Trial Outcomes & Findings for Renal Effect of Stribild or Other Tenofovir DF-containing Regimens Compared to Ritonavir-boosted Atazanavir Plus Abacavir/Lamivudine in Antiretroviral Treatment-naive HIV-1 Infected Adults (NCT NCT02246998)

NCT ID: NCT02246998

Last Updated: 2018-01-03

Results Overview

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 72 participants
• Primary outcome timeframe: Week 24
• Results posted on: 2018-01-03

Participant Flow

Participants were enrolled at study sites in Belgium, Ireland, Spain, and the United Kingdom. The first participant was screened on 15 Dec 2014. The last study visit occurred on 17 February 2016.

93 participants were screened.

Participant milestones

Measure	STB + Iohexol Elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate (STB; Stribild®; EVG/COBI/FTC/TDF; 150/150/200/300 mg) FDC tablet orally with food once daily for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day1), and Weeks 4, 8, 16, and 24	TVD + ATV/r + Iohexol FTC/TDF (TVD; Truvada®; 200/300 mg) FDC tablet + Atazanavir (ATV) 300 mg capsule + Ritonavir (RTV) 100 mg tablet orally with food once daily for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day 1), and Weeks 4, 8, 16, and 24	ATR + Iohexol EFV/FTC/TDF (ATR; Atripla® 600/200/300 mg) FDC tablet orally once daily on an empty stomach for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day1), and Weeks 4, 8, 16, and 24	ABC/3TC + ATV/r + Iohexol ABC/3TC (600/300 mg) FDC tablet + ATV 300 mg capsule + RTV 100 mg tablet orally with food once daily for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day1), and Weeks 4, 8, 16, and 24
Overall Study STARTED	18	18	18	18
Overall Study COMPLETED	16	15	15	16
Overall Study NOT COMPLETED	2	3	3	2

Reasons for withdrawal

Measure	STB + Iohexol Elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate (STB; Stribild®; EVG/COBI/FTC/TDF; 150/150/200/300 mg) FDC tablet orally with food once daily for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day1), and Weeks 4, 8, 16, and 24	TVD + ATV/r + Iohexol FTC/TDF (TVD; Truvada®; 200/300 mg) FDC tablet + Atazanavir (ATV) 300 mg capsule + Ritonavir (RTV) 100 mg tablet orally with food once daily for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day 1), and Weeks 4, 8, 16, and 24	ATR + Iohexol EFV/FTC/TDF (ATR; Atripla® 600/200/300 mg) FDC tablet orally once daily on an empty stomach for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day1), and Weeks 4, 8, 16, and 24	ABC/3TC + ATV/r + Iohexol ABC/3TC (600/300 mg) FDC tablet + ATV 300 mg capsule + RTV 100 mg tablet orally with food once daily for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day1), and Weeks 4, 8, 16, and 24
Overall Study Adverse Event	0	1	1	0
Overall Study Lost to Follow-up	1	0	0	1
Overall Study Randomized but Never Dosed	1	2	2	1

Baseline Characteristics

Renal Effect of Stribild or Other Tenofovir DF-containing Regimens Compared to Ritonavir-boosted Atazanavir Plus Abacavir/Lamivudine in Antiretroviral Treatment-naive HIV-1 Infected Adults

Baseline characteristics by cohort

Measure	STB + Iohexol n=17 Participants STB (150/150/200/300 mg) FDC tablet orally with food once daily for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day1), and Weeks 4, 8, 16, and 24	TVD + ATV/r + Iohexol n=16 Participants TVD (200/300 mg) FDC tablet + ATV 300 mg capsule + RTV 100 mg tablet orally with food once daily for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day 1), and Weeks 4, 8, 16, and 24	ATR + Iohexol n=16 Participants ATR (600/200/300 mg) FDC tablet orally once daily on an empty stomach for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day1), and Weeks 4, 8, 16, and 24	ABC/3TC + ATV/r + Iohexol n=17 Participants ABC/3TC (600/300 mg) FDC tablet + ATV 300 mg capsule + RTV 100 mg tablet orally with food once daily for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day1), and Weeks 4, 8, 16, and 24	Total n=66 Participants Total of all reporting groups
Age, Continuous	36 years STANDARD_DEVIATION 8.1 • n=5 Participants	34 years STANDARD_DEVIATION 8.4 • n=7 Participants	34 years STANDARD_DEVIATION 9.6 • n=5 Participants	34 years STANDARD_DEVIATION 7.5 • n=4 Participants	35 years STANDARD_DEVIATION 8.3 • n=21 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	2 Participants n=21 Participants
Sex: Female, Male Male	17 Participants n=5 Participants	15 Participants n=7 Participants	15 Participants n=5 Participants	17 Participants n=4 Participants	64 Participants n=21 Participants
Race/Ethnicity, Customized American Indian or Alaska Native	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants
Race/Ethnicity, Customized Asian	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	2 Participants n=21 Participants
Race/Ethnicity, Customized Black	2 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants	1 Participants n=4 Participants	6 Participants n=21 Participants
Race/Ethnicity, Customized White	13 Participants n=5 Participants	15 Participants n=7 Participants	13 Participants n=5 Participants	15 Participants n=4 Participants	56 Participants n=21 Participants
Race/Ethnicity, Customized Other	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants
Race/Ethnicity, Customized Hispanic or Latino	2 Participants n=5 Participants	3 Participants n=7 Participants	2 Participants n=5 Participants	0 Participants n=4 Participants	7 Participants n=21 Participants
Race/Ethnicity, Customized Not Hispanic or Latino	15 Participants n=5 Participants	13 Participants n=7 Participants	14 Participants n=5 Participants	17 Participants n=4 Participants	59 Participants n=21 Participants
Region of Enrollment Belgium	3 Participants n=5 Participants	2 Participants n=7 Participants	5 Participants n=5 Participants	4 Participants n=4 Participants	14 Participants n=21 Participants
Region of Enrollment Ireland	1 Participants n=5 Participants	3 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	5 Participants n=21 Participants
Region of Enrollment United Kingdom	11 Participants n=5 Participants	9 Participants n=7 Participants	9 Participants n=5 Participants	8 Participants n=4 Participants	37 Participants n=21 Participants
Region of Enrollment Spain	3 Participants n=5 Participants	4 Participants n=7 Participants	3 Participants n=5 Participants	6 Participants n=4 Participants	16 Participants n=21 Participants
Actual Glomerular Filtration Rate	111.8 mL/min STANDARD_DEVIATION 31.07 • n=5 Participants	112.0 mL/min STANDARD_DEVIATION 19.17 • n=7 Participants	105.4 mL/min STANDARD_DEVIATION 38.22 • n=5 Participants	96.6 mL/min STANDARD_DEVIATION 34.52 • n=4 Participants	106.4 mL/min STANDARD_DEVIATION 31.52 • n=21 Participants
Estimated Glomerular Filtration Rate by Cockcroft-Gault	120.8 mL/min STANDARD_DEVIATION 13.94 • n=5 Participants	121.2 mL/min STANDARD_DEVIATION 24.34 • n=7 Participants	119.5 mL/min STANDARD_DEVIATION 20.36 • n=5 Participants	122.6 mL/min STANDARD_DEVIATION 20.25 • n=4 Participants	121.0 mL/min STANDARD_DEVIATION 19.55 • n=21 Participants
Estimated Glomerular Filtration Rate by MDRD Formula	103.8 mL/min/1.73m2 STANDARD_DEVIATION 14.06 • n=5 Participants	110.6 mL/min/1.73m2 STANDARD_DEVIATION 18.47 • n=7 Participants	108.4 mL/min/1.73m2 STANDARD_DEVIATION 21.42 • n=5 Participants	105.5 mL/min/1.73m2 STANDARD_DEVIATION 12.59 • n=4 Participants	107.0 mL/min/1.73m2 STANDARD_DEVIATION 16.71 • n=21 Participants
CD4 Cell Count	552 cells/uL STANDARD_DEVIATION 177.8 • n=5 Participants	600 cells/uL STANDARD_DEVIATION 217.9 • n=7 Participants	553 cells/uL STANDARD_DEVIATION 215.8 • n=5 Participants	524 cells/uL STANDARD_DEVIATION 190.0 • n=4 Participants	557 cells/uL STANDARD_DEVIATION 197.8 • n=21 Participants

PRIMARY outcome

Timeframe: Week 24

Population: Participants in the pharmacodynamics (PD) analysis Set (all treated participants in each group, who have evaluable baseline and at least 1 postbaseline aGFR and /or eGFR at any visit) with available data were analyzed.

Outcome measures

Measure	STB + Iohexol n=17 Participants STB (150/150/200/300 mg) FDC tablet orally with food once daily for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day1), and Weeks 4, 8, 16, and 24	TVD + ATV/r + Iohexol n=15 Participants TVD (200/300 mg) FDC tablet + ATV 300 mg capsule + RTV 100 mg tablet orally with food once daily for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day 1), and Weeks 4, 8, 16, and 24	ATR + Iohexol n=15 Participants ATR (600/200/300 mg) FDC tablet orally once daily on an empty stomach for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day1), and Weeks 4, 8, 16, and 24	ABC/3TC + ATV/r + Iohexol n=17 Participants ABC/3TC (600/300 mg) FDC tablet + ATV 300 mg capsule + RTV 100 mg tablet orally with food once daily for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day1), and Weeks 4, 8, 16, and 24
Actual Glomerular Filtration Rate (aGFR) Using Iohexol Plasma Clearance (CLiohexol) at Week 24	103.6 mL/min Standard Deviation 23.28	104.9 mL/min Standard Deviation 27.16	111.1 mL/min Standard Deviation 23.23	101.0 mL/min Standard Deviation 27.01

PRIMARY outcome

Timeframe: Week 24

Population: Participants in the PD Analysis Set with available data were analyzed.

GFR is a measure of the rate at which blood is filtered by the kidney. Cockcroft-Gault is an equation (calculation) used to estimate GFR based on serum creatinine, weight, and gender. eGFR = (140 - age) * (mass in kg) * (0.85 if female) divided by 72 * serum creatinine in mg/dL

Outcome measures

Measure	STB + Iohexol n=16 Participants STB (150/150/200/300 mg) FDC tablet orally with food once daily for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day1), and Weeks 4, 8, 16, and 24	TVD + ATV/r + Iohexol n=15 Participants TVD (200/300 mg) FDC tablet + ATV 300 mg capsule + RTV 100 mg tablet orally with food once daily for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day 1), and Weeks 4, 8, 16, and 24	ATR + Iohexol n=15 Participants ATR (600/200/300 mg) FDC tablet orally once daily on an empty stomach for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day1), and Weeks 4, 8, 16, and 24	ABC/3TC + ATV/r + Iohexol n=16 Participants ABC/3TC (600/300 mg) FDC tablet + ATV 300 mg capsule + RTV 100 mg tablet orally with food once daily for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day1), and Weeks 4, 8, 16, and 24
Estimated GFR (eGFR) Calculated by Cockcroft-Gault Formula at Week 24	116.9 mL/min Standard Deviation 17.06	122.4 mL/min Standard Deviation 31.71	120.0 mL/min Standard Deviation 20.52	123.0 mL/min Standard Deviation 25.74

PRIMARY outcome

Timeframe: Week 24

Population: Participants in the PD Analysis Set with available data were analyzed.

MDRD is an equation (calculation) used to estimate GFR in participants with impaired renal function based on serum creatinine, age, race, and gender. eGFR (mL/min/1.73 m^2) = 186 * (Scr)^-1.154 * (Age)^(-0.203) * (0.742 if female) * (1.212 if black). Scr = serum creatinine in mg/dL

Outcome measures

Measure	STB + Iohexol n=16 Participants STB (150/150/200/300 mg) FDC tablet orally with food once daily for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day1), and Weeks 4, 8, 16, and 24	TVD + ATV/r + Iohexol n=15 Participants TVD (200/300 mg) FDC tablet + ATV 300 mg capsule + RTV 100 mg tablet orally with food once daily for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day 1), and Weeks 4, 8, 16, and 24	ATR + Iohexol n=15 Participants ATR (600/200/300 mg) FDC tablet orally once daily on an empty stomach for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day1), and Weeks 4, 8, 16, and 24	ABC/3TC + ATV/r + Iohexol n=16 Participants ABC/3TC (600/300 mg) FDC tablet + ATV 300 mg capsule + RTV 100 mg tablet orally with food once daily for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day1), and Weeks 4, 8, 16, and 24
Estimated GFR Calculated by Modification of Diet in Renal Disease (MDRD) Formula at Week 24	99.3 mL/min/1.73m^2 Standard Deviation 17.07	110.2 mL/min/1.73m^2 Standard Deviation 23.98	109.2 mL/min/1.73m^2 Standard Deviation 20.90	104.9 mL/min/1.73m^2 Standard Deviation 12.59

SECONDARY outcome

Timeframe: Up to 24 weeks plus 30 days

Population: Safety Analysis Set

Outcome measures

Measure	STB + Iohexol n=17 Participants STB (150/150/200/300 mg) FDC tablet orally with food once daily for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day1), and Weeks 4, 8, 16, and 24	TVD + ATV/r + Iohexol n=16 Participants TVD (200/300 mg) FDC tablet + ATV 300 mg capsule + RTV 100 mg tablet orally with food once daily for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day 1), and Weeks 4, 8, 16, and 24	ATR + Iohexol n=16 Participants ATR (600/200/300 mg) FDC tablet orally once daily on an empty stomach for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day1), and Weeks 4, 8, 16, and 24	ABC/3TC + ATV/r + Iohexol n=17 Participants ABC/3TC (600/300 mg) FDC tablet + ATV 300 mg capsule + RTV 100 mg tablet orally with food once daily for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day1), and Weeks 4, 8, 16, and 24
Percentage of Participants Experiencing Treatment-Emergent Graded Laboratory Abnormality: Urine Glucose (by Dipstick) Grade 1	0 Participants	0 Participants	0 Participants	0 Participants
Percentage of Participants Experiencing Treatment-Emergent Graded Laboratory Abnormality: Urine Glucose (by Dipstick) Grade 2	0 Participants	0 Participants	0 Participants	0 Participants
Percentage of Participants Experiencing Treatment-Emergent Graded Laboratory Abnormality: Urine Glucose (by Dipstick) Grade 3	0 Participants	0 Participants	0 Participants	0 Participants
Percentage of Participants Experiencing Treatment-Emergent Graded Laboratory Abnormality: Urine Glucose (by Dipstick) Grade 4	0 Participants	0 Participants	0 Participants	0 Participants
Percentage of Participants Experiencing Treatment-Emergent Graded Laboratory Abnormality: Urine Glucose (by Dipstick) Any Grade	0 Participants	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Up to 24 weeks plus 30 days

Population: Participants in the Safety Analysis Set with available data were analyzed.

