Trial Outcomes & Findings for HIV Attachment Inhibitor to Treat Human Immunodeficiency Virus 1 (HIV-1) Infections (NCT NCT01384734)

NCT ID: NCT01384734

Last Updated: 2018-11-14

Results Overview

Percentage of participants with plasma HIV 1 RNA \< 50 c/mL at Week 24 using the Food and Drug Administration (FDA) snapshot algorithm was assessed to evaluate the antiviral activity. Treatment comparisons were not performed as this was an estimation study. Response rates were tabulated by treatment arm with exact Clopper-Pearson binomial 95 percentage confidence intervals (CI). Virologic success or failure was determined by the last available HIV-1 RNA assessment while the participant was on-treatment within the snapshot window of the visit of interest. Intent-To-Treat-Exposed (ITT-E) Population includes all randomized participants who received at least one dose of study treatment.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 254 participants
• Primary outcome timeframe: Week 24
• Results posted on: 2018-11-14

Participant Flow

Participants with Human Immunodeficiency Virus (HIV-1) were randomized in ratio of 1:1:1:1:1 to 5 treatment arms of the study. Four groups with distinct dose of Fostemsavir (FTR, also referred BMS-663068) with Raltegravir (RAL) Tenofovir Disoproxil Fumarate (TDF). There was a reference group with ritonavir (r) boosted atazanavir (ATV), RAL and TDF.

A total of 581 participants were screened, 254 were enrolled of which 2 participants withdrew consent and 1 was randomized in error. A total 251 participants were randomized and treated of which 32 were in Monotherapy sub-study (only FTR) and continued to Primary study.

Participant milestones

Measure	FTR 400 mg BID/RAL/TDF Participants were randomized and administered 400 milligrams (mg) FTR twice daily (BID) (double-blind) along with 400 mg RAL BID (open label) and 300 mg TDF once daily (QD) (open label).	FTR 800 mg BID/RAL/TDF Participants were randomized and administered 800 mg of FTR BID (double-blind) along with 400 mg RAL BID (open label) and 300 mg TDF QD (open label).	FTR 600 mg QD/RAL/TDF Participants were randomized and administered 600 mg of FTR QD (double-blind) along with 400 mg RAL BID (open label) and 300 mg TDF QD (open label).	FTR 1200 mg QD/RAL/TDF Participants were randomized and administered 1200 mg of FTR QD along (double-blind) with 400 mg RAL BID (open label) and 300 mg TDF QD (open label).	ATV/r/RAL/TDF Participants were randomized to Reference group (open label) and administered ATV/r 300/100 mg once daily along with 400 mg RAL BID and 300 mg TDF QD.
Overall Study STARTED	50	49	51	50	51
Overall Study COMPLETED	33	25	28	22	22
Overall Study NOT COMPLETED	17	24	23	28	29

Reasons for withdrawal

Measure	FTR 400 mg BID/RAL/TDF Participants were randomized and administered 400 milligrams (mg) FTR twice daily (BID) (double-blind) along with 400 mg RAL BID (open label) and 300 mg TDF once daily (QD) (open label).	FTR 800 mg BID/RAL/TDF Participants were randomized and administered 800 mg of FTR BID (double-blind) along with 400 mg RAL BID (open label) and 300 mg TDF QD (open label).	FTR 600 mg QD/RAL/TDF Participants were randomized and administered 600 mg of FTR QD (double-blind) along with 400 mg RAL BID (open label) and 300 mg TDF QD (open label).	FTR 1200 mg QD/RAL/TDF Participants were randomized and administered 1200 mg of FTR QD along (double-blind) with 400 mg RAL BID (open label) and 300 mg TDF QD (open label).	ATV/r/RAL/TDF Participants were randomized to Reference group (open label) and administered ATV/r 300/100 mg once daily along with 400 mg RAL BID and 300 mg TDF QD.
Overall Study Adverse Event	0	3	0	2	7
Overall Study Death	1	0	1	0	0
Overall Study Continuation criteria not met	0	0	1	1	0
Overall Study Lack of Efficacy	3	7	4	4	2
Overall Study Lost to Follow-up	5	3	3	8	5
Overall Study Non-compliance with study drug	1	2	6	0	2
Overall Study Pregnancy	0	1	0	0	1
Overall Study Sponsor terminated	0	0	0	0	1
Overall Study Withdrawal by Subject	5	5	6	7	9
Overall Study Investigator relocating	0	2	0	3	1
Overall Study Unable to come back for visit	1	0	1	1	0
Overall Study Prison	0	0	1	0	0
Overall Study As per Exclusion criteria	0	1	0	0	0
Overall Study Missed End of treatment visit	0	0	0	1	0
Overall Study Adhesion problem	0	0	0	1	0
Overall Study Early termination	0	0	0	0	1
Overall Study Physician Decision	1	0	0	0	0

Baseline Characteristics

HIV Attachment Inhibitor to Treat Human Immunodeficiency Virus 1 (HIV-1) Infections

Baseline characteristics by cohort

Measure	FTR 400 mg BID/RAL/TDF n=50 Participants Participants were randomized and administered 400 mg FTR BID (double-blind) along with 400 mg RAL BID (open label) and 300 mg TDF once daily (QD) (open label).	FTR 800 mg BID/RAL/TDF n=49 Participants Participants were randomized and administered 800 mg of FTR BID (double-blind) along with 400 mg RAL BID (open label) and 300 mg TDF QD (open label).	FTR 600 mg QD/RAL/TDF n=51 Participants Participants were randomized and administered 600 mg of FTR QD (double-blind) along with 400 mg RAL BID (open label) and 300 mg TDF QD (open label).	FTR 1200 mg QD/RAL/TDF n=50 Participants Participants were randomized and administered 1200 mg of FTR QD along (double-blind) with 400 mg RAL BID (open label) and 300 mg TDF QD (open label).	ATV/r/RAL/TDF n=51 Participants Participants were randomized to Reference group (open label) and administered ATV/r 300/100 mg once daily along with 400 mg RAL BID and 300 mg TDF QD.	Total n=251 Participants Total of all reporting groups
Age, Continuous	38.1 Years STANDARD_DEVIATION 8.17 • n=5 Participants	38.4 Years STANDARD_DEVIATION 9.49 • n=7 Participants	40.1 Years STANDARD_DEVIATION 9.45 • n=5 Participants	39.2 Years STANDARD_DEVIATION 11.41 • n=4 Participants	39.7 Years STANDARD_DEVIATION 10.63 • n=21 Participants	39.1 Years STANDARD_DEVIATION 9.84 • n=8 Participants
Sex: Female, Male Female	19 Participants n=5 Participants	21 Participants n=7 Participants	22 Participants n=5 Participants	16 Participants n=4 Participants	22 Participants n=21 Participants	100 Participants n=8 Participants
Sex: Female, Male Male	31 Participants n=5 Participants	28 Participants n=7 Participants	29 Participants n=5 Participants	34 Participants n=4 Participants	29 Participants n=21 Participants	151 Participants n=8 Participants
Race/Ethnicity, Customized African American/African Heritage	14 Participants n=5 Participants	15 Participants n=7 Participants	16 Participants n=5 Participants	18 Participants n=4 Participants	13 Participants n=21 Participants	76 Participants n=8 Participants
Race/Ethnicity, Customized American Indian Or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants	1 Participants n=21 Participants	3 Participants n=8 Participants
Race/Ethnicity, Customized Asian	0 Participants n=5 Participants	2 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	2 Participants n=8 Participants
Race/Ethnicity, Customized White	20 Participants n=5 Participants	19 Participants n=7 Participants	17 Participants n=5 Participants	16 Participants n=4 Participants	23 Participants n=21 Participants	95 Participants n=8 Participants
Race/Ethnicity, Customized Other/Mixed	16 Participants n=5 Participants	13 Participants n=7 Participants	17 Participants n=5 Participants	15 Participants n=4 Participants	14 Participants n=21 Participants	75 Participants n=8 Participants

PRIMARY outcome

Timeframe: Week 24

Population: ITT-E Population

Percentage of participants with plasma HIV 1 RNA < 50 c/mL at Week 24 using the Food and Drug Administration (FDA) snapshot algorithm was assessed to evaluate the antiviral activity. Treatment comparisons were not performed as this was an estimation study. Response rates were tabulated by treatment arm with exact Clopper-Pearson binomial 95 percentage confidence intervals (CI). Virologic success or failure was determined by the last available HIV-1 RNA assessment while the participant was on-treatment within the snapshot window of the visit of interest. Intent-To-Treat-Exposed (ITT-E) Population includes all randomized participants who received at least one dose of study treatment.

Outcome measures

Measure	FTR 400 mg BID/RAL/TDF n=50 Participants Participants were randomized and administered 400 mg FTR BID (double-blind) along with 400 mg RAL BID (open label) and 300 mg TDF once daily (QD) (open label).	FTR 800 mg BID/RAL/TDF n=49 Participants Participants were randomized and administered 800 mg of FTR BID (double-blind) along with 400 mg RAL BID (open label) and 300 mg TDF QD (open label).	FTR 600 mg QD/RAL/TDF n=51 Participants Participants were randomized and administered 600 mg of FTR QD (double-blind) along with 400 mg RAL BID (open label) and 300 mg TDF QD (open label).	FTR 1200 mg QD/RAL/TDF n=50 Participants Participants were randomized and administered 1200 mg of FTR QD along (double-blind) with 400 mg RAL BID (open label) and 300 mg TDF QD (open label).	ATV/r/RAL/TDF n=51 Participants Participants were randomized to Reference group (open label) and administered ATV/r 300/100 mg once daily along with 400 mg RAL BID and 300 mg TDF QD.
Percentage of Participants With Plasma HIV-1 Ribonucleic Acid (RNA) < 50 Copies Per Milliliter (c/mL) at Week 24	80 Percentage of Participants Interval 66.3 to 90.0	69 Percentage of Participants Interval 54.6 to 81.7	76 Percentage of Participants Interval 62.5 to 87.2	72 Percentage of Participants Interval 57.5 to 83.8	75 Percentage of Participants Interval 60.4 to 85.7

PRIMARY outcome

Timeframe: Up to Week 24

Population: Safety Population

Any untoward event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly/birth defect, any other situation according to medical or scientific judgment or suspected transmission of an infectious agent via the study drug were categorized as SAE. AEs leading to discontinuation of study therapy were also reported as safety assessment. Safety population included all participants who received at least one dose of study treatment. Summaries of SAEs and AEs leading to discontinuation or withdrawal through Week 24 included AEs with onset on or after the start of study treatment (i.e. study date of first study treatment intake) up to and including the end of the Week 24 visit snapshot window.

