Trial Outcomes & Findings for Study to Evaluate Effect of Sofosbuvir/Velpatasvir/GS-9857 Fixed-Dose Combination on the Pharmacokinetics of a Representative Hormonal Contraceptive Medication, Norgestimate/Ethinyl Estradiol (NCT NCT02533427)

Results Overview

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

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

15 participants

Primary outcome timeframe

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

Results posted on

2020-09-02

Participant Flow

Participants were enrolled at a study site in New Zealand. The first participant was screened on 29 October 2015. The last study visit occurred on 18 March 2016.

15 participants were screened.

Participant milestones

Participant milestones
Measure	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).
Overall Study STARTED	15
Overall Study COMPLETED	15
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Study to Evaluate Effect of Sofosbuvir/Velpatasvir/GS-9857 Fixed-Dose Combination on the Pharmacokinetics of a Representative Hormonal Contraceptive Medication, Norgestimate/Ethinyl Estradiol

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	NGM/EE + SOF/VEL/VOX + VOX (Part A and Part B) n=15 Participants 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).
Age, Continuous	24 years STANDARD_DEVIATION 4.8 • n=99 Participants
Sex: Female, Male Female	15 Participants n=99 Participants
Sex: Female, Male Male	0 Participants n=99 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=99 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	15 Participants n=99 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=99 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=99 Participants
Race (NIH/OMB) Asian	0 Participants n=99 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	1 Participants n=99 Participants
Race (NIH/OMB) Black or African American	0 Participants n=99 Participants
Race (NIH/OMB) White	14 Participants n=99 Participants
Race (NIH/OMB) More than one race	0 Participants n=99 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=99 Participants

PRIMARY outcome

Timeframe: 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

Population: 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.

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

Outcome measures

Outcome measures
Measure	Part A: NGM/EE n=15 Participants 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).	Part B: NGM/EE + SOF/VEL/VOX + VOX n=15 Participants 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).
Pharmacokinetic (PK) Parameter: AUCtau of Norelgestromin	13757.4 hourspicogram/milliliter (hpg/mL) Standard Deviation 2478.44	14690.4 hourspicogram/milliliter (hpg/mL) Standard Deviation 2116.43

PRIMARY outcome

Timeframe: 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

Population: Participants in the PK Analysis Set were analyzed.

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

Outcome measures

Outcome measures
Measure	Part A: NGM/EE n=15 Participants 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).	Part B: NGM/EE + SOF/VEL/VOX + VOX n=15 Participants 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).
PK Parameter: AUCtau of Norgestrel	41.1 hoursnanogram/milliliter (hng/mL) Standard Deviation 11.05	47.3 hoursnanogram/milliliter (hng/mL) Standard Deviation 13.19

PRIMARY outcome

Timeframe: 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

Population: Participants in the PK Analysis Set were analyzed.

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

Outcome measures

Outcome measures
Measure	Part A: NGM/EE n=15 Participants 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).	Part B: NGM/EE + SOF/VEL/VOX + VOX n=15 Participants 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).
PK Parameter: AUCtau of Ethinyl Estradiol	835.2 h*pg/mL Standard Deviation 367.17	871.4 h*pg/mL Standard Deviation 355.33

PRIMARY outcome

Timeframe: 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

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

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

Outcome measures

Outcome measures
Measure	Part A: NGM/EE n=1 Participants 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).	Part B: NGM/EE + SOF/VEL/VOX + VOX n=4 Participants 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).
Pharmacokinetic (PK) Parameter: AUCtau of Norgestimate	0.2 h*ng/mL Standard Deviation NA Standard deviation was not calculated as data was available for only one participant.	0.5 h*ng/mL Standard Deviation 0.48

PRIMARY outcome

Timeframe: 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

Population: Participants in the PK Analysis Set were analyzed.

Cmax is defined as the maximum concentration of drug.

