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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

A Randomized, Open Label, Phase 4 Study Evaluating the Renal Effect of Elvitegravir/Cobicistat/Emtricitabine/Tenofovir DF or Other Tenofovir DF-containing Regimens (Ritonavir-boosted Atazanavir Plus Emtricitabine/Tenofovir DF or Efavirenz/Emtricitabine/Tenofovir DF) Compared to Ritonavir-boosted Atazanavir Plus Abacavir/Lamivudine in Antiretroviral Treatment-naïve HIV-1 Infected Adults With eGFR ≥70 mL/Min

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02246998
Enrollment
72
Registered
2014-09-23
Start date
2014-12-15
Completion date
2016-02-17
Last updated
2018-01-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV-1 Infection

Brief summary

The primary objective of this study is to assess glomerular function before and during administration of stribild (STB; elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate (E/C/F/TDF)) or a regimen containing TDF without cobicistat (COBI) as ritonavir (RTV)-boosted atazanavir (ATV/r) plus truvada (TVD; FTC/TDF) or atripla (ATR; efavirenz/emtricitabine/tenofovir disoproxil fumarate (EFV/FTC/TDF)) compared to a regimen containing neither TDF nor COBI as ATV/r plus abacavir/lamivudine (ABC/3TC) via determination of actual glomerular filtration rate (aGFR) using iohexol (a probe GFR marker) plasma clearance and estimated (calculated) glomerular filtration rate (eGFR).

Interventions

DRUGIohexol

1500 mg solution administered intravenously at baseline, and at Weeks 4, 8, 16, and 24

DRUGATV

300 mg capsule administered orally once daily with food

DRUGABC/3TC

600/300 mg FDC tablet administered orally once daily with food

DRUGSTB

150/150/200/300 mg fixed dose combination (FDC) tablet administered orally once daily with food

DRUGTVD

200/300 mg FDC tablet administered orally once daily with food

DRUGATR

600/200/300 mg FDC tablet administered orally once daily on an empty stomach at bedtime

DRUGRTV

100 mg tablet administered orally once daily with food

Sponsors

Gilead Sciences
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
No

Inclusion criteria

Key Inclusion Criteria: * Treatment naïve * Plasma HIV-1 RNA levels ≥ 5,000 copies/mL at Screening * CD4 cell count \> 200 cells/µL * Screening genotype report provided by the site must show sensitivity to FTC, TDF, EFV, ABC, 3TC, ATV and absence of study drug resistance mutations that include K65R, K70E and M184V in RT * Estimated GFR ≥ 70 mL/min * Hepatic transaminases (aspartate aminotransferase \[AST\] and alanine aminotransferase \[ALT\]) ≤ 5 × upper limit of normal (ULN) * Total bilirubin ≤ 1.5 mg/dL (≤ 26 umol/L), or normal direct bilirubin * Adequate hematologic function (absolute neutrophil count ≥ 1,000/mm\^3; platelets ≥ 50,000/mm\^3; hemoglobin ≥ 8.5 g/dL) * Serum amylase ≤ 5 × ULN (individuals with serum amylase \> 5 × ULN will remain eligible if serum lipase is ≤ 5 × ULN) * Normal electrocardiogram (ECG) or not clinically significant if abnormal ECG * Not pregnant or non-lactating females of non-childbearing potential. Or females with childbearing potential who agree to utilize highly effective contraception methods or be non-heterosexually active or practice sexual abstinence from screening throughout the duration of study treatment and for 90 days if taking EFV/FTC/TDF or for 30 days for all other study drugs following the last study drug dose * Males who agree to utilize a highly effective method of contraception during heterosexual intercourse or be non-heterosexually active, or practice sexual abstinence from first dose throughout the study period and for 90 days if taking EFV/FTC/TDF or for 30 days for all other study drugs following the last study drug dose. Males who agree to refrain from sperm donation from first dose until at least 90 days if taking EFV/FTC/TDF or for 30 days for all other study drugs following the last study drug dose * Body mass index (BMI) of 19 ≤ BMI ≤ 30 kg/m\^2 and body weight ≥ 40 kg * Life expectancy ≥ 1 year Key

Exclusion criteria

* HLA-B\*5701 allele positive * A new AIDS-defining condition diagnosed within the 30 days prior to screening * Hepatitis B surface antigen (HBsAg) positive * Hepatitis C virus (HCV) antibody positive and HCV RNA detectable * Individuals experiencing decompensated cirrhosis * Females who are breastfeeding * Positive serum pregnancy test * Have an implanted defibrillator or pacemaker * Current alcohol or substance that could potentially interfere with study compliance * A history of malignancy within the past 5 years (prior to screening) or ongoing malignancy other than cutaneous Kaposi's sarcoma (KS), basal cell carcinoma, or resected, non-invasive cutaneous squamous carcinoma. Individuals with cutaneous KS are eligible, but must not have received any systemic therapy for KS within 30 days of Day 1 Visit and must not be anticipated to require systemic therapy during the study * Active, serious infections (other than HIV-1 infection) requiring parenteral antibiotic or antifungal therapy within 30 days prior to Day 1 Visit Note: Other protocol defined Inclusion/

Design outcomes

Primary

MeasureTime frameDescription
Actual Glomerular Filtration Rate (aGFR) Using Iohexol Plasma Clearance (CLiohexol) at Week 24Week 24—
Estimated GFR (eGFR) Calculated by Cockcroft-Gault Formula at Week 24Week 24GFR 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
Estimated GFR Calculated by Modification of Diet in Renal Disease (MDRD) Formula at Week 24Week 24MDRD 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

Secondary

MeasureTime frameDescription
Percentage Change From Baseline in Urine Protein to Creatinine Ratio (mg/g) at Week 24Baseline; Week 24—
Percentage Change From Baseline in Urine β2-microglobulin to Creatinine Ratio (µg/g) at Week 24Baseline; Week 24—
Percentage Change From Baseline in Urine Retinol Binding Protein (RBP) to Creatinine Ratio (µg/g) at Week 24Baseline; Week 24—
Pharmacokinetic (PK) Parameter: Cmax for COBIPre-dose, 0, 0.5, 1, 2, 3, 4, 5, 6, and 10 hours post time zero at Weeks 4, 8, 16, and 24Cmax is defined as the maximum observed concentration of drug in plasma.
PK Parameter: Tmax for COBIPre-dose, 0, 0.5, 1, 2, 3, 4, 5, 6, and 10 hours post time zero at Weeks 4, 8, 16, and 24Tmax is defined as the time of Cmax.
PK Parameter: Clast for COBIPre-dose, 0, 0.5, 1, 2, 3, 4, 5, 6, and 10 hours post time zero at Weeks 4, 8, 16, and 24Clast is defined as the last observable concentration of drug.
PK Parameter: Tlast for COBIPre-dose, 0, 0.5, 1, 2, 3, 4, 5, 6, and 10 hours post time zero at Weeks 4, 8, 16, and 24* 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.
PK Parameter: Ctau for COBIPre-dose, 0, 0.5, 1, 2, 3, 4, 5, 6, and 10 hours post time zero at Weeks 4, 8, 16, and 24Ctau is defined as the observed drug concentration at the end of the dosing interval.
PK Parameter: λz for COBIPre-dose, 0, 0.5, 1, 2, 3, 4, 5, 6, and 10 hours post time zero at Weeks 4, 8, 16, and 24λz is defined as the terminal elimination rate constant.
PK Parameter: AUCtau for COBIPre-dose, 0, 0.5, 1, 2, 3, 4, 5, 6, and 10 hours post time zero at Weeks 4, 8, 16, and 24AUCtau is defined as the concentration of drug over time (area under the plasma concentration versus time curve over the dosing interval).
PK Parameter: t1/2 for COBIPredose, 0, 0.5, 1, 2, 3, 4, 5, 6, and 10 hours post time zero at Weeks 4, 8, 16, and 24t1/2 is defined as the estimate of the terminal elimination half-life of the drug.
PK Parameter: Cmax for RTVPre-dose, 0, 0.5, 1, 2, 3, 4, 5, 6, and 10 hours post time zero at Weeks 4, 8, 16, and 24—
PK Parameter: Tmax for RTVPre-dose, 0, 0.5, 1, 2, 3, 4, 5, 6, and 10 hours post time zero at Weeks 4, 8, 16, and 24—
PK Parameter: Clast for RTVPre-dose, 0, 0.5, 1, 2, 3, 4, 5, 6, and 10 hours post time zero at Weeks 4, 8, 16, and 24—
PK Parameter: Tlast for RTVPre-dose, 0, 0.5, 1, 2, 3, 4, 5, 6, and 10 hours post time zero at Weeks 4, 8, 16, and 24Plasma 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.
PK Parameter: Ctau for RTVPre-dose, 0, 0.5, 1, 2, 3, 4, 5, 6, and 10 hours post time zero at Weeks 4, 8, 16, and 24—
Percentage of Participants Experiencing Treatment-Emergent Graded Laboratory Abnormality: Urine Glucose (by Dipstick)Up to 24 weeks plus 30 days—
PK Parameter: λz for RTVPre-dose, 0, 0.5, 1, 2, 3, 4, 5, 6, and 10 hours post time zero at Weeks 4, 8, 16, and 24—
PK Parameter: t1/2 for RTVPre-dose, 0, 0.5, 1, 2, 3, 4, 5, 6, and 10 hours post time zero at Weeks 4, 8, 16, and 24—
PK Parameter: Cmax for TFVPre-dose, 0, 0.5, 1, 2, 3, 4, 5, 6, and 10 hours post time zero at Weeks 4, 8, 16, and 24—
PK Parameter: Tmax for TFVPre-dose, 0, 0.5, 1, 2, 3, 4, 5, 6, and 10 hours post time zero at Weeks 4, 8, 16, and 24—
PK Parameter: Clast for TFVPre-dose, 0, 0.5, 1, 2, 3, 4, 5, 6, and 10 hours post time zero at Weeks 4, 8, 16, and 24—
PK Parameter: Tlast for TFVPre-dose, 0, 0.5, 1, 2, 3, 4, 5, 6, and 10 hours post time zero at Weeks 4, 8, 16, and 24Plasma 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.
PK Parameter: Ctau for TFVPre-dose, 0, 0.5, 1, 2, 3, 4, 5, 6, and 10 hours post time zero at Weeks 4, 8, 16, and 24—
PK Parameter: λz for TFVPre-dose, 0, 0.5, 1, 2, 3, 4, 5, 6, and 10 hours post time zero at Weeks 4, 8, 16, and 24—
PK Parameter: AUCtau for TFVPre-dose, 0, 0.5, 1, 2, 3, 4, 5, 6, and 10 hours post time zero at Weeks 4, 8, 16, and 24—
PK Parameter: t1/2 for TFVPre-dose, 0, 0.5, 1, 2, 3, 4, 5, 6, and 10 hours post time zero at Weeks 4, 8, 16, and 24—
PK Parameter: AUCinf for IohexolPre-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 24AUC inf is defined as the concentration of drug extrapolated to infinite time (area under the plasma concentration versus time curve extrapolated to infinite time).
Percentage of Participants With HIV-1 RNA < 50 Copies/mL Week 24 as Determined by Snapshot AlgorithmWeek 24—
Change From Baseline in Cluster of Differentiation 4 Positive (CD4+) Cell Count at Week 24Baseline; Week 24—
Percentage of Participants Experiencing Adverse Events (AEs)Up to the last dose date plus 30 days (Up to 24 weeks plus 30 days)Incidences of adverse events and laboratory abnormalities will be summarized.
Percentage of Participants Experiencing Treatment Emergent (TE) Grade 3 or 4 Laboratory AbnormalitiesUp to the last dose date plus 30 days (Up to 24 weeks plus 30 days)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.
PK Parameter: AUCtau for RTVPre-dose, 0, 0.5, 1, 2, 3, 4, 5, 6, and 10 hours post time zero at Weeks 4, 8, 16, and 24—
Percentage of Participants Experiencing Treatment-Emergent Graded Laboratory Abnormality: Serum Glucose (Fasting)Up to 24 weeks plus 30 days—
Percentage Change From Baseline in Urine Albumin to Creatinine Ratio (mg/g) at Week 24Baseline; Week 24—

