Trial Outcomes & Findings for Tenofovir Disoproxil Fumarate/Emtricitabine/Efavirenz Versus Combivir/Efavirenz in Antiretroviral-Naive HIV-1 Infected Subjects (NCT NCT00112047)

NCT ID: NCT00112047

Last Updated: 2010-10-13

Results Overview

Participants who achieved/maintained confirmed HIV-1 RNA \< 400 c/mL had to satisfy the following criteria: 1) not experienced death, permanent study drug discontinuation, or addition of new antiretroviral drug except nevirapine in place of EFV prior to Week 48 visit; 2) achieved confirmed HIV-1 RNA \< 400 c/mL on 2 consecutive visits prior to Week 48 visit (ie, the first of the 2 consecutive HIV-1 RNA \< 400 c/mL occurred prior to the Week 48 visit; 3) not had confirmed HIV-1 RNA \> 400 c/mL after achievement of confirmed HIV RNA levels \< 400 c/mL prior to Week 48 visit.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 517 participants
• Primary outcome timeframe: 48 weeks
• Results posted on: 2010-10-13

Participant Flow

Participants were enrolled at 70 study sites in the United States and Europe. The first participant was screened on 29 July 2003; the last participant was randomized on 16 January 2004; the last participant observation for the primary endpoint analysis was 11 February 2005; the last participant last visit for end of study analysis was 10 June 2009.

Of the 517 enrolled participants, 6 received no study drug (the safety analysis set was therefore 511 participants: 257 [efavirenz+emtricitabine+tenofovir disoproxil fumarate group] and 254 [efavirenz+combivir group], respectively).

Participant milestones

Measure	EFV+FTC+TDF Participants in this group received 3 component drugs: efavirenz (EFV) 600 mg + emtricitabine (FTC) 200 mg + tenofovir disoproxil fumarate (tenofovir DF; TDF) 300 mg, each once daily, from the start of the study. At 96 weeks Truvada (\[TVD\] the fixed-dose combination pill containing FTC/TDF (200 mg/300 mg) replaced FTC + TDF; participants continued to receive EFV as before. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated central nervous system (CNS) toxicity. At Week 144 all participants who opted to roll over into the further 96-week study extension received Atripla (\[ATR\]; the fixed dose combination pill containing EFV/FTC/TDF, 600 mg/200 mg/300 mg) until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study.	CBV+EFV Participants in this group received EFV 600 mg once daily + Combivir (\[CBV\]; the fixed dose combination pill containing lamivudine + zidovudine \[150 mg/300 mg\]) twice daily from the start of the study until Week 144. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated CNS toxicity. At Week 144 all participants who opted to roll over into the additional 96-week study extension received ATR until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study.
Randomized Phase STARTED	257	254
Randomized Phase COMPLETED	187	166
Randomized Phase NOT COMPLETED	70	88
Atripla Phase STARTED	160	126
Atripla Phase COMPLETED	142	106
Atripla Phase NOT COMPLETED	18	20

Reasons for withdrawal

Measure	EFV+FTC+TDF Participants in this group received 3 component drugs: efavirenz (EFV) 600 mg + emtricitabine (FTC) 200 mg + tenofovir disoproxil fumarate (tenofovir DF; TDF) 300 mg, each once daily, from the start of the study. At 96 weeks Truvada (\[TVD\] the fixed-dose combination pill containing FTC/TDF (200 mg/300 mg) replaced FTC + TDF; participants continued to receive EFV as before. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated central nervous system (CNS) toxicity. At Week 144 all participants who opted to roll over into the further 96-week study extension received Atripla (\[ATR\]; the fixed dose combination pill containing EFV/FTC/TDF, 600 mg/200 mg/300 mg) until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study.	CBV+EFV Participants in this group received EFV 600 mg once daily + Combivir (\[CBV\]; the fixed dose combination pill containing lamivudine + zidovudine \[150 mg/300 mg\]) twice daily from the start of the study until Week 144. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated CNS toxicity. At Week 144 all participants who opted to roll over into the additional 96-week study extension received ATR until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study.
Randomized Phase Lost to Follow-up	26	33
Randomized Phase Adverse Event	10	10
Randomized Phase Withrawal of consent	10	18
Randomized Phase Sub-optimal virological response	3	13
Randomized Phase Noncompliance	8	4
Randomized Phase Protocol Violation	2	0
Randomized Phase Pregnancy	3	1
Randomized Phase Death	1	3
Randomized Phase Hepatitis C treatment contraindicated	0	1
Randomized Phase Inability to swallow pills	0	1
Randomized Phase Incarceration	3	2
Randomized Phase Moved out of State	0	1
Randomized Phase Baseline NNRTI resistance mutations	4	0
Randomized Phase High Hepatitis B DNA	0	1
Atripla Phase Adverse Event	2	1
Atripla Phase Lost to Follow-up	5	7
Atripla Phase Pregnancy	0	1
Atripla Phase Death	0	2
Atripla Phase Withdrew consent	7	7
Atripla Phase Sub-optimal virological response	0	1
Atripla Phase Non-compliance	1	0
Atripla Phase Other	3	1

Baseline Characteristics

Tenofovir Disoproxil Fumarate/Emtricitabine/Efavirenz Versus Combivir/Efavirenz in Antiretroviral-Naive HIV-1 Infected Subjects

Baseline characteristics by cohort

Measure	EFV+FTC+TDF n=255 Participants Participants in this group received 3 component drugs: efavirenz (EFV) 600 mg + emtricitabine (FTC) 200 mg + tenofovir disoproxil fumarate (tenofovir DF; TDF) 300 mg, each once daily, from the start of the study. At 96 weeks Truvada (\[TVD\] the fixed-dose combination pill containing FTC/TDF (200 mg/300 mg) replaced FTC + TDF; participants continued to receive EFV as before. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated central nervous system (CNS) toxicity. At Week 144 all participants who opted to roll over into the further 96-week study extension received Atripla (\[ATR\]; the fixed dose combination pill containing EFV/FTC/TDF, 600 mg/200 mg/300 mg) until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study.	CBV+EFV n=254 Participants Participants in this group received EFV 600 mg once daily + Combivir (\[CBV\]; the fixed dose combination pill containing lamivudine + zidovudine \[150 mg/300 mg\]) twice daily from the start of the study until Week 144. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated CNS toxicity. At Week 144 all participants who opted to roll over into the additional 96-week study extension received ATR until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study.	Total n=509 Participants Total of all reporting groups
Age Continuous	38 years STANDARD_DEVIATION 9.9 • n=93 Participants	38 years STANDARD_DEVIATION 9.0 • n=4 Participants	38 years STANDARD_DEVIATION 9.5 • n=27 Participants
Sex: Female, Male Female	36 Participants n=93 Participants	33 Participants n=4 Participants	69 Participants n=27 Participants
Sex: Female, Male Male	219 Participants n=93 Participants	221 Participants n=4 Participants	440 Participants n=27 Participants
Race/Ethnicity, Customized White	142 Participants n=93 Participants	156 Participants n=4 Participants	298 Participants n=27 Participants
Race/Ethnicity, Customized Black	65 Participants n=93 Participants	51 Participants n=4 Participants	116 Participants n=27 Participants
Race/Ethnicity, Customized Hispanic	39 Participants n=93 Participants	40 Participants n=4 Participants	79 Participants n=27 Participants
Race/Ethnicity, Customized Asian	3 Participants n=93 Participants	3 Participants n=4 Participants	6 Participants n=27 Participants
Race/Ethnicity, Customized Not allowed to report	0 Participants n=93 Participants	1 Participants n=4 Participants	1 Participants n=27 Participants
Race/Ethnicity, Customized Other	6 Participants n=93 Participants	3 Participants n=4 Participants	9 Participants n=27 Participants
HIV Status Asymptomatic	33 Participants n=93 Participants	26 Participants n=4 Participants	59 Participants n=27 Participants
HIV Status Symptomatic HIV Infection	117 Participants n=93 Participants	127 Participants n=4 Participants	244 Participants n=27 Participants
HIV Status AIDS	105 Participants n=93 Participants	101 Participants n=4 Participants	206 Participants n=27 Participants
CD4 cell count	246 Cells/mm^3 STANDARD_DEVIATION 171.9 • n=93 Participants	245 Cells/mm^3 STANDARD_DEVIATION 156.6 • n=4 Participants	245 Cells/mm^3 STANDARD_DEVIATION 164.2 • n=27 Participants
HIV-1 RNA	5.03 Log10 c/mL STANDARD_DEVIATION 0.54 • n=93 Participants	5.00 Log10 c/mL STANDARD_DEVIATION 0.51 • n=4 Participants	5.01 Log10 c/mL STANDARD_DEVIATION 0.52 • n=27 Participants

PRIMARY outcome

Timeframe: 48 weeks

Population: Modified intention to treat (MITT) analysis set included all randomized participants who received at least 1 dose of study treatment, no major protocol violations, and no baseline primary NNRTI resistance mutation (2 participants were not ART-naive at study start; 22 participants had NNRTI resistance mutations at baseline \[MITT analysis set: 487\])

Participants who achieved/maintained confirmed HIV-1 RNA < 400 c/mL had to satisfy the following criteria: 1) not experienced death, permanent study drug discontinuation, or addition of new antiretroviral drug except nevirapine in place of EFV prior to Week 48 visit; 2) achieved confirmed HIV-1 RNA < 400 c/mL on 2 consecutive visits prior to Week 48 visit (ie, the first of the 2 consecutive HIV-1 RNA < 400 c/mL occurred prior to the Week 48 visit; 3) not had confirmed HIV-1 RNA > 400 c/mL after achievement of confirmed HIV RNA levels < 400 c/mL prior to Week 48 visit.

Outcome measures

Measure	EFV+FTC+TDF n=244 Participants Participants in this group received 3 component drugs: efavirenz (EFV) 600 mg + emtricitabine (FTC) 200 mg + tenofovir disoproxil fumarate (tenofovir DF; TDF) 300 mg, each once daily, from the start of the study. At 96 weeks Truvada (\[TVD\] the fixed-dose combination pill containing FTC/TDF (200 mg/300 mg) replaced FTC + TDF; participants continued to receive EFV as before. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated central nervous system (CNS) toxicity. At Week 144 all participants who opted to roll over into the further 96-week study extension received Atripla (\[ATR\]; the fixed dose combination pill containing EFV/FTC/TDF, 600 mg/200 mg/300 mg) until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study.	CBV+EFV n=243 Participants Participants in this group received EFV 600 mg once daily + Combivir (\[CBV\]; the fixed dose combination pill containing lamivudine + zidovudine \[150 mg/300 mg\]) twice daily from the start of the study until Week 144. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated CNS toxicity. At Week 144 all participants who opted to roll over into the additional 96-week study extension received ATR until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study.
Percentage of Participants With Confirmed Plasma HIV-1 RNA < 400 c/mL at Week 48 (Defined by the Food and Drug Administration [FDA] Time-to-Loss-of Virologic Response [TLOVR] Algorithm	84.4 Percentage of participants	72.8 Percentage of participants

SECONDARY outcome

Timeframe: Week 48

Population: MITT analysis set included all randomized participants who received at least one dose of study medication, had no major protocol violations, and no baseline primary NNRTI resistance mutations (2 participants were not ART-naive at study start; 22 participants had NNRTI resistance mutations at baseline \[MITT analysis set: 487\])

Participants who achieved/maintained confirmed HIV-1 RNA < 50 c/mL had to satisfy the following criteria: 1) not experienced death, permanent study drug discontinuation, or addition of new antiretroviral drug except nevirapine in place of EFV prior to Week 48 visit; 2) achieved confirmed HIV-1 RNA < 50 c/mL on 2 consecutive visits prior to Week 48 visit (that is, the first of the 2 consecutive HIV-1 RNA < 50 c/mL occurred prior to the Week 48 visit; 3) not had confirmed HIV-1 RNA > 50 c/mL after achievement of confirmed HIV RNA levels < 50 c/mL prior to Week 48 visit.

Outcome measures

Measure	EFV+FTC+TDF n=244 Participants Participants in this group received 3 component drugs: efavirenz (EFV) 600 mg + emtricitabine (FTC) 200 mg + tenofovir disoproxil fumarate (tenofovir DF; TDF) 300 mg, each once daily, from the start of the study. At 96 weeks Truvada (\[TVD\] the fixed-dose combination pill containing FTC/TDF (200 mg/300 mg) replaced FTC + TDF; participants continued to receive EFV as before. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated central nervous system (CNS) toxicity. At Week 144 all participants who opted to roll over into the further 96-week study extension received Atripla (\[ATR\]; the fixed dose combination pill containing EFV/FTC/TDF, 600 mg/200 mg/300 mg) until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study.	CBV+EFV n=243 Participants Participants in this group received EFV 600 mg once daily + Combivir (\[CBV\]; the fixed dose combination pill containing lamivudine + zidovudine \[150 mg/300 mg\]) twice daily from the start of the study until Week 144. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated CNS toxicity. At Week 144 all participants who opted to roll over into the additional 96-week study extension received ATR until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study.
Percentage of Participants With Confirmed Plasma HIV-1 RNA < 50 c/mL at Week 48 (Defined by FDA TLOVR Algorithm)	79.5 Percentage of Participants	70.4 Percentage of Participants

SECONDARY outcome

Timeframe: 48 weeks

Population: Intention to Treat (ITT) analysis set (Missing Observation or Switch in ART=Failure). ITT analysis set included all randomized participants who received at least one dose of study medication, and had no major protocol violations (2 participants were not ART-naive at study start \[ITT analysis set: 509\]).

The percentage of participants with plasma HIV-1 RNA < 400 c/mL at Week 48. Participants with missing observations/changes in ART were considered to have HIV-1 RNA ≥ 400 c/mL (i.e., ITT missing or switch=failure analysis).

Outcome measures

Measure	EFV+FTC+TDF n=255 Participants Participants in this group received 3 component drugs: efavirenz (EFV) 600 mg + emtricitabine (FTC) 200 mg + tenofovir disoproxil fumarate (tenofovir DF; TDF) 300 mg, each once daily, from the start of the study. At 96 weeks Truvada (\[TVD\] the fixed-dose combination pill containing FTC/TDF (200 mg/300 mg) replaced FTC + TDF; participants continued to receive EFV as before. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated central nervous system (CNS) toxicity. At Week 144 all participants who opted to roll over into the further 96-week study extension received Atripla (\[ATR\]; the fixed dose combination pill containing EFV/FTC/TDF, 600 mg/200 mg/300 mg) until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study.	CBV+EFV n=254 Participants Participants in this group received EFV 600 mg once daily + Combivir (\[CBV\]; the fixed dose combination pill containing lamivudine + zidovudine \[150 mg/300 mg\]) twice daily from the start of the study until Week 144. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated CNS toxicity. At Week 144 all participants who opted to roll over into the additional 96-week study extension received ATR until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study.
Percentage of Participants With Plasma HIV-1 RNA < 400 c/mL at Week 48.	80.4 Percentage of Participants	69.3 Percentage of Participants

SECONDARY outcome

Timeframe: 48 Weeks

Population: ITT analysis set (Missing Observation or Switch in ART=Failure). ITT analysis set included all randomized participants who received at least one dose of study medication, and had no major protocol violations (2 participants were not ART-naive at study start \[ITT analysis set: 509\]).

The percentage of participants with plasma HIV-1 RNA < 50 c/mL at Week 48. Participants with missing observations/changes in ART were considered to have HIV-1 RNA ≥ 50 c/mL (i.e., ITT missing or switch=failure analysis).

Outcome measures

Measure	EFV+FTC+TDF n=255 Participants Participants in this group received 3 component drugs: efavirenz (EFV) 600 mg + emtricitabine (FTC) 200 mg + tenofovir disoproxil fumarate (tenofovir DF; TDF) 300 mg, each once daily, from the start of the study. At 96 weeks Truvada (\[TVD\] the fixed-dose combination pill containing FTC/TDF (200 mg/300 mg) replaced FTC + TDF; participants continued to receive EFV as before. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated central nervous system (CNS) toxicity. At Week 144 all participants who opted to roll over into the further 96-week study extension received Atripla (\[ATR\]; the fixed dose combination pill containing EFV/FTC/TDF, 600 mg/200 mg/300 mg) until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study.	CBV+EFV n=254 Participants Participants in this group received EFV 600 mg once daily + Combivir (\[CBV\]; the fixed dose combination pill containing lamivudine + zidovudine \[150 mg/300 mg\]) twice daily from the start of the study until Week 144. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated CNS toxicity. At Week 144 all participants who opted to roll over into the additional 96-week study extension received ATR until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study.
Percentage of Participants With HIV-1 RNA < 50 c/mL at Week 48	74.5 Percentage of Participants	66.9 Percentage of Participants

SECONDARY outcome

Timeframe: Baseline to 48 weeks

Population: ITT analysis set

TLOVR for participants who achieved a confirmed virologic response was the time to the earliest of: premature study regimen discontinuation or the first of 2 consecutive HIV-1 RNA ≥ 400 c/mL or last HIV-1 RNA ≥ 400 c/mL followed by loss to follow-up. If the time to HIV-1 RNA ≥ 400 c/mL was immediately preceded by missing scheduled visits then the time of virologic failure was replaced by the first such missing visit. Participants who had not achieved a confirmed virologic response before regimen discontinuation were considered "non-responders" on Study Day 1.