Outcome measures

Measure	FTR 400 mg BID/RAL/TDF n=50 Participants Participants were randomized and administered 400 mg FTR BID (double-blind) along with 400 mg RAL BID (open label) and 300 mg TDF once daily (QD) (open label).	FTR 800 mg BID/RAL/TDF n=49 Participants Participants were randomized and administered 800 mg of FTR BID (double-blind) along with 400 mg RAL BID (open label) and 300 mg TDF QD (open label).	FTR 600 mg QD/RAL/TDF n=51 Participants Participants were randomized and administered 600 mg of FTR QD (double-blind) along with 400 mg RAL BID (open label) and 300 mg TDF QD (open label).	FTR 1200 mg QD/RAL/TDF n=50 Participants Participants were randomized and administered 1200 mg of FTR QD along (double-blind) with 400 mg RAL BID (open label) and 300 mg TDF QD (open label).	ATV/r/RAL/TDF n=51 Participants Participants were randomized to Reference group (open label) and administered ATV/r 300/100 mg once daily along with 400 mg RAL BID and 300 mg TDF QD.
Number of Participants With Serious Adverse Events (SAE) and Discontinuation Due to AEs up to Week 24 SAE	3 Participants	4 Participants	4 Participants	2 Participants	5 Participants
Number of Participants With Serious Adverse Events (SAE) and Discontinuation Due to AEs up to Week 24 AEs leading to discontinuation	1 Participants	2 Participants	0 Participants	1 Participants	2 Participants

SECONDARY outcome

Timeframe: Baseline and up to Day 8 of the monotherapy period

Population: ITT-E Monotherapy Population

Change from monotherapy Baseline in log10 HIV RNA to assess the antiviral activity of temsavir following administration of selected doses of FTR administered orally to HIV-1-infected participants for 7 days. Baseline is defined as the last non-missing value on or before the date of first dose of study treatment. Change from Baseline was calculated as value at indicated time point minus Baseline value. ITT-E Monotherapy Population comprised of participants that were randomized and participated in the monotherapy sub-study and received at least one dose of FTR Monotherapy. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles).

Outcome measures

Measure	FTR 400 mg BID/RAL/TDF n=7 Participants Participants were randomized and administered 400 mg FTR BID (double-blind) along with 400 mg RAL BID (open label) and 300 mg TDF once daily (QD) (open label).	FTR 800 mg BID/RAL/TDF n=5 Participants Participants were randomized and administered 800 mg of FTR BID (double-blind) along with 400 mg RAL BID (open label) and 300 mg TDF QD (open label).	FTR 600 mg QD/RAL/TDF n=10 Participants Participants were randomized and administered 600 mg of FTR QD (double-blind) along with 400 mg RAL BID (open label) and 300 mg TDF QD (open label).	FTR 1200 mg QD/RAL/TDF n=10 Participants Participants were randomized and administered 1200 mg of FTR QD along (double-blind) with 400 mg RAL BID (open label) and 300 mg TDF QD (open label).	ATV/r/RAL/TDF Participants were randomized to Reference group (open label) and administered ATV/r 300/100 mg once daily along with 400 mg RAL BID and 300 mg TDF QD.
Change From Monotherapy Baseline in log10 HIV RNA of the Monotherapy Period Day 2, n=7, 5, 10, 9	0.220 log10 c/mL Standard Deviation 0.1630	0.149 log10 c/mL Standard Deviation 0.1820	0.126 log10 c/mL Standard Deviation 0.1811	0.126 log10 c/mL Standard Deviation 0.4216	—
Change From Monotherapy Baseline in log10 HIV RNA of the Monotherapy Period Day 5, n=7, 4, 10, 10	-0.340 log10 c/mL Standard Deviation 0.3185	-0.811 log10 c/mL Standard Deviation 0.3455	-0.593 log10 c/mL Standard Deviation 0.2429	-0.767 log10 c/mL Standard Deviation 0.6388	—
Change From Monotherapy Baseline in log10 HIV RNA of the Monotherapy Period Day 6, n=7, 5, 10, 10	-0.530 log10 c/mL Standard Deviation 0.3170	-1.082 log10 c/mL Standard Deviation 0.3388	-0.822 log10 c/mL Standard Deviation 0.3076	-1.053 log10 c/mL Standard Deviation 0.7491	—
Change From Monotherapy Baseline in log10 HIV RNA of the Monotherapy Period Day 7, n=6, 5, 10, 10	-0.556 log10 c/mL Standard Deviation 0.4264	-1.443 log10 c/mL Standard Deviation 0.4484	-1.086 log10 c/mL Standard Deviation 0.4216	-1.198 log10 c/mL Standard Deviation 0.6863	—
Change From Monotherapy Baseline in log10 HIV RNA of the Monotherapy Period Day 8, n=6, 4, 9, 9	-0.691 log10 c/mL Standard Deviation 0.5380	-1.372 log10 c/mL Standard Deviation 0.3208	-1.218 log10 c/mL Standard Deviation 0.3902	-1.470 log10 c/mL Standard Deviation 0.6570	—

SECONDARY outcome

Timeframe: Baseline and up to Day 8 of the monotherapy period

Population: ITT-E Monotherapy Population

Maximum decrease from monotherapy Baseline in log10 plasma HIV-1 RNA during monotherapy to assess the antiviral activity of temsavir following administration of selected doses of FTR administered orally to HIV-1-infected participants for 7 days. Baseline is defined as the last non-missing value on or before the date of first dose of study treatment. Change from Baseline was calculated as value at indicated time point minus Baseline value. The data for monotherapy nadir has been presented where nadir represents the maximum decrease from Baseline.

Outcome measures

Measure	FTR 400 mg BID/RAL/TDF n=7 Participants Participants were randomized and administered 400 mg FTR BID (double-blind) along with 400 mg RAL BID (open label) and 300 mg TDF once daily (QD) (open label).	FTR 800 mg BID/RAL/TDF n=5 Participants Participants were randomized and administered 800 mg of FTR BID (double-blind) along with 400 mg RAL BID (open label) and 300 mg TDF QD (open label).	FTR 600 mg QD/RAL/TDF n=10 Participants Participants were randomized and administered 600 mg of FTR QD (double-blind) along with 400 mg RAL BID (open label) and 300 mg TDF QD (open label).	FTR 1200 mg QD/RAL/TDF n=10 Participants Participants were randomized and administered 1200 mg of FTR QD along (double-blind) with 400 mg RAL BID (open label) and 300 mg TDF QD (open label).	ATV/r/RAL/TDF Participants were randomized to Reference group (open label) and administered ATV/r 300/100 mg once daily along with 400 mg RAL BID and 300 mg TDF QD.
Maximum Decrease From Monotherapy Baseline in log10 Plasma HIV-1 RNA	-0.770 log10 c/mL Standard Deviation 0.4487	-1.524 log10 c/mL Standard Deviation 0.3898	-1.250 log10 c/mL Standard Deviation 0.3818	-1.399 log10 c/mL Standard Deviation 0.6688	—

SECONDARY outcome

Timeframe: Up to Day 8 of the monotherapy period

Population: ITT-E Monotherapy Population

Percentage of participants with plasma HIV 1 RNA < 50 c/mL at Baseline of combination therapy was assessed to evaluate the antiviral activity of four doses of FTR. Baseline of combination therapy was the Day 1 of the combination therapy. Virologic success or failure was determined using the non-missing viral load value at Baseline of combination therapy. The assessment closest to the window target Study Day was used for the analysis. Only those participants with data available at the specified time points were analyzed.

Outcome measures

Measure	FTR 400 mg BID/RAL/TDF n=6 Participants Participants were randomized and administered 400 mg FTR BID (double-blind) along with 400 mg RAL BID (open label) and 300 mg TDF once daily (QD) (open label).	FTR 800 mg BID/RAL/TDF n=4 Participants Participants were randomized and administered 800 mg of FTR BID (double-blind) along with 400 mg RAL BID (open label) and 300 mg TDF QD (open label).	FTR 600 mg QD/RAL/TDF n=9 Participants Participants were randomized and administered 600 mg of FTR QD (double-blind) along with 400 mg RAL BID (open label) and 300 mg TDF QD (open label).	FTR 1200 mg QD/RAL/TDF n=9 Participants Participants were randomized and administered 1200 mg of FTR QD along (double-blind) with 400 mg RAL BID (open label) and 300 mg TDF QD (open label).	ATV/r/RAL/TDF Participants were randomized to Reference group (open label) and administered ATV/r 300/100 mg once daily along with 400 mg RAL BID and 300 mg TDF QD.
Percentage of Participants With Plasma HIV-1 RNA < 50 c/mL at Day 8 of the Monotherapy Period	0 Percentage of Participants Interval 0.0 to 45.9	0 Percentage of Participants Interval 0.0 to 60.2	0 Percentage of Participants Interval 0.0 to 33.6	11 Percentage of Participants Interval 0.3 to 48.2	—

SECONDARY outcome

Timeframe: Up to Day 8 of the monotherapy period

Population: ITT-E Monotherapy Population

Any untoward event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly/birth defect, any other situation according to medical or scientific judgment or suspected transmission of an infectious agent via the study drug were categorized as SAE. AEs leading to discontinuation of study therapy were also reported as safety assessment.

Outcome measures

Measure	FTR 400 mg BID/RAL/TDF n=7 Participants Participants were randomized and administered 400 mg FTR BID (double-blind) along with 400 mg RAL BID (open label) and 300 mg TDF once daily (QD) (open label).	FTR 800 mg BID/RAL/TDF n=5 Participants Participants were randomized and administered 800 mg of FTR BID (double-blind) along with 400 mg RAL BID (open label) and 300 mg TDF QD (open label).	FTR 600 mg QD/RAL/TDF n=10 Participants Participants were randomized and administered 600 mg of FTR QD (double-blind) along with 400 mg RAL BID (open label) and 300 mg TDF QD (open label).	FTR 1200 mg QD/RAL/TDF n=10 Participants Participants were randomized and administered 1200 mg of FTR QD along (double-blind) with 400 mg RAL BID (open label) and 300 mg TDF QD (open label).	ATV/r/RAL/TDF Participants were randomized to Reference group (open label) and administered ATV/r 300/100 mg once daily along with 400 mg RAL BID and 300 mg TDF QD.
Number of Participants With SAE and Discontinuation Due to AEs During Monotherapy Period SAE	0 Participants	0 Participants	0 Participants	0 Participants	—
Number of Participants With SAE and Discontinuation Due to AEs During Monotherapy Period AEs leading to discontinuation	0 Participants	0 Participants	0 Participants	0 Participants	—

SECONDARY outcome

Timeframe: Baseline and Day 8

Population: ITT-E Monotherapy Population

Blood was collected and CD4+ and CD8+ cell count assessment was done by flow cytometery and was carried out at Baseline (Day 1) to evaluate the immunological activity of multiple doses of FTR. Baseline is defined as the last non-missing value on or before the date of first dose of study treatment and the values are absolute values. Change from Baseline was calculated as value at indicated time point minus Baseline value. Only those participants with data available at the specified time points were analyzed.

