Study to Evaluate Effect of Sofosbuvir/Velpatasvir/GS-985... | NCT02533427

Label	Type	Description	Intervention Names
SOF/VEL/VOX + VOX	Experimental	Part A: Participants without a documented history of taking norgestimate/ethinyl estradiol for at least one menstrual cycle will receive norgestimate/ethinyl estradiol. Participants with a documented history of taking norgestimate/ethinyl estradiol may enroll directly into Part B of the study. Part B: Participants will continue taking norgestimate/ethinyl estradiol for the remainder of the study and will receive SOF/VEL/VOX FDC plus VOX.	Drug: SOF/VEL/VOX Drug: VOX Drug: Norgestimate/ethinyl estradiol

Name	Type	Description	Arm Group Labels	Other Names
SOF/VEL/VOX	Drug	400/100/100 mg FDC tablet administered orally once daily	SOF/VEL/VOX + VOX

Measure	Description	Time Frame
Pharmacokinetic (PK) Parameter: AUCtau of Norelgestromin	AUCtau is defined as concentration of drug over time (the area under the concentration verses time curve over the dosing interval).	Cycle 1,Study Day 14: Predose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 14, 16, 20, and 24 hours postdose; Cycle 2,Study Day 42: Predose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 14, 16, 20, and 24 hours postdose
PK Parameter: AUCtau of Norgestrel	AUCtau is defined as concentration of drug over time (the area under the concentration verses time curve over the dosing interval).	Cycle 1,Study Day 14: Predose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 14, 16, 20, and 24 hours postdose; Cycle 2,Study Day 42: Predose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 14, 16, 20, and 24 hours postdose
PK Parameter: AUCtau of Ethinyl Estradiol	AUCtau is defined as concentration of drug over time (the area under the concentration verses time curve over the dosing interval).	Cycle 1,Study Day 14: Predose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 14, 16, 20, and 24 hours postdose; Cycle 2,Study Day 42: Predose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 14, 16, 20, and 24 hours postdose
Pharmacokinetic (PK) Parameter: AUCtau of Norgestimate	AUCtau is defined as concentration of drug over time (the area under the concentration verses time curve over the dosing interval).	Cycle 1,Study Day 14:Predose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 14, 16, 20, and 24 hours postdose; Cycle 2,Study Day 42: Predose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 14, 16, 20, and 24 hours postdose
PK Parameter: Cmax of Norelgestromin	Cmax is defined as the maximum concentration of drug.

Measure	Description	Time Frame
Percentage of Participants Who Experienced Treatment-Emergent Adverse Events		First dose date up to the last dose date (maximum: 84 days) plus 10 days
Percentage of Participants Who Experienced Laboratory Abnormalities	Treatment-emergent laboratory abnormalities were defined as values that increase at least one toxicity grade from baseline. The most severe graded abnormality from all tests was counted for each participant. Grade 1: mild; Grade 2: moderate;Grade 3: severe or medically significant but not immediately life-threatening; Grade 4: life-threatening consequences.

Name	Affiliation	Role
Gilead Study Director	Gilead Sciences	Study Director

ID	Title	Description
FG000	NGM/EE + SOF/VEL/VOX + VOX (Part A and Part B)	Part A: Participants without a documented history of taking norgestimate/ethinyl estradiol (NGM/EE) for at least one menstrual cycle received NGM 0.180 mg/0.215 mg/0.25 mg/ EE 0.025 mg tablet orally once daily for one cycle (cycle=28 days). Part B: Participants continued NGM/EE through Cycle 1 and 2 received sofosbuvir (SOF)/velpatasvir (VEL)/voxilaprevir (VOX) fixed dose combination (FDC) 400/100/100 mg tablet + VOX 100 mg tablet orally once daily during cycle 2 (cycle=28 days).

ID	Title	Description
BG000	NGM/EE + SOF/VEL/VOX + VOX (Part A and Part B)	Part A: Participants without a documented history of taking norgestimate/ethinyl estradiol (NGM/EE) for at least one menstrual cycle received NGM 0.180 mg/0.215 mg/0.25 mg/ EE 0.025 mg tablet orally once daily for one cycle (cycle=28 days). Part B: Participants continued NGM/EE through Cycle 1 and 2 received sofosbuvir (SOF)/velpatasvir (VEL)/voxilaprevir (VOX) fixed dose combination (FDC) 400/100/100 mg tablet + VOX 100 mg tablet orally once daily during cycle 2 (cycle=28 days).

