| Primary | Actual Glomerular Filtration Rate (aGFR) Using Iohexol Plasma Clearance (CLiohexol) at Week 24 | | 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. | Posted | | Mean | Standard Deviation | mL/min | | Week 24 | | | | ID | Title | Description |
|---|
| OG000 | STB + Iohexol | 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 | | OG001 | 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 | | OG002 | 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 | | OG003 | 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 |
| | Units | Counts |
|---|
| Participants | - OG00017
- OG00115
- OG00215
- OG003
|
| | Title | Denominators | Categories |
|---|
| | | Title | Measurements |
|---|
| - OG000103.6± 23.28
- OG001104.9± 27.16
- OG002111.1± 23.23
- OG003
|
|
| |
| Primary | Estimated GFR (eGFR) Calculated by Cockcroft-Gault Formula at Week 24 | 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 | Participants in the PD Analysis Set with available data were analyzed. | Posted | | Mean | Standard Deviation | mL/min | | Week 24 | | | | ID | Title | Description |
|---|
| OG000 | STB + Iohexol | 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 | | OG001 | 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 | | OG002 | 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 |
|
| Primary | Estimated GFR Calculated by Modification of Diet in Renal Disease (MDRD) Formula at Week 24 | 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 | Participants in the PD Analysis Set with available data were analyzed. | Posted | | Mean | Standard Deviation | mL/min/1.73m^2 | | Week 24 | | | | ID | Title | Description |
|---|
| OG000 | STB + Iohexol | 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 | | OG001 | 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 | | OG002 | 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 |
|
| Secondary | Percentage of Participants Experiencing Treatment-Emergent Graded Laboratory Abnormality: Urine Glucose (by Dipstick) | | | Posted | | Count of Participants | | Participants | | Up to 24 weeks plus 30 days | | | | ID | Title | Description |
|---|
| OG000 | STB + Iohexol | 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 | | OG001 | 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 | | OG002 | 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 | | OG003 | 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 |
|
| Secondary | Percentage of Participants Experiencing Treatment-Emergent Graded Laboratory Abnormality: Serum Glucose (Fasting) | | Participants in the Safety Analysis Set with available data were analyzed. | Posted | | Number | | percentage of participants | | Up to 24 weeks plus 30 days | | | | ID | Title | Description |
|---|
| OG000 | STB + Iohexol | 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 | | OG001 | 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 | | OG002 | 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 | | OG003 | 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 |
|
| Secondary | Percentage Change From Baseline in Urine Albumin to Creatinine Ratio (mg/g) at Week 24 | | Participants in the PD Analysis Set with available data were analyzed. | Posted | | Median | Inter-Quartile Range | percentage change | | Baseline; Week 24 | | | | ID | Title | Description |
|---|
| OG000 | STB + Iohexol | 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 | | OG001 | 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 | | OG002 | 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 | | OG003 | 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 |
|
| Secondary | Percentage Change From Baseline in Urine Protein to Creatinine Ratio (mg/g) at Week 24 | | Participants in the PD Analysis Set with available data were analyzed. | Posted | | Median | Inter-Quartile Range | percentage change | | Baseline; Week 24 | | | | ID | Title | Description |
|---|
| OG000 | STB + Iohexol | 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 | | OG001 | 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 | | OG002 | 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 | | OG003 | 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 |
|
| Secondary | Percentage Change From Baseline in Urine β2-microglobulin to Creatinine Ratio (µg/g) at Week 24 | | Participants in the PD Analysis Set with available data were analyzed. | Posted | | Median | Inter-Quartile Range | percentage change | | Baseline; Week 24 | | | | ID | Title | Description |
|---|
| OG000 | STB + Iohexol | 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 | | OG001 | 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 | | OG002 | 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 | | OG003 | 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 |
|
| Secondary | Percentage Change From Baseline in Urine Retinol Binding Protein (RBP) to Creatinine Ratio (µg/g) at Week 24 | | Participants in the PD Analysis Set with available data were analyzed. | Posted | | Median | Inter-Quartile Range | percentage change | | Baseline; Week 24 | | | | ID | Title | Description |
