Trial Outcomes & Findings for TMC278-TiDP6-C215: A Clinical Trial in Treatment Naive HIV-subjects Patients Comparing TMC278 to Efavirenz in Combination With 2 Nucleoside/Nucleotide Reverse Transcriptase Inhibitors (NCT NCT00543725)

Last Updated: 2016-04-01

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

680 participants

Primary outcome timeframe

Week 48

Results posted on

2016-04-01

Participant Flow

A phase III, randomized, double-blind trial of TMC278 25 mg q.d. versus efavirenz 600mg q.d. in combination with a background regimen containing 2 nucleoside/nucleotide reverse transcriptase inhibitors in antiretroviral-naïve HIV-1 infected subjects

680 participants were randomized (340 in TMC 278 and 340 in efavirenz) but only 338 participants were treated with efavirenz (2 were randomized but not treated).

Participant milestones

Participant milestones
Measure	TMC278 25 mg tablet once daily	Efavirenz 600 mg once daily
Overall Study STARTED	340	338
Overall Study COMPLETED	272	264
Overall Study NOT COMPLETED	68	74

Reasons for withdrawal

Reasons for withdrawal
Measure	TMC278 25 mg tablet once daily	Efavirenz 600 mg once daily
Overall Study Adverse Event	18	27
Overall Study Sponsor's Decision	0	1
Overall Study Subject Non-Compliant	4	4
Overall Study Subject Ineligible To Continue The Trial	2	0
Overall Study Subject Reached A Virologic Endpoint	22	14
Overall Study Protocol Violation	0	1
Overall Study Withdrawal by Subject	4	13
Overall Study Lost to Follow-up	15	11
Overall Study Other	3	3

Baseline Characteristics

TMC278-TiDP6-C215: A Clinical Trial in Treatment Naive HIV-subjects Patients Comparing TMC278 to Efavirenz in Combination With 2 Nucleoside/Nucleotide Reverse Transcriptase Inhibitors

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	TMC278 n=340 Participants 25 mg tablet once daily	Efavirenz n=338 Participants 600 mg once daily	Total n=678 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	339 Participants n=5 Participants	337 Participants n=7 Participants	676 Participants n=5 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Age, Continuous	36.7 years STANDARD_DEVIATION 9.39 • n=5 Participants	36.4 years STANDARD_DEVIATION 8.92 • n=7 Participants	36.5 years STANDARD_DEVIATION 9.15 • n=5 Participants
Sex: Female, Male Female	90 Participants n=5 Participants	94 Participants n=7 Participants	184 Participants n=5 Participants
Sex: Female, Male Male	250 Participants n=5 Participants	244 Participants n=7 Participants	494 Participants n=5 Participants
Region Enroll Africa	19 participants n=5 Participants	38 participants n=7 Participants	57 participants n=5 Participants
Region Enroll Asia	59 participants n=5 Participants	61 participants n=7 Participants	120 participants n=5 Participants
Region Enroll Latin America	90 participants n=5 Participants	85 participants n=7 Participants	175 participants n=5 Participants
Region Enroll USA, Canada, Europe, Australia	172 participants n=5 Participants	154 participants n=7 Participants	326 participants n=5 Participants

PRIMARY outcome

Timeframe: Week 48

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

Outcome measures

Outcome measures
Measure	TMC278 n=340 Participants 25 mg tablet once daily	Efavirenz n=338 Participants 600 mg once daily
Number of Participants With Virological Response (Intent-to-Treat - Time to Loss of Virologic Response [TLOVR], <50 Copies Per mL) at Week 48 Responder	291 Participants	276 Participants
Number of Participants With Virological Response (Intent-to-Treat - Time to Loss of Virologic Response [TLOVR], <50 Copies Per mL) at Week 48 Virologic failure	24 Participants	18 Participants
Number of Participants With Virological Response (Intent-to-Treat - Time to Loss of Virologic Response [TLOVR], <50 Copies Per mL) at Week 48 Death	1 Participants	3 Participants
Number of Participants With Virological Response (Intent-to-Treat - Time to Loss of Virologic Response [TLOVR], <50 Copies Per mL) at Week 48 Discontinued due to AE	8 Participants	21 Participants
Number of Participants With Virological Response (Intent-to-Treat - Time to Loss of Virologic Response [TLOVR], <50 Copies Per mL) at Week 48 Discontinued due to other reason than AE	16 Participants	20 Participants