Outcome measures

Measure	EFV+FTC+TDF n=255 Participants Participants in this group received 3 component drugs: efavirenz (EFV) 600 mg + emtricitabine (FTC) 200 mg + tenofovir disoproxil fumarate (tenofovir DF; TDF) 300 mg, each once daily, from the start of the study. At 96 weeks Truvada (\[TVD\] the fixed-dose combination pill containing FTC/TDF (200 mg/300 mg) replaced FTC + TDF; participants continued to receive EFV as before. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated central nervous system (CNS) toxicity. At Week 144 all participants who opted to roll over into the further 96-week study extension received Atripla (\[ATR\]; the fixed dose combination pill containing EFV/FTC/TDF, 600 mg/200 mg/300 mg) until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study.	CBV+EFV n=254 Participants Participants in this group received EFV 600 mg once daily + Combivir (\[CBV\]; the fixed dose combination pill containing lamivudine + zidovudine \[150 mg/300 mg\]) twice daily from the start of the study until Week 144. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated CNS toxicity. At Week 144 all participants who opted to roll over into the additional 96-week study extension received ATR until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study.
Percentage of Participants With Loss of Virologic Response (HIV-1 RNA < 400 c/mL) at Week 48	19 Percentage of Participants	30 Percentage of Participants

SECONDARY outcome

Timeframe: Baseline to 48 Weeks

Population: ITT analysis set

TLOVR for participants who achieved a confirmed virologic response was the time to the earliest of: premature study regimen discontinuation or the first of 2 consecutive HIV-1 RNA ≥ 50 c/mL or last HIV-1 RNA ≥ 50 c/mL followed by loss to follow-up. If the time to HIV-1 RNA ≥ 50 c/mL was immediately preceded by missing scheduled visits then the time of virologic failure was replaced by the first such missing visit. Participants who had not achieved a confirmed virologic response before regimen discontinuation were considered "non-responders" on Study Day 1.

Outcome measures

Measure	EFV+FTC+TDF n=255 Participants Participants in this group received 3 component drugs: efavirenz (EFV) 600 mg + emtricitabine (FTC) 200 mg + tenofovir disoproxil fumarate (tenofovir DF; TDF) 300 mg, each once daily, from the start of the study. At 96 weeks Truvada (\[TVD\] the fixed-dose combination pill containing FTC/TDF (200 mg/300 mg) replaced FTC + TDF; participants continued to receive EFV as before. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated central nervous system (CNS) toxicity. At Week 144 all participants who opted to roll over into the further 96-week study extension received Atripla (\[ATR\]; the fixed dose combination pill containing EFV/FTC/TDF, 600 mg/200 mg/300 mg) until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study.	CBV+EFV n=254 Participants Participants in this group received EFV 600 mg once daily + Combivir (\[CBV\]; the fixed dose combination pill containing lamivudine + zidovudine \[150 mg/300 mg\]) twice daily from the start of the study until Week 144. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated CNS toxicity. At Week 144 all participants who opted to roll over into the additional 96-week study extension received ATR until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study.
Percentage of Participants With Loss of Virologic Response (HIV-1 RNA < 50 c/mL) at Week 48	23 Percentage of Participants	32 Percentage of Participants

SECONDARY outcome

Timeframe: Baseline to 48 Weeks

Population: ITT analysis set

Participants who achieved confirmed HIV-1 RNA < 400 c/mL but had not experienced a confirmed relapse were considered censored at the last HIV-1 RNA collection date.

Outcome measures

Measure	EFV+FTC+TDF n=255 Participants Participants in this group received 3 component drugs: efavirenz (EFV) 600 mg + emtricitabine (FTC) 200 mg + tenofovir disoproxil fumarate (tenofovir DF; TDF) 300 mg, each once daily, from the start of the study. At 96 weeks Truvada (\[TVD\] the fixed-dose combination pill containing FTC/TDF (200 mg/300 mg) replaced FTC + TDF; participants continued to receive EFV as before. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated central nervous system (CNS) toxicity. At Week 144 all participants who opted to roll over into the further 96-week study extension received Atripla (\[ATR\]; the fixed dose combination pill containing EFV/FTC/TDF, 600 mg/200 mg/300 mg) until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study.	CBV+EFV n=254 Participants Participants in this group received EFV 600 mg once daily + Combivir (\[CBV\]; the fixed dose combination pill containing lamivudine + zidovudine \[150 mg/300 mg\]) twice daily from the start of the study until Week 144. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated CNS toxicity. At Week 144 all participants who opted to roll over into the additional 96-week study extension received ATR until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study.
Percentage of Participants With Pure Virologic Failure (HIV-1 RNA < 400 c/mL) at Week 48	9 Percentage of Participants	16 Percentage of Participants

SECONDARY outcome

Timeframe: Baseline to 48 Weeks

Population: ITT analysis set

Participants who achieved confirmed HIV-1 RNA < 50 c/mL but had not experienced a confirmed relapse were considered censored at the last HIV-1 RNA collection date.

Outcome measures

Measure	EFV+FTC+TDF n=255 Participants Participants in this group received 3 component drugs: efavirenz (EFV) 600 mg + emtricitabine (FTC) 200 mg + tenofovir disoproxil fumarate (tenofovir DF; TDF) 300 mg, each once daily, from the start of the study. At 96 weeks Truvada (\[TVD\] the fixed-dose combination pill containing FTC/TDF (200 mg/300 mg) replaced FTC + TDF; participants continued to receive EFV as before. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated central nervous system (CNS) toxicity. At Week 144 all participants who opted to roll over into the further 96-week study extension received Atripla (\[ATR\]; the fixed dose combination pill containing EFV/FTC/TDF, 600 mg/200 mg/300 mg) until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study.	CBV+EFV n=254 Participants Participants in this group received EFV 600 mg once daily + Combivir (\[CBV\]; the fixed dose combination pill containing lamivudine + zidovudine \[150 mg/300 mg\]) twice daily from the start of the study until Week 144. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated CNS toxicity. At Week 144 all participants who opted to roll over into the additional 96-week study extension received ATR until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study.
Percentage of Participants With Pure Virologic Failure (HIV-1 RNA < 50 c/mL) at Week 48	16 Percentage of participants	24 Percentage of participants

SECONDARY outcome

Timeframe: Study baseline to Week 48

Population: As treated (AT) analysis set included all participants who received at least one dose of study medication and had not committed any major protocol violation.

Change from study baseline to Week 48 in HIV-1 RNA in log10 scale (Week 48 HIV-1 RNA value in log10 scale minus study baseline HIV-1 RNA value in log10 scale).

Outcome measures

Measure	EFV+FTC+TDF n=201 Participants Participants in this group received 3 component drugs: efavirenz (EFV) 600 mg + emtricitabine (FTC) 200 mg + tenofovir disoproxil fumarate (tenofovir DF; TDF) 300 mg, each once daily, from the start of the study. At 96 weeks Truvada (\[TVD\] the fixed-dose combination pill containing FTC/TDF (200 mg/300 mg) replaced FTC + TDF; participants continued to receive EFV as before. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated central nervous system (CNS) toxicity. At Week 144 all participants who opted to roll over into the further 96-week study extension received Atripla (\[ATR\]; the fixed dose combination pill containing EFV/FTC/TDF, 600 mg/200 mg/300 mg) until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study.	CBV+EFV n=172 Participants Participants in this group received EFV 600 mg once daily + Combivir (\[CBV\]; the fixed dose combination pill containing lamivudine + zidovudine \[150 mg/300 mg\]) twice daily from the start of the study until Week 144. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated CNS toxicity. At Week 144 all participants who opted to roll over into the additional 96-week study extension received ATR until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study.
Change From Study Baseline in HIV-1 RNA (Log10 c/mL) at Week 48	-3.31 Log10 c/mL Standard Deviation 0.54	-3.26 Log10 c/mL Standard Deviation 0.58

SECONDARY outcome

Timeframe: Study baseline to Week 48

Population: AT analysis set included all participants who received at least one dose of study medication and had not committed any major protocol violation.

Change from study baseline to Week 48 in CD4 cell count = Week 48 CD4 cell count value minus study baseline CD4 cell count value

Outcome measures

Measure	EFV+FTC+TDF n=199 Participants Participants in this group received 3 component drugs: efavirenz (EFV) 600 mg + emtricitabine (FTC) 200 mg + tenofovir disoproxil fumarate (tenofovir DF; TDF) 300 mg, each once daily, from the start of the study. At 96 weeks Truvada (\[TVD\] the fixed-dose combination pill containing FTC/TDF (200 mg/300 mg) replaced FTC + TDF; participants continued to receive EFV as before. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated central nervous system (CNS) toxicity. At Week 144 all participants who opted to roll over into the further 96-week study extension received Atripla (\[ATR\]; the fixed dose combination pill containing EFV/FTC/TDF, 600 mg/200 mg/300 mg) until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study.	CBV+EFV n=164 Participants Participants in this group received EFV 600 mg once daily + Combivir (\[CBV\]; the fixed dose combination pill containing lamivudine + zidovudine \[150 mg/300 mg\]) twice daily from the start of the study until Week 144. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated CNS toxicity. At Week 144 all participants who opted to roll over into the additional 96-week study extension received ATR until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study.
Change From Study Baseline in CD4 Cell Count (Cells/mm^3) at Week 48	190 CD4 Cell Count (cells/mm^3) Standard Deviation 111.7	158 CD4 Cell Count (cells/mm^3) Standard Deviation 107.3

SECONDARY outcome

Timeframe: 96 Weeks

Population: Week 96 efficacy analysis set excludes Week 48 responders who did not consent after Week 48 visits from MITT analysis set (Week 96 efficacy analysis set: \[463\])

Participants who achieved/maintained confirmed HIV-1 RNA < 400 c/mL had to satisfy the following criteria: 1) not experienced death, permanent study drug discontinuation, or addition of new antiretroviral drug except nevirapine in place of EFV prior to Week 96 visit; 2) achieved confirmed HIV-1 RNA < 400 c/mL on 2 consecutive visits prior to Week 96 visit (that is, the first of the 2 consecutive HIV-1 RNA < 400 c/mL occurred prior to the Week 96 visit; 3) not had confirmed HIV-1 RNA > 400 c/mL after achievement of confirmed HIV RNA levels < 400 c/mL prior to Week 96 visit.

Outcome measures

Measure	EFV+FTC+TDF n=232 Participants Participants in this group received 3 component drugs: efavirenz (EFV) 600 mg + emtricitabine (FTC) 200 mg + tenofovir disoproxil fumarate (tenofovir DF; TDF) 300 mg, each once daily, from the start of the study. At 96 weeks Truvada (\[TVD\] the fixed-dose combination pill containing FTC/TDF (200 mg/300 mg) replaced FTC + TDF; participants continued to receive EFV as before. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated central nervous system (CNS) toxicity. At Week 144 all participants who opted to roll over into the further 96-week study extension received Atripla (\[ATR\]; the fixed dose combination pill containing EFV/FTC/TDF, 600 mg/200 mg/300 mg) until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study.	CBV+EFV n=231 Participants Participants in this group received EFV 600 mg once daily + Combivir (\[CBV\]; the fixed dose combination pill containing lamivudine + zidovudine \[150 mg/300 mg\]) twice daily from the start of the study until Week 144. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated CNS toxicity. At Week 144 all participants who opted to roll over into the additional 96-week study extension received ATR until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study.
Percentage of Participants With Confirmed Plasma HIV-1 RNA < 400 c/mL at Week 96 (Defined by FDA TLOVR Algorithm)	74.6 Percentage of Participants	61.9 Percentage of Participants

SECONDARY outcome

Timeframe: Week 96

Population: Week 96 efficacy analysis excludes Week 48 responders who did not consent after Week 48 visits from MITT analysis set (Week 96 efficacy analysis set: \[465\])

Participants who achieved/maintained confirmed HIV-1 RNA < 50 c/mL had to satisfy the following criteria: 1) not experienced death, permanent study drug discontinuation, or addition of new antiretroviral drug except nevirapine in place of EFV prior to Week 96 visit; 2) achieved confirmed HIV-1 RNA < 50 c/mL on 2 consecutive visits prior to Week 96 visit (that is, the first of the 2 consecutive HIV-1 RNA < 50 c/mL occurred prior to the Week 96 visit; 3) not had confirmed HIV-1 RNA > 50 c/mL after achievement of confirmed HIV RNA levels < 50 c/mL prior to Week 96 visit.

Outcome measures

Measure	EFV+FTC+TDF n=232 Participants Participants in this group received 3 component drugs: efavirenz (EFV) 600 mg + emtricitabine (FTC) 200 mg + tenofovir disoproxil fumarate (tenofovir DF; TDF) 300 mg, each once daily, from the start of the study. At 96 weeks Truvada (\[TVD\] the fixed-dose combination pill containing FTC/TDF (200 mg/300 mg) replaced FTC + TDF; participants continued to receive EFV as before. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated central nervous system (CNS) toxicity. At Week 144 all participants who opted to roll over into the further 96-week study extension received Atripla (\[ATR\]; the fixed dose combination pill containing EFV/FTC/TDF, 600 mg/200 mg/300 mg) until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study.	CBV+EFV n=233 Participants Participants in this group received EFV 600 mg once daily + Combivir (\[CBV\]; the fixed dose combination pill containing lamivudine + zidovudine \[150 mg/300 mg\]) twice daily from the start of the study until Week 144. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated CNS toxicity. At Week 144 all participants who opted to roll over into the additional 96-week study extension received ATR until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study.
Percentage of Participants With Confirmed Plasma HIV-1 RNA < 50 c/mL at Week 96 (Defined by FDA TLOVR Algorithm)	67.2 Percentage of Participants	60.9 Percentage of Participants

SECONDARY outcome

Timeframe: Week 96

Population: MITT

TLOVR for participants with confirmed virologic response (2 consecutive HIV-1 RNA < 400 c/mL) prior to study drug discontinuation, was the time to the earliest of premature study regimen discontinuation, or confirmed HIV-1 RNA > 400 c/mL (2 consecutive HIV-1 RNA ≥ 400 c/mL, or the last HIV-1 RNA ≥ 400 c/mL followed by premature study regimen discontinuation due to loss to follow-up). Participants who did not achieve confirmed virologic response before premature study regimen discontinuation or last HIV-1 RNA, were assumed to have lost virologic response on Study Day 1.

Outcome measures

Measure	EFV+FTC+TDF n=244 Participants Participants in this group received 3 component drugs: efavirenz (EFV) 600 mg + emtricitabine (FTC) 200 mg + tenofovir disoproxil fumarate (tenofovir DF; TDF) 300 mg, each once daily, from the start of the study. At 96 weeks Truvada (\[TVD\] the fixed-dose combination pill containing FTC/TDF (200 mg/300 mg) replaced FTC + TDF; participants continued to receive EFV as before. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated central nervous system (CNS) toxicity. At Week 144 all participants who opted to roll over into the further 96-week study extension received Atripla (\[ATR\]; the fixed dose combination pill containing EFV/FTC/TDF, 600 mg/200 mg/300 mg) until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study.	CBV+EFV n=243 Participants Participants in this group received EFV 600 mg once daily + Combivir (\[CBV\]; the fixed dose combination pill containing lamivudine + zidovudine \[150 mg/300 mg\]) twice daily from the start of the study until Week 144. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated CNS toxicity. At Week 144 all participants who opted to roll over into the additional 96-week study extension received ATR until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study.
Percentage of Participants With Loss of Virologic Response (HIV-1 RNA < 400 c/mL) at Week 96	25 Percentage of Participants	37 Percentage of Participants

SECONDARY outcome

Timeframe: Week 96

Population: MITT

TLOVR for participants who achieved a confirmed virologic response was the time to the earliest of: premature study regimen discontinuation or the first of 2 consecutive HIV-1 RNA ≥ 50 c/mL or last HIV-1 RNA ≥ 50 c/mL followed by loss to follow-up. If the time to HIV-1 RNA ≥ 50 c/mL was immediately preceded by missing scheduled visits then the time of virologic failure was replaced by the first such missing visit. Participants who had not achieved a confirmed virologic response before regimen discontinuation were considered "non-responders" on Study Day 1.

