Cobicistat-containing Highly Active Antiretroviral Regime... | NCT01363011

Label	Type	Description	Intervention Names
E/C/F/TDF (Cohort 1)	Experimental	Participants who have not received prior antiretroviral (ARV) treatment and who are virologically unsuppressed at baseline will initiate treatment with elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate (E/C/F/TDF) single-tablet regimen (STR) for up to 96 weeks. Following Week 96, participants continued their treatment until all participants discontinued from the study or commercial approval of E/C/F/TDF was received in the applicable country.	Drug: E/C/F/TDF
COBI+PI+2 NRTI (Cohort 2)	Experimental	Participants who have received prior ARV treatment and who are virologically suppressed at baseline will continue their treatment regimen, switching the regimen's pharmacoenhancer component from ritonavir to cobicistat (COBI), and continuing their existing protease inhibitor (PI; either atazanavir (ATV) or darunavir (DRV)) plus 2 nucleoside reverse transcriptase inhibitor (NRTI) regimen for up to 96 weeks. Following Week 96, participants continued their treatment until all participants discontinued from the study or commercial approval of cobicistat was received in the applicable country.	Drug: COBI Drug: ATV Drug: DRV Drug: NRTI

Name	Type	Description	Arm Group Labels	Other Names
E/C/F/TDF	Drug	E/C/F/TDF (150/150/200/300 mg) STR administered orally once daily	E/C/F/TDF (Cohort 1)

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) Using the Cockcroft-Gault (CG) Equation at Week 24 (Cohort 1)	Change from baseline in eGFR-CG equation at Week 24 was analyzed in Cohort 1 (treatment-naive).	Baseline; Week 24
Change From Baseline in eGFR-CG at Week 24 (Cohort 2)	Change from baseline in eGFR-CG equation at Week 24 was analyzed in Cohort 2 (treatment-experienced).	Baseline; Week 24
Change From Baseline in eGFR Using the Modification of Diet in Renal (MDRD) Equation at Week 24 (Cohort 1)	Change from baseline in eGFR-MDRD equation at Week 24 was analyzed in Cohort 1 (treatment-naive). The calculation was normalized to 1.73 m^2 body surface area.	Baseline; Week 24
Change From Baseline in eGFR-MDRD at Week 24 (Cohort 2)	Change from baseline in eGFR-MDRD equation at Week 24 was analyzed in Cohort 2 (treatment-experienced). The calculation was normalized to 1.73 m^2 body surface area.	Baseline; Week 24
Change From Baseline in eGFR Using the Chronic Kidney Disease, Epidemiology Collaboration (CKD-EPI) Formula Based on Cystatin C Equation at Week 24 (Cohort 1)	Change from baseline in eGFR-CKD-EPI based on cystatin C equation (not adjusted for age, sex, and race) at Week 24 was analyzed in Cohort 1 (treatment-naive). The calculation was normalized to 1.73 m^2 body surface area.	Baseline; Week 24
Change From Baseline in eGFR-CKD-EPI Formula Based on Cystatin C Equation at Week 24 (Cohort 2)	Change from baseline in eGFR-CKD-EPI based on cystatin C equation (not adjusted for age, sex, and race) at Week 24 was analyzed in Cohort 2 (treatment-experienced). The calculation was normalized to 1.73 m^2 body surface area.

Secondary Outcomes

Measure	Description	Time Frame
Change From Baseline in eGFR-CG at Weeks 48 and 96 (Cohort 1)	Change from baseline in eGFR-CG at Weeks 48 and 96 were analyzed in Cohort 1 (treatment-naive). This outcome is to measure the long-term effect of COBI-containing regimens on renal parameters.	Baseline; Weeks 48 and 96
Change From Baseline in eGFR-CG at Weeks 48 and 96 (Cohort 2)

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Cohort 1 (treatment-naive)

Plasma HIV-1 RNA levels ≥ 1,000 copies/mL at screening
Screening genotype report must show sensitivity to FTC and TDF
No prior use of any approved or investigational antiretroviral drug for any length of time

Cohort 2 (treatment-experienced, pharmacoenhancer switch)

Subjects must be receiving ATV 300 mg/ritonavir (RTV) 100 mg plus 2 NRTIs OR DRV 800 mg/RTV 100 mg plus 2 NRTIs for at least 6 months prior to screening
Plasma HIV-1 RNA concentrations at undetectable levels in the 6 months preceding the screening visit and have HIV-1 RNA < 50 copies/mL at screening
Subjects experiencing intolerance to RTV (as determined by the investigator)

Both groups

The ability to understand and sign a written informed consent form
Normal ECG
Mild to moderate renal function
Stable renal function
Hepatic transaminases (AST and ALT) ≤ 5 x the upper limit of the normal range (ULN)
Total bilirubin ≤ 1.5 mg/dL, or normal direct bilirubin (subjects with documented Gilbert's Syndrome or hyperbilirubinemia due to atazanavir therapy may have total bilirubin up to 5 x ULN)
Adequate hematologic function
Serum amylase ≤ 5 x ULN
Males and females of childbearing potential must agree to utilize highly effective contraception methods from screening throughout the duration of study treatment and for 30 days following the last dose of study drug
Age ≥ 18 years

Exclusion Criteria:

New AIDS-defining condition diagnosed within the 30 days prior to screening
Receiving drug treatment for hepatitis C, or anticipated to receive treatment for hepatitis C
Subjects experiencing decompensated cirrhosis
Females who are breastfeeding
Positive serum pregnancy test (female of childbearing potential)
Implanted defibrillator or pacemaker
Current alcohol or substance use judged by the investigator to potentially interfere with subject study compliance
History of malignancy within the past 5 years or ongoing malignancy other than cutaneous Kaposi's sarcoma, basal cell carcinoma, or resected, noninvasive cutaneous squamous carcinoma
Active, serious infections (other than HIV-1 infection) requiring parenteral antibiotic or antifungal therapy within 30 days prior to baseline
Receiving ongoing therapy with any of medications contraindicated for use with elvitegravir (EVG), COBI, FTC, TDF, ATV, DRV; or subjects with any known allergies to the excipients of E/C/F/TDF STR, COBI tablets, ATV capsules or DRV tablets or contraindicated for the 2 NRTIs as part of the PI/co regimen
Participation in any other clinical trial without prior approval
Any other clinical condition or prior therapy that would make the subject unsuitable for the study or unable to comply with the dosing requirements

Name	Affiliation	Role
Javier Szwarcberg, MD	Gilead Sciences	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Spectrum Medical Group		Phoenix	Arizona	85012	United States
Health for Life Clinic

PubMed Identifier	Type	Citation	Retractions
25397568	Result	Fisher M, McDonald C, Moyle G, Martorell C, Ramgopal M, Laplante F, Curley J, Graham H, Tran-Muchowski C, Liu Y, Rhee M, Szwarcberg J. Switching from ritonavir to cobicistat in HIV patients with renal impairment who are virologically suppressed on a protease inhibitor. J Int AIDS Soc. 2014 Nov 2;17(4 Suppl 3):19824. doi: 10.7448/IAS.17.4.19824. eCollection 2014.
25469527

ID	Title	Description
FG000	E/C/F/TDF (Cohort 1)	Main Study: Participants who had not received prior antiretroviral (ARV) treatment and who were virologically unsuppressed at baseline initiated treatment with elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate (Stribild®; E/C/F/TDF) (150/150/200/300 mg) single-tablet regimen (STR) once daily for up to 96 weeks. Extension Phase: Participants continued their treatment until all participants discontinued from the study or commercial approval of E/C/F/TDF was received in the applicable country.

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) Using the Cockcroft-Gault (CG) Equation at Week 24 (Cohort 1)

Change from baseline in eGFR-CG equation at Week 24 was analyzed in Cohort 1 (treatment-naive).

Safety Analysis Set (treatment-naive only): participants in the treatment-naive group who were randomized and received at least one dose of study drug

Posted

Median

Inter-Quartile Range

mL/min

Baseline; Week 24

ID	Title	Description
OG000	E/C/F/TDF (Cohort 1)	Main Study: Participants who had not received prior ARV treatment and who were virologically unsuppressed at baseline initiated treatment with E/C/F/TDF (150/150/200/300 mg) STR once daily for up to 96 weeks. Extension Phase: Participants continued their treatment until all participants discontinued from the study or commercial approval of E/C/F/TDF was received in the applicable country.