SECONDARY outcome

Timeframe: Week 48

Population: The Intent-to-Treat 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 Wk 48 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=340 Participants 25 mg tablet once daily	Efavirenz n=338 Participants 600 mg once daily
Number of Participants With Virological Response (Intent-to-Treat - Snapshot, <50 Copies Per mL) at Week 48 Virologic Response (<50 copies/mL)	281 Participants	265 Participants
Number of Participants With Virological Response (Intent-to-Treat - Snapshot, <50 Copies Per mL) at Week 48 Virologic failure	41 Participants	38 Participants
Number of Participants With Virological Response (Intent-to-Treat - Snapshot, <50 Copies Per mL) at Week 48 No plasma viral load data in 48-week window	18 Participants	35 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=340 Participants 25 mg tablet once daily	Efavirenz n=338 Participants 600 mg once daily
Number of Participants With Virological Response (Intent-to-Treat - Time to Loss of Virologic Response [TLOVR], <50 Copies Per mL) at Week 96 Responder	269 Participants	258 Participants
Number of Participants With Virological Response (Intent-to-Treat - Time to Loss of Virologic Response [TLOVR], <50 Copies Per mL) at Week 96 Virologic failure	34 Participants	24 Participants
Number of Participants With Virological Response (Intent-to-Treat - Time to Loss of Virologic Response [TLOVR], <50 Copies Per mL) at Week 96 Death	1 Participants	3 Participants
Number of Participants With Virological Response (Intent-to-Treat - Time to Loss of Virologic Response [TLOVR], <50 Copies Per mL) at Week 96 Discontinued due to AE	16 Participants	23 Participants
Number of Participants With Virological Response (Intent-to-Treat - Time to Loss of Virologic Response [TLOVR], <50 Copies Per mL) at Week 96 Discontinued due to other reason than AE	20 Participants	30 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=340 Participants 25 mg tablet once daily	Efavirenz n=338 Participants 600 mg once daily
Number of Participants With Virological Response (Intent-to-Treat - Snapshot, <50 Copies Per mL) at Week 96 Virologic failure	53 Participants	38 Participants
Number of Participants With Virological Response (Intent-to-Treat - Snapshot, <50 Copies Per mL) at Week 96 Virologic response (<50 copies/mL)	259 Participants	254 Participants
Number of Participants With Virological Response (Intent-to-Treat - Snapshot, <50 Copies Per mL) at Week 96 No plasma viral load data in 96-Week window	28 Participants	46 Participants

SECONDARY outcome

Timeframe: Variable, ranging from 3 months up to maximum 18 months for TMC278 and 12 months for Efavirenz

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 post-Week 96 visit.

Outcome measures

Outcome measures
Measure	TMC278 n=269 Participants 25 mg tablet once daily	Efavirenz n=257 Participants 600 mg once daily
Number of Participants With Virological Response (Observed, <50 Copies/mL) at Last On-Treatment Visit (Post-Week 96).	260 Participants	246 Participants

SECONDARY outcome

Timeframe: Week 48

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

Virological response is defined as confirmed plasma viral load \< 400 HIV-1 (RNA) copies/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 \>= 400 copies/mL after being responder) or who were never suppressed (no confirmed viral load \<400 copies/mL).

Outcome measures

Outcome measures
Measure	TMC278 n=340 Participants 25 mg tablet once daily	Efavirenz n=338 Participants 600 mg once daily
Number of Participants With Virological Response (Intent-to-Treat - Time to Loss of Virologic Response [TLOVR], <400 Copies Per mL) at Week 48	300 Participants	286 Participants

SECONDARY outcome

Timeframe: Week 96

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

Virological response is defined as confirmed plasma viral load \< 400 HIV-1 (RNA) copies/mL at Week 96. 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 \>= 400 copies/mL after being responder) or who were never suppressed (no confirmed viral load \<400 copies/mL).

