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Safety and Efficacy of Sofosbuvir/Velpatasvir/Voxilaprevir Fixed-Dose Combination With or Without Ribavirin in Participants With Chronic Genotype 1 HCV Infection Previously Treated With a Direct Acting Antiviral Regimen

A Phase 2, Open-Label Study to Investigate the Safety and Efficacy of Sofosbuvir/GS-5816/GS-9857 Fixed-Dose Combination With or Without Ribavirin in Subjects With Chronic Genotype 1 HCV Infection Previously Treated With a Direct Acting Antiviral Regimen

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02536313
Enrollment
49
Registered
2015-08-31
Start date
2015-07-29
Completion date
2016-06-28
Last updated
2019-02-25

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

Conditions

Hepatitis C Virus Infection

Brief summary

The primary objective of this study is to evaluate the efficacy, safety, and tolerability of the treatment with sofosbuvir/velpatasvir/voxilaprevir (SOF/VEL/VOX) fixed dose combination (FDC) ± ribavirin (RBV) in participants with chronic genotype 1 hepatitis C virus (HCV) infection and prior treatment experience with a direct acting antiviral (DAA).

Interventions

DRUGSOF/VEL/VOX

400/100/100 mg FDC tablet administered orally once daily with food

DRUGRBV

Tablets administered orally in a divided daily dose according to package insert weight-based dosing recommendations (\< 75kg = 1000 mg and ≥ 75 kg = 1200 mg)

Sponsors

Gilead Sciences
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

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

Inclusion criteria

Key Inclusion Criteria: * Individuals with chronic HCV genotype 1 infection * Documented as treatment experienced with a direct acting antiviral-containing regimen without achieving sustained viral response * Absence of cirrhosis or presence of compensated cirrhosis * Screening laboratory values within defined thresholds * Must use specific contraceptive methods if female of childbearing potential or sexually active male Key

Exclusion criteria

* Co-infection with HIV or hepatitis B virus (HBV) * Current or prior history of clinical hepatic decompensation * Chronic use of systemic immunosuppressive agents * History of clinically significant illness or any other medical disorder that may interfere with individual's treatment, assessment or compliance with the protocol * Pregnant or a nursing female Note: Other protocol defined Inclusion/

Design outcomes

Primary

MeasureTime frameDescription
Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Cessation of Treatment (SVR12)Posttreatment Week 12SVR12 is defined as HCV RNA \< the lower limit of quantitation (LLOQ; ie, 15 IU/mL) at 12 weeks after stopping study treatment.
Percentage of Participants Who Permanently Discontinued SOF/VEL/VOX Due to an Adverse EventUp to 12 weeks—

Secondary

MeasureTime frameDescription
Percentage of Participants With SVR at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)Posttreatment Weeks 4 and 24SVR4 and SVR 24 are defined as HCV RNA \< LLOQ at 4 and 24 weeks after stopping study treatment, respectively.
Percentage of Participants With HCV RNA < LLOQ on TreatmentWeeks 1, 2, 4, 8 and 12—
HCV RNA Change From Baseline/Day 1 Through Week 12Weeks 1, 2, 4, 8, and 12—
Percentage of Participants With Virologic FailureUp to Posttreatment Week 24Virologic failure is defined as: * On-treatment virologic failure: * Breakthrough (confirmed HCV RNA ≥ LLOQ after having previously had HCV RNA \< LLOQ while on treatment), or * Rebound (confirmed \> 1 log10 IU/mL increase in HCV RNA from nadir while on treatment), or * Non-response (HCV RNA persistently ≥ LLOQ through 8 weeks of treatment) * Virologic relapse: * Confirmed HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA \< LLOQ at last on-treatment visit.

Countries

United States

Participant flow

Recruitment details

Participants were enrolled at 1 study site in the United States. The first participant was screened on 29 July 2015. The last study visit occurred on 28 June 2016.