Countries

Belgium, France, Ireland, Spain, United Kingdom

Participant flow

Recruitment details

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.

Pre-assignment details

93 participants were screened.

Participants by arm

ArmCount
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
17
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
16
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
16
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
17
Total66

Withdrawals & dropouts

PeriodReasonFG000FG001FG002FG003
Overall StudyAdverse Event0110
Overall StudyLost to Follow-up1001
Overall StudyRandomized but Never Dosed1221

Baseline characteristics

CharacteristicTotalABC/3TC + ATV/r + IohexolATR + IohexolTVD + ATV/r + IohexolSTB + Iohexol
Actual Glomerular Filtration Rate106.4 mL/min
STANDARD_DEVIATION 31.52
96.6 mL/min
STANDARD_DEVIATION 34.52
105.4 mL/min
STANDARD_DEVIATION 38.22
112.0 mL/min
STANDARD_DEVIATION 19.17
111.8 mL/min
STANDARD_DEVIATION 31.07
Age, Continuous35 years
STANDARD_DEVIATION 8.3
34 years
STANDARD_DEVIATION 7.5
34 years
STANDARD_DEVIATION 9.6
34 years
STANDARD_DEVIATION 8.4
36 years
STANDARD_DEVIATION 8.1
CD4 Cell Count557 cells/uL
STANDARD_DEVIATION 197.8
524 cells/uL
STANDARD_DEVIATION 190
553 cells/uL
STANDARD_DEVIATION 215.8
600 cells/uL
STANDARD_DEVIATION 217.9
552 cells/uL
STANDARD_DEVIATION 177.8
Estimated Glomerular Filtration Rate by Cockcroft-Gault121.0 mL/min
STANDARD_DEVIATION 19.55
122.6 mL/min
STANDARD_DEVIATION 20.25
119.5 mL/min
STANDARD_DEVIATION 20.36
121.2 mL/min
STANDARD_DEVIATION 24.34
120.8 mL/min
STANDARD_DEVIATION 13.94
Estimated Glomerular Filtration Rate by MDRD Formula107.0 mL/min/1.73m2
STANDARD_DEVIATION 16.71
105.5 mL/min/1.73m2
STANDARD_DEVIATION 12.59
108.4 mL/min/1.73m2
STANDARD_DEVIATION 21.42
110.6 mL/min/1.73m2
STANDARD_DEVIATION 18.47
103.8 mL/min/1.73m2
STANDARD_DEVIATION 14.06
Race/Ethnicity, Customized
American Indian or Alaska Native
1 Participants0 Participants0 Participants0 Participants1 Participants
Race/Ethnicity, Customized
Asian
2 Participants1 Participants0 Participants0 Participants1 Participants
Race/Ethnicity, Customized
Black
6 Participants1 Participants2 Participants1 Participants2 Participants
Race/Ethnicity, Customized
Hispanic or Latino
7 Participants0 Participants2 Participants3 Participants2 Participants
Race/Ethnicity, Customized
Not Hispanic or Latino
59 Participants17 Participants14 Participants13 Participants15 Participants
Race/Ethnicity, Customized
Other
1 Participants0 Participants1 Participants0 Participants0 Participants
Race/Ethnicity, Customized
White
56 Participants15 Participants13 Participants15 Participants13 Participants
Region of Enrollment
Belgium
14 Participants4 Participants5 Participants2 Participants3 Participants
Region of Enrollment
Ireland
5 Participants0 Participants1 Participants3 Participants1 Participants
Region of Enrollment
Spain
16 Participants6 Participants3 Participants4 Participants3 Participants
Region of Enrollment
United Kingdom
37 Participants8 Participants9 Participants9 Participants11 Participants
Sex: Female, Male
Female
2 Participants0 Participants1 Participants1 Participants0 Participants
Sex: Female, Male
Male
64 Participants17 Participants15 Participants15 Participants17 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
EG003
affected / at risk
deaths
Total, all-cause mortality
0 / 170 / 160 / 160 / 17
other
Total, other adverse events
11 / 1714 / 1613 / 1614 / 17
serious
Total, serious adverse events
1 / 171 / 161 / 162 / 17

Outcome results

Primary

Actual Glomerular Filtration Rate (aGFR) Using Iohexol Plasma Clearance (CLiohexol) at Week 24

Time frame: 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.

ArmMeasureValue (MEAN)Dispersion
STB + IohexolActual Glomerular Filtration Rate (aGFR) Using Iohexol Plasma Clearance (CLiohexol) at Week 24103.6 mL/minStandard Deviation 23.28
TVD + ATV/r + IohexolActual Glomerular Filtration Rate (aGFR) Using Iohexol Plasma Clearance (CLiohexol) at Week 24104.9 mL/minStandard Deviation 27.16
ATR + IohexolActual Glomerular Filtration Rate (aGFR) Using Iohexol Plasma Clearance (CLiohexol) at Week 24111.1 mL/minStandard Deviation 23.23
ABC/3TC + ATV/r + IohexolActual Glomerular Filtration Rate (aGFR) Using Iohexol Plasma Clearance (CLiohexol) at Week 24101.0 mL/minStandard Deviation 27.01
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

Time frame: Week 24

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

ArmMeasureValue (MEAN)Dispersion
STB + IohexolEstimated GFR Calculated by Modification of Diet in Renal Disease (MDRD) Formula at Week 2499.3 mL/min/1.73m^2Standard Deviation 17.07
TVD + ATV/r + IohexolEstimated GFR Calculated by Modification of Diet in Renal Disease (MDRD) Formula at Week 24110.2 mL/min/1.73m^2Standard Deviation 23.98
ATR + IohexolEstimated GFR Calculated by Modification of Diet in Renal Disease (MDRD) Formula at Week 24109.2 mL/min/1.73m^2Standard Deviation 20.9
ABC/3TC + ATV/r + IohexolEstimated GFR Calculated by Modification of Diet in Renal Disease (MDRD) Formula at Week 24104.9 mL/min/1.73m^2Standard Deviation 12.59
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