Outcome measures

Measure	EFV+FTC+TDF n=244 Participants Participants in this group received 3 component drugs: efavirenz (EFV) 600 mg + emtricitabine (FTC) 200 mg + tenofovir disoproxil fumarate (tenofovir DF; TDF) 300 mg, each once daily, from the start of the study. At 96 weeks Truvada (\[TVD\] the fixed-dose combination pill containing FTC/TDF (200 mg/300 mg) replaced FTC + TDF; participants continued to receive EFV as before. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated central nervous system (CNS) toxicity. At Week 144 all participants who opted to roll over into the further 96-week study extension received Atripla (\[ATR\]; the fixed dose combination pill containing EFV/FTC/TDF, 600 mg/200 mg/300 mg) until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study.	CBV+EFV n=243 Participants Participants in this group received EFV 600 mg once daily + Combivir (\[CBV\]; the fixed dose combination pill containing lamivudine + zidovudine \[150 mg/300 mg\]) twice daily from the start of the study until Week 144. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated CNS toxicity. At Week 144 all participants who opted to roll over into the additional 96-week study extension received ATR until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study.
Percentage of Participants With Loss of Virologic Response (HIV-1 RNA < 50 c/mL) at Week 96	32 Percentage of Participants	38 Percentage of Participants

SECONDARY outcome

Timeframe: Week 96

Population: MITT

Participants who achieved confirmed HIV-1 RNA < 400 c/mL but had not experienced a confirmed relapse were considered censored at the last HIV-1 RNA collection date.

Outcome measures

Measure	EFV+FTC+TDF n=244 Participants Participants in this group received 3 component drugs: efavirenz (EFV) 600 mg + emtricitabine (FTC) 200 mg + tenofovir disoproxil fumarate (tenofovir DF; TDF) 300 mg, each once daily, from the start of the study. At 96 weeks Truvada (\[TVD\] the fixed-dose combination pill containing FTC/TDF (200 mg/300 mg) replaced FTC + TDF; participants continued to receive EFV as before. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated central nervous system (CNS) toxicity. At Week 144 all participants who opted to roll over into the further 96-week study extension received Atripla (\[ATR\]; the fixed dose combination pill containing EFV/FTC/TDF, 600 mg/200 mg/300 mg) until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study.	CBV+EFV n=243 Participants Participants in this group received EFV 600 mg once daily + Combivir (\[CBV\]; the fixed dose combination pill containing lamivudine + zidovudine \[150 mg/300 mg\]) twice daily from the start of the study until Week 144. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated CNS toxicity. At Week 144 all participants who opted to roll over into the additional 96-week study extension received ATR until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study.
Percentage of Participants With Pure Virologic Failure (HIV-1 RNA < 400 c/mL) at Week 96	9 Percentage of Participants	17 Percentage of Participants

SECONDARY outcome

Timeframe: Week 96

Population: MITT

Participants who achieved confirmed HIV-1 RNA < 50 c/mL but had not experienced a confirmed relapse were considered censored at the last HIV-1 RNA collection date.

Outcome measures

Measure	EFV+FTC+TDF n=244 Participants Participants in this group received 3 component drugs: efavirenz (EFV) 600 mg + emtricitabine (FTC) 200 mg + tenofovir disoproxil fumarate (tenofovir DF; TDF) 300 mg, each once daily, from the start of the study. At 96 weeks Truvada (\[TVD\] the fixed-dose combination pill containing FTC/TDF (200 mg/300 mg) replaced FTC + TDF; participants continued to receive EFV as before. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated central nervous system (CNS) toxicity. At Week 144 all participants who opted to roll over into the further 96-week study extension received Atripla (\[ATR\]; the fixed dose combination pill containing EFV/FTC/TDF, 600 mg/200 mg/300 mg) until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study.	CBV+EFV n=243 Participants Participants in this group received EFV 600 mg once daily + Combivir (\[CBV\]; the fixed dose combination pill containing lamivudine + zidovudine \[150 mg/300 mg\]) twice daily from the start of the study until Week 144. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated CNS toxicity. At Week 144 all participants who opted to roll over into the additional 96-week study extension received ATR until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study.
Percentage of Participants With Pure Virologic Failure (HIV-1 RNA < 50 c/mL) at Week 96	20 Percentage of Participants	23 Percentage of Participants

SECONDARY outcome

Timeframe: Study baseline to Week 96

Population: AT analysis set included all participants who received at least one dose of study medication and had not committed any major protocol violation.

Change from study baseline to Week 96 in HIV-1 RNA in log10 scale (Week 96 HIV-1 RNA value in log10 scale minus study baseline HIV-1 RNA value in log10 scale).

Outcome measures

Measure	EFV+FTC+TDF n=170 Participants Participants in this group received 3 component drugs: efavirenz (EFV) 600 mg + emtricitabine (FTC) 200 mg + tenofovir disoproxil fumarate (tenofovir DF; TDF) 300 mg, each once daily, from the start of the study. At 96 weeks Truvada (\[TVD\] the fixed-dose combination pill containing FTC/TDF (200 mg/300 mg) replaced FTC + TDF; participants continued to receive EFV as before. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated central nervous system (CNS) toxicity. At Week 144 all participants who opted to roll over into the further 96-week study extension received Atripla (\[ATR\]; the fixed dose combination pill containing EFV/FTC/TDF, 600 mg/200 mg/300 mg) until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study.	CBV+EFV n=145 Participants Participants in this group received EFV 600 mg once daily + Combivir (\[CBV\]; the fixed dose combination pill containing lamivudine + zidovudine \[150 mg/300 mg\]) twice daily from the start of the study until Week 144. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated CNS toxicity. At Week 144 all participants who opted to roll over into the additional 96-week study extension received ATR until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study.
Change From Study Baseline in HIV-1 RNA (Log10 c/mL) at Week 96	-3.30 Log10 c/mL Standard Deviation 0.57	-3.25 Log10 c/mL Standard Deviation 0.59

SECONDARY outcome

Timeframe: Baseline to Week 96

Population: AT analysis set included all participants who received at least one dose of study medication and had not committed any major protocol violation.

Change from study baseline to Week 96 in CD4 cell count = Week 96 CD4 cell count value minus study baseline CD4 cell count value

Outcome measures

Measure	EFV+FTC+TDF n=166 Participants Participants in this group received 3 component drugs: efavirenz (EFV) 600 mg + emtricitabine (FTC) 200 mg + tenofovir disoproxil fumarate (tenofovir DF; TDF) 300 mg, each once daily, from the start of the study. At 96 weeks Truvada (\[TVD\] the fixed-dose combination pill containing FTC/TDF (200 mg/300 mg) replaced FTC + TDF; participants continued to receive EFV as before. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated central nervous system (CNS) toxicity. At Week 144 all participants who opted to roll over into the further 96-week study extension received Atripla (\[ATR\]; the fixed dose combination pill containing EFV/FTC/TDF, 600 mg/200 mg/300 mg) until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study.	CBV+EFV n=142 Participants Participants in this group received EFV 600 mg once daily + Combivir (\[CBV\]; the fixed dose combination pill containing lamivudine + zidovudine \[150 mg/300 mg\]) twice daily from the start of the study until Week 144. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated CNS toxicity. At Week 144 all participants who opted to roll over into the additional 96-week study extension received ATR until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study.
Change From Study Baseline in CD4 Cell Count (Cells/mm^3) at Week 96	270 CD4 Cell Count (cells/mm^3) Standard Deviation 147.5	237 CD4 Cell Count (cells/mm^3) Standard Deviation 136.4

SECONDARY outcome

Timeframe: Week 48 to Week 96

Population: ITT (whole body dual-energy X-ray absorptiometry \[DEXA\] scans to determine limb fat content were conducted only at selected sites at Week 48 and Week 96. ITT analysis set: 93)

Change from Week 48 to Week 96 in limb fat = Week 96 limb fat value minus Week 48 limb fat value.

Outcome measures

Measure	EFV+FTC+TDF n=49 Participants Participants in this group received 3 component drugs: efavirenz (EFV) 600 mg + emtricitabine (FTC) 200 mg + tenofovir disoproxil fumarate (tenofovir DF; TDF) 300 mg, each once daily, from the start of the study. At 96 weeks Truvada (\[TVD\] the fixed-dose combination pill containing FTC/TDF (200 mg/300 mg) replaced FTC + TDF; participants continued to receive EFV as before. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated central nervous system (CNS) toxicity. At Week 144 all participants who opted to roll over into the further 96-week study extension received Atripla (\[ATR\]; the fixed dose combination pill containing EFV/FTC/TDF, 600 mg/200 mg/300 mg) until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study.	CBV+EFV n=44 Participants Participants in this group received EFV 600 mg once daily + Combivir (\[CBV\]; the fixed dose combination pill containing lamivudine + zidovudine \[150 mg/300 mg\]) twice daily from the start of the study until Week 144. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated CNS toxicity. At Week 144 all participants who opted to roll over into the additional 96-week study extension received ATR until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study.
Change in Limb Fat (kg) From Week 48 to Week 96	0.74 limb fat (kg) Standard Deviation 1.60	-0.77 limb fat (kg) Standard Deviation 1.58

SECONDARY outcome

Timeframe: Week 48 to Week 96

Population: ITT (whole body DEXA scans to determine trunk fat content were conducted only at selected sites at Week 48 and Week 96. ITT analysis set: 93)

Change from Week 48 to Week 96 in trunk fat = Week 96 trunk fat value minus Week 48 trunk fat value

Outcome measures

Measure	EFV+FTC+TDF n=49 Participants Participants in this group received 3 component drugs: efavirenz (EFV) 600 mg + emtricitabine (FTC) 200 mg + tenofovir disoproxil fumarate (tenofovir DF; TDF) 300 mg, each once daily, from the start of the study. At 96 weeks Truvada (\[TVD\] the fixed-dose combination pill containing FTC/TDF (200 mg/300 mg) replaced FTC + TDF; participants continued to receive EFV as before. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated central nervous system (CNS) toxicity. At Week 144 all participants who opted to roll over into the further 96-week study extension received Atripla (\[ATR\]; the fixed dose combination pill containing EFV/FTC/TDF, 600 mg/200 mg/300 mg) until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study.	CBV+EFV n=44 Participants Participants in this group received EFV 600 mg once daily + Combivir (\[CBV\]; the fixed dose combination pill containing lamivudine + zidovudine \[150 mg/300 mg\]) twice daily from the start of the study until Week 144. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated CNS toxicity. At Week 144 all participants who opted to roll over into the additional 96-week study extension received ATR until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study.
Change in Trunk Fat (kg) From Week 48 to Week 96	0.94 trunk fat (kg) Standard Deviation 2.30	-0.04 trunk fat (kg) Standard Deviation 1.65

SECONDARY outcome

Timeframe: 48 weeks to 96 weeks

Population: ITT (whole body DEXA scans to determine total body fat content were conducted only at selected sites at Week 48 and Week 96. ITT analysis set for limb fat analyses: 93)

Change from Week 48 to Week 96 in total body fat = Week 96 total body fat value minus Week 48 total body fat value

Outcome measures

Measure	EFV+FTC+TDF n=49 Participants Participants in this group received 3 component drugs: efavirenz (EFV) 600 mg + emtricitabine (FTC) 200 mg + tenofovir disoproxil fumarate (tenofovir DF; TDF) 300 mg, each once daily, from the start of the study. At 96 weeks Truvada (\[TVD\] the fixed-dose combination pill containing FTC/TDF (200 mg/300 mg) replaced FTC + TDF; participants continued to receive EFV as before. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated central nervous system (CNS) toxicity. At Week 144 all participants who opted to roll over into the further 96-week study extension received Atripla (\[ATR\]; the fixed dose combination pill containing EFV/FTC/TDF, 600 mg/200 mg/300 mg) until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study.	CBV+EFV n=44 Participants Participants in this group received EFV 600 mg once daily + Combivir (\[CBV\]; the fixed dose combination pill containing lamivudine + zidovudine \[150 mg/300 mg\]) twice daily from the start of the study until Week 144. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated CNS toxicity. At Week 144 all participants who opted to roll over into the additional 96-week study extension received ATR until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study.
Change in Total Body Fat (kg) From Week 48 to Week 96	1.69 total body fat (kg) Standard Deviation 3.80	-0.82 total body fat (kg) Standard Deviation 3.01

SECONDARY outcome

Timeframe: 144 weeks

Population: Week 144 Efficacy Analysis set (excludes the Week 96 responders who did not consent after Week 96 visits from Week 96 efficacy analysis set \[Week 144 efficacy analysis set: 456).

Participants who achieved/maintained confirmed HIV-1 RNA < 400 c/mL had to satisfy the following: 1) not experienced death, permanent study drug discontinuation, or addition of new antiretroviral drug, except nevirapine in place of EFV, prior to Week 144 visit; 2) achieved confirmed HIV-1 RNA < 400 c/mL on 2 consecutive visits prior to Week 144 visit (i.e., the first of the 2 consecutive HIV-1 RNA < 400 c/mL occurred prior to the Week 144 visit; 3) not had confirmed HIV-1 RNA > 400 c/mL after achievement of confirmed HIV-1 RNA levels < 400 c/mL prior to Week 144 visit.

Outcome measures

Measure	EFV+FTC+TDF n=227 Participants Participants in this group received 3 component drugs: efavirenz (EFV) 600 mg + emtricitabine (FTC) 200 mg + tenofovir disoproxil fumarate (tenofovir DF; TDF) 300 mg, each once daily, from the start of the study. At 96 weeks Truvada (\[TVD\] the fixed-dose combination pill containing FTC/TDF (200 mg/300 mg) replaced FTC + TDF; participants continued to receive EFV as before. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated central nervous system (CNS) toxicity. At Week 144 all participants who opted to roll over into the further 96-week study extension received Atripla (\[ATR\]; the fixed dose combination pill containing EFV/FTC/TDF, 600 mg/200 mg/300 mg) until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study.	CBV+EFV n=229 Participants Participants in this group received EFV 600 mg once daily + Combivir (\[CBV\]; the fixed dose combination pill containing lamivudine + zidovudine \[150 mg/300 mg\]) twice daily from the start of the study until Week 144. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated CNS toxicity. At Week 144 all participants who opted to roll over into the additional 96-week study extension received ATR until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study.
Percentage of Participants With Confirmed Plasma HIV-1 RNA < 400 c/mL at Week 144 (Defined by FDA TLOVR Algorithm)	70.9 Percentage of Participants	58.1 Percentage of Participants

SECONDARY outcome

Timeframe: Week 144

Population: Week 144 Efficacy Analysis set (excludes the Week 96 responders who did not consent after Week 96 visits from Week 96 efficacy analysis set \[Week 144 efficacy analysis set: 458).

Participants who achieved/maintained confirmed HIV-1 RNA < 50 c/mL (c/mL) had to satisfy the following criteria: 1) not experienced death, permanent study drug discontinuation, or addition of new antiretroviral drug, except nevirapine in place of EFV, prior to Week 144 visit; 2) achieved confirmed HIV-1 RNA < 50 c/mL on 2 consecutive visits prior to Week 144 visit (that is, the first of the 2 consecutive HIV-1 RNA < 50 c/mL occurred prior to the Week 144 visit; 3) not had confirmed HIV-1 RNA > 50 c/mL after achievement of confirmed HIV-1 RNA levels < 50 c/mL prior to Week 144 visit.

Outcome measures

Measure	EFV+FTC+TDF n=227 Participants Participants in this group received 3 component drugs: efavirenz (EFV) 600 mg + emtricitabine (FTC) 200 mg + tenofovir disoproxil fumarate (tenofovir DF; TDF) 300 mg, each once daily, from the start of the study. At 96 weeks Truvada (\[TVD\] the fixed-dose combination pill containing FTC/TDF (200 mg/300 mg) replaced FTC + TDF; participants continued to receive EFV as before. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated central nervous system (CNS) toxicity. At Week 144 all participants who opted to roll over into the further 96-week study extension received Atripla (\[ATR\]; the fixed dose combination pill containing EFV/FTC/TDF, 600 mg/200 mg/300 mg) until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study.	CBV+EFV n=231 Participants Participants in this group received EFV 600 mg once daily + Combivir (\[CBV\]; the fixed dose combination pill containing lamivudine + zidovudine \[150 mg/300 mg\]) twice daily from the start of the study until Week 144. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated CNS toxicity. At Week 144 all participants who opted to roll over into the additional 96-week study extension received ATR until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study.
Percentage of Participants With Confirmed Plasma HIV-1 RNA < 50 c/mL at Week 144 (Defined by FDA TLOVR Algorithm)	64.3 Percentage of participants	56.3 Percentage of participants

SECONDARY outcome

Timeframe: Week 144

Population: ITT Analysis set

The percentage of participants with plasma HIV-1 RNA < 400 c/mL at Week 144. Participants with missing observations/changes in ART were considered to have HIV-1 RNA ≥ 400 c/mL (i.e., ITT missing or switch=failure analysis).

