Trial Outcomes & Findings for TMC278-TiDP6-C209: A Clinical Trial in Treatment Naive HIV-1 Patients Comparing TMC278 to Efavirenz in Combination With Tenofovir + Emtricitabine. (NCT NCT00540449)

Last Updated: 2016-03-29

Results Overview

Virological response is defined as confirmed plasma viral load less than (\<) 50 human immunodeficiency virus-1 (HIV-1) (ribonucleic acid \[RNA\]) copies/milliliter (ml) at Week 48. The TLOVR algorithm was used to derive response. Response needed to be confirmed at 2 consecutive visits and participants who permanently discontinued were considered nonresponders after discontinuation. Resuppression after confirmed virologic failure was considered as failure. Virologic Failure includes participants who were rebounder (confirmed viral load \>= 50 copies/ml after being responder) or who were never suppressed (no confirmed viral load \<50 copies/ml).

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

694 participants

Primary outcome timeframe

Week 48

Results posted on

2016-03-29

Participant Flow

One hundred and twelve sites in 21 countries randomized participants. In total, 694 participants were randomized: four participants did not start treatment and 690 participants started treatment (346 in the TMC278 group and 344 in the efavirenz \[control \] group).

Participant milestones

Participant milestones
Measure	TMC278 25 milligram (mg) tablet once daily for 96 weeks.	Efavirenz 600 mg once daily for 96 weeks.
Overall Study STARTED	346	344
Overall Study COMPLETED	262	266
Overall Study NOT COMPLETED	84	78

Reasons for withdrawal

Reasons for withdrawal
Measure	TMC278 25 milligram (mg) tablet once daily for 96 weeks.	Efavirenz 600 mg once daily for 96 weeks.
Overall Study Adverse Event	12	32
Overall Study Sponsor's Decision	1	1
Overall Study Subject Ineligible To Continue The Trial	2	1
Overall Study Lost to Follow-up	19	17
Overall Study Subject Non-Compliant	7	5
Overall Study Subject Reached A Virologic Endpoint	32	8
Overall Study Withdrawal by Subject	10	10
Overall Study Other	1	4

Baseline Characteristics

TMC278-TiDP6-C209: A Clinical Trial in Treatment Naive HIV-1 Patients Comparing TMC278 to Efavirenz in Combination With Tenofovir + Emtricitabine.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	TMC278 n=346 Participants 25 milligram (mg) tablet once daily for 96 weeks.	Efavirenz n=344 Participants 600 mg once daily for 96 weeks.	Total n=690 Participants Total of all reporting groups
Age, Categorical <=18 years	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	343 Participants n=5 Participants	343 Participants n=7 Participants	686 Participants n=5 Participants
Age, Categorical >=65 years	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Age, Continuous	37 years STANDARD_DEVIATION 9.68 • n=5 Participants	36.7 years STANDARD_DEVIATION 9.51 • n=7 Participants	36.8 years STANDARD_DEVIATION 9.59 • n=5 Participants
Sex: Female, Male Female	78 Participants n=5 Participants	69 Participants n=7 Participants	147 Participants n=5 Participants
Sex: Female, Male Male	268 Participants n=5 Participants	275 Participants n=7 Participants	543 Participants n=5 Participants
Region Enroll Africa	32 participants n=5 Participants	31 participants n=7 Participants	63 participants n=5 Participants
Region Enroll Asia	47 participants n=5 Participants	51 participants n=7 Participants	98 participants n=5 Participants
Region Enroll Latin America	60 participants n=5 Participants	69 participants n=7 Participants	129 participants n=5 Participants
Region Enroll USA, Canada, Europe, Australia	207 participants n=5 Participants	193 participants n=7 Participants	400 participants n=5 Participants

PRIMARY outcome

Timeframe: Week 48

Population: The ITT analysis set was considered the primary efficacy analysis set.