Time frame: Week 24

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

ArmMeasureValue (MEAN)Dispersion
STB + IohexolEstimated GFR (eGFR) Calculated by Cockcroft-Gault Formula at Week 24116.9 mL/minStandard Deviation 17.06
TVD + ATV/r + IohexolEstimated GFR (eGFR) Calculated by Cockcroft-Gault Formula at Week 24122.4 mL/minStandard Deviation 31.71
ATR + IohexolEstimated GFR (eGFR) Calculated by Cockcroft-Gault Formula at Week 24120.0 mL/minStandard Deviation 20.52
ABC/3TC + ATV/r + IohexolEstimated GFR (eGFR) Calculated by Cockcroft-Gault Formula at Week 24123.0 mL/minStandard Deviation 25.74
Secondary

Change From Baseline in Cluster of Differentiation 4 Positive (CD4+) Cell Count at Week 24

Time frame: Baseline; Week 24

Population: Full Analysis Set

ArmMeasureValue (MEAN)Dispersion
STB + IohexolChange From Baseline in Cluster of Differentiation 4 Positive (CD4+) Cell Count at Week 24139.63 cells/uLStandard Deviation 142.196
TVD + ATV/r + IohexolChange From Baseline in Cluster of Differentiation 4 Positive (CD4+) Cell Count at Week 24217.60 cells/uLStandard Deviation 195.375
ATR + IohexolChange From Baseline in Cluster of Differentiation 4 Positive (CD4+) Cell Count at Week 24204.33 cells/uLStandard Deviation 194.653
ABC/3TC + ATV/r + IohexolChange From Baseline in Cluster of Differentiation 4 Positive (CD4+) Cell Count at Week 24237.29 cells/uLStandard Deviation 201.222
Secondary

Percentage Change From Baseline in Urine Albumin to Creatinine Ratio (mg/g) at Week 24

Time frame: Baseline; Week 24

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

ArmMeasureValue (MEDIAN)
STB + IohexolPercentage Change From Baseline in Urine Albumin to Creatinine Ratio (mg/g) at Week 240.0 percentage change
TVD + ATV/r + IohexolPercentage Change From Baseline in Urine Albumin to Creatinine Ratio (mg/g) at Week 24-18.3 percentage change
ATR + IohexolPercentage Change From Baseline in Urine Albumin to Creatinine Ratio (mg/g) at Week 2450.0 percentage change
ABC/3TC + ATV/r + IohexolPercentage Change From Baseline in Urine Albumin to Creatinine Ratio (mg/g) at Week 24-16.7 percentage change
Secondary

Percentage Change From Baseline in Urine Protein to Creatinine Ratio (mg/g) at Week 24

Time frame: Baseline; Week 24

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

ArmMeasureValue (MEDIAN)
STB + IohexolPercentage Change From Baseline in Urine Protein to Creatinine Ratio (mg/g) at Week 245.7 percentage change
TVD + ATV/r + IohexolPercentage Change From Baseline in Urine Protein to Creatinine Ratio (mg/g) at Week 2417.5 percentage change
ATR + IohexolPercentage Change From Baseline in Urine Protein to Creatinine Ratio (mg/g) at Week 24-10.5 percentage change
ABC/3TC + ATV/r + IohexolPercentage Change From Baseline in Urine Protein to Creatinine Ratio (mg/g) at Week 247.1 percentage change
Secondary

Percentage Change From Baseline in Urine Retinol Binding Protein (RBP) to Creatinine Ratio (µg/g) at Week 24

Time frame: Baseline; Week 24

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

ArmMeasureValue (MEDIAN)
STB + IohexolPercentage Change From Baseline in Urine Retinol Binding Protein (RBP) to Creatinine Ratio (µg/g) at Week 2438.1 percentage change
TVD + ATV/r + IohexolPercentage Change From Baseline in Urine Retinol Binding Protein (RBP) to Creatinine Ratio (µg/g) at Week 2452.2 percentage change
ATR + IohexolPercentage Change From Baseline in Urine Retinol Binding Protein (RBP) to Creatinine Ratio (µg/g) at Week 2452.1 percentage change
ABC/3TC + ATV/r + IohexolPercentage Change From Baseline in Urine Retinol Binding Protein (RBP) to Creatinine Ratio (µg/g) at Week 244.8 percentage change
Secondary

Percentage Change From Baseline in Urine β2-microglobulin to Creatinine Ratio (µg/g) at Week 24

Time frame: Baseline; Week 24

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

ArmMeasureValue (MEDIAN)
STB + IohexolPercentage Change From Baseline in Urine β2-microglobulin to Creatinine Ratio (µg/g) at Week 24-5.1 percentage change
TVD + ATV/r + IohexolPercentage Change From Baseline in Urine β2-microglobulin to Creatinine Ratio (µg/g) at Week 24197.3 percentage change
ATR + IohexolPercentage Change From Baseline in Urine β2-microglobulin to Creatinine Ratio (µg/g) at Week 24-1.1 percentage change
ABC/3TC + ATV/r + IohexolPercentage Change From Baseline in Urine β2-microglobulin to Creatinine Ratio (µg/g) at Week 24-22.7 percentage change
Secondary

Percentage of Participants Experiencing Adverse Events (AEs)

Incidences of adverse events and laboratory abnormalities will be summarized.

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

Population: Safety Analysis Set

ArmMeasureGroupValue (NUMBER)
STB + IohexolPercentage of Participants Experiencing Adverse Events (AEs)Any Treatment-Emergent Adverse Events (TEAE)70.6 Percentage of participants
STB + IohexolPercentage of Participants Experiencing Adverse Events (AEs)Any Grade 3 or 4 Treatment-Emergent Adverse Event5.9 Percentage of participants
STB + IohexolPercentage of Participants Experiencing Adverse Events (AEs)Any Treatment-Emergent Study-Drug-Related AEs11.8 Percentage of participants
STB + IohexolPercentage of Participants Experiencing Adverse Events (AEs)Any TEAE Leading to Study Drug Discontinuation5.9 Percentage of participants
TVD + ATV/r + IohexolPercentage of Participants Experiencing Adverse Events (AEs)Any Grade 3 or 4 Treatment-Emergent Adverse Event12.5 Percentage of participants
TVD + ATV/r + IohexolPercentage of Participants Experiencing Adverse Events (AEs)Any Treatment-Emergent Study-Drug-Related AEs50.0 Percentage of participants
TVD + ATV/r + IohexolPercentage of Participants Experiencing Adverse Events (AEs)Any TEAE Leading to Study Drug Discontinuation6.3 Percentage of participants
TVD + ATV/r + IohexolPercentage of Participants Experiencing Adverse Events (AEs)Any Treatment-Emergent Adverse Events (TEAE)87.5 Percentage of participants
ATR + IohexolPercentage of Participants Experiencing Adverse Events (AEs)Any Treatment-Emergent Study-Drug-Related AEs68.8 Percentage of participants
ATR + IohexolPercentage of Participants Experiencing Adverse Events (AEs)Any Grade 3 or 4 Treatment-Emergent Adverse Event12.5 Percentage of participants
ATR + IohexolPercentage of Participants Experiencing Adverse Events (AEs)Any TEAE Leading to Study Drug Discontinuation6.3 Percentage of participants
ATR + IohexolPercentage of Participants Experiencing Adverse Events (AEs)Any Treatment-Emergent Adverse Events (TEAE)87.5 Percentage of participants
ABC/3TC + ATV/r + IohexolPercentage of Participants Experiencing Adverse Events (AEs)Any TEAE Leading to Study Drug Discontinuation0 Percentage of participants
ABC/3TC + ATV/r + IohexolPercentage of Participants Experiencing Adverse Events (AEs)Any Grade 3 or 4 Treatment-Emergent Adverse Event5.9 Percentage of participants
ABC/3TC + ATV/r + IohexolPercentage of Participants Experiencing Adverse Events (AEs)Any Treatment-Emergent Adverse Events (TEAE)88.2 Percentage of participants
ABC/3TC + ATV/r + IohexolPercentage of Participants Experiencing Adverse Events (AEs)Any Treatment-Emergent Study-Drug-Related AEs23.5 Percentage of participants
Secondary

Percentage of Participants Experiencing Treatment-Emergent Graded Laboratory Abnormality: Serum Glucose (Fasting)

