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Sofosbuvir/Velpatasvir Fixed-Dose Combination and Ribavirin for 12 or 24 Weeks in Participants With Chronic Genotype 1 or 2 Hepatitis C Virus Infection Who Have Previously Failed a Direct-Acting Antiviral-Containing Regimen

A Phase 3, Multicenter, Randomized, Open-Label Study to Investigate the Efficacy and Safety of Sofosbuvir/Velpatasvir Fixed-Dose Combination and Ribavirin for 12 or 24 Weeks in Subjects With Chronic Genotype 1 or 2 HCV Infection Who Have Previously Failed a Direct-Acting Antiviral-Containing Regimen

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02822794
Enrollment
117
Registered
2016-07-04
Start date
2016-07-25
Completion date
2017-08-25
Last updated
2018-11-14

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 antiviral efficacy, safety, and tolerability of therapy with sofosbuvir/velpatasvir (SOF/VEL) fixed-dose combination (FDC) and ribavirin (RBV) in participants with chronic genotype 1 or 2 hepatitis C virus (HCV) infection who have previously failed a direct-acting antiviral (DAA)-containing regimen.

Interventions

DRUGSOF/VEL

400/100 mg tablet administered orally once daily

DRUGRBV

Capsules administered orally in a divided daily dose according to package insert weight-based dosing recommendations (≤ 60 kg = 600 mg, \> 60 kg to ≤ 80 kg = 800 mg, and ≥ 80 kg = 1000 mg)

Sponsors

Gilead Sciences
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

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

Inclusion criteria

Key Inclusion Criteria: * Genotype 1 or 2 HCV infection * Chronic HCV infection (≥ 6 months prior to screening) documented by prior medical history or liver biopsy * Previously treated with a DAA-containing regimen of at least 4 week duration Note: Other protocol defined Inclusion/

Exclusion criteria

may apply.

Design outcomes

Primary

MeasureTime frameDescription
Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12)Posttreatment Week 12SVR12 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 Who Permanently Discontinued Any Study Drug Due to an Adverse EventUp to 24 weeks—

Secondary

MeasureTime frameDescription
Percentage of Participants With HCV RNA < LLOQ at Week 1Week 1—
Percentage of Participants With HCV RNA < LLOQ at Week 2Week 2—
Percentage of Participants With HCV RNA < LLOQ at Week 3Week 3—
Percentage of Participants With HCV RNA < LLOQ at Week 4Week 4—
Percentage of Participants With HCV RNA < LLOQ at Week 5Week 5—
Percentage of Participants With HCV RNA < LLOQ at Week 6Week 6—
Percentage of Participants With HCV RNA < LLOQ at Week 8Week 8—
Percentage of Participants With HCV RNA < LLOQ at Week 10Week 10—
Percentage of Participants With HCV RNA < LLOQ at Week 12Week 12—
Percentage of Participants With HCV RNA < LLOQ at Week 16Week 16—
Percentage of Participants With HCV RNA < LLOQ at Week 20Week 20—
Percentage of Participants With HCV RNA < LLOQ at Week 24Week 24—
Percentage of Participants With SVR at 4 Weeks After Discontinuation of Therapy (SVR4)Posttreatment Week 4SVR4 was defined as HCV RNA \< LLOQ at 4 weeks after stopping study treatment.
Change From Baseline in HCV RNA at Week 2Baseline; Week 2—
Change From Baseline in HCV RNA at Week 3Baseline; Week 3—
Change From Baseline in HCV RNA at Week 4Baseline; Week 4—
Change From Baseline in HCV RNA at Week 5Baseline; Week 5—
Change From Baseline in HCV RNA at Week 6Baseline; Week 6—
Change From Baseline in HCV RNA at Week 8Baseline; Week 8—
Change From Baseline in HCV RNA at Week 10Baseline; Week 10—
Change From Baseline in HCV RNA at Week 12Baseline; Week 12—
Change From Baseline in HCV RNA at Week 16Baseline; Week 16—
Change From Baseline in HCV RNA at Week 20Baseline; Week 20—
Change From Baseline in HCV RNA at Week 24Baseline; Week 24—
Percentage of Participants With Overall Virologic FailureUp to Posttreatment Week 24Virologic failure was 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.
Change From Baseline in HCV RNA at Week 1Baseline; Week 1—
Percentage of Participants With SVR at 24 Weeks After Discontinuation of Therapy (SVR24)Posttreatment Week 24SVR 24 was defined as HCV RNA \< LLOQ at 24 weeks after stopping study treatment.