Units	Counts
Participants	OG00033

Title

Denominators

Categories

Baseline (n = 33)

Title	Measurements
	OG00072.9(64.7 to 81.1)

Change at Week 24 (n = 30)

Title	Measurements
	OG000-5.2(-13.2 to 1.0)

Primary

Change From Baseline in eGFR-CG at Week 24 (Cohort 2)

Change from baseline in eGFR-CG equation at Week 24 was analyzed in Cohort 2 (treatment-experienced).

Safety Analysis Set (treatment-experienced only): participants in the treatment-experienced group who were randomized and received at least one dose of study drug

Posted

Median

Inter-Quartile Range

mL/min

Baseline; Week 24

ID	Title	Description
OG000	COBI+PI+2 NRTIs (Cohort 2)	Main Study: Participants who had received prior ARV treatment and who were virologically suppressed at baseline switched their regimen's pharmacoenhancer component from ritonavir to COBI 150 mg, while continuing the other components of their ARV regimen (ATV 300 mg or DRV 800 mg plus 2 NRTIs) for up to 96 weeks. These 2 NRTIs may have included ABC, 3TC/ZDV, DDI, FTC, ABC/3TC, 3TC, TDF, or FTC/TDF, administered according to prescribing information. Extension Phase: Participants continued their treatment until all participants discontinued from the study or commercial approval of cobicistat was received in the applicable country.

Units	Counts
Participants	OG000

Secondary

Change From Baseline in eGFR-CG at Weeks 48 and 96 (Cohort 1)

Change from baseline in eGFR-CG at Weeks 48 and 96 were analyzed in Cohort 1 (treatment-naive). This outcome is to measure the long-term effect of COBI-containing regimens on renal parameters.

Treatment-naive participants in the Safety Analysis Set with available data were analyzed.

Posted

Median

Inter-Quartile Range

mL/min

Baseline; Weeks 48 and 96

ID	Title	Description
OG000	E/C/F/TDF (Cohort 1)	Main Study: Participants who had not received prior ARV treatment and who were virologically unsuppressed at baseline initiated treatment with E/C/F/TDF (150/150/200/300 mg) STR once daily for up to 96 weeks. Extension Phase: Participants continued their treatment until all participants discontinued from the study or commercial approval of E/C/F/TDF was received in the applicable country.

Units	Counts
Participants	OG000

Secondary

Change From Baseline in eGFR-CG at Weeks 48 and 96 (Cohort 2)

Change from baseline in eGFR-CG at Weeks 48 and 96 were analyzed in Cohort 2 (treatment-experienced). This outcome is to measure the long-term effect of COBI-containing regimens on renal parameters.

Participants in the Safety Analysis Set (treatment-experienced only) with available data were analyzed.

Posted

Median

Inter-Quartile Range

mL/min

Baseline; Week 48

ID	Title	Description
OG000	COBI+PI+2 NRTIs (Cohort 2)	Main Study: Participants who had received prior ARV treatment and who were virologically suppressed at baseline switched their regimen's pharmacoenhancer component from ritonavir to COBI 150 mg, while continuing the other components of their ARV regimen (ATV 300 mg or DRV 800 mg plus 2 NRTIs) for up to 96 weeks. These 2 NRTIs may have included ABC, 3TC/ZDV, DDI, FTC, ABC/3TC, 3TC, TDF, or FTC/TDF, administered according to prescribing information. Extension Phase: Participants continued their treatment until all participants discontinued from the study or commercial approval of cobicistat was received in the applicable country.

Units	Counts
Participants	OG000

Secondary

Change From Baseline in eGFR-MDRD at Weeks 48 and 96 (Cohort 1)

Change from baseline in eGFR-MDRD at Weeks 48 and 96 were analyzed in Cohort 1 (treatment-naive). The calculation was normalized to 1.73 m^2 body surface area. This outcome is to measure the long-term effect of COBI-containing regimens on renal parameters.

Treatment-naive participants in the Safety Analysis Set with available data were analyzed.

Posted

Median

Inter-Quartile Range

mL/min/1.73 m^2

Baseline; Weeks 48 and 96

ID	Title	Description
OG000	E/C/F/TDF (Cohort 1)	Main Study: Participants who had not received prior ARV treatment and who were virologically unsuppressed at baseline initiated treatment with E/C/F/TDF (150/150/200/300 mg) STR once daily for up to 96 weeks. Extension Phase: Participants continued their treatment until all participants discontinued from the study or commercial approval of E/C/F/TDF was received in the applicable country.

Units	Counts
Participants	OG000

Secondary

Change From Baseline in eGFR-MDRD at Weeks 48 and 96 (Cohort 2)

Change from baseline in eGFR-MDRD at Weeks 48 and 96 were analyzed in Cohort 2 (treatment-experienced). The calculation was normalized to 1.73 m^2 body surface area. This outcome is to measure the long-term effect of COBI-containing regimens on renal parameters.

Treatment-experienced participants in the Safety Analysis Set with available data were analyzed.

Posted

Median

Inter-Quartile Range

mL/min/1.73 m^2

Baseline; Weeks 48 and 96

ID	Title	Description
OG000	COBI+PI+2 NRTIs (Cohort 2)	Main Study: Participants who had received prior ARV treatment and who were virologically suppressed at baseline switched their regimen's pharmacoenhancer component from ritonavir to COBI 150 mg, while continuing the other components of their ARV regimen (ATV 300 mg or DRV 800 mg plus 2 NRTIs) for up to 96 weeks. These 2 NRTIs may have included ABC, 3TC/ZDV, DDI, FTC, ABC/3TC, 3TC, TDF, or FTC/TDF, administered according to prescribing information. Extension Phase: Participants continued their treatment until all participants discontinued from the study or commercial approval of cobicistat was received in the applicable country.

Units	Counts
Participants

Secondary

Change From Baseline in eGFR-CKD-EPI Based on Cystatin C Equation at Weeks 48 and 96 (Cohort 1)

Change from baseline in eGFR-CKD-EPI based on cystatin C equation (not adjusted for age, sex, and race) at Weeks 48 and 96 were analyzed in Cohort 1 (treatment-naive). The calculation was normalized to 1.73 m^2 body surface area. This outcome is to measure the long-term effect of COBI-containing regimens on renal parameters.

Treatment-naive participants in the Safety Analysis Set with available data were analyzed.

Posted

Median

Inter-Quartile Range

mL/min/1.73 m^2

Baseline; Weeks 48 and 96

ID	Title	Description
OG000	E/C/F/TDF (Cohort 1)	Main Study: Participants who had not received prior ARV treatment and who were virologically unsuppressed at baseline initiated treatment with E/C/F/TDF (150/150/200/300 mg) STR once daily for up to 96 weeks. Extension Phase: Participants continued their treatment until all participants discontinued from the study or commercial approval of E/C/F/TDF was received in the applicable country.

Units	Counts
Participants	OG000

Secondary

Change From Baseline in eGFR-CKD-EPI Based on Cystatin C Equation at Weeks 48 and 96 (Cohort 2)

Change from baseline in eGFR-CKD-EPI based on cystatin C equation (not adjusted for age, sex, and race) at Weeks 48 and 96 were analyzed in Cohort 2 (treatment-experienced). The calculation was normalized to 1.73 m^2 body surface area. This outcome is to measure the long-term effect of COBI-containing regimens on renal parameters.

Treatment-experienced participants in the Safety Analysis Set with available data were analyzed.

Posted

Median

Inter-Quartile Range

mL/min/1.73 m^2

Baseline; Weeks 48 and 96

ID	Title	Description
OG000	COBI+PI+2 NRTIs (Cohort 2)	Main Study: Participants who had received prior ARV treatment and who were virologically suppressed at baseline switched their regimen's pharmacoenhancer component from ritonavir to COBI 150 mg, while continuing the other components of their ARV regimen (ATV 300 mg or DRV 800 mg plus 2 NRTIs) for up to 96 weeks. These 2 NRTIs may have included ABC, 3TC/ZDV, DDI, FTC, ABC/3TC, 3TC, TDF, or FTC/TDF, administered according to prescribing information. Extension Phase: Participants continued their treatment until all participants discontinued from the study or commercial approval of cobicistat was received in the applicable country.