Outcome measures

Outcome measures
Measure	TMC278 n=340 Participants 25 mg tablet once daily	Efavirenz n=338 Participants 600 mg once daily
Number of Participants With Virological Response (Intent-to-Treat - Time to Loss of Virologic Response [TLOVR], <400 Copies Per mL) at Week 96	283 Participants	270 Participants

SECONDARY outcome

Timeframe: Baseline, Week 48, and Week 96

Population: The Intent-to-Treat 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=339 Participants 25 mg tablet once daily	Efavirenz n=338 Participants 600 mg once daily
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	8.3 cells per microliter Interval 7.68 to 8.85	8.0 cells per microliter Interval 7.39 to 8.6
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	188.6 cells per microliter Interval 173.98 to 203.15	170.7 cells per microliter Interval 154.55 to 186.77
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	234.5 cells per microliter Interval 217.4 to 251.55	212.0 cells per microliter Interval 193.7 to 230.34
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 Interval 9.35 to 10.75	9.7 cells per microliter Interval 8.95 to 10.4

SECONDARY outcome

Timeframe: Week 96

Population: The Intent-to-Treat 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.

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=34 Participants 25 mg tablet once daily	Efavirenz n=24 Participants 600 mg once daily
Number of Participants With Virologic Failure for the Resistance Determinations by Developing Mutations: First Available On-Treatment Genotypic Data After Failure Treatment-emergent NNRTI RAM	17 Participants	11 Participants
Number of Participants With Virologic Failure for the Resistance Determinations by Developing Mutations: First Available On-Treatment Genotypic Data After Failure E138K	13 Participants	1 Participants
Number of Participants With Virologic Failure for the Resistance Determinations by Developing Mutations: First Available On-Treatment Genotypic Data After Failure H221Y	3 Participants	0 Participants
Number of Participants With Virologic Failure for the Resistance Determinations by Developing Mutations: First Available On-Treatment Genotypic Data After Failure K101E	3 Participants	2 Participants
Number of Participants With Virologic Failure for the Resistance Determinations by Developing Mutations: First Available On-Treatment Genotypic Data After Failure K103N	0 Participants	6 Participants
Number of Participants With Virologic Failure for the Resistance Determinations by Developing Mutations: First Available On-Treatment Genotypic Data After Failure V90I	2 Participants	1 Participants
Number of Participants With Virologic Failure for the Resistance Determinations by Developing Mutations: First Available On-Treatment Genotypic Data After Failure V106M	0 Participants	2 Participants
Number of Participants With Virologic Failure for the Resistance Determinations by Developing Mutations: First Available On-Treatment Genotypic Data After Failure V189I	2 Participants	0 Participants
Number of Participants With Virologic Failure for the Resistance Determinations by Developing Mutations: First Available On-Treatment Genotypic Data After Failure Y188C	0 Participants	2 Participants
Number of Participants With Virologic Failure for the Resistance Determinations by Developing Mutations: First Available On-Treatment Genotypic Data After Failure Treatment-emergent N(t)RTI RAM	17 Participants	6 Participants
Number of Participants With Virologic Failure for the Resistance Determinations by Developing Mutations: First Available On-Treatment Genotypic Data After Failure K65R	0 Participants	2 Participants
Number of Participants With Virologic Failure for the Resistance Determinations by Developing Mutations: First Available On-Treatment Genotypic Data After Failure K219E	2 Participants	0 Participants
Number of Participants With Virologic Failure for the Resistance Determinations by Developing Mutations: First Available On-Treatment Genotypic Data After Failure M184I	8 Participants	1 Participants
Number of Participants With Virologic Failure for the Resistance Determinations by Developing Mutations: First Available On-Treatment Genotypic Data After Failure M184V	10 Participants	3 Participants

Adverse Events

TMC278

Serious events: 32 serious events

Other events: 253 other events

Deaths: 0 deaths

Efavirenz

Serious events: 31 serious events

Other events: 259 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Additional Information