Countries

Japan

Participant flow

Recruitment details

Participants were enrolled at study sites in Japan. The first participant was screened on 25 July 2016. The last study visit occurred on 25 August 2017.

Pre-assignment details

132 participants were screened.

Participants by arm

ArmCount
SOF/VEL+RBV 12 Weeks (GT1)
SOF/VEL (400/100 mg) FDC tablet orally once daily + RBV capsule (600, 800, or 1000 mg daily based on weight) for 12 weeks in participants with genotype 1 (GT1) HCV infection
47
SOF/VEL+RBV 12 Weeks (GT2)
SOF/VEL (400/100 mg) FDC tablet orally once daily + RBV capsule (600, 800, or 1000 mg daily based on weight) for 12 weeks in participants with genotype 2 (GT2) HCV infection
10
SOF/VEL+RBV 24 Weeks (GT1)
SOF/VEL (400/100 mg) FDC tablet orally once daily + RBV capsule (600, 800, or 1000 mg daily based on weight) for 24 weeks in participants with genotype 1 (GT1) HCV infection
48
SOF/VEL+RBV 24 Weeks (GT2)
SOF/VEL (400/100 mg) FDC tablet orally once daily + RBV capsule (600, 800, or 1000 mg daily based on weight) for 24 weeks in participants with genotype 2 (GT2) HCV infection
12
Total117

Withdrawals & dropouts

PeriodReasonFG000FG001
Overall StudyWithdrew Consent10

Baseline characteristics

CharacteristicTotalSOF/VEL+RBV 12 Weeks (GT1)SOF/VEL+RBV 12 Weeks (GT2)SOF/VEL+RBV 24 Weeks (GT1)SOF/VEL+RBV 24 Weeks (GT2)
Age, Continuous63 years
STANDARD_DEVIATION 10.3
63 years
STANDARD_DEVIATION 9.7
59 years
STANDARD_DEVIATION 15.7
64 years
STANDARD_DEVIATION 10.1
61 years
STANDARD_DEVIATION 7.2
HCV genotype
Genotype 1a
3 Participants2 Participants0 Participants1 Participants0 Participants
HCV genotype
Genotype 1b
92 Participants45 Participants0 Participants47 Participants0 Participants
HCV genotype
Genotype 2a/2c
7 Participants0 Participants3 Participants0 Participants4 Participants
HCV genotype
Genotype 2b
6 Participants0 Participants2 Participants0 Participants4 Participants
HCV genotype
Genotype 2 (No Confirmed Subtype)
9 Participants0 Participants5 Participants0 Participants4 Participants
HCV RNA Category
< 800,000 IU/mL
25 Participants10 Participants1 Participants10 Participants4 Participants
HCV RNA Category
≥ 800,000 IU/mL
92 Participants37 Participants9 Participants38 Participants8 Participants
HCV RNA (log10 IU/mL)6.2 log10 IU/mL
STANDARD_DEVIATION 0.54
6.2 log10 IU/mL
STANDARD_DEVIATION 0.47
6.6 log10 IU/mL
STANDARD_DEVIATION 0.46
6.2 log10 IU/mL
STANDARD_DEVIATION 0.51
6.2 log10 IU/mL
STANDARD_DEVIATION 0.86
IL28b Status
CC
50 Participants15 Participants8 Participants21 Participants6 Participants
IL28b Status
CT
55 Participants28 Participants1 Participants20 Participants6 Participants
IL28b Status
TT
12 Participants4 Participants1 Participants7 Participants0 Participants
Race/Ethnicity, Customized
Asian
117 Participants47 Participants10 Participants48 Participants12 Participants
Race/Ethnicity, Customized
Not Hispanic or Latino
117 Participants47 Participants10 Participants48 Participants12 Participants
Sex: Female, Male
Female
67 Participants29 Participants5 Participants28 Participants5 Participants
Sex: Female, Male
Male
50 Participants18 Participants5 Participants20 Participants7 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 570 / 60
other
Total, other adverse events
43 / 5738 / 60
serious
Total, serious adverse events
0 / 574 / 60

Outcome results

Primary

Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event

Time frame: Up to 24 weeks

Population: Safety Analysis Set

ArmMeasureValue (NUMBER)
SOF/VEL+RBV 12 Weeks (GT1)Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event1.8 percentage of participants
SOF/VEL+RBV 12 Weeks (GT2)Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event3.3 percentage of participants
Primary

Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12)

SVR12 was 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: participants who were randomized and received at least 1 dose of study drug.