Outcome measures

Measure	EFV+FTC+TDF n=255 Participants Participants in this group received 3 component drugs: efavirenz (EFV) 600 mg + emtricitabine (FTC) 200 mg + tenofovir disoproxil fumarate (tenofovir DF; TDF) 300 mg, each once daily, from the start of the study. At 96 weeks Truvada (\[TVD\] the fixed-dose combination pill containing FTC/TDF (200 mg/300 mg) replaced FTC + TDF; participants continued to receive EFV as before. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated central nervous system (CNS) toxicity. At Week 144 all participants who opted to roll over into the further 96-week study extension received Atripla (\[ATR\]; the fixed dose combination pill containing EFV/FTC/TDF, 600 mg/200 mg/300 mg) until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study.	CBV+EFV n=254 Participants Participants in this group received EFV 600 mg once daily + Combivir (\[CBV\]; the fixed dose combination pill containing lamivudine + zidovudine \[150 mg/300 mg\]) twice daily from the start of the study until Week 144. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated CNS toxicity. At Week 144 all participants who opted to roll over into the additional 96-week study extension received ATR until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study.
Percentage of Participants With Plasma HIV-1 RNA < 400 c/mL at Week 144	63.1 Percentage of Participants	51.6 Percentage of Participants

SECONDARY outcome

Timeframe: Week 144

Population: ITT Analysis set (Missing Observation or Switch in ART=Failure)

The percentage of participants with plasma HIV-1 RNA < 50 c/mL at Week 144. Participants with missing observations/changes in ART were considered to have HIV-1 RNA ≥ 50 c/mL (i.e., ITT missing or switch=failure analysis).

Outcome measures

Measure	EFV+FTC+TDF n=255 Participants Participants in this group received 3 component drugs: efavirenz (EFV) 600 mg + emtricitabine (FTC) 200 mg + tenofovir disoproxil fumarate (tenofovir DF; TDF) 300 mg, each once daily, from the start of the study. At 96 weeks Truvada (\[TVD\] the fixed-dose combination pill containing FTC/TDF (200 mg/300 mg) replaced FTC + TDF; participants continued to receive EFV as before. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated central nervous system (CNS) toxicity. At Week 144 all participants who opted to roll over into the further 96-week study extension received Atripla (\[ATR\]; the fixed dose combination pill containing EFV/FTC/TDF, 600 mg/200 mg/300 mg) until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study.	CBV+EFV n=254 Participants Participants in this group received EFV 600 mg once daily + Combivir (\[CBV\]; the fixed dose combination pill containing lamivudine + zidovudine \[150 mg/300 mg\]) twice daily from the start of the study until Week 144. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated CNS toxicity. At Week 144 all participants who opted to roll over into the additional 96-week study extension received ATR until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study.
Percentage of Participants With Plasma HIV-1 RNA < 50 c/mL at Week 144	60.8 Percentage of Participants	50.4 Percentage of Participants

SECONDARY outcome

Timeframe: Week 144

Population: MITT

TLOVR for participants who achieved a confirmed virologic response was the time to the earliest of: premature study regimen discontinuation or the first of 2 consecutive HIV-1 RNA ≥ 400 c/mL or last HIV-1 RNA ≥ 400 c/mL followed by loss to follow-up. If the time to HIV-1 RNA ≥ 400 c/mL was immediately preceded by missing scheduled visits then the time of virologic failure was replaced by the first such missing visit. Participants who had not achieved a confirmed virologic response before regimen discontinuation were considered "non-responders" on Study Day 1.

Outcome measures

Measure	EFV+FTC+TDF n=244 Participants Participants in this group received 3 component drugs: efavirenz (EFV) 600 mg + emtricitabine (FTC) 200 mg + tenofovir disoproxil fumarate (tenofovir DF; TDF) 300 mg, each once daily, from the start of the study. At 96 weeks Truvada (\[TVD\] the fixed-dose combination pill containing FTC/TDF (200 mg/300 mg) replaced FTC + TDF; participants continued to receive EFV as before. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated central nervous system (CNS) toxicity. At Week 144 all participants who opted to roll over into the further 96-week study extension received Atripla (\[ATR\]; the fixed dose combination pill containing EFV/FTC/TDF, 600 mg/200 mg/300 mg) until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study.	CBV+EFV n=243 Participants Participants in this group received EFV 600 mg once daily + Combivir (\[CBV\]; the fixed dose combination pill containing lamivudine + zidovudine \[150 mg/300 mg\]) twice daily from the start of the study until Week 144. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated CNS toxicity. At Week 144 all participants who opted to roll over into the additional 96-week study extension received ATR until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study.
Percentage of Participants With Loss of Virologic Response (HIV-1 RNA < 400 c/mL) at Week 144	28 Percentage of Participants	41 Percentage of Participants

SECONDARY outcome

Timeframe: Week 144

Population: MITT

TLOVR for participants who achieved a confirmed virologic response was the time to the earliest of: premature study regimen discontinuation or the first of 2 consecutive HIV-1 RNA ≥ 50 c/mL or last HIV-1 RNA ≥ 50 c/mL followed by loss to follow-up. If the time to HIV-1 RNA ≥ 50 c/mL was immediately preceded by missing scheduled visits then the time of virologic failure was replaced by the first such missing visit. Participants who had not achieved a confirmed virologic response before regimen discontinuation were considered "non-responders" on Study Day 1.

Outcome measures

Measure	EFV+FTC+TDF n=244 Participants Participants in this group received 3 component drugs: efavirenz (EFV) 600 mg + emtricitabine (FTC) 200 mg + tenofovir disoproxil fumarate (tenofovir DF; TDF) 300 mg, each once daily, from the start of the study. At 96 weeks Truvada (\[TVD\] the fixed-dose combination pill containing FTC/TDF (200 mg/300 mg) replaced FTC + TDF; participants continued to receive EFV as before. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated central nervous system (CNS) toxicity. At Week 144 all participants who opted to roll over into the further 96-week study extension received Atripla (\[ATR\]; the fixed dose combination pill containing EFV/FTC/TDF, 600 mg/200 mg/300 mg) until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study.	CBV+EFV n=243 Participants Participants in this group received EFV 600 mg once daily + Combivir (\[CBV\]; the fixed dose combination pill containing lamivudine + zidovudine \[150 mg/300 mg\]) twice daily from the start of the study until Week 144. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated CNS toxicity. At Week 144 all participants who opted to roll over into the additional 96-week study extension received ATR until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study.
Percentage of Participants With Loss of Virologic Response (HIV-1 RNA < 50 c/mL) at Week 144	34 Percentage of Participants	43 Percentage of Participants

SECONDARY outcome

Timeframe: Week 144

Population: MITT

Participants who achieved confirmed HIV-1 RNA < 400 c/mL but had not experienced a confirmed relapse were considered censored at the last HIV-1 RNA collection date.

Outcome measures

Measure	EFV+FTC+TDF n=244 Participants Participants in this group received 3 component drugs: efavirenz (EFV) 600 mg + emtricitabine (FTC) 200 mg + tenofovir disoproxil fumarate (tenofovir DF; TDF) 300 mg, each once daily, from the start of the study. At 96 weeks Truvada (\[TVD\] the fixed-dose combination pill containing FTC/TDF (200 mg/300 mg) replaced FTC + TDF; participants continued to receive EFV as before. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated central nervous system (CNS) toxicity. At Week 144 all participants who opted to roll over into the further 96-week study extension received Atripla (\[ATR\]; the fixed dose combination pill containing EFV/FTC/TDF, 600 mg/200 mg/300 mg) until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study.	CBV+EFV n=243 Participants Participants in this group received EFV 600 mg once daily + Combivir (\[CBV\]; the fixed dose combination pill containing lamivudine + zidovudine \[150 mg/300 mg\]) twice daily from the start of the study until Week 144. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated CNS toxicity. At Week 144 all participants who opted to roll over into the additional 96-week study extension received ATR until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study.
Percentage of Participants With Pure Virological Failure (HIV-1 RNA < 400 c/mL) at Week 144	11 Percentage of participants	17 Percentage of participants

SECONDARY outcome

Timeframe: Week 144

Population: MITT

Participants who achieved confirmed HIV-1 RNA < 50 c/mL but had not experienced a confirmed relapse were considered censored at the last HIV-1 RNA collection date.

Outcome measures

Measure	EFV+FTC+TDF n=244 Participants Participants in this group received 3 component drugs: efavirenz (EFV) 600 mg + emtricitabine (FTC) 200 mg + tenofovir disoproxil fumarate (tenofovir DF; TDF) 300 mg, each once daily, from the start of the study. At 96 weeks Truvada (\[TVD\] the fixed-dose combination pill containing FTC/TDF (200 mg/300 mg) replaced FTC + TDF; participants continued to receive EFV as before. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated central nervous system (CNS) toxicity. At Week 144 all participants who opted to roll over into the further 96-week study extension received Atripla (\[ATR\]; the fixed dose combination pill containing EFV/FTC/TDF, 600 mg/200 mg/300 mg) until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study.	CBV+EFV n=243 Participants Participants in this group received EFV 600 mg once daily + Combivir (\[CBV\]; the fixed dose combination pill containing lamivudine + zidovudine \[150 mg/300 mg\]) twice daily from the start of the study until Week 144. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated CNS toxicity. At Week 144 all participants who opted to roll over into the additional 96-week study extension received ATR until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study.
Percentage of Participants With Pure Virological Failure (HIV-1 RNA < 50 c/mL) at Week 144	21 Percentage of Participants	25 Percentage of Participants

SECONDARY outcome

Timeframe: Study baseline to Week 144

Population: AT analysis set

Change from study baseline to Week 144 in HIV-1 RNA in log10 scale (Week 144 HIV-1 RNA value in log10 scale minus study baseline HIV-1 RNA value in log10 scale).

Outcome measures

Measure	EFV+FTC+TDF n=160 Participants Participants in this group received 3 component drugs: efavirenz (EFV) 600 mg + emtricitabine (FTC) 200 mg + tenofovir disoproxil fumarate (tenofovir DF; TDF) 300 mg, each once daily, from the start of the study. At 96 weeks Truvada (\[TVD\] the fixed-dose combination pill containing FTC/TDF (200 mg/300 mg) replaced FTC + TDF; participants continued to receive EFV as before. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated central nervous system (CNS) toxicity. At Week 144 all participants who opted to roll over into the further 96-week study extension received Atripla (\[ATR\]; the fixed dose combination pill containing EFV/FTC/TDF, 600 mg/200 mg/300 mg) until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study.	CBV+EFV n=124 Participants Participants in this group received EFV 600 mg once daily + Combivir (\[CBV\]; the fixed dose combination pill containing lamivudine + zidovudine \[150 mg/300 mg\]) twice daily from the start of the study until Week 144. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated CNS toxicity. At Week 144 all participants who opted to roll over into the additional 96-week study extension received ATR until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study.
Change From Study Baseline in HIV-1 RNA (Log10 c/mL) at Week 144	-3.32 Log10 c/mL Standard Deviation 0.54	-3.30 Log10 c/mL Standard Deviation 0.52

SECONDARY outcome

Timeframe: Baseline to Week 144

Population: AT analysis set

Change from study baseline to Week 144 in CD4 cell count = Week 144 CD4 cell count value minus study baseline CD4 cell count value

Outcome measures

Measure	EFV+FTC+TDF n=152 Participants Participants in this group received 3 component drugs: efavirenz (EFV) 600 mg + emtricitabine (FTC) 200 mg + tenofovir disoproxil fumarate (tenofovir DF; TDF) 300 mg, each once daily, from the start of the study. At 96 weeks Truvada (\[TVD\] the fixed-dose combination pill containing FTC/TDF (200 mg/300 mg) replaced FTC + TDF; participants continued to receive EFV as before. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated central nervous system (CNS) toxicity. At Week 144 all participants who opted to roll over into the further 96-week study extension received Atripla (\[ATR\]; the fixed dose combination pill containing EFV/FTC/TDF, 600 mg/200 mg/300 mg) until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study.	CBV+EFV n=122 Participants Participants in this group received EFV 600 mg once daily + Combivir (\[CBV\]; the fixed dose combination pill containing lamivudine + zidovudine \[150 mg/300 mg\]) twice daily from the start of the study until Week 144. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated CNS toxicity. At Week 144 all participants who opted to roll over into the additional 96-week study extension received ATR until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study.
Change From Study Baseline in CD4 Cell Count (Cells/mm^3) at Week 144	312 CD4 Cell Count (cells/mm^3) Standard Deviation 161.2	271 CD4 Cell Count (cells/mm^3) Standard Deviation 147.4

SECONDARY outcome

Timeframe: Week 48 to Week 144

Population: ITT (whole body DEXA scans to determine limb fat content were conducted only at selected sites at Week 48, Week 96 and Week 144. ITT analysis set: 86)

Change from Week 48 to Week 144 in limb fat = Week 144 limb fat value minus Week 48 limb fat value

Outcome measures

Measure	EFV+FTC+TDF n=48 Participants Participants in this group received 3 component drugs: efavirenz (EFV) 600 mg + emtricitabine (FTC) 200 mg + tenofovir disoproxil fumarate (tenofovir DF; TDF) 300 mg, each once daily, from the start of the study. At 96 weeks Truvada (\[TVD\] the fixed-dose combination pill containing FTC/TDF (200 mg/300 mg) replaced FTC + TDF; participants continued to receive EFV as before. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated central nervous system (CNS) toxicity. At Week 144 all participants who opted to roll over into the further 96-week study extension received Atripla (\[ATR\]; the fixed dose combination pill containing EFV/FTC/TDF, 600 mg/200 mg/300 mg) until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study.	CBV+EFV n=38 Participants Participants in this group received EFV 600 mg once daily + Combivir (\[CBV\]; the fixed dose combination pill containing lamivudine + zidovudine \[150 mg/300 mg\]) twice daily from the start of the study until Week 144. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated CNS toxicity. At Week 144 all participants who opted to roll over into the additional 96-week study extension received ATR until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study.
Change in Limb Fat (kg) From Week 48 to Week 144	1.13 limb fat (kg) Standard Deviation 1.93	-1.09 limb fat (kg) Standard Deviation 1.72

SECONDARY outcome

Timeframe: Week 48 to Week 144

Population: ITT (whole body DEXA scans to determine trunk fat content were conducted only at selected sites at Week 48, Week 96 and Week 144. ITT analysis set: 86)

Change from Week 48 to Week 144 in trunk fat = Week 144 trunk fat value minus Week 48 trunk fat value

Outcome measures

Measure	EFV+FTC+TDF n=48 Participants Participants in this group received 3 component drugs: efavirenz (EFV) 600 mg + emtricitabine (FTC) 200 mg + tenofovir disoproxil fumarate (tenofovir DF; TDF) 300 mg, each once daily, from the start of the study. At 96 weeks Truvada (\[TVD\] the fixed-dose combination pill containing FTC/TDF (200 mg/300 mg) replaced FTC + TDF; participants continued to receive EFV as before. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated central nervous system (CNS) toxicity. At Week 144 all participants who opted to roll over into the further 96-week study extension received Atripla (\[ATR\]; the fixed dose combination pill containing EFV/FTC/TDF, 600 mg/200 mg/300 mg) until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study.	CBV+EFV n=38 Participants Participants in this group received EFV 600 mg once daily + Combivir (\[CBV\]; the fixed dose combination pill containing lamivudine + zidovudine \[150 mg/300 mg\]) twice daily from the start of the study until Week 144. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated CNS toxicity. At Week 144 all participants who opted to roll over into the additional 96-week study extension received ATR until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study.
Change in Trunk Fat (kg) From Week 48 to Week 144	1.30 trunk fat (kg) Standard Deviation 2.40	-0.10 trunk fat (kg) Standard Deviation 1.79

SECONDARY outcome

Timeframe: Week 48 to Week 144

Population: ITT (whole body DEXA scans to determine total body fat content were conducted only at selected sites at Week 48, Week 96 and Week 144. ITT analysis set: 86)

Change from Week 48 to Week 144 in total body fat = Week 144 total body fat value minus Week 48 total body fat value

Outcome measures

Measure	EFV+FTC+TDF n=48 Participants Participants in this group received 3 component drugs: efavirenz (EFV) 600 mg + emtricitabine (FTC) 200 mg + tenofovir disoproxil fumarate (tenofovir DF; TDF) 300 mg, each once daily, from the start of the study. At 96 weeks Truvada (\[TVD\] the fixed-dose combination pill containing FTC/TDF (200 mg/300 mg) replaced FTC + TDF; participants continued to receive EFV as before. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated central nervous system (CNS) toxicity. At Week 144 all participants who opted to roll over into the further 96-week study extension received Atripla (\[ATR\]; the fixed dose combination pill containing EFV/FTC/TDF, 600 mg/200 mg/300 mg) until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study.	CBV+EFV n=38 Participants Participants in this group received EFV 600 mg once daily + Combivir (\[CBV\]; the fixed dose combination pill containing lamivudine + zidovudine \[150 mg/300 mg\]) twice daily from the start of the study until Week 144. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated CNS toxicity. At Week 144 all participants who opted to roll over into the additional 96-week study extension received ATR until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study.
Change in Total Body Fat (kg) From Week 48 to Week 144	2.47 total body fat (kg) Standard Deviation 4.22	-1.18 total body fat (kg) Standard Deviation 3.37

SECONDARY outcome

Timeframe: Week 144 (Atripla baseline) to Week 240 (Atripla Week 96)

Population: Atripla Efficacy Analysis Set (all participants who received at least one dose of Atripla). Data collected after permanent discontinuation of the study regimen was excluded from this analysis set.