Outcome measures

Measure	STB + Iohexol n=17 Participants STB (150/150/200/300 mg) FDC tablet orally with food once daily for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day1), and Weeks 4, 8, 16, and 24	TVD + ATV/r + Iohexol n=16 Participants TVD (200/300 mg) FDC tablet + ATV 300 mg capsule + RTV 100 mg tablet orally with food once daily for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day 1), and Weeks 4, 8, 16, and 24	ATR + Iohexol n=15 Participants ATR (600/200/300 mg) FDC tablet orally once daily on an empty stomach for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day1), and Weeks 4, 8, 16, and 24	ABC/3TC + ATV/r + Iohexol n=17 Participants ABC/3TC (600/300 mg) FDC tablet + ATV 300 mg capsule + RTV 100 mg tablet orally with food once daily for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day1), and Weeks 4, 8, 16, and 24
Percentage of Participants Experiencing Treatment-Emergent Graded Laboratory Abnormality: Serum Glucose (Fasting) Grade 1 (Hyperglycemia)	11.8 percentage of participants	12.5 percentage of participants	20.0 percentage of participants	0 percentage of participants
Percentage of Participants Experiencing Treatment-Emergent Graded Laboratory Abnormality: Serum Glucose (Fasting) Grade 1 (Hypoglycemia)	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants
Percentage of Participants Experiencing Treatment-Emergent Graded Laboratory Abnormality: Serum Glucose (Fasting) Grade 2 (Hyperglycemia)	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants
Percentage of Participants Experiencing Treatment-Emergent Graded Laboratory Abnormality: Serum Glucose (Fasting) Grade 2 (Hypoglycemia)	0 percentage of participants	6.3 percentage of participants	0 percentage of participants	0 percentage of participants
Percentage of Participants Experiencing Treatment-Emergent Graded Laboratory Abnormality: Serum Glucose (Fasting) Grade 3 (Hyperglycemia)	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants
Percentage of Participants Experiencing Treatment-Emergent Graded Laboratory Abnormality: Serum Glucose (Fasting) Grade 3 (Hypoglycemia)	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants
Percentage of Participants Experiencing Treatment-Emergent Graded Laboratory Abnormality: Serum Glucose (Fasting) Grade 4 (Hyperglycemia)	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants
Percentage of Participants Experiencing Treatment-Emergent Graded Laboratory Abnormality: Serum Glucose (Fasting) Grade 4 (Hypoglycemia)	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants
Percentage of Participants Experiencing Treatment-Emergent Graded Laboratory Abnormality: Serum Glucose (Fasting) Any grade (Hyperglycemia)	11.8 percentage of participants	12.5 percentage of participants	20.0 percentage of participants	0 percentage of participants
Percentage of Participants Experiencing Treatment-Emergent Graded Laboratory Abnormality: Serum Glucose (Fasting) Any grade (Hypoglycemia)	0 percentage of participants	6.3 percentage of participants	0 percentage of participants	0 percentage of participants

SECONDARY outcome

Timeframe: Baseline; Week 24

Population: Participants in the PD Analysis Set with available data were analyzed.

Outcome measures

Measure	STB + Iohexol n=16 Participants STB (150/150/200/300 mg) FDC tablet orally with food once daily for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day1), and Weeks 4, 8, 16, and 24	TVD + ATV/r + Iohexol n=14 Participants TVD (200/300 mg) FDC tablet + ATV 300 mg capsule + RTV 100 mg tablet orally with food once daily for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day 1), and Weeks 4, 8, 16, and 24	ATR + Iohexol n=13 Participants ATR (600/200/300 mg) FDC tablet orally once daily on an empty stomach for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day1), and Weeks 4, 8, 16, and 24	ABC/3TC + ATV/r + Iohexol n=17 Participants ABC/3TC (600/300 mg) FDC tablet + ATV 300 mg capsule + RTV 100 mg tablet orally with food once daily for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day1), and Weeks 4, 8, 16, and 24
Percentage Change From Baseline in Urine Albumin to Creatinine Ratio (mg/g) at Week 24	0.0 percentage change Interval -23.6 to 50.0	-18.3 percentage change Interval -57.1 to 50.0	50.0 percentage change Interval -25.0 to 100.0	-16.7 percentage change Interval -37.5 to 0.0

SECONDARY outcome

Timeframe: Baseline; Week 24

Population: Participants in the PD Analysis Set with available data were analyzed.

Outcome measures

Measure	STB + Iohexol n=16 Participants STB (150/150/200/300 mg) FDC tablet orally with food once daily for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day1), and Weeks 4, 8, 16, and 24	TVD + ATV/r + Iohexol n=14 Participants TVD (200/300 mg) FDC tablet + ATV 300 mg capsule + RTV 100 mg tablet orally with food once daily for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day 1), and Weeks 4, 8, 16, and 24	ATR + Iohexol n=15 Participants ATR (600/200/300 mg) FDC tablet orally once daily on an empty stomach for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day1), and Weeks 4, 8, 16, and 24	ABC/3TC + ATV/r + Iohexol n=17 Participants ABC/3TC (600/300 mg) FDC tablet + ATV 300 mg capsule + RTV 100 mg tablet orally with food once daily for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day1), and Weeks 4, 8, 16, and 24
Percentage Change From Baseline in Urine Protein to Creatinine Ratio (mg/g) at Week 24	5.7 percentage change Interval -11.0 to 22.5	17.5 percentage change Interval 0.0 to 45.7	-10.5 percentage change Interval -41.9 to 69.8	7.1 percentage change Interval -24.3 to 13.3

SECONDARY outcome

Timeframe: Baseline; Week 24

Population: Participants in the PD Analysis Set with available data were analyzed.

Outcome measures

Measure	STB + Iohexol n=16 Participants STB (150/150/200/300 mg) FDC tablet orally with food once daily for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day1), and Weeks 4, 8, 16, and 24	TVD + ATV/r + Iohexol n=14 Participants TVD (200/300 mg) FDC tablet + ATV 300 mg capsule + RTV 100 mg tablet orally with food once daily for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day 1), and Weeks 4, 8, 16, and 24	ATR + Iohexol n=13 Participants ATR (600/200/300 mg) FDC tablet orally once daily on an empty stomach for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day1), and Weeks 4, 8, 16, and 24	ABC/3TC + ATV/r + Iohexol n=17 Participants ABC/3TC (600/300 mg) FDC tablet + ATV 300 mg capsule + RTV 100 mg tablet orally with food once daily for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day1), and Weeks 4, 8, 16, and 24
Percentage Change From Baseline in Urine β2-microglobulin to Creatinine Ratio (µg/g) at Week 24	-5.1 percentage change Interval -48.2 to 22.8	197.3 percentage change Interval 21.7 to 328.7	-1.1 percentage change Interval -33.1 to 36.7	-22.7 percentage change Interval -60.8 to -6.0

SECONDARY outcome

Timeframe: Baseline; Week 24

Population: Participants in the PD Analysis Set with available data were analyzed.

Outcome measures

Measure	STB + Iohexol n=16 Participants STB (150/150/200/300 mg) FDC tablet orally with food once daily for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day1), and Weeks 4, 8, 16, and 24	TVD + ATV/r + Iohexol n=14 Participants TVD (200/300 mg) FDC tablet + ATV 300 mg capsule + RTV 100 mg tablet orally with food once daily for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day 1), and Weeks 4, 8, 16, and 24	ATR + Iohexol n=13 Participants ATR (600/200/300 mg) FDC tablet orally once daily on an empty stomach for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day1), and Weeks 4, 8, 16, and 24	ABC/3TC + ATV/r + Iohexol n=17 Participants ABC/3TC (600/300 mg) FDC tablet + ATV 300 mg capsule + RTV 100 mg tablet orally with food once daily for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day1), and Weeks 4, 8, 16, and 24
Percentage Change From Baseline in Urine Retinol Binding Protein (RBP) to Creatinine Ratio (µg/g) at Week 24	38.1 percentage change Interval -1.1 to 51.1	52.2 percentage change Interval 5.9 to 147.6	52.1 percentage change Interval -33.8 to 92.8	4.8 percentage change Interval -13.6 to 15.5

SECONDARY outcome

Timeframe: Pre-dose, 0, 0.5, 1, 2, 3, 4, 5, 6, and 10 hours post "time zero" at Weeks 4, 8, 16, and 24

Population: Participants in the COBI PK Analysis Set (all treated participants who have respective, evaluable PK profiles of COBI) with available data were analyzed.

Cmax is defined as the maximum observed concentration of drug in plasma.

Outcome measures

Measure	STB + Iohexol n=17 Participants STB (150/150/200/300 mg) FDC tablet orally with food once daily for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day1), and Weeks 4, 8, 16, and 24	TVD + ATV/r + Iohexol TVD (200/300 mg) FDC tablet + ATV 300 mg capsule + RTV 100 mg tablet orally with food once daily for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day 1), and Weeks 4, 8, 16, and 24	ATR + Iohexol ATR (600/200/300 mg) FDC tablet orally once daily on an empty stomach for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day1), and Weeks 4, 8, 16, and 24	ABC/3TC + ATV/r + Iohexol ABC/3TC (600/300 mg) FDC tablet + ATV 300 mg capsule + RTV 100 mg tablet orally with food once daily for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day1), and Weeks 4, 8, 16, and 24
Pharmacokinetic (PK) Parameter: Cmax for COBI Week 4	1189.1 ng/mL Standard Deviation 377.88	—	—	—
Pharmacokinetic (PK) Parameter: Cmax for COBI Week 8	1017.8 ng/mL Standard Deviation 388.09	—	—	—
Pharmacokinetic (PK) Parameter: Cmax for COBI Week 16	1197.3 ng/mL Standard Deviation 656.33	—	—	—
Pharmacokinetic (PK) Parameter: Cmax for COBI Week 24	1123.4 ng/mL Standard Deviation 430.41	—	—	—

SECONDARY outcome

Timeframe: Pre-dose, 0, 0.5, 1, 2, 3, 4, 5, 6, and 10 hours post "time zero" at Weeks 4, 8, 16, and 24

Population: Participants in the COBI PK Analysis Set with available data were analyzed.

Tmax is defined as the time of Cmax.

Outcome measures

Measure	STB + Iohexol n=17 Participants STB (150/150/200/300 mg) FDC tablet orally with food once daily for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day1), and Weeks 4, 8, 16, and 24	TVD + ATV/r + Iohexol TVD (200/300 mg) FDC tablet + ATV 300 mg capsule + RTV 100 mg tablet orally with food once daily for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day 1), and Weeks 4, 8, 16, and 24	ATR + Iohexol ATR (600/200/300 mg) FDC tablet orally once daily on an empty stomach for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day1), and Weeks 4, 8, 16, and 24	ABC/3TC + ATV/r + Iohexol ABC/3TC (600/300 mg) FDC tablet + ATV 300 mg capsule + RTV 100 mg tablet orally with food once daily for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day1), and Weeks 4, 8, 16, and 24
PK Parameter: Tmax for COBI Week 4	3.3 hours Interval 3.0 to 4.1	—	—	—
PK Parameter: Tmax for COBI Week 8	3.1 hours Interval 3.0 to 4.1	—	—	—
PK Parameter: Tmax for COBI Week 16	3.1 hours Interval 2.1 to 4.0	—	—	—
PK Parameter: Tmax for COBI Week 24	3.0 hours Interval 2.1 to 4.0	—	—	—

SECONDARY outcome

Timeframe: Pre-dose, 0, 0.5, 1, 2, 3, 4, 5, 6, and 10 hours post "time zero" at Weeks 4, 8, 16, and 24

Population: Participants in the COBI PK Analysis Set with available data were analyzed.

Clast is defined as the last observable concentration of drug.

Outcome measures

Measure	STB + Iohexol n=17 Participants STB (150/150/200/300 mg) FDC tablet orally with food once daily for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day1), and Weeks 4, 8, 16, and 24	TVD + ATV/r + Iohexol TVD (200/300 mg) FDC tablet + ATV 300 mg capsule + RTV 100 mg tablet orally with food once daily for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day 1), and Weeks 4, 8, 16, and 24	ATR + Iohexol ATR (600/200/300 mg) FDC tablet orally once daily on an empty stomach for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day1), and Weeks 4, 8, 16, and 24	ABC/3TC + ATV/r + Iohexol ABC/3TC (600/300 mg) FDC tablet + ATV 300 mg capsule + RTV 100 mg tablet orally with food once daily for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day1), and Weeks 4, 8, 16, and 24
PK Parameter: Clast for COBI Week 4	85.0 ng/mL Standard Deviation 126.69	—	—	—
PK Parameter: Clast for COBI Week 8	54.5 ng/mL Standard Deviation 59.58	—	—	—
PK Parameter: Clast for COBI Week 16	214.0 ng/mL Standard Deviation 693.66	—	—	—
PK Parameter: Clast for COBI Week 24	162.7 ng/mL Standard Deviation 299.48	—	—	—

SECONDARY outcome

Timeframe: Pre-dose, 0, 0.5, 1, 2, 3, 4, 5, 6, and 10 hours post "time zero" at Weeks 4, 8, 16, and 24

Population: Participants in the COBI PK Analysis Set with available data were analyzed.

• Tlast is defined as the time of Clast.
• Plasma samples for PK analysis were collected out to 10 hours postdose, and the predose concentration was used as a surrogate for the 24 hour concentration for PK parameter generation.

Outcome measures

Measure	STB + Iohexol n=17 Participants STB (150/150/200/300 mg) FDC tablet orally with food once daily for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day1), and Weeks 4, 8, 16, and 24	TVD + ATV/r + Iohexol TVD (200/300 mg) FDC tablet + ATV 300 mg capsule + RTV 100 mg tablet orally with food once daily for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day 1), and Weeks 4, 8, 16, and 24	ATR + Iohexol ATR (600/200/300 mg) FDC tablet orally once daily on an empty stomach for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day1), and Weeks 4, 8, 16, and 24	ABC/3TC + ATV/r + Iohexol ABC/3TC (600/300 mg) FDC tablet + ATV 300 mg capsule + RTV 100 mg tablet orally with food once daily for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day1), and Weeks 4, 8, 16, and 24
PK Parameter: Tlast for COBI Week 4	24.0 hours Interval 24.0 to 24.0	—	—	—
PK Parameter: Tlast for COBI Week 8	24.0 hours Interval 24.0 to 24.0	—	—	—
PK Parameter: Tlast for COBI Week 16	24.0 hours Interval 24.0 to 24.0	—	—	—
PK Parameter: Tlast for COBI Week 24	24.0 hours Interval 10.1 to 24.0	—	—	—

SECONDARY outcome

Timeframe: Pre-dose, 0, 0.5, 1, 2, 3, 4, 5, 6, and 10 hours post "time zero" at Weeks 4, 8, 16, and 24

Population: Participants in the COBI PK Analysis Set with available data were analyzed.

Ctau is defined as the observed drug concentration at the end of the dosing interval.

Outcome measures

Measure	STB + Iohexol n=17 Participants STB (150/150/200/300 mg) FDC tablet orally with food once daily for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day1), and Weeks 4, 8, 16, and 24	TVD + ATV/r + Iohexol TVD (200/300 mg) FDC tablet + ATV 300 mg capsule + RTV 100 mg tablet orally with food once daily for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day 1), and Weeks 4, 8, 16, and 24	ATR + Iohexol ATR (600/200/300 mg) FDC tablet orally once daily on an empty stomach for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day1), and Weeks 4, 8, 16, and 24	ABC/3TC + ATV/r + Iohexol ABC/3TC (600/300 mg) FDC tablet + ATV 300 mg capsule + RTV 100 mg tablet orally with food once daily for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day1), and Weeks 4, 8, 16, and 24
PK Parameter: Ctau for COBI Week 4	59.7 ng/mL Standard Deviation 113.31	—	—	—
PK Parameter: Ctau for COBI Week 8	26.0 ng/mL Standard Deviation 28.79	—	—	—
PK Parameter: Ctau for COBI Week 16	198.3 ng/mL Standard Deviation 697.06	—	—	—
PK Parameter: Ctau for COBI Week 24	82.7 ng/mL Standard Deviation 285.81	—	—	—

SECONDARY outcome

Timeframe: Pre-dose, 0, 0.5, 1, 2, 3, 4, 5, 6, and 10 hours post "time zero" at Weeks 4, 8, 16, and 24

Population: Participants in the COBI PK Analysis Set with available data were analyzed.

λz is defined as the terminal elimination rate constant.