Outcome measures

Outcome measures
Measure	TMC278 n=346 Participants 25 milligram (mg) tablet once daily for 96 weeks.	Efavirenz n=344 Participants 600 mg once daily for 96 weeks.
Number of Participants With Virological Response (Intent-to-Treat - Time to Loss of Virologic Response [TLOVR], <50 Copies/ml) at Week 48 Responder	287 Participants	285 Participants
Number of Participants With Virological Response (Intent-to-Treat - Time to Loss of Virologic Response [TLOVR], <50 Copies/ml) at Week 48 Virologic failure	38 Participants	15 Participants
Number of Participants With Virological Response (Intent-to-Treat - Time to Loss of Virologic Response [TLOVR], <50 Copies/ml) at Week 48 Discontinued due to Adverse Event (AE)	6 Participants	25 Participants
Number of Participants With Virological Response (Intent-to-Treat - Time to Loss of Virologic Response [TLOVR], <50 Copies/ml) at Week 48 Discontinued due to other reason than AE	15 Participants	19 Participants

SECONDARY outcome

Timeframe: Week 48

Population: The ITT analysis set was considered the primary efficacy analysis set.

The analysis is based on the last observed viral load (VL) data within the Week 48 window. Virologic response is defined as a VL\<50 copies/ml (observed case). Missing VL was considered as non-response. Virologic Failure includes subjects who had VL\>=50 copies/ml in the Wk48 window, subjects who discontinued early due to lack or loss of efficacy, subjects who discontinued for reasons other than an adverse event, death or lack or loss of efficacy and at the time of discontinuation had a VL\>=50 copies/ml and subjects who had a switch in background regimen that was not permitted by the protocol.

Outcome measures

Outcome measures
Measure	TMC278 n=346 Participants 25 milligram (mg) tablet once daily for 96 weeks.	Efavirenz n=344 Participants 600 mg once daily for 96 weeks.
The Number of Participants With Virological Response (Intent-to-Treat - Snapshot, <50 Copies/ml) at Week 48 No Viral Load Data in 48 week window	14 Participants	39 Participants
The Number of Participants With Virological Response (Intent-to-Treat - Snapshot, <50 Copies/ml) at Week 48 Virologic Response HIV RNA <50 copies/mL at Wk 48	285 Participants	281 Participants
The Number of Participants With Virological Response (Intent-to-Treat - Snapshot, <50 Copies/ml) at Week 48 Virologic Failure	47 Participants	24 Participants

SECONDARY outcome

Timeframe: Week 96

Population: The ITT analysis set was considered the primary efficacy analysis set.

Outcome measures

Outcome measures
Measure	TMC278 n=346 Participants 25 milligram (mg) tablet once daily for 96 weeks.	Efavirenz n=344 Participants 600 mg once daily for 96 weeks.
Number of Participants With Virological Response (Intent-to-Treat - Time to Loss of Virologic Response [TLOVR], <50 Copies/ml) at Week 96 Discontinued due to AE	10 Participants	29 Participants
Number of Participants With Virological Response (Intent-to-Treat - Time to Loss of Virologic Response [TLOVR], <50 Copies/ml) at Week 96 Responder	263 Participants	271 Participants
Number of Participants With Virological Response (Intent-to-Treat - Time to Loss of Virologic Response [TLOVR], <50 Copies/ml) at Week 96 Virologic failure	45 Participants	16 Participants
Number of Participants With Virological Response (Intent-to-Treat - Time to Loss of Virologic Response [TLOVR], <50 Copies/ml) at Week 96 Death	0 Participants	3 Participants
Number of Participants With Virological Response (Intent-to-Treat - Time to Loss of Virologic Response [TLOVR], <50 Copies/ml) at Week 96 Discontinued due to other reason than AE	28 Participants	25 Participants

SECONDARY outcome

Timeframe: Week 96

Population: The Intent-to-Treat analysis set was considered the primary efficacy analysis set.

Outcome measures

Outcome measures
Measure	TMC278 n=346 Participants 25 milligram (mg) tablet once daily for 96 weeks.	Efavirenz n=344 Participants 600 mg once daily for 96 weeks.
The Number of Participants With Virological Response (Intent-to-Treat - Snapshot, <50 Copies/ml) at Week 96 Virologic Response, <50 copies/ml	265 Participants	268 Participants
The Number of Participants With Virological Response (Intent-to-Treat - Snapshot, <50 Copies/ml) at Week 96 Virologic failure	54 Participants	27 Participants
The Number of Participants With Virological Response (Intent-to-Treat - Snapshot, <50 Copies/ml) at Week 96 No viral load data in the 96 week window	27 Participants	49 Participants

SECONDARY outcome

Timeframe: Variable, ranging from 3 months up to maximum 15 months for TMC278 and 12 months for Efavirenz after the 96-week visit

Population: Participants with at least 1 Post-Week 96 visit were included in the analysis.