Time frame: Up to 24 weeks plus 30 days

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

ArmMeasureGroupValue (NUMBER)
STB + IohexolPercentage of Participants Experiencing Treatment-Emergent Graded Laboratory Abnormality: Serum Glucose (Fasting)Grade 1 (Hyperglycemia)11.8 percentage of participants
STB + IohexolPercentage of Participants Experiencing Treatment-Emergent Graded Laboratory Abnormality: Serum Glucose (Fasting)Grade 1 (Hypoglycemia)0 percentage of participants
STB + IohexolPercentage of Participants Experiencing Treatment-Emergent Graded Laboratory Abnormality: Serum Glucose (Fasting)Grade 2 (Hyperglycemia)0 percentage of participants
STB + IohexolPercentage of Participants Experiencing Treatment-Emergent Graded Laboratory Abnormality: Serum Glucose (Fasting)Grade 2 (Hypoglycemia)0 percentage of participants
STB + IohexolPercentage of Participants Experiencing Treatment-Emergent Graded Laboratory Abnormality: Serum Glucose (Fasting)Grade 3 (Hyperglycemia)0 percentage of participants
STB + IohexolPercentage of Participants Experiencing Treatment-Emergent Graded Laboratory Abnormality: Serum Glucose (Fasting)Grade 3 (Hypoglycemia)0 percentage of participants
STB + IohexolPercentage of Participants Experiencing Treatment-Emergent Graded Laboratory Abnormality: Serum Glucose (Fasting)Grade 4 (Hyperglycemia)0 percentage of participants
STB + IohexolPercentage of Participants Experiencing Treatment-Emergent Graded Laboratory Abnormality: Serum Glucose (Fasting)Grade 4 (Hypoglycemia)0 percentage of participants
STB + IohexolPercentage of Participants Experiencing Treatment-Emergent Graded Laboratory Abnormality: Serum Glucose (Fasting)Any grade (Hyperglycemia)11.8 percentage of participants
STB + IohexolPercentage of Participants Experiencing Treatment-Emergent Graded Laboratory Abnormality: Serum Glucose (Fasting)Any grade (Hypoglycemia)0 percentage of participants
TVD + ATV/r + IohexolPercentage of Participants Experiencing Treatment-Emergent Graded Laboratory Abnormality: Serum Glucose (Fasting)Grade 2 (Hyperglycemia)0 percentage of participants
TVD + ATV/r + IohexolPercentage of Participants Experiencing Treatment-Emergent Graded Laboratory Abnormality: Serum Glucose (Fasting)Any grade (Hyperglycemia)12.5 percentage of participants
TVD + ATV/r + IohexolPercentage of Participants Experiencing Treatment-Emergent Graded Laboratory Abnormality: Serum Glucose (Fasting)Grade 2 (Hypoglycemia)6.3 percentage of participants
TVD + ATV/r + IohexolPercentage of Participants Experiencing Treatment-Emergent Graded Laboratory Abnormality: Serum Glucose (Fasting)Grade 3 (Hyperglycemia)0 percentage of participants
TVD + ATV/r + IohexolPercentage of Participants Experiencing Treatment-Emergent Graded Laboratory Abnormality: Serum Glucose (Fasting)Grade 3 (Hypoglycemia)0 percentage of participants
TVD + ATV/r + IohexolPercentage of Participants Experiencing Treatment-Emergent Graded Laboratory Abnormality: Serum Glucose (Fasting)Grade 4 (Hyperglycemia)0 percentage of participants
TVD + ATV/r + IohexolPercentage of Participants Experiencing Treatment-Emergent Graded Laboratory Abnormality: Serum Glucose (Fasting)Any grade (Hypoglycemia)6.3 percentage of participants
TVD + ATV/r + IohexolPercentage of Participants Experiencing Treatment-Emergent Graded Laboratory Abnormality: Serum Glucose (Fasting)Grade 4 (Hypoglycemia)0 percentage of participants
TVD + ATV/r + IohexolPercentage of Participants Experiencing Treatment-Emergent Graded Laboratory Abnormality: Serum Glucose (Fasting)Grade 1 (Hyperglycemia)12.5 percentage of participants
TVD + ATV/r + IohexolPercentage of Participants Experiencing Treatment-Emergent Graded Laboratory Abnormality: Serum Glucose (Fasting)Grade 1 (Hypoglycemia)0 percentage of participants
ATR + IohexolPercentage of Participants Experiencing Treatment-Emergent Graded Laboratory Abnormality: Serum Glucose (Fasting)Grade 4 (Hypoglycemia)0 percentage of participants
ATR + IohexolPercentage of Participants Experiencing Treatment-Emergent Graded Laboratory Abnormality: Serum Glucose (Fasting)Grade 4 (Hyperglycemia)0 percentage of participants
ATR + IohexolPercentage of Participants Experiencing Treatment-Emergent Graded Laboratory Abnormality: Serum Glucose (Fasting)Any grade (Hypoglycemia)0 percentage of participants
ATR + IohexolPercentage of Participants Experiencing Treatment-Emergent Graded Laboratory Abnormality: Serum Glucose (Fasting)Grade 1 (Hyperglycemia)20.0 percentage of participants
ATR + IohexolPercentage of Participants Experiencing Treatment-Emergent Graded Laboratory Abnormality: Serum Glucose (Fasting)Grade 2 (Hypoglycemia)0 percentage of participants
ATR + IohexolPercentage of Participants Experiencing Treatment-Emergent Graded Laboratory Abnormality: Serum Glucose (Fasting)Grade 3 (Hypoglycemia)0 percentage of participants
ATR + IohexolPercentage of Participants Experiencing Treatment-Emergent Graded Laboratory Abnormality: Serum Glucose (Fasting)Any grade (Hyperglycemia)20.0 percentage of participants
ATR + IohexolPercentage of Participants Experiencing Treatment-Emergent Graded Laboratory Abnormality: Serum Glucose (Fasting)Grade 1 (Hypoglycemia)0 percentage of participants
ATR + IohexolPercentage of Participants Experiencing Treatment-Emergent Graded Laboratory Abnormality: Serum Glucose (Fasting)Grade 3 (Hyperglycemia)0 percentage of participants
ATR + IohexolPercentage of Participants Experiencing Treatment-Emergent Graded Laboratory Abnormality: Serum Glucose (Fasting)Grade 2 (Hyperglycemia)0 percentage of participants
ABC/3TC + ATV/r + IohexolPercentage of Participants Experiencing Treatment-Emergent Graded Laboratory Abnormality: Serum Glucose (Fasting)Grade 3 (Hyperglycemia)0 percentage of participants
ABC/3TC + ATV/r + IohexolPercentage of Participants Experiencing Treatment-Emergent Graded Laboratory Abnormality: Serum Glucose (Fasting)Grade 4 (Hypoglycemia)0 percentage of participants
ABC/3TC + ATV/r + IohexolPercentage of Participants Experiencing Treatment-Emergent Graded Laboratory Abnormality: Serum Glucose (Fasting)Grade 3 (Hypoglycemia)0 percentage of participants
ABC/3TC + ATV/r + IohexolPercentage of Participants Experiencing Treatment-Emergent Graded Laboratory Abnormality: Serum Glucose (Fasting)Any grade (Hypoglycemia)0 percentage of participants
ABC/3TC + ATV/r + IohexolPercentage of Participants Experiencing Treatment-Emergent Graded Laboratory Abnormality: Serum Glucose (Fasting)Grade 4 (Hyperglycemia)0 percentage of participants
ABC/3TC + ATV/r + IohexolPercentage of Participants Experiencing Treatment-Emergent Graded Laboratory Abnormality: Serum Glucose (Fasting)Grade 1 (Hypoglycemia)0 percentage of participants
ABC/3TC + ATV/r + IohexolPercentage of Participants Experiencing Treatment-Emergent Graded Laboratory Abnormality: Serum Glucose (Fasting)Grade 2 (Hyperglycemia)0 percentage of participants
ABC/3TC + ATV/r + IohexolPercentage of Participants Experiencing Treatment-Emergent Graded Laboratory Abnormality: Serum Glucose (Fasting)Grade 2 (Hypoglycemia)0 percentage of participants
ABC/3TC + ATV/r + IohexolPercentage of Participants Experiencing Treatment-Emergent Graded Laboratory Abnormality: Serum Glucose (Fasting)Grade 1 (Hyperglycemia)0 percentage of participants
ABC/3TC + ATV/r + IohexolPercentage of Participants Experiencing Treatment-Emergent Graded Laboratory Abnormality: Serum Glucose (Fasting)Any grade (Hyperglycemia)0 percentage of participants
Secondary

Percentage of Participants Experiencing Treatment-Emergent Graded Laboratory Abnormality: Urine Glucose (by Dipstick)