Outcome measures

Measure	STB + Iohexol n=16 Participants STB (150/150/200/300 mg) FDC tablet orally with food once daily for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day1), and Weeks 4, 8, 16, and 24	TVD + ATV/r + Iohexol TVD (200/300 mg) FDC tablet + ATV 300 mg capsule + RTV 100 mg tablet orally with food once daily for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day 1), and Weeks 4, 8, 16, and 24	ATR + Iohexol ATR (600/200/300 mg) FDC tablet orally once daily on an empty stomach for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day1), and Weeks 4, 8, 16, and 24	ABC/3TC + ATV/r + Iohexol ABC/3TC (600/300 mg) FDC tablet + ATV 300 mg capsule + RTV 100 mg tablet orally with food once daily for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day1), and Weeks 4, 8, 16, and 24
PK Parameter: λz for COBI Week 4	0.179 1/hour Standard Deviation 0.0598	—	—	—
PK Parameter: λz for COBI Week 8	0.192 1/hour Standard Deviation 0.0481	—	—	—
PK Parameter: λz for COBI Week 16	0.206 1/hour Standard Deviation 0.0610	—	—	—
PK Parameter: λz for COBI Week 24	0.211 1/hour Standard Deviation 0.0844	—	—	—

SECONDARY outcome

Timeframe: Pre-dose, 0, 0.5, 1, 2, 3, 4, 5, 6, and 10 hours post "time zero" at Weeks 4, 8, 16, and 24

Population: Participants in the COBI PK Analysis Set with available data were analyzed.

AUCtau is defined as the concentration of drug over time (area under the plasma concentration versus time curve over the dosing interval).

Outcome measures

Measure	STB + Iohexol n=17 Participants STB (150/150/200/300 mg) FDC tablet orally with food once daily for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day1), and Weeks 4, 8, 16, and 24	TVD + ATV/r + Iohexol TVD (200/300 mg) FDC tablet + ATV 300 mg capsule + RTV 100 mg tablet orally with food once daily for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day 1), and Weeks 4, 8, 16, and 24	ATR + Iohexol ATR (600/200/300 mg) FDC tablet orally once daily on an empty stomach for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day1), and Weeks 4, 8, 16, and 24	ABC/3TC + ATV/r + Iohexol ABC/3TC (600/300 mg) FDC tablet + ATV 300 mg capsule + RTV 100 mg tablet orally with food once daily for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day1), and Weeks 4, 8, 16, and 24
PK Parameter: AUCtau for COBI Week 4	9225.8 h*ng/mL Standard Deviation 2786.60	—	—	—
PK Parameter: AUCtau for COBI Week 8	8127.4 h*ng/mL Standard Deviation 3217.12	—	—	—
PK Parameter: AUCtau for COBI Week 16	10684.8 h*ng/mL Standard Deviation 12567.09	—	—	—
PK Parameter: AUCtau for COBI Week 24	8391.3 h*ng/mL Standard Deviation 6132.50	—	—	—

SECONDARY outcome

Timeframe: Predose, 0, 0.5, 1, 2, 3, 4, 5, 6, and 10 hours post "time zero" at Weeks 4, 8, 16, and 24

Population: Participants in the COBI PK Analysis Set with available data were analyzed.

t1/2 is defined as the estimate of the terminal elimination half-life of the drug.

Outcome measures

Measure	STB + Iohexol n=17 Participants STB (150/150/200/300 mg) FDC tablet orally with food once daily for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day1), and Weeks 4, 8, 16, and 24	TVD + ATV/r + Iohexol TVD (200/300 mg) FDC tablet + ATV 300 mg capsule + RTV 100 mg tablet orally with food once daily for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day 1), and Weeks 4, 8, 16, and 24	ATR + Iohexol ATR (600/200/300 mg) FDC tablet orally once daily on an empty stomach for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day1), and Weeks 4, 8, 16, and 24	ABC/3TC + ATV/r + Iohexol ABC/3TC (600/300 mg) FDC tablet + ATV 300 mg capsule + RTV 100 mg tablet orally with food once daily for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day1), and Weeks 4, 8, 16, and 24
PK Parameter: t1/2 for COBI Week 4	3.80 hours Interval 3.24 to 4.63	—	—	—
PK Parameter: t1/2 for COBI Week 8	4.09 hours Interval 2.89 to 4.75	—	—	—
PK Parameter: t1/2 for COBI Week 16	3.42 hours Interval 2.91 to 4.18	—	—	—
PK Parameter: t1/2 for COBI Week 24	3.24 hours Interval 2.57 to 4.39	—	—	—

SECONDARY outcome

Timeframe: Pre-dose, 0, 0.5, 1, 2, 3, 4, 5, 6, and 10 hours post "time zero" at Weeks 4, 8, 16, and 24

Population: Participants in the RTV PK Analysis Set (all treated participants who have respective, evaluable PK profiles of RTV) with available data were analyzed.

Outcome measures

Measure	STB + Iohexol n=16 Participants STB (150/150/200/300 mg) FDC tablet orally with food once daily for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day1), and Weeks 4, 8, 16, and 24	TVD + ATV/r + Iohexol n=17 Participants TVD (200/300 mg) FDC tablet + ATV 300 mg capsule + RTV 100 mg tablet orally with food once daily for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day 1), and Weeks 4, 8, 16, and 24	ATR + Iohexol ATR (600/200/300 mg) FDC tablet orally once daily on an empty stomach for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day1), and Weeks 4, 8, 16, and 24	ABC/3TC + ATV/r + Iohexol ABC/3TC (600/300 mg) FDC tablet + ATV 300 mg capsule + RTV 100 mg tablet orally with food once daily for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day1), and Weeks 4, 8, 16, and 24
PK Parameter: Cmax for RTV Week 4	1260.0 ng/mL Standard Deviation 453.58	1352.1 ng/mL Standard Deviation 513.74	—	—
PK Parameter: Cmax for RTV Week 8	1142.3 ng/mL Standard Deviation 489.18	1326.2 ng/mL Standard Deviation 493.47	—	—
PK Parameter: Cmax for RTV Week 16	1144.8 ng/mL Standard Deviation 416.41	1557.6 ng/mL Standard Deviation 555.87	—	—
PK Parameter: Cmax for RTV Week 24	1217.7 ng/mL Standard Deviation 445.18	1485.4 ng/mL Standard Deviation 662.49	—	—

SECONDARY outcome

Timeframe: Pre-dose, 0, 0.5, 1, 2, 3, 4, 5, 6, and 10 hours post "time zero" at Weeks 4, 8, 16, and 24

Population: Participants in the RTV PK Analysis Set with available data were analyzed.

Outcome measures

Measure	STB + Iohexol n=16 Participants STB (150/150/200/300 mg) FDC tablet orally with food once daily for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day1), and Weeks 4, 8, 16, and 24	TVD + ATV/r + Iohexol n=17 Participants TVD (200/300 mg) FDC tablet + ATV 300 mg capsule + RTV 100 mg tablet orally with food once daily for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day 1), and Weeks 4, 8, 16, and 24	ATR + Iohexol ATR (600/200/300 mg) FDC tablet orally once daily on an empty stomach for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day1), and Weeks 4, 8, 16, and 24	ABC/3TC + ATV/r + Iohexol ABC/3TC (600/300 mg) FDC tablet + ATV 300 mg capsule + RTV 100 mg tablet orally with food once daily for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day1), and Weeks 4, 8, 16, and 24
PK Parameter: Tmax for RTV Week 4	4.0 hours Interval 3.2 to 4.6	4.0 hours Interval 2.1 to 4.1	—	—
PK Parameter: Tmax for RTV Week 8	4.0 hours Interval 2.5 to 5.1	4.0 hours Interval 3.0 to 4.1	—	—
PK Parameter: Tmax for RTV Week 16	4.1 hours Interval 3.0 to 5.1	4.0 hours Interval 2.2 to 4.1	—	—
PK Parameter: Tmax for RTV Week 24	4.0 hours Interval 3.0 to 5.0	4.0 hours Interval 3.0 to 4.1	—	—

SECONDARY outcome

Timeframe: Pre-dose, 0, 0.5, 1, 2, 3, 4, 5, 6, and 10 hours post "time zero" at Weeks 4, 8, 16, and 24

Population: Participants in the RTV PK Analysis Set with available data were analyzed.

Outcome measures

Measure	STB + Iohexol n=16 Participants STB (150/150/200/300 mg) FDC tablet orally with food once daily for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day1), and Weeks 4, 8, 16, and 24	TVD + ATV/r + Iohexol n=17 Participants TVD (200/300 mg) FDC tablet + ATV 300 mg capsule + RTV 100 mg tablet orally with food once daily for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day 1), and Weeks 4, 8, 16, and 24	ATR + Iohexol ATR (600/200/300 mg) FDC tablet orally once daily on an empty stomach for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day1), and Weeks 4, 8, 16, and 24	ABC/3TC + ATV/r + Iohexol ABC/3TC (600/300 mg) FDC tablet + ATV 300 mg capsule + RTV 100 mg tablet orally with food once daily for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day1), and Weeks 4, 8, 16, and 24
PK Parameter: Clast for RTV Week 4	59.5 ng/mL Standard Deviation 57.85	61.0 ng/mL Standard Deviation 56.51	—	—
PK Parameter: Clast for RTV Week 8	71.0 ng/mL Standard Deviation 91.24	85.5 ng/mL Standard Deviation 99.68	—	—
PK Parameter: Clast for RTV Week 16	69.2 ng/mL Standard Deviation 49.85	99.1 ng/mL Standard Deviation 92.42	—	—
PK Parameter: Clast for RTV Week 24	102.5 ng/mL Standard Deviation 182.16	187.9 ng/mL Standard Deviation 258.53	—	—

SECONDARY outcome

Timeframe: Pre-dose, 0, 0.5, 1, 2, 3, 4, 5, 6, and 10 hours post "time zero" at Weeks 4, 8, 16, and 24

Population: Participants in the RTV PK Analysis Set with available data were analyzed.

Plasma samples for PK analysis were collected out to 10 hours postdose, and the predose concentration was used as a surrogate for the 24 hour concentration for PK parameter generation.

Outcome measures

Measure	STB + Iohexol n=16 Participants STB (150/150/200/300 mg) FDC tablet orally with food once daily for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day1), and Weeks 4, 8, 16, and 24	TVD + ATV/r + Iohexol n=17 Participants TVD (200/300 mg) FDC tablet + ATV 300 mg capsule + RTV 100 mg tablet orally with food once daily for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day 1), and Weeks 4, 8, 16, and 24	ATR + Iohexol ATR (600/200/300 mg) FDC tablet orally once daily on an empty stomach for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day1), and Weeks 4, 8, 16, and 24	ABC/3TC + ATV/r + Iohexol ABC/3TC (600/300 mg) FDC tablet + ATV 300 mg capsule + RTV 100 mg tablet orally with food once daily for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day1), and Weeks 4, 8, 16, and 24
PK Parameter: Tlast for RTV Week 4	24.0 hours Interval 24.0 to 24.0	24.0 hours Interval 24.0 to 24.0	—	—
PK Parameter: Tlast for RTV Week 8	24.0 hours Interval 24.0 to 24.0	24.0 hours Interval 24.0 to 24.0	—	—
PK Parameter: Tlast for RTV Week 16	24.0 hours Interval 24.0 to 24.0	24.0 hours Interval 24.0 to 24.0	—	—
PK Parameter: Tlast for RTV Week 24	24.0 hours Interval 24.0 to 24.0	24.0 hours Interval 24.0 to 24.0	—	—

SECONDARY outcome

Timeframe: Pre-dose, 0, 0.5, 1, 2, 3, 4, 5, 6, and 10 hours post "time zero" at Weeks 4, 8, 16, and 24

Population: Participants in the RTV PK Analysis Set with available data were analyzed.

Outcome measures

Measure	STB + Iohexol n=16 Participants STB (150/150/200/300 mg) FDC tablet orally with food once daily for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day1), and Weeks 4, 8, 16, and 24	TVD + ATV/r + Iohexol n=17 Participants TVD (200/300 mg) FDC tablet + ATV 300 mg capsule + RTV 100 mg tablet orally with food once daily for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day 1), and Weeks 4, 8, 16, and 24	ATR + Iohexol ATR (600/200/300 mg) FDC tablet orally once daily on an empty stomach for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day1), and Weeks 4, 8, 16, and 24	ABC/3TC + ATV/r + Iohexol ABC/3TC (600/300 mg) FDC tablet + ATV 300 mg capsule + RTV 100 mg tablet orally with food once daily for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day1), and Weeks 4, 8, 16, and 24
PK Parameter: Ctau for RTV Week 4	59.5 ng/mL Standard Deviation 57.85	61.0 ng/mL Standard Deviation 56.51	—	—
PK Parameter: Ctau for RTV Week 8	71.0 ng/mL Standard Deviation 91.24	85.5 ng/mL Standard Deviation 99.68	—	—
PK Parameter: Ctau for RTV Week 16	69.2 ng/mL Standard Deviation 49.85	99.1 ng/mL Standard Deviation 92.42	—	—
PK Parameter: Ctau for RTV Week 24	102.5 ng/mL Standard Deviation 182.16	157.0 ng/mL Standard Deviation 246.75	—	—

SECONDARY outcome

Timeframe: Pre-dose, 0, 0.5, 1, 2, 3, 4, 5, 6, and 10 hours post "time zero" at Weeks 4, 8, 16, and 24

Population: Participants in the RTV PK Analysis Set with available data were analyzed.

Outcome measures

Measure	STB + Iohexol n=16 Participants STB (150/150/200/300 mg) FDC tablet orally with food once daily for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day1), and Weeks 4, 8, 16, and 24	TVD + ATV/r + Iohexol n=17 Participants TVD (200/300 mg) FDC tablet + ATV 300 mg capsule + RTV 100 mg tablet orally with food once daily for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day 1), and Weeks 4, 8, 16, and 24	ATR + Iohexol ATR (600/200/300 mg) FDC tablet orally once daily on an empty stomach for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day1), and Weeks 4, 8, 16, and 24	ABC/3TC + ATV/r + Iohexol ABC/3TC (600/300 mg) FDC tablet + ATV 300 mg capsule + RTV 100 mg tablet orally with food once daily for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day1), and Weeks 4, 8, 16, and 24
PK Parameter: AUCtau for RTV Week 4	8259.6 h*ng/mL Standard Deviation 3166.47	9649.1 h*ng/mL Standard Deviation 3713.87	—	—
PK Parameter: AUCtau for RTV Week 8	8362.0 h*ng/mL Standard Deviation 3544.53	9702.2 h*ng/mL Standard Deviation 3391.68	—	—
PK Parameter: AUCtau for RTV Week 16	8102.6 h*ng/mL Standard Deviation 3392.00	11148.0 h*ng/mL Standard Deviation 4482.33	—	—
PK Parameter: AUCtau for RTV Week 24	8907.0 h*ng/mL Standard Deviation 5182.65	12039.3 h*ng/mL Standard Deviation 6792.06	—	—

SECONDARY outcome

Timeframe: Pre-dose, 0, 0.5, 1, 2, 3, 4, 5, 6, and 10 hours post "time zero" at Weeks 4, 8, 16, and 24

Population: Participants in the RTV PK Analysis Set with available data were analyzed.

Outcome measures

Measure	STB + Iohexol n=16 Participants STB (150/150/200/300 mg) FDC tablet orally with food once daily for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day1), and Weeks 4, 8, 16, and 24	TVD + ATV/r + Iohexol n=17 Participants TVD (200/300 mg) FDC tablet + ATV 300 mg capsule + RTV 100 mg tablet orally with food once daily for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day 1), and Weeks 4, 8, 16, and 24	ATR + Iohexol ATR (600/200/300 mg) FDC tablet orally once daily on an empty stomach for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day1), and Weeks 4, 8, 16, and 24	ABC/3TC + ATV/r + Iohexol ABC/3TC (600/300 mg) FDC tablet + ATV 300 mg capsule + RTV 100 mg tablet orally with food once daily for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day1), and Weeks 4, 8, 16, and 24
PK Parameter: λz for RTV Week 16	0.138 1/hour Standard Deviation 0.0382	0.131 1/hour Standard Deviation 0.0291	—	—
PK Parameter: λz for RTV Week 24	0.133 1/hour Standard Deviation 0.0347	0.128 1/hour Standard Deviation 0.0469	—	—
PK Parameter: λz for RTV Week 4	0.156 1/hour Standard Deviation 0.0386	0.151 1/hour Standard Deviation 0.0346	—	—
PK Parameter: λz for RTV Week 8	0.144 1/hour Standard Deviation 0.0474	0.142 1/hour Standard Deviation 0.0281	—	—

SECONDARY outcome

Timeframe: Pre-dose, 0, 0.5, 1, 2, 3, 4, 5, 6, and 10 hours post "time zero" at Weeks 4, 8, 16, and 24

Population: Participants in the RTV PK Analysis Set with available data were analyzed.