Virological response is defined as (observed) plasma viral load less than 50 human immunodeficiency virus-type 1 (HIV-1) ribonucleic acid (RNA) copies per ml at the last on-treatment visit (post-Week 96).

Outcome measures

Outcome measures
Measure	TMC278 n=258 Participants 25 milligram (mg) tablet once daily for 96 weeks.	Efavirenz n=271 Participants 600 mg once daily for 96 weeks.
Number of Participants With Virological Response (Observed, <50 Copies/ml) at Last On-Treatment Visit (Post-Week 96).	245 Participants	261 Participants

SECONDARY outcome

Timeframe: Week 48

Population: The ITT analysis set was considered the primary efficacy analysis set.

Outcome measures

Outcome measures
Measure	TMC278 n=346 Participants 25 milligram (mg) tablet once daily for 96 weeks.	Efavirenz n=344 Participants 600 mg once daily for 96 weeks.
Number of Participants With Virological Response (Intent-to-Treat - Time to Loss of Virologic Response [TLOVR], <400 Copies/ml) at Week 48	297 Participants	293 Participants

SECONDARY outcome

Timeframe: Week 96

Population: The ITT analysis set was considered the primary efficacy analysis set.

Outcome measures

Outcome measures
Measure	TMC278 n=346 Participants 25 milligram (mg) tablet once daily for 96 weeks.	Efavirenz n=344 Participants 600 mg once daily for 96 weeks.
Number of Participants With Virological Response (Intent-to-Treat - Time to Loss of Virologic Response [TLOVR], <400 Copies/ml) at Week 96	273 Participants	278 Participants

SECONDARY outcome

Timeframe: Baseline, Week 48, and Week 96

Population: The ITT analysis set was considered the primary efficacy analysis set.

Change from baseline in CD4+ cell count was imputed in case of missing values: in case of premature discontinuation, data were imputed with the baseline value after discontinuation (i.e. change=0, Non-Completer \[NC\] = Failure); otherwise last observation carried forward was applied.

Outcome measures

Outcome measures
Measure	TMC278 n=346 Participants 25 milligram (mg) tablet once daily for 96 weeks.	Efavirenz n=344 Participants 600 mg once daily for 96 weeks.
Mean Change From Baseline to Week 48 and Week 96 in Absolute and Relative CD4+ Cell Counts (Using Imputed Data) Relative cell count, Week 96	10.1 cells per microliter Standard Deviation 7.5	10.2 cells per microliter Standard Deviation 7.2
Mean Change From Baseline to Week 48 and Week 96 in Absolute and Relative CD4+ Cell Counts (Using Imputed Data) Absolute cell count, Week 48	195.5 cells per microliter Standard Deviation 151.7	181.6 cells per microliter Standard Deviation 156.9
Mean Change From Baseline to Week 48 and Week 96 in Absolute and Relative CD4+ Cell Counts (Using Imputed Data) Absolute cell count, Week 96	220.7 cells per microliter Standard Deviation 167.1	226.7 cells per microliter Standard Deviation 188.9
Mean Change From Baseline to Week 48 and Week 96 in Absolute and Relative CD4+ Cell Counts (Using Imputed Data) Relative cell count, Week 48	8.6 cells per microliter Standard Deviation 5.8	8.7 cells per microliter Standard Deviation 6.0

SECONDARY outcome

Timeframe: Week 96

Population: The ITT analysis set was considered the primary efficacy analysis set. Here "N" (Number of Participants Analyzed) signifies number of Participants who were evaluable (had data) for this outcome measure.

Virologic failure for the resistance determinations was defined as lack of virologic response (never having had 2 consecutive plasma viral load \<50 copies/mL) and plasma viral load increase of \>=0.5 log 10 copies/mL above nadir (i.e., never suppressed), or confirmed loss of virologic response (2 consecutive plasma viral load \>=50 copies/mL after having had 2 consecutive plasma viral load \<50 copies/mL; i.e., rebounder), or discontinued with a last observed on-treatment plasma viral load \>=50 copies/mL after having had 2 consecutive plasma viral load \<50 copies/mL. For this study, treatment-emergent reverse transcriptase (RT) resistance associated mutations (RAMs) occurring in at least 2 virologic failures (for at least one treatment group) for the following lists are presented: i) Extended list of Non-nucleoside reverse transcriptase inhibitor (NNRTI RAMs) ii) IAS-USA list of Nucleoside/tide reverse transcriptase inhibitor (N\[t\]RTI RAMs).