Outcome measures

Measure	FTR 400 mg BID/RAL/TDF n=5 Participants Participants were randomized and administered 400 mg FTR BID (double-blind) along with 400 mg RAL BID (open label) and 300 mg TDF once daily (QD) (open label).	FTR 800 mg BID/RAL/TDF n=4 Participants Participants were randomized and administered 800 mg of FTR BID (double-blind) along with 400 mg RAL BID (open label) and 300 mg TDF QD (open label).	FTR 600 mg QD/RAL/TDF n=8 Participants Participants were randomized and administered 600 mg of FTR QD (double-blind) along with 400 mg RAL BID (open label) and 300 mg TDF QD (open label).	FTR 1200 mg QD/RAL/TDF n=8 Participants Participants were randomized and administered 1200 mg of FTR QD along (double-blind) with 400 mg RAL BID (open label) and 300 mg TDF QD (open label).	ATV/r/RAL/TDF Participants were randomized to Reference group (open label) and administered ATV/r 300/100 mg once daily along with 400 mg RAL BID and 300 mg TDF QD.
Change From Monotherapy Baseline in Cluster of Differentiation (CD)4+ and CD8+ T-cell Counts During Monotherapy CD4+	58.4 cells per cubic millimeter Standard Deviation 81.60	134.8 cells per cubic millimeter Standard Deviation 25.70	71.8 cells per cubic millimeter Standard Deviation 117.68	63.4 cells per cubic millimeter Standard Deviation 100.86	—
Change From Monotherapy Baseline in Cluster of Differentiation (CD)4+ and CD8+ T-cell Counts During Monotherapy CD8+	134.2 cells per cubic millimeter Standard Deviation 180.64	216.3 cells per cubic millimeter Standard Deviation 215.57	188.0 cells per cubic millimeter Standard Deviation 363.58	67.6 cells per cubic millimeter Standard Deviation 236.55	—

SECONDARY outcome

Timeframe: Baseline and Day 8

Population: ITT-E Monotherapy Population

Blood was collected and CD4+ and CD8+ proportion assessment was done by flow cytometery and was carried out at Baseline (Day 1) to evaluate the immunological activity of multiple doses of FTR. Baseline is defined as the last non-missing value on or before the date of first dose of study treatment and the values are absolute values. Change from Baseline was calculated as value at indicated time point minus Baseline value. Only those participants with data available at the specified time points were analyzed.

Outcome measures

Measure	FTR 400 mg BID/RAL/TDF n=6 Participants Participants were randomized and administered 400 mg FTR BID (double-blind) along with 400 mg RAL BID (open label) and 300 mg TDF once daily (QD) (open label).	FTR 800 mg BID/RAL/TDF n=4 Participants Participants were randomized and administered 800 mg of FTR BID (double-blind) along with 400 mg RAL BID (open label) and 300 mg TDF QD (open label).	FTR 600 mg QD/RAL/TDF n=9 Participants Participants were randomized and administered 600 mg of FTR QD (double-blind) along with 400 mg RAL BID (open label) and 300 mg TDF QD (open label).	FTR 1200 mg QD/RAL/TDF n=8 Participants Participants were randomized and administered 1200 mg of FTR QD along (double-blind) with 400 mg RAL BID (open label) and 300 mg TDF QD (open label).	ATV/r/RAL/TDF Participants were randomized to Reference group (open label) and administered ATV/r 300/100 mg once daily along with 400 mg RAL BID and 300 mg TDF QD.
Change From Monotherapy Baseline in CD4+ and CD8+ T-cell Proportion During Monotherapy CD4+	-0.005 cells per cubic millimeter Standard Deviation 0.0084	0.023 cells per cubic millimeter Standard Deviation 0.0299	0.008 cells per cubic millimeter Standard Deviation 0.0335	0.014 cells per cubic millimeter Standard Deviation 0.0320	—
Change From Monotherapy Baseline in CD4+ and CD8+ T-cell Proportion During Monotherapy CD8+	-0.003 cells per cubic millimeter Standard Deviation 0.0273	-0.040 cells per cubic millimeter Standard Deviation 0.0245	-0.009 cells per cubic millimeter Standard Deviation 0.0465	-0.021 cells per cubic millimeter Standard Deviation 0.0364	—

SECONDARY outcome

Timeframe: Weeks 48 and 96

Population: ITT-E Population

Percentage of participants with plasma HIV 1 RNA < 50 c/mL at Weeks 48 and 96 using the FDA snapshot algorithm was assessed to evaluate the antiviral activity. Treatment comparisons were not performed as this was an estimation study. Response rates were tabulated by treatment arm with exact Clopper-Pearson binomial 95 percentage CI. Virologic success or failure was determined by the last available HIV-1 RNA assessment while the participant was on-treatment within the snapshot window of the visit of interest.

Outcome measures

Measure	FTR 400 mg BID/RAL/TDF n=50 Participants Participants were randomized and administered 400 mg FTR BID (double-blind) along with 400 mg RAL BID (open label) and 300 mg TDF once daily (QD) (open label).	FTR 800 mg BID/RAL/TDF n=49 Participants Participants were randomized and administered 800 mg of FTR BID (double-blind) along with 400 mg RAL BID (open label) and 300 mg TDF QD (open label).	FTR 600 mg QD/RAL/TDF n=51 Participants Participants were randomized and administered 600 mg of FTR QD (double-blind) along with 400 mg RAL BID (open label) and 300 mg TDF QD (open label).	FTR 1200 mg QD/RAL/TDF n=50 Participants Participants were randomized and administered 1200 mg of FTR QD along (double-blind) with 400 mg RAL BID (open label) and 300 mg TDF QD (open label).	ATV/r/RAL/TDF n=51 Participants Participants were randomized to Reference group (open label) and administered ATV/r 300/100 mg once daily along with 400 mg RAL BID and 300 mg TDF QD.
Percentage of Participants With Plasma HIV-1 RNA < 50 c/mL at Primary Study Week 48	82 Percentage of Participants Interval 68.6 to 91.4	61 Percentage of Participants Interval 46.2 to 74.8	69 Percentage of Participants Interval 54.1 to 80.9	68 Percentage of Participants Interval 53.3 to 80.5	71 Percentage of Participants Interval 56.2 to 82.5
Percentage of Participants With Plasma HIV-1 RNA < 50 c/mL at Primary Study Week 96	78 Percentage of Participants Interval 64.0 to 88.5	49 Percentage of Participants Interval 34.4 to 63.7	63 Percentage of Participants Interval 48.1 to 75.9	58 Percentage of Participants Interval 43.2 to 71.8	57 Percentage of Participants Interval 42.2 to 70.7

SECONDARY outcome

Timeframe: Weeks 48 and 96

Population: Safety Population

Any untoward event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly/birth defect, any other situation according to medical or scientific judgment or suspected transmission of an infectious agent via the study drug were categorized as SAE. AEs leading to discontinuation of study therapy were also reported as safety assessment. Safety Population comprised of participants who received at least one dose of study treatment. Summaries of SAEs and AEs leading to discontinuation or withdrawal through Week X (where X = 48 or 96) included AEs with onset on or after the start of study treatment (i.e. study date of first study treatment intake) up to and including the end of the Week 48 and 96 visit snapshot window.

Outcome measures

Measure	FTR 400 mg BID/RAL/TDF n=50 Participants Participants were randomized and administered 400 mg FTR BID (double-blind) along with 400 mg RAL BID (open label) and 300 mg TDF once daily (QD) (open label).	FTR 800 mg BID/RAL/TDF n=49 Participants Participants were randomized and administered 800 mg of FTR BID (double-blind) along with 400 mg RAL BID (open label) and 300 mg TDF QD (open label).	FTR 600 mg QD/RAL/TDF n=51 Participants Participants were randomized and administered 600 mg of FTR QD (double-blind) along with 400 mg RAL BID (open label) and 300 mg TDF QD (open label).	FTR 1200 mg QD/RAL/TDF n=50 Participants Participants were randomized and administered 1200 mg of FTR QD along (double-blind) with 400 mg RAL BID (open label) and 300 mg TDF QD (open label).	ATV/r/RAL/TDF n=51 Participants Participants were randomized to Reference group (open label) and administered ATV/r 300/100 mg once daily along with 400 mg RAL BID and 300 mg TDF QD.
Number of Participants With SAE and Discontinuation Due to AEs During Primary Study SAE, Week 48	3 Participants	5 Participants	4 Participants	2 Participants	5 Participants
Number of Participants With SAE and Discontinuation Due to AEs During Primary Study SAE, Week 96	5 Participants	7 Participants	6 Participants	4 Participants	7 Participants
Number of Participants With SAE and Discontinuation Due to AEs During Primary Study AEs leading to discontinuation, Week 48	1 Participants	2 Participants	0 Participants	1 Participants	3 Participants
Number of Participants With SAE and Discontinuation Due to AEs During Primary Study AEs leading to discontinuation, Week 96	1 Participants	2 Participants	0 Participants	2 Participants	5 Participants

SECONDARY outcome

Timeframe: Baseline and Weeks 24, 48 and 96

Population: ITT-E Population

Blood was collected and CD4+ cell count assessment by flow cytometery was carried out at Baseline (Day 1), Weeks 24, 48 and 96 to evaluate the immunological activity of multiple doses of BMS-663068/GSK3684934. Baseline is defined as the last non-missing value on or before the date of first dose of study treatment and those values are absolute values. Change from Baseline was calculated as value at indicated time point minus Baseline value. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles).

Outcome measures

Measure	FTR 400 mg BID/RAL/TDF n=50 Participants Participants were randomized and administered 400 mg FTR BID (double-blind) along with 400 mg RAL BID (open label) and 300 mg TDF once daily (QD) (open label).	FTR 800 mg BID/RAL/TDF n=49 Participants Participants were randomized and administered 800 mg of FTR BID (double-blind) along with 400 mg RAL BID (open label) and 300 mg TDF QD (open label).	FTR 600 mg QD/RAL/TDF n=51 Participants Participants were randomized and administered 600 mg of FTR QD (double-blind) along with 400 mg RAL BID (open label) and 300 mg TDF QD (open label).	FTR 1200 mg QD/RAL/TDF n=50 Participants Participants were randomized and administered 1200 mg of FTR QD along (double-blind) with 400 mg RAL BID (open label) and 300 mg TDF QD (open label).	ATV/r/RAL/TDF n=51 Participants Participants were randomized to Reference group (open label) and administered ATV/r 300/100 mg once daily along with 400 mg RAL BID and 300 mg TDF QD.
Change From Baseline in CD4+ T-cell Count Week 24, n=41, 38, 48, 42, 40	134.3 Cells per cubic millimeter Standard Deviation 84.63	111.0 Cells per cubic millimeter Standard Deviation 123.75	109.5 Cells per cubic millimeter Standard Deviation 87.20	124.5 Cells per cubic millimeter Standard Deviation 111.04	119.4 Cells per cubic millimeter Standard Deviation 142.85
Change From Baseline in CD4+ T-cell Count Week 48, n=43, 34, 43, 41, 41	199.1 Cells per cubic millimeter Standard Deviation 124.24	158.7 Cells per cubic millimeter Standard Deviation 118.70	140.5 Cells per cubic millimeter Standard Deviation 97.16	155.4 Cells per cubic millimeter Standard Deviation 107.06	178.7 Cells per cubic millimeter Standard Deviation 133.90
Change From Baseline in CD4+ T-cell Count Week 96, n=42, 28, 35, 28, 31	264.6 Cells per cubic millimeter Standard Deviation 147.83	210.8 Cells per cubic millimeter Standard Deviation 158.03	175.7 Cells per cubic millimeter Standard Deviation 98.28	211.7 Cells per cubic millimeter Standard Deviation 151.03	250.1 Cells per cubic millimeter Standard Deviation 217.54

SECONDARY outcome

Timeframe: Up to Week 24

Population: ITT-E Resistance Tested through Week 24 Population

Participants who administered antiretroviral (ARV) with virologic failure (VF) were assessed. Genotypic substitution included assessment of Reverse Transcriptase (RT) substitution, Protease Inhibitor (PI) substitution and Integrase RAL substitution as per International Acquired Immune Deficiency Syndrome (AIDS) Society-USA (IAS-USA) list. ITT-E Resistance Tested through Week 24 population included participants who met the criteria for Resistance testing, and the confirmatory value or value at discontinuation occurred at or before the end of the Week 24 Snapshot analysis window. The criteria for resistance tested was participant who had virologic failure or met the following criteria a) Participants who achieved viral suppression (plasma HIV-1 RNA < 50 c/mL) and have confirmed plasma HIV-1 RNA >= 400 c/mL at any time during the study. b) Participants who were discontinued before achieving viral suppression (plasma HIV-1 RNA < 50 c/mL) after Week 8 with last plasma HIV-1 RNA >=400 c/mL.