Units	Counts
Participants	BG00015

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

Pharmacokinetic (PK) Parameter: AUCtau of Norelgestromin

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

The PK Analysis Set included all enrolled participants who took at least 1 dose of study drug and had at least 1 non-missing postdose plasma concentration value reported.

Posted

Mean

Standard Deviation

hours*picogram/milliliter (h*pg/mL)

Cycle 1,Study Day 14: Predose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 14, 16, 20, and 24 hours postdose; Cycle 2,Study Day 42: Predose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 14, 16, 20, and 24 hours postdose

ID	Title	Description
OG000	Part A: NGM/EE	Participants received NGM 0.180 mg/0.215 mg/0.25 mg/ EE 0.025 mg tablet orally once daily for cycle 1 (cycle = 28 days).
OG001	Part B: NGM/EE + SOF/VEL/VOX + VOX	Participants received NGM 0.180 mg/0.215 mg/0.25 mg/ EE 0.025 mg + sofosbuvir (SOF)/velpatasvir (VEL)/voxilaprevir (VOX) FDC 400/100/100 mg tablet + VOX 100 mg tablet orally once daily during cycle 2 (cycle = 28 days).

Units	Counts
Participants	OG00015 OG00115

Title

Denominators

Categories

Title	Measurements
	OG00013757.4± 2478.44 OG00114690.4± 2116.43

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001	Norelgestromin Part B/Part A					% Geometric Least Square Mean(GLSM)Ratio	107.36			2-Sided	90	103.19	111.69			Test/Reference: Norelgestromin Part B/Part A		Other

Primary

PK Parameter: AUCtau of Norgestrel

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

Participants in the PK Analysis Set were analyzed.

Posted

Mean

Standard Deviation

hours*nanogram/milliliter (h*ng/mL)

ID	Title	Description
OG000	Part A: NGM/EE	Participants received NGM 0.180 mg/0.215 mg/0.25 mg/ EE 0.025 mg tablet orally once daily for cycle 1 (cycle = 28 days).
OG001	Part B: NGM/EE + SOF/VEL/VOX + VOX	Participants received NGM 0.180 mg/0.215 mg/0.25 mg/ EE 0.025 mg + sofosbuvir (SOF)/velpatasvir (VEL)/voxilaprevir (VOX) FDC 400/100/100 mg tablet + VOX 100 mg tablet orally once daily during cycle 2 (cycle = 28 days).

Units	Counts
Participants

Primary

PK Parameter: AUCtau of Ethinyl Estradiol

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

Participants in the PK Analysis Set were analyzed.

Posted

Mean

Standard Deviation

h*pg/mL

ID	Title	Description
OG000	Part A: NGM/EE	Participants received NGM 0.180 mg/0.215 mg/0.25 mg/ EE 0.025 mg tablet orally once daily for cycle 1 (cycle = 28 days).
OG001	Part B: NGM/EE + SOF/VEL/VOX + VOX	Participants received NGM 0.180 mg/0.215 mg/0.25 mg/ EE 0.025 mg + sofosbuvir (SOF)/velpatasvir (VEL)/voxilaprevir (VOX) FDC 400/100/100 mg tablet + VOX 100 mg tablet orally once daily during cycle 2 (cycle = 28 days).

Units	Counts
Participants

Primary

Pharmacokinetic (PK) Parameter: AUCtau of Norgestimate

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

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

Posted

Mean

Standard Deviation

h*ng/mL

Cycle 1,Study Day 14:Predose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 14, 16, 20, and 24 hours postdose; Cycle 2,Study Day 42: Predose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 14, 16, 20, and 24 hours postdose

ID	Title	Description
OG000	Part A: NGM/EE	Participants received NGM 0.180 mg/0.215 mg/0.25 mg/ EE 0.025 mg tablet orally once daily for cycle 1 (cycle = 28 days).
OG001	Part B: NGM/EE + SOF/VEL/VOX + VOX	Participants received NGM 0.180 mg/0.215 mg/0.25 mg/ EE 0.025 mg + sofosbuvir (SOF)/velpatasvir (VEL)/voxilaprevir (VOX) FDC 400/100/100 mg tablet + VOX 100 mg tablet orally once daily during cycle 2 (cycle = 28 days).