Outcome measures

Outcome measures
Measure	TMC278 n=52 Participants 25 milligram (mg) tablet once daily for 96 weeks.	Efavirenz n=18 Participants 600 mg once daily for 96 weeks.
Number of Participants With Virologic Failure for the Resistance Determination by Emerging Resistance Associated Mutations: First Available On-Treatment Genotypic Data After Failure N(t)RTI RAM: K219E	3 Participants	0 Participants
Number of Participants With Virologic Failure for the Resistance Determination by Emerging Resistance Associated Mutations: First Available On-Treatment Genotypic Data After Failure Any RAM from Extended NNRTI RAMs list	29 Participants	9 Participants
Number of Participants With Virologic Failure for the Resistance Determination by Emerging Resistance Associated Mutations: First Available On-Treatment Genotypic Data After Failure NNRTI RAM: E138K	18 Participants	0 Participants
Number of Participants With Virologic Failure for the Resistance Determination by Emerging Resistance Associated Mutations: First Available On-Treatment Genotypic Data After Failure NNRTI RAM: K101E	5 Participants	0 Participants
Number of Participants With Virologic Failure for the Resistance Determination by Emerging Resistance Associated Mutations: First Available On-Treatment Genotypic Data After Failure NNRTI RAM: Y181C	5 Participants	0 Participants
Number of Participants With Virologic Failure for the Resistance Determination by Emerging Resistance Associated Mutations: First Available On-Treatment Genotypic Data After Failure NNRTI RAM: V90I	4 Participants	0 Participants
Number of Participants With Virologic Failure for the Resistance Determination by Emerging Resistance Associated Mutations: First Available On-Treatment Genotypic Data After Failure NNRTI RAM: V189I	4 Participants	0 Participants
Number of Participants With Virologic Failure for the Resistance Determination by Emerging Resistance Associated Mutations: First Available On-Treatment Genotypic Data After Failure NNRTI RAM: H221Y	4 Participants	0 Participants
Number of Participants With Virologic Failure for the Resistance Determination by Emerging Resistance Associated Mutations: First Available On-Treatment Genotypic Data After Failure NNRTI RAM: E138Q	3 Participants	0 Participants
Number of Participants With Virologic Failure for the Resistance Determination by Emerging Resistance Associated Mutations: First Available On-Treatment Genotypic Data After Failure NNRTI RAM: K103N	1 Participants	8 Participants
Number of Participants With Virologic Failure for the Resistance Determination by Emerging Resistance Associated Mutations: First Available On-Treatment Genotypic Data After Failure Any RAM from IAS-USA N(t)RTI RAMs list	31 Participants	5 Participants
Number of Participants With Virologic Failure for the Resistance Determination by Emerging Resistance Associated Mutations: First Available On-Treatment Genotypic Data After Failure N(t)RTI RAM: M184I	24 Participants	3 Participants
Number of Participants With Virologic Failure for the Resistance Determination by Emerging Resistance Associated Mutations: First Available On-Treatment Genotypic Data After Failure N(t)RTI RAM: M184V	7 Participants	3 Participants
Number of Participants With Virologic Failure for the Resistance Determination by Emerging Resistance Associated Mutations: First Available On-Treatment Genotypic Data After Failure N(t)RTI RAM: K065R	3 Participants	0 Participants
Number of Participants With Virologic Failure for the Resistance Determination by Emerging Resistance Associated Mutations: First Available On-Treatment Genotypic Data After Failure N(t)RTI RAM: Y115F	2 Participants	0 Participants

Adverse Events

TMC278

Serious events: 40 serious events

Other events: 231 other events

Deaths: 0 deaths

Efavirenz

Serious events: 43 serious events

Other events: 268 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Additional Information