Outcome measures

Measure	FTR 400 mg BID/RAL/TDF n=3 Participants Participants were randomized and administered 400 mg FTR BID (double-blind) along with 400 mg RAL BID (open label) and 300 mg TDF once daily (QD) (open label).	FTR 800 mg BID/RAL/TDF n=7 Participants Participants were randomized and administered 800 mg of FTR BID (double-blind) along with 400 mg RAL BID (open label) and 300 mg TDF QD (open label).	FTR 600 mg QD/RAL/TDF n=11 Participants Participants were randomized and administered 600 mg of FTR QD (double-blind) along with 400 mg RAL BID (open label) and 300 mg TDF QD (open label).	FTR 1200 mg QD/RAL/TDF n=3 Participants Participants were randomized and administered 1200 mg of FTR QD along (double-blind) with 400 mg RAL BID (open label) and 300 mg TDF QD (open label).	ATV/r/RAL/TDF n=5 Participants Participants were randomized to Reference group (open label) and administered ATV/r 300/100 mg once daily along with 400 mg RAL BID and 300 mg TDF QD.
Number of Participants With Newly-emergent Genotypic Substitutions at Week 24 PI substitution	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Newly-emergent Genotypic Substitutions at Week 24 RT substitution	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants
Number of Participants With Newly-emergent Genotypic Substitutions at Week 24 Integrase substitution	0 Participants	0 Participants	1 Participants	1 Participants	0 Participants

SECONDARY outcome

Timeframe: Up to Week 48

Population: ITT-E Resistance Tested through Week 48 Population

Participants who administered ARV with VF were assessed. Genotypic substitution included assessment of RT substitution, PI substitution and Integrase RAL substitution as per IAS-USA list. ITT-E Resistance Tested through Week 48 population included participants who met the criteria for Resistance testing, and the confirmatory value or value at discontinuation occurred at or before the end of the Week 48 Snapshot analysis window. The criteria for resistance tested was participant who had virologic failure or the following criteria a) Participants who achieved viral suppression (plasma HIV-1 RNA < 50 c/mL) and have confirmed plasma HIV-1 RNA >= 400 c/mL at any time during the study. b) Participants who were discontinued before achieving viral suppression (plasma HIV-1 RNA < 50 c/mL) after Week 8 with last plasma HIV-1 RNA >=400 c/mL.

Outcome measures

Measure	FTR 400 mg BID/RAL/TDF n=9 Participants Participants were randomized and administered 400 mg FTR BID (double-blind) along with 400 mg RAL BID (open label) and 300 mg TDF once daily (QD) (open label).	FTR 800 mg BID/RAL/TDF n=10 Participants Participants were randomized and administered 800 mg of FTR BID (double-blind) along with 400 mg RAL BID (open label) and 300 mg TDF QD (open label).	FTR 600 mg QD/RAL/TDF n=16 Participants Participants were randomized and administered 600 mg of FTR QD (double-blind) along with 400 mg RAL BID (open label) and 300 mg TDF QD (open label).	FTR 1200 mg QD/RAL/TDF n=9 Participants Participants were randomized and administered 1200 mg of FTR QD along (double-blind) with 400 mg RAL BID (open label) and 300 mg TDF QD (open label).	ATV/r/RAL/TDF n=6 Participants Participants were randomized to Reference group (open label) and administered ATV/r 300/100 mg once daily along with 400 mg RAL BID and 300 mg TDF QD.
Number of Participants With Newly-emergent Genotypic Substitutions at Week 48 PI substitution	1 Participants	0 Participants	0 Participants	1 Participants	0 Participants
Number of Participants With Newly-emergent Genotypic Substitutions at Week 48 RT substitution	0 Participants	0 Participants	0 Participants	2 Participants	0 Participants
Number of Participants With Newly-emergent Genotypic Substitutions at Week 48 Integrase substitution	1 Participants	1 Participants	1 Participants	2 Participants	0 Participants

SECONDARY outcome

Timeframe: Up to Week 96

Population: ITT-E Resistance Tested through Week 96 Population

Participants who administered ARV with VF were assessed. Genotypic substitution included assessment of RT substitution, PI substitution and Integrase RAL substitution as per IAS-USA list. ITT-E Resistance Tested through Week 96 population included participants who met the criteria for Resistance testing, and the confirmatory value or value at discontinuation occurred at or before the end of the Week 96 Snapshot analysis window. The criteria for resistance tested was participants with virologic failure or the following criteria a) Participants who achieved viral suppression (plasma HIV-1 RNA < 50 c/mL) and have confirmed plasma HIV-1 RNA >= 400 c/mL at any time during the study. b) Participants who were discontinued before achieving viral suppression (plasma HIV-1 RNA < 50 c/mL) after Week 8 with last plasma HIV-1 RNA >=400 c/mL.

Outcome measures

Measure	FTR 400 mg BID/RAL/TDF n=20 Participants Participants were randomized and administered 400 mg FTR BID (double-blind) along with 400 mg RAL BID (open label) and 300 mg TDF once daily (QD) (open label).	FTR 800 mg BID/RAL/TDF n=18 Participants Participants were randomized and administered 800 mg of FTR BID (double-blind) along with 400 mg RAL BID (open label) and 300 mg TDF QD (open label).	FTR 600 mg QD/RAL/TDF n=23 Participants Participants were randomized and administered 600 mg of FTR QD (double-blind) along with 400 mg RAL BID (open label) and 300 mg TDF QD (open label).	FTR 1200 mg QD/RAL/TDF n=13 Participants Participants were randomized and administered 1200 mg of FTR QD along (double-blind) with 400 mg RAL BID (open label) and 300 mg TDF QD (open label).	ATV/r/RAL/TDF n=11 Participants Participants were randomized to Reference group (open label) and administered ATV/r 300/100 mg once daily along with 400 mg RAL BID and 300 mg TDF QD.
Number of Participants With Newly-emergent Genotypic Substitutions at Week 96 PI substitution	3 Participants	1 Participants	2 Participants	2 Participants	0 Participants
Number of Participants With Newly-emergent Genotypic Substitutions at Week 96 RT substitution	2 Participants	1 Participants	2 Participants	2 Participants	1 Participants
Number of Participants With Newly-emergent Genotypic Substitutions at Week 96 Integrase RAL substitution	2 Participants	2 Participants	1 Participants	3 Participants	0 Participants

SECONDARY outcome

Timeframe: Baseline and up to Week 24

Population: ITT-E Resistance Tested through Week 24 Population

Virologic failure is defined clinically as confirmed plasma HIV-1 RNA >= 50 copies/mL at Week 24 or later or virologic rebound defined as confirmed HIV-1 RNA >=50 copies/mL at any time after prior confirmed suppression to <50 copies/mL OR confirmed >1 log10 copies/mL increase in HIV-1 RNA at any time above nadir level where nadir was >= 50 copies/mL . The phenotypic resistance to a drug is defined as a fold change (i.e, ratio of the IC50 of the clinical isolate to the IC50 of the reference strain) greater than the cut-off for reduced susceptibility. Maximum change from Baseline in Temsavir IC50 fold change based on all on-treatment values has been presented. Baseline is defined as the last non-missing value on or before the date of first dose of study treatment and those values are absolute values. Change from Baseline was calculated as value at indicated time point minus Baseline value. Only those participants available at the specified time points were analyzed.

Outcome measures

Measure	FTR 400 mg BID/RAL/TDF n=3 Participants Participants were randomized and administered 400 mg FTR BID (double-blind) along with 400 mg RAL BID (open label) and 300 mg TDF once daily (QD) (open label).	FTR 800 mg BID/RAL/TDF n=4 Participants Participants were randomized and administered 800 mg of FTR BID (double-blind) along with 400 mg RAL BID (open label) and 300 mg TDF QD (open label).	FTR 600 mg QD/RAL/TDF n=6 Participants Participants were randomized and administered 600 mg of FTR QD (double-blind) along with 400 mg RAL BID (open label) and 300 mg TDF QD (open label).	FTR 1200 mg QD/RAL/TDF n=2 Participants Participants were randomized and administered 1200 mg of FTR QD along (double-blind) with 400 mg RAL BID (open label) and 300 mg TDF QD (open label).	ATV/r/RAL/TDF Participants were randomized to Reference group (open label) and administered ATV/r 300/100 mg once daily along with 400 mg RAL BID and 300 mg TDF QD.
Maximum Change From Baseline in Inhibitory Concentration at 50% (IC50) Fold Change Among Participants With VF at Week 24	-2.350 IC50 Fold Change Standard Deviation 3.4536	1014.748 IC50 Fold Change Standard Deviation 2015.5876	101.627 IC50 Fold Change Standard Deviation 190.4849	39.030 IC50 Fold Change Standard Deviation 55.1119	—

SECONDARY outcome

Timeframe: Baseline and up to Week 48

Population: ITT-E Resistance Tested through Week 48 Population

Virologic failure is defined clinically as confirmed plasma HIV-1 RNA >= 50 copies/mL at Week 24 or later or later or virologic rebound defined as confirmed HIV-1 RNA >=50 copies/mL at any time after prior confirmed suppression to <50 copies/mL OR confirmed >1 log10 copies/mL increase in HIV-1 RNA at any time above nadir level where nadir was >= 50 copies/mL. The phenotypic resistance to a drug is defined as a fold change (i.e, ratio of the IC50 of the clinical isolate to the IC50 of the reference strain) greater than the cut-off for reduced susceptibility. Maximum change from Baseline in Temsavir IC50 fold change based on all on-treatment values has been presented. Baseline is defined as the last non-missing value on or before the date of first dose of study treatment and those values are absolute values. Change from Baseline was calculated as value at indicated time point minus Baseline value. Only those participants available at the specified time points were analyzed.

Outcome measures

Measure	FTR 400 mg BID/RAL/TDF n=5 Participants Participants were randomized and administered 400 mg FTR BID (double-blind) along with 400 mg RAL BID (open label) and 300 mg TDF once daily (QD) (open label).	FTR 800 mg BID/RAL/TDF n=7 Participants Participants were randomized and administered 800 mg of FTR BID (double-blind) along with 400 mg RAL BID (open label) and 300 mg TDF QD (open label).	FTR 600 mg QD/RAL/TDF n=8 Participants Participants were randomized and administered 600 mg of FTR QD (double-blind) along with 400 mg RAL BID (open label) and 300 mg TDF QD (open label).	FTR 1200 mg QD/RAL/TDF n=5 Participants Participants were randomized and administered 1200 mg of FTR QD along (double-blind) with 400 mg RAL BID (open label) and 300 mg TDF QD (open label).	ATV/r/RAL/TDF Participants were randomized to Reference group (open label) and administered ATV/r 300/100 mg once daily along with 400 mg RAL BID and 300 mg TDF QD.
Change From Baseline in IC50 Fold Change Among Participants With VF at Week 48	-2.624 IC50 Fold Change Standard Deviation 3.2819	586.776 IC50 Fold Change Standard Deviation 1521.9126	81.729 IC50 Fold Change Standard Deviation 165.4931	449.092 IC50 Fold Change Standard Deviation 647.9828	—

SECONDARY outcome

Timeframe: Baseline and up to Week 96

Population: ITT-E Resistance Tested through Week 96 Population

Virologic failure is defined clinically as confirmed plasma HIV-1 RNA >= 50 copies/mL at Week 24 or later or virologic rebound defined as confirmed HIV-1 RNA >=50 copies/mL at any time after prior confirmed suppression to <50 copies/mL OR confirmed >1 log10 copies/mL increase in HIV-1 RNA at any time above nadir level where nadir was >= 50 copies/mL. The phenotypic resistance to a drug is defined as a fold change (i.e, ratio of the IC50 of the clinical isolate to the IC50 of the reference strain) greater than the cut-off for reduced susceptibility. Maximum change from Baseline in Temsavir IC50 fold change based on all on-treatment values has been presented. Baseline is defined as the last non-missing value on or before the date of first dose of study treatment and those values are absolute values. Change from Baseline was calculated as value at indicated time point minus Baseline value. Only those participants available at the specified time points were analyzed.