Units	Counts
Participants

Primary

Change From Baseline in eGFR Using the Modification of Diet in Renal (MDRD) Equation at Week 24 (Cohort 1)

Change from baseline in eGFR-MDRD equation at Week 24 was analyzed in Cohort 1 (treatment-naive). The calculation was normalized to 1.73 m^2 body surface area.

Treatment-naive participants in the Safety Analysis Set with available data were analyzed.

Posted

Median

Inter-Quartile Range

mL/min/1.73 m^2

Baseline; Week 24

ID	Title	Description
OG000	E/C/F/TDF (Cohort 1)	Main Study: Participants who had not received prior ARV treatment and who were virologically unsuppressed at baseline initiated treatment with E/C/F/TDF (150/150/200/300 mg) STR once daily for up to 96 weeks. Extension Phase: Participants continued their treatment until all participants discontinued from the study or commercial approval of E/C/F/TDF was received in the applicable country.

Units	Counts
Participants	OG000

Primary

Change From Baseline in eGFR-MDRD at Week 24 (Cohort 2)

Change from baseline in eGFR-MDRD equation at Week 24 was analyzed in Cohort 2 (treatment-experienced). The calculation was normalized to 1.73 m^2 body surface area.

Treatment-experienced participants in the Safety Analysis Set with available data were analyzed.

Posted

Median

Inter-Quartile Range

mL/min/1.73 m^2

Baseline; Week 24

ID	Title	Description
OG000	COBI+PI+2 NRTIs (Cohort 2)	Main Study: Participants who had received prior ARV treatment and who were virologically suppressed at baseline switched their regimen's pharmacoenhancer component from ritonavir to COBI 150 mg, while continuing the other components of their ARV regimen (ATV 300 mg or DRV 800 mg plus 2 NRTIs) for up to 96 weeks. These 2 NRTIs may have included ABC, 3TC/ZDV, DDI, FTC, ABC/3TC, 3TC, TDF, or FTC/TDF, administered according to prescribing information. Extension Phase: Participants continued their treatment until all participants discontinued from the study or commercial approval of cobicistat was received in the applicable country.

Units	Counts
Participants	OG000

Primary

Change From Baseline in eGFR Using the Chronic Kidney Disease, Epidemiology Collaboration (CKD-EPI) Formula Based on Cystatin C Equation at Week 24 (Cohort 1)

Change from baseline in eGFR-CKD-EPI based on cystatin C equation (not adjusted for age, sex, and race) at Week 24 was analyzed in Cohort 1 (treatment-naive). The calculation was normalized to 1.73 m^2 body surface area.

Treatment-naive participants in the Safety Analysis Set with available data were analyzed.

Posted

Median

Inter-Quartile Range

mL/min/1.73 m^2

Baseline; Week 24

ID	Title	Description
OG000	E/C/F/TDF (Cohort 1)	Main Study: Participants who had not received prior ARV treatment and who were virologically unsuppressed at baseline initiated treatment with E/C/F/TDF (150/150/200/300 mg) STR once daily for up to 96 weeks. Extension Phase: Participants continued their treatment until all participants discontinued from the study or commercial approval of E/C/F/TDF was received in the applicable country.

Units	Counts
Participants	OG000

Primary

Change From Baseline in eGFR-CKD-EPI Formula Based on Cystatin C Equation at Week 24 (Cohort 2)

Change from baseline in eGFR-CKD-EPI based on cystatin C equation (not adjusted for age, sex, and race) at Week 24 was analyzed in Cohort 2 (treatment-experienced). The calculation was normalized to 1.73 m^2 body surface area.

Treatment-experienced participants in the Safety Analysis Set with available data were analyzed.

Posted

Median

Inter-Quartile Range

mL/min/1.73 m^2

Baseline; Week 24

ID	Title	Description
OG000	COBI+PI+2 NRTIs (Cohort 2)	Main Study: Participants who had received prior ARV treatment and who were virologically suppressed at baseline switched their regimen's pharmacoenhancer component from ritonavir to COBI 150 mg, while continuing the other components of their ARV regimen (ATV 300 mg or DRV 800 mg plus 2 NRTIs) for up to 96 weeks. These 2 NRTIs may have included ABC, 3TC/ZDV, DDI, FTC, ABC/3TC, 3TC, TDF, or FTC/TDF, administered according to prescribing information. Extension Phase: Participants continued their treatment until all participants discontinued from the study or commercial approval of cobicistat was received in the applicable country.

Units	Counts
Participants

Secondary

Change From Baseline in eGFR-CKD-EPI Based on Cystatin C Equation (Adjusted) at Weeks 48 and 96 (Cohort 1)

Change from baseline in eGFR-CKD-EPI based on cystatin C equation (adjusted for age, sex, and race) at Weeks 48 and 96 were analyzed in Cohort 1 (treatment-naive). The calculation was normalized to 1.73 m^2 body surface area. This outcome is to measure the long-term effect of COBI-containing regimens on renal parameters.

Treatment-naive participants in the Safety Analysis Set with available data were analyzed.

Posted

Median

Inter-Quartile Range

mL/min/1.73 m^2

Baseline; Weeks 48 and 96

ID	Title	Description
OG000	E/C/F/TDF (Cohort 1)	Main Study: Participants who had not received prior ARV treatment and who were virologically unsuppressed at baseline initiated treatment with E/C/F/TDF (150/150/200/300 mg) STR once daily for up to 96 weeks. Extension Phase: Participants continued their treatment until all participants discontinued from the study or commercial approval of E/C/F/TDF was received in the applicable country.

Units	Counts
Participants	OG000

Secondary

Change From Baseline in eGFR-CKD-EPI Based on Cystatin C Equation (Adjusted) at Weeks 48 and 96 (Cohort 2)

Change from baseline in eGFR-CKD-EPI based on cystatin C equation (adjusted for age, sex, and race) at Weeks 48 and 96 were analyzed in Cohort 2 (treatment-experienced). The calculation was normalized to 1.73 m^2 body surface area. This outcome is to measure the long-term effect of COBI-containing regimens on renal parameters.

Treatment-experienced participants in the Safety Analysis Set with available data were analyzed.

Posted

Median

Inter-Quartile Range

mL/min/1.73 m^2

Baseline; Weeks 48 and 96

ID	Title	Description
OG000	COBI+PI+2 NRTIs (Cohort 2)	Main Study: Participants who had received prior ARV treatment and who were virologically suppressed at baseline switched their regimen's pharmacoenhancer component from ritonavir to COBI 150 mg, while continuing the other components of their ARV regimen (ATV 300 mg or DRV 800 mg plus 2 NRTIs) for up to 96 weeks. These 2 NRTIs may have included ABC, 3TC/ZDV, DDI, FTC, ABC/3TC, 3TC, TDF, or FTC/TDF, administered according to prescribing information. Extension Phase: Participants continued their treatment until all participants discontinued from the study or commercial approval of cobicistat was received in the applicable country.

Units	Counts
Participants

Secondary

Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Weeks 48 and 96 (Cohort 1)

The percentage of participants with HIV-1 RNA < 50 copies/mL at Weeks 48 and 96 were analyzed in Cohort 1 (treatment-naive) using the FDA snapshot analysis algorithm.

Treatment-naive participants in the Full Analysis Set with available data was analyzed.

Posted

Number

percentage of participants

Weeks 48 and 96

ID	Title	Description
OG000	E/C/F/TDF (Cohort 1)	Main Study: Participants who had not received prior ARV treatment and who were virologically unsuppressed at baseline initiated treatment with E/C/F/TDF (150/150/200/300 mg) STR once daily for up to 96 weeks. Extension Phase: Participants continued their treatment until all participants discontinued from the study or commercial approval of E/C/F/TDF was received in the applicable country.

Units	Counts
Participants	OG000

Secondary

Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Weeks 48 and 96 (Cohort 2)

The percentage of participants with HIV-1 RNA < 50 copies/mL at Weeks 48 and 96 were analyzed in Cohort 2 (treatment-experienced) using the FDA snapshot analysis algorithm.

Treatment-experienced participants in the Full Analysis Set with available data were analyzed.