Participants who achieved/maintained confirmed HIV-1 RNA < 400 c/mL had to satisfy the following criteria: 1) not experienced death, permanent study drug discontinuation, or addition of new antiretroviral drug except nevirapine in place of EFV prior to Week 240 visit; 2) achieved confirmed HIV-1 RNA < 400 c/mL on 2 consecutive visits prior to Week 240 visit (that is, the first of the 2 consecutive HIV-1 RNA < 400 c/mL occurred prior to the Week 240 visit; 3) not had confirmed HIV-1 RNA > 400 c/mL after achievement of confirmed HIV RNA levels < 400 c/mL prior to Week 240 visit.

Outcome measures

Measure	EFV+FTC+TDF n=286 Participants Participants in this group received 3 component drugs: efavirenz (EFV) 600 mg + emtricitabine (FTC) 200 mg + tenofovir disoproxil fumarate (tenofovir DF; TDF) 300 mg, each once daily, from the start of the study. At 96 weeks Truvada (\[TVD\] the fixed-dose combination pill containing FTC/TDF (200 mg/300 mg) replaced FTC + TDF; participants continued to receive EFV as before. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated central nervous system (CNS) toxicity. At Week 144 all participants who opted to roll over into the further 96-week study extension received Atripla (\[ATR\]; the fixed dose combination pill containing EFV/FTC/TDF, 600 mg/200 mg/300 mg) until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study.	CBV+EFV Participants in this group received EFV 600 mg once daily + Combivir (\[CBV\]; the fixed dose combination pill containing lamivudine + zidovudine \[150 mg/300 mg\]) twice daily from the start of the study until Week 144. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated CNS toxicity. At Week 144 all participants who opted to roll over into the additional 96-week study extension received ATR until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study.
Percentage of Participants With Confirmed Plasma HIV-1 RNA < 400 c/mL at Week 240 (Atripla Week 96) Defined by the FDA TLOVR Algorithm	87 Percentage of Participants	—

SECONDARY outcome

Timeframe: Week 144 (Atripla baseline) to Week 240 (Atripla Week 96)

Population: Atripla Efficacy Analysis Set

Participants who achieved/maintained confirmed HIV-1 RNA < 50 c/mL had to satisfy the following criteria: 1) not experienced death, permanent study drug discontinuation, or addition of new antiretroviral drug except nevirapine in place of EFV prior to Week 240 visit; 2) achieved confirmed HIV-1 RNA < 50 c/mL on 2 consecutive visits prior to Week 240 visit (that is, the first of the 2 consecutive HIV-1 RNA < 50 c/mL occurred prior to the Week 240 visit; 3) not had confirmed HIV-1 RNA > 50 c/mL after achievement of confirmed HIV RNA levels < 50 c/mL prior to Week 240 visit.

Outcome measures

Measure	EFV+FTC+TDF n=286 Participants Participants in this group received 3 component drugs: efavirenz (EFV) 600 mg + emtricitabine (FTC) 200 mg + tenofovir disoproxil fumarate (tenofovir DF; TDF) 300 mg, each once daily, from the start of the study. At 96 weeks Truvada (\[TVD\] the fixed-dose combination pill containing FTC/TDF (200 mg/300 mg) replaced FTC + TDF; participants continued to receive EFV as before. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated central nervous system (CNS) toxicity. At Week 144 all participants who opted to roll over into the further 96-week study extension received Atripla (\[ATR\]; the fixed dose combination pill containing EFV/FTC/TDF, 600 mg/200 mg/300 mg) until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study.	CBV+EFV Participants in this group received EFV 600 mg once daily + Combivir (\[CBV\]; the fixed dose combination pill containing lamivudine + zidovudine \[150 mg/300 mg\]) twice daily from the start of the study until Week 144. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated CNS toxicity. At Week 144 all participants who opted to roll over into the additional 96-week study extension received ATR until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study.
Percentage of Participants With Confirmed Plasma HIV-1 RNA < 50 c/mL at Week 240 (Atripla Week 96) Defined by the FDA TLOVR Algorithm	85 Percentage of Participants	—

SECONDARY outcome

Timeframe: Week 240 (Atripla Week 96)

Population: Atripla Efficacy Analysis Set

The percentage of participants with plasma HIV-1 RNA < 400 c/mL at Week 240. Participants with missing observations/changes in ART were considered to have HIV-1 RNA ≥ 400 c/mL (i.e., ITT missing or switch=failure analysis).

Outcome measures

Measure	EFV+FTC+TDF n=160 Participants Participants in this group received 3 component drugs: efavirenz (EFV) 600 mg + emtricitabine (FTC) 200 mg + tenofovir disoproxil fumarate (tenofovir DF; TDF) 300 mg, each once daily, from the start of the study. At 96 weeks Truvada (\[TVD\] the fixed-dose combination pill containing FTC/TDF (200 mg/300 mg) replaced FTC + TDF; participants continued to receive EFV as before. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated central nervous system (CNS) toxicity. At Week 144 all participants who opted to roll over into the further 96-week study extension received Atripla (\[ATR\]; the fixed dose combination pill containing EFV/FTC/TDF, 600 mg/200 mg/300 mg) until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study.	CBV+EFV n=286 Participants Participants in this group received EFV 600 mg once daily + Combivir (\[CBV\]; the fixed dose combination pill containing lamivudine + zidovudine \[150 mg/300 mg\]) twice daily from the start of the study until Week 144. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated CNS toxicity. At Week 144 all participants who opted to roll over into the additional 96-week study extension received ATR until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study.
Percentage of Participants With Plasma HIV-1 RNA < 400 c/mL at Week 240 (Atripla Week 96)	87 Percentage of Participants	85 Percentage of Participants

SECONDARY outcome

Timeframe: Week 240 (Atripla Week 96)

Population: Atripla Efficacy Analysis Set

The percentage of participants with plasma HIV-1 RNA < 50 c/mL at Week 240. Participants with missing observations/changes in ART were considered to have HIV-1 RNA ≥ 50 c/mL (i.e., ITT missing or switch=failure analysis).

Outcome measures

Measure	EFV+FTC+TDF n=160 Participants Participants in this group received 3 component drugs: efavirenz (EFV) 600 mg + emtricitabine (FTC) 200 mg + tenofovir disoproxil fumarate (tenofovir DF; TDF) 300 mg, each once daily, from the start of the study. At 96 weeks Truvada (\[TVD\] the fixed-dose combination pill containing FTC/TDF (200 mg/300 mg) replaced FTC + TDF; participants continued to receive EFV as before. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated central nervous system (CNS) toxicity. At Week 144 all participants who opted to roll over into the further 96-week study extension received Atripla (\[ATR\]; the fixed dose combination pill containing EFV/FTC/TDF, 600 mg/200 mg/300 mg) until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study.	CBV+EFV n=286 Participants Participants in this group received EFV 600 mg once daily + Combivir (\[CBV\]; the fixed dose combination pill containing lamivudine + zidovudine \[150 mg/300 mg\]) twice daily from the start of the study until Week 144. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated CNS toxicity. At Week 144 all participants who opted to roll over into the additional 96-week study extension received ATR until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study.
Percentage of Participants With Plasma HIV-1 RNA < 50 c/mL at Week 240 (Atripla Week 96)	84 Percentage of Participants	82 Percentage of Participants

SECONDARY outcome

Timeframe: Week 144 (Atripla Baseline) to Week 240 (Atripla Week 96)

Population: Atripla Efficacy Analysis Set

TLOVR for participants who achieved a confirmed virologic response was the time to the earliest of: premature study regimen discontinuation or the first of 2 consecutive HIV-1 RNA ≥ 400 c/mL or last HIV-1 RNA ≥ 400 c/mL followed by loss to follow-up. If the time to HIV-1 RNA ≥ 400 c/mL was immediately preceded by missing scheduled visits then the time of virologic failure was replaced by the first such missing visit. Participants who had not achieved a confirmed virologic response before regimen discontinuation were considered "non-responders" on Study Day 1.

Outcome measures

Measure	EFV+FTC+TDF n=286 Participants Participants in this group received 3 component drugs: efavirenz (EFV) 600 mg + emtricitabine (FTC) 200 mg + tenofovir disoproxil fumarate (tenofovir DF; TDF) 300 mg, each once daily, from the start of the study. At 96 weeks Truvada (\[TVD\] the fixed-dose combination pill containing FTC/TDF (200 mg/300 mg) replaced FTC + TDF; participants continued to receive EFV as before. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated central nervous system (CNS) toxicity. At Week 144 all participants who opted to roll over into the further 96-week study extension received Atripla (\[ATR\]; the fixed dose combination pill containing EFV/FTC/TDF, 600 mg/200 mg/300 mg) until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study.	CBV+EFV Participants in this group received EFV 600 mg once daily + Combivir (\[CBV\]; the fixed dose combination pill containing lamivudine + zidovudine \[150 mg/300 mg\]) twice daily from the start of the study until Week 144. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated CNS toxicity. At Week 144 all participants who opted to roll over into the additional 96-week study extension received ATR until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study.
Percentage of Participants With Loss of Virologic Response (HIV-1 RNA < 400 c/mL) From Week 144 (Atripla Baseline) Through Week 240 (Atripla Week 96)	13 Percentage of Participants	—

SECONDARY outcome

Timeframe: Week 144 (Atripla Baseline) to Week 240 (Atripla Week 96)

Population: Atripla Efficacy Analysis Set

TLOVR for participants who achieved a confirmed virologic response was the time to the earliest of: premature study regimen discontinuation or the first of 2 consecutive HIV-1 RNA ≥ 50 c/mL or last HIV-1 RNA ≥ 50 c/mL followed by loss to follow-up. If the time to HIV-1 RNA ≥ 50 c/mL was immediately preceded by missing scheduled visits then the time of virologic failure was replaced by the first such missing visit. Participants who had not achieved a confirmed virologic response before regimen discontinuation were considered "non-responders" on Study Day 1.

Outcome measures

Measure	EFV+FTC+TDF n=286 Participants Participants in this group received 3 component drugs: efavirenz (EFV) 600 mg + emtricitabine (FTC) 200 mg + tenofovir disoproxil fumarate (tenofovir DF; TDF) 300 mg, each once daily, from the start of the study. At 96 weeks Truvada (\[TVD\] the fixed-dose combination pill containing FTC/TDF (200 mg/300 mg) replaced FTC + TDF; participants continued to receive EFV as before. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated central nervous system (CNS) toxicity. At Week 144 all participants who opted to roll over into the further 96-week study extension received Atripla (\[ATR\]; the fixed dose combination pill containing EFV/FTC/TDF, 600 mg/200 mg/300 mg) until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study.	CBV+EFV Participants in this group received EFV 600 mg once daily + Combivir (\[CBV\]; the fixed dose combination pill containing lamivudine + zidovudine \[150 mg/300 mg\]) twice daily from the start of the study until Week 144. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated CNS toxicity. At Week 144 all participants who opted to roll over into the additional 96-week study extension received ATR until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study.
Percentage of Participants With Loss of Virologic Response (HIV-1 RNA < 50 c/mL) From Week 144 (Atripla Baseline) Through Week 240 (Atripla Week 96)	15 Percentage of Participants	—

SECONDARY outcome

Timeframe: Week 240 (Atripla Week 96)

Population: MITT Analysis Set (EFV+FTC+TDF group from study baseline; N=244). Atripla Efficacy Analysis Set (All Atripla Group from Atripla baseline; N=286)

Participants who achieved confirmed HIV-1 RNA < 400 c/mL but had not experienced a confirmed relapse were considered censored at the last HIV-1 RNA collection date.

Outcome measures

Measure	EFV+FTC+TDF n=244 Participants Participants in this group received 3 component drugs: efavirenz (EFV) 600 mg + emtricitabine (FTC) 200 mg + tenofovir disoproxil fumarate (tenofovir DF; TDF) 300 mg, each once daily, from the start of the study. At 96 weeks Truvada (\[TVD\] the fixed-dose combination pill containing FTC/TDF (200 mg/300 mg) replaced FTC + TDF; participants continued to receive EFV as before. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated central nervous system (CNS) toxicity. At Week 144 all participants who opted to roll over into the further 96-week study extension received Atripla (\[ATR\]; the fixed dose combination pill containing EFV/FTC/TDF, 600 mg/200 mg/300 mg) until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study.	CBV+EFV n=286 Participants Participants in this group received EFV 600 mg once daily + Combivir (\[CBV\]; the fixed dose combination pill containing lamivudine + zidovudine \[150 mg/300 mg\]) twice daily from the start of the study until Week 144. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated CNS toxicity. At Week 144 all participants who opted to roll over into the additional 96-week study extension received ATR until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study.
Percentage of Participants With Pure Virological Failure (HIV-1 RNA < 400 c/mL) Through Week 240 (Atripla Week 96)	11 Percentage of Participants	2 Percentage of Participants

SECONDARY outcome

Timeframe: Week 240 (Atripla Week 96)

Population: MITT Analysis Set (EFV+FTC+TDF group from study baseline; N=244). Atripla Efficacy Analysis Set (All Atripla Group from Atripla baseline; N=286)

Participants who achieved confirmed HIV-1 RNA < 50 c/mL but had not experienced a confirmed relapse were considered censored at the last HIV-1 RNA collection date.