Medical Leader

Janssen Infectious Diseases BVBA

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: OTHER

Measure	TMC278 n=346 participants at risk 25 milligram (mg) tablet once daily for 96 weeks.	Efavirenz n=344 participants at risk 600 mg once daily for 96 weeks.
Infections and infestations Upper respiratory tract infection	15.3% 53/346 • Up to a maximum of 160 weeks for participants in the TMC278 treatment group and up to 147 weeks for participants in the efavirenz treatment group. Only subjects who had at least one of the TEAEs listed in the Other (non Serious) AE table are included in the Total no. subjects with Non-Serious Adverse Events.	14.8% 51/344 • Up to a maximum of 160 weeks for participants in the TMC278 treatment group and up to 147 weeks for participants in the efavirenz treatment group. Only subjects who had at least one of the TEAEs listed in the Other (non Serious) AE table are included in the Total no. subjects with Non-Serious Adverse Events.
Infections and infestations Nasopharyngitis	13.0% 45/346 • Up to a maximum of 160 weeks for participants in the TMC278 treatment group and up to 147 weeks for participants in the efavirenz treatment group. Only subjects who had at least one of the TEAEs listed in the Other (non Serious) AE table are included in the Total no. subjects with Non-Serious Adverse Events.	12.8% 44/344 • Up to a maximum of 160 weeks for participants in the TMC278 treatment group and up to 147 weeks for participants in the efavirenz treatment group. Only subjects who had at least one of the TEAEs listed in the Other (non Serious) AE table are included in the Total no. subjects with Non-Serious Adverse Events.
Infections and infestations Influenza	10.7% 37/346 • Up to a maximum of 160 weeks for participants in the TMC278 treatment group and up to 147 weeks for participants in the efavirenz treatment group. Only subjects who had at least one of the TEAEs listed in the Other (non Serious) AE table are included in the Total no. subjects with Non-Serious Adverse Events.	9.9% 34/344 • Up to a maximum of 160 weeks for participants in the TMC278 treatment group and up to 147 weeks for participants in the efavirenz treatment group. Only subjects who had at least one of the TEAEs listed in the Other (non Serious) AE table are included in the Total no. subjects with Non-Serious Adverse Events.
Nervous system disorders Headache	14.5% 50/346 • Up to a maximum of 160 weeks for participants in the TMC278 treatment group and up to 147 weeks for participants in the efavirenz treatment group. Only subjects who had at least one of the TEAEs listed in the Other (non Serious) AE table are included in the Total no. subjects with Non-Serious Adverse Events.	12.8% 44/344 • Up to a maximum of 160 weeks for participants in the TMC278 treatment group and up to 147 weeks for participants in the efavirenz treatment group. Only subjects who had at least one of the TEAEs listed in the Other (non Serious) AE table are included in the Total no. subjects with Non-Serious Adverse Events.
Nervous system disorders Dizziness	8.1% 28/346 • Up to a maximum of 160 weeks for participants in the TMC278 treatment group and up to 147 weeks for participants in the efavirenz treatment group. Only subjects who had at least one of the TEAEs listed in the Other (non Serious) AE table are included in the Total no. subjects with Non-Serious Adverse Events.	26.5% 91/344 • Up to a maximum of 160 weeks for participants in the TMC278 treatment group and up to 147 weeks for participants in the efavirenz treatment group. Only subjects who had at least one of the TEAEs listed in the Other (non Serious) AE table are included in the Total no. subjects with Non-Serious Adverse Events.
Nervous system disorders Somnolence	4.0% 14/346 • Up to a maximum of 160 weeks for participants in the TMC278 treatment group and up to 147 weeks for participants in the efavirenz treatment group. Only subjects who had at least one of the TEAEs listed in the Other (non Serious) AE table are included in the Total no. subjects with Non-Serious Adverse Events.	7.0% 24/344 • Up to a maximum of 160 weeks for participants in the TMC278 treatment group and up to 147 weeks for participants in the efavirenz treatment group. Only subjects who had at least one of the TEAEs listed in the Other (non Serious) AE table are included in the Total no. subjects with Non-Serious Adverse Events.
Gastrointestinal disorders Nausea	12.7% 44/346 • Up to a maximum of 160 weeks for participants in the TMC278 treatment group and up to 147 weeks for participants in the efavirenz treatment group. Only subjects who had at least one of the TEAEs listed in the Other (non Serious) AE table are included in the Total no. subjects with Non-Serious Adverse Events.	11.0% 38/344 • Up to a maximum of 160 weeks for participants in the TMC278 treatment group and up to 147 weeks for participants in the efavirenz treatment group. Only subjects who had at least one of the TEAEs listed in the Other (non Serious) AE table are included in the Total no. subjects with Non-Serious Adverse Events.