ArmMeasureValue (NUMBER)
SOF/VEL+RBV 12 Weeks (GT1)Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12)85.1 percentage of participants
SOF/VEL+RBV 12 Weeks (GT2)Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12)70.0 percentage of participants
SOF/VEL+RBV 24 Weeks (GT1)Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12)97.9 percentage of participants
SOF/VEL+RBV 24 Weeks (GT2)Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12)91.7 percentage of participants
p-value: <0.001Binomial test
p-value: <0.001Binomial test
Secondary

Change From Baseline in HCV RNA at Week 1

Time frame: Baseline; Week 1

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

ArmMeasureValue (MEAN)Dispersion
SOF/VEL+RBV 12 Weeks (GT1)Change From Baseline in HCV RNA at Week 1-4.40 log10 IU/mLStandard Deviation 0.64
SOF/VEL+RBV 12 Weeks (GT2)Change From Baseline in HCV RNA at Week 1-4.36 log10 IU/mLStandard Deviation 0.698
Secondary

Change From Baseline in HCV RNA at Week 10

Time frame: Baseline; Week 10

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

ArmMeasureValue (MEAN)Dispersion
SOF/VEL+RBV 12 Weeks (GT1)Change From Baseline in HCV RNA at Week 10-5.13 log10 IU/mLStandard Deviation 0.492
SOF/VEL+RBV 12 Weeks (GT2)Change From Baseline in HCV RNA at Week 10-5.06 log10 IU/mLStandard Deviation 0.589
Secondary

Change From Baseline in HCV RNA at Week 12

Time frame: Baseline; Week 12

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

ArmMeasureValue (MEAN)Dispersion
SOF/VEL+RBV 12 Weeks (GT1)Change From Baseline in HCV RNA at Week 12-5.13 log10 IU/mLStandard Deviation 0.492
SOF/VEL+RBV 12 Weeks (GT2)Change From Baseline in HCV RNA at Week 12-5.06 log10 IU/mLStandard Deviation 0.589
Secondary

Change From Baseline in HCV RNA at Week 16

Time frame: Baseline; Week 16

Population: Participants in the Full Analysis Set from the SOF/VEL+RBV 24 Weeks Group with available data were analyzed.

ArmMeasureValue (MEAN)Dispersion
SOF/VEL+RBV 12 Weeks (GT1)Change From Baseline in HCV RNA at Week 16-5.06 log10 IU/mLStandard Deviation 0.594
Secondary

Change From Baseline in HCV RNA at Week 2

Time frame: Baseline; Week 2

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

ArmMeasureValue (MEAN)Dispersion
SOF/VEL+RBV 12 Weeks (GT1)Change From Baseline in HCV RNA at Week 2-4.91 log10 IU/mLStandard Deviation 0.51
SOF/VEL+RBV 12 Weeks (GT2)Change From Baseline in HCV RNA at Week 2-4.89 log10 IU/mLStandard Deviation 0.603
Secondary

Change From Baseline in HCV RNA at Week 20

Time frame: Baseline; Week 20

Population: Participants in the Full Analysis Set from the SOF/VEL+RBV 24 Weeks Group with available data were analyzed.

ArmMeasureValue (MEAN)Dispersion
SOF/VEL+RBV 12 Weeks (GT1)Change From Baseline in HCV RNA at Week 20-5.06 log10 IU/mLStandard Deviation 0.594
Secondary

Change From Baseline in HCV RNA at Week 24

Time frame: Baseline; Week 24

Population: Participants in the Full Analysis Set from the SOF/VEL+RBV 24 Weeks Group with available data were analyzed.

ArmMeasureValue (MEAN)Dispersion
SOF/VEL+RBV 12 Weeks (GT1)Change From Baseline in HCV RNA at Week 24-5.06 log10 IU/mLStandard Deviation 0.594
Secondary

Change From Baseline in HCV RNA at Week 3

Time frame: Baseline; Week 3

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

ArmMeasureValue (MEAN)Dispersion
SOF/VEL+RBV 12 Weeks (GT1)Change From Baseline in HCV RNA at Week 3-5.07 log10 IU/mLStandard Deviation 0.506
SOF/VEL+RBV 12 Weeks (GT2)Change From Baseline in HCV RNA at Week 3-5.02 log10 IU/mLStandard Deviation 0.575
Secondary