Units	Counts
Participants

Primary

PK Parameter: Cmax of Norelgestromin

Cmax is defined as the maximum concentration of drug.

Participants in the PK Analysis Set were analyzed.

Posted

Mean

Standard Deviation

pg/mL

Cycle 1,Study Day 14:Predose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 14, 16, 20, and 24 hours postdose; Cycle 2,Study Day 42: Predose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 14, 16, 20, and 24 hours postdose

ID	Title	Description
OG000	Part A: NGM/EE	Participants received NGM 0.180 mg/0.215 mg/0.25 mg/ EE 0.025 mg tablet orally once daily for cycle 1 (cycle = 28 days).
OG001	Part B: NGM/EE + SOF/VEL/VOX + VOX	Participants received NGM 0.180 mg/0.215 mg/0.25 mg/ EE 0.025 mg + sofosbuvir (SOF)/velpatasvir (VEL)/voxilaprevir (VOX) FDC 400/100/100 mg tablet + VOX 100 mg tablet orally once daily during cycle 2 (cycle = 28 days).

Units	Counts
Participants	OG000

Primary

PK Parameter: Cmax of Norgestrel

Cmax is defined as the maximum concentration of drug.

Participants in the PK Analysis Set were analyzed.

Posted

Mean

Standard Deviation

ng/mL

ID	Title	Description
OG000	Part A: NGM/EE	Participants received NGM 0.180 mg/0.215 mg/0.25 mg/ EE 0.025 mg tablet orally once daily for cycle 1 (cycle = 28 days).
OG001	Part B: NGM/EE + SOF/VEL/VOX + VOX	Participants received NGM 0.180 mg/0.215 mg/0.25 mg/ EE 0.025 mg + sofosbuvir (SOF)/velpatasvir (VEL)/voxilaprevir (VOX) FDC 400/100/100 mg tablet + VOX 100 mg tablet orally once daily during cycle 2 (cycle = 28 days).

Units	Counts
Participants	OG000

Primary

PK Parameter: Cmax of Ethinyl Estradiol

Cmax is defined as the maximum concentration of drug.

Participants in the PK Analysis Set were analyzed.

Posted

Mean

Standard Deviation

pg/mL

ID	Title	Description
OG000	Part A: NGM/EE	Participants received NGM 0.180 mg/0.215 mg/0.25 mg/ EE 0.025 mg tablet orally once daily for cycle 1 (cycle = 28 days).
OG001	Part B: NGM/EE + SOF/VEL/VOX + VOX	Participants received NGM 0.180 mg/0.215 mg/0.25 mg/ EE 0.025 mg + sofosbuvir (SOF)/velpatasvir (VEL)/voxilaprevir (VOX) FDC 400/100/100 mg tablet + VOX 100 mg tablet orally once daily during cycle 2 (cycle = 28 days).

Units	Counts
Participants	OG000

Primary

PK Parameter: Cmax of Norgestimate

Cmax is defined as the maximum concentration of drug.

Participants in the PK Analysis Set were analyzed.

Posted

Mean

Standard Deviation

ng/mL

ID	Title	Description
OG000	Part A: NGM/EE	Participants received NGM 0.180 mg/0.215 mg/0.25 mg/ EE 0.025 mg tablet orally once daily for cycle 1 (cycle = 28 days).
OG001	Part B: NGM/EE + SOF/VEL/VOX + VOX	Participants received NGM 0.180 mg/0.215 mg/0.25 mg/ EE 0.025 mg + sofosbuvir (SOF)/velpatasvir (VEL)/voxilaprevir (VOX) FDC 400/100/100 mg tablet + VOX 100 mg tablet orally once daily during cycle 2 (cycle = 28 days).

Units	Counts
Participants	OG000

Primary

PK Parameter: Ctau of Norelgestromin

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

Participants in the PK Analysis Set were analyzed.

Posted

Mean

Standard Deviation

picogram/milliliter (pg/mL)

Part A:Cycle 1,Study Day 14:Predose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 14, 16, 20, and 24 hours postdose; Part B:Cycle 2,Study Day 42:Predose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 14, 16, 20, and 24 hours postdose

ID	Title	Description
OG000	Part A: NGM/EE	Participants received NGM 0.180 mg/0.215 mg/0.25 mg/ EE 0.025 mg tablet orally once daily for cycle 1 (cycle = 28 days).
OG001	Part B: NGM/EE + SOF/VEL/VOX + VOX	Participants received NGM 0.180 mg/0.215 mg/0.25 mg/ EE 0.025 mg + sofosbuvir (SOF)/velpatasvir (VEL)/voxilaprevir (VOX) FDC 400/100/100 mg tablet + VOX 100 mg tablet orally once daily during cycle 2 (cycle = 28 days).