Participants by arm

ArmCount
SOF/VEL/VOX
SOF/VEL/VOX (400/100/100 mg) FDC tablet orally once daily with food for 12 weeks
24
SOF/VEL/VOX + RBV
SOF/VEL/VOX (400/100/100 mg) FDC tablet + RBV (1000 or 1200 mg daily based on weight) tablet orally once daily with food for 12 weeks
25
Total49

Withdrawals & dropouts

PeriodReasonFG000FG001
Overall StudyLack of Efficacy01

Baseline characteristics

CharacteristicSOF/VEL/VOXSOF/VEL/VOX + RBVTotal
Age, Continuous54 years
STANDARD_DEVIATION 10.1
54 years
STANDARD_DEVIATION 14.1
54 years
STANDARD_DEVIATION 12.2
HCV RNA6.2 log10 IU/mL
STANDARD_DEVIATION 0.42
6.3 log10 IU/mL
STANDARD_DEVIATION 0.46
6.3 log10 IU/mL
STANDARD_DEVIATION 0.44
HCV RNA Category
< 800,000 IU/mL
4 Participants5 Participants9 Participants
HCV RNA Category
≥ 800,000 IU/mL
20 Participants20 Participants40 Participants
IL28b Status
CC
2 Participants5 Participants7 Participants
IL28b Status
CT
10 Participants13 Participants23 Participants
IL28b Status
TT
12 Participants7 Participants19 Participants
Race/Ethnicity, Customized
Black or African American
7 Participants3 Participants10 Participants
Race/Ethnicity, Customized
Hispanic or Latino
8 Participants8 Participants16 Participants
Race/Ethnicity, Customized
Not Hispanic or Latino
16 Participants17 Participants33 Participants
Race/Ethnicity, Customized
White
17 Participants22 Participants39 Participants
Sex: Female, Male
Female
8 Participants9 Participants17 Participants
Sex: Female, Male
Male
16 Participants16 Participants32 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 240 / 25
other
Total, other adverse events
6 / 2411 / 25
serious
Total, serious adverse events
1 / 240 / 25

Outcome results

Primary

Percentage of Participants Who Permanently Discontinued SOF/VEL/VOX Due to an Adverse Event

Time frame: Up to 12 weeks

Population: Safety Analysis Set: participants who took at least 1 dose of study drug

ArmMeasureValue (NUMBER)
SOF/VEL/VOXPercentage of Participants Who Permanently Discontinued SOF/VEL/VOX Due to an Adverse Event0 percentage of participants
SOF/VEL/VOX + RBVPercentage of Participants Who Permanently Discontinued SOF/VEL/VOX Due to an Adverse Event0 percentage of participants
Primary

Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Cessation of Treatment (SVR12)

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

Time frame: Posttreatment Week 12

Population: Full Analysis Set: all randomized/enrolled participants who took at least 1 dose of study drug.

ArmMeasureValue (NUMBER)
SOF/VEL/VOXPercentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Cessation of Treatment (SVR12)100.0 percentage of particpants
SOF/VEL/VOX + RBVPercentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Cessation of Treatment (SVR12)96.0 percentage of particpants
Secondary

HCV RNA Change From Baseline/Day 1 Through Week 12

Time frame: Weeks 1, 2, 4, 8, and 12

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

ArmMeasureGroupValue (MEAN)Dispersion
SOF/VEL/VOXHCV RNA Change From Baseline/Day 1 Through Week 12Change at Week 2-4.97 log10 IU/mLStandard Deviation 0.484
SOF/VEL/VOXHCV RNA Change From Baseline/Day 1 Through Week 12Change at Week 8-5.10 log10 IU/mLStandard Deviation 0.419
SOF/VEL/VOXHCV RNA Change From Baseline/Day 1 Through Week 12Change at Week 4-5.10 log10 IU/mLStandard Deviation 0.419
SOF/VEL/VOXHCV RNA Change From Baseline/Day 1 Through Week 12Change at Week 12-5.10 log10 IU/mLStandard Deviation 0.419
SOF/VEL/VOXHCV RNA Change From Baseline/Day 1 Through Week 12Change at Week 1-4.63 log10 IU/mLStandard Deviation 0.737
SOF/VEL/VOX + RBVHCV RNA Change From Baseline/Day 1 Through Week 12Change at Week 12-5.18 log10 IU/mLStandard Deviation 0.461
SOF/VEL/VOX + RBVHCV RNA Change From Baseline/Day 1 Through Week 12Change at Week 1-4.53 log10 IU/mLStandard Deviation 0.687
SOF/VEL/VOX + RBVHCV RNA Change From Baseline/Day 1 Through Week 12Change at Week 2-4.95 log10 IU/mLStandard Deviation 0.566
SOF/VEL/VOX + RBVHCV RNA Change From Baseline/Day 1 Through Week 12Change at Week 4-5.14 log10 IU/mLStandard Deviation 0.477
SOF/VEL/VOX + RBVHCV RNA Change From Baseline/Day 1 Through Week 12Change at Week 8-5.18 log10 IU/mLStandard Deviation 0.461
Secondary