Outcome measures

Measure	FTR 400 mg BID/RAL/TDF n=6 Participants Participants were randomized and administered 400 mg FTR BID (double-blind) along with 400 mg RAL BID (open label) and 300 mg TDF once daily (QD) (open label).	FTR 800 mg BID/RAL/TDF n=14 Participants Participants were randomized and administered 800 mg of FTR BID (double-blind) along with 400 mg RAL BID (open label) and 300 mg TDF QD (open label).	FTR 600 mg QD/RAL/TDF n=11 Participants Participants were randomized and administered 600 mg of FTR QD (double-blind) along with 400 mg RAL BID (open label) and 300 mg TDF QD (open label).	FTR 1200 mg QD/RAL/TDF n=9 Participants Participants were randomized and administered 1200 mg of FTR QD along (double-blind) with 400 mg RAL BID (open label) and 300 mg TDF QD (open label).	ATV/r/RAL/TDF Participants were randomized to Reference group (open label) and administered ATV/r 300/100 mg once daily along with 400 mg RAL BID and 300 mg TDF QD.
Change From Baseline in IC50 Fold Change Among Participants With VF at Week 96	25.480 IC50 Fold Change Standard Deviation 68.9030	419.901 IC50 Fold Change Standard Deviation 1092.5929	46.351 IC50 Fold Change Standard Deviation 157.9219	777.818 IC50 Fold Change Standard Deviation 1550.8887	—

