Borderline high to near or above optimal	1 participants	6 participants
Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Low-density Lipoprotein (LDL) at Week 24 Borderline high to borderline high	2 participants	3 participants
Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Low-density Lipoprotein (LDL) at Week 24 Borderline high to high	4 participants	3 participants
Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Low-density Lipoprotein (LDL) at Week 24 Borderline high to very high	3 participants	2 participants
Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Low-density Lipoprotein (LDL) at Week 24 High to optimal	0 participants	0 participants
Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Low-density Lipoprotein (LDL) at Week 24 High to near or above optimal	0 participants	0 participants
Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Low-density Lipoprotein (LDL) at Week 24 High to borderline high	0 participants	0 participants

SECONDARY outcome

Timeframe: Baseline, Week 48

Population: Safety Population

Blood samples were collected from participants for analysis of their lipid profile. Data are categorized by the maximum post-baseline threshold reached. <100 mg/dL, optimal; 100-<130 mg/dL, near/above optimal; 130-<160 mg/dL, borderline high; 160-<190 mg/dL, high; >=190 mg/dL, very high.

Outcome measures

Measure	ABC/3TC FDC n=192 Participants Abacavir (ABC) 600 mg/lamivudine (3TC) 300 mg fixed dose combination (FDC) once daily (QD) plus 600 mg efavirenz QD	TDF/FTC FDC n=193 Participants Tenofovir (TDF) 300 mg/emtricitabine (FTC) 200 mg FDC once daily (QD) plus 600 mg efavirenz QD
Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Low-density Lipoprotein (LDL) at Week 48 Optimal to optimal	20 participants	42 participants
Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Low-density Lipoprotein (LDL) at Week 48 Optimal to near or above optimal	38 participants	46 participants
Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Low-density Lipoprotein (LDL) at Week 48 Optimal to borderline high	27 participants	12 participants
Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Low-density Lipoprotein (LDL) at Week 48 Optimal to high	8 participants	1 participants
Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Low-density Lipoprotein (LDL) at Week 48 Optimal to very high	1 participants	0 participants
Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Low-density Lipoprotein (LDL) at Week 48 Near or above optimal to optimal	0 participants	3 participants
Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Low-density Lipoprotein (LDL) at Week 48 Near or above optimal to near or above optimal	4 participants	21 participants
Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Low-density Lipoprotein (LDL) at Week 48 Borderline high to optimal	0 participants	0 participants
Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Low-density Lipoprotein (LDL) at Week 48 Borderline high to near or above optimal	1 participants	3 participants
Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Low-density Lipoprotein (LDL) at Week 48 Borderline high to borderline high	2 participants	5 participants
Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Low-density Lipoprotein (LDL) at Week 48 Near or above optimal to borderline high	19 participants	13 participants
Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Low-density Lipoprotein (LDL) at Week 48 Near or above optimal to high	12 participants	6 participants
Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Low-density Lipoprotein (LDL) at Week 48 Near or above optimal to very high	4 participants	1 participants
Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Low-density Lipoprotein (LDL) at Week 48 Borderline high to very high	4 participants	2 participants
Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Low-density Lipoprotein (LDL) at Week 48 High to optimal	0 participants	0 participants
Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Low-density Lipoprotein (LDL) at Week 48 High to near or above optimal	0 participants	0 participants
Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Low-density Lipoprotein (LDL) at Week 48 High to borderline high	0 participants	0 participants
Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Low-density Lipoprotein (LDL) at Week 48 High to high	1 participants	1 participants
Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Low-density Lipoprotein (LDL) at Week 48 High to very high	0 participants	0 participants
Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Low-density Lipoprotein (LDL) at Week 48 Borderline high to high	3 participants	4 participants
Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Low-density Lipoprotein (LDL) at Week 48 Very high to optimal	0 participants	0 participants
Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Low-density Lipoprotein (LDL) at Week 48 Very high to borderline high	1 participants	0 participants
Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Low-density Lipoprotein (LDL) at Week 48 Very high to high	0 participants	0 participants
Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Low-density Lipoprotein (LDL) at Week 48 Very high to very high	1 participants	1 participants
Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Low-density Lipoprotein (LDL) at Week 48 Very high to near or above optimal	0 participants	0 participants

SECONDARY outcome

Timeframe: Baseline, Week 96

Population: Safety Population

Blood samples were collected from participants for analysis of their lipid profile. Data are categorized by the maximum post-baseline threshold reached. <100 mg/dL, optimal; 100-<130 mg/dL, near/above optimal; 130-<160 mg/dL, borderline high; 160-<190 mg/dL, high; >=190 mg/dL, very high.

Outcome measures

Measure	ABC/3TC FDC n=192 Participants Abacavir (ABC) 600 mg/lamivudine (3TC) 300 mg fixed dose combination (FDC) once daily (QD) plus 600 mg efavirenz QD	TDF/FTC FDC n=193 Participants Tenofovir (TDF) 300 mg/emtricitabine (FTC) 200 mg FDC once daily (QD) plus 600 mg efavirenz QD
Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Low-density Lipoprotein (LDL) at Week 96 Optimal to optimal	18 participants	37 participants
Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Low-density Lipoprotein (LDL) at Week 96 Optimal to near or above optimal	35 participants	46 participants
Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Low-density Lipoprotein (LDL) at Week 96 Optimal to borderline high	29 participants	17 participants
Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Low-density Lipoprotein (LDL) at Week 96 Optimal to high	9 participants	1 participants
Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Low-density Lipoprotein (LDL) at Week 96 Optimal to very high	3 participants	0 participants
Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Low-density Lipoprotein (LDL) at Week 96 Near or above optimal to optimal	0 participants	1 participants
Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Low-density Lipoprotein (LDL) at Week 96 Near or above optimal to near or above optimal	4 participants	19 participants
Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Low-density Lipoprotein (LDL) at Week 96 Near or above optimal to borderline high	17 participants	16 participants
Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Low-density Lipoprotein (LDL) at Week 96 Near or above optimal to high	12 participants	7 participants
Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Low-density Lipoprotein (LDL) at Week 96 Near or above optimal to very high	6 participants	2 participants
Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Low-density Lipoprotein (LDL) at Week 96 Borderline high to optimal	0 participants	0 participants
Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Low-density Lipoprotein (LDL) at Week 96 Borderline high to near or above optimal	1 participants	3 participants
Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Low-density Lipoprotein (LDL) at Week 96 Borderline high to borderline high	2 participants	5 participants
Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Low-density Lipoprotein (LDL) at Week 96 Borderline high to high	3 participants	3 participants
Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Low-density Lipoprotein (LDL) at Week 96 Borderline high to very high	4 participants	3 participants
Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Low-density Lipoprotein (LDL) at Week 96 High to optimal	0 participants	0 participants
Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Low-density Lipoprotein (LDL) at Week 96 High to near or above optimal	0 participants	0 participants
Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Low-density Lipoprotein (LDL) at Week 96 High to borderline high	0 participants	0 participants
Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Low-density Lipoprotein (LDL) at Week 96 High to high	1 participants	1 participants
Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Low-density Lipoprotein (LDL) at Week 96 High to very high	0 participants	0 participants
Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Low-density Lipoprotein (LDL) at Week 96 Very high to optimal	0 participants	0 participants
Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Low-density Lipoprotein (LDL) at Week 96 Very high to near or above optimal	0 participants	0 participants
Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Low-density Lipoprotein (LDL) at Week 96 Very high to borderline high	1 participants	0 participants
Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Low-density Lipoprotein (LDL) at Week 96 Very high to high	0 participants	0 participants
Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Low-density Lipoprotein (LDL) at Week 96 Very high to very high	1 participants	1 participants

SECONDARY outcome

Timeframe: Baseline, Week 24

Population: Safety Population

Blood samples were collected from participants for analysis of their lipid profile. Data are categorized by the maximum post-baseline threshold reached. <40 mg/dL, low; 40-<60 mg/dL, normal; >=60 mg/dL, high.

Outcome measures

Measure	ABC/3TC FDC n=192 Participants Abacavir (ABC) 600 mg/lamivudine (3TC) 300 mg fixed dose combination (FDC) once daily (QD) plus 600 mg efavirenz QD	TDF/FTC FDC n=193 Participants Tenofovir (TDF) 300 mg/emtricitabine (FTC) 200 mg FDC once daily (QD) plus 600 mg efavirenz QD
Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting High-density Lipoprotein (HDL) at Week 24 Low to low	19 participants	36 participants
Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting High-density Lipoprotein (HDL) at Week 24 Low to normal	72 participants	66 participants
Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting High-density Lipoprotein (HDL) at Week 24 Low to high	10 participants	9 participants
Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting High-density Lipoprotein (HDL) at Week 24 Normal to low	0 participants	1 participants
Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting High-density Lipoprotein (HDL) at Week 24 Normal to normal	12 participants	30 participants
Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting High-density Lipoprotein (HDL) at Week 24 Normal to high	26 participants	12 participants
Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting High-density Lipoprotein (HDL) at Week 24 High to low	0 participants	0 participants
Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting High-density Lipoprotein (HDL) at Week 24 High to normal	0 participants	3 participants
Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting High-density Lipoprotein (HDL) at Week 24 High to high	10 participants	5 participants

SECONDARY outcome

Timeframe: Baseline, Week 48

Population: Safety Population

Blood samples were collected from participants for analysis of their lipid profile. Data are categorized by the maximum post-baseline threshold reached. <40 mg/dL, low; 40-<60 mg/dL, normal; >=60 mg/dL, high.

Outcome measures

Measure	ABC/3TC FDC n=192 Participants Abacavir (ABC) 600 mg/lamivudine (3TC) 300 mg fixed dose combination (FDC) once daily (QD) plus 600 mg efavirenz QD	TDF/FTC FDC n=193 Participants Tenofovir (TDF) 300 mg/emtricitabine (FTC) 200 mg FDC once daily (QD) plus 600 mg efavirenz QD
Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting High-density Lipoprotein (HDL) at Week 48 Low to low	17 participants	28 participants
Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting High-density Lipoprotein (HDL) at Week 48 Low to normal	67 participants	73 participants
Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting High-density Lipoprotein (HDL) at Week 48 Low to high	18 participants	10 participants
Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting High-density Lipoprotein (HDL) at Week 48 Normal to low	0 participants	0 participants
Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting High-density Lipoprotein (HDL) at Week 48 Normal to normal	11 participants	23 participants
Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting High-density Lipoprotein (HDL) at Week 48 Normal to high	27 participants	20 participants
Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting High-density Lipoprotein (HDL) at Week 48 High to low	0 participants	0 participants
Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting High-density Lipoprotein (HDL) at Week 48 High to normal	0 participants	3 participants
Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting High-density Lipoprotein (HDL) at Week 48 High to high	10 participants	5 participants

SECONDARY outcome

Timeframe: Baseline, Week 96

Population: Safety Population

Blood samples were collected from participants for analysis of their lipid profile. Data are categorized by the maximum post-baseline threshold reached. <40 mg/dL, low; 40-<60 mg/dL, normal; >=60 mg/dL, high.