Units	Counts
Participants

Primary

PK Parameter: Ctau of Norgestrel

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

Participants in the PK Analysis Set were analyzed.

Posted

Mean

Standard Deviation

nanogram/milliliter (ng/mL)

ID	Title	Description
OG000	Part A: NGM/EE	Participants received NGM 0.180 mg/0.215 mg/0.25 mg/ EE 0.025 mg tablet orally once daily for cycle 1 (cycle = 28 days).
OG001	Part B: NGM/EE + SOF/VEL/VOX + VOX	Participants received NGM 0.180 mg/0.215 mg/0.25 mg/ EE 0.025 mg + sofosbuvir (SOF)/velpatasvir (VEL)/voxilaprevir (VOX) FDC 400/100/100 mg tablet + VOX 100 mg tablet orally once daily during cycle 2 (cycle = 28 days).

Units	Counts
Participants

Primary

PK Parameter: Ctau of Ethinyl Estradiol

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

Participants in the PK Analysis Set were analyzed.

Posted

Mean

Standard Deviation

pg/mL

ID	Title	Description
OG000	Part A: NGM/EE	Participants received NGM 0.180 mg/0.215 mg/0.25 mg/ EE 0.025 mg tablet orally once daily for cycle 1 (cycle = 28 days).
OG001	Part B: NGM/EE + SOF/VEL/VOX + VOX	Participants received NGM 0.180 mg/0.215 mg/0.25 mg/ EE 0.025 mg + sofosbuvir (SOF)/velpatasvir (VEL)/voxilaprevir (VOX) FDC 400/100/100 mg tablet + VOX 100 mg tablet orally once daily during cycle 2 (cycle = 28 days).

Units	Counts
Participants	OG000

Primary

PK Parameter: Ctau of Norgestimate

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

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

Posted

Mean

Standard Deviation

ng/mL

Cycle 1,Study Day 14: Predose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 14, 16, 20, and 24 hours postdose;Cycle 2,Study Day 42: Predose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 14, 16, 20, and 24 hours postdose

ID	Title	Description
OG000	Part A: NGM/EE	Participants received NGM 0.180 mg/0.215 mg/0.25 mg/ EE 0.025 mg tablet orally once daily for cycle 1 (cycle = 28 days).
OG001	Part B: NGM/EE + SOF/VEL/VOX + VOX	Participants received NGM 0.180 mg/0.215 mg/0.25 mg/ EE 0.025 mg + sofosbuvir (SOF)/velpatasvir (VEL)/voxilaprevir (VOX) FDC 400/100/100 mg tablet + VOX 100 mg tablet orally once daily during cycle 2 (cycle = 28 days).

Units	Counts
Participants

Secondary

Percentage of Participants Who Experienced Treatment-Emergent Adverse Events

The Safety Analysis Set included all enrolled participants who took at least 1 dose of study drug.

Posted

Number

percentage of participants

First dose date up to the last dose date (maximum: 84 days) plus 10 days

ID	Title	Description
OG000	Part A: NGM/EE	Participants received NGM 0.180 mg/0.215 mg/0.25 mg/ EE 0.025 mg tablet orally once daily for cycle 1 (cycle = 28 days).
OG001	Part B: NGM/EE + SOF/VEL/VOX + VOX	Participants received NGM 0.180 mg/0.215 mg/0.25 mg/ EE 0.025 mg + sofosbuvir (SOF)/velpatasvir (VEL)/voxilaprevir (VOX) FDC 400/100/100 mg tablet + VOX 100 mg tablet orally once daily during cycle 2 (cycle = 28 days).

Units	Counts
Participants	OG000

Secondary

Percentage of Participants Who Experienced Laboratory Abnormalities

Treatment-emergent laboratory abnormalities were defined as values that increase at least one toxicity grade from baseline. The most severe graded abnormality from all tests was counted for each participant. Grade 1: mild; Grade 2: moderate;Grade 3: severe or medically significant but not immediately life-threatening; Grade 4: life-threatening consequences.

Participants in the Safety Analysis Set were analyzed.