Medical Leader

Janssen Infectious Diseases BVBA

Phone: 32 14 641418

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: GT60

Measure	TMC278 n=340 participants at risk 25 mg tablet once daily	Efavirenz n=338 participants at risk 600 mg once daily
Infections and infestations Nasopharyngitis	14.7% 50/340 • Up to 164 weeks for participants in the TMC278 treatment group and up to 144 weeks for participants in the efavirenz treatment group. Only participants who had at least one of the treatment-emergent adverse events (TEAEs) listed in the Other (non Serious) adverse event (AE) table are included in the total number of participants with Non-Serious AEs.	13.9% 47/338 • Up to 164 weeks for participants in the TMC278 treatment group and up to 144 weeks for participants in the efavirenz treatment group. Only participants who had at least one of the treatment-emergent adverse events (TEAEs) listed in the Other (non Serious) adverse event (AE) table are included in the total number of participants with Non-Serious AEs.
Infections and infestations Upper respiratory tract infection	12.6% 43/340 • Up to 164 weeks for participants in the TMC278 treatment group and up to 144 weeks for participants in the efavirenz treatment group. Only participants who had at least one of the treatment-emergent adverse events (TEAEs) listed in the Other (non Serious) adverse event (AE) table are included in the total number of participants with Non-Serious AEs.	10.9% 37/338 • Up to 164 weeks for participants in the TMC278 treatment group and up to 144 weeks for participants in the efavirenz treatment group. Only participants who had at least one of the treatment-emergent adverse events (TEAEs) listed in the Other (non Serious) adverse event (AE) table are included in the total number of participants with Non-Serious AEs.
Infections and infestations Bronchitis	9.1% 31/340 • Up to 164 weeks for participants in the TMC278 treatment group and up to 144 weeks for participants in the efavirenz treatment group. Only participants who had at least one of the treatment-emergent adverse events (TEAEs) listed in the Other (non Serious) adverse event (AE) table are included in the total number of participants with Non-Serious AEs.	1.8% 6/338 • Up to 164 weeks for participants in the TMC278 treatment group and up to 144 weeks for participants in the efavirenz treatment group. Only participants who had at least one of the treatment-emergent adverse events (TEAEs) listed in the Other (non Serious) adverse event (AE) table are included in the total number of participants with Non-Serious AEs.
Infections and infestations Influenza	9.4% 32/340 • Up to 164 weeks for participants in the TMC278 treatment group and up to 144 weeks for participants in the efavirenz treatment group. Only participants who had at least one of the treatment-emergent adverse events (TEAEs) listed in the Other (non Serious) adverse event (AE) table are included in the total number of participants with Non-Serious AEs.	8.9% 30/338 • Up to 164 weeks for participants in the TMC278 treatment group and up to 144 weeks for participants in the efavirenz treatment group. Only participants who had at least one of the treatment-emergent adverse events (TEAEs) listed in the Other (non Serious) adverse event (AE) table are included in the total number of participants with Non-Serious AEs.
Infections and infestations Pharyngitis	5.9% 20/340 • Up to 164 weeks for participants in the TMC278 treatment group and up to 144 weeks for participants in the efavirenz treatment group. Only participants who had at least one of the treatment-emergent adverse events (TEAEs) listed in the Other (non Serious) adverse event (AE) table are included in the total number of participants with Non-Serious AEs.	4.1% 14/338 • Up to 164 weeks for participants in the TMC278 treatment group and up to 144 weeks for participants in the efavirenz treatment group. Only participants who had at least one of the treatment-emergent adverse events (TEAEs) listed in the Other (non Serious) adverse event (AE) table are included in the total number of participants with Non-Serious AEs.
Nervous system disorders Headache	17.9% 61/340 • Up to 164 weeks for participants in the TMC278 treatment group and up to 144 weeks for participants in the efavirenz treatment group. Only participants who had at least one of the treatment-emergent adverse events (TEAEs) listed in the Other (non Serious) adverse event (AE) table are included in the total number of participants with Non-Serious AEs.	15.7% 53/338 • Up to 164 weeks for participants in the TMC278 treatment group and up to 144 weeks for participants in the efavirenz treatment group. Only participants who had at least one of the treatment-emergent adverse events (TEAEs) listed in the Other (non Serious) adverse event (AE) table are included in the total number of participants with Non-Serious AEs.