|---|
| OG000 | STB + Iohexol | 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 | | OG001 | 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 | | OG002 | 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 | | OG003 | 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 |
|
| Secondary | Pharmacokinetic (PK) Parameter: Cmax for COBI | Cmax is defined as the maximum observed concentration of drug in plasma. | Participants in the COBI PK Analysis Set (all treated participants who have respective, evaluable PK profiles of COBI) with available data were analyzed. | Posted | | Mean | Standard Deviation | ng/mL | | Pre-dose, 0, 0.5, 1, 2, 3, 4, 5, 6, and 10 hours post "time zero" at Weeks 4, 8, 16, and 24 | | | | ID | Title | Description |
|---|
| OG000 | STB + Iohexol | 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 |
| |
| Secondary | PK Parameter: Tmax for COBI | Tmax is defined as the time of Cmax. | Participants in the COBI PK Analysis Set with available data were analyzed. | Posted | | Median | Inter-Quartile Range | hours | | Pre-dose, 0, 0.5, 1, 2, 3, 4, 5, 6, and 10 hours post "time zero" at Weeks 4, 8, 16, and 24 | | | | ID | Title | Description |
|---|
| OG000 | STB + Iohexol | 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 |
| |
| Secondary | PK Parameter: Clast for COBI | Clast is defined as the last observable concentration of drug. | Participants in the COBI PK Analysis Set with available data were analyzed. | Posted | | Mean | Standard Deviation | ng/mL | | Pre-dose, 0, 0.5, 1, 2, 3, 4, 5, 6, and 10 hours post "time zero" at Weeks 4, 8, 16, and 24 | | | | ID | Title | Description |
|---|
| OG000 | STB + Iohexol | 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 |
| |
| Secondary | PK Parameter: Tlast for COBI |
- 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.
| Participants in the COBI PK Analysis Set with available data were analyzed. | Posted | | Median | Inter-Quartile Range | hours | | Pre-dose, 0, 0.5, 1, 2, 3, 4, 5, 6, and 10 hours post "time zero" at Weeks 4, 8, 16, and 24 | | | | ID | Title | Description |
|---|
| OG000 | STB + Iohexol | 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 |
| |
| Secondary | PK Parameter: Ctau for COBI | Ctau is defined as the observed drug concentration at the end of the dosing interval. | Participants in the COBI PK Analysis Set with available data were analyzed. | Posted | | Mean | Standard Deviation | ng/mL | | Pre-dose, 0, 0.5, 1, 2, 3, 4, 5, 6, and 10 hours post "time zero" at Weeks 4, 8, 16, and 24 | | | | ID | Title | Description |
|---|
| OG000 | STB + Iohexol | 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 |
| |
| Secondary | PK Parameter: λz for COBI | λz is defined as the terminal elimination rate constant. | Participants in the COBI PK Analysis Set with available data were analyzed. | Posted | | Mean | Standard Deviation | 1/hour | | Pre-dose, 0, 0.5, 1, 2, 3, 4, 5, 6, and 10 hours post "time zero" at Weeks 4, 8, 16, and 24 | | | | ID | Title | Description |
|---|
| OG000 | STB + Iohexol | 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 |
| |
| Secondary | PK Parameter: AUCtau for COBI | AUCtau is defined as the concentration of drug over time (area under the plasma concentration versus time curve over the dosing interval). | Participants in the COBI PK Analysis Set with available data were analyzed. | Posted | | Mean | Standard Deviation | h*ng/mL | | Pre-dose, 0, 0.5, 1, 2, 3, 4, 5, 6, and 10 hours post "time zero" at Weeks 4, 8, 16, and 24 | | | | ID | Title | Description |
|---|
| OG000 | STB + Iohexol | 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 |
| |
| Secondary | PK Parameter: t1/2 for COBI | t1/2 is defined as the estimate of the terminal elimination half-life of the drug. | Participants in the COBI PK Analysis Set with available data were analyzed. | Posted | | Median | Inter-Quartile Range | hours | | Predose, 0, 0.5, 1, 2, 3, 4, 5, 6, and 10 hours post "time zero" at Weeks 4, 8, 16, and 24 | | | | ID | Title | Description |
|---|
| OG000 | STB + Iohexol | 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 |
| |
| Secondary | PK Parameter: Cmax for RTV | | Participants in the RTV PK Analysis Set (all treated participants who have respective, evaluable PK profiles of RTV) with available data were analyzed. | Posted | | Mean | Standard Deviation | ng/mL | | Pre-dose, 0, 0.5, 1, 2, 3, 4, 5, 6, and 10 hours post "time zero" at Weeks 4, 8, 16, and 24 | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | 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 |
| |
| Secondary | PK Parameter: Tmax for RTV | | Participants in the RTV PK Analysis Set with available data were analyzed. | Posted | | Median | Inter-Quartile Range | hours | | Pre-dose, 0, 0.5, 1, 2, 3, 4, 5, 6, and 10 hours post "time zero" at Weeks 4, 8, 16, and 24 | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | 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 |