Time frame: Up to 24 weeks plus 30 days

Population: Safety Analysis Set

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
STB + IohexolPercentage of Participants Experiencing Treatment-Emergent Graded Laboratory Abnormality: Urine Glucose (by Dipstick)Grade 40 Participants
STB + IohexolPercentage of Participants Experiencing Treatment-Emergent Graded Laboratory Abnormality: Urine Glucose (by Dipstick)Grade 20 Participants
STB + IohexolPercentage of Participants Experiencing Treatment-Emergent Graded Laboratory Abnormality: Urine Glucose (by Dipstick)Any Grade0 Participants
STB + IohexolPercentage of Participants Experiencing Treatment-Emergent Graded Laboratory Abnormality: Urine Glucose (by Dipstick)Grade 30 Participants
STB + IohexolPercentage of Participants Experiencing Treatment-Emergent Graded Laboratory Abnormality: Urine Glucose (by Dipstick)Grade 10 Participants
TVD + ATV/r + IohexolPercentage of Participants Experiencing Treatment-Emergent Graded Laboratory Abnormality: Urine Glucose (by Dipstick)Grade 30 Participants
TVD + ATV/r + IohexolPercentage of Participants Experiencing Treatment-Emergent Graded Laboratory Abnormality: Urine Glucose (by Dipstick)Grade 40 Participants
TVD + ATV/r + IohexolPercentage of Participants Experiencing Treatment-Emergent Graded Laboratory Abnormality: Urine Glucose (by Dipstick)Any Grade0 Participants
TVD + ATV/r + IohexolPercentage of Participants Experiencing Treatment-Emergent Graded Laboratory Abnormality: Urine Glucose (by Dipstick)Grade 20 Participants
TVD + ATV/r + IohexolPercentage of Participants Experiencing Treatment-Emergent Graded Laboratory Abnormality: Urine Glucose (by Dipstick)Grade 10 Participants
ATR + IohexolPercentage of Participants Experiencing Treatment-Emergent Graded Laboratory Abnormality: Urine Glucose (by Dipstick)Grade 30 Participants
ATR + IohexolPercentage of Participants Experiencing Treatment-Emergent Graded Laboratory Abnormality: Urine Glucose (by Dipstick)Grade 10 Participants
ATR + IohexolPercentage of Participants Experiencing Treatment-Emergent Graded Laboratory Abnormality: Urine Glucose (by Dipstick)Grade 20 Participants
ATR + IohexolPercentage of Participants Experiencing Treatment-Emergent Graded Laboratory Abnormality: Urine Glucose (by Dipstick)Grade 40 Participants
ATR + IohexolPercentage of Participants Experiencing Treatment-Emergent Graded Laboratory Abnormality: Urine Glucose (by Dipstick)Any Grade0 Participants
ABC/3TC + ATV/r + IohexolPercentage of Participants Experiencing Treatment-Emergent Graded Laboratory Abnormality: Urine Glucose (by Dipstick)Grade 40 Participants
ABC/3TC + ATV/r + IohexolPercentage of Participants Experiencing Treatment-Emergent Graded Laboratory Abnormality: Urine Glucose (by Dipstick)Grade 20 Participants
ABC/3TC + ATV/r + IohexolPercentage of Participants Experiencing Treatment-Emergent Graded Laboratory Abnormality: Urine Glucose (by Dipstick)Grade 10 Participants
ABC/3TC + ATV/r + IohexolPercentage of Participants Experiencing Treatment-Emergent Graded Laboratory Abnormality: Urine Glucose (by Dipstick)Grade 30 Participants
ABC/3TC + ATV/r + IohexolPercentage of Participants Experiencing Treatment-Emergent Graded Laboratory Abnormality: Urine Glucose (by Dipstick)Any Grade0 Participants
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.

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

Population: Safety Analysis Set

ArmMeasureGroupValue (NUMBER)
STB + IohexolPercentage of Participants Experiencing Treatment Emergent (TE) Grade 3 or 4 Laboratory AbnormalitiesAny Grade 3 or 4 TE Laboratory Abnormality5.9 Percentage of participants
STB + IohexolPercentage of Participants Experiencing Treatment Emergent (TE) Grade 3 or 4 Laboratory AbnormalitiesGrade 3 or 4 Total Bilirubin0 Percentage of participants
STB + IohexolPercentage of Participants Experiencing Treatment Emergent (TE) Grade 3 or 4 Laboratory AbnormalitiesGrade 3 or 4 CK5.9 Percentage of participants
STB + IohexolPercentage of Participants Experiencing Treatment Emergent (TE) Grade 3 or 4 Laboratory AbnormalitiesGrade 3 or 4 Neutrophils0 Percentage of participants
STB + IohexolPercentage of Participants Experiencing Treatment Emergent (TE) Grade 3 or 4 Laboratory AbnormalitiesGrade 3 or 4 Urine RBC0 Percentage of participants
STB + IohexolPercentage of Participants Experiencing Treatment Emergent (TE) Grade 3 or 4 Laboratory AbnormalitiesGrade 3 or 4 Amylase0 Percentage of participants
STB + IohexolPercentage of Participants Experiencing Treatment Emergent (TE) Grade 3 or 4 Laboratory AbnormalitiesGrade 3 or 4 AST0 Percentage of participants
TVD + ATV/r + IohexolPercentage of Participants Experiencing Treatment Emergent (TE) Grade 3 or 4 Laboratory AbnormalitiesGrade 3 or 4 Total Bilirubin12.5 Percentage of participants
TVD + ATV/r + IohexolPercentage of Participants Experiencing Treatment Emergent (TE) Grade 3 or 4 Laboratory AbnormalitiesGrade 3 or 4 AST6.3 Percentage of participants
TVD + ATV/r + IohexolPercentage of Participants Experiencing Treatment Emergent (TE) Grade 3 or 4 Laboratory AbnormalitiesGrade 3 or 4 Amylase0 Percentage of participants
TVD + ATV/r + IohexolPercentage of Participants Experiencing Treatment Emergent (TE) Grade 3 or 4 Laboratory AbnormalitiesGrade 3 or 4 CK18.8 Percentage of participants
TVD + ATV/r + IohexolPercentage of Participants Experiencing Treatment Emergent (TE) Grade 3 or 4 Laboratory AbnormalitiesGrade 3 or 4 Urine RBC7.7 Percentage of participants
TVD + ATV/r + IohexolPercentage of Participants Experiencing Treatment Emergent (TE) Grade 3 or 4 Laboratory AbnormalitiesGrade 3 or 4 Neutrophils6.3 Percentage of participants
TVD + ATV/r + IohexolPercentage of Participants Experiencing Treatment Emergent (TE) Grade 3 or 4 Laboratory AbnormalitiesAny Grade 3 or 4 TE Laboratory Abnormality25.0 Percentage of participants
ATR + IohexolPercentage of Participants Experiencing Treatment Emergent (TE) Grade 3 or 4 Laboratory AbnormalitiesGrade 3 or 4 AST0 Percentage of participants
ATR + IohexolPercentage of Participants Experiencing Treatment Emergent (TE) Grade 3 or 4 Laboratory AbnormalitiesAny Grade 3 or 4 TE Laboratory Abnormality12.5 Percentage of participants
ATR + IohexolPercentage of Participants Experiencing Treatment Emergent (TE) Grade 3 or 4 Laboratory AbnormalitiesGrade 3 or 4 Neutrophils0 Percentage of participants
ATR + IohexolPercentage of Participants Experiencing Treatment Emergent (TE) Grade 3 or 4 Laboratory AbnormalitiesGrade 3 or 4 Amylase6.3 Percentage of participants
ATR + IohexolPercentage of Participants Experiencing Treatment Emergent (TE) Grade 3 or 4 Laboratory AbnormalitiesGrade 3 or 4 CK6.3 Percentage of participants
ATR + IohexolPercentage of Participants Experiencing Treatment Emergent (TE) Grade 3 or 4 Laboratory AbnormalitiesGrade 3 or 4 Total Bilirubin0 Percentage of participants
ATR + IohexolPercentage of Participants Experiencing Treatment Emergent (TE) Grade 3 or 4 Laboratory AbnormalitiesGrade 3 or 4 Urine RBC0 Percentage of participants
ABC/3TC + ATV/r + IohexolPercentage of Participants Experiencing Treatment Emergent (TE) Grade 3 or 4 Laboratory AbnormalitiesGrade 3 or 4 Amylase0 Percentage of participants
ABC/3TC + ATV/r + IohexolPercentage of Participants Experiencing Treatment Emergent (TE) Grade 3 or 4 Laboratory AbnormalitiesGrade 3 or 4 Urine RBC0 Percentage of participants
ABC/3TC + ATV/r + IohexolPercentage of Participants Experiencing Treatment Emergent (TE) Grade 3 or 4 Laboratory AbnormalitiesGrade 3 or 4 Total Bilirubin52.9 Percentage of participants
ABC/3TC + ATV/r + IohexolPercentage of Participants Experiencing Treatment Emergent (TE) Grade 3 or 4 Laboratory AbnormalitiesGrade 3 or 4 Neutrophils0 Percentage of participants
ABC/3TC + ATV/r + IohexolPercentage of Participants Experiencing Treatment Emergent (TE) Grade 3 or 4 Laboratory AbnormalitiesAny Grade 3 or 4 TE Laboratory Abnormality52.9 Percentage of participants
ABC/3TC + ATV/r + IohexolPercentage of Participants Experiencing Treatment Emergent (TE) Grade 3 or 4 Laboratory AbnormalitiesGrade 3 or 4 CK5.9 Percentage of participants
ABC/3TC + ATV/r + IohexolPercentage of Participants Experiencing Treatment Emergent (TE) Grade 3 or 4 Laboratory AbnormalitiesGrade 3 or 4 AST0 Percentage of participants
Secondary

Percentage of Participants With HIV-1 RNA < 50 Copies/mL Week 24 as Determined by Snapshot Algorithm

Time frame: 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.

ArmMeasureValue (NUMBER)
STB + IohexolPercentage of Participants With HIV-1 RNA < 50 Copies/mL Week 24 as Determined by Snapshot Algorithm88.2 percentage of participants
TVD + ATV/r + IohexolPercentage of Participants With HIV-1 RNA < 50 Copies/mL Week 24 as Determined by Snapshot Algorithm81.3 percentage of participants
ATR + IohexolPercentage of Participants With HIV-1 RNA < 50 Copies/mL Week 24 as Determined by Snapshot Algorithm81.3 percentage of participants
ABC/3TC + ATV/r + IohexolPercentage of Participants With HIV-1 RNA < 50 Copies/mL Week 24 as Determined by Snapshot Algorithm88.2 percentage of participants
Secondary

Pharmacokinetic (PK) Parameter: Cmax for COBI

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

Time frame: 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.