Outcome measures

Measure	ABC/3TC FDC n=192 Participants Abacavir (ABC) 600 mg/lamivudine (3TC) 300 mg fixed dose combination (FDC) once daily (QD) plus 600 mg efavirenz QD	TDF/FTC FDC n=193 Participants Tenofovir (TDF) 300 mg/emtricitabine (FTC) 200 mg FDC once daily (QD) plus 600 mg efavirenz QD
Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting High-density Lipoprotein (HDL) at Week 96 Low to low	11 participants	23 participants
Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting High-density Lipoprotein (HDL) at Week 96 Low to normal	66 participants	75 participants
Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting High-density Lipoprotein (HDL) at Week 96 Low to high	25 participants	13 participants
Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting High-density Lipoprotein (HDL) at Week 96 Normal to low	0 participants	0 participants
Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting High-density Lipoprotein (HDL) at Week 96 Normal to normal	8 participants	17 participants
Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting High-density Lipoprotein (HDL) at Week 96 Normal to high	30 participants	27 participants
Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting High-density Lipoprotein (HDL) at Week 96 High to low	0 participants	0 participants
Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting High-density Lipoprotein (HDL) at Week 96 High to normal	0 participants	1 participants
Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting High-density Lipoprotein (HDL) at Week 96 High to high	10 participants	7 participants

SECONDARY outcome

Timeframe: Baseline, Week 24

Population: Safety Population

Blood samples were collected from participants for analysis of their lipid profile. Data are categorized by the maximum post-baseline threshold reached. <150 mg/dL, normal; 150-<200 mg/dL, borderline high; 200-<500 mg/dL, high; >=500 mg/dL, very high.

Outcome measures

Measure	ABC/3TC FDC n=192 Participants Abacavir (ABC) 600 mg/lamivudine (3TC) 300 mg fixed dose combination (FDC) once daily (QD) plus 600 mg efavirenz QD	TDF/FTC FDC n=193 Participants Tenofovir (TDF) 300 mg/emtricitabine (FTC) 200 mg FDC once daily (QD) plus 600 mg efavirenz QD
Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting Triglycerides at Week 24 Normal to normal	63 participants	78 participants
Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting Triglycerides at Week 24 Normal to borderline high	21 participants	19 participants
Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting Triglycerides at Week 24 Normal to high	23 participants	9 participants
Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting Triglycerides at Week 24 Normal to very high	0 participants	0 participants
Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting Triglycerides at Week 24 Borderline high to normal	5 participants	7 participants
Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting Triglycerides at Week 24 Borderline high to borderline high	5 participants	10 participants
Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting Triglycerides at Week 24 Borderline high to high	9 participants	15 participants
Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting Triglycerides at Week 24 Borderline high to very high	0 participants	0 participants
Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting Triglycerides at Week 24 High to normal	2 participants	6 participants
Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting Triglycerides at Week 24 High to borderline high	5 participants	3 participants
Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting Triglycerides at Week 24 High to high	12 participants	15 participants
Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting Triglycerides at Week 24 High to very high	3 participants	0 participants
Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting Triglycerides at Week 24 Very high to normal	0 participants	0 participants
Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting Triglycerides at Week 24 Very high to borderline high	0 participants	0 participants
Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting Triglycerides at Week 24 Very high to high	0 participants	1 participants
Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting Triglycerides at Week 24 Very high to very high	1 participants	0 participants

SECONDARY outcome

Timeframe: Baseline, Week 48

Population: Safety Population

Blood samples were collected from participants for analysis of their lipid profile. Data are categorized by the maximum post-baseline threshold reached. <150 mg/dL, normal; 150-<200 mg/dL, borderline high; 200-<500 mg/dL, high; >=500 mg/dL, very high.

Outcome measures

Measure	ABC/3TC FDC n=192 Participants Abacavir (ABC) 600 mg/lamivudine (3TC) 300 mg fixed dose combination (FDC) once daily (QD) plus 600 mg efavirenz QD	TDF/FTC FDC n=193 Participants Tenofovir (TDF) 300 mg/emtricitabine (FTC) 200 mg FDC once daily (QD) plus 600 mg efavirenz QD
Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting Triglycerides at Week 48 Normal to normal	55 participants	70 participants
Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting Triglycerides at Week 48 Normal to borderline high	22 participants	23 participants
Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting Triglycerides at Week 48 Normal to high	30 participants	12 participants
Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting Triglycerides at Week 48 Normal to very high	0 participants	1 participants
Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting Triglycerides at Week 48 Borderline high to normal	4 participants	6 participants
Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting Triglycerides at Week 48 Borderline high to borderline high	5 participants	7 participants
Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting Triglycerides at Week 48 Borderline high to high	11 participants	19 participants
Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting Triglycerides at Week 48 Borderline high to very high	0 participants	0 participants
Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting Triglycerides at Week 48 High to normal	2 participants	5 participants
Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting Triglycerides at Week 48 High to borderline high	4 participants	3 participants
Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting Triglycerides at Week 48 High to high	12 participants	15 participants
Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting Triglycerides at Week 48 High to very high	4 participants	0 participants
Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting Triglycerides at Week 48 Very high to normal	0 participants	0 participants
Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting Triglycerides at Week 48 Very high to borderline high	0 participants	0 participants
Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting Triglycerides at Week 48 Very high to high	0 participants	1 participants
Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting Triglycerides at Week 48 Very high to very high	1 participants	0 participants

SECONDARY outcome

Timeframe: Baseline, Week 96

Population: Safety Population

Blood samples were collected from participants for analysis of their lipid profile. Data are categorized by the maximum post-baseline threshold reached. <150 mg/dL, normal; 150->200 mg/dL, borderline high; 200-<500 mg/dL, high;>= 500 mg/dL, very high.

Outcome measures

Measure	ABC/3TC FDC n=192 Participants Abacavir (ABC) 600 mg/lamivudine (3TC) 300 mg fixed dose combination (FDC) once daily (QD) plus 600 mg efavirenz QD	TDF/FTC FDC n=193 Participants Tenofovir (TDF) 300 mg/emtricitabine (FTC) 200 mg FDC once daily (QD) plus 600 mg efavirenz QD
Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting Triglycerides at Week 96 Normal to normal	47 participants	55 participants
Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting Triglycerides at Week 96 Normal to borderline high	25 participants	31 participants
Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting Triglycerides at Week 96 Normal to high	34 participants	20 participants
Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting Triglycerides at Week 96 Normal to very high	1 participants	1 participants
Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting Triglycerides at Week 96 Borderline high to normal	4 participants	5 participants
Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting Triglycerides at Week 96 Borderline high to borderline high	4 participants	8 participants
Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting Triglycerides at Week 96 Borderline high to high	11 participants	19 participants
Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting Triglycerides at Week 96 Borderline high to very high	1 participants	0 participants
Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting Triglycerides at Week 96 High to normal	2 participants	5 participants
Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting Triglycerides at Week 96 High to borderline high	4 participants	2 participants
Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting Triglycerides at Week 96 High to high	11 participants	16 participants
Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting Triglycerides at Week 96 High to very high	5 participants	0 participants
Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting Triglycerides at Week 96 Very high to normal	0 participants	0 participants
Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting Triglycerides at Week 96 Very high to borderline high	0 participants	0 participants
Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting Triglycerides at Week 96 Very high to high	0 participants	1 participants
Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting Triglycerides at Week 96 Very high to very high	1 participants	0 participants

SECONDARY outcome

Timeframe: Week 24

Population: Safety Population

The DAIDS toxicity table provides descriptive terminology for grading the severity of adult adverse events. Laboratory grades also provide ranges for each parameter. Grade 1: mild, Grade 2: moderate, Grade 3: severe, Grade 4: potentially life-threatening. LDL, low-density lipid; HDL, high-density lipid. Treatment emergent refers to any toxicity that was not present prior to the start of study drug treatment.