Outcome measures

Measure	EFV+FTC+TDF n=244 Participants Participants in this group received 3 component drugs: efavirenz (EFV) 600 mg + emtricitabine (FTC) 200 mg + tenofovir disoproxil fumarate (tenofovir DF; TDF) 300 mg, each once daily, from the start of the study. At 96 weeks Truvada (\[TVD\] the fixed-dose combination pill containing FTC/TDF (200 mg/300 mg) replaced FTC + TDF; participants continued to receive EFV as before. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated central nervous system (CNS) toxicity. At Week 144 all participants who opted to roll over into the further 96-week study extension received Atripla (\[ATR\]; the fixed dose combination pill containing EFV/FTC/TDF, 600 mg/200 mg/300 mg) until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study.	CBV+EFV n=286 Participants Participants in this group received EFV 600 mg once daily + Combivir (\[CBV\]; the fixed dose combination pill containing lamivudine + zidovudine \[150 mg/300 mg\]) twice daily from the start of the study until Week 144. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated CNS toxicity. At Week 144 all participants who opted to roll over into the additional 96-week study extension received ATR until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study.
Percentage of Participants With Pure Virological Failure (HIV-1 RNA < 50 c/mL) Through Week 240 (Atripla Week 96)	22 Percentage of Participants	4 Percentage of Participants

SECONDARY outcome

Timeframe: Study/Atripla baseline to Week 240 (Atripla Week 96)

Population: Atripla Efficacy Analysis Set

Change from baseline to Week 240 (Atripla Week 96) in CD4 cell count = Week 240 (Atripla Week 96) CD4 cell count value minus baseline CD4 cell count value

Outcome measures

Measure	EFV+FTC+TDF n=138 Participants Participants in this group received 3 component drugs: efavirenz (EFV) 600 mg + emtricitabine (FTC) 200 mg + tenofovir disoproxil fumarate (tenofovir DF; TDF) 300 mg, each once daily, from the start of the study. At 96 weeks Truvada (\[TVD\] the fixed-dose combination pill containing FTC/TDF (200 mg/300 mg) replaced FTC + TDF; participants continued to receive EFV as before. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated central nervous system (CNS) toxicity. At Week 144 all participants who opted to roll over into the further 96-week study extension received Atripla (\[ATR\]; the fixed dose combination pill containing EFV/FTC/TDF, 600 mg/200 mg/300 mg) until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study.	CBV+EFV n=243 Participants Participants in this group received EFV 600 mg once daily + Combivir (\[CBV\]; the fixed dose combination pill containing lamivudine + zidovudine \[150 mg/300 mg\]) twice daily from the start of the study until Week 144. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated CNS toxicity. At Week 144 all participants who opted to roll over into the additional 96-week study extension received ATR until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study.
Change From Baseline in CD4 Cell Count (Cells/mm^3) at Week 240 (Atripla Week 96)	346 CD4 Cell count (Cells/mm^3) Standard Deviation 197.2	42 CD4 Cell count (Cells/mm^3) Standard Deviation 148.2

SECONDARY outcome

Timeframe: Week 144 (Atripla Baseline) to Week 240 (Atripla Week 96)

Population: Atripla Efficacy Analysis Set

Change from Week 144 (Atripla Baseline) to Week 240 (Atripla Week 96) in limb fat = Week 240 (Atripla Week 96) limb fat value minus Week 144 (Atripla Baseline) limb fat value

Outcome measures

Measure	EFV+FTC+TDF n=213 Participants Participants in this group received 3 component drugs: efavirenz (EFV) 600 mg + emtricitabine (FTC) 200 mg + tenofovir disoproxil fumarate (tenofovir DF; TDF) 300 mg, each once daily, from the start of the study. At 96 weeks Truvada (\[TVD\] the fixed-dose combination pill containing FTC/TDF (200 mg/300 mg) replaced FTC + TDF; participants continued to receive EFV as before. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated central nervous system (CNS) toxicity. At Week 144 all participants who opted to roll over into the further 96-week study extension received Atripla (\[ATR\]; the fixed dose combination pill containing EFV/FTC/TDF, 600 mg/200 mg/300 mg) until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study.	CBV+EFV Participants in this group received EFV 600 mg once daily + Combivir (\[CBV\]; the fixed dose combination pill containing lamivudine + zidovudine \[150 mg/300 mg\]) twice daily from the start of the study until Week 144. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated CNS toxicity. At Week 144 all participants who opted to roll over into the additional 96-week study extension received ATR until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study.
Change in Limb Fat (kg) From Week 144 (Atripla Baseline) to Week 240 (Atripla Week 96)	0.12 limb fat (kg) Standard Deviation 1.657	—

SECONDARY outcome

Timeframe: Week 144 (Atripla Baseline) to Week 240 (Atripla Week 96)

Population: Atripla Efficacy Analysis Set

Change from Week 144 (Atripla Baseline) to Week 240 (Atripla Week 96) in trunk fat = Week 240 (Atripla Week 96) trunk fat value minus Week 144 (Atripla Baseline) trunk fat value

Outcome measures

Measure	EFV+FTC+TDF n=213 Participants Participants in this group received 3 component drugs: efavirenz (EFV) 600 mg + emtricitabine (FTC) 200 mg + tenofovir disoproxil fumarate (tenofovir DF; TDF) 300 mg, each once daily, from the start of the study. At 96 weeks Truvada (\[TVD\] the fixed-dose combination pill containing FTC/TDF (200 mg/300 mg) replaced FTC + TDF; participants continued to receive EFV as before. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated central nervous system (CNS) toxicity. At Week 144 all participants who opted to roll over into the further 96-week study extension received Atripla (\[ATR\]; the fixed dose combination pill containing EFV/FTC/TDF, 600 mg/200 mg/300 mg) until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study.	CBV+EFV Participants in this group received EFV 600 mg once daily + Combivir (\[CBV\]; the fixed dose combination pill containing lamivudine + zidovudine \[150 mg/300 mg\]) twice daily from the start of the study until Week 144. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated CNS toxicity. At Week 144 all participants who opted to roll over into the additional 96-week study extension received ATR until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study.
Change in Trunk Fat (kg) From Week 144 (Atripla Baseline) to Week 240 (Atripla Week 96)	0.27 trunk fat (kg) Standard Deviation 2.242	—

SECONDARY outcome

Timeframe: Week 144 (Atripla Baseline) to Week 240 (Atripla Week 96)

Population: Atripla Efficacy Analysis Set

Change from Week 144 (Atripla Baseline) to Week 240 (Atripla Week 96) in total body fat = Week 240 (Atripla Week 96) total body fat value minus Week 144 (Atripla Baseline) total body fat value

Outcome measures

Measure	EFV+FTC+TDF n=212 Participants Participants in this group received 3 component drugs: efavirenz (EFV) 600 mg + emtricitabine (FTC) 200 mg + tenofovir disoproxil fumarate (tenofovir DF; TDF) 300 mg, each once daily, from the start of the study. At 96 weeks Truvada (\[TVD\] the fixed-dose combination pill containing FTC/TDF (200 mg/300 mg) replaced FTC + TDF; participants continued to receive EFV as before. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated central nervous system (CNS) toxicity. At Week 144 all participants who opted to roll over into the further 96-week study extension received Atripla (\[ATR\]; the fixed dose combination pill containing EFV/FTC/TDF, 600 mg/200 mg/300 mg) until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study.	CBV+EFV Participants in this group received EFV 600 mg once daily + Combivir (\[CBV\]; the fixed dose combination pill containing lamivudine + zidovudine \[150 mg/300 mg\]) twice daily from the start of the study until Week 144. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated CNS toxicity. At Week 144 all participants who opted to roll over into the additional 96-week study extension received ATR until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study.
Change in Total Body Fat (kg) From Week 144 (Atripla Baseline) to Week 240 (Atripla Week 96)	0.37 total body fat (kg) Standard Deviation 3.747	—

SECONDARY outcome

Timeframe: Week 144 ([W 144]; Atripla baseline) to Week 240 ([W 240]; Atripla Week 96)

Population: Atripla Efficacy Analysis Set

Participants were asked: "In general, how satisfied are you with the convenience and simplicity of your current treatment regimen?" Possible responses were on a 4-category scale: "very satisfied"; "somewhat satisfied"; "somewhat dissatisfied"; and "very dissatisfied". For the evaluation of changes in treatment satisfaction from Week 144 (Atripla baseline) to Week 240 (Atripla Week 96) responses were dichotomized into "very satisfied" and "not very satisfied" ("not very satisfied" included "very dissatisfied"; "somewhat dissatisfied"; and "somewhat satisfied").

Outcome measures

Measure	EFV+FTC+TDF n=225 Participants Participants in this group received 3 component drugs: efavirenz (EFV) 600 mg + emtricitabine (FTC) 200 mg + tenofovir disoproxil fumarate (tenofovir DF; TDF) 300 mg, each once daily, from the start of the study. At 96 weeks Truvada (\[TVD\] the fixed-dose combination pill containing FTC/TDF (200 mg/300 mg) replaced FTC + TDF; participants continued to receive EFV as before. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated central nervous system (CNS) toxicity. At Week 144 all participants who opted to roll over into the further 96-week study extension received Atripla (\[ATR\]; the fixed dose combination pill containing EFV/FTC/TDF, 600 mg/200 mg/300 mg) until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study.	CBV+EFV Participants in this group received EFV 600 mg once daily + Combivir (\[CBV\]; the fixed dose combination pill containing lamivudine + zidovudine \[150 mg/300 mg\]) twice daily from the start of the study until Week 144. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated CNS toxicity. At Week 144 all participants who opted to roll over into the additional 96-week study extension received ATR until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study.
Treatment Satisfaction Questionnaire (Satisfaction With Convenience and Simplicity of Current Treatment Regimen): Change From Week 144 to Week 240 in the Category Shift From Atripla Baseline. Very satisfied (W 144 and W 240)	182 Participants	—
Treatment Satisfaction Questionnaire (Satisfaction With Convenience and Simplicity of Current Treatment Regimen): Change From Week 144 to Week 240 in the Category Shift From Atripla Baseline. Not very satisfied (W 144 and W 240)	6 Participants	—
Treatment Satisfaction Questionnaire (Satisfaction With Convenience and Simplicity of Current Treatment Regimen): Change From Week 144 to Week 240 in the Category Shift From Atripla Baseline. Very satisfied (W 144); not very satisfied (W 240)	8 Participants	—
Treatment Satisfaction Questionnaire (Satisfaction With Convenience and Simplicity of Current Treatment Regimen): Change From Week 144 to Week 240 in the Category Shift From Atripla Baseline. Not very satisfied (W 144); very satisfied (W 240)	29 Participants	—

SECONDARY outcome

Timeframe: Week 144 ([W 144]; Atripla baseline) to Week 240 ([W 240]; Atripla Week 96)

Population: Atripla Efficacy Analysis Set

Participants were asked: "In general, how satisfied are you with the ability of your current treatment regimen to control your HIV infection?" Possible responses were on a 4-category scale: "very satisfied"; "somewhat satisfied"; "somewhat dissatisfied"; and "very dissatisfied". For the evaluation of changes in treatment satisfaction from Week 144 (Atripla baseline) to Week 240 (Atripla Week 96) responses were dichotomized into "very satisfied" and "not very satisfied" ("not very satisfied" included "very dissatisfied"; "somewhat dissatisfied"; and "somewhat satisfied").

Outcome measures

Measure	EFV+FTC+TDF n=226 Participants Participants in this group received 3 component drugs: efavirenz (EFV) 600 mg + emtricitabine (FTC) 200 mg + tenofovir disoproxil fumarate (tenofovir DF; TDF) 300 mg, each once daily, from the start of the study. At 96 weeks Truvada (\[TVD\] the fixed-dose combination pill containing FTC/TDF (200 mg/300 mg) replaced FTC + TDF; participants continued to receive EFV as before. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated central nervous system (CNS) toxicity. At Week 144 all participants who opted to roll over into the further 96-week study extension received Atripla (\[ATR\]; the fixed dose combination pill containing EFV/FTC/TDF, 600 mg/200 mg/300 mg) until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study.	CBV+EFV Participants in this group received EFV 600 mg once daily + Combivir (\[CBV\]; the fixed dose combination pill containing lamivudine + zidovudine \[150 mg/300 mg\]) twice daily from the start of the study until Week 144. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated CNS toxicity. At Week 144 all participants who opted to roll over into the additional 96-week study extension received ATR until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study.
Treatment Satisfaction Questionnaire (Satisfaction With Current Treatment Regimen to Control HIV): Change From Week 144 to Week 240 in the Category Shift From Atripla Baseline. Very satisfied (W 144 and W 240)	192 Participants	—
Treatment Satisfaction Questionnaire (Satisfaction With Current Treatment Regimen to Control HIV): Change From Week 144 to Week 240 in the Category Shift From Atripla Baseline. Not very satisfied (W 144 and W 240)	8 Participants	—
Treatment Satisfaction Questionnaire (Satisfaction With Current Treatment Regimen to Control HIV): Change From Week 144 to Week 240 in the Category Shift From Atripla Baseline. Very satisfied (W 144); not very satisfied (W 240)	9 Participants	—
Treatment Satisfaction Questionnaire (Satisfaction With Current Treatment Regimen to Control HIV): Change From Week 144 to Week 240 in the Category Shift From Atripla Baseline. Not very satisfied (W 144); very satisfied (W 240)	17 Participants	—

SECONDARY outcome

Timeframe: Week 144 ([W 144]; Atripla baseline) to Week 240 ([W 240]; Atripla Week 96)

Population: Atripla Efficacy Analysis Set

Participants were asked: "In general, how satisfied are you with your ability to tolerate your current treatment regimen?" Possible responses were on a 4-category scale: "very satisfied"; "somewhat satisfied"; "somewhat dissatisfied"; and "very dissatisfied". For the evaluation of changes in treatment satisfaction from Week 144 (Atripla baseline) to Week 240 (Atripla Week 96) responses were dichotomized into "very satisfied" and "not very satisfied" ("not very satisfied" included "very dissatisfied"; "somewhat dissatisfied"; and "somewhat satisfied").

Outcome measures

Measure	EFV+FTC+TDF n=226 Participants Participants in this group received 3 component drugs: efavirenz (EFV) 600 mg + emtricitabine (FTC) 200 mg + tenofovir disoproxil fumarate (tenofovir DF; TDF) 300 mg, each once daily, from the start of the study. At 96 weeks Truvada (\[TVD\] the fixed-dose combination pill containing FTC/TDF (200 mg/300 mg) replaced FTC + TDF; participants continued to receive EFV as before. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated central nervous system (CNS) toxicity. At Week 144 all participants who opted to roll over into the further 96-week study extension received Atripla (\[ATR\]; the fixed dose combination pill containing EFV/FTC/TDF, 600 mg/200 mg/300 mg) until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study.	CBV+EFV Participants in this group received EFV 600 mg once daily + Combivir (\[CBV\]; the fixed dose combination pill containing lamivudine + zidovudine \[150 mg/300 mg\]) twice daily from the start of the study until Week 144. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated CNS toxicity. At Week 144 all participants who opted to roll over into the additional 96-week study extension received ATR until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study.
Treatment Satisfaction Questionnaire (Satisfaction With Tolerability of Current Treatment Regimen) Change From Week 144 to Week 240 in the Category Shift From Atripla Baseline. Not very satisfied (W 144 and W 240)	21 Participants	—
Treatment Satisfaction Questionnaire (Satisfaction With Tolerability of Current Treatment Regimen) Change From Week 144 to Week 240 in the Category Shift From Atripla Baseline. Very satisfied (W 144); not very satisfied (W 240)	13 Participants	—
Treatment Satisfaction Questionnaire (Satisfaction With Tolerability of Current Treatment Regimen) Change From Week 144 to Week 240 in the Category Shift From Atripla Baseline. Very satisfied (W 144 and W 240)	166 Participants	—
Treatment Satisfaction Questionnaire (Satisfaction With Tolerability of Current Treatment Regimen) Change From Week 144 to Week 240 in the Category Shift From Atripla Baseline. Not very satisfied (W 144); very satisfied (W 240)	26 Participants	—

SECONDARY outcome

Timeframe: Week 144 ([W 144]; Atripla baseline) to Week 240 ([W 240]; Atripla Week 96)

Population: Atripla Efficacy Analysis Set

Participants were asked: "In general, how satisfied are you with your current treatment regimen?" Possible responses were on a 4-category scale: "very satisfied"; "somewhat satisfied"; "somewhat dissatisfied"; and "very dissatisfied". For the evaluation of changes in treatment satisfaction from Week 144 (Atripla baseline) to Week 240 (Atripla Week 96) responses were dichotomized into "very satisfied" and "not very satisfied" ("not very satisfied" included "very dissatisfied"; "somewhat dissatisfied"; and "somewhat satisfied").

Outcome measures

Measure	EFV+FTC+TDF n=222 Participants Participants in this group received 3 component drugs: efavirenz (EFV) 600 mg + emtricitabine (FTC) 200 mg + tenofovir disoproxil fumarate (tenofovir DF; TDF) 300 mg, each once daily, from the start of the study. At 96 weeks Truvada (\[TVD\] the fixed-dose combination pill containing FTC/TDF (200 mg/300 mg) replaced FTC + TDF; participants continued to receive EFV as before. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated central nervous system (CNS) toxicity. At Week 144 all participants who opted to roll over into the further 96-week study extension received Atripla (\[ATR\]; the fixed dose combination pill containing EFV/FTC/TDF, 600 mg/200 mg/300 mg) until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study.	CBV+EFV Participants in this group received EFV 600 mg once daily + Combivir (\[CBV\]; the fixed dose combination pill containing lamivudine + zidovudine \[150 mg/300 mg\]) twice daily from the start of the study until Week 144. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated CNS toxicity. At Week 144 all participants who opted to roll over into the additional 96-week study extension received ATR until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study.
Treatment Satisfaction Questionnaire (General Satisfaction With Current Treatment Regimen): Change From Week 144 to Week 240 in the Category Shift From Atripla Baseline. Not very satisfied (W 144 and W 240)	10 Participants	—
Treatment Satisfaction Questionnaire (General Satisfaction With Current Treatment Regimen): Change From Week 144 to Week 240 in the Category Shift From Atripla Baseline. Very satisfied (W 144); not very satisfied (W 240)	9 Participants	—
Treatment Satisfaction Questionnaire (General Satisfaction With Current Treatment Regimen): Change From Week 144 to Week 240 in the Category Shift From Atripla Baseline. Very satisfied (W 144 and W 240)	180 Participants	—
Treatment Satisfaction Questionnaire (General Satisfaction With Current Treatment Regimen): Change From Week 144 to Week 240 in the Category Shift From Atripla Baseline. Not very satisfied (W 144); very satisfied (W 240)	23 Participants	—

SECONDARY outcome

Timeframe: Week 144 ([W 144]; Atripla baseline) to Week 240 ([W 240]; Atripla Week 96)

Population: Atripla Efficacy Analysis Set

Participants were asked: "How bothered are you with the side effects of your current treatment regimen?" Possible responses were on a 4-category scale: "does not bother me"; "bothers me a little bit"; "bothers me a lot"; and "bothers me terribly". For the evaluation of the change in treatment satisfaction from Week 144 (Atripla baseline) to Week 240 (Atripla Week 96) responses were dichotomized into "does not bother me" and "bothers me" ("bothers me" included "bothers me a little bit"; "bothers me a lot"; "bothers me terribly").