Posted

Number

percentage of participants

Weeks 48 and 96

ID	Title	Description
OG000	COBI+PI+2 NRTIs (Cohort 2)	Main Study: Participants who had received prior ARV treatment and who were virologically suppressed at baseline switched their regimen's pharmacoenhancer component from ritonavir to COBI 150 mg, while continuing the other components of their ARV regimen (ATV 300 mg or DRV 800 mg plus 2 NRTIs) for up to 96 weeks. These 2 NRTIs may have included ABC, 3TC/ZDV, DDI, FTC, ABC/3TC, 3TC, TDF, or FTC/TDF, administered according to prescribing information. Extension Phase: Participants continued their treatment until all participants discontinued from the study or commercial approval of cobicistat was received in the applicable country.

Units	Counts
Participants	OG000

Secondary

Percentage of Participants Who Experienced Adverse Events (Cohort 1)

Adverse events (AEs) occurring from baseline up to 30 days following the last dose of study drug were summarized for Cohort 1 (treatment-naive). A participant was counted once if they had a qualifying event.

Safety Analysis Set (treatment-naive only)

Posted

Number

percentage of participants

Up to 147 weeks plus 30 days

ID	Title	Description
OG000	E/C/F/TDF (Cohort 1)	Main Study: Participants who had not received prior ARV treatment and who were virologically unsuppressed at baseline initiated treatment with E/C/F/TDF (150/150/200/300 mg) STR once daily for up to 96 weeks. Extension Phase: Participants continued their treatment until all participants discontinued from the study or commercial approval of E/C/F/TDF was received in the applicable country.

Units	Counts
Participants	OG000

Primary

Change From Baseline in eGFR-CKD-EPI Based on Cystatin C Equation, Adjusted at Week 24 (Cohort 1)

Change from baseline in eGFR-CKD-EPI based on cystatin C equation (adjusted for age, sex, and race) at Week 24 was analyzed in Cohort 1 (treatment-naive). The calculation was normalized to 1.73 m^2 body surface area.

Treatment-naive participants in the Safety Analysis Set with available data were analyzed.

Posted

Median

Inter-Quartile Range

mL/min/1.73 m^2

Baseline; Week 24

ID	Title	Description
OG000	E/C/F/TDF (Cohort 1)	Main Study: Participants who had not received prior ARV treatment and who were virologically unsuppressed at baseline initiated treatment with E/C/F/TDF (150/150/200/300 mg) STR once daily for up to 96 weeks. Extension Phase: Participants continued their treatment until all participants discontinued from the study or commercial approval of E/C/F/TDF was received in the applicable country.

Units	Counts
Participants	OG000

Primary

Change From Baseline in eGFR-CKD-EPI Based on Cystatin C Equation, Adjusted at Week 24 (Cohort 2)

Change from baseline in eGFR-CKD-EPI based on cystatin C equation (adjusted for age, sex, and race) at Week 24 was analyzed in Cohort 2 (treatment-experienced). The calculation was normalized to 1.73 m^2 body surface area.

Treatment-experienced participants in the Safety Analysis Set with available data were analyzed.

Posted

Median

Inter-Quartile Range

mL/min/1.73 m^2

Baseline; Week 24

ID	Title	Description
OG000	COBI+PI+2 NRTIs (Cohort 2)	Main Study: Participants who had received prior ARV treatment and who were virologically suppressed at baseline switched their regimen's pharmacoenhancer component from ritonavir to COBI 150 mg, while continuing the other components of their ARV regimen (ATV 300 mg or DRV 800 mg plus 2 NRTIs) for up to 96 weeks. These 2 NRTIs may have included ABC, 3TC/ZDV, DDI, FTC, ABC/3TC, 3TC, TDF, or FTC/TDF, administered according to prescribing information. Extension Phase: Participants continued their treatment until all participants discontinued from the study or commercial approval of cobicistat was received in the applicable country.

Units	Counts
Participants

Primary

Change From Baseline in Actual Glomerular Filtration Rate (aGFR) at Weeks 2, 4, and 24 (Cohort 1)

Change from baseline in aGFR at Weeks 2, 4, and 24 was analyzed in Cohort 1 (treatment-naive). aGFR was calculated using iohexol plasma clearance.

Pharmacokinetic/Pharmacodynamic (PK/PD) Substudy Analysis Set (treatment-naive only): participants in the treatment-naive group who were enrolled and received at least one dose of study drug and who had data for steady-state PK parameters at the relevant time points were analyzed.

Posted

Number

mL/min

Baseline; Weeks 2, 4, and 24

ID	Title	Description
OG000	E/C/F/TDF (Cohort 1)	Main Study: Participants who had not received prior ARV treatment and who were virologically unsuppressed at baseline initiated treatment with E/C/F/TDF (150/150/200/300 mg) STR once daily for up to 96 weeks. Extension Phase: Participants continued their treatment until all participants discontinued from the study or commercial approval of E/C/F/TDF was received in the applicable country.

Units	Counts
Participants	OG000

Primary

Change From Baseline in aGFR at Weeks 2, 4, and 24 (Cohort 2)

Change from baseline in aGFR at Weeks 2, 4, and 24 was analyzed in Cohort 2 (treatment-experienced). aGFR was calculated using iohexol plasma clearance.

PK/PD Substudy Analysis Set (treatment-experienced only): participants in the treatment-experienced group who were enrolled and received at least one dose of study drug and who had data for steady-state PK parameters at the relevant time points were analyzed.

Posted

Median

Inter-Quartile Range

mL/min

Baseline; Weeks 2, 4, and 24

ID	Title	Description
OG000	COBI+PI+2 NRTIs (Cohort 2)	Main Study: Participants who had received prior ARV treatment and who were virologically suppressed at baseline switched their regimen's pharmacoenhancer component from ritonavir to COBI 150 mg, while continuing the other components of their ARV regimen (ATV 300 mg or DRV 800 mg plus 2 NRTIs) for up to 96 weeks. These 2 NRTIs may have included ABC, 3TC/ZDV, DDI, FTC, ABC/3TC, 3TC, TDF, or FTC/TDF, administered according to prescribing information. Extension Phase: Participants continued their treatment until all participants discontinued from the study or commercial approval of cobicistat was received in the applicable country.

Units	Counts
Participants

Primary

Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 24 (Cohort 1)

The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 24 was analyzed in Cohort 1 (treatment-naive) using the FDA snapshot analysis algorithm.

Full Analysis Set (treatment-naive only): participants in the treatment-naive group who were randomized and received at least one dose of study drug

Posted

Number

percentage of participants

Week 24

ID	Title	Description
OG000	E/C/F/TDF (Cohort 1)	Main Study: Participants who had not received prior ARV treatment and who were virologically unsuppressed at baseline initiated treatment with E/C/F/TDF (150/150/200/300 mg) STR once daily for up to 96 weeks. Extension Phase: Participants continued their treatment until all participants discontinued from the study or commercial approval of E/C/F/TDF was received in the applicable country.

Units	Counts
Participants	OG000

Primary

Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 24 (Cohort 2)

The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 24 was analyzed in Cohort 2 (treatment-experienced) using the FDA snapshot analysis algorithm.

Full Analysis Set (treatment-experienced only): participants in the treatment-experienced group who were randomized and received at least one dose of study drug

Posted

Number

percentage of participants

Week 24

ID	Title	Description
OG000	COBI+PI+2 NRTIs (Cohort 2)	Main Study: Participants who had received prior ARV treatment and who were virologically suppressed at baseline switched their regimen's pharmacoenhancer component from ritonavir to COBI 150 mg, while continuing the other components of their ARV regimen (ATV 300 mg or DRV 800 mg plus 2 NRTIs) for up to 96 weeks. These 2 NRTIs may have included ABC, 3TC/ZDV, DDI, FTC, ABC/3TC, 3TC, TDF, or FTC/TDF, administered according to prescribing information. Extension Phase: Participants continued their treatment until all participants discontinued from the study or commercial approval of cobicistat was received in the applicable country.

Units	Counts
Participants	OG000

Secondary

Percentage of Participants Who Experienced Adverse Events (Cohort 2)

Adverse events (AEs) occurring from baseline up to 30 days following the last dose of study drug were summarized for Cohort 2 (treatment-experienced). A participant was counted once if they had a qualifying event.

