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SOF/VEL/VOX

Phase 2

HCV Infection | Small molecule | Other |Gilead Sciences, Inc.|Last Updated: Sep 2, 2020

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
CONTROLLEDBiomarker
Total Trials2
Total Enrollment53
FDA Designations
No designations recorded
Clinical Trials (2)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01958281Sofosbuvir Plus Ribavirin, or Ledipasvir/Sofosbuvir in Adults With HCV Infection and Renal InsufficiencyPHASE2 COMPLETED 38 — — Oct 7, 2013Oct 19, 2017Aug 8, 201810 United States, New Zealand +1
NCT02533427Study to Evaluate Effect of Sofosbuvir/Velpatasvir/GS-9857 Fixed-Dose Combination on the Pharmacokinetics of a Representative Hormonal Contraceptive Medication, Norgestimate/Ethinyl EstradiolPHASE1 COMPLETED 15 — — Oct 29, 2015Mar 18, 2016Sep 2, 20201 New Zealand
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Study Endpoints
Primary Endpoints
Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12)
Posttreatment Week 12

SVR12 was defined as HCV RNA \< the lower limit of quantitation (LLOQ; ie, 15 IU/mL) at 12 weeks after stopping study treatment.

Percentage of Participants Experiencing Treatment-Emergent Adverse Events
Up to 24 weeks plus 30 days
Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities
Up to 24 weeks plus 30 days

Treatment-emergent laboratory abnormalities were defined as values that increased by at least 1 toxicity grade from baseline at any time postbaseline up to the date of last dose of study drug plus 30 days.

Percentage of Participants Experiencing Clinically Significant 12-lead Electrocardiogram (ECG) Abnormalities
Up to 24 weeks plus 30 days
Percentage of Participants Experiencing Treatment-Emergent Adverse Events Associated With Vital Sign Abnormalities
Up to 24 weeks plus 30 days
Pharmacokinetic (PK) Parameter: AUCtau of SOF, Its Metabolites (GS-566500 and GS-331007), and RBV at Week 2 (Cohorts 1 and 2)
Predose, 0.25, 0.5, 1, 2, 4, 6, 8, 10, and 12 hours postdose at Week 2

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

PK Parameter: AUCtau of SOF, Its Metabolites (GS-566500 and GS-331007), and RBV at Week 12 (Cohorts 1 and 2)
Predose, 0.25, 0.5, 1, 2, 4, 6, 8, 10, and 12 hours postdose at Week 12

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

PK Parameter: AUCtau of SOF, Its Metabolites (GS-566500 and GS-331007), and LDV at Week 2 or 4 (Cohort 3)
Predose, 0.25, 0.5, 1, 2, 4, 6, 8, 10, and 12 hours postdose at Week 2 or 4

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

PK Parameter: Cmax of SOF, Its Metabolites (GS-566500 and GS-331007), and RBV at Week 2 (Cohorts 1 and 2)
Predose, 0.25, 0.5, 1, 2, 4, 6, 8, 10, and 12 hours postdose at Week 2

Cmax is defined as the maximum concentration of drug.

PK Parameter: Cmax of SOF, Its Metabolites (GS-566500 and GS-331007), and RBV at Week 12 (Cohorts 1 and 2)
Predose, 0.25, 0.5, 1, 2, 4, 6, 8, 10, and 12 hours postdose at Week 12

Cmax is defined as the maximum concentration of drug.

PK Parameter: Cmax of SOF, Its Metabolites (GS-566500 and GS-331007), and LDV at Week 2 or 4 (Cohort 3)
Predose, 0.25, 0.5, 1, 2, 4, 6, 8, 10, and 12 hours postdose at Week 2 or 4

Cmax is defined as the maximum concentration of drug.

PK Parameter: Ctau of SOF, Its Metabolites (GS-566500 and GS-331007), and RBV at Week 2 (Cohorts 1 and 2)
Predose, 0.25, 0.5, 1, 2, 4, 6, 8, 10, and 12 hours postdose at Week 2

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

PK Parameter: Ctau of SOF, Its Metabolites (GS-566500 and GS-331007), and RBV at Week 12 (Cohorts 1 and 2)
Predose, 0.25, 0.5, 1, 2, 4, 6, 8, 10, and 12 hours postdose at Week 12

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

PK Parameter: Ctau of SOF, Its Metabolites (GS-566500 and GS-331007), and LDV at Week 2 or 4 (Cohort 3)
Predose, 0.25, 0.5, 1, 2, 4, 6, 8, 10, and 12 hours postdose at Week 2 or 4

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

Pharmacokinetic (PK) Parameter: AUCtau of Norelgestromin
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

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

PK Parameter: AUCtau of Norgestrel
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

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

PK Parameter: AUCtau of Ethinyl Estradiol
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

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

Pharmacokinetic (PK) Parameter: AUCtau of Norgestimate
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

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

PK Parameter: Cmax of Norelgestromin
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

Cmax is defined as the maximum concentration of drug.

PK Parameter: Cmax of Norgestrel
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

Cmax is defined as the maximum concentration of drug.

PK Parameter: Cmax of Ethinyl Estradiol
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

Cmax is defined as the maximum concentration of drug.

PK Parameter: Cmax of Norgestimate
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

Cmax is defined as the maximum concentration of drug.

PK Parameter: Ctau of Norelgestromin
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

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

PK Parameter: Ctau of Norgestrel
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

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

PK Parameter: Ctau of Ethinyl Estradiol
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

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

PK Parameter: Ctau of Norgestimate
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

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

Secondary Endpoints
Percentage of Participants With SVR at 4 Weeks After Discontinuation of Therapy (SVR4)
Posttreatment Week 4
Percentage of Participants With SVR at 24 Weeks After Discontinuation of Therapy (SVR24)
Posttreatment Week 24
Percentage of Participants With Overall Virologic Failure
Up to Posttreatment Week 24
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelSEQUENTIAL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
SOF 200 mg + RBV 200 mg (Cohort 1)EXPERIMENTALParticipants with genotype 1 or 3 HCV infection will receive SOF 200 mg (2 × 100 mg tablets) plus RBV once daily for 24 weeks.
SOF 400 mg + RBV 200 mg (Cohort 2)EXPERIMENTALParticipants with genotype 1 or 3 HCV infection will receive SOF 400 mg (4 × 100 mg tablets or 1 × 400 mg tablet) plus RBV once daily for 24 weeks.
LDV/SOF (Cohort 3)EXPERIMENTALParticipants with genotype 1 or 4 HCV infection will receive LDV/SOF once daily for 12 weeks.
SOF/VEL/VOX + VOXEXPERIMENTALPart 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.
Interventions
NameTypeDescription
SOFDRUGTablet(s) administered orally once daily
RBVDRUG200 mg tablet administered orally once daily
LDV/SOFDRUG90/400 mg fixed-dose combination (FDC) tablet administered orally once daily
SOF/VEL/VOXDRUG400/100/100 mg FDC tablet administered orally once daily
VOXDRUG100 mg tablet administered orally once daily
Norgestimate/ethinyl estradiolDRUGNorgestimate 0.180 mg/0.215 mg/0.25 mg/ethinyl estradiol 0.025 mg tablet administered orally once daily according to the package insert
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites10

Key Inclusion Criteria: * Cohorts 1 and 2: chronic genotype 1 or 3 HCV infection * Cohort 3: chronic genotype 1 or 4 HCV infection * HCV RNA ≥ 10\^4 IU/mL at screening * Screening labs within defined thresholds * Cirrhosis determination at screening Key Exclusion Criteria: * Females who are pregn...

Countries:United StatesNew ZealandPuerto Rico
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