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Efficacy And Safety Of Sofosbuvir/Velpatasvir Fixed Dose Combination With Ribavirin in Chronic HCV Infected Adults Who Participated in a Prior Gilead Sponsored HCV Treatment Study

An Open Label Study to Evaluate The Efficacy And Safety Of Sofosbuvir/GS-5816 Fixed Dose Combination With Ribavirin For 24 Weeks In Chronic HCV Infected Subjects Who Participated In A Prior Gilead Sponsored HCV Treatment Study

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02300103
Enrollment
69
Registered
2014-11-24
Start date
2014-12-01
Completion date
2016-09-15
Last updated
2018-11-16

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 treatment with sofosbuvir/velpatasvir (Epclusa®; SOF/VEL) with ribavirin (RBV) for 24 weeks in adults with chronic hepatitis C virus (HCV) infection who participated in a prior Gilead sponsored study and did not achieve sustained virologic response (SVR).

Interventions

DRUGRBV

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

DRUGSOF/VEL

400/100 mg FDC tablet administered orally once daily

Sponsors

Gilead Sciences
Lead SponsorINDUSTRY

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
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 * HCV genotype determined by the Central Laboratory * HCV RNA \> LLOQ at screening * Participated and completed a Gilead sponsored HCV treatment study of direct acting antiviral (DAA) containing regimens. * Male and female of childbearing potential must agree to use protocol specified method(s) of contraception Key

Exclusion criteria

* Current or prior history: Clinically-significant illness (other than HCV) or any other major medical disorder that may interfere with treatment, assessment or compliance with the protocol; individuals currently under evaluation for a potentially clinically-significant illness (other than HCV) are also excluded. * Screening ECG with clinically significant abnormalities * Laboratory results outside of acceptable ranges at screening * Infection with hepatitis B virus (HBV) or human immunodeficiency virus (HIV) NOTE: Other protocol defined Inclusion/

Design outcomes

Primary

MeasureTime frameDescription
Percentage of Participants With Sustained Virologic Response 12 Weeks After Discontinuation of Therapy (SVR12)Posttreatment Week 12SVR12 is defined as HCV RNA \< the lower limit of quantitation (LLOQ) 12 weeks following the last dose of study drug.
Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse EventUp to 24 weeks—

Secondary

MeasureTime frameDescription
Percentage of Participants With Sustained Virologic Response 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)Posttreatment Weeks 4 and 24SVR4 and SVR24 are defined as HCV RNA \< LLOQ at 4 and 24 weeks following the last dose of study drug.
Percentage of Participants With HCV RNA < LLOQ On-treatmentBaseline to Week 24—
HCV RNA Change From BaselineBaseline to Week 24—
Percentage of Participants With 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

Countries

Australia, New Zealand, Puerto Rico, United States

Participant flow

Recruitment details

Participants were enrolled at 31 study sites in North America and Asia Pacific. The first participant was screened on 01 December 2014. The last study visit occurred on 15 September 2016.

Pre-assignment details

74 participants were screened.

Participants by arm

ArmCount
SOF/VEL+RBV
SOF/VEL (400/100mg) FDC tablet once daily + RBV tablets (1000 mg or 1200 mg) for 24 weeks
69
Total69

Withdrawals & dropouts

PeriodReasonFG000
Overall StudyLack of Efficacy3
Overall StudyProtocol Violation1
Overall StudyWithdrew Consent2

Baseline characteristics

CharacteristicSOF/VEL+RBV
Age, Continuous57 years
STANDARD_DEVIATION 7.7
HCV RNA6.4 log10 IU/mL
STANDARD_DEVIATION 0.67
HCV RNA Category
< 800,000 IU/mL
15 Participants
HCV RNA Category
≥ 800,000 IU/mL
54 Participants
IL28b Status
CC
23 Participants
IL28b Status
CT
32 Participants
IL28b Status
TT
14 Participants
Race/Ethnicity, Customized
Asian
2 Participants
Race/Ethnicity, Customized
Black or African American
3 Participants
Race/Ethnicity, Customized
Hispanic or Latino
5 Participants
Race/Ethnicity, Customized
Native Hawaiian or Pacific Islander
3 Participants
Race/Ethnicity, Customized
Not Hispanic or Latino
64 Participants
Race/Ethnicity, Customized
White
61 Participants
Region of Enrollment
Australia
5 Participants
Region of Enrollment
New Zealand
29 Participants
Region of Enrollment
United States
35 Participants
Sex: Female, Male
Female
16 Participants
Sex: Female, Male
Male
53 Participants

Adverse events

Event typeEG000
affected / at risk
deaths
Total, all-cause mortality
0 / 69
other
Total, other adverse events
55 / 69
serious
Total, serious adverse events
1 / 69

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+RBVPercentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event5.8 percentage of participants
Primary

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

SVR12 is defined as HCV RNA \< the lower limit of quantitation (LLOQ) 12 weeks following the last dose of study drug.