| |
| Secondary | PK Parameter: Clast for RTV | | Participants in the RTV PK Analysis Set with available data were analyzed. | Posted | | Mean | Standard Deviation | ng/mL | | Pre-dose, 0, 0.5, 1, 2, 3, 4, 5, 6, and 10 hours post "time zero" at Weeks 4, 8, 16, and 24 | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | 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 |
| |
| Secondary | PK Parameter: Tlast for RTV | 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. | Participants in the RTV PK Analysis Set with available data were analyzed. | Posted | | Median | Inter-Quartile Range | hours | | Pre-dose, 0, 0.5, 1, 2, 3, 4, 5, 6, and 10 hours post "time zero" at Weeks 4, 8, 16, and 24 | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | 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 |
| |
| Secondary | PK Parameter: Ctau for RTV | | Participants in the RTV PK Analysis Set with available data were analyzed. | Posted | | Mean | Standard Deviation | ng/mL | | Pre-dose, 0, 0.5, 1, 2, 3, 4, 5, 6, and 10 hours post "time zero" at Weeks 4, 8, 16, and 24 | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | 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 |
| |
| Secondary | PK Parameter: AUCtau for RTV | | Participants in the RTV PK Analysis Set with available data were analyzed. | Posted | | Mean | Standard Deviation | h*ng/mL | | Pre-dose, 0, 0.5, 1, 2, 3, 4, 5, 6, and 10 hours post "time zero" at Weeks 4, 8, 16, and 24 | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | 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 |
| |
| Secondary | PK Parameter: λz for RTV | | Participants in the RTV PK Analysis Set with available data were analyzed. | Posted | | Mean | Standard Deviation | 1/hour | | Pre-dose, 0, 0.5, 1, 2, 3, 4, 5, 6, and 10 hours post "time zero" at Weeks 4, 8, 16, and 24 | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | 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 |
| |
| Secondary | PK Parameter: t1/2 for RTV | | Participants in the RTV PK Analysis Set with available data were analyzed. | Posted | | Median | Inter-Quartile Range | hours | | Pre-dose, 0, 0.5, 1, 2, 3, 4, 5, 6, and 10 hours post "time zero" at Weeks 4, 8, 16, and 24 | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | 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 |
| |
| Secondary | PK Parameter: Cmax for TFV | | Participants in the TFV PK Analysis Set (all treated participants who have respective, evaluable PK profiles of TFV) with available data were analyzed. | Posted | | Mean | Standard Deviation | ng/mL | | Pre-dose, 0, 0.5, 1, 2, 3, 4, 5, 6, and 10 hours post "time zero" at Weeks 4, 8, 16, and 24 | | | | ID | Title | Description |
|---|
| OG000 | STB + Iohexol | 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 | | OG001 | 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 | | OG002 | 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 |
| |
| Secondary | PK Parameter: Tmax for TFV | | Participants in the TFV PK Analysis Set with available data were analyzed. | Posted | | Median | Inter-Quartile Range | hours | | Pre-dose, 0, 0.5, 1, 2, 3, 4, 5, 6, and 10 hours post "time zero" at Weeks 4, 8, 16, and 24 | | | | ID | Title | Description |
|---|
| OG000 | STB + Iohexol | 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 | | OG001 | 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 | | OG002 | 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 |
| |
| Secondary | PK Parameter: Clast for TFV | | Participants in the TFV PK Analysis Set with available data were analyzed. | Posted | | Mean | Standard Deviation | ng/mL | | Pre-dose, 0, 0.5, 1, 2, 3, 4, 5, 6, and 10 hours post "time zero" at Weeks 4, 8, 16, and 24 | | | | ID | Title | Description |
|---|
| OG000 | STB + Iohexol | 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 | | OG001 | 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 | | OG002 | 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 |
| |
| Secondary | PK Parameter: Tlast for TFV | 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. | Participants in the TFV PK Analysis Set with available data were analyzed. | Posted | | Median | Inter-Quartile Range | hours | | Pre-dose, 0, 0.5, 1, 2, 3, 4, 5, 6, and 10 hours post "time zero" at Weeks 4, 8, 16, and 24 | | | | ID | Title | Description |
|---|
| OG000 | STB + Iohexol | 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 | | OG001 | 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 | | OG002 | 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 |
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| Secondary | PK Parameter: Ctau for TFV | | Participants in the TFV PK Analysis Set with available data were analyzed. | Posted | | Mean | Standard Deviation | ng/mL | | Pre-dose, 0, 0.5, 1, 2, 3, 4, 5, 6, and 10 hours post "time zero" at Weeks 4, 8, 16, and 24 | | | | ID | Title | Description |