Outcome measures

Measure	ABC/3TC FDC n=192 Participants Abacavir (ABC) 600 mg/lamivudine (3TC) 300 mg fixed dose combination (FDC) once daily (QD) plus 600 mg efavirenz QD	TDF/FTC FDC n=193 Participants Tenofovir (TDF) 300 mg/emtricitabine (FTC) 200 mg FDC once daily (QD) plus 600 mg efavirenz QD
Number of Participants With the Indicated Treatment-emergent Division of AIDS (DAIDS) Toxicities at Week 24 LDL cholesterol, Grade 4	0 participants	0 participants
Number of Participants With the Indicated Treatment-emergent Division of AIDS (DAIDS) Toxicities at Week 24 Cholesterol, Grade 3	6 participants	1 participants
Number of Participants With the Indicated Treatment-emergent Division of AIDS (DAIDS) Toxicities at Week 24 Cholesterol, Grade 4	0 participants	0 participants
Number of Participants With the Indicated Treatment-emergent Division of AIDS (DAIDS) Toxicities at Week 24 LDL cholesterol, Grade 3	8 participants	3 participants
Number of Participants With the Indicated Treatment-emergent Division of AIDS (DAIDS) Toxicities at Week 24 Alanine aminotransferase, Grade 4	1 participants	1 participants
Number of Participants With the Indicated Treatment-emergent Division of AIDS (DAIDS) Toxicities at Week 24 Aspartate aminotransferase, Grade 3	1 participants	0 participants
Number of Participants With the Indicated Treatment-emergent Division of AIDS (DAIDS) Toxicities at Week 24 Aspartate aminotransferase, Grade 4	1 participants	2 participants
Number of Participants With the Indicated Treatment-emergent Division of AIDS (DAIDS) Toxicities at Week 24 Alkaline phosphatase, Grade 3	0 participants	1 participants
Number of Participants With the Indicated Treatment-emergent Division of AIDS (DAIDS) Toxicities at Week 24 Alkaline phosphatase, Grade 4	0 participants	0 participants
Number of Participants With the Indicated Treatment-emergent Division of AIDS (DAIDS) Toxicities at Week 24 Creatinine kinase, Grade 3	0 participants	1 participants
Number of Participants With the Indicated Treatment-emergent Division of AIDS (DAIDS) Toxicities at Week 24 Creatinine kinase, Grade 4	1 participants	1 participants
Number of Participants With the Indicated Treatment-emergent Division of AIDS (DAIDS) Toxicities at Week 24 Non-HDL cholesterol, Grade 3	19 participants	5 participants
Number of Participants With the Indicated Treatment-emergent Division of AIDS (DAIDS) Toxicities at Week 24 Non-HDL cholesterol, Grade 4	0 participants	0 participants
Number of Participants With the Indicated Treatment-emergent Division of AIDS (DAIDS) Toxicities at Week 24 Triglycerides, Grade 3	2 participants	0 participants
Number of Participants With the Indicated Treatment-emergent Division of AIDS (DAIDS) Toxicities at Week 24 Triglycerides, Grade 4	0 participants	0 participants
Number of Participants With the Indicated Treatment-emergent Division of AIDS (DAIDS) Toxicities at Week 24 Alanine aminotransferase, Grade 3	1 participants	3 participants
Number of Participants With the Indicated Treatment-emergent Division of AIDS (DAIDS) Toxicities at Week 24 Lipase, Grade 3	3 participants	1 participants
Number of Participants With the Indicated Treatment-emergent Division of AIDS (DAIDS) Toxicities at Week 24 Lipase, Grade 4	2 participants	0 participants
Number of Participants With the Indicated Treatment-emergent Division of AIDS (DAIDS) Toxicities at Week 24 Hyperkalaemia, Grade 3	0 participants	0 participants
Number of Participants With the Indicated Treatment-emergent Division of AIDS (DAIDS) Toxicities at Week 24 Hyperkalaemia, Grade 4	1 participants	1 participants
Number of Participants With the Indicated Treatment-emergent Division of AIDS (DAIDS) Toxicities at Week 24 Glomerular filtration rate, MDRD, Grade 3	1 participants	1 participants
Number of Participants With the Indicated Treatment-emergent Division of AIDS (DAIDS) Toxicities at Week 24 Glomerular filtration rate, MDRD, Grade 4	0 participants	0 participants
Number of Participants With the Indicated Treatment-emergent Division of AIDS (DAIDS) Toxicities at Week 24 Total neutrophils, Grade 3	1 participants	0 participants
Number of Participants With the Indicated Treatment-emergent Division of AIDS (DAIDS) Toxicities at Week 24 Total neutrophils, Grade 4	1 participants	2 participants
Number of Participants With the Indicated Treatment-emergent Division of AIDS (DAIDS) Toxicities at Week 24 Thrombocytopenia, Grade 3	1 participants	0 participants
Number of Participants With the Indicated Treatment-emergent Division of AIDS (DAIDS) Toxicities at Week 24 Thrombocytopenia, Grade 4	0 participants	0 participants
Number of Participants With the Indicated Treatment-emergent Division of AIDS (DAIDS) Toxicities at Week 24 Phosphorus inorganic, Grade 3	1 participants	1 participants
Number of Participants With the Indicated Treatment-emergent Division of AIDS (DAIDS) Toxicities at Week 24 Phosphorus inorganic, Grade 4	0 participants	0 participants

SECONDARY outcome

Timeframe: Week 48

Population: Safety Population

The DAIDS toxicity table provides descriptive terminology for grading the severity of adult adverse events. Laboratory grades also provide ranges for each parameter. Grade 1: mild, Grade 2: moderate, Grade 3: severe, Grade 4: potentially life-threatening. LDL, low-density lipid; HDL, high-density lipid. Treatment emergent refers to any toxicity that was not present prior to the start of study drug treatment.

Outcome measures

Measure	ABC/3TC FDC n=192 Participants Abacavir (ABC) 600 mg/lamivudine (3TC) 300 mg fixed dose combination (FDC) once daily (QD) plus 600 mg efavirenz QD	TDF/FTC FDC n=193 Participants Tenofovir (TDF) 300 mg/emtricitabine (FTC) 200 mg FDC once daily (QD) plus 600 mg efavirenz QD
Number of Participants With the Indicated Treatment-emergent Division of AIDS (DAIDS) Toxicities at Week 48 Alkaline phosphatase, Grade 3	0 participants	1 participants
Number of Participants With the Indicated Treatment-emergent Division of AIDS (DAIDS) Toxicities at Week 48 Alkaline phosphatase, Grade 4	0 participants	0 participants
Number of Participants With the Indicated Treatment-emergent Division of AIDS (DAIDS) Toxicities at Week 48 Total bilirubin Grade 3	1 participants	0 participants
Number of Participants With the Indicated Treatment-emergent Division of AIDS (DAIDS) Toxicities at Week 48 Total bilirubin, Grade 4	0 participants	0 participants
Number of Participants With the Indicated Treatment-emergent Division of AIDS (DAIDS) Toxicities at Week 48 Creatinine kinase, Grade 3	0 participants	2 participants
Number of Participants With the Indicated Treatment-emergent Division of AIDS (DAIDS) Toxicities at Week 48 Creatinine kinase, Grade 4	1 participants	1 participants
Number of Participants With the Indicated Treatment-emergent Division of AIDS (DAIDS) Toxicities at Week 48 Hyperkalaemia, Grade 4	2 participants	2 participants
Number of Participants With the Indicated Treatment-emergent Division of AIDS (DAIDS) Toxicities at Week 48 Glomerular filtration rate, MDRD, Grade 3	1 participants	1 participants
Number of Participants With the Indicated Treatment-emergent Division of AIDS (DAIDS) Toxicities at Week 48 Glomerular filtration rate, MDRD, Grade 4	0 participants	0 participants
Number of Participants With the Indicated Treatment-emergent Division of AIDS (DAIDS) Toxicities at Week 48 Total neutrophils, Grade 3	2 participants	0 participants
Number of Participants With the Indicated Treatment-emergent Division of AIDS (DAIDS) Toxicities at Week 48 Total neutrophils, Grade 4	3 participants	2 participants
Number of Participants With the Indicated Treatment-emergent Division of AIDS (DAIDS) Toxicities at Week 48 Thrombocytopenia, Grade 4	0 participants	0 participants
Number of Participants With the Indicated Treatment-emergent Division of AIDS (DAIDS) Toxicities at Week 48 Phosphorus inorganic, Grade 3	3 participants	1 participants
Number of Participants With the Indicated Treatment-emergent Division of AIDS (DAIDS) Toxicities at Week 48 Lipase, Grade 3	5 participants	1 participants
Number of Participants With the Indicated Treatment-emergent Division of AIDS (DAIDS) Toxicities at Week 48 Lipase, Grade 4	2 participants	0 participants
Number of Participants With the Indicated Treatment-emergent Division of AIDS (DAIDS) Toxicities at Week 48 Hyperkalaemia, Grade 3	0 participants	0 participants
Number of Participants With the Indicated Treatment-emergent Division of AIDS (DAIDS) Toxicities at Week 48 LDL cholesterol, Grade 3	9 participants	3 participants
Number of Participants With the Indicated Treatment-emergent Division of AIDS (DAIDS) Toxicities at Week 48 Alanine aminotransferase, Grade 3	2 participants	4 participants
Number of Participants With the Indicated Treatment-emergent Division of AIDS (DAIDS) Toxicities at Week 48 Phosphorus inorganic, Grade 4	0 participants	0 participants
Number of Participants With the Indicated Treatment-emergent Division of AIDS (DAIDS) Toxicities at Week 48 LDL cholesterol, Grade 4	0 participants	0 participants
Number of Participants With the Indicated Treatment-emergent Division of AIDS (DAIDS) Toxicities at Week 48 Non-HDL cholesterol, Grade 3	20 participants	6 participants
Number of Participants With the Indicated Treatment-emergent Division of AIDS (DAIDS) Toxicities at Week 48 Non-HDL cholesterol, Grade 4	0 participants	0 participants
Number of Participants With the Indicated Treatment-emergent Division of AIDS (DAIDS) Toxicities at Week 48 Triglycerides, Grade 3	3 participants	0 participants
Number of Participants With the Indicated Treatment-emergent Division of AIDS (DAIDS) Toxicities at Week 48 Triglycerides, Grade 4	0 participants	0 participants
Number of Participants With the Indicated Treatment-emergent Division of AIDS (DAIDS) Toxicities at Week 48 Alanine aminotransferase, Grade 4	2 participants	1 participants
Number of Participants With the Indicated Treatment-emergent Division of AIDS (DAIDS) Toxicities at Week 48 Aspartate aminotransferase, Grade 3	2 participants	0 participants
Number of Participants With the Indicated Treatment-emergent Division of AIDS (DAIDS) Toxicities at Week 48 Aspartate aminotransferase, Grade 4	2 participants	2 participants
Number of Participants With the Indicated Treatment-emergent Division of AIDS (DAIDS) Toxicities at Week 48 Cholesterol, Grade 3	7 participants	1 participants
Number of Participants With the Indicated Treatment-emergent Division of AIDS (DAIDS) Toxicities at Week 48 Cholesterol, Grade 4	0 participants	0 participants

SECONDARY outcome

Timeframe: Week 96

Population: Safety Population

The DAIDS toxicity table provides descriptive terminology for grading the severity of adult adverse events. Laboratory grades also provide ranges for each parameter. Grade 1: mild, Grade 2: moderate, Grade 3: severe, Grade 4: potentially life-threatening. LDL, low-density lipid; HDL, high-density lipid. Treatment emergent refers to any toxicity that was not present prior to the start of study drug therapy.