Adverse Events

FTR/RAL/TDF Total

Serious events: 35 serious events

Other events: 163 other events

Deaths: 3 deaths

ATV/r/RAL/TDF

Serious events: 8 serious events

Other events: 46 other events

Deaths: 0 deaths

Serious adverse events

Measure	FTR/RAL/TDF Total n=200 participants at risk All participants who were randomized to receive either of FTR 400mg BID, 800 mg BID, 600mg QD or 1200 mg QD (double-blind) along with 400 mg RAL BID (open label) and 300 mg TDF QD (open label).	ATV/r/RAL/TDF n=51 participants at risk Participants were randomized to Reference group (open label) and administered ATV/r 300/100 mg once daily along with 400 mg RAL BID and 300 mg TDF QD.
Infections and infestations Bone tuberculosis	1.0% 2/200 • Number of events 2 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of study treatment (Day 1) until 2117 days The analysis was based on the Safety Population. Adverse events data were not reported cumulatively for all intervention concentrations, and were only reported cumulatively per FTR or ATV/r interventions.	0.00% 0/51 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of study treatment (Day 1) until 2117 days The analysis was based on the Safety Population. Adverse events data were not reported cumulatively for all intervention concentrations, and were only reported cumulatively per FTR or ATV/r interventions.
Infections and infestations Anal abscess	0.50% 1/200 • Number of events 1 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of study treatment (Day 1) until 2117 days The analysis was based on the Safety Population. Adverse events data were not reported cumulatively for all intervention concentrations, and were only reported cumulatively per FTR or ATV/r interventions.	0.00% 0/51 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of study treatment (Day 1) until 2117 days The analysis was based on the Safety Population. Adverse events data were not reported cumulatively for all intervention concentrations, and were only reported cumulatively per FTR or ATV/r interventions.
Infections and infestations Cellulitis	0.50% 1/200 • Number of events 1 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of study treatment (Day 1) until 2117 days The analysis was based on the Safety Population. Adverse events data were not reported cumulatively for all intervention concentrations, and were only reported cumulatively per FTR or ATV/r interventions.	0.00% 0/51 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of study treatment (Day 1) until 2117 days The analysis was based on the Safety Population. Adverse events data were not reported cumulatively for all intervention concentrations, and were only reported cumulatively per FTR or ATV/r interventions.
Infections and infestations Cellulitis staphylococcal	0.50% 1/200 • Number of events 1 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of study treatment (Day 1) until 2117 days The analysis was based on the Safety Population. Adverse events data were not reported cumulatively for all intervention concentrations, and were only reported cumulatively per FTR or ATV/r interventions.	0.00% 0/51 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of study treatment (Day 1) until 2117 days The analysis was based on the Safety Population. Adverse events data were not reported cumulatively for all intervention concentrations, and were only reported cumulatively per FTR or ATV/r interventions.
Infections and infestations Disseminated tuberculosis	0.50% 1/200 • Number of events 1 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of study treatment (Day 1) until 2117 days The analysis was based on the Safety Population. Adverse events data were not reported cumulatively for all intervention concentrations, and were only reported cumulatively per FTR or ATV/r interventions.	0.00% 0/51 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of study treatment (Day 1) until 2117 days The analysis was based on the Safety Population. Adverse events data were not reported cumulatively for all intervention concentrations, and were only reported cumulatively per FTR or ATV/r interventions.
Infections and infestations Herpes zoster	0.50% 1/200 • Number of events 1 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of study treatment (Day 1) until 2117 days The analysis was based on the Safety Population. Adverse events data were not reported cumulatively for all intervention concentrations, and were only reported cumulatively per FTR or ATV/r interventions.	0.00% 0/51 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of study treatment (Day 1) until 2117 days The analysis was based on the Safety Population. Adverse events data were not reported cumulatively for all intervention concentrations, and were only reported cumulatively per FTR or ATV/r interventions.
Infections and infestations Influenza	0.00% 0/200 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of study treatment (Day 1) until 2117 days The analysis was based on the Safety Population. Adverse events data were not reported cumulatively for all intervention concentrations, and were only reported cumulatively per FTR or ATV/r interventions.	2.0% 1/51 • Number of events 1 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of study treatment (Day 1) until 2117 days The analysis was based on the Safety Population. Adverse events data were not reported cumulatively for all intervention concentrations, and were only reported cumulatively per FTR or ATV/r interventions.
Infections and infestations Lymphangitis	0.50% 1/200 • Number of events 1 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of study treatment (Day 1) until 2117 days The analysis was based on the Safety Population. Adverse events data were not reported cumulatively for all intervention concentrations, and were only reported cumulatively per FTR or ATV/r interventions.	0.00% 0/51 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of study treatment (Day 1) until 2117 days The analysis was based on the Safety Population. Adverse events data were not reported cumulatively for all intervention concentrations, and were only reported cumulatively per FTR or ATV/r interventions.
Infections and infestations Meningoencephalitis herpetic	0.50% 1/200 • Number of events 1 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of study treatment (Day 1) until 2117 days The analysis was based on the Safety Population. Adverse events data were not reported cumulatively for all intervention concentrations, and were only reported cumulatively per FTR or ATV/r interventions.	0.00% 0/51 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of study treatment (Day 1) until 2117 days The analysis was based on the Safety Population. Adverse events data were not reported cumulatively for all intervention concentrations, and were only reported cumulatively per FTR or ATV/r interventions.
Infections and infestations Oral candidiasis	0.50% 1/200 • Number of events 1 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of study treatment (Day 1) until 2117 days The analysis was based on the Safety Population. Adverse events data were not reported cumulatively for all intervention concentrations, and were only reported cumulatively per FTR or ATV/r interventions.	0.00% 0/51 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of study treatment (Day 1) until 2117 days The analysis was based on the Safety Population. Adverse events data were not reported cumulatively for all intervention concentrations, and were only reported cumulatively per FTR or ATV/r interventions.
Infections and infestations Pneumonia	0.00% 0/200 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of study treatment (Day 1) until 2117 days The analysis was based on the Safety Population. Adverse events data were not reported cumulatively for all intervention concentrations, and were only reported cumulatively per FTR or ATV/r interventions.	2.0% 1/51 • Number of events 1 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of study treatment (Day 1) until 2117 days The analysis was based on the Safety Population. Adverse events data were not reported cumulatively for all intervention concentrations, and were only reported cumulatively per FTR or ATV/r interventions.
Infections and infestations Pyelonephritis acute	0.00% 0/200 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of study treatment (Day 1) until 2117 days The analysis was based on the Safety Population. Adverse events data were not reported cumulatively for all intervention concentrations, and were only reported cumulatively per FTR or ATV/r interventions.	2.0% 1/51 • Number of events 1 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of study treatment (Day 1) until 2117 days The analysis was based on the Safety Population. Adverse events data were not reported cumulatively for all intervention concentrations, and were only reported cumulatively per FTR or ATV/r interventions.
Infections and infestations Sepsis	0.50% 1/200 • Number of events 1 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of study treatment (Day 1) until 2117 days The analysis was based on the Safety Population. Adverse events data were not reported cumulatively for all intervention concentrations, and were only reported cumulatively per FTR or ATV/r interventions.	0.00% 0/51 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of study treatment (Day 1) until 2117 days The analysis was based on the Safety Population. Adverse events data were not reported cumulatively for all intervention concentrations, and were only reported cumulatively per FTR or ATV/r interventions.
Injury, poisoning and procedural complications Overdose	1.5% 3/200 • Number of events 5 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of study treatment (Day 1) until 2117 days The analysis was based on the Safety Population. Adverse events data were not reported cumulatively for all intervention concentrations, and were only reported cumulatively per FTR or ATV/r interventions.	2.0% 1/51 • Number of events 2 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of study treatment (Day 1) until 2117 days The analysis was based on the Safety Population. Adverse events data were not reported cumulatively for all intervention concentrations, and were only reported cumulatively per FTR or ATV/r interventions.
Injury, poisoning and procedural complications Accidental overdose	1.0% 2/200 • Number of events 2 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of study treatment (Day 1) until 2117 days The analysis was based on the Safety Population. Adverse events data were not reported cumulatively for all intervention concentrations, and were only reported cumulatively per FTR or ATV/r interventions.	0.00% 0/51 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of study treatment (Day 1) until 2117 days The analysis was based on the Safety Population. Adverse events data were not reported cumulatively for all intervention concentrations, and were only reported cumulatively per FTR or ATV/r interventions.
Injury, poisoning and procedural complications Ankle fracture	0.00% 0/200 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of study treatment (Day 1) until 2117 days The analysis was based on the Safety Population. Adverse events data were not reported cumulatively for all intervention concentrations, and were only reported cumulatively per FTR or ATV/r interventions.	2.0% 1/51 • Number of events 1 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of study treatment (Day 1) until 2117 days The analysis was based on the Safety Population. Adverse events data were not reported cumulatively for all intervention concentrations, and were only reported cumulatively per FTR or ATV/r interventions.
Injury, poisoning and procedural complications Gun shot wound	0.50% 1/200 • Number of events 1 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of study treatment (Day 1) until 2117 days The analysis was based on the Safety Population. Adverse events data were not reported cumulatively for all intervention concentrations, and were only reported cumulatively per FTR or ATV/r interventions.	0.00% 0/51 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of study treatment (Day 1) until 2117 days The analysis was based on the Safety Population. Adverse events data were not reported cumulatively for all intervention concentrations, and were only reported cumulatively per FTR or ATV/r interventions.
Gastrointestinal disorders Abdominal pain	1.0% 2/200 • Number of events 2 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of study treatment (Day 1) until 2117 days The analysis was based on the Safety Population. Adverse events data were not reported cumulatively for all intervention concentrations, and were only reported cumulatively per FTR or ATV/r interventions.	0.00% 0/51 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of study treatment (Day 1) until 2117 days The analysis was based on the Safety Population. Adverse events data were not reported cumulatively for all intervention concentrations, and were only reported cumulatively per FTR or ATV/r interventions.
Gastrointestinal disorders Diarrhoea	0.50% 1/200 • Number of events 1 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of study treatment (Day 1) until 2117 days The analysis was based on the Safety Population. Adverse events data were not reported cumulatively for all intervention concentrations, and were only reported cumulatively per FTR or ATV/r interventions.	2.0% 1/51 • Number of events 1 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of study treatment (Day 1) until 2117 days The analysis was based on the Safety Population. Adverse events data were not reported cumulatively for all intervention concentrations, and were only reported cumulatively per FTR or ATV/r interventions.
Gastrointestinal disorders Abdominal pain upper	0.00% 0/200 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of study treatment (Day 1) until 2117 days The analysis was based on the Safety Population. Adverse events data were not reported cumulatively for all intervention concentrations, and were only reported cumulatively per FTR or ATV/r interventions.	2.0% 1/51 • Number of events 1 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of study treatment (Day 1) until 2117 days The analysis was based on the Safety Population. Adverse events data were not reported cumulatively for all intervention concentrations, and were only reported cumulatively per FTR or ATV/r interventions.
Gastrointestinal disorders Oesophageal varices haemorrhage	0.50% 1/200 • Number of events 1 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of study treatment (Day 1) until 2117 days The analysis was based on the Safety Population. Adverse events data were not reported cumulatively for all intervention concentrations, and were only reported cumulatively per FTR or ATV/r interventions.	0.00% 0/51 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of study treatment (Day 1) until 2117 days The analysis was based on the Safety Population. Adverse events data were not reported cumulatively for all intervention concentrations, and were only reported cumulatively per FTR or ATV/r interventions.
Musculoskeletal and connective tissue disorders Back pain	0.50% 1/200 • Number of events 1 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of study treatment (Day 1) until 2117 days The analysis was based on the Safety Population. Adverse events data were not reported cumulatively for all intervention concentrations, and were only reported cumulatively per FTR or ATV/r interventions.	0.00% 0/51 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of study treatment (Day 1) until 2117 days The analysis was based on the Safety Population. Adverse events data were not reported cumulatively for all intervention concentrations, and were only reported cumulatively per FTR or ATV/r interventions.
