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Efficacy and Safety of Sofosbuvir/Velpatasvir Fixed-Dose Combination (FDC) and Sofosbuvir/Velpatasvir FDC and Ribavirin in Participants With Chronic Genotype 3 HCV Infection and Cirrhosis

A Phase 2, Multicenter, Randomized, Open-Label Study to Evaluate the Efficacy and Safety of Sofosbuvir/Velpatasvir Fixed Dose Combination (FDC) and Sofosbuvir/Velpatasvir FDC and Ribavirin in Subjects With Chronic Genotype 3 HCV Infection and Cirrhosis

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02781558
Enrollment
204
Registered
2016-05-24
Start date
2016-07-29
Completion date
2017-10-27
Last updated
2018-11-27

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 objectives of this study are to evaluate the efficacy, safety, and tolerability of sofosbuvir/velpatasvir (SOF/VEL) fixed-dose combination (FDC) and SOF/VEL FDC and ribavirin (RBV) for 12 weeks in participants with chronic genotype 3 hepatitis C virus (HCV) infection and compensated cirrhosis.

Interventions

DRUGSOF/VEL

400/100 mg FDC tablet administered orally once daily

DRUGRBV

RBV tablets administered orally in a divided daily dose according to package insert weight-based dosing recommendations (\< 75 kg = 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: * Willing and able to provide written informed consent * Individuals with chronic genotype 3 HCV infection and compensated cirrhosis * Individuals with or without HIV-1 coinfection Key

Exclusion criteria

* History of clinically significant illness or any other medical disorder that may interfere with individual's treatment assessment or compliance with the protocol * Co-infection with active hepatitis B virus * Laboratory results outside the acceptable ranges at screening * Pregnant or nursing female * Chronic liver disease not caused by HCV Note: Other protocol defined Inclusion/

Design outcomes

Primary

MeasureTime frameDescription
Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Cessation 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 (Which Included SOF/VEL and RBV) Due to Any Adverse EventPosttreatment Week 12—

Secondary

MeasureTime frameDescription
Percentage of Participants Who Have HCV RNA < LLOQ at Week 4Week 4—
Percentage of Participants Who Have HCV RNA < LLOQ at Week 8Week 8—
Percentage of Participants Who Have HCV RNA < LLOQ at Week 12Week 12—
HCV RNA at Week 2Week 2—
HCV RNA at Week 4Week 4—
HCV RNA at Week 8Week 8—
Percentage of Participants Who Attain Sustained Virologic Response at 4 Weeks After Cessation of the Study Treatment Regimen (SVR4)Posttreatment Week 4SVR4 was defined as HCV RNA \< the lower limit of quantitation (LLOQ; ie, 15 IU/mL) 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 4Baseline; Week 4—
Change From Baseline in HCV RNA at Week 8Baseline; Week 8—
Change From Baseline in HCV RNA at Week 12Baseline; Week 12—
Percentage of Participants With Virologic FailureUp to Posttreatment Week 12Virologic failure was defined as * On-treatment virologic failure: * Breakthrough (confirmed HCV RNA ≥ LLOQ after having previously had HCV RNA \< LLOQ on 2 consecutive measurements 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: * HCV RNA ≥ LLOQ during the post-treatment period having achieved HCV RNA \< LLOQ at end of treatment, confirmed with 2 consecutive values or last available post-treatment measurement
HCV RNA at Week 12Week 12—
Percentage of Participants Who Have HCV RNA < LLOQ at Week 2Week 2—

Countries

Spain

Participant flow

Recruitment details

Participants were enrolled at study sites in Spain. The first participant was screened on 29 July 2016. The last study visit occurred on 27 October 2017.