Outcome measures

Measure	ABC/3TC FDC n=192 Participants Abacavir (ABC) 600 mg/lamivudine (3TC) 300 mg fixed dose combination (FDC) once daily (QD) plus 600 mg efavirenz QD	TDF/FTC FDC n=193 Participants Tenofovir (TDF) 300 mg/emtricitabine (FTC) 200 mg FDC once daily (QD) plus 600 mg efavirenz QD
Number of Participants With the Indicated Treatment-emergent Division of AIDS (DAIDS) Toxicities at Week 96 Cholesterol, Grade 3	9 participants	1 participants
Number of Participants With the Indicated Treatment-emergent Division of AIDS (DAIDS) Toxicities at Week 96 Cholesterol, Grade 4	0 participants	0 participants
Number of Participants With the Indicated Treatment-emergent Division of AIDS (DAIDS) Toxicities at Week 96 LDL cholesterol, Grade 3	13 participants	5 participants
Number of Participants With the Indicated Treatment-emergent Division of AIDS (DAIDS) Toxicities at Week 96 LDL cholesterol, Grade 4	0 participants	0 participants
Number of Participants With the Indicated Treatment-emergent Division of AIDS (DAIDS) Toxicities at Week 96 Non-HDL cholesterol, Grade 3	22 participants	5 participants
Number of Participants With the Indicated Treatment-emergent Division of AIDS (DAIDS) Toxicities at Week 96 Non-HDL cholesterol, Grade 4	0 participants	0 participants
Number of Participants With the Indicated Treatment-emergent Division of AIDS (DAIDS) Toxicities at Week 96 Triglycerides, Grade 3	2 participants	0 participants
Number of Participants With the Indicated Treatment-emergent Division of AIDS (DAIDS) Toxicities at Week 96 Triglycerides, Grade 4	1 participants	0 participants
Number of Participants With the Indicated Treatment-emergent Division of AIDS (DAIDS) Toxicities at Week 96 Alanine aminotransferase, Grade 3	2 participants	4 participants
Number of Participants With the Indicated Treatment-emergent Division of AIDS (DAIDS) Toxicities at Week 96 Alanine aminotransferase, Grade 4	2 participants	1 participants
Number of Participants With the Indicated Treatment-emergent Division of AIDS (DAIDS) Toxicities at Week 96 Aspartate aminotransferase, Grade 3	2 participants	1 participants
Number of Participants With the Indicated Treatment-emergent Division of AIDS (DAIDS) Toxicities at Week 96 Aspartate aminotransferase, Grade 4	2 participants	2 participants
Number of Participants With the Indicated Treatment-emergent Division of AIDS (DAIDS) Toxicities at Week 96 Alkaline phosphatase, Grade 3	0 participants	1 participants
Number of Participants With the Indicated Treatment-emergent Division of AIDS (DAIDS) Toxicities at Week 96 Alkaline phosphatase, Grade 4	0 participants	0 participants
Number of Participants With the Indicated Treatment-emergent Division of AIDS (DAIDS) Toxicities at Week 96 Hyperkalaemia, Grade 4	2 participants	0 participants
Number of Participants With the Indicated Treatment-emergent Division of AIDS (DAIDS) Toxicities at Week 96 Total bilirubin, Grade 3	1 participants	0 participants
Number of Participants With the Indicated Treatment-emergent Division of AIDS (DAIDS) Toxicities at Week 96 Total bilirubin, Grade 4	0 participants	0 participants
Number of Participants With the Indicated Treatment-emergent Division of AIDS (DAIDS) Toxicities at Week 96 Creatinine kinase, Grade 3	0 participants	2 participants
Number of Participants With the Indicated Treatment-emergent Division of AIDS (DAIDS) Toxicities at Week 96 Creatinine kinase, Grade 4	1 participants	2 participants
Number of Participants With the Indicated Treatment-emergent Division of AIDS (DAIDS) Toxicities at Week 96 Phosphorus inorganic, Grade 3	4 participants	3 participants
Number of Participants With the Indicated Treatment-emergent Division of AIDS (DAIDS) Toxicities at Week 96 Phosphorus inorganic, Grade 4	0 participants	0 participants
Number of Participants With the Indicated Treatment-emergent Division of AIDS (DAIDS) Toxicities at Week 96 Lipase, Grade 3	6 participants	2 participants
Number of Participants With the Indicated Treatment-emergent Division of AIDS (DAIDS) Toxicities at Week 96 Lipase, Grade 4	4 participants	2 participants
Number of Participants With the Indicated Treatment-emergent Division of AIDS (DAIDS) Toxicities at Week 96 Hyperkalaemia, Grade 3	0 participants	0 participants
Number of Participants With the Indicated Treatment-emergent Division of AIDS (DAIDS) Toxicities at Week 96 Glomerular filtration rate, MDRD, Grade 3	1 participants	1 participants
Number of Participants With the Indicated Treatment-emergent Division of AIDS (DAIDS) Toxicities at Week 96 Glomerular filtration rate, MDRD, Grade 4	0 participants	0 participants
Number of Participants With the Indicated Treatment-emergent Division of AIDS (DAIDS) Toxicities at Week 96 Total neutrophils, Grade 3	3 participants	1 participants
Number of Participants With the Indicated Treatment-emergent Division of AIDS (DAIDS) Toxicities at Week 96 Total neutrophils, Grade 4	5 participants	3 participants
Number of Participants With the Indicated Treatment-emergent Division of AIDS (DAIDS) Toxicities at Week 96 Thrombocytopenia, Grade 3	1 participants	0 participants
Number of Participants With the Indicated Treatment-emergent Division of AIDS (DAIDS) Toxicities at Week 96 Thrombocytopenia, Grade 4	0 participants	0 participants

SECONDARY outcome

Timeframe: Week 24

Population: ITT-E Population. Failures and missing values are derived according to the Time to Loss of Virologic Response (TLOVR) Food and Drug Administration (FDA) algorithm.

HIV-1 RNA level (viral load) is a strong predictor of the rate of HIV disease progression. It was measured from plasma (participant blood samples) taken at all visits throughout the study. HIV, human immunodeficiency virus; RNA, ribonucleic acid. Viral load is a measure of the severity of the HIV infection.

Outcome measures

Measure	ABC/3TC FDC n=192 Participants Abacavir (ABC) 600 mg/lamivudine (3TC) 300 mg fixed dose combination (FDC) once daily (QD) plus 600 mg efavirenz QD	TDF/FTC FDC n=193 Participants Tenofovir (TDF) 300 mg/emtricitabine (FTC) 200 mg FDC once daily (QD) plus 600 mg efavirenz QD
Number of Participants With HIV-1 RNA <50 Copies/Milliliter (c/mL) and 400 c/mL at Week 24 <50 copies/mL	126 participants	144 participants
Number of Participants With HIV-1 RNA <50 Copies/Milliliter (c/mL) and 400 c/mL at Week 24 <400 copies/mL	147 participants	168 participants

SECONDARY outcome

Timeframe: Week 48

Population: ITT-E Population. Failures and missing values are derived according to the Time to Loss of Virologic Response (TLOVR) Food and Drug Administration (FDA) algorithm.

HIV-1 RNA level (viral load) is a strong predictor of the rate of HIV disease progression. It was measured from plasma (participant blood samples) taken at all visits throughout the study. HIV, human immunodeficiency virus; RNA, ribonucleic acid. Viral load is a measure of the severity of the HIV infection.

Outcome measures

Measure	ABC/3TC FDC n=192 Participants Abacavir (ABC) 600 mg/lamivudine (3TC) 300 mg fixed dose combination (FDC) once daily (QD) plus 600 mg efavirenz QD	TDF/FTC FDC n=193 Participants Tenofovir (TDF) 300 mg/emtricitabine (FTC) 200 mg FDC once daily (QD) plus 600 mg efavirenz QD
Number of Participants With HIV-1 RNA <50 Copies/Milliliter (c/mL) and 400 c/mL at Week 48 <50 copies/mL	121 participants	145 participants
Number of Participants With HIV-1 RNA <50 Copies/Milliliter (c/mL) and 400 c/mL at Week 48 <400 copies/mL	130 participants	151 participants

SECONDARY outcome

Timeframe: Week 96

Population: ITT-E Population. Failures and missing values are derived according to the Time to Loss of Virologic Response (TLOVR) Food and Drug Administration (FDA) algorithm.

HIV-1 RNA level (viral load) is a strong predictor of the rate of HIV disease progression. It was measured from plasma (participant blood samples) taken at all visits throughout the study. HIV, human immunodeficiency virus; RNA, ribonucleic acid. Viral load is a measure of the severity of the HIV infection.

Outcome measures

Measure	ABC/3TC FDC n=192 Participants Abacavir (ABC) 600 mg/lamivudine (3TC) 300 mg fixed dose combination (FDC) once daily (QD) plus 600 mg efavirenz QD	TDF/FTC FDC n=193 Participants Tenofovir (TDF) 300 mg/emtricitabine (FTC) 200 mg FDC once daily (QD) plus 600 mg efavirenz QD
Number of Participants With HIV-1 RNA <50 Copies/Milliliter (c/mL) and 400 c/mL at Week 96 <50 copies/mL	98 participants	113 participants
Number of Participants With HIV-1 RNA <50 Copies/Milliliter (c/mL) and 400 c/mL at Week 96 <400 copies/mL	110 participants	126 participants

SECONDARY outcome

Timeframe: Baseline, Week 24

Population: ITT-E Population. Some participants had withdrawn by Week 24.

CD4+ counts are used to monitor the progression of HIV disease and the strength of the immune system. The number of CD4+ cells decreases as HIV disease progresses. Cell counts were measured from participant blood samples taken throughout the study.

Outcome measures

Measure	ABC/3TC FDC n=153 Participants Abacavir (ABC) 600 mg/lamivudine (3TC) 300 mg fixed dose combination (FDC) once daily (QD) plus 600 mg efavirenz QD	TDF/FTC FDC n=172 Participants Tenofovir (TDF) 300 mg/emtricitabine (FTC) 200 mg FDC once daily (QD) plus 600 mg efavirenz QD
Change From Baseline in Cluster Difference 4 (CD4+) Cell Count at Week 24	110.0 cells/millimeters cubed (mm^3) Interval 50.0 to 180.0	100.0 cells/millimeters cubed (mm^3) Interval 45.0 to 150.0

SECONDARY outcome

Timeframe: Baseline, Week 48

Population: ITT-E Population. Some participants had withdrawn by Week 48.