Musculoskeletal and connective tissue disorders Intervertebral disc protrusion	0.50% 1/200 • Number of events 1 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of study treatment (Day 1) until 2117 days The analysis was based on the Safety Population. Adverse events data were not reported cumulatively for all intervention concentrations, and were only reported cumulatively per FTR or ATV/r interventions.	0.00% 0/51 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of study treatment (Day 1) until 2117 days The analysis was based on the Safety Population. Adverse events data were not reported cumulatively for all intervention concentrations, and were only reported cumulatively per FTR or ATV/r interventions.
Musculoskeletal and connective tissue disorders Myalgia	0.50% 1/200 • Number of events 1 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of study treatment (Day 1) until 2117 days The analysis was based on the Safety Population. Adverse events data were not reported cumulatively for all intervention concentrations, and were only reported cumulatively per FTR or ATV/r interventions.	0.00% 0/51 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of study treatment (Day 1) until 2117 days The analysis was based on the Safety Population. Adverse events data were not reported cumulatively for all intervention concentrations, and were only reported cumulatively per FTR or ATV/r interventions.
Musculoskeletal and connective tissue disorders Osteonecrosis	0.50% 1/200 • Number of events 1 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of study treatment (Day 1) until 2117 days The analysis was based on the Safety Population. Adverse events data were not reported cumulatively for all intervention concentrations, and were only reported cumulatively per FTR or ATV/r interventions.	0.00% 0/51 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of study treatment (Day 1) until 2117 days The analysis was based on the Safety Population. Adverse events data were not reported cumulatively for all intervention concentrations, and were only reported cumulatively per FTR or ATV/r interventions.
Psychiatric disorders Acute stress disorder	0.50% 1/200 • Number of events 1 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of study treatment (Day 1) until 2117 days The analysis was based on the Safety Population. Adverse events data were not reported cumulatively for all intervention concentrations, and were only reported cumulatively per FTR or ATV/r interventions.	0.00% 0/51 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of study treatment (Day 1) until 2117 days The analysis was based on the Safety Population. Adverse events data were not reported cumulatively for all intervention concentrations, and were only reported cumulatively per FTR or ATV/r interventions.
Psychiatric disorders Completed suicide	0.50% 1/200 • Number of events 1 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of study treatment (Day 1) until 2117 days The analysis was based on the Safety Population. Adverse events data were not reported cumulatively for all intervention concentrations, and were only reported cumulatively per FTR or ATV/r interventions.	0.00% 0/51 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of study treatment (Day 1) until 2117 days The analysis was based on the Safety Population. Adverse events data were not reported cumulatively for all intervention concentrations, and were only reported cumulatively per FTR or ATV/r interventions.
Psychiatric disorders Depression	0.50% 1/200 • Number of events 1 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of study treatment (Day 1) until 2117 days The analysis was based on the Safety Population. Adverse events data were not reported cumulatively for all intervention concentrations, and were only reported cumulatively per FTR or ATV/r interventions.	0.00% 0/51 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of study treatment (Day 1) until 2117 days The analysis was based on the Safety Population. Adverse events data were not reported cumulatively for all intervention concentrations, and were only reported cumulatively per FTR or ATV/r interventions.
Psychiatric disorders Suicide attempt	0.50% 1/200 • Number of events 2 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of study treatment (Day 1) until 2117 days The analysis was based on the Safety Population. Adverse events data were not reported cumulatively for all intervention concentrations, and were only reported cumulatively per FTR or ATV/r interventions.	0.00% 0/51 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of study treatment (Day 1) until 2117 days The analysis was based on the Safety Population. Adverse events data were not reported cumulatively for all intervention concentrations, and were only reported cumulatively per FTR or ATV/r interventions.
Nervous system disorders Migraine	0.00% 0/200 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of study treatment (Day 1) until 2117 days The analysis was based on the Safety Population. Adverse events data were not reported cumulatively for all intervention concentrations, and were only reported cumulatively per FTR or ATV/r interventions.	2.0% 1/51 • Number of events 1 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of study treatment (Day 1) until 2117 days The analysis was based on the Safety Population. Adverse events data were not reported cumulatively for all intervention concentrations, and were only reported cumulatively per FTR or ATV/r interventions.
Nervous system disorders Post herpetic neuralgia	0.50% 1/200 • Number of events 1 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of study treatment (Day 1) until 2117 days The analysis was based on the Safety Population. Adverse events data were not reported cumulatively for all intervention concentrations, and were only reported cumulatively per FTR or ATV/r interventions.	0.00% 0/51 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of study treatment (Day 1) until 2117 days The analysis was based on the Safety Population. Adverse events data were not reported cumulatively for all intervention concentrations, and were only reported cumulatively per FTR or ATV/r interventions.
Nervous system disorders Syncope	0.50% 1/200 • Number of events 1 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of study treatment (Day 1) until 2117 days The analysis was based on the Safety Population. Adverse events data were not reported cumulatively for all intervention concentrations, and were only reported cumulatively per FTR or ATV/r interventions.	0.00% 0/51 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of study treatment (Day 1) until 2117 days The analysis was based on the Safety Population. Adverse events data were not reported cumulatively for all intervention concentrations, and were only reported cumulatively per FTR or ATV/r interventions.
Hepatobiliary disorders Cholecystitis chronic	0.50% 1/200 • Number of events 1 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of study treatment (Day 1) until 2117 days The analysis was based on the Safety Population. Adverse events data were not reported cumulatively for all intervention concentrations, and were only reported cumulatively per FTR or ATV/r interventions.	0.00% 0/51 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of study treatment (Day 1) until 2117 days The analysis was based on the Safety Population. Adverse events data were not reported cumulatively for all intervention concentrations, and were only reported cumulatively per FTR or ATV/r interventions.
Hepatobiliary disorders Cholelithiasis	0.00% 0/200 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of study treatment (Day 1) until 2117 days The analysis was based on the Safety Population. Adverse events data were not reported cumulatively for all intervention concentrations, and were only reported cumulatively per FTR or ATV/r interventions.	2.0% 1/51 • Number of events 1 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of study treatment (Day 1) until 2117 days The analysis was based on the Safety Population. Adverse events data were not reported cumulatively for all intervention concentrations, and were only reported cumulatively per FTR or ATV/r interventions.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Adenocarcinoma of salivary gland	0.50% 1/200 • Number of events 1 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of study treatment (Day 1) until 2117 days The analysis was based on the Safety Population. Adverse events data were not reported cumulatively for all intervention concentrations, and were only reported cumulatively per FTR or ATV/r interventions.	0.00% 0/51 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of study treatment (Day 1) until 2117 days The analysis was based on the Safety Population. Adverse events data were not reported cumulatively for all intervention concentrations, and were only reported cumulatively per FTR or ATV/r interventions.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Ovarian neoplasm	0.50% 1/200 • Number of events 1 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of study treatment (Day 1) until 2117 days The analysis was based on the Safety Population. Adverse events data were not reported cumulatively for all intervention concentrations, and were only reported cumulatively per FTR or ATV/r interventions.	0.00% 0/51 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of study treatment (Day 1) until 2117 days The analysis was based on the Safety Population. Adverse events data were not reported cumulatively for all intervention concentrations, and were only reported cumulatively per FTR or ATV/r interventions.
Blood and lymphatic system disorders Neutropenia	0.50% 1/200 • Number of events 1 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of study treatment (Day 1) until 2117 days The analysis was based on the Safety Population. Adverse events data were not reported cumulatively for all intervention concentrations, and were only reported cumulatively per FTR or ATV/r interventions.	0.00% 0/51 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of study treatment (Day 1) until 2117 days The analysis was based on the Safety Population. Adverse events data were not reported cumulatively for all intervention concentrations, and were only reported cumulatively per FTR or ATV/r interventions.
Ear and labyrinth disorders Vertigo	0.50% 1/200 • Number of events 1 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of study treatment (Day 1) until 2117 days The analysis was based on the Safety Population. Adverse events data were not reported cumulatively for all intervention concentrations, and were only reported cumulatively per FTR or ATV/r interventions.	0.00% 0/51 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of study treatment (Day 1) until 2117 days The analysis was based on the Safety Population. Adverse events data were not reported cumulatively for all intervention concentrations, and were only reported cumulatively per FTR or ATV/r interventions.
Investigations Blood creatine phosphokinase increased	0.50% 1/200 • Number of events 1 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of study treatment (Day 1) until 2117 days The analysis was based on the Safety Population. Adverse events data were not reported cumulatively for all intervention concentrations, and were only reported cumulatively per FTR or ATV/r interventions.	0.00% 0/51 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of study treatment (Day 1) until 2117 days The analysis was based on the Safety Population. Adverse events data were not reported cumulatively for all intervention concentrations, and were only reported cumulatively per FTR or ATV/r interventions.
Metabolism and nutrition disorders Decreased appetite	0.50% 1/200 • Number of events 1 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of study treatment (Day 1) until 2117 days The analysis was based on the Safety Population. Adverse events data were not reported cumulatively for all intervention concentrations, and were only reported cumulatively per FTR or ATV/r interventions.	0.00% 0/51 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of study treatment (Day 1) until 2117 days The analysis was based on the Safety Population. Adverse events data were not reported cumulatively for all intervention concentrations, and were only reported cumulatively per FTR or ATV/r interventions.
Pregnancy, puerperium and perinatal conditions Abortion spontaneous	0.50% 1/200 • Number of events 1 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of study treatment (Day 1) until 2117 days The analysis was based on the Safety Population. Adverse events data were not reported cumulatively for all intervention concentrations, and were only reported cumulatively per FTR or ATV/r interventions.	0.00% 0/51 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of study treatment (Day 1) until 2117 days The analysis was based on the Safety Population. Adverse events data were not reported cumulatively for all intervention concentrations, and were only reported cumulatively per FTR or ATV/r interventions.
Renal and urinary disorders Acute kidney injury	0.50% 1/200 • Number of events 1 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of study treatment (Day 1) until 2117 days The analysis was based on the Safety Population. Adverse events data were not reported cumulatively for all intervention concentrations, and were only reported cumulatively per FTR or ATV/r interventions.	0.00% 0/51 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of study treatment (Day 1) until 2117 days The analysis was based on the Safety Population. Adverse events data were not reported cumulatively for all intervention concentrations, and were only reported cumulatively per FTR or ATV/r interventions.
Respiratory, thoracic and mediastinal disorders Obstructive airways disorder	0.50% 1/200 • Number of events 1 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of study treatment (Day 1) until 2117 days The analysis was based on the Safety Population. Adverse events data were not reported cumulatively for all intervention concentrations, and were only reported cumulatively per FTR or ATV/r interventions.	0.00% 0/51 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of study treatment (Day 1) until 2117 days The analysis was based on the Safety Population. Adverse events data were not reported cumulatively for all intervention concentrations, and were only reported cumulatively per FTR or ATV/r interventions.
Surgical and medical procedures Hysterectomy	0.50% 1/200 • Number of events 1 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of study treatment (Day 1) until 2117 days The analysis was based on the Safety Population. Adverse events data were not reported cumulatively for all intervention concentrations, and were only reported cumulatively per FTR or ATV/r interventions.	0.00% 0/51 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of study treatment (Day 1) until 2117 days The analysis was based on the Safety Population. Adverse events data were not reported cumulatively for all intervention concentrations, and were only reported cumulatively per FTR or ATV/r interventions.
Vascular disorders Deep vein thrombosis	0.50% 1/200 • Number of events 1 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of study treatment (Day 1) until 2117 days The analysis was based on the Safety Population. Adverse events data were not reported cumulatively for all intervention concentrations, and were only reported cumulatively per FTR or ATV/r interventions.	0.00% 0/51 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of study treatment (Day 1) until 2117 days The analysis was based on the Safety Population. Adverse events data were not reported cumulatively for all intervention concentrations, and were only reported cumulatively per FTR or ATV/r interventions.