Outcome measures

Outcome measures
Measure	Part A: NGM/EE n=15 Participants 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).	Part B: NGM/EE + SOF/VEL/VOX + VOX n=15 Participants 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).
PK Parameter: Cmax of Norelgestromin	1080.9 pg/mL Standard Deviation 221.11	1162.2 pg/mL Standard Deviation 209.53

PRIMARY outcome

Timeframe: 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

Population: Participants in the PK Analysis Set were analyzed.

Cmax is defined as the maximum concentration of drug.

Outcome measures

Outcome measures
Measure	Part A: NGM/EE n=15 Participants 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).	Part B: NGM/EE + SOF/VEL/VOX + VOX n=15 Participants 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).
PK Parameter: Cmax of Norgestrel	2.0 ng/mL Standard Deviation 0.52	2.3 ng/mL Standard Deviation 0.61

PRIMARY outcome

Timeframe: 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

Population: Participants in the PK Analysis Set were analyzed.

Cmax is defined as the maximum concentration of drug.

Outcome measures

Outcome measures
Measure	Part A: NGM/EE n=15 Participants 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).	Part B: NGM/EE + SOF/VEL/VOX + VOX n=15 Participants 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).
PK Parameter: Cmax of Ethinyl Estradiol	68.4 pg/mL Standard Deviation 31.06	80.6 pg/mL Standard Deviation 28.44

PRIMARY outcome

Timeframe: 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

Population: Participants in the PK Analysis Set were analyzed.

Cmax is defined as the maximum concentration of drug.

Outcome measures

Outcome measures
Measure	Part A: NGM/EE n=15 Participants 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).	Part B: NGM/EE + SOF/VEL/VOX + VOX n=15 Participants 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).
PK Parameter: Cmax of Norgestimate	0.0 ng/mL Standard Deviation 0.04	0.1 ng/mL Standard Deviation 0.05

PRIMARY outcome

Timeframe: 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

Population: Participants in the PK Analysis Set were analyzed.

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

Outcome measures

Outcome measures
Measure	Part A: NGM/EE n=15 Participants 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).	Part B: NGM/EE + SOF/VEL/VOX + VOX n=15 Participants 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).
PK Parameter: Ctau of Norelgestromin	364.1 picogram/milliliter (pg/mL) Standard Deviation 76.74	413.9 picogram/milliliter (pg/mL) Standard Deviation 73.78

PRIMARY outcome

Timeframe: 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

Population: Participants in the PK Analysis Set were analyzed.

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

Outcome measures

Outcome measures
Measure	Part A: NGM/EE n=15 Participants 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).	Part B: NGM/EE + SOF/VEL/VOX + VOX n=15 Participants 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).
PK Parameter: Ctau of Norgestrel	1.5 nanogram/milliliter (ng/mL) Standard Deviation 0.37	1.8 nanogram/milliliter (ng/mL) Standard Deviation 0.55

PRIMARY outcome

Timeframe: 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

Population: Participants in the PK Analysis Set were analyzed.

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

Outcome measures

Outcome measures
Measure	Part A: NGM/EE n=15 Participants 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).	Part B: NGM/EE + SOF/VEL/VOX + VOX n=15 Participants 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).
PK Parameter: Ctau of Ethinyl Estradiol	19.7 pg/mL Standard Deviation 10.82	18.2 pg/mL Standard Deviation 10.39

PRIMARY outcome

Timeframe: 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

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

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

Outcome measures

Outcome measures
Measure	Part A: NGM/EE n=6 Participants 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).	Part B: NGM/EE + SOF/VEL/VOX + VOX n=3 Participants 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).
PK Parameter: Ctau of Norgestimate	0.0 ng/mL Standard Deviation 0.00	0.0 ng/mL Standard Deviation 0.00

SECONDARY outcome

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

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

Outcome measures

Outcome measures
Measure	Part A: NGM/EE n=15 Participants 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).	Part B: NGM/EE + SOF/VEL/VOX + VOX n=15 Participants 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).
Percentage of Participants Who Experienced Treatment-Emergent Adverse Events	66.7 percentage of participants	93.3 percentage of participants

SECONDARY outcome

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

Population: Participants in the Safety Analysis Set were analyzed.