CD4+ counts are used to monitor the progression of HIV disease and the strength of the immune system. The number of CD4+ cells decreases as HIV disease progresses. Cell counts were measured from participant blood samples taken throughout the study.

Outcome measures

Measure	ABC/3TC FDC n=136 Participants Abacavir (ABC) 600 mg/lamivudine (3TC) 300 mg fixed dose combination (FDC) once daily (QD) plus 600 mg efavirenz QD	TDF/FTC FDC n=156 Participants Tenofovir (TDF) 300 mg/emtricitabine (FTC) 200 mg FDC once daily (QD) plus 600 mg efavirenz QD
Change From Baseline in Cluster Difference 4 (CD4+) Cell Count at Week 48	150.0 cells/mm^3 Interval 95.0 to 270.0	150.0 cells/mm^3 Interval 80.0 to 215.0

SECONDARY outcome

Timeframe: Baseline, Week 96

Population: ITT-E Population. Some participants had withdrawn by Week 96.

CD4+ counts are used to monitor the progression of HIV disease and the strength of the immune system. The number of CD4+ cells decreases as HIV disease progresses. Cell counts were measured from participant blood samples taken throughout the study.

Outcome measures

Measure	ABC/3TC FDC n=110 Participants Abacavir (ABC) 600 mg/lamivudine (3TC) 300 mg fixed dose combination (FDC) once daily (QD) plus 600 mg efavirenz QD	TDF/FTC FDC n=128 Participants Tenofovir (TDF) 300 mg/emtricitabine (FTC) 200 mg FDC once daily (QD) plus 600 mg efavirenz QD
Change From Baseline in Cluster Difference 4 (CD4+) Cell Count at Week 96	235.0 cells/mm^3 Interval 130.0 to 390.0	220.0 cells/mm^3 Interval 150.0 to 315.0

SECONDARY outcome

Timeframe: Week 96

Population: On-Treatment Resistance: all participants who fulfilled the definition of protocol-defined virological failure (VF) who had paired baseline and VF genotypic data for analysis. One ABC/3TC participant took prohibited medication that potentially lowered efavirenz levels just prior to VF, allowing for the emergence of unexpected NRTI resistance.

Viral resistance was measured using blood samples collected from participants throughout the study. NRTI, nucleoside reverse transcriptase inhibitor; NNRTI, non-nucleoside reverse transcriptase inhibitor. Virological failure was defined as any one of: participant does not achieve a 1 log10 copies (cop)/mL decrease in plasma HIV-1 RNA by Week (Wk) 4, or has two consecutive plasma HIV-1 RNA measures >=400 cop/mL separated by at least 2-4 wk after being previously <=400 cop/mL on/after Wk 4, or has two consecutive plasma HIV-1 RNA measures >400 cop/mL separated by at least 2-4 wk on/after Wk 24.

Outcome measures

Measure	ABC/3TC FDC n=7 Participants Abacavir (ABC) 600 mg/lamivudine (3TC) 300 mg fixed dose combination (FDC) once daily (QD) plus 600 mg efavirenz QD	TDF/FTC FDC n=3 Participants Tenofovir (TDF) 300 mg/emtricitabine (FTC) 200 mg FDC once daily (QD) plus 600 mg efavirenz QD
Number of Participants Classified as Protocol-defined Failures With Treatment-emergent Resistance to Study Drug in the Indicated Viruses at Week 96 Any treatment-emergent mutation	4 participants	0 participants
Number of Participants Classified as Protocol-defined Failures With Treatment-emergent Resistance to Study Drug in the Indicated Viruses at Week 96 NRTI	4 participants	0 participants
Number of Participants Classified as Protocol-defined Failures With Treatment-emergent Resistance to Study Drug in the Indicated Viruses at Week 96 NNRTI	2 participants	0 participants

SECONDARY outcome

Timeframe: Baseline to Week 96

Population: ITT-E Population. The number of participants analyzed differed by visit because some had withdrawn during the study and some did not have an assessment performed.

Participants were asked at each visit whether or not they utilized unplanned healthcare resources.

Outcome measures

Measure	ABC/3TC FDC n=178 Participants Abacavir (ABC) 600 mg/lamivudine (3TC) 300 mg fixed dose combination (FDC) once daily (QD) plus 600 mg efavirenz QD	TDF/FTC FDC n=183 Participants Tenofovir (TDF) 300 mg/emtricitabine (FTC) 200 mg FDC once daily (QD) plus 600 mg efavirenz QD
Number of Participants Who Indicated "Yes" or "No" to the Question of Whether Unplanned Healthcare Resources Were Utilized Week 60, No, n=129, 148	82 participants	104 participants
Number of Participants Who Indicated "Yes" or "No" to the Question of Whether Unplanned Healthcare Resources Were Utilized Week 4, Yes, n=178, 183	60 participants	49 participants
Number of Participants Who Indicated "Yes" or "No" to the Question of Whether Unplanned Healthcare Resources Were Utilized Week 4, No, n=178, 183	118 participants	134 participants
Number of Participants Who Indicated "Yes" or "No" to the Question of Whether Unplanned Healthcare Resources Were Utilized Week 12, Yes, n=162, 177	56 participants	47 participants
Number of Participants Who Indicated "Yes" or "No" to the Question of Whether Unplanned Healthcare Resources Were Utilized Week 12, No, n=162, 177	106 participants	130 participants
Number of Participants Who Indicated "Yes" or "No" to the Question of Whether Unplanned Healthcare Resources Were Utilized Week 24, Yes, n=156, 173	70 participants	59 participants
Number of Participants Who Indicated "Yes" or "No" to the Question of Whether Unplanned Healthcare Resources Were Utilized Week 24, No, n=156, 173	86 participants	114 participants
Number of Participants Who Indicated "Yes" or "No" to the Question of Whether Unplanned Healthcare Resources Were Utilized Week 36, Yes, n=148, 169	48 participants	50 participants
Number of Participants Who Indicated "Yes" or "No" to the Question of Whether Unplanned Healthcare Resources Were Utilized Week 36, No, n=148, 169	100 participants	119 participants
Number of Participants Who Indicated "Yes" or "No" to the Question of Whether Unplanned Healthcare Resources Were Utilized Week 48, Yes, n=137, 161	44 participants	36 participants
Number of Participants Who Indicated "Yes" or "No" to the Question of Whether Unplanned Healthcare Resources Were Utilized Week 48, No, n=137, 161	93 participants	125 participants
Number of Participants Who Indicated "Yes" or "No" to the Question of Whether Unplanned Healthcare Resources Were Utilized Week 60, Yes, n=129, 148	47 participants	44 participants
Number of Participants Who Indicated "Yes" or "No" to the Question of Whether Unplanned Healthcare Resources Were Utilized Week 72, Yes, n=126, 139	48 participants	40 participants
Number of Participants Who Indicated "Yes" or "No" to the Question of Whether Unplanned Healthcare Resources Were Utilized Week 72, No, n=126, 139	78 participants	99 participants
Number of Participants Who Indicated "Yes" or "No" to the Question of Whether Unplanned Healthcare Resources Were Utilized Week 84, Yes, n=121, 136	34 participants	24 participants
Number of Participants Who Indicated "Yes" or "No" to the Question of Whether Unplanned Healthcare Resources Were Utilized Week 84, No, n=121, 136	87 participants	108 participants
Number of Participants Who Indicated "Yes" or "No" to the Question of Whether Unplanned Healthcare Resources Were Utilized Week 96, Yes, n=113, 135	30 participants	17 participants
Number of Participants Who Indicated "Yes" or "No" to the Question of Whether Unplanned Healthcare Resources Were Utilized Week 96, No, n=113, 135	83 participants	118 participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline, Week 96

Population: Safety Biomarker Population: all randomized participants who received at least one dose of study medication and had at least one parameter measured at Baseline and at least one post-baseline visit. Some participants had withdrawn by Week 96.

Renal biomarkers were analyzed using urine samples collected from participants at baseline and Week 96. Renal biomarkers may be an indicator of various aspects of kidney function. The ratio was calculated by dividing the change from baseline albumin value by the urine creatinine value. Albumin is measured in milligrams per millimole (mg/mmol).

Outcome measures

Measure	ABC/3TC FDC n=103 Participants Abacavir (ABC) 600 mg/lamivudine (3TC) 300 mg fixed dose combination (FDC) once daily (QD) plus 600 mg efavirenz QD	TDF/FTC FDC n=120 Participants Tenofovir (TDF) 300 mg/emtricitabine (FTC) 200 mg FDC once daily (QD) plus 600 mg efavirenz QD
Exploratory Analysis of Change From Baseline in Albumin as a Ratio to Urine Creatinine at Week 96	0.872 ratio Interval 0.716 to 1.062	0.973 ratio Interval 0.806 to 1.174

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline, Week 96

Population: Safety Population. Some participants had withdrawn by Week 96.

Renal biomarkers were analyzed using urine samples collected from participants at baseline and Week 96. Renal biomarkers may be an indicator of various aspects of kidney function. The ratio was calculated by dividing the change from baseline B2M value by the urine creatinine value. B2M, beta 2 microglobulin (measured in mg/mmol).

Outcome measures

Measure	ABC/3TC FDC n=87 Participants Abacavir (ABC) 600 mg/lamivudine (3TC) 300 mg fixed dose combination (FDC) once daily (QD) plus 600 mg efavirenz QD	TDF/FTC FDC n=105 Participants Tenofovir (TDF) 300 mg/emtricitabine (FTC) 200 mg FDC once daily (QD) plus 600 mg efavirenz QD
Exploratory Analysis of Change From Baseline in Beta 2 Microglobulin (B2M) as a Ratio to Urine Creatinine at Week 96	0.542 ratio Interval 0.37 to 0.792	0.984 ratio Interval 0.684 to 1.416

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline, Week 96

Population: Safety Biomarker Population: all randomized participants who received at least one dose of study medication and had at least one parameter measured at Baseline and at least one post-baseline visit. Some participants had withdrawn by Week 96.

Renal biomarkers were analyzed using urine samples collected from participants at baseline and Week 96. Renal biomarkers may be an indicator of various aspects of kidney function. The ratio was calculated by dividing the change from baseline NAG value by the urine creatinine value. NAG, N-acetyl-B-glucosaminidase (measured in micromoles per hour per millimole [umol/h/mmol]).