Nervous system disorders Dizziness	12.4% 42/340 • Up to 164 weeks for participants in the TMC278 treatment group and up to 144 weeks for participants in the efavirenz treatment group. Only participants who had at least one of the treatment-emergent adverse events (TEAEs) listed in the Other (non Serious) adverse event (AE) table are included in the total number of participants with Non-Serious AEs.	32.8% 111/338 • Up to 164 weeks for participants in the TMC278 treatment group and up to 144 weeks for participants in the efavirenz treatment group. Only participants who had at least one of the treatment-emergent adverse events (TEAEs) listed in the Other (non Serious) adverse event (AE) table are included in the total number of participants with Non-Serious AEs.
Nervous system disorders Somnolence	5.0% 17/340 • Up to 164 weeks for participants in the TMC278 treatment group and up to 144 weeks for participants in the efavirenz treatment group. Only participants who had at least one of the treatment-emergent adverse events (TEAEs) listed in the Other (non Serious) adverse event (AE) table are included in the total number of participants with Non-Serious AEs.	8.3% 28/338 • Up to 164 weeks for participants in the TMC278 treatment group and up to 144 weeks for participants in the efavirenz treatment group. Only participants who had at least one of the treatment-emergent adverse events (TEAEs) listed in the Other (non Serious) adverse event (AE) table are included in the total number of participants with Non-Serious AEs.
Gastrointestinal disorders Nausea	16.8% 57/340 • Up to 164 weeks for participants in the TMC278 treatment group and up to 144 weeks for participants in the efavirenz treatment group. Only participants who had at least one of the treatment-emergent adverse events (TEAEs) listed in the Other (non Serious) adverse event (AE) table are included in the total number of participants with Non-Serious AEs.	19.8% 67/338 • Up to 164 weeks for participants in the TMC278 treatment group and up to 144 weeks for participants in the efavirenz treatment group. Only participants who had at least one of the treatment-emergent adverse events (TEAEs) listed in the Other (non Serious) adverse event (AE) table are included in the total number of participants with Non-Serious AEs.
Gastrointestinal disorders Diarrhoea	14.4% 49/340 • Up to 164 weeks for participants in the TMC278 treatment group and up to 144 weeks for participants in the efavirenz treatment group. Only participants who had at least one of the treatment-emergent adverse events (TEAEs) listed in the Other (non Serious) adverse event (AE) table are included in the total number of participants with Non-Serious AEs.	15.7% 53/338 • Up to 164 weeks for participants in the TMC278 treatment group and up to 144 weeks for participants in the efavirenz treatment group. Only participants who had at least one of the treatment-emergent adverse events (TEAEs) listed in the Other (non Serious) adverse event (AE) table are included in the total number of participants with Non-Serious AEs.
Gastrointestinal disorders Vomiting	6.5% 22/340 • Up to 164 weeks for participants in the TMC278 treatment group and up to 144 weeks for participants in the efavirenz treatment group. Only participants who had at least one of the treatment-emergent adverse events (TEAEs) listed in the Other (non Serious) adverse event (AE) table are included in the total number of participants with Non-Serious AEs.	7.7% 26/338 • Up to 164 weeks for participants in the TMC278 treatment group and up to 144 weeks for participants in the efavirenz treatment group. Only participants who had at least one of the treatment-emergent adverse events (TEAEs) listed in the Other (non Serious) adverse event (AE) table are included in the total number of participants with Non-Serious AEs.
Psychiatric disorders Insomnia	11.2% 38/340 • Up to 164 weeks for participants in the TMC278 treatment group and up to 144 weeks for participants in the efavirenz treatment group. Only participants who had at least one of the treatment-emergent adverse events (TEAEs) listed in the Other (non Serious) adverse event (AE) table are included in the total number of participants with Non-Serious AEs.	6.2% 21/338 • Up to 164 weeks for participants in the TMC278 treatment group and up to 144 weeks for participants in the efavirenz treatment group. Only participants who had at least one of the treatment-emergent adverse events (TEAEs) listed in the Other (non Serious) adverse event (AE) table are included in the total number of participants with Non-Serious AEs.