Time frame: Posttreatment Week 12

Population: Full Analysis Set: all enrolled participants who received at least one dose of study drug.

ArmMeasureValue (NUMBER)
SOF/VEL+RBVPercentage of Participants With Sustained Virologic Response 12 Weeks After Discontinuation of Therapy (SVR12)91.3 percentage of participants
Secondary

HCV RNA Change From Baseline

Time frame: Baseline to Week 24

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

ArmMeasureGroupValue (MEAN)Dispersion
SOF/VEL+RBVHCV RNA Change From BaselineWeek 12-5.23 log10 IU/mLStandard Deviation 0.679
SOF/VEL+RBVHCV RNA Change From BaselineWeek 16-5.23 log10 IU/mLStandard Deviation 0.679
SOF/VEL+RBVHCV RNA Change From BaselineWeek 8-5.23 log10 IU/mLStandard Deviation 0.675
SOF/VEL+RBVHCV RNA Change From BaselineWeek 20-5.23 log10 IU/mLStandard Deviation 0.679
SOF/VEL+RBVHCV RNA Change From BaselineWeek 24-5.23 log10 IU/mLStandard Deviation 0.679
SOF/VEL+RBVHCV RNA Change From BaselineWeek 1-4.45 log10 IU/mLStandard Deviation 0.615
SOF/VEL+RBVHCV RNA Change From BaselineWeek 2-5.04 log10 IU/mLStandard Deviation 0.685
SOF/VEL+RBVHCV RNA Change From BaselineWeek 4-5.18 log10 IU/mLStandard Deviation 0.719
SOF/VEL+RBVHCV RNA Change From BaselineWeek 6-5.23 log10 IU/mLStandard Deviation 0.669
Secondary

Percentage of Participants With HCV RNA < LLOQ On-treatment

Time frame: Baseline to Week 24

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

ArmMeasureGroupValue (NUMBER)
SOF/VEL+RBVPercentage of Participants With HCV RNA < LLOQ On-treatmentWeek 115.9 percentage of participants
SOF/VEL+RBVPercentage of Participants With HCV RNA < LLOQ On-treatmentWeek 260.9 percentage of participants
SOF/VEL+RBVPercentage of Participants With HCV RNA < LLOQ On-treatmentWeek 491.3 percentage of participants
SOF/VEL+RBVPercentage of Participants With HCV RNA < LLOQ On-treatmentWeek 698.5 percentage of participants
SOF/VEL+RBVPercentage of Participants With HCV RNA < LLOQ On-treatmentWeek 897.1 percentage of participants
SOF/VEL+RBVPercentage of Participants With HCV RNA < LLOQ On-treatmentWeek 1298.5 percentage of participants
SOF/VEL+RBVPercentage of Participants With HCV RNA < LLOQ On-treatmentWeek 16100.0 percentage of participants
SOF/VEL+RBVPercentage of Participants With HCV RNA < LLOQ On-treatmentWeek 20100.0 percentage of participants
SOF/VEL+RBVPercentage of Participants With HCV RNA < LLOQ On-treatmentWeek 24100.0 percentage of participants
Secondary

Percentage of Participants With Sustained Virologic Response 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)

SVR4 and SVR24 are defined as HCV RNA \< LLOQ at 4 and 24 weeks following the last dose of study drug.

Time frame: Posttreatment Weeks 4 and 24

Population: Full Analysis Set

ArmMeasureGroupValue (NUMBER)
SOF/VEL+RBVPercentage of Participants With Sustained Virologic Response 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)SVR492.8 percentage of participants
SOF/VEL+RBVPercentage of Participants With Sustained Virologic Response 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)SVR2489.9 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 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+RBVPercentage of Participants With Virologic Failure7.2 percentage of participants

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