Outcome measures

Measure	ABC/3TC FDC n=103 Participants Abacavir (ABC) 600 mg/lamivudine (3TC) 300 mg fixed dose combination (FDC) once daily (QD) plus 600 mg efavirenz QD	TDF/FTC FDC n=120 Participants Tenofovir (TDF) 300 mg/emtricitabine (FTC) 200 mg FDC once daily (QD) plus 600 mg efavirenz QD
Exploratory Analysis of Change From Baseline in N-acetyl-B-glucosaminidase (NAG) as a Ratio to Urine Creatinine at Week 96	0.868 ratio Interval 0.774 to 0.974	0.939 ratio Interval 0.844 to 1.044

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline, Week 96

Population: Safety Biomarker Population: all randomized participants who received at least one dose of study medication and had at least one parameter measured at Baseline and at least one post-baseline visit. Some participants had withdrawn by Week 96.

Renal biomarkers were analyzed using urine samples collected from participants at baseline and Week 96. Renal biomarkers may be an indicator of various aspects of kidney function. The ratio was calculated by dividing the change from baseline RBP value by the urine creatinine value. RBP, retinol binding protein (measured in micrograms per millimole [ug/mmol]).

Outcome measures

Measure	ABC/3TC FDC n=103 Participants Abacavir (ABC) 600 mg/lamivudine (3TC) 300 mg fixed dose combination (FDC) once daily (QD) plus 600 mg efavirenz QD	TDF/FTC FDC n=120 Participants Tenofovir (TDF) 300 mg/emtricitabine (FTC) 200 mg FDC once daily (QD) plus 600 mg efavirenz QD
Exploratory Analysis of Change From Baseline in Retinol Binding Protein (RBP) as a Ratio to Urine Creatinine at Week 96	1.099 ratio Interval 0.882 to 1.369	1.550 ratio Interval 1.247 to 1.927

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline, Week 96

Population: Safety Biomarker Population. Some participants had withdrawn by Week 96.

P1NP is a bone biomarker that was analyzed using blood samples collected from participants at baseline and Week 96. Bone biomarkers may be an indicator of bone turnover.

Outcome measures

Measure	ABC/3TC FDC n=94 Participants Abacavir (ABC) 600 mg/lamivudine (3TC) 300 mg fixed dose combination (FDC) once daily (QD) plus 600 mg efavirenz QD	TDF/FTC FDC n=114 Participants Tenofovir (TDF) 300 mg/emtricitabine (FTC) 200 mg FDC once daily (QD) plus 600 mg efavirenz QD
Exploratory Analysis of Change From Baseline in Procollagen Type 1 Amino-terminal Propeptide (P1NP) at Week 96	1.2 micrograms per Liter (ug/L) Interval 1.1 to 1.2	1.4 micrograms per Liter (ug/L) Interval 1.3 to 1.5

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline, Week 96

Population: Safety Biomarker Population. Some participants had withdrawn by Week 96.

Bone biomarkers were analyzed using blood samples collected from participants at baseline and Week 96. Bone biomarkers may be an indicator of bone turnover.

Outcome measures

Measure	ABC/3TC FDC n=94 Participants Abacavir (ABC) 600 mg/lamivudine (3TC) 300 mg fixed dose combination (FDC) once daily (QD) plus 600 mg efavirenz QD	TDF/FTC FDC n=114 Participants Tenofovir (TDF) 300 mg/emtricitabine (FTC) 200 mg FDC once daily (QD) plus 600 mg efavirenz QD
Exploratory Analysis of Change From Baseline in Type 1 Collagen Cross-linked C-telopeptide at Week 96	89.9 nanograms per Liter (ng/L) Interval 25.1 to 154.7	203.6 nanograms per Liter (ng/L) Interval 143.3 to 264.0

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline, Week 96

Population: Safety Biomarker Population. Some participants had withdrawn by Week 96.

Bone biomarkers were analyzed using blood samples collected from participants at baseline and Week 96. Bone biomarkers may be an indicator of bone turnover.

Outcome measures

Measure	ABC/3TC FDC n=94 Participants Abacavir (ABC) 600 mg/lamivudine (3TC) 300 mg fixed dose combination (FDC) once daily (QD) plus 600 mg efavirenz QD	TDF/FTC FDC n=114 Participants Tenofovir (TDF) 300 mg/emtricitabine (FTC) 200 mg FDC once daily (QD) plus 600 mg efavirenz QD
Exploratory Analysis of Change From Baseline in Osteocalcin at Week 96	3.01 ug/L Interval 0.87 to 5.14	5.79 ug/L Interval 3.68 to 7.9

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline, Week 96

Population: Safety Biomarker Population. Some participants had withdrawn by Week 96.

Bone biomarkers were analyzed using blood samples collected from participants at baseline and Week 96. Bone biomarkers may be an indicator of bone turnover.

Outcome measures

Measure	ABC/3TC FDC n=93 Participants Abacavir (ABC) 600 mg/lamivudine (3TC) 300 mg fixed dose combination (FDC) once daily (QD) plus 600 mg efavirenz QD	TDF/FTC FDC n=114 Participants Tenofovir (TDF) 300 mg/emtricitabine (FTC) 200 mg FDC once daily (QD) plus 600 mg efavirenz QD
Exploratory Analysis of Change From Baseline in Bone Specific Alkaline Phosphatase (BSAP) at Week 96	1.111 ug/L Interval -0.426 to 2.649	2.542 ug/L Interval 1.028 to 4.056