Psychiatric disorders Abnormal dreams	5.6% 19/340 • Up to 164 weeks for participants in the TMC278 treatment group and up to 144 weeks for participants in the efavirenz treatment group. Only participants who had at least one of the treatment-emergent adverse events (TEAEs) listed in the Other (non Serious) adverse event (AE) table are included in the total number of participants with Non-Serious AEs.	7.7% 26/338 • Up to 164 weeks for participants in the TMC278 treatment group and up to 144 weeks for participants in the efavirenz treatment group. Only participants who had at least one of the treatment-emergent adverse events (TEAEs) listed in the Other (non Serious) adverse event (AE) table are included in the total number of participants with Non-Serious AEs.
Psychiatric disorders Depression	7.1% 24/340 • Up to 164 weeks for participants in the TMC278 treatment group and up to 144 weeks for participants in the efavirenz treatment group. Only participants who had at least one of the treatment-emergent adverse events (TEAEs) listed in the Other (non Serious) adverse event (AE) table are included in the total number of participants with Non-Serious AEs.	5.6% 19/338 • Up to 164 weeks for participants in the TMC278 treatment group and up to 144 weeks for participants in the efavirenz treatment group. Only participants who had at least one of the treatment-emergent adverse events (TEAEs) listed in the Other (non Serious) adverse event (AE) table are included in the total number of participants with Non-Serious AEs.
Respiratory, thoracic and mediastinal disorders Cough	9.7% 33/340 • Up to 164 weeks for participants in the TMC278 treatment group and up to 144 weeks for participants in the efavirenz treatment group. Only participants who had at least one of the treatment-emergent adverse events (TEAEs) listed in the Other (non Serious) adverse event (AE) table are included in the total number of participants with Non-Serious AEs.	4.4% 15/338 • Up to 164 weeks for participants in the TMC278 treatment group and up to 144 weeks for participants in the efavirenz treatment group. Only participants who had at least one of the treatment-emergent adverse events (TEAEs) listed in the Other (non Serious) adverse event (AE) table are included in the total number of participants with Non-Serious AEs.
General disorders Fatigue	5.9% 20/340 • Up to 164 weeks for participants in the TMC278 treatment group and up to 144 weeks for participants in the efavirenz treatment group. Only participants who had at least one of the treatment-emergent adverse events (TEAEs) listed in the Other (non Serious) adverse event (AE) table are included in the total number of participants with Non-Serious AEs.	8.6% 29/338 • Up to 164 weeks for participants in the TMC278 treatment group and up to 144 weeks for participants in the efavirenz treatment group. Only participants who had at least one of the treatment-emergent adverse events (TEAEs) listed in the Other (non Serious) adverse event (AE) table are included in the total number of participants with Non-Serious AEs.
Musculoskeletal and connective tissue disorders Back pain	4.7% 16/340 • Up to 164 weeks for participants in the TMC278 treatment group and up to 144 weeks for participants in the efavirenz treatment group. Only participants who had at least one of the treatment-emergent adverse events (TEAEs) listed in the Other (non Serious) adverse event (AE) table are included in the total number of participants with Non-Serious AEs.	8.9% 30/338 • Up to 164 weeks for participants in the TMC278 treatment group and up to 144 weeks for participants in the efavirenz treatment group. Only participants who had at least one of the treatment-emergent adverse events (TEAEs) listed in the Other (non Serious) adverse event (AE) table are included in the total number of participants with Non-Serious AEs.
Skin and subcutaneous tissue disorders Rash	4.4% 15/340 • Up to 164 weeks for participants in the TMC278 treatment group and up to 144 weeks for participants in the efavirenz treatment group. Only participants who had at least one of the treatment-emergent adverse events (TEAEs) listed in the Other (non Serious) adverse event (AE) table are included in the total number of participants with Non-Serious AEs.	14.5% 49/338 • Up to 164 weeks for participants in the TMC278 treatment group and up to 144 weeks for participants in the efavirenz treatment group. Only participants who had at least one of the treatment-emergent adverse events (TEAEs) listed in the Other (non Serious) adverse event (AE) table are included in the total number of participants with Non-Serious AEs.
General disorders Pyrexia	4.4% 15/340 • Up to 164 weeks for participants in the TMC278 treatment group and up to 144 weeks for participants in the efavirenz treatment group. Only participants who had at least one of the treatment-emergent adverse events (TEAEs) listed in the Other (non Serious) adverse event (AE) table are included in the total number of participants with Non-Serious AEs.	5.0% 17/338 • Up to 164 weeks for participants in the TMC278 treatment group and up to 144 weeks for participants in the efavirenz treatment group. Only participants who had at least one of the treatment-emergent adverse events (TEAEs) listed in the Other (non Serious) adverse event (AE) table are included in the total number of participants with Non-Serious AEs.