Posted

Number

percentage of participants

First dose date up to the last dose date (maximum: 84 days) plus 10 days

ID	Title	Description
OG000	Part A: NGM/EE	Participants received NGM 0.180 mg/0.215 mg/0.25 mg/ EE 0.025 mg tablet orally once daily for cycle 1 (cycle = 28 days).
OG001	Part B: NGM/EE + SOF/VEL/VOX + VOX	Participants received NGM 0.180 mg/0.215 mg/0.25 mg/ EE 0.025 mg + sofosbuvir (SOF)/velpatasvir (VEL)/voxilaprevir (VOX) FDC 400/100/100 mg tablet + VOX 100 mg tablet orally once daily during cycle 2 (cycle = 28 days).

Units	Counts
Participants

Secondary

PK Parameter: Tmax of Norelgestromin, Norgestrel, Ethinyl Estradiol, and Norgestimate

Tmax is defined as the time (observed time point) of Cmax.

Participants in the PK Analysis Set with available were analyzed.

Posted

Median

Inter-Quartile Range

hours

ID	Title	Description
OG000	Part A: NGM/EE	Participants received NGM 0.180 mg/0.215 mg/0.25 mg/ EE 0.025 mg tablet orally once daily for cycle 1 (cycle = 28 days).
OG001	Part B: NGM/EE + SOF/VEL/VOX + VOX	Participants received NGM 0.180 mg/0.215 mg/0.25 mg/ EE 0.025 mg + sofosbuvir (SOF)/velpatasvir (VEL)/voxilaprevir (VOX) FDC 400/100/100 mg tablet + VOX 100 mg tablet orally once daily during cycle 2 (cycle = 28 days).

Units	Counts
Participants

Secondary

PK Parameter: Tlast of Norelgestromin, Norgestrel, Ethinyl Estradiol, and Norgestimate

Tlast is defined as the time (observed time point) of Clast.

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

Posted

Median

Inter-Quartile Range

hours

ID	Title	Description
OG000	Part A: NGM/EE	Participants received NGM 0.180 mg/0.215 mg/0.25 mg/ EE 0.025 mg tablet orally once daily for cycle 1 (cycle = 28 days).
OG001	Part B: NGM/EE + SOF/VEL/VOX + VOX	Participants received NGM 0.180 mg/0.215 mg/0.25 mg/ EE 0.025 mg + sofosbuvir (SOF)/velpatasvir (VEL)/voxilaprevir (VOX) FDC 400/100/100 mg tablet + VOX 100 mg tablet orally once daily during cycle 2 (cycle = 28 days).

Units	Counts
Participants

Secondary

PK Parameter: λz of Norelgestromin, Norgestrel, Ethinyl Estradiol, and Norgestimate

λz is defined as the terminal elimination rate constant, estimated by linear regression of the terminal elimination phase of the log plasma concentration of drug versus time curve of the drug.

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

Posted

Mean

Standard Deviation

1/hours (1/h)

Cycle 1,Study Day 14: Predose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 14, 16, 20, and 24 hours postdose; Cycle 2,Study Day 42:Predose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 14, 16, 20, and 24 hours postdose

ID	Title	Description
OG000	Part A: NGM/EE	Participants received NGM 0.180 mg/0.215 mg/0.25 mg/ EE 0.025 mg tablet orally once daily for cycle 1 (cycle = 28 days).
OG001	Part B: NGM/EE + SOF/VEL/VOX + VOX	Participants received NGM 0.180 mg/0.215 mg/0.25 mg/ EE 0.025 mg + sofosbuvir (SOF)/velpatasvir (VEL)/voxilaprevir (VOX) FDC 400/100/100 mg tablet + VOX 100 mg tablet orally once daily during cycle 2 (cycle = 28 days).

Units	Counts
Participants

Secondary

PK Parameter: t1/2 of Norelgestromin, Norgestrel, Ethinyl Estradiol, and Norgestimate

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

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

Posted

Median

Inter-Quartile Range

hours

ID	Title	Description
OG000	Part A: NGM/EE	Participants received NGM 0.180 mg/0.215 mg/0.25 mg/ EE 0.025 mg tablet orally once daily for cycle 1 (cycle = 28 days).
OG001	Part B: NGM/EE + SOF/VEL/VOX + VOX	Participants received NGM 0.180 mg/0.215 mg/0.25 mg/ EE 0.025 mg + sofosbuvir (SOF)/velpatasvir (VEL)/voxilaprevir (VOX) FDC 400/100/100 mg tablet + VOX 100 mg tablet orally once daily during cycle 2 (cycle = 28 days).