Change From Baseline in HCV RNA at Week 4

Time frame: Baseline; Week 4

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

ArmMeasureValue (MEAN)Dispersion
SOF/VEL+RBV 12 Weeks (GT1)Change From Baseline in HCV RNA at Week 4-5.12 log10 IU/mLStandard Deviation 0.486
SOF/VEL+RBV 12 Weeks (GT2)Change From Baseline in HCV RNA at Week 4-5.04 log10 IU/mLStandard Deviation 0.58
Secondary

Change From Baseline in HCV RNA at Week 5

Time frame: Baseline; Week 5

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

ArmMeasureValue (MEAN)Dispersion
SOF/VEL+RBV 12 Weeks (GT1)Change From Baseline in HCV RNA at Week 5-5.13 log10 IU/mLStandard Deviation 0.487
SOF/VEL+RBV 12 Weeks (GT2)Change From Baseline in HCV RNA at Week 5-5.05 log10 IU/mLStandard Deviation 0.579
Secondary

Change From Baseline in HCV RNA at Week 6

Time frame: Baseline; Week 6

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

ArmMeasureValue (MEAN)Dispersion
SOF/VEL+RBV 12 Weeks (GT1)Change From Baseline in HCV RNA at Week 6-5.13 log10 IU/mLStandard Deviation 0.492
SOF/VEL+RBV 12 Weeks (GT2)Change From Baseline in HCV RNA at Week 6-5.05 log10 IU/mLStandard Deviation 0.579
Secondary

Change From Baseline in HCV RNA at Week 8

Time frame: Baseline; Week 8

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

ArmMeasureValue (MEAN)Dispersion
SOF/VEL+RBV 12 Weeks (GT1)Change From Baseline in HCV RNA at Week 8-5.13 log10 IU/mLStandard Deviation 0.492
SOF/VEL+RBV 12 Weeks (GT2)Change From Baseline in HCV RNA at Week 8-5.06 log10 IU/mLStandard Deviation 0.584
Secondary

Percentage of Participants With HCV RNA < LLOQ at Week 1

Time frame: Week 1

Population: Full Analysis Set

ArmMeasureValue (NUMBER)
SOF/VEL+RBV 12 Weeks (GT1)Percentage of Participants With HCV RNA < LLOQ at Week 121.1 percentage of participants
SOF/VEL+RBV 12 Weeks (GT2)Percentage of Participants With HCV RNA < LLOQ at Week 125.0 percentage of participants
Secondary

Percentage of Participants With HCV RNA < LLOQ at Week 10

Time frame: Week 10

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

ArmMeasureValue (NUMBER)
SOF/VEL+RBV 12 Weeks (GT1)Percentage of Participants With HCV RNA < LLOQ at Week 10100.0 percentage of participants
SOF/VEL+RBV 12 Weeks (GT2)Percentage of Participants With HCV RNA < LLOQ at Week 10100.0 percentage of participants
Secondary

Percentage of Participants With HCV RNA < LLOQ at Week 12

Time frame: Week 12

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

ArmMeasureValue (NUMBER)
SOF/VEL+RBV 12 Weeks (GT1)Percentage of Participants With HCV RNA < LLOQ at Week 12100.0 percentage of participants
SOF/VEL+RBV 12 Weeks (GT2)Percentage of Participants With HCV RNA < LLOQ at Week 12100.0 percentage of participants
Secondary

Percentage of Participants With HCV RNA < LLOQ at Week 16

Time frame: Week 16

Population: Participants in the Full Analysis Set from the SOF/VEL+RBV 24 Weeks Group with available data were analyzed.

ArmMeasureValue (NUMBER)
SOF/VEL+RBV 12 Weeks (GT1)Percentage of Participants With HCV RNA < LLOQ at Week 16100.0 percentage of participants
Secondary

Percentage of Participants With HCV RNA < LLOQ at Week 2

Time frame: Week 2

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

ArmMeasureValue (NUMBER)
SOF/VEL+RBV 12 Weeks (GT1)Percentage of Participants With HCV RNA < LLOQ at Week 264.3 percentage of participants
SOF/VEL+RBV 12 Weeks (GT2)Percentage of Participants With HCV RNA < LLOQ at Week 270.0 percentage of participants
Secondary

Percentage of Participants With HCV RNA < LLOQ at Week 20

Time frame: Week 20

Population: Participants in the Full Analysis Set from the SOF/VEL+RBV 24 Weeks Group with available data were analyzed.