Outcome measures

Measure	STB + Iohexol n=16 Participants STB (150/150/200/300 mg) FDC tablet orally with food once daily for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day1), and Weeks 4, 8, 16, and 24	TVD + ATV/r + Iohexol n=17 Participants TVD (200/300 mg) FDC tablet + ATV 300 mg capsule + RTV 100 mg tablet orally with food once daily for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day 1), and Weeks 4, 8, 16, and 24	ATR + Iohexol ATR (600/200/300 mg) FDC tablet orally once daily on an empty stomach for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day1), and Weeks 4, 8, 16, and 24	ABC/3TC + ATV/r + Iohexol ABC/3TC (600/300 mg) FDC tablet + ATV 300 mg capsule + RTV 100 mg tablet orally with food once daily for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day1), and Weeks 4, 8, 16, and 24
PK Parameter: t1/2 for RTV Week 4	4.56 hours Interval 3.77 to 4.99	4.53 hours Interval 3.83 to 6.01	—	—
PK Parameter: t1/2 for RTV Week 8	4.85 hours Interval 3.75 to 5.34	4.68 hours Interval 4.31 to 5.69	—	—
PK Parameter: t1/2 for RTV Week 16	5.39 hours Interval 4.22 to 6.22	5.57 hours Interval 4.68 to 6.0	—	—
PK Parameter: t1/2 for RTV Week 24	5.08 hours Interval 4.49 to 5.78	4.82 hours Interval 4.25 to 6.41	—	—

SECONDARY outcome

Timeframe: Pre-dose, 0, 0.5, 1, 2, 3, 4, 5, 6, and 10 hours post "time zero" at Weeks 4, 8, 16, and 24

Population: Participants in the TFV PK Analysis Set (all treated participants who have respective, evaluable PK profiles of TFV) with available data were analyzed.

Outcome measures

Measure	STB + Iohexol n=17 Participants STB (150/150/200/300 mg) FDC tablet orally with food once daily for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day1), and Weeks 4, 8, 16, and 24	TVD + ATV/r + Iohexol n=16 Participants TVD (200/300 mg) FDC tablet + ATV 300 mg capsule + RTV 100 mg tablet orally with food once daily for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day 1), and Weeks 4, 8, 16, and 24	ATR + Iohexol n=15 Participants ATR (600/200/300 mg) FDC tablet orally once daily on an empty stomach for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day1), and Weeks 4, 8, 16, and 24	ABC/3TC + ATV/r + Iohexol ABC/3TC (600/300 mg) FDC tablet + ATV 300 mg capsule + RTV 100 mg tablet orally with food once daily for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day1), and Weeks 4, 8, 16, and 24
PK Parameter: Cmax for TFV Week 4	371.2 ng/mL Standard Deviation 94.46	301.6 ng/mL Standard Deviation 116.36	298.3 ng/mL Standard Deviation 100.36	—
PK Parameter: Cmax for TFV Week 8	379.8 ng/mL Standard Deviation 87.44	343.0 ng/mL Standard Deviation 133.97	325.5 ng/mL Standard Deviation 149.48	—
PK Parameter: Cmax for TFV Week 16	399.5 ng/mL Standard Deviation 169.51	319.4 ng/mL Standard Deviation 146.41	298.6 ng/mL Standard Deviation 107.11	—
PK Parameter: Cmax for TFV Week 24	394.4 ng/mL Standard Deviation 131.09	350.7 ng/mL Standard Deviation 126.91	305.9 ng/mL Standard Deviation 106.24	—

SECONDARY outcome

Timeframe: Pre-dose, 0, 0.5, 1, 2, 3, 4, 5, 6, and 10 hours post "time zero" at Weeks 4, 8, 16, and 24

Population: Participants in the TFV PK Analysis Set with available data were analyzed.

Outcome measures

Measure	STB + Iohexol n=17 Participants STB (150/150/200/300 mg) FDC tablet orally with food once daily for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day1), and Weeks 4, 8, 16, and 24	TVD + ATV/r + Iohexol n=16 Participants TVD (200/300 mg) FDC tablet + ATV 300 mg capsule + RTV 100 mg tablet orally with food once daily for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day 1), and Weeks 4, 8, 16, and 24	ATR + Iohexol n=15 Participants ATR (600/200/300 mg) FDC tablet orally once daily on an empty stomach for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day1), and Weeks 4, 8, 16, and 24	ABC/3TC + ATV/r + Iohexol ABC/3TC (600/300 mg) FDC tablet + ATV 300 mg capsule + RTV 100 mg tablet orally with food once daily for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day1), and Weeks 4, 8, 16, and 24
PK Parameter: Tmax for TFV Week 4	2.0 hours Interval 1.3 to 3.1	3.0 hours Interval 1.5 to 3.1	1.1 hours Interval 0.6 to 2.0	—
PK Parameter: Tmax for TFV Week 8	2.0 hours Interval 2.0 to 2.1	3.0 hours Interval 2.0 to 3.1	1.0 hours Interval 0.6 to 1.1	—
PK Parameter: Tmax for TFV Week 16	2.1 hours Interval 1.1 to 3.1	2.1 hours Interval 1.0 to 3.1	1.2 hours Interval 1.0 to 2.1	—
PK Parameter: Tmax for TFV Week 24	2.0 hours Interval 1.1 to 3.0	2.1 hours Interval 1.1 to 3.2	1.1 hours Interval 0.6 to 2.0	—

SECONDARY outcome

Timeframe: Pre-dose, 0, 0.5, 1, 2, 3, 4, 5, 6, and 10 hours post "time zero" at Weeks 4, 8, 16, and 24

Population: Participants in the TFV PK Analysis Set with available data were analyzed.

Outcome measures

Measure	STB + Iohexol n=17 Participants STB (150/150/200/300 mg) FDC tablet orally with food once daily for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day1), and Weeks 4, 8, 16, and 24	TVD + ATV/r + Iohexol n=16 Participants TVD (200/300 mg) FDC tablet + ATV 300 mg capsule + RTV 100 mg tablet orally with food once daily for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day 1), and Weeks 4, 8, 16, and 24	ATR + Iohexol n=15 Participants ATR (600/200/300 mg) FDC tablet orally once daily on an empty stomach for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day1), and Weeks 4, 8, 16, and 24	ABC/3TC + ATV/r + Iohexol ABC/3TC (600/300 mg) FDC tablet + ATV 300 mg capsule + RTV 100 mg tablet orally with food once daily for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day1), and Weeks 4, 8, 16, and 24
PK Parameter: Clast for TFV Week 4	81.1 ng/mL Standard Deviation 32.41	73.1 ng/mL Standard Deviation 23.74	55.4 ng/mL Standard Deviation 15.52	—
PK Parameter: Clast for TFV Week 8	80.9 ng/mL Standard Deviation 35.12	78.2 ng/mL Standard Deviation 31.27	53.4 ng/mL Standard Deviation 18.83	—
PK Parameter: Clast for TFV Week 16	128.5 ng/mL Standard Deviation 184.17	74.5 ng/mL Standard Deviation 26.01	63.0 ng/mL Standard Deviation 19.25	—
PK Parameter: Clast for TFV Week 24	78.5 ng/mL Standard Deviation 53.04	87.3 ng/mL Standard Deviation 41.20	58.5 ng/mL Standard Deviation 16.45	—

SECONDARY outcome

Timeframe: Pre-dose, 0, 0.5, 1, 2, 3, 4, 5, 6, and 10 hours post "time zero" at Weeks 4, 8, 16, and 24

Population: Participants in the TFV PK Analysis Set with available data were analyzed.

Plasma samples for PK analysis were collected out to 10 hours postdose, and the predose concentration was used as a surrogate for the 24 hour concentration for PK parameter generation.

Outcome measures

Measure	STB + Iohexol n=17 Participants STB (150/150/200/300 mg) FDC tablet orally with food once daily for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day1), and Weeks 4, 8, 16, and 24	TVD + ATV/r + Iohexol n=16 Participants TVD (200/300 mg) FDC tablet + ATV 300 mg capsule + RTV 100 mg tablet orally with food once daily for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day 1), and Weeks 4, 8, 16, and 24	ATR + Iohexol n=15 Participants ATR (600/200/300 mg) FDC tablet orally once daily on an empty stomach for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day1), and Weeks 4, 8, 16, and 24	ABC/3TC + ATV/r + Iohexol ABC/3TC (600/300 mg) FDC tablet + ATV 300 mg capsule + RTV 100 mg tablet orally with food once daily for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day1), and Weeks 4, 8, 16, and 24
PK Parameter: Tlast for TFV Week 4	24.0 hours Interval 24.0 to 24.0	24.0 hours Interval 24.0 to 24.0	24.0 hours Interval 24.0 to 24.0	—
PK Parameter: Tlast for TFV Week 8	24.0 hours Interval 24.0 to 24.0	24.0 hours Interval 24.0 to 24.0	24.0 hours Interval 24.0 to 24.0	—
PK Parameter: Tlast for TFV Week 16	24.0 hours Interval 24.0 to 24.0	24.0 hours Interval 24.0 to 24.0	24.0 hours Interval 24.0 to 24.0	—
PK Parameter: Tlast for TFV Week 24	24.0 hours Interval 24.0 to 24.0	24.0 hours Interval 24.0 to 24.0	24.0 hours Interval 24.0 to 24.0	—

SECONDARY outcome

Timeframe: Pre-dose, 0, 0.5, 1, 2, 3, 4, 5, 6, and 10 hours post "time zero" at Weeks 4, 8, 16, and 24

Population: Participants in the TFV PK Analysis Set with available data were analyzed.

Outcome measures

Measure	STB + Iohexol n=17 Participants STB (150/150/200/300 mg) FDC tablet orally with food once daily for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day1), and Weeks 4, 8, 16, and 24	TVD + ATV/r + Iohexol n=16 Participants TVD (200/300 mg) FDC tablet + ATV 300 mg capsule + RTV 100 mg tablet orally with food once daily for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day 1), and Weeks 4, 8, 16, and 24	ATR + Iohexol n=15 Participants ATR (600/200/300 mg) FDC tablet orally once daily on an empty stomach for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day1), and Weeks 4, 8, 16, and 24	ABC/3TC + ATV/r + Iohexol ABC/3TC (600/300 mg) FDC tablet + ATV 300 mg capsule + RTV 100 mg tablet orally with food once daily for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day1), and Weeks 4, 8, 16, and 24
PK Parameter: Ctau for TFV Week 4	74.6 ng/mL Standard Deviation 36.88	73.1 ng/mL Standard Deviation 23.74	55.4 ng/mL Standard Deviation 15.52	—
PK Parameter: Ctau for TFV Week 8	75.8 ng/mL Standard Deviation 40.16	78.2 ng/mL Standard Deviation 31.27	48.8 ng/mL Standard Deviation 23.27	—
PK Parameter: Ctau for TFV Week 16	128.5 ng/mL Standard Deviation 184.17	74.5 ng/mL Standard Deviation 26.01	57.5 ng/mL Standard Deviation 24.41	—
PK Parameter: Ctau for TFV Week 24	71.7 ng/mL Standard Deviation 57.06	77.3 ng/mL Standard Deviation 43.06	54.2 ng/mL Standard Deviation 22.17	—

SECONDARY outcome

Timeframe: Pre-dose, 0, 0.5, 1, 2, 3, 4, 5, 6, and 10 hours post "time zero" at Weeks 4, 8, 16, and 24

Population: Participants in the TFV PK Analysis Set with available data were analyzed.

Outcome measures

Measure	STB + Iohexol n=17 Participants STB (150/150/200/300 mg) FDC tablet orally with food once daily for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day1), and Weeks 4, 8, 16, and 24	TVD + ATV/r + Iohexol n=16 Participants TVD (200/300 mg) FDC tablet + ATV 300 mg capsule + RTV 100 mg tablet orally with food once daily for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day 1), and Weeks 4, 8, 16, and 24	ATR + Iohexol n=15 Participants ATR (600/200/300 mg) FDC tablet orally once daily on an empty stomach for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day1), and Weeks 4, 8, 16, and 24	ABC/3TC + ATV/r + Iohexol ABC/3TC (600/300 mg) FDC tablet + ATV 300 mg capsule + RTV 100 mg tablet orally with food once daily for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day1), and Weeks 4, 8, 16, and 24
PK Parameter: λz for TFV Week 4	0.045 1/hour Standard Deviation 0.0148	0.048 1/hour Standard Deviation 0.0059	0.037 1/hour Standard Deviation 0.0133	—
PK Parameter: λz for TFV Week 8	0.051 1/hour Standard Deviation 0.0167	0.048 1/hour Standard Deviation 0.0158	0.041 1/hour Standard Deviation 0.0197	—
PK Parameter: λz for TFV Week 16	0.047 1/hour Standard Deviation 0.0173	0.047 1/hour Standard Deviation 0.0115	0.033 1/hour Standard Deviation 0.0166	—
PK Parameter: λz for TFV Week 24	0.051 1/hour Standard Deviation 0.0195	0.046 1/hour Standard Deviation 0.0184	0.035 1/hour Standard Deviation 0.0138	—

SECONDARY outcome

Timeframe: Pre-dose, 0, 0.5, 1, 2, 3, 4, 5, 6, and 10 hours post "time zero" at Weeks 4, 8, 16, and 24

Population: Participants in the TFV PK Analysis Set with available data were analyzed.

Outcome measures

Measure	STB + Iohexol n=17 Participants STB (150/150/200/300 mg) FDC tablet orally with food once daily for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day1), and Weeks 4, 8, 16, and 24	TVD + ATV/r + Iohexol n=16 Participants TVD (200/300 mg) FDC tablet + ATV 300 mg capsule + RTV 100 mg tablet orally with food once daily for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day 1), and Weeks 4, 8, 16, and 24	ATR + Iohexol n=15 Participants ATR (600/200/300 mg) FDC tablet orally once daily on an empty stomach for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day1), and Weeks 4, 8, 16, and 24	ABC/3TC + ATV/r + Iohexol ABC/3TC (600/300 mg) FDC tablet + ATV 300 mg capsule + RTV 100 mg tablet orally with food once daily for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day1), and Weeks 4, 8, 16, and 24
PK Parameter: AUCtau for TFV Week 4	3370.2 h*ng/mL Standard Deviation 1000.75	3151.2 h*ng/mL Standard Deviation 1107.18	2244.8 h*ng/mL Standard Deviation 572.09	—
PK Parameter: AUCtau for TFV Week 8	3549.7 h*ng/mL Standard Deviation 1238.03	3361.9 h*ng/mL Standard Deviation 1152.04	2250.8 h*ng/mL Standard Deviation 555.79	—
PK Parameter: AUCtau for TFV Week 16	3939.7 h*ng/mL Standard Deviation 2499.63	3234.7 h*ng/mL Standard Deviation 1207.58	2326.4 h*ng/mL Standard Deviation 494.24	—
PK Parameter: AUCtau for TFV Week 24	3307.0 h*ng/mL Standard Deviation 1387.97	3451.5 h*ng/mL Standard Deviation 1075.47	2265.7 h*ng/mL Standard Deviation 412.87	—

SECONDARY outcome

Timeframe: Pre-dose, 0, 0.5, 1, 2, 3, 4, 5, 6, and 10 hours post "time zero" at Weeks 4, 8, 16, and 24

Population: Participants in the TFV PK Analysis Set with available data were analyzed.