Units	Counts
Participants

Secondary

PK Parameter: CLss/F Ethinyl Estradiol, and Norgestimate

CLss/F is defined as the apparent steady state oral clearance following administration of the drug.

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

Posted

Mean

Standard Deviation

milliliter/hour (mL/h)

\Cycle 1,Study Day 14: Predose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 14, 16, 20, and 24 hours postdose; Cycle 2,Study Day 42: Predose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 14, 16, 20, and 24 hours postdose

ID	Title	Description
OG000	Part A: NGM/EE	Participants received NGM 0.180 mg/0.215 mg/0.25 mg/ EE 0.025 mg tablet orally once daily for cycle 1 (cycle = 28 days).
OG001	Part B: NGM/EE + SOF/VEL/VOX + VOX	Participants received NGM 0.180 mg/0.215 mg/0.25 mg/ EE 0.025 mg + sofosbuvir (SOF)/velpatasvir (VEL)/voxilaprevir (VOX) FDC 400/100/100 mg tablet + VOX 100 mg tablet orally once daily during cycle 2 (cycle = 28 days).

Units	Counts
Participants

Secondary

PK Parameter: Cmax of Sofosbuvir (SOF), SOF Metabolites (GS-566500 and GS-331007), Velpatasvir (VEL), and Voxilaprevir (VOX)

Cmax is defined as the maximum concentration of drug.

Participants in the PK Analysis Set who were enrolled in Part B and received NGM+ SOV/VEL/VOX + VOX were analyzed.

Posted

Mean

Standard Deviation

ng/mL

Cycle 2, Study Day 42: Predose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 14, 16, 20, and 24 hours postdose

ID	Title	Description
OG000	Part B: NGM/EE + SOF/VEL/VOX + VOX	Participants received NGM 0.180 mg/0.215 mg/0.25 mg/ EE 0.025 mg + sofosbuvir (SOF)/velpatasvir (VEL)/voxilaprevir (VOX) FDC 400/100/100 mg tablet + VOX 100 mg tablet orally once daily during cycle 2 (cycle = 28 days).

Units	Counts
Participants	OG000

Secondary

PK Parameter: Tmax of SOF, SOF Metabolites (GS-566500 and GS-331007), VEL, and VOX

Tmax is defined as the time (observed time point) of Cmax.

Participants in the PK Analysis Set who were enrolled in Part B and received NGM+ SOV/VEL/VOX + VOX were analyzed.

Posted

Median

Inter-Quartile Range

hours

Cycle 2, Study Day 42: Predose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 14, 16, 20, and 24 hours postdose

ID	Title	Description
OG000	Part B: NGM/EE + SOF/VEL/VOX + VOX	Participants received NGM 0.180 mg/0.215 mg/0.25 mg/ EE 0.025 mg + sofosbuvir (SOF)/velpatasvir (VEL)/voxilaprevir (VOX) FDC 400/100/100 mg tablet + VOX 100 mg tablet orally once daily during cycle 2 (cycle = 28 days).

Units	Counts
Participants	OG000

Secondary

PK Parameter: Tlast of SOF, SOF Metabolites (GS-566500 and GS-331007), VEL, and VOX

Tlast is defined as the time (observed time point) of Clast.

Participants in the PK Analysis Set who were enrolled in Part B and received NGM+ SOV/VEL/VOX + VOX were analyzed.

Posted

Median

Inter-Quartile Range

hours

Cycle 2, Study Day 42: Predose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 14, 16, 20, and 24 hours postdose

ID	Title	Description
OG000	Part B: NGM/EE + SOF/VEL/VOX + VOX	Participants received NGM 0.180 mg/0.215 mg/0.25 mg/ EE 0.025 mg + sofosbuvir (SOF)/velpatasvir (VEL)/voxilaprevir (VOX) FDC 400/100/100 mg tablet + VOX 100 mg tablet orally once daily during cycle 2 (cycle = 28 days).

Units	Counts
Participants	OG000

Secondary

PK Parameter: Ctau of SOF Metabolites (GS-566500 and GS-331007), VEL, and VOX

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

Participants in the PK Analysis Set who were enrolled in Part B and received NGM+ SOV/VEL/VOX + VOX were analyzed.