Adverse Events

ABC/3TC FDC

Serious events: 31 serious events

Other events: 172 other events

Deaths: 0 deaths

TDF/FTC FDC

Serious events: 20 serious events

Other events: 175 other events

Deaths: 0 deaths

Serious adverse events

Measure	ABC/3TC FDC n=192 participants at risk Abacavir (ABC) 600 mg/lamivudine (3TC) 300 mg fixed dose combination (FDC) once daily (QD) plus 600 mg efavirenz QD	TDF/FTC FDC n=193 participants at risk Tenofovir (TDF) 300 mg/emtricitabine (FTC) 200 mg FDC once daily (QD) plus 600 mg efavirenz QD
Immune system disorders Drug hypersensitivity	2.6% 5/192 Serious adverse events (SAEs) and adverse events (AEs) were collected in the Safety Population, comprised of all randomized participants who received at least one dose of study medication.	0.52% 1/193 Serious adverse events (SAEs) and adverse events (AEs) were collected in the Safety Population, comprised of all randomized participants who received at least one dose of study medication.
Infections and infestations Pneumonia	2.6% 5/192 Serious adverse events (SAEs) and adverse events (AEs) were collected in the Safety Population, comprised of all randomized participants who received at least one dose of study medication.	0.52% 1/193 Serious adverse events (SAEs) and adverse events (AEs) were collected in the Safety Population, comprised of all randomized participants who received at least one dose of study medication.
Immune system disorders Hypersensitivity	1.6% 3/192 Serious adverse events (SAEs) and adverse events (AEs) were collected in the Safety Population, comprised of all randomized participants who received at least one dose of study medication.	0.00% 0/193 Serious adverse events (SAEs) and adverse events (AEs) were collected in the Safety Population, comprised of all randomized participants who received at least one dose of study medication.
Infections and infestations Gastroenteritis	1.0% 2/192 Serious adverse events (SAEs) and adverse events (AEs) were collected in the Safety Population, comprised of all randomized participants who received at least one dose of study medication.	0.00% 0/193 Serious adverse events (SAEs) and adverse events (AEs) were collected in the Safety Population, comprised of all randomized participants who received at least one dose of study medication.
Immune system disorders Immune reconstitution syndrome	1.0% 2/192 Serious adverse events (SAEs) and adverse events (AEs) were collected in the Safety Population, comprised of all randomized participants who received at least one dose of study medication.	0.00% 0/193 Serious adverse events (SAEs) and adverse events (AEs) were collected in the Safety Population, comprised of all randomized participants who received at least one dose of study medication.
Infections and infestations Lower respiratory tract infection	0.52% 1/192 Serious adverse events (SAEs) and adverse events (AEs) were collected in the Safety Population, comprised of all randomized participants who received at least one dose of study medication.	0.52% 1/193 Serious adverse events (SAEs) and adverse events (AEs) were collected in the Safety Population, comprised of all randomized participants who received at least one dose of study medication.
Infections and infestations Pulmonary tuberculosis	0.52% 1/192 Serious adverse events (SAEs) and adverse events (AEs) were collected in the Safety Population, comprised of all randomized participants who received at least one dose of study medication.	0.52% 1/193 Serious adverse events (SAEs) and adverse events (AEs) were collected in the Safety Population, comprised of all randomized participants who received at least one dose of study medication.
Infections and infestations Abscess limb	0.00% 0/192 Serious adverse events (SAEs) and adverse events (AEs) were collected in the Safety Population, comprised of all randomized participants who received at least one dose of study medication.	0.52% 1/193 Serious adverse events (SAEs) and adverse events (AEs) were collected in the Safety Population, comprised of all randomized participants who received at least one dose of study medication.
Infections and infestations Endocarditis	0.00% 0/192 Serious adverse events (SAEs) and adverse events (AEs) were collected in the Safety Population, comprised of all randomized participants who received at least one dose of study medication.	0.52% 1/193 Serious adverse events (SAEs) and adverse events (AEs) were collected in the Safety Population, comprised of all randomized participants who received at least one dose of study medication.
Infections and infestations Erysipelas	0.52% 1/192 Serious adverse events (SAEs) and adverse events (AEs) were collected in the Safety Population, comprised of all randomized participants who received at least one dose of study medication.	0.00% 0/193 Serious adverse events (SAEs) and adverse events (AEs) were collected in the Safety Population, comprised of all randomized participants who received at least one dose of study medication.
Infections and infestations Eye infection toxoplasmal	0.52% 1/192 Serious adverse events (SAEs) and adverse events (AEs) were collected in the Safety Population, comprised of all randomized participants who received at least one dose of study medication.	0.00% 0/193 Serious adverse events (SAEs) and adverse events (AEs) were collected in the Safety Population, comprised of all randomized participants who received at least one dose of study medication.
Infections and infestations Herpes Zoster	0.52% 1/192 Serious adverse events (SAEs) and adverse events (AEs) were collected in the Safety Population, comprised of all randomized participants who received at least one dose of study medication.	0.00% 0/193 Serious adverse events (SAEs) and adverse events (AEs) were collected in the Safety Population, comprised of all randomized participants who received at least one dose of study medication.
Infections and infestations Scrotal abscess	0.52% 1/192 Serious adverse events (SAEs) and adverse events (AEs) were collected in the Safety Population, comprised of all randomized participants who received at least one dose of study medication.	0.00% 0/193 Serious adverse events (SAEs) and adverse events (AEs) were collected in the Safety Population, comprised of all randomized participants who received at least one dose of study medication.
Infections and infestations Staphylococcal abscess	0.00% 0/192 Serious adverse events (SAEs) and adverse events (AEs) were collected in the Safety Population, comprised of all randomized participants who received at least one dose of study medication.	0.52% 1/193 Serious adverse events (SAEs) and adverse events (AEs) were collected in the Safety Population, comprised of all randomized participants who received at least one dose of study medication.
Infections and infestations Tuberculosis	0.52% 1/192 Serious adverse events (SAEs) and adverse events (AEs) were collected in the Safety Population, comprised of all randomized participants who received at least one dose of study medication.	0.00% 0/193 Serious adverse events (SAEs) and adverse events (AEs) were collected in the Safety Population, comprised of all randomized participants who received at least one dose of study medication.
Infections and infestations Viral infection	0.52% 1/192 Serious adverse events (SAEs) and adverse events (AEs) were collected in the Safety Population, comprised of all randomized participants who received at least one dose of study medication.	0.00% 0/193 Serious adverse events (SAEs) and adverse events (AEs) were collected in the Safety Population, comprised of all randomized participants who received at least one dose of study medication.
Injury, poisoning and procedural complications Accidental overdose	0.52% 1/192 Serious adverse events (SAEs) and adverse events (AEs) were collected in the Safety Population, comprised of all randomized participants who received at least one dose of study medication.	0.00% 0/193 Serious adverse events (SAEs) and adverse events (AEs) were collected in the Safety Population, comprised of all randomized participants who received at least one dose of study medication.
Injury, poisoning and procedural complications Ankle fracture	0.00% 0/192 Serious adverse events (SAEs) and adverse events (AEs) were collected in the Safety Population, comprised of all randomized participants who received at least one dose of study medication.	0.52% 1/193 Serious adverse events (SAEs) and adverse events (AEs) were collected in the Safety Population, comprised of all randomized participants who received at least one dose of study medication.
Injury, poisoning and procedural complications Forearm fracture	0.00% 0/192 Serious adverse events (SAEs) and adverse events (AEs) were collected in the Safety Population, comprised of all randomized participants who received at least one dose of study medication.	0.52% 1/193 Serious adverse events (SAEs) and adverse events (AEs) were collected in the Safety Population, comprised of all randomized participants who received at least one dose of study medication.
Injury, poisoning and procedural complications Humerus fracture	0.00% 0/192 Serious adverse events (SAEs) and adverse events (AEs) were collected in the Safety Population, comprised of all randomized participants who received at least one dose of study medication.	0.52% 1/193 Serious adverse events (SAEs) and adverse events (AEs) were collected in the Safety Population, comprised of all randomized participants who received at least one dose of study medication.
Injury, poisoning and procedural complications Meniscus lesion	0.52% 1/192 Serious adverse events (SAEs) and adverse events (AEs) were collected in the Safety Population, comprised of all randomized participants who received at least one dose of study medication.	0.00% 0/193 Serious adverse events (SAEs) and adverse events (AEs) were collected in the Safety Population, comprised of all randomized participants who received at least one dose of study medication.
Gastrointestinal disorders Abdominal hernia	0.52% 1/192 Serious adverse events (SAEs) and adverse events (AEs) were collected in the Safety Population, comprised of all randomized participants who received at least one dose of study medication.	0.00% 0/193 Serious adverse events (SAEs) and adverse events (AEs) were collected in the Safety Population, comprised of all randomized participants who received at least one dose of study medication.
Gastrointestinal disorders Diverticulum	0.52% 1/192 Serious adverse events (SAEs) and adverse events (AEs) were collected in the Safety Population, comprised of all randomized participants who received at least one dose of study medication.	0.00% 0/193 Serious adverse events (SAEs) and adverse events (AEs) were collected in the Safety Population, comprised of all randomized participants who received at least one dose of study medication.
Gastrointestinal disorders Gastritis	0.52% 1/192 Serious adverse events (SAEs) and adverse events (AEs) were collected in the Safety Population, comprised of all randomized participants who received at least one dose of study medication.	0.00% 0/193 Serious adverse events (SAEs) and adverse events (AEs) were collected in the Safety Population, comprised of all randomized participants who received at least one dose of study medication.
Gastrointestinal disorders Rectal haemorrhage	0.52% 1/192 Serious adverse events (SAEs) and adverse events (AEs) were collected in the Safety Population, comprised of all randomized participants who received at least one dose of study medication.	0.00% 0/193 Serious adverse events (SAEs) and adverse events (AEs) were collected in the Safety Population, comprised of all randomized participants who received at least one dose of study medication.
Hepatobiliary disorders Cholecystitis	0.52% 1/192 Serious adverse events (SAEs) and adverse events (AEs) were collected in the Safety Population, comprised of all randomized participants who received at least one dose of study medication.	0.00% 0/193 Serious adverse events (SAEs) and adverse events (AEs) were collected in the Safety Population, comprised of all randomized participants who received at least one dose of study medication.
Hepatobiliary disorders Cholelithiasis	0.52% 1/192 Serious adverse events (SAEs) and adverse events (AEs) were collected in the Safety Population, comprised of all randomized participants who received at least one dose of study medication.	0.00% 0/193 Serious adverse events (SAEs) and adverse events (AEs) were collected in the Safety Population, comprised of all randomized participants who received at least one dose of study medication.
Hepatobiliary disorders Cholestasis	0.00% 0/192 Serious adverse events (SAEs) and adverse events (AEs) were collected in the Safety Population, comprised of all randomized participants who received at least one dose of study medication.	0.52% 1/193 Serious adverse events (SAEs) and adverse events (AEs) were collected in the Safety Population, comprised of all randomized participants who received at least one dose of study medication.
Hepatobiliary disorders Cytolytic hepatitis	0.00% 0/192 Serious adverse events (SAEs) and adverse events (AEs) were collected in the Safety Population, comprised of all randomized participants who received at least one dose of study medication.	0.52% 1/193 Serious adverse events (SAEs) and adverse events (AEs) were collected in the Safety Population, comprised of all randomized participants who received at least one dose of study medication.
Hepatobiliary disorders Hepatitis	0.00% 0/192 Serious adverse events (SAEs) and adverse events (AEs) were collected in the Safety Population, comprised of all randomized participants who received at least one dose of study medication.	0.52% 1/193 Serious adverse events (SAEs) and adverse events (AEs) were collected in the Safety Population, comprised of all randomized participants who received at least one dose of study medication.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Burkitt's lymphoma	0.00% 0/192 Serious adverse events (SAEs) and adverse events (AEs) were collected in the Safety Population, comprised of all randomized participants who received at least one dose of study medication.	0.52% 1/193 Serious adverse events (SAEs) and adverse events (AEs) were collected in the Safety Population, comprised of all randomized participants who received at least one dose of study medication.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lymphoma	0.00% 0/192 Serious adverse events (SAEs) and adverse events (AEs) were collected in the Safety Population, comprised of all randomized participants who received at least one dose of study medication.	0.52% 1/193 Serious adverse events (SAEs) and adverse events (AEs) were collected in the Safety Population, comprised of all randomized participants who received at least one dose of study medication.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Thymoma	0.52% 1/192 Serious adverse events (SAEs) and adverse events (AEs) were collected in the Safety Population, comprised of all randomized participants who received at least one dose of study medication.	0.00% 0/193 Serious adverse events (SAEs) and adverse events (AEs) were collected in the Safety Population, comprised of all randomized participants who received at least one dose of study medication.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/192 Serious adverse events (SAEs) and adverse events (AEs) were collected in the Safety Population, comprised of all randomized participants who received at least one dose of study medication.	0.52% 1/193 Serious adverse events (SAEs) and adverse events (AEs) were collected in the Safety Population, comprised of all randomized participants who received at least one dose of study medication.
Musculoskeletal and connective tissue disorders Osteoarthritis	0.00% 0/192 Serious adverse events (SAEs) and adverse events (AEs) were collected in the Safety Population, comprised of all randomized participants who received at least one dose of study medication.	0.52% 1/193 Serious adverse events (SAEs) and adverse events (AEs) were collected in the Safety Population, comprised of all randomized participants who received at least one dose of study medication.
Nervous system disorders Convulsion	0.52% 1/192 Serious adverse events (SAEs) and adverse events (AEs) were collected in the Safety Population, comprised of all randomized participants who received at least one dose of study medication.	0.00% 0/193 Serious adverse events (SAEs) and adverse events (AEs) were collected in the Safety Population, comprised of all randomized participants who received at least one dose of study medication.
Nervous system disorders Transient ischaemic attack	0.00% 0/192 Serious adverse events (SAEs) and adverse events (AEs) were collected in the Safety Population, comprised of all randomized participants who received at least one dose of study medication.	0.52% 1/193 Serious adverse events (SAEs) and adverse events (AEs) were collected in the Safety Population, comprised of all randomized participants who received at least one dose of study medication.
Psychiatric disorders Acute stress disorder	0.00% 0/192 Serious adverse events (SAEs) and adverse events (AEs) were collected in the Safety Population, comprised of all randomized participants who received at least one dose of study medication.	0.52% 1/193 Serious adverse events (SAEs) and adverse events (AEs) were collected in the Safety Population, comprised of all randomized participants who received at least one dose of study medication.
Psychiatric disorders Apathy	0.00% 0/192 Serious adverse events (SAEs) and adverse events (AEs) were collected in the Safety Population, comprised of all randomized participants who received at least one dose of study medication.	0.52% 1/193 Serious adverse events (SAEs) and adverse events (AEs) were collected in the Safety Population, comprised of all randomized participants who received at least one dose of study medication.
Blood and lymphatic system disorders Neutropenia	0.52% 1/192 Serious adverse events (SAEs) and adverse events (AEs) were collected in the Safety Population, comprised of all randomized participants who received at least one dose of study medication.	0.00% 0/193 Serious adverse events (SAEs) and adverse events (AEs) were collected in the Safety Population, comprised of all randomized participants who received at least one dose of study medication.
Cardiac disorders Acute myocardial infarction	0.00% 0/192 Serious adverse events (SAEs) and adverse events (AEs) were collected in the Safety Population, comprised of all randomized participants who received at least one dose of study medication.	0.52% 1/193 Serious adverse events (SAEs) and adverse events (AEs) were collected in the Safety Population, comprised of all randomized participants who received at least one dose of study medication.
Congenital, familial and genetic disorders Porphyria non-acute	0.52% 1/192 Serious adverse events (SAEs) and adverse events (AEs) were collected in the Safety Population, comprised of all randomized participants who received at least one dose of study medication.	0.00% 0/193 Serious adverse events (SAEs) and adverse events (AEs) were collected in the Safety Population, comprised of all randomized participants who received at least one dose of study medication.
Endocrine disorders Goitre	0.00% 0/192 Serious adverse events (SAEs) and adverse events (AEs) were collected in the Safety Population, comprised of all randomized participants who received at least one dose of study medication.	0.52% 1/193 Serious adverse events (SAEs) and adverse events (AEs) were collected in the Safety Population, comprised of all randomized participants who received at least one dose of study medication.
General disorders Pyrexia	0.52% 1/192 Serious adverse events (SAEs) and adverse events (AEs) were collected in the Safety Population, comprised of all randomized participants who received at least one dose of study medication.	0.00% 0/193 Serious adverse events (SAEs) and adverse events (AEs) were collected in the Safety Population, comprised of all randomized participants who received at least one dose of study medication.
Investigations Cardiac murmur	0.52% 1/192 Serious adverse events (SAEs) and adverse events (AEs) were collected in the Safety Population, comprised of all randomized participants who received at least one dose of study medication.	0.00% 0/193 Serious adverse events (SAEs) and adverse events (AEs) were collected in the Safety Population, comprised of all randomized participants who received at least one dose of study medication.
Metabolism and nutrition disorders Dehydration	0.52% 1/192 Serious adverse events (SAEs) and adverse events (AEs) were collected in the Safety Population, comprised of all randomized participants who received at least one dose of study medication.	0.00% 0/193 Serious adverse events (SAEs) and adverse events (AEs) were collected in the Safety Population, comprised of all randomized participants who received at least one dose of study medication.
Renal and urinary disorders Renal failure	0.52% 1/192 Serious adverse events (SAEs) and adverse events (AEs) were collected in the Safety Population, comprised of all randomized participants who received at least one dose of study medication.	0.00% 0/193 Serious adverse events (SAEs) and adverse events (AEs) were collected in the Safety Population, comprised of all randomized participants who received at least one dose of study medication.
Reproductive system and breast disorders Epididymitis	0.00% 0/192 Serious adverse events (SAEs) and adverse events (AEs) were collected in the Safety Population, comprised of all randomized participants who received at least one dose of study medication.	0.52% 1/193 Serious adverse events (SAEs) and adverse events (AEs) were collected in the Safety Population, comprised of all randomized participants who received at least one dose of study medication.
Respiratory, thoracic and mediastinal disorders Asthma	0.52% 1/192 Serious adverse events (SAEs) and adverse events (AEs) were collected in the Safety Population, comprised of all randomized participants who received at least one dose of study medication.	0.00% 0/193 Serious adverse events (SAEs) and adverse events (AEs) were collected in the Safety Population, comprised of all randomized participants who received at least one dose of study medication.
Skin and subcutaneous tissue disorders Rash maculo-papular	0.52% 1/192 Serious adverse events (SAEs) and adverse events (AEs) were collected in the Safety Population, comprised of all randomized participants who received at least one dose of study medication.	0.00% 0/193 Serious adverse events (SAEs) and adverse events (AEs) were collected in the Safety Population, comprised of all randomized participants who received at least one dose of study medication.