Safety Analysis Set (treatment-experienced only)

Posted

Number

percentage of participants

Up to 166 weeks plus 30 days

ID	Title	Description
OG000	COBI+PI+2 NRTIs (Cohort 2)	Main Study: Participants who had received prior ARV treatment and who were virologically suppressed at baseline switched their regimen's pharmacoenhancer component from ritonavir to COBI 150 mg, while continuing the other components of their ARV regimen (ATV 300 mg or DRV 800 mg plus 2 NRTIs) for up to 96 weeks. These 2 NRTIs may have included ABC, 3TC/ZDV, DDI, FTC, ABC/3TC, 3TC, TDF, or FTC/TDF, administered according to prescribing information. Extension Phase: Participants continued their treatment until all participants discontinued from the study or commercial approval of cobicistat was received in the applicable country.

Units	Counts
Participants	OG000

Secondary

Percentage of Participants Who Experienced Graded Laboratory Abnormalities (Cohort 1)

Laboratory abnormalities were summarized for Cohort 1 (treatment-naive) and were defined as values that increased at least one toxicity grade from baseline at any time postbaseline up to and including the date of last dose of study drug plus 30 days. A participant was counted once if they had a qualifying event.

Safety Analysis Set (treatment-naive only)

Posted

Number

percentage of participants

Up to 147 weeks plus 30 days

ID	Title	Description
OG000	E/C/F/TDF (Cohort 1)	Main Study: Participants who had not received prior ARV treatment and who were virologically unsuppressed at baseline initiated treatment with E/C/F/TDF (150/150/200/300 mg) STR once daily for up to 96 weeks. Extension Phase: Participants continued their treatment until all participants discontinued from the study or commercial approval of E/C/F/TDF was received in the applicable country.

Units	Counts
Participants	OG000

Secondary

Percentage of Participants Who Experienced Graded Laboratory Abnormalities (Cohort 2)

Laboratory abnormalities were summarized for Cohort 2 (treatment-experienced) and were defined as values that increased at least one toxicity grade from baseline at any time postbaseline up to and including the date of last dose of study drug plus 30 days. A participant was counted once if they had a qualifying event.

Treatment-experienced participants in the Safety Analysis Set with available data were analyzed.

Posted

Number

percentage of participants

Up to 166 weeks plus 30 days

ID	Title	Description
OG000	COBI+PI+2 NRTIs (Cohort 2)	Main Study: Participants who had received prior ARV treatment and who were virologically suppressed at baseline switched their regimen's pharmacoenhancer component from ritonavir to COBI 150 mg, while continuing the other components of their ARV regimen (ATV 300 mg or DRV 800 mg plus 2 NRTIs) for up to 96 weeks. These 2 NRTIs may have included ABC, 3TC/ZDV, DDI, FTC, ABC/3TC, 3TC, TDF, or FTC/TDF, administered according to prescribing information. Extension Phase: Participants continued their treatment until all participants discontinued from the study or commercial approval of cobicistat was received in the applicable country.

Units	Counts
Participants

Secondary

Plasma Pharmacokinetics of COBI: AUCtau (Cohort 1)

AUCtau was analyzed for Cohort 1 (treatment-naive) and was defined as the concentration of drug over time (area under the plasma concentration versus time curve over the dosing interval).

PK/PD Substudy Analysis Set (treatment-naive only)

Posted

Number

h*ng/mL

Blood samples were collected at 0 (predose), 0.5, 1.0, 2.0, 3.0, 4.0, 5.0, 8.0, 12.0, and 24.0 hours postdose at baseline and Weeks 2, 4, and 24.

ID	Title	Description
OG000	E/C/F/TDF (Cohort 1)	Main Study: Participants who had not received prior ARV treatment and who were virologically unsuppressed at baseline initiated treatment with E/C/F/TDF (150/150/200/300 mg) STR once daily for up to 96 weeks. Extension Phase: Participants continued their treatment until all participants discontinued from the study or commercial approval of E/C/F/TDF was received in the applicable country.

Units	Counts
Participants	OG000

Secondary

Plasma Pharmacokinetics of COBI: AUCtau (Cohort 2)

AUCtau was analyzed for Cohort 2 (treatment-experienced) and was defined as the concentration of drug over time (area under the plasma concentration versus time curve over the dosing interval).

Participants in the PK/PD Substudy Analysis Set (treatment-experienced only) with available postbaseline data were analyzed.

Posted

Mean

Standard Deviation

h*ng/mL

Blood samples were collected at 0 (predose), 0.5, 1.0, 2.0, 3.0, 4.0, 5.0, 8.0, 12.0, and 24.0 hours postdose at baseline and Weeks 2, 4, and 24.

ID	Title	Description
OG000	COBI+PI+2 NRTIs (Cohort 2)	Main Study: Participants who had received prior ARV treatment and who were virologically suppressed at baseline switched their regimen's pharmacoenhancer component from ritonavir to COBI 150 mg, while continuing the other components of their ARV regimen (ATV 300 mg or DRV 800 mg plus 2 NRTIs) for up to 96 weeks. These 2 NRTIs may have included ABC, 3TC/ZDV, DDI, FTC, ABC/3TC, 3TC, TDF, or FTC/TDF, administered according to prescribing information. Extension Phase: Participants continued their treatment until all participants discontinued from the study or commercial approval of cobicistat was received in the applicable country.

Units	Counts
Participants

Secondary

Plasma Pharmacokinetics of COBI: Cmax (Cohort 1)

Cmax was analyzed for Cohort 1 (treatment-naive) and was defined as the maximum observed concentration of drug in plasma.

PK/PD Substudy Analysis Set (treatment-naive only)

Posted

Number

ng/mL

Blood samples were collected at 0 (predose), 0.5, 1.0, 2.0, 3.0, 4.0, 5.0, 8.0, 12.0, and 24.0 hours postdose at baseline and Weeks 2, 4, and 24.

ID	Title	Description
OG000	E/C/F/TDF (Cohort 1)	Main Study: Participants who had not received prior ARV treatment and who were virologically unsuppressed at baseline initiated treatment with E/C/F/TDF (150/150/200/300 mg) STR once daily for up to 96 weeks. Extension Phase: Participants continued their treatment until all participants discontinued from the study or commercial approval of E/C/F/TDF was received in the applicable country.

Units	Counts
Participants	OG000

Secondary

Plasma Pharmacokinetics of COBI: Cmax (Cohort 2)

Cmax was analyzed for Cohort 2 (treatment-experienced) and was defined as the maximum observed concentration of drug in plasma.

Participants in the PK/PD Substudy Analysis Set (treatment-experienced only) with available postbaseline data were analyzed.

Posted

Mean

Standard Deviation

ng/mL

Blood samples were collected at 0 (predose), 0.5, 1.0, 2.0, 3.0, 4.0, 5.0, 8.0, 12.0, and 24.0 hours postdose at baseline and Weeks 2, 4, and 24.

ID	Title	Description
OG000	COBI+PI+2 NRTIs (Cohort 2)	Main Study: Participants who had received prior ARV treatment and who were virologically suppressed at baseline switched their regimen's pharmacoenhancer component from ritonavir to COBI 150 mg, while continuing the other components of their ARV regimen (ATV 300 mg or DRV 800 mg plus 2 NRTIs) for up to 96 weeks. These 2 NRTIs may have included ABC, 3TC/ZDV, DDI, FTC, ABC/3TC, 3TC, TDF, or FTC/TDF, administered according to prescribing information. Extension Phase: Participants continued their treatment until all participants discontinued from the study or commercial approval of cobicistat was received in the applicable country.

Units	Counts
Participants

Secondary

Plasma Pharmacokinetics of COBI: Ctau (Cohort 1)

Ctau was analyzed for Cohort 1 (treatment-naive) and was defined as the observed drug concentration at the end of the dosing interval.

PK/PD Substudy Analysis Set (treatment-naive only)

Posted

Number

ng/mL

Blood samples were collected at 0 (predose), 0.5, 1.0, 2.0, 3.0, 4.0, 5.0, 8.0, 12.0, and 24.0 hours postdose at baseline and Weeks 2, 4, and 24.

ID	Title	Description
OG000	E/C/F/TDF (Cohort 1)	Main Study: Participants who had not received prior ARV treatment and who were virologically unsuppressed at baseline initiated treatment with E/C/F/TDF (150/150/200/300 mg) STR once daily for up to 96 weeks. Extension Phase: Participants continued their treatment until all participants discontinued from the study or commercial approval of E/C/F/TDF was received in the applicable country.