ArmMeasureValue (NUMBER)
SOF/VEL+RBV 12 Weeks (GT1)Percentage of Participants With HCV RNA < LLOQ at Week 20100.0 percentage of participants
Secondary

Percentage of Participants With HCV RNA < LLOQ at Week 24

Time frame: Week 24

Population: Participants in the Full Analysis Set from the SOF/VEL+RBV 24 Weeks Group with available data were analyzed.

ArmMeasureValue (NUMBER)
SOF/VEL+RBV 12 Weeks (GT1)Percentage of Participants With HCV RNA < LLOQ at Week 24100.0 percentage of participants
Secondary

Percentage of Participants With HCV RNA < LLOQ at Week 3

Time frame: Week 3

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

ArmMeasureValue (NUMBER)
SOF/VEL+RBV 12 Weeks (GT1)Percentage of Participants With HCV RNA < LLOQ at Week 391.1 percentage of participants
SOF/VEL+RBV 12 Weeks (GT2)Percentage of Participants With HCV RNA < LLOQ at Week 390.0 percentage of participants
Secondary

Percentage of Participants With HCV RNA < LLOQ at Week 4

Time frame: Week 4

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

ArmMeasureValue (NUMBER)
SOF/VEL+RBV 12 Weeks (GT1)Percentage of Participants With HCV RNA < LLOQ at Week 498.2 percentage of participants
SOF/VEL+RBV 12 Weeks (GT2)Percentage of Participants With HCV RNA < LLOQ at Week 498.3 percentage of participants
Secondary

Percentage of Participants With HCV RNA < LLOQ at Week 5

Time frame: Week 5

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

ArmMeasureValue (NUMBER)
SOF/VEL+RBV 12 Weeks (GT1)Percentage of Participants With HCV RNA < LLOQ at Week 598.2 percentage of participants
SOF/VEL+RBV 12 Weeks (GT2)Percentage of Participants With HCV RNA < LLOQ at Week 598.3 percentage of participants
Secondary

Percentage of Participants With HCV RNA < LLOQ at Week 6

Time frame: Week 6

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

ArmMeasureValue (NUMBER)
SOF/VEL+RBV 12 Weeks (GT1)Percentage of Participants With HCV RNA < LLOQ at Week 6100.0 percentage of participants
SOF/VEL+RBV 12 Weeks (GT2)Percentage of Participants With HCV RNA < LLOQ at Week 698.3 percentage of participants
Secondary

Percentage of Participants With HCV RNA < LLOQ at Week 8

Time frame: Week 8

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

ArmMeasureValue (NUMBER)
SOF/VEL+RBV 12 Weeks (GT1)Percentage of Participants With HCV RNA < LLOQ at Week 8100.0 percentage of participants
SOF/VEL+RBV 12 Weeks (GT2)Percentage of Participants With HCV RNA < LLOQ at Week 8100.0 percentage of participants
Secondary

Percentage of Participants With Overall Virologic Failure

Virologic failure was 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+RBV 12 Weeks (GT1)Percentage of Participants With Overall Virologic Failure15.8 percentage of participants
SOF/VEL+RBV 12 Weeks (GT2)Percentage of Participants With Overall Virologic Failure3.3 percentage of participants
Secondary

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

SVR 24 was defined as HCV RNA \< LLOQ at 24 weeks after stopping study treatment.

Time frame: Posttreatment Week 24

Population: Full Analysis Set

ArmMeasureValue (NUMBER)
SOF/VEL+RBV 12 Weeks (GT1)Percentage of Participants With SVR at 24 Weeks After Discontinuation of Therapy (SVR24)82.5 percentage of participants
SOF/VEL+RBV 12 Weeks (GT2)Percentage of Participants With SVR at 24 Weeks After Discontinuation of Therapy (SVR24)96.7 percentage of participants
Secondary

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

SVR4 was defined as HCV RNA \< LLOQ at 4 weeks after stopping study treatment.

Time frame: Posttreatment Week 4

Population: Full Analysis Set

ArmMeasureValue (NUMBER)
SOF/VEL+RBV 12 Weeks (GT1)Percentage of Participants With SVR at 4 Weeks After Discontinuation of Therapy (SVR4)86.0 percentage of participants
SOF/VEL+RBV 12 Weeks (GT2)Percentage of Participants With SVR at 4 Weeks After Discontinuation of Therapy (SVR4)98.3 percentage of participants

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026