Participants by arm

ArmCount
SOF/VEL
SOF/VEL 400/100 mg FDC tablet once daily for 12 weeks
101
SOF/VEL + RBV
SOF/VEL 400/100 mg FDC tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks
103
Total204

Withdrawals & dropouts

PeriodReasonFG000FG001
Overall StudyAdverse Event10
Overall StudyLost to Follow-up22

Baseline characteristics

CharacteristicSOF/VELSOF/VEL + RBVTotal
Age, Continuous51 years
STANDARD_DEVIATION 7.3
51 years
STANDARD_DEVIATION 7.6
51 years
STANDARD_DEVIATION 7.4
HCV RNA6.2 log10 IU/mL
STANDARD_DEVIATION 0.64
6.3 log10 IU/mL
STANDARD_DEVIATION 0.56
6.2 log10 IU/mL
STANDARD_DEVIATION 0.6
HCV RNA Category
< 800,000 IU/mL
32 Participants24 Participants56 Participants
HCV RNA Category
≥ 800,000 IU/mL
69 Participants79 Participants148 Participants
IL28B
CC
64 Participants53 Participants117 Participants
IL28B
Missing
1 Participants0 Participants1 Participants
IL28B
Non-CC
36 Participants50 Participants86 Participants
Race/Ethnicity, Customized
Asian
17 Participants8 Participants25 Participants
Race/Ethnicity, Customized
Hispanic or Latino
9 Participants10 Participants19 Participants
Race/Ethnicity, Customized
Not Hispanic or Latino
92 Participants93 Participants185 Participants
Race/Ethnicity, Customized
White
84 Participants95 Participants179 Participants
Sex: Female, Male
Female
26 Participants16 Participants42 Participants
Sex: Female, Male
Male
75 Participants87 Participants162 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 1010 / 103
other
Total, other adverse events
24 / 10155 / 103
serious
Total, serious adverse events
4 / 1012 / 103

Outcome results

Primary

Percentage of Participants Who Permanently Discontinued Any Study Drug (Which Included SOF/VEL and RBV) Due to Any Adverse Event

Time frame: Posttreatment Week 12

Population: Safety Analysis Set

ArmMeasureValue (NUMBER)
SOF/VELPercentage of Participants Who Permanently Discontinued Any Study Drug (Which Included SOF/VEL and RBV) Due to Any Adverse Event1.0 percentage of participants
SOF/VEL + RBVPercentage of Participants Who Permanently Discontinued Any Study Drug (Which Included SOF/VEL and RBV) Due to Any Adverse Event1.9 percentage of participants
Primary

Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Cessation 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: all randomized participants who took at least 1 dose of any study drug

ArmMeasureValue (NUMBER)
SOF/VELPercentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Cessation of Therapy (SVR12)91.1 percentage of participants
SOF/VEL + RBVPercentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Cessation of Therapy (SVR12)96.1 percentage of participants
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/VELChange From Baseline in HCV RNA at Week 12-5.04 log10 IU/mLStandard Deviation 0.64
SOF/VEL + RBVChange From Baseline in HCV RNA at Week 12-5.13 log10 IU/mLStandard Deviation 0.568
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/VELChange From Baseline in HCV RNA at Week 2-4.67 log10 IU/mLStandard Deviation 0.627
SOF/VEL + RBVChange From Baseline in HCV RNA at Week 2-4.80 log10 IU/mLStandard Deviation 0.58
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/VELChange From Baseline in HCV RNA at Week 4-4.96 log10 IU/mLStandard Deviation 0.641
SOF/VEL + RBVChange From Baseline in HCV RNA at Week 4-5.09 log10 IU/mLStandard Deviation 0.559
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/VELChange From Baseline in HCV RNA at Week 8-5.04 log10 IU/mLStandard Deviation 0.638
SOF/VEL + RBVChange From Baseline in HCV RNA at Week 8-5.13 log10 IU/mLStandard Deviation 0.565
Secondary

HCV RNA at Week 12

Time frame: Week 12

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

ArmMeasureValue (MEAN)Dispersion
SOF/VELHCV RNA at Week 121.15 log10 IU/mLStandard Deviation 0.018
SOF/VEL + RBVHCV RNA at Week 121.15 log10 IU/mLStandard Deviation 0
Secondary