Units	Counts
Participants	OG000

Secondary

Plasma Pharmacokinetics of COBI: Ctau (Cohort 2)

Ctau was analyzed for Cohort 2 (treatment-experienced) and was defined as the observed drug concentration at the end of the dosing interval.

Participants in the PK/PD Substudy Analysis Set (treatment-experienced only) with available postbaseline data were analyzed.

Posted

Mean

Standard Deviation

ng/mL

Blood samples were collected at 0 (predose), 0.5, 1.0, 2.0, 3.0, 4.0, 5.0, 8.0, 12.0, and 24.0 hours postdose at baseline and Weeks 2, 4, and 24.

ID	Title	Description
OG000	COBI+PI+2 NRTIs (Cohort 2)	Main Study: Participants who had received prior ARV treatment and who were virologically suppressed at baseline switched their regimen's pharmacoenhancer component from ritonavir to COBI 150 mg, while continuing the other components of their ARV regimen (ATV 300 mg or DRV 800 mg plus 2 NRTIs) for up to 96 weeks. These 2 NRTIs may have included ABC, 3TC/ZDV, DDI, FTC, ABC/3TC, 3TC, TDF, or FTC/TDF, administered according to prescribing information. Extension Phase: Participants continued their treatment until all participants discontinued from the study or commercial approval of cobicistat was received in the applicable country.

Units	Counts
Participants

Secondary

Plasma Pharmacokinetics of COBI: Tmax (Cohort 1)

Tmax was analyzed for Cohort 1 (treatment-naive) and was defined as the time of Cmax.

PK/PD Substudy Analysis Set (treatment-naive only)

Posted

Number

hours

Blood samples were collected at 0 (predose), 0.5, 1.0, 2.0, 3.0, 4.0, 5.0, 8.0, 12.0, and 24.0 hours postdose at baseline and Weeks 2, 4, and 24.

ID	Title	Description
OG000	E/C/F/TDF (Cohort 1)	Main Study: Participants who had not received prior ARV treatment and who were virologically unsuppressed at baseline initiated treatment with E/C/F/TDF (150/150/200/300 mg) STR once daily for up to 96 weeks. Extension Phase: Participants continued their treatment until all participants discontinued from the study or commercial approval of E/C/F/TDF was received in the applicable country.

Units	Counts
Participants	OG000

Secondary

Plasma Pharmacokinetics of COBI: Tmax (Cohort 2)

Tmax was analyzed for Cohort 2 (treatment-experienced) and was defined as the time of Cmax.

Participants in the PK/PD Substudy Analysis Set (treatment-experienced only) with available postbaseline data were analyzed.

Posted

Median

Inter-Quartile Range

hours

Blood samples were collected at 0 (predose), 0.5, 1.0, 2.0, 3.0, 4.0, 5.0, 8.0, 12.0, and 24.0 hours postdose at baseline and Weeks 2, 4, and 24.

ID	Title	Description
OG000	COBI+PI+2 NRTIs (Cohort 2)	Main Study: Participants who had received prior ARV treatment and who were virologically suppressed at baseline switched their regimen's pharmacoenhancer component from ritonavir to COBI 150 mg, while continuing the other components of their ARV regimen (ATV 300 mg or DRV 800 mg plus 2 NRTIs) for up to 96 weeks. These 2 NRTIs may have included ABC, 3TC/ZDV, DDI, FTC, ABC/3TC, 3TC, TDF, or FTC/TDF, administered according to prescribing information. Extension Phase: Participants continued their treatment until all participants discontinued from the study or commercial approval of cobicistat was received in the applicable country.

Units	Counts
Participants	OG000

Secondary

Plasma Pharmacokinetics of COBI: t1/2 (Cohort 1)

t1/2 was analyzed for Cohort 1 (treatment-naive) and was defined as the estimate of the terminal elimination half-life of the drug.

PK/PD Substudy Analysis Set (treatment-naive only)

Posted

Number

hours

Blood samples were collected at 0 (predose), 0.5, 1.0, 2.0, 3.0, 4.0, 5.0, 8.0, 12.0, and 24.0 hours postdose at baseline and Weeks 2, 4, and 24.

ID	Title	Description
OG000	E/C/F/TDF (Cohort 1)	Main Study: Participants who had not received prior ARV treatment and who were virologically unsuppressed at baseline initiated treatment with E/C/F/TDF (150/150/200/300 mg) STR once daily for up to 96 weeks. Extension Phase: Participants continued their treatment until all participants discontinued from the study or commercial approval of E/C/F/TDF was received in the applicable country.

Units	Counts
Participants	OG000

Secondary

Plasma Pharmacokinetics of COBI: t1/2 (Cohort 2)

t1/2 was analyzed for Cohort 2 (treatment-experienced) and was defined as the estimate of the terminal elimination half-life of the drug.

Participants in the PK/PD Substudy Analysis Set (treatment-experienced only) with available postbaseline data were analyzed.

Posted

Median

Inter-Quartile Range

hours

Blood samples were collected at 0 (predose), 0.5, 1.0, 2.0, 3.0, 4.0, 5.0, 8.0, 12.0, and 24.0 hours postdose at baseline and Weeks 2, 4, and 24.

ID	Title	Description
OG000	COBI+PI+2 NRTIs (Cohort 2)	Main Study: Participants who had received prior ARV treatment and who were virologically suppressed at baseline switched their regimen's pharmacoenhancer component from ritonavir to COBI 150 mg, while continuing the other components of their ARV regimen (ATV 300 mg or DRV 800 mg plus 2 NRTIs) for up to 96 weeks. These 2 NRTIs may have included ABC, 3TC/ZDV, DDI, FTC, ABC/3TC, 3TC, TDF, or FTC/TDF, administered according to prescribing information. Extension Phase: Participants continued their treatment until all participants discontinued from the study or commercial approval of cobicistat was received in the applicable country.