Infections and infestations Anogenital warts	5.0% 17/340 • Up to 164 weeks for participants in the TMC278 treatment group and up to 144 weeks for participants in the efavirenz treatment group. Only participants who had at least one of the treatment-emergent adverse events (TEAEs) listed in the Other (non Serious) adverse event (AE) table are included in the total number of participants with Non-Serious AEs.	4.1% 14/338 • Up to 164 weeks for participants in the TMC278 treatment group and up to 144 weeks for participants in the efavirenz treatment group. Only participants who had at least one of the treatment-emergent adverse events (TEAEs) listed in the Other (non Serious) adverse event (AE) table are included in the total number of participants with Non-Serious AEs.
Infections and infestations Sinusitis	5.0% 17/340 • Up to 164 weeks for participants in the TMC278 treatment group and up to 144 weeks for participants in the efavirenz treatment group. Only participants who had at least one of the treatment-emergent adverse events (TEAEs) listed in the Other (non Serious) adverse event (AE) table are included in the total number of participants with Non-Serious AEs.	5.6% 19/338 • Up to 164 weeks for participants in the TMC278 treatment group and up to 144 weeks for participants in the efavirenz treatment group. Only participants who had at least one of the treatment-emergent adverse events (TEAEs) listed in the Other (non Serious) adverse event (AE) table are included in the total number of participants with Non-Serious AEs.
Musculoskeletal and connective tissue disorders Arthralgia	2.9% 10/340 • Up to 164 weeks for participants in the TMC278 treatment group and up to 144 weeks for participants in the efavirenz treatment group. Only participants who had at least one of the treatment-emergent adverse events (TEAEs) listed in the Other (non Serious) adverse event (AE) table are included in the total number of participants with Non-Serious AEs.	5.0% 17/338 • Up to 164 weeks for participants in the TMC278 treatment group and up to 144 weeks for participants in the efavirenz treatment group. Only participants who had at least one of the treatment-emergent adverse events (TEAEs) listed in the Other (non Serious) adverse event (AE) table are included in the total number of participants with Non-Serious AEs.
Respiratory, thoracic and mediastinal disorders Pharyngolaryngeal pain	5.6% 19/340 • Up to 164 weeks for participants in the TMC278 treatment group and up to 144 weeks for participants in the efavirenz treatment group. Only participants who had at least one of the treatment-emergent adverse events (TEAEs) listed in the Other (non Serious) adverse event (AE) table are included in the total number of participants with Non-Serious AEs.	1.8% 6/338 • Up to 164 weeks for participants in the TMC278 treatment group and up to 144 weeks for participants in the efavirenz treatment group. Only participants who had at least one of the treatment-emergent adverse events (TEAEs) listed in the Other (non Serious) adverse event (AE) table are included in the total number of participants with Non-Serious AEs.
Skin and subcutaneous tissue disorders Pruritus	4.4% 15/340 • Up to 164 weeks for participants in the TMC278 treatment group and up to 144 weeks for participants in the efavirenz treatment group. Only participants who had at least one of the treatment-emergent adverse events (TEAEs) listed in the Other (non Serious) adverse event (AE) table are included in the total number of participants with Non-Serious AEs.	5.0% 17/338 • Up to 164 weeks for participants in the TMC278 treatment group and up to 144 weeks for participants in the efavirenz treatment group. Only participants who had at least one of the treatment-emergent adverse events (TEAEs) listed in the Other (non Serious) adverse event (AE) table are included in the total number of participants with Non-Serious AEs.
Vascular disorders Hypertension	6.8% 23/340 • Up to 164 weeks for participants in the TMC278 treatment group and up to 144 weeks for participants in the efavirenz treatment group. Only participants who had at least one of the treatment-emergent adverse events (TEAEs) listed in the Other (non Serious) adverse event (AE) table are included in the total number of participants with Non-Serious AEs.	3.6% 12/338 • Up to 164 weeks for participants in the TMC278 treatment group and up to 144 weeks for participants in the efavirenz treatment group. Only participants who had at least one of the treatment-emergent adverse events (TEAEs) listed in the Other (non Serious) adverse event (AE) table are included in the total number of participants with Non-Serious AEs.