HCV RNA at Week 2

Time frame: Week 2

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

ArmMeasureValue (MEAN)Dispersion
SOF/VELHCV RNA at Week 21.52 log10 IU/mLStandard Deviation 0.513
SOF/VEL + RBVHCV RNA at Week 21.47 log10 IU/mLStandard Deviation 0.413
Secondary

HCV RNA at Week 4

Time frame: Week 4

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

ArmMeasureValue (MEAN)Dispersion
SOF/VELHCV RNA at Week 41.22 log10 IU/mLStandard Deviation 0.257
SOF/VEL + RBVHCV RNA at Week 41.19 log10 IU/mLStandard Deviation 0.152
Secondary

HCV RNA at Week 8

Time frame: Week 8

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

ArmMeasureValue (MEAN)Dispersion
SOF/VELHCV RNA at Week 81.15 log10 IU/mLStandard Deviation 0.04
SOF/VEL + RBVHCV RNA at Week 81.15 log10 IU/mLStandard Deviation 0
Secondary

Percentage of Participants Who Attain Sustained Virologic Response at 4 Weeks After Cessation of the Study Treatment Regimen (SVR4)

SVR4 was defined as HCV RNA \< the lower limit of quantitation (LLOQ; ie, 15 IU/mL) at 4 weeks after stopping study treatment.

Time frame: Posttreatment Week 4

Population: Full Analysis Set

ArmMeasureValue (NUMBER)
SOF/VELPercentage of Participants Who Attain Sustained Virologic Response at 4 Weeks After Cessation of the Study Treatment Regimen (SVR4)93.1 percentage of participants
SOF/VEL + RBVPercentage of Participants Who Attain Sustained Virologic Response at 4 Weeks After Cessation of the Study Treatment Regimen (SVR4)97.1 percentage of participants
Secondary

Percentage of Participants Who Have 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/VELPercentage of Participants Who Have HCV RNA < LLOQ at Week 1299.0 percentage of participants
SOF/VEL + RBVPercentage of Participants Who Have HCV RNA < LLOQ at Week 12100.0 percentage of participants
Secondary

Percentage of Participants Who Have 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/VELPercentage of Participants Who Have HCV RNA < LLOQ at Week 251.0 percentage of participants
SOF/VEL + RBVPercentage of Participants Who Have HCV RNA < LLOQ at Week 244.7 percentage of participants
Secondary

Percentage of Participants Who Have 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/VELPercentage of Participants Who Have HCV RNA < LLOQ at Week 485.0 percentage of participants
SOF/VEL + RBVPercentage of Participants Who Have HCV RNA < LLOQ at Week 490.3 percentage of participants
Secondary

Percentage of Participants Who Have 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/VELPercentage of Participants Who Have HCV RNA < LLOQ at Week 899.0 percentage of participants
SOF/VEL + RBVPercentage of Participants Who Have HCV RNA < LLOQ at Week 8100.0 percentage of participants
Secondary

Percentage of Participants With Virologic Failure

Virologic failure was defined as * On-treatment virologic failure: * Breakthrough (confirmed HCV RNA ≥ LLOQ after having previously had HCV RNA \< LLOQ on 2 consecutive measurements 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: * HCV RNA ≥ LLOQ during the post-treatment period having achieved HCV RNA \< LLOQ at end of treatment, confirmed with 2 consecutive values or last available post-treatment measurement

Time frame: Up to Posttreatment Week 12

Population: Full Analysis Set

ArmMeasureValue (NUMBER)
SOF/VELPercentage of Participants With Virologic Failure5.9 percentage of participants
SOF/VEL + RBVPercentage of Participants With Virologic Failure1.9 percentage of participants

Source: ClinicalTrials.gov · Data processed: Mar 6, 2026