Outcome measures

Measure	EFV+FTC+TDF n=226 Participants Participants in this group received 3 component drugs: efavirenz (EFV) 600 mg + emtricitabine (FTC) 200 mg + tenofovir disoproxil fumarate (tenofovir DF; TDF) 300 mg, each once daily, from the start of the study. At 96 weeks Truvada (\[TVD\] the fixed-dose combination pill containing FTC/TDF (200 mg/300 mg) replaced FTC + TDF; participants continued to receive EFV as before. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated central nervous system (CNS) toxicity. At Week 144 all participants who opted to roll over into the further 96-week study extension received Atripla (\[ATR\]; the fixed dose combination pill containing EFV/FTC/TDF, 600 mg/200 mg/300 mg) until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study.	CBV+EFV Participants in this group received EFV 600 mg once daily + Combivir (\[CBV\]; the fixed dose combination pill containing lamivudine + zidovudine \[150 mg/300 mg\]) twice daily from the start of the study until Week 144. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated CNS toxicity. At Week 144 all participants who opted to roll over into the additional 96-week study extension received ATR until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study.
Treatment Satisfaction Questionnaire (Bothered With the Side Effects of Current Treatment Regimen): Change From Week 144 to Week 240 in the Category Shift From Atripla Baseline. Bothers me (W 144 and W 240)	41 Participants	—
Treatment Satisfaction Questionnaire (Bothered With the Side Effects of Current Treatment Regimen): Change From Week 144 to Week 240 in the Category Shift From Atripla Baseline. Does not bother me (W 144 and W 240)	126 Participants	—
Treatment Satisfaction Questionnaire (Bothered With the Side Effects of Current Treatment Regimen): Change From Week 144 to Week 240 in the Category Shift From Atripla Baseline. Bothers me (W 144); does not bother me (W 240)	31 Participants	—
Treatment Satisfaction Questionnaire (Bothered With the Side Effects of Current Treatment Regimen): Change From Week 144 to Week 240 in the Category Shift From Atripla Baseline. Does not bother me (W 144); bothers me (W 240)	28 Participants	—

SECONDARY outcome

Timeframe: Week 144 (Atripla Baseline) to Week 240 (Atripla Week 96)

Population: Atripla Efficacy Analysis Set

The change from Week 144 (Atripla baseline) to Week 240 (Atripla Week 96) in the SF-12v2 Health Survey: Physical Component Summary (PCS). The SF-12v2 includes 8 concepts commonly represented in health surveys: physical functioning, role functioning physical, bodily pain, general health, vitality, social functioning, role functioning emotional, and mental health. Results are expressed in terms of 2 composite scores: the PCS and the Mental Component Summary (MCS). PCS and MCS values can range from 0 to 100 and are designed to have a mean value of 50 and SD of 10 (in the general population).

Outcome measures

Measure	EFV+FTC+TDF n=213 Participants Participants in this group received 3 component drugs: efavirenz (EFV) 600 mg + emtricitabine (FTC) 200 mg + tenofovir disoproxil fumarate (tenofovir DF; TDF) 300 mg, each once daily, from the start of the study. At 96 weeks Truvada (\[TVD\] the fixed-dose combination pill containing FTC/TDF (200 mg/300 mg) replaced FTC + TDF; participants continued to receive EFV as before. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated central nervous system (CNS) toxicity. At Week 144 all participants who opted to roll over into the further 96-week study extension received Atripla (\[ATR\]; the fixed dose combination pill containing EFV/FTC/TDF, 600 mg/200 mg/300 mg) until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study.	CBV+EFV Participants in this group received EFV 600 mg once daily + Combivir (\[CBV\]; the fixed dose combination pill containing lamivudine + zidovudine \[150 mg/300 mg\]) twice daily from the start of the study until Week 144. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated CNS toxicity. At Week 144 all participants who opted to roll over into the additional 96-week study extension received ATR until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study.
Quality of Life (SF-12v2 Health Survey: Physical Component Summary) Change From Week 144 (Atripla Baseline) to Week 240 (Atripla Week 96)	0.0 Composite Score Standard Deviation 6.80	—

SECONDARY outcome

Timeframe: Week 144 (Atripla Baseline) to Week 240 (Atripla Week 96)

Population: Atripla Efficacy Analysis Set

The change from Week 144 (Atripla baseline) to Week 240 (Atripla Week 96) in the SF-12v2 Health Survey MCS. The SF-12v2 includes 8 concepts commonly represented in health surveys: physical functioning, role functioning physical, bodily pain, general health, vitality, social functioning, role functioning emotional, and mental health. Results are expressed in terms of 2 composite scores: the PCS and the MCS. PCS and MCS values can range from 0 to 100 and are designed to have a mean value of 50 and a SD of 10 (in the general population).

Outcome measures

Measure	EFV+FTC+TDF n=213 Participants Participants in this group received 3 component drugs: efavirenz (EFV) 600 mg + emtricitabine (FTC) 200 mg + tenofovir disoproxil fumarate (tenofovir DF; TDF) 300 mg, each once daily, from the start of the study. At 96 weeks Truvada (\[TVD\] the fixed-dose combination pill containing FTC/TDF (200 mg/300 mg) replaced FTC + TDF; participants continued to receive EFV as before. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated central nervous system (CNS) toxicity. At Week 144 all participants who opted to roll over into the further 96-week study extension received Atripla (\[ATR\]; the fixed dose combination pill containing EFV/FTC/TDF, 600 mg/200 mg/300 mg) until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study.	CBV+EFV Participants in this group received EFV 600 mg once daily + Combivir (\[CBV\]; the fixed dose combination pill containing lamivudine + zidovudine \[150 mg/300 mg\]) twice daily from the start of the study until Week 144. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated CNS toxicity. At Week 144 all participants who opted to roll over into the additional 96-week study extension received ATR until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study.
Quality of Life (SF-12v2 Health Survey: Mental Component Summary) Change From Week 144 (Atripla Baseline) to Week 240 (Atripla Week 96)	0.9 Composite Score Standard Deviation 8.65	—

Adverse Events

FTC+TDF+EFV (Baseline to 144 Weeks)

Serious events: 29 serious events

Other events: 233 other events

Deaths: 0 deaths

FTC+TDF+EFV/ATR (Baseline to 240 Weeks)

Serious events: 24 serious events

Other events: 152 other events

Deaths: 0 deaths

CBV+EFV (Baseline to 144 Weeks)

Serious events: 35 serious events

Other events: 222 other events

Deaths: 0 deaths

All Atripla (Week 144 to 240)

Serious events: 14 serious events

Other events: 190 other events

Deaths: 0 deaths

Serious adverse events

Measure	FTC+TDF+EFV (Baseline to 144 Weeks) n=257 participants at risk Exposure to the component drugs EFV+FTC+TDF during the randomized treatment phase was up to 144 weeks (TVD replaced FTC+TDF from Week 96). For this safety population, N=257.	FTC+TDF+EFV/ATR (Baseline to 240 Weeks) n=160 participants at risk Exposure to the component drugs EFV+FTC+TDF during the randomized treatment phase and during the Atripla treatment phase was up to 240 weeks (TVD replaced FTC+TDF at Week 96; ATR replaced TVD+EFV at Week 144). Exposure to ATR for 6 participants at sites in France was up to 288 weeks (this was due to a protocol amendment which allowed these participants to continue to receive ATR until it became commercially available). For this safety population, N=160.	CBV+EFV (Baseline to 144 Weeks) n=254 participants at risk Exposure to CBV+EFV during the randomized treatment phase was up to 144 weeks. For this safety population, N=254.	All Atripla (Week 144 to 240) n=286 participants at risk Exposure for all participants from both treatment groups who switched to ATR at Week 144 and continued treatment to Week 240 was up to 96 weeks. Exposure to ATR for 6 participants at sites in France was up to 144 weeks (this was due to a protocol amendment which allowed these participants to continue to receive ATR until it became commercially available). For this safety population, N=286.
Gastrointestinal disorders Abdominal Pain	0.39% 1/257 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).	0.00% 0/160 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).	0.00% 0/254 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).	0.00% 0/286 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).
Cardiac disorders Acute Myocardial Infarction	0.39% 1/257 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).	0.00% 0/160 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).	0.00% 0/254 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).	0.35% 1/286 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).
Respiratory, thoracic and mediastinal disorders Acute Pulmonary Edema	0.00% 0/257 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).	0.00% 0/160 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).	0.39% 1/254 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).	0.00% 0/286 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).
Psychiatric disorders Alcoholism	0.39% 1/257 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).	0.62% 1/160 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).	0.00% 0/254 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).	0.00% 0/286 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).
Blood and lymphatic system disorders Anaemia	0.00% 0/257 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).	0.00% 0/160 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).	2.8% 7/254 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).	0.00% 0/286 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Anal Cancer Metastatic	0.00% 0/257 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).	0.62% 1/160 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).	0.00% 0/254 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).	0.35% 1/286 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).
Infections and infestations Appendicitis	0.78% 2/257 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).	1.2% 2/160 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).	0.79% 2/254 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).	0.00% 0/286 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).
Endocrine disorders Basedow's Disease	0.39% 1/257 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).	0.00% 0/160 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).	0.00% 0/254 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).	0.00% 0/286 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).
Reproductive system and breast disorders Benign Prostatic Hyperplasia	0.00% 0/257 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).	0.62% 1/160 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).	0.00% 0/254 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).	0.35% 1/286 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).
Cardiac disorders Cardiac Disorder	0.00% 0/257 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).	0.00% 0/160 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).	0.00% 0/254 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).	0.35% 1/286 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).
Nervous system disorders Carpal Tunnel Syndrome	0.00% 0/257 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).	0.00% 0/160 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).	0.39% 1/254 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).	0.00% 0/286 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).
Infections and infestations Catheter Sepsis	0.00% 0/257 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).	0.00% 0/160 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).	0.39% 1/254 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).	0.00% 0/286 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).
Infections and infestations Cellulitis	0.00% 0/257 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).	0.00% 0/160 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).	0.39% 1/254 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).	0.00% 0/286 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).
Infections and infestations Cellulitis Staphylococcus	0.00% 0/257 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).	0.00% 0/160 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).	0.39% 1/254 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).	0.00% 0/286 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).
Nervous system disorders Cerebrovascular Accident	0.00% 0/257 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).	0.00% 0/160 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).	0.39% 1/254 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).	0.35% 1/286 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).
Nervous system disorders Cervicobrachial Syndrome	0.00% 0/257 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).	0.00% 0/160 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).	0.39% 1/254 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).	0.00% 0/286 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cervix Carcinoma Stage 0	0.39% 1/257 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).	0.00% 0/160 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).	0.00% 0/254 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).	0.00% 0/286 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).
General disorders Chest pain	0.00% 0/257 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).	0.00% 0/160 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).	0.39% 1/254 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).	0.00% 0/286 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).
Surgical and medical procedures Cholecystectomy	0.39% 1/257 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).	0.00% 0/160 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).	0.00% 0/254 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).	0.00% 0/286 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).
Psychiatric disorders Completed Suicide	0.00% 0/257 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).	0.00% 0/160 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).	0.00% 0/254 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).	0.35% 1/286 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).
Nervous system disorders Convulsion	0.00% 0/257 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).	0.00% 0/160 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).	0.39% 1/254 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).	0.00% 0/286 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).
Gastrointestinal disorders Dental Caries	0.39% 1/257 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).	0.62% 1/160 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).	0.00% 0/254 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).	0.00% 0/286 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).
Psychiatric disorders Depression	0.00% 0/257 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).	0.00% 0/160 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).	0.39% 1/254 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).	0.00% 0/286 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).
Skin and subcutaneous tissue disorders Drug Eruption	0.39% 1/257 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).	0.00% 0/160 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).	0.00% 0/254 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).	0.00% 0/286 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).
Pregnancy, puerperium and perinatal conditions Ectopic Pregnancy	0.39% 1/257 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).	0.00% 0/160 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).	0.00% 0/254 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).	0.00% 0/286 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).
Infections and infestations Enterocolitis Infectious	0.00% 0/257 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).	0.00% 0/160 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).	0.39% 1/254 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).	0.00% 0/286 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).
Infections and infestations Escherichia Bacteriemia	0.00% 0/257 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).	0.00% 0/160 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).	0.39% 1/254 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).	0.00% 0/286 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).
Injury, poisoning and procedural complications Femoral Neck Fracture	0.39% 1/257 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).	0.00% 0/160 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).	0.00% 0/254 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).	0.00% 0/286 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).
Infections and infestations Furuncle	0.00% 0/257 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).	0.00% 0/160 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).	0.39% 1/254 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).	0.00% 0/286 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).
Gastrointestinal disorders Gastritis	0.00% 0/257 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).	0.00% 0/160 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).	0.39% 1/254 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).	0.00% 0/286 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).
Infections and infestations Gastroenteritis Cryptosporidial	0.39% 1/257 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).	0.62% 1/160 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).	0.00% 0/254 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).	0.00% 0/286 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).
Infections and infestations Gastroenteritis Salmonella	0.00% 0/257 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).	0.62% 1/160 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).	0.00% 0/254 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).	0.35% 1/286 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).
Infections and infestations Hepatitis C	0.00% 0/257 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).	0.62% 1/160 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).	0.00% 0/254 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).	0.35% 1/286 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).
Respiratory, thoracic and mediastinal disorders Hiccups	0.39% 1/257 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).	0.00% 0/160 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).	0.00% 0/254 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).	0.00% 0/286 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).
Metabolism and nutrition disorders Hypercreatinaemia	0.00% 0/257 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).	0.00% 0/160 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).	0.39% 1/254 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).	0.00% 0/286 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).
Vascular disorders Hypertensive Crisis	0.39% 1/257 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).	0.00% 0/160 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).	0.00% 0/254 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).	0.00% 0/286 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).
Metabolism and nutrition disorders Hypoglycemia	0.00% 0/257 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).	0.00% 0/160 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).	0.39% 1/254 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).	0.00% 0/286 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).
Immune system disorders Immune Reconstitution Syndrome	0.00% 0/257 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).	0.00% 0/160 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).	0.39% 1/254 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).	0.00% 0/286 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).
Injury, poisoning and procedural complications Incisional Hernia	0.00% 0/257 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).	0.00% 0/160 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).	0.39% 1/254 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).	0.00% 0/286 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).
Injury, poisoning and procedural complications Intentional Overdose	0.39% 1/257 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).	0.62% 1/160 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).	0.00% 0/254 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).	0.00% 0/286 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Kaposi's Sarcoma	0.39% 1/257 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).	0.00% 0/160 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).	0.00% 0/254 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).	0.00% 0/286 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).
Infections and infestations Lobar Pneumonia	0.39% 1/257 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).	0.62% 1/160 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).	0.00% 0/254 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).	0.00% 0/286 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).
Injury, poisoning and procedural complications Lower Limb Fracture	0.00% 0/257 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).	0.00% 0/160 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).	0.39% 1/254 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).	0.00% 0/286 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).
Infections and infestations Lower Respiratory Tract Infection	0.00% 0/257 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).	0.00% 0/160 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).	0.39% 1/254 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).	0.00% 0/286 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung Adenocarcinoma	0.39% 1/257 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).	0.00% 0/160 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).	0.00% 0/254 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).	0.00% 0/286 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).
Infections and infestations Mastoiditis	0.39% 1/257 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).	0.00% 0/160 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).	0.00% 0/254 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).	0.00% 0/286 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).
Infections and infestations Meningitis Cryptococcal	0.39% 1/257 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).	0.00% 0/160 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).	0.39% 1/254 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).	0.00% 0/286 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).
Infections and infestations Meningitis Viral	0.00% 0/257 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).	0.00% 0/160 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).	0.39% 1/254 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).	0.00% 0/286 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).
Nervous system disorders Meningorrhagia	0.39% 1/257 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).	0.62% 1/160 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).	0.00% 0/254 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).	0.00% 0/286 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastatic Neoplasm	0.00% 0/257 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).	0.00% 0/160 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).	0.39% 1/254 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).	0.00% 0/286 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).
Infections and infestations Mycobacterium Avium Complex Infection	0.00% 0/257 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).	0.00% 0/160 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).	0.39% 1/254 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).	0.00% 0/286 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).
Infections and infestations Mycobacterium Kansasii Infection	0.39% 1/257 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).	0.00% 0/160 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).	0.00% 0/254 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).	0.00% 0/286 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).
Renal and urinary disorders Nephrolithiasis	0.78% 2/257 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).	1.2% 2/160 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).	0.00% 0/254 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).	0.00% 0/286 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).
Skin and subcutaneous tissue disorders Neurodermatitis	0.39% 1/257 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).	0.62% 1/160 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).	0.00% 0/254 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).	0.00% 0/286 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).
Cardiac disorders Nodal Rhythm	0.39% 1/257 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).	0.62% 1/160 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).	0.00% 0/254 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).	0.00% 0/286 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Non-Hodgkin's Lymphoma	0.39% 1/257 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).	0.00% 0/160 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).	0.00% 0/254 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).	0.00% 0/286 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).
Musculoskeletal and connective tissue disorders Osteonecrosis	0.00% 0/257 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).	0.62% 1/160 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).	0.00% 0/254 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).	0.35% 1/286 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).
Gastrointestinal disorders Pancreatitis	0.39% 1/257 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).	0.00% 0/160 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).	0.00% 0/254 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).	0.00% 0/286 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).
Gastrointestinal disorders Pancreatitis Acute	0.00% 0/257 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).	0.00% 0/160 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).	0.39% 1/254 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).	0.00% 0/286 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).
Vascular disorders Peripheral Ischemia	0.00% 0/257 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).	0.00% 0/160 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).	0.39% 1/254 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).	0.00% 0/286 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).
Infections and infestations Perirectal abscess	0.39% 1/257 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).	0.62% 1/160 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).	0.00% 0/254 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).	0.00% 0/286 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).
Infections and infestations Pneumonia	0.78% 2/257 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).	1.9% 3/160 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).	0.79% 2/254 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).	0.35% 1/286 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).
Infections and infestations Progressive Multifocal Leukoencephalopathy	0.00% 0/257 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).	0.00% 0/160 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).	0.39% 1/254 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).	0.00% 0/286 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).
Psychiatric disorders Psychotic Disorder	0.00% 0/257 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).	0.00% 0/160 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).	0.39% 1/254 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).	0.00% 0/286 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).
Infections and infestations Rectal Abscess	0.00% 0/257 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).	0.00% 0/160 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).	0.39% 1/254 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).	0.00% 0/286 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).
Infections and infestations Secondary Syphilis	0.00% 0/257 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).	0.62% 1/160 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).	0.00% 0/254 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).	0.35% 1/286 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).
Infections and infestations Sepsis	0.39% 1/257 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).	0.00% 0/160 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).	0.00% 0/254 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).	0.00% 0/286 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).
Surgical and medical procedures Splenectomy	0.39% 1/257 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).	0.00% 0/160 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).	0.00% 0/254 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).	0.00% 0/286 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).
Infections and infestations Staphylococcal Abscess	0.00% 0/257 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).	0.00% 0/160 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).	0.79% 2/254 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).	0.00% 0/286 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).
Infections and infestations Subcutaneous Abscess	0.00% 0/257 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).	1.2% 2/160 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).	0.00% 0/254 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).	0.70% 2/286 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).
Psychiatric disorders Suicidal Ideation	0.00% 0/257 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).	0.00% 0/160 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).	0.39% 1/254 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).	0.00% 0/286 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).
Nervous system disorders Syncope	0.00% 0/257 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).	0.00% 0/160 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).	0.39% 1/254 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).	0.00% 0/286 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).
Cardiac disorders Tachyarrhythmia	0.00% 0/257 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).	0.00% 0/160 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).	0.00% 0/254 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).	0.35% 1/286 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).
Infections and infestations Tonsillitis Streptococcal	0.39% 1/257 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).	0.62% 1/160 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).	0.00% 0/254 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).	0.00% 0/286 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).
Nervous system disorders Transient Ischemic Attack	0.39% 1/257 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).	0.62% 1/160 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).	0.00% 0/254 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).	0.00% 0/286 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).
Injury, poisoning and procedural complications Traumatic Brain Injury	0.00% 0/257 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).	0.00% 0/160 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).	0.39% 1/254 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).	0.00% 0/286 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).
Infections and infestations Upper Respiratory Tract Infection	0.00% 0/257 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).	0.62% 1/160 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).	0.00% 0/254 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).	0.35% 1/286 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).
Renal and urinary disorders Ureteric Obstruction	0.39% 1/257 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).	0.62% 1/160 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).	0.00% 0/254 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).	0.00% 0/286 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Uterine Leiomyoma	0.00% 0/257 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).	0.00% 0/160 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).	0.39% 1/254 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).	0.00% 0/286 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).
Injury, poisoning and procedural complications Vascular Graft Occlusion	0.00% 0/257 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).	0.00% 0/160 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).	0.39% 1/254 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).	0.00% 0/286 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).