Gastrointestinal disorders Diarrhoea	14.7% 51/346 • Up to a maximum of 160 weeks for participants in the TMC278 treatment group and up to 147 weeks for participants in the efavirenz treatment group. Only subjects who had at least one of the TEAEs listed in the Other (non Serious) AE table are included in the Total no. subjects with Non-Serious Adverse Events.	17.7% 61/344 • Up to a maximum of 160 weeks for participants in the TMC278 treatment group and up to 147 weeks for participants in the efavirenz treatment group. Only subjects who had at least one of the TEAEs listed in the Other (non Serious) AE table are included in the Total no. subjects with Non-Serious Adverse Events.
Psychiatric disorders Abnormal dreams	8.4% 29/346 • Up to a maximum of 160 weeks for participants in the TMC278 treatment group and up to 147 weeks for participants in the efavirenz treatment group. Only subjects who had at least one of the TEAEs listed in the Other (non Serious) AE table are included in the Total no. subjects with Non-Serious Adverse Events.	11.9% 41/344 • Up to a maximum of 160 weeks for participants in the TMC278 treatment group and up to 147 weeks for participants in the efavirenz treatment group. Only subjects who had at least one of the TEAEs listed in the Other (non Serious) AE table are included in the Total no. subjects with Non-Serious Adverse Events.
Psychiatric disorders Insomnia	10.4% 36/346 • Up to a maximum of 160 weeks for participants in the TMC278 treatment group and up to 147 weeks for participants in the efavirenz treatment group. Only subjects who had at least one of the TEAEs listed in the Other (non Serious) AE table are included in the Total no. subjects with Non-Serious Adverse Events.	11.3% 39/344 • Up to a maximum of 160 weeks for participants in the TMC278 treatment group and up to 147 weeks for participants in the efavirenz treatment group. Only subjects who had at least one of the TEAEs listed in the Other (non Serious) AE table are included in the Total no. subjects with Non-Serious Adverse Events.
Psychiatric disorders Depression	7.2% 25/346 • Up to a maximum of 160 weeks for participants in the TMC278 treatment group and up to 147 weeks for participants in the efavirenz treatment group. Only subjects who had at least one of the TEAEs listed in the Other (non Serious) AE table are included in the Total no. subjects with Non-Serious Adverse Events.	6.1% 21/344 • Up to a maximum of 160 weeks for participants in the TMC278 treatment group and up to 147 weeks for participants in the efavirenz treatment group. Only subjects who had at least one of the TEAEs listed in the Other (non Serious) AE table are included in the Total no. subjects with Non-Serious Adverse Events.
Psychiatric disorders Anxiety	2.6% 9/346 • Up to a maximum of 160 weeks for participants in the TMC278 treatment group and up to 147 weeks for participants in the efavirenz treatment group. Only subjects who had at least one of the TEAEs listed in the Other (non Serious) AE table are included in the Total no. subjects with Non-Serious Adverse Events.	7.8% 27/344 • Up to a maximum of 160 weeks for participants in the TMC278 treatment group and up to 147 weeks for participants in the efavirenz treatment group. Only subjects who had at least one of the TEAEs listed in the Other (non Serious) AE table are included in the Total no. subjects with Non-Serious Adverse Events.
Skin and subcutaneous tissue disorders Rash	7.5% 26/346 • Up to a maximum of 160 weeks for participants in the TMC278 treatment group and up to 147 weeks for participants in the efavirenz treatment group. Only subjects who had at least one of the TEAEs listed in the Other (non Serious) AE table are included in the Total no. subjects with Non-Serious Adverse Events.	12.2% 42/344 • Up to a maximum of 160 weeks for participants in the TMC278 treatment group and up to 147 weeks for participants in the efavirenz treatment group. Only subjects who had at least one of the TEAEs listed in the Other (non Serious) AE table are included in the Total no. subjects with Non-Serious Adverse Events.
General disorders Fatigue	5.8% 20/346 • Up to a maximum of 160 weeks for participants in the TMC278 treatment group and up to 147 weeks for participants in the efavirenz treatment group. Only subjects who had at least one of the TEAEs listed in the Other (non Serious) AE table are included in the Total no. subjects with Non-Serious Adverse Events.	9.0% 31/344 • Up to a maximum of 160 weeks for participants in the TMC278 treatment group and up to 147 weeks for participants in the efavirenz treatment group. Only subjects who had at least one of the TEAEs listed in the Other (non Serious) AE table are included in the Total no. subjects with Non-Serious Adverse Events.