Units	Counts
Participants

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA 17.1	Systematic Assessment	EG0001 affected33 at risk EG0010 affected73 at risk
Acute coronary syndrome	Cardiac disorders	MedDRA 17.1	Systematic Assessment	EG0000 affected33 at risk EG0011 affected73 at risk
Acute myocardial infarction	Cardiac disorders	MedDRA 17.1	Systematic Assessment	EG0000 affected33 at risk EG0011 affected73 at risk
Angina pectoris	Cardiac disorders	MedDRA 17.1	Systematic Assessment	EG0000 affected33 at risk EG0011 affected73 at risk
Coronary artery stenosis	Cardiac disorders	MedDRA 17.1	Systematic Assessment	EG0000 affected33 at risk EG0011 affected73 at risk
Right ventricular failure	Cardiac disorders	MedDRA 17.1	Systematic Assessment	EG0001 affected33 at risk EG0010 affected73 at risk
Gastrointestinal fistula	Gastrointestinal disorders	MedDRA 17.1	Systematic Assessment	EG0000 affected33 at risk EG0011 affected73 at risk
Nausea	Gastrointestinal disorders	MedDRA 17.1	Systematic Assessment	EG0000 affected33 at risk EG0011 affected73 at risk
Peptic ulcer	Gastrointestinal disorders	MedDRA 17.1	Systematic Assessment	EG0000 affected33 at risk EG0011 affected73 at risk
Chest pain	General disorders	MedDRA 17.1	Systematic Assessment	EG0000 affected33 at risk EG0011 affected73 at risk
Cholecystitis chronic	Hepatobiliary disorders	MedDRA 17.1	Systematic Assessment	EG0000 affected33 at risk EG0011 affected73 at risk
Cellulitis	Infections and infestations	MedDRA 17.1	Systematic Assessment	EG0000 affected33 at risk EG0011 affected73 at risk
Hepatitis C	Infections and infestations	MedDRA 17.1	Systematic Assessment	EG0001 affected33 at risk EG0010 affected73 at risk
Infected cyst	Infections and infestations	MedDRA 17.1	Systematic Assessment	EG0001 affected33 at risk EG0010 affected73 at risk
Pelvic inflammatory disease	Infections and infestations	MedDRA 17.1	Systematic Assessment	EG0000 affected33 at risk EG0011 affected73 at risk
Sepsis	Infections and infestations	MedDRA 17.1	Systematic Assessment	EG0000 affected33 at risk EG0011 affected73 at risk
Skull fracture	Injury, poisoning and procedural complications	MedDRA 17.1	Systematic Assessment	EG0000 affected33 at risk EG0011 affected73 at risk
Blood creatine phosphokinase increased	Investigations	MedDRA 17.1	Systematic Assessment	EG0001 affected33 at risk EG0010 affected73 at risk
Transaminases increased	Investigations	MedDRA 17.1	Systematic Assessment	EG0000 affected33 at risk EG0011 affected73 at risk
Diabetes mellitus	Metabolism and nutrition disorders	MedDRA 17.1	Systematic Assessment	EG0001 affected33 at risk EG0010 affected73 at risk
Hodgkin's disease	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 17.1	Systematic Assessment	EG0001 affected33 at risk EG0010 affected73 at risk
Lymphoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 17.1	Systematic Assessment	EG0001 affected33 at risk EG0010 affected73 at risk
Cerebral ischaemia	Nervous system disorders	MedDRA 17.1	Systematic Assessment	EG0000 affected33 at risk EG0011 affected73 at risk
Convulsion	Nervous system disorders	MedDRA 17.1	Systematic Assessment	EG0000 affected33 at risk EG0011 affected73 at risk
Hemiparesis	Nervous system disorders	MedDRA 17.1	Systematic Assessment	EG0000 affected33 at risk EG0011 affected73 at risk
Suicidal ideation	Psychiatric disorders	MedDRA 17.1	Systematic Assessment	EG0000 affected33 at risk EG0011 affected73 at risk
Nephrolithiasis	Renal and urinary disorders	MedDRA 17.1	Systematic Assessment	EG0000 affected33 at risk EG0011 affected73 at risk
Angioedema	Skin and subcutaneous tissue disorders	MedDRA 17.1	Systematic Assessment	EG0001 affected33 at risk EG0011 affected73 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA 17.1	Systematic Assessment	EG0003 affected33 at risk EG0011 affected73 at risk
Lymphadenopathy	Blood and lymphatic system disorders	MedDRA 17.1	Systematic Assessment	EG0002 affected33 at risk EG0012 affected73 at risk
Neutropenia	Blood and lymphatic system disorders	MedDRA 17.1	Systematic Assessment	EG0002 affected33 at risk EG0010 affected73 at risk
Vision blurred	Eye disorders	MedDRA 17.1	Systematic Assessment	EG0003 affected33 at risk EG0011 affected73 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA 17.1	Systematic Assessment	EG0003 affected33 at risk EG0011 affected73 at risk
Abdominal pain upper	Gastrointestinal disorders	MedDRA 17.1	Systematic Assessment	EG0002 affected33 at risk EG0014 affected73 at risk
Constipation	Gastrointestinal disorders	MedDRA 17.1	Systematic Assessment	EG0003 affected33 at risk EG0015 affected73 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 17.1	Systematic Assessment	EG00012 affected33 at risk EG00110 affected73 at risk
Dyspepsia	Gastrointestinal disorders	MedDRA 17.1	Systematic Assessment	EG0003 affected33 at risk EG0013 affected73 at risk
Nausea	Gastrointestinal disorders	MedDRA 17.1	Systematic Assessment	EG0006 affected33 at risk EG0019 affected73 at risk
Proctalgia	Gastrointestinal disorders	MedDRA 17.1	Systematic Assessment	EG0002 affected33 at risk EG0010 affected73 at risk
Vomiting	Gastrointestinal disorders	MedDRA 17.1	Systematic Assessment	EG0005 affected33 at risk EG0014 affected73 at risk
Fatigue	General disorders	MedDRA 17.1	Systematic Assessment	EG0003 affected33 at risk EG0015 affected73 at risk
Oedema peripheral	General disorders	MedDRA 17.1	Systematic Assessment	EG0003 affected33 at risk EG0015 affected73 at risk
Pain	General disorders	MedDRA 17.1	Systematic Assessment	EG0002 affected33 at risk EG0012 affected73 at risk
Hyperbilirubinaemia	Hepatobiliary disorders	MedDRA 17.1	Systematic Assessment	EG0000 affected33 at risk EG0018 affected73 at risk
Acute sinusitis	Infections and infestations	MedDRA 17.1	Systematic Assessment	EG0001 affected33 at risk EG0014 affected73 at risk
Bronchitis	Infections and infestations	MedDRA 17.1	Systematic Assessment	EG0003 affected33 at risk EG00110 affected73 at risk
Chikungunya virus infection	Infections and infestations	MedDRA 17.1	Systematic Assessment	EG0002 affected33 at risk EG0011 affected73 at risk
Conjunctivitis	Infections and infestations	MedDRA 17.1	Systematic Assessment	EG0000 affected33 at risk EG0014 affected73 at risk
Folliculitis	Infections and infestations	MedDRA 17.1	Systematic Assessment	EG0002 affected33 at risk EG0015 affected73 at risk
Gastroenteritis	Infections and infestations	MedDRA 17.1	Systematic Assessment	EG0002 affected33 at risk EG0012 affected73 at risk
Herpes simplex	Infections and infestations	MedDRA 17.1	Systematic Assessment	EG0002 affected33 at risk EG0011 affected73 at risk
Influenza	Infections and infestations	MedDRA 17.1	Systematic Assessment	EG0004 affected33 at risk EG0018 affected73 at risk
Lower respiratory tract infection	Infections and infestations	MedDRA 17.1	Systematic Assessment	EG0001 affected33 at risk EG0015 affected73 at risk
Nasopharyngitis	Infections and infestations	MedDRA 17.1	Systematic Assessment	EG0006 affected33 at risk EG00114 affected73 at risk
Oral candidiasis	Infections and infestations	MedDRA 17.1	Systematic Assessment	EG0003 affected33 at risk EG0011 affected73 at risk
Pyuria	Infections and infestations	MedDRA 17.1	Systematic Assessment	EG0003 affected33 at risk EG0011 affected73 at risk
Rhinitis	Infections and infestations	MedDRA 17.1	Systematic Assessment	EG0002 affected33 at risk EG0014 affected73 at risk
Sinusitis	Infections and infestations	MedDRA 17.1	Systematic Assessment	EG0004 affected33 at risk EG0017 affected73 at risk
Syphilis	Infections and infestations	MedDRA 17.1	Systematic Assessment	EG0004 affected33 at risk EG0011 affected73 at risk
Tinea cruris	Infections and infestations	MedDRA 17.1	Systematic Assessment	EG0002 affected33 at risk EG0010 affected73 at risk
Tinea pedis	Infections and infestations	MedDRA 17.1	Systematic Assessment	EG0002 affected33 at risk EG0011 affected73 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA 17.1	Systematic Assessment	EG0001 affected33 at risk EG00115 affected73 at risk
Urethritis	Infections and infestations	MedDRA 17.1	Systematic Assessment	EG0002 affected33 at risk EG0011 affected73 at risk
Urinary tract infection	Infections and infestations	MedDRA 17.1	Systematic Assessment	EG0005 affected33 at risk EG0013 affected73 at risk
Blood alkaline phosphatase increased	Investigations	MedDRA 17.1	Systematic Assessment	EG0002 affected33 at risk EG0010 affected73 at risk
Blood creatine phosphokinase increased	Investigations	MedDRA 17.1	Systematic Assessment	EG0002 affected33 at risk EG0012 affected73 at risk
Glomerular filtration rate decreased	Investigations	MedDRA 17.1	Systematic Assessment	EG0002 affected33 at risk EG0012 affected73 at risk
Decreased appetite	Metabolism and nutrition disorders	MedDRA 17.1	Systematic Assessment	EG0003 affected33 at risk EG0015 affected73 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA 17.1	Systematic Assessment	EG0002 affected33 at risk EG0010 affected73 at risk
Gout	Metabolism and nutrition disorders	MedDRA 17.1	Systematic Assessment	EG0002 affected33 at risk EG0012 affected73 at risk
Hypercholesterolaemia	Metabolism and nutrition disorders	MedDRA 17.1	Systematic Assessment	EG0002 affected33 at risk EG0011 affected73 at risk
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA 17.1	Systematic Assessment	EG0002 affected33 at risk EG0012 affected73 at risk
Hyperlipidaemia	Metabolism and nutrition disorders	MedDRA 17.1	Systematic Assessment	EG0002 affected33 at risk EG0010 affected73 at risk
Hypertriglyceridaemia	Metabolism and nutrition disorders	MedDRA 17.1	Systematic Assessment	EG0000 affected33 at risk EG0014 affected73 at risk
Hypokalaemia	Metabolism and nutrition disorders	MedDRA 17.1	Systematic Assessment	EG0001 affected33 at risk EG0014 affected73 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 17.1	Systematic Assessment	EG0002 affected33 at risk EG0019 affected73 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 17.1	Systematic Assessment	EG0005 affected33 at risk EG0015 affected73 at risk
Muscle spasms	Musculoskeletal and connective tissue disorders	MedDRA 17.1	Systematic Assessment	EG0001 affected33 at risk EG0015 affected73 at risk
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	MedDRA 17.1	Systematic Assessment	EG0001 affected33 at risk EG0015 affected73 at risk
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA 17.1	Systematic Assessment	EG0003 affected33 at risk EG0016 affected73 at risk
Osteopenia	Musculoskeletal and connective tissue disorders	MedDRA 17.1	Systematic Assessment	EG0002 affected33 at risk EG0010 affected73 at risk
Osteoporosis	Musculoskeletal and connective tissue disorders	MedDRA 17.1	Systematic Assessment	EG0002 affected33 at risk EG0012 affected73 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA 17.1	Systematic Assessment	EG0004 affected33 at risk EG0014 affected73 at risk
Dizziness	Nervous system disorders	MedDRA 17.1	Systematic Assessment	EG0003 affected33 at risk EG0017 affected73 at risk
Headache	Nervous system disorders	MedDRA 17.1	Systematic Assessment	EG0006 affected33 at risk EG00110 affected73 at risk
Abnormal dreams	Psychiatric disorders	MedDRA 17.1	Systematic Assessment	EG0001 affected33 at risk EG0014 affected73 at risk
Depression	Psychiatric disorders	MedDRA 17.1	Systematic Assessment	EG0002 affected33 at risk EG0013 affected73 at risk
Insomnia	Psychiatric disorders	MedDRA 17.1	Systematic Assessment	EG0007 affected33 at risk EG0016 affected73 at risk
Haematuria	Renal and urinary disorders	MedDRA 17.1	Systematic Assessment	EG0001 affected33 at risk EG0016 affected73 at risk
Nephrolithiasis	Renal and urinary disorders	MedDRA 17.1	Systematic Assessment	EG0002 affected33 at risk EG0012 affected73 at risk
Renal cyst	Renal and urinary disorders	MedDRA 17.1	Systematic Assessment	EG0002 affected33 at risk EG0011 affected73 at risk
Benign prostatic hyperplasia	Reproductive system and breast disorders	MedDRA 17.1	Systematic Assessment	EG0000 affected33 at risk EG0014 affected73 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 17.1	Systematic Assessment	EG0002 affected33 at risk EG0018 affected73 at risk
Hiccups	Respiratory, thoracic and mediastinal disorders	MedDRA 17.1	Systematic Assessment	EG0002 affected33 at risk EG0010 affected73 at risk
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	MedDRA 17.1	Systematic Assessment	EG0002 affected33 at risk EG0012 affected73 at risk
Acne	Skin and subcutaneous tissue disorders	MedDRA 17.1	Systematic Assessment	EG0002 affected33 at risk EG0010 affected73 at risk
Actinic keratosis	Skin and subcutaneous tissue disorders	MedDRA 17.1	Systematic Assessment	EG0000 affected33 at risk EG0014 affected73 at risk
Dry skin	Skin and subcutaneous tissue disorders	MedDRA 17.1	Systematic Assessment	EG0002 affected33 at risk EG0010 affected73 at risk
Pruritus	Skin and subcutaneous tissue disorders	MedDRA 17.1	Systematic Assessment	EG0002 affected33 at risk EG0011 affected73 at risk
Rash	Skin and subcutaneous tissue disorders	MedDRA 17.1	Systematic Assessment	EG0002 affected33 at risk EG0018 affected73 at risk
Skin lesion	Skin and subcutaneous tissue disorders	MedDRA 17.1	Systematic Assessment	EG0000 affected33 at risk EG0015 affected73 at risk
Hypertension	Vascular disorders	MedDRA 17.1	Systematic Assessment	EG0002 affected33 at risk EG0015 affected73 at risk