Other adverse events

Measure	FTR/RAL/TDF Total n=200 participants at risk All participants who were randomized to receive either of FTR 400mg BID, 800 mg BID, 600mg QD or 1200 mg QD (double-blind) along with 400 mg RAL BID (open label) and 300 mg TDF QD (open label).	ATV/r/RAL/TDF n=51 participants at risk Participants were randomized to Reference group (open label) and administered ATV/r 300/100 mg once daily along with 400 mg RAL BID and 300 mg TDF QD.
Infections and infestations Lower respiratory tract infection	5.0% 10/200 • Number of events 12 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of study treatment (Day 1) until 2117 days The analysis was based on the Safety Population. Adverse events data were not reported cumulatively for all intervention concentrations, and were only reported cumulatively per FTR or ATV/r interventions.	2.0% 1/51 • Number of events 1 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of study treatment (Day 1) until 2117 days The analysis was based on the Safety Population. Adverse events data were not reported cumulatively for all intervention concentrations, and were only reported cumulatively per FTR or ATV/r interventions.
Infections and infestations Onychomycosis	4.0% 8/200 • Number of events 8 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of study treatment (Day 1) until 2117 days The analysis was based on the Safety Population. Adverse events data were not reported cumulatively for all intervention concentrations, and were only reported cumulatively per FTR or ATV/r interventions.	5.9% 3/51 • Number of events 3 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of study treatment (Day 1) until 2117 days The analysis was based on the Safety Population. Adverse events data were not reported cumulatively for all intervention concentrations, and were only reported cumulatively per FTR or ATV/r interventions.
Infections and infestations Sinusitis	2.5% 5/200 • Number of events 12 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of study treatment (Day 1) until 2117 days The analysis was based on the Safety Population. Adverse events data were not reported cumulatively for all intervention concentrations, and were only reported cumulatively per FTR or ATV/r interventions.	7.8% 4/51 • Number of events 12 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of study treatment (Day 1) until 2117 days The analysis was based on the Safety Population. Adverse events data were not reported cumulatively for all intervention concentrations, and were only reported cumulatively per FTR or ATV/r interventions.
Infections and infestations Nasopharyngitis	16.0% 32/200 • Number of events 52 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of study treatment (Day 1) until 2117 days The analysis was based on the Safety Population. Adverse events data were not reported cumulatively for all intervention concentrations, and were only reported cumulatively per FTR or ATV/r interventions.	9.8% 5/51 • Number of events 10 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of study treatment (Day 1) until 2117 days The analysis was based on the Safety Population. Adverse events data were not reported cumulatively for all intervention concentrations, and were only reported cumulatively per FTR or ATV/r interventions.
Infections and infestations Upper respiratory tract infection	13.5% 27/200 • Number of events 47 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of study treatment (Day 1) until 2117 days The analysis was based on the Safety Population. Adverse events data were not reported cumulatively for all intervention concentrations, and were only reported cumulatively per FTR or ATV/r interventions.	13.7% 7/51 • Number of events 7 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of study treatment (Day 1) until 2117 days The analysis was based on the Safety Population. Adverse events data were not reported cumulatively for all intervention concentrations, and were only reported cumulatively per FTR or ATV/r interventions.
Infections and infestations Urinary tract infection	14.0% 28/200 • Number of events 62 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of study treatment (Day 1) until 2117 days The analysis was based on the Safety Population. Adverse events data were not reported cumulatively for all intervention concentrations, and were only reported cumulatively per FTR or ATV/r interventions.	11.8% 6/51 • Number of events 19 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of study treatment (Day 1) until 2117 days The analysis was based on the Safety Population. Adverse events data were not reported cumulatively for all intervention concentrations, and were only reported cumulatively per FTR or ATV/r interventions.
Infections and infestations Influenza	11.0% 22/200 • Number of events 43 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of study treatment (Day 1) until 2117 days The analysis was based on the Safety Population. Adverse events data were not reported cumulatively for all intervention concentrations, and were only reported cumulatively per FTR or ATV/r interventions.	13.7% 7/51 • Number of events 8 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of study treatment (Day 1) until 2117 days The analysis was based on the Safety Population. Adverse events data were not reported cumulatively for all intervention concentrations, and were only reported cumulatively per FTR or ATV/r interventions.
Infections and infestations Bronchitis	11.0% 22/200 • Number of events 34 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of study treatment (Day 1) until 2117 days The analysis was based on the Safety Population. Adverse events data were not reported cumulatively for all intervention concentrations, and were only reported cumulatively per FTR or ATV/r interventions.	7.8% 4/51 • Number of events 4 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of study treatment (Day 1) until 2117 days The analysis was based on the Safety Population. Adverse events data were not reported cumulatively for all intervention concentrations, and were only reported cumulatively per FTR or ATV/r interventions.
Infections and infestations Pharyngitis	8.5% 17/200 • Number of events 19 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of study treatment (Day 1) until 2117 days The analysis was based on the Safety Population. Adverse events data were not reported cumulatively for all intervention concentrations, and were only reported cumulatively per FTR or ATV/r interventions.	9.8% 5/51 • Number of events 5 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of study treatment (Day 1) until 2117 days The analysis was based on the Safety Population. Adverse events data were not reported cumulatively for all intervention concentrations, and were only reported cumulatively per FTR or ATV/r interventions.
Infections and infestations Herpes zoster	8.5% 17/200 • Number of events 20 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of study treatment (Day 1) until 2117 days The analysis was based on the Safety Population. Adverse events data were not reported cumulatively for all intervention concentrations, and were only reported cumulatively per FTR or ATV/r interventions.	3.9% 2/51 • Number of events 2 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of study treatment (Day 1) until 2117 days The analysis was based on the Safety Population. Adverse events data were not reported cumulatively for all intervention concentrations, and were only reported cumulatively per FTR or ATV/r interventions.
Infections and infestations Gastroenteritis	5.5% 11/200 • Number of events 11 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of study treatment (Day 1) until 2117 days The analysis was based on the Safety Population. Adverse events data were not reported cumulatively for all intervention concentrations, and were only reported cumulatively per FTR or ATV/r interventions.	11.8% 6/51 • Number of events 6 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of study treatment (Day 1) until 2117 days The analysis was based on the Safety Population. Adverse events data were not reported cumulatively for all intervention concentrations, and were only reported cumulatively per FTR or ATV/r interventions.
Gastrointestinal disorders Diarrhoea	18.5% 37/200 • Number of events 48 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of study treatment (Day 1) until 2117 days The analysis was based on the Safety Population. Adverse events data were not reported cumulatively for all intervention concentrations, and were only reported cumulatively per FTR or ATV/r interventions.	19.6% 10/51 • Number of events 16 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of study treatment (Day 1) until 2117 days The analysis was based on the Safety Population. Adverse events data were not reported cumulatively for all intervention concentrations, and were only reported cumulatively per FTR or ATV/r interventions.
Gastrointestinal disorders Nausea	9.5% 19/200 • Number of events 22 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of study treatment (Day 1) until 2117 days The analysis was based on the Safety Population. Adverse events data were not reported cumulatively for all intervention concentrations, and were only reported cumulatively per FTR or ATV/r interventions.	11.8% 6/51 • Number of events 18 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of study treatment (Day 1) until 2117 days The analysis was based on the Safety Population. Adverse events data were not reported cumulatively for all intervention concentrations, and were only reported cumulatively per FTR or ATV/r interventions.
Gastrointestinal disorders Vomiting	8.0% 16/200 • Number of events 18 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of study treatment (Day 1) until 2117 days The analysis was based on the Safety Population. Adverse events data were not reported cumulatively for all intervention concentrations, and were only reported cumulatively per FTR or ATV/r interventions.	11.8% 6/51 • Number of events 8 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of study treatment (Day 1) until 2117 days The analysis was based on the Safety Population. Adverse events data were not reported cumulatively for all intervention concentrations, and were only reported cumulatively per FTR or ATV/r interventions.
Gastrointestinal disorders Abdominal pain	6.5% 13/200 • Number of events 13 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of study treatment (Day 1) until 2117 days The analysis was based on the Safety Population. Adverse events data were not reported cumulatively for all intervention concentrations, and were only reported cumulatively per FTR or ATV/r interventions.	7.8% 4/51 • Number of events 6 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of study treatment (Day 1) until 2117 days The analysis was based on the Safety Population. Adverse events data were not reported cumulatively for all intervention concentrations, and were only reported cumulatively per FTR or ATV/r interventions.
Gastrointestinal disorders Dyspepsia	6.0% 12/200 • Number of events 13 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of study treatment (Day 1) until 2117 days The analysis was based on the Safety Population. Adverse events data were not reported cumulatively for all intervention concentrations, and were only reported cumulatively per FTR or ATV/r interventions.	3.9% 2/51 • Number of events 2 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of study treatment (Day 1) until 2117 days The analysis was based on the Safety Population. Adverse events data were not reported cumulatively for all intervention concentrations, and were only reported cumulatively per FTR or ATV/r interventions.
Gastrointestinal disorders Constipation	5.5% 11/200 • Number of events 12 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of study treatment (Day 1) until 2117 days The analysis was based on the Safety Population. Adverse events data were not reported cumulatively for all intervention concentrations, and were only reported cumulatively per FTR or ATV/r interventions.	0.00% 0/51 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of study treatment (Day 1) until 2117 days The analysis was based on the Safety Population. Adverse events data were not reported cumulatively for all intervention concentrations, and were only reported cumulatively per FTR or ATV/r interventions.
Nervous system disorders Headache	19.0% 38/200 • Number of events 64 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of study treatment (Day 1) until 2117 days The analysis was based on the Safety Population. Adverse events data were not reported cumulatively for all intervention concentrations, and were only reported cumulatively per FTR or ATV/r interventions.	11.8% 6/51 • Number of events 18 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of study treatment (Day 1) until 2117 days The analysis was based on the Safety Population. Adverse events data were not reported cumulatively for all intervention concentrations, and were only reported cumulatively per FTR or ATV/r interventions.
Nervous system disorders Dizziness	4.5% 9/200 • Number of events 9 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of study treatment (Day 1) until 2117 days The analysis was based on the Safety Population. Adverse events data were not reported cumulatively for all intervention concentrations, and were only reported cumulatively per FTR or ATV/r interventions.	7.8% 4/51 • Number of events 6 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of study treatment (Day 1) until 2117 days The analysis was based on the Safety Population. Adverse events data were not reported cumulatively for all intervention concentrations, and were only reported cumulatively per FTR or ATV/r interventions.
Musculoskeletal and connective tissue disorders Back pain	10.0% 20/200 • Number of events 25 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of study treatment (Day 1) until 2117 days The analysis was based on the Safety Population. Adverse events data were not reported cumulatively for all intervention concentrations, and were only reported cumulatively per FTR or ATV/r interventions.	5.9% 3/51 • Number of events 3 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of study treatment (Day 1) until 2117 days The analysis was based on the Safety Population. Adverse events data were not reported cumulatively for all intervention concentrations, and were only reported cumulatively per FTR or ATV/r interventions.
Musculoskeletal and connective tissue disorders Arthralgia	9.0% 18/200 • Number of events 22 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of study treatment (Day 1) until 2117 days The analysis was based on the Safety Population. Adverse events data were not reported cumulatively for all intervention concentrations, and were only reported cumulatively per FTR or ATV/r interventions.	2.0% 1/51 • Number of events 1 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of study treatment (Day 1) until 2117 days The analysis was based on the Safety Population. Adverse events data were not reported cumulatively for all intervention concentrations, and were only reported cumulatively per FTR or ATV/r interventions.
Musculoskeletal and connective tissue disorders Pain in extremity	7.0% 14/200 • Number of events 17 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of study treatment (Day 1) until 2117 days The analysis was based on the Safety Population. Adverse events data were not reported cumulatively for all intervention concentrations, and were only reported cumulatively per FTR or ATV/r interventions.	2.0% 1/51 • Number of events 1 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of study treatment (Day 1) until 2117 days The analysis was based on the Safety Population. Adverse events data were not reported cumulatively for all intervention concentrations, and were only reported cumulatively per FTR or ATV/r interventions.
Musculoskeletal and connective tissue disorders Myalgia	5.0% 10/200 • Number of events 10 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of study treatment (Day 1) until 2117 days The analysis was based on the Safety Population. Adverse events data were not reported cumulatively for all intervention concentrations, and were only reported cumulatively per FTR or ATV/r interventions.	0.00% 0/51 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of study treatment (Day 1) until 2117 days The analysis was based on the Safety Population. Adverse events data were not reported cumulatively for all intervention concentrations, and were only reported cumulatively per FTR or ATV/r interventions.
Investigations Blood creatine phosphokinase increased	4.5% 9/200 • Number of events 16 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of study treatment (Day 1) until 2117 days The analysis was based on the Safety Population. Adverse events data were not reported cumulatively for all intervention concentrations, and were only reported cumulatively per FTR or ATV/r interventions.	5.9% 3/51 • Number of events 5 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of study treatment (Day 1) until 2117 days The analysis was based on the Safety Population. Adverse events data were not reported cumulatively for all intervention concentrations, and were only reported cumulatively per FTR or ATV/r interventions.
Investigations Alanine aminotransferase increased	3.0% 6/200 • Number of events 6 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of study treatment (Day 1) until 2117 days The analysis was based on the Safety Population. Adverse events data were not reported cumulatively for all intervention concentrations, and were only reported cumulatively per FTR or ATV/r interventions.	7.8% 4/51 • Number of events 6 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of study treatment (Day 1) until 2117 days The analysis was based on the Safety Population. Adverse events data were not reported cumulatively for all intervention concentrations, and were only reported cumulatively per FTR or ATV/r interventions.
Investigations Blood bilirubin increased	0.50% 1/200 • Number of events 1 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of study treatment (Day 1) until 2117 days The analysis was based on the Safety Population. Adverse events data were not reported cumulatively for all intervention concentrations, and were only reported cumulatively per FTR or ATV/r interventions.	7.8% 4/51 • Number of events 9 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of study treatment (Day 1) until 2117 days The analysis was based on the Safety Population. Adverse events data were not reported cumulatively for all intervention concentrations, and were only reported cumulatively per FTR or ATV/r interventions.
Hepatobiliary disorders Hyperbilirubinaemia	0.00% 0/200 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of study treatment (Day 1) until 2117 days The analysis was based on the Safety Population. Adverse events data were not reported cumulatively for all intervention concentrations, and were only reported cumulatively per FTR or ATV/r interventions.	21.6% 11/51 • Number of events 35 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of study treatment (Day 1) until 2117 days The analysis was based on the Safety Population. Adverse events data were not reported cumulatively for all intervention concentrations, and were only reported cumulatively per FTR or ATV/r interventions.
Hepatobiliary disorders Jaundice	0.00% 0/200 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of study treatment (Day 1) until 2117 days The analysis was based on the Safety Population. Adverse events data were not reported cumulatively for all intervention concentrations, and were only reported cumulatively per FTR or ATV/r interventions.	15.7% 8/51 • Number of events 9 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of study treatment (Day 1) until 2117 days The analysis was based on the Safety Population. Adverse events data were not reported cumulatively for all intervention concentrations, and were only reported cumulatively per FTR or ATV/r interventions.
Hepatobiliary disorders Ocular icterus	0.50% 1/200 • Number of events 1 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of study treatment (Day 1) until 2117 days The analysis was based on the Safety Population. Adverse events data were not reported cumulatively for all intervention concentrations, and were only reported cumulatively per FTR or ATV/r interventions.	13.7% 7/51 • Number of events 8 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of study treatment (Day 1) until 2117 days The analysis was based on the Safety Population. Adverse events data were not reported cumulatively for all intervention concentrations, and were only reported cumulatively per FTR or ATV/r interventions.
Respiratory, thoracic and mediastinal disorders Cough	8.5% 17/200 • Number of events 21 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of study treatment (Day 1) until 2117 days The analysis was based on the Safety Population. Adverse events data were not reported cumulatively for all intervention concentrations, and were only reported cumulatively per FTR or ATV/r interventions.	3.9% 2/51 • Number of events 2 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of study treatment (Day 1) until 2117 days The analysis was based on the Safety Population. Adverse events data were not reported cumulatively for all intervention concentrations, and were only reported cumulatively per FTR or ATV/r interventions.
Skin and subcutaneous tissue disorders Rash	7.5% 15/200 • Number of events 21 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of study treatment (Day 1) until 2117 days The analysis was based on the Safety Population. Adverse events data were not reported cumulatively for all intervention concentrations, and were only reported cumulatively per FTR or ATV/r interventions.	0.00% 0/51 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of study treatment (Day 1) until 2117 days The analysis was based on the Safety Population. Adverse events data were not reported cumulatively for all intervention concentrations, and were only reported cumulatively per FTR or ATV/r interventions.
Skin and subcutaneous tissue disorders Alopecia	0.00% 0/200 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of study treatment (Day 1) until 2117 days The analysis was based on the Safety Population. Adverse events data were not reported cumulatively for all intervention concentrations, and were only reported cumulatively per FTR or ATV/r interventions.	5.9% 3/51 • Number of events 3 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of study treatment (Day 1) until 2117 days The analysis was based on the Safety Population. Adverse events data were not reported cumulatively for all intervention concentrations, and were only reported cumulatively per FTR or ATV/r interventions.
Vascular disorders Hypertension	7.5% 15/200 • Number of events 16 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of study treatment (Day 1) until 2117 days The analysis was based on the Safety Population. Adverse events data were not reported cumulatively for all intervention concentrations, and were only reported cumulatively per FTR or ATV/r interventions.	5.9% 3/51 • Number of events 3 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of study treatment (Day 1) until 2117 days The analysis was based on the Safety Population. Adverse events data were not reported cumulatively for all intervention concentrations, and were only reported cumulatively per FTR or ATV/r interventions.
General disorders Fatigue	5.5% 11/200 • Number of events 14 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of study treatment (Day 1) until 2117 days The analysis was based on the Safety Population. Adverse events data were not reported cumulatively for all intervention concentrations, and were only reported cumulatively per FTR or ATV/r interventions.	7.8% 4/51 • Number of events 4 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of study treatment (Day 1) until 2117 days The analysis was based on the Safety Population. Adverse events data were not reported cumulatively for all intervention concentrations, and were only reported cumulatively per FTR or ATV/r interventions.
Psychiatric disorders Insomnia	6.5% 13/200 • Number of events 16 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of study treatment (Day 1) until 2117 days The analysis was based on the Safety Population. Adverse events data were not reported cumulatively for all intervention concentrations, and were only reported cumulatively per FTR or ATV/r interventions.	3.9% 2/51 • Number of events 2 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of study treatment (Day 1) until 2117 days The analysis was based on the Safety Population. Adverse events data were not reported cumulatively for all intervention concentrations, and were only reported cumulatively per FTR or ATV/r interventions.

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