ArmMeasureGroupValue (MEAN)Dispersion
STB + IohexolPharmacokinetic (PK) Parameter: Cmax for COBIWeek 41189.1 ng/mLStandard Deviation 377.88
STB + IohexolPharmacokinetic (PK) Parameter: Cmax for COBIWeek 81017.8 ng/mLStandard Deviation 388.09
STB + IohexolPharmacokinetic (PK) Parameter: Cmax for COBIWeek 161197.3 ng/mLStandard Deviation 656.33
STB + IohexolPharmacokinetic (PK) Parameter: Cmax for COBIWeek 241123.4 ng/mLStandard Deviation 430.41
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).

Time frame: 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.

ArmMeasureGroupValue (MEAN)Dispersion
STB + IohexolPK Parameter: AUCinf for IohexolWeek 4521.8 h*µg/mLStandard Deviation 121.67
STB + IohexolPK Parameter: AUCinf for IohexolDay 1511.2 h*µg/mLStandard Deviation 172.71
STB + IohexolPK Parameter: AUCinf for IohexolWeek 24545.8 h*µg/mLStandard Deviation 127.34
STB + IohexolPK Parameter: AUCinf for IohexolWeek 16494.3 h*µg/mLStandard Deviation 113.6
STB + IohexolPK Parameter: AUCinf for IohexolWeek 8517.8 h*µg/mLStandard Deviation 170.24
TVD + ATV/r + IohexolPK Parameter: AUCinf for IohexolDay 1486.8 h*µg/mLStandard Deviation 108.28
TVD + ATV/r + IohexolPK Parameter: AUCinf for IohexolWeek 4496.2 h*µg/mLStandard Deviation 153.05
TVD + ATV/r + IohexolPK Parameter: AUCinf for IohexolWeek 16509.5 h*µg/mLStandard Deviation 156.98
TVD + ATV/r + IohexolPK Parameter: AUCinf for IohexolWeek 24561.2 h*µg/mLStandard Deviation 214.26
TVD + ATV/r + IohexolPK Parameter: AUCinf for IohexolWeek 8574.8 h*µg/mLStandard Deviation 382.63
ATR + IohexolPK Parameter: AUCinf for IohexolWeek 4512.6 h*µg/mLStandard Deviation 163.89
ATR + IohexolPK Parameter: AUCinf for IohexolWeek 16504.8 h*µg/mLStandard Deviation 95.07
ATR + IohexolPK Parameter: AUCinf for IohexolWeek 8510.6 h*µg/mLStandard Deviation 136.4
ATR + IohexolPK Parameter: AUCinf for IohexolDay 1706.9 h*µg/mLStandard Deviation 647.25
ATR + IohexolPK Parameter: AUCinf for IohexolWeek 24507.1 h*µg/mLStandard Deviation 113.45
ABC/3TC + ATV/r + IohexolPK Parameter: AUCinf for IohexolWeek 4720.5 h*µg/mLStandard Deviation 657.95
ABC/3TC + ATV/r + IohexolPK Parameter: AUCinf for IohexolWeek 24606.5 h*µg/mLStandard Deviation 321.4
ABC/3TC + ATV/r + IohexolPK Parameter: AUCinf for IohexolDay 1695.2 h*µg/mLStandard Deviation 523.33
ABC/3TC + ATV/r + IohexolPK Parameter: AUCinf for IohexolWeek 16725.9 h*µg/mLStandard Deviation 843.22
ABC/3TC + ATV/r + IohexolPK Parameter: AUCinf for IohexolWeek 8667.0 h*µg/mLStandard Deviation 559.06
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).

Time frame: 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.

ArmMeasureGroupValue (MEAN)Dispersion
STB + IohexolPK Parameter: AUCtau for COBIWeek 49225.8 h*ng/mLStandard Deviation 2786.6
STB + IohexolPK Parameter: AUCtau for COBIWeek 88127.4 h*ng/mLStandard Deviation 3217.12
STB + IohexolPK Parameter: AUCtau for COBIWeek 1610684.8 h*ng/mLStandard Deviation 12567.09
STB + IohexolPK Parameter: AUCtau for COBIWeek 248391.3 h*ng/mLStandard Deviation 6132.5
Secondary

PK Parameter: AUCtau for RTV

Time frame: 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.

ArmMeasureGroupValue (MEAN)Dispersion
STB + IohexolPK Parameter: AUCtau for RTVWeek 48259.6 h*ng/mLStandard Deviation 3166.47
STB + IohexolPK Parameter: AUCtau for RTVWeek 88362.0 h*ng/mLStandard Deviation 3544.53
STB + IohexolPK Parameter: AUCtau for RTVWeek 168102.6 h*ng/mLStandard Deviation 3392
STB + IohexolPK Parameter: AUCtau for RTVWeek 248907.0 h*ng/mLStandard Deviation 5182.65
TVD + ATV/r + IohexolPK Parameter: AUCtau for RTVWeek 2412039.3 h*ng/mLStandard Deviation 6792.06
TVD + ATV/r + IohexolPK Parameter: AUCtau for RTVWeek 49649.1 h*ng/mLStandard Deviation 3713.87
TVD + ATV/r + IohexolPK Parameter: AUCtau for RTVWeek 1611148.0 h*ng/mLStandard Deviation 4482.33
TVD + ATV/r + IohexolPK Parameter: AUCtau for RTVWeek 89702.2 h*ng/mLStandard Deviation 3391.68
Secondary

PK Parameter: AUCtau for TFV

Time frame: 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.

ArmMeasureGroupValue (MEAN)Dispersion
STB + IohexolPK Parameter: AUCtau for TFVWeek 43370.2 h*ng/mLStandard Deviation 1000.75
STB + IohexolPK Parameter: AUCtau for TFVWeek 83549.7 h*ng/mLStandard Deviation 1238.03
STB + IohexolPK Parameter: AUCtau for TFVWeek 163939.7 h*ng/mLStandard Deviation 2499.63
STB + IohexolPK Parameter: AUCtau for TFVWeek 243307.0 h*ng/mLStandard Deviation 1387.97
TVD + ATV/r + IohexolPK Parameter: AUCtau for TFVWeek 243451.5 h*ng/mLStandard Deviation 1075.47
TVD + ATV/r + IohexolPK Parameter: AUCtau for TFVWeek 43151.2 h*ng/mLStandard Deviation 1107.18
TVD + ATV/r + IohexolPK Parameter: AUCtau for TFVWeek 163234.7 h*ng/mLStandard Deviation 1207.58
TVD + ATV/r + IohexolPK Parameter: AUCtau for TFVWeek 83361.9 h*ng/mLStandard Deviation 1152.04
ATR + IohexolPK Parameter: AUCtau for TFVWeek 242265.7 h*ng/mLStandard Deviation 412.87
ATR + IohexolPK Parameter: AUCtau for TFVWeek 82250.8 h*ng/mLStandard Deviation 555.79
ATR + IohexolPK Parameter: AUCtau for TFVWeek 162326.4 h*ng/mLStandard Deviation 494.24
ATR + IohexolPK Parameter: AUCtau for TFVWeek 42244.8 h*ng/mLStandard Deviation 572.09
Secondary

PK Parameter: Clast for COBI

Clast is defined as the last observable concentration of drug.

Time frame: 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.

ArmMeasureGroupValue (MEAN)Dispersion
STB + IohexolPK Parameter: Clast for COBIWeek 485.0 ng/mLStandard Deviation 126.69
STB + IohexolPK Parameter: Clast for COBIWeek 854.5 ng/mLStandard Deviation 59.58
STB + IohexolPK Parameter: Clast for COBIWeek 16214.0 ng/mLStandard Deviation 693.66
STB + IohexolPK Parameter: Clast for COBIWeek 24162.7 ng/mLStandard Deviation 299.48
Secondary

PK Parameter: Clast for RTV

Time frame: 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.

ArmMeasureGroupValue (MEAN)Dispersion
STB + IohexolPK Parameter: Clast for RTVWeek 459.5 ng/mLStandard Deviation 57.85
STB + IohexolPK Parameter: Clast for RTVWeek 871.0 ng/mLStandard Deviation 91.24
STB + IohexolPK Parameter: Clast for RTVWeek 1669.2 ng/mLStandard Deviation 49.85
STB + IohexolPK Parameter: Clast for RTVWeek 24102.5 ng/mLStandard Deviation 182.16
TVD + ATV/r + IohexolPK Parameter: Clast for RTVWeek 24187.9 ng/mLStandard Deviation 258.53
TVD + ATV/r + IohexolPK Parameter: Clast for RTVWeek 461.0 ng/mLStandard Deviation 56.51
TVD + ATV/r + IohexolPK Parameter: Clast for RTVWeek 1699.1 ng/mLStandard Deviation 92.42
TVD + ATV/r + IohexolPK Parameter: Clast for RTVWeek 885.5 ng/mLStandard Deviation 99.68
Secondary

PK Parameter: Clast for TFV

Time frame: 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.