Gastrointestinal disorders Vomiting	4.3% 15/346 • Up to a maximum of 160 weeks for participants in the TMC278 treatment group and up to 147 weeks for participants in the efavirenz treatment group. Only subjects who had at least one of the TEAEs listed in the Other (non Serious) AE table are included in the Total no. subjects with Non-Serious Adverse Events.	6.1% 21/344 • Up to a maximum of 160 weeks for participants in the TMC278 treatment group and up to 147 weeks for participants in the efavirenz treatment group. Only subjects who had at least one of the TEAEs listed in the Other (non Serious) AE table are included in the Total no. subjects with Non-Serious Adverse Events.
Infections and infestations Syphilis	6.4% 22/346 • Up to a maximum of 160 weeks for participants in the TMC278 treatment group and up to 147 weeks for participants in the efavirenz treatment group. Only subjects who had at least one of the TEAEs listed in the Other (non Serious) AE table are included in the Total no. subjects with Non-Serious Adverse Events.	4.4% 15/344 • Up to a maximum of 160 weeks for participants in the TMC278 treatment group and up to 147 weeks for participants in the efavirenz treatment group. Only subjects who had at least one of the TEAEs listed in the Other (non Serious) AE table are included in the Total no. subjects with Non-Serious Adverse Events.
Musculoskeletal and connective tissue disorders Arthralgia	4.3% 15/346 • Up to a maximum of 160 weeks for participants in the TMC278 treatment group and up to 147 weeks for participants in the efavirenz treatment group. Only subjects who had at least one of the TEAEs listed in the Other (non Serious) AE table are included in the Total no. subjects with Non-Serious Adverse Events.	5.8% 20/344 • Up to a maximum of 160 weeks for participants in the TMC278 treatment group and up to 147 weeks for participants in the efavirenz treatment group. Only subjects who had at least one of the TEAEs listed in the Other (non Serious) AE table are included in the Total no. subjects with Non-Serious Adverse Events.
Musculoskeletal and connective tissue disorders Back pain	6.6% 23/346 • Up to a maximum of 160 weeks for participants in the TMC278 treatment group and up to 147 weeks for participants in the efavirenz treatment group. Only subjects who had at least one of the TEAEs listed in the Other (non Serious) AE table are included in the Total no. subjects with Non-Serious Adverse Events.	7.0% 24/344 • Up to a maximum of 160 weeks for participants in the TMC278 treatment group and up to 147 weeks for participants in the efavirenz treatment group. Only subjects who had at least one of the TEAEs listed in the Other (non Serious) AE table are included in the Total no. subjects with Non-Serious Adverse Events.
Respiratory, thoracic and mediastinal disorders Cough	6.6% 23/346 • Up to a maximum of 160 weeks for participants in the TMC278 treatment group and up to 147 weeks for participants in the efavirenz treatment group. Only subjects who had at least one of the TEAEs listed in the Other (non Serious) AE table are included in the Total no. subjects with Non-Serious Adverse Events.	5.8% 20/344 • Up to a maximum of 160 weeks for participants in the TMC278 treatment group and up to 147 weeks for participants in the efavirenz treatment group. Only subjects who had at least one of the TEAEs listed in the Other (non Serious) AE table are included in the Total no. subjects with Non-Serious Adverse Events.
Skin and subcutaneous tissue disorders Pruritus	2.3% 8/346 • Up to a maximum of 160 weeks for participants in the TMC278 treatment group and up to 147 weeks for participants in the efavirenz treatment group. Only subjects who had at least one of the TEAEs listed in the Other (non Serious) AE table are included in the Total no. subjects with Non-Serious Adverse Events.	5.2% 18/344 • Up to a maximum of 160 weeks for participants in the TMC278 treatment group and up to 147 weeks for participants in the efavirenz treatment group. Only subjects who had at least one of the TEAEs listed in the Other (non Serious) AE table are included in the Total no. subjects with Non-Serious Adverse Events.
Vascular disorders Hypertension	6.1% 21/346 • Up to a maximum of 160 weeks for participants in the TMC278 treatment group and up to 147 weeks for participants in the efavirenz treatment group. Only subjects who had at least one of the TEAEs listed in the Other (non Serious) AE table are included in the Total no. subjects with Non-Serious Adverse Events.	5.2% 18/344 • Up to a maximum of 160 weeks for participants in the TMC278 treatment group and up to 147 weeks for participants in the efavirenz treatment group. Only subjects who had at least one of the TEAEs listed in the Other (non Serious) AE table are included in the Total no. subjects with Non-Serious Adverse Events.