Other adverse events

Measure	ABC/3TC FDC n=192 participants at risk Abacavir (ABC) 600 mg/lamivudine (3TC) 300 mg fixed dose combination (FDC) once daily (QD) plus 600 mg efavirenz QD	TDF/FTC FDC n=193 participants at risk Tenofovir (TDF) 300 mg/emtricitabine (FTC) 200 mg FDC once daily (QD) plus 600 mg efavirenz QD
Infections and infestations Nasopharyngitis	20.3% 39/192 Serious adverse events (SAEs) and adverse events (AEs) were collected in the Safety Population, comprised of all randomized participants who received at least one dose of study medication.	18.7% 36/193 Serious adverse events (SAEs) and adverse events (AEs) were collected in the Safety Population, comprised of all randomized participants who received at least one dose of study medication.
Infections and infestations Influenza	6.2% 12/192 Serious adverse events (SAEs) and adverse events (AEs) were collected in the Safety Population, comprised of all randomized participants who received at least one dose of study medication.	7.3% 14/193 Serious adverse events (SAEs) and adverse events (AEs) were collected in the Safety Population, comprised of all randomized participants who received at least one dose of study medication.
Nervous system disorders Dizziness	25.0% 48/192 Serious adverse events (SAEs) and adverse events (AEs) were collected in the Safety Population, comprised of all randomized participants who received at least one dose of study medication.	24.9% 48/193 Serious adverse events (SAEs) and adverse events (AEs) were collected in the Safety Population, comprised of all randomized participants who received at least one dose of study medication.
Nervous system disorders Headache	8.9% 17/192 Serious adverse events (SAEs) and adverse events (AEs) were collected in the Safety Population, comprised of all randomized participants who received at least one dose of study medication.	15.0% 29/193 Serious adverse events (SAEs) and adverse events (AEs) were collected in the Safety Population, comprised of all randomized participants who received at least one dose of study medication.
Psychiatric disorders Abnormal dreams	12.0% 23/192 Serious adverse events (SAEs) and adverse events (AEs) were collected in the Safety Population, comprised of all randomized participants who received at least one dose of study medication.	11.4% 22/193 Serious adverse events (SAEs) and adverse events (AEs) were collected in the Safety Population, comprised of all randomized participants who received at least one dose of study medication.
Psychiatric disorders Insomnia	10.9% 21/192 Serious adverse events (SAEs) and adverse events (AEs) were collected in the Safety Population, comprised of all randomized participants who received at least one dose of study medication.	9.3% 18/193 Serious adverse events (SAEs) and adverse events (AEs) were collected in the Safety Population, comprised of all randomized participants who received at least one dose of study medication.
Psychiatric disorders Sleep disorder	7.3% 14/192 Serious adverse events (SAEs) and adverse events (AEs) were collected in the Safety Population, comprised of all randomized participants who received at least one dose of study medication.	8.3% 16/193 Serious adverse events (SAEs) and adverse events (AEs) were collected in the Safety Population, comprised of all randomized participants who received at least one dose of study medication.
Psychiatric disorders Depression	7.3% 14/192 Serious adverse events (SAEs) and adverse events (AEs) were collected in the Safety Population, comprised of all randomized participants who received at least one dose of study medication.	7.8% 15/193 Serious adverse events (SAEs) and adverse events (AEs) were collected in the Safety Population, comprised of all randomized participants who received at least one dose of study medication.
Gastrointestinal disorders Diarrhoea	18.8% 36/192 Serious adverse events (SAEs) and adverse events (AEs) were collected in the Safety Population, comprised of all randomized participants who received at least one dose of study medication.	14.0% 27/193 Serious adverse events (SAEs) and adverse events (AEs) were collected in the Safety Population, comprised of all randomized participants who received at least one dose of study medication.
Gastrointestinal disorders Nausea	8.9% 17/192 Serious adverse events (SAEs) and adverse events (AEs) were collected in the Safety Population, comprised of all randomized participants who received at least one dose of study medication.	8.3% 16/193 Serious adverse events (SAEs) and adverse events (AEs) were collected in the Safety Population, comprised of all randomized participants who received at least one dose of study medication.
Gastrointestinal disorders Vomiting	6.2% 12/192 Serious adverse events (SAEs) and adverse events (AEs) were collected in the Safety Population, comprised of all randomized participants who received at least one dose of study medication.	5.7% 11/193 Serious adverse events (SAEs) and adverse events (AEs) were collected in the Safety Population, comprised of all randomized participants who received at least one dose of study medication.
Skin and subcutaneous tissue disorders Rash	9.4% 18/192 Serious adverse events (SAEs) and adverse events (AEs) were collected in the Safety Population, comprised of all randomized participants who received at least one dose of study medication.	10.4% 20/193 Serious adverse events (SAEs) and adverse events (AEs) were collected in the Safety Population, comprised of all randomized participants who received at least one dose of study medication.
General disorders Fatigue	7.3% 14/192 Serious adverse events (SAEs) and adverse events (AEs) were collected in the Safety Population, comprised of all randomized participants who received at least one dose of study medication.	8.3% 16/193 Serious adverse events (SAEs) and adverse events (AEs) were collected in the Safety Population, comprised of all randomized participants who received at least one dose of study medication.
Musculoskeletal and connective tissue disorders Back pain	5.7% 11/192 Serious adverse events (SAEs) and adverse events (AEs) were collected in the Safety Population, comprised of all randomized participants who received at least one dose of study medication.	8.3% 16/193 Serious adverse events (SAEs) and adverse events (AEs) were collected in the Safety Population, comprised of all randomized participants who received at least one dose of study medication.
Respiratory, thoracic and mediastinal disorders Cough	8.9% 17/192 Serious adverse events (SAEs) and adverse events (AEs) were collected in the Safety Population, comprised of all randomized participants who received at least one dose of study medication.	6.7% 13/193 Serious adverse events (SAEs) and adverse events (AEs) were collected in the Safety Population, comprised of all randomized participants who received at least one dose of study medication.
Investigations Bone density decreased	2.6% 5/192 Serious adverse events (SAEs) and adverse events (AEs) were collected in the Safety Population, comprised of all randomized participants who received at least one dose of study medication.	7.8% 15/193 Serious adverse events (SAEs) and adverse events (AEs) were collected in the Safety Population, comprised of all randomized participants who received at least one dose of study medication.

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