Outcome measures

Measure	STB + Iohexol n=17 Participants STB (150/150/200/300 mg) FDC tablet orally with food once daily for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day1), and Weeks 4, 8, 16, and 24	TVD + ATV/r + Iohexol n=16 Participants TVD (200/300 mg) FDC tablet + ATV 300 mg capsule + RTV 100 mg tablet orally with food once daily for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day 1), and Weeks 4, 8, 16, and 24	ATR + Iohexol n=15 Participants ATR (600/200/300 mg) FDC tablet orally once daily on an empty stomach for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day1), and Weeks 4, 8, 16, and 24	ABC/3TC + ATV/r + Iohexol ABC/3TC (600/300 mg) FDC tablet + ATV 300 mg capsule + RTV 100 mg tablet orally with food once daily for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day1), and Weeks 4, 8, 16, and 24
PK Parameter: t1/2 for TFV Week 24	13.99 hours Interval 11.91 to 18.52	16.17 hours Interval 13.18 to 21.37	21.54 hours Interval 19.39 to 27.32	—
PK Parameter: t1/2 for TFV Week 4	15.73 hours Interval 12.49 to 18.9	14.10 hours Interval 13.28 to 16.81	20.65 hours Interval 15.3 to 26.75	—
PK Parameter: t1/2 for TFV Week 8	14.40 hours Interval 12.07 to 16.83	15.82 hours Interval 11.94 to 19.53	18.81 hours Interval 13.08 to 25.14	—
PK Parameter: t1/2 for TFV Week 16	14.41 hours Interval 13.11 to 19.87	14.72 hours Interval 12.76 to 16.73	22.78 hours Interval 16.88 to 32.15	—

SECONDARY outcome

Timeframe: Pre-dose, 0, 0.5, 1, 2, 3, 4, 5, 6, and 10 hours post "time zero" on Day 1 and Weeks 4, 8, 16, and 24

Population: Participants in the iohexol PK Analysis Set (all treated participants who have respective, evaluable PK profiles of iohexol) with available data were analyzed.

AUC inf is defined as the concentration of drug extrapolated to infinite time (area under the plasma concentration versus time curve extrapolated to infinite time).

Outcome measures

Measure	STB + Iohexol n=17 Participants STB (150/150/200/300 mg) FDC tablet orally with food once daily for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day1), and Weeks 4, 8, 16, and 24	TVD + ATV/r + Iohexol n=16 Participants TVD (200/300 mg) FDC tablet + ATV 300 mg capsule + RTV 100 mg tablet orally with food once daily for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day 1), and Weeks 4, 8, 16, and 24	ATR + Iohexol n=16 Participants ATR (600/200/300 mg) FDC tablet orally once daily on an empty stomach for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day1), and Weeks 4, 8, 16, and 24	ABC/3TC + ATV/r + Iohexol n=17 Participants ABC/3TC (600/300 mg) FDC tablet + ATV 300 mg capsule + RTV 100 mg tablet orally with food once daily for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day1), and Weeks 4, 8, 16, and 24
PK Parameter: AUCinf for Iohexol Day 1	511.2 h*µg/mL Standard Deviation 172.71	486.8 h*µg/mL Standard Deviation 108.28	706.9 h*µg/mL Standard Deviation 647.25	695.2 h*µg/mL Standard Deviation 523.33
PK Parameter: AUCinf for Iohexol Week 4	521.8 h*µg/mL Standard Deviation 121.67	496.2 h*µg/mL Standard Deviation 153.05	512.6 h*µg/mL Standard Deviation 163.89	720.5 h*µg/mL Standard Deviation 657.95
PK Parameter: AUCinf for Iohexol Week 8	517.8 h*µg/mL Standard Deviation 170.24	574.8 h*µg/mL Standard Deviation 382.63	510.6 h*µg/mL Standard Deviation 136.40	667.0 h*µg/mL Standard Deviation 559.06
PK Parameter: AUCinf for Iohexol Week 16	494.3 h*µg/mL Standard Deviation 113.60	509.5 h*µg/mL Standard Deviation 156.98	504.8 h*µg/mL Standard Deviation 95.07	725.9 h*µg/mL Standard Deviation 843.22
PK Parameter: AUCinf for Iohexol Week 24	545.8 h*µg/mL Standard Deviation 127.34	561.2 h*µg/mL Standard Deviation 214.26	507.1 h*µg/mL Standard Deviation 113.45	606.5 h*µg/mL Standard Deviation 321.40

SECONDARY outcome

Timeframe: Week 24

Population: Full Analysis Set (FAS): all participants who (1) are randomized into the study and (2) have received at least one dose of study drug.

Outcome measures

Measure	STB + Iohexol n=17 Participants STB (150/150/200/300 mg) FDC tablet orally with food once daily for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day1), and Weeks 4, 8, 16, and 24	TVD + ATV/r + Iohexol n=16 Participants TVD (200/300 mg) FDC tablet + ATV 300 mg capsule + RTV 100 mg tablet orally with food once daily for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day 1), and Weeks 4, 8, 16, and 24	ATR + Iohexol n=13 Participants ATR (600/200/300 mg) FDC tablet orally once daily on an empty stomach for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day1), and Weeks 4, 8, 16, and 24	ABC/3TC + ATV/r + Iohexol n=15 Participants ABC/3TC (600/300 mg) FDC tablet + ATV 300 mg capsule + RTV 100 mg tablet orally with food once daily for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day1), and Weeks 4, 8, 16, and 24
Percentage of Participants With HIV-1 RNA < 50 Copies/mL Week 24 as Determined by Snapshot Algorithm	88.2 percentage of participants	81.3 percentage of participants	81.3 percentage of participants	88.2 percentage of participants

SECONDARY outcome

Timeframe: Baseline; Week 24

Population: Full Analysis Set

Outcome measures

Measure	STB + Iohexol n=16 Participants STB (150/150/200/300 mg) FDC tablet orally with food once daily for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day1), and Weeks 4, 8, 16, and 24	TVD + ATV/r + Iohexol n=15 Participants TVD (200/300 mg) FDC tablet + ATV 300 mg capsule + RTV 100 mg tablet orally with food once daily for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day 1), and Weeks 4, 8, 16, and 24	ATR + Iohexol n=15 Participants ATR (600/200/300 mg) FDC tablet orally once daily on an empty stomach for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day1), and Weeks 4, 8, 16, and 24	ABC/3TC + ATV/r + Iohexol n=17 Participants ABC/3TC (600/300 mg) FDC tablet + ATV 300 mg capsule + RTV 100 mg tablet orally with food once daily for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day1), and Weeks 4, 8, 16, and 24
Change From Baseline in Cluster of Differentiation 4 Positive (CD4+) Cell Count at Week 24	139.63 cells/uL Standard Deviation 142.196	217.60 cells/uL Standard Deviation 195.375	204.33 cells/uL Standard Deviation 194.653	237.29 cells/uL Standard Deviation 201.222

SECONDARY outcome

Timeframe: Up to the last dose date plus 30 days (Up to 24 weeks plus 30 days)

Population: Safety Analysis Set

Incidences of adverse events and laboratory abnormalities will be summarized.

Outcome measures

Measure	STB + Iohexol n=17 Participants STB (150/150/200/300 mg) FDC tablet orally with food once daily for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day1), and Weeks 4, 8, 16, and 24	TVD + ATV/r + Iohexol n=16 Participants TVD (200/300 mg) FDC tablet + ATV 300 mg capsule + RTV 100 mg tablet orally with food once daily for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day 1), and Weeks 4, 8, 16, and 24	ATR + Iohexol n=16 Participants ATR (600/200/300 mg) FDC tablet orally once daily on an empty stomach for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day1), and Weeks 4, 8, 16, and 24	ABC/3TC + ATV/r + Iohexol n=17 Participants ABC/3TC (600/300 mg) FDC tablet + ATV 300 mg capsule + RTV 100 mg tablet orally with food once daily for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day1), and Weeks 4, 8, 16, and 24
Percentage of Participants Experiencing Adverse Events (AEs) Any Treatment-Emergent Adverse Events (TEAE)	70.6 Percentage of participants	87.5 Percentage of participants	87.5 Percentage of participants	88.2 Percentage of participants
Percentage of Participants Experiencing Adverse Events (AEs) Any Grade 3 or 4 Treatment-Emergent Adverse Event	5.9 Percentage of participants	12.5 Percentage of participants	12.5 Percentage of participants	5.9 Percentage of participants
Percentage of Participants Experiencing Adverse Events (AEs) Any Treatment-Emergent Study-Drug-Related AEs	11.8 Percentage of participants	50.0 Percentage of participants	68.8 Percentage of participants	23.5 Percentage of participants
Percentage of Participants Experiencing Adverse Events (AEs) Any TEAE Leading to Study Drug Discontinuation	5.9 Percentage of participants	6.3 Percentage of participants	6.3 Percentage of participants	0 Percentage of participants

SECONDARY outcome

Timeframe: Up to the last dose date plus 30 days (Up to 24 weeks plus 30 days)

Population: Safety Analysis Set

Graded laboratory abnormalities were defined as values that increased at least one toxicity grade from predose at any postdose up to the last dose date of study drug plus 30 days. The most severe graded abnormality from all tests was counted for each participant.

Outcome measures

Measure	STB + Iohexol n=17 Participants STB (150/150/200/300 mg) FDC tablet orally with food once daily for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day1), and Weeks 4, 8, 16, and 24	TVD + ATV/r + Iohexol n=16 Participants TVD (200/300 mg) FDC tablet + ATV 300 mg capsule + RTV 100 mg tablet orally with food once daily for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day 1), and Weeks 4, 8, 16, and 24	ATR + Iohexol n=16 Participants ATR (600/200/300 mg) FDC tablet orally once daily on an empty stomach for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day1), and Weeks 4, 8, 16, and 24	ABC/3TC + ATV/r + Iohexol n=17 Participants ABC/3TC (600/300 mg) FDC tablet + ATV 300 mg capsule + RTV 100 mg tablet orally with food once daily for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day1), and Weeks 4, 8, 16, and 24
Percentage of Participants Experiencing Treatment Emergent (TE) Grade 3 or 4 Laboratory Abnormalities Any Grade 3 or 4 TE Laboratory Abnormality	5.9 Percentage of participants	25.0 Percentage of participants	12.5 Percentage of participants	52.9 Percentage of participants
Percentage of Participants Experiencing Treatment Emergent (TE) Grade 3 or 4 Laboratory Abnormalities Grade 3 or 4 Neutrophils	0 Percentage of participants	6.3 Percentage of participants	0 Percentage of participants	0 Percentage of participants
Percentage of Participants Experiencing Treatment Emergent (TE) Grade 3 or 4 Laboratory Abnormalities Grade 3 or 4 Amylase	0 Percentage of participants	0 Percentage of participants	6.3 Percentage of participants	0 Percentage of participants
Percentage of Participants Experiencing Treatment Emergent (TE) Grade 3 or 4 Laboratory Abnormalities Grade 3 or 4 AST	0 Percentage of participants	6.3 Percentage of participants	0 Percentage of participants	0 Percentage of participants
Percentage of Participants Experiencing Treatment Emergent (TE) Grade 3 or 4 Laboratory Abnormalities Grade 3 or 4 CK	5.9 Percentage of participants	18.8 Percentage of participants	6.3 Percentage of participants	5.9 Percentage of participants
Percentage of Participants Experiencing Treatment Emergent (TE) Grade 3 or 4 Laboratory Abnormalities Grade 3 or 4 Total Bilirubin	0 Percentage of participants	12.5 Percentage of participants	0 Percentage of participants	52.9 Percentage of participants
Percentage of Participants Experiencing Treatment Emergent (TE) Grade 3 or 4 Laboratory Abnormalities Grade 3 or 4 Urine RBC	0 Percentage of participants	7.7 Percentage of participants	0 Percentage of participants	0 Percentage of participants

Adverse Events

STB + Iohexol

Serious events: 1 serious events

Other events: 11 other events

Deaths: 0 deaths

TVD + ATV/r + Iohexol

Serious events: 1 serious events

Other events: 14 other events

Deaths: 0 deaths

ATR + Iohexol

Serious events: 1 serious events

Other events: 13 other events

Deaths: 0 deaths

ABC/3TC + ATV/r + Iohexol

Serious events: 2 serious events

Other events: 14 other events

Deaths: 0 deaths

Serious adverse events

Measure	STB + Iohexol n=17 participants at risk STB (150/150/200/300 mg) FDC tablet orally with food once daily for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day1), and Weeks 4, 8, 16, and 24	TVD + ATV/r + Iohexol n=16 participants at risk TVD (200/300 mg) FDC tablet + ATV 300 mg capsule + RTV 100 mg tablet orally with food once daily for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day 1), and Weeks 4, 8, 16, and 24	ATR + Iohexol n=16 participants at risk ATR (600/200/300 mg) FDC tablet orally once daily on an empty stomach for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day1), and Weeks 4, 8, 16, and 24	ABC/3TC + ATV/r + Iohexol n=17 participants at risk ABC/3TC (600/300 mg) FDC tablet + ATV 300 mg capsule + RTV 100 mg tablet orally with food once daily for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day1), and Weeks 4, 8, 16, and 24
Hepatobiliary disorders LIVER INJURY	0.00% 0/17 • Baseline to 30 days after last dose of study drug (up to 24 weeks plus 30 days) Safety Analysis Set	6.2% 1/16 • Baseline to 30 days after last dose of study drug (up to 24 weeks plus 30 days) Safety Analysis Set	0.00% 0/16 • Baseline to 30 days after last dose of study drug (up to 24 weeks plus 30 days) Safety Analysis Set	0.00% 0/17 • Baseline to 30 days after last dose of study drug (up to 24 weeks plus 30 days) Safety Analysis Set
Infections and infestations ANAL ABSCESS	0.00% 0/17 • Baseline to 30 days after last dose of study drug (up to 24 weeks plus 30 days) Safety Analysis Set	0.00% 0/16 • Baseline to 30 days after last dose of study drug (up to 24 weeks plus 30 days) Safety Analysis Set	0.00% 0/16 • Baseline to 30 days after last dose of study drug (up to 24 weeks plus 30 days) Safety Analysis Set	5.9% 1/17 • Baseline to 30 days after last dose of study drug (up to 24 weeks plus 30 days) Safety Analysis Set
Infections and infestations PNEUMONIA BACTERIAL	0.00% 0/17 • Baseline to 30 days after last dose of study drug (up to 24 weeks plus 30 days) Safety Analysis Set	0.00% 0/16 • Baseline to 30 days after last dose of study drug (up to 24 weeks plus 30 days) Safety Analysis Set	6.2% 1/16 • Baseline to 30 days after last dose of study drug (up to 24 weeks plus 30 days) Safety Analysis Set	0.00% 0/17 • Baseline to 30 days after last dose of study drug (up to 24 weeks plus 30 days) Safety Analysis Set
Injury, poisoning and procedural complications OVERDOSE	0.00% 0/17 • Baseline to 30 days after last dose of study drug (up to 24 weeks plus 30 days) Safety Analysis Set	6.2% 1/16 • Baseline to 30 days after last dose of study drug (up to 24 weeks plus 30 days) Safety Analysis Set	0.00% 0/16 • Baseline to 30 days after last dose of study drug (up to 24 weeks plus 30 days) Safety Analysis Set	0.00% 0/17 • Baseline to 30 days after last dose of study drug (up to 24 weeks plus 30 days) Safety Analysis Set
Injury, poisoning and procedural complications UPPER LIMB FRACTURE	5.9% 1/17 • Baseline to 30 days after last dose of study drug (up to 24 weeks plus 30 days) Safety Analysis Set	0.00% 0/16 • Baseline to 30 days after last dose of study drug (up to 24 weeks plus 30 days) Safety Analysis Set	0.00% 0/16 • Baseline to 30 days after last dose of study drug (up to 24 weeks plus 30 days) Safety Analysis Set	0.00% 0/17 • Baseline to 30 days after last dose of study drug (up to 24 weeks plus 30 days) Safety Analysis Set
Psychiatric disorders INTENTIONAL SELF-INJURY	0.00% 0/17 • Baseline to 30 days after last dose of study drug (up to 24 weeks plus 30 days) Safety Analysis Set	0.00% 0/16 • Baseline to 30 days after last dose of study drug (up to 24 weeks plus 30 days) Safety Analysis Set	0.00% 0/16 • Baseline to 30 days after last dose of study drug (up to 24 weeks plus 30 days) Safety Analysis Set	5.9% 1/17 • Baseline to 30 days after last dose of study drug (up to 24 weeks plus 30 days) Safety Analysis Set
Renal and urinary disorders ACUTE KIDNEY INJURY	0.00% 0/17 • Baseline to 30 days after last dose of study drug (up to 24 weeks plus 30 days) Safety Analysis Set	6.2% 1/16 • Baseline to 30 days after last dose of study drug (up to 24 weeks plus 30 days) Safety Analysis Set	0.00% 0/16 • Baseline to 30 days after last dose of study drug (up to 24 weeks plus 30 days) Safety Analysis Set	0.00% 0/17 • Baseline to 30 days after last dose of study drug (up to 24 weeks plus 30 days) Safety Analysis Set