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.

Outcome measures

Outcome measures
Measure	Part A: NGM/EE n=15 Participants 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).	Part B: NGM/EE + SOF/VEL/VOX + VOX n=15 Participants 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).
Percentage of Participants Who Experienced Laboratory Abnormalities Grade 1	60.0 percentage of participants	53.3 percentage of participants
Percentage of Participants Who Experienced Laboratory Abnormalities Grade 2	13.3 percentage of participants	6.7 percentage of participants
Percentage of Participants Who Experienced Laboratory Abnormalities Grade 3	13.3 percentage of participants	0.0 percentage of participants
Percentage of Participants Who Experienced Laboratory Abnormalities Grade 4	0.0 percentage of participants	0.0 percentage of participants

SECONDARY outcome

Timeframe: 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

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

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

Outcome measures

Outcome measures
Measure	Part A: NGM/EE n=15 Participants 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).	Part B: NGM/EE + SOF/VEL/VOX + VOX n=15 Participants 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).
PK Parameter: Tmax of Norelgestromin, Norgestrel, Ethinyl Estradiol, and Norgestimate Norelgestromin	3.00 hours Interval 2.0 to 4.0	3.00 hours Interval 1.5 to 4.0
PK Parameter: Tmax of Norelgestromin, Norgestrel, Ethinyl Estradiol, and Norgestimate Norgestrel	4.00 hours Interval 2.5 to 8.0	4.00 hours Interval 2.5 to 6.0
PK Parameter: Tmax of Norelgestromin, Norgestrel, Ethinyl Estradiol, and Norgestimate Ethinyl Estradiol	3.00 hours Interval 1.5 to 3.0	2.00 hours Interval 1.5 to 3.13
PK Parameter: Tmax of Norelgestromin, Norgestrel, Ethinyl Estradiol, and Norgestimate Norgestimate	1.50 hours Interval 1.0 to 1.5	1.50 hours Interval 1.25 to 3.0

SECONDARY outcome

Timeframe: 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

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

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

Outcome measures

Outcome measures
Measure	Part A: NGM/EE n=15 Participants 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).	Part B: NGM/EE + SOF/VEL/VOX + VOX n=15 Participants 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).
PK Parameter: Tlast of Norelgestromin, Norgestrel, Ethinyl Estradiol, and Norgestimate Norelgestromin	24.00 hours Interval 24.0 to 24.0	24.00 hours Interval 24.0 to 24.0
PK Parameter: Tlast of Norelgestromin, Norgestrel, Ethinyl Estradiol, and Norgestimate Norgestrel	24.00 hours Interval 24.0 to 24.0	24.00 hours Interval 24.0 to 24.0
PK Parameter: Tlast of Norelgestromin, Norgestrel, Ethinyl Estradiol, and Norgestimate Ethinyl Estradiol	24.00 hours Interval 24.0 to 24.0	24.00 hours Interval 24.0 to 24.0
PK Parameter: Tlast of Norelgestromin, Norgestrel, Ethinyl Estradiol, and Norgestimate Norgestimate	1.50 hours Interval 1.5 to 2.0	2.75 hours Interval 2.0 to 3.0

SECONDARY outcome

Timeframe: 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

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

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.

Outcome measures

Outcome measures
Measure	Part A: NGM/EE n=15 Participants 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).	Part B: NGM/EE + SOF/VEL/VOX + VOX n=15 Participants 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).
PK Parameter: λz of Norelgestromin, Norgestrel, Ethinyl Estradiol, and Norgestimate Norelgestromin	0.035 1/hours (1/h) Standard Deviation 0.0095	0.025 1/hours (1/h) Standard Deviation 0.0084
PK Parameter: λz of Norelgestromin, Norgestrel, Ethinyl Estradiol, and Norgestimate Norgestrel	0.016 1/hours (1/h) Standard Deviation 0.0081	0.012 1/hours (1/h) Standard Deviation 0.0039
PK Parameter: λz of Norelgestromin, Norgestrel, Ethinyl Estradiol, and Norgestimate Ethinyl Estradiol	0.053 1/hours (1/h) Standard Deviation 0.0230	0.059 1/hours (1/h) Standard Deviation 0.0186
PK Parameter: λz of Norelgestromin, Norgestrel, Ethinyl Estradiol, and Norgestimate Norgestimate	0.674 1/hours (1/h) Standard Deviation NA Standard deviation was not calculated as data was available for only one participant.	0.392 1/hours (1/h) Standard Deviation 0.3674