Other adverse events

Measure	FTC+TDF+EFV (Baseline to 144 Weeks) n=257 participants at risk Exposure to the component drugs EFV+FTC+TDF during the randomized treatment phase was up to 144 weeks (TVD replaced FTC+TDF from Week 96). For this safety population, N=257.	FTC+TDF+EFV/ATR (Baseline to 240 Weeks) n=160 participants at risk Exposure to the component drugs EFV+FTC+TDF during the randomized treatment phase and during the Atripla treatment phase was up to 240 weeks (TVD replaced FTC+TDF at Week 96; ATR replaced TVD+EFV at Week 144). Exposure to ATR for 6 participants at sites in France was up to 288 weeks (this was due to a protocol amendment which allowed these participants to continue to receive ATR until it became commercially available). For this safety population, N=160.	CBV+EFV (Baseline to 144 Weeks) n=254 participants at risk Exposure to CBV+EFV during the randomized treatment phase was up to 144 weeks. For this safety population, N=254.	All Atripla (Week 144 to 240) n=286 participants at risk Exposure for all participants from both treatment groups who switched to ATR at Week 144 and continued treatment to Week 240 was up to 96 weeks. Exposure to ATR for 6 participants at sites in France was up to 144 weeks (this was due to a protocol amendment which allowed these participants to continue to receive ATR until it became commercially available). For this safety population, N=286.
Skin and subcutaneous tissue disorders Rash	15.2% 39/257 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).	16.9% 27/160 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).	13.0% 33/254 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).	2.8% 8/286 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).
Gastrointestinal disorders Abdominal Pain	4.7% 12/257 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).	5.6% 9/160 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).	5.5% 14/254 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).	1.4% 4/286 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).
Psychiatric disorders Abnormal Dreams	17.5% 45/257 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).	20.6% 33/160 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).	13.4% 34/254 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).	1.0% 3/286 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).
Blood and lymphatic system disorders Anaemia	0.78% 2/257 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).	0.00% 0/160 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).	6.7% 17/254 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).	0.00% 0/286 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).
Infections and infestations Anogenital Warts	3.9% 10/257 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).	5.6% 9/160 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).	5.5% 14/254 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).	1.7% 5/286 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).
Psychiatric disorders Anxiety	5.8% 15/257 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).	9.4% 15/160 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).	7.5% 19/254 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).	2.4% 7/286 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).
Musculoskeletal and connective tissue disorders Arthralgia	7.4% 19/257 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).	10.6% 17/160 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).	5.5% 14/254 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).	4.2% 12/286 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).
Musculoskeletal and connective tissue disorders Back Pain	10.1% 26/257 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).	15.0% 24/160 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).	7.9% 20/254 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).	5.6% 16/286 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).
Infections and infestations Bronchitis	8.6% 22/257 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).	13.1% 21/160 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).	5.5% 14/254 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).	3.1% 9/286 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).
General disorders Chest Pain	0.00% 0/257 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).	5.0% 8/160 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).	0.00% 0/254 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).	1.0% 3/286 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).
Eye disorders Conjunctivitis	0.00% 0/257 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).	8.1% 13/160 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).	0.00% 0/254 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).	2.1% 6/286 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).
Respiratory, thoracic and mediastinal disorders Cough	12.1% 31/257 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).	20.0% 32/160 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).	12.2% 31/254 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).	5.2% 15/286 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).
Psychiatric disorders Depression	14.8% 38/257 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).	18.8% 30/160 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).	12.6% 32/254 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).	7.3% 21/286 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).
Gastrointestinal disorders Diarrhoea	28.4% 73/257 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).	35.6% 57/160 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).	19.7% 50/254 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).	10.1% 29/286 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).
Nervous system disorders Dizziness	27.6% 71/257 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).	31.2% 50/160 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).	29.1% 74/254 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).	3.1% 9/286 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).
Gastrointestinal disorders Dyspepsia	3.1% 8/257 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).	5.0% 8/160 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).	5.9% 15/254 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).	1.7% 5/286 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).
Infections and infestations Ear Infection	0.00% 0/257 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).	5.6% 9/160 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).	0.00% 0/254 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).	1.0% 3/286 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).
Skin and subcutaneous tissue disorders Eczema	0.00% 0/257 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).	6.2% 10/160 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).	0.00% 0/254 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).	1.0% 3/286 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).
Reproductive system and breast disorders Erectile Dysfunction	0.00% 0/257 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).	5.6% 9/160 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).	0.00% 0/254 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).	0.70% 2/286 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).
General disorders Fatigue	17.9% 46/257 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).	21.2% 34/160 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).	18.1% 46/254 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).	4.9% 14/286 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).
Infections and infestations Folliculitis	5.8% 15/257 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).	7.5% 12/160 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).	4.7% 12/254 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).	0.70% 2/286 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).
Infections and infestations Gastroenteritis	0.00% 0/257 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).	5.6% 9/160 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).	0.00% 0/254 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).	1.4% 4/286 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).
Gastrointestinal disorders Gastrooesophageal Reflux Disease	0.00% 0/257 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).	5.0% 8/160 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).	0.00% 0/254 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).	1.4% 4/286 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).
Gastrointestinal disorders Haemorrhoids	3.9% 10/257 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).	6.9% 11/160 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).	5.1% 13/254 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).	2.4% 7/286 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).
Nervous system disorders Headache	19.8% 51/257 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).	25.0% 40/160 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).	16.9% 43/254 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).	5.6% 16/286 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).
Infections and infestations Herpes Simplex	7.0% 18/257 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).	0.00% 0/160 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).	8.3% 21/254 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).	0.00% 0/286 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).
Infections and infestations Herpes Zoster	4.7% 12/257 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).	8.1% 13/160 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).	5.1% 13/254 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).	2.8% 8/286 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).
Vascular disorders Hypertension	0.00% 0/257 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).	8.1% 13/160 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).	0.00% 0/254 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).	3.8% 11/286 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).
Infections and infestations Influenza	7.4% 19/257 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).	10.6% 17/160 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).	4.3% 11/254 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).	4.2% 12/286 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).
Psychiatric disorders Insomnia	17.1% 44/257 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).	23.8% 38/160 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).	17.7% 45/254 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).	7.7% 22/286 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).
Blood and lymphatic system disorders Lymphadenopathy	0.00% 0/257 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).	5.0% 8/160 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).	0.00% 0/254 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).	1.4% 4/286 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).
Musculoskeletal and connective tissue disorders Myalgia	6.6% 17/257 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).	8.1% 13/160 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).	4.3% 11/254 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).	0.70% 2/286 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).
Respiratory, thoracic and mediastinal disorders Nasal Congestion	6.6% 17/257 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).	10.0% 16/160 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).	3.5% 9/254 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).	3.8% 11/286 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).
Infections and infestations Nasopharyngitis	17.5% 45/257 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).	30.6% 49/160 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).	13.0% 33/254 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).	14.7% 42/286 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).
Gastrointestinal disorders Nausea	25.7% 66/257 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).	23.1% 37/160 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).	32.7% 83/254 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).	2.1% 6/286 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).
Skin and subcutaneous tissue disorders Night Sweats	6.2% 16/257 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).	5.6% 9/160 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).	3.5% 9/254 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).	2.1% 6/286 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).
Infections and infestations Onychomycosis	0.00% 0/257 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).	8.1% 13/160 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).	0.00% 0/254 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).	1.7% 5/286 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).
Infections and infestations Oral Herpes	0.00% 0/257 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).	6.2% 10/160 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).	0.00% 0/254 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).	1.4% 4/286 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).
Respiratory, thoracic and mediastinal disorders Oropharyngeal Pain	0.00% 0/257 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).	10.0% 16/160 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).	0.00% 0/254 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).	2.8% 8/286 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).
Musculoskeletal and connective tissue disorders Pain in Extremity	0.00% 0/257 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).	7.5% 12/160 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).	0.00% 0/254 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).	2.4% 7/286 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).
Respiratory, thoracic and mediastinal disorders Pharyngolaryngeal Pain	5.4% 14/257 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).	0.00% 0/160 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).	11.0% 28/254 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).	0.00% 0/286 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).
Skin and subcutaneous tissue disorders Pruritis	6.2% 16/257 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).	7.5% 12/160 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).	5.9% 15/254 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).	1.4% 4/286 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).
Respiratory, thoracic and mediastinal disorders Pulmonary Congestion	0.00% 0/257 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).	6.9% 11/160 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).	0.00% 0/254 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).	1.7% 5/286 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).
General disorders Pyrexia	9.3% 24/257 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).	15.0% 24/160 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).	6.7% 17/254 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).	4.2% 12/286 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).
Respiratory, thoracic and mediastinal disorders Rhinitis Allergic	0.00% 0/257 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).	6.2% 10/160 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).	0.00% 0/254 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).	1.0% 3/286 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).
Immune system disorders Seasonal Allergy	0.00% 0/257 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).	11.2% 18/160 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).	0.00% 0/254 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).	4.2% 12/286 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).
Respiratory, thoracic and mediastinal disorders Sinus Congestion	4.7% 12/257 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).	8.8% 14/160 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).	8.3% 21/254 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).	4.2% 12/286 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).
Infections and infestations Sinusitis	12.8% 33/257 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).	21.9% 35/160 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).	6.7% 17/254 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).	6.6% 19/286 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).
Nervous system disorders Somnolence	7.0% 18/257 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).	7.5% 12/160 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).	6.7% 17/254 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).	0.00% 0/286 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).
Infections and infestations Syphilis	0.00% 0/257 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).	6.9% 11/160 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).	0.00% 0/254 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).	3.8% 11/286 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).
Infections and infestations Tinea Pedis	0.00% 0/257 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).	6.2% 10/160 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).	0.00% 0/254 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).	2.8% 8/286 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).
Infections and infestations Tooth Abscess	0.00% 0/257 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).	5.6% 9/160 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).	0.00% 0/254 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).	0.70% 2/286 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).
Infections and infestations Upper Respiratory Tract Infection	18.7% 48/257 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).	30.6% 49/160 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).	10.6% 27/254 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).	10.5% 30/286 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).
Gastrointestinal disorders Vomiting	7.8% 20/257 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).	9.4% 15/160 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).	13.0% 33/254 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).	1.0% 3/286 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).
Investigations Weight Decreased	0.00% 0/257 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).	5.6% 9/160 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).	0.00% 0/254 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).	1.7% 5/286 • Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla). AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).

Additional Information

Dara Wambach MA, Associate Director, Regulatory Affairs

Gilead Sciences

Phone: 650-522-5163

Email: dara.wambach@gilead.com

Results disclosure agreements

• Principal investigator is a sponsor employee The PI may publish study results 2 years after the completion of the study or earlier with the advance written permission of Gilead. The PI will submit any proposed publication or presentation of study results together with the name of the proposed scientific journal, forum or confeence to Gilead prior to submission or presentation (30 days prior for manuscripts and 15 days for abstracts and oral presentations).
• Publication restrictions are in place

Restriction type: OTHER