Other adverse events

Measure	STB + Iohexol n=17 participants at risk STB (150/150/200/300 mg) FDC tablet orally with food once daily for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day1), and Weeks 4, 8, 16, and 24	TVD + ATV/r + Iohexol n=16 participants at risk TVD (200/300 mg) FDC tablet + ATV 300 mg capsule + RTV 100 mg tablet orally with food once daily for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day 1), and Weeks 4, 8, 16, and 24	ATR + Iohexol n=16 participants at risk ATR (600/200/300 mg) FDC tablet orally once daily on an empty stomach for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day1), and Weeks 4, 8, 16, and 24	ABC/3TC + ATV/r + Iohexol n=17 participants at risk ABC/3TC (600/300 mg) FDC tablet + ATV 300 mg capsule + RTV 100 mg tablet orally with food once daily for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day1), and Weeks 4, 8, 16, and 24
Blood and lymphatic system disorders ANAEMIA	0.00% 0/17 • Baseline to 30 days after last dose of study drug (up to 24 weeks plus 30 days) Safety Analysis Set	0.00% 0/16 • Baseline to 30 days after last dose of study drug (up to 24 weeks plus 30 days) Safety Analysis Set	0.00% 0/16 • Baseline to 30 days after last dose of study drug (up to 24 weeks plus 30 days) Safety Analysis Set	5.9% 1/17 • Baseline to 30 days after last dose of study drug (up to 24 weeks plus 30 days) Safety Analysis Set
Eye disorders EYE PAIN	5.9% 1/17 • Baseline to 30 days after last dose of study drug (up to 24 weeks plus 30 days) Safety Analysis Set	0.00% 0/16 • Baseline to 30 days after last dose of study drug (up to 24 weeks plus 30 days) Safety Analysis Set	0.00% 0/16 • Baseline to 30 days after last dose of study drug (up to 24 weeks plus 30 days) Safety Analysis Set	0.00% 0/17 • Baseline to 30 days after last dose of study drug (up to 24 weeks plus 30 days) Safety Analysis Set
Eye disorders OCULAR ICTERUS	0.00% 0/17 • Baseline to 30 days after last dose of study drug (up to 24 weeks plus 30 days) Safety Analysis Set	18.8% 3/16 • Baseline to 30 days after last dose of study drug (up to 24 weeks plus 30 days) Safety Analysis Set	0.00% 0/16 • Baseline to 30 days after last dose of study drug (up to 24 weeks plus 30 days) Safety Analysis Set	5.9% 1/17 • Baseline to 30 days after last dose of study drug (up to 24 weeks plus 30 days) Safety Analysis Set
Gastrointestinal disorders ANAL FISSURE	5.9% 1/17 • Baseline to 30 days after last dose of study drug (up to 24 weeks plus 30 days) Safety Analysis Set	0.00% 0/16 • Baseline to 30 days after last dose of study drug (up to 24 weeks plus 30 days) Safety Analysis Set	0.00% 0/16 • Baseline to 30 days after last dose of study drug (up to 24 weeks plus 30 days) Safety Analysis Set	0.00% 0/17 • Baseline to 30 days after last dose of study drug (up to 24 weeks plus 30 days) Safety Analysis Set
Gastrointestinal disorders CONSTIPATION	5.9% 1/17 • Baseline to 30 days after last dose of study drug (up to 24 weeks plus 30 days) Safety Analysis Set	0.00% 0/16 • Baseline to 30 days after last dose of study drug (up to 24 weeks plus 30 days) Safety Analysis Set	0.00% 0/16 • Baseline to 30 days after last dose of study drug (up to 24 weeks plus 30 days) Safety Analysis Set	0.00% 0/17 • Baseline to 30 days after last dose of study drug (up to 24 weeks plus 30 days) Safety Analysis Set
Gastrointestinal disorders DIARRHOEA	17.6% 3/17 • Baseline to 30 days after last dose of study drug (up to 24 weeks plus 30 days) Safety Analysis Set	31.2% 5/16 • Baseline to 30 days after last dose of study drug (up to 24 weeks plus 30 days) Safety Analysis Set	12.5% 2/16 • Baseline to 30 days after last dose of study drug (up to 24 weeks plus 30 days) Safety Analysis Set	23.5% 4/17 • Baseline to 30 days after last dose of study drug (up to 24 weeks plus 30 days) Safety Analysis Set
Gastrointestinal disorders DIARRHOEA HAEMORRHAGIC	0.00% 0/17 • Baseline to 30 days after last dose of study drug (up to 24 weeks plus 30 days) Safety Analysis Set	0.00% 0/16 • Baseline to 30 days after last dose of study drug (up to 24 weeks plus 30 days) Safety Analysis Set	0.00% 0/16 • Baseline to 30 days after last dose of study drug (up to 24 weeks plus 30 days) Safety Analysis Set	5.9% 1/17 • Baseline to 30 days after last dose of study drug (up to 24 weeks plus 30 days) Safety Analysis Set
Gastrointestinal disorders DRY MOUTH	5.9% 1/17 • Baseline to 30 days after last dose of study drug (up to 24 weeks plus 30 days) Safety Analysis Set	0.00% 0/16 • Baseline to 30 days after last dose of study drug (up to 24 weeks plus 30 days) Safety Analysis Set	0.00% 0/16 • Baseline to 30 days after last dose of study drug (up to 24 weeks plus 30 days) Safety Analysis Set	0.00% 0/17 • Baseline to 30 days after last dose of study drug (up to 24 weeks plus 30 days) Safety Analysis Set
Gastrointestinal disorders DYSPEPSIA	0.00% 0/17 • Baseline to 30 days after last dose of study drug (up to 24 weeks plus 30 days) Safety Analysis Set	6.2% 1/16 • Baseline to 30 days after last dose of study drug (up to 24 weeks plus 30 days) Safety Analysis Set	0.00% 0/16 • Baseline to 30 days after last dose of study drug (up to 24 weeks plus 30 days) Safety Analysis Set	5.9% 1/17 • Baseline to 30 days after last dose of study drug (up to 24 weeks plus 30 days) Safety Analysis Set
Gastrointestinal disorders FLATULENCE	5.9% 1/17 • Baseline to 30 days after last dose of study drug (up to 24 weeks plus 30 days) Safety Analysis Set	0.00% 0/16 • Baseline to 30 days after last dose of study drug (up to 24 weeks plus 30 days) Safety Analysis Set	0.00% 0/16 • Baseline to 30 days after last dose of study drug (up to 24 weeks plus 30 days) Safety Analysis Set	5.9% 1/17 • Baseline to 30 days after last dose of study drug (up to 24 weeks plus 30 days) Safety Analysis Set
Gastrointestinal disorders HAEMORRHOIDS	5.9% 1/17 • Baseline to 30 days after last dose of study drug (up to 24 weeks plus 30 days) Safety Analysis Set	0.00% 0/16 • Baseline to 30 days after last dose of study drug (up to 24 weeks plus 30 days) Safety Analysis Set	0.00% 0/16 • Baseline to 30 days after last dose of study drug (up to 24 weeks plus 30 days) Safety Analysis Set	0.00% 0/17 • Baseline to 30 days after last dose of study drug (up to 24 weeks plus 30 days) Safety Analysis Set
Gastrointestinal disorders NAUSEA	5.9% 1/17 • Baseline to 30 days after last dose of study drug (up to 24 weeks plus 30 days) Safety Analysis Set	12.5% 2/16 • Baseline to 30 days after last dose of study drug (up to 24 weeks plus 30 days) Safety Analysis Set	0.00% 0/16 • Baseline to 30 days after last dose of study drug (up to 24 weeks plus 30 days) Safety Analysis Set	5.9% 1/17 • Baseline to 30 days after last dose of study drug (up to 24 weeks plus 30 days) Safety Analysis Set
Gastrointestinal disorders TOOTHACHE	0.00% 0/17 • Baseline to 30 days after last dose of study drug (up to 24 weeks plus 30 days) Safety Analysis Set	0.00% 0/16 • Baseline to 30 days after last dose of study drug (up to 24 weeks plus 30 days) Safety Analysis Set	12.5% 2/16 • Baseline to 30 days after last dose of study drug (up to 24 weeks plus 30 days) Safety Analysis Set	5.9% 1/17 • Baseline to 30 days after last dose of study drug (up to 24 weeks plus 30 days) Safety Analysis Set
Gastrointestinal disorders VOMITING	0.00% 0/17 • Baseline to 30 days after last dose of study drug (up to 24 weeks plus 30 days) Safety Analysis Set	0.00% 0/16 • Baseline to 30 days after last dose of study drug (up to 24 weeks plus 30 days) Safety Analysis Set	6.2% 1/16 • Baseline to 30 days after last dose of study drug (up to 24 weeks plus 30 days) Safety Analysis Set	0.00% 0/17 • Baseline to 30 days after last dose of study drug (up to 24 weeks plus 30 days) Safety Analysis Set
General disorders ASTHENIA	0.00% 0/17 • Baseline to 30 days after last dose of study drug (up to 24 weeks plus 30 days) Safety Analysis Set	0.00% 0/16 • Baseline to 30 days after last dose of study drug (up to 24 weeks plus 30 days) Safety Analysis Set	0.00% 0/16 • Baseline to 30 days after last dose of study drug (up to 24 weeks plus 30 days) Safety Analysis Set	5.9% 1/17 • Baseline to 30 days after last dose of study drug (up to 24 weeks plus 30 days) Safety Analysis Set
General disorders FATIGUE	11.8% 2/17 • Baseline to 30 days after last dose of study drug (up to 24 weeks plus 30 days) Safety Analysis Set	6.2% 1/16 • Baseline to 30 days after last dose of study drug (up to 24 weeks plus 30 days) Safety Analysis Set	0.00% 0/16 • Baseline to 30 days after last dose of study drug (up to 24 weeks plus 30 days) Safety Analysis Set	0.00% 0/17 • Baseline to 30 days after last dose of study drug (up to 24 weeks plus 30 days) Safety Analysis Set
General disorders INFLUENZA LIKE ILLNESS	0.00% 0/17 • Baseline to 30 days after last dose of study drug (up to 24 weeks plus 30 days) Safety Analysis Set	6.2% 1/16 • Baseline to 30 days after last dose of study drug (up to 24 weeks plus 30 days) Safety Analysis Set	6.2% 1/16 • Baseline to 30 days after last dose of study drug (up to 24 weeks plus 30 days) Safety Analysis Set	5.9% 1/17 • Baseline to 30 days after last dose of study drug (up to 24 weeks plus 30 days) Safety Analysis Set
General disorders PAIN	0.00% 0/17 • Baseline to 30 days after last dose of study drug (up to 24 weeks plus 30 days) Safety Analysis Set	0.00% 0/16 • Baseline to 30 days after last dose of study drug (up to 24 weeks plus 30 days) Safety Analysis Set	6.2% 1/16 • Baseline to 30 days after last dose of study drug (up to 24 weeks plus 30 days) Safety Analysis Set	0.00% 0/17 • Baseline to 30 days after last dose of study drug (up to 24 weeks plus 30 days) Safety Analysis Set
General disorders PYREXIA	0.00% 0/17 • Baseline to 30 days after last dose of study drug (up to 24 weeks plus 30 days) Safety Analysis Set	6.2% 1/16 • Baseline to 30 days after last dose of study drug (up to 24 weeks plus 30 days) Safety Analysis Set	0.00% 0/16 • Baseline to 30 days after last dose of study drug (up to 24 weeks plus 30 days) Safety Analysis Set	0.00% 0/17 • Baseline to 30 days after last dose of study drug (up to 24 weeks plus 30 days) Safety Analysis Set
Hepatobiliary disorders JAUNDICE	0.00% 0/17 • Baseline to 30 days after last dose of study drug (up to 24 weeks plus 30 days) Safety Analysis Set	12.5% 2/16 • Baseline to 30 days after last dose of study drug (up to 24 weeks plus 30 days) Safety Analysis Set	0.00% 0/16 • Baseline to 30 days after last dose of study drug (up to 24 weeks plus 30 days) Safety Analysis Set	5.9% 1/17 • Baseline to 30 days after last dose of study drug (up to 24 weeks plus 30 days) Safety Analysis Set
Immune system disorders SEASONAL ALLERGY	0.00% 0/17 • Baseline to 30 days after last dose of study drug (up to 24 weeks plus 30 days) Safety Analysis Set	0.00% 0/16 • Baseline to 30 days after last dose of study drug (up to 24 weeks plus 30 days) Safety Analysis Set	0.00% 0/16 • Baseline to 30 days after last dose of study drug (up to 24 weeks plus 30 days) Safety Analysis Set	5.9% 1/17 • Baseline to 30 days after last dose of study drug (up to 24 weeks plus 30 days) Safety Analysis Set
Infections and infestations ACUTE HEPATITIS C	0.00% 0/17 • Baseline to 30 days after last dose of study drug (up to 24 weeks plus 30 days) Safety Analysis Set	0.00% 0/16 • Baseline to 30 days after last dose of study drug (up to 24 weeks plus 30 days) Safety Analysis Set	6.2% 1/16 • Baseline to 30 days after last dose of study drug (up to 24 weeks plus 30 days) Safety Analysis Set	0.00% 0/17 • Baseline to 30 days after last dose of study drug (up to 24 weeks plus 30 days) Safety Analysis Set
Infections and infestations ANAL CHLAMYDIA INFECTION	0.00% 0/17 • Baseline to 30 days after last dose of study drug (up to 24 weeks plus 30 days) Safety Analysis Set	6.2% 1/16 • Baseline to 30 days after last dose of study drug (up to 24 weeks plus 30 days) Safety Analysis Set	0.00% 0/16 • Baseline to 30 days after last dose of study drug (up to 24 weeks plus 30 days) Safety Analysis Set	0.00% 0/17 • Baseline to 30 days after last dose of study drug (up to 24 weeks plus 30 days) Safety Analysis Set
Infections and infestations CYSTITIS	0.00% 0/17 • Baseline to 30 days after last dose of study drug (up to 24 weeks plus 30 days) Safety Analysis Set	0.00% 0/16 • Baseline to 30 days after last dose of study drug (up to 24 weeks plus 30 days) Safety Analysis Set	6.2% 1/16 • Baseline to 30 days after last dose of study drug (up to 24 weeks plus 30 days) Safety Analysis Set	0.00% 0/17 • Baseline to 30 days after last dose of study drug (up to 24 weeks plus 30 days) Safety Analysis Set
Infections and infestations EAR INFECTION	5.9% 1/17 • Baseline to 30 days after last dose of study drug (up to 24 weeks plus 30 days) Safety Analysis Set	0.00% 0/16 • Baseline to 30 days after last dose of study drug (up to 24 weeks plus 30 days) Safety Analysis Set	0.00% 0/16 • Baseline to 30 days after last dose of study drug (up to 24 weeks plus 30 days) Safety Analysis Set	0.00% 0/17 • Baseline to 30 days after last dose of study drug (up to 24 weeks plus 30 days) Safety Analysis Set
Infections and infestations EYE ABSCESS	0.00% 0/17 • Baseline to 30 days after last dose of study drug (up to 24 weeks plus 30 days) Safety Analysis Set	6.2% 1/16 • Baseline to 30 days after last dose of study drug (up to 24 weeks plus 30 days) Safety Analysis Set	0.00% 0/16 • Baseline to 30 days after last dose of study drug (up to 24 weeks plus 30 days) Safety Analysis Set	0.00% 0/17 • Baseline to 30 days after last dose of study drug (up to 24 weeks plus 30 days) Safety Analysis Set