SECONDARY outcome

Timeframe: 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

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

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

Outcome measures

Outcome measures
Measure	Part A: NGM/EE n=15 Participants 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).	Part B: NGM/EE + SOF/VEL/VOX + VOX n=15 Participants 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).
PK Parameter: t1/2 of Norelgestromin, Norgestrel, Ethinyl Estradiol, and Norgestimate Norelgestromin	18.91 hours Interval 17.08 to 23.42	28.95 hours Interval 21.9 to 36.02
PK Parameter: t1/2 of Norelgestromin, Norgestrel, Ethinyl Estradiol, and Norgestimate Norgestrel	33.76 hours Interval 30.76 to 78.76	57.42 hours Interval 49.41 to 82.93
PK Parameter: t1/2 of Norelgestromin, Norgestrel, Ethinyl Estradiol, and Norgestimate Ethinyl Estradiol	13.68 hours Interval 10.01 to 21.06	10.78 hours Interval 9.48 to 15.67
PK Parameter: t1/2 of Norelgestromin, Norgestrel, Ethinyl Estradiol, and Norgestimate Norgestimate	1.03 hours Interval 1.03 to 1.03	2.30 hours Interval 1.49 to 7.86

SECONDARY outcome

Timeframe: \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

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

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

Outcome measures

Outcome measures
Measure	Part A: NGM/EE n=15 Participants 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).	Part B: NGM/EE + SOF/VEL/VOX + VOX n=15 Participants 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).
PK Parameter: CLss/F Ethinyl Estradiol, and Norgestimate Ethinyl Estradiol	34226.8 milliliter/hour (mL/h) Standard Deviation 12691.91	32000.0 milliliter/hour (mL/h) Standard Deviation 9530.52
PK Parameter: CLss/F Ethinyl Estradiol, and Norgestimate Norgestimate	1285855.5 milliliter/hour (mL/h) Standard Deviation NA Standard deviation was not calculated as data was available for only one participant.	617498.8 milliliter/hour (mL/h) Standard Deviation 350620.05

SECONDARY outcome

Timeframe: 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

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

Cmax is defined as the maximum concentration of drug.

Outcome measures

Outcome measures
Measure	Part A: NGM/EE n=15 Participants 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).	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).
PK Parameter: Cmax of Sofosbuvir (SOF), SOF Metabolites (GS-566500 and GS-331007), Velpatasvir (VEL), and Voxilaprevir (VOX) SOF	967.6 ng/mL Standard Deviation 322.20	—
PK Parameter: Cmax of Sofosbuvir (SOF), SOF Metabolites (GS-566500 and GS-331007), Velpatasvir (VEL), and Voxilaprevir (VOX) GS-566500	491.1 ng/mL Standard Deviation 107.66	—
PK Parameter: Cmax of Sofosbuvir (SOF), SOF Metabolites (GS-566500 and GS-331007), Velpatasvir (VEL), and Voxilaprevir (VOX) GS-331007	979.4 ng/mL Standard Deviation 119.43	—
PK Parameter: Cmax of Sofosbuvir (SOF), SOF Metabolites (GS-566500 and GS-331007), Velpatasvir (VEL), and Voxilaprevir (VOX) VEL	853.3 ng/mL Standard Deviation 161.60	—
PK Parameter: Cmax of Sofosbuvir (SOF), SOF Metabolites (GS-566500 and GS-331007), Velpatasvir (VEL), and Voxilaprevir (VOX) VOX	512.4 ng/mL Standard Deviation 171.71	—