Posted

Mean

Standard Deviation

ng/mL

Cycle 2, Study Day 42: Predose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 14, 16, 20, and 24 hours postdose

ID	Title	Description
OG000	Part B: NGM/EE + SOF/VEL/VOX + VOX	Participants received NGM 0.180 mg/0.215 mg/0.25 mg/ EE 0.025 mg + sofosbuvir (SOF)/velpatasvir (VEL)/voxilaprevir (VOX) FDC 400/100/100 mg tablet + VOX 100 mg tablet orally once daily during cycle 2 (cycle = 28 days).

Units	Counts
Participants	OG000

Secondary

PK Parameter: λz of SOF, SOF Metabolites (GS-566500 and GS-331007), VEL, and VOX

λz is defined as the terminal elimination rate constant, estimated by linear regression of the terminal elimination phase of the log plasma concentration of drug versus time curve of the drug.

Participants in the PK Analysis Set who were enrolled in Part B and received NGM+ SOV/VEL/VOX + VOX were analyzed.

Posted

Mean

Standard Deviation

1/h

Cycle 2, Study Day 42: Predose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 14, 16, 20, and 24 hours postdose

ID	Title	Description
OG000	Part B: NGM/EE + SOF/VEL/VOX + VOX	Participants received NGM 0.180 mg/0.215 mg/0.25 mg/ EE 0.025 mg + sofosbuvir (SOF)/velpatasvir (VEL)/voxilaprevir (VOX) FDC 400/100/100 mg tablet + VOX 100 mg tablet orally once daily during cycle 2 (cycle = 28 days).

Units	Counts
Participants	OG000

Secondary

PK Parameter: AUCtau of SOF, SOF Metabolites (GS-566500 and GS-331007), VEL, and VOX

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

Participants in the PK Analysis Set who were enrolled in Part B and received NGM+ SOV/VEL/VOX + VOX were analyzed.

Posted

Mean

Standard Deviation

h*ng/mL

Cycle 2, Study Day 42: Predose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 14, 16, 20, and 24 hours postdose

ID	Title	Description
OG000	Part B: NGM/EE + SOF/VEL/VOX + VOX	Participants received NGM 0.180 mg/0.215 mg/0.25 mg/ EE 0.025 mg + sofosbuvir (SOF)/velpatasvir (VEL)/voxilaprevir (VOX) FDC 400/100/100 mg tablet + VOX 100 mg tablet orally once daily during cycle 2 (cycle = 28 days).

Units	Counts
Participants	OG000

Secondary

PK Parameter: CLss/F of SOF, VEL, and VOX

CLss/F is defined as the apparent steady state oral clearance following administration of the drug.

Participants in the PK Analysis Set who were enrolled in Part B and received NGM+ SOV/VEL/VOX + VOX were analyzed.

Posted

Mean

Standard Deviation

mL/h

Cycle 2, Study Day 42: Predose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 14, 16, 20, and 24 hours postdose

ID	Title	Description
OG000	Part B: NGM/EE + SOF/VEL/VOX + VOX	Participants received NGM 0.180 mg/0.215 mg/0.25 mg/ EE 0.025 mg + sofosbuvir (SOF)/velpatasvir (VEL)/voxilaprevir (VOX) FDC 400/100/100 mg tablet + VOX 100 mg tablet orally once daily during cycle 2 (cycle = 28 days).

Units	Counts
Participants	OG000

Secondary

PK Parameter: t1/2 of SOF, SOF Metabolites (GS-566500 and GS-331007), VEL, and VOX

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

Participants in the PK Analysis Set who were enrolled in Part B and received NGM+ SOV/VEL/VOX + VOX were analyzed.

Posted

Median

Inter-Quartile Range

hours

Cycle 2, Study Day 42: Predose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 14, 16, 20, and 24 hours postdose

ID	Title	Description
OG000	Part B: NGM/EE + SOF/VEL/VOX + VOX	Participants received NGM 0.180 mg/0.215 mg/0.25 mg/ EE 0.025 mg + sofosbuvir (SOF)/velpatasvir (VEL)/voxilaprevir (VOX) FDC 400/100/100 mg tablet + VOX 100 mg tablet orally once daily during cycle 2 (cycle = 28 days).