Infections and infestations EYELID BOIL	0.00% 0/17 • Baseline to 30 days after last dose of study drug (up to 24 weeks plus 30 days) Safety Analysis Set	0.00% 0/16 • Baseline to 30 days after last dose of study drug (up to 24 weeks plus 30 days) Safety Analysis Set	0.00% 0/16 • Baseline to 30 days after last dose of study drug (up to 24 weeks plus 30 days) Safety Analysis Set	5.9% 1/17 • Baseline to 30 days after last dose of study drug (up to 24 weeks plus 30 days) Safety Analysis Set
Infections and infestations FUNGAL SKIN INFECTION	0.00% 0/17 • Baseline to 30 days after last dose of study drug (up to 24 weeks plus 30 days) Safety Analysis Set	0.00% 0/16 • Baseline to 30 days after last dose of study drug (up to 24 weeks plus 30 days) Safety Analysis Set	6.2% 1/16 • Baseline to 30 days after last dose of study drug (up to 24 weeks plus 30 days) Safety Analysis Set	0.00% 0/17 • Baseline to 30 days after last dose of study drug (up to 24 weeks plus 30 days) Safety Analysis Set
Infections and infestations FURUNCLE	5.9% 1/17 • Baseline to 30 days after last dose of study drug (up to 24 weeks plus 30 days) Safety Analysis Set	0.00% 0/16 • Baseline to 30 days after last dose of study drug (up to 24 weeks plus 30 days) Safety Analysis Set	0.00% 0/16 • Baseline to 30 days after last dose of study drug (up to 24 weeks plus 30 days) Safety Analysis Set	0.00% 0/17 • Baseline to 30 days after last dose of study drug (up to 24 weeks plus 30 days) Safety Analysis Set
Infections and infestations GASTROENTERITIS	0.00% 0/17 • Baseline to 30 days after last dose of study drug (up to 24 weeks plus 30 days) Safety Analysis Set	0.00% 0/16 • Baseline to 30 days after last dose of study drug (up to 24 weeks plus 30 days) Safety Analysis Set	0.00% 0/16 • Baseline to 30 days after last dose of study drug (up to 24 weeks plus 30 days) Safety Analysis Set	5.9% 1/17 • Baseline to 30 days after last dose of study drug (up to 24 weeks plus 30 days) Safety Analysis Set
Infections and infestations GONORRHOEA	0.00% 0/17 • Baseline to 30 days after last dose of study drug (up to 24 weeks plus 30 days) Safety Analysis Set	18.8% 3/16 • Baseline to 30 days after last dose of study drug (up to 24 weeks plus 30 days) Safety Analysis Set	6.2% 1/16 • Baseline to 30 days after last dose of study drug (up to 24 weeks plus 30 days) Safety Analysis Set	5.9% 1/17 • Baseline to 30 days after last dose of study drug (up to 24 weeks plus 30 days) Safety Analysis Set
Infections and infestations LARYNGITIS	0.00% 0/17 • Baseline to 30 days after last dose of study drug (up to 24 weeks plus 30 days) Safety Analysis Set	0.00% 0/16 • Baseline to 30 days after last dose of study drug (up to 24 weeks plus 30 days) Safety Analysis Set	0.00% 0/16 • Baseline to 30 days after last dose of study drug (up to 24 weeks plus 30 days) Safety Analysis Set	5.9% 1/17 • Baseline to 30 days after last dose of study drug (up to 24 weeks plus 30 days) Safety Analysis Set
Infections and infestations NASOPHARYNGITIS	5.9% 1/17 • Baseline to 30 days after last dose of study drug (up to 24 weeks plus 30 days) Safety Analysis Set	18.8% 3/16 • Baseline to 30 days after last dose of study drug (up to 24 weeks plus 30 days) Safety Analysis Set	18.8% 3/16 • Baseline to 30 days after last dose of study drug (up to 24 weeks plus 30 days) Safety Analysis Set	11.8% 2/17 • Baseline to 30 days after last dose of study drug (up to 24 weeks plus 30 days) Safety Analysis Set
Infections and infestations ONYCHOMYCOSIS	0.00% 0/17 • Baseline to 30 days after last dose of study drug (up to 24 weeks plus 30 days) Safety Analysis Set	6.2% 1/16 • Baseline to 30 days after last dose of study drug (up to 24 weeks plus 30 days) Safety Analysis Set	0.00% 0/16 • Baseline to 30 days after last dose of study drug (up to 24 weeks plus 30 days) Safety Analysis Set	0.00% 0/17 • Baseline to 30 days after last dose of study drug (up to 24 weeks plus 30 days) Safety Analysis Set
Infections and infestations OTITIS EXTERNA	0.00% 0/17 • Baseline to 30 days after last dose of study drug (up to 24 weeks plus 30 days) Safety Analysis Set	0.00% 0/16 • Baseline to 30 days after last dose of study drug (up to 24 weeks plus 30 days) Safety Analysis Set	6.2% 1/16 • Baseline to 30 days after last dose of study drug (up to 24 weeks plus 30 days) Safety Analysis Set	0.00% 0/17 • Baseline to 30 days after last dose of study drug (up to 24 weeks plus 30 days) Safety Analysis Set
Infections and infestations RESPIRATORY TRACT INFECTION	5.9% 1/17 • Baseline to 30 days after last dose of study drug (up to 24 weeks plus 30 days) Safety Analysis Set	6.2% 1/16 • Baseline to 30 days after last dose of study drug (up to 24 weeks plus 30 days) Safety Analysis Set	0.00% 0/16 • Baseline to 30 days after last dose of study drug (up to 24 weeks plus 30 days) Safety Analysis Set	0.00% 0/17 • Baseline to 30 days after last dose of study drug (up to 24 weeks plus 30 days) Safety Analysis Set
Infections and infestations SYPHILIS	5.9% 1/17 • Baseline to 30 days after last dose of study drug (up to 24 weeks plus 30 days) Safety Analysis Set	0.00% 0/16 • Baseline to 30 days after last dose of study drug (up to 24 weeks plus 30 days) Safety Analysis Set	0.00% 0/16 • Baseline to 30 days after last dose of study drug (up to 24 weeks plus 30 days) Safety Analysis Set	0.00% 0/17 • Baseline to 30 days after last dose of study drug (up to 24 weeks plus 30 days) Safety Analysis Set
Infections and infestations TINEA CRURIS	5.9% 1/17 • Baseline to 30 days after last dose of study drug (up to 24 weeks plus 30 days) Safety Analysis Set	0.00% 0/16 • Baseline to 30 days after last dose of study drug (up to 24 weeks plus 30 days) Safety Analysis Set	0.00% 0/16 • Baseline to 30 days after last dose of study drug (up to 24 weeks plus 30 days) Safety Analysis Set	0.00% 0/17 • Baseline to 30 days after last dose of study drug (up to 24 weeks plus 30 days) Safety Analysis Set
Infections and infestations TINEA PEDIS	11.8% 2/17 • Baseline to 30 days after last dose of study drug (up to 24 weeks plus 30 days) Safety Analysis Set	0.00% 0/16 • Baseline to 30 days after last dose of study drug (up to 24 weeks plus 30 days) Safety Analysis Set	0.00% 0/16 • Baseline to 30 days after last dose of study drug (up to 24 weeks plus 30 days) Safety Analysis Set	0.00% 0/17 • Baseline to 30 days after last dose of study drug (up to 24 weeks plus 30 days) Safety Analysis Set
Infections and infestations TINEA VERSICOLOUR	0.00% 0/17 • Baseline to 30 days after last dose of study drug (up to 24 weeks plus 30 days) Safety Analysis Set	0.00% 0/16 • Baseline to 30 days after last dose of study drug (up to 24 weeks plus 30 days) Safety Analysis Set	6.2% 1/16 • Baseline to 30 days after last dose of study drug (up to 24 weeks plus 30 days) Safety Analysis Set	0.00% 0/17 • Baseline to 30 days after last dose of study drug (up to 24 weeks plus 30 days) Safety Analysis Set
Infections and infestations UPPER RESPIRATORY TRACT INFECTION	0.00% 0/17 • Baseline to 30 days after last dose of study drug (up to 24 weeks plus 30 days) Safety Analysis Set	6.2% 1/16 • Baseline to 30 days after last dose of study drug (up to 24 weeks plus 30 days) Safety Analysis Set	0.00% 0/16 • Baseline to 30 days after last dose of study drug (up to 24 weeks plus 30 days) Safety Analysis Set	5.9% 1/17 • Baseline to 30 days after last dose of study drug (up to 24 weeks plus 30 days) Safety Analysis Set
Injury, poisoning and procedural complications PROCEDURAL PAIN	0.00% 0/17 • Baseline to 30 days after last dose of study drug (up to 24 weeks plus 30 days) Safety Analysis Set	0.00% 0/16 • Baseline to 30 days after last dose of study drug (up to 24 weeks plus 30 days) Safety Analysis Set	6.2% 1/16 • Baseline to 30 days after last dose of study drug (up to 24 weeks plus 30 days) Safety Analysis Set	0.00% 0/17 • Baseline to 30 days after last dose of study drug (up to 24 weeks plus 30 days) Safety Analysis Set
Injury, poisoning and procedural complications TRAUMATIC HAEMATOMA	5.9% 1/17 • Baseline to 30 days after last dose of study drug (up to 24 weeks plus 30 days) Safety Analysis Set	0.00% 0/16 • Baseline to 30 days after last dose of study drug (up to 24 weeks plus 30 days) Safety Analysis Set	0.00% 0/16 • Baseline to 30 days after last dose of study drug (up to 24 weeks plus 30 days) Safety Analysis Set	0.00% 0/17 • Baseline to 30 days after last dose of study drug (up to 24 weeks plus 30 days) Safety Analysis Set
Investigations BLOOD CREATINE PHOSPHOKINASE INCREASED	0.00% 0/17 • Baseline to 30 days after last dose of study drug (up to 24 weeks plus 30 days) Safety Analysis Set	12.5% 2/16 • Baseline to 30 days after last dose of study drug (up to 24 weeks plus 30 days) Safety Analysis Set	0.00% 0/16 • Baseline to 30 days after last dose of study drug (up to 24 weeks plus 30 days) Safety Analysis Set	0.00% 0/17 • Baseline to 30 days after last dose of study drug (up to 24 weeks plus 30 days) Safety Analysis Set
Investigations LIVER FUNCTION TEST ABNORMAL	0.00% 0/17 • Baseline to 30 days after last dose of study drug (up to 24 weeks plus 30 days) Safety Analysis Set	6.2% 1/16 • Baseline to 30 days after last dose of study drug (up to 24 weeks plus 30 days) Safety Analysis Set	0.00% 0/16 • Baseline to 30 days after last dose of study drug (up to 24 weeks plus 30 days) Safety Analysis Set	0.00% 0/17 • Baseline to 30 days after last dose of study drug (up to 24 weeks plus 30 days) Safety Analysis Set
Metabolism and nutrition disorders INCREASED APPETITE	0.00% 0/17 • Baseline to 30 days after last dose of study drug (up to 24 weeks plus 30 days) Safety Analysis Set	6.2% 1/16 • Baseline to 30 days after last dose of study drug (up to 24 weeks plus 30 days) Safety Analysis Set	0.00% 0/16 • Baseline to 30 days after last dose of study drug (up to 24 weeks plus 30 days) Safety Analysis Set	0.00% 0/17 • Baseline to 30 days after last dose of study drug (up to 24 weeks plus 30 days) Safety Analysis Set
Musculoskeletal and connective tissue disorders ARTHRALGIA	5.9% 1/17 • Baseline to 30 days after last dose of study drug (up to 24 weeks plus 30 days) Safety Analysis Set	0.00% 0/16 • Baseline to 30 days after last dose of study drug (up to 24 weeks plus 30 days) Safety Analysis Set	0.00% 0/16 • Baseline to 30 days after last dose of study drug (up to 24 weeks plus 30 days) Safety Analysis Set	0.00% 0/17 • Baseline to 30 days after last dose of study drug (up to 24 weeks plus 30 days) Safety Analysis Set
Musculoskeletal and connective tissue disorders NECK PAIN	0.00% 0/17 • Baseline to 30 days after last dose of study drug (up to 24 weeks plus 30 days) Safety Analysis Set	0.00% 0/16 • Baseline to 30 days after last dose of study drug (up to 24 weeks plus 30 days) Safety Analysis Set	0.00% 0/16 • Baseline to 30 days after last dose of study drug (up to 24 weeks plus 30 days) Safety Analysis Set	5.9% 1/17 • Baseline to 30 days after last dose of study drug (up to 24 weeks plus 30 days) Safety Analysis Set
Neoplasms benign, malignant and unspecified (incl cysts and polyps) ANOGENITAL WARTS	0.00% 0/17 • Baseline to 30 days after last dose of study drug (up to 24 weeks plus 30 days) Safety Analysis Set	0.00% 0/16 • Baseline to 30 days after last dose of study drug (up to 24 weeks plus 30 days) Safety Analysis Set	6.2% 1/16 • Baseline to 30 days after last dose of study drug (up to 24 weeks plus 30 days) Safety Analysis Set	0.00% 0/17 • Baseline to 30 days after last dose of study drug (up to 24 weeks plus 30 days) Safety Analysis Set
Nervous system disorders DIZZINESS	0.00% 0/17 • Baseline to 30 days after last dose of study drug (up to 24 weeks plus 30 days) Safety Analysis Set	6.2% 1/16 • Baseline to 30 days after last dose of study drug (up to 24 weeks plus 30 days) Safety Analysis Set	43.8% 7/16 • Baseline to 30 days after last dose of study drug (up to 24 weeks plus 30 days) Safety Analysis Set	0.00% 0/17 • Baseline to 30 days after last dose of study drug (up to 24 weeks plus 30 days) Safety Analysis Set
Nervous system disorders HEAD DISCOMFORT	0.00% 0/17 • Baseline to 30 days after last dose of study drug (up to 24 weeks plus 30 days) Safety Analysis Set	6.2% 1/16 • Baseline to 30 days after last dose of study drug (up to 24 weeks plus 30 days) Safety Analysis Set	0.00% 0/16 • Baseline to 30 days after last dose of study drug (up to 24 weeks plus 30 days) Safety Analysis Set	0.00% 0/17 • Baseline to 30 days after last dose of study drug (up to 24 weeks plus 30 days) Safety Analysis Set
Nervous system disorders HEADACHE	11.8% 2/17 • Baseline to 30 days after last dose of study drug (up to 24 weeks plus 30 days) Safety Analysis Set	6.2% 1/16 • Baseline to 30 days after last dose of study drug (up to 24 weeks plus 30 days) Safety Analysis Set	12.5% 2/16 • Baseline to 30 days after last dose of study drug (up to 24 weeks plus 30 days) Safety Analysis Set	17.6% 3/17 • Baseline to 30 days after last dose of study drug (up to 24 weeks plus 30 days) Safety Analysis Set