SECONDARY outcome

Timeframe: 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

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

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

Outcome measures

Outcome measures
Measure	Part A: NGM/EE n=15 Participants 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).	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).
PK Parameter: Tmax of SOF, SOF Metabolites (GS-566500 and GS-331007), VEL, and VOX VEL	4.00 hours Interval 4.0 to 6.0	—
PK Parameter: Tmax of SOF, SOF Metabolites (GS-566500 and GS-331007), VEL, and VOX SOF	2.50 hours Interval 1.0 to 3.0	—
PK Parameter: Tmax of SOF, SOF Metabolites (GS-566500 and GS-331007), VEL, and VOX GS-566500	4.00 hours Interval 3.0 to 4.0	—
PK Parameter: Tmax of SOF, SOF Metabolites (GS-566500 and GS-331007), VEL, and VOX GS-331007	4.00 hours Interval 4.0 to 6.0	—
PK Parameter: Tmax of SOF, SOF Metabolites (GS-566500 and GS-331007), VEL, and VOX VOX	6.00 hours Interval 4.0 to 6.02	—

SECONDARY outcome

Timeframe: 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

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

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

Outcome measures

Outcome measures
Measure	Part A: NGM/EE n=15 Participants 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).	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).
PK Parameter: Tlast of SOF, SOF Metabolites (GS-566500 and GS-331007), VEL, and VOX SOF	6.00 hours Interval 6.0 to 8.0	—
PK Parameter: Tlast of SOF, SOF Metabolites (GS-566500 and GS-331007), VEL, and VOX GS-566500	16.00 hours Interval 16.0 to 20.0	—
PK Parameter: Tlast of SOF, SOF Metabolites (GS-566500 and GS-331007), VEL, and VOX GS-331007	24.00 hours Interval 24.0 to 24.0	—
PK Parameter: Tlast of SOF, SOF Metabolites (GS-566500 and GS-331007), VEL, and VOX VEL	24.00 hours Interval 24.0 to 24.0	—
PK Parameter: Tlast of SOF, SOF Metabolites (GS-566500 and GS-331007), VEL, and VOX VOX	24.00 hours Interval 24.0 to 24.0	—

SECONDARY outcome

Timeframe: 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

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

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

Outcome measures

Outcome measures
Measure	Part A: NGM/EE n=15 Participants 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).	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).
PK Parameter: Ctau of SOF Metabolites (GS-566500 and GS-331007), VEL, and VOX GS-566500	10.6 ng/mL Standard Deviation NA Standard deviation was not calculated as data was available for only one participant.	—
PK Parameter: Ctau of SOF Metabolites (GS-566500 and GS-331007), VEL, and VOX GS-331007	323.1 ng/mL Standard Deviation 67.24	—
PK Parameter: Ctau of SOF Metabolites (GS-566500 and GS-331007), VEL, and VOX VEL	154.6 ng/mL Standard Deviation 46.71	—
PK Parameter: Ctau of SOF Metabolites (GS-566500 and GS-331007), VEL, and VOX VOX	56.1 ng/mL Standard Deviation 59.02	—

SECONDARY outcome

Timeframe: 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

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

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.

Outcome measures

Outcome measures
Measure	Part A: NGM/EE n=15 Participants 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).	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).
PK Parameter: λz of SOF, SOF Metabolites (GS-566500 and GS-331007), VEL, and VOX SOF	1.160 1/h Standard Deviation 0.4753	—
PK Parameter: λz of SOF, SOF Metabolites (GS-566500 and GS-331007), VEL, and VOX GS-566500	0.247 1/h Standard Deviation 0.0247	—
PK Parameter: λz of SOF, SOF Metabolites (GS-566500 and GS-331007), VEL, and VOX GS-331007	0.020 1/h Standard Deviation 0.0091	—
PK Parameter: λz of SOF, SOF Metabolites (GS-566500 and GS-331007), VEL, and VOX VEL	0.037 1/h Standard Deviation 0.0103	—
PK Parameter: λz of SOF, SOF Metabolites (GS-566500 and GS-331007), VEL, and VOX VOX	0.077 1/h Standard Deviation 0.0277	—