Percentage of Participants With HCV RNA < LLOQ on Treatment

Time frame: Weeks 1, 2, 4, 8 and 12

Population: Full Analysis Set

ArmMeasureGroupValue (NUMBER)
SOF/VEL/VOXPercentage of Participants With HCV RNA < LLOQ on TreatmentWeek 279.2 percentage of participants
SOF/VEL/VOXPercentage of Participants With HCV RNA < LLOQ on TreatmentWeek 8100.0 percentage of participants
SOF/VEL/VOXPercentage of Participants With HCV RNA < LLOQ on TreatmentWeek 4100 percentage of participants
SOF/VEL/VOXPercentage of Participants With HCV RNA < LLOQ on TreatmentWeek 12100.0 percentage of participants
SOF/VEL/VOXPercentage of Participants With HCV RNA < LLOQ on TreatmentWeek 154.2 percentage of participants
SOF/VEL/VOX + RBVPercentage of Participants With HCV RNA < LLOQ on TreatmentWeek 12100.0 percentage of participants
SOF/VEL/VOX + RBVPercentage of Participants With HCV RNA < LLOQ on TreatmentWeek 140 percentage of participants
SOF/VEL/VOX + RBVPercentage of Participants With HCV RNA < LLOQ on TreatmentWeek 260.0 percentage of participants
SOF/VEL/VOX + RBVPercentage of Participants With HCV RNA < LLOQ on TreatmentWeek 492.0 percentage of participants
SOF/VEL/VOX + RBVPercentage of Participants With HCV RNA < LLOQ on TreatmentWeek 8100.0 percentage of participants
Secondary

Percentage of Participants With SVR at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)

SVR4 and SVR 24 are defined as HCV RNA \< LLOQ at 4 and 24 weeks after stopping study treatment, respectively.

Time frame: Posttreatment Weeks 4 and 24

Population: Full Analysis Set

ArmMeasureGroupValue (NUMBER)
SOF/VEL/VOXPercentage of Participants With SVR at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)SVR4100.0 percentage of participants
SOF/VEL/VOXPercentage of Participants With SVR at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)SVR24100.0 percentage of participants
SOF/VEL/VOX + RBVPercentage of Participants With SVR at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)SVR496.0 percentage of participants
SOF/VEL/VOX + RBVPercentage of Participants With SVR at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)SVR2496.0 percentage of participants
Secondary

Percentage of Participants With Virologic Failure

Virologic failure is defined as: * On-treatment virologic failure: * Breakthrough (confirmed HCV RNA ≥ LLOQ after having previously had HCV RNA \< LLOQ while on treatment), or * Rebound (confirmed \> 1 log10 IU/mL increase in HCV RNA from nadir while on treatment), or * Non-response (HCV RNA persistently ≥ LLOQ through 8 weeks of treatment) * Virologic relapse: * Confirmed HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA \< LLOQ at last on-treatment visit.

Time frame: Up to Posttreatment Week 24

Population: Full Analysis Set

ArmMeasureValue (NUMBER)
SOF/VEL/VOXPercentage of Participants With Virologic Failure0 percentage of participants
SOF/VEL/VOX + RBVPercentage of Participants With Virologic Failure4.0 percentage of participants

Source: ClinicalTrials.gov · Data processed: Feb 17, 2026