ID	Term
D000163	Acquired Immunodeficiency Syndrome
D015658	HIV Infections

ID	Term
D000086982	Blood-Borne Infections
D003141	Communicable Diseases
D007239	Infections
D015229	Sexually Transmitted Diseases, Viral
D012749	Sexually Transmitted Diseases
D016180	Lentivirus Infections
D012192	Retroviridae Infections
D012327	RNA Virus Infections
D014777	Virus Diseases
D012897	Slow Virus Diseases
D000091662	Genital Diseases
D000091642	Urogenital Diseases
D007153	Immunologic Deficiency Syndromes
D007154	Immune System Diseases

ID	Term
D000069545	Elvitegravir, Cobicistat, Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination
D000069547	Cobicistat
D000069446	Atazanavir Sulfate
D000069454	Darunavir

ID	Term
D002219	Carbamates
D000144	Acids, Acyclic
D002264	Carboxylic Acids
D009930	Organic Chemicals
D000068698	Tenofovir
D063065	Organophosphonates
D009943	Organophosphorus Compounds
D013844	Thiazoles
D013457	Sulfur Compounds
D001393	Azoles
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds
D000068679	Emtricitabine
D003841	Deoxycytidine
D003562	Cytidine
D011741	Pyrimidine Nucleosides
D011743	Pyrimidines
D000225	Adenine
D011687	Purines
D006574	Heterocyclic Compounds, 2-Ring
D000072471	Heterocyclic Compounds, Fused-Ring
D003853	Deoxyribonucleosides
D009705	Nucleosides
D009706	Nucleic Acids, Nucleotides, and Nucleosides
D004338	Drug Combinations
D004364	Pharmaceutical Preparations
D011725	Pyridines
D009842	Oligopeptides
D010455	Peptides
D000602	Amino Acids, Peptides, and Proteins
D013449	Sulfonamides
D000577	Amides
D013450	Sulfones
D005663	Furans

ID	Title	Description
BG000	E/C/F/TDF (Cohort 1)	Main Study: Participants who had not received prior ARV treatment and who were virologically unsuppressed at baseline initiated treatment with E/C/F/TDF (150/150/200/300 mg) STR once daily for up to 96 weeks. Extension Phase: Participants continued their treatment until all participants discontinued from the study or commercial approval of E/C/F/TDF was received in the applicable country.
BG001	COBI+PI+2 NRTIs (Cohort 2)	Main Study: Participants who had received prior ARV treatment and who were virologically suppressed at baseline switched their regimen's pharmacoenhancer component from ritonavir to COBI 150 mg, while continuing the other components of their ARV regimen (ATV 300 mg or DRV 800 mg plus 2 NRTIs) for up to 96 weeks. These 2 NRTIs may have included ABC, 3TC/ZDV, DDI, FTC, ABC/3TC, 3TC, TDF, or FTC/TDF, administered according to prescribing information. Extension Phase: Participants continued their treatment until all participants discontinued from the study or commercial approval of cobicistat was received in the applicable country.
BG002	Total	Total of all reporting groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	E/C/F/TDF (Cohort 1)	Main Study: Participants who had not received prior ARV treatment and who were virologically unsuppressed at baseline initiated treatment with E/C/F/TDF (150/150/200/300 mg) STR once daily for up to 96 weeks. Extension Phase: Participants continued their treatment until all participants discontinued from the study or commercial approval of E/C/F/TDF was received in the applicable country.			6	33	31	33
EG001	COBI+PI+2 NRTIs (Cohort 2)	Main Study: Participants who had received prior ARV treatment and who were virologically suppressed at baseline switched their regimen's pharmacoenhancer component from ritonavir to COBI 150 mg, while continuing the other components of their ARV regimen (ATV 300 mg or DRV 800 mg plus 2 NRTI) for up to 96 weeks. These 2 NRTIs may have included ABC, 3TC/ZDV, DDI, FTC, ABC/3TC, 3TC, TDF, or FTC/TDF, administered according to prescribing information. Extension Phase: Participants continued their treatment until all participants discontinued from the study or commercial approval of cobicistat was received in the applicable country.			11	73	66	73