SECONDARY outcome

Timeframe: 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

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

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

Outcome measures

Outcome measures
Measure	Part A: NGM/EE n=15 Participants 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).	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).
PK Parameter: AUCtau of SOF, SOF Metabolites (GS-566500 and GS-331007), VEL, and VOX SOF	1997.2 h*ng/mL Standard Deviation 802.99	—
PK Parameter: AUCtau of SOF, SOF Metabolites (GS-566500 and GS-331007), VEL, and VOX GS-566500	2769.3 h*ng/mL Standard Deviation 446.51	—
PK Parameter: AUCtau of SOF, SOF Metabolites (GS-566500 and GS-331007), VEL, and VOX GS-331007	12098.9 h*ng/mL Standard Deviation 1929.14	—
PK Parameter: AUCtau of SOF, SOF Metabolites (GS-566500 and GS-331007), VEL, and VOX VEL	8226.3 h*ng/mL Standard Deviation 2056.25	—
PK Parameter: AUCtau of SOF, SOF Metabolites (GS-566500 and GS-331007), VEL, and VOX VOX	3857.9 h*ng/mL Standard Deviation 1216.12	—

SECONDARY outcome

Timeframe: 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

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

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

Outcome measures

Outcome measures
Measure	Part A: NGM/EE n=15 Participants 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).	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).
PK Parameter: CLss/F of SOF, VEL, and VOX SOF	218383.1 mL/h Standard Deviation 53265.75	—
PK Parameter: CLss/F of SOF, VEL, and VOX VEL	12757.3 mL/h Standard Deviation 2673.70	—
PK Parameter: CLss/F of SOF, VEL, and VOX VOX	56071.5 mL/h Standard Deviation 15234.72	—

SECONDARY outcome

Timeframe: 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

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

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

Outcome measures

Outcome measures
Measure	Part A: NGM/EE n=15 Participants 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).	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).
PK Parameter: t1/2 of SOF, SOF Metabolites (GS-566500 and GS-331007), VEL, and VOX SOF	0.68 hours Interval 0.45 to 0.81	—
PK Parameter: t1/2 of SOF, SOF Metabolites (GS-566500 and GS-331007), VEL, and VOX GS-566500	2.70 hours Interval 2.61 to 3.04	—
PK Parameter: t1/2 of SOF, SOF Metabolites (GS-566500 and GS-331007), VEL, and VOX GS-331007	30.06 hours Interval 24.96 to 75.66	—
PK Parameter: t1/2 of SOF, SOF Metabolites (GS-566500 and GS-331007), VEL, and VOX VEL	19.75 hours Interval 15.46 to 24.92	—
PK Parameter: t1/2 of SOF, SOF Metabolites (GS-566500 and GS-331007), VEL, and VOX VOX	8.51 hours Interval 7.56 to 13.55	—

Adverse Events

Part A: NGM/EE

Serious events: 0 serious events

Other events: 10 other events

Deaths: 0 deaths

Part B: NGM/EE + SOF/VEL/VOX + VOX

Serious events: 0 serious events

Other events: 14 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Additional Information

Gilead Clinical Study Information Center

Gilead Sciences

Phone: 1-833-445-3230 (GILEAD-0)

Email: [email protected]