Nervous system disorders HYPOAESTHESIA	5.9% 1/17 • Baseline to 30 days after last dose of study drug (up to 24 weeks plus 30 days) Safety Analysis Set	0.00% 0/16 • Baseline to 30 days after last dose of study drug (up to 24 weeks plus 30 days) Safety Analysis Set	0.00% 0/16 • Baseline to 30 days after last dose of study drug (up to 24 weeks plus 30 days) Safety Analysis Set	0.00% 0/17 • Baseline to 30 days after last dose of study drug (up to 24 weeks plus 30 days) Safety Analysis Set
Nervous system disorders LETHARGY	0.00% 0/17 • Baseline to 30 days after last dose of study drug (up to 24 weeks plus 30 days) Safety Analysis Set	6.2% 1/16 • Baseline to 30 days after last dose of study drug (up to 24 weeks plus 30 days) Safety Analysis Set	0.00% 0/16 • Baseline to 30 days after last dose of study drug (up to 24 weeks plus 30 days) Safety Analysis Set	0.00% 0/17 • Baseline to 30 days after last dose of study drug (up to 24 weeks plus 30 days) Safety Analysis Set
Nervous system disorders NERVOUS SYSTEM DISORDER	0.00% 0/17 • Baseline to 30 days after last dose of study drug (up to 24 weeks plus 30 days) Safety Analysis Set	0.00% 0/16 • Baseline to 30 days after last dose of study drug (up to 24 weeks plus 30 days) Safety Analysis Set	6.2% 1/16 • Baseline to 30 days after last dose of study drug (up to 24 weeks plus 30 days) Safety Analysis Set	0.00% 0/17 • Baseline to 30 days after last dose of study drug (up to 24 weeks plus 30 days) Safety Analysis Set
Psychiatric disorders ABNORMAL BEHAVIOUR	0.00% 0/17 • Baseline to 30 days after last dose of study drug (up to 24 weeks plus 30 days) Safety Analysis Set	6.2% 1/16 • Baseline to 30 days after last dose of study drug (up to 24 weeks plus 30 days) Safety Analysis Set	0.00% 0/16 • Baseline to 30 days after last dose of study drug (up to 24 weeks plus 30 days) Safety Analysis Set	0.00% 0/17 • Baseline to 30 days after last dose of study drug (up to 24 weeks plus 30 days) Safety Analysis Set
Psychiatric disorders ABNORMAL DREAMS	0.00% 0/17 • Baseline to 30 days after last dose of study drug (up to 24 weeks plus 30 days) Safety Analysis Set	0.00% 0/16 • Baseline to 30 days after last dose of study drug (up to 24 weeks plus 30 days) Safety Analysis Set	6.2% 1/16 • Baseline to 30 days after last dose of study drug (up to 24 weeks plus 30 days) Safety Analysis Set	0.00% 0/17 • Baseline to 30 days after last dose of study drug (up to 24 weeks plus 30 days) Safety Analysis Set
Psychiatric disorders DEPRESSED MOOD	0.00% 0/17 • Baseline to 30 days after last dose of study drug (up to 24 weeks plus 30 days) Safety Analysis Set	6.2% 1/16 • Baseline to 30 days after last dose of study drug (up to 24 weeks plus 30 days) Safety Analysis Set	6.2% 1/16 • Baseline to 30 days after last dose of study drug (up to 24 weeks plus 30 days) Safety Analysis Set	0.00% 0/17 • Baseline to 30 days after last dose of study drug (up to 24 weeks plus 30 days) Safety Analysis Set
Psychiatric disorders DISORIENTATION	5.9% 1/17 • Baseline to 30 days after last dose of study drug (up to 24 weeks plus 30 days) Safety Analysis Set	0.00% 0/16 • Baseline to 30 days after last dose of study drug (up to 24 weeks plus 30 days) Safety Analysis Set	0.00% 0/16 • Baseline to 30 days after last dose of study drug (up to 24 weeks plus 30 days) Safety Analysis Set	0.00% 0/17 • Baseline to 30 days after last dose of study drug (up to 24 weeks plus 30 days) Safety Analysis Set
Psychiatric disorders INDIFFERENCE	5.9% 1/17 • Baseline to 30 days after last dose of study drug (up to 24 weeks plus 30 days) Safety Analysis Set	0.00% 0/16 • Baseline to 30 days after last dose of study drug (up to 24 weeks plus 30 days) Safety Analysis Set	0.00% 0/16 • Baseline to 30 days after last dose of study drug (up to 24 weeks plus 30 days) Safety Analysis Set	0.00% 0/17 • Baseline to 30 days after last dose of study drug (up to 24 weeks plus 30 days) Safety Analysis Set
Psychiatric disorders INSOMNIA	5.9% 1/17 • Baseline to 30 days after last dose of study drug (up to 24 weeks plus 30 days) Safety Analysis Set	0.00% 0/16 • Baseline to 30 days after last dose of study drug (up to 24 weeks plus 30 days) Safety Analysis Set	6.2% 1/16 • Baseline to 30 days after last dose of study drug (up to 24 weeks plus 30 days) Safety Analysis Set	11.8% 2/17 • Baseline to 30 days after last dose of study drug (up to 24 weeks plus 30 days) Safety Analysis Set
Psychiatric disorders NIGHTMARE	0.00% 0/17 • Baseline to 30 days after last dose of study drug (up to 24 weeks plus 30 days) Safety Analysis Set	0.00% 0/16 • Baseline to 30 days after last dose of study drug (up to 24 weeks plus 30 days) Safety Analysis Set	12.5% 2/16 • Baseline to 30 days after last dose of study drug (up to 24 weeks plus 30 days) Safety Analysis Set	0.00% 0/17 • Baseline to 30 days after last dose of study drug (up to 24 weeks plus 30 days) Safety Analysis Set
Psychiatric disorders SLEEP DISORDER	5.9% 1/17 • Baseline to 30 days after last dose of study drug (up to 24 weeks plus 30 days) Safety Analysis Set	0.00% 0/16 • Baseline to 30 days after last dose of study drug (up to 24 weeks plus 30 days) Safety Analysis Set	0.00% 0/16 • Baseline to 30 days after last dose of study drug (up to 24 weeks plus 30 days) Safety Analysis Set	0.00% 0/17 • Baseline to 30 days after last dose of study drug (up to 24 weeks plus 30 days) Safety Analysis Set
Psychiatric disorders TERMINAL INSOMNIA	0.00% 0/17 • Baseline to 30 days after last dose of study drug (up to 24 weeks plus 30 days) Safety Analysis Set	6.2% 1/16 • Baseline to 30 days after last dose of study drug (up to 24 weeks plus 30 days) Safety Analysis Set	0.00% 0/16 • Baseline to 30 days after last dose of study drug (up to 24 weeks plus 30 days) Safety Analysis Set	0.00% 0/17 • Baseline to 30 days after last dose of study drug (up to 24 weeks plus 30 days) Safety Analysis Set
Respiratory, thoracic and mediastinal disorders CATARRH	0.00% 0/17 • Baseline to 30 days after last dose of study drug (up to 24 weeks plus 30 days) Safety Analysis Set	0.00% 0/16 • Baseline to 30 days after last dose of study drug (up to 24 weeks plus 30 days) Safety Analysis Set	0.00% 0/16 • Baseline to 30 days after last dose of study drug (up to 24 weeks plus 30 days) Safety Analysis Set	5.9% 1/17 • Baseline to 30 days after last dose of study drug (up to 24 weeks plus 30 days) Safety Analysis Set
Respiratory, thoracic and mediastinal disorders COUGH	5.9% 1/17 • Baseline to 30 days after last dose of study drug (up to 24 weeks plus 30 days) Safety Analysis Set	0.00% 0/16 • Baseline to 30 days after last dose of study drug (up to 24 weeks plus 30 days) Safety Analysis Set	12.5% 2/16 • Baseline to 30 days after last dose of study drug (up to 24 weeks plus 30 days) Safety Analysis Set	0.00% 0/17 • Baseline to 30 days after last dose of study drug (up to 24 weeks plus 30 days) Safety Analysis Set
Respiratory, thoracic and mediastinal disorders NASAL CONGESTION	0.00% 0/17 • Baseline to 30 days after last dose of study drug (up to 24 weeks plus 30 days) Safety Analysis Set	6.2% 1/16 • Baseline to 30 days after last dose of study drug (up to 24 weeks plus 30 days) Safety Analysis Set	0.00% 0/16 • Baseline to 30 days after last dose of study drug (up to 24 weeks plus 30 days) Safety Analysis Set	5.9% 1/17 • Baseline to 30 days after last dose of study drug (up to 24 weeks plus 30 days) Safety Analysis Set
Respiratory, thoracic and mediastinal disorders OROPHARYNGEAL PAIN	0.00% 0/17 • Baseline to 30 days after last dose of study drug (up to 24 weeks plus 30 days) Safety Analysis Set	0.00% 0/16 • Baseline to 30 days after last dose of study drug (up to 24 weeks plus 30 days) Safety Analysis Set	0.00% 0/16 • Baseline to 30 days after last dose of study drug (up to 24 weeks plus 30 days) Safety Analysis Set	5.9% 1/17 • Baseline to 30 days after last dose of study drug (up to 24 weeks plus 30 days) Safety Analysis Set
Skin and subcutaneous tissue disorders DERMATITIS ALLERGIC	0.00% 0/17 • Baseline to 30 days after last dose of study drug (up to 24 weeks plus 30 days) Safety Analysis Set	0.00% 0/16 • Baseline to 30 days after last dose of study drug (up to 24 weeks plus 30 days) Safety Analysis Set	0.00% 0/16 • Baseline to 30 days after last dose of study drug (up to 24 weeks plus 30 days) Safety Analysis Set	5.9% 1/17 • Baseline to 30 days after last dose of study drug (up to 24 weeks plus 30 days) Safety Analysis Set
Skin and subcutaneous tissue disorders ERYTHEMA	5.9% 1/17 • Baseline to 30 days after last dose of study drug (up to 24 weeks plus 30 days) Safety Analysis Set	0.00% 0/16 • Baseline to 30 days after last dose of study drug (up to 24 weeks plus 30 days) Safety Analysis Set	0.00% 0/16 • Baseline to 30 days after last dose of study drug (up to 24 weeks plus 30 days) Safety Analysis Set	0.00% 0/17 • Baseline to 30 days after last dose of study drug (up to 24 weeks plus 30 days) Safety Analysis Set
Skin and subcutaneous tissue disorders INGROWING NAIL	5.9% 1/17 • Baseline to 30 days after last dose of study drug (up to 24 weeks plus 30 days) Safety Analysis Set	0.00% 0/16 • Baseline to 30 days after last dose of study drug (up to 24 weeks plus 30 days) Safety Analysis Set	0.00% 0/16 • Baseline to 30 days after last dose of study drug (up to 24 weeks plus 30 days) Safety Analysis Set	0.00% 0/17 • Baseline to 30 days after last dose of study drug (up to 24 weeks plus 30 days) Safety Analysis Set
Skin and subcutaneous tissue disorders PRURITUS	0.00% 0/17 • Baseline to 30 days after last dose of study drug (up to 24 weeks plus 30 days) Safety Analysis Set	0.00% 0/16 • Baseline to 30 days after last dose of study drug (up to 24 weeks plus 30 days) Safety Analysis Set	0.00% 0/16 • Baseline to 30 days after last dose of study drug (up to 24 weeks plus 30 days) Safety Analysis Set	5.9% 1/17 • Baseline to 30 days after last dose of study drug (up to 24 weeks plus 30 days) Safety Analysis Set
Skin and subcutaneous tissue disorders RASH	0.00% 0/17 • Baseline to 30 days after last dose of study drug (up to 24 weeks plus 30 days) Safety Analysis Set	12.5% 2/16 • Baseline to 30 days after last dose of study drug (up to 24 weeks plus 30 days) Safety Analysis Set	12.5% 2/16 • Baseline to 30 days after last dose of study drug (up to 24 weeks plus 30 days) Safety Analysis Set	0.00% 0/17 • Baseline to 30 days after last dose of study drug (up to 24 weeks plus 30 days) Safety Analysis Set
Skin and subcutaneous tissue disorders RASH ERYTHEMATOUS	5.9% 1/17 • Baseline to 30 days after last dose of study drug (up to 24 weeks plus 30 days) Safety Analysis Set	0.00% 0/16 • Baseline to 30 days after last dose of study drug (up to 24 weeks plus 30 days) Safety Analysis Set	0.00% 0/16 • Baseline to 30 days after last dose of study drug (up to 24 weeks plus 30 days) Safety Analysis Set	0.00% 0/17 • Baseline to 30 days after last dose of study drug (up to 24 weeks plus 30 days) Safety Analysis Set
Vascular disorders HAEMATOMA	5.9% 1/17 • Baseline to 30 days after last dose of study drug (up to 24 weeks plus 30 days) Safety Analysis Set	0.00% 0/16 • Baseline to 30 days after last dose of study drug (up to 24 weeks plus 30 days) Safety Analysis Set	6.2% 1/16 • Baseline to 30 days after last dose of study drug (up to 24 weeks plus 30 days) Safety Analysis Set	0.00% 0/17 • Baseline to 30 days after last dose of study drug (up to 24 weeks plus 30 days) Safety Analysis Set
Vascular disorders HOT FLUSH	0.00% 0/17 • Baseline to 30 days after last dose of study drug (up to 24 weeks plus 30 days) Safety Analysis Set	0.00% 0/16 • Baseline to 30 days after last dose of study drug (up to 24 weeks plus 30 days) Safety Analysis Set	6.2% 1/16 • Baseline to 30 days after last dose of study drug (up to 24 weeks plus 30 days) Safety Analysis Set	0.00% 0/17 • Baseline to 30 days after last dose of study drug (up to 24 weeks plus 30 days) Safety Analysis Set
Vascular disorders HYPOTENSION	0.00% 0/17 • Baseline to 30 days after last dose of study drug (up to 24 weeks plus 30 days) Safety Analysis Set	6.2% 1/16 • Baseline to 30 days after last dose of study drug (up to 24 weeks plus 30 days) Safety Analysis Set	0.00% 0/16 • Baseline to 30 days after last dose of study drug (up to 24 weeks plus 30 days) Safety Analysis Set	0.00% 0/17 • Baseline to 30 days after last dose of study drug (up to 24 weeks plus 30 days) Safety Analysis Set
Vascular disorders SPIDER VEIN	0.00% 0/17 • Baseline to 30 days after last dose of study drug (up to 24 weeks plus 30 days) Safety Analysis Set	6.2% 1/16 • Baseline to 30 days after last dose of study drug (up to 24 weeks plus 30 days) Safety Analysis Set	0.00% 0/16 • Baseline to 30 days after last dose of study drug (up to 24 weeks plus 30 days) Safety Analysis Set	0.00% 0/17 • Baseline to 30 days after last dose of study drug (up to 24 weeks plus 30 days) Safety Analysis Set

Additional Information

Clinical Trial Disclosures

Gilead Sciences

Email: ClinicalTrialDisclosures@gilead.com

Results disclosure agreements

• Principal investigator is a sponsor employee After conclusion of the study and without prior written approval from Gilead, investigators in this study may communicate, orally present, or publish in scientific journals or other media only after the following conditions have been met: * The results of the study in their entirety have been publicly disclosed by or with the consent of Gilead in an abstract, manuscript, or presentation form; or * The study has been completed at all study sites for at least 2 years
• Publication restrictions are in place

Restriction type: OTHER