|---|
| OG000 | STB + Iohexol | 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 | | OG001 | 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 | | OG002 | 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 |
| |
| Secondary | PK Parameter: λz for TFV | | Participants in the TFV PK Analysis Set with available data were analyzed. | Posted | | Mean | Standard Deviation | 1/hour | | Pre-dose, 0, 0.5, 1, 2, 3, 4, 5, 6, and 10 hours post "time zero" at Weeks 4, 8, 16, and 24 | | | | ID | Title | Description |
|---|
| OG000 | STB + Iohexol | 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 | | OG001 | 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 | | OG002 | 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 |
| |
| Secondary | PK Parameter: AUCtau for TFV | | Participants in the TFV PK Analysis Set with available data were analyzed. | Posted | | Mean | Standard Deviation | h*ng/mL | | Pre-dose, 0, 0.5, 1, 2, 3, 4, 5, 6, and 10 hours post "time zero" at Weeks 4, 8, 16, and 24 | | | | ID | Title | Description |
|---|
| OG000 | STB + Iohexol | 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 | | OG001 | 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 | | OG002 | 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 |
| |
| Secondary | PK Parameter: t1/2 for TFV | | Participants in the TFV PK Analysis Set with available data were analyzed. | Posted | | Median | Inter-Quartile Range | hours | | Pre-dose, 0, 0.5, 1, 2, 3, 4, 5, 6, and 10 hours post "time zero" at Weeks 4, 8, 16, and 24 | | | | ID | Title | Description |
|---|
| OG000 | STB + Iohexol | 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 | | OG001 | 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 | | OG002 | 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 |
| |
| Secondary | PK Parameter: AUCinf for Iohexol | 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). | Participants in the iohexol PK Analysis Set (all treated participants who have respective, evaluable PK profiles of iohexol) with available data were analyzed. | Posted | | Mean | Standard Deviation | h*µg/mL | | 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 | | | | ID | Title | Description |
|---|
| OG000 | STB + Iohexol | 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 | | OG001 | 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 | | OG002 | 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 (Day 1), and Weeks 4, 8, 16, and 24 |
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| Secondary | Percentage of Participants With HIV-1 RNA < 50 Copies/mL Week 24 as Determined by Snapshot Algorithm | | Full Analysis Set (FAS): all participants who (1) are randomized into the study and (2) have received at least one dose of study drug. | Posted | | Number | | percentage of participants | | Week 24 | | | | ID | Title | Description |
|---|
| OG000 | STB + Iohexol | 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 | | OG001 | 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 | | OG002 | 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 | | OG003 | 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 |
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| Secondary | Change From Baseline in Cluster of Differentiation 4 Positive (CD4+) Cell Count at Week 24 | | | Posted | | Mean | Standard Deviation | cells/uL | | Baseline; Week 24 | | | | ID | Title | Description |
|---|
| OG000 | STB + Iohexol | 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 | | OG001 | 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 | | OG002 | 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 | | OG003 | 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 |
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| Secondary | Percentage of Participants Experiencing Adverse Events (AEs) | Incidences of adverse events and laboratory abnormalities will be summarized. | | Posted | | Number | | Percentage of participants | | Up to the last dose date plus 30 days (Up to 24 weeks plus 30 days) | | | | ID | Title | Description |
|---|
| OG000 | STB + Iohexol | 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 | | OG001 | 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 | | OG002 | 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 | | OG003 | ABC/3TC + ATV/r + Iohexol | |
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| Secondary | Percentage of Participants Experiencing Treatment Emergent (TE) Grade 3 or 4 Laboratory Abnormalities | 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. | | Posted | | Number | | Percentage of participants | | Up to the last dose date plus 30 days (Up to 24 weeks plus 30 days) | | | | ID | Title | Description |
|---|
| OG000 | STB + Iohexol | 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 | | OG001 | 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 | | OG002 | 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 |
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