Results disclosure agreements

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

Restriction type: OTHER

Measure	Part A: NGM/EE n=15 participants at risk 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).	Part B: NGM/EE + SOF/VEL/VOX + VOX n=15 participants at risk 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).
Gastrointestinal disorders Abdominal discomfort	0.00% 0/15 • First dose date up to the last dose date (maximum: 84 days) plus 10 days The Safety Analysis Set included all enrolled participants who took at least 1 dose of study drug.	6.7% 1/15 • First dose date up to the last dose date (maximum: 84 days) plus 10 days The Safety Analysis Set included all enrolled participants who took at least 1 dose of study drug.
Gastrointestinal disorders Abdominal pain	0.00% 0/15 • First dose date up to the last dose date (maximum: 84 days) plus 10 days The Safety Analysis Set included all enrolled participants who took at least 1 dose of study drug.	20.0% 3/15 • First dose date up to the last dose date (maximum: 84 days) plus 10 days The Safety Analysis Set included all enrolled participants who took at least 1 dose of study drug.
Gastrointestinal disorders Diarrhoea	13.3% 2/15 • First dose date up to the last dose date (maximum: 84 days) plus 10 days The Safety Analysis Set included all enrolled participants who took at least 1 dose of study drug.	33.3% 5/15 • First dose date up to the last dose date (maximum: 84 days) plus 10 days The Safety Analysis Set included all enrolled participants who took at least 1 dose of study drug.
Gastrointestinal disorders Flatulence	0.00% 0/15 • First dose date up to the last dose date (maximum: 84 days) plus 10 days The Safety Analysis Set included all enrolled participants who took at least 1 dose of study drug.	13.3% 2/15 • First dose date up to the last dose date (maximum: 84 days) plus 10 days The Safety Analysis Set included all enrolled participants who took at least 1 dose of study drug.
Gastrointestinal disorders Gingival ulceration	0.00% 0/15 • First dose date up to the last dose date (maximum: 84 days) plus 10 days The Safety Analysis Set included all enrolled participants who took at least 1 dose of study drug.	6.7% 1/15 • First dose date up to the last dose date (maximum: 84 days) plus 10 days The Safety Analysis Set included all enrolled participants who took at least 1 dose of study drug.
Gastrointestinal disorders Nausea	6.7% 1/15 • First dose date up to the last dose date (maximum: 84 days) plus 10 days The Safety Analysis Set included all enrolled participants who took at least 1 dose of study drug.	60.0% 9/15 • First dose date up to the last dose date (maximum: 84 days) plus 10 days The Safety Analysis Set included all enrolled participants who took at least 1 dose of study drug.
Gastrointestinal disorders Vomiting	0.00% 0/15 • First dose date up to the last dose date (maximum: 84 days) plus 10 days The Safety Analysis Set included all enrolled participants who took at least 1 dose of study drug.	20.0% 3/15 • First dose date up to the last dose date (maximum: 84 days) plus 10 days The Safety Analysis Set included all enrolled participants who took at least 1 dose of study drug.
General disorders Chills	6.7% 1/15 • First dose date up to the last dose date (maximum: 84 days) plus 10 days The Safety Analysis Set included all enrolled participants who took at least 1 dose of study drug.	0.00% 0/15 • First dose date up to the last dose date (maximum: 84 days) plus 10 days The Safety Analysis Set included all enrolled participants who took at least 1 dose of study drug.
General disorders Fatigue	0.00% 0/15 • First dose date up to the last dose date (maximum: 84 days) plus 10 days The Safety Analysis Set included all enrolled participants who took at least 1 dose of study drug.	20.0% 3/15 • First dose date up to the last dose date (maximum: 84 days) plus 10 days The Safety Analysis Set included all enrolled participants who took at least 1 dose of study drug.
Immune system disorders Hypersensitivity	6.7% 1/15 • First dose date up to the last dose date (maximum: 84 days) plus 10 days The Safety Analysis Set included all enrolled participants who took at least 1 dose of study drug.	0.00% 0/15 • First dose date up to the last dose date (maximum: 84 days) plus 10 days The Safety Analysis Set included all enrolled participants who took at least 1 dose of study drug.