Units	Counts
Participants	OG000

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Abdominal discomfort	Gastrointestinal disorders	MedDRA (19.0)	Systematic Assessment	EG0000 affected15 at risk EG0011 affected15 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA (19.0)	Systematic Assessment	EG0000 affected15 at risk EG0013 affected15 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA (19.0)	Systematic Assessment	EG0002 affected15 at risk EG0015 affected15 at risk
Flatulence	Gastrointestinal disorders	MedDRA (19.0)	Systematic Assessment	EG0000 affected15 at risk EG0012 affected15 at risk
Gingival ulceration	Gastrointestinal disorders	MedDRA (19.0)	Systematic Assessment	EG0000 affected15 at risk EG0011 affected15 at risk
Nausea	Gastrointestinal disorders	MedDRA (19.0)	Systematic Assessment	EG0001 affected15 at risk EG0019 affected15 at risk
Vomiting	Gastrointestinal disorders	MedDRA (19.0)	Systematic Assessment	EG0000 affected15 at risk EG0013 affected15 at risk
Chills	General disorders	MedDRA (19.0)	Systematic Assessment	EG0001 affected15 at risk EG0010 affected15 at risk
Fatigue	General disorders	MedDRA (19.0)	Systematic Assessment	EG0000 affected15 at risk EG0013 affected15 at risk
Hypersensitivity	Immune system disorders	MedDRA (19.0)	Systematic Assessment	EG0001 affected15 at risk EG0010 affected15 at risk
Oral herpes	Infections and infestations	MedDRA (19.0)	Systematic Assessment	EG0000 affected15 at risk EG0011 affected15 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA (19.0)	Systematic Assessment	EG0002 affected15 at risk EG0010 affected15 at risk
Urinary tract infection	Infections and infestations	MedDRA (19.0)	Systematic Assessment	EG0001 affected15 at risk EG0010 affected15 at risk
Arthropod bite	Injury, poisoning and procedural complications	MedDRA (19.0)	Systematic Assessment	EG0001 affected15 at risk EG0010 affected15 at risk
Skin abrasion	Injury, poisoning and procedural complications	MedDRA (19.0)	Systematic Assessment	EG0000 affected15 at risk EG0011 affected15 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA (19.0)	Systematic Assessment	EG0000 affected15 at risk EG0011 affected15 at risk
Dizziness	Nervous system disorders	MedDRA (19.0)	Systematic Assessment	EG0002 affected15 at risk EG0010 affected15 at risk
Headache	Nervous system disorders	MedDRA (19.0)	Systematic Assessment	EG0006 affected15 at risk EG0016 affected15 at risk
Presyncope	Nervous system disorders	MedDRA (19.0)	Systematic Assessment	EG0001 affected15 at risk EG0010 affected15 at risk
Metrorrhagia	Reproductive system and breast disorders	MedDRA (19.0)	Systematic Assessment	EG0001 affected15 at risk EG0011 affected15 at risk
Nasal congestion	Respiratory, thoracic and mediastinal disorders	MedDRA (19.0)	Systematic Assessment	EG0001 affected15 at risk EG0010 affected15 at risk

ID	Term
D000086982	Blood-Borne Infections
D003141	Communicable Diseases
D007239	Infections
D006525	Hepatitis, Viral, Human
D014777	Virus Diseases
D018178	Flaviviridae Infections
D012327	RNA Virus Infections
D006505	Hepatitis
D008107	Liver Diseases
D004066	Digestive System Diseases

ID	Term
C000611331	sofosbuvir-velpatasvir drug combination
C000619503	voxilaprevir
D000077266	Moxifloxacin

ID	Term
D024841	Fluoroquinolones
D042462	4-Quinolones
D015363	Quinolones
D011804	Quinolines
D006574	Heterocyclic Compounds, 2-Ring
D000072471	Heterocyclic Compounds, Fused-Ring
D006571	Heterocyclic Compounds

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Part A: NGM/EE	Participants received NGM 0.180 mg/0.215 mg/0.25 mg/ EE 0.025 mg tablet orally once daily for 1 cycle (cycle = 28 days).	0	15	0	15	10	15
EG001	Part B: NGM/EE + SOF/VEL/VOX + VOX	Participants received NGM 0.180 mg/0.215 mg/0.25 mg/ EE 0.025 mg + sofosbuvir (SOF)/velpatasvir (VEL)/voxilaprevir (VOX) FDC 400/100/100 mg tablet + VOX 100 mg orally once daily for 2 cycles (cycle = 28 days).	0	15	0	15	14	15