ArmMeasureGroupValue (MEAN)Dispersion
STB + IohexolPK Parameter: Clast for TFVWeek 481.1 ng/mLStandard Deviation 32.41
STB + IohexolPK Parameter: Clast for TFVWeek 880.9 ng/mLStandard Deviation 35.12
STB + IohexolPK Parameter: Clast for TFVWeek 16128.5 ng/mLStandard Deviation 184.17
STB + IohexolPK Parameter: Clast for TFVWeek 2478.5 ng/mLStandard Deviation 53.04
TVD + ATV/r + IohexolPK Parameter: Clast for TFVWeek 2487.3 ng/mLStandard Deviation 41.2
TVD + ATV/r + IohexolPK Parameter: Clast for TFVWeek 473.1 ng/mLStandard Deviation 23.74
TVD + ATV/r + IohexolPK Parameter: Clast for TFVWeek 1674.5 ng/mLStandard Deviation 26.01
TVD + ATV/r + IohexolPK Parameter: Clast for TFVWeek 878.2 ng/mLStandard Deviation 31.27
ATR + IohexolPK Parameter: Clast for TFVWeek 2458.5 ng/mLStandard Deviation 16.45
ATR + IohexolPK Parameter: Clast for TFVWeek 853.4 ng/mLStandard Deviation 18.83
ATR + IohexolPK Parameter: Clast for TFVWeek 1663.0 ng/mLStandard Deviation 19.25
ATR + IohexolPK Parameter: Clast for TFVWeek 455.4 ng/mLStandard Deviation 15.52
Secondary

PK Parameter: Cmax for RTV

Time frame: 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.

ArmMeasureGroupValue (MEAN)Dispersion
STB + IohexolPK Parameter: Cmax for RTVWeek 41260.0 ng/mLStandard Deviation 453.58
STB + IohexolPK Parameter: Cmax for RTVWeek 81142.3 ng/mLStandard Deviation 489.18
STB + IohexolPK Parameter: Cmax for RTVWeek 161144.8 ng/mLStandard Deviation 416.41
STB + IohexolPK Parameter: Cmax for RTVWeek 241217.7 ng/mLStandard Deviation 445.18
TVD + ATV/r + IohexolPK Parameter: Cmax for RTVWeek 241485.4 ng/mLStandard Deviation 662.49
TVD + ATV/r + IohexolPK Parameter: Cmax for RTVWeek 41352.1 ng/mLStandard Deviation 513.74
TVD + ATV/r + IohexolPK Parameter: Cmax for RTVWeek 161557.6 ng/mLStandard Deviation 555.87
TVD + ATV/r + IohexolPK Parameter: Cmax for RTVWeek 81326.2 ng/mLStandard Deviation 493.47
Secondary

PK Parameter: Cmax for TFV

Time frame: 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.

ArmMeasureGroupValue (MEAN)Dispersion
STB + IohexolPK Parameter: Cmax for TFVWeek 4371.2 ng/mLStandard Deviation 94.46
STB + IohexolPK Parameter: Cmax for TFVWeek 8379.8 ng/mLStandard Deviation 87.44
STB + IohexolPK Parameter: Cmax for TFVWeek 16399.5 ng/mLStandard Deviation 169.51
STB + IohexolPK Parameter: Cmax for TFVWeek 24394.4 ng/mLStandard Deviation 131.09
TVD + ATV/r + IohexolPK Parameter: Cmax for TFVWeek 24350.7 ng/mLStandard Deviation 126.91
TVD + ATV/r + IohexolPK Parameter: Cmax for TFVWeek 4301.6 ng/mLStandard Deviation 116.36
TVD + ATV/r + IohexolPK Parameter: Cmax for TFVWeek 16319.4 ng/mLStandard Deviation 146.41
TVD + ATV/r + IohexolPK Parameter: Cmax for TFVWeek 8343.0 ng/mLStandard Deviation 133.97
ATR + IohexolPK Parameter: Cmax for TFVWeek 24305.9 ng/mLStandard Deviation 106.24
ATR + IohexolPK Parameter: Cmax for TFVWeek 8325.5 ng/mLStandard Deviation 149.48
ATR + IohexolPK Parameter: Cmax for TFVWeek 16298.6 ng/mLStandard Deviation 107.11
ATR + IohexolPK Parameter: Cmax for TFVWeek 4298.3 ng/mLStandard Deviation 100.36
Secondary

PK Parameter: Ctau for COBI

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

Time frame: 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.

ArmMeasureGroupValue (MEAN)Dispersion
STB + IohexolPK Parameter: Ctau for COBIWeek 459.7 ng/mLStandard Deviation 113.31
STB + IohexolPK Parameter: Ctau for COBIWeek 826.0 ng/mLStandard Deviation 28.79
STB + IohexolPK Parameter: Ctau for COBIWeek 16198.3 ng/mLStandard Deviation 697.06
STB + IohexolPK Parameter: Ctau for COBIWeek 2482.7 ng/mLStandard Deviation 285.81
Secondary

PK Parameter: Ctau for RTV

Time frame: 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.

ArmMeasureGroupValue (MEAN)Dispersion
STB + IohexolPK Parameter: Ctau for RTVWeek 459.5 ng/mLStandard Deviation 57.85
STB + IohexolPK Parameter: Ctau for RTVWeek 871.0 ng/mLStandard Deviation 91.24
STB + IohexolPK Parameter: Ctau for RTVWeek 1669.2 ng/mLStandard Deviation 49.85
STB + IohexolPK Parameter: Ctau for RTVWeek 24102.5 ng/mLStandard Deviation 182.16
TVD + ATV/r + IohexolPK Parameter: Ctau for RTVWeek 24157.0 ng/mLStandard Deviation 246.75
TVD + ATV/r + IohexolPK Parameter: Ctau for RTVWeek 461.0 ng/mLStandard Deviation 56.51
TVD + ATV/r + IohexolPK Parameter: Ctau for RTVWeek 1699.1 ng/mLStandard Deviation 92.42
TVD + ATV/r + IohexolPK Parameter: Ctau for RTVWeek 885.5 ng/mLStandard Deviation 99.68
Secondary

PK Parameter: Ctau for TFV

Time frame: 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.

ArmMeasureGroupValue (MEAN)Dispersion
STB + IohexolPK Parameter: Ctau for TFVWeek 875.8 ng/mLStandard Deviation 40.16
STB + IohexolPK Parameter: Ctau for TFVWeek 474.6 ng/mLStandard Deviation 36.88
STB + IohexolPK Parameter: Ctau for TFVWeek 16128.5 ng/mLStandard Deviation 184.17
STB + IohexolPK Parameter: Ctau for TFVWeek 2471.7 ng/mLStandard Deviation 57.06
TVD + ATV/r + IohexolPK Parameter: Ctau for TFVWeek 2477.3 ng/mLStandard Deviation 43.06
TVD + ATV/r + IohexolPK Parameter: Ctau for TFVWeek 1674.5 ng/mLStandard Deviation 26.01
TVD + ATV/r + IohexolPK Parameter: Ctau for TFVWeek 473.1 ng/mLStandard Deviation 23.74
TVD + ATV/r + IohexolPK Parameter: Ctau for TFVWeek 878.2 ng/mLStandard Deviation 31.27
ATR + IohexolPK Parameter: Ctau for TFVWeek 455.4 ng/mLStandard Deviation 15.52
ATR + IohexolPK Parameter: Ctau for TFVWeek 848.8 ng/mLStandard Deviation 23.27
ATR + IohexolPK Parameter: Ctau for TFVWeek 1657.5 ng/mLStandard Deviation 24.41
ATR + IohexolPK Parameter: Ctau for TFVWeek 2454.2 ng/mLStandard Deviation 22.17
Secondary

PK Parameter: t1/2 for COBI

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

Time frame: 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.

ArmMeasureGroupValue (MEDIAN)
STB + IohexolPK Parameter: t1/2 for COBIWeek 43.80 hours
STB + IohexolPK Parameter: t1/2 for COBIWeek 84.09 hours
STB + IohexolPK Parameter: t1/2 for COBIWeek 163.42 hours
STB + IohexolPK Parameter: t1/2 for COBIWeek 243.24 hours
Secondary

PK Parameter: t1/2 for RTV

Time frame: 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.

ArmMeasureGroupValue (MEDIAN)
STB + IohexolPK Parameter: t1/2 for RTVWeek 44.56 hours
STB + IohexolPK Parameter: t1/2 for RTVWeek 84.85 hours
STB + IohexolPK Parameter: t1/2 for RTVWeek 165.39 hours
STB + IohexolPK Parameter: t1/2 for RTVWeek 245.08 hours
TVD + ATV/r + IohexolPK Parameter: t1/2 for RTVWeek 244.82 hours
TVD + ATV/r + IohexolPK Parameter: t1/2 for RTVWeek 44.53 hours
TVD + ATV/r + IohexolPK Parameter: t1/2 for RTVWeek 165.57 hours
TVD + ATV/r + IohexolPK Parameter: t1/2 for RTVWeek 84.68 hours
Secondary

PK Parameter: t1/2 for TFV

Time frame: 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.