Infections and infestations Oral herpes	0.00% 0/15 • First dose date up to the last dose date (maximum: 84 days) plus 10 days The Safety Analysis Set included all enrolled participants who took at least 1 dose of study drug.	6.7% 1/15 • First dose date up to the last dose date (maximum: 84 days) plus 10 days The Safety Analysis Set included all enrolled participants who took at least 1 dose of study drug.
Infections and infestations Upper respiratory tract infection	13.3% 2/15 • First dose date up to the last dose date (maximum: 84 days) plus 10 days The Safety Analysis Set included all enrolled participants who took at least 1 dose of study drug.	0.00% 0/15 • First dose date up to the last dose date (maximum: 84 days) plus 10 days The Safety Analysis Set included all enrolled participants who took at least 1 dose of study drug.
Infections and infestations Urinary tract infection	6.7% 1/15 • First dose date up to the last dose date (maximum: 84 days) plus 10 days The Safety Analysis Set included all enrolled participants who took at least 1 dose of study drug.	0.00% 0/15 • First dose date up to the last dose date (maximum: 84 days) plus 10 days The Safety Analysis Set included all enrolled participants who took at least 1 dose of study drug.
Injury, poisoning and procedural complications Arthropod bite	6.7% 1/15 • First dose date up to the last dose date (maximum: 84 days) plus 10 days The Safety Analysis Set included all enrolled participants who took at least 1 dose of study drug.	0.00% 0/15 • First dose date up to the last dose date (maximum: 84 days) plus 10 days The Safety Analysis Set included all enrolled participants who took at least 1 dose of study drug.
Injury, poisoning and procedural complications Skin abrasion	0.00% 0/15 • First dose date up to the last dose date (maximum: 84 days) plus 10 days The Safety Analysis Set included all enrolled participants who took at least 1 dose of study drug.	6.7% 1/15 • First dose date up to the last dose date (maximum: 84 days) plus 10 days The Safety Analysis Set included all enrolled participants who took at least 1 dose of study drug.
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 0/15 • First dose date up to the last dose date (maximum: 84 days) plus 10 days The Safety Analysis Set included all enrolled participants who took at least 1 dose of study drug.	6.7% 1/15 • First dose date up to the last dose date (maximum: 84 days) plus 10 days The Safety Analysis Set included all enrolled participants who took at least 1 dose of study drug.
Nervous system disorders Dizziness	13.3% 2/15 • First dose date up to the last dose date (maximum: 84 days) plus 10 days The Safety Analysis Set included all enrolled participants who took at least 1 dose of study drug.	0.00% 0/15 • First dose date up to the last dose date (maximum: 84 days) plus 10 days The Safety Analysis Set included all enrolled participants who took at least 1 dose of study drug.
Nervous system disorders Headache	40.0% 6/15 • First dose date up to the last dose date (maximum: 84 days) plus 10 days The Safety Analysis Set included all enrolled participants who took at least 1 dose of study drug.	40.0% 6/15 • First dose date up to the last dose date (maximum: 84 days) plus 10 days The Safety Analysis Set included all enrolled participants who took at least 1 dose of study drug.
Nervous system disorders Presyncope	6.7% 1/15 • First dose date up to the last dose date (maximum: 84 days) plus 10 days The Safety Analysis Set included all enrolled participants who took at least 1 dose of study drug.	0.00% 0/15 • First dose date up to the last dose date (maximum: 84 days) plus 10 days The Safety Analysis Set included all enrolled participants who took at least 1 dose of study drug.
Reproductive system and breast disorders Metrorrhagia	6.7% 1/15 • First dose date up to the last dose date (maximum: 84 days) plus 10 days The Safety Analysis Set included all enrolled participants who took at least 1 dose of study drug.	6.7% 1/15 • First dose date up to the last dose date (maximum: 84 days) plus 10 days The Safety Analysis Set included all enrolled participants who took at least 1 dose of study drug.
Respiratory, thoracic and mediastinal disorders Nasal congestion	6.7% 1/15 • First dose date up to the last dose date (maximum: 84 days) plus 10 days The Safety Analysis Set included all enrolled participants who took at least 1 dose of study drug.	0.00% 0/15 • First dose date up to the last dose date (maximum: 84 days) plus 10 days The Safety Analysis Set included all enrolled participants who took at least 1 dose of study drug.