ArmMeasureGroupValue (MEDIAN)
STB + IohexolPK Parameter: t1/2 for TFVWeek 415.73 hours
STB + IohexolPK Parameter: t1/2 for TFVWeek 814.40 hours
STB + IohexolPK Parameter: t1/2 for TFVWeek 1614.41 hours
STB + IohexolPK Parameter: t1/2 for TFVWeek 2413.99 hours
TVD + ATV/r + IohexolPK Parameter: t1/2 for TFVWeek 2416.17 hours
TVD + ATV/r + IohexolPK Parameter: t1/2 for TFVWeek 414.10 hours
TVD + ATV/r + IohexolPK Parameter: t1/2 for TFVWeek 1614.72 hours
TVD + ATV/r + IohexolPK Parameter: t1/2 for TFVWeek 815.82 hours
ATR + IohexolPK Parameter: t1/2 for TFVWeek 2421.54 hours
ATR + IohexolPK Parameter: t1/2 for TFVWeek 818.81 hours
ATR + IohexolPK Parameter: t1/2 for TFVWeek 1622.78 hours
ATR + IohexolPK Parameter: t1/2 for TFVWeek 420.65 hours
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.

Time frame: 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.

ArmMeasureGroupValue (MEDIAN)
STB + IohexolPK Parameter: Tlast for COBIWeek 424.0 hours
STB + IohexolPK Parameter: Tlast for COBIWeek 824.0 hours
STB + IohexolPK Parameter: Tlast for COBIWeek 1624.0 hours
STB + IohexolPK Parameter: Tlast for COBIWeek 2424.0 hours
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.

Time frame: 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.

ArmMeasureGroupValue (MEDIAN)
STB + IohexolPK Parameter: Tlast for RTVWeek 424.0 hours
STB + IohexolPK Parameter: Tlast for RTVWeek 824.0 hours
STB + IohexolPK Parameter: Tlast for RTVWeek 1624.0 hours
STB + IohexolPK Parameter: Tlast for RTVWeek 2424.0 hours
TVD + ATV/r + IohexolPK Parameter: Tlast for RTVWeek 2424.0 hours
TVD + ATV/r + IohexolPK Parameter: Tlast for RTVWeek 424.0 hours
TVD + ATV/r + IohexolPK Parameter: Tlast for RTVWeek 1624.0 hours
TVD + ATV/r + IohexolPK Parameter: Tlast for RTVWeek 824.0 hours
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.

Time frame: 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.

ArmMeasureGroupValue (MEDIAN)
STB + IohexolPK Parameter: Tlast for TFVWeek 424.0 hours
STB + IohexolPK Parameter: Tlast for TFVWeek 824.0 hours
STB + IohexolPK Parameter: Tlast for TFVWeek 1624.0 hours
STB + IohexolPK Parameter: Tlast for TFVWeek 2424.0 hours
TVD + ATV/r + IohexolPK Parameter: Tlast for TFVWeek 2424.0 hours
TVD + ATV/r + IohexolPK Parameter: Tlast for TFVWeek 424.0 hours
TVD + ATV/r + IohexolPK Parameter: Tlast for TFVWeek 1624.0 hours
TVD + ATV/r + IohexolPK Parameter: Tlast for TFVWeek 824.0 hours
ATR + IohexolPK Parameter: Tlast for TFVWeek 2424.0 hours
ATR + IohexolPK Parameter: Tlast for TFVWeek 824.0 hours
ATR + IohexolPK Parameter: Tlast for TFVWeek 1624.0 hours
ATR + IohexolPK Parameter: Tlast for TFVWeek 424.0 hours
Secondary

PK Parameter: Tmax for COBI

Tmax is defined as the time of Cmax.

Time frame: 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.

ArmMeasureGroupValue (MEDIAN)
STB + IohexolPK Parameter: Tmax for COBIWeek 83.1 hours
STB + IohexolPK Parameter: Tmax for COBIWeek 43.3 hours
STB + IohexolPK Parameter: Tmax for COBIWeek 163.1 hours
STB + IohexolPK Parameter: Tmax for COBIWeek 243.0 hours
Secondary

PK Parameter: Tmax for RTV

Time frame: 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.

ArmMeasureGroupValue (MEDIAN)
STB + IohexolPK Parameter: Tmax for RTVWeek 44.0 hours
STB + IohexolPK Parameter: Tmax for RTVWeek 84.0 hours
STB + IohexolPK Parameter: Tmax for RTVWeek 164.1 hours
STB + IohexolPK Parameter: Tmax for RTVWeek 244.0 hours
TVD + ATV/r + IohexolPK Parameter: Tmax for RTVWeek 244.0 hours
TVD + ATV/r + IohexolPK Parameter: Tmax for RTVWeek 44.0 hours
TVD + ATV/r + IohexolPK Parameter: Tmax for RTVWeek 164.0 hours
TVD + ATV/r + IohexolPK Parameter: Tmax for RTVWeek 84.0 hours
Secondary

PK Parameter: Tmax for TFV

Time frame: 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.

ArmMeasureGroupValue (MEDIAN)
STB + IohexolPK Parameter: Tmax for TFVWeek 42.0 hours
STB + IohexolPK Parameter: Tmax for TFVWeek 82.0 hours
STB + IohexolPK Parameter: Tmax for TFVWeek 162.1 hours
STB + IohexolPK Parameter: Tmax for TFVWeek 242.0 hours
TVD + ATV/r + IohexolPK Parameter: Tmax for TFVWeek 242.1 hours
TVD + ATV/r + IohexolPK Parameter: Tmax for TFVWeek 43.0 hours
TVD + ATV/r + IohexolPK Parameter: Tmax for TFVWeek 162.1 hours
TVD + ATV/r + IohexolPK Parameter: Tmax for TFVWeek 83.0 hours
ATR + IohexolPK Parameter: Tmax for TFVWeek 241.1 hours
ATR + IohexolPK Parameter: Tmax for TFVWeek 81.0 hours
ATR + IohexolPK Parameter: Tmax for TFVWeek 161.2 hours
ATR + IohexolPK Parameter: Tmax for TFVWeek 41.1 hours
Secondary

PK Parameter: λz for COBI

λz is defined as the terminal elimination rate constant.

Time frame: 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.

ArmMeasureGroupValue (MEAN)Dispersion
STB + IohexolPK Parameter: λz for COBIWeek 40.179 1/hourStandard Deviation 0.0598
STB + IohexolPK Parameter: λz for COBIWeek 80.192 1/hourStandard Deviation 0.0481
STB + IohexolPK Parameter: λz for COBIWeek 160.206 1/hourStandard Deviation 0.061
STB + IohexolPK Parameter: λz for COBIWeek 240.211 1/hourStandard Deviation 0.0844
Secondary

PK Parameter: λz for RTV

Time frame: 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.

ArmMeasureGroupValue (MEAN)Dispersion
STB + IohexolPK Parameter: λz for RTVWeek 40.156 1/hourStandard Deviation 0.0386
STB + IohexolPK Parameter: λz for RTVWeek 80.144 1/hourStandard Deviation 0.0474
STB + IohexolPK Parameter: λz for RTVWeek 160.138 1/hourStandard Deviation 0.0382
STB + IohexolPK Parameter: λz for RTVWeek 240.133 1/hourStandard Deviation 0.0347
TVD + ATV/r + IohexolPK Parameter: λz for RTVWeek 240.128 1/hourStandard Deviation 0.0469
TVD + ATV/r + IohexolPK Parameter: λz for RTVWeek 40.151 1/hourStandard Deviation 0.0346
TVD + ATV/r + IohexolPK Parameter: λz for RTVWeek 160.131 1/hourStandard Deviation 0.0291
TVD + ATV/r + IohexolPK Parameter: λz for RTVWeek 80.142 1/hourStandard Deviation 0.0281
Secondary

PK Parameter: λz for TFV

Time frame: 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.

ArmMeasureGroupValue (MEAN)Dispersion
STB + IohexolPK Parameter: λz for TFVWeek 40.045 1/hourStandard Deviation 0.0148
STB + IohexolPK Parameter: λz for TFVWeek 80.051 1/hourStandard Deviation 0.0167
STB + IohexolPK Parameter: λz for TFVWeek 160.047 1/hourStandard Deviation 0.0173
STB + IohexolPK Parameter: λz for TFVWeek 240.051 1/hourStandard Deviation 0.0195
TVD + ATV/r + IohexolPK Parameter: λz for TFVWeek 240.046 1/hourStandard Deviation 0.0184
TVD + ATV/r + IohexolPK Parameter: λz for TFVWeek 40.048 1/hourStandard Deviation 0.0059
TVD + ATV/r + IohexolPK Parameter: λz for TFVWeek 160.047 1/hourStandard Deviation 0.0115
TVD + ATV/r + IohexolPK Parameter: λz for TFVWeek 80.048 1/hourStandard Deviation 0.0158
ATR + IohexolPK Parameter: λz for TFVWeek 240.035 1/hourStandard Deviation 0.0138
ATR + IohexolPK Parameter: λz for TFVWeek 80.041 1/hourStandard Deviation 0.0197
ATR + IohexolPK Parameter: λz for TFVWeek 160.033 1/hourStandard Deviation 0.0166
ATR + IohexolPK Parameter: λz for TFVWeek 40.037 1/hourStandard Deviation 0.0133

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026